UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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: September 30, 2017
or
[ ] | TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________ to _____________.
Commission File Number: 000-13789
MARINA BIOTECH, INC.
(Exact name of registrant as specified in its charter)
Delaware | 11-2658569 | |
(State
or other jurisdiction of
incorporation or organization) |
(IRS
Employer
Identification No.) |
17870 Castleton Street, Suite 250 City of Industry, California |
91748 | |
(Address of principal executive offices) | (Zip Code) |
(626) 964-5788
(Registrant’s telephone number, including area code)
N/A
(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. Yes [X] 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). Yes [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small 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] |
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 7(a)(2)(B) of the Securities Act: [ ]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X].
A s of November 13, 2017, there were 10,521,278 shares of the registrant’s common stock outstanding.
MARINA BIOTECH, INC.
FORM 10-Q
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017
TABLE OF CONTENTS
Items 3, 4 and 5 have not been included as they are not applicable.
2 |
PART I – FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARINA BIOTECH, INC.
Condensed Consolidated Balance Sheets
September 30, 2017 | December 31, 2016 | |||||||
(Unaudited) | (Audited) | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash | $ | 8,676 | $ | 105,347 | ||||
Prepaid expenses and other assets | 54,631 | 211,133 | ||||||
Total current assets | 63,307 | 316,480 | ||||||
Intangible assets, net of amortization | 2,679,235 | 2,311,877 | ||||||
Goodwill | 3,502,829 | 3,558,076 | ||||||
6,182,064 | 5,869,953 | |||||||
Total assets | $ | 6,245,371 | $ | 6,186,433 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 1,027,508 | $ | 663,261 | ||||
Due to related party | 382,332 | 83,166 | ||||||
Accrued expenses | 1,022,369 | 1,393,521 | ||||||
Accrued fee payable | 320,000 | - | ||||||
Notes payable | 441,023 | 435,998 | ||||||
Notes payable to related parties | 92,590 | - | ||||||
Convertible notes payable | 406,324 | - | ||||||
Convertible notes payable to related parties | 559,029 | 250,000 | ||||||
Fair value of liabilities for price adjustable warrants | 248,068 | 141,723 | ||||||
Derivative liability | 115,271 | - | ||||||
Total current liabilities | 4,614,514 | 2,967,669 | ||||||
Commitments and contingencies (Note 8) | ||||||||
Stockholders’ equity | ||||||||
Preferred stock, $0.01 par value; 100,000 shares authorized | ||||||||
Series C convertible preferred stock, $0.01 par value; $5,100 liquidation preference; 1,200 shares authorized; 750 and 1,020 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | - | - | ||||||
Series D convertible preferred stock, $0.01 par value; $300 liquidation preference; 220 shares authorized; 60 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | - | - | ||||||
Common stock, $0.006 par value; 180,000,000 shares authorized, 10,021,220 and 8,977,138 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 60,127 | 53,863 | ||||||
Additional paid-in capital | 6,850,567 | 5,115,983 | ||||||
Deferred compensation | (102,600 | ) | - | |||||
Accumulated deficit | (5,177,237 | ) | (1,951,082 | ) | ||||
Total stockholders’ equity | 1,630,857 | 3,218,764 | ||||||
Total liabilities and stockholders’ equity | $ | 6,245,371 | $ | 6,186,433 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3 |
MARINA BIOTECH, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue | ||||||||||||||||
License and other revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
Operating expenses | ||||||||||||||||
Research and development | 232,896 | 50,683 | 746,221 | 107,910 | ||||||||||||
General and administrative | 680,063 | 47,065 | 1,878,301 | 232,469 | ||||||||||||
Amortization | 123,038 | - | 327,642 | - | ||||||||||||
Total operating expenses | 1,035,997 | 97,748 | 2,952,164 | 340,379 | ||||||||||||
Loss from operations | (1,035,997 | ) | (97,748 | ) | (2,952,164 | ) | (340,379 | ) | ||||||||
Other income (expense) | ||||||||||||||||
Interest expense | (24,301 | ) | (378 | ) | (51,575 | ) | (378 | ) | ||||||||
Change in fair value liability of warrants | 7,442 | - | (106,345 | ) | - | |||||||||||
Change in fair value of derivative liability | 80,672 | - | (115,271 | ) | - | |||||||||||
63,813 | (378 | ) | (273,191 | ) | (378 | ) | ||||||||||
Loss before provision for income taxes | (972,184 | ) | (98,126 | ) | (3,225,355 | ) | (340,757 | ) | ||||||||
Provision for income taxes | - | 800 | 800 | 800 | ||||||||||||
Net loss | $ | (972,184 | ) | $ | (98,926 | ) | $ | (3,226,155 | ) | $ | (341,557 | ) | ||||
Net loss per share – basic and diluted | $ | (0.10 | ) | $ | (0.02 | ) | $ | (0.33 | ) | $ | (0.08 | ) | ||||
Weighted average shares outstanding | 9,869,672 | 4,227,641 | 9,645,954 | 4,118,826 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4 |
MARINA BIOTECH, INC.
Condensed Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
Common Stock |
Additional
|
Deferred | Accumulated | |||||||||||||||||||||
Number | Par Value | Capital | Compensation | Deficit | Total | |||||||||||||||||||
Balance, December 31, 2016 | 8,977,138 | $ | 53,863 | $ | 5,115,983 | $ | – | $ | (1,951,082 | ) | $ | 3,218,764 | ||||||||||||
Sale of common stock to related party | 86,207 | 517 | 249,483 | – | – | 250,000 | ||||||||||||||||||
Common stock issued for services | 30,000 | 180 | 53,820 | – | – | 54,000 | ||||||||||||||||||
Common stock issued for accounts payable | 622,296 | 3,734 | 972,980 | – | – | 976,714 | ||||||||||||||||||
Return of common stock for note receivable | (8,725 | ) | (52 | ) | (31,352 | ) | – | – | (31,404 | ) | ||||||||||||||
Restricted stock issued to officers | 70,000 | 420 | 245,580 | (102,600 | ) | – | 143,400 | |||||||||||||||||
Share based compensation | – | – | 74,895 | – | – | 74,895 | ||||||||||||||||||
Exercise of warrants to common stock | 60,944 | 366 | 170,277 | – | – | 170,643 | ||||||||||||||||||
Conversion of Series C Preferred to common stock | 180,000 | 1,080 | (1,080 | ) | – | – | ||||||||||||||||||
Effects of rounding due to reverse split | 3,360 | 19 | (19 | ) | – | – | – | |||||||||||||||||
Net loss | – | – | – | (3,226,155 | ) | (3,226,155 | ) | |||||||||||||||||
Balance, September 30, 2017 | 10,021,220 | 60,127 | $ | 6,850,567 | $ | (102,600 | ) | $ | (5,177,237 | ) | 1,630,857 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5 |
MARINA BIOTECH, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
For the Nine Months Ended September 30, | ||||||||
2017 | 2016 | |||||||
Cash Flows Used in Operating Activities: | ||||||||
Net loss | $ | (3,226,155 | ) | $ | (341,557 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Share based compensation | 218,295 | - | ||||||
Common shares issued for third party services | 54,000 | - | ||||||
Warrants issued for services | - | 36,470 | ||||||
Amortization of intangibles | 327,642 | - | ||||||
Change in fair value liabilities for price adjustable warrants | 106,345 | - | ||||||
Change in fair value of derivative liability | 115,271 | - | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | 125,098 | (479 | ) | |||||
Accounts payable | 419,494 | 64,928 | ||||||
Accrued expenses | 637,642 | (1,355 | ) | |||||
Accrued fee | - | - | ||||||
Due to related party | 299,166 | (54,150 | ) | |||||
Net Cash Used in Operating Activities | (923,202 | ) | (296,143 | ) | ||||
Cash Flows Used in Investing Activities: | ||||||||
Purchase of intangible asset | (375,000 | ) | - | |||||
Net Cash Used in Investing Activities | (375,000 | ) | - | |||||
Cash Flows from Financing Activities: | ||||||||
Proceeds from sale of common stock to related party | 250,000 | - | ||||||
Proceeds from notes payable, related party | 90,888 | - | ||||||
Proceeds from convertible notes | 400,000 | 50,000 | ||||||
Proceeds from convertible notes, related parties | 290,000 | - | ||||||
Proceeds from exercise of warrants to common stock | 170,643 | - | ||||||
Net Cash Provided by Financing Activities | 1,201,531 | 50,000 | ||||||
(Decrease) in cash | (96,671 | ) | (246,143 | ) | ||||
Cash – Beginning of Period | 105,347 | 261,848 | ||||||
Cash - End of Period | $ | 8,676 | $ | 15,705 | ||||
Supplementary Cash Flow Information: | ||||||||
Interest paid | $ | - | $ | - | ||||
Income taxes paid | $ | 800 | $ | - | ||||
Non-cash Investing and Financing Activities: | , | |||||||
Issuance of warrants for services | $ | - | $ | 36,470 | ||||
Common stock issued for accrued expenses | $ | 976,714 | $ | - | ||||
Return of common stock for other assets | $ | 31,404 | $ | - | ||||
Adjustment to goodwill for change in value of pre-acquisition accounts payable | $ | 55,247 | $ | - | ||||
Accrued interest | $ | 32,080 | ||||||
Assumption of Liabilities for acquisition | $ | 320,000 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6 |
MARINA BIOTECH, INC.
Notes to Condensed Consolidated Financial Statements
FOR THE THREE and NINE MONTHS ENDED SEPTEMBER 30, 2017
(Unaudited)
Note 1 – Nature of Operations, Basis of Presentation and Significant Accounting Policies
Business Overview
Marina Biotech, Inc. and its wholly-owned subsidiaries, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc., Atossa Healthcare, Inc., and IthenaPharma, Inc. (collectively “Marina,” “we,” “our,” or “us”) is a fully integrated, commercial stage biopharmaceutical company delivering proprietary drug therapeutics for significant unmet medical needs in the U.S., Europe and certain additional international markets. Its portfolio of products currently focuses on fixed dose combinations (“FDC”) in hypertension, arthritis, pain and oncology allowing for innovative solutions to such unmet medical needs. Its mission is to provide effective and patient centric treatment for hypertension – including resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also called Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.
In doing so, we have created a universal platform for the effective treatment of hypertension as well as for the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, and the other products in our pipeline, devices for therapeutic drug monitoring, blood pressure, and other cardiac monitors, as well as services such as counseling and prescription reminders.
We currently have one commercial and three clinical development programs underway: (i) Prestalia®, a single-pill fixed dose combination of perindopril, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine, a calcium channel blocker (“CCB”), which has been approved by the U.S. Food and Drug Administration (“FDA”) and is actively marketed in the U.S.; (ii) our next generation celecoxib program drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103, each of which is an FDC of celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (“NSAID”) and either lisinopril (IT-102) or olmesartan (IT-103) – both Lisinopril and olmesartan are antihypertension drugs; (iii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (“FAP”); and (iv) CEQ508 combined with IT-103 to treat Colorectal Cancer.
Our current focus is primarily on the commercialization of Prestalia and secondarily the development of IT-102 and IT-103. We believe that by combining a COX-2 inhibitor with an antihypertensive in a single FDC oral tablet, IT-102 and IT-103 will each offer improved safety profiles as compared to currently available and previously marketed COX-2 inhibitors as well as address patients with chronic pain who are commonly taking antihypertension drugs concurrently. We further believe that the current opioid addiction epidemic in the U.S. has been driven in part by the withdrawal from the market of certain COX-2 inhibitors due to their associated risk of cardiovascular-related adverse events. We plan to license or divest our other assets since they no longer align with our focus on the treatment of hypertension.
We intend to create value through the continued commercialization of our FDA-approved product, Prestalia, while moving our FDC development programs forward to further strengthen our commercial presence. We intend to retain ownership and control of all of our product candidates, but in the interest of accelerated growth and market penetration, we will also consider partnerships with pharmaceutical or biotechnology companies in order to reduce time to market and to balance development risks, both clinically and financially.
As our strategy is to be a fully integrated biopharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with a secondary focus on advancing our FDC pipeline to further enhance our commercial presence.
7 |
Reverse Merger with IThenaPharma
On November 15, 2016, Marina entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among IthenaPharma, Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). For a more detailed discussion on the reverse merger, refer to Note 2 – Intangible Assets below as well as our 2016 Annual Report on Form 10K filed with the SEC.
IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary Fixed Dose Combination (“FDC”) technology and point of care Therapeutic Drug Monitoring (“TDM”). Through the combination of these technologies, IThenaPharma is looking to deliver therapies with improved compliance and personalized dosing. IThena’s lead products are the celecoxib FDCs which include IT-102 and IT-103, fixed dose combinations of celecoxib and lisinopril and celecoxib and olmesartan, respectively. IT-102 and IT-103 are being developed as celecoxib without the drug induced edema associated with celecoxib alone. IT-102 and IT-103 are being developed initially for combined arthritis / hypertension and subsequently for treatment of pain, or cancer, or other indications requiring high doses of celecoxib.
Reverse Stock Split
On August 1, 2017, we filed a Certificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the OTCQB tier of the OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. Unless indicated otherwise, all share and per share information included in these financial statements give effect to the reverse split.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete audited financial statements. The accompanying unaudited financial information should be read in conjunction with the audited consolidated financial statements, including the notes thereto, as of and for the year ended December 31, 2016, included in our 2016 Annual Report on Form 10-K filed with the SEC. The information furnished in this report reflects all adjustments (consisting of normal recurring adjustments), which are, in the opinion of management, necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented. The results of operations for the nine months ended September 30, 2017 are not necessarily indicative of the results for the year ending December 31, 2017 or for any future period.
Principles of Consolidation
The consolidated financial statements include the accounts of IThenaPharma Inc. and Marina Biotech, Inc. and the wholly-owned subsidiaries, Cequent, MDRNA, and Atossa, and eliminate any inter-company balances and transactions.
Going Concern and Management’s Liquidity Plans
The accompanying condensed consolidated financial statements have been prepared on the basis that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. At September 30, 2017, we had a significant accumulated deficit of $5,177,237 and a negative working capital of $4,551,207. We had obtained a line of credit from Autotelic Inc. of $500,000, of which we have utilized $92,590. As such, we currently have approximately $407,000 of available funds under our line of credit under this line of credit with Autotelic Inc. We believe this amount of available funds is sufficient to fund our operations through December 31, 2017. Our operating activities consume the majority of our cash resources. We anticipate that we will continue to incur operating losses as we execute our commercialization plans, as well as strategic and business development initiatives. In addition, we have had and will continue to have negative cash flows from operations, at least into the near future. We have previously funded, and plan to continue funding, our losses primarily through the sale of common and preferred stock, combined with or without warrants, the sale of notes, revenue provided from our license agreements and, to a lesser extent, equipment financing facilities and secured loans. However, we cannot be certain that we will be able to obtain such funds required for our operations at terms acceptable to us or at all. In 2016, we funded operations primarily through the issuance of convertible debt and license-related revenues.
8 |
There is substantial doubt about our ability to continue as a going concern for one year from the issuance date of this Form 10-Q, which may affect our ability to obtain future financing or engage in strategic transactions, and may require us to curtail our operations. We cannot predict, with certainty, the outcome of our actions to generate liquidity, including the availability of additional equity or debt financing, or whether such actions would generate the expected liquidity as currently planned.
Summary of Significant Accounting Policies
Use of Estimates
The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reported period. Significant areas requiring the use of management estimates include valuation allowance for deferred income tax assets and fair value of financial instruments. Actual results could differ materially from such estimates under different assumptions or circumstances.
Fair Value of Financial Instruments
We consider the fair value of cash, accounts payable, due to related parties, notes payable, notes payable to related parties, convertible notes payable and accrued liabilities not to be materially different from their carrying value. These financial instruments have short-term maturities. We follow authoritative guidance with respect to fair value reporting issued by the Financial Accounting Standards Board (“FASB”) for financial assets and liabilities, which defines fair value, provides guidance for measuring fair value and requires certain disclosures. The guidance does not apply to measurements related to share-based payments. The guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:
Level 1: | Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities. |
Level 2: | Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active. |
Level 3: | Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use. |
Our cash is subject to fair value measurement and is determined by Level 1 inputs. We measure the liability for committed stock issuances with a fixed share number using Level 1 inputs. We measure the liability for price adjustable warrants and certain features embedded in notes, using the probability adjusted Black-Scholes option pricing model (“Black-Scholes”), which management has determined approximates values using more complex methods, using Level 3 inputs. The following tables summarize our liabilities measured at fair value on a recurring basis as of September 30, 2017 and December 31, 2016:
9 |
Balance
at
September 30, 2017 |
Level
1
Quoted prices in active markets for identical assets |
Level
2
Significant other observable inputs |
Level
3
Inputs |
|||||||||||||
Liabilities: | ||||||||||||||||
Fair value liability for price adjustable warrants | $ | 248,068 | $ | - | $ | - | $ | 248,068 | ||||||||
Derivative liability | 115,271 | - | - | 115,271 | ||||||||||||
Total liabilities at fair value | $ | 363,339 | $ | - | $ | - | $ | 363,339 |
Balance at December 31, 2016 |
Level
1
Quoted prices in active markets for identical assets |
Level
2
Significant other observable inputs |
Level
3
Significant unobservable inputs |
|||||||||||||
Liabilities: | ||||||||||||||||
Fair value liability for price adjustable warrants | $ | 141,723 | $ | - | $ | - | $ | 141,723 | ||||||||
Total liabilities at fair value | $ | 141,723 | $ | - | $ | - | $ | 141,723 |
The following presents activity of the fair value liability of price adjustable warrants determined by Level 3 inputs for the period ended September 30, 2017:
Fair
value
liability for price adjustable warrants |
||||
Balance at December 31, 2016 | $ | 141,723 | ||
Change in fair value included in condensed consolidated statement of operations | 106,345 | |||
Balance at September 30, 2017 | $ | 248,068 |
The fair value liability of price adjustable warrants for the nine months ended September 30, 2017 was determined using the probability adjusted Black-Scholes option pricing model using exercise prices of $2.80 to $7.50, stock price of $2.70, volatility of 174% to 225%, contractual lives of 0.1 to 4.1 years, and risk-free rates of 0.62% to 1.93%.
