Notes
to Condensed Consolidated Financial Statements
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2018
(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. (“MDRNA”), Cequent Pharmaceuticals, Inc. (“Cequent”),
Atossa Healthcare, Inc. (“Atossa”), and IthenaPharma, Inc. (“Ithena”) (collectively “Marina,”
“we,” “our,” or “us”) is a fully integrated, commercial stage pharmaceutical 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. 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® (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 FDC of perindopril
argentine (perindoprol), an angiotensin-converting-enzyme (“ACE”) inhibitor and amlodipine besylate (amlodipine),
a calcium channel blocker (“CCB”), which has been approved by the U.S. Food and Drug Administration (“FDA”)
and is 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.
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”).
As
reported in our Annual Report on Form 10-K, in April 2018, we raised in excess of $10 million, net of fees and expenses, from
a private placement of our newly created Series E Convertible Preferred Stock (See Recent Developments: Series E Convertible Preferred Stock Private Placement Offering below). Further, in May 2018, we raised an additional $2 million, net of fees and expenses,
from the private placement. In July 2018, we raised $1.4 million net of fees and expenses, from a private placement of our newly
created Series F Convertible Preferred Stock. The use of funds from the private placement will be on the commercialization
of Prestalia, funding working capital, capital expenditure needs, payment of certain liabilities and other general corporate requirements.
For the development of IT-102 and IT-103, we will seek partners or raise additional funds to advance the development programs.
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.
In
July 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which
we sold 308 shares of our Series F convertible preferred stock at a purchase price of $5,000 per share. See Note 9 – Subsequent
Events.
We
intend to create value through the 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 pharmaceutical 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
Stock Split
In
August 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 and Notes to the Consolidated 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, 2017, included in our 2017 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 six months ended June 30, 2018 are not necessarily indicative of
the results for the year ending December 31, 2018 or for any future period.
Principles
of Consolidation
The
consolidated financial statements include the accounts of IThena and Marina Biotech, Inc. and the wholly-owned subsidiaries, Cequent,
MDRNA, and Atossa, and eliminate any inter-company balances and transactions.
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, legal contingencies
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. There were no liabilities measured at fair value as of June 30, 2018 or December
31, 2017.
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 June 30, 2018 or December
31, 2017.
Revenue
Recognition
The
Company has adopted the new revenue recognition guidelines in accordance with ASC 606,
Revenue from Contracts with Customers
(ASC 606), commencing from the period under this report.
The
Company analyzes its contracts to assess that they are within the scope and in accordance with ASC 606. In determining the appropriate
amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, whether for goods and
services or licensing, the Company performs the following steps: (i) identification of the promised goods or services in the contract;
(ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in
the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv)
allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue
when (or as) the Company satisfies each performance obligation.
In
terms of licensing agreements entered into by the Company, they typically include payment of one or more of the following: non-refundable,
up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services;
and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenues,
except for revenues from royalties on net sales of licensed products, which are classified as royalty revenues. The core principle
of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the
consideration that is expected to be received in exchange for those goods or services.
Amounts
received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s consolidated
balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified
in current liabilities. Amounts recognized as revenue prior to receipt are recorded as contract assets in the Company’s
consolidated balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve
months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer.
At
contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct
goods and services that represent a performance obligation. A promised good or service may not be identified as a performance
obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other
promises in the contract (either because it is not capable of being separated or because it is not separable in the context of
the contract), or if the performance obligation does not provide the customer with a material right.
The
Company considers the terms of the contract and its customary business practices to determine the transaction price. The transaction
price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or
services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts,
or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is
when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.
If
it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement
to all identified performance obligations based on the relative standalone selling prices. The relative selling price for each
deliverable is estimated using objective evidence if it is available. If objective evidence is not available, the Company uses
its best estimate of the selling price for the deliverable.
Revenue
is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer.
An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the
services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction
of the relevant performance obligation using an appropriate input or output method based on the nature of the good or service
promised to the customer.
After
contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain
events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception.
Management
may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying
performance obligations, estimating the transaction price, estimating the stand-alone selling prices of identified performance
obligations, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates
and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations.
During
the three months ended June 30, 2018, the Company entered into certain contracts for the sale and distribution of Prestalia and
shipped orders totaling approximately $58,000. The Company has not recognized this revenue since it cannot yet determine that
collectability of the entire amount is probable.
