UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

(Mark One)

 

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended  June 30, 2017

 

or

 

[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______________________________ to ____________________

 

Commission File Number: 0-21214

 

CAPSTONE THERAPEUTICS CORP.
(Exact name of registrant as specified in its charter)

 

Delaware 86-0585310
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification No.)

 

1275 W. Washington Street, Suite 104, Tempe, Arizona 85281
(Address of principal executive offices) (Zip Code)

 

(602) 286-5520

(Registrant's telephone number, including area code)

 

(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. [X] Yes [_] No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

[X] Yes [_] No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. Large accelerated filer Accelerated filer ___
Non-accelerated filer ___ (do not check if a smaller reporting company) Smaller reporting company _ X __

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [_] Yes [X] No

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 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. [_]

 

 

APPLICABLE ONLY TO CORPORATE ISSUERS:

 

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.

 

54,385,411 shares of common stock outstanding as of August 1, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  2  

 

C APSTONE THERAPEUTICS CORP.

 

INDEX

 

      Page No.
  Forward Looking Statements 4
     
Part I Financial Information  
     
  Item 1. Financial Statements (Unaudited)  
     
  Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2016 5
     
  Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2017 and 2016 6
     
  Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2017 and 2016 7
     
  Notes to Condensed Consolidated Financial Statements 8
     
  Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 16
     
  Item 4. Controls and Procedures 20
     
Part II Other Information  
     
  Item 1. Legal Proceedings 20
     
  Item 6. Exhibits 20

 

EXHIBIT 10.1

EXHIBIT 10.2

EXHIBIT 10.3

EXHIBIT 10.4

EXHIBIT 10.5

EXHIBIT 31.1

EXHIBIT 31.2

EXHIBIT 32

EXHIBIT 101

 

  3  

 

Forward Looking Statements


We may from time to time make written or oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to stockholders. The safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 protects companies from liability for their forward looking statements if they comply with the requirements of that Act. This Quarterly Report on Form 10-Q should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2016, and contains forward-looking statements made pursuant to that safe harbor. These forward-looking statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could materially affect actual results, levels of activity, performance or achievements. Factors that may cause actual results to differ materially from current expectations, which we describe in more detail in this section titled “Risks,” include, but are not limited to:

 

failure of the Company, or its joint venture, LipimetiX Development, Inc., to obtain additional funds to continue operations;
effect of non-compliance with the Securities and Exchange Commission’s (“SEC”) Rules and Regulations requiring our Annual Report on Form 10-K for the years ended December 31, 2016 and 2015, filed with the SEC on March 15, 2017 and March 30, 2016, respectively, to include an opinion of an Independent Public Accountant, and our Current Reports on Form 10-Q filed with the Securities Exchange Commission in 2016 and 2017 to be reviewed by an Independent Public Accountant;
failure of the Company’s common stock to continue to be listed at the OTCQB stock market;
the impact of the terms or conditions of agreements associated with funds obtained to fund operations;
failure to obtain additional funds required to complete clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies approval for product candidates or secure development agreements with pharmaceutical manufacturers;
the impact of using a virtual operating model;
unfavorable results of product candidate development efforts;
unfavorable results of pre-clinical or clinical testing;
delays in obtaining, or failure to obtain FDA or comparable foreign agencies approvals;
increased regulation by the FDA or comparable foreign agencies;
the introduction of competitive products;
impairment of license, patent or other proprietary rights;
the impact of present and future joint venture, collaborative or partnering agreements or the lack thereof; and
failure to successfully implement our drug development strategy for AEM-28 and its analogs.

 

If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected. Any forward-looking statement you read in this Quarterly Report on Form 10-Q reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, business strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

 

  4  

 

PART I – Financial Information

Item 1. Financial Statements

 

CAPSTONE THERAPEUTICS CORP.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(Unaudited)

 

    June 30,   December 31,
    2017   2016
    (Unaudited)   (Unaudited)
ASSETS                
Current assets                
Cash and cash equivalents   $ 437     $ 698  
Other current assets     47       131  
Total current assets     484       829  
                 
Patent license rights, net     274       353  
Furniture and equipment, net     -       -  
Total assets   $ 758     $ 1,182  
                 
LIABILITIES AND EQUITY                
Current liabilities                
Accounts payable   $ 393     $ 249  
Other accrued liabilities     80       55  
Convertible Promissary Notes Payable     1,000       1,000  
Total current liabilities     1,473       1,304  
                 
                 
                 
Equity                
Capstone Therapeutics Corp. Stockholders' Equity                
Common Stock $.0005 par value;     20       20  
150,000,000 shares authorized; 40,885,411 shares                
outstanding June 30, 2017 and December 31, 2016 - See Note F                
Additional paid-in capital     189,477       189,477  
Accumulated deficit     (190,212 )     (189,619 )
Total Capstone Therapeutics Corp. stockholders' equity (deficit)     (715 )     (122 )
Noncontrolling interest     -       -  
Total equity     (715 )     (122 )
Total liabilities and equity   $ 758     $ 1,182  

 

See notes to unaudited consolidated financial statements

 

  5  

 

CAPSTONE THERAPEUTICS Corp.

CONDENSED CONSOLIDATED Statements of Operations

(in thousands, except per share data)

(Unaudited)

 

    Three months ended June 30,   Six months ended June 30,
    2017   2016   2017   2016
                 
OPERATING EXPENSES                                
General and administrative   $ 102     $ 157     $ 215     $ 382  
Research and development     112       220       379       377  
Total operating expenses     214       377       594       759  
                                 
Interest and other expense, net     (6 )     25       9       36  
Loss from operations before taxes     208       402       603       795  
Income tax benefit     (2 )     (12 )     (10 )     (26 )
NET LOSS     206       390       593       769  
Less: Net Loss attributable to the noncontrolling                                
interest     -       -       -       -  
Net Loss attributable to Capstone                                
Therapeutics Corp. stockholders   $ 206     $ 390     $ 593     $ 769  
Per Share Information:                                
Net loss, basic and diluted, attributable to                                
Capstone Therapeutic Corp. stockholders   $ 0.01     $ 0.01     $ 0.01     $ 0.02  
Basic and diluted shares outstanding     40,885       40,885       40,885       40,885  

 

See notes to unaudited condensed consolidated financial statements

 

  6  

 

CAPSTONE THERAPEUTICS Corp.

CONDENSED CONSOLIDATED Statements of CASH FLOWS

(in thousands)

(Unaudited)

 

    Six months ended June 30,
    2017   2016
         
OPERATING ACTIVITIES                
Net loss   $ (593 )   $ (769 )
Non cash items:                
Depreciation and amortization     86       89  
Non-cash stock-based compensation     -       32  
Change in other operating items:                
Other current assets     77       159  
Accounts payable     144       148  
Other accrued liabilities     25       22  
Cash flows used in operating activities     (261 )     (319 )
INVESTING ACTIVITIES                
Cash flows provided by investing activities     -       -  
                 
FINANCING ACTIVITIES                
Cash flows provided by financing activities     -       -  
NET DECREASE IN CASH AND CASH EQUIVALENTS     (261 )     (319 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD     698       1,011  
CASH AND CASH EQUIVALENTS, END OF PERIOD   $ 437     $ 692  

 

See notes to unaudited consolidated financial statements

 

  7  

 

CAPSTONE THERAPEUTICS CORP.

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2017

 

Note A. OVERVIEW OF BUSINESS

 

D escription of the Business

 

Capstone Therapeutics Corp. (the “Company”, “we”, “our” or “us”) is a biotechnology company committed to developing a pipeline of novel peptides aimed at helping patients with under-served medical conditions. Previously, we were focused on the development and commercialization of two product platforms: AZX100 and Chrysalin (TP508). In 2012, we terminated the license for Chrysalin (targeting orthopedic indications). In 2014, we terminated the license for AZX100 (targeting dermal scar reduction). Capstone no longer has any rights to or interest in Chrysalin or AZX100.

 

On August 3, 2012, we entered into a joint venture, LipimetiX Development, LLC, (now LipimetiX Development, Inc.), (the “JV”), to develop Apo E mimetic peptide molecule AEM-28 and its analogs. The JV had a development plan to pursue regulatory approval of AEM-28, and/or an analog, as treatment for Homozygous Familial Hypercholesterolemia (granted Orphan Drug Designation by FDA in 2012) and other hyperlipidemic indications. The initial development plan extended through Phase 1a and 1b/2a clinical trials and was completed in the fourth quarter of 2014. The clinical trials had a safety primary endpoint and an efficacy endpoint targeting reduction of cholesterol and triglycerides.

 

The JV received allowance from regulatory authorities in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 were randomized, double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest doses from Phase 1a (Phase 1b/2a in patients with hypercholesterolemia and healthy volunteers with elevated cholesterol and high Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker endpoints.

 

Concurrent with the clinical development activities of AEM-28, the JV has performed pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-14, and a new formulation, that has the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent life (application filed with the U.S. Patent and Trademark Office in 2015). The JV’s current intent is to prioritize the development of AEM-28-14.

 

The JV and the Company are exploring fundraising, partnering or licensing, to obtain additional funding to continue development activities of AEM-28-14, and operations.

 

The JV and the Company do not have sufficient funding at this time to continue additional material development activities of AEM-28-14. The JV may conduct future clinical trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions permit.

 

  8  

 

The Company, funding permitting, intends to continue limiting its internal operations to a virtual operating model while monitoring and participating in the management of JV’s AEM-28-14 development activities.

 

 

Description of Current Peptide Drug Candidates.

 

Apo E Mimetic Peptide Molecule – AEM-28 and its analogs

 

Apolipoprotein E is a 299 amino acid protein that plays an important role in lipoprotein metabolism. Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream. Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28 and its analogs, including AEM-28-14, is a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid), and both contain a domain that anchors into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan sulfate proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and its analogs, including AEM-28-14, as Apo E mimetics, have the potential to restore the ability of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28-14. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases. Our joint venture has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for a broad domain of Apo E mimetic peptides, including AEM-28 and its analogs.

 

Company History

 

Prior to November 26, 2003, we developed, manufactured and marketed proprietary, technologically advanced orthopedic products designed to promote the healing of musculoskeletal bone and tissue, with particular emphasis on fracture healing and spine repair. Our product lines, which included bone growth stimulation and fracture fixation devices, are referred to as our “Bone Device Business.” In November 2003, we sold our Bone Device Business.

 

In August 2004, we purchased substantially all of the assets and intellectual property of Chrysalis Biotechnology, Inc., including its exclusive worldwide license for Chrysalin, a peptide, for all medical indications. Subsequently, our efforts were focused on research and development of Chrysalin with the goal of commercializing our products in fresh fracture healing. (In March 2012, we returned all rights to the Chrysalin intellectual property and no longer have any interest in, or rights to, Chrysalin.)

 

In February 2006, we purchased certain assets and assumed certain liabilities of AzERx, Inc. Under the terms of the transaction, we acquired an exclusive license for the core intellectual property relating to AZX100, an anti-fibrotic peptide. In 2014, we terminated the License Agreement with AzTE (Licensor) for the core intellectual property relating to AZX100 and returned all interest in and rights to the AZX100 intellectual property to the Licensor.

 

On August 3, 2012, we entered into a joint venture (see Note B below), to develop Apo E mimetic peptide molecule AEM-28 and its analogs.

 

  9  

 

Our development activities represent a single operating segment as they share the same product development path and utilized the same Company resources. As a result, we determined that it is appropriate to reflect our operations as one reportable segment.

 

OrthoLogic Corp. commenced doing business under the trade name of Capstone Therapeutics on October 1, 2008, and we formally changed our name from OrthoLogic Corp. to Capstone Therapeutics Corp. on May 21, 2010.

 

In these notes, references to “we”, “our”, “us”, the “Company”, “Capstone Therapeutics”, “Capstone”, and “OrthoLogic” refer to Capstone Therapeutics Corp. References to our joint venture or “JV”, refer to LipimetiX Development, Inc. (formerly LipimetiX Development, LLC).

 

Basis of presentation, Going Concern, and Management’s Plans. The accompanying financials statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

 

Management has determined that the Company will require additional capital above its current cash and working capital balances to further develop AEM-28-14 or continue operations. Accordingly, the Company has significantly reduced its development activities. The Company’s corporate strategy is to raise funds by possibly engaging in a strategic/merger transaction, or conducting a private or public offering of debt or equity securities for capital. The audit opinion of our independent accounting firm on our December 31, 2014 financial statements, included in our Annual report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2015, included an explanatory paragraph as to the uncertainty with regards to our ability to raise funds to implement the future business strategy of the Company, raising substantial doubt about the Company’s ability to continue as a going concern. In August 2016, the Company’s joint venture raised net funds of $946,000 in a Series B-1 Preferred Stock and Warrant offering. As described in Note F to the Financial Statements included in this Quarterly Report on Form 10-Q, the Company, on July 14, 2017, raised $3,440,000, with net proceeds of approximately $2,078,000, after paying off the Convertible Promissory Notes described in Note C and transaction costs. As discussed in Note B to the Financial Statements included in this Quarterly Report on Form 10-Q, in August 2017, the Company used $1,000,000 of the net proceeds to purchase 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock. These funds will allow the joint venture to continue its development activities, but additional funds will be required for the joint venture to reach its AEM-28-14 development goals and for the Company to continue its planned operations.

