Loading, Please Wait...
MENLO PARK, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, today reported its financial results for the third quarter ended September 30, 2019.
“Our recently announced completion of Phase 1a and the start of recruitment for Phase 1b of our CB4211 clinical study is a key step in the examination of the tolerability and pharmacokinetics of CB4211, and a significant milestone for the first clinical study of a mitochondria based therapeutic in humans,” said Steven Engle, Chief Executive Officer. “In parallel, we continued to move our preclinical programs forward by evaluating novel peptides in new animal studies of fibrotic diseases, cancer, and type 2 diabetes. We believe that CB4211 is the first of a number of candidates that our mitochondria-based technology platform will identify for advancement into the clinic.”
During the third quarter and more recently, Dr. Pinchas Cohen and Dr. Nir Barzilai continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases:
Third Quarter Investor Call and Slide Presentation:
Date: November 6, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)
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 November 6, 2019, through 11:59 p.m. Eastern Time on November 27, 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# 13694507. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.
CohBar’s lead clinical program is based on CB4211, a first-in-class mitochondria based therapeutic, 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, which has been shown to play a significant role in the regulation of metabolism, and was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators. In 2018, CB4211 entered a Phase 1a/1b clinical trial which includes an evaluation of biological activity relevant to NASH and obesity. NASH is a chronic and silent disease in its early stages that can progress to more serious disease stages, such as advanced fibrosis, cirrhosis, liver failure or liver cancer. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is 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, 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 mitochondrial-derived 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 peptides into therapeutics that offer the potential to address a broad range of age-related diseases, including nonalcoholic steatohepatitis (NASH), obesity, fibrotic diseases, cancer, type 2 diabetes, and cardiovascular and neurodegenerative diseases. The company’s lead compound, CB4211, is in a phase 1a/1b clinical trial that includes an evaluation of biological activity relevant to NASH and obesity. To date, the company and its founders have discovered more than 100 mitochondrial-derived peptides. For additional company information, please visit www.cohbar.com.
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 including but not limited to statements regarding anticipated outcomes of research and clinical trials for our lead candidate, CB4211, or other mitochondria based therapeutic (MBT) candidates; expectations regarding the future market for any drug we may develop; expectations regarding the growth of MBTs as a significant future class of drug products; and statements regarding anticipated therapeutic properties and potential of our MBTs or the properties, potential and effects of newly-discovered mitochondrial-derived peptides. 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 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; and our ability to establish and maintain partnerships with corporate and industry partners. 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.
Investor and Media
Jeff Biunno, CFO
LifeSci Advisors, LLC
|Condensed Balance Sheets|
| As of
|September 30, 2019||December 31, 2018|
|Prepaid expenses and other current assets||484,355||260,630|
|Total current assets||14,904,132||22,443,398|
|Property and equipment, net||435,745||520,740|
|Intangible assets, net||19,423||20,233|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued payroll and other compensation||164,085||667,661|
|Total current liabilities||1,195,146||2,162,209|
|Notes payable, net of debt discount and offering costs of $656,275 and $986,163 as of September 30, 2019 and|
|December 31, 2018, respectively||3,246,225||2,916,337|
|Commitments and contingencies|
|Preferred stock, $0.001 par value, Authorized 5,000,000 shares;|
|No shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively||-||-|
|Common stock, $0.001 par value, Authorized 75,000,000 shares;|
|Issued and outstanding 42,861,422 shares as of September 30, 2019 and 42,578,208 as of December 31, 2018||42,861||42,578|
|Additional paid-in capital||60,211,715||57,868,593|
|Total stockholders’ equity||10,977,970||17,962,618|
|Total liabilities and stockholders’ equity||$||15,419,341||$||23,041,164|
|Condensed Statements of Operations|
|For The Three Months Ended September 30,||For The Nine Months Ended September 30,|
|Research and development||1,943,746||3,435,509||4,734,020||7,948,951|
|General and administrative||1,283,721||1,061,709||4,279,223||3,290,113|
|Total operating expenses||3,227,467||4,497,218||9,013,243||11,239,064|
|Other (expense) income:|
|Amortization of debt discount and offering costs||(109,963||)||(109,943||)||(329,888||)||(215,187||)|
|Total other (expense) income||(121,960||)||(115,824||)||(314,810||)||(276,676||)|
|Basic and diluted net loss per share||$||(0.08||)||$||(0.11||)||$||(0.22||)||$||(0.28||)|
|Weighted average common shares outstanding - basic and diluted||42,861,422||42,478,877||42,766,300||40,815,309|