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MENLO PARK, Calif., March 18, 2019 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, today reported its financial results for the fourth quarter ended December 31, 2018.
“We continue to focus on getting CB4211 back into the clinic as soon as possible, and have engaged in direct discussions this month with the FDA about our revised clinical plan,” said Philippe Calais, CohBar’s interim chief executive officer. “At the same time, our increased investment in research is enabling significant progress in evaluating our new peptides in an expanded range of disease models, and uncovering mechanisms that open new potential opportunities for additional therapeutic targets. We also continue to make progress optimizing novel peptides as potential therapeutics for type 2 diabetes and cancer. These developments on multiple fronts reinforce our belief in the therapeutic potential of our portfolio of mitochondrial peptides to treat multiple age-related diseases.”
Fourth Quarter 2018 and Recent Clinical, Research and Business Highlights:
During the fourth quarter and more recently, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.
Fourth Quarter 2018 Financial Highlights
Fourth Quarter Investor Call and Slide Presentation:
Date: March 18, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)
We kindly request that you please call into the conference audio and log into WebEx approximately 10 minutes prior to the start time so that we can begin promptly.
An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 18, 2019, through 11:59 p.m. Eastern Time on April 8, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 8144256. The audio replay along with the slide presentation will also be available on the homepage at www.cohbar.com from March 18, 2019 through April 8, 2019.
CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. 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.
CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs for the treatment of age-related diseases. MBTs originate from the discovery by CohBar’s founders of a novel group of peptides within the mitochondrial genome which regulate metabolism and cell death, and whose biological activity declines with age. CohBar’s efforts focus on the development of these mitochondrial-derived peptides (MDPs) into clinically relevant MBTs that offer the potential to address a broad range of age-related diseases with underlying metabolic dysfunction, including nonalcoholic steatohepatitis (NASH), obesity, type 2 diabetes, cancer, and cardiovascular and neurodegenerative diseases. To date, the company and its founders have discovered more than 100 MDPs.
For additional company information, please visit www.cohbar.com.
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 lead CB4211 drug candidate program, including statements regarding the suspension of the Phase 1 clinical trial for CB4211, planned steps to address the adverse events, suggested causes of injection site reactions and anticipated resumption of the Phase 1 clinical trial for CB4211. Forward-looking statements are based on current expectations, projections and interpretations that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by CohBar. These include the possibility that the Phase 1 clinical trial will remain suspended for longer than anticipated or may not be resumed; CohBar’s 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 as a clinical candidate or its commercial potential. 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, 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.
Investor and Media
Jeff Biunno, CFO
LifeSci Advisors, LLC
|December 31, 2018||December 31, 2017|
|Prepaid expenses and other current assets||260,630||164,274|
|Total current assets||22,443,398||8,616,733|
|Property and equipment, net||520,740||176,531|
|Intangible assets, net||20,233||23,051|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued payroll and other compensation||667,661||503,133|
|Total current liabilities||2,162,209||1,244,306|
|Notes payable, net of debt discount and offering costs of $986,163 and $0 as of December 31, 2018 and 2017,|
|Commitments and contingencies|
|Preferred stock, $0.001 par value, Authorized 5,000,000 shares;|
|No shares issued and outstanding as of December 31, 2018 and 2017, respectively||-||-|
|Common stock, $0.001 par value, Authorized 75,000,000 shares;|
|Issued and outstanding 42,578,208 shares as of December 31, 2018 and 39,439,505 as of December 31, 2017||42,578||39,440|
|Additional paid-in capital||57,868,593||31,822,161|
|Total stockholders’ equity||17,962,618||7,618,913|
|Total liabilities and stockholders’ equity||$||23,041,164||$||8,863,219|
|Statements of Operations|
|For The Three Months Ended December 31,||For The Years Ended December 31,|
|Research and development||2,085,662||1,791,212||10,034,613||6,675,080|
|General and administrative||2,009,604||1,059,565||5,299,717||3,184,166|
|Total operating expenses||4,095,266||2,850,777||15,334,330||9,859,246|
|Other income (expense):|
|Amortization of debt discount and offering costs||(109,963)||-||(325,150)||(59)|
|Total other (expense) income||(94,859)||17,381||(371,535)||26,094|
|Basic and diluted net loss per share||$||(0.10)||$||(0.07)||$||(0.38)||$||(0.26)|
|Weighted average common shares outstanding - basic and diluted||42,557,400||39,405,355||41,254,411||37,478,883|