10-Q
1
form10-q.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
[X]
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2020
OR
[ ]
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
file number: 001-38418
COCRYSTAL
PHARMA, INC.
(Exact
name of registrant as specified in its charter)
Delaware
35-2528215
(State
or Other Jurisdiction of
(I.R.S.
Employer
Incorporation
or Organization)
Identification
No.)
19805
North Creek Parkway Bothell, WA
98011
(Address
of Principal Executive Office)
(Zip
Code)
Registrant’s
telephone number, including area code: (786) 459-1831
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 every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (Sec.232.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit 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 smaller
reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer
[ ]
Accelerated
filer
[ ]
Non-accelerated
filer
[X]
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 13(a) of the Exchange Act. [ ]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [ ] No [X]
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
Trading
Symbol(s)
Name
of each exchange on which registered
Common
Stock
COCP
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market)
As of November 13, 2020, the number
of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 68,563,512.
COCRYSTAL
PHARMA, INC.
FORM
10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2020
INDEX
Part I - FINANCIAL INFORMATION
Item
1.
Condensed Consolidated Balance Sheets
F-1
Condensed Consolidated Statements of Operations
F-2
Condensed Consolidated Statements of Stockholders’ Equity
F-3
Condensed Consolidated Statements of Cash Flows
F-4
Notes to the Condensed Consolidated Financial Statements
F-5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
3
Item 3. Quantitative and Qualitative Disclosures About Market Risk
7
Item 4. Controls and Procedures
7
Part II - OTHER INFORMATION
Item 1. Legal Proceedings
8
Item 1.A. Risk Factors
9
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
9
Item 3. Defaults Upon Senior Securities
9
Item 4. Mine Safety Disclosures
9
Item 5. Other
9
Item 6. Exhibits
9
SIGNATURES
11
Part
I – FINANCIAL INFORMATION
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(in
thousands, except per share data)
September 30, 2020
December 31, 2019
(unaudited)
Assets
Current assets:
Cash
$ 31,781
$ 7,418
Restricted cash
50
50
Accounts receivable
581
644
Prepaid expenses and other current assets
487
169
Total current assets
32,899
8,281
Property and equipment, net
635
431
Deposits
46
50
Operating lease right-of-use assets, net (including $51 to related party)
544
677
Goodwill
19,092
19,092
Total assets
$ 53,216
$ 28,531
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses
$ 2,350
$ 1,999
Current maturities of finance lease liabilities
40
103
Current maturities of operating lease liabilities (including $53 to related party)
188
177
Derivative liabilities
36
7
Total current liabilities
2,614
2,286
Long-term liabilities:
Finance lease liabilities
44
14
Operating lease liabilities (including $0 to related party)
381
523
Total long-term liabilities
425
537
Total liabilities
3,039
2,823
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000 shares authorized as of September 30, 2020 and December 31, 2019; 68,564 and 35,150 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
69
36
Additional paid-in capital
293,523
260,932
Accumulated deficit
(243,415 )
(235,260 )
Total stockholders’ equity
50,177
25,708
Total liabilities and stockholders’ equity
$ 53,216
$ 28,531
See
accompanying notes to condensed consolidated financial statements.
F- 1
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in
thousands, except per share data)
Three months ended
September 30,
Nine months ended
September 30,
2020
2019
2020
2019
Revenues:
Collaboration revenue
$ 489
$ 492
$ 1,504
$ 6,162
Operating expenses:
Research and development
2,077
1,077
5,336
3,046
General and administrative
1,121
1,223
4,288
3,597
Total operating expenses
3,198
2,300
9,624
6,643
Loss from operations
(2,709 )
(1,808 )
(8,120 )
(481 )
Other income (expense):
Interest expense, net
(2 )
(5 )
(6 )
(16 )
Change in fair value of derivative liabilities
41
33
(29 )
173
Total other income (expense), net
39
28
(35 )
157
Net loss
$ (2,670 )
$ (1,780 )
$ (8,155 )
$ (324 )
Net loss per common share:
Loss per share, basic and diluted
$ (0.05 )
$ (0.06 )
$ (0.16 )
$ (0.01 )
Weighted average number of common shares outstanding, basic and diluted
57,555
31,621
50,491
31,201
See
accompanying notes to condensed consolidated financial statements.
F- 2
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
(in
thousands)
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2019
35,150
$ 36
$ 260,932
$ (235,260 )
$ 25,708
Stock-based compensation
-
-
107
-
107
Sale of common stock, net of transaction costs
16,991
17
16,589
-
16,606
Net loss
-
-
-
(1,990 )
(1,990 )
Balance as of March 31, 2020
52,141
$ 53
$ 277,628
$ (237,250 )
$ 40,431
Stock-based compensation
-
-
119
-
119
Net loss
-
-
-
(3,495 )
(3,495 )
Balance as of June 30, 2020
52,141
$ 53
$ 277,747
$ (240,745 )
$ 37,055
Stock-based compensation
-
-
237
-
237
Sale of common stock, net of transaction costs
16,423
16
15,539
-
15,555
Net loss
-
-
-
(2,670 )
(2,670 )
Balance as of September 30, 2020
68,564
69
293,523
(243,415 )
50,177
Common Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of December 31, 2018
29,938
$ 30
$ 253,949
$ (187,091 )
$ 66,888
Stock-based compensation
-
-
33
-
33
Sale of common stock, net of transaction costs
1,683
2
3,926
-
3,928
Net income
-
-
-
2,971
2,971
Balance as of March 31, 2019
31,621
$ 32
$ 257,908
$ (184,120 )
$ 73,820
Stock-based compensation
-
-
113
-
113
Net loss
-
-
-
(1,515 )
(1,515 )
Balance as of June 30, 2019
31,621
$ 32
$ 258,021
$ (185,635 )
$ 72,418
Stock-based compensation
-
-
107
-
107
Net loss
-
-
-
(1,780 )
(1,780 )
Balance as of September 30, 2019
31,621
$ 32
$ 258,128
$ (187,415 )
$ 70,745
See
accompanying notes to condensed consolidated financial statements.
F- 3
COCRYSTAL
PHARMA, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in
thousands)
Nine months ended
September 30,
2020
2019
Operating activities:
Net loss
$ (8,155 )
$ (324 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
112
69
Amortization of right of use assets
133
114
Stock-based compensation
463
253
Payments on operating lease liabilities
(131 )
(94 )
Change in fair value of derivative liabilities
29
(173 )
Changes in operating assets and liabilities:
Accounts receivable
63
(768 )
Prepaid expenses and other current assets
(318 )
(10 )
Deposits
4
(10 )
Accounts payable and accrued expenses
351
613
Deferred rent
-
(3 )
Net cash used in operating activities
(7,449 )
(333 )
Investing activities:
Purchases of property and equipment
(239 )
(144 )
Net cash used in investing activities
(239 )
(144 )
Financing activities:
Proceeds from issuance of common stock
32,161
3,928
Payments on finance lease liabilities
(110 )
(159 )
Net cash provided by financing activities
32,051
3,769
Net increase in cash and restricted cash
24,363
3,292
Cash and restricted cash at beginning of period
7,468
2,752
Cash and restricted cash at end of period
$ 31,831
$ 6,044
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES:
Recognition of finance lease right-of-use asset and liability
$ 77
$ -
Recognition of operating lease right-of-use assets and operating lease liabilities upon adoption of ASC Topic 842, Leases
$ -
$ 833
See
accompanying notes to condensed consolidated financial statements.
F- 4
COCRYSTAL
PHARMA, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1.
Organization and Business
Cocrystal
Pharma, Inc. (“we”, the “Company” or “Cocrystal”), a biopharmaceutical company incorporated
in Delaware, has been developing novel technologies and approaches to create first-in-class or best-in-class antiviral drug candidates
since its initial funding in 2008. Our focus is to pursue the development and commercialization of broad-spectrum antiviral drug
candidates that will transform the treatment and prophylaxis of viral diseases in humans. By concentrating our research and development
efforts on inhibiting viral replication, we plan to leverage our infrastructure and expertise in these areas.
The
Company’s activities since inception have principally consisted of acquiring product and technology rights, raising capital,
performing research and development and conducting clinical trials. Successful completion of the Company’s development programs,
obtaining regulatory approvals of its products and, ultimately, the attainment of profitable operations is dependent on future
events, including, among other things, its ability to access potential markets, secure financing, develop a customer base, attract,
retain and motivate qualified personnel, and develop strategic alliances. Through September 30, 2020, the Company has primarily
funded its operations through equity offerings and strategic partnerships, including collaboration with Merck Sharp & Dohme
Corp. (“Merck”).
2.
Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed consolidated financial statements have been prepared in accordance with United States generally accepted
accounting principles (“U.S. GAAP”) for interim financial information, the instructions to Form 10-Q and Article 10
of Regulation S-X set forth by the Securities and Exchange Commission (“SEC”). They do not include all of the information
and notes required by generally accepted accounting principles for complete financial statements. In the opinion of management,
all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The
results of operations for the interim periods presented are not necessarily indicative of the results of operations for the entire
fiscal year. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s
annual report on Form 10-K for the year ended December 31, 2019 filed on March 27, 2020 (“Annual Report”).