During
the three months ended March 31, 2018, Marina entered into a Licensing Agreement, whereby Marina granted exclusive rights to the
company’s DiLA
2
delivery system in exchange for an upfront payment of $200,000 and further potential future consideration
dependent upon event and sales-based milestones. Under the terms of the agreement, Marina has agreed to assign ownership of the
intellectual property associated with the DiLA
2
delivery system to the purchaser. The Company has yet to complete certain
performance obligations under the agreement and accordingly has deferred the recognition of revenue from the sale of the asset
until such obligations are fulfilled.
Recently
Issued Accounting Pronouncements
In
May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Under the provisions of ASU 2014-09,
entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange
for goods and services provided. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017. The
Company adopted the provisions of this standard effective January 1, 2018.
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 (loss) since such inclusion would be anti-dilutive:
|
|
Three
and Six Months Ended June 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
Stock options outstanding
|
|
|
1,122,457
|
|
|
|
233,400
|
|
Warrants
|
|
|
33,028,829
|
|
|
|
2,492,945
|
|
Shares to be issued upon conversion
of notes payable
|
|
|
-
|
|
|
|
312,050
|
|
Restricted common
stock
|
|
|
-
|
|
|
|
70,000
|
|
Total
|
|
|
34,151,286
|
|
|
|
3,108,395
|
|
Reclassification
of Prior Period Presentation
Certain
prior period amounts have been reclassified for consistency with the current period presentation. These reclassifications had
no effect on the reported results of operations or cash flows.
Note
2 – Intangible Assets
Acquisition
of Prestalia & Dyrct Axess
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 $620,000 (consisting
of $300,000 in cash plus the assumption of certain liabilities of Symplmed in the amount of approximately $320,000), 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 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.
The
purchase price of $620,000 had been allocated based on a preliminary estimate of the fair value of the assets acquired and is
included in intangible assets as of December 31, 2017 and June 30, 2018. No subsequent adjustments were deemed necessary by the
Company.
Further,
we hired our current Chief Commercial Officer, who was the President and Chief Executive Officer of Symplmed, which appointment
became effective in June 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 vesting on the six (6) month anniversary
of the date of grant. These shares were fully vested on December 31, 2017.
In
furtherance of the acquisition and commercialization of Prestalia, in July 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 for $75,000 in cash.
The
following table summarizes the estimated fair value of the identifiable intangible asset acquired, their useful life, and method
of amortization:
|
|
Estimated
Fair
Value
|
|
|
Estimated
Useful
Life
(Years)
|
|
|
Annual
Amortization
Expense
|
|
Intangible asset from the
Merger
|
|
$
|
2,361,066
|
|
|
|
6.0
|
|
|
$
|
393,511
|
|
Intangible asset - Prestalia
|
|
|
620,000
|
|
|
|
6.6
|
|
|
|
94,177
|
|
Intangible asset – DyrctAxess
|
|
|
75,000
|
|
|
|
14.0
|
|
|
|
5,357
|
|
Total
|
|
$
|
3,056,066
|
|
|
|
|
|
|
$
|
493,045
|
|
The
net intangible asset was $2,309,451, net of accumulated amortization of $746,615, as of June 30, 2018. Amortization expense was
$246,523 and $204,604 for the six months ended June 30, 2018 and 2017, respectively, and $123,262 and $106,226 for the three months
ended June 30, 2018 and 2017, 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 Autotelic Inc., a related party that is partly-owned by one of
the Company’s Board members, namely Vuong Trieu, Ph.D., effective November 15, 2016. Autotelic Inc. currently owns less
than 5% 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 requires a 90-day written termination notice in the event either party requires to
terminate such services. In August 2018, we have notified Autotelic that we are terminating the services under the MSA and that
such services would end on October 31, 2018.
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 six months ended June 30, 2018 and 2017, Autotelic Inc. billed a total of $616,385 and $317,044, including
personnel costs of $284,091 and $243,944, respectively. An unpaid balance of $64,478 and $730,629 is included in due to related
party in the accompanying balance sheet as of June 30, 2018 and December 31, 2017, respectively.
In
April 2018, and in connection with the closing of our private placement on that date, we entered into a Compromise and Settlement
Agreement with Autotelic Inc. pursuant to which we agreed to issue to Autotelic Inc. an aggregate of 162.59 shares of Preferred
Stock and Warrants to purchase up to 1,219,425 shares of common stock to satisfy accrued and unpaid fees in the aggregate amount
of approximately $812,950, and other liabilities, owed to Autotelic Inc. as of March 31, 2018 pursuant to the MSA. The Securities
that were issued to Autotelic Inc., which were issued upon the closing described above, have the same terms and conditions as
the Securities that were issued to investors in the offering (See Note 5). Such warrants have a five-year term, an exercise
price of $0.55. In addition, we issued 1,345,040 warrants to purchase shares of common stock to Autotelic to satisfy a liability
to issue warrants as of March 31, 2018. Such warrants have a five-year term, an exercise price of $0.55, and have a fair value
of $1,494,469 resulting in a loss on settlement of debt of $754,697.