The following presents activity of the derivative liability determined by Level 3 inputs for the period ended September 30, 2017:
Fair
value
liability |
||||
Balance at December 31, 2016 | $ | - | ||
Additions | 195,943 | |||
Change in fair value included in condensed consolidated statement of operations | (80,672 | ) | ||
Balance at September 30, 2017 | $ | 115,271 |
10 |
The fair value liability of derivative liability for the nine months ended September 30, 2017 was determined using the binomial pricing model using exercise prices of $2.80, stock price of $2.70, volatility of 168%, contractual life of 1 year, and a risk-free rate of 1.31%.
Impairment of Long-Lived Assets
We review all of our long-lived assets for impairment indicators throughout the year and perform detailed testing whenever impairment indicators are present. In addition, we perform detailed impairment testing for indefinite-lived intangible assets, at least annually, at December 31. When necessary, we record charges for impairments. Specifically:
● | For finite-lived intangible assets, such as developed technology rights, and for other long-lived assets, we compare the undiscounted amount of the projected cash flows associated with the asset, or asset group, to the carrying amount. If the carrying amount is found to be greater, we record an impairment loss for the excess of book value over fair value. In addition, in all cases of an impairment review, we re-evaluate the remaining useful lives of the assets and modify them, as appropriate; and |
● | For indefinite-lived intangible assets, such as acquired in-process R&D assets, each year and whenever impairment indicators are present, we determine the fair value of the asset and record an impairment loss for the excess of book value over fair value, if any. |
Management determined that no impairment indicators were present and that no impairment charges were necessary as of September 30, 2017 or December 31, 2016.
Net Income (Loss) per Common Share
Basic net income (loss) per common share (after giving effect of the one for ten reverse stock split) is computed by dividing the net income (loss) by the weighted average number of common shares outstanding during the period, excluding any unvested restricted stock awards. Diluted net income (loss) per share includes the effect of common stock equivalents (stock options, unvested restricted stock, and warrants) when, under either the treasury or if-converted method, such inclusion in the computation would be dilutive. Net income (loss) is adjusted for the dilutive effect of the change in fair value liability for price adjustable warrants, if applicable. The following number of shares have been excluded from diluted net income (loss) since such inclusion would be anti-dilutive:
Nine
months ended
September 30, |
||||||||
2017 | 2016 | |||||||
Stock options outstanding | 233,400 | - | ||||||
Warrants | 2,492,945 | 13,917 | ||||||
Convertible Notes Payable | 315,746 | - | ||||||
Restricted common stock | 70,000 | |||||||
Total | 3,112,091 | 13,917 |
Note 2 – Intangible Assets
Reverse Merger with IThenaPharma
On November 15, 2016, we entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among Marina Biotech, Inc., IThenaPharma Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). Upon completion of the Merger and subject to the applicable provisions of the Merger Agreement, Merger Sub has ceased to exist and IThena continues as the surviving corporation of the Merger and as a wholly-owned subsidiary of Marina. As consideration for the Merger, Marina issued to the former shareholders of IThena 58,392,828 shares of the Company’s common stock (5,839,283 shares after adjustment for the Company’s 1 for 10 reverse stock split in August 2017), representing approximately 65% of the issued and outstanding shares of Marina’s common stock following the completion of the Merger. Outstanding warrants to purchase 30,000 shares of common stock of IThena were converted into warrants to purchase common stock of Marina. In addition, Marina appointed Vuong Trieu, the president of IThena, as the Chairman of the Board of Directors of Marina, effective November 15, 2016. Dr. Trieu, in his capacity as the IThena representative, later appointed Philippe P. Calais, Ph.D., as a member of the Board of Directors of Marina effective December 8, 2016, pursuant to the rights granted to the former shareholders of IThena in the Merger Agreement.
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As the former shareholders of IThena control greater than 50% of the Company subsequent to the Merger, for accounting purposes, the Merger was treated as a “reverse acquisition” and IThena is considered the accounting acquirer. IThena accounted for the acquisition of Marina under the purchase accounting method following completion. Accordingly, IThena’s historical results of operations replace Marina’s historical results of operations for all periods prior to the Merger, and for all periods following the Merger, the results of operations of both companies are included. As a result of the Merger, while we have presented the results for the three and nine months ended September 30, 2017 and 2016; the results for the 2016 periods reflect only the results of IThena.
The purchase price of approximately $3.7 million represents the consideration in the reverse merger transaction and is calculated based on the number of shares of common stock of the combined company that Marina stockholders owned as of the closing of the transaction and the fair value of assets and liabilities assumed by IThena.
The number of shares of common stock Marina issued to IThena stockholders is calculated pursuant to the terms of the Merger Agreement based on Marina common stock outstanding as of November 15, 2016, as follows (retroactively adjusted for the 1 for 10 reverse stock split in August 2017):
Shares of Marina common stock outstanding as of November 15, 2016 | 3,137,855 | |||
Divided by the percentage of Marina ownership of combined company | 35 | % | ||
Adjusted total shares of common stock of combined company | 8,977,138 | |||
Multiplied by the assumed percentage of IThena ownership of combined company | 65 | % | ||
Shares of Marina common stock issued to IThena upon closing of transaction | 5,839,283 |
The application of the acquisition method of accounting is dependent upon certain valuations and other studies that have yet to be completed. The purchase price allocation will remain preliminary until IThena management determines the fair values of assets acquired and liabilities assumed. The final determination of the purchase price allocation is anticipated to be completed as soon as practicable after completion of the transaction and will be based on the fair values of the assets acquired and liabilities assumed as of the transaction closing date. The final amounts allocated to assets acquired and liabilities assumed could differ significantly from the amounts presented.
The purchase price as of September 30, 2017 has been allocated based on a preliminary estimate of the fair value of assets acquired and liabilities assumed:
The above estimated purchase price allocation and goodwill valuation reflects changes in fair value determinations of $55,246 for the nine months ended September 30, 2017 and approximately $1,238,000 since the Merger date. As part of the Merger, the Company allocated $3,502,829 to goodwill. Additionally, a substantial portion of the assets acquired were allocated to identifiable intangible assets. The fair value of the identifiable intangible asset is determined primarily using the “income approach,” which requires a forecast of all the expected future cash flows.
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On November 15, 2016, Marina agreed to issue to Novosom Verwaltungs GmbH (“Novosom”) 0.15 million shares of common stock upon the closing of the Merger in consideration of Novosom’s agreement that the consummation of the Merger would not constitute a “Liquidity Event” under that certain Asset Purchase Agreement dated as of July 27, 2010 between and among Marina, Novosom and Steffen Panzner, Ph.D., and thus that no additional consideration under such agreement would be due to Novosom as a result of the consummation of the Merger.
In July 2016, Marina pledged to issue common stock valued at approximately $15,000 to Novosom for the portion due under our July 2010 Asset Purchase Agreement with Novosom, related to Marina’s license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. In November 2016, we issued 11,905 shares with a value of approximately $15,000 to Novosom as the equity component owed under our July 2016 license agreement.
Acquisition of Assets from Symplmed
In June 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Symplmed Pharmaceuticals LLC (“Symplmed”) pursuant to which we purchased from Symplmed, for aggregate consideration of approximately $0.62 million (consisting of $0.4 million in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $0.32 million), Symplmed’s assets relating to a single-pill FDC of perindopril arginine and amlodipine besylate known as Prestalia® (“Prestalia”), that has been approved by the FDA for the treatment of hypertension. In addition, as part of the transactions contemplated by the Purchase Agreement: (i) Symplmed agreed to transfer to us, not later than 150 days following the closing date, the New Drug Applications for the approval of Prestalia as a new drug by the FDA; and (ii) Symplmed assigned to us all of its rights and obligations under that certain Amended and Restated License and Commercialization Agreement by and between Symplmed and Les Laboratoires Servier (“Servier”) dated January 11, 2012, pursuant to which Symplmed has an exclusive license from Servier to manufacture, have manufactured, develop, promote, market, distribute and sell Prestalia in the U.S. (and its territories and possessions) in consideration of regulatory and sales-based milestone payments and royalty payments based on net sales. Management has determined that this acquisition was deemed an asset purchase under FASB ASC 805.
Further, we entered into an offer letter to hire our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective on June 22, 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares to vest on the six (6) month anniversary of the date of grant.
In furtherance of the acquisition and commercialization of Prestalia, on July 21, 2017 we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also known as Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.
The purchase price of $0.62 million has been allocated based on a preliminary estimate of the fair value of the assets acquired and is included in intangible assets as of September 30, 2017, and is subject to change.
The following table summarizes the estimated fair value of the identifiable intangible asset acquired, their useful life, and method of amortization:
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Estimated
Fair Value |
Estimated
Useful Life (Years) |
Annual
Amortization Expense |
||||||||||
Intangible asset from Merger | $ | 2,361,066 | 6 | $ | 393,511 | |||||||
Intangible asset - Prestalia | 620,000 | 6 | 103,333 | |||||||||
Intangible asset – DyrctAxess | 75,000 | 6 | 12,500 | |||||||||
Total | $ | 3,056,066 | $ | 509,344 |
The net intangible asset was $2,679,235, net of accumulated amortization of $376,831, as of September 30, 2017. Amortization expense was $327,642 and $0 for the nine months ended September 30, 2017 and 2016, respectively.
Note 3 - Related Party Transactions
Due to Related Party
The Company and other related entities have a commonality of ownership and/or management control, and as a result, the reported operating results and /or financial position of the Company could significantly differ from what would have been obtained if such entities were autonomous.
The Company has a Master Services Agreement (“MSA”) with a related party that is partly-owned by the Company’s Executive Chairman, Autotelic Inc., effective November 15, 2016. Autotelic Inc. owns less than 10% of the Company. The MSA states that Autotelic Inc. will provide business functions and services to the Company and allows Autotelic Inc. to charge the Company for these expenses paid on its behalf. The MSA includes personnel costs allocated based on amount of time incurred and other services such as consultant fees, clinical studies, conferences and other operating expenses incurred on behalf of the Company. The MSA between Marina and Autotelic Inc. was effective on the reverse merger date of November 15, 2016.
During the period commencing November 15, 2016 (the “Effective Date”) and ending on the date that the Company has completed an equity offering of either common or preferred stock in which the gross proceeds therefrom is no less than $10 million (the “Equity Financing Date”), the Company shall pay Autotelic the following compensation: cash in an amount equal to the actual labor cost (paid on a monthly basis), plus 100% markup in warrants for shares of the Company’s common stock with a strike price equal to the fair market value of the Company’s common stock at the time said warrants are issued. The Company shall also pay Autotelic for the services provided by third party contractors plus 20% mark up. The warrant price per share will be calculated based on the Black-Scholes model.
After the Equity Financing Date, the Company shall pay Autotelic Inc. a cash amount equal to the actual labor cost plus 100% mark up of provided services and 20% mark up of provided services by third party contractors or material used in connection with the performance of the contracts, including but not limited to clinical trial, non-clinical trial, Contract Manufacturing Organizations (“CMO”), FDA regulatory process, Contract Research Organizations (“CRO”) and Chemistry and Manufacturing Controls (“CMC”).
In accordance with the MSA, Autotelic Inc. billed the Company for personnel and service expenses Autotelic Inc. incurred on behalf of the Company. For the nine months ended September 30, 2017 and 2016, Autotelic Inc. billed a total of $492,406 and $238,673, including personnel costs of $386,954 and $99,425, respectively. An unpaid balance of $382,332 is recorded as due to related party in the accompanying balance sheet as of September 30, 2017. The Company agreed to issue warrants at a future date for the remaining balance due of $388,745, which is included in accrued expenses as of September 30, 2017.
Convertible Notes Payable
In July 2016, IThena issued convertible promissory notes with an aggregate principal balance of $50,000 to certain related-party investors. Borrowings under each of these convertible notes bore interest at 3% per annum and these notes mature on June 30, 2018. Upon the completion of certain funding events, IThena had the right to convert the outstanding principal amount of these notes into shares of the IThena’s common stock. The notes were assumed by Autotelic Inc. on November 15, 2016 as part of its acquisition of the technology asset (IT-101).
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Convertible Notes Payable, Dr. Trieu
In connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, our Executive Chairman, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses. Dr. Trieu has advanced the full $540,000 under the Line Letter as of September 30, 2017 ($250,000 as of December 31, 2016). Accrued interest on the Line Letter was $19,029 and $0 as of September 30, 2017 and December 31, 2016, respectively, and is included in convertible notes payable to related parties on the accompanying balance sheets. The line of credit is currently convertible at any time into shares of the Company’s common stock at a price of $2.80 per share.
Line Letter with Autotelic Inc.
On April 4, 2017, the Company entered into a Line Letter with Autotelic Inc for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic Inc. is., a stockholder of IThenaPharma that became the holder of 525,535 shares of Marina common stock as a result of the Merger, and an entity of which Dr. Trieu serves as Chairman of the Board. Autotelic Inc. was to consider requests for advances under the Line Letter until September 1, 2017. The Company and Autotelic Inc. are in discussions to extend this line letter through December 31, 2017. Autotelic Inc. shall have the right at any time for any reason in its sole and absolute discretion to terminate the line of credit available under the Line Letter or to reduce the maximum amount available thereunder without notice. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued to Autotelic Inc., and are due and payable upon demand by Autotelic, Inc.
The balance under the line was $92,590 as of September 30, 2017 and is included in notes to related parties on the accompanying balance sheet. As such, we currently have approximately $407,000 of available funds under this line of credit.
Note 4 – Notes Payable
Note Purchase Agreement and Amendment
In June 2016, Marina entered into a Note Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”), pursuant to which Marina issued to the Purchasers unsecured promissory notes in the aggregate principal amount of $300,000 (the “Notes”). Interest was to accrue on the unpaid principal balance of the Notes at the rate of 12% per annum beginning on September 20, 2016. The Notes were due and payable on June 20, 2017, provided, that, upon the closing of a financing transaction that occurs while the Notes are outstanding, each Purchaser shall have the right to either: (i) accelerate the maturity date of the Note held by such Purchaser or (ii) convert the entire outstanding principal balance under the Note held by such Purchaser and accrued interest thereon into Marina’s securities that are issued and sold at the closing of such financing transaction.
In July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to those Notes and the warrants to purchase shares of our common stock that are currently held by the Purchasers and that were originally issued pursuant to a certain Note and Warrant Purchase Agreement dated as of February 10, 2012 by and among Marina, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto (as amended from time to time), to, among other things, extend the maturity date of the Notes to December 31, 2017 and to extend the price protection applicable to certain of the warrants held by the Purchasers with respect to dilutive offerings afforded thereunder to February 10, 2020. Refer to our Form 10-Q for the six months ended June 30, 2017 for a more detailed discussion and additional terms for these Notes.
As of September 30, 2017, the accrued interest expense on the Notes amounted to $37,500, with a total balance of principal and interest of $337,500.
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Note Payable – Service Provider
In December 2016, we entered into an Agreement and Promissory Note with a law firm for past services performed totaling $121,523. The note calls for monthly payments of $6,000 per month, beginning with an initial payment on March 31, 2017. The note is unsecured and non-interest bearing. The note will be considered paid in full if the Company pays $100,000 by December 31, 2017. The balance due on the note was $103,523 as of September 30, 2017.
Bridge Note Financing
In June 2017, we issued convertible promissory notes (the “Notes”) in the aggregate principal amount of $400,000 to 10 investors pursuant to a Note Purchase Agreement (the “Note Purchase Agreement”) that we entered into with such investors. The Notes bear interest at a rate of five percent (5%) per annum and are due and payable at any time on or after the earlier of (i) June 1, 2018 and (ii) the occurrence of an event of default (as defined in the Note Purchase Agreement). Our Executive Chairman and our Chief Science Officer were each investors in the Notes.
Upon written notice delivered to us by the holders of a majority in interest of the aggregate principal amount of Notes that are outstanding at the time of such calculation (the “Majority Holders”) not more than five (5) days following the maturity date of the Notes, the Majority Holders shall have the right, but not the obligation, on behalf of themselves and all other holders of Notes, upon written notice delivered to us, to elect to convert the entire unpaid principal amount of all, but not less than all, of the Notes and the accrued and unpaid interest thereon into such number of shares of our common stock as is equal to, with respect to each Note: (x) the entire unpaid principal amount of such Note and the accrued and unpaid interest thereon on the date of the delivery of such notice by (y) $3.50.
As of September 30, 2017, the accrued interest expense on the Notes amounted to $6,324, with a total balance of principal and interest of $406,324.
Note 5 – Stockholders’ Equity
Preferred Stock
Marina designated 1,000 shares as Series B Preferred Stock (“Series B Preferred”) and 90,000 shares as Series A Junior Participating Preferred Stock (“Series A Preferred”). No shares of Series B Preferred or Series A Preferred are outstanding. In March 2014, Marina designated 1,200 shares as Series C Convertible Preferred Stock (“Series C Preferred”). In August 2015, Marina designated 220 shares as Series D Convertible Preferred Stock (“Series D Preferred”).