Principles
of Consolidation
The
consolidated financial statements include the accounts of Cocrystal Pharma, Inc. and its wholly owned subsidiaries: Cocrystal
Discovery, Inc., Cocrystal Merger Sub, Inc., Baker Cummins Corp. and Biozone Laboratories, Inc. Intercompany transactions and
balances have been eliminated.
Segments
The
Company operates in only one segment. Management uses cash flows as the primary measure to manage its business and does not segment
its business for internal reporting or decision-making.
Use
of Estimates
Preparation
of the Company’s consolidated financial statements in conformance with U.S. GAAP requires the Company’s management
to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure
of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The significant
estimates in the Company’s consolidated financial statements relate to the valuation of equity awards and derivative liabilities,
recoverability of deferred tax assets, estimated useful lives of fixed assets, and forecast assumptions used in the valuation
of intangible assets and goodwill. The Company bases estimates and assumptions on historical experience, when available, and on
various factors that it believes to be reasonable under the circumstances. However, if future results are not consistent with
our estimates and assumptions, including as a result of the COVID-19 global pandemic, then we may be exposed to an impairment
charge, which could be material. The Company evaluates its estimates and assumptions on an ongoing basis, and its actual results
may differ from estimates made under different assumptions or conditions.
F- 5
Concentrations
of Credit Risk
Financial
instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash deposited
in accounts held at two U.S. financial institutions, which may, at times, exceed federally insured limits of $250,000 for each
institution accounts are held. At September 30, 2020 and December 31, 2019, our primary operating account held approximately $31,781,000
and $7,418,000, respectively, and our collateral account balance was $50,000 at a different institution. The Company has not experienced
any losses in such accounts and believes it is not exposed to significant risks thereof.
As
of September 30, 2020, 100% of our revenue and receivables are from one customer, Merck Sharp & Dohme Corp.
Fair
Value Measurements
FASB
Accounting Standards Codification (“ASC”) 820 defines fair value, establishes a framework for measuring fair value
under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined under
ASC 820 as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. Valuation techniques used to measure fair value under ASC 820 must maximize the use of observable inputs and minimize the
use of unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs, of which the first
two are considered observable and the last unobservable, that may be used to measure fair value which are the following:
Level
1 — quoted prices in active markets for identical assets or liabilities.
Level
2 — other significant observable inputs for the assets or liabilities through corroboration with market data at the
measurement date.
Level
3 — significant unobservable inputs that reflect management’s best estimate of what market participants would
use to price the assets or liabilities at the measurement date.
The
Company categorizes its cash and restricted cash as Level 1 fair value measurements. The Company categorizes its warrants
potentially settleable in cash as Level 2 fair value measurements. The warrants potentially settleable in cash are measured
at fair value on a recurring basis and are being marked to fair value at each reporting date until they are completely
settled or meet the requirements to be accounted for as component of stockholders’ equity. The warrants are valued
using the Black-Scholes option pricing model as discussed in Note 7 – Warrants.
At
September 30, 2020 and December 31, 2019, the carrying amounts of financial assets and liabilities, such as cash, accounts receivable,
other assets, and accounts payable and accrued expenses approximate their fair values due to their short-term nature. The carrying
values of notes payable and lease liabilities approximate their fair values due to the fact that the interest rates on these obligations
are based on prevailing market interest rates.
The
Company’s derivative liabilities are considered Level 2 measurements.
Goodwill
In
November 2014, goodwill was recorded in connection with the acquisition of RFS Pharma.
We
evaluate indefinite-lived intangible assets and goodwill for impairment annually, as of November 30, or more frequently when events
or circumstances indicate that impairment may have occurred. As part of the impairment evaluation, we may elect to perform an
assessment of qualitative factors. If this qualitative assessment indicates that it is more likely than not that the fair value
of the indefinite-lived intangible asset or the reporting unit (for goodwill) is less than its carrying value, we then would proceed
with the quantitative impairment test to compare the fair value to the carrying value and record an impairment charge if the carrying
value exceeds the fair value.
Fair
value is typically estimated using an income approach based on the present value of future discounted cash flows. The significant
estimates in the discounted cash flow model primarily include the discount rate, and rates of future revenue and expense growth
and/or profitability of the acquired assets. In performing the impairment test, the Company considered, among other factors, the
Company’s intention for future use of acquired assets, analyses of historical financial performance and estimates of future
performance of Cocrystal’s product candidates.
F- 6
At
September 30, 2020, the Company had goodwill of $19,092,000. The Company previously completed its annual impairment test in November
2019, and at that time determined the fair value of its reporting unit, under both the Company’s Nasdaq market capitalization
and an income approach analysis; both methods were less than the carrying value as of December 31, 2019; therefore, management
considered goodwill to be impaired. This resulted in a $46,103,000 impairment in 2019. The Company plans to conduct its next annual
impairment test in November 2020.
Based
on management’s assessment on September 30, 2020, no further impairment of Goodwill is required.
Long-Lived
Assets
The
Company regularly reviews the carrying value and estimated lives of its long-lived assets, including property and equipment, to
determine whether indicators of impairment may exist which warrant adjustments to carrying values or estimated useful lives. The
determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income
from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s
business objective. Should an impairment exist, the impairment loss would be measured based on the excess of the carrying amount
over the asset’s fair value.
Research
and Development Expenses
All
research and development costs are expensed as incurred.
Revenue
Recognition
The
Company recognizes revenue from research and development arrangements. In accordance with Accounting Standards Codification (“ASC”)
Topic 606– Revenue from Contracts with Customers (“Topic 606”), revenue is recognized when a customer
obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which the Company
expects to be entitled to receive in exchange for these goods and services.
In
November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic
808 and Topic 606 . This ASU provides guidance on whether certain transactions between collaborative arrangement participants
should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context
of a unit of account. Accordingly, this amendment added unit of account guidance in Topic 606 when an entity is assessing whether
the collaborative arrangement, or a part of the arrangement, is within the scope of Topic 606. In addition, the amendment provides
certain guidance on presenting the collaborative arrangement transaction together with Topic 606.
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration
Agreement”) with Merck to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the
Collaboration Agreement, Merck will fund research and development for the program, including clinical development, and will be
responsible for worldwide commercialization of any products derived from the collaboration.
Revenue
recorded for the three and nine months ended September 30, 2020 was $489,000 and $1,504,000 respectively, compared with $492,000
and $6,162,000 for the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, accounts receivable
of $581,000 was due from Merck.
Income
Taxes
The
Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities
are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using
enacted tax rates and laws that are expected to be in effect when the differences are expected to be recovered or settled. Realization
of deferred tax assets is dependent upon future taxable income. A valuation allowance is recognized if it is more likely than
not that some portion or all of a deferred tax asset will not be realized based on the weight of available evidence, including
expected future earnings. The Company recognizes an uncertain tax position in its financial statements when it concludes that
a tax position is more likely than not to be sustained upon examination based solely on its technical merits. Only after a tax
position passes the first step of recognition will measurement be required. Under the measurement step, the tax benefit is measured
as the largest amount of benefit that is more likely than not to be realized upon effective settlement. This is determined on
a cumulative probability basis. The full impact of any change in recognition or measurement is reflected in the period in which
such change occurs. The Company elects to accrue any interest or penalties related to income taxes as part of its income tax expense.
F- 7
As
of September 30, 2020, the Company assessed its income tax expense based on its projected future taxable income for the year ended
December 31, 2020 and therefore recorded no amount for income tax expense for the nine months ended September 30, 2020. In addition,
the Company has significant deferred tax assets available to offset income tax expense due to net operating loss carry forwards
which are currently subject to a full valuation allowance based on the Company’s assessment of future taxable income. Refer
to our Annual Report on Form 10-K for the year ended December 31, 2019 for more information.
Franchise
Taxes
As
of June 30, 2020, the Company amended its franchise tax filed for 2018 period, which the result is a credit balance of $126,000.
The Company recognized $51,000 as expense for the period from January 1, 2020 through September 30, 2020; the balance of $75,000
is recorded as prepaid expense to be amortized until September 30, 2021. Franchise taxes are included in the general and administrative
expenses.
Stock-Based
Compensation
The
Company recognizes compensation expense using a fair value-based method for costs related to stock-based payments, including stock
options. The fair value of options awarded to employees is measured on the date of grant using the Black-Scholes option pricing
model and is recognized as expense over the requisite service period on a straight-line basis.
Use
of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected
term, and a risk-free interest rate. The Company estimates volatility using a blend of its own historical stock price volatility
as well as that of market comparable entities since the Company’s common stock has limited trading history and limited observable
volatility of its own. The expected term of the options is estimated by using the Securities and Exchange Commission Staff Bulletin
No. 107’s Simplified Method for Estimating Expected Term . The risk-free interest rate is estimated using comparable
published federal funds rates.