Resignation
and Appointment of Officer and Directors
On
April 27, 2018, our Board of Directors (the “Board”) increased the size of the entire Board from five (5) directors
to seven (7) directors, and it appointed each of Erik Emerson and Tim Boris to fill the vacancies created thereby.
In
May 2018, each of Philip C. Ranker and Philippe P. Calais, Ph.D. resigned as members of the Board, and all committees thereof,
effective immediately. In connection with their resignations: (i) each of Mr. Ranker and Dr. Calais released us from all claims
arising prior to the date of his resignation; (ii) we granted to Mr. Ranker fully-vested options to purchase up to 200,000 shares
of our common stock at an exercise price equal to $0.98 per share of common stock; and (iii) we granted to Dr. Calais fully-vested
options to purchase up to 80,000 shares of our common stock at an exercise price equal to $0.98 per share of common stock. The
foregoing options are exercisable for a period of five years from the grant date.
In
May 2018, the Board accepted the resignation of Joseph W. Ramelli, our Chief Executive Officer, whereby Mr. Ramelli resigned as
an officer of our company, and as a director and/or officer of any and all subsidiaries of our company, effective immediately,
to pursue other opportunities. In connection with his resignation, Mr. Ramelli released us from all claims arising prior to the
date of his resignation and affirmed his obligations to be bound by the restrictive covenants contained in the employment agreement
between Mr. Ramelli and our company dated February 2, 2017, and we: (i) agreed to make severance payments to Mr. Ramelli in the
amount of $60,000 to be paid over a six (6) month period; and (ii) granted to Mr. Ramelli fully-vested options, exercisable for
a period of five years from the grant date, to purchase up to 100,000 shares of our common stock at an exercise price equal to
$0.98 per share of common stock. In May 2018, the Board appointed Vuong Trieu, a director of the Company and former Executive
Chairman, to serve as our Interim Chief Executive Officer, to replace Mr. Ramelli, effective with Mr. Ramelli’s departure.
In his capacity as Interim Chief Executive Officer, Dr. Trieu received a salary in the amount of $20,000 per month. Dr. Trieu
resigned from the position of Interim Chief Executive Officer on June 18, 2018.
On
June 18, 2018, the Board appointed Robert C. Moscato, Jr., to serve as our Chief Executive Officer effective immediately. In connection
with the appointment of Mr. Moscato as Chief Executive Officer, Dr. Trieu resigned as Interim Chief Executive Officer, and also
from his position as Executive Chairman of our company, effective immediately.
On
June 18, 2018, the Board appointed Uli Hacksell, Ph.D.to serve as a member of the Board, and as Chairman of the Board, effective
July 1, 2018. Dr. Hacksell agreed to devote half of his business time to Marina.
On
June 28, 2018, the Board appointed Mr. Moscato to serve as a member of the Board, effective July 1, 2018.
Issuance
of Preferred Stock and Warrants to Directors
In
April 2018, and in connection with the closing of our private placement on that date, we entered into Compromise and Settlement
Agreements with four of the current members of our Board of Directors and one former member of our Board of Directors pursuant
to which we agreed to issue to such directors an aggregate of 58.25 shares of Preferred Stock and Warrants to purchase up to 436,875
shares of common stock to satisfy accrued and unpaid fees owed to such directors for service as members of the Board of Directors
during the period ending on December 31, 2017 in the aggregate amount of approximately $291,250. The Securities that were issued
to the directors, which were issued upon the closing of our private placement described above, have the same terms and conditions
as the Securities that were issued to investors in the offering.
Transactions
with BioMauris, LLC
During
the six months ended June 30, 2018, the company paid a total of $309,116 for services provided by BioMauris, LLC, of which Erik
Emerson, our Chief Commercial Officer and a director of Marina, is Executive Chairman. A total of $33,016 was due to
BioMauris, LLC as of June 30, 2018.
