UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report: August 10, 2021
(Date of earliest event reported)
COHBAR, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-38326 | 26-1299952 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
1455 Adams Drive, Suite 2050
Menlo Park, CA 94025
(Address of principal executive offices and zip code)
(650) 446-7888
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12(b)) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) |
Name of each exchange on which registered |
||
Common Stock | CWBR | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
COHBAR, INC.
FORM 8-K
Item 2.02 | Results of Operations and Financial Condition. |
On August 10, 2021, CohBar, Inc. (the “Company)
issued a press release announcing its financial results for the quarter ended June 30, 2021. A copy of the press release is attached
as Exhibit 99.1.
The information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 (the “Securities Act”) or the Exchange Act, except as otherwise expressly stated in such filing.
Item 8.01 | Other Events. |
On August 10, 2021, the Company issued a press release announcing the results of its Phase 1a/1b clinical trial of CB4211. A copy of the press release is attached as Exhibit 99.2.
Also, on August 10, 2021, the Company is hosting a conference call to discuss the results of its Phase 1a/1b clinical trial of CB4211, its financial results for the quarter ended June 30, 2021 and other business updates. A copy of the presentation related to this conference call is attached as Exhibit 99.3 to this report and incorporated by reference herein.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
The following exhibits are furnished herewith and this list is intended to constitute the exhibit index:
99.1 | CohBar, Inc. press release dated August 10, 2021. | |
99.2 | CohBar, Inc. press release dated August 10, 2021. | |
99.3 | CohBar, Inc. presentation dated August 10, 2021. | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
COHBAR, INC. | ||
(Registrant) | ||
August 10, 2021 | By: | /s/ Jeffrey F. Biunno |
(Date) | Jeffrey F. Biunno | |
Chief Financial Officer |
2
Exhibit 99.1
CohBar Reports Second Quarter 2021
Financial Results and Provides Business Update
Company to host conference call and webcast at 5:00 p.m. ET
MENLO PARK, Calif., August 10, 2021 – 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
- | Please visit https://us02web.zoom.us/j/84796437737?pwd=R2t0eEFRVDVlVDVZMTdhT0pGWVVsUT09 and enter password CWBR, or | |
- | Go to www.cohbar.com and click on CohBar Q2 2021 Investor 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 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.
2
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
3
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 |
4
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 |
5
Exhibit 99.2
CohBar Announces Positive Topline Results from the Phase 1a/1b Study of CB4211 Under
Development for NASH and Obesity
● | CB4211 was well-tolerated and appeared safe with no serious adverse events |
● | Robust reductions in ALT and AST |
● | Reduction in glucose and trend towards body weight reduction |
● | Company to host conference call and webcast at 5:00 p.m. ET |
MENLO PARK, Calif., August 10, 2021 – CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, today announced topline results from the multi-center, randomized, double-blind, placebo-controlled Phase 1a/1b clinical study of CB4211, under development for nonalcoholic steatohepatitis (NASH) and obesity. The study met its primary endpoint showing that CB4211 was well-tolerated and appeared safe with no serious adverse events. Evaluation of the exploratory pharmacodynamic endpoints from the Phase 1b stage of the study comparing CB4211 to placebo demonstrated robust and significant reductions in key biomarkers of liver damage, ALT and AST, a significant decrease in glucose levels, and a trend towards lower body weight after four weeks of treatment. Both the CB4211 and placebo groups had substantial reductions in liver fat content compared to baseline.
Key findings from the topline data of the Phase 1b portion of the study are summarized below.
Biomarker |
CB4211
(n = 11) |
Placebo (n = 9) |
Difference from Placebo | |||||||||
ALT
(% reduction from baseline) |
-21 | % | 4 | % | -25 | * | ||||||
Proportion of subjects with >17 U/L decrease in ALT(1)
|
27 | % | 11 | % | 16 | % | ||||||
AST
(% reduction from baseline) |
-28 | % | -11 | % | -17 | %* | ||||||
Glucose
(% reduction from baseline) |
-6 | % | 0 | % | -6 | %* |
ALT: Alanine aminotransferase. AST: Aspartate aminotransferase.