Share
Issuance Costs
The
Company accounts for direct and incremental costs related to the issuance of its capital stock as a reduction in the proceeds
from such issuances. In the case, the Company incurs certain expenses related to the offering of equity security, the Company
complies with the requirements of FASB 340-10-S99-1with regards to offering costs.
Common
Stock Purchase Warrants and Other Derivative Financial Instruments
We
classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement
or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our
own stock as defined in ASC 815-40, Contracts in Entity’s Own Equity . We classify as assets or liabilities any contracts
that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event
is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement
or net-share settlement). We assess classification of our common stock purchase warrants and other freestanding derivatives at
each reporting date to determine whether a change in classification between assets and liabilities is required.
Net
Income (Loss) per Share
The
Company accounts for and discloses net income (loss) per common share in accordance with FASB ASC Topic 260, Earnings Per Share .
Basic income (loss) per common share is computed by dividing income (loss) attributable to common stockholders by the weighted
average number of common shares outstanding. Diluted net income (loss) per common share is computed by dividing net income (loss)
attributable to common stockholders by the weighted average number of common shares that would have been outstanding during the
period assuming the issuance of common stock for all potential dilutive common shares outstanding. Potential common shares consist
of shares issuable upon the exercise of stock options and warrants and the conversion of convertible notes payable.
F- 8
The
following table sets forth the number of potential common shares excluded from the calculations of net loss per diluted share
because their inclusion would be anti-dilutive (in thousands):
September 30,
2020
2019
Outstanding options to purchase common stock
1,801
931
Warrants to purchase common stock
243
243
Total
2,044
1,174
Recent
Accounting Pronouncements
In
August 2020, the FASB issued ASU No. 2020-06 (“ASU 2020-06”) “Debt—Debt with Conversion and Other Options
(Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible
Instruments and Contracts in an Entity’s Own Equity.” ASU 2020-06 will simplify the accounting for convertible
instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting
the accounting models will result in fewer embedded conversion features being separately recognized from the host contract as
compared with current GAAP. Convertible instruments that continue to be subject to separation models are (1) those with embedded
conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and
that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial
premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope
exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06
will be effective January 1, 2024, for the Company. Early adoption is permitted, but no earlier than January 1, 2021, including
interim periods within that year. Management is currently evaluating the effect of the adoption of ASU 2020-06 on the consolidated
financial statements, but currently does not believe ASU 2020-06 will have a significant impact on the Company’s accounting
for its convertible debt instruments as they are not considered indexed to the Company’s own stock. The effect will largely
depend on the composition and terms of the financial instruments at the time of adoption.
In
June 2016, the FASB issued ASU No. 2016-13, Credit Losses - Measurement of Credit Losses on Financial Instruments (“ASC
326”). The standard significantly changes how entities will measure credit losses for most financial assets, including accounts
and notes receivables. The standard will replace today’s “incurred loss” approach with an “expected loss”
model, under which companies will recognize allowances based on expected rather than incurred losses. Entities will apply the
standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting
period in which the guidance is effective. The standard is effective for interim and annual reporting periods beginning after
December 15, 2019. The adoption of ASU 2016-13 is not expected to have a material impact on the Company’s financial position,
results of operations, and cash flows.
Other
recent authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified
Public Accountants, and the Securities and Exchange Commission (“SEC”) did not, or are not expected to, have a material
impact on the Company’s consolidated financial statements and related disclosures.
3.
Property and Equipment
Property
and equipment are recorded at cost and depreciated over the estimated useful lives of the underlying assets (three to five years)
using the straight-line method. As of September 30, 2020, and December 31, 2019, property and equipment consists of (in thousands):
September 30, 2020
December 31, 2019
Lab equipment
$ 1,498
$ 1,073
Finance lease right-of-use lab equipment obtained in exchange for finance lease liabilities
119
347
Computer and office equipment
120
92
Total property and equipment
1,737
1,512
Less: accumulated depreciation and amortization
(1,102 )
(1,081 )
Property and equipment, net
$ 635
$ 431
Total
depreciation and amortization expense was $44,000 and $112,000 for the three and nine months ended September 30, 2020, which includes
amortization expense of $6,000 and $38,000 related to finance lease right-of-use lab equipment, respectively. For additional finance
leases information, refer to Note 9 – Commitments and Contingencies.
4.
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consisted of the following (in thousands) as of:
September 30, 2020
December 31, 2019
Accounts payable
$ 1,485
$ 1,511
Accrued compensation
183
83
Accrued other expenses
682
405
Total accounts payable and accrued expenses
$ 2,350
$ 1,999
Accounts
payable and accrued other expenses contain unpaid general and administrative expenses and costs related to research and development
that have been billed and estimated unbilled, respectively, as of period-end.
F- 9
5.
Common Stock
As
of September 30, 2020, the Company has authorized 100,000,000 shares of common stock, $0.001 par value per share. The Company
had 68,563,512 and 35,150,000 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively.
The
holders of common stock are entitled to one vote for each share of common stock held.
On
January 29, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which
the Company agreed to sell and issue, in a registered direct offering, 3,492,063 shares of common stock at a purchase price per
share of $0.63 for aggregate net proceeds to the Company of approximately $1.5 million, after deducting fees payable to the placement
agent and other estimated offering expenses payable by the Company. The Company closed the offering on January 31, 2020.
On
February 27, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to
which the Company agreed to sell and issue, in a registered direct offering, 8,461,540 shares of common stock at a purchase price
per share of $1.30 for aggregate net proceeds to the Company of approximately $10.1 million, after deducting fees payable to the
placement agent and other estimated offering expenses payable by the Company. The Company closed the offering on February 28,
2020.
On
March 9, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which
the Company agreed to sell and issue, in a registered direct offering, 5,037,038 shares of common stock at a purchase price per
share of $1.35 for aggregate net proceeds to the Company of approximately $5.0 million, after deducting fees payable to the placement
agent, lock-up settlement fee and other estimated offering expenses payable by the Company. The Company closed the offering on
March 10, 2020.
On
June 2, 2020, the Company provided written notice to A.G.P./Alliance Global Partners (“AGP”) of its election to terminate
the Amended and Restated Equity Distribution Agreement, dated October 30, 2019, by and between the Company and AGP, as amended
on January 29, 2020 (the “AGP Agreement”). The termination of the AGP Agreement was effective June 3, 2020.
On
July 1, 2020, the Company entered into an At-The-Market Offering Agreement with H.C. Wainwright & Co., LLC (“Wainwright”),
pursuant to which the Company may issue and sell over time and from time to time, to or through Wainwright, up to $10,000,000
of shares of the Company’s common stock. The Company has not sold any shares pursuant to this ATM during the nine months
ended September 30, 2020.
On August 31, 2020, the Company closed
an underwritten public offering of its common stock totaling 16,422,813 shares at public offering price of $1.05 per share sold
to Wainwright for net proceeds of approximately $15.6 million, after deducting fees payable to the placement agent and other offering
expenses payable by the Company. The 16,422,813 shares of common stock sold in the offering includes 2,137,098 shares
pursuant to Wainwright’s partial exercise of its over-allotment option to purchase additional shares of common stock, pursuant
to the Amended and Restated Underwriting Agreement, dated as of August 26, 2020, between the Company and Wainwright.
6.
Stock Based Awards
Equity
Incentive Plans
The
Company adopted an equity incentive plan in 2007 (the “2007 Plan”) under which 1,786,635 shares of common stock had
been reserved for issuance to employees and nonemployee directors and consultants of the Company. The Company no longer issues
any awards under the 2007 Plan. Holders of outstanding incentive stock options granted under the 2007 Plan are eligible to purchase
shares of the Company’s common stock at an exercise price equal to no less than the fair market value of such stock on the
date of grant. The maximum term of options granted under the 2007 Plan was ten years.
The
Company adopted a second equity incentive plan in 2015 (the “2015 Plan”) under which 2,705,237 (including 1,038,570
initially transferred from the 2007 Plan) shares of common stock have been reserved for issuance to employees, and nonemployee
directors and consultants of the Company. Recipients of incentive stock options granted under the 2015 Plan shall be eligible
to purchase shares of the Company’s common stock at an exercise price equal to no less than the estimated fair market value
of such stock on the date of grant. The maximum term of options granted under the 2015 Plan is ten years. As of September 30,
2020, 2,718,020 options remain available for future grants under the 2015 Plan.
F- 10
The
following table summarizes stock option transactions for the 2007 Plan and 2015 Plan, collectively, for the nine months ended
September 30, 2020 (in thousands, except per share amounts):
Number of
Shares
Available
for Grant
Total
Options
Outstanding
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Balance at December 31, 2019
3,588
931
$ 4.14
$ -
Exercised
-
-
-
-
Granted
(878 )
878
1.33
_
Cancelled
8
(8 )
2.94
-
Balance at September 30, 2020
2,718
1,801
2.78
_
The
Company accounts for share-based awards to employees and nonemployee directors and consultants in accordance with the provisions
of ASC 718, Compensation—Stock Compensation. , and under the recently issued guidance following FASB’s pronouncement,
ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting .
Under ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair
value is recognized over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes
option pricing model, and accounts for forfeitures when they occur. For the three and nine months ended September 30, 2020 and
2019, equity-based compensation expense recorded was $237,000 and $463,000, and $108,000 and $253,000, respectively.
During
the nine months ended September 30, 2020 the Company granted stock options to officers, directors, employees and consultants to
purchase a total of 878,000 shares of common stock. The options have an exercise price of $1.33 per share, expire in ten years,
and vest as follows: one half vests on the one year anniversary of the grant date and the remainder will vest in eight equal quarterly
increments with the first such quarterly increment vesting on September 30, 2021. The total fair value of these options at the
grant date was approximately $944,000 using the Black-Scholes Option pricing model.
The
fair value of share option award is estimated using the Black-Scholes option pricing method based on the following weighted-average
assumptions:
Nine Months Ended September 30,
2020
2019
Risk-free interest rate
0.43 %
2.99 %
Average expected term (years)
5.9
6.1
Expected volatility
107.45 %
90.00 %
Expected dividend yield
0.00
0.00
The
risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of measurement corresponding with the
expected term of the share option award; the expected term represents the weighted-average period of time that share option awards
granted are expected to be outstanding giving consideration to vesting schedules and historical participant exercise behavior;
the expected volatility is based upon historical volatility of the Company’s common stock; and the expected dividend yield
is based on the fact that the Company has not paid dividends in the past and does not expect to pay dividends in the future.
As
of September 30, 2020, there was approximately $1,661,000 of total unrecognized compensation expense related to non-vested stock
options that is expected to be recognized over a weighted average period of 8.5 years. For options granted and outstanding, there
were 515,564 options outstanding which were fully vested or expected to vest, with an aggregate intrinsic value of $0, a weighted
average exercise price of $2.77, and weighted average remaining contractual term of 6.8 years at September 30, 2020. For vested
and exercisable options, outstanding shares totaled 515,564, with an aggregate intrinsic value of $0. These options had a weighted
average exercise price of $5.24 per share and a weighted-average remaining contractual term of 6.8 years at September 30, 2020.
The
aggregate intrinsic value of outstanding and exercisable options at September 30, 2020 was calculated based on the closing price
of the Company’s common stock as reported on The Nasdaq Capital Market on September 30, 2020 of $0.93 per share less the
exercise price of the options. The aggregate intrinsic value is calculated based on the positive difference between the closing
fair market value of the Company’s common stock and the exercise price of the underlying options.
Common
Stock Reserved for Future Issuance
The
following table presents information concerning common stock available for future issuance (in thousands) as of:
September 30, 2020
September 30, 2019
Stock options issued and outstanding
1,801
931
Shares authorized for future option grants
2,718
3,588
Warrants outstanding
243
243
Total
4,762
4,762
F- 11
7.
Warrants
The
following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the
nine months ended September 30, 2020 (in thousands):
Warrants
Accounted for as:
Equity
Warrants Accounted for as: Liabilities
May 2018
Warrants
October 2013
Warrants
January 2014
Warrants
Total
Outstanding, December 31, 2019
84
26
133
243
Exercised
-
-
-
-
Granted
-
-
-
-
Expired
-
-
-
-
Outstanding, September 30, 2020
84
26
133
243
Expiration date:
October 27, 2022
October 24, 2023
January 16, 2024
The
following is a summary of activity in the number of warrants outstanding to purchase the Company’s common stock for the
nine months ended September 30, 2019 (in thousands):
Warrants
Accounted for as:
Equity
Warrants Accounted for as: Liabilities
May 2018
Warrants
October 2013
Warrants
January 2014
Warrants
Total
Outstanding, December 31, 2018
84
26
133
243
Exercised
-
-
-
-
Granted
-
-
-
-
Expired
-
-
-
-
Outstanding, September 30, 2019
84
26
133
243
Expiration date:
October 27, 2022
October 24, 2023
January 16, 2024
Warrants
Classified as Liabilities
Liability-classified
warrants consist of warrants issued by Biozone in connection with equity financings in October 2013 and January 2014, which were
assumed by the Company in connection with its merger with Biozone in January 2014. Warrants accounted for as liabilities have
the potential to be settled in cash or are not indexed to the Company’s own stock.
The
estimated fair value of outstanding warrants accounted for as liabilities is determined at each balance sheet date. Any decrease
or increase in the estimated fair value of the warrant liability since the most recent balance sheet date is recorded in the condensed
consolidated statement of operations as changes in fair value of derivative liabilities.
The
fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following
inputs as of September 30, 2020:
October 2013
Warrants
January 2014
Warrants
Strike price
$ 15.00
$ 15.00
Expected dividend yield
0.00 %
0.00 %
Contractual term (years)
3.1
3.3
Cumulative volatility
116.46 %
114.97 %
Risk-free rate
0.15 %
0.17 %
Value
$ 0.21
$ 0.23
The
fair value of the warrants classified as liabilities is estimated using the Black-Scholes option-pricing model with the following
inputs as of December 31, 2019:
October 2013
Warrants
January 2014
Warrants
Strike price
$ 15.00
$ 15.00
Expected dividend yield
0.00 %
0.00 %
Contractual term (years)
3.8
4.0
Cumulative volatility
89.59 %
90.58 %
Risk-free rate
1.67 %
1.68 %
Value
$ 0.04
$ 0.05
The
Company estimates volatility using a blend of its own historical stock price volatility as well as that of market comparable entities
since the Company’s common stock has limited trading history and limited observable volatility of its own. The expected
life assumption is based on the remaining contractual terms of the warrants. The risk-free rate is based on the zero coupon rates
in effect at the balance sheet date. The dividend yield used in the pricing model is zero, because the Company has no present
intention to pay cash dividends.
8.
Licenses and Collaborations
Merck
On
January 2, 2019, the Company entered into an Exclusive License and Research Collaboration Agreement (the “Collaboration
Agreement”) with Merck to discover and develop certain proprietary influenza A/B antiviral agents. Under the terms of the
Collaboration Agreement, Merck funds research and development for the program, including clinical development, and will be responsible
for worldwide commercialization of any products derived from the collaboration. Cocrystal received an upfront payment of $4,000,000
in 2019 and is eligible to receive payments related to designated development, regulatory and sales milestones with the potential
to earn up to $156,000,000, as well as royalties on product sales. Merck can terminate the Collaboration Agreement at any time
prior to the first commercial sale of the first product developed under the Collaboration Agreement, in its sole discretion, without
cause.
The
Company recognized $1,504,000 in revenues on the condensed consolidated statement of operations for the nine months ended September
30, 2020 related to influenza A/B program research and development expenses for the first nine months of 2020.
F- 12
Kansas
State University Research Foundation
Cocrystal
entered into a License Agreement with Kansas State University Research Foundation (“KSURF”) on February 18, 2020 to
further develop certain proprietary broad-spectrum antiviral compounds for the treatment of Norovirus and Coronavirus infections.
Pursuant
to the terms of the License Agreement, KSURF granted the Company an exclusive royalty bearing license to practice under certain
patent rights, under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses, and related
know-how, including to make and sell therapeutic, diagnostic and prophylactic products.
The
Company agreed to pay KSURF a one-time non-refundable license initiation fee of $80,000 under the License Agreement, and annual
license maintenance fees. The Company also agreed to make certain future milestone payments, dependent upon the progress of clinical
trials, regulatory approvals, and initiation of commercial sales in the United States and certain countries outside the United
States.
On
April 19, 2020, the Company entered into a second License Agreement with KSURF in addition to the License Agreement entered into
in February 2020.
Pursuant
to the terms of the second License Agreement, KSURF granted the Company an exclusive royalty bearing license to practice under
certain patent rights under patent applications covering antivirals against coronaviruses, caliciviruses, and picornaviruses,
and related know-how, including to make and sell therapeutic, diagnostic and prophylactic products.
The
Company agreed to pay KSURF a one-time non-refundable license initiation fee and annual license maintenance fees. The Company
also agreed to make certain future milestone payments, dependent upon the progress of clinical trials, regulatory approvals, and
initiation of commercial sales in the United States and certain countries outside the United States.
9.
Commitments and Contingencies
Commitments
In
the ordinary course of business, the Company enters into non-cancelable leases to purchase equipment and for its facilities, including
related party leases (see Note 10 – Transactions with Related Parties). Leases are accounted for as operating leases or
finance leases, in accordance with ASC 842, Leases .
Operating
Leases
The
Company leases office space in Miami, Florida and laboratory space in Bothell, Washington under operating leases that expire on
August 31, 2021 and January 31, 2024, respectively. The Company recently signed an amendment to the Bothell, Washington lease
agreement by extending the lease term for a period of sixty months from February 2019 through January 2024. For operating leases,
the weighted average discount rate is 8.0% and the weighted average remaining lease term is 3.1 years.