Note
4 – Notes Payable
Following
is a breakdown of notes payable as of June 30, 2018 and December 31, 2017:
|
|
June
30, 2018
|
|
|
December
31, 2017
|
|
|
|
|
|
|
|
|
Notes payable
|
|
$
|
-
|
|
|
$
|
97,523
|
|
Convertible notes
payable
|
|
|
-
|
|
|
|
346,700
|
|
Total notes payable
|
|
$
|
-
|
|
|
$
|
444,223
|
|
|
|
|
|
|
|
|
|
|
Notes payable – related parties
|
|
|
-
|
|
|
$
|
93,662
|
|
Convertible notes
payable – related parties (net of debt discount of $0 and $113,171 as of June 30, 2018 and December 31, 2017,
respectively)
|
|
|
-
|
|
|
|
1,368,378
|
|
Total notes payable
– related parties
|
|
$
|
-
|
|
|
$
|
1,462,040
|
|
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 called for monthly payments of $6,000 per month, beginning with an initial payment on March 31, 2017. The note was unsecured
and non-interest bearing. The note was paid in full in May 2018. The balance due on the note was $0 and $97,523 as of June 30,
2018 and December 31, 2017, respectively.
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
“2016 Notes”). Interest accrued on the unpaid principal balance of the 2016 Notes at the rate of 12% per annum beginning
on September 20, 2016. The 2016 Notes were due and payable on June 20, 2017.
In
July 2017, we entered into an amendment agreement (the “Amendment Agreement”) with respect to those 2016 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, Cequent 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 2016 Notes to December 31, 2017, to provide for the issuance of consideration securities at a cost of $375,000 (“Consideration
Securities”) 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 2016 Notes.
In
April 2018, and in connection with the closing of our private placement on that date, we issued to the holders (such holders,
the “June 2016 Noteholders”) an aggregate of 71.46 shares of Preferred Stock and Warrants to purchase up to 535,950
shares of common stock as a result of the conversion of the 2016 Notes. As a result of the conversion of the 2016 Notes and the
issuance of the Securities to the June 2016 Noteholders, the entire unpaid principal balance of the 2016 Notes, and the accrued
and unpaid interest thereon, has been satisfied in full, and such notes are no longer outstanding.
In
addition, in April 2018, and in connection with the closing of our private placement on that date, we issued to the June 2016
Noteholders an aggregate of 75 shares of Preferred Stock and Warrants to purchase up to 562,500 shares of common stock in full
and complete satisfaction of our obligations to issue $375,000 worth of Consideration Securities to the 2016 Noteholders pursuant
to that certain amendment agreement dated July 3, 2017 by and among our company and the June 2016 Noteholders.
As
of June 30, 2018 and December 31, 2017, the accrued interest expense on the Notes amounted to $0 and $46,700, respectively, with
a total balance of principal and interest of $0 and $346,700, respectively.
Bridge
Note Financing
In
June 2017, we issued convertible promissory notes (the “2017 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 2017 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
then Executive Chairman and our Chief Science Officer were each investors in the 2017 Notes.
Upon
written notice delivered to us by the holders of a majority in interest of the aggregate principal amount of 2017 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 2017 Notes, the Majority Holders shall have the right, but not the obligation, on behalf of themselves and all other
holders of 2017 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 2017 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 June 30, 2018 and December 31, 2017, the accrued interest expense on the 2017 Notes amounted to $0 and $11,365, with a total
balance of principal and interest of $0 and $411,365, respectively, and is included in notes payable – related parties on
the accompanying balance sheet.
In April 2018, and in
connection with the closing of our private placement on that date, we issued to the holders (the “June 2017 Noteholders”)
pursuant to Note Purchase Agreements that we entered into with the June 2017 Noteholders during June 2017 an aggregate of 83.44
shares of Preferred Stock and Warrants to purchase up to 505,705 shares of common stock, (of which 9.27 shares were subsequently
cancelled and paid to such holders an aggregate of $46 thousand in cash
)
as full and complete satisfaction of the unpaid principal balance
(and
accrued but unpaid interest thereon) owed by us to the June 2017 Noteholders under the 2017 Notes. As a result of the conversion
of the 2017 Notes and the issuance of the Securities to the June 2016 Noteholders (and payment of cash), the entire unpaid principal
balance of the 2017 Notes, and the accrued and unpaid interest thereon, has been satisfied in full, and such notes are no longer
outstanding. The Securities that were issued to the June 2017 Noteholders have the same terms and conditions as the Securities
that were issued to investors in the offering.
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 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).