Series C Preferred
Each share of Series C Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $7.50 per share. In June 2015, an investor converted 90 shares of Series C Preferred into 60,000 shares of common stock with a value of $5.40 per share. In November 2015, an investor converted an additional 90 shares of Series C Preferred into 60,000 shares of common stock with a value of $3.10 per share. On September 15, 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock in a cashless exercise.
Series D Preferred
In August 2015, Marina entered into a Securities Purchase Agreement with certain investors pursuant to which Marina sold 220 shares of Series D Preferred, and warrants to purchase up to 344,000 shares of Marina’s common stock at an initial exercise price of $4.00 per share before August 2021, for an aggregate purchase price of $1.1 million. Each share of Series D Preferred has a stated value of $5,000 per share and is convertible into shares of common stock at a conversion price of $4.00 per share. The Series D Preferred is initially convertible into an aggregate of 275,000 shares of Marina’s common stock, subject to certain limitations and adjustments, has a 5% stated dividend rate, is not redeemable and has voting rights on an as-converted basis. In November 2015, an investor converted 50 shares of Series D Preferred into 62,500 shares of common stock. In February 2016, an investor converted 110 shares of Series D Preferred into 137,500 shares of common stock.
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Common Stock
Our common stock currently trades on the OTCQB tier of the OTC Markets.
Stock Issuances
In February 2017, we entered into two privately negotiated transactions pursuant to which we issued an aggregate of 615,368 shares of our common stock for an effective price per share of $2.90 to settle aggregate liabilities of approximately $948,000, which had been reflected in accrued expenses as of December 31, 2016.
In February 2017, we issued 30,000 shares of our common stock with a fair value of $1.80 per share to a consultant providing investment advisory services.
In February 2017, we issued 10,000 restricted shares of our common stock with a fair value of $1.40 per share to our CEO for services.
In February 2017, we entered into a Stock Purchase Agreement with LipoMedics, a related party, pursuant to which we issued to LipoMedics an aggregate of 86,207 shares of our common stock for a total purchase price of $250,000.
In March 2017, we entered into a Settlement Agreement, whereby a note receivable for $45,000 was settled with a cash payment by the note holder to the Company of $14,049, the surrender of 6,000 warrants, and the surrender of 8,725 shares of common stock held by the noteholder, which were cancelled effective March 31, 2017.
In April 2017, the Company entered into a Compromise and Release Agreement to settle $36,047 due to a service provider for $15,957 in cash and $20,090 of the Company’s common stock at $2.90 per share (for a total issuance of 6,928 shares). The Company issued 6,928 shares to the service provider in May 2017.
In May 2017, the holders of warrants to purchase 60,944 shares of our common stock at an exercise price of $2.80 per share exercised such warrants, yielding aggregate gross proceeds to us of $170,643.
In June 2017, we entered into an offer letter to hire our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment became effective on June 22, 2017. We also agreed in such offer letter to issue 60,000 restricted shares of our common stock under our 2014 Long-Term Incentive Plan to our Chief Commercial Officer, with all of such shares to vest on the six (6) month anniversary of the date of grant. These shares were issued in June 2017.
In August 2017, in connection with the reverse split, we issued 3,360 shares of common stock due to rounding at exchange and participant levels.
In September 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock on a cashless basis.
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Warrants
As of September 30, 2017, there were 2,492,945 warrants outstanding, with a weighted average exercise price of $4.40 per share, and annual expirations as follows:
Expiring in 2017 | - | |||
Expiring in 2018 | 11,383 | |||
Expiring in 2019 | 600,000 | |||
Expiring in 2020 | 1,189,079 | |||
Expiring in 2021 | 343,750 | |||
Expiring thereafter | 348,733 | |||
2,492,945 |
On May 21, 2017, the holders of warrants to purchase 60,944 shares of our common stock at an exercise price of $2.80 per share exercised such warrants, yielding aggregate gross proceeds to us of $170,643.
A total of 149,111 warrants expired in May 2017.
Note 6 — Stock Incentive Plans
Stock Options
Stock option activity was as follows:
Options Outstanding | ||||||||
Shares |
Weighted
Average Exercise Price |
|||||||
Outstanding, December 31, 2016 | 168,811 | $ | 36.80 | |||||
Options granted | 64,600 | 1.70 | ||||||
Options expired | (11 | ) | 5,264.00 | |||||
Outstanding, September 30, 2017 | 233,400 | 26.85 | ||||||
Exercisable, September 30, 2017 | 193,100 | $ | 32.10 |
The following table summarizes additional information on Marina’s stock options outstanding at September 30, 2017:
Options Outstanding | Options Exercisable | |||||||||||||||||||
Range of
Exercise
|
Number
Outstanding |
Weighted-
Average Remaining Contractual Life (Years) |
Weighted
Average Exercise Price |
Number
Exercisable |
Weighted
Average Exercise Price |
|||||||||||||||
$ | 0.10 | 14,000 | 4.30 | $ | 1.00 | 14,000 | $ | 1.00 | ||||||||||||
$ | 0.17 - .018 | 64,600 | 4.13 | 1.72 | 24,300 | 1.70 | ||||||||||||||
$ | 0.26 - 0.82 | 48,400 | 2.73 | 4.62 | 48,400 | 4.62 | ||||||||||||||
$ | 1.07 - $2.20 | 102,150 | 5.74 | 10.73 | 102,150 | 10.73 | ||||||||||||||
$ | 47.60 - $87.60 | 2,100 | .69 | 676.00 | 2,100 | 676.00 | ||||||||||||||
$ | 127.60 - $207.60 | 2,150 | .69 | 1,582.98 | 2,150 | 1,582.98 | ||||||||||||||
Totals | 233,400 | 4.53 | $ | 26.85 | 193,100 | $ | 32.10 |
Weighted-Average Exercisable Remaining Contractual Life (Years) 4.53
In January 2017, the Company granted a total of 48,600 stock options to directors and officers for services. One-half of the options vest immediately and one-half of the options vest on the one-year anniversary of the grant date. The options have an exercise price of $1.70 and a five-year term.
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In February 2017, the Company granted a total of 16,000 stock options to key employees for services. The options vest on the one-year anniversary of the grant date, have an exercise price of $1.80, and have a five-year term.
Subsequent to the date of the financial statements, in October 2017, we appointed our Chief Financial Officer and our Chief Legal Officer. In connection with these appointments, we granted to each such officer options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan, with all of such options vesting and becoming exercisable on the one-year anniversary of the grant date.
At September 30, 2017, we had $36,573 of total unrecognized compensation expense related to unvested stock options. Total expense related to stock options was $59,568 for the nine months ended September 30, 2017.
At September 30, 2017, the intrinsic value of options outstanding or exercisable was $201,100 as there were 101,800 options outstanding with an exercise price less than $2.80, the per share closing market price of our common stock at that date.
Note 7 — Intellectual Property and Collaborative Agreements
Novosom Agreements
In July 2010, Marina entered into an agreement pursuant to which Marina acquired intellectual property for Novosom’s SMARTICLES-based liposomal delivery system. In February 2016, Marina issued Novosom 20,548 shares of common stock valued at approximately $58,000 as additional consideration under such agreement.
In March 2016, Marina entered into a license agreement covering certain of Marina’s platforms for the delivery of an undisclosed genome editing technology. Under the terms of the agreement, Marina received an upfront license fee of $250,000 and could receive up to $40 million in success-based milestones. In April 2016, Marina issued Novosom 47,468 shares of common stock valued at approximately $75,000 for amounts due under this agreement.
In July 2016, Marina entered into a license agreement with an undisclosed licensee that grants such licensee rights to use Marina’s technology and intellectual property to develop and commercialize products combining certain molecules with Marina’s liposomal delivery technology known as NOV582. Under the terms of this agreement, the licensee agreed to pay to us an upfront license fee in the amount of $350,000 (to be paid in installments through the end of 2017), along with milestone payments on a per-licensed-product basis and royalty payments in the low single digit percentages. As of September 30, 2016, Marina had received $50,000 per the terms of this license agreement. In November 2016, we issued 11,905 shares with a value of $15,000 to Novosom as the equity component owed under Marina’s July 2016 license agreement.
Arrangements with LipoMedics
In February 2017, we entered into a License Agreement (the “License Agreement”) with LipoMedics, pursuant to which, among other things, we provided to LipoMedics a license to our SMARTICLES platform for further development of Lipomedics’s proprietary phospholipid nanoparticles that can deliver protein, small molecule drugs, and peptides. These are not currently being developed at Marina and Marina has no IP around these products. On the same date, we also entered into a Stock Purchase Agreement with LipoMedics pursuant to which we issued to LipoMedics an aggregate of 86,207 shares of our common stock for a total purchase price of $250,000.
Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if LipoMedics determines to pursue further development and commercialization of products under the License Agreement, LipoMedics agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $2.90 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which LipoMedics notifies us that it intends to pursue further development or commercialization of a licensed product.
If LipoMedics breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to LipoMedics specifying the breach, if LipoMedics fails to cure such material breach within such sixty (60) day period. LipoMedics may terminate the License Agreement by giving thirty (30) days’ prior written notice to us.
Vuong Trieu, Ph.D., our Executive Chairman, is the Chairman of the Board and Chief Operating Officer of LipoMedics.
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In consideration Lipomedics agreed to the following fee schedule: 1) Evaluations License Fee. Simultaneous with the execution and delivery of the License Agreement, Lipomedics shall enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Lipomedics, pursuant to which Marina will sell to Lipomedics shares of the common stock of Marina for an aggregate purchase price of $0.25 million, with the purchase price for each share of Marina common stock being $2.90. 2) Commercial License Fee. Unless the License Agreement is earlier terminated, within thirty (30) days following Lipomedics’s delivery of an Evaluation Notice advising that it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products. 3) For up to and including three Licensed Products, Lipomedics shall pay to Marina a milestone (collectively the “Sales Milestones”) of $10 million upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than $500 million for a given Licensed Product and of $20 million upon reaching Commercial Sales in any given twelve month period equal to or greater than $1 million for such Licensed Product, such payments to be made within thirty (30) days following the month in which such Commercial Sale targets are met.
Arrangements with Oncotelic Inc.
In July 2017, we entered into a License Agreement (the “License Agreement”) with Oncotelic, Inc. (“Oncotelic”) pursuant to which, among other things, we provided to Oncotelic a license to our SMARTICLES platform for the delivery of antisense DNA therapeutics, as well as a license to our conformationally restricted nucleotide (“CRN”) technology with respect to TGF-Beta. Under the terms of the License Agreement, Oncotelic also agreed to purchase 49,019 shares of our common stock for an aggregate purchase price of $0.25 million ($5.10 per share), with such purchase and sale to be made pursuant to a Stock Purchase Agreement to be entered into between us and Oncotelic within thirty (30) days following the date of the License Agreement.
Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if Oncotelic determines to pursue further development and commercialization of products under the License Agreement, Oncotelic agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $0.5 million, with the purchase price for each share of common stock being the greater of $5.10 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which Oncotelic notifies us that it intends to pursue further development or commercialization of a licensed product.
If Oncotelic breaches the License Agreement, we shall have the right to terminate the License Agreement effective sixty (60) days following delivery of written notice to Oncotelic specifying the breach, if Oncotelic fails to cure such material breach within such sixty (60) day period. Oncotelic may terminate the License Agreement by giving thirty (30) days’ prior written notice to us.
Dr. Trieu, our Executive Chairman, is the principal stockholder and Chief Executive Officer of Oncotelic.
Sale of DiLA 2 Assets
In July 2017, we entered into a binding term sheet with a third-party purchaser (“Purchaser”) pursuant to which Purchaser will purchase from us the patents, know-how, agreements, records and certain other assets relating to our DiLA 2 delivery system. The consideration to be paid by Purchaser to us as a result of this transaction shall consist of: (i) an initial payment of $0.3 million to be paid upon the closing of the asset sale; and (ii) an additional $1.2 million to be paid upon the first to occur of (x) a financing in which third party investors purchase equity and/or debt securities of Purchaser resulting in aggregate proceeds to Purchaser of not less than $15 million and (y) the twelve-month anniversary of the closing.
The closing of the transaction is subject to the negotiation, execution and delivery of a definitive asset purchase agreement and Purchaser’s determination that its due diligence has been completed and has been found satisfactory, in Purchaser’s sole discretion.
In the term sheet, we agreed that we will negotiate exclusively with Purchaser with respect to the sale of the DiLA 2 assets for a period of ninety (90) days from the date of the term sheet. Although this ninety (90) day period has expired according to the term sheet, negotiations are ongoing between us and the Purchaser.
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Pursuant to the term sheet, at any time following the closing of the transaction and prior to the payment to us of the additional $1.2 million payment, Purchaser may elect to unwind the transaction by providing written notice to such effect to us. Within thirty (30) days of Purchaser’s issuance of such notice, Purchaser shall assign the DiLA 2 assets back to us.
We will retain an exclusive, fully paid and royalty free license to DiLA 2 outside of the field of gene editing as well as the rights to license DiLA 2 outside of gene editing.
Asset Purchase Agreement
In July 2017, Marina entered into an Asset Purchase Agreement with Symplmed Pharmaceuticals LLC and its wholly-owned subsidiary Symplmed Technologies, LLC pursuant to which the Company purchased from the Sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the Sellers relating to the Sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care (see Note 2).
Note 8 – Commitments and Contingencies
Amendment to Agreement with Windlas Healthcare Private Limited
On August 17, 2017, we entered into an amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), relating to the development by Windlas of certain pharmaceutical products to be used for conducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties.
Litigation
Because of the nature of the Company’s activities, the Company is subject to claims and/or threatened legal actions, which arise out of the normal course of business. Other than the disclosure below, as of the date of this filing, the Company is not aware of any pending lawsuits against the Company, its officers or directors.
The Company has been named on a complaint filed in New York State as a defendant in the matter entitled Vaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. While this complaint has been filed in the Supreme Court of the State of New York, the Company has not been legally served. The complaint alleges, in relevant part, that: (i) the sale by Symplmed Pharmaceuticals, Inc. of its assets related to its Prestalia product, and the sale by Symplmed Technologies, Inc. of its assets related to its DyrctAxess platform, should be set aside pursuant to New York law as they were consummated without fair consideration to the sellers (the “Symplmed Defendants”), and thereby had the effect of fraudulently depriving the creditors of the Symplmed Defendants, including Vaya Pharma, Inc., of funds that could have been used to pay their debts; and (ii) the Company is liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company is only contractually responsible for liabilities that accrue after the parties entered into the agreement for Prestalia and any liabilities that existed prior to the agreement are contractually held by Symplmed. If and when the Company is legally served, it is the intention of the Company to dispute jurisdiction, the sufficiency of the pleading and the claims set forth in this complaint, and to defend this matter, vigorously. However, due to the inherent uncertainties of litigation, the ultimate outcome of this matter is uncertain. An unfavorable outcome could materially and adversely affect the business, financial condition and results of operations of the Company.
Note 9 - Subsequent Events
Except for the event(s) discussed in this Note 9, there were no subsequent events that required recognition or disclosure. The Company evaluated subsequent events through the date the financial statements were issued and filed with the Securities and Exchange Commission.
In September 2017, we entered into an engagement letter with a financial advisor pursuant to which, among other things, we agreed to issue to such financial advisor, in partial consideration of the services to be rendered under the engagement letter, an aggregate of 500,058 shares of our common stock. The shares were issued in November 2017.
I n October 2017, we appointed our Chief Financial Officer and our Chief Legal Officer. In connection with these appointments, we granted to each such officer options to purchase up to 60,000 shares of our common stock under our 2014 Long-Term Incentive Plan, with all of such options vesting and becoming exercisable on the one-year anniversary of the grant date.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
This report contains forward-looking statements. The following discussion should be read in conjunction with the financial statements and related notes contained in our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (“SEC”) on March 31, 2017. Certain statements made in this discussion are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are projections in respect of future events or financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements made in a quarterly report on Form 10-Q may include statements about:
● | our ability to obtain additional and substantial funding for our company on an immediate basis, whether pursuant to a capital raising transaction arising from the sale of our securities, a strategic transaction, debt or otherwise and at terms acceptable to us; |
● | our ability to attract and/or maintain research, development, commercialization and manufacturing partners; |
● | the ability of our company and/or a partner to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; |
● | the ability of our company and/or a partner to obtain required governmental approvals, including product and patent approvals; |
● | the ability of our company and/or a partner to develop and commercialize products that can compete favorably with those of our competitors; |
● | the timing of costs and expenses related to the research and development programs of our company and/or our partners; |
● | the timing and recognition of revenue from milestone payments and other sources not related to product sales; |
our ability to satisfy our disclosure obligations under the Securities Exchange Act of 1934, as amended, and to maintain the registration of our common stock thereunder; | |
● | our ability to attract and retain qualified officers, employees and consultants as necessary; and |
● | the costs associated with any product liability claims, patent prosecution, patent infringement lawsuits and other lawsuits. |
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the SEC on March 31, 2017, any of which may cause our company’s or our industry’s 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. These risks may cause the Company’s or its industry’s actual results, levels of activity or performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. We are under no duty to update any forward-looking statements after the date of this report to conform these statements to actual results.
As used in this quarterly report and unless otherwise indicated, the terms “we,” “us,” “our” or the “Company” refer to Marina Biotech, Inc., a Delaware corporation, and its wholly-owned subsidiaries, , MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and Atossa HealthCare, Inc.; and IThenaPharma Inc. Unless otherwise specified, all dollar amounts are expressed in United States dollars. Our common stock is currently listed on the OTC Market, OTCQB tier, under the symbol “MRNA.”
