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CohBar Reports Second Quarter 2021 Financial Results and Provides Business Update

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CohBar, Inc. (NASDAQ: CWBR) reported its Q2 2021 financial results, highlighting positive topline data from its Phase 1a/1b trial of CB4211, aimed at treating NASH and obesity. The study met primary endpoints with no serious adverse events and showed significant improvements in liver biomarkers and glucose levels. However, cash reserves decreased to $13.8 million from $21 million at the end of 2020, with a net loss of $5.2 million. R&D and G&A expenses increased, raising concerns about future financial sustainability.

Positive
  • Positive topline data from CB4211 trial for NASH and obesity.
  • Study met primary endpoints demonstrating safety and tolerability.
  • Significant reductions in ALT and AST liver biomarkers.
Negative
  • Cash reserves declined from $21 million to $13.8 million.
  • Net loss increased to $5.2 million from $4.1 million year-over-year.
  • R&D expenses rose to $2.6 million, an increase from $1.5 million.

Company to host conference call and webcast at 5:00 p.m. ET

MENLO PARK, Calif., Aug. 10, 2021 (GLOBE NEWSWIRE) -- CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today reported its financial results for the second quarter ended June 30, 2021.

“Our positive CB4211 topline data announcement today marks an important milestone in our path towards demonstrating the full potential of our novel therapeutic platform sourced from the mitochondrial genome,” stated Dr. Joseph Sarret, Chief Executive Officer. “In parallel with our ongoing analysis of the promising data from the CB4211 study, we are diligently working to enable CB5138-3 to enter the clinic next year for the treatment of idiopathic pulmonary fibrosis. This is an exciting time for the company as we look forward to continued progress in the development of product candidates designed to address serious unmet medical needs.”

Second Quarter 2021 and Recent Highlights

  • Announced Positive Topline Data from the Phase 1a/1b Study of CB4211 Being Developed for the Treatment of Nonalcoholic Steatohepatitis (NASH) and Obesity: Today, the company announced topline results from the multi-center, randomized, double-blind, placebo-controlled Phase 1a/1b clinical study of CB4211, under development for NASH and obesity. The study met its primary endpoints as CB4211 was well-tolerated and appeared safe with no serious adverse events. The evaluation of the exploratory endpoints showed robust and statistically significant improvements in key biomarkers of liver damage, ALT and AST, and in glucose levels in the CB4211 group compared to placebo. There was a trend towards lower body weight in the CB4211 group after four weeks of treatment.
  • 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. Dr. Sarret is a seasoned executive with a track record of success in biotechnology.

Second Quarter 2021 Financial Highlights

  • Cash and Investments: CohBar had cash and investments of $13.8 million as of June 30, 2021, compared to $21 million as of December 31, 2020. The cash burn for the quarter ended June 30, 2021, was approximately $4.6 million.
  • R&D Expenses: Research and development expenses were $2.6 million for the three months ended June 30, 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 compensations costs.
  • G&A Expenses: General and administrative expenses were $2.6 million for the three months ended June 30, 2021, compared to $1.4 million in the prior year quarter.  The increase in general and administrative expenses was primarily due to higher compensation and stock-based compensation costs and increased D&O insurance premiums.    
  • Net Loss: For the three months ended June 30, 2021, net loss, which included $1.0 million of non-cash expenses, was $5.2 million, or $0.08 per basic and diluted share. 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.

Second Quarter Investor Call:

Date: August 10, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

  • Dial-in U.S. and Canada: (877) 300-8521
  • Dial-in International: (412) 317-6026
  • Conference ID No.: 10159293

Slide Presentation

For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Zoom approximately 10 minutes prior to its start. Please note, no audio will be available through Zoom.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on August 10, 2021, through 11:59 p.m. Eastern Time on August 31, 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# 10159293. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

About CohBar

CohBar (NASDAQ: CWBR) is a clinical stage biotechnology company focused on the research and development of mitochondria based therapeutics, an emerging class of drugs for the treatment of chronic and age-related diseases. Mitochondria based therapeutics originate from the discovery by CohBar’s founders of a novel group of naturally occurring peptide sequences within the mitochondrial genome, some of which have been shown to have the potential to regulate key processes in multiple systems and organs in the body. To date, the company has discovered more than 100 mitochondrial derived peptides and generated over 1,000 analogs. CohBar’s efforts focus on the development of these peptides into therapeutics that offer the potential to address a broad range of diseases associated with the underlying impact of mitochondrial dysfunction. The company’s lead compound, CB4211, recently completed a Phase 1a/1b clinical trial for NASH and obesity. In addition, CohBar has four preclinical programs with the most advanced being CB5138-3 for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases, which is currently in IND-enabling studies. The preclinical programs also include the CB5064 Analogs for acute respiratory distress syndrome (ARDS) including COVID-19 associated ARDS, CB5046 Analogs for CXCR4-related cancer and orphan diseases, and MBT3 Analogs for cancer immunotherapy.

For additional company information, please visit www.cohbar.com.

