CohBar Reports Third Quarter 2021 Financial Results and Provides Business Update
November 15 2021 - 4:02PM
CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company
developing mitochondria based therapeutics to treat chronic
diseases and extend healthy lifespan, today reported its financial
results for the third quarter ended September 30, 2021.
“We were pleased to report positive topline data
from our first clinical study this past quarter and believe that
this data not only demonstrates the potential of our CB4211 program
but also validates our unique approach of creating novel
therapeutics sourced from the mitochondrial genome,” stated Dr.
Joseph Sarret, Chief Executive Officer. “With a strengthened
balance sheet from our recent financing, we are now well-positioned
to continue to advance our pipeline.”
Third Quarter 2021 and Recent Highlights
-
Positive Topline Data Announced from the Phase 1a/1b Study
of CB4211 Being Developed for the Treatment of Nonalcoholic
Steatohepatitis (NASH) and Obesity: In August, the company
announced topline results from the multi-center, randomized,
double-blind, placebo-controlled Phase 1a/1b clinical study of
CB4211, under development for NASH and obesity. The study met its
primary endpoints as CB4211 was well-tolerated and appeared safe
with no serious adverse events. The evaluation of the exploratory
endpoints showed robust and statistically significant improvements
in key biomarkers of liver damage, ALT and AST, as well as in
glucose levels in the CB4211 group compared to placebo. There was a
trend towards lower body weight in the CB4211 group after four
weeks of treatment.
-
CB4211 Phase 1b Data Selected for Late Breaker Presentation
at The Liver Meeting® 2021: In October, the company
announced that data from its CB4211 Phase 1a/1b clinical study had
been selected for presentation during the late-breaking poster
session at The American Association for the Study of Liver Diseases
(AASLD) Annual Meeting (The Liver Meeting® 2021). The lead author
on the poster was Dr. Rohit Loomba, MD, MHSc, Professor of
Medicine, Director, NAFLD Research Center, and Director of
Hepatology, University of California at San Diego. The poster can
be viewed by visiting: CohBar's Publication Page.
-
U.S. Patent Granted Covering CB4211 Compositions and Use
for Treating NASH: In September, the company announced
that the United States Patent and Trademark Office had granted a
patent covering CohBar’s lead candidate CB4211 and related
compositions, as well as methods of treatment, including methods of
treating NASH. This foundational patent will be eligible for
listing in the FDA Orange Book upon approval of CB4211 as a
therapeutic in the United States.
-
Completed $15M Financing: On November
1st, the company completed an underwritten public offering of
common stock and warrants, with aggregate gross proceeds of
approximately $15 million. The company intends to use the proceeds
from this offering to fund research and development and other
general corporate purposes.
-
Gained additional bank research
coverage: Recently, Wall Street
bank Cantor Fitzgerald initiated coverage on CohBar and issued a
research report on the company.
- Carol
Nast and Joanne Yun, Ph.D. Appointed to the Board of
Directors: The company announced the appointment Carol
Nast and Joanne Yun, Ph.D. as independent directors. Ms. Nast has
spent her career in executive level positions with both large
multinational companies and early-stage companies in the medical
industry. Dr. Yun brings extensive research and development,
commercial, and governance experience from the pharmaceutical
industry.
Third Quarter 2021 Financial Highlights
- Cash and
Investments: The company had cash and investments of $15
million as of September 30, 2021, compared to $21 million as of
December 31, 2020. The cash burn for the quarter ended September
30, 2021, was approximately $3.3 million.
- R&D Expenses:
Research and development expenses were $1.6 million for the three
months ended September 30, 2021, compared to $1.2 million in the
prior year quarter. The increase in research and development
expenses was primarily due to the investment in the company’s
research programs focused on the continued development of its
peptides partially offset by a decrease in stock based
compensations costs.
- G&A
Expenses: General and administrative expenses were
$1.8 million for the three months ended September 30, 2021,
compared to $1.4 million in the prior year quarter. The
increase in general and administrative expenses was primarily due
to higher stock-based compensation
costs.
- Net Loss: For the
three months ended September 30, 2021, net loss, which included
$0.7 million of non-cash expenses, was $3.4 million, or $0.05 per
basic and diluted share. For the three months ended September 30,
2020, net loss, which included $0.9 million of non-cash expenses,
was $3.2 million, or $0.06 per basic and diluted share.
