UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

 

FORM 8-K/A

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): April 27, 2021

 

 

 

PALISADE BIO, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

 

Delaware

(State or Other Jurisdiction
of Incorporation)

 

001-33672

(Commission File Number)

 

 

52-2007292

(IRS Employer Identification No.)

 

 

5800 Armada Drive, Suite 210

Carlsbad, California

(Address of Principal Executive Offices)

 

 

92008

(Zip Code)

 

 

Registrant’s telephone number, including area code: (858) 704-4900

 

N/A

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.01 per share PALI Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

 

Explanatory Note

 

As previously reported, on April 27, 2021, Palisade Bio completed its business combination with Leading Biosciences, Inc. (“Leading Sub”), in accordance with the terms of the Agreement and Plan of Merger, dated December 16, 2020 (the “Merger Agreement”), by and among the Palisade Bio, Townsgate Acquisition Sub 1, Inc. (“Merger Sub”) and Leading Sub, pursuant to which Merger Sub merged with and into Leading Sub, with Leading Sub surviving as a wholly owned subsidiary of the Company (the “Merger”). This Amendment No. 1 on Form 8-K/A is being filed by Palisade Bio to amend the Current Report on Form 8-K filed on April 27, 2021 (the “Original Report”), solely to provide the disclosures required by Item 9.01 of Form 8-K that were not previously filed with the Original Report.

 

Item 9.01 Financial Statements and Exhibits

 

(a) Financial Statements of Business Acquired

 

The financial statements required by Item 9.01(a) and the notes related thereto are filed as Exhibit 99.1 to this report.

 

(b) Pro Forma Financial Information

 

The pro forma financial information required by Item 9.01(b) and the notes related thereto are filed as Exhibit 99.2 to this report.

 

(d) Exhibits

 

Exhibit
No.

 

Description

   
23.1   Consent of Registered Independent Public Accounting Firm
     
99.1   Condensed financial statements of Leading Biosciences, Inc., as of March 31, 2021 (unaudited) and December 31, 2020, and for the three months ended March 31, 2021 and 2020 (unaudited).
     
   

Audited financial statements of Leading BioSciences, Inc. as of December 31, 2020 and 2019.

   
99.2   Unaudited pro forma condensed combined balance sheet as of March 31, 2021, the unaudited pro forma condensed combined statement of operations and comprehensive loss for the three months ended March 31, 2021 and the unaudited pro forma condensed combined statement of operations and comprehensive loss for the year ended December 31, 2020.
     

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

       
  Palisade Bio, Inc.
     
  By:   /s/ Thomas M. Hallam
  Name:   Thomas M. Hallam
  Title:   Chief Executive Officer

 

Date: July 13, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 23.1 

Consent of Independent Registered Public Accounting Firm

 

Palisade Bio, Inc.

Carlsbad, California

 

We hereby consent to the incorporation by reference in the Registration Statements on Form S-3 (Nos. 333-218608, 333-219195 and 333-236543), Form S-4 (No. 333-251659), and Form S-8 (Nos. 333-172563, 333-194881, and 333-220813) of Palisade Bio, Inc. (formerly Seneca Biopharma, Inc.) of our report dated July 13, 2021, related to the financial statements of Leading Biosciences, Inc. (the “Company”), which appears in this Form 8-K/A. Our report contains an explanatory paragraph regarding the Company’s ability to continue as a going concern.

 

/s/ BDO USA, LLP

 

San Diego, California

July 13, 2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit 99.1

 

 

Leading Biosciences, INC.

 

Financial Statements

 

 

As of March 31, 2021 (unaudited) and December 31, 2020 and for the Three Months Ended March 31, 2021 and 2020 (unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

  1  

 

Table of Contents

 

Page

 

Condensed Balance Sheets as of March 31, 2021 (unaudited) and December 31, 2020   3
     
Condensed Statements of Operations for the three months ended March 31, 2021 and 2020 (unaudited)   4
     
Condensed Statements of Convertible Preferred Stock and Stockholders’ Deficit as of March 31, 2021 and 2020 (unaudited)   5
     
Condensed Statements of Cash Flows for the three months ended March 31, 2021 and 2020 (unaudited)   6
     
Notes to Condensed Financial Statements (unaudited)   7

 

 

 

 

 

 

 

 

 

 

  2  

 

Leading BioSciences, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

 

    March 31, 2021   December 31, 2020
    (Unaudited)    
ASSETS                
Current assets:                
Cash and cash equivalents   $ 615     $ 713  
Accounts receivable     -       59  
Prepaid expenses and other current assets     103       124  
Total current assets     718       896  
Restricted cash     26       26  
Deferred transaction costs     2,337       1,817  
Right-of-use asset     236       275  
Property and equipment, net     4       5  
Total assets   $ 3,321     $ 3,019  
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 3,863     $ 2,537  
Accrued liabilities     2,022       2,740  
Accrued compensation and benefits     1,582       1,590  
Current portion of lease liability     176       168  
Current portion of debt     2,036       578  
Current portion of related party debt, net     517       469  
Total current liabilities     10,196       8,082  
Warrant liability     3,620       1,830  
Non-current portion of debt           94  
Lease liability, net of current portion     65       112  
Total liabilities     13,881       10,118  
Commitments and contingencies (Note 11)                
Series C convertible preferred stock, $0.001 par value; 33,594,625 shares authorized as of March 31, 2021 (unaudited) and December 31, 2020; 11,674,131 shares issued and outstanding at March 31, 2021(unaudited) and December 31, 2020; liquidation preference of $10.4 million as of March 31, 2021 (unaudited) and December 31, 2020     9,503       9,503  
Stockholders’ deficit:                
Common stock, $0.001 par value; 250,000,000 shares authorized as of March 31, 2021 (unaudited) and December 31, 2020; 102,041,277 shares issued and outstanding at March 31, 2021 (unaudited) and December 31, 2020     102       102  
Additional paid-in capital     51,891       51,322  
Accumulated deficit     (72,056 )     (68,026 )
Total stockholders' deficit     (20,063 )     (16,602 )
Total liabilities, convertible preferred stock and stockholders' deficit   $ 3,321     $ 3,019  

 

The accompanying notes are an integral part of these condensed financial statements.

 

  3  

 

Leading BioSciences, Inc.

Condensed Statements of Operations

(in thousands, except share and per share amounts)

 

    Three Months Ended
    March 31,
    2021   2020
    (Unaudited)
Operating expenses:                
Research and development   $ 692     $ 1,251  
General and administrative     1,262       1,143  
Total operating expenses     1,954       2,394  
Loss from operations     (1,954 )     (2,394 )
Other income (expense):                
Gain on forgiveness of PPP loan     279        
Loss on issuance of secured debt     (686 )      
Change in fair value of warrant liability     42        
Interest expense     (1,711 )     (1 )
Other income           11  
Total other income (expense)     (2,076 )     10  
Net loss   $ (4,030 )   $ (2,384 )
Net loss per share attributable to common shareholders, basic and diluted   $ (0.04 )   $ (0.02 )
Weighted–average common shares used to compute basic and diluted net loss per share attributable to common shareholders     102,041,277       102,029,290  

 

The accompanying notes are an integral part of these condensed financial statements.

 

  4  

 

Leading BioSciences, Inc.
Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except share amounts)
(Unaudited)
               

 

    Series C                    
    Convertible                
    Preferred Stock   Common Stock   Additional       Total
                    Paid-in   Accumulated   Stockholders'
    Shares   Amount   Shares   Amount   Capital   Deficit   Deficit
Balance, December 31, 2020     11,674,131     $ 9,503       102,041,277     $ 102     $ 51,322     $ (68,026 )   $ (16,602 )
Stock-based compensation expense     -       -       -       -       569       -       569  
Net loss     -       -       -       -       -       (4,030 )     (4,030 )
Balance, March 31, 2021     11,674,131     $ 9,503       102,041,277     $ 102     $ 51,891     $ (72,056 )   $ (20,063 )

 

 

Leading  BioSciences, Inc.
Statements of Convertible Preferred Stock and Stockholders’ Deficit
(in thousands, except share amounts)
(Unaudited)
               

 

    Series C                    
    Convertible
Preferred Stock
  Common Stock   Additional       Total
                    Paid-in   Accumulated   Stockholders'
    Shares   Amount   Shares   Amount   Capital   Deficit   Deficit
Balance, December 31, 2019     11,674,131     $ 9,503       102,029,290     $ 102     $ 49,270     $ (57,704 )   $ (8,332 )
Stock-based compensation expense     -       -       -       -       487       -       487  
Net loss     -       -       -       -       -       (2,384 )     (2,384 )
Balance, March 31, 2020     11,674,131     $ 9,503       102,029,290     $ 102     $ 49,757     $ (60,088 )   $ (10,229 )

 

  5  

 

Leading BioSciences, Inc.

Condensed Statements of Cash Flows

(in thousands)

 

    Three Months Ended March 31,
    2021   2020
    (unaudited)
Net loss   $ (4,030 )   $ (2,384 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization     1       -  
Noncash lease expense     39       34  
Gain on forgiveness of PPP loan     (279 )     -  
Accretion of debt discount     1,590       -  
Loss on issuance of debt     686       -  
Change in fair value of warrant liability     (42 )     -  
Stock-based compensation     569       487  
Changes in operating assets and liabilities:                
Accounts receivable     59       -  
Prepaid and other assets     21       63  
Accounts payable and accrued liabilities     183      

513

 
Accrued compensation     (8 )    

-

Operating lease liabilities     (39 )     (33 )
Other long-term liabilities     -       1  
Net cash used in operating activities     (1,250 )     (1,319 )
Cash flows from financing activities:                
Payments on debt     (11 )     -  
Proceeds from issuance of debt and warrants     1,250       -  
Payment of debt issuance costs     (87 )     -  
Net cash provided by financing activities     1,152       -  
Net decrease in cash, cash equivalents and restricted cash     (98 )     (1,319 )
Cash, cash equivalents and restricted cash, beginning of period     739       3,623  
Cash, cash equivalents and restricted cash, ending of period   $ 641     $ 2,304  
Reconciliation of cash, cash equivalents and restricted cash to the balance sheets:                
Cash and cash equivalents     615       2,278  
Restricted cash     26       26  
Total cash, cash equivalents and restricted cash   $ 641     $ 2,304  
Supplemental disclosure of cash flows:                
Interest paid   $ 3     $

-

 
Supplemental disclosures of non-cash investing and financing activities:                
Deferred transaction costs in accounts payable and accrued liabilities   $ 2,337     $ -  
Deferred equity issuance costs included in accounts payable   $ 41     $ -  
Debt issuance costs included in accounts payable   $ 16     $ -  

 

The accompanying notes are an integral part of these condensed financial statements.

 

  6  

 

Leading BioSciences, Inc.

Notes to Financial Statements

(Unaudited)

 

1. Organization, Business and Basis of Presentation

 

Description of Business

 

Leading BioSciences, Inc. (“LBS” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies to improve the lives of patients affected by a broad range of diseases and conditions triggered by gastrointestinal dysregulation. The Company is applying its knowledge and its industry experience to develop oral small-molecule drugs to maintain the integrity of the gut epithelial barrier, microbiome, and gut immune cells to improve acute and chronic Gastrobiome™-mediated outcomes. The Company’s initial focus is combatting the interruption of GI function (ileus) following major surgery to reduce recovery times and shorten patients’ length of stay in the hospital. The Company’s programs have the potential to prevent the formation of post-operative adhesions, as well as to address the myriad health conditions and complications associated with chronic disruption of the intestinal mucosal barrier. The Company was incorporated in the state of Delaware on September 6, 2011, and is based in Carlsbad, California.

 

On April 27, 2021, LBS completed an asset acquisition with Seneca Biopharma Inc. (“Seneca”) in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of December 16, 2020, (the “Merger Agreement”) by and among Seneca, Townsgate Acquisition Sub 1, Inc., a wholly owned subsidiary of Seneca (“Merger Sub”), and LBS, pursuant to which Merger Sub merged with and into LBS, with LBS surviving as a wholly owned subsidiary of Seneca (the “Merger”). Concurrent with the closing of the Merger, LBS outstanding common stock, common stock warrants and options for the purchase of LBS common stock (“common stock equivalents”) were exchanged for Seneca common stock, Seneca common stock warrants and options for the purchase of Seneca common stock at a ratio of 0.2719 shares of LBS common stock equivalents to one share of Seneca common stock equivalents (“the Exchange Ratio”), including the effects of Seneca’s one-for-six reverse stock split (“Reverse Stock Split”). The accompanying financial statements and notes thereto do not reflect the Exchange Ratio or Reverse Stock Split.

 

Unaudited Interim Financial Information

 

The accompanying unaudited condensed financial statements as of March 31, 2021, and for the three months ended March 31, 2021 and 2020, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial reporting. Accordingly, these condensed financial statements do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, these unaudited interim condensed financial statements contain all adjustments necessary, all which are of a normal and recurring nature, to state fairly the Company’s financial position, results of operations and cash flows. Interim results are not necessarily indicative of results for a full year or future periods. These condensed financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and notes. The most significant estimates in the Company’s financial statements relate to clinical trial accruals and valuation of derivative liabilities and stock-based compensation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

 

  7  

 

Segment Information

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment which consists of research and development activities.

 

Liquidity and Going Concern

 

The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The Company has experienced losses and negative cash flows from operations since its inception. At March 31, 2021, the Company had an accumulated deficit of $72.1 million and cash and cash equivalents of $0.6 million. The Company expects to continue to incur losses into the foreseeable future. The successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

 

Historically, the Company has funded its operations primarily through a combination of debt and equity financings. Management’s plans continue to be focused on raising additional capital or other financings, such as potential partnering events of the Company’s existing technology. However, no assurance can be given at this time as to whether the Company will achieve these objectives. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will not be sufficient to fund the Company’s obligations for at least 12 months from the date of issuance of these financial statements. The Company’s ability to execute its operating plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these financial statements are issued. The financial statements do not include any adjustments for the recovery and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

The Company plans to continue to fund its operations through cash and cash equivalents on hand, as well as through future equity offerings, debt financings, other third-party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects.

 

COVID-19

 

On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID- 19 pandemic”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally.

 

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted. The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act also appropriated funds for the U.S. Small Business Administration Paycheck Protection Program loans that are forgivable in certain situations to promote continued employment, as well as Economic Injury Disaster Loans to provide liquidity to small businesses harmed by COVID-19.

 

In April 2020, as a result of impacts and risks associated with the current COVID-19 pandemic, the Company paused enrollment and program activities surrounding the Company’s clinical trials. The COVID-19 pandemic has not affected the production or supply of the Company’s patent-protected therapeutic candidate, LB1148. The COVID-19 pandemic may cause additional delays of the Company’s clinical trials or adversely impact the Company’s business. The Company cannot predict how legal and regulatory responses to concerns about COVID-19 or other major public health issues will impact the Company’s business, nor can it predict potential adverse impacts related to the availability of capital to fund the Company’s operations. Additionally, the Company’s workforce and outside consultants may also be affected, which could result in an adverse impact on the Company’s ability to conduct business. Any of these factors, alone or in combination with others, could harm the Company’s business, results of operations, financial condition or liquidity. However, the magnitude, timing, and duration of any such potential financial impacts cannot be reasonably estimated at this time.

 

  8  

 

2. Summary of Significant Accounting Policies

 

Cash and Cash Equivalents

 

Cash and cash equivalents represent cash available in readily available checking and money market accounts. The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.

 

Restricted Cash

 

At each March 31, 2021 and December 31, 2020, the Company held restricted cash of $26,000 in a separate restricted bank account as collateral for the Company’s corporate credit card program. The Company has classified these deposits as long-term restricted cash on its condensed balance sheets.

 

Deferred Transaction Costs

 

Deferred Transaction Costs consists of the direct and incremental costs incurred by the Company related to the acquisition of assets under the Merger Agreement (See Note 13 – Subsequent Events). These costs represent legal, accounting and other direct costs related to the Company’s efforts to complete a reverse merger. As of March 31, 2021 and December 31, 2020, deferred transaction costs were approximately $2.3 million and $1.8 million, respectively.

 

Concentration of Credit Risk

 

Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions and in money market accounts, and at times balances may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held nor has the Company experienced any losses in these accounts.

 

Property and Equipment, Net

 

Property and equipment, which consist of computers, are stated at cost less accumulated depreciation. Depreciation is recognized using the straight-line method over the estimated useful lives of the assets (approximately three years). Repair and maintenance costs that do not improve service potential or extend economic life are expensed as incurred.

 

Convertible Preferred Stock

 

The Company’s convertible preferred stock has been classified as temporary equity, instead of permanent equity within stockholders’ deficit, in the balance sheets, in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities as the stock conditionally redeemable upon certain change in control events outside of the Company’s control, including the liquidation, sale or transfer of control of the Company. Upon such change in control events the holders of the convertible preferred stock can cause its redemption.

 

The Company did not adjust the carrying values of the convertible preferred stock to its redemption value as of March 31, 2021 or December 31, 2020, since a liquidation event was not probable of occurrence. Subsequent adjustments to increase or decrease the carrying values to the ultimate liquidation values will be made only if, and when, it becomes probable such a liquidation event will occur.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments consist principally of cash equivalents, accounts receivable, restricted cash, accounts payable, accrued liabilities, debt and derivative liabilities. The carrying amounts of financial instruments such as cash equivalents, accounts receivable, restricted cash, accounts payable, and accrued liabilities approximate their related fair values due to the short-term nature of these instruments. The carrying value of the Company’s current and non-current debt approximates its fair value due to the market rate of interest. The Company’s derivative financial instruments are carried at fair value based on unobservable market inputs. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis.

 

Derivative Financial Instruments

 

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates its financial instruments, including warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. The Company values its derivatives using the Black-Scholes option-pricing model or other acceptable valuation models, including Monte-Carlo simulations. Derivative instruments accounted for as liabilities are valued at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities, is re-assessed at the end of each reporting period.

 

  9  

 

The Company reviews the terms of debt instruments, equity instruments and other financing arrangements to determine whether there are embedded derivative features, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument. Additionally, in connection with the issuance of financing instruments, the Company may issue freestanding options and warrants, including options or warrants to non-employees in exchange for consulting or other services performed.

 

The Company accounts for its common stock warrants in accordance with Accounting Standards Codification (“ASC”) ASC Topic 815, Derivatives and Hedging (“ASC 815”). Based upon the provisions of ASC 815, the Company accounts for common stock warrants as liabilities if the warrant requires net cash settlement or gives the holder the option of net cash settlement or it fails the equity classification criteria. The Company accounts for common stock warrants as equity if the contract requires physical settlement or net physical settlement or if the Company has the option of physical settlement or net physical settlement and the warrants meet the requirements to be classified as equity. Common stock warrants classified as liabilities are initially recorded at fair value and remeasured at fair value each balance sheet date with the offset adjustments recorded in change in fair value of warrant liability within the condensed statements of operations. Common stock warrants classified as equity are initially measured at fair value on the grant date and are not subsequently remeasured.

 

Research and Development Costs

 

Research and development expenses consist primarily of salaries and other personnel related expenses including stock-based compensation costs, preclinical costs, clinical trial costs, costs related to acquiring and manufacturing clinical trial materials and contract services. All research and development costs are expensed as incurred.

 

Clinical Trial Expenses

 

Expenses related to clinical studies are based on estimates of the services received and efforts expended pursuant to the Company’s contract arrangements. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s service providers will temporarily exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients, site initiation and the completion of clinical milestones. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense balance accordingly. Historically, the Company’s estimated accrued liabilities have materially approximated actual expense incurred. Clinical trial expenses are included in research and development expense.

 

Patent Costs

 

Costs related to filing and pursuing patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are included in general and administrative expenses.

 

Debt Issuance Costs

 

Debt issuance costs incurred to obtain debt financing are deferred and are amortized over the term of the debt using the effective interest method. Debt issuance costs are recorded as a reduction to the carrying value of the debt and are amortized to interest expense for in the condensed statements of operations.

 

Income Taxes

 

The Company follows the ASC 740, Income Taxes, or ASC Topic 740 (‘ASC 740’), in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some of or all the deferred tax assets will not be realized.

 

  10  

 

The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

 

Stock-Based Compensation

 

Stock-based compensation expense represents the cost of the grant date fair value of employee and non-employee stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company recognizes forfeitures as they occur as a reduction of expense. The Company estimates the fair value of employee and non-employee stock option grants using the Black-Scholes option pricing model.

 

Net Loss Per Share

 

Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. The Company’s Series C convertible preferred stock (the "Convertible Preferred Stock"), and the Senior Secured Promissory Note Warrants issued in the pre-merger financing contain non-forfeitable rights to dividends with the common stockholders, and therefore are considered to be participating securities. The Convertible Preferred Stock and the warrants do not have a contractual obligation to fund the losses of the Company; therefore, the application of the “two class method” is not required when the Company is in a net loss position.

 

Diluted loss per share is computed using the more dilutive of the two class method or the treasury stock and if-converted methods. Dilutive earnings per share under the two class method is calculated by dividing net income available to common stockholders as adjusted for the participating impacts of the participating securities, by the weighted-average number of shares outstanding plus the dilutive impact of all other potential dilutive common shares. Dilutive earnings per share under the treasury stock and if-converted methods is calculated by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the dilutive impact of all potential dilutive common shares. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

 

The following potential common shares were excluded from diluted net loss per share because the effects would have been anti-dilutive:

 

    Three months ended March 31,
    2021   2020
Employee stock options     29,977,910       29,152,879  
Warrants for common stock     10,663,149       3,671,775  
Series C convertible preferred stock     11,674,131       11,674,131  
Total     52,315,190       44,498,785  

 

Comprehensive Loss

 

Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive loss was the same as its reported net loss for all periods presented.

 

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Recently Adopted Accounting Pronouncements

  

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes (“ASU 2019-12"), as part of its initiative to reduce complexity in accounting standards. The amendments in ASU 2019-12 are effective for fiscal years beginning after December 15, 2020, including interim periods therein. Early adoption of the standard is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. As required by ASU 2019-12, we adopted this ASU effective January 1, 2021. The adoption of ASU No. 2019-12 did not have a material impact on the Company's financial position, results of operations or cash flows.

  

Recently Issued Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. After the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The Company is currently evaluating the potential impact that this standard may have on its financial statements and related disclosures.

 

In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40) — Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity’s own equity (1) permits settlement in unregistered shares, (2) whether counterparty rights rank higher stockholder’s rights, and (3) whether collateral is required. In addition, the ASU requires incremental disclosure related to contracts on the entity’s own equity and clarifies the treatment of certain financial instruments accounted for under this ASU on earnings per share. This ASU may be applied on a full retrospective of modified retrospective basis. For smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption of the ASU is permitted for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the potential impact that this standard may have on its financial statements and related disclosures.

 

3. Balance Sheet Details

 

Accrued liabilities consisted of the following (in thousands):  

 

    March 31,   December 31,
    2021   2020
         
Accrued accounts payable   $ 75     $ 1,018  
Accrued clinical trial costs     876       875  
Accrued director stipends     863       759  
Accrued other     208       88  
    $ 2,022     $ 2,740  

 

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4. Fair Value Measurements

 

The Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based on assumptions that market participants would use in pricing an asset or liability. The fair value hierarchy requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value

 

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

 

1) Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;  
2) Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
3) Level 3: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

  

The second tranche of Senior Secured Promissory Notes and the Senior Secured Promissory Note Warrants were issued on February 1, 2021. The initial fair value of the second tranche of the Senior Secured Promissory Note Warrant liability of $1.8 million was determined using a Monte Carlo simulation model that considered: (i) the starting stock price of $0.4816, (ii) certain key event dates such as expected capital financings, (iii) expected re-levered volatility of approximately 88 percent, (iv) risk-free interest rate of approximately one-half percent, (v) contractual terms of approximately 5.8 years and (vii) a zero percent dividend rate. The exercise price reset features embedded in the warrants were valued using a Monte Carlo based valuation model. The Monte Carlo valuation technique was utilized because it embodies all of the requisite assumptions (including the underlying price, exercise price, term, volatility, and risk-free interest-rate) that are necessary to fair value these instruments. Estimating fair values of derivative financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock. Because derivative financial instruments are initially and subsequently carried at fair values, the Company’s income will reflect the volatility in these estimate and assumption changes.