Forward-Looking Statements

This news release contains forward-looking statements that are not historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to statements regarding timing and anticipated outcomes of research and clinical trials for our mitochondria based therapeutic (MBT) candidates; expectations regarding the growth of MBTs as a significant future class of drug products; and statements regarding anticipated therapeutic properties and potential of our mitochondrial peptide analogs, MBTs and other potential therapies. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include: our ability to successfully advance drug discovery and development programs, including the delay or termination of ongoing clinical trials and the timing of announcements and updates relating to our clinical trials and related data; our possible inability to mitigate the prevalence and/or persistence of the injection site reactions, receipt of unfavorable feedback from regulators regarding the safety or tolerability of CB4211 or the possibility of other developments affecting the viability of CB4211 or CB5138-3 as a clinical candidate or its commercial potential; results that are different from earlier data results including less favorable results that may not support further clinical development; our ability to raise additional capital when necessary to continue our operations; our ability to recruit and retain key management and scientific personnel; the risk that our intellectual property may not be adequately protected; our ability to establish and maintain partnerships with corporate and industry partners; and risks related to the impact on our business of the COVID-19 pandemic or similar public health crises. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission and applicable Canadian securities regulators, which are available on our website, and at www.sec.gov or www.sedar.com.

You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this news release are made as of the date hereof and CohBar does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts:
Jordyn Tarazi
Director of Investor Relations
CohBar, Inc.
(650) 445-4441
Jordyn.tarazi@cohbar.com


CohBar, Inc.
Condensed Balance Sheets
     
   As of
  June 30, 2021 December 31, 2020
  (unaudited)  
                                                     ASSETS    
Current assets:    
Cash $1,603,151  $2,894,575 
Investments  12,221,227   18,120,266 
Prepaid expenses and other current assets  1,045,848   413,692 
Total current assets  14,870,226   21,428,533 
Property and equipment, net  328,078   394,004 
Intangible assets, net  17,535   18,075 
Other assets  69,620   67,403 
Total assets $15,285,459  $21,908,015 
     
LIABILITIES AND STOCKHOLDERS’ EQUITY     
Current liabilities:    
Accounts payable $1,858,409  $727,599 
Accrued liabilities  186,021   1,141,741 
Accrued payroll and other compensation  731,817   853,335 
Note payable, net of debt discount and offering costs of $17,441 and $15,656 as of June 30, 2021 and    
December 31, 2020, respectively  357,559   349,344 
Total current liabilities  3,133,806   3,072,019 
Notes payable, net of debt discount and offering costs of $0 and $26,159 as of June 30, 2021 and    
December 31, 2020, respectively  -   348,841 
Total liabilities  3,133,806   3,420,860 
     
Commitments and contingencies    
     
Stockholders’ equity:    
Preferred stock, $0.001 par value, Authorized 5,000,000 shares;    
No shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  -   - 
Common stock, $0.001 par value, Authorized 180,000,000 shares;    
Issued and outstanding 62,269,427 shares as of June 30, 2021 and 61,117,524 as of December 31, 2020  62,269   61,118 
Additional paid-in capital  90,609,379   87,684,323 
Accumulated deficit  (78,519,995)  (69,258,286)
Total stockholders’ equity  12,151,653   18,487,155 
Total liabilities and stockholders’ equity $15,285,459  $21,908,015 
     


CohBar, Inc.
Condensed Statements of Operations
(unaudited)
         
  For The Three Months Ended June 30,  For The Six Months Ended June 30,
   2021   2020   2021   2020 
         
Revenues $-  $-  $-  $- 
         
Operating expenses:        
Research and development  2,617,675   1,545,043   5,272,447   2,994,915 
General and administrative  2,584,364   1,390,671   3,943,043   3,222,292 
Total operating expenses  5,202,039   2,935,714   9,215,490   6,217,207 
Operating loss  (5,202,039)  (2,935,714)  (9,215,490)  (6,217,207)
         
Other income (expense):        
Interest income  (33)  1,743   3,140   37,195 
Interest expense  (10,425)  (77,837)  (24,985)  (155,673)
Equity modification expense  -   (998,643)  -   (1,801,043)
Amortization of debt discount and offering costs  (10,868)  (92,078)  (24,374)  (183,361)
Total other expense  (21,326)  (1,166,815)  (46,219)  (2,102,882)
Net loss $(5,223,365) $(4,102,529) $(9,261,709) $(8,320,089)
Basic and diluted net loss per share $(0.08) $(0.09) $(0.15) $(0.19)
Weighted average common shares outstanding - basic and diluted  61,860,023   43,336,953   61,710,979   43,228,161 
         

FAQ

What were CohBar's financial results for Q2 2021?

CohBar reported a net loss of $5.2 million and cash reserves of $13.8 million.

What is the significance of the CB4211 trial results announced by CohBar?

The trial results showed safety, tolerability, and significant improvements in biomarkers for liver damage.

When will the next CohBar conference call take place?

The next conference call is scheduled for August 10, 2021, at 5:00 p.m. ET.

How did research and development expenses change for CohBar in Q2 2021?

R&D expenses increased to $2.6 million from $1.5 million in the previous year.

What are the future plans for CohBar's product candidates?

CohBar plans to advance CB5138-3 into clinical trials for idiopathic pulmonary fibrosis next year.

COHBAR INC

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Biotechnology
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Menlo Park