 

These financial statements have been prepared on a going concern basis and do not include any adjustments that might result the future success or lack thereof, of fundraising activities.

 

In the opinion of management, the unaudited condensed interim financial statements include all adjustments necessary for the fair presentation of our financial position, results of operations, and cash flows, and all adjustments were of a normal recurring nature. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the complete fiscal year. The financial statements include the consolidated results of Capstone Therapeutics Corp. and our 64% (62.2% on a Series B-1 and B-2 Preferred Stock as-converted basis) owned subsidiary, LipimetiX Development, Inc. Intercompany transactions have been eliminated.

 

Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to Securities and Exchange Commission rules and regulations, although we believe that the disclosures herein are adequate to make the information presented not misleading. These unaudited condensed financial statements should be read in conjunction with the financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2016.

 

  10  

 

Use of Estimates

 

The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires that management make a number of assumptions and estimates that affect the reported amounts of assets, liabilities, and expenses in our financial statements and accompanying notes. Management bases its estimates on historical experience and various other assumptions believed to be reasonable. Although these estimates are based on management’s assumptions regarding current events and actions that may impact us in the future, actual results may differ from these estimates and assumptions.

 

The Convertible Promissory Notes, as described in Note C to the Financial Statements included in this Quarterly Report on Form 10-Q, were previously classified as a long-term payable due to their right to be converted into either the Company’s common stock or preferred stock. As part of the July 14, 2017 sale of the Company’s common stock and receipt of a secured loan, as described in Note F to the Financial Statements included in this Quarterly Report on Form 10-Q, the Convertible Promissory Notes’ Lenders elected to have the Convertible Promissory Notes paid off and not to convert the debt into either the Company’s Common Stock or Preferred Stock. Accordingly, the Convertible Promissory Notes have been reclassified to current liabilities.

 

Legal and Other Contingencies

 

The Company is subject to legal proceedings and claims that arise in the ordinary course of business. The Company records a liability when it is probable that a loss has been incurred and the amount is reasonably estimable. There is significant judgment required in both the probability determination and as to whether an exposure can be reasonably estimated. In the opinion of management, there was not at least a reasonable possibility the Company may have incurred a material loss with respect to loss contingencies.

 

Joint Venture Accounting

 

The Company entered into a joint venture in which it has contributed $6,000,000, and the noncontrolling interests have contributed certain patent license rights. As discussed in Note B to the Financial Statements included in this Quarterly Report on Form 10-Q, in August 2017, the Company purchased 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock for $1,000,000. Neither the Company nor the noncontrolling interests have an obligation to contribute additional funds to the joint venture or to assume any joint venture liabilities or to provide a guarantee of either joint venture performance or any joint venture liability. The financial position and results of operations of the joint venture are presented on a consolidated basis with the financial position and results of operations of the Company. Intercompany transactions have been eliminated. Joint venture losses were recorded on the basis of common ownership equity interests until common ownership equity was reduced to $0. Subsequent joint venture losses were allocated to the Series A and B-1 preferred ownership. Subsequent to March 31, 2013, all joint venture losses had been allocated to the Company. On August 25, 2016, the JV raised $1,012,000 ($946,000 net of issuance costs) in a Series B-1 Preferred Stock and Warrant offering and in 2016, $946,000 in losses were allocated to the Series B-1 Preferred Stock ownership interests. As of June 30,2017, losses incurred by the JV exceeded the capital accounts of the JV. The Company has a revolving loan agreement with the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits or other funds obtained) of $1,600,000, with the net amount due December 31, 2016. As described in Note C to the Financial Statements included in this Quarterly Report on Form 10-Q, the due date of the revolving loan has been extended to July 15, 2020, with early payment required upon certain additional funding of the joint venture by non-affiliated parties. Losses incurred by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent of net outstanding advances.

 

  11  

 

Cash and Cash Equivalents

 

At June 30, 2017, cash and cash equivalents included money market accounts.

 

Recent Accounting Pronouncements

 

In August 2014, the Financial Accounting Standards Board issued Accounting Standard Update (“ASU”) No. 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40)(“Update”): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, providing a requirement under U.S. GAAP for an entity’s management to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date the financial statements are issued; and if those conditions exist, to disclose that fact, the conditions and the potential effects on the entity’s ability to meet its obligations. The Update will be effective for an annual period ending after December 15, 2016, with early application permitted . If additional funds are not obtained to continue the development of AEM-28-14, it will impair our ability to reach our joint venture AEM-28-14 development goals and possibly to continue as a going concern. In August 2016, the Company’s joint venture raised net funds of $946,000 in a Series B-1 Preferred Stock and Warrant offering. As described in Note F to the Financial Statements included in this Quarterly Report on Form 10-Q, the Company on July 14, 2017, raised $3,440,000, with net proceeds of approximately $2,078,000, after paying off the Convertible Promissory Notes described in Note C and transaction costs. As discussed in Note B to the Financial Statements included in this Quarterly Report on Form 10-Q, in August 2017, the Company purchased 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock for $1,000,000. These funds will allow the joint venture to continue its development activities, but additional funds will be required for the joint venture to reach its AEM-28-14 development goals and for the Company to continue its planned operations. If we do not continue as a going concern, the Company may incur additional losses, up to, and possibly exceeding our joint venture investment balance.

 

Note B. JOINT VENTURE FOR DEVELOPMENT OF APO E MIMETIC PEPTIDE MOLECULE AEM-28 AND ANALOGS

 

On August 3, 2012, we entered into a Contribution Agreement with LipimetiX, LLC to form a joint venture, LipimetiX Development, LLC (“JV”), to develop Apo E mimetic molecules, including AEM-28 and its analogs. In June 2015, the JV converted from a limited liability company to a corporation, LipimetiX Development, Inc. The Company contributed $6 million, which included $1 million for 600,000 voting common ownership units (now common stock), representing 60% ownership in the JV, and $5 million for 5,000,000 non-voting preferred ownership units (now preferred stock), which have preferential distribution rights. On March 31, 2016, the Company converted 1,500,000 shares of its preferred stock into 120,000 shares of common stock, increasing its common stock ownership from 60% to 64%. On August 11, 2017, the currently $3,500,000 (3,500,000 shares) of preferred stock became convertible, at the Company’s option, into common stock, at the lower of the Series B-1 Preferred Stock Conversion Price, as may be adjusted for certain events, or the price of the next LipimetiX Development, Inc. financing, exceeding $1,000,000, independently set valuation and terms. On August 11, 2017, the Company purchased 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock for $1,000,000. As discussed below, the JV Series B-1 and B-2 Preferred Stock issuances, because of the participating and conversion features of the preferred stock, effectively changes the Company’s ownership in the JV to 62.2%.

 

LipimetiX, LLC contributed all intellectual property rights for Apo E mimetic molecules it owned and assigned its Exclusive License Agreement between The University of Alabama at Birmingham Research Foundation (“UABRF”) and LipimetiX, LLC, for the UABRF intellectual property related to Apo E mimetic molecules AEM-28 and its analogs to the JV, in return for 400,000 voting common ownership units (now common stock) representing 40% ownership in JV (now 36% or 30.6% on an “as converted” basis), and $378,000 in cash (for certain initial patent-related costs and legal expenses).

 

  12  

 

On August 25, 2016, LipimetiX Development, Inc. closed a Series B-1 Preferred Stock offering, raising funds of $1,012,000 ($946,000 net of issuance costs of approximately $66,000). Individual accredited investors and management participated in the financing. This initial closing of the Series B-1 preferred stock offering resulted in the issuance of 94,537 shares of preferred stock, convertible to an equal number of the JV’s common stock at the election of the holders, and warrants to purchase an additional 33,088 shares of JV preferred stock, at an exercise price of $10.70, with a ten-year term. The preferred stock represented 7.8% of the post-closing common stock of the JV, on an “as-converted” basis. Following this initial Series B-1 closing, on an “as converted” basis, the Company owned 59.3% of the JV.

 

As disclosed above, the Company purchased 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock for $1,000,000. Following this Series B-2 closing, on an “as converted” basis, the Company owned 62.2% of the JV. Series B (B-1 and B-2) preferred stock is a participating preferred stock. As a participating preferred, the preferred stock will earn a 5% dividend, payable only upon the election by the JV or in liquidation. Prior to the JV common stock holders receiving distributions, the participating preferred stockholders will receive their earned dividends and payback of their original investment. Subsequently, the participating preferred will participate in future distributions on an equal “as converted” share basis with common stock holders. The Series B preferred stock has “as converted” voting rights and other terms standard to a security of this nature.

 

LipimetiX, LLC was formed by the principals of Benu BioPharma, Inc. (“Benu”) and UABRF to commercialize UABRF’s intellectual property related to Apo E mimetic molecules, including AEM-28 and analogs. Benu is composed of Dennis I. Goldberg, Ph.D. and Eric M. Morrel, Ph.D. The Exclusive License Agreement, as amended, calls for payment of patent filing, maintenance and other related patent fees, as well as a royalty of 3% on Net Sales of Licensed Products during the Term of the Agreement. The Agreement terminates upon the expiration of all Valid Patent Claims within the Licensed Patents, which are currently estimated to expire between 2019 and 2035. The Agreement, as amended, also calls for annual maintenance payments of $25,000, various milestone payments of $50,000 to $500,000 and minimum royalty payments of $500,000 to $1,000,000 per year commencing on January 1 of the first calendar year following the year in which the First Commercial Sale occurs. UABRF will also be paid 5% of Non-Royalty Income received.

 

Concurrent with entering into the Contribution Agreement and the First Amendment and Consent to Assignment of Exclusive License Agreement between LipimetiX, LLC, UABRF and the Company, the Company and LipimetiX, LLC entered into a Limited Liability Company Agreement for JV which established a Joint Development Committee (“JDC”) to manage JV development activities. Upon conversion by the JV from a limited liability company to a corporation, the parties entered into a Stockholders Agreement for the JV, and the JDC was replaced by a Board of Directors (JV Board). The JV Board is composed of three members appointed by the non-Company common stock ownership group, three members appointed by the Company and one member appointed by the Series B-1 Preferred Stockholders. Non-development JV decisions, including the issuance of new equity, incurrence of debt, entry into strategic transactions, licenses or development agreements, sales of assets and liquidation, and approval of annual budgets, will be decided by a majority vote of the common and Series B Preferred Stock (voting on an “as converted” basis) stockholders.

 

The JV, on August 3, 2012, entered into a Management Agreement with Benu to manage JV development activities for a monthly fee of approximately $63,000 during the twenty-seven month development period, and an Accounting Services Agreement with the Company to manage JV accounting and administrative functions. The services related to these agreements have been completed. New Management and Accounting Services Agreements were entered into effective June 1, 2016. The new monthly management fee is $80,000 and the new monthly accounting services fee is $10,000. However, no Management or Accounting Services fees are due or payable except to the extent funding is available, as unanimously approved by members of the JV Board of Directors and as reflected in the approved operating budget in effect at that time. In connection with the Series B-1 Preferred Stock issuance, Management Fees totaling $300,000 and Accounting Fees totaling $60,000 were paid in 2016. In August 2017 the Accounting Services Agreement monthly fee was increased to $20,000 and will thereafter be accrued but not payable, until certain levels of joint venture funding are obtained from non-affiliated parties. In August 2017, a Management Fee of $150,000 payable in 2017 and $150,000 payable in 2018 was approved by the joint venture’s Board of Directors.

 

  13  

 

The joint venture formation was as follows ($000’s):

 

Patent license rights   $ 1,045  
Noncontrolling interests     (667 )
Cash paid at formation   $ 378  

 

Patent license rights were recorded at their estimated fair value and are being amortized on a straight-line basis over the key patent life of eighty months.

