On November 6, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, reported its financial results for the third quarter ended September 30, 2019 (Press release, CohBar, NOV 6, 2019, View Source [SID1234550451]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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."
Business Highlights
●Completed CB4211 Phase 1a and intiated Phase 1b patient recruitment: CohBar recently completed the Phase 1a stage of the Phase 1a/1b clinical trial. Patient recruitment has started for the Phase 1b stage that includes an evaluation of biological activity relevant to nonalcoholic steatohepatitis (NASH) and obesity. Results from both stages of the study are anticipated in mid-2020.
●Advanced peptides targeting cancer and fibrotic diseases: The company initiated additional preclinical studies evaluating novel peptides in animal models of fibrotic diseases, cancer, and type 2 diabetes. Preliminary evidence of anti-fibrotic activity was previously observed in an animal model of idiopathic pulmonary fibrosis. Fibrotic disease is a major unmet medical need contributing to approximately one-third of deaths worldwide. Previous preliminary in vitro data demonstrated the potential for CohBar peptides to enhance the killing of cancer cells by human immune cells. The market for cancer immunotherapy is projected to grow significantly to over $100 billion by 2023.
●Expanded Board of Directors: Biotech veteran Misha Petkevich joined the CohBar board of directors in October. Mr. Petkevich brings to the company more than three decades of financial and investment experience with life sciences companies in senior managment roles at V2M Capital, Robertson Stephens & Co. and Hambrecht & Quist.
●Presented at the Cantor Healthcare Conference and BIO Investor Forum: CohBar CEO Steven Engle presented and met with investors at the Cantor conference in New York, which featured more than 200 innovative public and private companies and a large audience of healthcare focused investors. A recording of the presentation is available at www.cohbar.com. He also presented at the BIO Investor Forum in San Francisco, which featured investment trends and opportunities in life sciences with emphasis on emerging public companies.
●Outreach to analysts and investors: During the quarter, CohBar management introduced the company’s technology and programs to a number of biotechnology analysts. The company also met with biotech focused institutional investors and existing shareholders in New York, Boston, Tel Aviv, London and California.
●Strengthened patent portfolio: The company received notification of the issuance of patents for MOTS-c in China and for a method of use in treating diabetes in the U.S. Notice of Allowance was also issued by the USPTO for the CohBar trademark.
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:
·Dr. Cohen delivered a keynote presentation on "Systems Biology of the Mitochondria: Tools for Discovery of Aging Targets" at the International Perspectives on Geroscience, Weizmann Institute, in Rehoboth, Israel, in September 2019. In addition, Dr. Cohen co-authored "Effects of air pollution on mitochondrial function, mitochondrial DNA methylation, and mitochondrial peptide expression," published in Mitochondrion, and "Metabolomic profile of diet-induced obesity mice in response to humanin and small humanin-like peptide 2 treatment," published in Metabolomics. This summer, Dr. Cohen was elected as a fellow of the Gerontological Society of America.
·Dr Barzilai delivered opening remarks and a presentation entitled "Improving healthspan of the elderly: Not science fiction anymore," at the International Geroscience Meeting in Rehoboth, Israel, in September 2019. Dr. Barzilai also delivered presentations on improving healthspan and aging research at the 6th Aging Research, Drug Discovery and AI Forum during the Basel Life Congress, in Basel, Switzerland, in September 2019, at The International European Geroscience Meeting in Madrid, Spain, in September 2019 and was a featured speaker the Metabesity conference in Washington, D.C., in October 2019. In addition, Dr. Barzilai was an honored guest at the Global Leader Symposium in August 2019, in Venice, Italy and at the Milken Institute, as a participant on the Panel on Aging in Washington, D.C. In October 2019, Dr. Barzilai authored an article published in the Journal of Alzheimers Disease entitled "Frailty and Risk of Incident Motoric Cognitive Risk Syndrome" and co-authored the article entitled "A meta-analysis of genome-wide association studies identifies multiple longevity genes," published in Nature Communications.
Financial Highlights
●Cash and Investments. CohBar had cash and investments of $14.4 million as of September 30, 2019, compared to $22.2 million as of December 31, 2018. The cash burn for the quarter ended September 30, 2019, was approximately $2.5 million.
●R&D Expenses. Research and development expenses were $1.9 million for the three months ended September 30, 2019, compared to $3.4 million in the prior year quarter. The decrease was primarily due to lower preclinical, clinical and stock-based compensation costs in the quarter, partially offset by an increase in costs associated with our research programs focused on the continuing development of peptides.
●G&A Expenses. General and administrative expenses were $1.3 million for the three months ended September 30, 2019, compared to $1.1 million in the prior year quarter. The increase was primarily due to increased investor relations and insurance premium costs and director fees.
●Net Loss. 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. For the three months ended September 30, 2018, net loss, which included $1.7 million of non-cash expenses, was $4.6 million, or $0.11 per basic and diluted share.
Third Quarter Investor Call and Slide Presentation:
Date: November 6, 2019
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.: 13694507
Slide Presentation
-Go to www.webex.com, click on the ‘Join’ button and enter meeting number 920 124 970 and Password CWBR, or
-Go to www.cohbar.com and click on Q3 2019 Shareholder Presentation at 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 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.
About CB4211
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.