The
following table summarizes the Company’s maturities of operating lease liabilities, by year and in aggregate, as of September
30, 2020 (in thousands):
2020 (excluding the nine months ended September 30, 2020)
$ 57
2021
213
2022
178
2023
183
Thereafter
15
Total operating lease payments
646
Less: present value discount
(77 )
Total operating lease liabilities
$ 569
The
operating lease liabilities summarized above do not include variable common area maintenance (CAM) charges, which are contractual
liabilities under the Company’s Bothell, Washington lease. CAM charges for the Bothell, Washington facility are calculated
annually based on actual common expenses for the building incurred by the lessor and proportionately billed to tenants based on
leased square footage. For the nine months ended September 30, 2020 and 2019, approximately $54,000 and $60,000 of variable lease
expense (CAM) was included in general and administrative operating expenses on the condensed consolidated statements of operations.
The
minimum lease payments above include the amounts that would be paid if the Company maintains its Bothell lease for the five-year
term, starting February 2019. The Company has the right to terminate this lease after three years on January 31, 2022, by giving
prior notice at least nine months before the early termination date and by paying a termination fee equal to the sum of unamortized
leasing commissions and reimbursement for tenant improvements provided by the landlord amortized at 8.0% over the extended term.
On
September 1, 2018, the Company entered into a lease agreement with a limited liability company controlled by Dr. Phillip Frost,
a director and a principal shareholder of the Company (see Note 10 – Transactions with Related Parties). The lease term
is three years with an optional three-year extension. On an annualized basis, straight-line rent expense is approximately $58,000,
including fixed and estimable fees and taxes. As of September 30, 2020, operating lease rights include $51,000 and operating lease
liabilities include $53,000 relating to this lease.
F- 13
For
the nine months ended September 30, 2020 and 2019, operating lease expense, excluding short-term leases, finance leases and CAM
charges, totaled approximately $171,000 and $169,000, respectively, of which $44,000 and $43,000 in each period was to a related
party.
Finance
Leases
In
November 2018, the Company entered into two lease agreements to acquire lab equipment with 18 monthly payments of $18,000 payable
through May 27, 2020 and 36 monthly payments of $1,000 payable through November 21, 2021, respectively; in September 2020 the
Company entered into a new lease agreement to acquire lab equipment with 36 payments of $2,000 monthly payable through April 16,
2023. For finance leases, the weighted average discount rate is 8.0% and the weighted average remaining lease term is 3.4 years.
The
following table summarizes the Company’s maturities of finance lease liabilities, by year and in aggregate, as of September
30, 2020 (in thousands):
2020 (excluding the nine months ended September 30, 2020)
$ 11
2021
44
2022
29
2023
7
Total finance lease payments
91
Less: present value discount
(7 )
Total finance lease liabilities
$ 84
The
leased lab equipment is depreciable over five years and is presented net of accumulated depreciation on the condensed consolidated
balance sheets under property and equipment. As of September 30, 2020, total right-of-use lab equipment and accumulated depreciation
recognized under finance leases is $119,000 and $21,000, respectively, and depreciation expense for the nine months ended September
30, 2020 was $38,000. As of December 31, 2019, total right-of-use assets lab equipment exchanged for finance lease liabilities
was $347,000 and accumulated depreciation for lab equipment under finance leases was $75,000.
At
September 30, 2020, the aggregate outstanding balance of finance lease liabilities, current and long-term, is $84,000 and the
Company expects to pay future interest charges of $7,000 over the remaining finance lease terms. At December 31, 2019, the aggregate
outstanding balance of finance lease liabilities, current and long-term, was $117,000 and the Company expects to pay future interest
charges of $4,000 over the remaining finance lease terms. For the nine months ended September 30, 2020, the Company paid $107,000
and $6,000 in principal and interest, respectively, totaling financing cash out flows of $113,000, net of interest expense, for
amount included in the measurement of lease liabilities for finance leases. For the nine months ended September 30, 2019, the
Company paid $159,000 and $16,000 in principal and interest, respectively, totaling financing cash out flows of $175,000 for
amounts included in the measurement of lease liabilities for finance leases and added back to net income the $16,000 of interest
expense under cash flows from operating activities.
Contingencies
From
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business.
As of the date of this report, except as described below, the Company is not aware of any proceedings, threatened or pending,
against it which, if determined adversely, would have a material effect on its business, results of operations, cash flows or
financial position.
On
September 20, 2018, Anthony Pepe, individually and on behalf of a class, filed with the United States District Court for the District
of New Jersey a complaint against the Company, certain current and former executive officers and directors of the Company and
the other defendants named therein for violation of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder. The
class consists of the persons and entities who purchased the Company’s common stock during the period from September 23,
2013 through September 7, 2018. Pepe also alleges violation of other sections of the Exchange Act by the defendants named in the
complaint other than the Company. Pepe seeks damages, pre-judgment and post-judgment interest, reasonable attorneys’ fees,
expert fees and other costs.
On
January 16, 2019, Ms. Susan Church, a stockholder of the Company, filed with the United States District Court for the Western
District of Washington a derivative suit against certain current and former executive officers and directors of the Company alleging
breach of fiduciary duties, unjust enrichment, waste of corporate assets, and violations of the rules governing proxy solicitation.
Church seeks, among other things, money damages, disgorgement of profits from alleged wrongful conduct, including cash bonuses,
pre-judgment and post-judgment interest, reasonable attorneys’ fees, expert fees and other costs.
On
July 2, 2020, the Company negotiated and executed term sheets with respect to the proposed settlement of the class action, the
derivative lawsuit discussed above, and two related derivative actions. The term sheets are subject to approval by the court.
As of September 30, 2020, the Company agreed to pay $450,000 for its share of the total proposed class action settlement. The
final settlement hearing for the class action and derivative lawsuits is scheduled for December 16, 2020.
As
for the settlement of the derivative lawsuits, the Company agreed to make certain corporate governance changes. On September
22, 2020, United States District Court for the District of New Jersey, where one of the derivative actions was pending,
entered an order preliminarily approving the Stipulation and Agreement of Settlement, dated August 20, 2020 (the
“Stipulation”) by and among the plaintiffs in the derivative actions, the Company as the nominal defendant, and
defendants, including certain of the Company’s current and former directors and officers. The settlement as documented
in the Stipulation covers all three derivative actions and is subject to the approval of the Court. The proposed settlement
requires that certain defendants named in the Stipulation, other than the Company, pay the plaintiffs’ attorneys’
fees and expenses in the amount of $275,000, and that the Company adopt within 60 days of the final approval of the
settlement by the Court certain corporate governance enhancements.
Liberty
Insurance Underwriters Inc. filed suit against us in federal court in Delaware seeking a declaratory judgment that it is not liable
to defend us in the class and derivative litigation. The insurance company also is claiming it is entitled to recover $1 million
it advanced to us in connection with a prior SEC investigation, of which the Company disagrees with the insurance company position.
We have retained counsel to defend us which has filed an answer to the complaint.
F- 14
In
November 2017, Lee Pederson, a former Biozone lawyer, filed a lawsuit in the U.S. District Court in Minnesota against co-defendants
the Company, Dr. Phillip Frost, OPKO Health, Inc. and Brian Keller alleging that defendants engaged in wrongful conduct related
to Biozone, including causing Biozone to enter into an allegedly improper licensing agreement and engaged in alleged market manipulation.
On September 13, 2018, the United States District Court granted the Company and its co-defendants’ motion to dismiss Pederson’s
amended complaint for lack of personal jurisdiction in Minnesota. On October 11, 2018, Pederson filed a notice of appeal with
the United States Court of Appeals for the Eighth Circuit. The plaintiff’s appeal was denied and the dismissal affirmed.
In July 2019, Lee Pederson filed another lawsuit in the U.S. District Court in Minnesota against co-defendants the Company, Dr.
Frost, and Daniel Fisher. In his complaint, Pederson alleges tortious interference by the Company and Dr. Frost with an alleged
collaboration agreement between Mr. Pederson and Mr. Fisher. Mr. Pederson seeks damages in the amount of $800,000 or such other
amount as may be determined at trial. This lawsuit had previously been stayed by the court, pending disposition of Pederson’s
first lawsuit. With that first lawsuit having been dismissed and appeal denied, the stay was lifted, and the Company was served
in July 2020 with the complaint initiating that second lawsuit. The Company is reviewing the complaint with counsel. On October
14, 2020, the Company and co-defendants’ motions for, among other things, dismissal for lack of personal jurisdiction in
that second lawsuit were heard by the court, and the Company and co-defendants are awaiting a ruling from the trial court.
On
May 19, 2020, A.G.P./Alliance Global Partners (“AGP”), which had previously acted as the Company’s underwriter,
placement agent and sales agent in connection with the Company’s registered and exempt equity offerings, filed a lawsuit
against the Company in the United States District Court for the Southern District of New York alleging violation of a lock-up
provision under the Placement Agent Agreement, dated January 28, 2020 (the “Placement Agent Agreement”), by and between
the Company and AGP. AGP seeks (i) damages estimated in the complaint to be in excess of $1 million and attorneys’ fees,
and (ii) declaratory relief. The Company has filed a motion to dismiss the complaint.
