Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or
the “Company”), a clinical stage biotechnology company
discovering and developing novel antiviral therapeutics,
announced today its financial results for the quarter ended
September 30, 2019 and provided a corporate update.
“2019 has been an active and very productive
year for the Company. We continue to drive our clinical and
research programs forward and believe we now have established a
clear development pathway for our lead program CC-31244 for the
ultrashort treatment of HepC,” commented Dr. Gary Wilcox, Chairman
and Chief Executive Officer of Cocrystal. “Over the past nine
months, we have worked closely with the Merck team advancing the
influenza A/B antiviral agents and have had monthly and quarterly
collaborative discussions that are guiding the next phase of this
important program. We are very encouraged by the scientific
developments made to-date and expect the lead influenza A/B
molecule to be selected in the fourth quarter of next year.”
“On the corporate side, we expect to close the
year with a strong financial position, having secured enough cash
runway to fund operations through 2020. Additionally, we remain
opportunistic as we advance our ongoing business development
discussions with the goal of securing additional strategic
partnerships across our pipeline in order to infuse non-dilutive
capital into the Company, as witnessed by our Merck transaction. As
we move into 2020, we believe the Company is well positioned to
successfully achieve the corporate and clinical milestones in front
of us,” added Dr. Wilcox.
Programs Overview
Influenza A/B Inhibitors: Exclusive license and
collaboration agreement with Merck to discover and develop certain
proprietary influenza A/B antiviral agents.
- Under the terms of the agreement, Merck is funding all research
and development for the program, including clinical development,
and will be responsible for worldwide commercialization of any
products derived from the collaboration.
Upcoming Influenza A/B Program
Milestones
- Lead influenza A/B molecule to advance into clinical study is
expected to be selected in Q4 2020.
CC-42344 Influenza Program:
Novel, broad spectrum influenza antivirals that are specifically
designed to be effective against all significant A strains of the
influenza virus and to have a high barrier to resistance due to the
way they target the virus’ replication machinery.
- Lead molecule in development: CC-42344 has shown excellent
antiviral activity against influenza A strains, including avian
pandemic strains and Tamiflu® resistant strains, and shows a
favorable pharmacokinetic and safety profile.
- CC-42344 has synergistic effects with approved influenza
antivirals, including Xofluza and Tamiflu.
- CC-42344 is currently being evaluated in preclinical
IND-enabling studies for the treatment of influenza. Company
expects to move into clinical development in 2020.
Upcoming CC-42344 Program
Milestones
- Complete preclinical IND-enabling
studies in Q1 2020.
- File a regulatory submission in Q4
2020.
- Initiate Phase 1 study evaluating
CC-42344 for the treatment of influenza in Q4 2020.
CC-31244 HepC Clinical Program: Pan-Genotypic
Non-Nucleoside Inhibitor for Ultrashort Treatment
- Lead molecule: CC-31244, an investigational, oral,
broad-spectrum replication inhibitor called a non-nucleoside
inhibitor (NNI), currently in Phase 2 program.
- New positive data from U.S. Phase 2a study recently presented
at the AASLD 2019 Liver Meeting:
- Patients that achieved sustained virologic response (SVR) 12,
which is considered a cure had significantly higher frequencies of
terminally differentiated effector memory CD8+ T cells compared
with those who relapsed, allowing identification of patients more
likely to respond to ultrashort treatment.
- Planning additional toxicology study to extend CC-31244 safety
profile.
- Planning Phase 2b study of CC-31244 with new data to target
patients and include six weeks of CC-31244 along with six weeks
treatment of Gilead’s Epclusa.
- Enrollment in the investigator-sponsored Phase 2a study of
CC-31244 in Hong Kong SAR, China being conducted at the Humanity
& Health Research Centre, Humanity and Health Medical Group
remains ongoing. The Phase 2a study in Hong Kong is designed to
evaluate the safety, tolerability and preliminary efficacy of
Cocrystal’s CC-31244 in combination with Sofosbuvir and Daclatasvir
with or without a protease inhibitor, for the treatment of HepC.
The expected completion of enrollment has been delayed a quarter
due, in part, to the civil unrest and political instability in Hong
Kong.