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Corporate Overview
We are a fully integrated, commercial stage biopharmaceutical company delivering proprietary drug therapeutics for significant unmet medical needs in the U.S., Europe and certain additional international markets. Our portfolio of products currently focuses on fixed dose combinations (“FDC”) in hypertension, arthritis, pain and oncology allowing for innovative solutions to such unmet medical needs. Our mission is to provide effective and patient centric treatment for hypertension – including resistant hypertension. In this connection, we acquired from Symplmed and its wholly-owned subsidiary, Symplmed Technologies, LLC, certain of the intellectual property assets related to the patented technology platform known as DyrctAxess, also called Total Care, that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care.
In doing so, we have created a universal platform for the effective treatment of hypertension as well as for the distribution of FDC hypertensive drugs, such as our FDA-approved product Prestalia, and the other products in our pipeline, devices for therapeutic drug monitoring, blood pressure, and other cardiac monitors, as well as services such as counseling and prescription reminders.
We currently have one commercial and three clinical development programs underway: (i) Prestalia®, a single-pill fixed dose combination of perindopril, an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine, a calcium channel blocker (“CCB”), which has been approved by the U.S. Food and Drug Administration (“FDA”) and is actively marketed in the U.S.; (ii) our next generation celecoxib program drug candidates for the treatment of acute and chronic pain, IT-102 and IT-103, each of which is an FDC of celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (“NSAID”) and either lisinopril (IT-102) or olmesartan (IT-103) – both Lisinopril and olmesartan are antihypertension drugs; (iii) CEQ508, an oral delivery of small interfering RNA (“siRNA”) against beta-catenin, combined with IT-102 to suppress polyps in the precancerous syndrome and orphan indication Familial Adenomatous Polyposis (“FAP”); and (iv) CEQ508 combined with IT-103 to treat Colorectal Cancer.
Our current focus is primarily on the commercialization of Prestalia and secondarily the development of IT-102 and IT-103. We believe that by combining a COX-2 inhibitor with an antihypertensive in a single FDC oral tablet, IT-102 and IT-103 will each offer improved safety profiles as compared to currently available and previously marketed COX-2 inhibitors as well as address patients with chronic pain who are commonly taking antihypertension drugs concurrently. We further believe that the current opioid addiction epidemic in the U.S. has been driven in part by the withdrawal from the market of certain COX-2 inhibitors due to their associated risk of cardiovascular-related adverse events. We plan to license or divest our other assets since they no longer align with our focus on the treatment of hypertension.
We intend to create value through the continued commercialization of our FDA-approved product, Prestalia, while moving our FDC development programs forward to further strengthen our commercial presence. We intend to retain ownership and control of all of our product candidates, but in the interest of accelerated growth and market penetration, we will also consider partnerships with pharmaceutical or biotechnology companies in order to reduce time to market and to balance development risks, both clinically and financially.
As our strategy is to be a fully integrated biopharmaceutical company, we will drive a primary corporate focus on revenue generation through our commercial assets, with a secondary focus on advancing our FDC pipeline to further enhance our commercial presence.
Reverse Merger with IThenaPharma
Marina was incorporated under the laws of the State of Delaware under the name Nastech Pharmaceutical Company on September 23, 1983, and IThena was incorporated under the laws of the State of Delaware on September 3, 2014. On November 15, 2016, Marina entered into, and consummated the transactions contemplated by, an Agreement and Plan of Merger between and among Marina, IThenaPharma Inc., a Delaware corporation (“IThena”), IThena Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of Marina (“Merger Sub”), and Vuong Trieu as the IThena representative (the “Merger Agreement”), pursuant to which IThena merged into Merger Sub (the “Merger”). IThena is deemed to be the accounting acquirer in the Merger, and thus the historical financial statements of IThena are treated as the historical financial statements of our company and are reflected in our quarterly and annual reports for periods ending after the effective time of the Merger, or November 15, 2016. Accordingly, beginning with our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as filed with the SEC on March 31, 2017, we have reported the results of IThena and Marina and their respective subsidiaries on a consolidated basis. As a result of the Merger, while we have presented the results for the three and nine periods ended September 30, 2017 and 2016, the results for the 2016 periods reflect only the results of IThena.
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IThena is a developer of personalized therapies for combined pain/hypertension through its proprietary FDC technology and point of care Therapeutic Drug Monitoring system (“TDM”). Through the combination of these technologies, IThena is looking to deliver therapies with improved compliance and personalized dosing. IThena’s lead products are the celecoxib FDCs which include IT-102 and IT-103, FDCs of celecoxib and lisinopril and celecoxib and olmesartan, respectively. IT-102 and IT-103 are being developed as celecoxib without the drug induced edema associated with celecoxib alone. IT-102 and IT-103 are being developed initially for combined arthritis / hypertension and subsequently for treatment of pain, or cancer, or other indications requiring high doses of celecoxib.
Acquisition of Prestalia
Subsequent to the Merger we executed on our strategy to become a commercial stage company with the acquisition of Prestalia from Symplmed. Specifically, on June 6, 2017 we entered into an Asset Purchase Agreement with Symplmed for the purchase of Prestalia, which is an FDA-approved and marketed anti-hypertensive drug. This is a FDC of perindopril arginine, an ACE inhibitor, and amlodipine besylate, a calcium channel blocker (“CCB”), and is indicated as a first line therapy for hypertension control.
We believe that the acquisition of Prestalia transforms our company from a clinical stage company to a commercial organization. Prestalia was approved in January 2015 and has been marketed in select U.S. states since then by Symplmed. Prestalia sales saw solid growth through September of 2016, via new patient acquisition and strong patient retention. Due to lack of funding, further revenues and marketing of Prestalia was ceased by the end of calendar year 2016. In the near term our focus will be dedicated to re-acquiring prior Prestalia patients, with subsequent efforts dedicated to building a strong sales team to fully market the product. This includes our efforts to re-establish our relationships with our contract manufacturers to support marketing Prestalia.
We believe that the Prestalia acquisition will not only make us a revenue-stage company, but also that the marketing, distribution and sales network that we will build will pave a strong foundation for the promotion and commercialization of our two other hypertension pipeline products – namely IT-102 and IT-103, as well as any other similar products that we internally develop or acquire.
Line Letters with Related Parties
In connection with the Merger, Marina entered into a line of credit dated November 15, 2016 with Dr. Trieu, our Executive Chairman, for an unsecured line of credit in an amount not to exceed $540,000, to be used for current operating expenses (“Line Letter”). As of September 30, 2017, Dr. Trieu has advanced an aggregate of $540,00 under the Line Letter. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by a demand promissory note issued to Dr. Trieu, and are due and payable upon demand by Dr. Trieu.
On April 4, 2017, we entered into a Line Letter with Autotelic for an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses. Autotelic was to consider requests for advances under the Line Letter until September 1, 2017. The Company and Autotelic Inc. are in discussions to extend this line letter through December 31, 2017. Advances made under the Line Letter bear interest at the rate of five percent (5%) per annum, are evidenced by the Demand Promissory Note issued to Autotelic, and are due and payable upon demand by Autotelic. We currently have approximately $407,000 of available funds under this line of credit. We believe that this available cash is sufficient to fund our operations through December 31, 2017.
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Recent Developments During the Three Months Ended September 30, 2017
Amendment of Notes and Warrants
On July 3, 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to those certain promissory notes in the aggregate principal amount of $300,000 (each a “Note” and collectively the “Notes”) that we issued to two accredited investors (the “Purchasers”) pursuant to that certain Note Purchase Agreement dated June 20, 2016 by and among us and the Purchasers (the “Purchase Agreement”), and those certain warrants to purchase up to an aggregate of 951,263 shares of our common stock that were originally issued pursuant to that certain Note and Warrant Purchase Agreement dated as of February 10, 2012 by and among the Company, MDRNA Research, Inc., Cequent Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto (as amended from time to time), that are currently held by the Purchasers, and that were amended concurrently with the Purchase Agreement to, among other things, extend the price protection with respect to dilutive offerings afforded thereunder to June 19, 2017 (such warrants, as so amended, the “Amended Prior Warrants”).
Pursuant to the Amendment Agreement, among other things: (i) the maturity date of the Notes was extended from June 20, 2017 to December 31, 2017; (iii) the Purchasers agreed, upon the closing of any financing transaction yielding aggregate gross proceeds to us of not less than $3 million that occurs while the Notes are outstanding (any such financing transaction, the “Qualifying Financing Transaction”), to convert the outstanding principal balance and any accrued interest thereon into the securities of our company to be issued and sold at the closing of the Qualifying Financing Transaction at the most favorable price and terms at which our securities are sold to investors in the Qualifying Financing Transaction; (iv) the parties agreed to extend the price protection with respect to the Amended Prior Warrants resulting from dilutive issuances until the expiration of the term of the Amended Prior Warrants (currently February 10, 2020); provided, that such protection shall not apply to the Qualifying Financing Transaction; and (v) we agreed to issue to the Purchasers, on a pro rata basis, such number of our securities as are being issued to investors in the Qualifying Financing Transaction as have an aggregate purchase price equal to $375,000.
Arrangements with Oncotelic Inc.
On July 17, 2017, we entered into a License Agreement (the “License Agreement”) with Oncotelic, Inc. (“Oncotelic”) pursuant to which, among other things, we provided to Oncotelic a license to our SMARTICLES platform for the delivery of antisense DNA therapeutics, as well as a license to our conformationally restricted nucleotide (“CRN”) technology with respect to TGF-Beta. Under the terms of the License Agreement, Oncotelic also agreed to purchase 49,019 shares of our common stock for an aggregate purchase price of $250,000 ($5.10 per share), with such purchase and sale to be made pursuant to a Stock Purchase Agreement to be entered into between us and Oncotelic within thirty (30) days following the date of the License Agreement.
Under the terms of the License Agreement, we could receive up to $90 million in success-based milestones based on commercial sales of licensed products. In addition, if Oncotelic determines to pursue further development and commercialization of products under the License Agreement, Oncotelic agreed, in connection therewith, to purchase shares of our common stock for an aggregate purchase price of $500,000, with the purchase price for each share of common stock being the greater of $5.10 or the volume weighted average price of our common stock for the thirty (30) trading days immediately preceding the date on which Oncotelic notifies us that it intends to pursue further development or commercialization of a licensed product.
Dr. Trieu, our Executive Chairman, is the principal stockholder and Chief Executive Officer of Oncotelic.
Sale of DiLA 2 Assets
On July 21, 2017, we entered into a binding term sheet with a third-party purchaser (the “Purchaser”) pursuant to which the Purchaser will purchase from us the patents, know-how, agreements, records and certain other assets relating to our DiLA 2 delivery system. The consideration to be paid by Purchaser to us as a result of this transaction shall consist of: (i) an initial payment of $300,000 to be paid upon the closing of the asset sale; and (ii) an additional $1.2 million to be paid upon the first to occur of (x) a financing in which third party investors purchase equity and/or debt securities of Purchaser resulting in aggregate proceeds to Purchaser of not less than $15 million and (y) the twelve-month anniversary of the closing.
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The closing of the transaction is subject to the negotiation, execution and delivery of a definitive asset purchase agreement and Purchaser’s determination that its due diligence has been completed and has been found satisfactory, in Purchaser’s sole discretion.
We agreed that we will negotiate exclusively with Purchaser with respect to the sale of the DiLA 2 assets for a period of ninety (90) days from the date of the term sheet. Although this ninety (90) day period has expired according to the term sheet, negotiations are ongoing between us and the Purchaser. Pursuant to the term sheet, at any time following the closing of the transaction and prior to the payment to us of the additional $1.2 million payment, Purchaser may elect to unwind the transaction by providing written notice to such effect to us. Within thirty (30) days of Purchaser’s issuance of such notice, Purchaser shall assign the DiLA 2 assets back to us. We will retain an exclusive, fully paid and royalty free license to DiLA 2 outside of the field of gene editing as well as the rights to license DiLA 2 outside of gene editing.
Acquisition of DyrctAxess Platform
On July 21, 2017, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Symplmed Pharmaceuticals LLC (“Symplmed Pharma”) and its wholly-owned subsidiary Symplmed Technologies, LLC (“Symplmed Tech”, and together with Symplmed Pharma, each as “Seller” and together the “Sellers”) pursuant to which we purchased from the Sellers, for an aggregate purchase price of $75,000 in cash, certain specified assets of the Sellers relating to the Sellers’ patented technology platform known as DyrctAxess that offers enhanced efficiency, control and information to empower patients, physicians and manufacturers to help achieve optimal care. The parties entered into the Purchase Agreement in furtherance of the obligations of Symplmed Pharma pursuant to that certain Asset Purchase Agreement dated as of June 5, 2017 between the Company and Symplmed Pharma pursuant to which, among other things, the Company acquired the assets of Symplmed Pharma relating to Prestalia.
Reverse Stock Split
On August 1, 2017, we filed a Certificate of Amendment of our Amended and Restated Certificate of Incorporation to effect a one-for-ten reverse split of our issued and outstanding shares of common stock. Our common stock commenced trading on the OTCQB tier of the OTC Markets on a split-adjusted basis on Thursday, August 3, 2017. There was no change to the authorized shares of our common stock as a result of the reverse split. No fractional shares were issued in connection with the reverse split; any fraction of a share of common stock that would otherwise have resulted from the reverse split was rounded up to the nearest whole share of common stock.
Amendment to Agreement with Windlas Healthcare Private Limited
On August 17, 2017, we entered into an amendment (the “Amendment”) of that certain Pharmaceutical Development Agreement dated as of March 30, 2017 by and between Windlas Healthcare Private Limited (“Windlas”) and our company (the “Development Agreement”), relating to the development by Windlas of certain pharmaceutical products to be used for conducting clinical trials or for regulatory submissions, as more fully described therein. Pursuant to the Amendment, we and Windlas agreed to amend the Development Agreement to reflect our agreement to issue to Windlas, and Windlas’ agreement to accept from us, in lieu of cash payments with respect to forty percent (40%) of the total amount reflected on invoices sent from time to time by Windlas to us, shares of our common stock having an aggregate value equal to forty percent (40%) of such invoiced amount (with the remaining portion of the invoiced amount being paid in cash). The maximum value of common stock that may be issued to Windlas pursuant to the Development Agreement (as modified by the Amendment) is $2 million. The parties also agreed that the foregoing payment arrangement would apply to any Contract Manufacturing and Supply Agreement (or similar agreement) relating to the manufacturing of commercial batches of the products covered by the Development Agreement that may be entered into between the parties.
Sale of Smarticles Assets
On September 8, 2017, we entered into an Intellectual Property Purchase Agreement (the “IP Purchase Agreement”) with Novosom Verwaltungs GmbH (“Novosom”) pursuant to which we sold to Novosom substantially all of our intellectual property estate relating to our Smarticles delivery technology (the “Smarticles IP”). We previously acquired such Smarticles IP from Novosom pursuant to that certain Asset Purchase Agreement dated July 27, 2010 between us and Novosom (the “Original Purchase Agreement”). Following the date of the Original Purchase Agreement, we entered into certain agreements with third parties pursuant to which we provided to such third parties certain licenses and rights with respect to the Smarticles IP (the “License Agreements”).
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As per the IP Purchase Agreement, Novosom paid to us $1.00 in cash, and thereafter we shall no longer be responsible for the ongoing costs of maintaining the Smarticles IP. In addition, the parties agreed that we would retain rights to any future payments that may be due to us from licensees pursuant to the License Agreements, including milestone and royalty payments, if any, and Novosom agreed to relinquish any rights that it may have under the Original Purchase Agreement to any portion of such payments.
Appointment of Executive Officers
On October 2, 2017, we entered into an Offer Letter with Amit Shah pursuant to which Mr. Shah shall serve as our Chief Financial Officer, and on October 12, 2017, we entered into an Offer Letter with Peter D. Weinstein, Ph.D., J.D. pursuant to which Dr. Weinstein shall serve as our Chief Legal Officer, in each case effective immediately. We agreed to pay a base salary of $120,000 per year to Mr. Shah and a base salary of $150,000 per year to Dr. Weinstein. It is anticipated that each of Mr. Shah and Dr. Weinstein will devote approximately 50% of his business time to the performance of his duties for the Company. Each such officer shall be shall be entitled to receive a discretionary bonus as determined by our Board of Directors in an amount up to 40% of such officer’s base salary. Our obligations to make the foregoing payments shall not become effective unless and until the closing of a single capital raising transaction involving the issuance by us of our equity (or equity-linked) securities yielding aggregate gross proceeds to us of not less than $5 million on or prior to December 31, 2017. We also granted to each such officer options to purchase up to 60,000 shares of our common stock at an exercise price of $2.70 per share (with respect to Mr. Shah) and $2.40 per share (with respect to Dr. Weinstein) under our 2014 Long-Term Incentive Plan, with all of such options vesting and becoming exercisable on the one-year anniversary of the grant date.
Results of Operations
Comparison of the Three Months Ended September 30, 2017 to the Three Months Ended September 30, 2017
Our loss before income taxes for the three months ended September 30, 2017 is summarized as follows in comparison to the three months ended September 30, 2016. As a result of the November 2016 Merger with IThena, the results of operations for the three months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended September 30, 2016 include only the results of IThena.
Three Months Ended | ||||||||
September 30, 2017 | September 30, 2016 | |||||||
Revenues | $ | - | $ | - | ||||
Research and development | 232,896 | 50,683 | ||||||
General and administrative expenses | 680,063 | 47,065 | ||||||
Amortization | 123,038 | - | ||||||
Other income (expense), net | 63,813 | (378 | ) | |||||
Loss before provision for income taxes | $ | (972,184 | ) | $ | (98,126 | ) |
Revenues
We had no revenues in the three months ended September 30, 2017 or 2016. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.