While
the Company intends to defend itself vigorously from the claims in the aforementioned disputes, it is unable to predict the outcome
of these legal proceedings. Any potential loss as a result of these legal proceedings cannot be reasonably estimated. As a result,
the Company has not recorded a loss contingency for any of the aforementioned claims.
COVID-19
Our
administrative and finance activities are fully functional out of our Miami, Florida location and our research laboratory in Bothell,
Washington remains open for essential operations while meeting COVID-19 quarantine challenges. Our scientists are also able to
continue working on site and remotely and we remain committed to meeting our corporate and development milestones throughout the
year. We have experienced delays in our supply chain and with service partners as a result of the COVID-19 pandemic. Also because
of the unknown impact from the COVID-19 pandemic, it may have unanticipated material adverse effects on us in a number of ways
including:
●
If
our scientists and other personnel (or their family members) are infected with the virus, it may hamper our ability to engage
in ongoing research activities;
●
Similarly,
we rely on third parties who can be similarly impacted;
●
If
these third parties are affected by COVID-19, they may focus on other activities which they may devote their limited time
to other priorities rather than to our joint research;
●
We
may experience a shortage of laboratory materials which would impact our research activities;
●
As
a result of the continuing impact of the virus, we may fail to get access to third party laboratories which would impact our
research activities; and
●
We
may sustain problems due to the serious short-term and possible longer term serious economic disruptions as our economy faces
unprecedented uncertainty.
10.
Transactions with Related Parties
In
September 2018, the Company leased administrative offices from a limited liability company owned by one of the Company’s
directors and principal shareholder, Dr. Phillip Frost. The operating lease term is three years with an optional three-year extension.
On an annualized basis, straight-line lease expense, including taxes and fees, for this location is approximately $58,000. In
September 2018, the Company paid a lease deposit of $4,000 and total amounts paid in connection with this operating lease were
$44,000 and $42,000 for the nine months ended September 30, 2020 and 2019, respectively.
F- 15
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Cocrystal
Pharma, Inc. (the “Company” or “Cocrystal”) is a clinical stage biotechnology company seeking to discover
and develop novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. We employ unique structure-based
technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies are designed
to efficiently deliver small molecule therapeutics that are safe, effective and convenient to administer. We have identified promising
preclinical and early clinical stage antiviral compounds for unmet medical needs including Influenza Virus, Coronavirus, Hepatitis
C virus (“HCV”), and Norovirus infections.
Impact
of COVID-19 Pandemic
A
novel strain of coronavirus which causes COVID-19 continues to spread and severely impact the economy of the United States and
other countries around the world. We are committed to being a part of the coordinated public and private sector response to this
unprecedented challenge.
We
have put preparedness plans in place at our facilities to maintain continuity of operations, while also taking steps to keep visitors
and employees healthy and safe. In line with recommendations to reduce large gatherings and increase social distancing, we have,
where practical, transitioned many office-based colleagues to a remote work environment.
The
consequences of the COVID-19 pandemic and the impact on the national and global economy continues to evolve and the full extent
of the impact is uncertain as of the date of this filing.
Research
and Development Update
During
the nine months ended September 30, 2020, the Company focused its research and development efforts primarily in four areas:
Influenza
Programs
Merck
Collaboration - Influenza A/B: On January 2, 2019, we entered into an Exclusive License and Research Collaboration Agreement (the
“Collaboration Agreement”) with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop certain
proprietary influenza A/B antiviral agents.
Under
the terms of the Collaboration Agreement, Merck is funding research and development for the program at Cocrystal and Merck, including
clinical development at Merck, and Merck is responsible for worldwide commercialization of any products derived from the collaboration.
The Company received an upfront payment of $4,000,000 and is eligible to receive milestone payments related to designated development,
regulatory and sales milestones with the potential to earn up to $156,000,000, as well as royalties on product sales. The Collaboration
Agreement operates under a Research Operating Plan (ROP) which includes goals for both organizations. The Company achieved its
anticipated goals in 2019 and through the third quarter of 2020.
CC-42344
Lead Molecule – Influenza A: We have several preclinical candidates under development for the treatment of influenza infection.
CC-42344, a novel PB2 inhibitor, has been selected as a preclinical lead. This candidate binds to a highly conserved PB2 site
of influenza polymerase complex (PB1: PB2: PA) and exhibits a novel mechanism of action. CC-42344 showed excellent preclinical
antiviral activity against influenza A strains, including avian pandemic strains and oseltamivir-resistant strains, and has a
favorable pharmacokinetic profile. We are currently conducting the remaining preclinical IND enabling activities and plan to initiate
a Phase 1 study during 2021.
Coronavirus
During
the nine months ended September 30, 2020, the Company initiated a coronavirus program targeting the SARS-CoV-2 virus that is responsible
for the COVID-19 pandemic. There is currently one COVID-19 antiviral treatment approved by the U.S. Food and Drug Administration
(“FDA”) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about
88 pounds) for the treatment of COVID-19 requiring hospitalization, although there are certain other drugs that may offer relief
and the federal government has funded ongoing vaccine research.
The
Company is currently advancing its Coronavirus program leveraging the rights to preclinical leads from its License Agreements
with KSURF to further develop certain proprietary broad-spectrum antiviral compounds for the treatment of coronavirus infections
(COVID-19). Cocrystal intends to pursue research and development of these antiviral compounds for coronavirus, including preclinical
and clinical development. The Company’s recent additional License Agreement from KSURF significantly expands and further
advances its COVID-19 program by providing additional novel anti-coronavirus compounds for further development.
We
initiated preclinical studies in our COVID-19 program during the second quarter and identified additional replication inhibitors
utilizing our proprietary platform technology during the third quarter of this year. The Company anticipates the selection of
its lead preclinical molecule in the fourth quarter of 2020.
3
Hepatitis
C
CC-31244,
our HCV Non-Nucleoside Polymerase Inhibitor (“NNI”), is a potential best-in-class pan-genotypic inhibitor of NS5B
polymerase for the treatment of HCV infection. It has the potential to be an important component in an all-oral ultra-short HCV
combination therapy. The Company filed an Investigational New Drug (“IND”) application with the FDA on February 28,
2018 and received notice from the FDA on March 29, 2018 that its IND was now open and the Company was cleared to initiate its
Phase 2a clinical study evaluating CC-31244 for the treatment of HCV infected individuals.
In
June 2018, the Company began enrollment in and initiation of patient dosing in its Phase 2a clinical study evaluating CC-31244
for the treatment of HCV infected individuals and completed the enrollment in September 2018. The Phase 2a open-label study was
designed to evaluate the safety, tolerability and preliminary efficacy of CC-31244 in combination with Epclusa, an approved twelve-week
HCV drug. Patients were treated with CC-31244 and Epclusa for two weeks and then Epclusa alone for an additional four weeks for
a total of six weeks.
On
January 22, 2019 the Company announced safety and preliminary efficacy data for the Phase 2a study. All subjects had completed
the six-week treatment regimen. The treatment was well tolerated with no study discontinuations due to adverse events. Eight of
12 subjects achieved the primary efficacy endpoint of sustained virologic response at 12 weeks after completion of treatment (SVR12).
SVR12 is defined as undetectable virus in blood 12 weeks after completion of treatment and is considered a virologic cure. The
eight subjects that achieved SVR12 had significantly higher frequencies of terminally differentiated effector memory CD8+ T cells
compared with the four that relapsed at both baseline and at end-of-6-week treatment. The trial and the final study report have
been completed.
In
October 2018, the Company signed a Clinical Trial Agreement for an investigator-initiated study with the Humanity & Health
Research Centre (“HHRC”) in Hong Kong, China. Due to unrest in Hong Kong and the coronavirus pandemic, the clinical
trial agreement has been terminated effective March 24, 2020.
The
Company is in partnership discussions for further clinical development of CC-31244. There can be no assurance that any discussions
will result in a partnership.
Norovirus
Infections
We
continue to identify and develop inhibitors of replication using the Company’s proprietary structure-based drug design technology
platform. Cocrystal recently entered into License Agreements with the KSURF to further develop certain proprietary broad-spectrum
antiviral compounds for humans to treat Norovirus and Coronavirus infections. Preclinical activities for our Norovirus program
are currently under way. The Company expects to complete its proof-of-concept animal model study in the fourth quarter of 2020.
Results
of Operations for the Three and Nine Months Ended September 30, 2020 compared to the Three and Nine Months Ended September 30,
2019
Revenue
Revenue
recorded for the three and nine months ended September 30, 2020 was $489,000 and $1,504,000, respectively, compared with $492,000
and $6,162,000 for the three and nine months ended September 30, 2019, respectively. The revenue for the nine months ended September
30, 2020 included $4,368,000 as consideration in exchange for conveyance of intellectual property rights at the signing of the
Merck Collaboration Agreement executed on January 2, 2019. Currently, reimbursement of research and development expenses under
the Collaboration Agreement is our only source of revenue.