In
November 2017, the Company issued a convertible promissory note with a related party (a trust affiliated with Isaac Blech, a member
of our Board of Directors) for $500,000 (the “Blech Note”), with annual interest at 8%, maturing on March 31, 2018,
and convertible at the price equal to any financing transaction involving the sale by the Company of its equity securities yielding
aggregate gross proceeds to the Company of not less than $5 million. The note included warrants to purchase 66,667 shares of the
Company’s common stock, with a 5-year term and an exercise price of $0.75.
In
April 2018, and in connection with the closing of our private placement on that date, we issued to the trust an aggregate of 103.18
shares of Preferred Stock and Warrants to purchase up to 777,750 shares of common stock as a result of the conversion of the Blech
Note in the original principal amount of $500,000. As a result of the conversion of the Blech Note and the issuance of the Securities
to the holder thereof, the entire unpaid principal balance of the Blech Notes, and the accrued and unpaid interest thereon, has
been satisfied in full, and the Blech Note is no longer outstanding. The Securities that were issued to the holder of the Blech
Note have the same terms and conditions as the Securities that were issued to investors in the offering.
The
Blech Note included a debt discount of $162,210 consisting of loan costs of $50,000 and the fair value of the warrants of $112,210.
Total amortization of this debt discount was 113,171 for the six months ended June 30, 2018, with a remaining unamortized value
of $0. Total principal and interest was $0 and $504,274 as of June 30, 2018 and December 31, 2017, respectively, and is included
in notes payable – related parties on the accompanying balance sheet.
Convertible
Notes Payable, Dr. Trieu
In
connection with the Merger, Marina entered into a Line Letter dated November 15, 2016 with Dr. Trieu, a director of the Company
and our former Executive Chairman and Interim CEO, 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 December 31, 2017. The
line of credit was convertible at any time into shares of the Company’s common stock at a price of $1.77 per share.
In
April 2018, and in connection with the closing of our private placement on that date, we issued to Dr. Trieu 114.63 shares of
Preferred Stock and Warrants to purchase up to 859,725 shares of common stock as full and complete satisfaction of the unpaid
principal balance (and accrued but unpaid interest thereon) owed by us to Dr. Trieu under that certain line of credit in the amount
of up to $540,000 that was provided by Dr. Trieu to us, all of which had been drawn down as of the date of the closing of our
private placement. As such, the Line of Credit was terminated in April 2018. The Securities that were issued to Dr. Trieu have
the same terms and conditions as the Securities that were issued to investors in the offering.
Accrued
interest on the Line Letter was $0 and $25,836 as of June 30, 2018 and December 31, 2017, respectively, and is included in notes
payable - related parties on the accompanying consolidated balance sheets.
Line
Letter with Autotelic, Inc.
In
April 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. 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. Autotelic Inc. advanced funds after September 1, 2017 but is no longer considering
additional requests for advances as of December 31, 2017.
In
April 2018, and in connection with the closing of our private placement on that date, we issued to Autotelic Inc. 19 shares of
Preferred Stock and Warrants to purchase up to 142,500 shares of common stock as full and complete satisfaction of the unpaid
principal balance (and accrued but unpaid interest thereon) owed by us to Autotelic Inc. under that certain line of credit in
the amount of up to $500,000 that was provided by Autotelic Inc. to us, of which $90,816 had been drawn down as of the date of
the closing described above. As such, in April 2018, the line of credit with Autotelic Inc was terminated. The Securities that
were issued to Autotelic Inc. have the same terms and conditions as the Securities that were issued to investors in the offering.
The
balance under the line was $0 and $93,662, including accrued interest of $0 and $2,847 as of June 30, 2018 and December 31, 2017,
respectively, and is included in notes payable - related parties on the accompanying consolidated balance sheet.
Note
5 – Stockholders’ Equity
Preferred
Stock
Marina
has authorized 100,000 shares of preferred stock for issuance and has 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”). In April 2018, Marina designated 3,500 shares of Series E Convertible Preferred
Stock. In July 2018, Marina designated 2,200 shares of Series F Convertible Preferred Stock.
Series
C Preferred
Each
share of Series C Preferred has a stated value of $5,000 per share, has a $5,100 liquidation preference per share, has voting
rights of 666.67 votes per share, and is convertible into shares of common stock at a conversion price of $7.50 per share. In
September 2017, an investor converted 270 shares of Series C Preferred stock into 180,000 shares of our common stock.
In
June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock.
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, has a liquidation preference of $300 per share, has voting rights of 1,250 votes 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
May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock.