 

During 2020, the fair value of the Senior Secured Promissory Note warrant liability was determined using a Monte Carlo simulation model that considered: (i) the starting stock price of $0.4816, (ii) certain key event dates such as expected capital financings, (iii) expected re-levered volatility of approximately 87 percent, (iv) risk-free interest rate of approximately one-half percent, (v) contractual terms of approximately six years and (vi) a zero percent dividend rate. The exercise price reset features embedded in the warrants were valued using a Monte Carlo based valuation model. The Monte Carlo valuation technique was utilized because it embodies all of the requisite assumptions (including the underlying price, exercise price, term, volatility, and risk-free interest-rate) that are necessary to fair value these instruments. Estimating fair values of derivative financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock. Because derivative financial instruments are initially and subsequently carried at fair values, the Company’s income will reflect the volatility in these estimate and assumption changes. The fair value is subjective and is affected by changes in inputs to the valuation model including management’s assumptions regarding estimates of timing and the probability of each embedded conversion feature occurring. The initial fair value of the first tranche of Senior Secured Promissory Note Warrants was $1.9 million. Changes in these assumptions can materially affect the fair value.  Changes in fair value are recognized as a component of other income (expense) in the statement of operations.

  

As of March 31, 2021, the fair value of the Senior Secured Promissory Note Warrants was determined using a Monte Carlo simulation model that considered: (i) the starting stock price of $0.4816, (ii) certain key event dates such expected capital financings (iii) contractual interim reset periods of the warrant, and (iv) expected re-levered volatility of approximately 90 percent.

 

The following table summarizes the activity of the Company’s Level 3 warrant liability (in thousands):

 

    Warrant Liability
Opening value at January 1, 2020   $  
Initial fair value at the original issuance date     1,868  
Change in fair value during the period     (38 )
Ending value at December 31, 2020     1,830  
Initial fair value at the original issuance date     1,832  
Change in fair value during the period     (42 )
Ending value at March 31, 2021   $ 3,620  

 

As of March 31, 2021 and December 31, 2020, the Company did not hold any financial assets or Level 1 or Level 2 financial liabilities measured at fair value on a recurring basis. As of March 31, 2021 and December 31, 2020, Level 3 financial liabilities measured at fair value consisted solely of the Company’s warrant liability issued in conjunction with its Senior Secured Promissory Notes (Note 5 - Debt).  The fair value of the Senior Secured Promissory Note Warrant liability as of March 31, 2021 and December 31, 2020 was $3.6 million and $1.8 million, respectively.

 

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5. Debt

 

Financing Agreements

 

In June and October 2020, the Company entered into agreements to finance certain insurance policies (“the Financing agreements”). The Financing Agreements have a stated interest rate of 8.35%, are payable over ten months and are secured by the Company’s insurance policies. As of March 31, 2021 and December 31, 2020, the aggregate remaining balance due under the Financing Agreements was $11,000 and $22,000, respectively.

 

Unsecured Promissory Notes

 

December 2019 Note

 

On December 18, 2019, the Company issued an unsecured promissory note for a principal sum of $100,000 to a consultant as payment for consulting services performed in 2019 (“the December 2019 Note”). The December 2019 Note had a maturity date in December 2020. The outstanding principal under the December 2019 note accrues interest at the annual rate of five percent simple interest. All principal plus accrued interest on the note is due and payable the earlier of the date which the Company closes on five million or more in revenue or gross financing proceeds or the maturity date. On December 18, 2020 (“the Amendment Effective Date”), the Company and the consultant mutually agreed to amend the terms of the December 2019 Note to extend the maturity date from December 18, 2020 to March 19, 2021. No other terms of the December 2019 Note were modified. Under the terms of the amendment, the Company had to pay the accrued and unpaid interest of $5,000, through the Amendment Effective Date and will continue to accrue through the amended maturity date. On March 19, 2021, the maturity date was further extended to June 19, 2021. The Company determined that the present value in the change of cash flows was not greater than ten percent and therefore the amendment was account for as a modification.  

 

As of March 31, 2021 and December 31, 2020, the outstanding balance on the note, including accrued interest was $102,000 and $105,000, respectively, which is reported within the current portion of debt on the balance sheets.  Upon the occurrence of certain Events of Default, including but not limited to the Company’s failure to satisfy its payment obligations under the note or the breach of certain non-financial covenants under the note, the lender will have the right, among other remedies, to declare all unpaid balance immediately due and payable.   

 

July 2020 Note

 

On July 9, 2020, the Company issued an unsecured promissory note for a principal sum of $125,000 with an original issue discount of 20 percent (“the July 2020 Note”). There were no issuance costs related to this transaction. Interest accrues on the unpaid principal amount at a rate equal to ten percent per annum, compounded annually. Principal and any accrued but unpaid interest under this note shall be due and payable upon demand of the holder at any time following the earlier to occur of (a) the date on which the Company receives at least $1,250,000 in gross proceeds from the issuance of equity securities or securities convertible into or exercisable for equity securities or (b) the 120th day following the issuance date of the note. In connection with the July 2020 Note, the Company issued the noteholder a warrant to purchase 25,000 shares of common stock, $0.001 par value per share.  The warrants have an exercise price of $0.73 per share, are immediately exercisable and will expire ten years from the grant date. On November 6, 2020, the Company and the lender mutually agreed to extend the maturity date of the July 2020 Note for an additional 120 days, or through March 6, 2021. No other terms of the original agreement were amended. The Company paid all outstanding accrued interest, which approximated $4,000, in conjunction with amendment and interest will continue to accrue at the original stated interest rate. On March 6, 2021, the maturity date was further extended to June 6, 2021. The Company determined that the present value in the change of cash flows was not greater than 10 percent and therefore the amendment was accounted for as a modification. On May 25, 2021, Palisade Bio, LBS and the noteholder amended the July 2020 Note to extend the maturity date to November 15, 2021 (see Note 13 – Subsequent Events).

 

As of March 31, 2021 and December 31, 2020, the outstanding balance of the note, including accrued interest, was $125,000 and $126,000, respectively.   

 

October 2020 Note 

  

On October 16, 2020, the Company issued an unsecured promissory note to the Yuma Regional Medical Center for a principal sum of $500,000 with an original issue discount of 10 percent. Interest accrues on the unpaid principal amount at a rate equal to 10 percent per annum, compounded annually. The note is due and payable 180 days from the issuance date, or April 14, 2021. See Note 7 – Common Stock Warrants for details of the warrants issued with the October 2020 Note and Note 13 – Subsequent Events for details related to the October 2020 Note Amendment.  

 

As of March 31, 2021 and December 31, 2020, the outstanding balance of the note, including accrued interest, was $523,000 and $510,000, respectively.

 

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Senior Secured Promissory Notes

 

In connection with the transactions contemplated by the Merger, on December 16, 2020, (i) the Company entered into a securities purchase agreement with an institutional investor (the “Investor”) pursuant to which, among other things, the Company agreed to issue senior secured promissory notes in the aggregate principal amount of up to $5.0 million, in exchange for an aggregate purchase price of up to $3.75 million, representing an aggregate original issue discount of up to $1.25 million (the “Senior Secured Promissory Notes”) and warrants (“Senior Secured Promissory Note Warrants”) to purchase shares of the Company’s common stock, and (ii) Seneca and the Company entered into a separate securities purchase agreement with the Investor pursuant to which, among other things, the Investor agreed to invest $20.0 million in cash and cancel any outstanding principal and interest on the Senior Secured Promissory Notes immediately prior to the closing of the Merger in exchange for shares of Series 1 Preferred Stock of the Company to be issued immediately prior to the closing of the Merger and warrants to purchase shares of Seneca’s common stock to be issued after the closing of the Merger, in private placement transactions. The Senior Secured Promissory Notes had a first closing on December 17, 2020 and a second closing on February 1, 2021 resulting in the issuance of $1.7 million in aggregate principal of Senior Secured Promissory Notes and Senior Secured Promissory Note Warrants to acquire 3,460,687 shares of common stock, with an exercise price of $0.4816 per share, at each closing. The third closing was at a date to be determined by the Company between March 16, 2021 and the closing of the Merger. The Company did not elect to draw down the third tranche. At issuance, the fair value of the first tranche of the Senior Secured Promissory Note Warrants exceeded the debt proceeds, resulting in a $0.8 million loss on issuance of debt. At issuance, the fair value of the second tranche of the Senior Secured Promissory Note Warrants exceeded the debt proceeds, resulting in a $0.7 million loss on issuance of debt. The debt was recognized at a zero-dollar carrying value and is being accreted to the principal amount of the debt, on a straight-line basis, through a charge to interest expense in the statement of operations.

 

The following table summarizes the outstanding balances associated with the Company’s Senior Secured Promissory Notes for the periods presented (in thousands):

 

    Principal   Unamortized Debt Discount   Carrying Value   Accrued Interest
March 31, 2021   $ 3,334     $ (1,649 )   $ 1,685     $ 114  
December 31, 2020   $ 1,667     $ (1,537 )   $ 130     $ 10  

 

The Senior Secured Promissory Notes accrue interest at a rate of 15 percent based upon a 360-day year and is payable in arrears. See Note 13 – Subsequent Events, for additional information regarding the cancellation of the Senior Secured Promissory Notes immediately prior to the closing of the Company’s Merger (as defined in Note 13).

 

Paycheck Protection Program (“PPP”)

 

In April 2020, the Company applied for and received $279,000 from the PPP (the “PPP Loan”) as government aid for payroll, rent and utilities. There were no issuance costs related to this transaction. The PPP Loan accrues simple interest at a rate of one percent per annum and has an original maturity date of April 2022. Payments of principal and interest are deferred for the ten-month period following the loan forgiveness period, which is defined as the 8-week or 24-week period following the loan origination date, at which time the loan balance is payable in monthly installments unless the Company applies for, and receives, forgiveness in accordance with the CARES Act and the terms of the loan executed by the Company and its lender.

 

The application for these funds required the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to take into account its current business activity and its ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. The certification made by the Company did not contain any objective criteria and is subject to interpretation. Based in part on the Company’s assessment of other sources of liquidity, the uncertainty associated with future revenues created by the COVID-19 pandemic and related governmental responses, and the going concern uncertainty reflected in the Company’s financial statements, the Company believed in good faith that it met the eligibility requirements for the PPP Loan. If, despite the good-faith belief that given the Company’s circumstances all eligibility requirements for the PPP Loan were satisfied, it is later determined that the Company had violated any applicable laws or regulations or it is otherwise determined the Company was ineligible to receive the PPP Loan, it may be required to repay the PPP Loan in its entirety and/or be subject to additional penalties and potential liabilities.

 

On June 5, 2020, the Paycheck Protection Program Flexibility Act (the “PPP Flexibility Act”) was signed into law, extending the PPP Loan forgiveness period from 8 weeks to 24 weeks after loan origination, reducing the required amount of payroll expenditures from 75 percent to 60 percent, removing the prior ban on borrowers taking advantage of payroll tax deferral after loan forgiveness and allowing for the amendment of the maturity date on existing loans from two years to five years.

 

In January 2021, the Company received notification the PPP Loan was forgiven and recognized a gain a $279,000, in other income in the condensed statements of operations.

 

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6. Stockholders’ Deficit

 

Classes of Stock

 

As of March 31, 2021 and December 31, 2020, the Company was authorized to issue 250,000,000 shares of $0.001 par value Common Stock and 33,594,625 shares of $0.001 par value convertible preferred stock (the “Convertible Preferred Stock”). Of the authorized number of shares of Convertible Preferred Stock, 33,594,625 shares were designated to Series C Preferred Stock (“Series C”).

 

Series C Convertible Preferred Stock

 

On March 8, 2019, the Company entered into an agreement with a lead investor for the purchase and sale, of up to an aggregate of $30 million of Series C. The actual committed Series C investment resulted in two closings for total proceeds of $10.0 million. Issuance costs associated with financing were $215,000 which resulted in net proceeds of approximately $9.8 million. On March 8, 2019, the Company completed the initial closing, which was comprised of 8,398,656 shares of Series C at an offering price of $0.893 per share. Contemporaneous with the initial closing, the lead investor agreed to purchase 2,799,552 additional shares of Series C at an offering price of $0.893 at a future date (“Additional Tranche Right”). The lead investor exercised its right on August 15, 2019. The Company issued 1,500,000 warrants to purchase common stock at an exercise price of $1.12 per share in connection with the first closing and issued 500,000 warrants to purchase common stock at exercise price of $1.12 per share in connection with the second closing. The warrants were classified as equity and were measured using a Black-Scholes valuation model.

  

In addition to the Series C issued to the lead investor, the Company issued 475,923 shares of Series C to other investors for net proceeds of $425,000 during 2019. The Company issued 35,000 warrants to purchase common stock at an exercise price of $1.12 per share to these other investors. The warrants were classified as equity and were measured using a Black-Scholes valuation model.

 

Dividends

 

From and after the date of the issuance of any shares of Series C, dividends at the rate of eight percent per annum of the Original Issue Price (as defined below) shall accrue on such shares of Series C (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series C). The “Original Issue Price” shall mean $0.893 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series C. Accruing dividends shall accrue from day to day, whether or not declared, and shall not be cumulative; provided however, that such accruing dividends shall be payable only when, as, and if declared by the board of directors of the Corporation and the Corporation shall be under no obligation to pay such accruing dividends. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company (other than dividends on shares of Common Stock payable in shares of Common Stocks) unless the holders of the Series C then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series C.

 

Liquidation

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the Series C shareholders shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders in such deemed liquidation event or the available proceeds, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, an amount per share equal to one times (1x) the Original Issue Price, plus any dividends declared but unpaid thereon (the “Liquidation Preference”). If upon any such liquidation, dissolution or winding up of the Company or deemed liquidation event, the assets of the Corporation available for distribution to its stockholders shall be insufficient to pay the holders of shares of Series C the full Liquidation Preference, the holders of shares of Series C shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. The Series C is subject to redemption upon the occurrence of uncertain events, such as change in control, not solely within the Company’s control. Accordingly, the Series C is included within temporary equity on the balance sheet. The Company does not consider the change in control to be probable and accordingly the Company does not adjust the Series C Preferred Stock to redemption value. The liquidation preference of the Series C as of each March 31, 2021 and December 31, 2020 was $10.4 million.

 

Voting

 

On any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series C shall be entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Series C held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.

 

  16  

 

Conversion

 

Each share of Series C shall be convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of Common Stock as is determined by dividing the Original Issue Price by the Conversion Price (as defined below) in effect at the time of conversion. The “Conversion Price” of the Series C Preferred Stock shall initially be equal to $0.893.

 

Upon either (a) the closing of the sale of shares of Common Stock to the public at a price of at least one-and-a half times (1.5x) the Original Issue Price (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Common Stock), in a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $40.0 million of gross proceeds, (b) the closing of a merger or other business combination with an existing public company that results in at least $35.0 million of cash and cash equivalents on the surviving company’s balance sheet as of the closing date of such transaction, or (c) the date and time, or the occurrence of an event, specified by vote or written consent of the required holders (the time of such closing or the date and time specified or the time of the event specified in such vote or written consent is referred to herein as the “Mandatory Conversion Time”), then (i) all outstanding shares of Series C shall automatically be converted into shares of Common Stock, at the then effective conversion rate as calculated and (ii) such shares may not be reissued by the Company.

 

Common Shares

 

Each share of Common Stock is entitled to one vote at all meetings of stockholders. All shares of Common Stock are equal to each other with respect to liquidation rights and dividend rights. There are no preemptive rights to purchase any additional shares of Common Stock. In the event of liquidation, dissolution or winding up of the Company, holders of shares of Common Stock will be entitled to receive on a pro rata basis all assets of the Company remaining after satisfaction of all liabilities and all liquidation preferences, if any, granted to holders of preferred stock.

 

After payment of any dividends on Convertible Preferred Stock, the holders of outstanding shares of Common Stock are entitled to receive dividends out of assets legally available therefore at such times and in such amounts as the board of directors may from time to time determine. Holders of Common Stock will share equally on a per share basis in any dividend declared by the board of directors. The Company has not paid any dividends on Common Stock and does not anticipate paying any cash dividends on such stock in the foreseeable future. In the event of a merger or consolidation, all holders of Common Stock will be entitled to receive the same per share consideration.

 

7. Common Stock Warrants

 

From time to time, the Company issues warrants to its investors, creditors and various other individuals, as noted above. The Company’s outstanding common stock warrants that are classified as equity warrants are included as a component of stockholder’s equity at the date of grant at the relative fair value at that grant date. Common stock warrants accounted for as liabilities in accordance with ASC 815 are included in non-current liabilities. The warrants have an exercise price ranging from $0.48 to $1.12 per share and generally expire ten years after the date of issuance. The Company had common stock warrants issuable and outstanding of 10,663,149 and 7,202,462 at March 31, 2021 and December 31, 2020, respectively.

 

2017 Convertible Notes Warrants

 

In connection with the 2017 Convertible Notes, the Company issued the investors 300,000 warrants (“2017 Convertible Note Warrants”) to purchase common stock at $0.75 per share. The 2017 Convertible Note Warrants expire ten years from the date of issuance and meet the criteria for equity classification. Accordingly, the fair value of the 2017 Convertible Notes and Warrants were estimated on the date of issuance using a Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis.

 

In June 2018, the 2017 Convertible Notes were modified to extend the maturity date to December 31, 2018. In conjunction with the extension, the Company issued the holders additional warrants (“2017 Modification Warrants”) which also included terms for down round protection. The amendment also provided the Company with the option to further extend the maturity date to June 30, 2019 subject to the issuance of additional warrants. The 2017 Modification Warrants met the criteria to be classified as equity as the Company early adopted ASU 2017-11, Accounting for Certain Financial Instruments with Down Round Features, which allows certain down round features to be excluded from the consideration of whether the instrument may be classified as equity. As such, the 2017 Modification Warrants were recognized in equity at a fair value of $45,000 on the June 30, 2018 date of issuance. As the 2017 Modification Warrants were issued by the Company to creditors at the time of the extension, the fair value of the modification was capitalized as debt issuance cost and amortized over the remaining term of the debt. As a result of the Series C Financing, in March 2019, these warrant holders consented to the exchange of these warrants for new warrants (“2017 Modification New Warrants”) with the same expiration date but with an exercise price equal to $1.12 per share to reflect the adjusted exercise price in satisfaction of the down-round feature of the original warrant agreement. As recognition of this event, and in accordance with ASU 2017-11, the change in fair value of $12,000 was recorded as a deemed dividend.

 

  17  

 

On December 31, 2018, the Company exercised its option to extend the maturity date of the 2017 Convertible Notes to June 30, 2019 and as such, additional warrants (“2017 Extension Warrants”) were issued. The 2017 Extension Warrants were issued with the same provisions as the 2017 Modification Warrants with the exception of having a fixed exercise price of $1.12 per share. The 2017 Extension Warrants expire ten years from the date of issuance and meet the criteria for equity classification. As the 2017 Extension Warrants were not issued until March 2019, the Company recognized a warrants issuable equity value of fair value of $87,068 in additional paid in capital using the Black-Scholes valuation model on December 31, 2018, to record the 166,421 2017 Extension Warrants issuable, upon the Company’s election to extend the 2017 Convertible Notes maturity date.

 

2018 Notes Agreement Warrants

 

Pursuant to the 2018 Notes Agreement, the Company issued to each Lender a warrant (“2018 Secured Notes Warrants”) to purchase that number of shares of the Company’s Common Stock, $0.001 par value per share, equal to ten percent of such Lender’s principal note amount for an exercise price of $0.75 per share. The warrants are immediately exercisable and will expire ten years from the grant date.

 

The 2018 Secured Notes Warrants meet the criteria for classification as equity. Accordingly, the fair value of the 2018 Secured Notes and 2018 Secured Notes Warrants were estimated on the date of issuance using the Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis. The debt discounts on the 2018 Secured Notes were amortized over the contractual period of the notes using the effective interest rate method.

 

2018 Convertible Notes Warrants

 

In connection with the 2018 Convertible Notes, the Company issued the investors warrants (“2018 Convertible Notes Warrants”) to purchase shares of Common Stock. During the years ended December 31, 2019 and December 31, 2018, the Company issued 94,500 and 199,500 warrants, respectively, in connection with the 2018 Convertible Notes. The number of shares of common stock for which the 2018 Convertible Notes Warrants may be exercised is equal to 35 percent of the amount of principal and accrued but unpaid interest of the 2018 Convertible Note. The 2018 Convertible Notes Warrants expire ten years from the date of issuance and meet the criteria for liability classification. The fair value of the 2018 Convertible Notes Warrants to purchase common stock issued in connection with the 2018 Convertible Notes was estimated on the date of issuance using a Monte Carlo simulation model and the proceeds were allocated to the warrants based on its standalone fair value, with the residual proceeds allocated to the Convertible Notes. The debt discounts on the 2018 Convertible Notes were amortized over the contractual period of the notes using the effective interest rate method.

 

During March 2019 and in contemplation of the Series C Financing, all of the 2018 Convertible Note Warrants were exchanged for warrants (“2018 Convertible Notes New Warrants”) with a fixed number of shares and explicit exercise price. The 2018 Convertible Notes New Warrants expire ten years from the date of issuance and meet the criteria for equity classification. Accordingly, the derivative liability was remeasured immediately before reclassification with a credit to earnings for the change in fair value.

 

October 2020 Note Warrants

 

In connection with the issuance of the October 2020 Note, the Company issued the holder a warrant to purchase 45,000 shares of common stock.  The warrants have an exercise price of $0.73, are immediately exercisable and will expire ten years from the grant date. The October 2020 Note Warrants meet the criteria for classification as equity. Accordingly, the fair value of the October Notes and October 2020 Note Warrants were estimated on the date of issuance using the Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis. The debt discounts on the October 2020 Note Warrants were amortized over the contractual period of the notes using the effective interest rate method.

 

Senior Secured Promissory Note Warrants

 

In connection with the issuance of each tranche of the Senior Secured Promissory Notes, the Company issued the investor a warrant for the purchase of up to 3,460,687 shares of the Company’s common stock (the Senior Secured Promissory Note Warrants) and identified an investor put right to offset future equity purchases in exchange for settlement of the Senior Secured Promissory Notes. For each tranche, the investor may receive 3,460,687 additional warrants per tranche. The Senior Secured Promissory Note Warrants have an exercise price of $0.4816 per share and expire five years from the date of registration or April 27, 2026 (see Note 13 – Subsequent Events for details of the Merger). The Senior Secured Promissory Note Warrants did not meet the criteria for equity classification because of multiple features, including a potential adjustment to the exercise price and the potential for cash settlement of the warrants; therefore the warrants are accounted for as liabilities in accordance with ASC 815. At each issuance date, the Company recognized the Senior Secured Promissory Note Warrants at fair value. The Company valued the Senior Secured Promissory Note Warrants upon the date of issuance using a Monte-Carlo valuation model with a resulting fair value of $1.8 million and $1.9 million at February 1, 2021 and December 31, 2020, respectively. As the fair value of the Senior Secured Promissory Note Warrants exceeded the proceeds from the Senior Secured Promissory Notes, a loss of $0.7 million and $0.8 million was recognized at issuance on February 1, 2021 and December 17, 2020, respectively. (See Note 5 – Debt for further discussion). The Senior Secured Promissory Note Warrants will be revalued at fair value each reporting period in accordance with ASC 815.