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Expenses
Our expenses for the three months ended September 30, 2017 are summarized as follows in comparison to our expenses for the three months ended September 30, 2016. As stated above, as a result of the November 2016 Merger with IThena, the results of operations for the three months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended September 30, 2016 include only the results of IThena:
Research and Development
Research and development (“R&D”) expense increased by $182,213, as compared to the three months ended September 30, 2016, primarily due to costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $96,151, on a non-cash basis, through the issuance of warrants valued at $96,151. Other R&D expenses consist of costs of sublicensing fees, clinical development, pre-clinical studies, consulting, other outside services, and other costs.
General and Administrative
General and administrative (“G&A”) expense increased by $632,998 for the three months ended September 30, 2107, as compared to the three months ended September 30, 2016, primarily due to personnel costs of $192,676 and costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $46,859, on a non-cash basis, through the issuance of warrants valued at $46,859. Other G&A expenses consisted of legal costs of approximately $176,000, accounting and auditing fees of approximately $50,000, approximately $56,000 for board member fees and approximately $37,000 for insurance costs. No similar expenses were recorded during the three months ended September 30, 2016.
Amortization Expense
Amortization expenses relates to amortization of intangible assets acquired in the November 15, 2016 merger and the asset purchases on June 5, 2017 and July 21, 2017, with a combined estimated fair value of $3,056,066.
Other Income (Expense)
Three Months Ended | ||||||||
September 30, 2017 | September 30, 2016 | |||||||
Interest expense | $ | (24,301 | ) | $ | (378 | ) | ||
Change in fair value liability of warrants | 7,442 | - | ||||||
Change in fair value of derivative liability | 80,672 | - | ||||||
Total other expense, net | $ | 63,813 | $ | (378 | ) |
Total net other expense for the three months ended September 30, 2017 increased $64,191 compared to the three months ended September 30, 2016. The increase is primarily attributable to a decrease in the estimated fair value of price adjustable warrants and the derivative liability of approximately $7,000 and $81,000, respectively, partially offset by an increase in interest expense of $24,000 on notes payable assumed in the Merger.
The fair value liability is revalued each balance sheet date utilizing probability-weighted Black-Scholes computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively.
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Comparison of the Nine Months Ended September 30, 2017 to the Nine Months Ended September 30, 2016
As a result of the Merger with IThena, the results of operations for the nine months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the nine months ended September 30, 2016 include only the expenses of IThena. Our loss before income taxes for the nine months ended September 30, 2017 is summarized as follows in comparison to the nine months ended September 30, 2016:
Nine Months Ended | ||||||||
September 30, 2017 | September 30, 2016 | |||||||
Revenues | $ | - | $ | - | ||||
Research and development | 746,221 | 107,910 | ||||||
General and administrative expenses | 1,878,301 | 232,469 | ||||||
Amortization | 327,642 | - | ||||||
Other income (expense), net | (273,191 | ) | (378 | ) | ||||
Loss before provision for income taxes | $ | (3,225,355 | ) | $ | (340,757 | ) |
Revenues
We had no in revenues in the nine months ended September 30, 2017 or 2016. The majority of our licensing deals provide for clinical and regulatory milestones, so significant revenues could result from the existing licenses, but are uncertain as to timing or probability. We will continue to seek research and development collaborations as well as licensing transactions to fund business operations.
Expenses
Our expenses for the nine months ended September 30, 2017 are summarized as follows in comparison to our expenses for the nine months ended September 30, 2016. As a result of the November 2016 Merger with IThena, the results of operations for the three months ended September 30, 2017 include the operating expenses of Marina and IThena while the results for the three months ended September 30, 2016 include only the results of IThena.
Research and Development
Research and development (“R&D”) expense increased by $638,311, as compared to the nine months ended September 30, 2016, primarily due to costs related to the MSA with Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $245,255 and, on a non-cash basis, through the issuance of warrants valued at $245,255. Other R&D expenses consist of costs of sublicensing fees, clinical development, pre-clinical studies, consulting, other outside services, and other costs.
General and Administrative
General and administrative (“G&A”) expense increased by $1,645,832 for the nine months ended September 30, 2107, as compared to the nine months ended September 30, 2016, primarily due to personnel costs and costs related to the MSA with Autotelic Inc., where the Company pays Autotelic Inc., where the Company pays cash to Autotelic Inc. for their services totaling $141,699 and, on a non-cash basis, through the issuance of warrants valued at $141,699. Other G&A expenses consisted of legal costs of approximately $540,000, accounting and auditing fees of approximately $194,000, approximately $169,000 for board member fees and approximately $97,000 for insurance costs. No similar expenses were recorded during the nine months ended September 30, 2016.
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Amortization Expense
Amortization expenses relates to amortization of intangible assets acquired in the Merger and the asset purchases on June 5, 2017 and July 21, 2017, with a combined estimated fair value of $3,056,066.
Other Income (Expense)
Nine Months Ended | ||||||||
September 30,2017 | September 30, 2016 | |||||||
Interest expense | $ | (51,575 | ) | $ | (378 | ) | ||
Change in fair value liability of warrants | (106,345 | ) | - | |||||
Change in fair value of derivative liability | (115,271 | ) | - | |||||
Total other expense, net | $ | (273,191 | ) | $ | (378 | ) |
Total net other expense for the nine months ended September 30, 2017 increased $272,813 compared to the nine months ended September 30, 2016. The increase is primarily attributable to an increase in the estimated fair value of price adjustable warrants and derivative liability and interest expense on notes payable acquired in the Merger.
The fair value liability is revalued each balance sheet date utilizing probability-weighted Black-Scholes computations, with the decrease or increase in fair value being reported in the statement of operations as other income or expense, respectively.
Liquidity & Capital Resources
Working Capital Deficiency
September 30, 2017 | December 31, 2016 | |||||||
Current assets | $ | 63,307 | $ | 316,480 | ||||
Current liabilities | (4,614,514 | ) | (2,967,669 | ) | ||||
Working capital deficiency | $ | (4,551,207 | ) | $ | (2,651,189 | ) |
Current assets decreased by $253,173, which was attributable to a decrease in cash of $96,671 and a decrease in prepaid expenses of $156,502.
Current liabilities increased by $1,646,845, which was primarily attributable to an increase of accounts payable of $364,247, an increase of $299,166 in amounts due related parties, and an increase of $715,353 in convertible notes to related and unrelated parties.
Cash Flows
Nine Months Ended | ||||||||
September 30, 2017 | September 30, 2016 | |||||||
Net cash used in operating activities | $ | (923,202 | ) | $ | (296,143 | ) | ||
Net cash used in investing activities | (375,000 | ) | - | |||||
Net cash provided by financing activities | 1,201,531 | 50,000 | ||||||
Increase (decrease) in cash and cash equivalents | $ | (96,671 | ) | $ | (246,143 | ) |
The increase in net cash used in operating activities during the nine months ended September 30, 2017, compared to 2016, was mainly due to increased operating expenses subsequent to the Merger, offset by non-cash stock compensation of $272,000, amortization of intangibles of $328,000, an increase in accounts payable of $355,000, an increase in accrued expenses of $639,000 and an increase in amounts due to related party of $353,000.
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The Company used cash of $300,000 in investing activities for payments towards the July 21, 2017 Prestalia acquisition and $75,000 towards the DyrctAxess acquisition during the nine months ended September 30, 2017. This investment was made to transform the Company to be a commercial stage company from a development stage company.
The $1,151,531 increase in net cash provided by financing activities during the nine months ended September 30, 2017, compared to 2016, is primarily attributable to proceeds of $250,000 from the sale of stock, $380,888 from additional borrowings on related party notes and convertible notes, $400,000 from the issuance of convertible notes, and $170,643 received from the conversion of warrants to common stock.
We will need to raise additional operating capital in calendar year 2017 in order to maintain our operations and to realize our business plan. Without additional sources of cash and/or the deferral, reduction, or elimination of significant planned expenditures, we may not have the cash resources to continue as a going concern thereafter.
Going Concern
The condensed consolidated financial statements contained in this report have been prepared assuming that the Company will continue as a going concern. We have an accumulated deficit for the period from inception through September 30, 2017 in excess of $5 million, as well as negative cash flows from operating activities. We had obtained a line of credit from Autotelic Inc. of $500,000, of which we have utilized $92,590. As such, we currently have approximately $407,000 of available funds under our line of credit with Autotelic Inc. that is being used to maintain operations. We believe that this available cash is sufficient to fund our operations through December 31, 2017. These factors raise substantial doubt about our ability to continue as a going concern. Management is in the process of evaluating various financing alternatives for operations, as we will need to finance future research and development and operational activities and general and administrative expenses through fund raising in the public or private debt and equity markets and strategic transactions.
The interim condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability. If we raise additional funds through the issuance of equity or equity-linked securities, the percentage ownership of current shareholders could be reduced, and such securities might have rights, preferences or privileges senior to our common stock. Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, we may not be able to take advantage of prospective business endeavors or opportunities, which could significantly and materially restrict our future plans for developing our business and achieving commercial revenues. If we are unable to obtain the necessary capital when needed, we may have to cease operations.
During 2016 and 2017, we have funded our losses primarily through the sale of common stock and warrants, revenue provided from our license agreements, loans provided by Dr. Trieu and Autotelic Inc. pursuant to the Line Letters, the issuance of convertible notes and, to a lesser extent, equipment financing facilities and secured loans. During the nine months ended September 30, 2017, we raised $250,000 from the private placement of our equity securities, raised $400,000 from the issuance of convertible notes, received $170,643 from the conversion of warrants to common stock, and borrowed $380,888 under the Line Letter from Dr. Trieu. In addition, in April 2017, we entered into an additional credit agreement with Autotelic Inc., pursuant to which Autotelic Inc. offered to the Company an unsecured line of credit in an amount not to exceed $500,000, to be used for current operating expenses of the Company. We have utilized $92,590 and have approximately $407,000 available under the Line Letter with Autotelic Inc. We believe that the cash available to us under this Line Letter will be sufficient to fund our operations through December 31, 2017.
Future Financing
We will require additional funds to implement the growth strategy for our business. As mentioned above, we have, in the past, raised additional capital to both supplement our commercialization, clinical development and operational expenses. We will need to raise additional funds required through equity financing, debt financing, strategic alliances or other sources, which may result in further dilution in the equity ownership of our shares. There can be no assurance that additional financing will be available when needed or, if available, that it can be obtained on commercially reasonable terms. If we will not be able to obtain the additional financing on a timely basis as required, or generate significant material revenues from operations, we will not be able to meet our other obligations as they become due and will be forced to scale down or perhaps even cease our operations.
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Off-Balance Sheet Arrangements
As of September 30, 2017, we did not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in the notes to our financial statements included herein for the period ended September 30, 2017 and in the notes to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016.
New and Recently Adopted Accounting Pronouncements
Any new and recently adopted accounting pronouncements are more fully described in Note 1 to our financial statements included herein for the period ended September 30, 2017.
ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 4 CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our senior management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Management identified material weaknesses in internal control over financial reporting as described under the heading “Management Report on Internal Control” contained in Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “2016 Form 10-K”), which have not been fully remediated, and therefore our principal executive officer and our principal financial officer concluded that, as of September 30, 2017, our disclosure controls and procedures were not effective.
Internal Control Over Financial Reporting
Management has reported to the Board of Directors and the Audit Committee thereof material weaknesses described under the heading “Management Report on Internal Control” contained in Item 9A of the 2016 Form 10-K. The material weaknesses discussed therein have not been fully remediated. There have been no changes in our internal control over financial reporting or in other factors during the fiscal quarter ended September 30, 2017 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. To remediate the material weakness identified in our Form 10-K for the year ended December 31, 2016, we plan to hire additional experienced accounting and other personnel to assist with filings and financial record keeping, and to take additional steps to improve our financial reporting systems and enhance our existing policies, procedures and controls, as resources allow. In connection with such remediation efforts, in October 2017 we engaged Amit Shah to serve as our Chief Financial Officer.
Because of its inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
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The Company has been named on a complaint filed in New York State as a defendant in the matter entitled Vaya Pharma, Inc. v. Symplmed Technologies, Inc., Symplmed Pharmaceuticals, Inc., Erik Emerson and Marina Biotech, Inc. While this complaint has been filed in the Supreme Court of the State of New York, the Company has not been legally served. The complaint alleges, in relevant part, that: (i) the sale by Symplmed Pharmaceuticals, Inc. of its assets related to its Prestalia product, and the sale by Symplmed Technologies, Inc. of its assets related to its DyrctAxess platform, should be set aside pursuant to New York law as they were consummated without fair consideration to the sellers (the “Symplmed Defendants”), and thereby had the effect of fraudulently depriving the creditors of the Symplmed Defendants, including Vaya Pharma, Inc., of funds that could have been used to pay their debts; and (ii) the Company is liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant to the agreement the Company is only contractually responsible for liabilities that accrue after the parties entered into the agreement for Prestalia and any liabilities that existed prior to the agreement are contractually held by Symplmed. If and when the Company is legally served, it is the intention of the Company to dispute jurisdiction, the sufficiency of the pleading and the claims set forth in this complaint, and to defend this matter, vigorously. However, due to the inherent uncertainties of litigation, the ultimate outcome of this matter is uncertain. An unfavorable outcome could materially and adversely affect the business, financial condition and results of operations of the Company.
An investment in our common stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “Annual Report”), as filed with the SEC on March 31, 2017, in addition to other information contained in those documents and reports that we have filed with the SEC pursuant to the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, since the date of the filing of the Annual Report, including, without limitation, this Quarterly Report on Form 10-Q, in evaluating our company and its business before purchasing shares of our common stock. Our business, operating results and financial condition could be adversely affected due to any of those risks.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
In September 2017, we entered into an engagement letter with a financial advisor pursuant to which, among other things, we agreed to issue to such financial advisor, in partial consideration of the services to be rendered under the engagement letter, an aggregate of 500,058 shares of our common stock. The shares were issued in November 2017. The shares were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended.
During the fiscal quarter ended September 30, 2017 we issued 180,000 unregistered shares of common stock to the holders of our Series C Convertible Preferred Stock in connection with the conversion of 270 shares of our Series C Convertible Preferred Stock. These securities were issued in reliance on the exemption from registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Rule 506(b) of Regulation D promulgated thereunder.
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(1) Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and the omitted material has been filed separately with the SEC.
* Filed or furnished herewith.
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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.
MARINA BIOTECH, INC. | |
Date: November 13, 2017 | /s/ Joseph W. Ramelli |
Joseph W. Ramelli | |
Chief Executive Officer | |
(Principal Executive Officer) | |
Date: November 13, 2017 | /s/ Amit Shah |
Amit Shah | |
Chief Financial Officer | |
(Principal Financial Officer and Principal Accounting Officer) |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
LICENSE AGREEMENT
This LICENSE AGREEMENT (this “ Agreement ”) is made and entered into this 17 th day of July, 2017 (the “ Effective Date ”) by and between Marina Biotech, Inc. (formerly known as MDRNA, Inc.), a Delaware corporation (“ Marina ”), and Oncotelic, Inc., a Delaware corporation, (“ Oncotelic ”).
WHEREAS, Marina is the owner of NOV340 and other lipid nanoparticle delivery technologies collectively referred to as the SMARTICLES™ technology (as further defined below, the “ SMARTICLES™ Technology ”) and certain antisense nucleotides collectively referred to as Conformationally Restricted Nucleotides or “CRN” (the “ CRN Molecules ”); and
WHEREAS , Oncotelic desires to license the Marina Technology (as defined below) (i) to ascertain whether the Delivery Technologies (as defined below) can be utilized to develop products in the SMARTICLES™ Field (as defined below), (ii) whether the CRN Molecules can be developed into products targeting transforming growth factor beta (TGF-beta) and (iii), if so, to commercialize such products.