Series
E Convertible Preferred Stock Private Placement
In
April and May 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant
to which we sold 2,812 shares of our Series E convertible preferred stock (the “Preferred Stock”), at a purchase price
of $5,000 per share of Preferred Stock. Each share of Preferred Stock is initially convertible into shares of our common stock
at a conversion price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”,
and collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of common stock for each share
of common stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55
per share of common stock, subject to adjustment thereunder. The Preferred Stock accrues 8% dividends per annum and are payable
in cash or stock at the Company’s discretion. The cumulative dividends are required obligations to be paid each year
by the Company. The Preferred Stock has voting rights, dividend rights, liquidation preferences, conversion rights and anti-dilution
rights as described in the Certificate of Designation of Preferences, Rights and Limitations of the Preferred Stock, which we
filed with the Secretary of State of Delaware in April 2018. The Warrants have full-ratchet anti-dilution protection, are exercisable
for a period of five years and contain customary exercise limitations.
We
received net proceeds of approximately $12.3 million from the sale of the Preferred Stock, after deducting placement agent fees
and estimated expenses payable by us of approximately $2 million associated with such closing. We intend to use the proceeds of
the offering for funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs,
capital expenditures, the repayment of certain liabilities and other general corporate purposes. In connection with the private
placement described above, we also issued to the placement agent for such private placement a Warrant to purchase 2,958,460 shares
of our common stock.
We
accrued dividends on the Series E Preferred Stock of $270,620 for the three months and six months ended June 30, 2018.
No similar dividends were accrued for the same periods of 2017.
Series
F Convertible Preferred Share Private Placement Offering
In
July 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which
we sold 308 shares of our Series F convertible preferred stock at a purchase price of $5,000 per share. See Note 9 – Subsequent
Events.
Common
Stock
Our
common stock currently trades on the OTCQB tier of the OTC Markets under the symbol “MRNA”. We currently have 11,241,684
shares of our common stock outstanding.
Stock
Issuances
In
addition to the common stock issuances described above, we issued the following shares of the Company’s common stock during
the six months ended June 30, 2018.
As
discussed in Note 7, in May 2018, we issued to Novosom 51,988 shares of our common stock as additional consideration pursuant
to the Asset Purchase Agreement, dated as of July 27, 2010, between our company and Novosom. Such shares were due to Novosom as
a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc.
in February 2017.
As
discussed in Note 8, in April 2018, we entered into a Stipulation of Settlement with Vaya Pharma and issued a total of 210,084
shares of our common stock with a fair value of $250,000.
In
May 2018, an investor converted 20 shares of Series D Preferred into 25,000 shares of common stock.
In
June 2018, an investor converted 650 shares of Series C Preferred stock into 433,334 shares of our common stock.
Warrants
As
of June 30, 2018, there were 33,028,829 warrants outstanding, with a weighted average exercise price of $0.81 per share, and annual
expirations as follows:
Expiring in 2018
|
|
|
-
|
|
Expiring in 2019
|
|
|
600,000
|
|
Expiring in 2020
|
|
|
1,189,079
|
|
Expiring in 2021
|
|
|
343,750
|
|
Expiring in 2022
|
|
|
29,202,227
|
|
Expiring thereafter
|
|
|
1,693,773
|
|
|
|
|
33,028,829
|
|
The
above includes 29,135,560 warrants issued in April and May 2018 in connection with our Series E Preferred Stock offering with
a fair value of $31,106,896 which are reflected in additional paid-in capital and additional paid in capital-warrants on the accompanying
condensed consolidated statement of stockholder’s equity. The warrants have a five-year term and an exercise price of $0.55.
There was no expense related to these warrants.
Additionally,
the above includes 1,345,040 warrants issued to Autotelic, Inc. in April 2018 to satisfy accrued and unpaid fees in the aggregate
amount of approximately $739,772, and other liabilities, owed to Autotelic Inc. as of March 31, 2018. The warrants have a five-year
term, an exercise price of $0.55, and have a fair value of $1,494,469 resulting in a loss on settlement of liability of $754,697.
The
above includes price adjustable warrants totaling 1,895,013 which are described more fully in our 2017 Annual Report on Form 10-K.
A
total of 11,131 warrants expired during the six months ended June 30, 2018. 252 warrants have since expired in July 2018.