* | Statistically significant versus placebo, p<0.05 by unpaired t test |
(1) | A decrease in ALT by 17 U/L or more is significantly associated with histologic response in NASH (Loomba R et al. Gastroenterology, 2019; 156 (1): 88-95) |
MRI-PDFF Data |
CB4211 (25 mg) (n = 11) |
Placebo (n = 9) |
||||||
Baseline Liver Fat Content (LFC)
|
21.1 | % | 15.9 | % | ||||
Percent Reduction in LFC (Absolute)
|
-5.03 | % | -4.88 | % | ||||
Proportion of Responders Achieving >30% Relative Reduction in LFC | 36 | % | 33 | % |
MRI-PDFF: Magnetic resonance imaging – proton density fat fraction.
“The results from the Phase 1b CB4211 study are promising,” stated Dr. Rohit Loomba, MD, MHSc, Professor of Medicine, Director, NAFLD Research Center, and Director of Hepatology, University of California at San Diego. “Demonstrating significant reductions of this magnitude in both serum ALT and AST relative to placebo after only four weeks suggests a potential for improvement in liver health if we continue to see further improvements over a longer period of time in patients with NASH. Improvements in serum ALT and AST are key predictors of histologic response independent of liver fat change; CB4211 shows great promise as a potential candidate for further development in NASH for this growing epidemic of silent and progressive liver disease.”
The results from both portions of the study indicate that CB4211 was well-tolerated and appeared safe with no serious adverse events. The only adverse events occurring in >10% of subjects receiving CB4211 in the four-week Phase 1b portion of the study were transient and generally mild to moderate injection site reactions.
“We are pleased with the positive outcome of our first human trial of CB4211 and look forward to working with disease experts to explore the next steps for our CB4211 program,” stated Dr. Joseph Sarret, CohBar’s Chief Executive Officer. “These impressive results validate our novel approach of using the mitochondrial genome as a valuable source of potential therapeutic peptides to treat serious systemic diseases.”
The Phase 1a stage of the study was a double blind, placebo-controlled single ascending dose and multiple ascending dose assessment of safety, tolerability, and pharmacokinetics over one week in 65 healthy adults, to select the most appropriate dose for the Phase 1b stage. The Phase 1b study was a randomized, double-blind, placebo-controlled evaluation of a 25 mg dose of CB4211 given once daily by subcutaneous injection for four weeks in 20 obese subjects with nonalcoholic fatty liver disease (NAFLD). The primary endpoints were safety and tolerability, with a secondary endpoint of pharmacokinetics, and exploratory endpoints of changes in liver fat, body weight, and biomarkers relevant to NASH, obesity, and metabolic disease. Subjects were required to have a minimum of 10% liver fat at enrollment, and to stay in the clinical study unit during the four weeks of treatment. This study was conducted at four sites.
CB4211 is the first mitochondria based therapeutic to enter clinical testing. Mitochondria based therapeutics are an emerging class of drugs based on novel analogs of peptide sequences discovered by CohBar scientists in 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.
The company is continuing to analyze the data and plans to present additional results and analyses at a future scientific meeting.
2
Conference 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
- | Please visit https://us02web.zoom.us/j/84796437737?pwd=R2t0eEFRVDVlVDVZMTdhT0pGWVVsUT09 and enter password CWBR, or |
- | Go to www.cohbar.com and click on CohBar Q2 2021 Investor 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 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 CB4211
CB4211 is a first-in-class mitochondria based therapeutic (MBT) that recently completed a Phase 1a/1b clinical study for the treatment of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial derived peptide (MDP), which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators. NASH has been estimated to affect as many as 30 million adults in the U.S., and there is currently no approved treatment for the disease.
3
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 which 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; 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 than and 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
4
Exhibit 99.3
Breakthrough Mitochondrial Science A Source for Novel Therapeutics Q2 Investor Presentation August 2021 NASDAQ: CWBR
Forward Looking Statements 2 This presentation contains forward - looking statements which 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 our cash forecasts ; anticipated outcomes of research and clinical trials for our mitochondria based therapeutic (MBT) candidates ; expectations regarding the timing and progression of our CB 4211 clinical trial, the expected timing of delivery of data, and the anticipated timing and progression of our other programs ; 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 and MBTs, including but not limited to the treatment of COVID - 19 ARDS . 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 ; 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 CB 4211 or the possibility of other developments affecting the viability of CB 4211 as a clinical candidate or its commercial potential ; results that are different from earlier data results including less favorable than and 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 ; risks related to the impact on our business of the COVID - 19 pandemic or similar public health crises ; and our ability to establish and maintain partnerships with corporate and industry partners . 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 presentation is 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 .