 

  18  

 

The following table summarizes warrant activity for the three months ended March 31, 2021:

 

    Number of Warrants   Weighted Average Exercise Price   Weighted Average Remaining Contractual Life (Years)
Warrants outstanding, December 31, 2020     7,202,462     $ 0.76       6.28  
Granted     3,460,687     $ 0.48       -  
Exercised     -     $ -       -  
Forfeited, expired or cancelled     -     $ -       -  
Warrants outstanding, March 31, 2021     10,663,149     $ 0.54       5.86  

 

8. Equity Incentive Plan

 

The Company’s Employee, Director and Consultant Equity Incentive Plan (the “Plan”) provides for the grant of the following stock awards to employees, directors and consultants of the Company: incentive stock options and non-statutory stock options. The current number of shares authorized and reserved for issuance under the Plan is 35,000,000 shares of common stock. The number and terms of options granted under the Plan are determined by the Board of Directors when granted. Options are exercisable for a period determined by the board of directors, generally not more than 10 years following the date of grant. The Company estimates the fair value of each stock option using the Black-Scholes option pricing model under ASC 718.

 

During the three months ended March 31, 2021, no options were issued.

 

The allocation of stock-based compensation for all stock awards is as follows (in thousands):

 

    Three Months Ended March 31,
    2021   2020
Research and development   $ 274     $ 140  
General and administrative     295       347  
Total stock-based compensation expense   $ 569     $ 487  

 

Officer Settlement Agreements

 

The Company’s former Chief Executive Officer resigned in 2016. The Company reached a settlement (“Settlement Agreement”) with the former Chief Executive Officer in 2017 wherein certain options for the purchase of 2,550,000 shares of the Company’s common stock, were modified (“the Modified Options”) which allowed for a potential put right under certain circumstances. The put right expired unexercised in the fourth quarter of 2019. As of March 31, 2021, the Modified Options, with an exercise price of $0.40 per share, remained outstanding. 

 

The Company’s former Chief Development Officer was terminated in February 2021. As part of the separation package, the Company’s board of directors agreed to (i) accelerate vesting by four months for the former employee’s outstanding options and (ii) allow up to seven years from the termination date for the former employee to exercise all vested options. The Company concluded the actions taken by the Company resulted in modification accounting. The Company determined the incremental fair value of the options was $225,000, which was expensed to research and development expenses in the condensed statements of operations during the three-month period ended March 31, 2021. 

 

9. Employee Benefits

 

Effective June 20, 2016, the Company adopted a defined contribution 401(k) plan. All employees are eligible to participate in the plan beginning on the first day of employment. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation. No matching contributions have been made by the Company since the adoption of the 401(k) plan.

 

10. License Agreements

 

License Agreements with the Regents of the University of California

 

The Company has entered into two license agreements, as amended, with the Regents of the University of California (“Regents”) for exclusive commercial rights to certain patents, technology and know-how. The technology is related to the Company’s products under development. The Regents are entitled to certain development and sales milestones.

 

In conjunction with the Co-Development and Distribution Agreement with Newsoara, the Company is obligated to pay the Regents royalties for its portion of the sublicense income equal to 30 percent of one-third of the upfront payment and milestone payment received. As of March 31, 2021 and December 31, 2020, a royalty payable of $115,000 and $125,000, respectively was included in Accounts Payable.

 

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11. Commitments and Contingencies

 

Facility Leases

 

The Company leases office space for its corporate headquarters under a non-cancelable facility operating lease for 4,911 square feet located in Carlsbad, California. The Company originally subleased this office space starting in July 2017 with the lease expiring in January 2019. There were no future payments due under this non-cancelable operating lease as of December 31, 2018.

 

In January 2019, the Company entered into a six-month facility operating lease in Carlsbad, California. The lease commenced on February 1, 2019 with contractual rent payments of approximately $15,500 per month through the lease expiration date in July 2019. No tenant improvement allowances or common area maintenance lease components exist as part of the lease. The Company accounted for this lease by applying the practical expedient for short-term leases which resulted in the Company recognizing expense on a straight-line basis over the lease term. The total short-term lease cost was approximately $93,000 and such amounts were recorded within general and administrative expenses on the statement of operations.

 

In July 2019, the Company entered into a facility operating lease (the “July 2019 Headquarter Lease”) in Carlsbad, California. The initial contractual term is three years commencing on August 1, 2019 and expiring on July 31, 2022. The Company has the option to renew this lease for an additional 36-month period at the prevailing market rent upon completion of the initial lease term. The Company has determined it is not reasonably certain that it will exercise this renewal option. Therefore, the lease term is determined to be a total of three years commencing on August 1, 2019 and expiring on July 31, 2022. Commencing in August 2019, the Company will pay contractual monthly lease payments of $16,000 for the first 12 months. The contractual monthly lease payments are subject to 3 percent escalations at the first and second lease commencement anniversary.

 

The July 2019 Headquarter Lease is also subject to additional variable charges for common area maintenance, insurance, taxes and other operating costs. This additional variable rent expense is not estimable at lease inception. Therefore, it is excluded from the Company’s straight-line expense calculation at lease inception and is expensed as incurred. All fixed and variable lease payment amounts were recorded within general and administrative expenses on the statement of operations.

 

The ROU Asset was $236,000 and $275,000 at March 31, 2021 and December 31, 2020, respectively. The Lease Liability was $241,000 and $280,000 at March 31, 2021 and December 31, 2020, respectively.

 

Office lease deferral of payments concession

 

On April 29, 2020, the Company entered into a rent deferral agreement with its landlord pursuant to the financial impacts of the COVID-19 pandemic on the Company. Under the terms of the arrangement, the Company would begin repaying any deferred balance in equal installments prorated over six months beginning October 2020. Through March 31, 2021, the Company was still in discussions with its landlord regarding the extension of the deferral period. As of March 31, 2021 and December 31, 2020, deferred balances under this arrangement totaled $126,000 and $87,000, respectively, and are included in accounts payable on the Company’s condensed balance sheets. 

 

Legal Proceedings

 

Between January 8 and March 3, 2021, nine individual lawsuits (captioned Sheridan v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00166 (S.D.N.Y. filed Jan. 8, 2021); Pirjamaat v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00172 (S.D.N.Y. filed Jan. 8, 2021); Johnson v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00310 (S.D.N.Y. filed Jan. 13, 2021); Mathews v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00242 (E.D.N.Y. filed Jan. 15, 2021); Pechal v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00585 (S.D.N.Y. filed Jan. 22, 2021); Curtis v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00292 (D. Del. Feb. 25, 2021); Valdez v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00980 (E.D. Pa. Mar. 1, 2021); Anderson v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00326 (D. Del. Mar. 2, 2021); and McIntire v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-01869 (S.D.N.Y. Mar. 3, 2021)) were filed in federal court by alleged Seneca Biopharma, Inc. (“Seneca”) stockholders challenging the proposed merger of Seneca and the Company (the “Merger”). The complaints name Seneca and Seneca’s board of directors as defendants. The Sheridan, Valdez, and Pirjamaat complaints name the Company as an additional defendant.

 

On March 18, 2021, Seneca filed an amendment to the Registration Statement on Form 8-K, which contained certain supplemental disclosures intended to moot the plaintiffs’ disclosure claims (the “Supplemental Disclosures”). Thereafter, all nine cases were voluntarily dismissed, and counsel for plaintiffs requested a mootness fee for the purported benefit conferred on Seneca’s stockholders in connection with the Supplemental Disclosures. The parties engaged in a negotiation and settled for a mootness fee of $216,000 in the second quarter of 2021. No amounts were accrued for these matters in Leading Biosciences’ financial statements as of 3/31/21 or 12/31/20 as the settlement was reached with Seneca.

 

From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. Management believes there are no claims or actions pending against the Company through March 31, 2021, which will have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position or results of operations. Litigation, however, is subject to inherent uncertainties, and an adverse result in such matters may arise from time to time that may harm the Company’s business.

 

Indemnification

 

In accordance with the Company’s amended and restated memorandum and articles of association, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.

 

  20  

 

12. Related Party Transactions

 

Director stipends

 

Unpaid cash stipends owed to our directors for their annual board service are recorded on the Company’s condensed balance sheets within accrued liabilities. These liabilities were $863,000 and $759,000 as of March 31, 2021 and December 31, 2020, respectively.

 

13. Subsequent Events

 

The Company has evaluated subsequent events through July 13, 2021, the date of issuance of the condensed financial statements.

 

Option Expiration

 

On April 2, 2021, the 2,550,000 options outstanding pursuant to the Company’s Settlement Agreement, as defined in Note 7, with its former CEO expired unexercised.

 

Merger

 

On April 27, 2021, pursuant to the Agreement and Plan of Merger (the “Merger Agreement”), dated as of December 16, 2020, by and among Palisade Bio, Inc., formerly known as Seneca Biopharma, Inc., Leading Biosciences, Inc. and Townsgate Acquisition Sub 1, Inc., a wholly owned subsidiary of Seneca Biopharma (“Merger Sub”), LBS completed the previously announced merger transaction with Seneca Biopharma, pursuant to which Merger Sub merged with and into LBS, with LBS surviving such merger as a wholly owned subsidiary of Seneca Biopharma (the “Merger”). Also, in connection with the closing of the Merger, Seneca Biopharma, Inc. changed its name to Palisade Bio, Inc. and the business conducted by Seneca Biopharma became primarily the business conducted by LBS.

 

Pre-Merger Financing

 

On April 27, 2021, Palisade Bio, Inc., formerly known as Seneca Biopharma, Inc. and LBS completed a previously announced private placement transaction with an institutional investor (the “Investor”) at a per share purchase price of $0.4816 (without giving effect to the Exchange Ratio or the Reverse Stock Split) (the “Purchase Price”) for an aggregate purchase price of $20,000,000 in cash plus the cancelation of outstanding principal and interest on the notes previously issued to the Investor (the “Pre-Merger Financing”), whereby immediately prior to the Closing, among other things, LBS issued to the Investor shares of LBS Series 1 Preferred Stock pursuant to the Securities Purchase Agreement, dated December 16, 2020, by and among Palisade Bio, LBS and the Investor (the “Securities Purchase Agreement”).

 

At the closing of the Pre-Merger Financing, (i) LBS issued to the Investor shares of LBS Series 1 Preferred Stock (the “Initial Shares” and, as converted pursuant to the Exchange Ratio in the Merger into the right to receive approximately 1,325,892 shares of Palisade Bio Common Stock, the “Converted Initial Shares”) without giving effect to any limitations set forth in the Securities Purchase Agreement and (ii) LBS deposited into an escrow account three times the number of Initial Shares of LBS Series 1 Preferred Stock (the “Additional Shares”, and, as converted pursuant to the Exchange Ratio in the Merger into the right to receive approximately 3,977,676 shares of Palisade Bio Common Stock, the “Converted Additional Shares”) for the benefit of the Investor if 85% of the average of the five lowest volume-weighted average trading prices of a share of Palisade Bio Common Stock as quoted on the Nasdaq Capital Market during the 10 trading day period immediately preceding the 16th trading day following the Effective Time, divided by five, is lower than the per share Purchase Price or if the five lowest weighted average prices of Palisade Bio Common Stock during the 10 trading day period immediately preceding each of the 45th, 90th and 135th days following the Effective Time, divided by five, is lower than the per share Purchase Price, then, in each case, the Investor will be issued such number of Converted Additional Shares equal to the Purchase Price divided by the lowest of such weighted average prices. Any Converted Additional Shares not delivered to the Investor from escrow will be returned to the Palisade Bio.

 

Issuance of Stock and Warrant to Ecoban Securities, LLC (“Ecoban”)

 

Subsequent to the Merger, on May 25, 2021, Palisade Bio issued to Ecoban (i) a warrant to purchase 18,353 shares of Palisade’s common stock (post reverse stock split and post exchange ratio) at a price of $17.72 per share (post reverse stock split and post exchange ratio) and (ii) 118,833 shares of Common Stock (post reverse stock split and post exchange ratio), as payment for a success fee for closing the Merger and Pre-Merger Financing.

 

Issuance of Equity Warrant

 

Subsequent to the Merger, on May 20, 2021, pursuant to the terms of the Securities Purchase Agreement, Palisade Bio issued to the Investor a warrant to purchase 4,995,893 shares of Common Stock at a price of $4.70 per share (the “Equity Warrant”), post reverse stock split and post exchange ratio. The Equity Warrant is immediately exercisable and will have a term of five years from the date all of the shares underlying the Equity Warrant have been registered for resale. The exercise price and number of shares underlying the Equity Warrant may be subject to adjustment, if any, following each of the 45th, 90th and 135th days following April 27, 2021.

 

  21  

 

Amendment of Promissory Notes and Issuance of New Warrants

 

In 2020, LBS issued and sold to certain holders (i) unsecured promissory notes in the aggregate principal amount of $0.6 million with an interest rate of 10% per annum and (ii) warrants to purchase an aggregate of 70,000 shares of common stock of LBS at an exercise price of $0.73 per share (the “Old Warrants”). In connection with the Merger, the Old Note Warrants automatically converted into warrants to purchase an aggregate of 1,904 shares of Common Stock at a purchase price of $26.84 per share.

 

On May 25, 2021, Palisade Bio, LBS and the noteholders amended the notes to extend the maturity date of the notes to November 15, 2021 (the “Notes Amendment”). In connection with the Notes Amendment, the Old Warrants were canceled, and the Palisade issued warrants to the Noteholders to purchase an aggregate of 8,000 shares of Common Stock at a purchase price of $6.00 per share (the “New Warrants”).

 

 

 

 

 

 

 

 

 

 

 

 

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Leading Biosciences, INC. 

 

Financial Statements

 

For the Years Ended December 31, 2020 and 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  1  

 

Table of Contents

 

Page(s)

 

Balance Sheets   5
     
Statements of Operations   6
     
Statements of Convertible Preferred Stock and Stockholders’ Deficit   7
     
Statements of Cash Flows   8
     
Notes to Financial Statements   9

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  2  

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Stockholders and the Board of Directors 

Leading Biosciences, Inc.

San Diego, California

 

Opinion on the Financial Statements

 

We have audited the accompanying balance sheets of Leading Biosciences, Inc. (the “Company”) as of December 31, 2020 and 2019, the related statements of operations, convertible preferred stock and stockholders’ deficit, and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2020 and 2019, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

 

Going Concern Uncertainty

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note 1 to the financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

Critical Audit Matters

 

The critical audit matter communicated below is matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee of the Company’s board of directors and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.

 

Accounting for Senior Secured Notes and Classification of Warrants

 

As described in Note 5 to the financial statements, in December of 2020, (i) the Company entered into a securities purchase agreement with an institutional investor pursuant to which, among other things, the Company agreed to issue senior secured promissory notes in the aggregate principal amount of up to $5.0 million, in exchange for an aggregate purchase price of up to $3.75 million, and warrants to purchase shares of the Company’s common stock. The first tranche was issued in December of 2020 resulting in the issuance of $1.7 million in aggregate principal of senior secured promissory notes and warrants to acquire 3,460,687 shares of common stock.

 

  3  

 

We identified the accounting for the senior secured notes, including the evaluation for potential embedded derivatives, and classification of the related warrants as a critical audit matter. The application of the accounting guidance appliable to the senior secured notes, including the evaluation for potential embedded derivatives, and the classification of the related warrants is complex and therefore, applying such guidance to the contract terms is subjective and requires significant judgment. Auditing these elements involved especially challenging auditor judgment due to the nature of the terms of the senior secured notes and related warrants and the effort required to address these matters, including the extent of specialized skills and knowledge needed.

 

The primary procedures we performed to address this critical audit matter included:

 

· Inspecting the agreements associated with the securities purchase agreement and evaluating the completeness and accuracy of the Company’s technical accounting analysis and application of the relevant accounting literature.

 

· Utilizing personnel with specialized knowledge and skills in technical accounting to assist in assessing management’s analysis of the senior secured notes, the evaluation for potential embedded derivatives, and classification of the related warrants including: (i) evaluating the contracts to identify relevant terms that affect the recognition in the financial statements, and (ii) assessing the appropriateness of conclusions reached by management.

 

/s/ BDO USA, LLP

 

We have served as the Company's auditor since 2017.

 

San Diego, California

July 13, 2021

 

 

 

 



To the Share

 

 

 

 

 

 

 

 

 


 

 

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Leading BioSciences, Inc.

Balance Sheets

(in thousands, except share and per share amounts)

 

    December 31, 2020   December 31, 2019
         
ASSETS                
Current assets:                
Cash and cash equivalents   $ 713     $ 3,597  
Accounts receivable     59       -  
Prepaid expenses and other current assets     124       124  
Total current assets     896       3,721  
Restricted cash     26       26  
Deferred transaction costs     1,817       -  
Right-of-use asset     275       418  
Property and equipment, net     5       2  
Total assets   $ 3,019     $ 4,167  
                 
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' DEFICIT                
Current liabilities:                
Accounts payable   $ 2,537     $ 2,047  
Accrued liabilities     2,740       332  
Accrued compensation and benefits     1,590       96  
Current portion of lease liability     168       140  
Current portion of debt, net     578       100  
Current portion of related party debt, net     469       -  
Total current liabilities     8,082       2,715  
Warrant liability     1,830       -  
Non-current portion of debt     94       -  
Non-current portion of lease liability     112       281  
Total liabilities     10,118       2,996  
                 
Commitments and contingencies (Note 11)                
                 
Series C convertible preferred stock, $0.001 par value; 33,594,625 shares authorized as of December 31, 2020 and December 31, 2019; 11,674,131 shares issued and outstanding at December 31, 2020 and December 31, 2019; liquidation preference of $10.4 million as of December 31, 2020 and December 31, 2019     9,503       9,503  
                 
Stockholders’ deficit:                
Common stock, $0.001 par value; 250,000,000 shares authorized as of December 31, 2020 and December 31, 2019; 102,041,277 and 102,029,290 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively     102       102  
Additional paid-in capital     51,322       49,270  
Accumulated deficit     (68,026 )     (57,704 )
Total stockholders' deficit     (16,602 )     (8,332 )
Total liabilities, convertible preferred stock and stockholders' deficit   $ 3,019     $ 4,167  

 

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Leading BioSciences, Inc.

Statements of Operations

(in thousands, except share and per share amounts)

 

    Year ended December 31,
    2020   2019
         
Operating expenses:        
Research and development   $ 3,099     $ 3,239  
General and administrative     6,198       7,272  
Gain on derecognition of payable     -       (1,384 )
Total operating expenses     9,297       9,127  
Loss from operations     (9,297 )     (9,127 )
Other income (expense):                
Loss on extinguishment of debt     -       (1,022 )
Loss on issuance of secured debt     (841 )     -  
Change in fair value of warrant liability     38       158  
Change in fair value of put right     -       128  
Interest expense     (235 )     (250 )
Other income     13       61  
Total other income (expense)     (1,025 )     (925 )
Net loss   $ (10,322 )   $ (10,052 )
Net loss attributable to common shareholders   $ (10,322 )   $ (10,064 )
Net loss per share attributable to common shareholders, basic and diluted   $ (0.10 )   $ (0.11 )
Weighted–average common shares used to compute basic and diluted net loss per share attributable to common shareholders     102,036,449       91,920,704  

 

The accompanying notes are an integral part of these financial statements. 

 

  6  

 

Leading  BioSciences, Inc.

Statements of Convertible Preferred Stock and Stockholders’ Deficit

(in thousands, except share amounts)

 

    Series C   Series B1   Series A2   Series A1                    
    Convertible
Preferred Stock
  Convertible
Preferred Stock
  Convertible
Preferred Stock
  Convertible
Preferred Stock
  Common Stock   Additional       Total
                                            Paid-in   Accumulated   Stockholders'
    Shares   Amount   Shares   Amount   Shares   Amount   Shares   Amount   Shares   Amount   Capital   Deficit   Deficit
Balance, December 31, 2018     -     $ -       11,762,069     $ 20,977       1,610,000     $ 8,344       5,250,000     $ 7,589       46,331,038     $ 46     $ 2,408     $ (47,652 )   $ (45,198 )
Conversion of preferred stock to common stock     -       -       (11,762,069 )     (20,977 )     (1,610,000 )     (8,344 )     (5,250,000 )     (7,589 )     44,163,938       44       36,866       -       36,910  
Issuance of Series C Convertible Preferred Stock, net of issuance costs of $215     11,674,131       9,503       -       -       -       -       -       -       -       -       -       -       -  
Issuance of common stock warrants in connection with Series C financing     -       -       -       -       -       -       -       -       -       -       628       -       628  
Reclassification of warrant liability to equity     -       -       -       -       -       -       -       -       -       -       101       -       101  
Conversion of debt and interest to common stock     -       -       -       -       -       -       -       -       11,479,748       12       5,962       -       5,974  
Stock-based compensation expense     -       -       -       -       -       -       -       -       -       -       3,325       -       3,325  
Reclassification of option award from equity to liability for related party (Note 7)     -       -       -       -       -       -       -       -       -       -       (128 )     -       (128 )
Termination of tranche right liability     -       -       -       -       -       -       -       -       -       -       79       -       79  
Issuance of common stock for stock option exercises     -       -       -       -       -       -       -       -       44,800       -       18       -       18  
Issuance of common stock for vendor payments     -       -       -       -       -       -       -       -       9,766       -       11       -       11  
Net loss     -       -       -       -       -       -       -       -       -       -       -       (10,052 )     (10,052 )
                                                                                                         
Balance, December 31, 2019     11,674,131       9,503       -       -       -       -       -       -       102,029,290       102       49,270       (57,704 )     (8,332 )
Stock-based compensation expense     -       -       -       -       -       -       -       -       -       -       2,014       -       2,014  
Issuance of common stock to vendor     -       -       -       -       -       -       -       -       11,987       -       9       -       9  
Issuance of common stock warrants related to promissory note     -       -       -       -       -       -       -       -       -       -       29       -       29  
Net loss     -       -       -       -       -       -       -       -       -       -       -       (10,322 )     (10,322 )
                                                                                                         
Balance, December 31, 2020     11,674,131     $ 9,503       -     $ -       -     $ -       -     $ -       102,041,277     $ 102     $ 51,322     $ (68,026 )   $ (16,602 )

 

  7  

 

Leading  BioSciences, Inc.

Statements of Cash Flows

(In thousands)

 

    Year Ended December 31,
    2020   2019
     
Cash flows from operating activities                
Net loss   $ (10,322 )   $ (10,052 )
Adjustments to reconcile net loss to net cash used operating activities:                
Depreciation     3       3  
Gain on derecognition of payable     -       (1,384 )
Accretion of debt discount and non-cash interest expense     202       166  
Change in fair value of warrant liability     (38 )     (158 )
Change in fair value of put right     -       (128 )
Accrued and unpaid interest     -       51  
Non-cash lease expense     143       54  
Loss on issuance of secured debt     841       -  
Stock-based compensation     2,014       3,325  
Loss on extinguishment of debt     -       1,022  
Changes in operating assets and liabilities:                
Accounts receivable     (59 )     250  
Prepaid expenses and other assets     89       (63 )
Accounts payable and accrued liabilities     1,006       836  
Accrued compensation     1,494       (630 )
Change in lease liability     (141 )     (51 )
Net cash used in operating activities     (4,768 )     (6,759 )
                 
Cash flows from investing activities                
Purchases of property and equipment     (6 )     -  
Net cash used in investing activities     (6 )     -  
                 
Cash flows from financing activities                
Proceeds from issuance of Series C, warrants and tranche right, net of issuance costs     -       10,210  
Payments on related party notes     -       (116 )
Proceeds from exercise of stock options     -       18  
Proceeds from issuance of 2018 convertible notes     -       270  
Payments on debt     (27 )     (374 )
Payment of debt issuance costs     (87 )     -  
Net proceeds from issuance of related party debt     450       -  
Net proceeds from issuance of debt and warrants     1,554       -  
Net cash provided by financing activities   $ 1,890     $ 10,008  
                 
Net change in cash, cash equivalents and restricted cash   $ (2,884 )   $ 3,249  
Cash, cash equivalents and restricted cash, beginning of period     3,623       374  
Cash, cash equivalents and restricted cash, end of period   $ 739     $ 3,623  
                 
Reconciliation of cash, cash equivalents and restricted cash to the balance sheets:                
Cash and cash equivalents   $ 713     $ 3,597  
Restricted cash     26       26  
Total cash, cash equivalents and restricted cash   $ 739     $ 3,623  
Supplemental disclosure of cash flows:                
Interest paid   $ 55     $ 35  
Supplemental disclosures of non-cash investing and financing activities:                
Debt discount for issuance of warrants   $ 29     $ 83  
Deferred transaction costs in accounts payable and accrued liabilities   $ 1,817     $ -  
Deferred equity issuance costs included in accounts payable   $ 41     $ -  
Debt issuance costs included in accounts payable   $ 61     $ -  
Debt discount for beneficial conversion feature   $ -     $ 628  
Operating lease liabilities arising from obtaining right-of-use assets   $ -     $ 472  
Derivative liabilities issued with Series C Convertible Preferred Stock   $ -     $ 79  
Issuance of common stock upon conversion of preferred stock   $ -     $ 36,910  
Issuance of common stock upon conversion of debt and interest   $ -     $ 5,974  
Deemed dividend on modification of equity classified warrant   $ -     $ 12  
Issuance of promissory note for settlement of trade payables   $ -     $ 100  
Issuance of common stock for settlement of trade payables   $ 9     $ 11  
Termination of tranche right liability issued with Series C Convertible Preferred Stock   $ -     $ (79 )

 

The accompanying notes are an integral part of these financial statements.

