On May 17, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2021 (Press release, CohBar, MAY 17, 2021, View Source [SID1234580118]).

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"I am excited about the potential of CohBar’s mitochondria based therapeutic programs to make a significant difference in the lives of patients," stated Dr. Joseph Sarret, Chief Executive Officer. "We look forward to the Phase 1b data from our trial of CB4211 for the treatment of NASH and obesity in early July 2021. In parallel, we are continuing to advance our preclinical pipeline, most notably initiating IND-enabling studies with CB5138-3 for fibrotic diseases, including IPF, putting us on track for our goal of having at least 2 clinical-stage programs in 2022."

First Quarter 2021 and Recent Highlights

Completed last subject visit in the Phase 1b stage of the clinical study of CB4211 under development for nonalcoholic steatohepatitis (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. The primary endpoints are safety and tolerability, with a secondary endpoint of pharmacokinetics, and exploratory endpoints of changes in liver fat, body weight, and biomarkers relevant to NASH, obesity, and metabolic disease. The company expects to release topline data in early July 2021.
Nominated CB5138-3 as lead clinical candidate for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases and initiated IND-enabling activities: In March, the company announced the selection of CB5138-3 for advancement into IND-enabling activities, 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.
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, including an evaluation using the golden Syrian hamster SARS-CoV-2 model, which has been used in the assessment of other COVID-19 therapeutics.
Appointed Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director: In April, the company announced the appointment of Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director, effective May 3, 2021. Dr. Sarret is a seasoned executive with a track record of success in biotechnology.
Gained additional bank research coverage: Recently, Wall Street banks Aegis Capital and Maxim Group initiated coverage on CohBar and issued research reports on the company.
Founders’ Update

During the first 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 and his colleagues published three landmark papers on the role of MOTS-c in human health. The first, "MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis," published in Nature Communication, outlined the exercise mimetic actions of MOTS-c, and described the fitness- and health-enhancing effects of this hormone. The second paper, entitled "MOTS-c reduces myostatin and muscle atrophy signaling," published in the American Journal of Physiology, described a key mechanism for MOTS-c action, namely its effect on suppressing the myokine myostatin in animal models, which has implications for possible utility in diseases like frailty and sarcopenia. The third paper, entitled "A pro-diabetogenic mtDNA polymorphism in the mitochondrial-derived peptide, MOTS-c," published in the journal Aging, described the effects of a mutation in the MOTS-c gene, found in up to 8% of Japanese, Koreans and Northern Chinese. This mutation results in a "bio-inactive" variant of MOTS-c that is unable to induce the insulin-sensitizing and weight-loss effects the "wild-type" form elicits in male animals. Men who carry this mutation have elevated levels of (inactive) MOTS-c, increased abdominal fat and an elevated risk for type-2 diabetes; this risk is further increased in the subset of these men who are also sedentary, providing additional support for the relationship between MOTS-c and exercise.

Dr. Barzilai was featured at several conferences related to aging, including the "Annual Aging Research and Drug Discovery 2020: From aging mechanisms to interventions" symposium and publication. In addition, he was featured at the National University of Singapore Yong Loo Lin School of Medicine’s Healthy Longevity series in a webinar titled "Age Later: Lessons for This Pandemic and the Next". Dr. Barzilai was a keynote speaker at the Annual International (bio)Medical Students Meeting (AIMS) Meeting and the Geneva Science and Diplomacy Anticipator. He was also a panelist on the "Living Healthily to 120 and Beyond" session at the Fifth International Vatican Conference.

First Quarter 2021 Financial Highlights

Cash and Investments: CohBar had cash and investments of $17.8 million as of March 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended March 31, 2021, was approximately $4.2 million.

R&D Expenses: Research and development expenses were $2.7 million for the three months ended March 31, 2021, compared to $1.5 million in the prior year quarter. The increase in research and development expenses was primarily due to the investment in the company’s research programs focused on the continued development of its peptides, and an increase in clinical trial costs due to the timing of those expenses, partially offset by a decrease in stock-based compensation costs.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended March 31, 2021, compared to $1.8 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to lower stock-based compensation costs.

Net Loss: For the three months ended March 31, 2021, net loss, which included $0.4 million of non-cash expenses, was $4.0 million, or $0.07 per basic and diluted share. For the three months ended March 31, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share.
First Quarter Investor Call:

Date: May 17, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio Only

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13718702
An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time on June 7, 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# 13718702. The audio recording will also be available at www.cohbar.com during the same period. For this call there will not be a slide presentation