On November 16, 2020 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 third quarter ended September 30, 2020 (Press release, CohBar, NOV 16, 2020, View Source [SID1234571138]).
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"We are pleased to announce that half of the planned subjects have completed dosing in our Phase 1b study evaluating CB4211 as potential treatments for NASH and obesity," said Steven Engle, CohBar’s Chief Executive Officer. "We currently expect top line data from the study in the second quarter of 2021, subject to the potential impact of COVID-19. Our preclinical programs are also progressing, with recent data for a CB5138 Analog in combination with the standard of care suggesting additional potential for improved treatments of Idiopathic Pulmonary Fibrosis. Our goal is to identify a clinical candidate for our IPF program early in the first quarter of 2021, subject to successful completion of the remaining required studies. In our CB5064 program for potential use in COVID-19/ARDS, we generated positive preliminary results in a preclinical model of Acute Respiratory Distress Syndrome."
"In order to finance these exciting programs, we raised $15 million during the quarter to advance our expanded R&D pipeline, added biotech focused institutional investors, and gained additional research analyst coverage," Mr. Engle continued. "We also expanded awareness and increased investor engagement by presenting at eight industry and healthcare bank conferences, and meeting with family offices and high net worth investors. Going forward, we are continuing to execute on our vision to treat multiple chronic diseases and extend healthy lifespan."
Third Quarter 2020 and Recent Highlights
Completed dosing in half of the planned subjects in the Phase 1b stage of the clinical study of CB4211 for 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. In August, the company announced the first subject had been dosed. 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.
Showed that the combination of a CB5138 Analog antifibrotic peptide and nintedanib produced enhanced effects: In October, the company announced new preclinical data demonstrating that a CB5138 Analog has enhanced effects when combined with nintedanib, the leading treatment for Idiopathic Pulmonary Fibrosis (IPF), suggesting potential utility for combination therapy in IPF. The new data from the therapeutic mouse model of IPF showed that treatment with the combination of CB5138-2 and nintedanib produced greater reductions in fibrosis, inflammation, pro-inflammatory cytokine levels, and collagen deposition compared to either treatment alone. IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 187,000 people worldwide.
Presented antifibrotic results at the American Thoracic Society: In August, the company presented new pre-clinical efficacy results in a poster presentation at the American Thoracic Society 2020 International Conference. Antifibrotic and anti-inflammatory effects were demonstrated for MBT2 (CB5138-1) in vitro in human cells and in vivo in prophylactic and therapeutic preclinical models of IPF.
Generated preliminary efficacy in preclinical study of apelin agonists in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and ARDS: In August, the company announced preliminary results in an evaluation of its CB5064 Analogs in an ARDS model. These positive results included reduced levels of fluid accumulation, neutrophil infiltration, and cytokine secretion. These are key processes underlying the lethal consequences of severe ARDS and COVID-19 associated ARDS. The company expects the apelin agonists to have potential to treat ARDS patients in general, of which there are approximately three million globally. CohBar previously presented data at the 2019 ADA Conference showing the activity of its CB5064 Analogs on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of type 2 diabetes.
Raised $15M in new capital and added biotech focused institutional investors: In August, the company completed a public offering to support its clinical and preclinical programs. The company received aggregate gross proceeds of approximately $15 million before commissions and other estimated offering expenses. The company issued 12.3M units at a price of $1.22 per unit. Each unit consists of one share of the company’s common stock and one warrant to purchase 0.75 of a share of common stock at a per share exercise price of $1.44.
Gained additional bank research coverage: Recently, Wall Street banks ROTH Capital Partners and WBB Securities initiated coverage on CohBar. Brookline Capital Markets initiated coverage in May.
Hosted key opinion leader webinar on IPF and CohBar’s antifibrotic peptides: The company hosted a key opinion leader webinar on the current treatment landscape in IPF, the unmet medical need, and positive findings from preclinical studies of its CB5138 Analogs. This event was led by world-class medical expert Dr. Toby Maher, Director of Interstitial Lung Disease and Professor of Medicine at the Keck School of Medicine, University of Southern California. Dr. Toby Maher provided an authoritative and insightful overview of the IPF situation, emphasizing the urgent need for new treatments. CohBar’s Chief Scientific Officer, Ken Cundy, presented recent results from CohBar’s antifibrotic program.
Continued investment community outreach and continued partnering efforts: In the third quarter, the company presented and hosted meetings at several healthcare banking conferences: H.C. Wainwright NASH, H.C. Wainwright, and Oppenheimer. CohBar spoke at two COVID-19 conferences: ROTH COVID-19 Therapeutics in Development and Sachs Novel Coronavirus Investment Forum. The company also spoke at Targeting Metabesity, and at the BIO Investor Forum where the company met with prospective investors. Recently, the company presented at the BIO-Europe conference and continues to proactively engage in business development discussions.
Founders’ Update
During the third 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 published two papers on how the genomics of mitochondrial DNA are related to diseases of aging, "A Mitochondrial Genome-Wide Association Study of Cataract in a Latino Population" in the Translational Vision Science & Technology Journal and "Mito-Omics and immune function: Applying novel mitochondrial omic techniques to the context of the aging immune system" in the Translation Medicine of Aging Journal.
Dr. Barzilai was a key speaker at the Aging Research & Drug Discovery (ARDD) Meeting. He also was interviewed by the Wall Street Journal, Bloomberg, and The Sun among other publications, and was featured in the Peter Attia Drive and Demystifying Science podcasts.
Third Quarter 2020 Financial Highlights
Cash and Investments: CohBar had cash, cash equivalents and investments of $23.4 million as of September 30, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended September 30, 2020, was approximately $2.9 million.
R&D Expenses: Research and development expenses were $1.2 million for the three months ended September 30, 2020, compared to $1.9 million in the prior year quarter. The decrease in research and development expenses was primarily due to lower clinical trial and stock-based compensation costs related to the timing of those expenses.
G&A Expenses: General and administrative expenses were $1.4 million for the three months ended September 30, 2020, compared to $1.3 million in the prior year quarter. The increase in general and administrative expenses was primarily due increased legal costs related to protecting our intellectual property.
Net Loss: For the three months ended September 30, 2020, net loss, which included $0.9 million of non-cash expenses, was $3.2 million, or $0.06 per basic and diluted share. For the three months ended September 30, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.3 million, or $0.08 per basic and diluted share.
Third Quarter Investor Call and Slide Presentation:
Date: November 16, 2020
Time: 5:00 p.m. ET (2:00 p.m. PT)
Conference Audio
Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13711606
Slide Presentation
Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 312 1885 and password CWBR, or
Go to www.cohbar.com and click on Q3 2020 Shareholder Presentation at the top of homepage.
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 16, 2020, through 11:59 p.m. Eastern Time on December 7, 2020. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13711606. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.