 

  8  

 

Leading BioSciences, Inc.

Notes to Financial Statements

 

1. Organization, Business and Basis of Presentation

 

Description of Business

 

Leading BioSciences, Inc. (“LBS” or the “Company”) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies to improve the lives of patients affected by a broad range of diseases and conditions triggered by gastrointestinal dysregulation. The Company is applying its knowledge and its industry experience to develop oral small-molecule drugs to maintain the integrity of the gut epithelial barrier, microbiome, and gut immune cells to improve acute and chronic Gastrobiome™-mediated outcomes. The Company’s initial focus is combatting the interruption of GI function (ileus) following major surgery to reduce recovery times and shorten patients’ length of stay in the hospital. The Company’s programs have the potential to prevent the formation of post-operative adhesions, as well as to address the myriad health conditions and complications associated with chronic disruption of the intestinal mucosal barrier. The Company was incorporated in the state of Delaware on September 6, 2011, and is based in Carlsbad, California.

 

On April 27, 2021, LBS completed an asset acquisition with Seneca Biopharma Inc. (“Seneca”) in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of December 16, 2020, (the “Merger Agreement”) by and among Seneca, Townsgate Acquisition Sub 1, Inc., a wholly owned subsidiary of Seneca (“Merger Sub”), and LBS, pursuant to which Merger Sub merged with and into LBS, with LBS surviving as a wholly owned subsidiary of Seneca (the “Merger”). Concurrent with the closing of the Merger, LBS outstanding common stock, common stock warrants and options for the purchase of LBS common stock (“common stock equivalents”) were exchanged for Seneca common stock, Seneca common stock warrants and options for the purchase of Seneca common stock at a ratio of 0.2719 shares of LBS common stock equivalents to one share of Seneca common stock equivalents (“the Exchange Ratio”), including the effects of Seneca’s one-for-six reverse stock split (“Reverse Stock Split”). The accompanying financial statements and notes thereto do not reflect the Exchange Ratio or Reverse Stock Split.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s financial statements and notes. The most significant estimates in the Company’s financial statements relate to clinical trial accruals and valuation of derivative liabilities and stock-based compensation. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

 

Segment Information

 

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment which consists of research and development activities.

 

Liquidity and Going Concern

 

The Company has a limited operating history and the sales and income potential of the Company’s business and market are unproven. The Company has experienced losses and negative cash flows from operations since its inception. At December 31, 2020, the Company had an accumulated deficit of $68.0 million and cash and cash equivalents of $713,000. The Company expects to continue to incur losses into the foreseeable future. The successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

 

Historically, the Company has funded its operations primarily through a combination of debt and equity financings. Management’s plans continue to be focused on raising additional capital or other financings, such as potential partnering events of the Company’s existing technology. However, no assurance can be given at this time as to whether the Company will achieve these objectives. Based on the Company’s current business plan, management believes that existing cash and cash equivalents will not be sufficient to fund the Company’s obligations for at least 12 months from the date of issuance of these financial statements. The Company’s ability to execute its operating plan depends on its ability to obtain additional funding through equity offerings, debt financings or potential licensing and collaboration arrangements. The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business. However, the Company’s current working capital, anticipated operating expenses and net losses raise substantial doubt about its ability to continue as a going concern for a period of one year following the date that these financial statements are issued. The financial statements do not include any adjustments for the recovery and classification of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

  9  

 

The Company plans to continue to fund its operations through cash and cash equivalents on hand, as well as through the pre-Merger financing, future equity offerings, debt financings, other third-party funding, and potential licensing or collaboration arrangements. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to the Company. Even if the Company raises additional capital, it may also be required to modify, delay or abandon some of its plans, which could have a material adverse effect on the Company’s business, operating results and financial condition and the Company’s ability to achieve its intended business objectives. Any of these actions could materially harm the Company’s business, results of operations and future prospects.

 

COVID-19

 

On January 30, 2020, the World Health Organization (“WHO”) announced a global health emergency because of a new strain of coronavirus originating in Wuhan, China (the “COVID- 19 pandemic”) and the risks to the international community as the virus spreads globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. 

 

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted. The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act also appropriated funds for the U.S. Small Business Administration Paycheck Protection Program loans that are forgivable in certain situations to promote continued employment, as well as Economic Injury Disaster Loans to provide liquidity to small businesses harmed by COVID-19. 

 

In April 2020, as a result of impacts and risks associated with the current COVID-19 pandemic, the Company paused enrollment and program activities surrounding the Company’s clinical trials. The COVID-19 pandemic has not affected the production or supply of the Company’s patent-protected therapeutic candidate, LB1148.   

 

The COVID-19 pandemic may cause additional delays of the Company’s clinical trials or adversely impact the Company’s business. The Company cannot predict how legal and regulatory responses to concerns about COVID-19 or other major public health issues will impact the Company’s business, nor can it predict potential adverse impacts related to the availability of capital to fund the Company’s operations. Additionally, the Company’s workforce and outside consultants may also be affected, which could result in an adverse impact on the Company’s ability to conduct business. Any of these factors, alone or in combination with others, could harm the Company’s business, results of operations, financial condition or liquidity. However, the magnitude, timing, and duration of any such potential financial impacts cannot be reasonably estimated at this time. 

 

2. Summary of Significant Accounting Policies

 

Cash and Cash Equivalents

 

Cash and cash equivalents represent cash available in readily available checking and money market accounts. The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.

 

Restricted Cash

 

At each December 31, 2020 and 2019, the Company held restricted cash of $26,000 in a separate restricted bank account as collateral for the Company’s corporate credit card program. The Company has classified these deposits as long-term restricted cash on its balance sheets.

 

Concentration of Credit Risk

 

Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions and in money market accounts, and at times balances may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held nor has the Company experienced any losses in these accounts.

 

Deferred Transaction Costs

 

Deferred Transaction Costs consists of the direct and incremental costs incurred by the Company related to the acquisition of the assets under the Merger Agreement (See Note 14 – Subsequent Events). These costs represent legal, accounting and other direct costs related to the Company’s efforts to complete a reverse merger. As of December 31, 2020, deferred transaction costs were approximately $1.8 million.

 

  10  

 

Property and Equipment, Net

 

Property and equipment, which consist of computers, are stated at cost less accumulated depreciation. Depreciation is recognized using the straight-line method over the estimated useful lives of the assets (approximately three years). Repair and maintenance costs that do not improve service potential or extend economic life are expensed as incurred.

 

Right-of-Use Assets and Lease Liabilities

 

The Company assesses whether a contract is or contains a lease at contract inception. That is, if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company applies a single recognition and measurement approach for all leases, except for short-term leases. The Company recognizes lease liabilities representing obligations to make lease payments and right-of-use assets representing the right to use the underlying assets.

 

The Company has an operating lease for its facility. Beginning January 1, 2019, the Company adopted ASU No. 2016-02, Leases (“Topic 842”), which amended the existing accounting standards for the accounting for leases. Most significant among the changes in the standard is the recognition of ROU assets and lease liabilities by lessees for those leases classified as operating leases under current U.S. GAAP. The Company adopted the new lease standard using the modified-retrospective method, which did not result in a cumulative effect adjustment to accumulated deficit at the beginning of 2019. In connection with the adoption, the Company has elected to utilize the package of practical expedients, including: (i) not reassess the lease classification for any expired or existing leases; (ii) not reassess the treatment of initial direct costs as they related to existing leases; and (iii) not reassess whether expired or existing contracts are or contain leases. The adoption of the new lease standard had a material effect on the Company’s balance sheets; however, it did not have a material effect on its statements of operations and statements of cash flows. Upon adoption, the Company recorded ROU assets, current portion of lease liabilities and non-current portion of lease liabilities in its balance sheets of $472,000, $129,000 and $327,000, respectively. See Note 10—Commitments and Contingencies.

 

ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at the commencement date. The Company uses the implicit discount rate when readily determinable; however, as none of the Company’s leases provides an implicit rate, the Company uses the estimated incremental borrowing rate (the rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term) based on the information available at commencement date in determining the present value of lease payments. At commencement, the operating lease ROU asset equals the lease liability adjusted for accrued or prepaid lease payments and lease incentives. Lease terms may include options to extend or terminate the lease when it is reasonably certain the Company will exercise the option. Lease expense is recognized on a straight-line basis over the lease term.

 

The Company considers payments for common area maintenance, real estate taxes and management fees to be variable non-lease components, which are expensed as incurred. The Company elected to not separate lease and non-lease components of its operating leases in which it is the lessee and lessor.

 

Practical expedients elected

 

The Company has elected to apply the following practical expedients:

 

Short-term lease recognition exemption (i.e., those leases that have a lease term of 12 months or less from the commencement date and do not contain a purchase option). Lease payments on short-term leases are recognized as expense on a straight-line basis over the lease term.

 

Combining lease and non-lease components into a single component for all classes of underlying assets.

 

The effective date transition method practical expedient which included the package of practical expedients that permits companies to not re-assess lease classification for leases which were in existence as of the new lease standard adoption date and to not re-assess the initial direct costs capitalization conclusions which existed prior to the new lease standard adoption date.

 

Convertible Preferred Stock

 

The Company’s convertible preferred stock has been classified as temporary equity, instead of permanent equity within stockholders’ deficit, in the balance sheets, in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities as the stock conditionally redeemable upon certain change in control events outside of the Company’s control, including the liquidation, sale or transfer of control of the Company. Upon such change in control events the holders of the convertible preferred stock can cause its redemption.

 

  11  

 

The Company did not adjust the carrying values of the convertible preferred stock to its redemption value as of December 31, 2020 or 2019, since a liquidation event was not probable of occurrence. Subsequent adjustments to increase or decrease the carrying values to the ultimate liquidation values will be made only if, and when, it becomes probable such a liquidation event will occur.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments consist principally of cash equivalents, accounts receivable, restricted cash, accounts payable, accrued liabilities, debt and derivative liabilities. The carrying amounts of financial instruments such as cash equivalents, accounts receivable, restricted cash, accounts payable, and accrued liabilities approximate their related fair values due to the short-term nature of these instruments. The carrying value of the Company’s current and non-current debt approximates its fair value due to the market rate of interest. The Company’s derivative financial instruments are carried at fair value based on unobservable market inputs. None of the Company’s non-financial assets or liabilities are recorded at fair value on a non-recurring basis.

 

Derivative Financial Instruments

 

The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates all of its financial instruments, including warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. The Company values its derivatives using the Black-Scholes option-pricing model or other acceptable valuation models, including Monte Carlo simulations. Derivative instruments accounted for as liabilities are valued at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities, is re-assessed at the end of each reporting period.

 

The Company reviews the terms of convertible and secured debt, equity instruments and other financing arrangements to determine whether there are embedded derivative features, including embedded conversion options that are required to be bifurcated and accounted for separately as a derivative financial instrument. Additionally, in connection with the issuance of financing instruments, the Company may issue freestanding options and warrants, including options or warrants to non-employees in exchange for consulting or other services performed.

 

The Company accounts for common stock warrants in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC Topic 815, Derivatives and Hedging (“ASC 815”). Based upon the provisions of ASC 815, the Company accounts for common stock warrants as liabilities if the warrant requires net cash settlement or gives the holder the option of net cash settlement or it fails the equity classification criteria. The Company accounts for common stock warrants as equity if the contract requires physical settlement or net physical settlement or if the Company has the option of physical settlement or net physical settlement and the warrants meet the requirements to be classified as equity. Common stock warrants classified as liabilities are initially recorded at fair value and remeasured at fair value each balance sheet date with the offset adjustments recorded in change in fair value of warrant liability within the statements of operations. Common stock warrants classified as equity are initially measured at fair value on the grant date and are not subsequently remeasured.

  

Revenue Recognition

 

The Company has entered into research and development collaborations, which may include research and development services and licenses of internally developed technologies. The Company recognizes revenues when customers obtain control of promised goods or services, in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. The Company recognizes revenues following the five-step model prescribed under ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”): (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) the Company satisfies the performance obligation.

 

Identify the Contract with a Customer

 

A customer is a party that has entered into a contract with the Company, where the purpose of the contract is to obtain a product or a service that is an output of the Company’s ordinary activities in exchange for consideration. To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each party’s rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that the Company will collect substantially all of the consideration to which it is entitled to receive in exchange for the transfer of the product or the service.

 

  12  

 

Identify the Performance Obligations in the Contract

 

A performance obligation is defined as a promise to transfer a product or a service to a customer. The Company identifies each promise to transfer a product or a service (or a bundle of products or services, or a series of products and services that are substantially the same and have the same pattern of transfer) that is distinct. A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) the Company’s promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract. Each distinct promise to transfer a product or a service is a unit of accounting for revenue recognition. The determination of whether performance obligations in a contract are distinct may require significant judgment. If a promise to transfer a product or a service is not separately identifiable from other promises in the contract, such promises should be combined into a single performance obligation.

 

Determine the Transaction Price

 

The transaction price is the amount of consideration the Company is entitled to receive in exchange for the transfer of control of a product or a service to a customer. To determine the transaction price, the Company considers the existence of any significant financing component, the effects of any variable elements, noncash considerations and consideration payable to the customer. If a significant financing component exists, the transaction price is adjusted for the time value of money. If an element of variability exists, the Company must estimate the consideration it expects to receive and uses that amount as the basis for recognizing revenue as the product or the service is transferred to the customer. There are two methods for determining the amount of variable consideration: (i) the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts, and (ii) the mostly likely amount method, which identifies the single most likely amount in a range of possible consideration amounts.

 

Payments received under commercial arrangements, such as licensing technology rights, may include non-refundable fees at the inception of the arrangements, co-development reimbursements, milestone payments for specific achievements designated in the agreements, and royalties on the sale of products. At the inception of arrangements that include milestone payments, we use judgment to evaluate whether the milestones are probable of being achieved and we estimate the amount to include in the transaction price using the most likely method. If it is probable that a significant revenue reversal will not occur, the estimated amount is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not included in the transaction price until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of development milestones and any related constraint and, as necessary, we adjust our estimate of the overall transaction price. Any adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. To date, we have not recognized any material cumulative catch-up adjustments from changes in our estimate of the transaction price.

 

Allocate the Transaction Price to the Performance Obligations in the Contract

 

If a contract has multiple performance obligations, the Company allocates the transaction price to each distinct performance obligation in an amount that reflects the consideration the Company is entitled to receive in exchange for satisfying each distinct performance obligation. For each distinct performance obligation, revenue is recognized when (or as) the Company transfers control of the product or the service applicable to such performance obligation.

 

Recognize Revenue

 

The Company recognizes revenue when, or as, it satisfies a performance obligation by transferring a promised good or service to a customer and the customer obtains control of the good or service. Revenue related to the grant of a license that is a distinct performance obligation and that is deemed to be functional IP is recognized at the point in time that the Company has the right to payment for the license, the customer has legal title to the license and can direct the use of the license, the customer has the significant risks and rewards of ownership of the license and the customer has accepted the asset (i.e., license) by signing the license agreement.

 

Research and Development Costs

 

Research and development expenses consist primarily of salaries and other personnel related expenses including stock-based compensation costs, preclinical costs, clinical trial costs, costs related to acquiring and manufacturing clinical trial materials, and contract services. All research and development costs are expensed as incurred.

 

Clinical Trial Expenses

 

Expenses related to clinical studies are based on estimates of the services received and efforts expended pursuant to the Company’s contract arrangements. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to the Company’s service providers will temporarily exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of patients, site initiation and the completion of clinical milestones. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from its estimate, the Company adjusts the accrual or prepaid expense balance accordingly. Historically, the Company’s estimated accrued liabilities have materially approximated actual expense incurred. Clinical trial expenses are included in research and development expense.

 

  13  

 

Patent Costs

 

Costs related to filing and pursuing patent applications (including direct application fees, and the legal and consulting expenses related to making such applications) are expensed as incurred, as recoverability of such expenditures is uncertain. Patent costs are included in general and administrative expenses.

 

Debt Issuance Costs

 

Debt issuance costs incurred to obtain debt financings are deferred and are amortized over the term of the debt using the effective interest method. Debt issuance costs are recorded as a reduction to the carrying value of the debt and are amortized to interest expense in the statements of operations.

 

Income Taxes

 

The Company follows the FASB’s ASC 740, Income Taxes, or ASC 740, in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax assets and liabilities for expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.

 

The Company accounts for uncertain tax positions pursuant to ASC 740, which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

 

Stock-Based Compensation

 

Stock-based compensation expense represents the cost of the grant date fair value of employee and non-employee stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company recognizes forfeitures as they occur. The Company estimates the fair value of employee and non-employee stock option grants using the Black-Scholes option pricing model. 

 

Net Loss Per Share

 

Basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. The Company’s Series C convertible preferred stock (the "Convertible Preferred Stock"), and the Senior Secured Promissory Note Warrants issued in the pre-merger financing contain non-forfeitable rights to dividends with the common stockholders, and therefore are considered to be participating securities. The Convertible Preferred Stock and the warrants do not have a contractual obligation to fund the losses of the Company; therefore, the application of the “two class method” is not required when the Company is in a net loss position.

 

Diluted loss per share is computed using the more dilutive of the two class method or the treasury stock and if-converted methods. Dilutive earnings per share under the two class method is calculated by dividing net income available to common stockholders as adjusted for the participating impacts of the participating securities, by the weighted-average number of shares outstanding plus the dilutive impact of all other potential dilutive common shares. Dilutive earnings per share under the treasury stock and if-converted methods is calculated by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the dilutive impact of all potential dilutive common shares. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the potentially dilutive securities would be antidilutive.

 

The Company has calculated basic and diluted loss per share as follows (in thousands):

 

    Year Ended December 31,
    2020   2019
Numerator:                
                 
Net loss   $ (10,322 )   $ (10,052 )
Deemed dividend on freestanding warrant down round trigger     -       (12 )
Numerator for basic and diluted EPS   $ (10,322 )   $ (10,064 )

 

  14  

 

The following potential common shares were excluded from diluted net loss per share because the effects would have been antidilutive:

 

    Year ended December 31,
    2020   2019
Employee stock options     30,410,243       27,550,730  
Warrants for common stock     7,202,462       3,671,775  
Series A1 convertible preferred stock*     -       1,927,397  
Series A2 convertible preferred stock*     -       1,799,671  
Series B1 convertible preferred stock*     -       4,406,240  
Series C convertible preferred stock     11,674,131       8,117,627  
2017 convertible notes*     -       1,228,280  
2018 convertible notes*     -       261,088  
      49,286,836       48,962,808  

 

*The calculation of this dilutive instrument's weighted-average term outstanding for the year ended December 31, 2019 includes the pro-rated term for the period January 1, 2019 through March 8, 2019, at which point these instruments all converted into common stock of the Company (“the Common Stock”) pursuant to the Series C Financing (as defined below) (Note 6), which is not relevant to the year-ended December 31, 2020.

 

Comprehensive Loss

 

Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive loss was the same as its reported net loss for all periods presented.

 

Recently Adopted Accounting Pronouncements

 

In August 2018, the FASB issued ASU 2018-13, Changes to the Disclosure Requirements for Fair Value Measurement, which modifies certain disclosure requirements on fair value measurements. As required by ASU 2018-13, we adopted this ASU effective January 1, 2020. The adoption of ASU No. 2018-13 did not have a material impact on the Company's financial position, results of operations or cash flows.

 

In November 2018, the FASB issued ASU 2018-18, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements, and ASC Topic 606, Revenue from Contracts with Customers. The guidance, among other items, clarifies certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. As required by ASU 2018-18, we adopted this ASU effective January 1, 2020. The adoption of ASU No. 2018-18 did not have a material impact on the Company's financial position, results of operations or cash flows.

 

Recently Issued Accounting Pronouncements

 

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments— Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The Company is currently evaluating the potential impact that this standard may have on its financial statements and related disclosures.

 

  15  

 

In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, as part of its initiative to reduce complexity in accounting standards. The amendments in the ASU are effective for fiscal years beginning after December 15, 2020, including interim periods therein. Early adoption of the standard is permitted, including adoption in interim or annual periods for which financial statements have not yet been issued. We did not early adopt this ASU. The Company is currently evaluating the impact of the adoption of this standard on its financial statements.

 

In August 2020, FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which, among other things, provides guidance on how to account for contracts on an entity’s own equity. This ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, the ASU eliminated the need for the Company to assess whether a contract on the entity’s own equity (1) permits settlement in unregistered shares, (2) whether counterparty rights rank higher shareholder’s rights, and (3) whether collateral is required. In addition, the ASU requires incremental disclosure related to contracts on the entity’s own equity and clarifies the treatment of certain financial instruments accounted for under this ASU on earnings per share. This ASU may be applied on a full retrospective or modified retrospective basis. For smaller reporting companies, this ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption of the ASU is permitted for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the potential impact that this standard may have on its financial statements and related disclosures.

 

3. Balance Sheet Details

 

Accrued liabilities consisted of the following (in thousands):

 

    December 31,
    2020   2019
         
Accrued accounts payable   $ 1,018     $ 26  
Accrued clinical trial costs     875       83  
Accrued director stipends     759       218  
Accrued other     88       5  
    $ 2,740     $ 332  

 

4. Fair Value Measurements   

 

The Company follows ASC 820-10, Fair Value Measurements and Disclosures, which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement determined based on assumptions that market participants would use in pricing an asset or liability. The fair value hierarchy requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

 

As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

 

· Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;
· Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
· Level 3: Unobservable inputs for which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.

 

  16  

 

As of December 31, 2019, the Company did not have any financial assets or liabilities carried at fair value. As of December 31, 2020, the Company did not hold any financial assets or Level 1 or Level 2 financial liabilities. As of December 31, 2020, Level 3 financial liabilities measured at fair value consisted solely of the Company’s warrant liability issued in conjunction with its Senior Secured Promissory Notes (Note 5 - Debt). The fair value of the Senior Secured Note Warrant liability as of December 31, 2020 was $1.8 million.

 

As discussed in Note 5 - Debt, the Company entered into the 2018 Convertible Notes (as defined below) agreement providing warrants related to such financing event that met the definition of a derivative instrument in accordance with ASC 815 (the “Derivative Liability”). The Derivative Liability was required to be recorded at its estimated fair value initially and on a recurring basis (“the 2018 Liability Classified Warrants”). An initial fair value valuation was performed at issuance in October 2018. As further discussed in Note 5 - Debt, these warrants were exchanged for new warrants in contemplation of the Series C Financing (as defined below) in March 2019 and met the requirements for equity classification. Accordingly, the Derivative Liability was remeasured immediately before reclassification with a credit to earnings for the change in fair value.

