- Two First-in-Class Mitochondria Based Therapeutics Advanced into IND-Enabling Activities. On September 30, 2016, CohBar announced the selection of two optimized analogs from its MOTS-c program for advancement into IND-enabling activities. The clinical candidates, CB4209 and CB4211, demonstrated significant and competitively differentiated therapeutic potential in preclinical models for the treatment of obesity. Additional confirmatory studies are planned to determine therapeutic potential for the treatment of NASH, and as a potential add-on to other drugs for the treatment of type 2 diabetes. On October 13, 2016, the Company hosted a conference call with investors, providing details on its preclinical studies and outlining the potential for its clinical candidates to address the unmet medical needs and market opportunities in obesity, NASH and type 2 diabetes. The Company expects to file an IND for its first clinical candidate by the end of 2017 and to initiate a Phase 1 clinical trial in early 2018. A replay of the investor call is available on the Company's website at: www.cohbar.com.
- Additional Biologically Active Peptides Discovered in the Mitochondrial Genome and 25 New Provisional Patent Applications filed. On October 13, 2016, CohBar announced the discovery of a large number of new biologically active peptides encoded within the genome of the mitochondria, together with the filing of 25 new provisional patent applications. The Company continues to evaluate these new peptides as possible additions to its pipeline of therapeutics for internal development or partnership opportunities, and expects to file additional patent applications going forward.
- Expanded Investment Community Outreach. During the third quarter, CohBar continued its retail investment community outreach with non-deal roadshows in the Midwest and Northeast regions of the U.S., and expanded its Investor Relations program with the hiring of Anna Schram as Director of Investor Relations. Following the September 30 th announcement of the advancement of its clinical candidates into IND-enabling activities, the Company continued to build awareness with additional roadshows in the U.S. and Canada. More recently, CohBar's CEO Simon Allen presented the new preclinical data and met with institutional investors and potential pharma partners at the BIO Investor Forum 2016 in San Francisco. An audio replay of the BIO presentation is available on the Company's website at www.cohbar.com.
- Dr. Pinchas Cohen was the keynote speaker at the Rejuvenation Biotechnology Conference 2016 hosted at The Buck Center for Research on Aging in California in August 2016, and was a visiting lecturer at The 17th International Congress of Endocrinology in Beijing, in September 2016.
- Dr. Nir Barzilai was a featured speaker at the First International Conference on "Founder Populations and their contribution to our understanding of Biology and History - Lessons from the Jewish Genome" in July 2016, in Haifa Israel, and was the keynote speaker at the Benzon Symposium No. 62, "Genome Instability and Neurodegeneration" in August 2016, in Copenhagen, Denmark.
Summary of Third Quarter Financial Results
- Cash and Investments. CohBar had cash, cash equivalents and investments of $8,089,242 on September 30, 2016, compared to $10,291,487 on December 31, 2015.
- R&D Expenses. Research and development expenses were $1,056,429 in the three months ended September 30, 2016 compared to $547,029 in the prior year period, a $509,400 increase. The increase in research and development expenses was due primarily to an increase in expenses related to the Company's efforts to develop optimized MBT candidates and an increase in salary, benefits and stock-based compensation due to the expansion of its scientific staff.
- G&A Expenses. General and administrative expenses were $598,507 in the three months ended September 30, 2016 compared to $531,841 in the prior year period, a $66,666 increase. The increase in general and administrative expenses was primarily due to an increase in salary, benefits and stock-based compensation from the expansion of the Company's executive team with the addition of its new Chief Executive Officer, offset by the timing of a bonus accrued in the previous year quarter with no corresponding expense in the current year period.
- Net Loss. For the three months ended September 30, 2016, net loss was $1,653,729 or $0.05 per share basic and diluted, compared to a net loss of $1,079,256, or $0.03 per share basic and diluted, for the three months ended September 30, 2015.
For additional company information, please visit www.cohbar.com.Forward-Looking Statements This news release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include CohBar's plans and expectations for its CB4209 and CB4211 candidate program, including anticipated timing and results of IND-enabling activities, regulatory submissions and initiation of clinical trials, statements regarding the therapeutic potential of these and other mitochondria based therapeutics, and the potential for additional discoveries, and expectations regarding future patent applications. Forward-looking statements are based on current expectations, estimates and projections that involve a number of risks and uncertainties that could cause actual results to differ materially from those anticipated by CohBar. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated commencement and completion dates for IND-enabling and initial clinical studies, as well as the possibility of unfavorable study results, including unfavorable new data and additional analyses of existing data; risks associated with initial data, including the risk that results of additional pre-clinical or clinical studies may be different from (including less favorable than) the earlier data results and may not support further clinical development; whether and when any investigational new drug application may be filed with regulatory authorities for CB4209 or CB4211; whether and when regulatory authorities may approve any such applications, and other decisions by regulatory authorities that could affect the availability or commercial potential of CB4209 or CB4211. Additional risks and uncertainties include CohBar's ability to retain key personnel, expand its research operations, and obtain financing necessary to continue its operations and fund its candidate programs. 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
|Condensed Balance Sheets|
|September 30, 2016||December 31, 2015|
|Cash and cash equivalents||$||6,012,237||$||4,803,687|
|Prepaid expenses and other current assets||82,256||88,223|
|Total current assets||8,171,498||10,379,710|
|Property and equipment, net||225,313||199,575|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued payroll and other compensation||237,667||217,250|
|Note payable, net of debt discount||205,152||-|
|Total current liabilities||1,010,827||582,693|
|Note payable, net of debt discount||-||205,005|
|Commitments and contingencies|
|Preferred stock, $0.001 par value, Authorized 5,000,000 shares;|
|No shares issued and outstanding as of September 30, 2016 and December 31, 2015, respectively||-||-|
|Common stock, $0.001 par value, Authorized 75,000,000 shares;|
|Issued and outstanding 33,432,514 shares as of September 30, 2016 and 32,320,891 as of December 31, 2015||33,433||32,321|
|Additional paid-in capital||20,112,032||18,114,295|
|Total stockholders' equity||7,413,077||9,812,079|
|Total liabilities and stockholders' equity||$||8,423,904||$||10,599,777|
|Condensed Statements of Operations|
|For The Three Months Ended September 30,||For The Nine Months Ended September 30,|
|Research and development||1,056,429||547,029||2,646,125||1,257,075|
|General and administrative||598,507||531,841||1,753,008||1,467,759|
|Total operating expenses||1,654,936||1,078,870||4,399,133||2,724,834|
|Other income (expense):|
|Amortization of debt discount||(49)||(49)||(147)||(147)|
|Total other income (expense)||1,207||(386)||1,282||(3,216)|
|Basic and diluted net loss per share||$||(0.05)||$||(0.03)||$||(0.13)||$||(0.09)|
|Weighted average common shares outstanding - basic and diluted||33,416,874||32,320,891||32,878,254||31,951,056|