NOW THEREFORE, in consideration of the promises and of the mutual covenants and agreements contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties intend to be legally bound as follows:
1. | Definitions . For purposes of this Agreement, the following terms shall have the meanings set forth below: |
1.1 | “ Affiliates ” means, as to any party, any corporation or business entity controlled by, controlling, or under common control with such party. For this purpose, “control” shall mean direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock or income interest in such corporation or other business entity, or such other relationship as, in fact, constitutes actual control. |
1.2 | “ API ” means a CRN Molecule or other antisense nucleotide. To be clear, API is meant to include solely peptides, or proteins that are not restricted by the [***] Agreement. |
1.3 | “ Commercial Sale ” means, with respect to a Licensed Product in any jurisdiction in the Territory, a commercial transfer, lease or disposition for value of such Licensed Product in such jurisdiction to a third party in a bona fide arm’s length transaction after marketing approval from the relevant regulatory authority in such jurisdiction has been obtained. |
[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
1.4 | “ Conformationally Restricted Nucleotides ” means nucleotides the conformations of which are restricted through the use of Marina’s Technology. |
1.5 | “ Control ” or “ Controlled ” means, with respect to any know-how, patent rights or other intellectual property rights, that a party has the legal authority or right (whether by ownership, license or otherwise) to grant a license, sublicense, access or right to use (as applicable) under such know-how, patent rights, or other intellectual property rights, including to the other party on the terms and conditions set forth herein, as applicable, in each case without breaching the terms of any agreement with a third party. |
1.6 | “ CRN Field ” means the targeting of TGF-Beta in mammals (including humans) using Conformationally Restricted Nucleotides. |
1.7 | “ CRN Molecules ” means certain patented Conformationally Restricted Nucleotides that can be substituted within an RNA- or DNA-based oligonucleotide analog in which a chemical bridge connects the C2’ and C4’ carbons of ribose. The chemical bridge in the ribose of a CRN locks the ribose in a fixed conformation, which in turn restricts the flexibility of the nucleobase and phosphate group. |
1.8 | “ CRN Technology ” means all know-how and other information owned or Controlled by Marina relating specifically to the production or use of CRN Molecules. |
1.9 | “ Delivery Technologies ” means the SMARTICLES™ Technology and such other technologies as may be added to this Agreement by agreement of the parties hereto. |
1.10 | “ Field ” means the CRN Field and the SMARTICLES™ Field. |
1.11 | “ First Commercial Sale ” with respect a Licensed Product means the first Commercial Sale (without regard to approved indication) in any jurisdiction in the Territory in a bona fide arm’s length transaction after marketing approval from the relevant regulatory authority in such jurisdiction has been obtained. |
1.12 | “ IND ” means an ‘investigational new drug application’ as such term is used under the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, and all regulations promulgated thereunder, or any equivalent application to the relevant regulatory authority in any jurisdiction in the Territory other than the United States. |
1.13 | “ Licensed Product ” means, as the context may require, (a) a product incorporating CRN Molecules for use solely in the CRN Field and/or (b) a therapeutic, diagnostic, prophylactic and palliative product comprised of an API (other than a CRN Molecule) which is delivered to a cell of therapeutic interest or used for diagnostic, prophylactic and palliative purposes using the SMARTICLES™ Technology. For clarity, (i) Licensed Products which incorporate different APIs shall be considered different Licensed Products, and (ii) regardless of which Delivery Technology or combination thereof is used, Licensed Products which incorporate the same API even if approved for different uses or indications or in multiple jurisdictions or countries in the Territory, shall be considered the same Licensed Product. |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
1.14 | “ Marina Intellectual Property ” has the meaning set forth in Section 5.1. |
1.15 | “ Marina Know-How ” has the meaning set forth in Section 5.1. |
1.16 | “ Marina Patents ” means (i) the patents and patent applications identified in Part I of Schedule A (the “ Delivery Patents ”) and Part II of Schedule A (the “ CRN Patents ”) and, together with the Delivery Patents, (the “ Marina Patents” ), (ii) any other patents and patent applications owned or Controlled by Marina as of the Effective Date that have claims covering a Delivery Technology or a CRN Molecule, and (iii) any other patents and patent applications that are owned solely or Controlled by Marina at any time during the New Technology Period and that have claims covering a Delivery Technology or any modifications or improvements to any inventions and or technology that is the subject of the patents and patent applications described in clauses (i) and (ii) of this definition. For clarity, Marina Patents will include any such applications pending at any time during the New Technology Period (and patents issued in respect to such applications regardless of when issued), including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications. |
1.17 | “ Marina Technology ” has the meaning set forth in Section 5.1. |
1.18 | “ New Technology Period ” means the three (3) year period following the Effective Date except that the New Technology Period means the term of this Agreement in respect of (i) any Innovations developed by Oncotelic as contemplated by Section 5.1.1(ii) and Section 5.1.2 or (ii) any patents and patent applications that have claims covering any such Innovations. |
1.19 | “ [***] ” means [***], which has obtained certain expertise in developing and manufacturing delivery technologies and formulations using Delivery Technologies. |
1.20 | “ [***] Agreement ” means the License Agreement between [***] and Marina dated as of [***], as the same may be amended, modified or extended from time to time. |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
1.21 | “ SMARTICLES™ Field ” means all therapeutic, diagnostic, prophylactic and palliative uses in mammals (including humans). |
1.22 | “ SMARTICLES™ Technology ” means Marina’s NOV340 and other related lipid nanoparticle delivery technology and lipids owned or Controlled by Marina as of the Effective Date, or that comes to be owned or Controlled by Marina at any time during the New Technology Period, based on fully charge-reversible particles allowing delivery of active substance (siRNA, single-stranded oligonucleotides, etc.) inside a cell either by local or systemic administration. |
1.23 | “ Stock Purchase Agreement ” means that Stock Purchase Agreement entered into as of the Effective Date among Marina and those Purchasers named therein. |
1.24 | “ Territory ” means worldwide. |
1.25 | “ TGF-Beta ” means transforming growth factor beta, a group of structurally related cell regulatory peptides that control proliferation, differentiation and other functions in many cell types. |
2. | Grant of License . Subject to the terms of this Agreement, Marina hereby grants to Oncotelic (a) a [***], sublicensable through multiple tiers (subject to Section 7) license (the ““ SMARTICLES™ License ”) under the SMARTICLES™ Technology and the SMARTICLES™ Intellectual Property (i) to research, develop, make, have made, import, use, offer for sale or sell Licensed Products in the SMARTICLES™ Field in the Territory, and (b) an exclusive, sublicensable through multiple tiers (subject to Section 7) license (the “ CRN License ”) under the CRN Technology and the CRN Intellectual Property to research, develop, make, have made, import, use, offer for sale or sell Licensed Products that include CRN Molecules in the CRN Field in the Territory (clauses (a) and (b) collectively, the “ Agreed Purpose ”), all in accordance with the terms and conditions of this Agreement. |
2.1 | The parties acknowledge that Marina has previously granted an exclusive license under the Marina Patents and the Marina Technology for “all fields of use other than therapeutic, diagnostic, prophylactic and palliative uses in mammals (including humans) (the “ Prior Granted Fields ”). In the event that any right to practice the Marina Patents or the Marina Technology in the Prior Granted Fields reverts to Marina during the term of this Agreement (as defined in Section 15.1.1), Marina shall notify Oncotelic within thirty (30) days thereafter, which notice shall contain Marina’s offer to amend the definition of the SMARTICLES™ Field in this Agreement (without further consideration from Oncotelic) to include such reverted Prior Granted Field (the “ Reverted Field ”). Upon acceptance in writing by Oncotelic of such offer, the same rights previously granted to Oncotelic with regard to the original SMARTICLES™ Field shall be extended to the Reverted Field automatically, and without further action by the parties, provided that Oncotelic complies with all of the terms and conditions of this Agreement with respect to any Licensed Product made, used or sold in the Reverted Field. Oncotelic shall be responsible and shall reimburse Marina upon demand for all costs and expenses incurred by Marina to maintain such rights extended to the Reverted Field. | |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
2.2 | Oncotelic (or its sublicensees) shall be responsible at their own expense for manufacturing or having manufactured the Licensed Products, providing the staff, animals, tools and equipment, materials and laboratory space necessary to research, develop, and clinically evaluate Licensed Products (including reporting of the data generated from such evaluation procedures). |
2.3 | This Agreement does not preclude Marina from granting other licenses of the Marina Technology or the Marina Patents to third parties for manufacturing or any other purposes. |
2.4 | Each party acknowledges that the rights and licenses granted under this Article 2 and elsewhere in this Agreement are limited to the scope expressly granted. Accordingly, except for the rights and licenses expressly granted in this Agreement, neither party is granted any right or license under or to any technology, patents or other intellectual property rights of the other party, nor shall any such right or license be implied or imputed, by estoppel or otherwise. All rights with respect to the technology, patents or other intellectual property of a party that are not specifically granted herein are reserved to the owner thereof. |
3. | Technology Transfer; Evaluation of Delivery Technologies. |
3.1 | Oncotelic represents and warrants that it has the expertise necessary to appreciate the significance of all Marina Technology provided to it by Marina and to handle any related physical materials with care and without danger to Oncotelic, its employees, Marina or the public. Oncotelic acknowledges and agrees that it has requested and received from Marina all information and advice which it reasonably believes is necessary to ensure that it is capable of handling the physical materials in a safe and prudent manner. Oncotelic shall not expose to or use in humans any of the physical materials except as permitted by applicable law and Oncotelic will in any event conduct its activities with such physical materials in compliance with all applicable laws. |
3.2 | Marina will be responsible for making available to Oncotelic or (subject to Section 9.2) to [***] or other contract manufacturer identified to Marina, upon written request and without charge (except as set forth in Section 3.3), all Marina Know-How relevant to the Agreed Purpose. |
3.3 | Oncotelic shall use commercially reasonable efforts to determine whether it believes the Delivery Technologies may improve the delivery of APIs and to keep Marina reasonably informed regarding the progress of its evaluation program. No later than (i) any filing by Oncotelic or any of its sublicensees of an IND in respect of a Licensed Product or (ii) three (3) years following the Effective Date, whichever is earlier, Oncotelic shall provide written notice to Marina including a summary of the results of Oncotelic’s evaluation program and whether it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products (the “ Evaluation Notice ”). |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
4. | Representations and Warranties. |
4.1 | General Representations and Warranties . Each party hereby represents and warrants to the other party that such party: |
4.1.1 | is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated; |
4.1.2 | has the full corporate or organizational power and authority, and has obtained all approvals, permits and consents necessary, to enter into this Agreement and to perform its obligations hereunder; and |
4.1.3 | this Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms. |
4.2 | Marina . Marina hereby covenants, represents and warrants to Oncotelic that: |
4.2.1 | Marina is the owner of record of the Marina Technology and the Marina Intellectual Property, and Marina has all rights necessary to grant the rights and licenses under the Marina Technology and the Marina Intellectual Property which are granted to Oncotelic under this Agreement; |
4.2.2 | Marina knows of no reason why the Marina Patents should not be valid and enforceable, or why any pending patent applications within the Marina Patents should not, if resulting in issued Marina Patents, be valid and enforceable, and no third party has alleged in writing that any of the Marina Patents is invalid or unenforceable; |
4.2.3 | Marina is not bound by, and none of the Marina Intellectual Property is subject to, any contract that in any way limits or restricts the ability of Marina to use, exploit, assert, or enforce any such Marina Intellectual Property asset anywhere in the world; |
4.2.4 | Marina has not granted, and will not grant, any rights in the Delivery Technologies that are inconsistent with the licenses and rights granted to Oncotelic under this Agreement; |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
4.2.5 | the Marina Patents are not subject to any pending re-examination, opposition, interference or litigation proceedings; |
4.2.6 | no claims of infringement, misappropriation or other conflict with any intellectual property rights or other rights of any third party were pending in the twelve (12) months preceding the Effective Date, are pending or, to Marina’s knowledge, are threatened with respect to the Marina Technology or the Marina Intellectual Property; |
4.2.7 | Marina believes its commercial relationship with [***] is in good legal standing. [***] has not given Marina notice (written or oral) terminating, canceling, reducing the volume under, or renegotiating the pricing terms or any other material terms of any contract or relationship with Marina and Marina has no reason to believe that [***] intends to take any of such actions; and |
4.2.8 | Based on Marina’s preclinical studies and clinical experience disclosed to Marina by licensees through the Effective Date, Marina is not aware of any undesirable experiences associated with the use of a medical product in a patient or any other facts or circumstances, in each case related to or involving the use of a Delivery Technology, that could reasonably be expected to cause any regulatory agency or other governmental authority to question the suitability, safety, or efficacy of such Delivery Technology for delivery of therapeutics inside a cell or used for diagnostic, prophylactic and palliative purposes. |
5. | Intellectual Property. |
5.1 | Marina Intellectual Property . |
5.1.1 | As between the parties, Marina shall be the exclusive owner of, and shall have all right, title and interest in (a) all technology (including the Delivery Technologies and the CRN Technology), discoveries, innovations, or improvements, know-how, documentation, reports, information, records, processes, procedures, raw data, specimens and/or other work product owned or Controlled by Marina (all of the foregoing collectively, the “ Marina Know-How ”), which Marina Know-How either (i) predates the Effective Date or (ii), subject to Section 5.1.2, does not exist at the Effective Date, is developed by Oncotelic by reference to or in reliance on the Marina Know How, and is generally applicable to the manufacture or use of SMARTICLES™ or CRN Molecules or to the delivery using a Delivery Technology of both APIs and macromolecules other than APIs (all of the foregoing, including the Marina Know-How, collectively, the “ Marina Technology ”), and (b) all Marina Patents, and any other patents and other intellectual property rights related to or based solely upon the Marina Know-How (the Marina Technology and the Marina Patents, collectively, the “ Marina Intellectual Property ”). Except as provided herein, no license, express or implied, by estoppel or otherwise, to any Marina Technology or Marina Intellectual Property is granted herein. | |
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5.1.2 | If at any time Oncotelic determines that it may develop any technology, discoveries, innovations, or improvements (each, an “ Innovation ”) which would be considered Marina Technology under Section 5.1.1(ii), then Oncotelic shall promptly notify Marina in writing thereof, generally describing the anticipated Innovation and the development plan for realizing such Innovation and confirming Marina’s ownership rights to such Innovation pursuant to Section 5.1.1(ii). Oncotelic may also submit simultaneously a term sheet outlining the proposed terms for a license of such Innovation from Marina. Marina shall have the unrestricted right to use (and to license and sublicense), in the Territory each such Innovation outside the Field hereunder, and upon the termination of this Agreement Marina shall own all of the rights to practice each Innovation in the Territory. |
(a) Any such description and term sheet shall be deemed Confidential Information of Oncotelic hereunder unless and until the parties enter into a definitive license agreement with respect to such Innovation, in which case the treatment of such description and terms shall be addressed in such definitive agreement.
(b) If Oncotelic submits a proposed term sheet regarding an Innovation to Marina after the expiration of the New Technology Period, then within a reasonable time following receipt of such notice, the parties shall enter into negotiations regarding Oncotelic’s proposal. All such negotiations shall be conducted by the parties in good faith. If, despite such good faith negotiations, Marina and Oncotelic do not reach agreement on the terms of such an agreement within three (3) months (or such longer period as agreed by the parties in writing) from the notification in writing by Oncotelic to Marina, then Oncotelic may proceed with such Innovation at its own risk, with the understanding that it will have no right to practice such Innovation outside the Field without the written agreement of Marina and will be obligated under Section 5.3 to assign all of its right, title and interest in such Innovation to Marina; provided , that if, after such assignment, Marina offers licensing conditions for such Innovation to a Third Party for any country in the Territory that are, taken as a whole, financially and/or commercially materially more favorable than those that were last proposed by Oncotelic in writing in the parties’ negotiations, Marina shall propose those new terms in writing to Oncotelic, which shall have thirty (30) days after receipt of such new terms to exercise the right to negotiate in good faith and execute with Marina an agreement on the same terms and conditions as those offered by Marina to such Third Party. After expiration of such thirty (30) days, Marina shall be free to enter into an agreement with such Third Party on such terms.
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(c) Notwithstanding the foregoing, Marina shall have the sole and exclusive right to seek patent protection for each Innovation, and any patent application filed during the New Technology Period or issued patent claiming such Innovation shall constitute a Marina Patent covered by the license set forth herein. Oncotelic shall cooperate with all reasonable requests of Marina in furtherance of such patent application. Marina agrees that it will not license (or disclose any non-public information regarding) any Innovation to any Third Party seeking to utilize any Delivery Technology in conjunction with any gene-editing technology, provided , that Marina shall have no liability to Oncotelic if another licensee of a Delivery Technology, without any breach by Marina of the foregoing, independently develops (as evidenced by such licensee’s contemporaneous records) technology, discoveries, innovations, or improvements substantially similar to an Innovation.