 

The financial position and results of operations of the joint venture are presented on a consolidated basis with the financial position and results of operations of the Company. Intercompany transactions have been eliminated. In the Company’s consolidated financial statements, joint venture losses were recorded on the basis of common ownership equity interests until common ownership equity was reduced to $0. Subsequent joint venture losses were being allocated to the Series A preferred ownership equity (100% Company). Subsequent to March 31, 2013, all joint venture losses had been allocated to the Company. On August 25, 2016 the JV raised $1,012,000, ($946,000 net of issuance costs) in a Series B-1 Preferred Stock and Warrant offering and in 2016, $946,000 of losses were allocated to the Series B-1 Preferred Stock ownership interests. As of June 30, 2017, losses incurred by the JV exceeded the capital accounts of the JV. The Company has a revolving loan agreement with the joint venture to advance the joint venture funds for operations in an amount not to exceed a net (net of expected tax credits or other funds obtained) of $1,600,000, with the net amount due December 31, 2016. In August 2017, the due date of the revolving loan was extended toJuly 15, 2020, with early payment required upon certain additional funding of the joint venture by non-affiliated parties. Subsequent to June 30, 2017, interest due on the revolving loan will be accrued and payable only upon certain additional funding of the joint venture by non-affiliated parties. Losses incurred by the joint venture in excess of the capital accounts of the joint venture will be allocated to the Company to the extent of net outstanding advances. At June 30, 2017, outstanding advances on the revolving loan agreement totaled $1,600,000.

 

The joint venture incurred net operating expenses, prior to the elimination of intercompany transactions, of $409,000 in 2017 and $8,881,000 for the period from August 3, 2012 (inception) to June 30, 2017, of which $409,000, and $7,269,000, respectively, have been recorded by the Company. The joint venture operating expenses are included in research and development expenses in the condensed consolidated statements of operations.

 

Neither the Company nor the noncontrolling interests have an obligation to contribute additional funds to the joint venture or to assume any joint venture liabilities or to provide a guarantee of either joint venture performance or any joint venture liability. Losses allocated to the common stock noncontrolling interests represent an additional potential loss for the Company as the common stock noncontrolling interests are not obligated to contribute assets to the joint venture, and depending on the ultimate outcome of the joint venture, the Company could potentially absorb all losses associated with the joint venture. From formation of the joint venture, August 3, 2012, through June 30, 2017, losses totaling $667,000 have been allocated to the common stock noncontrolling interests. If the joint venture or Company is unable to obtain additional funding, the ability of the joint venture to continue development of AEM-28-14, would be impaired as would the joint venture’s ability to continue operations. If the joint venture does not continue as a going concern, at June 30, 2017 the Company would incur an additional loss of $667,000 for the joint venture losses allocated to the common stock noncontrolling interests.

 

  14  

 

Note C. CONVERTIBLE PROMISSORY NOTES PAYABLE

 

On December 11, 2015, we entered into a Securities Purchase Agreement with Biotechnology Value Fund affiliated entities Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P., Investment 10, LLC, and MSI BVF SPV,), which provided $1,000,000 in funding for our operations in the form of Convertible Promissory Notes. The Convertible Promissory Notes bear interest at 5% and were due April 30, 2017, with the due date subsequently extended to July 14, 2017. A portion of the funds were advanced to JV to initiate preclinical development activities for our lead commercial drug candidate, AEM-28-14. As described in Note F to this Quarterly Report on Form 10-Q, the Convertible Promissory Notes and accrued interest thereon of $1,079,000 were paid off on July 14, 2017.

 

Note D. Australian Refundable Research & Development Credit

 

In March 2014, LipimetiX Development LLC, (Now LipimetiX Development, Inc. - see Note B) formed a wholly-owned Australian subsidiary, Lipimetix Australia Pty Ltd, to conduct Phase 1a and Phase1b/2a clinical trials in Australia. Currently Australian tax regulations provide for a refundable research and development tax credit equal to either 43.5% or 45% (depending on the tax period) of qualified expenditures. Subsequent to the end of its Australian tax years, Lipimetix Australia Pty Ltd intends to submit claims for a refundable research and development tax credit. The transitional Australian tax periods/years granted for Lipimetix Australia Pty Ltd end on June 30, 2014, December 31, 2014 and thereafter December 31 of each succeeding year. For the tax year ended June 30, 2014, Lipimetix Australia Pty Ltd received a refundable research and development tax credit of AUD$227,000. For the tax years ended December 31, 2014 and 2015 Lipimetix Australia Pty Ltd received a refundable research and development tax credit of AUD$301,000 and AUD$189,000, respectively. For the year ended December 31, 2016 a AUD$84,000 refundable research and development tax credit was received by Lipimetix Australia Pty Ltd. For the six months ended June 30, 2017, an additional AUD$11,000 refundable research and development tax credit has been recorded by LipimetiX Australia Pty Ltd.

 

Note E: Contingency – Non-Compliance with Securities and Exchange Commission Reporting Requirements and OTCQB Market Requirements

 

Our current level of funds available for operation has led to additional cost cutting, which included the decision to not engage an independent public accountant to audit and express an opinion on our December 31, 2016 and 2015, respectively, financial statements included in our Annual Report on Form 10-K filed with the SEC on March 31, 2017, or to review our Current Reports on Form 10-Q filed with the SEC in 2016 and 2017, as required by current SEC rules and regulations, and as required to be listed on the OTCQB Market. We cannot currently predict the response to these actions by the SEC or the OTCQB Market, nor the effects of their actions, including the possible effect on the trading of our common stock. The decision to not engage an independent public accountant to audit and express an opinion on our December 31, 2016 and 2015 financial statements or review our Current Reports on Form 10-Q could have a material adverse effect on the Company and its Stockholders.

 

  15  

 

Note F: SUBSEQUENT EVENTS – SALE OF COMMON STOCK, SECURED LOAN AND PAY OFF OF CONVERTIBLE PROMISSORY NOTES

 

As described in our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 17, 2017, on July 14, 2017, the Company entered into a Securities Purchase, Loan and Security Agreement (the “Agreement”) with BP Peptides, LLC (“Brookstone"). The net funds will be used to fund our operations, infuse new capital into our joint venture, LipimetiX Development, Inc. ("JV") (As described in Note B to this Quarterly Report on Form 10-Q, in August 2017, the Company purchased 93,458 shares of LipimetiX Development, Inc.’s Series B-2 Preferred Stock for $1,000,000.), to continue its AEM-28-14 development activities, and pay off the Convertible Promissory Notes (as described in Note C to this Quarterly Report on Form 10-Q) totaling $1,000,000, plus $79,000 in accrued interest.

 

Pursuant to the Agreement, Brookstone funded an aggregate of $3,440,000, with net proceeds of approximately $2,078,000, after paying off the Convertible Promissory Notes and transaction costs, of which $1,102,500 was for the purchase of 13,500,000 newly issued shares of our Common Stock, and $2,427,500 was in the form of a secured loan, due October 15, 2020. The secured loan bears interest at 6% per annum, with interest payable quarterly, and is secured by a security interest in all of our assets. As part of the Agreement, the Company and Brookstone entered into a Registration Rights Agreement granting Brookstone certain demand and piggyback registration rights.

 

As disclosed above, management has determined that the Company will require additional capital above its current cash and working capital balances to further develop AEM-28-14. Accordingly, the Company will continue to limit its development activities. The Company’s corporate strategy is to raise funds either by the Company, or directly in its joint venture, by possibly engaging in a strategic/merger transaction, or conducting a private or public offering of debt or equity securities for capital.

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The following is management’s discussion of significant events in the three and six month periods ended June 30, 2017 and factors that affected our interim financial condition and results of operations. This should be read in conjunction with our “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2016.

 

Overview of the Business

 

Capstone Therapeutics Corp. (the “Company”, “we”, “our” or “us”) is a biotechnology company committed to developing a pipeline of novel peptides aimed at helping patients with under-served medical conditions. Previously, we were focused on the development and commercialization of two product platforms: AZX100 and Chrysalin (TP508). In 2012, we terminated the license for Chrysalin (targeting orthopedic indications). In 2014, we terminated the license for AZX100 (targeting dermal scar reduction). Capstone no longer has any rights to or interest in Chrysalin or AZX100.

 

On August 3, 2012, we entered into a joint venture, LipimetiX Development, LLC, (now LipimetiX Development, Inc.), (the “JV”), to develop Apo E mimetic peptide molecule AEM-28 and its analogs. The JV has a development plan to pursue regulatory approval of AEM-28, and/or an analog, as treatment for Homozygous Familial Hypercholesterolemia (granted Orphan Drug Designation by FDA in 2012) and other hyperlipidemic indications. The initial development plan extended through Phase 1a and 1b/2a clinical trials and was completed in the fourth quarter of 2014. The clinical trials had a safety primary endpoint and an efficacy endpoint targeting reduction of cholesterol and triglycerides.

 

  16  

 

The JV received allowance from regulatory authorities in Australia permitting the JV to proceed with the planned clinical trials. The Phase 1a clinical trial commenced in Australia in April 2014 and the Phase 1b/2a clinical trial commenced in Australia in June 2014. The clinical trials for AEM-28 were randomized, double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of six escalating single doses (Phase 1a in healthy patients with elevated cholesterol) and multiple ascending doses of the three highest doses from Phase 1a (Phase 1b/2a in patients with hypercholesterolemia and healthy volunteers with elevated cholesterol and high Body Mass Index). The Phase 1a clinical trial consisted of 36 patients and the Phase 1b/2a consisted of 15 patients. Both clinical trials were completed in 2014 and the Medical Safety Committee, reviewing all safety-related aspects of the clinical trials, observed a generally acceptable safety profile. As first-in-man studies, the primary endpoint was safety; yet efficacy measurements analyzing pharmacodynamics yielded statistical significance in the pooled dataset favoring AEM-28 versus placebo in multiple lipid biomarker endpoints.

 

Concurrent with the clinical development activities of AEM-28, the JV has performed pre-clinical studies that have identified an analog of AEM-28, referred to as AEM-28-14, and a new formulation, that has the potential of increased efficacy, higher human dose toleration and an extended composition of matter patent life (application filed with the U.S. Patent and Trademark Office in 2015). The JV’s current intent is to prioritize the development of AEM-28-14.

 

The JV and the Company are exploring fundraising, partnering or licensing, to obtain additional funding to continue development activities of AEM-28-14, and operations.

 

The JV and the Company do not have sufficient funding at this time to continue additional material development activities of AEM-28-14. The JV may conduct future clinical trials in Australia, the USA, and other regulatory jurisdictions if regulatory approvals, additional funding, and other conditions permit.

 

The Company, funding permitting, intends to continue limiting its internal operations to a virtual operating model while monitoring and participating in the management of JV’s AEM-28-14 development activities.

 

 

Description of Current Peptide Drug Candidates.

 

Apo E Mimetic Peptide Molecule – AEM-28 and its analogs

 

Apolipoprotein E is a 299 amino acid protein that plays an important role in lipoprotein metabolism. Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream. Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries. AEM-28 is a 28 amino acid mimetic of Apo E and AEM-28 and its analogs, including AEM-28-14, is a 28 amino acid mimetic of Apo E (with an aminohexanoic acid group and a phospholipid), and both contain a domain that anchors into a lipoprotein surface while also providing the Apo E receptor binding domain, which allows clearance through the heparan sulfate proteoglycan (HSPG) receptors (Syndecan-1) in the liver. AEM-28 and its analogs, including AEM-28-14, as Apo E mimetics, have the potential to restore the ability of these atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28-14. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases. Our joint venture has an Exclusive License Agreement with the University of Alabama at Birmingham Research Foundation for a broad domain of Apo E mimetic peptides, including AEM-28 and its analogs.

 

  17  

 

Critical Accounting Policies


Our critical accounting policies are those that affect, or could affect our financial statements materially and involve a significant level of judgment by management. The accounting policies and related risks described in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 15, 2017, for the year ended December 31, 2016 are those that depend most heavily on these judgments and estimates. As of June 30, 2017, there have been no material changes to any of the critical accounting policies contained in our Annual Report for the year ended December 31, 2016.

  

Results of Operations Comparing Three-Month Period Ended June 30, 2017 to the Corresponding Period in 2016.

 

General and Administrative (“G&A”) Expenses: G&A expenses related to our ongoing operations were $102,000 in the second quarter of 2017 compared to $157,000 in the second quarter of 2016. Administration expenses decreased primarily due to reductions from our cost cutting efforts.

 

Research and Development Expenses: Research and development expenses were $112,000 in the second quarter of 2017 compared to $220,000 in the second quarter of 2016. Our development activities of AEM-28-14 will continue to be limited, as we attempt to obtain additional funding.

 

Net Loss attributable to Capstone Therapeutics stockholders: We incurred a net loss in the second quarter of 2017 of $.2 million compared to a net loss of $.4 million in the second quarter of 2016. Our operations and the development activities of AEM-28-14 will continue to be limited, as we attempt to obtain additional funding.

  

Results of Operations Comparing Six-Month Period Ended June 30, 2017 to the Corresponding Period in 2016.

