Advances Two Clinical Candidates into
IND-Enabling Activities
Discovers New Mitochondrial-Derived Peptides
and Expands IP Portfolio
CohBar, Inc. (OTCQX: CWBR and TSXV: COB.U), an innovative
biotechnology company focused on developing mitochondria based
therapeutics (MBTs) to treat diseases associated with aging and
increase healthy lifespan, today reported financial results for the
third quarter ended September 30, 2016.
“The advancement of our optimized MOTS-c analogs, CB4209 and
CB4211, to IND-enabling activities during the third quarter was a
significant milestone for CohBar, and an important step in
demonstrating the potential of MBTs for the treatment of metabolic
disorders underlying age-related diseases,” said Simon Allen,
CohBar’s CEO. “Together with our confirmatory studies for obesity
and nonalcoholic steatohepatitis, or NASH, which is an advanced
form of fatty liver disease, we are evaluating the clinical
candidates for combination therapy in type 2 diabetes. At the same
time, we’ve continued to mine the mitochondrial genome for new
biologically active peptides, broadened our IP portfolio and
further secured our position as a leader in mitochondria based
therapeutics.”
Business Highlights and Developments:
- Two First-in-Class Mitochondria
Based Therapeutics Advanced into IND-Enabling Activities. On
September 30, 2016, CohBar announced the selection of two optimized
analogs from its MOTS-c program for advancement into IND-enabling
activities. The clinical candidates, CB4209 and CB4211,
demonstrated significant and competitively differentiated
therapeutic potential in preclinical models for the treatment of
obesity. Additional confirmatory studies are planned to determine
therapeutic potential for the treatment of NASH, and as a potential
add-on to other drugs for the treatment of type 2 diabetes. On
October 13, 2016, the Company hosted a conference call with
investors, providing details on its preclinical studies and
outlining the potential for its clinical candidates to address the
unmet medical needs and market opportunities in obesity, NASH and
type 2 diabetes. The Company expects to file an IND for its first
clinical candidate by the end of 2017 and to initiate a Phase 1
clinical trial in early 2018. A replay of the investor call is
available on the Company’s website at: www.cohbar.com.
- Additional Biologically Active
Peptides Discovered in the Mitochondrial Genome and 25 New
Provisional Patent Applications filed. On October 13, 2016,
CohBar announced the discovery of a large number of new
biologically active peptides encoded within the genome of the
mitochondria, together with the filing of 25 new provisional patent
applications. The Company continues to evaluate these new peptides
as possible additions to its pipeline of therapeutics for internal
development or partnership opportunities, and expects to file
additional patent applications going forward.
- Expanded Investment Community
Outreach. During the third quarter, CohBar continued its retail
investment community outreach with non-deal roadshows in the
Midwest and Northeast regions of the U.S., and expanded its
Investor Relations program with the hiring of Anna Schram as
Director of Investor Relations. Following the September 30th
announcement of the advancement of its clinical candidates into
IND-enabling activities, the Company continued to build awareness
with additional roadshows in the U.S. and Canada. More recently,
CohBar’s CEO Simon Allen presented the new preclinical data and met
with institutional investors and potential pharma partners at the
BIO Investor Forum 2016 in San Francisco. An audio replay of the
BIO presentation is available on the Company’s website at
www.cohbar.com.
During the third quarter, CohBar’s founders continued to receive
international recognition for their leadership in the study of
aging and for their innovations and discoveries in the treatment of
age-related diseases:
- Dr. Pinchas Cohen was the
keynote speaker at the Rejuvenation Biotechnology Conference 2016
hosted at The Buck Center for Research on Aging in California in
August 2016, and was a visiting lecturer at The 17th International
Congress of Endocrinology in Beijing, in September 2016.
- Dr. Nir Barzilai was a featured
speaker at the First International Conference on “Founder
Populations and their contribution to our understanding of Biology
and History – Lessons from the Jewish Genome” in July 2016, in
Haifa Israel, and was the keynote speaker at the Benzon Symposium
No. 62, “Genome Instability and Neurodegeneration” in August 2016,
in Copenhagen, Denmark.
In addition, the founders’ research received media coverage
during the third quarter in both consumer and financial media
outlets including: The Toronto Star, “The search for the ‘Holy
Grail’ of human longevity” (August 7, 2016); The Economist, “The
fight to cheat death is hotting up” (August 13, 2016) and “How
medical science hopes to slow down ageing” (August 14, 2016); and
Men’s Health, “How we can increase our healthspans” (September 2,
2016).
Summary of Third Quarter Financial Results
- Cash and Investments. CohBar had
cash, cash equivalents and investments of $8,089,242 on September
30, 2016, compared to $10,291,487 on December 31, 2015.
- R&D Expenses. Research and
development expenses were $1,056,429 in the three months ended
September 30, 2016 compared to $547,029 in the prior year period, a
$509,400 increase. The increase in research and development
expenses was due primarily to an increase in expenses
related to the Company’s efforts to develop optimized MBT
candidates and an increase in salary, benefits and stock-based
compensation due to the expansion of its scientific staff.
- G&A Expenses. General and
administrative expenses were $598,507 in the three months ended
September 30, 2016 compared to $531,841 in the prior year period, a
$66,666 increase. The increase in general and administrative
expenses was primarily due to an increase in salary, benefits and
stock-based compensation from the expansion of the Company’s
executive team with the addition of its new Chief Executive
Officer, offset by the timing of a bonus accrued in the previous
year quarter with no corresponding expense in the current year
period.