 

The fair value of the 2018 Liability Classified Warrants was determined based on a probability-weighted valuation model of the various embedded features of the Company’s outstanding debt and equity instruments. The fair value is subjective and is affected by changes in inputs to the valuation model including management’s assumptions regarding estimates of timing and the probability of each embedded conversion feature occurring. Changes in these assumptions can materially affect the fair value.

 

As described in Note 6 – Stockholders’ Deficit, in connection with the Series C Financing, the lead investor of the Series C Financing purchased the right to purchase additional shares of Series C convertible preferred stock (“Additional Tranche Right”). The fair value of Additional Tranche Right was determined based on a probability-weighted valuation model and recorded as a Tranche Liability. As noted in Note 6 – Stockholders’ Deficit, the investor exercised this right in 2019 and the obligation was no longer outstanding as of December 31, 2019.

 

During 2020, the fair value, $1.9 million, of the Senior Secured Promissory Note warrant liability was determined using a Monte Carlo simulation model that considered: (i) the starting stock price of $0.4816, (ii) certain key event dates such expected capital financings, (iii) expected re-levered volatility of approximately 87 percent, (iv) risk-free interest rate of one-half percent, (v) contractual terms of approximately six years and (vi) a zero percent dividend rate. The exercise price reset features embedded in the warrants were valued using a Monte Carlo based valuation model. The Monte Carlo valuation technique was utilized because it embodies all of the requisite assumptions (including the underlying price, exercise price, term, volatility, and risk-free interest-rate) that are necessary to fair value these instruments. Estimating fair values of derivative financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. In addition, option-based techniques are highly volatile and sensitive to changes in the trading market price of the Company’s common stock. Because derivative financial instruments are initially and subsequently carried at fair values, the Company’s income will reflect the volatility in these estimate and assumption changes. The fair value is subjective and is affected by changes in inputs to the valuation model including management’s assumptions regarding estimates of timing and the probability of each embedded conversion feature occurring. Changes in these assumptions can materially affect the fair value. Changes in fair value are recognized as a component of other income (expense) in the statement of operations.

 

The following table summarizes the activity of the Company’s Level 3 derivative liabilities (in thousands):

 

    Warrant Liability   Tranche Liability
Opening value at January 1, 2019   $ 176     $  
Initial fair value at the original issuance date     83       79  
Change in fair value during the period     (158 )      
Settlement of derivative liabilities     (101 )     (79 )
Ending value at December 31, 2019            
Initial fair value at the original issuance date     1,868        
Change in fair value during the period     (38 )      
Ending value at December 31, 2020   $ 1,830     $  

 

5. Debt

 

Debt consisted of the following as of December 31, 2020 and 2019 (in thousands):

 

    December 31,   December 31,
    2020   2019
Financing agreement   $ 22     $ -  
Unsecured promissory notes     231       100  
Related party note     510       -  
Senior Secured debt     1,677       -  
Paycheck Protection Program Loan     279       -  
Total debt     2,719       100  
Less: Unamortized debt discounts     (1,578 )     -  
Total debt, net     1,141       100  
Less: current portion of debt     (1,047 )     (100 )
Non-current portion of debt   $ 94     $ -  

 

  17  

 

Financing Agreements

 

In June and October 2020, the Company entered into agreements to finance certain insurance policies (“the Financing agreements”). The Financing Agreements have a stated interest rate of 8.35%, are payable over ten months and are secured by the Company’s insurance policies. As of December 31, 2020, the aggregate remaining balance due under the Financing Agreements was $22,000.

 

Unsecured Promissory Notes

 

December 2019 Note

 

On December 18, 2019, the Company issued an unsecured promissory note for a principal sum of $100,000 to a consultant as payment for consulting services performed in 2019 (“the December 2019 Note”). The December 2019 Note had a maturity date in December 2020. The outstanding principal under the December 2019 note accrues interest at the annual rate of five percent simple interest. All principal plus accrued interest on the note is due and payable the earlier of the date which the Company closes on five million or more in revenue or gross financing proceeds or the maturity date. On December 18, 2020 (“the Amendment Effective Date”), the Company and the consultant mutually agreed to amend the terms of the December 2019 Note to extend the maturity date from December 18, 2020 to March 19, 2021. No other terms of the December 2019 Note were modified. Under the terms of the amendment, the Company had to pay the accrued and unpaid interest of $5,000, through the Amendment Effective Date and will continue to accrue through the amended maturity date. See Note 14 – Subsequent Events for an additional amendment to further extend the maturity date of the December 2019 Note to June 19, 2021.

 

As of December 31, 2020 and 2019, the outstanding balance on the note, including accrued interest, was $105,000 and $100,000, respectively, which is reported within the current portion of debt on the balance sheets. The Company determined that the present value in the change of cash flows was not greater than ten percent and therefore the amendment was accounted for as a modification. Upon the occurrence of certain Events of Default, including but not limited to the Company’s failure to satisfy its payment obligations under the note or the breach of certain non-financial covenants under the note, the lender will have the right, among other remedies, to declare all unpaid balance immediately due and payable. 

 

July 2020 Note

 

On July 9, 2020, the Company issued an unsecured promissory note for a principal sum of $125,000 with an original issue discount of 20 percent (“the July 2020 Note”). There were no issuance costs related to this transaction. Interest accrues on the unpaid principal amount at a rate equal to ten percent per annum, compounded annually. Principal and any accrued but unpaid interest under this note shall be due and payable upon demand of the holder at any time following the earlier to occur of (a) the date on which the Company receives at least $1,250,000 in gross proceeds from the issuance of equity securities or securities convertible into or exercisable for equity securities or (b) the 120th day following the issuance date of the note. In connection with the July 2020 Note, the Company issued the noteholder a warrant to purchase 25,000 shares of common stock, $0.001 par value per share.  The warrants have an exercise price of $0.73 per share, are immediately exercisable and will expire ten years from the grant date. On November 6, 2020, the Company and the lender mutually agreed to extend the maturity date of the July 2020 Note for an additional 120 days, or through March 6, 2021. No other terms of the original agreement were amended. The Company paid all outstanding accrued interest, which approximated $4,000, in conjunction with amendment and interest will continue to accrue at the original stated interest rate. See Note 14 – Subsequent Events for an additional amendment to further extend the maturity date of the July 2020 Note to June 6, 2021.

 

  18  

 

As of December 31, 2020, the outstanding balance of the note, including accrued interest, was $126,000.  The Company determined that the present value in the change of cash flows was not greater than 10 percent and therefore the amendment was accounted for as a modification.

 

October 2020 Note

 

On October 16, 2020, the Company issued an unsecured promissory note to the Yuma Regional Medical Center for a principal sum of $500,000 with an original issue discount of 10 percent. Interest accrues on the unpaid principal amount at a rate equal to 10 percent per annum, compounded annually. The note is due and payable 180 days from the issuance date, or April 14, 2021. See Note 7 – Common Stock Warrants for details of the warrants issued with the October 2020 Note and Note 14 – Subsequent Events for details related to the October 2020 Note Amendment.

 

As of December 31, 2020, the outstanding balance of the note, including accrued interest, was $510,000.

 

2017 Convertible Notes and Warrant Agreement

 

In 2017, the Company issued $2,775,000 aggregate principal amount of Convertible Senior Secured Promissory Notes (“2017 Convertible Notes”). A beneficial conversion feature was recognized upon issuance of the 2017 Convertible Notes. Issuance costs related to the transaction were immaterial. See Note 12 – Related Party Transactions for additional amounts of 2017 Convertible Notes issued. During the first half of 2018, the Company issued an additional $225,000 aggregate principal amount of 2017 Convertible Notes. The 2017 Convertible Notes had an original maturity date of June 30, 2018 and accrued interest at a rate of eight percent per annum. The Company, at its election, had the option to pay interest monthly or accrue the interest and pay it upon maturity.

 

In connection with the issuance of the 2017 Convertible Notes, the Company recognized an aggregate Beneficial Conversion Feature (“BCF”) charge of approximately $1.3 million. The BCF was recognized as debt discount and accreted to interest expense over the life of the 2017 Convertible Notes using the effective interest method, until conversion in March 2019. The Company recorded $38,000 and $0.8 million of interest expense related to the amortization of the debt discount associated with the BCF for the year ended December 31, 2019, which included the accretion of $26,000 representing the remaining unrecognized debt discount associated with the BCF upon conversion.

 

As a condition to and immediately prior to the first closing of the Series C financing in March 2019, the holders of the 2017 Convertible Notes agreed to convert their notes (including all principal and accrued interest) into 7,472,085 shares of Common Stock. The conversion into Common Stock was accounted for as a conversion and the remaining unamortized discount of $96,000 was accelerated and recorded to interest expense upon conversion. See Note 7 – Common Stock Warrants for details of the warrants issued with the 2017 Convertible Notes.

 

2018 Secured Notes and Warrant Agreement

 

In March 2018, the Company entered into Secured Notes and Warrant Agreement (“2018 Notes Agreement”) with several investors (collectively “the Lenders”) for up to a maximum aggregate amount of $1,250,000, pursuant to which the Lenders agreed to lend the Company $950,000 in a series of secured promissory notes (“2018 Secured Notes”). See Note 12 – Related Party Transactions for additional amounts of 2018 Secured Notes issued. The Company’s obligations under the 2018 Secured Notes Agreement were secured by a lien and security interest in the Company’s intellectual property. All the 2018 Secured Notes ranked pari passu in respect to payment of principal and interest upon any dissolution, liquidation or winding up of the Company.

 

The outstanding principal amount of the 2018 Secured Notes bore interest at a rate of 15 percent per annum. Interest accrued and was payable monthly to the Lenders from the date of issuance until such date on which the entire principal balance outstanding was paid in full or on the maturity date, March 31, 2019.

 

The original terms of the 2018 Secured Notes Agreement did not allow for conversion into any of the Company’s stock. As a condition to and immediately prior to the Series C Financing, the holders of the 2018 Secured Notes agreed to convert their notes into 2,107,384 shares of Common Stock of the Company. This conversion was accounted for as a debt extinguishment resulting in a loss on extinguishment of $429,000 recognized for the year ended December 31, 2019 based upon the fair value of the shares of Common Stock received upon extinguishment. See Note 7 – Common Stock Warrants for details of the warrants issued with the 2018 Notes Agreement.

 

2018 Convertible Notes and Warrant Agreement

 

In 2018, the Company issued $570,000 aggregate principal amount of Convertible Senior Secured Promissory Notes (“2018 Convertible Notes”). In 2019, the Company issued an additional $270,000 aggregate principal amount of 2018 Convertible Notes. The 2018 Convertible Notes had an original maturity date of January 1, 2020 and accrued simple interest at a rate of eight percent per annum, which was due and payable on the maturity date.

 

  19  

 

Upon the consummation of an equity financing in which the Company raised at least five million (excluding the conversion of prior convertible notes and any other outstanding indebtedness to the Company), the holders will have the option to convert all (but not less than all) of the 2018 Convertible Notes plus any accrued but unpaid interest into the same securities comprising a successful equity event, at a price per share of 80 percent of the lowest issue price paid per share of such other securities.

 

The 2018 Convertible Notes converted in connection with the Series C Financing in March 2019. As a condition to and immediately prior to the Series C Financing, the holders of the 2018 Convertible Notes agreed to convert their notes (including all principal and accrued interest) into 1,900,279 shares of Common Stock. The conversion was accounted for as a debt extinguishment with a loss on extinguishment of $592,000 recognized for the year ended December 31, 2019. See Note 7 – Common Stock Warrants for details of the warrants issued with the 2018 Convertible Notes.

 

Senior Secured Promissory Note 

 

In connection with the transactions contemplated by the Merger, on December 16, 2020, (i) the Company entered into a securities purchase agreement with an institutional investor (the “Investor”) pursuant to which, among other things, the Company agreed to issue senior secured promissory notes in the aggregate principal amount of up to $5.0 million, in exchange for an aggregate purchase price of up to $3.75 million, representing an aggregate original issue discount of up to $1.25 million (the “Senior Secured Promissory Notes”) and warrants (“Senior Secured Promissory Note Warrants”) to purchase shares of the Company’s common stock, and (ii) Seneca and the Company entered into a separate securities purchase agreement with the Investor pursuant to which, among other things, the Investor agreed to invest $20.0 million in cash and cancel any outstanding principal and interest on the Senior Secured Promissory Notes immediately prior to the closing of the Merger in exchange for shares of Series 1 Preferred Stock of the Company to be issued immediately prior to the closing of the Merger and warrants to purchase shares of Seneca’s common stock to be issued after the closing of the Merger, in private placement transactions. The Senior Secured Promissory Notes had a first closing on December 17, 2020 and a second closing on February 1, 2021 resulting in the issuance of $1.7 million in aggregate principal of Senior Secured Promissory Notes and Senior Secured Promissory Note Warrants to acquire 3,460,687 shares of common stock, with an exercise price of $0.4816 per share, at each closing. The third closing was at a date to be determined by the Company between March 16, 2021 and the closing of the merger. The Company did not elect to draw down the third tranche. At issuance of the first tranche, the fair value of the Senior Secured Promissory Note Warrants exceeded the debt proceeds resulting in a $0.8 million loss on issuance of debt. The debt was recognized at a zero-dollar carrying value and is being accreted to the principal amount of the debt, on a straight-line basis, through a charge to interest expense in the statement of operations.

 

The following table sets summarizes outstanding amounts associated with the Senior Secured Promissory Notes (in thousands):

 

    Principal   Unamortized Debt Discount   Carrying Value   Accrued Interest
December 31, 2020   $ 1,667     $ (1,537 )   $ 130     $ 10  

 

The following table sets forth the interest expense recognized related to the Company’s debt (in thousands):

 

    December 31,   December 31,
    2020   2019
Contractual interest expense   $ 42     $ 49  
Non-cash interest expense     193       201  
Total interest expense   $ 235     $ 250  

  

Paycheck Protection Program (“PPP”) 

 

In April 2020, the Company applied for and received $279,000 from the PPP (the “PPP Loan”) as government aid for payroll, rent and utilities. There were no issuance costs related to this transaction. The PPP Loan accrues simple interest at a rate of one percent per annum and has an original maturity date of April 2022. Payments of principal and interest are deferred for the ten-month period following the loan forgiveness period, which is defined as the 8-week or 24-week period following the loan origination date, at which time the loan balance is payable in monthly installments unless the Company applies for, and receives, forgiveness in accordance with the CARES Act and the terms of the loan executed by the Company and its lender. 

 

The application for these funds required the Company to, in good faith, certify that the current economic uncertainty made the loan request necessary to support the ongoing operations of the Company. This certification further required the Company to take into account its current business activity and its ability to access other sources of liquidity sufficient to support ongoing operations in a manner that is not significantly detrimental to the business. The certification made by the Company did not contain any objective criteria and is subject to interpretation. Based in part on the Company’s assessment of other sources of liquidity, the uncertainty associated with future revenues created by the COVID-19 pandemic and related governmental responses, and the going concern uncertainty reflected in the Company’s financial statements, the Company believed in good faith that it met the eligibility requirements for the PPP Loan. If, despite the good-faith belief that given the Company’s circumstances all eligibility requirements for the PPP Loan were satisfied, it is later determined that the Company had violated any applicable laws or regulations or it is otherwise determined the Company was ineligible to receive the PPP Loan, it may be required to repay the PPP Loan in its entirety and/or be subject to additional penalties and potential liabilities. 

 

  20  

 

On June 5, 2020, the Paycheck Protection Program Flexibility Act (the “PPP Flexibility Act”) was signed into law, extending the PPP Loan forgiveness period from 8 weeks to 24 weeks after loan origination, reducing the required amount of payroll expenditures from 75 percent to 60 percent, removing the prior ban on borrowers taking advantage of payroll tax deferral after loan forgiveness and allowing for the amendment of the maturity date on existing loans from two years to five years.  

 

In December 2020, the Company filed its application for forgiveness of the PPP Loan. The PPP Loan’s outstanding debt and accrued interest balance is reported on the balance sheet as of and December 31, 2020, of which approximately $185,000 is due within 12 months and is reported in current portion of debt, net. See Note 14 – Subsequent Events, for additional information regarding the PPP Loan.

 

Future Minimum Debt Payments

 

The following table summarizes future minimum debt payments as of December 31, 2020 (in thousands):

 

    Future Debt Payments
Fiscal year        
2021   $ 2,625  
2022     94  
2023     -  
2024     -  
2025 and thereafter     -  
Total debt maturities     2,719  
Less: debt discounts     (1,578 )
Total future minimum payments     1,141  
Less: current portion of debt     (1,047 )
Non-current portion of debt   $ 94  

 

6. Stockholders’ Deficit

 

Series C Convertible Preferred Stock

 

On March 8, 2019, the Company entered into an agreement with a lead investor for the purchase and sale, of up to an aggregate of 30 million shares of Series C for net proceeds of $9.8 million, net of issuance costs of $215,000, in two closings (the “Series C Financing”). On March 8, 2019, the Company completed the initial closing, which was comprised of 8,398,656 shares of Series C at an offering price of $0.893 per share. Contemporaneous with the initial closing, the lead investor agreed to purchase 2,799,552 additional shares of Series C at an offering price of $0.893 at a future date (“Additional Tranche Right”). The lead investor exercised such right on August 15, 2019. The Company issued 1,500,000 warrants to purchase common stock at an exercise price of $1.12 per share in connection with the first closing and issued 500,000 warrants to purchase common stock at exercise price of $1.12 per share in connection with the second closing. The warrants were classified as equity and were measured using a Black-Scholes valuation model.

 

At issuance, the Additional Tranche Right met the criteria for liability classification under ASC 480. The Company valued the Additional Tranche Right at $79,000 and recorded this right as a liability on the balance sheets. As of December 31, 2019, the Additional Tranche Right was no longer outstanding.

 

As of December 31, 2019, in addition to the Series C issued to the lead investor, the Company had issued 475,923 shares of Series C to other investors for net proceeds of $425,000. The Company issued 35,000 warrants to purchase common stock at an exercise price of $1.12 per share to these other investors. The warrants were classified as equity and were measured using a Black-Scholes valuation model.

 

Dividends

 

From and after the date of the issuance of any shares of Series C, dividends at the rate of eight percent (8 percent) per annum of the Original Issue Price (as defined below) shall accrue on such shares of Series C (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series C). The “Original Issue Price” shall mean $0.893 per share, subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Series C. Accruing dividends shall accrue from day to day, whether or not declared, and shall not be cumulative; provided however, that such accruing dividends shall be payable only when, as, and if declared by the board of directors of the Corporation and the Corporation shall be under no obligation to pay such accruing dividends. The Company shall not declare, pay or set aside any dividends on shares of any other class or series of capital stock of the Company (other than dividends on shares of Common Stock payable in shares of Common Stocks) unless the holders of the Series C then outstanding shall first receive, or simultaneously receive, a dividend on each outstanding share of Series C.

 

Liquidation

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series C then outstanding shall be entitled to be paid out of the assets of the Company available for distribution to its stockholders or, in the case of a deemed liquidation event, out of the consideration payable to stockholders in such deemed liquidation event or the available proceeds, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, an amount per share equal to one times (1x) the Original Issue Price, plus any dividends declared but unpaid thereon (the “Liquidation Preference”). If upon any such liquidation, dissolution or winding up of the Company or deemed liquidation event, the assets of the Corporation available for distribution to its stockholders shall be insufficient to pay the holders of shares of Series C the full Liquidation Preference, the holders of shares of Series C shall share ratably in any distribution of the assets available for distribution in proportion to the respective amounts which would otherwise be payable in respect of the shares held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full. The Series C is subject to redemption upon the occurrence of uncertain events, such as change in control, not solely within the Company’s control. Accordingly, the Series C is included within temporary equity on the balance sheets. The Company does not consider the change in control to be probable and accordingly the Company does not adjust the Series C Preferred Stock to redemption value. The liquidation preference of the Series C as of each December 31, 2020 and 2019 was $10.4 million. 

 

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Voting

 

On any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series C shall be entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Series C held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.

 

Conversion

 

Each share of Series C shall be convertible, at the option of the holder thereof, at any time and from time to time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and non-assessable shares of Common Stock as is determined by dividing the Original Issue Price by the Conversion Price (as defined below) in effect at the time of conversion. The “Conversion Price” of the Series C Preferred Stock shall initially be equal to $0.893.

 

Upon either (a) the closing of the sale of shares of Common Stock to the public at a price of at least one-and-a-half times (1.5x) the Original Issue Price (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Common Stock), in a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $40.0 million of gross proceeds, (b) the closing of a merger or other business combination with an existing public company that results in at least $35.0 million of cash and cash equivalents on the surviving company’s balance sheets as of the closing date of such transaction, or (c) the date and time, or the occurrence of an event, specified by vote or written consent of the required holders (the time of such closing or the date and time specified or the time of the event specified in such vote or written consent is referred to herein as the “Mandatory Conversion Time”), then (i) all outstanding shares of Series C shall automatically be converted into shares of Common Stock, at the then effective conversion rate as calculated and (ii) such shares may not be reissued by the Company.

 

Common Stock

 

In March 2019, as a condition to and immediately prior to the initial closing of the Series C Financing, all previously outstanding shares of the Company’s Series A1, A2 and B1 Convertible Preferred Stock converted into shares of Common Stock at the existing conversion rates of 2.0, 6.0 and 2.0408, respectively.

 

Each share of Common Stock is entitled to one vote at all meetings of shareholders. All shares of Common Stock are equal to each other with respect to liquidation rights and dividend rights. There are no preemptive rights to purchase any additional shares of Common Stock. In the event of liquidation, dissolution or winding up of the Company, holders of shares of Common Stock will be entitled to receive on a pro rata basis all assets of the Company remaining after satisfaction of all liabilities and all liquidation preferences, if any, granted to holders of preferred stock.

 

After payment of any dividends on Convertible Preferred Stock, the holders of outstanding shares of Common Stock are entitled to receive dividends out of assets legally available therefore at such times and in such amounts as the board of directors may from time to time determine. Holders of Common Stock will share equally on a per share basis in any dividend declared by the board of directors. The Company has not paid any dividends on Common Stock and do not anticipate paying any cash dividends on such stock in the foreseeable future. In the event of a merger or consolidation, all holders of Common Stock will be entitled to receive the same per share consideration.

 

As of December 31, 2020 and 2019, the Company had reserved shares of Common Stock, on an as-if converted basis, for issuance as follows (in thousands):

 

    December 31,   December 31,
    2020   2019
Series C convertible preferred stock outstanding     11,674       11,674  
Common stock options outstanding     30,410       27,551  
Common stock warrants outstanding     7,202       3,672  
Common stock options available for issuance under the Plan     4,181       7,040  
Total     53,467       49,937  

 

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7. Common Stock Warrants

 

From time to time, the Company issues warrants for the purchase of the Company’s common stock to its investors, creditors and various other individuals, as noted below. Equity classified warrants for the purchase of the Company’s common stock are included as additional paid-in capital, a component of stockholder’s deficit. Common stock warrants accounted for as liabilities in accordance with ASC 815 are included in non-current liabilities. The warrants have an exercise price ranging from $0.48 to $1.12 per share and generally expire five and ten years after the date of issuance. The Company had common stock warrants issuable and outstanding of 7,202,462 and 3,671,775, at December 31, 2020 and 2019, respectively.

 

2017 Convertible Notes Warrants

 

In connection with the 2017 Convertible Notes, the Company issued the investors 300,000 warrants (“2017 Convertible Note Warrants”) to purchase common stock at $0.75 per share. The 2017 Convertible Note Warrants expire ten years from the date of issuance and meet the criteria for equity classification. Accordingly, the fair value of the 2017 Convertible Notes and Warrants were estimated on the date of issuance using a Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis.

