On March 29, 2022 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases, reported its financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update (Press release, CohBar, MAR 29, 2022, View Source [SID1234611114]).

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"2021 was a year of significant growth for CohBar, highlighted by positive topline data from our first human study and the demonstration of clinical proof-of-concept for our platform, the nomination of our second clinical candidate, and the addition of high-quality talent to our leadership and Board," stated Dr. Joseph Sarret, Chief Executive Officer. "As we begin 2022, we are well-positioned to advance our mission and execute on our goals. Today, we announced that we have aligned our resources to focus on three main areas – the development of our IPF program, CB5138-3, the discovery of additional novel peptide families through our novel Mito+ platform, and securing a partner for further development of CB4211. I’m optimistic about this focused strategy and excited for what our team can achieve in 2022 and beyond."

Recent Corporate Updates

●Focused Pipeline to Advance Key Programs: CohBar has aligned its resources to focus on three main areas: (1) the development of its novel peptide analog, CB5138-3, for the treatment of idiopathic pulmonary fibrosis (IPF). In addition to the ongoing IND-enabling studies, the company is focused on optimizing drug delivery to increase the likelihood of success in the clinic for this hard-to-treat patient population. The IND for this program is now expected to be submitted in the second half of 2023; (2) the discovery and development of additional novel peptide families using the company’s novel Mito+ platform; and (3) the pursuit of a partnership for further development of CB4211.

●Appointed Nick Vlahakis, MBBS, as Acting Chief Medical Officer: Today, CohBar announced the appointment of Nick Vlahakis, MBBS, as acting Chief Medical Officer. Dr. Vlahakis is an experienced pulmonary and critical care clinician with clinical development expertise encompassing both early and late stage trials across a wide range of therapeutic areas, including IPF. Before joining CohBar, he was VP and Head of Clinical Development at Global Blood Therapeutics Inc. (GBT) where he advanced voxelotor (Oxbryta) to approval in sickle cell disease. Prior to GBT, he served as the VP and Head of the Respiratory Disease Area at Unity Biotechnology, developing clinical strategy for pre-clinical assets across a broad range of respiratory diseases. Dr. Vlahakis began his industry career at Genentech, serving as clinical lead for products in early and late clinical development. Prior to Genentech, Dr. Vlahakis was on faculty at Mayo Clinic and had an NIH-funded lab studying the biology of fibrosis, acute lung injury and angiogenesis. Dr. Vlahakis received his MBBS medical degree at the University of Adelaide in Australia and completed his Internal Medicine residency and Pulmonary Fellowship at Mayo Clinic. He is also a published scientist with more than 60 peer-reviewed articles.

Fourth Quarter 2021 Highlights

●Announced Changes to its Board of Directors and R&D Leadership. In December 2021, the company announced that its founders Drs. Nir Barzilai, Pinchas Cohen, and John Amatruda transitioned from the Board of Directors to a reconstituted Scientific Advisory Board. In addition, Ken Cundy, Ph.D., resigned as Chief Scientific Officer, effective March 31, 2022, and the company appointed Kent Grindstaff, Ph.D. as Senior Vice President of Research, effective January 4, 2022.

●Completed Equity Financing: In November 2021, the company completed an underwritten public offering of common stock and warrants, with aggregate gross proceeds of approximately $15 million. The company intends to use the proceeds from this offering to fund research and development and other general corporate purposes.

●Presented Late-Breaking Poster on CB4211 at The Liver Meeting 2021: In November 2021, the company presented data from its Phase 1a/1b clinical study of CB4211 during The American Association for the Study of Liver Diseases (AASLD) Annual Meeting (The Liver Meeting 2021).

Fourth Quarter 2021 Financial Highlights

●Cash and Investments: The company had cash and investments of $26.2 million as of December 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended December 31, 2021 was approximately $3.0 million.

●R&D Expenses: Research and development expenses were $0.8 million for the three months ended December 31, 2021, compared to $2.7 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and preclinical costs due to the timing of those costs.

●G&A Expenses: General and administrative expenses were $2.0 million for the three months ended December 31, 2021, compared to $1.7 million in the prior year quarter. The increase in general and administrative expenses was primarily due to higher stock-based compensation costs.

●Net Loss: For the three months ended December 31, 2021, net loss, which included $0.6 million of non-cash expenses, was $2.8 million, or $0.04 per basic and diluted share. 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.

Fourth Quarter and Full-Year 2021 Investor Call:

Webcast

-A simultaneous webcast of the call will be accessible via the Investors section of the CohBar website at www.cohbar.com.

For individuals participating in the Investor Call or webcast, please call or login to the conference audio 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 29, 2022, through 11:59 p.m. Eastern Time on April 19, 2022. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13726040. The audio recording will also be available at www.cohbar.com during the same period.