 

General and Administrative (“G&A”) Expenses: G&A expenses related to our ongoing operations were $215,000 in the first six months of 2017 compared to $382,000 in the first six months of 2016. Administration expenses decreased primarily due to a 50% reduction in salaries and consulting fee rates taken by all staff and consultants in March 2016 and reductions from our cost cutting efforts.

 

  18  

 

Research and Development Expenses: Research and development expenses were $379,000 for the first six months of 2017 compared to $377,000 for the first six months of 2016. Our development activities of AEM-28-14 will continue to be limited, as we attempt to obtain additional funding.

 

Net Loss attributable to Capstone Therapeutics stockholders: We incurred a net loss in the first six months of 2017 of $.6 million compared to a net loss of $.8 million in the first six months of 2016. Our operations and the development activities of AEM-28-14 will continue to be limited, as we attempt to obtain additional funding.

  

Liquidity and Capital Resources

 

With the sale of our Bone Device Business in November 2003, we sold all of our revenue producing operations. Since that time, we have primarily relied on our cash and investments to finance all our operations, the focus of which has been research and development of our product candidates.

 

On August 3, 2012, we entered into a joint venture, to develop Apo E mimetic peptide AEM-28 and its analogs. We contributed $6.0 million and through September 30, 2016 we have loaned an additional $1,600,000 to the JV. The JV raised $1,012,000 ($946,000 net of issuance costs) in the JV’s Series B-1 Preferred Stock and Warrant offering in August 2016. As described in Note F to the Financial Statements included in this Quarterly Report on Form 10-Q, the Company on July 14, 2017, raised $3,440,000, with net proceeds of approximately $2,078,000, after paying off the Convertible Promissory Notes described in Note C and transaction costs. At June 30, 2017, we had cash and cash equivalents of $437,000, of which $286,000 is held by our JV.

 

We intend to continue limiting our internal operations to a virtual operating model in 2017, however, without additional funding, we will limit the development activities of AEM-28-14. Lack of additional funding for development activities of AEM-28-14 could would impair our ability to continue our current operations as planned.

 

Funding permitting, our planned operations in 2017 consist of continuing monitoring and participating in the management of the JV’s AEM-28-14 development activities.

 

Our future research and development and other expenses will vary significantly from prior periods and depend on the Company’s decisions on future JV operations and obtaining additional funding.

 

We will require additional funds if we chose to extend the development of AEM-28-14. We cannot currently predict the amount of funds that will be required if we chose to extend the development activities of AEM-28-14 and its analogs and to continue operations. In any event, to complete the clinical trials and supporting research and production efforts necessary to obtain FDA or comparable foreign agencies’ approval for product candidates would require us to obtain additional capital. New sources of funds, including raising capital through the sales of our debt or equity securities, joint venture or other forms of joint development arrangements, sales of development rights, or licensing agreements, may not be available or may only be available on terms that would have a material adverse impact on our existing stockholders’ interests.

 

As discussed in Note F to the Financial Statement included in this Quarterly Report on Form 10-Q, on July 14, 2017, the Company received a secured loan of $ 2,427,500, due October 15, 2020, from BP Peptides, LLC, an entity that currently own approximately 34.1% of the Company’s common stock.

 

  19  

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and principal financial and accounting officer, has reviewed and evaluated our disclosure controls and procedures (as defined in the Securities Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 10-Q. Based on that evaluation, our management, including our principal executive officer and principal financial and accounting officer, has concluded that our disclosure controls and procedures were effective as of the end of the period covered by this Form 10-Q in ensuring that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and is accumulated and communicated to management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 

Part II – Other Information

 

Item 1. Legal Proceedings

 

None

 

 

Item 6. Exhibits

 

See the Exhibit Index following this report.

 

 

 

 

 

 

  20  

 

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.

 

 

 

CAPSTONE THERAPEUTICS CORP.

(Registrant)

 

 

Signature Title Date
     

/s/ John M. Holliman, III

John M. Holliman, III

 

 

Chairman and Chief Executive Officer

(Principal Executive Officer)

August 14, 2017

/s/ Les M. Taeger

Les M. Taeger

Senior Vice President and Chief

Financial Officer

(Principal Financial and Accounting Officer)

August 14, 2017
     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  21  

 

Capstone Therapeutics Corp.

(the “Company”)

Exhibit Index to Quarterly Report on Form 10-Q

For the Quarterly Period Ended June 30, 2017

 

No. Description Incorporated by Reference To: Filed Herewith
10.1 Series B-2 Preferred Stock Purchase Agreement, dated August 11, 2017, by and between Capstone Therapeutics Corp. and LipimetiX Development, Inc.   X
10.2 First Amendment to the Amended and Restated Stockholders Agreement of LipimetiX Development, Inc., dated August 11, 2017   X
10.3 Joinder of August 25, 2016 Registration Rights Agreement of LipimetiX Development, Inc., dated August 11, 2017   X
10.4 Certificate of Amendment of Amended and Restated Certificate of Incorporation of LipimetiX Development, Inc.   X
10.5 First Amendment to Bylaws of LipimentiX Development, Inc., dated August 11, 2017    
31.1 Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as amended.   X
31.2 Certification of Principal Financial and Accounting Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as amended.   X
32 Certification of Principal Executive Officer and Principal Financial and Accounting Officer Pursuant to 18 U.S.C. Section 1350.*    
101

The following financial information from our Quarterly Report on Form 10-Q for the second quarter of fiscal year 2017, filed with the SEC on August 14, 2017 formatted in Extensible Business Reporting Language (XBRL): (i) the Condensed Consolidated Balance Sheets as of June 30, 2017 and December 31, 2016, (ii) the Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2017 and 2016 (iii) the Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2017 and 2016, and (iv) Notes to Unaudited Condensed Consolidated Financial Statements.

 

 

* Furnished herewith

  X

 

Exhibit 31.1

 

CERTIFICATION

 

I, John M. Holliman, III certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Capstone Therapeutics Corp.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: August 14, 2017

 

By: /s/ John M. Holliman, III                   

John M. Holliman, III
Chairman and Chief Executive Officer

(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION

 

I, Les M. Taeger, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Capstone Therapeutics Corp.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 14, 2017

 

By: /s/ Les M. Taeger                                                

Les M. Taeger
Senior Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

Exhibit 32

 

 

CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

In connection with the Quarterly Report of Capstone Therapeutics Corp. (the “Company”) on Form 10-Q for the period ended June 30, 2017 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of John M. Holliman, III, Executive Chairman and Principal Executive Officer of the Company, and Les M. Taeger, Senior Vice President and Chief Financial Officer, and Principal Financial and Accounting Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: August 14, 2017

 

/s/ John M. Holliman, III

John M. Holliman, III

Chairman and Chief Executive Officer

(Principal Executive Officer)

 

 

/s/ Les M. Taeger

Les M. Taeger

Senior Vice President and Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Capstone Therapeutics Corp. and will be retained by Capstone Therapeutics Corp. and furnished to the Securities and Exchange Commission or its staff upon request.

EXHIBIT 10.1

 

 

 

 

 

 

 

SERIES B-2 PREFERRED STOCK PURCHASE AGREEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TABLE OF CONTENTS

 

Page

1. Purchase and Sale of Preferred Stock 1

 

1.1 Sale and Issuance of Series B Preferred Stock 1

 

1.2 Closing; Delivery 1

 

1.3 Defined Terms Used in this Agreement 2

 

2. Representations and Warranties of the Company 3

 

2.1 Organization, Good Standing, Corporate Power and Qualification 3

 

2.2 Capitalization 3

 

2.3 Subsidiaries 4

 

2.4 Authorization 5

 

2.5 Valid Issuance of Shares 5

 

2.6 Governmental Consents and Filings 5

 

2.7 Litigation 6

 

2.8 Intellectual Property 6

 

2.9 Compliance with Other Instruments 6

 

2.10 Agreements; Actions 6

 

2.11 Certain Transactions 7

 

2.12 Tax Returns and Payments 7

 

2.13 Permits 7

 

2.14 Disclosure 7

 

3. Representations, Warranties and Covenants of the Purchaser 8

 

3.1 Authorization 8

 

3.2 Purchase Entirely for Own Account 8

 

3.3 Disclosure of Information 8

 

3.4 Restricted Securities; No Public Market 8

 

3.5 High Degree of Risk; Reliance on Own Advisors 9

 

3.6 Legends 9

 

3.7 Accredited Investor 9

 

3.8 No General Solicitation 9

 

3.9 Acknowledgment of Plan 10

 

i

 

 

TABLE OF CONTENTS
(continued)

 

Page

4. Conditions to the Purchaser’s Obligations at Closing 10

 

4.1 Representations and Warranties 10

 

4.2 Performance 10

 

4.3 Qualifications 10

 

4.4 Registration Rights Agreement 10

 

4.5 Preemptive Rights 10

 

5. Conditions of the Company’s Obligations at Closing 10

 

5.1 Representations and Warranties 10

 

5.2 Performance 10

 

5.3 Qualifications 10

 

5.4 Registration Rights Agreement 10

 

6. Miscellaneous 11

 

6.1 Survival of Warranties 11

 

6.2 Successors and Assigns 11

 

6.3 Governing Law 11

 

6.4 Counterparts 11

 

6.5 Titles and Subtitles 11

 

6.6 Notices 11

 

6.7 Intentionally Omitted 11

 

6.8 Intentionally Omitted 11

 

6.9 Attorneys’ Fees 11

 

6.10 Amendments and Waivers 12

 

6.11 Severability 12

 

6.12 Delays or Omissions 12

 

6.13 Entire Agreement 12

 

6.14 Intentionally Omitted 12

 

6.15 Dispute Resolution 12

 

6.16 Waiver of Jury Trial 12

 

ii

 

 

SERIES B-2 PREFERRED STOCK PURCHASE AGREEMENT

 

This Series B-2 Preferred Stock Purchase Agreement (this “Agreement”) is made and entered into as of August 11, 2017, by and among LipimetiX Development, Inc., a Delaware corporation (the “Company”), and Capstone Therapeutics Corp., a Delaware corporation (the “Purchaser”).

 

RECITALS

 

The Company previously sold to investors 94,537 shares of the Company’s Series B-1 Preferred, par value $0.00001 per share (the “ Series B-1 Preferred Stock ”).

 

The Company now desires to sell to the Purchaser, and the Purchaser desires to purchase from the Company, shares of the Company’s Series B-2 Preferred Stock, par value $0.00001 per share (the “ Series B-2 Preferred Stock ” or collectively with the Series B-1 Preferred Stock, the “ Series B Preferred Stock ”), on the terms and subject to the conditions set forth in this Agreement.

 

AGREEMENT

 

The parties hereby agree as follows:

 

1.                   Purchase and Sale of Preferred Stock .

 

1.1               Sale and Issuance of Series B Preferred Stock .

 

(a)                 The Company previously filed with the Secretary of State of the State of Delaware on August 24, 2016 the Amended and Restated Certificate of Incorporation (the “ Restated Certificate ”).

 

(b)                Subject to the terms and conditions of this Agreement, the Purchaser agrees to purchase at the Closing and the Company agrees to sell and issue to the Purchaser at the Closing 93,458 shares of Series B-2 Preferred Stock for an aggregate purchase price of One Million Dollars ($1,000,000). The shares of Series B-2 Preferred Stock issued to the Purchaser pursuant to this Agreement shall be referred to in this Agreement as the “ Shares .”

 

1.2               Closing; Delivery .

 

(a)                 The purchase and sale of the Shares shall take place remotely via the exchange of documents and signatures, on August 11, 2017, or at such other time and place as the Company and the Purchaser mutually agree upon, orally or in writing (which time and place are designated as the “ Closing ”).

 

(b)                At the Closing, the Company shall deliver to the Purchaser a certificate representing the Shares being purchased by Purchaser at the Closing against payment of the purchase price therefor by check payable to the Company or by wire transfer to a bank account designated by the Company.

 

 

 

1.3               Defined Terms Used in this Agreement . In addition to the terms defined above, the following terms used in this Agreement shall be construed to have the meanings set forth or referenced below.

 

(a)                 Accounting Services Agreement ” means that certain Accounting Services Agreement, effective as of August 3, 2012, as amended from time to time, by and between the Company and Capstone Therapeutics Corp.

 

(b)                Affiliate ” means, with respect to any specified Person, any other Person who, directly or indirectly, controls, is controlled by, or is under common control with such Person, including, without limitation, any general partner, managing member, officer or director of such Person or any venture capital fund now or hereafter existing that is controlled by one or more general partners or managing members of, or shares the same management company with, such Person.

 

(c)                 Amended and Restated Stockholders Agreement ” means that certain Amended and Restated Stockholders Agreement, by and among the Company and the stockholders party thereto.

