UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

þ     QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2017

 

☐    TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from         to          

 

Commission File Number 000-55334

 

  COHBAR, INC.  
  (Exact name of registrant as specified in its charter)  

 

Delaware   26-1299952

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

1455 Adams Drive, Suite 2050

Menlo Park, CA 94025

( Address of principal executive offices) (Zip Code)

 

(650) 446-7888

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports).    Yes   þ         No   ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   þ         No  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐   Accelerated filer ☐   Non-accelerated filer ☐   Smaller reporting company  þ   Emerging growth company  þ
        (Do not check if a smaller reporting 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.

 

Indication by check mark whether the registrant is a shell company (as defined in Rue 12b-2 of the Exchange Act) Yes  ☐        No   þ

 

As of August 9, 2017 the registrant had outstanding 39,295,754 shares of common stock.

 

 

 

 

 

COHBAR, INC.

FORM 10-Q

For the Quarterly Period Ended June 30, 2017

 

    Page
    Number
  PART I – FINANCIAL INFORMATION  
     
Item 1 Financial Statements 1
     
Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations

11

     
Item 3 Quantitative and Qualitative Disclosures About Market Risk 15
     
Item 4 Evaluation of Disclosure Controls and Procedures 15
     
  PART II – OTHER INFORMATION  
     
Item 1 Legal Proceedings 16
     
Item 1A Risk Factors 16
     
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds 16
     
Item 3 Defaults Upon Senior Securities 16
     
Item 4 Mine Safety Disclosures 16
     
Item 5 Other Information 16
     
Item 6 Exhibits

17

     
  SIGNATURES 18

 

 

 

PART I. FINANCIAL INFORMATION

 

Item 1.    Financial Statements

 

CohBar, Inc.

Condensed Balance Sheets

 

    As of  
    June 30, 2017     December 31, 2016  
    (unaudited)        
ASSETS            
Current assets:            
Cash   $ 4,633,845     $ 3,257,458  
Investments     3,097,846       5,428,962  
Subscription receivable     -       522,326  
Prepaid expenses and other current assets     173,512       110,822  
Total current assets     7,905,203       9,319,568  
Property and equipment, net     198,964       230,512  
Deferred offering costs     35,154       -  
Other assets     38,285       36,810  
Total assets   $ 8,177,606     $ 9,586,890  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable   $ 757,010     $ 103,294  
Accrued liabilities     81,853       132,780  
Accrued payroll and other compensation     161,332       447,641  
Note payable, net of debt discount of $0 and $59 as of June 30, 2017 and December 31, 2016, respectively     102,630       205,201  
Total liabilities     1,102,825       888,916  
                 
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, 2017 and December 31, 2016, respectively     -       -  
Common stock, $0.001 par value, Authorized 75,000,000 shares; Issued and outstanding 35,857,701 shares as of June 30, 2017 and 34,807,881 as of December 31, 2016     35,858       34,808  
Additional paid-in capital     25,587,108       23,072,702  
Accumulated deficit     (18,548,185 )     (14,409,536 )
Total stockholders’ equity     7,074,781       8,697,974  
Total liabilities and stockholders’ equity   $ 8,177,606     $ 9,586,890  

 

The accompanying notes are an integral part of these condensed financial statements

 

1

 

 

CohBar, Inc.
Condensed Statements of Operations
(unaudited)

 

    For The Three Months Ended June 30,     For The Six Months Ended June 30,  
    2017     2016     2017     2016  
                         
Revenues   $ -     $ -     $ -     $ -  
                                 
Operating expenses:                                
Research and development     1,274,634       852,596       2,567,414       1,589,696  
General and administrative     635,007       674,569       1,575,096       1,154,501  
Total operating expenses     1,909,641       1,527,165       4,142,510       2,744,197  
Operating loss     (1,909,641 )     (1,527,165 )     (4,142,510 )     (2,744,197 )
                                 
Other income (expense):                                
Interest income     4,242       1,274       6,405       3,930  
Interest expense     (1,140 )     (1,882 )     (2,485 )     (3,757 )
Amortization of debt discount     -       (49 )     (59 )     (98 )
Total other income (expense)     3,102       (657 )     3,861       75  
Net loss   $ (1,906,539 )   $ (1,527,822 )   $ (4,138,649 )   $ (2,744,122 )
Basic and diluted net loss per share   $ (0.05 )   $ (0.05 )   $ (0.12 )   $ (0.08 )
Weighted average common shares outstanding - basic and diluted     35,857,701       32,880,589       35,823,121       32,605,984  

 

The accompanying notes are an integral part of these condensed financial statements

 

2

 

 

CohBar, Inc.
Condensed Statements of Cash Flows
(unaudited)