Third Quarter Investor Call:
Date: |
|
November 15, 2021 |
Time: |
|
5:00 p.m. ET (2:00 p.m. PT) |
Conference Audio
- Dial-in U.S. and Canada: (844) 825-9789
- Dial-in International: (412) 317-5180
- Conference ID No.: 10161656
For individuals participating in the Investor
Call, please call into the conference audio approximately 10
minutes prior to its start.
An audio replay of the call will be available
beginning at 8:00 p.m. Eastern Time on November 15, 2021, through
11:59 p.m. Eastern Time on December 6, 2021. To access the
recording please dial (844) 512-2921 in the U.S. and Canada, or
(412) 317-6671 internationally, and reference Conference ID#
10161656. The audio recording will also be available at
www.cohbar.com during the same period.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical stage
biotechnology company focused on the research and development of
mitochondria based therapeutics, an emerging class of drugs for the
treatment of chronic and age-related diseases. Mitochondria based
therapeutics originate from the discovery by CohBar’s founders of a
novel group of naturally occurring peptide sequences within the
mitochondrial genome, some of which have been shown to have the
potential to regulate key processes in multiple systems and organs
in the body. To date, the company has discovered more than 100
mitochondrial derived peptides and generated over 1,000 analogs.
CohBar’s efforts focus on the development of these peptides into
therapeutics that offer the potential to address a broad range of
diseases associated with the underlying impact of mitochondrial
dysfunction. The company’s lead compound, CB4211, which is under
development for the treatment of NASH and obesity, recently
completed a successful Phase 1a/1b clinical trial. In addition,
CohBar has four preclinical programs, the most advanced of which is
CB5138-3, a peptide with broad anti-fibrotic and anti-inflammatory
properties. This program is currently in IND-enabling studies with
the goal of filing an IND and initiating a First-in-Human study in
2022 with an initial indication of idiopathic pulmonary fibrosis.
The company also has a program in ARDS, including COVID-19
associated ARDS, as well as two peptide families with potential
utility in treating various forms of cancer.
For additional company information, please visit
www.cohbar.com.
Forward-Looking Statements
This news release contains forward-looking
statements that are not historical facts within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, projections, anticipated events and other future
conditions. In some cases you can identify these statements by
forward-looking words such as “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “could,” “should,” “would,”
“project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or
the negative or plural of these words or similar expressions.
Examples of such forward-looking statements include but are not
limited to statements regarding timing and anticipated outcomes of
research and clinical trials for our mitochondria based therapeutic
(MBT) candidates; expectations regarding the growth of MBTs as a
significant future class of drug products; the ability to
provide patent protection for our programs; the potential listing
of the CB4211 patent in the FDA’s Orange Book; and statements
regarding anticipated therapeutic properties and potential of our
mitochondrial peptide analogs, MBTs and other potential therapies.
You are cautioned that such statements are not guarantees of future
performance and that actual results or developments may differ
materially from those set forth in these forward-looking
statements. Factors that could cause actual results to differ
materially from these forward-looking statements include: our
ability to successfully advance drug discovery and development
programs, including the delay or termination of ongoing clinical
trials and the timing of announcements and updates relating to our
clinical trials and related data; our possible inability to
mitigate the prevalence and/or persistence of the injection site
reactions, receipt of unfavorable feedback from regulators
regarding the safety or tolerability of CB4211 or the possibility
of other developments affecting the viability of CB4211 or CB5138-3
as a clinical candidate or its commercial potential; results that
are different from earlier data results including less favorable
results that may not support further clinical development; our
ability to raise additional capital when necessary to continue our
operations; our ability to recruit and retain key management and
scientific personnel; the risk that our intellectual property may
not be adequately protected; our ability to establish and maintain
partnerships with corporate and industry partners; and risks
related to the impact on our business of the COVID-19 pandemic or
similar public health crises. Additional assumptions, risks and
uncertainties are described in detail in our registration
statements, reports and other filings with the Securities and
Exchange Commission and applicable Canadian securities regulators,
which are available on our website, and at www.sec.gov
or www.sedar.com.
The forward-looking statements and other
information contained in this news release are made as of the date
hereof and CohBar does not undertake any obligation to update
publicly or revise any forward-looking statements or information,
whether as a result of new information, future events or otherwise,
unless so required by applicable securities laws. Nothing herein
shall constitute an offer to sell or the solicitation of an offer
to buy any securities.