 

(d)                Code ” means the Internal Revenue Code of 1986, as amended.

 

(e)                 Company Covered Person ” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any Person listed in the first paragraph of Rule 506(d)(1).

 

(f)                 Company Intellectual Property ” means all patents, patent applications, trademarks, trademark applications, service marks, service mark applications, tradenames, copyrights, trade secrets, domain names, mask works, information and proprietary rights and processes, similar or other intellectual property rights, subject matter of any of the foregoing, tangible embodiments of any of the foregoing, licenses in, to and under any of the foregoing, and any and all such cases that are owned or used by the Company in the conduct of the Company’s business as now conducted and as presently proposed to be conducted.

 

(g)                Key Consultants ” means any executive-level employee of Benu BioPharma, Inc., as well as any employee or consultant of Benu BioPharma, Inc. who either alone or in concert with others develops, invents, programs or designs any Company Intellectual Property pursuant to the Management Agreement.

 

(h)                Knowledge ” including the phrase “ to the Company’s knowledge ” shall mean the actual knowledge of the Company’s executive officers.

 

(i)                  Management Agreement ” means that certain Management Agreement, dated as of August 3, 2012, by and among the Company, Benu BioPharma, Inc. and certain affiliates of Benu BioPharma, Inc., as amended from time to time.

 

(j)                  Material Adverse Effect ” means a material adverse effect on the business, assets (including intangible assets), liabilities, financial condition, property, or results of operations of the Company.

 

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(k)                Person ” means any individual, corporation, partnership, trust, limited liability company, association or other entity.

 

(l)                  Registration Rights Agreement ” means that certain Registration Rights Agreement, by and among the Company and the stockholders party thereto.

 

(m)              Securities ” means the Shares and the Common Stock issuable upon the conversion of the Shares.

 

(n)                Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

(o)                Transaction Agreements ” means this Agreement, the Amended and Restated Stockholders Agreement, and the Registration Rights Agreement.

 

2.                   Representations and Warranties of the Company . The Company hereby represents and warrants to the Purchaser that, except as set forth on the Disclosure Schedule attached as Exhibit A to this Agreement, which exceptions shall be deemed to be part of the representations and warranties made hereunder, the following representations are true and complete as of the date of the Closing, except as otherwise indicated. The Disclosure Schedule shall be arranged in sections corresponding to the numbered and lettered sections and subsections contained in this Section 2, and the disclosures in any section or subsection of the Disclosure Schedule shall qualify other sections and subsections in this Section 2 only to the extent it is readily apparent from a reading of the disclosure that such disclosure is applicable to such other sections and subsections.

 

2.1               Organization, Good Standing, Corporate Power and Qualification . The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as presently conducted and as proposed to be conducted. The Company is duly qualified to transact business and is in good standing in each jurisdiction in which the failure to so qualify would have a Material Adverse Effect.

 

2.2               Capitalization .

 

(a)                 The authorized capital of the Company consists, immediately prior to the Closing, of:

 

(i)                  3,000,000 shares of Class A-1 and Class A-2 common stock, $.00001 par value per share (the “ Common Stock ”), 1,120,000 shares of which are issued and outstanding immediately prior to the Closing. All of the outstanding shares of Common Stock have been duly authorized, are fully paid and nonassessable and were issued in compliance with all applicable federal and state securities laws.

 

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(ii)                5,000,000 shares of Series A Preferred Stock, $.00001 par value per share (the “ Series A Preferred Stock ”) of which 3,500,000 shares are issued and outstanding immediately prior to the Closing. The rights, privileges and preferences of the Preferred Stock are as stated in the Restated Certificate and as provided by the Delaware General Corporation Law.

 

(iii)              350,000 shares of Series B-1 Preferred Stock, $.00001 par value per share, of which 94,537 shares are issued and outstanding immediately prior to the Closing, and 1,200,000 shares of Series B- 2 Preferred Stock, $.00001 par value per share, none of which are issued and outstanding immediately prior to the Closing. The rights, privileges and preferences of the Preferred Stock are as stated in the Restated Certificate and as provided by the Delaware General Corporation Law. There are outstanding Warrants to purchase an additional 33,088 shares of Series B-1 Preferred Stock at a purchase price of $10.70 per share, subject to adjustment as set forth therein.

 

(b)                The Company has adopted an equity incentive plan (the “ Stock Plan ”) and has reserved 71,500 shares of Class A-1 Common Stock, which represented six percent (6%) of the total outstanding shares of Common Stock on a fully diluted basis (prior to issuance of the Series B-1 Preferred Shares), for issuance to officers, directors, employees and consultants of the Company pursuant to the Stock Plan. Concurrent with the Closing, the Company's Board of Directors has approved an increase in the total number of shares of Class A-1 Common Stock available for grant under the Stock Plan from 71,500 to 83,480, which is equal to approximately six percent (6%) of the total outstanding shares of Class A-1 Common Stock on a fully diluted basis after giving effect to the issuance of the Shares, but excluding the shares issuable upon exercise of the Warrants described in Subsection 2.2(a)(iii) of this Agreement.

 

(c)                 Subsection 2.2(c) of the Disclosure Schedule sets forth the capitalization of the Company immediately following the Closing including the number of shares of the following: (i) issued and outstanding Class A-1 Common Stock and Class A-2 Common Stock; (ii) granted stock options, including vesting schedule and exercise price; (iii) shares of Common Stock reserved for future award grants under the Stock Plan; (iv) each series of Preferred Stock; and (v) warrants or stock purchase rights, if any. Except for (A) the conversion privileges of the Shares to be issued under this Agreement and the Series B-1 Preferred Stock, (B) the Warrants described in Schedule 2.2(c) , (C) the rights provided in the Stockholders Agreement, and (D) the securities and rights described in Subsection 2.2(a)(iii) of this Agreement and Subsection 2.2(c) of the Disclosure Schedule, there are no outstanding options, warrants, rights (including conversion or preemptive rights and rights of first refusal or similar rights) or agreements, orally or in writing, to purchase or acquire from the Company any shares of Common Stock or Preferred Stock, or any securities convertible into or exchangeable for shares of Common Stock or Preferred Stock.

 

2.3               Subsidiaries . The Company currently owns all of the outstanding equity of LipimetiX Australia Pty Ltd (“ LipimetiX Australia ”). The Company formed LipimetiX Australia in order to allow the Company to perform clinical trials in Australia and to participate in a program sponsored by the Australian government which may provide reimbursement to the Company of forty-three and one-half percent (43.5%) of allowable expenses incurred by the Company in Australia to perform such clinical trials. Except for LipimetiX Australia, the Company does not currently own or control, directly or indirectly, any interest in any other corporation, partnership, trust, joint venture, limited liability company, association, or other business entity.

 

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2.4               Authorization . All corporate action required to be taken by the Company’s Board of Directors and stockholders in order to authorize the Company to enter into the Transaction Agreements, and to issue the Shares, as applicable, at the Closing, and to issue the Common Stock issuable upon conversion of the Shares, has been taken or will be taken prior to the Closing. All action on the part of the officers of the Company necessary for the execution and delivery of the Transaction Agreements, the performance of all obligations of the Company under the Transaction Agreements to be performed as of the Closing, and the issuance and delivery of the Shares has been taken or will be taken prior to the Closing. The Transaction Agreements, when executed and delivered by the Company, shall constitute valid and legally binding obligations of the Company, enforceable against the Company in accordance with their respective terms except (i) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance, or other laws of general application relating to or affecting the enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief, or other equitable remedies, or (iii) to the extent indemnification provisions contained in the Transaction Agreements may be limited by applicable federal or state securities laws.

 

2.5               Valid Issuance of Shares .

 

(a)                 The Shares, when issued, sold and delivered in accordance with the terms and for the consideration set forth in this Agreement will be validly issued, fully paid and nonassessable and free of restrictions on transfer other than restrictions on transfer under the Transaction Agreements, applicable state and federal securities laws and liens or encumbrances created by or imposed by a Purchaser. Assuming the accuracy of the representations of the Purchaser in Section 3 of this Agreement and subject to the filings described in Subsection 2.6 below, the Shares will be issued in compliance with all applicable federal and state securities laws. The Common Stock issuable upon conversion of the Shares have been duly reserved for issuance, and upon issuance in accordance with the terms of the Restated Certificate, will be validly issued, fully paid and nonassessable and free of restrictions on transfer other than restrictions on transfer under the Transaction Agreements, applicable federal and state securities laws and liens or encumbrances created by or imposed by a Purchaser.

 

(b)                No “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) of the Securities Act (a “ Disqualification Event ”) is applicable to the Company or, to the Company’s knowledge, any Company Covered Person, except for a Disqualification Event as to which Rule 506(d)(2)(ii–iv) or (d)(3), is applicable.

 

2.6               Governmental Consents and Filings . Assuming the accuracy of the representations made by the Purchaser in Section 3 of this Agreement, no consent, approval, order or authorization of, or registration, qualification, designation, declaration or filing with, any federal, state or local governmental authority is required on the part of the Company in connection with the consummation of the transactions contemplated by this Agreement, except for (i) the filing of the Restated Certificate, which will have been filed as of the Closing, and (ii) filings pursuant to Regulation D of the Securities Act, and applicable state securities laws, which have been made or will be made in a timely manner.

 

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2.7               Litigation . There is no claim, action, suit, proceeding, arbitration, complaint, charge or investigation pending or to the Company’s knowledge, currently threatened in writing (i) against the Company; or (ii) to the Company’s knowledge, that questions the validity of the Transaction Agreements or the right of the Company to enter into them, or to consummate the transactions contemplated by the Transaction Agreements; or (iii) to the Company’s knowledge, that would reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect.

 

2.8               Intellectual Property . The Company possesses certain intellectual rights pursuant to the Exclusive License Agreement, dated August 26, 2011, between The UAB Research Foundation and LipimetiX Development, LLC, as amended and assigned to the Company, governing the license and exploitation of the Licensed Patents, as defined therein, relating to Apolipoprotein E mimetic peptides. The Company has also filed one formulation patent application with the United States Patent and Trademark Office.

 

2.9               Compliance with Other Instruments . The Company is not in violation or default (i) of any provisions of its Restated Certificate or Bylaws, (ii) of any instrument, judgment, order, writ or decree, (iii) except as described below, under any note, indenture or mortgage, or (iv) under any lease, agreement, contract or purchase order to which it is a party or by which it is bound that is required to be listed on the Disclosure Schedule, or (v) to its knowledge, of any provision of federal or state statute, rule or regulation applicable to the Company, the violation of which would have a Material Adverse Effect. The Company is past due on its obligations to repay a $1,600,000 loan from Capstone Therapeutics Corp. Capstone Therapeutics Corp. is considering the possible extension of the maturity date for such loan to July 15, 2020, with accruing interest, with a mandatory prepayment under certain circumstances, which loan will be convertible as described in the Disclosure Schedule. The execution, delivery and performance of the Transaction Agreements and the consummation of the transactions contemplated by the Transaction Agreements will not result in any such violation or be in conflict with or constitute, with or without the passage of time and giving of notice, either (i) a default under any such provision, instrument, judgment, order, writ, decree, contract or agreement, or (ii) an event which results in the creation of any lien, charge or encumbrance upon any assets of the Company or the suspension, revocation, forfeiture, or nonrenewal of any material permit or license applicable to the Company.

 

2.10           Agreements; Actions .

 

(a)                 Except for the Transaction Agreements, the Exclusive License Agreement, the Management Agreement and the Accounting Services Agreement, there are no agreements, understandings, instruments, contracts or proposed transactions to which the Company is a party or by which it is bound that involve (i) obligations (contingent or otherwise) of, or payments to, the Company in excess of $1,000,000, (ii) the license of any patent, copyright, trademark, trade secret or other proprietary right to or from the Company, (iii) the grant of rights to manufacture, produce, assemble, license, market, or sell its products to any other Person that limit the Company’s exclusive right to develop, manufacture, assemble, distribute, market or sell its products, or (iv) indemnification by the Company with respect to infringements of proprietary rights.

 

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(b)                The Company has not (i) declared or paid any dividends, or authorized or made any distribution upon or with respect to any class or series of its capital stock, (ii) incurred any indebtedness for money borrowed other than indebtedness in the aggregate principal amount of approximately $1,600,000 owed to Capstone Therapeutics Corp., or indebtedness incurred in the ordinary course of business, (iii) made any loans or advances to any Person, other than ordinary advances for travel expenses, or (iv) sold, exchanged or otherwise disposed of any of its assets or rights, other than the sale of its inventory in the ordinary course of business. For the purposes of (a) and (b) of this Subsection 2.9 , all indebtedness, liabilities, agreements, understandings, instruments, contracts and proposed transactions involving the same Person (including Persons the Company has reason to believe are affiliated with each other) shall be aggregated for the purpose of meeting the individual minimum dollar amounts of such subsection.

