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 fourth quarter ended December 31, 2020.
“We made significant progress with our Phase 1b
clinical study and preclinical programs,” stated Steven Engle,
CohBar’s Chief Executive Officer. “We completed enrollment in the
CB4211 Phase 1b study for the treatment of NASH and obesity and
nominated a CB5138 Analog as our second clinical candidate based on
positive preclinical studies during the last quarter. We also
initiated a collaboration with NIAID to evaluate the potential of
CB5064 Analogs for the treatment of COVID-19 associated ARDS, which
followed confirmatory results in a preclinical model of ARDS.
Overall, we are pleased with the advancement of our portfolio this
past quarter and look forward to sharing our first clinical results
on the CB4211 program.”
Fourth Quarter 2020 and Recent Highlights
- Completed
enrollment in the Phase 1b stage of the clinical study of CB4211
under development for 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. Nonalcoholic
steatohepatitis (NASH) has been estimated to
affect as many as 12% of adults in the U.S., and there is currently
no approved treatment for the disease. The company plans to
announce last subject visit, which is anticipated in April. The
company currently expects topline data at the end of the second
quarter based on timing of the last subject visit and other
factors.
- Nominated
CB5138-3 as lead clinical candidate for Idiopathic Pulmonary
Fibrosis (IPF) and other fibrotic diseases: In March, the
company announced the selection of CB5138-3 for advancement into
IND-enabling activities. CohBar completed candidate screening and
selected CB5138-3 based on its preclinical efficacy, preliminary
safety data, and drug-like properties. CohBar has initiated
IND-enabling activities for CB5138-3 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. IPF is a chronic, progressive, debilitating, and usually
fatal interstitial lung disease that affects approximately 187,000
people worldwide.
- 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, such as the golden Syrian hamster
SARS-CoV-2 model which has been used in the assessment of other
COVID-19 therapeutics.
- Generated confirmatory
results in preclinical study of CB5064 Analog apelin receptor
agonists in COVID-19 Associated ARDS
and ARDS: In December, the company announced
confirmatory results in an evaluation of its CB5064 Analogs in an
ARDS model. These positive results included reduced levels of fluid
accumulation and cytokine secretion. These are key processes
underlying the lethal consequences of severe ARDS and COVID-19
associated ARDS. Based on these results, the company believes that
these apelin agonists could be a potential treatment for ARDS
patients in general, of which there are approximately three million
globally.
- Hosted key
opinion leader webinar on IPF and CohBar’s antifibrotic
peptides: In November, the company hosted a key opinion
leader webinar on the current treatment landscape in IPF, the unmet
medical need, and positive findings from preclinical studies of its
CB5138 Analogs. The keynote speaker was world-class medical expert
Dr. Toby Maher, Director of Interstitial Lung Disease and Professor
of Medicine at the Keck School of Medicine, University of Southern
California. Dr. Maher provided an authoritative and insightful
overview of the IPF landscape, emphasizing the urgent need for new
treatments. CohBar’s Chief Scientific Officer, Ken Cundy, Ph.D.,
presented recent results from CohBar’s antifibrotic program.
- Gained
additional bank research coverage: Recently, Wall Street
banks Aegis Capital, Chardan Capital, and WBB Securities initiated
coverage on CohBar and issued research reports on the company.
Previously, ROTH Capital and Brookline Capital Markets initiated
research coverage in 2020.
- Featured in
prominent biotechnology and business media: Recently,
CohBar has been featured in publications such as BioSpace,
Longevity Technology, and Chief Executive Magazine. For more
information, please visit the Newsroom page on CohBar’s website at
www.cohbar.com/news-media/newsroom.
Founders’ Update
During the fourth 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 published a paper on the mechanisms of action of the
mitochondrial peptide, Humanin, titled “The IL-27 Component
EBI-3 and its Receptor Subunit IL-27Rα Are Essential for the
Cytoprotective Action of Humanin on Male Germ Cells” in the
journal Biology of Reproduction; and a commentary in the PBS
periodical Next Avenue, entitled “COVID-19 and the Future
of Aging: Prospects for Geroscience.”
Dr. Barzilai was a keynote speaker at the Quest for a COVID-19
Vaccine at the New York Academy of Science event in a presentation
titled “Immunosenescence and COVID-19 Vaccines for the Elderly” and
at AFAR’s The Future is Now: Innovations in AI and Big Data for
Healthspan and Longevity event. He also was interviewed by the Wall
Street Journal, Bloomberg, and The Sun among other publications,
and was featured in the Peter Attia Drive and Demystifying Science
podcasts.
Fourth Quarter 2020 Financial Highlights
- Cash and Investments: CohBar had cash, cash
equivalents and investments of $21.0 million as of December 31,
2020, compared to $12.6 million as of December 31, 2019. The cash
burn for the quarter ended December 31, 2020, was approximately
$2.4 million.
- R&D Expenses: Research and development
expenses were $2.7 million for the three months ended December 31,
2020, compared to $1.9 million in the prior year quarter. The
increase in research and development expenses was primarily due to
higher clinical trial costs related to the timing of those expenses
offset by lower stock-based compensation costs.
- G&A Expenses: General and administrative
expenses were $1.7 million for both the three months ended December
31, 2020 and 2019.
- Net Loss: For the three months ended December
31, 2020, net loss, which included $0.6 million of non-cash
expenses, was $4.7 million, or $0.08 per basic and diluted share.