Presentation Information 3 Investor Update and Slide Presentation 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 Please visit the Zoom link available in the press release issued today, click on the ‘Join’ button and enter Password CWBR, o r go to www.cohbar.com and click on Q2 2021 Investor Presentation at top of homepage 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. Easte rn 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.
Today’s Agenda 4 • Overview • CB4211 Topline Data • Pipeline • Financials • Looking Ahead • Q&A
NASDAQ: CWBR Overview 5
6 CohBar Opportunity • Leader in developing mitochondria based therapeutics • Novel approach leveraging over a billion years of evolution • Recent clinical milestone • Positive CB4211 Phase 1a/1b topline data for lead candidate under development for NASH and obesity • Near - term milestones • IND for CB5138 - 3 for the potential treatment of Idiopathic Pulmonary Fibrosis (IPF) in 2022 • Pipeline targeting chronic diseases • Initial focus on inflammatory and fibrotic conditions • Comprehensive IP strategy based on first mover advantage • 12 issued patents; >65 patent filings
SUBCUTANEOUS ADIPOSE TISSUE SYSTEMIC CIRCULATION PORTAL VEIN VISCERAL ADIPOSE TISSUE Splanchnic FFA Delivery HEPATOCYTE Targeting Free Fatty Acid Release from Fat Cells Inhibition/Regulation of Lipolysis • NALFD: excess free fatty acid released from abdominal fat cells by lipolysis - flows directly to the liver • Excess fatty acid in liver leads to NASH: liver fat deposits, inflammation, fibrosis, cirrhosis, and ultimately liver cancer • Inhibiting lipolysis reduces fatty acid release CB4211: Novel Mechanism of Action Relevant to NASH Source: Nutrients 2015,7, 9453 – 9474 Molecular Mechanism – Enhances Insulin Signaling Regulation of Insulin Signaling • Insulin receptor and insulin signaling play a central role in metabolic regulation • CB4211 enhances the action of insulin in vitro: • Inhibits lipolysis in fat cells (adipocytes) • Decreases free fatty acid release to liver • Decreases glucose production by liver cells • Increases glucose consumption by muscle cells. • Molecular mechanism of action presented at ADA in June 2018: CB4211 is a Potential Treatment for Metabolic Diseases with Novel Mechanism of Action: Sensitization of the Insulin Receptor • Further evidence that some MDP’s are important regulators of key metabolic pathways in the body 7
NASDAQ: CWBR A Phase 1a/1b Study of Safety, Tolerability, and Pharmacokinetics of CB4211 in Healthy Non - obese Subjects and Subjects with Nonalcoholic Fatty Liver Disease: Topline Data
CB4211 Phase 1a: Study Design and Subject Disposition Phase 1a Study Design • Randomized, double - blind, placebo - controlled study • 6 cohorts of Single Ascending Dose (SAD) and 3 cohorts Multiple (7 - day) Ascending Dose (MAD) • Healthy adult volunteers (up to 8 per cohort) randomized (3:1) to CB4211 versus placebo Phase 1a Subject Disposition • 65 healthy subjects enrolled and randomized to CB4211 or placebo • Initially enrolled four single ascending dose (SAD) and one multiple ascending dose (MAD) cohort • Persistent local deposition of drug at injection site led to interruption of study to modify formulation • Additional cohorts (two SAD and two MAD) completed with modified formulation • No subjects discontinued treatment 9