 

In June 2018, the 2017 Convertible Notes were modified to extend the maturity date to December 31, 2018. In conjunction with the extension, the Company issued the holders additional warrants (“2017 Modification Warrants”) which also included terms for down round protection. The amendment also provided the Company with the option to further extend the maturity date to June 30, 2019 subject to the issuance of additional warrants. The 2017 Modification Warrants met the criteria to be classified as equity as the Company early adopted ASU 2017-11, Accounting for Certain Financial Instruments with Down Round Features, which allows certain down round features to be excluded from the consideration of whether the instrument may be classified as equity. As such, the 2017 Modification Warrants were recognized in equity at a fair value of $45,000 on the June 30, 2018 date of issuance. As the 2017 Modification Warrants were issued by the Company to creditors at the time of the extension, the fair value of the modification was capitalized as debt issuance cost and amortized over the remaining term of the debt. As a result of the Series C Financing, in March 2019, these warrant holders consented to the exchange of these warrants for new warrants (“2017 Modification New Warrants”) with the same expiration date but with an exercise price equal to $1.12 per share to reflect the adjusted exercise price in satisfaction of the down-round feature of the original warrant agreement. As recognition of this event, and in accordance with ASU 2017-11, the change in fair value of $12,000 was recorded as a deemed dividend.

 

On December 31, 2018, the Company exercised its option to extend the maturity date of the 2017 Convertible Notes to June 30, 2019 and as such, additional warrants (“2017 Extension Warrants”) were issued. The 2017 Extension Warrants were issued with the same provisions as the 2017 Modification Warrants with the exception of having a fixed exercise price of $1.12 per share. The 2017 Extension Warrants expire ten years from the date of issuance and meet the criteria for equity classification. As the 2017 Extension Warrants were not issued until March 2019, the Company recognized a warrants issuable equity value of fair value of $87,068 in additional paid in capital using the Black-Scholes valuation model on December 31, 2018, to record the 166,421 2017 Extension Warrants issuable, upon the Company’s election to extend the 2017 Convertible Notes maturity date.

 

2018 Notes Agreement Warrants

 

Pursuant to the 2018 Notes Agreement, the Company issued to each Lender a warrant (“2018 Secured Notes Warrants”) to purchase that number of shares of the Company’s Common Stock, $0.001 par value per share, equal to ten percent of such Lender’s principal note amount for an exercise price of $0.75 per share. The warrants are immediately exercisable and will expire ten years from the grant date.

 

The 2018 Secured Notes Warrants meet the criteria for classification as equity. Accordingly, the fair value of the 2018 Secured Notes and 2018 Secured Notes Warrants were estimated on the date of issuance using the Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis. The debt discounts on the 2018 Secured Notes were amortized over the contractual period of the notes using the effective interest rate method.

 

2018 Convertible Notes Warrants

 

In connection with the 2018 Convertible Notes, the Company issued the investors warrants (“2018 Convertible Notes Warrants”) to purchase shares of Common Stock. During the years ended December 31, 2019 and December 31, 2018, the Company issued 94,500 and 199,500 warrants, respectively, in connection with the 2018 Convertible Notes. The number of shares of common stock for which the 2018 Convertible Notes Warrants may be exercised is equal to 35 percent of the amount of principal and accrued but unpaid interest of the 2018 Convertible Note. The 2018 Convertible Notes Warrants expire ten years from the date of issuance and meet the criteria for liability classification. The fair value of the 2018 Convertible Notes Warrants to purchase common stock issued in connection with the 2018 Convertible Notes was estimated on the date of issuance using a Monte Carlo simulation model and the proceeds were allocated to the warrants based on its standalone fair value, with the residual proceeds allocated to the Convertible Notes. The debt discounts on the 2018 Convertible Notes were amortized over the contractual period of the notes using the effective interest rate method.

 

During March 2019 and in contemplation of the Series C Financing, all of the 2018 Convertible Note Warrants were exchanged for warrants (“2018 Convertible Notes New Warrants”) with a fixed number of shares and explicit exercise price. The 2018 Convertible Notes New Warrants expire ten years from the date of issuance and meet the criteria for equity classification. Accordingly, the derivative liability was remeasured immediately before reclassification with a credit to earnings for the change in fair value.

 

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October 2020 Note Warrants

 

In connection with the issuance of the October 2020 Note, the Company issued the holder a warrant to purchase 45,000 shares of common stock.  The warrants have an exercise price of $0.73, are immediately exercisable and will expire ten years from the grant date. The October 2020 Note Warrants meet the criteria for classification as equity. Accordingly, the fair value of the October Notes and October 2020 Note Warrants were estimated on the date of issuance using the Black-Scholes valuation model and the proceeds were allocated across each component on a relative fair value basis. The debt discounts on the October 2020 Note Warrants were amortized over the contractual period of the notes using the effective interest rate method.

 

Senior Secured Promissory Note Warrants

 

In connection with the issuance of the Senior Secured Promissory Notes, the Company issued the investor a warrant for the purchase of up to 3,460,687 shares of the Company’s common stock (the Senior Secured Promissory Note Warrants). In addition, if each additional tranche is drawn down, the investor may receive up to 3,460,687 of additional warrants per tranche. The Senior Secured Promissory Note Warrants have an exercise price of $0.4816 per share and expire five years from the date of registration or April 27, 2026 (see Note 14 – Subsequent Events for details of the Merger). The Senior Secured Promissory Note Warrants did not meet the criteria for equity classification because of multiple features, including a potential adjustment to the exercise price and the potential for cash settlement of the warrants; therefore the warrants are accounted for as liabilities in accordance with ASC 815. The Company valued the Senior Secured Promissory Note Warrants using a Monte-Carlo valuation model with a resulting fair value of $1.9 million. The Company recognized the Senior Secured Promissory Note Warrants at fair value at the date of issuance of the notes. As the fair value of the Senior Secured Promissory Note Warrants, at issuance on December 17, 2020, exceeded the note proceeds, a loss on debt issuance of $0.8 million was recognized during 2020. The Senior Secured Promissory Note Warrants will be revalued at fair value each reporting period in accordance with ASC 815.

 

The following table summarizes warrant activity for the years ended December 31, 2020 and 2019:

 

    Number of Warrants   Weighted Average Exercise Price   Weighted Average Remaining Contractual Life (Years)
Warrants issuable and outstanding, December 31, 2018     1,542,275     $ 1.06       8.31  
Granted     2,583,921     $ 1.15       -  
Exercised     -     $ -       -  
Forfeited, expired or cancelled     (454,421 )   $ 1.90       -  
Warrants outstanding, December 31, 2019     3,671,775     $ 1.02       8.47  
Granted     3,530,687     $ 0.48       -  
Exercised     -     $ -       -  
Forfeited, expired or cancelled     -     $ -       -  
Warrants outstanding, December 31, 2020     7,202,462     $ 0.76       6.28  

 

8. Equity Incentive Plan

 

The Company’s Employee, Director and Consultant Equity Incentive Plan (the “Plan”) provides for the grant of the following stock awards to employees, directors and consultants of the Company: incentive stock options and non-statutory stock options. The current number of shares authorized and reserved for issuance under the Plan is 35,000,000 shares of common stock. The number and terms of options granted under the Plan are determined by the board of directors when granted. Options are exercisable for a period determined by the board of directors, generally not more than ten years following the date of grant. The Company estimates the fair value of each stock option using the Black-Scholes option pricing model under ASC 718. The following table summarizes stock option activity and related information under all equity plans for the year ended December 31, 2020:

 

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    Options Outstanding   Weighted-average Exercise Price   Weighted-average Remaining Contractual Term (in years)   Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2019     27,550,730     $ 0.91       7.20     $ 3,027  
Granted     2,859,513     $ 0.73                  
Exercised     -     $ -                  
Cancelled or forfeited     -     $ -                  
Outstanding at December 31, 2020     30,410,243     $ 0.89       6.49     $ 1,541  
Options vested and expected to vest at December 31, 2020     30,410,243     $ 0.89       6.49     $ 1,541  
Options exercisable at December 31, 2020     27,281,915     $ 0.89       6.22     $ 1,541  

  

The weighted-average grant date fair value of options granted during the years ended December 31, 2020 and 2019 was $0.55 and $0.43, respectively.

 

As of December 31, 2020, the unrecognized compensation cost related to outstanding options was $1.4 million which was expected to be recognized over a weighted-average period of approximately 1.54 years.

 

The allocation of stock-based compensation for all stock awards is as follows (in thousands):

 

    Year Ended December 31,
    2020   2019
Research and development   $ 534     $ 462  
General and administrative     1,480       2,863  
Total stock-based compensation expense   $ 2,014     $ 3,325  

  

The weighted-average assumptions used in the Black-Scholes option pricing model to determine the fair value of stock option grants were as follows:

 

    December 31,
    2020   2019
Expected term (years)     8.18       6.69  
Risk-free interest rate     0.98 %     2.22 %
Expected dividend yield     -       -  
Volatility     80.0 %     80.0 %

  

Risk-free interest rate.  The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants.

 

Expected dividend yield.  The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends.

 

Expected volatility.  Due to the Company’s limited operating history and lack of company-specific historical or implied volatility, the expected volatility assumption is based on historical volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry.  

 

Expected term.  The expected term represents the period of time that options are expected to be outstanding. As the Company does not have sufficient historical exercise behavior, it determines the expected life assumption using the simplified method, which is an average of the contractual term of the option and its vesting period. 

  

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Executive Officer Settlement Agreement

 

The Company’s former Chief Executive Officer resigned in 2016. The Company reached a settlement (“Settlement Agreement”) with the former Chief Executive Officer in 2017 wherein certain options for the purchase of 2,550,000 shares of the Company’s common stock, were modified (“the Modified Options”) which allowed for a potential put right under certain circumstances. The put right expired unexercised in the fourth quarter of 2019. As of December 31, 2020, the Modified Options, with an exercise price of $0.40 per share, remained outstanding. The Company recognized a gain of $128,000 in the fourth quarter of 2019 due to the expiration of the put feature. See Note 14 – Subsequent Events for information regarding the expiration of the Modified Options. 

 

Restricted Stock Award

 

In May 2020, the Company issued a restricted stock award for 11,987 shares of the Company’s common stock (“the Restricted Award”). The Restricted Award was fully vested upon grant and was issued as partial settlement for services from a vendor.

 

9. Employee Benefits

 

Effective June 20, 2016, the Company adopted a defined contribution 401(k) plan. All employees are eligible to participate in the plan beginning on the first day of employment. Under the terms of the plan, employees may make voluntary contributions as a percent of compensation. No matching contributions have been made by the Company since the adoption of the 401(k) plan.

 

10. Collaboration and License Agreements

 

Co-Development and Distribution Agreement

 

In February 2018, the Company entered into a co-development and distribution agreement (“Co-Development and Distribution Agreement”) with Biolead Medical Technology Ltd. to develop and commercialize the Company’s proprietary LB1148 formulation (the “Commercial Product”). Biolead Medical Technology Ltd. subsequently transferred all of its rights under the Co-Development and Distribution Agreement to Newsoara Biopharma Co., Ltd. (“Newsoara”). The development and commercialization rights are specific to the territories comprising the People’s Republic of China, including the Hong Kong Special Administrative region and the Macao Special Administrative Region, but excluding Taiwan (collectively the “Chinese Territory”). The Company retains all development and commercialization rights outside the Territory.

 

In 2018, the Company recognized $1 million in revenue from the upfront payment. The Company has the right to receive future milestones and royalties which are fully constrained.

 

During the years ended December 31, 2020 and 2019, the Company recognized no revenue under this arrangement. As of December 31, 2020, there was no deferred revenue related to the arrangement.

 

License Agreements with the Regents of the University of California

 

The Company has entered into two license agreements, as amended, with the Regents of the University of California (“Regents”) for exclusive commercial rights to certain patents, technology and know-how. The technology is related to the Company’s products under development. The Regents are entitled to certain development and sales milestones.

 

In February 2018, in conjunction with the Co-Development and Distribution Agreement with Newsoara, the Company was obligated to pay the Regents $125,000 in royalties for its portion of the sublicense income equal to 30 percent of one-third of the upfront payment and milestone payment received. As of December 31, 2020 and 2019, the $125,000 royalty payable was included in Accounts Payable.

 

11. Commitments and Contingencies

 

Facility Leases

 

The Company leases office space for its corporate headquarters under a non-cancelable facility operating lease for 4,911 square feet located in Carlsbad, California. The Company originally subleased this office space starting in July 2017 with the lease expiring in January 2019. There were no future payments due under this non-cancelable operating lease as of December 31, 2018.

 

In January 2019, the Company entered into a six-month facility operating lease in Carlsbad, California. The lease commenced on February 1, 2019 with contractual rent payments of approximately $15,500 per month through the lease expiration date in July 2019. No tenant improvement allowances or common area maintenance lease components exist as part of the lease. The Company accounted for this lease by applying the practical expedient for short-term leases which resulted in the Company recognizing expense on a straight-line basis over the lease term. The total short-term lease cost was approximately $93,000 and such amounts were recorded within general and administrative expenses on the statement of operations.

 

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In July 2019, the Company entered into a facility operating lease (the “July 2019 Headquarter Lease”) in Carlsbad, California. The initial contractual term is three years commencing on August 1, 2019 and expiring on July 31, 2022. The Company has the option to renew this lease for an additional 36-month period at the prevailing market rent upon completion of the initial lease term. The Company has determined it is not reasonably certain that it will exercise this renewal option. Therefore, the lease term is determined to be a total of three years commencing on August 1, 2019 and expiring on July 31, 2022. Commencing in August 2019, the Company will pay contractual monthly lease payments of $16,000 for the first 12 months. The contractual monthly lease payments are subject to 3 percent escalations at the first and second lease commencement anniversary.

 

The July 2019 Headquarter Lease is also subject to additional variable charges for common area maintenance, insurance, taxes and other operating costs. This additional variable rent expense is not estimable at lease inception. Therefore, it is excluded from the Company’s straight-line expense calculation at lease inception and is expensed as incurred. All fixed and variable lease payment amounts were recorded within general and administrative expenses on the statement of operations.

 

The Company’s incremental borrowing rate was 15 percent as of January 1, 2019 (the adoption date of Topic 842). The incremental borrowing rate for the Company’s continues to be 15 percent as of December 31, 2020.

 

Office lease deferral of payments concession

 

On April 29, 2020, the Company entered into a rent deferral agreement with its landlord pursuant to the financial impacts of the COVID-19 pandemic on the Company. Under the terms of the arrangement, the Company would begin repaying any deferred balance in equal installments prorated over six months beginning October 2020. Through December 31, 2020, the Company was in discussions with its landlord regarding the extension of the deferral period. As of December 31, 2020, deferred balances under this arrangement total $87,000 and are included in accounts payable on the Company’s balance sheets. 

 

The Company had the following activity related to its operating leases as of and during the years ended December 31, (in thousands):

 

    Year Ended December 31,
    2020   2019
                 
Lease cost   $ 194     $ 183  

 

Supplemental balance sheets information related to operating leases as follows (in thousands):

 

    December 31,
    2020   2019
Assets        
Right-of-use asset   $ 275     $ 418  
Liabilities                
Current portion of lease liability   $ 168     $ 140  
Non-current portion of lease liability     112       281  
Total lease liabilities   $ 280     $ 421  

 

Supplemental cashflow information related to leases is as follows:

 

    Year Ended December 31,
    2020   2019
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows used for operating leases (in thousands)   $ 141     $ 51  
                 
Weighted-average remaining lease term in years     1.6       2.5  
Weighted-average discount rate     15 %     15 %

 

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Future minimum payments of lease liabilities were as follows (in thousands):

 

Years ending December 31,   Operating Leases
2021   $ 197  
2022     117  
2023     -  
2024     -  
2025     -  
Total minimum lease payments     314  
Less: imputed interest     (34 )
Total future minimum lease payments     280  
Less: current portion of lease liability     (168 )
Non-current portion of lease liability   $ 112  

 

Derecognition of Accounts Payable

 

The Company engaged a third-party vendor to perform clinical research services in 2014. The Company was not satisfied with the services performed by the vendor and believed there was a breach of contract by the vendor. The Company’s board of directors voted to terminate the study and the Company stopped making any further payments in 2016. The amounts accrued represented amounts invoiced by the vendor and not paid by the Company. The vendor did not pursue any further collection of the invoiced amounts, and the Company did not pursue any claims for breach of contract. Upon lapse of the statute of limitations, during the first quarter of 2019, the Company derecognized the outstanding accounts payable balance and recorded a gain in the amount of $1.4 million as a contra expense in the operating expense section of the statement of operations.

 

Accrued Employee Compensation

 

As of December 31, 2020, certain Company executives and employees voluntarily agreed to temporarily suspend a portion of their salary benefits and bonuses. As of December 31, 2020, $1.1 million was accrued related to these suspended salary benefits and bonuses which were paid upon the closing of the Merger in the second quarter of 2021. See Note 14 – Subsequent Events, for information on closing of the Merger.

 

Legal Proceedings

 

Between January 8 and March 3, 2021, nine individual lawsuits (captioned Sheridan v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00166 (S.D.N.Y. filed Jan. 8, 2021); Pirjamaat v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00172 (S.D.N.Y. filed Jan. 8, 2021); Johnson v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00310 (S.D.N.Y. filed Jan. 13, 2021); Mathews v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00242 (E.D.N.Y. filed Jan. 15, 2021); Pechal v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00585 (S.D.N.Y. filed Jan. 22, 2021); Curtis v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00292 (D. Del. Feb. 25, 2021); Valdez v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00980 (E.D. Pa. Mar. 1, 2021); Anderson v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-00326 (D. Del. Mar. 2, 2021); and McIntire v. Seneca Biopharma, Inc., et al., Case No. 1:21-cv-01869 (S.D.N.Y. Mar. 3, 2021)) were filed in federal court by alleged Seneca Biopharma, Inc. (“Seneca”) stockholders challenging the proposed merger of Seneca and the Company (the “Merger”). The complaints name Seneca and Seneca’s board of directors as defendants. The Sheridan, Valdez, and Pirjamaat complaints name the Company as an additional defendant.

 

On March 18, 2021, Seneca filed an amendment to the Registration Statement on Form 8-K, which contained certain supplemental disclosures intended to moot the plaintiffs’ disclosure claims (the “Supplemental Disclosures”). Thereafter, all nine cases were voluntarily dismissed, and counsel for plaintiffs requested a mootness fee for the purported benefit conferred on Seneca’s stockholders in connection with the Supplemental Disclosures. The parties engaged in a negotiation and settled for a mootness fee of $216,000 in the second quarter of 2021. No amounts were accrued for these matters in Leading Biosciences’ financial statements as of 3/31/21 or 12/31/20 as the settlement was reached with Seneca.

 

From time to time, the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. Management believes there are no claims or actions pending against the Company at December 31, 2020 which will have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position or results of operations. Litigation, however, is subject to inherent uncertainties, and an adverse result in such matters may arise from time to time that may harm the Company’s business.

 

Indemnification

 

In accordance with the Company’s amended and restated memorandum and articles of association, the Company has indemnification obligations to its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims. 

 

12. Related Party Transactions

 

Unsecured Related Party Notes

 

In November 2013, the Company entered into an unsecured promissory note in the amount of $50,000 with an executive officer of the Company. The note bore interest at five percent and was due and payable upon the Company receiving a qualified financing of at least $10 million, but no later than November 2020. The Company fully repaid the remaining outstanding principal and accrued interest balance in 2019.

 

In May 2015, the Company entered into an unsecured promissory note of $94,000 with a shareholder and director of the Company. The note bore interest at five percent and was due and payable upon the Company receiving a qualified financing of at least $10 million, but no later than May 2022. During 2015, the Company made payments on the note totaling $58,000. The Company fully repaid the remaining outstanding principal and accrued interest balance in 2019.

 

The Yuma Regional Medical Center (“YRMC”) is an equity investor in the Company and is considered a related party. As discussed in Note 5, on October 16, 2020, the Company entered into an unsecured promissory note of $500,000 with YRMC. For details surrounding this promissory note, see Note 5.

 

  28  

 

Convertible and Secured Notes

 

2017 Convertible Notes

 

Between February 2017 and June 2018, the Company issued $100,000 in 2017 Convertible Notes to a director and $235,000 in 2017 Convertible Notes to an executive officer of the Company on the same terms outlined in Note 5 - Debt. In connection with the Series C Financing, these notes were converted to Common Stock in accordance with the terms outlined in Note 5 - Debt.

 

2018 Secured Notes

 

Between March 2018 and May 2018, the Company issued $275,000 in 2018 Secured Notes to two directors and $200,000 in 2018 Secured Notes to an executive officer of the Company under the same terms outlined in Note 4 above. In February 2019, a director, who had purchased a $250,000 2018 Secured Note from the Company, sold the 2018 Secured Note to a non-related party. In March 2019, an executive officer of the Company purchased a 2018 Secured Note for $25,000 from a non-related party noteholder. Also, in March 2019, an executive officer of the Company purchased a 2018 Secured Note for $10,000 from a director of the Company. In connection with the Series C Financing, these 2018 Secured Notes were converted to Common Stock in accordance with the terms outlined in Note 6 – Stockholders’ Deficit.

 

Director stipends

 

Unpaid cash stipends owed to our directors for their annual board service are recorded on our balance sheets within accrued liabilities. These liabilities were $759,000 and $218,000 as of December 31, 2020 and 2019, respectively.

 

13. Income Taxes

 

The components of the provision for income taxes are as follows (in thousands):

 

    Year Ended December 31,
    2020   2019
Current:                
Federal   $ -     $ -  
State     1       1  
Total current provision     1       1  
Deferred                
Federal     -       -  
State     -       -  
Total deferred provision     -       -  
Income tax expense   $ 1     $ 1  

 

Provision

 

Taxes on income vary from the statutory federal income tax rate applied to earnings before tax on income as follows (in thousands):

 

    Year Ended December 31,
    2020   2019
Statutory federal income tax rate of 21 percent applied to earnings before income taxes and extraordinary items   $ (2,168 )   $ (2,111 )
State taxes - net of federal benefit     1       1  
Meals and entertainment     1       5  
Warrants     (8 )     (33 )
Stock-based compensation     97       86  
Valuation allowance     1,891       2,007  
Others     187       46  
    $ 1     $ 1  

 

  29  

 

Deferred income tax assets and liabilities arising from differences between accounting for financial statement purposes and tax purposes, less valuation reserves at year end are as follows (in thousands):

 

    Year Ended December 31,
    2020   2019
Deferred tax assets:                
Accrued expenses   $ 512     $ 20  
Charitable contributions carryforward     -       11  
Lease accounting     2       -  
Net operating loss carryforwards     8,073       6,987  
Stock compensation     1,438       1,111  
Total deferred tax assets     10,025       8,129  
                 
Deferred tax liabilities:                
Prepaid expense     (7 )     (4 )
Total deferred tax liabilities     (7 )     (4 )
                 
Net deferred tax asset     10,018       8,125  
Valuation Allowance     (10,018 )     (8,125 )
Net deferred taxes   $ -     $ -  

 

As of December 31, 2020, the Company had federal net operating loss carry forwards of approximately $38.4 million. Of this amount, approximately $15.9 million arose in tax years ending after December 31, 2017 and will carry forward indefinitely. The federal net operating loss carryforwards arising in tax years ending before January 1, 2018 of approximately $22.6 million will begin to expire in 2031 unless previously utilized. Pursuant to Internal Revenue Code (“IRC”) Sections 382 and 383, annual use of the Company's net operating loss carryforwards may be limited in the event a cumulative change in ownership of more than 50 percent occurs within a three-year period. The Company has not performed an analysis to determine if it has experienced an IRC Section 382 and 383 ownership change.

 

Deferred tax assets and liabilities are recognized for temporary differences and unused tax losses to the extent that realization of the related tax benefits is more likely than not. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods when the deferred tax assets become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on the uncertainty of the realization of its deferred tax assets, a valuation allowance has been established against the company's net deferred tax assets.

 

The Company files income tax return in the U.S. federal jurisdiction and various states. The Company's tax returns for tax years 2017 and forward remain subject to examination by the Internal Revenue Service and the various state taxing authorities.