 

(c)                 The Company is not a guarantor or indemnitor of any indebtedness of any other Person.

 

2.11           Certain Transactions . The Company is not indebted, directly or indirectly, to any of its directors, officers or employees or to their respective spouses or children or to any Affiliate of any of the foregoing, other than in connection with expenses or advances of expenses incurred in the ordinary course of business or employee relocation expenses and for other customary employee benefits made generally available to all employees. None of the Company’s directors, officers or employees, or any members of their immediate families, or any Affiliate of the foregoing are, directly or indirectly, indebted to the Company.

 

2.12           Tax Returns and Payments . There are no federal, state, county, local or foreign taxes due and payable by the Company which have not been timely paid. There are no accrued and unpaid federal, state, country, local or foreign taxes of the Company which are due, whether or not assessed or disputed. There have been no examinations or audits of any tax returns or reports by any applicable federal, state, local or foreign governmental agency. The Company has duly and timely filed all federal, state, county, local and foreign tax returns required to have been filed by it and there are in effect no waivers of applicable statutes of limitations with respect to taxes for any year.

 

2.13           Permits . The Company has all franchises, permits, licenses and any similar authority necessary for the conduct of its business, the lack of which could reasonably be expected to have a Material Adverse Effect. The Company is not in default in any material respect under any of such franchises, permits, licenses or other similar authority.

 

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2.14           Disclosure . The Company has made available to the Purchaser all the information reasonably available to the Company that the Purchaser has requested for deciding whether to acquire the Shares. No representation or warranty of the Company contained in this Agreement, as qualified by the Disclosure Schedule, and no certificate furnished or to be furnished to the Purchaser at the Closing contains any untrue statement of a material fact or, to the Company’s knowledge, omits to state a material fact necessary in order to make the statements contained herein or therein not misleading in light of the circumstances under which they were made. It is understood that this representation is qualified by the fact that the Company has not delivered to the Purchaser, and has not been requested to deliver, a private placement or similar memorandum or any written disclosure of the types of information customarily furnished to purchasers of securities.

 

3.                   Representations, Warranties and Covenants of the Purchaser . The Purchaser hereby represents and warrants to the Company, severally and not jointly, that:

 

3.1               Authorization . The Purchaser has full power and authority to enter into the Transaction Agreements. The Transaction Agreements to which the Purchaser is a party, when executed and delivered by the Purchaser, will constitute valid and legally binding obligations of the Purchaser, enforceable in accordance with their terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance and any other laws of general application affecting enforcement of creditors’ rights generally, and as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies, or (b) to the extent the indemnification provisions contained in the Transaction Agreements may be limited by applicable federal or state securities laws.

 

3.2               Purchase Entirely for Own Account . This Agreement is made with the Purchaser in reliance upon the Purchaser’s representation to the Company, which by the Purchaser’s execution of this Agreement, the Purchaser hereby confirms, that the Shares, to be acquired by the Purchaser will be acquired for investment for the Purchaser’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and that the Purchaser has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Agreement, the Purchaser further represents that the Purchaser does not presently have any contract, undertaking, agreement or arrangement with any Person to sell, transfer or grant participations to such Person or to any third Person, with respect to any of the Shares.

 

3.3               Disclosure of Information . The Purchaser has had an opportunity to discuss the Company’s business, management, financial affairs and the terms and conditions of the offering of the Shares with the Company’s management and has had an opportunity to review the Company’s facilities. The foregoing, however, does not limit or modify the representations and warranties of the Company in Section 2 of this Agreement or the right of the Purchaser to rely thereon.

 

3.4               Restricted Securities; No Public Market . The Purchaser understands that the Securities have not been, and will not be, registered under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of the Purchaser’s representations as expressed herein. The Purchaser understands that the Shares and Common Stock issuable upon conversion of the Shares will be, “restricted securities” under applicable U.S. federal and state securities laws and that, pursuant to these laws, the Purchaser must hold the Securities indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. The Purchaser acknowledges that the Company has no obligation to register or qualify the Securities for resale except as set forth in the Registration Rights Agreement. The Purchaser further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements including, but not limited to, the time and manner of sale, the holding period for the Securities, and on requirements relating to the Company which are outside of the Purchaser’s control, and which the Company is under no obligation and may not be able to satisfy. The Purchaser understands that no public market now exists for the Securities, and that the Company has made no assurances that a public market will ever exist for the Securities.

 

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3.5               High Degree of Risk; Reliance on Own Advisors . The Purchaser acknowledges that an investment in the Securities involves a high degree of risk and there can be no assurance regarding the current or future economic value of the Securities or the performance of the Company or its business operations.

 

3.6               Legends . The Purchaser understands that the Shares and any securities issued in respect of or exchange for the Shares may be notated with one or all of the following legends:

 

“THE SHARES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH TRANSFER MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.”

 

(a)                 Any legend set forth in, or required by, the other Transaction Agreements.

 

(b)                Any legend required by the securities laws of any state to the extent such laws are applicable to the Shares or Warrant Shares represented by the certificate, instrument, or book entry so legended.

 

3.7               Accredited Investor . The Purchaser is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

 

3.8               No General Solicitation . Neither the Purchaser, nor any of its officers, directors, employees, agents, stockholders or partners has either directly or indirectly, including, through a broker or finder (a) engaged in any general solicitation, or (b) published any advertisement in connection with the offer and sale of the Shares.

 

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3.9               Acknowledgment of Plan . The Purchaser also acknowledges that the Company may increase the number of shares available under the Stock Plan as set forth in the Disclosure Schedule.

 

4.                   Conditions to the Purchaser’s Obligations at Closing . The obligations of the Purchaser to purchase Shares at the Closing are subject to the fulfillment, on or before Closing, of each of the following conditions, unless otherwise waived:

 

4.1               Representations and Warranties . The representations and warranties of the Company contained in Section 2 shall be true and correct in all respects as of the Closing.

 

4.2               Performance . The Company shall have performed and complied with all covenants, agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by the Company on or before Closing.

 

4.3               Qualifications . All authorizations, approvals or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Shares pursuant to this Agreement shall be obtained and effective as of Closing.

 

4.4               Registration Rights Agreement . The Company and the Purchaser shall have executed and delivered a Joinder Agreement as to the Registration Rights Agreement.

 

4.5               Preemptive Rights . The Company shall have fully satisfied (including with respect to rights of timely notification) or obtained enforceable waivers in respect of any preemptive or similar rights directly or indirectly affecting any of its securities.

 

5.                   Conditions of the Company’s Obligations at Closing . The obligations of the Company to sell Shares to the Purchaser at the Closing are subject to the fulfillment, on or before the Closing, of each of the following conditions, unless otherwise waived:

 

5.1               Representations and Warranties . The representations and warranties of the Purchaser contained in Section 3 shall be true and correct in all respects as of the Closing.

 

5.2               Performance . The Purchaser shall have performed and complied with all covenants, agreements, obligations and conditions contained in this Agreement that are required to be performed or complied with by it on or before Closing.

 

5.3               Qualifications . All authorizations, approvals or permits, if any, of any governmental authority or regulatory body of the United States or of any state that are required in connection with the lawful issuance and sale of the Shares pursuant to this Agreement shall be obtained and effective as of the Closing.

 

5.4               Registration Rights Agreement . The Purchaser shall have executed and delivered the Joinder to the Registration Rights Agreement.

 

  10  

 

6.                   Miscellaneous .

 

6.1               Survival of Warranties . Unless otherwise set forth in this Agreement, the representations and warranties of the Company and the Purchaser contained in or made pursuant to this Agreement shall survive the execution and delivery of this Agreement and the Closing and shall in no way be affected by any investigation or knowledge of the subject matter thereof made by or on behalf of the Purchaser or the Company.

 

6.2               Successors and Assigns . The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

6.3               Governing Law . This Agreement shall be governed by the internal law of the State of Delaware.

 

6.4               Counterparts . This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g. , www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

6.5               Titles and Subtitles . The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

6.6               Notices . All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given upon the earlier of actual receipt, or (a) personal delivery to the party to be notified, (b) when sent, if sent by electronic mail or facsimile during normal business hours of the recipient, and if not sent during normal business hours, then on the recipient’s next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) business day after deposit with a nationally recognized overnight courier, freight prepaid, specifying next business day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their address as set forth on the signature page or Exhibit A, or to such e-mail address, facsimile number or address as subsequently modified by written notice given in accordance with this Subsection 6.6.

 

6.7               Intentionally Omitted .

 

6.8               Intentionally Omitted .

 

6.9               Attorneys’ Fees . If any action at law or in equity (including, arbitration) is necessary to enforce or interpret the terms of any of the Transaction Agreements, the prevailing party shall be entitled to reasonable attorneys’ fees, costs and necessary disbursements in addition to any other relief to which such party may be entitled.

 

  11  

 

6.10           Amendments and Waivers . Any term of this Agreement may be amended, terminated or waived only with the written consent of the Company and the Purchaser.

 

6.11           Severability . The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision.

 

6.12           Delays or Omissions . No delay or omission to exercise any right, power or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power or remedy of such non-breaching or non-defaulting party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

 

6.13           Entire Agreement . This Agreement (including the Exhibits hereto) and the other Transaction Agreements constitute the full and entire understanding and agreement between the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties are expressly canceled.

 

6.14           Intentionally Omitted .

 

6.15           Dispute Resolution . The parties (a) hereby irrevocably and unconditionally submit to the jurisdiction of the state courts of Arizona and to the jurisdiction of the United States District Court for the District of Arizona for the purpose of any suit, action or other proceeding arising out of or based upon this Agreement, (b) agree not to commence any suit, action or other proceeding arising out of or based upon this Agreement except in the state courts of Arizona or the United States District Court for the District of Arizona, and (c) hereby waive, and agree not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court.

 

  12  

 

6.16           Waiver of Jury Trial . EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, THE OTHER TRANSACTION DOCUMENTS, THE SECURITIES OR THE SUBJECT MATTER HEREOF OR THEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER OF THIS TRANSACTION, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS. THIS SECTION HAS BEEN FULLY DISCUSSED BY EACH OF THE PARTIES HERETO AND THESE PROVISIONS WILL NOT BE SUBJECT TO ANY EXCEPTIONS. EACH PARTY HERETO HEREBY FURTHER WARRANTS AND REPRESENTS THAT SUCH PARTY HAS REVIEWED THIS WAIVER WITH ITS LEGAL COUNSEL, AND THAT SUCH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS FOLLOWING CONSULTATION WITH LEGAL COUNSEL.

 

[Signature Pages Follow.]

 

 

 

 

 

 

 

 

 

 

 

  13  

 

IN WITNESS WHEREOF, the parties have executed this Series B Preferred Stock and Warrant Purchase Agreement as of the date first written above.

 

COMPANY:

 

LIPIMETIX DEVELOPMENT, INC.

 

By: /s/ Dennis I. Goldberg, Ph.D.                                 

 

Name: Dennis I. Goldberg, Ph.D.

 

Title: President and CEO

 

Address:    5 Commonwealth Rd., Suite 2A

Natick, Massachusetts 01760

Attn: Dennis I. Goldberg, Ph.D.

Email: dgoldberg@lipimetix.com

 

with a copy to :

 

Leslie M. Taeger

Senior Vice President &

Chief Financial Officer

Capstone Therapeutics Corp.

1275 W. Washington St., Suite 104

Tempe, AZ 85281

 

 

 

[Signature Page to Stock Purchase Agreement]

 

 

PURCHASER:

 

 

CAPSTONE THERAPEUTICS CORP.

 

By: /s/ Leslie M. Taeger                           

 

Name: Leslie M. Taeger

 

Title: Senior Vice President & Chief Financial Officer

 

Address: 1235 W. Washington Street, #104

 

Tempe, Arizona 85281

 

 

 

 

 

 

 

 

[Signature Page to Stock Purchase Agreement]

 

 

EXHIBIT A

 

DISCLOSURE SCHEDULE

 

Capstone Revolving Line of Credit

 

At June 30, 2016, the outstanding balance of the Revolving Line of Credit “(Line”) extended to LipimetiX Development, Inc. (“JV” or “LipimetiX”) by Capstone Therapeutics Corp. was $1,600,000. The Line bears interest at 5% and has been extended to be due and payable no later than July 15, 2020, subject to earlier payment under certain circumstances. The outstanding principal and accrued interest is convertible at the option of the lender at a conversion price equal to the lower of the Series B-1 Conversion Price or the purchase price in the next equity financing of LipimetiX Development, Inc.

