On April 2, 2018 CohBar, Inc. (NASDAQ: CWBR and TSXV: COB.U) ("CohBar" or the "Company"), an innovative biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported its financial results for the fourth quarter ended December 31, 2017 (Press release, CohBar, APR 2, 2018, View Source [SID1234525114]).
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"We continue to progress CB4211 toward a mid-year clinical entry for our Phase 1a/1b study in obese subjects with NAFLD," said Simon Allen, CohBar CEO. "We are also making great progress in understanding the novel mechanism of action of CB4211 which we believe may translate into broader applications. CohBar also completed a seamless transition to the NASDAQ at the end of the fourth quarter to enhance trading liquidity, increase our market visibility, and better enable us to expand our institutional investor base as we become a clinical-stage company this year."
Recent and Fourth Quarter 2017 Business and Preclinical Development Highlights:
●Expansion of CohBar’s Board of Directors. CohBar Co-founder Dr. John Amatruda joined the CohBar Board of Directors in December 2017. Dr. Amatruda adds tremendous experience to the CohBar Board, having spent 25 years as a senior pharmaceutical research executive (at Merck Research Laboratories and Bayer Corporation), together with over 40 years practicing and teaching medicine at Columbia University and Yale University.
●CB4211 Clinical Study Design Expanded. In November, 2017, CohBar announced an expanded clinical study design for CB4211, its lead clinical candidate for nonalcoholic steatohepatitis (NASH) and obesity. The expanded design includes an exploratory Phase 1b assessment of activity in obese subjects with NAFLD, which is intended to substantially accelerate activity readouts relevant to NASH and obesity in advance of a Phase 2 study. The Company plans to initiate the Phase 1a/1b clinical trial in mid-2018, with an activity readout expected in early 2019.
●Increased Visibility on CB4211 Mechanism of Action. CohBar’s ongoing investigation of the molecular mechanisms underlying CB4211’s efficacy in animal models of NASH and obesity has identified interaction with a cell-surface receptor that plays a key role in metabolic regulation. The Company intends to present its findings at a scientific conference during the year.
●Investment and Scientific Community Outreach. During the fourth quarter, CohBar’s CEO Simon Allen presented an overview of the Company and its clinical development program at The Bio Investor Forum and Torrey Hills Capital’s Emerging Growth Conference.
●Approved for Listing on the NASDAQ Capital Market. On December 15, 2017, CohBar’s common stock commenced trading on the NASDAQ Capital Market under the ticker symbol CWBR. The NASDAQ stock market trades more equities than any other US exchange and the Company’s listing is expected to provide increased liquidity, additional visibility in the marketplace, and enhanced access to capital markets.
●Private Placement Offering. On March 29, 2018 the Company issued and sold $2.1 million of non-convertible unsecured promissory notes, together with warrants to purchase 428,500 shares of common stock. Closing of a second tranche of the previously announced private placement is expected to occur on or before April 15, 2018.
During the fourth quarter, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.
●Dr. Cohen was an author of two clinical studies on mitochondrial peptides published during the quarter: "Downregulation of circulating MOTS-c levels in patients with coronary endothelial dysfunction," in the International Journal of Cardiology (December 2017); and "Low circulating levels of the mitochondrial-peptide hormone SHLP2: novel biomarker for prostate cancer risk," in Oncotarget (2017 Nov. 7). Dr. Cohen was also awarded grants for several new studies related to mitochondrial peptides including: "Role of the Mitochondrial Peptide Humanin in Regulating Aging and Lifespan" (NIH); "Ethnic Disparity of the Mitochondrial Peptides and Prostate Cancer Risk" (DOD) and "Characterization of the Heathspan promoting Activity of Humanin" (AFAR BIG Award).
●Dr. Barzilai was a keynote speaker at the "Pathways to Extend Healthspan Symposium" at Bar Ilan University, and the Jackson Laboratories "Forum for Healthcare Innovation" at the University of Connecticut. He also was a featured speaker at "Metabesity 2017" in London, UK; "Biology of Aging – Impactful Interventions" in Singapore; and the "Inflammation, Aging and Chronic Disease Conference" at Stanford University. More recently, Dr. Barzilai delivered the "David Cugell Memorial Lectureship" at Northwestern University. During the quarter, Dr. Barzilai was also an author of two studies entitled: "Association between Sleep Patterns and Health in Families with Exceptional Longevity," published in Frontiers of Medicine; and "System-wide Benefits of Intermeal Fasting by Autophagy" published in Cell Metabolism.
Fourth Quarter 2017 Financial Highlights
●Cash and Investments. CohBar had cash and investments of $8,452,459 on December 31, 2017, compared to $8,686,420 on December 31, 2016.
●R&D Expenses. Research and development expenses were $1,791,212 in the three months ended December 31, 2017 compared to $960,390 in the prior year quarter. The increase was due primarily to the costs related to our IND-enabling activities for advancing our lead drug candidate into clinical studies and the initial costs incurred relating to the Company’s anticipated clinical trials.
●G&A Expenses. General and administrative expenses were $1,059,565 in the three months ended December 31, 2017, compared to $717,054 in the prior year quarter. The increase was primarily due the bonus accruals made in the fourth quarter and compliance costs associated with the Company’s move to the NASDAQ exchange.
●Net Loss. For the three months ended December 31, 2017, net loss was $2,833,396, or $0.07 per basic and diluted share, compared to a net loss of $1,677,148, or $0.05 per basic and diluted share, for the three months ended December 31, 2016.
Fourth Quarter Investor Call Information
Date: April 2, 2018
Time: 2:00 p.m. PDT (5:00 p.m. EDT)
Dial-in U.S. and Canada: 1-800-239-9838
Dial-in International: 1-323-794-2551
Conference ID# 4690749
Slide Presentation – go to www.webex.com, click on the ‘Join’ button and enter Meeting Number 921930268 and Password Q4call, or alternatively, go to www.cohbar.com.
For individuals participating in the Investor Call and Slide Presentation, we request that you please call into the audio, and log into WebEx or go to CohBar’s website, approximately 10 minutes before the start of the presentation, so that we can begin promptly.
An audio replay of the call will be available beginning at 5:00 p.m. (PDT) on April 2, 2018, through 9:00 p.m. (PDT) on April 30, 2018. To access the recording please dial 1-844-512-2921 in the U.S. and Canada, or 1-412-317-6671 internationally, and reference Conference ID# 4690749. The audio replay will also be available at www.cohbar.com from April 3, through April 30, 2018.
The slide presentation will be available at www.cohbar.com from 2:00 p.m. (PDT) on April 2, through April 30, 2018