For the three months ended December 31, 2019, net loss, which
included $0.7 million of non-cash expenses, was $3.7 million, or
$0.09 per basic and diluted share.
Fourth Quarter Investor Call and Slide
Presentation:Date: March 30, 2021Time: 5:00 p.m. ET (2:00
p.m. PT)
Conference Audio
- Dial-in U.S. and Canada: (877) 451-6152
- Dial-in International: (201) 389-0879
- Conference ID No.: 13717040
Slide Presentation
- Go to www.webex.com, click on the ‘Join a Meeting’ button and
enter meeting number 145 355 3814 and password CWBR, or
- Go to www.cohbar.com and click on Q4 2020 Shareholder
Presentation at the top of homepage.
For individuals participating in the Investor Call and Slide
Presentation, please call into the conference audio and log into
Webex 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 March 30, 2021, through 11:59 p.m. Eastern
Time on April 20, 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# 13717040. The audio recording along
with the slide presentation 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, 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 which 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; 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 than and 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 |
|
December 31, 2020 |
|
December 31, 2019 |
|
|
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
2,894,575 |
|
|
$ |
12,563,853 |
|
Investments |
|
18,120,266 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
413,692 |
|
|
|
361,311 |
|
Total current assets |
|
21,428,533 |
|
|
|
12,925,164 |
|
Property and equipment, net |
|
394,004 |
|
|
|
523,677 |
|
Intangible assets, net |
|
18,075 |
|
|
|
19,154 |
|
Other assets |
|
67,403 |
|
|
|
64,242 |
|
Total assets |
$ |
21,908,015 |
|
|
$ |
13,532,237 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
727,599 |
|
|
$ |
444,776 |
|
Accrued liabilities |
|
1,141,741 |
|
|
|
916,692 |
|
Accrued payroll and other compensation |
|
853,335 |
|
|
|
677,755 |
|
Note payable, net of debt discount and offering costs of $15,656
and $0 as of December 31, 2020 and 2019, respectively |
|
349,344 |
|
|
|
- |
|
Total current liabilities |
|
3,072,019 |
|
|
|
2,039,223 |
|
Notes payable, net of debt discount and offering costs of $26,159
and $546,312 as of December 31, 2020 and 2019,
respectively |
|
348,841 |
|
|
|
3,356,188 |
|
Total liabilities |
|
3,420,860 |
|
|
|
5,395,411 |
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par value, Authorized 5,000,000
shares; |
|
|
|
No shares issued and outstanding as of December 31, 2020 and
December 31, 2019, respectively |
|
- |
|
|
|
- |
|
Common stock, $0.001 par value, Authorized 180,000,000 shares; |
|
|
|
Issued and outstanding 61,117,524 shares as of December 31, 2020
and 43,069,418 as of December 31, 2019 |
|
61,118 |
|
|
|
43,069 |
|
Additional paid-in capital |
|
87,684,323 |
|
|
|
61,087,082 |
|
Accumulated deficit |
|
(69,258,286 |
) |
|
|
(52,993,325 |
) |
Total stockholders’ equity |
|
18,487,155 |
|
|
|
8,136,826 |
|
Total liabilities and stockholders’ equity |
$ |
21,908,015 |
|
|
$ |
13,532,237 |
|
|
|
|
|
|
CohBar,
Inc. |
Statements
of Operations |
|
|
|
|
|
|
|
|
|
For The Three Months Ended December 31, |
|
For The Years Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,697,165 |
|
|
|
1,897,908 |
|
|
|
6,937,610 |
|
|
|
6,631,928 |
|
General and administrative |
|
1,667,587 |
|
|
|
1,671,883 |
|
|
|
6,261,905 |
|
|
|
5,951,106 |
|
Total operating expenses |
|
4,364,752 |
|
|
|
3,569,791 |
|
|
|
13,199,515 |
|
|
|
12,583,034 |
|
Operating
loss |
|
(4,364,752 |
) |
|
|
(3,569,791 |
) |
|
|
(13,199,515 |
) |
|
|
(12,583,034 |
) |
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
Interest
income |
|
3,085 |
|
|
|
41,727 |
|
|
|
41,149 |
|
|
|
290,313 |
|
Interest
expense |
|
(77,046 |
) |
|
|
(78,692 |
) |
|
|
(311,410 |
) |
|
|
(312,200 |
) |
Equity
modification expense |
|
- |
|
|
|
- |
|
|
|
(2,290,688 |
) |
|
|
- |
|
Amortization
of debt discount and offering costs |
|
(269,237 |
) |
|
|
(109,963 |
) |
|
|
(504,497 |
) |
|
|
(439,851 |
) |
Total other expense |
|
(343,198 |
) |
|
|
(146,928 |
) |
|
|
(3,065,446 |
) |
|
|
(461,738 |
) |
Net
loss |
$ |
(4,707,950 |
) |
|
$ |
(3,716,719 |
) |
|
$ |
(16,264,961 |
) |
|
$ |
(13,044,772 |
) |
Basic and
diluted net loss per share |
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.30 |
) |
Weighted
average common shares outstanding - basic and diluted |
|
58,477,667 |
|
|
|
42,964,881 |
|
|
|
48,814,353 |
|
|
|
42,816,616 |
|
|
|
|
|
|
|
|
|
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