 

The Company accounts for taxation under ASC Subtopic 740-10, which clarifies the accounting for uncertain tax positions. ASC Subtopic 740-10 requires that the Company recognize the impact of a tax position in its financial statement if the position is more likely than not to be sustained upon examination based on the technical merits of the position. The Company did not have any uncertain income tax positions as of December 31, 2020.

 

ASC 740-10 requires the Company to accrue interest and penalties where there is an underpayment of taxes based on the Company's best estimate of the amount to ultimately be paid. The Company identified no unrecorded material uncertain tax positions as of December 31, 2020, consequently no interest or penalties have been accrued by the Company. The Company does not anticipate a significant change to its unrecognized tax benefits within the next 12 months.

 

On March 27, 2020, the United States enacted the CARES Act. The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the United States economy and fund a nationwide effort to curtail the effect of COVID-19. While the CARES Act provides sweeping tax changes in response to the COVID-19 pandemic, the related income tax provisions did not have a material impact on the Company.

 

On December 27, 2020, the United States enacted the Consolidated Appropriations Act, 2021 (the "Appropriations Act"). Included in the tax provisions are a number of items directly related to COVID-19 relief such as a provision allowing recipients of Paycheck Protection Program (“PPP”) loans to deduct associated costs and an extension and significant expansion of the employee retention credit originally enacted in the CARES Act. There was no material impact from the provisions of the Appropriations Act in 2020.

 

  30  

 

14. Subsequent Events

 

The Company has evaluated subsequent events through July 13, 2021, the date of issuance of the financial statements.

 

PPP Loan Forgiveness

 

In January 2021, the Company received notification the PPP Loan was forgiven and recognized a gain a $279,000, in other income in the statements of operations.    

 

Option Modification

 

The Company’s former Chief Development Officer was terminated in February 2021. As part of the separation agreement, the Company’s board of directors agreed to (i) accelerate vesting by four months for the former employee’s outstanding options and (ii) allow up to seven years from the termination date for the former employee to exercise all vested options. The Company concluded these actions resulted in an accounting modification of these awards.

 

Amended Unsecured Promissory Notes

 

July 2020 Note

 

On March 19, 2021, the Company and a consultant to the Company further amended the terms of the July 2020 Note (See Note 5 – Debt) to further extend the maturity date from March 19, 2021 to June 19, 2021. Interest continues to accrue under the terms of the original unsecured promissory note and is due and payable with the principal on June 19, 2021. On May 25, 2021, Palisade Bio, LBS and the noteholder amended the July 2020 note to extend the maturity date of the note to November 15, 2021 (the “Notes Amendment”). In connection with the Notes Amendment, the original warrant issued with this note was canceled and Palisade Bio issued a new warrant to purchase 3,000 shares of Common Stock at a purchase price of $6.00 per share.

 

December 2019 Note

 

On March 19, 2021, the Company and a consultant to the Company further amended the terms of the December 2019 Note (See Note 5 – Debt) to further extend the maturity date from March 19, 2021 to June 19, 2021. Interest continues to accrue under the terms of the original unsecured promissory note and is due and payable with the principal on June 19, 2021.

 

October 2020 Note

 

On May 25, 2021, Palisade Bio, LBS and the noteholder amended the October 2020 Note to extend the maturity date of the note to November 15, 2021 (the “Notes Amendment”). In connection with the Notes Amendment, the original warrant issued with this note was canceled and Palisade Bio issued a new warrant to purchase 5,000 shares of Common Stock at a purchase price of $6.00 per share.

 

Senior Secured Note

 

The second tranche of the Senior Secured Notes was drawn on February 1, 2021 for a principal note amount of $1.7 million along with a warrant to purchase up to 3,460,687 shares of the Company’s Common Stock.

 

Option Expiration 

 

On April 2, 2021, the 2,550,000 options outstanding pursuant to the Company’s Settlement Agreement, as defined in Note 8 – Equity Incentive Plan, with its former CEO expired unexercised.

 

Merger

 

On April 27, 2021, pursuant to the Agreement and Plan of Merger (the “Merger Agreement”), dated as of December 16, 2020, by and among Palisade Bio, Inc., formerly known as Seneca Biopharma, Inc., Leading Biosciences, Inc. and Townsgate Acquisition Sub 1, Inc., a wholly owned subsidiary of Seneca Biopharma (“Merger Sub”), LBS completed the previously announced merger transaction with Seneca Biopharma, pursuant to which Merger Sub merged with and into LBS, with LBS surviving such merger as a wholly owned subsidiary of Seneca Biopharma (the “Merger”). Also, in connection with the closing of the Merger, Seneca Biopharma, Inc. changed its name to Palisade Bio, Inc. and the business conducted by Seneca Biopharma became primarily the business conducted by LBS. By virtue of the Merger, all outstanding Series C Preferred Stock was converted to LBS Common Stock.

 

Pre-Merger Financing

 

On April 27, 2021, Palisade Bio, Inc., formerly known as Seneca Biopharma, Inc. and LBS completed a previously announced private placement transaction with an institutional investor (the “Investor”) at a per share purchase price of $0.4816 (without giving effect to the Exchange Ratio or the Reverse Stock Split) (the “Purchase Price”) for an aggregate purchase price of $20,000,000 in cash plus the cancelation of outstanding principal and interest on the notes previously issued to the Investor (the “Pre-Merger Financing”), whereby immediately prior to the Closing, among other things, LBS issued to the Investor shares of LBS Series 1 Preferred Stock pursuant to the Securities Purchase Agreement, dated December 16, 2020, by and among the Palisade Bio, LBS and the Investor (the “Securities Purchase Agreement”).

 

  31  

 

At the closing of the Pre-Merger Financing, (i) LBS issued to the Investor shares of LBS Series 1 Preferred Stock (the “Initial Shares” and, as converted pursuant to the Exchange Ratio in the Merger into the right to receive approximately 1,325,892 shares of Palisade Bio Common Stock, the “Converted Initial Shares”) without giving effect to any limitations set forth in the Securities Purchase Agreement and (ii) LBS deposited into an escrow account three times the number of Initial Shares of LBS Series 1 Preferred Stock (the “Additional Shares”, and, as converted pursuant to the Exchange Ratio in the Merger into the right to receive approximately 3,977,676 shares of Palisade Bio Common Stock, the “Converted Additional Shares”) for the benefit of the Investor if 85% of the average of the five lowest volume-weighted average trading prices of a share of Palisade Bio Common Stock as quoted on the Nasdaq Capital Market during the 10 trading day period immediately preceding the 16th trading day following the Effective Time, divided by five, is lower than the per share Purchase Price or if the five lowest weighted average prices of Palisade Bio Common Stock during the 10 trading day period immediately preceding each of the 45th, 90th and 135th days following the Effective Time, divided by five, is lower than the per share Purchase Price, then, in each case, the Investor will be issued such number of Converted Additional Shares equal to the Purchase Price divided by the lowest of such weighted average prices. Any Converted Additional Shares not delivered to the Investor from escrow will be returned to the Palisade Bio.

 

Issuance of Stock and Warrant to Ecoban Securities, LLC (“Ecoban”)

 

Subsequent to the Merger, on May 25, 2021, Palisade Bio issued to Ecoban (i) a warrant to purchase 18,353 shares of Palisade’s common stock (post reverse stock split and post exchange ratio) at a price of $17.72 per share (post reverse stock split and post exchange ratio) and (ii) 118,833 shares of Common Stock (post reverse stock split and post exchange ratio), as payment for a success fee for closing the Merger and Pre-Merger Financing.

 

Issuance of Equity Warrant

 

Subsequent to the Merger, on May 20, 2021, pursuant to the terms of the Securities Purchase Agreement, Palisade Bio issued to the Investor a warrant to purchase 4,995,893 shares of Common Stock at a price of $4.70 per share (the “Equity Warrant”), post reverse stock split and post exchange ratio. The Equity Warrant is immediately exercisable and will have a term of five years from the date all of the shares underlying the Equity Warrant have been registered for resale. The exercise price and number of shares underlying the Equity Warrant may be subject to adjustment, if any, following each of the 45th, 90th and 135th days following April 27, 2021.

 

 

 

 

 

 

 

 

32

 

Exhibit 99.2

 

UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

 

The unaudited pro forma condensed combined financial information does not give effect to the proposed Reverse Split.

 

The following unaudited pro forma condensed combined financial information was prepared using the acquisition method of accounting under U.S. generally accepted accounting principles (“GAAP”). For accounting purposes, Leading BioSciences, Inc. (“LBS”) is considered to be acquiring Seneca Biopharma, Inc. (“Seneca”) and the merger is expected to be accounted for as a reverse asset acquisition. LBS is considered the accounting acquirer even though Seneca will be the issuer of the common stock in the Merger. To determine the accounting for this transaction under GAAP, a company must assess whether an integrated set of assets and activities should be accounted for as an acquisition of a business or as an asset acquisition. The guidance requires an initial screen test to determine if substantially all of the fair value of the gross assets, excluding cash and cash equivalents, acquired is concentrated in a single asset or group of similar assets. If that screen is met, the assets are not a business. In connection with the acquisition of Seneca, substantially all of the fair value is concentrated in in-process research and development (“IPR&D”) and no employees nor substantive processes are being acquired, as such, the acquisition is expected to be treated as an asset acquisition.

 

The unaudited pro forma condensed combined balance sheet data assumes that the merger took place on March 31, 2021, and combines the historical balance sheets of Seneca and LBS as of such date. The unaudited pro forma condensed combined statements of operations and comprehensive loss for the year ended December 31, 2020, and the three months ended March 31, 2021, assumes that the merger took place as of January 1, 2020, and combines the historical results of Seneca and LBS for the year ended December 31, 2020, and the three months ended March 31, 2021. The unaudited pro forma condensed combined financial information was prepared in accordance with GAAP and pursuant to the rules and regulations of Article 11 of SEC Regulation S-X.

 

Seneca’s assets and liabilities will be measured and recognized at their relative fair value allocations as of the transaction date with any value associated with IPR&D being expensed as there is no alternative future use, and combined with the assets, liabilities and results of operations of LBS after the consummation of the merger.

 

The merger is expected to be accounted for as a reverse asset acquisition in accordance with U.S. GAAP. LBS will be deemed to be the accounting acquirer for financial reporting purposes. This determination is based on the facts that, immediately following the merger: (i) LBS stockholders owned a substantial majority of the voting rights of the combined organization; (ii) LBS designated a majority (five of eight) of the initial members of the board of directors of the combined organization; and (iii) LBS’s senior management held all key positions in senior management of the combined organization and no employees will be retained from Seneca. The transaction is expected to be accounted for as a reverse asset acquisition as the fair value of the acquired preclinical assets is deemed to be substantially concentrated in a group of similar assets that do not meet the definition of a business. Accordingly, for accounting purposes: (i) the merger will be treated as the equivalent of LBS issuing stock to acquire the net assets of Seneca, (ii) the net assets of Seneca will be recorded based upon their fair values at the time of closing, (iii) the reported historical operating results of the combined company prior to the merger will be those of LBS and (iv) for periods prior to the transaction, shareholders’ equity of the combined company is presented based on the historical equity.

 

The unaudited pro forma condensed combined financial information is based on the assumptions and adjustments that are described in the accompanying notes. Accordingly, the pro forma adjustments are preliminary, subject to further revision as additional information becomes available and additional analyses are performed and have been made solely for the purpose of providing unaudited pro forma condensed combined financial information.


 

 

  PF-1  

 

Differences between these preliminary estimates and the final accounting, expected to be completed after the Closing, will occur and these differences could have a material impact on the accompanying unaudited pro forma condensed combined financial information and the combined company’s future results of operations and financial position. In addition, differences between the preliminary and final amounts will likely occur as a result of the amount of cash used for Seneca’s operations and other changes in Seneca’s assets and liabilities prior to the Closing.

 

The unaudited pro forma condensed combined financial information does not give effect to the potential impact of current financial conditions, regulatory matters, operating efficiencies or other savings or expenses that may be associated with the integration of the two companies. The unaudited pro forma condensed combined financial information is preliminary and has been prepared for illustrative purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that would have been realized had Seneca and LBS been a combined company during the specified periods. The actual results reported in periods following the merger may differ significantly from those reflected in the unaudited pro forma condensed combined financial information presented herein for a number of reasons, including, but not limited to, differences in the assumptions used to prepare this pro forma financial information.

 

The unaudited pro forma condensed combined financial information, including the notes thereto, should be read in conjunction with the separate historical financial statements of Seneca and LBS, and their respective management’s discussion and analysis of financial condition and results of operations included elsewhere in the proxy statement/prospectus/information statement filed the SEC on December 23, 2020, as amended. Seneca’s audited statement of operations for the year ended December 31, 2020, is derived from Seneca’s Annual Report on Form 10-K for the year ended December 31, 2020. Seneca’s unaudited financial statements for the three months ended March 31, 2021, are derived from Seneca’s Quarterly Report on Form 10-Q for the three months ended March 31, 2021.

 

Accounting rules require evaluation of certain assumptions, estimates, or determination of financial statement classifications which are completed during the measurement period as defined in current accounting standards. The accounting policies of Seneca may materially vary from those of LBS. During preparation of the unaudited pro forma condensed combined financial information, management has performed a preliminary analysis and is aware of one existing accounting policy incongruence regarding Seneca’s patent cost capitalization treatment. Further information regarding Seneca’s patent cost capitalization policy is provided in Transaction Accounting Adjustment M of the Pro Formas Adjustments and it did not result in a material adjustment to the unaudited pro forma condensed combined financial information. Management is not aware of any other material differences, and accordingly, this unaudited pro forma condensed combined financial information assumes no material differences in accounting policies. Following the acquisition, management will conduct a final review of Seneca’s accounting policies in order to determine if differences in accounting policies require adjustment or reclassification of Seneca’s results of operations or reclassification of assets or liabilities to conform to LBS’s accounting policies and classifications. As a result of this review, management may identify differences that, when conformed, could have a material impact on these unaudited pro forma condensed combined financial statements.

 

 

  PF-2  

 

 

Unaudited Pro Forma Condensed Combined Balance Sheet

March 31, 2021

(in thousands)

 

 

    Seneca   Leading BioSciences   Transaction Accounting
Adjustments
  Notes   Pro Forma
Combined
Assets                                    
Current assets:                                    
Cash and cash equivalents   $ 6,561     $ 615     $ 18,425     J   $ 25,601  
Trade and other receivables     25       -       (25 )   N     -  
Prepaid expenses and other current assets     1,309       103       (841 )   N     571  
Disposal group assets held for sale     861       -       (459 )   M     402  
Total current assets     8,756       718       17,100           26,574  
Restricted cash     -       26       -           26  
Deferred transaction costs     -       2,337       (2,337)     D     -  
Property and equipment, net     7       4       (7 )   I     4  
Right-of-use and other assets     10       236       (10 )   N     236  
Patents, net     142       -       (142 )   M     -  
Total assets   $ 8,915     $ 3,321     $ 14,604         $ 26,840  
Liabilities, convertible preferred stock, and stockholders’ equity (deficit)                                    
Current liabilities:                                    
Accounts payable and accrued expenses   $ 521     $ 5,885     $ 1,588     C, D   $ 7,994  
Accrued compensation     274       1,582       1,986         G     3,842  
Current portion of lease liability     -       176       -           176  
Current portion of debt     -       2,036       (1,798)     K     238  
Current portion of related party debt, net     -       517       -           517  
Disposal group liabilities associated with assets held for sale     220       -       -           220  
Total current liabilities     1,015       10,196       1,776           12,987  
Lease liability, net of current portion     -       65       -           65  
Non-current portion of debt     -       -       -           -  
Warrant liabilities, at fair value     171       3,620       16,225     J, O     20,016  
Total liabilities     1,186       13,881       18,001           33,068  
Convertible preferred stock     -       9,503       (9,503 )   F     -  
Stockholders’ equity (deficit):                                    
Preferred stock     2       -       (2 )   A     -  
Common stock     29       102       (10)     A, F, J, K     121  
Additional paid-in capital     248,228       51,891       (202,505 )   S     97,614  
Accumulated other comprehensive income (loss)     (3 )     -       3     A     -  
Accumulated deficit     (240,527 )     (72,056 )     208,620     R     (103,963 )
Total stockholders’ equity (deficit)     7,729       (20,063 )     6,106           (6,228)  
Total liabilities, convertible preferred stock, and stockholders’ equity   $ 8,915     $ 3,321     $ 14,604         $ 26,840  

 

 

  PF-3  

 

Unaudited Pro Forma Condensed Combined Statement of Operations and Comprehensive Loss

For the Three Months Ended March 31, 2021

(in thousands, except per share and share amounts)

 

 

    Seneca   Leading BioSciences   Transaction Accounting
Adjustments
  Notes   Pro Forma
Combined
Revenues:                                    
Revenue   $ -     $ -     $ -         $ -  
Total revenues     -       -       -           -  
Operating expenses:                                    
General and administrative     1,721       1,262       126     G, H, I, P     3,109  
Research and development     471       692       -           1,163  
Total operating expenses     2,192       1,954       126           4,272  
Loss from operations     (2,192 )     (1,954 )     (126 )         (4,272 )
Interest income (expense), net     3       (1,711 )     -           (1,708 )
Gain on forgiveness of debt     -       279       -           279  
Loss on issuance of secured debt     -       (686 )     -           (686 )
Gain (loss) on change in fair value of warrant liability and put right     (96 )     42       -           (54 )
Total other income (expense)     (93 )     (2,076 )     -           (2,169 )
Net loss   $ (2,285 )   $ (4,030 )   $ (126 )       $ (6,441 )
                                     
Net loss per share, basic and diluted   $ (0.79 )   $ (0.04 )               $ (0.53 )
Weighted average common shares outstanding, basic and diluted     2,886,446       102,041,277       (92,828,985 )   F, J, K, L     12,098,738  

 

 

 

 

 

 

 

 

  PF-4  

 

Unaudited Pro Forma Condensed Combined Statement of Operations and Comprehensive Loss

For the Year Ended December 31, 2020

(in thousands, except per share and share amounts)

 

 

    Seneca   Leading BioSciences   Transaction Accounting
Adjustments
  Notes   Pro Forma
Combined
Revenues:                                    
Revenue   $ 13     $ -     $ -         $ 13  
Total revenues     13       -       -           13  
Operating expenses:                                    
General and administrative     8,671       6,198       6,399     E, G, I, P, Q     21,268  
Research and development     2,018       3,099       -           5,117  
In process R&D     -       -       27,538     H     27,538  
Total operating expenses     10,689       9,297       33,937           53,923  
Loss from operations     (10,676 )     (9,297 )     (33,937 )         (53,910 )
Interest income (expense), net     20       (235 )     -           (215 )
Other income (expense), net     -       13       -           13  
Loss on issuance of secured debt     -       (841 )     -           (841 )
Gain (loss) on change in fair value of warrant liability and put right     9       38       -           47  
Warrant inducement and other expense     (5,620 )     -       -           (5,620 )
Total other income (expense)     (5,591 )     (1,025 )     -           (6,616 )
Net loss   $ (16,267 )   $ (10,322 )   $ (33,937 )       $ (60,526 )
Net loss per share, basic and diluted   $ (1.17 )   $ (0.10 )               $ (5.00 )
Weighted average common shares outstanding, basic and diluted     13,869,272       102,036,449       (103,806,983 )   F, J, K, L     12,098,738  

 

 

 

 

 

 

 

 

 

 

  PF-5  

 

NOTES TO THE UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

 

  1. Description of Transaction

 

On December 16, 2020, Seneca and LBS entered into an Agreement and Plan of Merger (the “Merger Agreement”), pursuant to which a wholly-owned subsidiary of Seneca will merge with and into LBS, with LBS surviving as a wholly-owned subsidiary of Seneca (the “Merger”).

 

On April 27, 2021, the effective closing time of the Merger (the “Effective Time”), each share of common stock of LBS, $0.001 par value per share (including the shares of common stock issuable upon conversion of all shares of Series C preferred stock of LBS, par value $0.001 per share (the “LBS Series C Preferred Stock”) prior to the Merger) (the “LBS Common Stock”) and each share of non-voting share of Series 1 preferred stock of LBS, $0.001 par value per share (the “LBS Series 1 Preferred Stock”), are expected to convert into 54,337,290 shares, $0.01 par value per share (the “Seneca Common Stock”), subject to adjustment into 9,058,436 shares of Seneca Common Stock, for the one-for-six Reverse Split of Seneca Common Stock implemented prior to the consummation of the Merger, and further adjusted based on Seneca’s net cash in connection with the closing of the Merger (to the extent Seneca’s net cash is over $5.0 million or under $4.5 million) (final post-exchange ratio adjustment of 0.02719).

 

At the Effective Time, Seneca’s stockholders continue to own and hold their then existing shares of Seneca Common Stock and shares of preferred stock, $0.01 par value per share, of Seneca, subject to adjustment for the reverse stock split described herein. Seneca assumed outstanding and unexercised options to purchase shares of LBS Common Stock, and in connection with the Merger such options were converted into options to purchase shares of Seneca Common Stock, with the number of shares and exercise price being adjusted by an exchange ratio of 0.02719 shares of Seneca Common Stock issuable upon exercise of each option to purchase one share of LBS Common Stock. Each warrant to purchase LBS Common Stock outstanding and unexercised immediately prior to the Effective Time, including the Bridge Warrants, was assumed by Seneca and became a warrant to purchase shares of Seneca Common Stock, with the number of shares and exercise price being adjusted by an exchange ratio of 0.02719 shares of Seneca Common Stock issuable upon exercise of each warrant to purchase one share of LBS Common Stock. As of immediately prior to the Effective Time (i) all outstanding and unexercised options to purchase shares of Seneca Common Stock with an exercise price of greater than $1.60 were cancelled and have no further force and effect, (ii) all outstanding and unexercised options to purchase shares of Seneca Common Stock with an exercise price equal to or less than $1.60 remain effective and outstanding, and (iii) all of Seneca’s outstanding restricted stock unit awards were accelerated in full.

 

In addition, in connection with the transactions contemplated by the Merger, on December 16, 2020, (i) LBS entered into a securities purchase agreement with an institutional investor (the “Investor”) pursuant to which, among other things, LBS agreed to issue senior secured promissory notes in the aggregate principal amount of up to $5.0 million, in exchange for an aggregate purchase price of up to $3.75 million, representing an aggregate original issue discount of up to $1.25 million (the “Bridge Notes”) and warrants to purchase shares of LBS Common Stock, and (ii) Seneca and LBS entered into a separate securities purchase agreement with the Investor pursuant to which, among other things, the Investor agreed to invest $20.0 million in cash and cancel any outstanding principal and interest on the Bridge Notes immediately prior to the closing of the Merger in exchange for shares of LBS Series 1 Preferred Stock (“the Initial Shares”) at a per share purchase price of $0.4816 (the “Purchase Price”) to be issued immediately prior to the closing of the Merger and warrants to purchase shares of Seneca Common Stock to be issued after the closing of the Merger, in private placement transactions (collectively, the “Pre-Merger Financing”).

 

Upon the execution of the one-for-six Reverse Split, the surviving combined company’s total shares outstanding was 12,098,738. Of which, LBS shareholders owned 9,058,436 shares (74.9% ownership) and Seneca shareholders owned 3,040,302 shares (25.1%).

 

In addition, the combined company deposited three times the number of Initial Shares of LBS Series 1 Preferred Stock into escrow with an escrow agent, and exchanged them for Seneca Common Stock in the Merger, in whole or in part, based on the formula provided below. As a result of the Merger, at the Effective Time, each Initial Share automatically converted into the right to receive a number of shares (the “Converted Initial Shares”) of Seneca Common Stock equal to the number of Initial Shares multiplied by the Exchange Ratio. Further, at the Effective Time, each Additional Share placed into escrow with the escrow agent automatically converted into the right to receive a number of shares (the “Converted Additional Shares”) of Seneca Common Stock equal to the number of Additional Shares multiplied by the Exchange Ratio. If 85% of the sum of the five lowest weighted average prices of the Seneca Common Stock during the 10 trading day period immediately preceding the 16th trading day following the Effective Time (the “Initial Reset Date”), divided by five, is lower than the per share Purchase Price or if the five lowest weighted average prices of the Seneca Common Stock during the 10 trading day period immediately preceding each of the 45th, 90th and 135th days following the Effective Time (together with the Initial Reset Date, each a “Reset Date”), divided by five, is lower than the per share Purchase Price, then, in each case, the Investor will be issued such number of Converted Additional Shares equal to the Purchase Price divided by the lowest of such weighted average prices. Any Converted Additional Shares not delivered to the Investor from escrow will be returned to Seneca. As of the second reset period, the reset price of $3.88 resulted in 100% of the Additional Shares being issued to the Investor.