Note
6 — Stock Incentive Plans
Stock
Options
Stock
option activity was as follows:
|
|
Options
Outstanding
|
|
|
|
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
Outstanding, December 31, 2017
|
|
|
745,707
|
|
|
$
|
8.84
|
|
Options granted
|
|
|
399,000
|
|
|
|
1.01
|
|
Options expired
/ forfeited
|
|
|
(22,250
|
)
|
|
|
220.70
|
|
Outstanding, June 30, 2018
|
|
|
1,122,457
|
|
|
|
1.86
|
|
Exercisable, June 30, 2018
|
|
|
590,519
|
|
|
$
|
1.76
|
|
The
following table summarizes additional information on Marina’s stock options outstanding at June 30, 2018:
|
|
|
Options
Outstanding
|
|
|
Options
Exercisable
|
|
Range
of
Exercise
Prices
|
|
|
Number
Outstanding
|
|
|
Weighted-
Average
Remaining
Contractual
Life (Years)
|
|
|
Weighted
Average
Exercise Price
|
|
|
Number
Exercisable
|
|
|
Weighted
Average
Exercise Price
|
|
|
$0.98
|
|
|
|
380,000
|
|
|
|
4.84
|
|
|
$
|
0.98
|
|
|
|
380,000
|
|
|
$
|
0.98
|
|
|
$1.00
|
|
|
|
14,000
|
|
|
|
3.38
|
|
|
$
|
1.00
|
|
|
|
14,000
|
|
|
$
|
1.00
|
|
|
$1.50
– $1.80
|
|
|
|
553,007
|
|
|
|
8.59
|
|
|
|
1.78
|
|
|
|
141,069
|
|
|
|
1.75
|
|
|
$2.60
– $8.20
|
|
|
|
150,400
|
|
|
|
3.83
|
|
|
|
2.94
|
|
|
|
30,400
|
|
|
|
4.48
|
|
|
$10.70
– $22.00
|
|
|
|
25,050
|
|
|
|
1.23
|
|
|
|
10.81
|
|
|
|
25,050
|
|
|
|
10.81
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals
|
|
|
|
1,122,457
|
|
|
|
6.46
|
|
|
$
|
1.86
|
|
|
|
590,519
|
|
|
$
|
1.76
|
|
Weighted-Average
Exercisable Remaining Contractual Life (Years) 4.92
In
January 2018, the Company granted a total of 19,000 stock options to directors and officers for services. The options have an
exercise price of $1.56 and a five-year term.
In
May 2018, the Company granted a total of 380,000 stock options to directors and officers for services. The options have an exercise
price of $0.98 and a five-year term.
As
of June 30, 2018, we had $717,996 of total unrecognized compensation expense related to unvested stock options. Total expense
related to stock options was $493,038 and $59,568 for the six months ended June 30, 2018 and 2017, respectively, and $374,159
and $15,328 for the three months ended June 30, 2018 and 2017, respectively.
In
July 2018, we granted our Chief Executive Officer, Robert
Moscato Jr. 1,500,000 Incentive Stock Options; Uli Hacksell, Ph.D., the Chairman of our Board, 1,000,000 Incentive Stock Options;
and Erik Emerson, our Chief Commercial Officer, 1,125,000 Incentive Stock Options.
As
of June 30, 2018, the intrinsic value of options outstanding or exercisable was $0 as there were no options outstanding with an
exercise price less than $0.63, 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 with Novosom Verwaltungs GmbH (“Novosom”), 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. 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.
In
May 2018, we issued to Novosom 51,988 shares of our common stock, with a fair value of $75,000, as additional consideration pursuant
to the Asset Purchase Agreement, dated as of July 27, 2010, between our company and Novosom. Such shares were due to Novosom as
a result of the receipt by our company of a license fee under the License Agreement that we entered into with Lipomedics Inc.
in February 2017.
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.
Vuong
Trieu, Ph.D., one of our Board members, is the Chairman of the Board and Chief Operating Officer of LipoMedics.
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. Oncotelic
has not completed the purchase of the stock and we have not been able to reach to a definitive agreement, as such we have terminated
the agreement.
Agreement
with Autotelic BIO
On
January 11, 2018, we entered into a binding agreement with Autotelic BIO (“ATB”) pursuant to which, among other things,
and subject to the satisfaction of certain conditions on or prior to January 15, 2019, we shall grant to ATB a perpetual exclusive
right of development and marketing of our IT-103 product candidate, which is a fixed dose combination of celecoxib and olmesartan
medoxomil (the “Product”), at the currently approved dose/approved indications only for celecoxib (100 mg, 200mg and
400mg) for combined hypertension and arthritis only, with such right extending throughout the entire world (excluding the United
States and Canada, and the territories of such countries) (the “Territory”). The grant of the license would be memorialized
in a definitive license agreement to be entered into between the parties. The conditions to the grant of the license include,
without limitation, that: (i) ATB shall obtain funding in a certain specified amount (the “Fundraising”); or (ii)
ATB shall obtain a co-development and licensing deal with other third-party pharmaceutical companies with respect to the Product;
or (iii) ATB shall obtain a government-sponsored research and development project in the Republic of Korea.