4
Research
and Development Expenses
Research
and development expenses consist primarily of compensation-related costs for our employees dedicated to research and development
activities and for our Scientific Advisory Board members, as well as lab supplies, lab services, and facilities and equipment
costs related to our research and development programs. During the first quarter of 2020, we initiated a Coronavirus program targeting
the SARS-CoV-2 virus that is responsible for the COVID-19 pandemic. There is currently no approved specific vaccine or antiviral
treatment available for COVID-19.
Total
research and development expenses for the three and nine months ended September 30, 2020 were $2,077,000 and $5,336,000, respectively,
compared with $1,077,000 and $3,046,000 for the three and nine months ended September 30, 2019, respectively. The increase for
the three and nine months ended September 30, 2020 compared to the three months ended September 30, 2019 was primarily due to
increases in COVID-19 and Influenza A programs.
General
and Administrative Expenses
General
and administrative expenses include compensation-related costs for our employees dedicated to general and administrative activities,
legal fees, audit and tax fees, consultants and professional services, and general corporate expenses.
General
and administrative expenses for the three and nine months ended September 30, 2020 were $1,121,000 and $4,288,000, respectively,
compared with $1,223,000 and $3,597,000 for the three and nine months ended September 30, 2019, respectively. The increase for
the three and nine months ended September 30, 2020 compared to the three months ended September 30, 2019 was primarily due to
litigation costs, insurance increases and executive compensation.
Interest
Expense, Net
Interest
expense for the three and nine months ended September 30, 2020 was $2,000 and $6,000, respectively, compared with $5,000 and $16,000
for the three and nine months ended September 30, 2019, respectively. The interest amounts represent interest incurred on finance
leased lab equipment in 2019.
Other
Income/(Expense)
In
accordance with U.S. GAAP, we record other income or expense based upon the computed change in fair value of our outstanding warrants
that are accounted for as liabilities. The fair value of our outstanding warrants is inversely related to the fair value of the
underlying common stock; as such, an increase in the price of our common stock during a given period generally results in other
expense. Conversely, a decrease in the price of our common stock generally results in other income, which is what occurred during
both periods. The change in the fair value of derivative liabilities for the nine months ended September 30, 2020 and 2019 was
$(29,000) and $173,000, respectively.
Net
Loss
Net
loss for the three and nine months ended September 30, 2020 was $2,670,000 and $8,155,000, respectively, compared with a net loss
of $1,780,000 and $324,000 for the three and nine months ended September 30, 2019, respectively, as a result of revenue and expenses
described above.
Liquidity
and Capital Resources
Net
cash used in operating activities was $7,449,000 for the nine months ended September 30, 2020 compared with net cash used by operating
activities of $333,000 for the same period in 2019. This was primarily due to the $4,000,000 upfront payment from Merck at the
signing of the Collaboration Agreement in January 2019.
Net
cash used for investing activities was approximately $239,000 for the nine months ended September 30, 2020 compared with $144,000
net cash used in the same period in 2019. For the nine months ended September 30, 2020 and 2019, net cash used for investing activities
consisted primarily of capital spending for computers and lab equipment.
Net
cash provided by financing activities totaled $32,051,000 for the nine months ended September 30, 2020 compared with $3,769,000
for the same period in 2019. This was primarily due to the sale of common stock in three registered direct offerings and one underwritten
public offering during the nine months ended September 30, 2020.
5
The
Company has not yet established an ongoing source of revenue sufficient to cover its operating costs. The Company had $31,781,000
cash on September 30, 2020 and believes this is sufficient to maintain planned operations for well beyond the next 12 months.
We
have focused our efforts on research and development activities, including through collaborations with suitable partners. We have
been profitable on a quarterly basis but have never been profitable on an annual basis. We have no products approved for sale
and have incurred operating losses and negative operating cash flows on an annual basis since inception.
The
Company’s interim consolidated financial statements are prepared using generally accepted accounting principles in the United
States of America applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business.
Historically,
public, and private equity offerings have been our principal source of liquidity. During the nine months ended September 30, 2020,
the Company closed the following four registered offerings of its Common Stock.
On
January 29, 2020, the Company entered into a Placement Agency Agreement with AGP, pursuant to which AGP agreed to serve as the
placement agent in connection with the registered offering of 3,492,063 shares of Common Stock at a public offering price of $0.63
per share for aggregate gross proceeds to the Company of approximately $2.2 million, before deducting fees payable to the placement
agent and other estimated offering expenses payable by the Company. In connection with the offering, the Company also entered
into Securities Purchase Agreements with certain investors named therein, pursuant to which the Company agreed to issue the Shares
directly to investors. The Company closed the offering on January 31, 2020.
On
February 27, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to
which the Company agreed to sell and issue, in a registered direct offering, 8,461,540 shares of Common Stock at a purchase price
per share of $1.30 for aggregate gross proceeds to the Company of approximately $11.0 million, before deducting fees payable to
the placement agent and other estimated offering expenses payable by the Company. The Company closed the offering on February
28, 2020.
On
March 9, 2020, the Company entered into a securities purchase agreement with certain institutional investors, pursuant to which
the Company agreed to sell and issue, in a registered direct offering, 5,037,038 shares of Common Stock at a purchase price per
share of $1.35 for aggregate gross proceeds to the Company of approximately $6.8 million, before deducting fees payable to the
placement agent and other estimated offering expenses payable by the Company. The Company closed the offering on March 10, 2020.
On
July 1, 2020 Company entered into an At-The-Market Offering Agreement (“ATM Agreement”) with H.C. Wainwright &
Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell over time and from time to time, to or through
Wainwright, up to $10,000,000 of shares of the Company’s common stock. The Company has not sold any shares pursuant to this
ATM as of the date of this filing.
On
August 26, 2020, the Company entered into an Underwriting Agreement (as amended and restated, the “Underwriting Agreement”)
with Wainwright, pursuant to which the Company agreed to issue and sell 14,285,715 shares of the Company’s common stock,
par value $0.001 per share, at a public offering price of $1.05 per share, less underwriting discounts and commissions (the “Offering”).
Under the terms of the Underwriting Agreement, the Company granted Wainwright a 30-day option to purchase up to an additional
2,142,857 shares of common stock at the same offering price to the public, solely to cover over-allotments, which was partially
exercised. The Company received approximately $15.6 million in net proceeds from the Offering, after deducting underwriting discounts
and offering expenses. The Company closed the offering on August 31, 2020.
As
the Company continues to incur losses, achieving profitability is dependent upon the successful development, approval and commercialization
of its product candidates, and achieving a level of revenues adequate to support the Company’s cost structure. The Company
may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital.
Management intends to fund future operations through additional private or public equity offerings and through arrangements with
strategic partners or from other sources. There can be no assurance, however, that additional funding will be available on terms
acceptable to the Company, or at all, and any equity financing may be very dilutive to existing shareholders.
Cautionary
Note Regarding Forward-Looking Statements
This report includes forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential earnings under the Collaboration
Agreement; the expected progress of, and the anticipated timing of achieving the value-driving milestones in, our Influenza program,
including the initiation of the Phase 1 study in 2021; the expected progress of, and the anticipated timing of achieving the value-driving
milestones in, our coronavirus program, including identifying additional replication inhibitors using our proprietary platform
technology and the selection of a preclinical lead molecule in Q4 2020; the expected progress of, and the anticipated timing of
achieving the value-driving milestones in, our norovirus program, including completing the proof-of-concept animal model study
in the fourth quarter of 2020; and future liquidity. The words “believe,” “may,” “estimate,”
“continue,” “anticipate,” “intend,” “should,” “plan,” “could,”
“target,” “potential,” “is likely,” “will,” “expect” and similar expressions,
as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely
on our current expectations and projections about future events and financial trends that we believe may affect our financial condition,
results of operations, business strategy and financial needs.
6
The
results anticipated by any or all of these forward-looking statements might not occur. Important factors that could cause actual
results to differ from those in the forward-looking statements include the risks arising from the impact of the COVID-19 pandemic
on our Company, including its future effect on the U.S. and global economies, supply chain disruptions, our continued ability
to proceed with our programs, receive necessary regulatory approvals and continue to rely on certain third parties, risks arising
from our reliance on continuing collaboration with Merck under the Collaboration Agreement, the future results of preclinical
and clinical studies, general risks arising from clinical trials, receipt of regulatory approvals, development of effective treatments
and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and our ability to find
and enter into agreements with suitable collaboration partners. Further information on our risk factors is contained in our filings
with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2019, as updated and supplemented by the
Quarterly Report on Form 10-Q for the three months ended June 30, 2020. We undertake no obligation to publicly update or revise
any forward-looking statements, whether as the result of new information, future events or otherwise.
Critical
Accounting Policies and Estimates
In
our Annual Report on Form 10-K for the year ended December 31, 2019, we disclosed our critical accounting policies and estimates
upon which our financial statements are derived.
Accounting
estimates. The preparation of financial statements in conformity with accounting principles generally accepted in the U.S.
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 revenues and expenses
during the reporting period. Actual results could differ significantly from these estimates
Goodwill.