Upcoming CC-31244 Clinical Program
Milestones:
- Complete patient enrollment in
investigator-sponsored Hong Kong Phase 2a study in Q1 2020.
- Commence Phase 2b enabling
toxicology study in H2 2020.
- Advance discussions with potential
strategic partners to secure development and commercialization
licensing agreement.
For additional information about
the U.S. Phase 2a study of CC-31244 for the treatment of
viral hepatitis C, please visit ClinicalTrials.gov and
reference identifier NCT03501550.
Summary of Financial Results for the
Quarter Ended September 30, 2019
As of September 30, 2019, the Company had
approximately $6,044,000 cash on hand. On November 4, 2019, the
Company closed a public offering and received gross proceeds of
approximately $3.0 million and net proceeds of $2.6 million. Based
on management’s current projections, the Company expects to have
sufficient cash to fund operations through the end of 2020.
The Company recorded revenue for the three and
nine months ended September 30, 2019 of $492,000 and $6,162,000,
respectively, compared to no revenue during the same periods ended
September 30, 2018. Revenue resulted from the Merck Collaboration
during the three months ended September 30, 2019 and consisted of
program services and expense reimbursements received for research
and development costs associated with the Company’s influenza A/B
program in accordance with the Merck Collaboration Agreement, and
for the nine months ended September 30, 2019 of program services,
expense reimbursements and an initial license payment.
Total research and development expenses for the
three and nine months ended September 30, 2019 were approximately
$1,077,000 and $3,046,000, respectively, compared with
approximately $1,467,000 and $3,464,000 for the three and nine
months ended September 30, 2018, respectively.
General and administrative expenses for the
three and nine months ended September 30, 2019 were approximately
$1,223,000 and $3,597,000, respectively, compared with $952,000 and
$3,157,000 for the three and nine months ended September 30, 2018,
respectively.
The Company reported net loss for the three and
nine months ended September 30, 2019 of approximately $1,780,000
and $324,000, respectively, compared with a net loss of
approximately $1,868,000 and $4,762,000 for the three and nine
months ended September 30, 2018, respectively.
About Cocrystal Pharma,
Inc.
Cocrystal Pharma, Inc. is a clinical stage
biotechnology company discovering and developing novel antiviral
therapeutics that target the replication machinery of influenza
viruses, hepatitis C viruses, and noroviruses. Cocrystal employs
unique structure-based technologies and Nobel Prize winning
expertise to create first- and best-in-class antiviral drugs. For
further information about Cocrystal, please visit
www.cocrystalpharma.com.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including anticipated advancements under our
collaboration agreement with Merck, achievement of expected
near-term clinical and research milestones, including the selection
of the lead influenza A/B molecule, the expected progress and
timing of the influenza A IND-enabling studies, filing of a
regulatory submission and Phase 1 study, the anticipated progress
and timing of the HepC Phase 2a study in Hong Kong, expected
advancement of discussions with potential strategic partners, and
our 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.
Some or all of the events anticipated by these forward-looking
statements may not occur. Important factors that could cause actual
results to differ from those in the forward-looking statements
include, but are not limited to, risks arising from our reliance on
continuing collaboration with Merck under the collaboration
agreement, the availability of products manufactured by third
parties, the results of preclinical and clinical studies, the
research organizations’ inability to recruit subjects and complete
the studies timely or at all, including as the result of civil
unrest and political instability in Hong Kong, general risks
arising from clinical trials, receipt of regulatory approvals, our
ability to find and enter into agreements with suitable
collaboration partners, litigation expenses and other expenses and
factors that affect the capital markets in general and early stage
biotechnology companies specifically. 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,
2018, as updated and supplemented by the Quarterly Report on Form
10-Q for the quarter ended June 30, 2019. Any forward-looking
statement made by us herein speaks only as of the date on which it
is made. Factors or events that could cause our actual results to
differ may emerge from time to time, and it is not possible for us
to predict all of them. We undertake no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by law.
