On August 13, 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 second quarter ended June 30, 2020 (Press release, CohBar, AUG 13, 2020, View Source [SID1234563593]).
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"Today, we announced positive preliminary preclinical results in ARDS as a first step in our new COVID-19 ARDS program," said Steven Engle, CohBar’s Chief Executive Officer. "Recently, we resumed our Phase 1b study in NASH and obesity and we presented new positive results from our antifibrotic peptide program at the American Thoracic Society’s Virtual Conference. We were pleased to report that CohBar was added to the Russell 2000 and raised $4.5 million during the quarter from our at-the-market facility. With these new programs and results, our confidence continues to grow in CohBar’s vision of developing new therapeutics from mitochondrially encoded peptides to treat multiple chronic diseases and extend healthy lifespan."
Second Quarter 2020 and Recent Highlights
Resumed CB4211 clinical study for NASH and Obesity: In July, the company announced that it had resumed screening and enrollment in the Phase 1b stage of its Phase 1a/1b clinical trial of CB4211, its lead candidate for treating nonalcoholic steatohepatitis (NASH) and obesity, following a temporary pause in response to the COVID-19 pandemic. 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.
Generated preliminary preclinical data in new program targeting COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and ARDS: Today, the company announced new preliminary results in the evaluation of its CB5064 analogs in an ARDS model, which showed reduced levels of fluid accumulation, cytokine secretion, and neutrophil infiltration. In May, the company chose a new disease target for its apelin agonists program: COVID-19 associated ARDS. The company expects the apelin agonists to also affect ARDS in general, which impacts approximately three million patients globally. CohBar previously presented data at the 2019 ADA Conference showing the beneficial effects of this novel family of peptides on glucose tolerance, insulin sensitivity, and weight loss in an obese mouse model of type 2 diabetes.
Presented new antifibrotic results at the American Thoracic Society: In August, the company presented new 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 idiopathic pulmonary fibrosis (IPF). IPF is a chronic, progressive, debilitating, and usually fatal interstitial lung disease that affects approximately 100,000 people in the U.S.
Gained research coverage of CohBar: In May, Wall Street firm Brookline Capital Markets initiated coverage on CohBar.
Met with pharmaceutical companies at BIO 2020: In June, the company presented and hosted meetings at the BIO 2020 Conference with top pharmaceutical and biotechnology companies. In a panel on aging, CohBar’s CEO spoke on the "Redefining What it Means to Get Old: New Breakthroughs in Aging Biology."
Raised $4.5M in new capital: In June, the company sold 2,350,067 shares of common stock at an average price of $1.925 per share under an at-the-market offering program. The company received aggregate gross proceeds of approximately $4.5 million, before commissions and other estimated offering expenses totaling approximately $0.2 million.
CohBar added to the Russell Indexes: On June 26, the company joined the Russell 2000 and 3000 Indexes. The Russell 2000 Index serves as a leading benchmark for small-cap stocks in the United States.
Continued investment community outreach: In July, the company presented its new COVID-19 ARDS program at the Sachs Novel Coronavirus Investment Forum.
Conducted Annual General Meeting: In June, the company held its Annual General Meeting and provided a review and update on its progress and plans. The slides are available on the company’s website at www.cohbar.com.
Founders Update
During the second 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 on the study of mitochondrial science, aging and age-related diseases.
Dr. Cohen chaired the University of Southern California Public Health Policy Advisory Committee that oversaw returning to campus after the COVID-19 related shutdown. He also published a commentary linking this topic to aging research titled "COVID-19: The Importance of GeroScience in Promising Research Directions." During this period, under Dr. Cohen’s leadership, USC was awarded a USC-Buck Nathan Shock Center of Excellence in the Biology of Aging, joining a nation-wide network of seven other centers, including the one at Einstein, led by Dr. Barzilai. Dr. Cohen also published two papers on the importance of mitochondrial peptides on healthy aging and longevity. These papers are "The mitochondrial derived peptide humanin is a regulator of lifespan and healthspan" and "Peptides derived from small mitochondrial open reading frames: Genomic, biological, and therapeutic implications."
Dr. Barzilai’s book Age Later has been published by St. Martin’s Press and is available on Amazon. It describes the background of mitochondrial derived peptides and the founding of CohBar. Also, Dr. Barzilai gave talks that recognized CohBar in the Longevity Technology and Longevity Leadership meetings. He also participated in a new TEDx and was mentioned in Bloomberg, The New York Times, Wired, Wall Street Journal, among others.
Second Quarter 2020 Financial Highlights
Cash and Investments: CohBar had cash, cash equivalents and investments of $12.3 million as of June 30, 2020, compared to $12.6 million as of December 31, 2019. The cash burn for the quarter ended June 30, 2020, was approximately $2.5 million.
R&D Expenses: Research and development expenses were $1.5 million for the three months ended June 30, 2020, compared to $1.4 million in the prior year quarter. The increase in research and development expenses was primarily due to higher consulting costs.
G&A Expenses: General and administrative expenses were $1.4 million for the three months ended June 30, 2020, compared to $1.5 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to lower recruiting and travel expenses.
Net Loss: For the three months ended June 30, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.1 million, or $0.09 per basic and diluted share. For the three months ended June 30, 2019, net loss, which included $0.8 million of non-cash expenses, was $3.1 million, or $0.07 per basic and diluted share.
Second Quarter Investor Call and Slide Presentation:
Date: August 13, 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.: 13707178
Slide Presentation
Go to www.webex.com, click on the ‘Join a Meeting’ button and enter meeting number 145 324 6260 and Password CWBR, or
Go to www.cohbar.com and click on Q2 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 August 13, 2020, through 11:59 p.m. Eastern Time on September 3, 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# 13707178. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.