CB4211 Phase 1b: Study Design CB4211 (25 mg QD SC) (n = 11) Placebo (n = 9) Baseline Week 4 Primary Endpoints: • Safety and tolerability Secondary Endpoint: • Pharmacokinetics Exploratory Endpoints: • Liver fat content (MRI - PDFF) • Body weight • Biomarkers of NASH and metabolic disease Screening • 18 to 60 years of age • BMI ≥30.0 kg/m 2 • Body weight ≤115 kg • Liver fat >10% (MRI - PDFF) • Various other entry criteria* • Four clinical sites in US Randomized, Double - blind, Placebo - controlled Study *Inclusion criteria also included history of Fatty Liver Index (FLI) score >60, FLI score >60 at Screening, or documented his tor y of fatty liver with imaging results ( eg , standard positive ultrasound or Fibroscan controlled attenuation parameter (CAP) >300 decibels (dB)/m) indicating liver fat >10% within 6 months of Screening. For furt he r details see Clinicaltrial.gov record NCT03998514. Subjects were confined for the duration of the study and provided a standardized diet based on baseline energy expenditure 10
CB4211 Phase 1b: Subject Disposition Phase 1b • 23 obese subjects with NAFLD were enrolled and randomized (1:1) to receive CB4211 or placebo • 3 subjects discontinued treatment before final assessment: 2 for COVID - 19, one withdrew consent • 20 subjects completed end of treatment PD assessments • Final distribution was 11 on CB4211 and 9 on placebo 11
Phase 1b Results: Changes in Key PD Biomarkers (Day 28) Biomarker CB4211 (25 mg) (n = 11) Placebo (n = 9) Difference from Placebo ALT (% reduction from baseline) - 21% 4% - 25%* Proportion of subjects with >17 U/L decrease in ALT (1) 27% 11% 16% AST (% reduction from baseline) - 28% - 11% - 17%* Glucose (% reduction from baseline) - 6% 0% - 6%* *Statistically significant difference, p<0.05 vs. placebo. Data are least square means. (1) A decrease in ALT by 17 U/L or more is significantly associated with histologic response in NASH. (Loomba R et al. Gastroente rol ogy 2019,156:88 - 95) 12
Phase 1b Results: CB4211 Significantly Reduced ALT and AST Percent Change from Baseline in ALT CB4211 reduced ALT by 21% and AST by 28% at Week 4 0 1 2 3 4 -40% -30% -20% -10% 0% 10% Percent Change from Baseline in AST Weeks C h a n g e i n A S T * Placebo CB4211 Percent Change from Baseline in AST *Statistically significant, p<0.05 vs. placebo Data are mean +/ - SEM 0 1 2 3 4 -40% -30% -20% -10% 0% 10% 20% Percent Change from Baseline in ALT Weeks C h a n g e i n A L T Placebo CB4211 * * # 13
Phase 1b Results: ALT Response Predictive of NASH Resolution Proportion of Subjects with >17 U/L Decrease in ALT (1) Placebo CB4211 0% 10% 20% 30% Proportion >17 decALT 11% 27% (1) A decrease in ALT by 17 U/L or more is significantly associated with histologic response in NASH. (Loomba R et al. Gastro ent erology 2019,156:88 - 95) ALT reduction in subjects on CB4211 was predictive of a positive NASH response 14
Phase 1b Results: Comparison to Historical ALT Data for 4 - Week Studies (1) CB4211 reduced ALT as much or more than other NASH candidates Parameter CB4211 (CohBar) (25 mg) (SC injection) MET409 ( Metacrine ) (50 mg) (oral) DUR - 928 ( Durect ) (300 mg) (IV injection) CRV43 ( Hepion ) (225 mg) (oral) Ocaliva (Intercept) (50 mg) (oral) Resmetirom (Madrigal) (100 mg) (oral) Semaglutide (Novo - Nordisk) (0.4 mg) (2) (SC injection) # of Subjects 11 10 20 15 21 25 102 % Reduction in ALT at Week 4 - 21.0% - 16.5 - 17% - 21.1% Increased at Week 6 - 21% at Week 12 - 13% at Week 4 of 52 Weeks Placebo Adjusted % Reduction in ALT - 25.5% No placebo arm No placebo arm - 15.0% N/A - 13.3% at Week 12 - 13% at Week 4 of 52 Weeks (1) All data regarding third - party studies on this slide are based on public information from third - party studies in different s tages of development, and not our own. Conclusions on this slide are not based on head - to - head results. (2) Data extracted from reports for Week 4 time point in a 52 - week study. Currently in Phase 3 15