 

Benu BioPharma Management Services Agreement

 

The JV entered into a Management Services Agreement with Benu BioPharma, Inc. (“Benu”) to manage development activities. Benu is composed of Dennis I. Goldberg, Ph.D., Phillip M. Friden, Ph.D., and Eric M. Morrel, Ph.D.   The current monthly management fee is $80,000. However, no Management fees are due or payable except to the extent funding is available, as unanimously approved by members of the Company's Board of Directors and as reflected in the approved operating budget in effect at that time.  Following the Series B-2 closing, Benu will be paid up to $300,000 as a stated use of Series B-2 proceeds.

 

Capstone Accounting Services Agreement

 

The JV entered into an Accounting Services Agreement with Capstone Therapeutics Corp. to manage accounting and administrative functions. The monthly accounting services fee is being increased to $20,000. However, no Accounting Services fees are due or payable except to the extent funding is available, as reflected in the approved operating budget in effect at that time. If LipimetiX closes a financing or significant licensing transaction with net proceeds of Five Million Dollars or more, the LipimetiX will be required to start paying the fee at the rate of $10, 000 per month. If LipimetiX closes a financing or significant licensing transaction with net proceeds of Ten Million Dollars or more, then LipimetiX will be required to start paying the fee at the rate of $20, 000 per month. Any unpaid amounts will continue to accrue, but will be paid in full when a liquidation or change of control event occurs or cumulative financings (post Series B-1) or licensing revenues total Twenty Million Dollars.

 

LipimetiX Stock Plan

 

The LipimetiX Stock Plan was approved by the LipimetiX board and a majority of shareholders on June 10, 2016 for the purpose of incentivizing key management, board and consultants who contribute to the success of LipimetiX. On that date, the board authorized a pool of 71,500 common shares (6% of fully-diluted shares outstanding prior to the Series B-1 financing) for potential grant.  At the same meeting, the board granted a total of 67,026 options to Dr. Goldberg, Dr. Friden, Dr. Morell, Dr. Anantharamaiah, Dr. Steer, Dr. Garber, Mr. Taeger and Mr. Holliman, recognizing past and future service to LipimetiX.  The options are priced at 10% of the price per share of the Series B-1 or $1.07 per share and are 50% vested as of grant with remaining vesting on a monthly linear basis over 24 months. Concurrent with the Closing, the Company's Board of Directors has approved an increase in the total number of shares of Class A-1 Common Stock available for grant under the Stock Plan from 71,500 to 83,480, which is equal to approximately six percent (6%) of the total outstanding shares of Class A-1 Common Stock on a fully diluted basis after giving effect to the issuance of the Shares, but excluding the shares issuable upon exercise of the Warrants described in Subsection 2.2(a)(iii) of this Agreement.

 

 

 

Series A Preferred Stock

 

Concurrently with this transaction, the Amended and Restated Certificate of Incorporation of LipimetiX Development, Inc. is being amended to provide that the Series A Preferred Stock will be convertible at the option of the holder into shares of Class A-1 Common Stock at a Series A Conversion Price equal to the lesser of the Series B-1 Conversion Price or the purchase price in the next equity financing of LipimetiX Development, Inc.

 

Schedule 2.2(c)

 

Attached hereto.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EXHIBIT 10.2

 

FIRST AMENDMENT TO THE

AMENDED AND RESTATED STOCKHOLDERS AGREEMENT

OF

LIPIMETIX DEVELOPMENT, INC.

 

This FIRST AMENDMENT TO THE AMENDED AND RESTATED STOCKHOLDERS AGREEMENT (the “ First Amendment ”) is entered into to be effective as of August 11, 2017 (the “ Effective Date ”) by and among LipimetiX Development, Inc., a Delaware corporation (the “ Company ”), and the stockholders executing this First Amendment below representing the Required Holders (as defined below).

 

RECITALS

 

WHEREAS, the Company and the stockholders of the Company entered into that certain Amended and Restated Stockholders Agreement, dated as of August 25, 2016 (the “ Stockholders Agreement ”);

 

WHEREAS, pursuant to Section 11.1 of the Stockholders Agreement, the Stockholders Agreement may be amended by a Supermajority in Interest of the Stockholders (as defined therein);

 

WHEREAS, the Company and the undersigned stockholders, representing a Supermajority in Interest, desire to amend the Stockholders Agreement.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the foregoing and of the mutual promises and conditions hereinafter set forth, the parties hereto agree as follows:

 

A.                 Definitions . Capitalized terms not otherwise defined herein shall have the meaning ascribed to such terms as set forth in the Original Agreement unless the context clearly requires otherwise. References provided in this First Amendment to the “Agreement” shall be deemed to refer to the Original Agreement as modified by this First Amendment.

 

B.                  Amendment of Definition of “New Shares.” The definition of “New Shares” in Section 1.1 is hereby amended by replacing clause (b) with the following: “(b) Common Shares issuable upon the exercise of options, warrants or other rights to purchase such shares issued or issuable pursuant to the Company’s stock option plan(s) in effect from time to time, or upon the conversion of shares of Series A Preferred Stock or Series B Preferred Stock or convertible debt approved by the Board,”.

 

C.                  Amendment of Section 2 . Section 2.1 is hereby amended to read in its entirety as set forth below:

 

2.1        Board of Directors; Composition; Vacancies . Each Stockholder shall vote (in person, by proxy or by action by written consent, as applicable) all of such Stockholder’s Capital Stock, whether now owned or hereafter acquired or which such Stockholder may be empowered to vote, from time to time and at all times, in whatever manner shall be necessary to ensure that the number of directors who comprise the Board shall be seven (7) and the members of the Board shall consist of the following:

 

 

 

(a)       Subject to the provisions of Section 2.1(e) below, the Board shall be comprised as follows: (i) provided that the LX Stockholders continue to hold any Shares, three (3) individuals designated in writing by the LX Majority Holders (the “ LX Directors ”), who shall initially be Dennis I. Goldberg, Ph.D., Eric Morrel, Ph.D., and a person to be designated by the LX Majority Holders; (ii) provided that the CAPS Stockholders continue to hold any Shares, three (3) individuals designated in writing by the CAPS Majority Holders (the “ CAPS Directors ”), who shall initially be J.M. Holliman, III, Randolph C. Steer, M.D., Ph.D., and Michael M. Toporek; and (iii) provided that the Series B Investors continue to hold any shares of Series B-1 Preferred Stock, one individual, provided such individual constitutes a Qualified Designee as defined below, designated in writing by the Series B-1 Majority Holders (the “ Series B Director ”), who shall initially be Randall R. Lunn. To the extent that any of the clauses in (i) through (iii) shall not be applicable because the LX Stockholders, CAPS Stockholders or Series B Investors, as applicable, no longer hold any of the applicable shares of the Company, any members of the Board who would otherwise have been designated in accordance with the terms thereof shall instead be voted upon by all of the stockholders of the Company entitled to vote thereon in accordance with, and pursuant to, the Certificate of Incorporation.

 

(b)       In the event that a vacancy is created on the Board at any time due to the death, disability, retirement, resignation or removal of a LX Director and provided that the LX Majority Holders are still entitled to designate the LX Directors pursuant to Section 2.1(a) above, then the LX Majority Holders shall have the right to designate an individual to fill such vacancy, provided that such individual constitutes a Qualified Designee, and the Company and each Stockholder hereby agree to take such actions as may be required to ensure the election or appointment of such designee to fill such vacancy on the Board. In the event that the LX Majority Holders shall fail to designate in writing a representative to fill a vacant LX Director position on the Board, and such failure shall continue for more than fifteen (15) days after notice from any director to the LX Stockholders with respect to such failure, then the vacant position shall be filled by an individual designated by the LX Directors then in office; provided , however , that such individual shall be removed from such position if the LX Majority Holders so direct and simultaneously designate a new LX Director.

 

(c)       In the event that a vacancy is created on the Board at any time due to the death, disability, retirement, resignation or removal of a CAPS Director and provided that the CAPS Majority Holders are still entitled to designate the CAPS Directors pursuant to Section 2.1(a) above, then the CAPS Majority Holders shall have the right to designate an individual to fill such vacancy, provided that such individual constitutes a Qualified Designee, and the Company and each Stockholder hereby agree to take such actions as may be required to ensure the election or appointment of such designee to fill such vacancy on the Board. In the event that the CAPS Majority Holders shall fail to designate in writing a representative to fill a vacant CAPS Director position on the Board, and such failure shall continue for more than fifteen (15) days after notice from any director to the CAPS Stockholders with respect to such failure, then the vacant position shall be filled by an individual designated by the CAPS Directors then in office; provided , however , that such individual shall be removed from such position if the CAPS Majority Holders so direct and simultaneously designate a new CAPS Director.

 

 

 

(d)       In the event that a vacancy is created on the Board at any time due to the death, disability, retirement, resignation or removal of a Series B Director and provided that the Series B-1 Majority Holders are still entitled to designate the applicable Series B Director pursuant to Section 2.1(a) above, then the Series B-1 Majority Holders shall have the right to designate an individual to fill such vacancy, provided that such individual constitutes a Qualified Designee, and the Company and each Stockholder hereby agree to take such actions as may be required to ensure the election or appointment of such designee to fill such vacancy on the Board. In the event that the Series B-1 Majority Holders shall fail to designate in writing a representative to fill the vacant Series B Director position on the Board, and such failure shall continue for more than fifteen (15) days after notice from any director to the Series B Investors with respect to such failure, then the vacant position shall be filled by the remaining Directors then in office; provided , however , that such individual shall be removed from such position if the Series B-1 Majority Holders so direct and simultaneously designate a new Series B Director.

 

(e)       As used herein, a “ Qualified Designee ” shall mean a designee for election to the Board that satisfies the following requirements:

 

(i)       none of the “bad actor” disqualifying events described in Rule 506(d)(1)(i)-(viii) promulgated under the Securities Act of 1933, as amended (each, a “ Disqualification Event ”) shall be applicable to such designee; and

 

(ii)       Such designee shall not be employed by, provide services to, or otherwise be affiliated with a Directly Competitive Business.

 

D.                 Full Force and Effect . All of the provisions of the Original Agreement are ratified and confirmed except as modified by this First Amendment.

 

E.                  Counterpart . This First Amendment may be executed in one or more counterparts, each of which shall be deemed an original but all of which together shall be deemed one original. PDF or facsimile copies of manually executed signature pages to this First Amendment are fully binding and enforceable without the need for delivery of the original manually executed signature page.

 

F.                   Cooperation . Each party hereto agrees to execute and deliver such additional documents and instruments and to perform such additional acts as any party may reasonably request or as may be reasonably necessary or appropriate to effectuate, consummate and perform any other terms, provisions, or conditions of this First Amendment or the Original Agreement.

 

[Remainder of page intentionally left blank. Signature page follows.]

 

 

 

 

 

IN WITNESS WHEREOF, the parties have executed this First Amendment, effective as of the date first set forth above.

 

 

 

 

COMPANY:

 

LIPIMETIX DEVELOPMENT, INC.

 

 

By: /s/ Dennis I. Goldberg, Ph.D.                   

Name: Dennis I. Goldberg, Ph.D.                    

Title: President & CEO                                     

 

 

 

 

 

STOCKHOLDERS :

 

 

CAPS:

 

CAPSTONE THERAPEUTICS CORP.,
a Delaware corporation

 

By: /s/ John M. Holliman, III                 

J.M. Holliman, III

Executive Chairman

 

LX STOCKHOLDERS:

 

/s/ Dennis I. Goldberg, Ph.D.                 

Dennis I. Goldberg, Ph.D.

 

/s/ M. Francis                                           

Estate of Philip M. Friden, Ph.D.

 

/s/ Eric Morrel, Ph.D.                              

Eric Morrel, Ph.D.

 

/s/ G.M. Anantharamaiah                       

G.M. Anantharamaiah

 

/s/ Palgunachari Mayakonda                 

Palgunachari Mayakonda

 

_____________________________

Frederick Meyer

 

 

 

 

 

 

  Michael Webb

 

______________________________

Jeffrey Elton

 

 

THE UAB RESEARCH FOUNDATION

 

 

By: ___________________________

Kathy L. Nugent

Chief Executive Officer

 

 

 

 

 

SERIES B INVESTORS :

 

 

 

JAMES W. STUCKERT REVOCABLE TRUST

 

By: ________________________________

 

Its: ________________________________

 

 

 

SOLOMON ODEN HOWELL REV. TRUST

 

By: ________________________________

 

Its: ________________________________

 

 

 

___________________________________

John F. Rasor, Sole and Separate

 

 

 

___________________________________

John M. Holliman III, Sole and Separate

 

 

NAPEAN CAPITAL GROUP, LLC

 

By: ________________________________

 

Its: ________________________________

 

 

 

 

___________________________________

Parvinderjit Singh Khanuja

 

 

 

 

 

 

THE TAMBOLI FAMILY TRUST

 

By: ________________________________

 

Its: ________________________________

 

 

MLPF&S AS CUSTODIAN FBO MARK PRYNN

 

By: ________________________________

 

Its: ________________________________

 

 

SATISH JOSHI AND SHIMA JOSHI FAMILY TRUST DATED NOV. 1st, 1996

 

By: ________________________________

 

Its: ________________________________

 

 

 

___________________________________

Quinn P. Williams

 

 

 

___________________________________

Randall R. Lunn

 

 

 

___________________________________

Harry George

 

 

 

 

 

EXHIBIT 10.3

 

JOINDER AND COUNTERPART SIGNATURE PAGE OF
REGISTRATION RIGHTS AGREEMENT OF
LIPIMETIX DEVELOPMENT, INC.