Contacts: Jordyn TaraziDirector of Investor
RelationsCohBar, Inc.(650) 445-4441Jordyn.tarazi@cohbar.com
CohBar,
Inc. |
Condensed
Balance Sheets |
|
|
|
|
|
|
|
As of |
|
September 30, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
9,180,407 |
|
|
$ |
2,894,575 |
|
Investments |
|
5,834,761 |
|
|
|
18,120,266 |
|
Prepaid expenses and other current assets |
|
810,307 |
|
|
|
413,692 |
|
Total current assets |
|
15,825,475 |
|
|
|
21,428,533 |
|
Property and equipment, net |
|
293,485 |
|
|
|
394,004 |
|
Intangible assets, net |
|
19,616 |
|
|
|
18,075 |
|
Other assets |
|
69,620 |
|
|
|
67,403 |
|
Total assets |
$ |
16,208,196 |
|
|
$ |
21,908,015 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,306,928 |
|
|
$ |
727,599 |
|
Accrued liabilities |
|
155,612 |
|
|
|
1,141,741 |
|
Accrued payroll and other compensation |
|
512,990 |
|
|
|
853,335 |
|
Note payable, net of debt discount and offering costs of $13,082
and $15,656 as of September 30, 2021 and |
|
|
|
December 31, 2020, respectively |
|
361,918 |
|
|
|
349,344 |
|
Total current liabilities |
|
2,337,448 |
|
|
|
3,072,019 |
|
Notes payable, net of debt discount and offering costs of $0 and
$26,159 as of September 30, 2021 and |
|
|
|
December 31, 2020, respectively |
|
- |
|
|
|
348,841 |
|
Total liabilities |
|
2,337,448 |
|
|
|
3,420,860 |
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, Authorized 5,000,000
shares; |
|
|
|
No shares issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively |
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, Authorized 180,000,000 shares; |
|
|
|
Issued and outstanding 65,027,988 shares as of September 30, 2021
and 61,117,524 as of December 31, 2020 |
|
65,028 |
|
|
|
61,118 |
|
Additional paid-in capital |
|
95,747,473 |
|
|
|
87,684,323 |
|
Accumulated deficit |
|
(81,941,753 |
) |
|
|
(69,258,286 |
) |
Total stockholders’ equity |
|
13,870,748 |
|
|
|
18,487,155 |
|
Total liabilities and stockholders’ equity |
$ |
16,208,196 |
|
|
$ |
21,908,015 |
|
|
|
|
|
CohBar,
Inc. |
Condensed
Statements of Operations |
(unaudited) |
|
|
|
|
|
|
|
|
|
For The Three Months Ended September 30, |
|
For The Nine Months Ended September 30, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
1,634,063 |
|
|
|
1,245,530 |
|
|
|
6,906,510 |
|
|
|
4,240,445 |
|
General and administrative |
|
1,777,000 |
|
|
|
1,372,026 |
|
|
|
5,720,043 |
|
|
|
4,594,318 |
|
Total operating expenses |
|
3,411,063 |
|
|
|
2,617,556 |
|
|
|
12,626,553 |
|
|
|
8,834,763 |
|
Operating
loss |
|
(3,411,063 |
) |
|
|
(2,617,556 |
) |
|
|
(12,626,553 |
) |
|
|
(8,834,763 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest
income |
|
1,226 |
|
|
|
872 |
|
|
|
4,366 |
|
|
|
38,064 |
|
Interest
expense |
|
(7,562 |
) |
|
|
(78,691 |
) |
|
|
(32,547 |
) |
|
|
(234,364 |
) |
Equity
modification expense |
|
- |
|
|
|
(489,645 |
) |
|
|
- |
|
|
|
(2,290,688 |
) |
Amortization
of debt discount and offering costs |
|
(4,359 |
) |
|
|
(51,899 |
) |
|
|
(28,733 |
) |
|
|
(235,260 |
) |
Total other expense |
|
(10,695 |
) |
|
|
(619,363 |
) |
|
|
(56,914 |
) |
|
|
(2,722,248 |
) |
Net
loss |
$ |
(3,421,758 |
) |
|
$ |
(3,236,919 |
) |
|
$ |
(12,683,467 |
) |
|
$ |
(11,557,011 |
) |
Basic and
diluted net loss per share |
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.25 |
) |
Weighted
average common shares outstanding - basic and diluted |
|
63,890,584 |
|
|
|
50,201,985 |
|
|
|
62,439,560 |
|
|
|
45,569,737 |
|
|
|
|
|
|
|
|
|
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