The
agreement provides that, following the date on which the license is granted: (A) if ATB should sub-license the Product, we and
ATB would share all proceeds of such sub-license equally; and (B) if ATB markets the Product on its own, ATB would provide us
with a royalty equal to a percentage of net profits in the mid-single digits. The agreement also provides that ATB will make a
payment to us in the amount of $100,000 upon the successful completion of the Fundraising, and a payment to us in the amount of
$300,000 following the date on which we have provided certain specified technology and assistance regarding the manufacturing
and production of the Product. We will be entitled to the clinical trial data and any enhancements and inventions developed by
ATB during this process.
Autotelic
LLC, an entity that owns approximately 22% of the issued and outstanding shares of our common stock and of which Dr. Trieu, a
current director of the Company and former Executive Chairman and Interim CEO, serves as Chief Executive Officer, owns approximately
19% of the issued and outstanding shares of the common stock of ATB.
License
of DiLA
2
Assets
On
March 16, 2018, Marina entered into a Licensing Agreement, whereby Marina granted exclusive rights to the company’s DiLA
2
delivery system in exchange for an upfront payment of $200,000 and further potential future consideration dependent upon
event and sales-based milestones. Under the terms of the agreement, Marina has agreed to assign ownership of the intellectual
property associated with the DiLA
2
delivery system to the purchaser. The Company has yet to complete certain performance
obligations under the agreement and accordingly has deferred the recognition of revenue from the sale of the asset until such
obligations are fulfilled.
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 (“Sellers”) 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 our activities, we are 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, we are not aware of any pending lawsuits against
us, our officers or our directors.
We
had 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 had been filed in the Supreme
Court of the State of New York, we had not been legally served. The complaint alleged, 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) we were liable, as successor, for any and all claims by Vaya Pharma, Inc. against the Symplmed Defendants, though pursuant
to the agreement we are 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. In April 2018, we entered
into a Stipulation of Settlement requiring us to issue to Vaya Pharma 210,084 shares of our common stock with a fair value of
$250,000, which shares were issued in April of 2018. We accrued $0 and $250,000, as of June 30, 2018 and December 31, 2017, respectively,
and such amount was included in accrued expenses on the accompanying consolidated balance sheets.
Note
9 - Subsequent Events
Except
for the events 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.
Series
F Convertible Preferred Share Private Placement Offering
In
July 2018, we entered into Subscription Agreements with certain accredited investors and conducted a closing pursuant to which
we sold 308 shares of our Series F convertible preferred stock (the “Preferred Stock”), at a purchase price of $5,000
per share of Preferred Stock. Each share of Preferred Stock is initially convertible into shares of our common stock at a conversion
price of $0.50 per share of common stock. In addition, each investor received a 5-year warrant (the “Warrants”, and
collectively with the Preferred Stock, the “Securities”) to purchase 0.75 shares of common stock for each share of
common stock issuable upon the conversion of the Preferred Stock purchased by such investor at an exercise price equal to $0.55
per share of common stock, subject to adjustment thereunder. The Preferred Stock has voting rights, dividend rights, liquidation
preferences, conversion rights and anti-dilution rights as described in the Certificate of Designation of Preferences, Rights
and Limitations of the Preferred Stock, which we filed with the Secretary of State of Delaware in July 2018. The Warrants have
full-ratchet anti-dilution protection, are exercisable for a period of five years and contain customary exercise limitations.
We
received proceeds of approximately $1.4 million from the sale of the Securities, after deducting placement agent fees and estimated
expenses payable by us of approximately $180,000 associated with such closing. We intend to use the proceeds of the offering for
funding our commercial operations to the sale and promotion of our Prestalia product, working capital needs, capital expenditures,
the repayment of certain liabilities and other general corporate purposes. In connection with the private placement described
above, we also issued to the placement agent for such private placement a Warrant to purchase 308,000 shares of our common stock.
The Warrant has a five-year term and an exercise price of $0.55 per share.
Stock
Option Grants
In
July 2018, we granted our Chief Executive Officer, Robert Moscato Jr. 1,500,000 Incentive Stock Options; Uli Hacksell, Ph. D.,
the Chairman of our Board, 1,000,000 Incentive Stock Options; and Erik Emerson, our Chief Commercial Officer, 1,125,000 Incentive
Stock Options.