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 first quarter ended March 31, 2021.
“I am excited about the potential of CohBar’s mitochondria based
therapeutic programs to make a significant difference in the lives
of patients,” stated Dr. Joseph Sarret, Chief Executive Officer.
“We look forward to the Phase 1b data from our trial of CB4211 for
the treatment of NASH and obesity in early July 2021. In parallel,
we are continuing to advance our preclinical pipeline, most notably
initiating IND-enabling studies with CB5138-3 for fibrotic
diseases, including IPF, putting us on track for our goal of having
at least 2 clinical-stage programs in 2022.”
First Quarter 2021 and Recent Highlights
- Completed
last subject visit in the Phase 1b stage of the clinical study of
CB4211 under development for nonalcoholic
steatohepatitis (NASH) and
obesity: The ongoing study evaluates CB4211 in subjects
with non-alcoholic fatty liver disease (NAFLD) and obesity with at
least 10% liver fat. The primary endpoints are safety and
tolerability, with a secondary endpoint of pharmacokinetics, and
exploratory endpoints of changes in liver fat, body weight, and
biomarkers relevant to NASH, obesity, and metabolic disease. The
company expects to release topline data in early July 2021.
- Nominated
CB5138-3 as lead clinical candidate for Idiopathic Pulmonary
Fibrosis (IPF) and other fibrotic diseases and initiated
IND-enabling activities: In March, the company announced
the selection of CB5138-3 for advancement into IND-enabling
activities, with the goal of starting clinical studies in 2022. In
addition, the company is continuing to evaluate the efficacy of
CB5138 Analogs in models of other fibrotic diseases.
- Signed a Non-Clinical
Evaluation Agreement (NCEA) with the National Institute of Allergy
and Infectious Diseases (NIAID) to evaluate the potential of CB5064
Analogs for the treatment of COVID-19 Associated Acute Respiratory
Distress Syndrome (ARDS): In January, the company
announced it will be utilizing the non-clinical and pre-clinical
services program offered by the NIAID, a division of the National
Institutes of Health (NIH). NIAID will be responsible for any study
conducted under the NCEA, including an evaluation using the golden
Syrian hamster SARS-CoV-2 model, which has been used in the
assessment of other COVID-19 therapeutics.
- Appointed Joseph J. Sarret,
M.D., J.D. as Chief Executive Officer and Director: In
April, the company announced the appointment of Joseph J. Sarret,
M.D., J.D. as Chief Executive Officer and Director, effective May
3, 2021. Dr. Sarret is a seasoned executive with a track record of
success in biotechnology.
- Gained
additional bank research coverage: Recently, Wall Street
banks Aegis Capital and Maxim Group initiated coverage on CohBar
and issued research reports on the company.
Founders’ Update
During the first quarter and subsequent period, CohBar’s
founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School
of Gerontology, and Dr. Nir Barzilai, Director of the Institute for
Aging Research at Albert Einstein College of Medicine, continued to
present and publish on the study of mitochondrial science, aging
and age-related diseases.
Dr. Cohen and his colleagues published three landmark papers on
the role of MOTS-c in human health. The first, “MOTS-c is an
exercise-induced mitochondrial-encoded regulator of age-dependent
physical decline and muscle homeostasis,” published in Nature
Communication, outlined the exercise mimetic actions of MOTS-c, and
described the fitness- and health-enhancing effects of this
hormone. The second paper, entitled “MOTS-c reduces myostatin and
muscle atrophy signaling,” published in the American Journal of
Physiology, described a key mechanism for MOTS-c action, namely its
effect on suppressing the myokine myostatin in animal models, which
has implications for possible utility in diseases like frailty and
sarcopenia. The third paper, entitled “A pro-diabetogenic mtDNA
polymorphism in the mitochondrial-derived peptide, MOTS-c,”
published in the journal Aging, described the effects of a mutation
in the MOTS-c gene, found in up to 8% of Japanese, Koreans and
Northern Chinese. This mutation results in a “bio-inactive” variant
of MOTS-c that is unable to induce the insulin-sensitizing and
weight-loss effects the “wild-type” form elicits in male animals.
Men who carry this mutation have elevated levels of (inactive)
MOTS-c, increased abdominal fat and an elevated risk for type-2
diabetes; this risk is further increased in the subset of these men
who are also sedentary, providing additional support for the
relationship between MOTS-c and exercise.
Dr. Barzilai was featured at several conferences related to
aging, including the “Annual Aging Research and Drug Discovery
2020: From aging mechanisms to interventions” symposium and
publication. In addition, he was featured at the National
University of Singapore Yong Loo Lin School of Medicine’s Healthy
Longevity series in a webinar titled “Age Later: Lessons for This
Pandemic and the Next”. Dr. Barzilai was a keynote speaker at the
Annual International (bio)Medical Students Meeting (AIMS) Meeting
and the Geneva Science and Diplomacy Anticipator. He was also a
panelist on the “Living Healthily to 120 and Beyond” session at the
Fifth International Vatican Conference.
First Quarter 2021 Financial Highlights
- Cash and Investments: CohBar had cash and
investments of $17.8 million as of March 31, 2021, compared to
$21.0 million as of December 31, 2020. The cash burn for the
quarter ended March 31, 2021, was approximately $4.2
million.