- Net Loss. For the three months
ended September 30, 2016, net loss was $1,653,729 or $0.05 per
share basic and diluted, compared to a net loss of $1,079,256, or
$0.03 per share basic and diluted, for the three months ended
September 30, 2015.
About CohBar
CohBar (OTCQX: CWBR and TSXV: COB.U) is a leader in the research
and development of mitochondria based therapeutics, an emerging
class of drugs for the treatment of diseases associated with aging.
MBTs originate from the discovery of a novel group of peptides
within the genome of mitochondria, the powerhouses of the cell.
This groundbreaking discovery was made by our founders, world
leaders in the biology of aging, metabolism and mitochondrial
genomics. MBTs offer the potential to address a broad range of
diseases such as obesity, nonalcoholic steatohepatitis (NASH), type
2 diabetes, cancer, atherosclerosis and neurodegenerative
disorders.
For additional company information, please
visit www.cohbar.com.
Forward-Looking Statements
This news release contains forward-looking statements
(statements which are not historical facts) within the meaning of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include CohBar’s plans and expectations
for its CB4209 and CB4211 candidate program, including anticipated
timing and results of IND-enabling activities, regulatory
submissions and initiation of clinical trials, statements regarding
the therapeutic potential of these and other mitochondria based
therapeutics, and the potential for additional discoveries, and
expectations regarding future patent applications. Forward-looking
statements are based on current expectations, estimates and
projections that involve a number of risks and uncertainties that
could cause actual results to differ materially from those
anticipated by CohBar. These risks and uncertainties include, among
other things, the uncertainties inherent in research and
development, including the ability to meet anticipated commencement
and completion dates for IND-enabling and initial clinical studies,
as well as the possibility of unfavorable study results, including
unfavorable new data and additional analyses of existing data;
risks associated with initial data, including the risk that results
of additional pre-clinical or clinical studies may be different
from (including less favorable than) the earlier data results and
may not support further clinical development; whether and when any
investigational new drug application may be filed with regulatory
authorities for CB4209 or CB4211; whether and when regulatory
authorities may approve any such applications, and other decisions
by regulatory authorities that could affect the availability or
commercial potential of CB4209 or CB4211. Additional risks and
uncertainties include CohBar’s ability to retain key personnel,
expand its research operations, and obtain financing necessary to
continue its operations and fund its candidate
programs. 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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
CohBar, Inc. Condensed Balance Sheets
As of September 30, 2016
December 31, 2015 (unaudited) ASSETS
Current assets: Cash and cash equivalents $ 6,012,237 $
4,803,687 Investments 2,077,005 5,487,800 Prepaid expenses and
other current assets 82,256 88,223
Total current assets 8,171,498 10,379,710 Property and equipment,
net 225,313 199,575 Other assets 27,093 20,492
Total assets $ 8,423,904 $ 10,599,777
LIABILITIES AND STOCKHOLDERS’ EQUITY Current
liabilities: Accounts payable $ 424,064 $ 209,730 Accrued
liabilities 143,944 155,713 Accrued payroll and other compensation
237,667 217,250 Note payable, net of debt discount 205,152
- Total current liabilities 1,010,827 582,693
Note payable, net of debt discount - 205,005
Total liabilities 1,010,827 787,698
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, 2016 and December 31, 2015, respectively - - Common
stock, $0.001 par value, Authorized 75,000,000 shares; Issued and
outstanding 33,432,514 shares as of September 30, 2016 and
32,320,891 as of December 31, 2015 33,433 32,321 Additional paid-in
capital 20,112,032 18,114,295 Accumulated deficit
(12,732,388 ) (8,334,537 ) Total stockholders’ equity
7,413,077 9,812,079 Total liabilities and
stockholders’ equity $ 8,423,904 $ 10,599,777
CohBar, Inc. Condensed Statements of
Operations (unaudited)
For The Three Months Ended September
30, For The Nine Months Ended September 30, 2016
2015 2016 2015 Revenues $ - $ -
$ - $ -
Operating expenses: Research and development
1,056,429 547,029 2,646,125 1,257,075 General and administrative
598,507 531,841 1,753,008 1,467,759
Total operating expenses 1,654,936 1,078,870
4,399,133 2,724,834 Operating loss (1,654,936)
(1,078,870) (4,399,133) (2,724,834)
Other
income (expense): Interest income 3,142 1,451 7,072 3,650
Interest expense (1,886) (1,755) (5,643) (5,267) Other expense -
(33) - (1,452) Amortization of debt discount (49)
(49) (147) (147) Total other income (expense)
1,207 (386) 1,282 (3,216) Net loss $
(1,653,729) $ (1,079,256) $ (4,397,851) $ (2,728,050) Basic and
diluted net loss per share $ (0.05) $ (0.03) $ (0.13) $ (0.09)
Weighted average common shares outstanding - basic and diluted
33,416,874 32,320,891 32,878,254
31,951,056
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161114005318/en/
Investor and Media Contact:CohBar, Inc.Anna Schram,
650-446-7888 ext. 114anna.schram@cohbar.com
CohBar Inc. (TSXV:COB.U)
Historical Stock Chart
From Sep 2024 to Oct 2024
CohBar Inc. (TSXV:COB.U)
Historical Stock Chart
From Oct 2023 to Oct 2024