As of September 30, 2020, the Company had a goodwill of $19,092,000. Goodwill is tested at least annually for impairment or
when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable, by assessing
qualitative factors or performing a quantitative analysis in determining whether it is more. The Company’s last annual impairment
assessment was on November 30, 2019.
Revenue
recognition. Effective in the fourth quarter of 2018, we adopted Accounting Standards Codification (“ASC”) Topic
606– Revenue from Contracts with Customers .
Readers
are encouraged to review these disclosures in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019
in conjunction with the review of this report.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
We
carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer
and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”) as of the end of the period covered by this
report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls
and procedures as of September 30, 2020 were effective to ensure that information required to be disclosed by us in reports that
we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the Securities and Exchange Commission’s rules and forms.
Changes
in Internal Control over Financial Reporting
There
were no material changes in our internal controls over financial reporting or in other factors that could materially affect, or
are reasonably likely to affect, our internal controls over financial reporting during the quarter ended September 30, 2020. Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, 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.
7
PART
II — OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From
time to time, the Company is a party to, or otherwise involved in, legal proceedings arising in the normal course of business.
Except as set forth below, during the period covered by this report, there have been no material changes to the description of
legal proceedings set forth in our Annual Report on Form 10-K for the year ended December 31, 2019.
On
July 2, 2020, the Company negotiated and executed term sheets with respect to the proposed settlement of the previously disclosed
class action and three related derivative lawsuits. The term sheets are subject to approval by the court. As of September 30,
2020, the Company agreed to pay $450,000 for its share of the total proposed class action settlement. The final settlement hearing
for the class action and derivative lawsuits is scheduled for December 16, 2020.
As
for the settlement of the derivative lawsuits, the Company agreed to make certain corporate governance changes. On September 22,
2020, United States District Court for the District of New Jersey, where one of the derivative actions was pending, entered an
order preliminarily approving the Stipulation and Agreement of Settlement, dated August 20, 2020 (the “Stipulation”)
by and among the plaintiffs in the derivative actions, the Company as the nominal defendant, and defendants, including certain
of the Company’s current and former directors and officers. The settlement as documented in the Stipulation covers all three
derivative actions and is subject to the approval of the Court. The proposed settlement requires that certain defendants named
in the Stipulation, other than the Company, pay the plaintiffs’ attorneys’ fees and expenses in the amount of $275,000,
and that the Company adopt within 60 days of the final approval of the settlement by the Court certain corporate governance enhancements.
A settlement hearing for the derivative action is scheduled for December 16, 2020.
In
November 2017, Lee Pederson, a former Biozone lawyer, filed a lawsuit in U.S. District Court in Minnesota against co-defendants
the Company, Dr. Phillip Frost, OPKO Health, Inc. and Brian Keller alleging that defendants engaged in wrongful conduct related
to Biozone, including causing Biozone to enter into an allegedly improper licensing agreement and engaged in alleged market manipulation.
On September 13, 2018, the United States District Court granted the Company and its co-defendants’ motion to dismiss Pederson’s
amended complaint for lack of personal jurisdiction in Minnesota. On October 11, 2018, Pederson filed a notice of appeal with
the United States Court of Appeals for the Eighth Circuit. The plaintiff’s appeal was denied and the dismissal affirmed.
In July 2019, Lee Pederson filed another lawsuit in the U.S. District Court in Minnesota against co-defendants the Company, Dr.
Frost, and Daniel Fisher. In his complaint, Pederson alleges tortious interference by the Company and Dr. Frost with an alleged
collaboration agreement between Mr. Pederson and Mr. Fisher. Mr. Pederson seeks damages in the amount of $800,000 or such other
amount as may be determined at trial. This lawsuit had previously been stayed by the court, pending disposition of Pederson’s
first lawsuit. With that first lawsuit having been dismissed and appeal denied, the stay was lifted, and the Company was served
in July 2020 with the complaint initiating that second lawsuit. The Company is reviewing the complaint with counsel. On October
14, 2020, the Company and co-defendants’ motions for, among other things, dismissal for lack of personal jurisdiction in
that second lawsuit were heard by the court, and the Company and co-defendants are awaiting a ruling from the trial court.
8
ITEM
1.A RISK FACTORS
The
information presented below updates, and should be read in conjunction with, the risk factors and information disclosed in our
Annual Report on Form 10-K for the year ended December 31, 2019, as updated and supplemented by the Quarterly Report on Form 10-Q
for the three months ended June 30, 2020.
Our
Coronavirus program is in the preclinical stage and we face significant competition from multiple parties pursuing the development
of an effective COVID-19 treatment or a vaccine, some of which have significantly more advanced product candidates and substantially
more resources. If we fail to gain market share as the result of our competitors developing and successfully commercializing effective
COVID-19 therapies or vaccines more quickly than we do, our business and future prospects would be materially and adversely affected.
Our COVID-19 program is the preclinical stage.
We initiated preclinical studies during the second quarter of 2020 and anticipate the selection of the lead preclinical molecule
in the fourth quarter of 2020. We may be unable to produce an effective therapy in a timely manner or at all. Additionally, we
are committing substantial financial and other resources to our COVID-19 program, which may negatively impact our other programs.
Further, in the wake of the global COVID-19 pandemic a number of third parties, including large biotechnology and pharmaceutical
companies and academic institutions have been conducting research aimed at development of an effective treatment for, or a vaccine
against, COVID-19. Some of our competitors have substantially more resources, including government funding, than we do and have
existing products in significantly more advanced stages of development. For example, the FDA has recently approved remdesivir,
an investigational antiviral agent developed by Gilead Sciences, Inc. (“Gilead”), for the treatment of patients with
COVID-19 requiring hospitalization. In addition, the FDA has issued an emergency use authorization for the investigational
monoclonal antibody therapy for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Further, Pfizer Inc.
and BioNTech SE have announced positive preliminary data from the ongoing Phase 3 clinical trial of their vaccine candidate.
If we are unable to timely advance our Coronavirus program or if we fail to gain market share as the result of our competitors
developing and successfully commercializing effective COVID-19 therapies more quickly than we do, our business and future prospects
would be materially and adversely affected.
Failure
to meet the continued listing requirements of The Nasdaq Capital Market, could result in delisting of our common stock, which
in its turn would negatively affect the price of our common stock and limit investors’ ability to trade in our common stock.
Our
common stock trades on The Nasdaq Capital Market (“Nasdaq”). Nasdaq rules impose certain continued listing requirements,
including the minimum $1 bid price, corporate governance standards and number of public stockholders. As previously disclosed,
on November, 2020, we were notified by Nasdaq that we were not compliant with its closing bid price requirement because the closing
bid price of our common stock was below $1.00 per share for 30 consecutive trading days. The Company has until May 3, 2021 to
regain compliance, subject to a potential 180 calendar day extension. If we fail to regain compliance by the prescribed deadlines,
or fail to meet the other continued listing requirements in the future, Nasdaq would take steps to delist our common stock. If
our common stock is delisted from Nasdaq, we could face significant material adverse consequences, including:
●
a
limited availability of market quotations for our common stock;
●
reduced
liquidity with respect to our common stock;
●
a
determination that our shares of common stock are a “penny stock” which will require broker-dealers trading in
our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary
trading market for our common stock;
●
a
limited amount of news and analyst coverage for our company; and
●
a
limited ability to issue additional securities or obtain additional financing in the future.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
All
recent unregistered sales of securities have been previously reported.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
The
exhibits listed in the accompanying “Exhibit Index” are filed or incorporated by reference as part of this Form 10-Q.
9
EXHIBIT
INDEX
Exhibit
Incorporated
by Reference
Filed
or
Furnished
No.
Exhibit
Description
Form
Date
Number
Herewith
3.1
Certificate of Incorporation, as amended
10-Q
8/9/18
3.1
3.2
Bylaws
8-K
12/1/14
3.4
31.1
Certification of Principal Executive Officer (302)
Filed
31.2
Certification of Principal Financial Officer (302)
Filed
32.1
Certification of Principal Executive and Principal Financial Officer (906)
Furnished*
101.INS
XBRL
Instance Document
Filed
101.SCH
XBRL
Taxonomy Extension Schema Document
Filed
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase Document
Filed
101.DEF
XBRL
Taxonomy Extension Definition Linkbase Document
Filed
101.LAB
XBRL
Taxonomy Extension Label Linkbase Document
Filed
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase Document
Filed
*
This exhibit is being furnished rather than filed and shall not be deemed incorporated by reference into any filing, in accordance
with Item 601 of Regulation S-K.
Copies
of this report (including the financial statements) and any of the exhibits referred to above will be furnished at no cost to
our shareholders who make a written request to our Corporate Secretary at Cocrystal Pharma, Inc., 4400 Biscayne Blvd, Suite 101,
Miami, FL 33137.
10
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Cocrystal
Pharma, Inc.
Dated:
November 13, 2020
By:
/s/
Gary Wilcox
Gary
Wilcox
Chief
Executive Officer
(Principal
Executive Officer)
Dated:
November 13, 2020
By:
/s/
James Martin
James
Martin
Chief
Financial Officer
(Principal
Financial Officer)
11
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.