Phase 1b Results: CB4211 Reduced Fasting Glucose Levels Percent Change from Baseline in Glucose CB4211 reduced fasting glucose by 6% at Week 4 0 1 2 3 4 -10% -5% 0% 5% Percent Change from Baseline in Glucose Weeks C h a n g e i n G l u c o s e # Placebo CB4211 Data are mean +/ - SEM. *Statistically significant, p<0.05 vs. placebo. Percent Change from Baseline in Glucose CB4211 reduced fasting glucose by 6% at Week 4 Change in Body Weight Percent Change from Baseline in Body Weight CB4211 showed trend to reduced body weight 16
Phase 1b Results: Change from Baseline in Liver Fat Content (MRI - PDFF) Percent Absolute Reduction in LFC Placebo CB4211 -10% -8% -6% -4% -2% 0% -4.88% -5.03% Reduction in absolute LFC at Week 4 for CB4211 was comparable to other NASH candidates. However, liver fat content was also reduced in placebo arm - possibly the result of confinement for 4 weeks on a controlled diet Proportion achieving ≥ 30% Relative LFC Reduction* 17 *A relative reduction of 30% in liver fat is associated with a histological response in non - alcoholic steatohepatitis (Patel J e t al. Therap Adv Gastroenterol 2016, 9(5): 692 - 701)
Phase 1a/1b Topline Safety Data: Positive Primary Outcome Positive Results for Primary Outcome: Safety and Tolerability • CB4211 was well - tolerated and appeared safe with no serious adverse events • All adverse events were transient and generally mild to moderate • AEs occurring in >10% of subjects treated with CB4211: • Injection site reactions: CB4211 (79%) vs Placebo (33%) 18 Secondary Outcome: Pharmacokinetics – Data pending
Phase 1b Topline Activity Data: Positive Exploratory Outcomes Positive Results from Exploratory Trend Analysis at 4 Weeks • Robust and significant reductions in ALT, AST versus placebo • ALT reduction favorable vs other NASH candidates in 4 - week studies • ALT reduction predictive of potential benefit in NASH resolution • Significant reduction in glucose – suggests improvement in metabolic homeostasis • Trend towards lower body weight – corroborating the preclinical results • Liver fat content was reduced substantially in both active and placebo arms • Additional analysis of biomarker data is planned These positive topline data support the further development of CB4211 for NASH CohBar plans to present additional data from this study at an upcoming scientific meeting 19
NASDAQ: CWBR Pipeline
Healthy Liver NAFLD Fat Accumulation (Steatosis) NASH Steatosis, Cellular Injury and Inflammation Fibrosis/ Cirrhosis Liver Failure Cancer (HCC) Transplant Death Nonalcoholic Steatohepatitis (NASH) Obesity/Type 2 Diabetes Metabolic Dysfunction Overnutrition Sedentary Lifestyle 21
Pipeline MBT Programs Potential Indications Preclinical IND Enabling Activities Phase 1a Phase 1b Clinical CB4211 NASH Obesity Preclinical CB5138 - 3 IPF, Fibrotic Diseases Apelin Agonists COVID - 19 ARDS, ARDS CXCR4 Inhibitors Cancer, Other Diseases Immunotherapy Peptides Cancer Immunotherapy 22
NASDAQ: CWBR Financials
Summary Financials Income Statement ($000s) 2Q 2021 2Q 2020 Research & Development $2,618 $1,545 General & Administrative 2,584 1,391 Net Loss (5,223) (4,103) Net Loss Per Share – Basic & Diluted (0.08) (0.09) Balance Sheet ($000s) 09/30/20 12/31/20 Cash & Investments $13,824 $21,015 Stockholders Equity 12,152 18,487 Cash Burn 4.6M 2.4M 24
NASDAQ: CWBR Looking Ahead
Potential Milestones 2021 – 2022* 26 2H2021 • CB4211 • Initiate activities to support next CB4211 clinical study • Accelerate partnership discussions • Third clinical candidate: Select candidate and initiate IND enabling activities based on study results 2022 • CB5138 - 3 for IPF and other fibrotic diseases: File new IND and begin first in human clinical trial *Some activities require additional funding
NASDAQ: CWBR Q&A
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