 

As of August 11, 2017, the undersigned has executed this counterpart signature to the Registration Rights Agreement entered into as of August 25, 2016, by and among the Company, the Common Holders and the Investors (as such terms are defined therein), and does hereby agree to be bound by all of the obligations as an “Investor” thereunder and the terms thereof as though originally an Investor thereto.

 

 

CAPSTONE THERAPEUTICS CORP.,

a Delaware corporation

 

 

By: /s/ Leslie M. Taeger              

Name: Leslie M. Taeger              

Title: CFO                                      

 

 

EXHIBIT 10.4

 

CERTIFICATE OF AMENDMENT

OF

AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

LIPIMETIX DEVELOPMENT, INC.

 

LIPIMETIX DEVELOPMENT, INC., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the “ Corporation ”), hereby certifies as follows:

 

First: The name of the Corporation is LipimetiX Development, Inc.

 

Second:         The Amended and Restated Certificate of Incorporation of the Corporation is hereby amended by adding a new Section 7 of Part B of Article Fourth to read in its entirety as set forth below, and renumbering each of current Sections 7 and 8 to be Sections 8 and 9 respectively:

 

7.        Optional Conversion of Series A Preferred . The holders of the Series A Preferred Stock shall have conversion rights as set forth below (the “Conversion Rights”). For purposes of this Section 7, references herein to “Common Stock” shall refer to “Class A-1 Common Stock”.

 

7.1        Right to Convert .

 

7.1.1        Conversion Ratio . Each share of Series A Preferred Stock 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 Series A Issue Value (as defined below) by the Series A Conversion Price (as defined below) in effect at the time of conversion. The Series A Issue Value shall be the Series A Original Issue Price less the aggregate dividends paid with respect to each share of Series A Preferred Stock. The Series A Conversion Price will be equal to the lesser of the Series B-1 Conversion Price or the price per share of the shares issued in the next equity financing of the Corporation with proceeds of at least One Million Dollars ($1,000,000), as determined by the Board of Directors of the Corporation and identified as such in the minutes or resolutions of the Board of Directors of the Corporation approving the issuance of such equity.

 

7.1.2        Termination of Conversion Rights . In the event of a liquidation, dissolution or winding up of the Corporation or a Deemed Liquidation Event, the Conversion Rights shall terminate at the close of business on the last full day preceding the date fixed for the payment of any such amounts distributable on such event to the holders of Series A Preferred Stock.

 

 

 

7.2        Fractional Shares . No fractional shares of Common Stock shall be issued upon conversion of the Series A Preferred Stock. In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of a share of Common Stock as determined in good faith by the Board of Directors of the Corporation. Whether or not fractional shares would be issuable upon such conversion shall be determined on the basis of the total number of shares of Series A Preferred Stock the holder is at the time converting into Common Stock and the aggregate number of shares of Common Stock issuable upon such conversion.

 

7.3        Mechanics of Conversion .

 

7.3.1        Notice of Conversion . In order for a holder of Series A Preferred Stock to voluntarily convert shares of Series A Preferred Stock into shares of Common Stock, such holder shall (a) provide written notice to the Corporation’s transfer agent at the office of the transfer agent for the Series A Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent) that such holder elects to convert all or any number of such holder’s shares of Series A Preferred Stock and, if applicable, any event on which such conversion is contingent and (b), if such holder’s shares are certificated, surrender the certificate or certificates for such shares of Series A Preferred Stock (or, if such registered holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate), at the office of the transfer agent for the Series A Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent). Such notice shall state such holder’s name or the names of the nominees in which such holder wishes the shares of Common Stock to be issued. If required by the Corporation, any certificates surrendered for conversion shall be endorsed or accompanied by a written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or his, her or its attorney duly authorized in writing. The close of business on the date of receipt by the transfer agent (or by the Corporation if the Corporation serves as its own transfer agent) of such notice and, if applicable, certificates (or lost certificate affidavit and agreement) shall be the time of conversion (the “Conversion Time”), and the shares of Common Stock issuable upon conversion of the specified shares shall be deemed to be outstanding of record as of such date. The Corporation shall, as soon as practicable after the Conversion Time (i) issue and deliver to such holder of Series A Preferred Stock, or to his, her or its nominees, a certificate or certificates for the number of full shares of Common Stock issuable upon such conversion in accordance with the provisions hereof and a certificate for the number (if any) of the shares of Series A Preferred Stock represented by the surrendered certificate that were not converted into Common Stock, (ii) pay in cash such amount as provided in Subsection 7.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and (iii) pay all declared but unpaid dividends on the shares of Series A Preferred Stock converted.

 

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7.3.2        Reservation of Shares . The Corporation shall at all times when the Series A Preferred Stock shall be outstanding, reserve and keep available out of its authorized but unissued capital stock, for the purpose of effecting the conversion of the Series A Preferred Stock, such number of its duly authorized shares of Common Stock as shall from time to time be sufficient to effect the conversion of all outstanding Series A Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock shall not be sufficient to effect the conversion of all then outstanding shares of the Series A Preferred Stock, the Corporation shall take such corporate action as may be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes, including, without limitation, engaging in best efforts to obtain the requisite stockholder approval of any necessary amendment to the Certificate of Incorporation. Before taking any action which would cause an adjustment reducing the Series A Conversion Price below the then par value of the shares of Common Stock issuable upon conversion of the Series A Preferred Stock, the Corporation will take any corporate action which may, in the opinion of its counsel, be necessary in order that the Corporation may validly and legally issue fully paid and non-assessable shares of Common Stock at such adjusted Series A Conversion Price.

 

7.3.3        Effect of Conversion . All shares of Series A Preferred Stock which shall have been surrendered for conversion as herein provided shall no longer be deemed to be outstanding and all rights with respect to such shares shall immediately cease and terminate at the Conversion Time, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor, to receive payment in lieu of any fraction of a share otherwise issuable upon such conversion as provided in Subsection 7.2 . Any shares of Series A Preferred Stock so converted shall be retired and cancelled and may not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Series A Preferred Stock accordingly.

 

7.3.4        No Further Adjustment . Upon any such conversion, no adjustment to the Series A Conversion Price shall be made for any declared but unpaid dividends on the Series A Preferred Stock surrendered for conversion or on the Common Stock delivered upon conversion.

 

7.3.5        Taxes . The Corporation shall pay any and all issue and other similar taxes that may be payable in respect of any issuance or delivery of shares of Common Stock upon conversion of shares of Series A Preferred Stock pursuant to this Section 7 . The Corporation shall not, however, be required to pay any tax which may be payable in respect of any transfer involved in the issuance and delivery of shares of Common Stock in a name other than that in which the shares of Series A Preferred Stock so converted were registered, and no such issuance or delivery shall be made unless and until the person or entity requesting such issuance has paid to the Corporation the amount of any such tax or has established, to the satisfaction of the Corporation, that such tax has been paid.

 

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7.4        Adjustment for Merger or Reorganization, etc . Subject to the provisions of Subsection 7.3 , if there shall occur any reorganization, recapitalization, reclassification, consolidation or merger involving the Corporation in which the Common Stock (but not the Series A Preferred Stock) is converted into or exchanged for securities, cash or other property (other than a transaction resulting in an adjustment of the Series A Conversion Price), then, following any such reorganization, recapitalization, reclassification, consolidation or merger, each share of Series A Preferred Stock shall thereafter be convertible in lieu of the Common Stock into which it was convertible prior to such event into the kind and amount of securities, cash or other property which a holder of the number of shares of Common Stock of the Corporation issuable upon conversion of one share of Series A Preferred Stock immediately prior to such reorganization, recapitalization, reclassification, consolidation or merger would have been entitled to receive pursuant to such transaction; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors of the Corporation) shall be made in the application of the provisions in this Section 7 with respect to the rights and interests thereafter of the holders of the Series A Preferred Stock, to the end that the provisions set forth in this Section 7 shall thereafter be applicable, as nearly as reasonably may be, in relation to any securities or other property thereafter deliverable upon the conversion of the Series A Preferred Stock.

 

7.5        Certificate as to Adjustments . Upon the occurrence of each adjustment or readjustment of the Series A Conversion Price, the Corporation at its expense shall, as promptly as reasonably practicable but in any event not later than ten (10) days thereafter, compute such adjustment or readjustment in accordance with the terms hereof and furnish to each holder of Series A Preferred Stock a certificate setting forth such adjustment or readjustment (including the kind and amount of securities, cash or other property into which the Series A Preferred Stock is convertible) and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, as promptly as reasonably practicable after the written request at any time of any holder of Series A Preferred Stock (but in any event not later than ten (10) days thereafter), furnish or cause to be furnished to such holder a certificate setting forth (i) the Series A Conversion Price then in effect, and (ii) the number of shares of Common Stock and the amount, if any, of other securities, cash or property which then would be received upon the conversion of Series A Preferred Stock.

 

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7.6        Notice of Record Date . In the event:

 

(a)       the Corporation shall take a record of the holders of its Common Stock (or other capital stock or securities at the time issuable upon conversion of the Series A Preferred Stock) for the purpose of entitling or enabling them to receive any dividend or other distribution, or to receive any right to subscribe for or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or

 

(b)       of any capital reorganization of the Corporation, any reclassification of the Common Stock of the Corporation, or any Deemed Liquidation Event; or

 

(c)       of the voluntary or involuntary dissolution, liquidation or winding-up of the Corporation,

 

then, and in each such case, the Corporation will send or cause to be sent to the holders of the Series A Preferred Stock a notice specifying, as the case may be, (i) the record date for such dividend, distribution or right, and the amount and character of such dividend, distribution or right, or (ii) the effective date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up is proposed to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or such other capital stock or securities at the time issuable upon the conversion of the Series A Preferred Stock) shall be entitled to exchange their shares of Common Stock (or such other capital stock or securities) for securities or other property deliverable upon such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up, and the amount per share and character of such exchange applicable to the Series A Preferred Stock and the Common Stock. Such notice shall be sent at least fifteen (15) days prior to the record date or effective date for the event specified in such notice.

 

Third:        The foregoing amendment of the Certificate of Incorporation of the Corporation, as amended, herein certified has been duly adopted in accordance with the provisions of Sections 228 and 242 of the General Corporation Law of the State of Delaware.

 

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In Witness Whereof , the undersigned authorized officer of LipimetiX Development, Inc. has caused this Certificate of Amendment of Certificate of Incorporation to be signed this _ 11th ____ day of ___ August ___, 2017.

 

LIPIMETIX DEVELOPMENT, INC.

 

 

 

By: /s/ Dennis I. Goldberg, Ph.D.         

 

Name: Dennis I. Goldberg, Ph.D.          

Title: President & CEO                           

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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EXHIBIT 10.5

 

 

 

FIRST AMENDMENT TO BYLAWS
OF
LIPIMETIX DEVELOPMENT, INC.

 

(August 10, 2017)

 

The First Amendment to Bylaws (the “ Bylaws ”) of LipimetiX Development, Inc., a Delaware corporation (the “ Corporation ”) are hereby amended as follows:

 

1.                   Section 2.1. of Article II of the Bylaws is hereby amended to read in its entirety as follows:

 

Section 2.1. Number; Qualifications . The authorized number of directors of the Corporation shall be fixed from time to time by the Board of Directors, but shall not be less than two (2) nor more than ten (10). Directors need not be stockholders.

 

2.                   Except as expressly modified by this First Amendment, all of the terms of the Bylaws shall remain in full force and effect. In the event of any inconsistency or contradiction between the Bylaws and this First Amendment, this First Amendment shall control.

 

3.                   The Secretary of the Corporation does hereby certify on behalf of the Corporation that this First Amendment has been duly adopted by the Corporation’s Board of Directors on August 10, 2017.

 

 

 

By : /s/ John M. Holliman, III

Name: John M. Holliman, III

Title: Secretary/Treasurer