5.2 | Oncotelic Intellectual Property . As between the parties, Oncotelic shall be the exclusive owner of and shall have all rights, title and interest in (a) all technology (including the Oncotelic Technology), discoveries, innovations, or improvements, know-how, documentation, reports, information, records, processes, procedures, raw data, specimens and/or other work product owned or Controlled by Oncotelic (all of the foregoing collectively, the “ Oncotelic Know-How ”) which Oncotelic Know-How either (i) predates the Effective Date or does not exist at the Effective Date and is independently generated by or on behalf of Oncotelic without reference to or in reliance on any Marina Technology, or (ii) does not exist at the Effective Date, is developed by either party by reference to or in reliance on any Marina Technology and is not an Innovation covered by Section 5.1.2 (all of the foregoing, including the Oncotelic Know-How, collectively, the “ Oncotelic Technology ”) and (b) all patent and other intellectual property rights related to or based solely upon Oncotelic Know-How (all of the foregoing collectively, the “ Oncotelic Intellectual Property ”). |
5.3 | Assignments of Intellectual Property Rights . To the extent any intellectual property rights in any technology do not vest by operation of law or otherwise in the correct party consistent with the parties’ intention reflected in Sections 5.1 and 5.1.2(b), each of Oncotelic or Marina, as the case may be, agrees to assign and does hereby assign to the other party all of its rights, title, and interest, including intellectual property rights, in any such technology that the other party is entitled to own pursuant to Sections 5.1 or 5.1.2(b), as the case may be. The assignee party under this Section 5.3 shall have the sole and exclusive right to file, prosecute, maintain and enforce all intellectual property rights in all such technology. The assigning party under this Section 5.3 shall provide reasonable assistance at no extra cost to the assignee party to carry out this provision. |
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5.4 | Maintenance of Patents. Marina agrees to use commercially reasonable efforts (a) to maintain each of the issued Marina Patents and (b) to pursue issuance of patents in respect of any patent applications included in the Marina Patents. If Marina determines to abandon or cease pursuing issuance of any Marina Patent in any particular jurisdiction, Marina will provide prior written notice to Oncotelic of such intention to abandon or decline responsibility not less than thirty (30) days prior to the last allowable date for filing or taking any other action required with respect to such Marina Patent. |
6. | Initial License Period . Notwithstanding Article 2 above, for a period commencing on the Effective Date and ending on the date that Oncotelic pays the Commercial License Fee (as defined in Section 8.2) (such period, the “ Initial License Period ”), Oncotelic and its sublicensees shall not sell or have sold any Licensed Product to any third parties for use in the Field anywhere in the Territory; provided , however , the prohibition in this Article 6 shall not restrict in any manner the purchase or sale of any quantities of Licensed Product intended for use in research and development activities, in clinical trials, in connection with regulatory submissions for marketing approvals, in compassionate use cases, or similar non-commercial activities. Additionally, during the Initial License Period, Oncotelic and its sublicensees shall not make any application for a patent or other intellectual property protection in any country of the world related to technology, discoveries, innovations, or improvements discovered or reduced to practice that refers to or relies on any Delivery Technology and that is specifically applicable to the delivery using a Delivery Technology of APIs, without prior notification to Marina. Oncotelic shall include in each sublicense entered into during the Initial License Period an express acknowledgement by such sublicensee that it is subject to the restrictions set forth in this Section and that Marina shall be deemed a third party beneficiary of such restrictions. Any breach of such restrictions by such sublicensee shall be deemed a breach of this Agreement by Oncotelic. |
7. | Sublicenses. The License includes the right to grant sublicenses within the scope thereof. Oncotelic and any sublicensee (with respect to any lower tier sublicense) shall include in any sublicense agreement with its sublicensees an explicit reference to this Agreement, provided , however , Oncotelic shall continue to be primarily liable for payment and performance of all of Oncotelic’s obligations due to Marina under this Agreement. All sublicense agreements with sublicensees shall be consistent with the terms and conditions hereunder. Oncotelic shall notify Marina in writing within thirty (30) days of any sublicense granted, including without limitation the identity of the sublicensee, the term, and the general scope of the rights granted. All such information regarding a sublicense shall be deemed Confidential Information of Oncotelic. |
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8. | Payments . In consideration of the execution by Marina of this Agreement, Oncotelic shall make the following payments to Marina: |
8.1 | Evaluations License Fee . Simultaneous with the execution and delivery of this Agreement, Oncotelic shall enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Oncotelic, pursuant to which Marina will sell to Oncotelic shares of the common stock of Marina for an aggregate purchase price of $250,000, with the purchase price for each share of Marina common stock being $0.45. |
8.2 | Commercial License Fee . Unless this Agreement is earlier terminated, within thirty (30) days following Oncotelic’s delivery of an Evaluation Notice (as defined in Section 3.3) advising that it intends to pursue, or cause to be pursued, further development and commercialization of Licensed Products, Oncotelic shall, in connection therewith (and as a condition thereto), enter into a Stock Purchase Agreement in form and substance reasonably acceptable to Marina and Oncotelic, pursuant to which Marina will sell to Oncotelic shares of the common stock of Marina for an aggregate purchase price of $500,000, with the purchase price for each share of Marina common stock being the greater of $0.45 or the volume weighted average price of the Marina common stock for the thirty (30) trading days immediately preceding the date on which Oncotelic delivers the Evaluation Notice to Marina. |
8.3 | For up to and including three Licensed Products achieving Commercial Sales in the amounts specified below, Oncotelic shall pay to Marina a milestone (collectively the “ Sales Milestones ”) of Ten Million Dollars ($10,000,000) upon reaching Commercial Sales in the Territory in any given twelve month period equal to or greater than [***] Dollars ($[***]) for a given Licensed Product and of Twenty Million Dollars ($20,000,000) upon reaching Commercial Sales in any given twelve month period equal to or greater than [***] Dollars ($[***]) for such Licensed Product, such payments to be made within thirty (30) days following the month in which such Commercial Sale targets are met. For clarity’s sake, the aggregate amount of Sales Milestones paid hereunder may not exceed in any event Ninety Million Dollars ($90,000,000). There is no milestone payments for any Licensed Products achieving Commercial Sales after the third such Licensed Product. |
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9. | Confidentiality. |
9.1 | Definition . “Confidential Information” as used in this Agreement will include all non-public oral and written information and material, in tangible or intangible form (including but not limited to Marina Intellectual Property and Oncotelic Intellectual Property) which one party furnishes (“ Disclosing Party ”), directly or indirectly, to the other party (“ Receiving Party ”). Confidential Information expressly does not include: |
(a) information that was already known to the Receiving Party without obligation of confidentiality prior to disclosure of it to the Receiving Party by the Disclosing Party;
(b) information that is disclosed to the Receiving Party without obligation or confidentiality by a third party who has the right to make such disclosure;
(c) information that is in the public domain or hereafter enters the public domain through no fault of the Receiving Party; and
(d) information that was independently developed by the Receiving Party without any reliance on Confidential Information of the Disclosing Party.
9.2 | Non-Disclosure . The Receiving Party shall (i) keep the Disclosing Party’s Confidential Information in strict confidence; (ii) protect it with the same degree of care as the Receiving Party treats its own confidential information, but with no less than reasonable care; (iii) not, without the prior written consent of the Disclosing Party, disclose or permit it to be disclosed to anyone other than (A) the Receiving Party’s actual or prospective sublicensees, directors, officers, employees, agents, independent contractors or consultants who have a legitimate need to know the Confidential Information in connection with the Agreed Purpose, or (B) regulatory authorities in connection with regulatory submissions or other communications related to any Licensed Product; and (iv) will not use and will not permit its sublicensees, directors, officers, employees, agents, independent contractors or consultants to use the Disclosing Party’s Confidential Information for any reason other than the Agreed Purpose. The Receiving Party shall only make disclosure to its actual or prospective sublicensees, directors, officers, employees, agents, independent contractors or consultants who are bound by the confidentiality obligations at least as restrictive as those set forth in this Agreement. |
9.3 | Compelled Disclosure . In the event the Receiving Party is required by any court or legislative or administrative body (by oral questions, interrogatories, requests for information or documents, subpoena, civil investigation demand or similar process) to disclose any Confidential Information of the Disclosing Party, the Receiving Party shall provide the Disclosing Party with prompt notice of such requirement in order to afford the Disclosing Party an opportunity to seek an appropriate protective order or to legally contest such disclosure. The Receiving Party shall cooperate, at the Disclosing Party’s expense, with all reasonable requests of the Disclosing Party for assistance in seeking such order or contesting such disclosure. However, if the Disclosing Party is unable to obtain or does not seek such protective order and the Receiving Party is, in the opinion of its counsel, compelled to disclose such Confidential Information under pain or liability for contempt or other censure or penalty, disclosure of such information may be made without liability. |
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9.4 | Return of Confidential Information . Upon demand by the Disclosing Party, the Receiving Party shall return and deliver all Confidential Information of the Disclosing Party which was disclosed to it, and the Receiving Party shall destroy all copies, summaries, compilations or analyses thereof, in whatever form maintained or derived and a senior officer of the Receiving Party shall, upon request, certify as to such return and destruction. Notwithstanding the foregoing, (a) during the term of this Agreement, Oncotelic and its sublicensees may retain any Marina Know-How licensed under Article 2, and (b) following any such demand, the Receiving Party (i) may retain one copy of the Confidential Information for legal purposes by the Receiving Party’s legal division, including for the purpose of certifying the scope and nature of the documents received under this Agreement, and (ii) will not be required to destroy any computer files stored securely by the Receiving Party that are created during automatic system back-up. |
9.5 | Publicity; Terms of Agreement . The parties shall treat the existence and material terms of this Agreement as Confidential Information and shall not disclose such Confidential Information to third parties without the prior written consent of the other party or except as provided in this Section 9.5. |
9.5.1 | The parties agree that upon execution of this Agreement or shortly thereafter, Marina may issue a press release substantially and materially in the form attached hereto as Exhibit B . Except for such press release or as otherwise required by applicable law or applicable stock exchange requirements, neither Marina nor Oncotelic shall issue or cause the publication of any other press release or public announcement with respect to the transactions contemplated by this Agreement without the express prior approval of the other party, which approval shall not be unreasonably withheld or delayed; provided that, each of Marina and Oncotelic may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the other party pursuant to this Section 9.5.1 and which do not reveal non-public information about the other party. With respect to complying with the disclosure requirements of the Securities and Exchange Commission or other regulatory agencies, in connection with any required filing of this Agreement with such agency, the parties shall consult with one another concerning which terms of this Agreement shall be requested to be redacted in any public disclosure of the Agreement by the agency, and each party shall seek confidential treatment by the agency in public disclosure of the Agreement by the agency for all sensitive commercial, financial and technical information. |
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9.5.2 | Each party may disclose Confidential Information with respect to the existence and material terms of this Agreement and the transactions contemplated by this Agreement (i) to Affiliates and potential commercial partners who need to know such information for the development, manufacture and commercialization of Licensed Products, (ii) to bankers, lawyers, accountants, agents or other third parties in connection with due diligence or similar investigations, and (iii) to potential third party investors in confidential financing documents or potential acquirers or merger partners in confidence pursuant to due diligence; provided in each case that any such party or person receiving such Confidential Information is bound by obligations of confidentiality and non-use at least as restrictive as those set forth herein. |
10. | Return of Property. |
10.1 | Return of Marina’s Property . Oncotelic acknowledges that Marina’s sole and exclusive property includes all materials and information provided by Marina to Oncotelic, whether or not constituting Marina Intellectual Property or Confidential Information and whether or not related to the Agreed Purpose. Oncotelic agrees to promptly deliver or destroy Marina’s property that is then in Oncotelic’s possession, including but not limited to, Marina Intellectual Property, upon the earlier of Marina’s request or the termination of this Agreement. Notwithstanding the foregoing, during the term of this Agreement, Oncotelic and its sublicensees may retain any Marina Know-How licensed under Article 2. Oncotelic shall not make or retain any copies of Marina Intellectual Property or any other materials supplied by Marina, except as provided in Section 9.4. |
10.2 | Return of Oncotelic’s Property . Marina acknowledges that Oncotelic’s sole and exclusive property includes all materials and information provided by Oncotelic to Marina, whether or not constituting Oncotelic Intellectual Property or Confidential Information of Oncotelic and whether or not related to the performance of the Agreed Purpose. Marina agrees to promptly deliver Oncotelic’s property that is then in Marina’s possession to Oncotelic, including but not limited to, Oncotelic Intellectual Property, upon the earlier of Oncotelic’s request or the termination of this Agreement. Marina shall not make or retain any copies of Oncotelic Intellectual Property or any other materials supplied by Oncotelic, except as provided in Section 9.4. |
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11. | Indemnification. |
11.1 | By Oncotelic. Oncotelic shall defend, indemnify, and hold harmless Marina, its Affiliates (other than Oncotelic) and their respective directors, officers, shareholders, employees and agents (“ Marina Indemnitees ”), from and against any and all liabilities, claims, damages, losses, penalties, fines, costs, expenses (including reasonable attorneys’ fees), judgments or settlements (collectively, “ Liabilities ”) arising from or occurring as a result of any investigation, claim, action, suit, or other proceeding by any Person other than the parties (each, a “ Third Party Claim ”) against a Marina Indemnitee, which Third Party Claim is due to or based upon: (a) any breach of a representation, warranty, covenant or agreement made or undertaken by Oncotelic under this Agreement; (b) any negligent or more culpable act of Oncotelic, or any of its Affiliates or sublicensees under this Agreement; or (c) the development, manufacture, use, offer for sale, sale, importation or marketing of any Licensed Product by Oncotelic, or any of its Affiliates or sublicensees. However, Oncotelic shall not indemnify or hold harmless any Marina Indemnitee from any Liabilities to the extent that such Liabilities were the direct result of the acts or omissions of a Marina Indemnitee, or any breach of any term or warranty of this Agreement by Marina. |
11.2 | By Marina . Marina shall defend, indemnify, and hold harmless Oncotelic, its Affiliates (other than Marina) and their respective directors, officers, shareholders, employees and agents (“ Oncotelic Indemnitees ”), from and against any and all Liabilities arising from or occurring as a result of a Third Party Claim against a Oncotelic Indemnitee, which Third Party Claim is due to or based upon: (a) any breach of a representation, warranty, covenant or agreement made or undertaken by Marina under this Agreement; (b) any negligent or more culpable act of Marina or its Affiliates under this Agreement, or (c) based on a claim that use of Marina Technology or Marina Intellectual Property in connection with the manufacture, use or sale of a Licensed Product infringes or misappropriates any third party intellectual property rights, except that Marina shall not have any liability to Oncotelic to the extent that the challenged use of Marina Technology or Marina Intellectual Property in combination with macromolecules other than APIs or other methods or technologies for producing macromolecules (including other gene-editing technologies) would not itself be infringing. However, Marina shall not indemnify or hold harmless any Oncotelic Indemnitee from any Liabilities to the extent that such Liabilities were the direct result of the acts or omissions of a Oncotelic Indemnitee or any breach of any term or warranty of this Agreement by Oncotelic. |
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11.3 | Indemnification Procedures . In the event an Indemnitee (either a Oncotelic Indemnitee or a Marina Indemnitee) intends to claim indemnification under this Article 11, such Indemnitee shall provide the indemnifying party with prompt notice of the Third Party Claim. The indemnifying party shall have the right to control, with counsel of its choice, the defense thereof or to settle any such Third Party Claim; provided, however, that the indemnifying party shall not enter into any settlement that admits fault, wrongdoing or damages or restricts the Indemnitee’s business in any way without the affected Indemnitee’s written consent, such consent not to be unreasonably withheld or delayed. The affected Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any Third Party Claim that has been assumed by the indemnifying party. The affected Indemnitee shall cooperate with all reasonable requests of the indemnifying party and its legal representatives in the investigation and defense of any Third Party Claim covered by this Article 11. An Indemnitee shall not, except at its own cost, voluntarily make any payment or incur any expense with respect to any claim or suit without the prior written consent of the indemnifying party, which such party shall not be required to give. |
12. | Use of Names . Nothing contained in this Agreement shall be construed as conferring any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, trade dress or other designation of either party hereto (including any contraction, abbreviation or simulation of any of the foregoing), save as expressly stated herein. Each party hereto agrees not to use or refer to this Agreement or any provision hereof in any promotional activity without the express written approval of the other party, such approval not to be unreasonably withheld, conditioned or delayed. |
13. | Warranty Disclaimer . EXCEPT AS EXPRESSLY SET FORTH HEREIN, (I) MARINA MAKES NO WARRANTIES WITH RESPECT TO THE MARINA TECHNOLOGY OR THE MARINA INTELLECTUAL PROPERTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND (II) THE MARINA TECHNOLOGY IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND AND USE BY ONCOTELIC OF THE MARINA TECHNOLOGY IS AT ONCOTELIC’S OWN RISK; AND (III) ONCOTELIC MAKES NO WARRANTIES WITH RESPECT TO THE ONCOTELIC TECHNOLOGY OR THE ONCOTELIC INTELLECTUAL PROPERTY, EITHER EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND (IV) THE ONCOTELIC TECHNOLOGY IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND AND USE BY MARINA OF THE ONCOTELIC TECHNOLOGY IS AT MARINA’S OWN RISK. |
14. | Limitation on Liability . EXCEPT FOR BREACHES OF A PARTY’S CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OR A PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF THIRD PARTY CLAIMS UNDER ARTICLE 11, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES, EVEN IF SUCH PARTY HAD NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. |
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15. | Term and Termination. |
15.1 | Term . |
15.1.1 | This Agreement shall commence on the Effective Date and shall continue, unless terminated earlier as provided in this Article 15, in full force and effect as to each Licensed Product on a country-by-country basis until the last to expire Marina Patent in such country covering such Licensed Product. Upon the expiration (but not the earlier termination) of this Agreement in a given country in accordance with this Section 15.1.1, the licenses and rights granted by Marina to Oncotelic under this Agreement will continue on a fully paid-up, royalty-free and irrevocable basis in such country. |
15.1.2 | Notwithstanding anything in this Agreement to the contrary, in the event that Oncotelic fails (i) to timely deliver the Evaluation Notice or (ii) to timely pay the Commercial License Fee, this Agreement shall automatically and without further action by Marina terminate in its entirety. |
15.2 | Termination |
15.2.1 | By Marina . In the event Oncotelic breaches this Agreement, Marina shall have the right to terminate this Agreement effective sixty (60) days following delivery of written notice to Oncotelic referencing this Section 15.2.1 and specifying the breach, if Oncotelic fails to cure such material breach within such sixty (60) day period; provided , that if Oncotelic advises Marina in writing within such sixty (60) day period that such breach cannot reasonably be cured within such sixty (60) day period, and if in the reasonable judgment of Marina, Oncotelic is diligently seeking to cure such breach during such sixty (60) day period, then such sixty (60) day period shall be extended an additional sixty (60) days for an aggregate of 120 days after written notice of termination, and if Oncotelic fails to cure such material breach by the end of such 120-day period this Agreement shall automatically and without further action by Marina terminate in its entirety. |