 

 

  PF-6  

 

In addition, the Milestone Recipients may be entitled to receive certain Milestone Payments. A Milestone Payment may be made following the 135th day following the Final Reset Date to the extent any Converted Additional Shares not issued to the Investor are returned from escrow to Seneca unissued pursuant to the Pre-Merger Financing. If this occurs, the Milestone Recipients will be entitled to receive a number of additional shares of Seneca Common Stock equal to the number of Converted Additional Shares that are returned to Seneca, on a pro rata basis to each such Milestone Recipient.

 

Further, immediately prior to the Effective Time, Seneca and Silvestre Law Group (the “CVR Agent” and “CVR Holders’ Representative”) will enter into a Contingent Value Rights Agreement (the “CVR Agreement”). Pursuant to the CVR Agreement, each share of Seneca Common Stock held (including any warrant shares exercisable for Seneca Common Stock) by Seneca stockholders and Seneca warrant holders of record as of immediately prior to the Effective Time will receive one contingent value right (“CVR”) entitling holders of such shares (the “CVR Holders”) to receive certain net proceeds, if any, derived from the sale or license of all or any part of the intellectual property owned, licensed or controlled by Seneca that is necessary for the operation of the business of Seneca as conducted as of the Effective Time and in existence as of the Effective Time (the “Seneca Legacy Technology”) pursuant to an agreement entered into: (i) during the period beginning at the Effective Time and ending on the date that is 18 months following the Effective Time or (ii) prior to the Effective Time and not consummated prior to the Asset Milestone Payment (as defined below) (a “Legacy Monetization”) and entitled to be received prior to the 48-month anniversary of the Effective Time. The CVRs will not be transferable by the CVR Holders, except in certain limited circumstances, will not have any voting or dividend rights, will not be certificated or evidenced by any instrument, will not accrue interest and will not be registered with the Securities and Exchange Commission (“SEC”) or listed for trading on any exchange. Each CVR will entitle the CVR Holder to receive a pro rata portion of 80 percent of the net proceeds, if any, from each respective Legacy Monetization event.

 

     
  2. Basis of Pro Forma Presentation
       

The above unaudited pro forma condensed combined financial information includes the effect of the one-for-six Reverse Split in the Pro Forma Adjustments.

 

The unaudited pro forma condensed combined financial information was prepared in accordance with SEC Regulation S-X Article 11, the asset acquisition accounting guidance set forth in Accounting Standards Codification 805, Business Combinations (“ASC 805”) using the acquisition method of accounting and the final SEC rules issued on May 20, 2020, that amends the financial statement requirements for acquisitions and dispositions of businesses and related Pro Forma financial information. Accordingly, the comparative periods reported in the Pro Forma are as follows:

 

· The unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and the year ended December 31, 2020, give effect to the merger as if it had been consummated on January 1, 2020.

 

· The unaudited pro forma condensed combined balance sheet as of March 31, 2021, gives effect to the Merger as if it had been consummated on March 31, 2021.


 

 

  PF-7  

 

Based on LBS’s preliminary review of LBS’s and Seneca’s summary of significant accounting policies and preliminary discussions between management teams of LBS and Seneca, the nature and amount of any adjustments to the historical financial statements of Seneca to conform its accounting policies to those of LBS are not expected to be material. Management is aware of one existing accounting policy incongruence regarding Seneca’s patent cost capitalization treatment. Further information regarding Seneca’s patent cost capitalization policy is provided in Transaction Accounting Adjustment M of the Pro Formas Adjustments and it did not result in a material adjustment to the unaudited pro forma condensed combined financial information. Upon completion of the Merger, further review of Seneca’s accounting policies may result in additional revisions to Seneca’s accounting policies and classifications to conform to those of LBS.

 

The unaudited pro forma condensed combined financial information has been prepared with the expectation that the merger will be treated as an asset acquisition, with LBS treated as the accounting acquirer. Since Seneca is the legal acquirer, the merger will be accounted for as a reverse asset acquisition. To determine the accounting for this transaction under GAAP, a company must assess whether an integrated set of assets and activities should be accounted for as an acquisition of a business or an asset acquisition. Substantially all of the fair value is included in IPR&D and no substantive processes are being acquired. As such, the Merger is expected to be treated as an asset acquisition. Asset acquisitions are to be accounted for by allocating costs, including transaction costs, of the acquisition to the acquired assets based on their relative fair value basis. For the purpose of measuring the estimated fair value of the assets acquired and liabilities assumed, LBS estimated the fair values as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The fair value measurements utilize estimates based on key assumptions of the merger, including historical and current market data. The unaudited pro forma adjustments included herein are preliminary and will be adjusted as additional information becomes available and as additional analyses are performed. The final purchase price allocation will be determined subsequent to the merger, and the final amounts of the assets acquired, and liabilities assumed may differ materially from the values recorded in the pro forma financial information.

 

The historical financial statements of combined Seneca-LBS company have been adjusted to give pro forma effect to reflect the accounting for the transaction in accordance with U.S. GAAP. In addition, the Pro Forma statements are prepared in accordance with the amended requirements in Regulation S-X Article 11 (dated May 20, 2020) which requires that pro forma financial information to include Transaction Accounting Adjustments to the historical financial information of the registrant. Transaction Accounting Adjustments are adjustments that are required to reflect the application of US GAAP to Merger.

 

The Transaction Accounting Adjustments are based on available information and assumptions that management believes are reasonable. However, such adjustments are estimates and actual experience may differ from expectations. There are no autonomous entity adjustments included in the unaudited pro forma condensed consolidated financial statements. Additionally, Regulation S-X Article 11 permits registrants to reflect in the notes to the pro forma financial information forward-looking information that depicts the synergies and dis-synergies identified by management in determining to consummate or integrate the Merger for which pro forma effect is being given. LBS and Seneca expect to incur costs associated with integrating the operations of LBS and Seneca after the merger is completed. The unaudited pro forma condensed combined financial information does not reflect the costs of any integration activities or benefits that may result from realization of future cost savings from operating efficiencies expected to result from the merger because management does not believe these adjustments would enhance an understanding of the pro forma effects of the Merger.

 

The unaudited pro forma condensed combined financial information may differ from the final purchase accounting for a number of reasons, including the fact that the estimates of fair values of assets and liabilities acquired are preliminary and subject to change when the valuation and other studies are finalized. The differences that may occur between the preliminary estimates and the final purchase accounting could have a material impact on the accompanying unaudited pro forma condensed combined financial information.

 

 

  PF-8  

 

The unaudited pro forma condensed combined financial information should not be relied upon as being indicative of the historical results that would have been achieved had the companies always been combined or the future results that the combined company will experience. The unaudited pro forma condensed combined financial statements, including the notes thereto, should be read in conjunction with the separate historical consolidated financial statements of Seneca and LBS.

 

  3. Estimated Purchase Price

 

The accompanying unaudited pro forma condensed combined financial statements reflect an estimated reverse asset acquisition price of approximately $33.8 million. Given that the estimated purchase price is variable depending upon the price of Seneca Common Stock acquired upon consummation of the merger, management performed a sensitivity analysis over the change in purchase consideration based on +/– 10% volatility in Seneca Common Stock price. An increase or decrease in the Seneca Common Stock price by 10% would increase or decrease the purchase consideration by approximately $3.0 million with an offsetting adjustment to IPR&D.

 

The total estimated purchase price and allocated purchase price is summarized as follows (in thousands, except share and per share data):

 

Number of shares of the combined company to be owned by Seneca’s stockholders(i)     3,040,302  
Multiplied by the fair value per share of Seneca’s common stock(ii)   $ 9.96  
Total   $ 30,281  
Estimated transaction costs(iii)     3,502  
Total estimated purchase price   $ 33,784  

 

 

For purposes of this pro forma analysis, the above estimated purchase price has been allocated based on a preliminary estimate of the fair value of assets and liabilities to be acquired.

 

Net assets as of March 31, 2021   $ 6,245  
In process research and development(iv)     27,538  
Total estimated purchase price   $ 33,784  

 

(i) Represents the actual post one-to-six Reverse Split effected number of shares of Seneca common stock, Seneca preferred stock to be converted to common stock, Senecas RSUs, and Seneca Warrants outstanding immediately prior to the merger. For purposes of this unaudited pro forma condensed combined financial information, the number of shares represents 2,884,348 shares of Seneca common stock outstanding, 6,479 shares of Seneca preferred stock converted to common stock, 8,817 of Seneca RSUs outstanding, 12,500 CMO Shares issued and 128,158 Seneca Warrants converted to common stock.
(ii) The estimated purchase price was based on the closing price as reported on the Nasdaq Capital Market on April 27, 2021 (i.e., the Merger close date).
(iii) The final purchase price arising from the actual transaction costs immediately prior to the Closing of the merger could result in a total purchase price different from that assumed in this unaudited pro forma condensed combined financial information, and that difference may be material. Therefore, the estimated consideration expected to be transferred reflected in this unaudited pro forma condensed combined financial information does not purport to represent what the actual consideration transferred will be when the merger is completed. The actual purchase price will fluctuate until the final transaction costs are known and the final valuation of the purchase consideration could differ significantly from the current estimate.
(iv) IPR&D represents the research and development projects of Seneca which were in-process, but not yet completed, and which Leading Bio may plan to advance. Current accounting standards require that the fair value of IPR&D projects acquired in an asset acquisition with no alternative future use be allocated a portion of the consideration transferred and charged to expense at the acquisition date. The acquired assets did not have outputs or employees. The actual purchase price allocated to IPR&D will fluctuate until the closing date of the merger, and the final valuation of the IPR&D consideration could differ significantly from the current estimate.


 

 

  PF-9  

 

Contingent consideration with respect to the CVR has not been recorded in the accompanying unaudited pro forma condensed combined financial statements as the CVRs are not currently probable and estimable. A liability for the CVRs is recorded only when payment under the CVR Agreement is determined to be both probable and estimable, which is not expected to occur until the contingencies under the CVR Agreement are resolved. Upon recognition, the amounts pursuant to the CVR Agreement will be included in the cost of IPR&D and expensed at such time.

 

 

4. Pro Forma Adjustments

 

 Adjustments included in the column under the heading “Pro Forma Adjustments” are primarily based on information contained within the Merger Agreement. Further analysis will be performed after the completion of the merger to confirm the necessity of these estimates.

 

Given LBS’s history of net losses and valuation allowance, management assumed a statutory tax rate of 0%. Therefore, the pro forma adjustments to the unaudited pro forma condensed combined statements of operations and comprehensive loss resulted in no additional income tax adjustment to the pro forma financials.

 

The unaudited pro forma adjustments included in the unaudited pro forma condensed combined financial information are as follows (in thousands, except share and per share data):

 

A.

To eliminate Seneca’s pre-merger preferred stock, common stock, additional paid-in-capital, accumulated other comprehensive loss and accumulated deficit balances.

 

B.

To reflect the fair value of the number of Seneca shares issued as consideration for the acquisition. In addition, to reflect the expense associated with the acquisition of Seneca’s IPR&D which has no anticipated go-forward alternative use and the associated R&D efforts were abandoned.

 

C.

To record Seneca’s $422 of estimated transaction costs associated with advisory fees and transactional fees, incurred subsequent to March 31, 2021, to the unaudited pro forma condensed combined balance sheet at March 31, 2021. This $422 of estimated transaction costs is reflected in the condensed combined statements of operations and comprehensive loss for the year ended December 31, 2020, through transaction accounting adjustment E. All other Seneca transaction costs are already reflected within the three months ended March 31, 2021, and the year ended December 31, 2020, respectively, condensed combined statements of operations and comprehensive loss of the Seneca. These costs will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

 

D.

To record LBS’s $1,166 of estimated transaction costs associated with advisory fees and transactional fees incurred subsequent to March 31, 2021. Total transaction costs of $3,502 are anticipated to be incurred. Approximately $2,337 of transaction costs are already reflected within the three months ended March 31, 2021, and the year ended December 31, 2020, respectively, condensed combined statements of operations and comprehensive loss of the LBS. Upon the close of the Merger, all capitalized transaction costs will be reflected in the reverse asset acquisition's purchase price accounting. These costs are predominantly allocated to IPR&D, that has no future alternative use, and therefore are anticipated to be recorded as a reduction to accumulated deficit in the purchase price allocation. These costs will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

   
E.

To record LBS’s and Seneca’s $1,166 and $422 of transaction costs, that are anticipated to be incurred after March 31, 2021, in the condensed combined statements of operations and comprehensive loss for the year ended December 31, 2020. These costs will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

 

F.

To reflect the adjustments for (i) LBS’s weighted-average common stock outstanding and (ii) the conversion of LBS’s convertible preferred stock to Seneca Common Stock in accordance with the preferred stock conversion rights.

 

 

 

  PF-10  

 

G. To reflect a one-time $4,431 Seneca pre-combination compensation expense within the unaudited pro forma condensed combined statements of operations and comprehensive loss for the year ended December 31, 2020, related to severance and benefits for terminated Seneca executives. Such amounts are due to the terminated Seneca executives in accordance with their employment agreements' "change in control" and "termination without cause" provisions. A pro forma adjustment of $1,986 is reflected with the unaudited pro forma condensed combined balance sheet at March 31, 2021, to accrued for remaining amounts owed to the terminated executives after March 31, 2021. In addition, Seneca’s adjustments for the exclusion of $4 and $17 pre-combination stock compensation expense for the three months ended March 31, 2021, and the year ended December 31, 2020, respectively. No adjustment is required to the unaudited pro forma condensed combined balance sheet at March 31, 2021, as there is no remaining unvested compensation expense for Seneca’s restricted stock units as of March 31, 2021. These costs will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

 

H

 

To reflect the expensing of Seneca's IPR&D that LBS acquired in the Merger, within the unaudited pro forma condensed combined statement of operations and comprehensive loss for the year ended December 31, 2020, due to Seneca's IPR&D having no future alternative use as part of the combined company's go-forward operations. This is a one-time expense in connection with the merger that is not expected to have a recurring impact on the Company’s statements of operations and comprehensive loss subsequent to the merger.

 

I.

To eliminate Seneca’s pre-merger depreciation and related property and equipment which will not be used in the continuing operations of the combined company, and which no longer have a carrying value as of March 31, 2021, from the unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and for the year ended December 31, 2020, and unaudited pro forma condensed combined balance sheet as of March 31, 2021. This pro forma adjustment also includes the elimination of the patent amortization expense resulting from accounting policy alignment (see pro forma adjustment M) from the unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and for the year ended December 31, 2020.

 

J.

To reflect the Pre-Merger Financing upon Closing for a total of $20,000 in gross proceeds for LBS Series 1 Preferred Stock at a per share purchase of $0.4816. The accounting treatment under Accounting Standards Codification (ASC) 480 – Distinguishing Liabilities from Equity and ASC 815 – Derivatives and Hedging is in process related to the Pre-Merger Financing, including the accounting classification of the Investor Warrants and Additional Shares. Each Investor Warrants shall be for the right to purchase one share of common stock of the combined company post-merger, in a quantity equal to 100% of the total investment amount divided by the final purchase price of the pre-merger LBS’s shares. The Investor Warrants shall expire five (5) years from the effectiveness of the registration statement. For purposes of these pro formas, the Pre-Merger Financing has been classified as a liability on the unaudited pro forma condensed combined balance sheet due to the Investors Warrants not meeting all the criteria that would have otherwise permitted equity classification.

The Investor Warrants are measured at fair value at issuance in an estimated amount of $16,179. The amount of financing proceeds received is first allocated to the Investor Warrants with the remaining proceeds, if any, allocated to the LBS Series 1 Preferred Stock. The liability recognized for the Pre-Merger Financing is subject to remeasurement at fair value as of each reporting period with offsetting impacts of the fair value changes to the statements of operations and comprehensive loss. 

 

LBS anticipates incurring an estimated $1,575 in equity issuance costs associated with the Pre-Merger Financing. This estimated amount has been reflected as a reduction to the cash proceeds received and a corresponding reduction to additional paid in capital.

 

K.

On May 27, 2020, LBS entered into a non-binding agreement with certain investors for an offering of up to an aggregate of $3,300 of senior secured bridge notes and warrants (“2020 Bridge Financing”) which will be issued at a 25% original issuance discount, resulting in cash proceeds of $2,500 (to be received in total no later than 90 days after Closing). On December 16, 2020, the Company drew down the first tranche of $1,250 and an additional second tranche of $1,250 on February 1, 2021. The notes within the 2020 Bridge Financing accrue interest at a rate of 15% per year, payable at maturity of 180 days after the Closing date with certain permitted extension clauses. The lender agreed to convert any outstanding principal and interest on the Bridge Loans immediately prior to the closing of the Merger in exchange for shares of LBS Series 1 Preferred Stock equal to the amount to be converted divided by $0.4816. The lender also received warrants to purchase a total number of shares of common stock equal to $3,300 (the total aggregate principal of the senior secured bridge notes) divided by the initial per share exercise price of $0.4816. The accounting treatment under ASC 480 – Distinguishing Liabilities from Equity and ASC 815 – Derivatives and Hedging is in process related to the 2020 Bridge Financing Pre-Merger Financing, including the accounting classification of the warrants. The warrants included in the 2020 Bridge Financing have been classified as a liability due to the warrants not meeting all the criteria that would have otherwise permitted equity classification.

 

  PF-11  

 

 

The initial recognition of the 2020 Bridge Financing is already reflected within the unaudited pro forma condensed combined balance sheet at March 31, 2021. A pro forma adjustment is recorded to the unaudited pro forma condensed combined balance sheet at March 31, 2021, to reflect the conversion of the outstanding principal and interest on the Bridge Loans immediately prior to the closing of the Merger in exchange for shares of LBS Series 1 Preferred Stock.

Interest expense related to the coupon interest rate and amortization of debt discount is reflected in the condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and for the year ended December 31, 2020. No pro forma adjustment has been reflected within the condensed combined statements of operations and comprehensive loss for the remaining coupon interest rate and amortization of debt discount during the stub period April 1, 2021, through the Merger date of April 27, 2021, as it is not considered material. After the Merger closed, the Company will not replace the Bridge Financing with other permanent debt financing . Therefore, the interest expense associated with the Bridge Financing will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.

 

L.

The unaudited pro forma combined basic and diluted earnings per share for the three months ended March 31, 2021, and the year ended December 31, 2020, reflects the weighted-average common shares outstanding of the combined company, adjusted for Seneca’s one-for-six Reverse Split, of outstanding shares as of the transaction date of 12,098,738. The “Transaction Accounting Adjustments” column includes the adjustment to the combined company’s weighted-average common shares outstanding resulting from the conversion at closing of the Merger of each share of outstanding LBS convertible preferred stock into one share of Seneca Common Stock, and as adjusted to reflect the Exchange Ratio of 1 to 0.02719.

 

Estimated number of shares of the combined company to be owned by Seneca’s stockholders   3,040,302  
LBS’s outstanding shares at the estimated Exchange Ratio   2,774,502  
Conversion of LBS Series C Preferred Stock at the estimated Exchange Ratio (F)   317,420  
Shares issued in connection with the Altium Bridge Notes and Equity Financing at the Exchange Ratio (J, K)   1,325,892  
Escrow shares issued in connection with the Altium Financing (K)   3,977,676  
Conversion of Warrant Shares issued in connection with the Altium Bridge Notes and Equity Financing (J, K)   662,946  
Pro forma - Basic and diluted weighted average number of shares   12,098,738  

 


  PF-12  

 

M.

To reflect an accounting policy conformity regarding patent costs for the combined post-combination company. Seneca’s accounting policy is to capitalize patent costs and amortize such costs over the useful life of the patents. LBS’s accounting policy is to expense these costs as incurred. This pro forma adjustment reflects the derecognition of all previously capitalized patent costs from the pro forma condensed combined balance sheet as of March 31, 2021. The patent expense resulting from accounting policy alignment (see pro forma adjustment I) is eliminated from the unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and for the year ended December 31, 2020. Seneca did not have any other patent acquisition costs incurred during the unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and for the year ended December 31, 2020.

 

N.

To reflect an adjustment to Seneca’s current carrying value of trade and other receivables, prepaid and other current assets, right-of-use and other assets to the estimated fair value that will approximately exist at the time of Closing. The estimated fair value of these items is preliminary and subject to change after LBS finalizes its review of the specific nature and timing of such assets.

 

O.

To reflect the reclassification of certain Seneca warrants from equity classification to liability classification as the result of a cash settled written put option provision upon a “Fundamental Transaction”, which was triggered upon the signing of the definitive merger agreement. An estimation of the warrant liability’s fair value, based on a Black-Scholes model, is required at the time of reclassification. The estimated fair value is preliminary and subject to change upon Closing. 

 

 

P.

 

 

 

 

To reflect new compensation arrangements with two LBS key executives in connection with the Merger resulting in an increase in the annual salary for these executives from their previous salary. Accordingly, adjustments of $58 and $230 are reflected within the unaudited pro forma condensed combined statements of operations and comprehensive loss for the three months ended March 31, 2021, and year ended December 31, 2020, respectively.

 

Q.

To reflect the fair value of stock compensation expense associated with issuing one-time equity option grants to two LBS key executives within the unaudited pro forma condensed combined balance sheet at March 31, 2021. The executives’ current employee agreements stipulate that such issuance would occur in connection with the closing of a merger or initial public offering transaction. The awards are fully vested upon issuance with no requisite future service requirements. This pro forma adjustment is also reflected in the year ended December 31, 2020, condensed combined statements of operations and comprehensive loss. These costs will not affect the Company’s condensed combined statements of operations and comprehensive loss beyond 12 months after the acquisition date.  

  

R.

To record the following adjustments to accumulated deficit (in thousands):

 

    March 31,
2021
Elimination of Seneca’s accumulated deficit (A)   $ 242,011  
Impact of expensed IPR&D acquired from Seneca (B)     (27,538 )
Impact of Seneca’s estimated transaction costs (C)     (422 )
Impact of Seneca’s estimated executive severance and benefits (G)     (1,987 )
Impact of fair value adjustment to Seneca’s PP&E (I)     (7 )
Impact of LBS’s conversion of the 2020 Bridge Financing to equity (K)     (1,649 )
Impact of fair value adjustment to Seneca’s Patents (M)     (601 )
Impact of fair value adjustment to Seneca’s trade and other receivables, prepaid and other current assets, and right-of-use and other assets (N)     (876 )
Impact of stock-based compensation fair value related to one-time, fully vested equity options to two LBS key executives (Q)     (311 )
Total   $ 208,620  

 

  PF-13  

 

S.

To record the following adjustments to additional paid-in-capital (in thousands):

    March 31,
2021
Elimination of Seneca’s additional paid-in-capital (A)   $ (248,228 )
To reflect the estimated purchase price allocation impacts to additional paid-in-capital (B)     30,251  
To reflect LBS’s conversion of its outstanding preferred stock to common stock post-merger (F)     9,566  
To reflect LBS’s Pre-Merger Financing in connection with the merger (J)     2,195  
To reflect LBS’s issuance of warrants for the 2020 Bridge Financing and the conversion of the 2020 Bridge Financing to equity (K)     3,445  
To reflect certain Seneca warrants reclassification from equity to liability in connection with the merger (O)     (45 )
Impact of stock-based compensation fair value related to one-time, fully vested equity options to two LBS key executives (Q)     311  
Total   $ (202,505 )

 

 

PF-14