- R&D Expenses: Research and development
expenses were $2.7 million for the three months ended March 31,
2021, compared to $1.5 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, and an increase in clinical
trial costs due to the timing of those expenses, partially offset
by a decrease in stock-based compensation costs.
- G&A Expenses: General and administrative
expenses were $1.4 million for the three months ended March 31,
2021, compared to $1.8 million in the prior year
quarter. The decrease in general and administrative
expenses was primarily due to lower stock-based compensation
costs.
- Net Loss: For the three months ended March 31,
2021, net loss, which included $0.4 million of non-cash expenses,
was $4.0 million, or $0.07 per basic and diluted share. For the
three months ended March 31, 2020, net loss, which included $1.8
million of non-cash expenses, was $4.2 million, or $0.10 per basic
and diluted share.
First Quarter Investor Call:Date: May 17,
2021Time: 5:00 p.m. ET (2:00 p.m. PT)
Conference Audio Only
- Dial-in U.S. and Canada: (877) 451-6152
- Dial-in International: (201) 389-0879
- Conference ID No.: 13718702
An audio replay of the call will be available beginning at 8:00
p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time
on June 7, 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# 13718702. The audio recording will also be
available at www.cohbar.com during the same period. For this call
there will not be a slide presentation.
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, is in the Phase 1b stage of a
Phase 1a/1b clinical trial for NASH and obesity. In addition,
CohBar has four preclinical programs: CB5138 Analogs for
fibrotic diseases, CB5064 Analogs for COVID-19 associated
ARDS, CB5046 Analogs for CXCR4-related cancer and orphan diseases,
and MBT3 Analogs for cancer immunotherapy.
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; 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.
You are cautioned that such statements are not
guarantees of future performance and that our actual results may
differ materially from those set forth in the forward-looking
statements. 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. |
Balance
Sheets |
|
|
|
|
|
|
|
|
As of |
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash |
|
$ |
1,817,354 |
|
|
$ |
2,894,575 |
|
Investments |
|
|
15,999,690 |
|
|
|
18,120,266 |
|
Prepaid expenses and other current assets |
|
|
343,673 |
|
|
|
413,692 |
|
Total current assets |
|
|
18,160,717 |
|
|
|
21,428,533 |
|
Property and equipment, net |
|
|
357,589 |
|
|
|
394,004 |
|
Intangible assets, net |
|
|
17,805 |
|
|
|
18,075 |
|
Other assets |
|
|
69,620 |
|
|
|
67,403 |
|
Total assets |
|
$ |
18,605,731 |
|
|
$ |
21,908,015 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
1,052,031 |
|
|
$ |
727,599 |
|
Accrued liabilities |
|
|
314,821 |
|
|
|
1,141,741 |
|
Accrued payroll and other compensation |
|
|
816,550 |
|
|
|
853,335 |
|
Note payable, net of debt discount and offering costs of $6,509 and
$15,656 as of March 31, 2021 and |
|
|
|
December 31, 2020, respectively |
|
|
273,491 |
|
|
|
349,344 |
|
Total current liabilities |
|
|
2,456,893 |
|
|
|
3,072,019 |
|
Notes payable, net of debt discount and offering costs of $21,800
and $26,159 as of March 31, 2021 and |
|
|
|
December 31, 2020, respectively |
|
|
353,200 |
|
|
|
348,841 |
|
Total liabilities |
|
|
2,810,093 |
|
|
|
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 March 31, 2021 and December
31, 2020, respectively |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, Authorized 180,000,000 shares; |
|
|
|
|
Issued and outstanding 61,788,325 shares as of March 31, 2021 and
61,117,524 as of December 31, 2020 |
|
|
61,788 |
|
|
|
61,118 |
|
Additional paid-in capital |
|
|
89,030,480 |
|
|
|
87,684,323 |
|
Accumulated deficit |
|
|
(73,296,630 |
) |
|
|
(69,258,286 |
) |
Total stockholders’ equity |
|
|
15,795,638 |
|
|
|
18,487,155 |
|
Total liabilities and stockholders’ equity |
|
$ |
18,605,731 |
|
|
$ |
21,908,015 |
|
|
|
|
|
|
CohBar,
Inc. |
Condensed
Statements of Operations |
(unaudited) |
|
|
|
|
|
|
|
For The Three Months Ended March 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
Revenues. |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
2,654,772 |
|
|
|
1,449,872 |
|
General and administrative |
|
|
1,358,679 |
|
|
|
1,831,621 |
|
Total operating expenses |
|
|
4,013,451 |
|
|
|
3,281,493 |
|
Operating
loss |
|
|
(4,013,451 |
) |
|
|
(3,281,493 |
) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
Interest
income |
|
|
3,173 |
|
|
|
35,449 |
|
Interest
expense |
|
|
(14,560 |
) |
|
|
(77,836 |
) |
Equity
modification expense |
|
|
- |
|
|
|
(802,400 |
) |
Amortization
of debt discount and offering costs |
|
|
(13,506 |
) |
|
|
(91,283 |
) |
Total other expense |
|
|
(24,893 |
) |
|
|
(936,070 |
) |
Net
loss |
|
$ |
(4,038,344 |
) |
|
$ |
(4,217,563 |
) |
Basic and
diluted net loss per share |
|
$ |
(0.07 |
) |
|
$ |
(0.10 |
) |
Weighted
average common shares outstanding - basic and diluted |
|
|
61,560,279 |
|
|
|
43,119,369 |
|
|
|
|
|
|
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