15.2.2 | By Oncotelic . Any provision herein notwithstanding, Oncotelic shall have the right to terminate this Agreement by giving Marina thirty (30) days prior written notice referencing this Section 15.2.2. |
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15.3 | Effect of Termination/Expiration . |
15.3.1 | Reversion of Rights . As of the effective date of a termination pursuant to Section 15.2 and except as provided in this Section 15.3, the rights and licenses granted by Marina to Oncotelic under Article 2 shall terminate and all rights in the Marina Technology and the Marina Intellectual Property shall revert to Marina. |
15.3.2 | No Release . Termination of this Agreement shall not release either party hereto from any liability which at the time of such termination has already accrued to the other party. |
15.3.3 | Stock on Hand . In the event this Agreement is terminated for any reason, Oncotelic shall deliver to Marina, as soon as practicable after termination, a report indicating the quantity and description of Licensed Products on hand, on order, or in the course of manufacture as of the date of expiration or termination. Marina shall have the right to conduct a physical inventory of Oncotelic’s premises (and those of its sublicensees) to ascertain or verify such final report. In the event Oncotelic or such sublicensee refuses to permit Marina to conduct such physical inventory, Marina shall retain all legal and equitable rights that it may have in the premises. If such termination occurs after payment of the Commercial License Fee, Oncotelic and its sublicensees shall have the right, for a period of six (6) months following termination, to sell or otherwise dispose of all such Licensed Products. |
15.3.4 | Return of Information. Oncotelic shall forthwith deliver to Marina (and, unless a sublicensee has entered agreements with Marina pursuant to Section 15.3.5, shall cause such sublicensee to deliver) (a) a right of reference to any regulatory filings made by Oncotelic (or such sublicensee) with respect to Licensed Products (provided that Marina shall reimburse Oncotelic or such sublicensee for any costs or expenses incurred to provide any such rights of reference) and (b) all reports, memoranda, drawings, data, flow sheets and other documents and all copies thereof which contain or describe any research performed utilizing the Marina Technology or containing any Confidential Information of Marina. |
15.3.5 | Rights of Sublicensees . If this Agreement terminates for any reason (a) prior to payment by Oncotelic of the Commercial License Fee, then all sublicenses granted by Oncotelic shall automatically terminate and (b) after payment by Oncotelic of the Commercial License Fee, then each of Oncotelic’s sublicensees will, from the effective date of such termination, be deemed to have become a direct licensee of Marina with respect to the rights originally sublicensed to the sublicensee by Oncotelic, and Marina agrees that it will confirm the foregoing in writing at the request and for the benefit of Oncotelic and/or the sublicensee; provided, that (i) such sublicensee is not in breach of its sublicense agreement, (ii) such sublicensee promptly agrees to comply with all of the terms of this Agreement to the extent applicable with respect to the rights originally sublicensed to it by Oncotelic, (iii) such sublicensee promptly agrees to pay directly to Marina such sublicensee’s payments under such sublicense to the extent applicable to the rights sublicensed to it by Oncotelic and (iv) Marina shall have no obligations under such sublicense that are different from or greater than its obligations to Oncotelic under this Agreement; provided , further, that any such sublicensee shall only be responsible for any payments that become due as a result solely of such sublicensee’s activities after the effective date of any such termination and such sublicensee will be credited for any license payments already paid prior to the effective date of any such termination as if such payment had been made by such sublicensee. |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
16. | Bankruptcy Code . All rights and licenses granted under this Agreement will be deemed licenses of rights to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code for purposes of Section 365(n) of the U.S. Bankruptcy Code and Oncotelic will retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. In addition, in the event that during the term of this Agreement, Marina files a voluntary petition in bankruptcy, is adjudicated a bankrupt, makes a general assignment for the benefit of creditors, admits in writing that it is insolvent or fails to discharge within sixty (60) days an involuntary petition in bankruptcy filed against it, then (i) Oncotelic will have a right of access to the information, patents and technology of Marina licensed under this Agreement consistent with the terms of this Agreement for purposes of 11 U.S.C. Section 365(n), (ii) Oncotelic as a licensee of intellectual property under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code, subject to its ongoing payment obligations as provided in U.S.C. 365(n) and (iii) Oncotelic shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such information, intellectual property and all embodiments of such intellectual property, which, if not already in Oncotelic’s possession, shall be promptly delivered to Oncotelic (A) upon any such commencement of a bankruptcy proceeding upon Oncotelic’s written request therefor unless Marina continues to perform all of its obligations under this Agreement, or (B) if not delivered under clause (A) above, following the rejection of this Agreement by or on behalf of Marina, upon written request therefor by Oncotelic. |
17. | Miscellaneous. |
17.1 | Force Majeure . Neither Oncotelic nor Marina shall be responsible for failure or delay in performance of its obligations related to the Agreed Purpose due to causes beyond its reasonable control, including but not limited to, acts of God, governmental actions, fire, earthquake, labor difficulty, shortages, civil disturbances, transportation problems, interruptions of power or communications, failure of suppliers or subcontractors, or natural disasters. |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
17.2 | Relationship of the Parties . The relationship of the parties is that of independent contractors, and nothing herein shall be construed as establishing one party, its Affiliates, or any of its or their employees as the agent, legal representative, partner, employee, or servant of the other party or its Affiliates. Neither party shall have any right, power or authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other party or its Affiliates. |
17.3 | Waiver and Severability . No waiver by either party of any breach of any provision hereof shall constitute a waiver of any other breach of that or any other provision hereof. If any part, term or provision herein is determined to be invalid or unenforceable, the remainder of the terms and conditions herein shall not be affected, and shall otherwise remain in full force and effect. |
17.4 | Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflicts of law rules, provided that those matters pertaining to the validity or enforceability of patent rights shall be interpreted and enforced in accordance with the laws of the territory in which such patent rights exist. |
17.5 | Assignment . Neither party shall assign this Agreement without the prior written consent of the other party. Notwithstanding the foregoing, either party may assign or transfer this Agreement to an Affiliate or to a successor to the party’s business by merger, consolidation, or similar business combination transaction, sale of stock, or sale of substantially all assets to which this Agreement relates, provided that, in the case of any assignment or transfer of this Agreement to an Affiliate, the assigning or transferring party shall remain fully liable for all of its obligations hereunder. As a condition to the effectiveness of any permitted assignment hereunder, any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the non-assigning party, expressly assume performance of all rights and/or obligations of the assigning party under this Agreement. This Agreement shall be binding upon and shall inure to the benefit of each party’s permitted successors-in-interest and permitted assigns. Any assignment or attempted assignment by either party in violation of the terms of this Section 17.5 shall be null and void and of no legal effect. |
17.6 | Entire Agreement . This Agreement constitutes the entire, full, and complete agreement of the parties concerning the subject matter hereof, and supersedes all prior agreements, negotiations, representations, and discussions, written or oral, express or implied, between the parties in relation thereto. This Agreement may only be amended or modified by a writing signed by both parties hereto. |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
17.7 | Notices . Any consent, notice or report required or permitted to be given or made under this Agreement by one of the parties to the other shall be in writing, (a) delivered personally, (b) sent by registered or certified mail, return receipt requested, or (c) sent by reputable overnight business courier, in each case to such other party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the addressor, and shall be effective upon receipt by the addressee: |
If to Marina: | Marina Biotech, Inc. | |
17870 Castleton Street | ||
Suite 250 | ||
City of Industry, CA 91748 | ||
Attention: Chief Executive Officer | ||
With a copy to: | Pryor Cashman LLP | |
7 Times Square | ||
New York, NY 10036 | ||
Attention: Lawrence Remmel, Esq. | ||
If to Oncotelic: | Oncotelic Inc. | |
29397 Agoura Rd., Suite 107 | ||
Agoura Hills, CA 91301 | ||
Attention: Chief Executive Officer | ||
With a copy to: | _________________________ | |
_________________________ | ||
_________________________ | ||
_________________________ |
[signature page follows]
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
[Signature Page to License Agreement]
IN WITNESS WHEREOF , the parties have caused this License Agreement to be executed as of the date first written above.
MARINA BIOTECH, INC. | ONCOTELIC, INC. | |||
By: | /s/ Joseph W. Ramelli | By: | /s/ Larn Hwang | |
Joseph W. Ramelli, CEO | Larn Hwang, CSO | |||
Date: | July 17, 2017 | Date: | July 18, 2017 |
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[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Exhibit A
Marina Patents
Part I Patents Covering Delivery Technologies —
No. | Serial No. | Title | Country | Status | ||||
1. | International Application No. PCT/EP2006/009013 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | WIPO | National Stage | ||||
2. | Australia Patent No.2006291429 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | Australia | Issued | ||||
3. | Canada Patent No. 2,622,584 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | Canada | Issued | ||||
4. | Canada Appl. No. 2,889,540 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | Canada | Pending | ||||
5. | Japan Patent No. 5,571,308 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | Japan | Issued | ||||
6. | European Patent Application No. 06254821.9 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | European Pat Office | Pending | ||||
7. | US Patent No. 9,066,867 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | U.S. | Issued | ||||
8. | US Application No. 14/538,809 | IMPROVEMENTS IN OR RELATING TO AMPHOTERIC LIPOSOMES | U.S. | Pending | ||||
9. | International Application No. PCT/EP2002/001880 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | WIPO | National Stage | ||||
10. | European Patent No. 1,363,601 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | European Pat Office | Issued | ||||
11. | EP 1,363,601 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | Austria | Issued | ||||
12. | EP 1,363,601 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | Belgium | Issued | ||||
13. | EP 1,363,601 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | Switzerland | Issued | ||||
14. | DE 50210271.3 | AMPHOTERIC LIPOSOMES AND THE USE THEREOF | Germany | Issued |
[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Part II – Patents Covering CRN Technology and CRN Molecules
No. | Serial No. | Title | Country | Status | ||||
1. | International Application No. PCT/US2011/033980 | NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS AND USES THEREOF (CRN) | WIPO | National Stage | ||||
2. | European Application No. 11717901.0 | NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS AND USES THEREOF (CRN) | European Pat Office | Pending | ||||
3. | US Application No. 14/623,498 | NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTROICTED MONOMERS AND USES THEREOF (CRN) | U.S. | Pending | ||||
4. | International Application No. PCT/US2012/054308 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | WIPO | National Stage | ||||
5. | Australia Application No. 2012304358 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | Australia | Allowed | ||||
6. | Singapore Patent No. 11201401314P | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | Singapore | Issued | ||||
7. | US Application No. 14/343,607 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | U.S. | Allowed | ||||
8. | European Application No. 12758731.9 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | European Pat Office | Pending | ||||
9. | Canada Application No. 2,863,253 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | Canada | Pending | ||||
10. | China Application No. 201280054375.5 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | China | Pending | ||||
11. | Hong Kong Application No. 14112251.3 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | Hong Kong | Pending | ||||
12. | Korea Application No. 10-2014-7009037 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | Republic of Korea | Pending | ||||
13. | India Application No. 710-KOLNP/2014 | SYNTHESIS AND USES OF NUCLEIC ACID COMPOUNDS WITH CONFORMATIONALLY RESTRICTED MONOMERS (CRN) | India | Pending | ||||
14. | US Patent No. 6,083,482 | CONFORMATIONALLY LOCKED NUCLEOSIDES AND OLIGONUCLEOTIDES (CRN) | U.S. | Issued |
[CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
EXHIBIT B
Press Release
News Release
Marina Biotech Announces a License Agreement to SMARTICLES and CRN Platforms for Antisense DNA therapeutics
City of Industry, CA July [ ], 2017 – Marina Biotech, Inc. (OTCQB: MRNA) a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer, today announced that they have entered into a license agreement with Oncotelic, Inc. regarding the Company’s SMARTICLES™ platform for the delivery of antisense DNA therapeutics. This represents the first time that the Company’s SMARTICLES™ technologies have been licensed in connection with delivery of Marina’s proprietary Conformationally Restricted Nucleotides and other antisense nucleotides. Under terms of the agreement, Oncotelic will invest $250,000 in Marina at a share price of $0.51. In addition, Marina may receive in certain circumstances a commercial license fee consummated by the sale to Oncotelic of shares of the common stock of Marina for an aggregate purchase price of $500,000, with the purchase price for each share of Marina common stock being the greater of $0.51 or the volume weighted average price of the Marina common stock at the time of purchase, and as well sales milestones, which sales milestones shall not exceed in any event Ninety Million Dollars ($90,000,000). Further details of the agreement were not disclosed.
“With the execution of this license agreement, the company extends its runway and enters into new areas medicine,” stated Joseph W. Ramelli, CEO of Marina Biotech. “We are now beginning to see our delivery technologies used with various types of molecules and entities. We hope our delivery technologies continue to provide new therapeutic opportunities to the patient community.”
About Marina Biotech, Inc.
Marina Biotech’s focus is to treat the intersection of arthritis, pain, hypertension, and oncology diseases using combination therapies of already approved drugs. The company is developing and commercializing late stage, non-addictive pain therapeutics. The company’s ‘next-generation of celecoxib,’ including IT-102 and IT-103, are designed to control the dangerous side-effect of edema that prohibits the drug from being prescribed at higher doses. These have the potential of replacing opioids and combatting the opioid epidemic. Additionally we are developing therapeutic microbiome using the only orally bioavailable siRNAs platform against FAP and IBD. Additional information about Marina Biotech is available at http://www.marinabio.com .
Marina Biotech Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to successfully integrate its business operations with those of IthenaPharma; (ii) the ability of Marina Biotech to obtain funding to support its clinical development; (iii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iv) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (v) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (vi) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.
MARINA BIOTECH, INC.
17870 Castleton Street, Suite 250
City of Industry, California 91748
August 3, 2017
EOS Holdings LLC
2560 Highvale Drive
Las Vegas, NV 89134
Peak Capital Advisory Limited
Flat F, 9/F, Tower 1
Harbour Green
8 Sham Mong Road
Kowloon, Hong Kong
Dear Sir / Madam:
Reference is hereby made to that certain letter agreement dated July 3, 2017 (the “ Letter Agreement ”) between and among Marina Biotech, Inc. (the “ Company ”), EOS Holdings LLC (“ EOS ”) and Peak Capital Advisory Limited (“ Peak ” and, together with EOS, the “ Purchasers ”). Capitalized terms used but not defined herein shall have the respective meanings ascribed to such terms in the Letter Agreement (or the agreements and instruments that were referenced therein or amended thereby, as applicable).
By executing below, the Company and the undersigned Purchasers hereby agree that, in the event that: (i) the Notes that are held by the Purchasers are to convert into New Securities of the Company as a result of the closing of the offering contemplated by the Registration Statement on Form S-1 that the Company filed with the U.S. Securities and Exchange Commission (the “ Commission ”) on June 26, 2017 (No. 333-218982); and (ii) the Company is advised by the Commission that it is unable to register the issuance of such New Securities on such registration statement, then the Company shall file with the Commission, within fifteen (15) days following the closing of such offering, a registration statement on Form S-1 (or such other form as the Company is then eligible to use for such registration) (the “ Resale Registration Statement ”) to register the resale of the New Securities that are issuable to the Purchasers as a result of the conversion of the Notes in such offering (or, with respect to any New Securities that are exercisable or convertible for Common Stock, the shares of Common Stock issuable to the Purchasers upon the exercise or conversion of such New Securities), and shall use its commercially reasonable efforts to cause the Resale Registration Statement to be declared effective by the Commission within sixty (60) days of the filing thereof (the “ Effectiveness Deadline ”); provided , that if the Resale Registration Statement is not declared effective by the Commission on or before the Effectiveness Deadline, then, as full relief for the damages to the Purchasers by reason thereof, the Company shall pay to each Purchaser, on a pro rata basis, for every thirty (30) day period following the Effectiveness Deadline and prior to the date on which the Resale Registration Statement is declared effective by the Commission (such date, the “ Effectiveness Date ”), an amount in cash equal to two percent (2%) of the unpaid principal amount of the Notes and accrued and unpaid interest thereon as of the date of their conversion (such payments, “ Registration Delay Payments ”). Registration Delay Payments shall cease to accrue on the Effectiveness Date, and shall be made on a monthly basis beginning on the earlier of one month following the Effectiveness Deadline or the Effectiveness Date. No Registration Delay Payments shall be owed with respect to any period during which all of the New Securities to be registered on the Resale Registration Statement may be sold by the Purchasers without restriction under Ruler 144 promulgated under the Securities Act of 1933, as amended (including, without limitation, volume restrictions), and without the need for current public information required by Rule 144(c)(1). For the avoidance of doubt, in the event that the Effectiveness Date occurs in the middle of any thirty (30) day period, including the initial thirty (30) day period, during which Registration Delay Payments would be owed, then the Purchaser shall only be entitled to Registration Delay Payments for such number of days during such period prior to the Effectiveness Date.
Except as expressly set forth herein, all of the other terms, conditions, covenants and provisions contained in the Letter Agreement (and in the agreements and instruments that were referenced therein or amended thereby) are, and shall continue to be, in full force and effect.
This letter agreement and its enforcement shall be governed by, and construed in accordance with, the laws of the State of New York, without regard to conflicts-of-law principles.
This letter agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, admissible into evidence, and all of which together shall be deemed to be a single instrument. If any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.
[ remainder of page intentionally left blank; signature page follows ]
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Please acknowledge your agreement with the foregoing by signing in the space provided below.
MARINA BIOTECH, INC. | ||||
By: | /s/ Vuong Trieu | |||
Name: | Vuong Trieu | |||
Title: | Chairman | |||
AGREED AND ACCEPTED: | ||||
EOS HOLDINGS LLC | ||||
By: | /s/ Jon Carnes | |||
Name: | Jon Carnes | |||
Title: | Manager | |||
PEAK CAPITAL ADVISORY LIMITED | ||||
By: | /s/ Feng Bai Ye | |||
Name: | Feng Bai Ye | |||
Title: | Director |
3 |
Exhibit 31.1
MARINA BIOTECH, INC.
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph W. Ramelli, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Marina Biotech, Inc.; |
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 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 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 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. |
By: | /s/ Joseph W. Ramelli | |
Joseph W. Ramelli | ||
Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 13, 2017 |
Exhibit 31.2
MARINA BIOTECH, INC.
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Amit Shah, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Marina Biotech, Inc.; |
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 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 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 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. |
By: | /s/ Amit Shah | |
Amit Shah | ||
Chief Financial Officer | ||
(Principal Financial Officer and Principal Accounting Officer) | ||
Date: November 13, 2017 |
Exhibit 32.1
MARINA BIOTECH, INC.
CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report on Form 10-Q of Marina Biotech, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.
By: | /s/ Joseph W. Ramelli | |
Joseph W. Ramelli | ||
Chief Executive Officer | ||
(Principal Executive Officer) | ||
Date: November 13, 2017 |
Exhibit 32.2
MARINA BIOTECH, INC.
CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report on Form 10-Q of Marina Biotech, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.
By: | /s/ Amit Shah | |
Amit Shah | ||
Chief Financial Officer | ||
(Principal Financial Officer and Principal Accounting Officer) | ||
Date: November 13, 2017 |