Investor and Media
Contact:Jenene Thomas Communications, LLC(833)
475-8247COCP@jtcir.com
###
COCRYSTAL PHARMA, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except per share
data)
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
5,994 |
|
|
$ |
2,723 |
|
Restricted cash |
|
|
50 |
|
|
|
29 |
|
Accounts receivable |
|
|
768 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
201 |
|
|
|
191 |
|
Total current assets |
|
|
7,013 |
|
|
|
2,943 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
459 |
|
|
|
384 |
|
Deposits |
|
|
50 |
|
|
|
40 |
|
Operating lease right-of-use
assets, net |
|
|
720 |
|
|
|
- |
|
Goodwill |
|
|
65,195 |
|
|
|
65,195 |
|
Total assets |
|
$ |
73,437 |
|
|
$ |
68,562 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,690 |
|
|
$ |
1,077 |
|
Deferred rent |
|
|
- |
|
|
|
3 |
|
Current maturities of finance lease liabilities |
|
|
154 |
|
|
|
214 |
|
Current maturities of operating lease liabilities |
|
|
171 |
|
|
|
- |
|
Derivative liabilities |
|
|
90 |
|
|
|
263 |
|
Total current liabilities |
|
|
2,105 |
|
|
|
1,557 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Finance lease liabilities |
|
|
18 |
|
|
|
117 |
|
Operating lease liabilities |
|
|
569 |
|
|
|
- |
|
Total long-term
liabilities |
|
|
587 |
|
|
|
117 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,692 |
|
|
|
1,674 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $.001 par value;
100,000 shares authorized as of September 30, 2019 and December 31,
2018; 31,621 and 29,938 shares issued and outstanding as of
September 30, 2019 and December 31, 2018, respectively |
|
|
32 |
|
|
|
30 |
|
Additional paid-in
capital |
|
|
258,128 |
|
|
|
253,949 |
|
Accumulated deficit |
|
|
(187,415 |
) |
|
|
(187,091 |
) |
Total stockholders’
equity |
|
|
70,745 |
|
|
|
66,888 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
|
$ |
73,437 |
|
|
$ |
68,562 |
|
See accompanying notes to condensed consolidated
financial statements.
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, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
492 |
|
|
|
$ |
- |
|
|
|
$ |
6,162 |
|
|
|
$ |
- |
|
|
Total Revenues |
|
|
492 |
|
|
|
|
- |
|
|
|
|
6,162 |
|
|
|
|
- |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,077 |
|
|
|
|
1,467 |
|
|
|
|
3,046 |
|
|
|
|
3,464 |
|
|
General and administrative |
|
|
1,223 |
|
|
|
|
952 |
|
|
|
|
3,597 |
|
|
|
|
3,157 |
|
|
Total operating expenses |
|
|
2,300 |
|
|
|
|
2,419 |
|
|
|
|
6,643 |
|
|
|
|
6,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(1,808 |
) |
|
|
|
(2,419 |
) |
|
|
|
(481 |
) |
|
|
|
(6,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(5 |
) |
|
|
|
- |
|
|
|
|
(16 |
) |
|
|
|
(55 |
) |
|
Gain on settlement of mortgage note receivable |
|
|
- |
|
|
|
|
- |
|
|
|
|
- |
|
|
|
|
106 |
|
|
Loss on disposal of property and equipment |
|
|
- |
|
|
|
|
(61 |
) |
|
|
|
- |
|
|
|
|
(61 |
) |
|
Change in fair value of derivative liabilities |
|
|
33 |
|
|
|
|
129 |
|
|
|
|
173 |
|
|
|
|
410 |
|
|
Total other income, net |
|
|
28 |
|
|
|
|
68 |
|
|
|
|
157 |
|
|
|
|
400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(1,780 |
) |
|
|
|
(2,351 |
) |
|
|
|
(324 |
) |
|
|
|
(6,221 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
- |
|
|
|
|
483 |
|
|
|
|
- |
|
|
|
|
1,459 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(1,780 |
) |
|
|
$ |
(1,868 |
) |
|
|
$ |
(324 |
) |
|
|
$ |
(4,762 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic and
diluted |
|
$ |
(0.06 |
) |
|
|
$ |
(0.06 |
) |
|
|
$ |
(0.01 |
) |
|
|
$ |
(0.17 |
) |
|
Weighted average number of
common shares outstanding, basic and diluted |
|
|
31,621 |
|
|
|
|
29,923 |
|
|
|
|
31,201 |
|
|
|
|
27,360 |
|
|
See accompanying notes to condensed consolidated
financial statements.
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