 

    For The Six Months Ended June 30,  
    2017     2016  
Cash flows from operating activities:            
Net loss   $ (4,138,649 )   $ (2,744,122 )
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation     32,976       25,512  
Stock-based compensation     612,964       333,301  
Amortization of debt discount     59       98  
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets     (62,690 )     (49,278 )
Accounts payable     653,716       43,131  
Accrued liabilities     (50,927 )     (29,002 )
Accrued payroll and other compensation     (286,309 )     12,936  
Net cash used in operating activities     (3,238,860 )     (2,407,424 )
                 
Cash flows from investing activities:                
Purchases of property and equipment     (1,428 )     (35,913 )
Payment for security deposit     (1,475 )     (6,601 )
Purchases of investments     (8,677,884 )     (6,583,937 )
Proceeds from redemptions of investments     11,009,000       8,649,000  
Net cash provided by investing activities     2,328,213       2,022,549  
                 
Cash flows from financing activities:                
Deferred offering costs     (35,154 )     -  
Proceeds from exercise of warrants     2,404,993       712,246  
Repayment of note payable     (102,630 )     -  
Proceeds from exercise of compensation options     -       496,376  
Proceeds from exercise of employee stock options     19,825       2,600  
Net cash provided by financing activities     2,287,034       1,211,222  
                 
Net increase in cash     1,376,387       826,347  
Cash at beginning of period     3,257,458       4,803,687  
Cash at end of period   $ 4,633,845     $ 5,630,034  
                 
Supplemental disclosure of cash flow information:                
Income taxes paid   $ 2,057     $ 1,300  
Interest paid   $ 14,363     $ -  

 

The accompanying notes are an integral part of these condensed financial statements

 

3

 

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 1 - Business Organization

 

CohBar, Inc. (“CohBar” or the “Company”) is an innovative biotechnology company and a leader in the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs with the potential to treat a wide range of diseases associated with aging and metabolic dysfunction, including obesity, fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), type 2 diabetes mellitus (T2D), cancer, atherosclerosis, cardiovascular disease, and neurodegenerative diseases such as Alzheimer’s.

 

The Company’s primary activities include research and development of its MBT pipeline, securing intellectual property protection, managing collaborations with contract research organizations (“CROs”) and academic institutions and raising capital. To date, the Company has not generated any revenues from operations and does not expect to generate any revenues in the near future. The Company has financed its operations primarily with proceeds from sales of its equity securities, including its initial public offering (“IPO”), private placements and the exercise of outstanding warrants and stock options.

 

The unaudited interim condensed financial statements of the Company have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and the rules and regulations of the Securities and Exchange Commission (“SEC”). They do not include all information and footnotes required by U.S. GAAP for complete financial statements. Except as disclosed herein, there have been no material changes in the information disclosed in the notes to the financial statements for the year ended December 31, 2016, included in the Company’s Annual Report on Form 10-K (the “2016 Form 10-K”), filed with the SEC on March 31, 2017. The interim unaudited condensed financial statements should be read in conjunction with those audited financial statements included in the 2016 Form 10-K. In the opinion of management, all adjustments considered necessary for fair presentation, consisting solely of normal recurring adjustments, have been made. Operating results for the three and six month periods ended June 30, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017, or any other period.

 

Note 2 - Management’s Liquidity Plans

 

As of June 30, 2017, the Company had working capital and stockholders’ equity of $6,802,378 and $7,074,781, respectively. During the six months ended June 30, 2017, the Company incurred a net loss of $4,138,649. The Company has not generated any revenues, has incurred net losses since inception and does not expect to generate revenues in the near term.

 

Based on current budget assumptions, the cash and investments on hand as of June 30, 2017, and the proceeds received from the Company’s private placement completed on July 14, 2017 (see Note 8, Subsequent Events ), the Company believes that it has sufficient capital to meet its operating expenses and obligations for the next twelve months from the date of this filing. However, if unanticipated difficulties or circumstances arise the Company may require additional capital sooner to support its operations. If the Company is unable to raise additional capital whenever necessary it may be forced to decelerate or curtail its research and development activities and delay planned FDA filings and clinical activities until such time as additional capital becomes available. Such limitation of the Company’s activities would allow the Company to slow its rate of spending and extend its use of cash until additional capital is raised. There can be no assurance that such a plan will be successful. There is no assurance that additional financing will be available when needed or that the Company will be able to obtain such financing on reasonable terms.

 

4

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

   

Note 3 - Summary of Significant Accounting Policies

 

Basis of Presentation

 

All amounts are presented in U.S. Dollars.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at dates of the financial statements and the reported amounts of revenue and expenses during the periods. Actual results could differ from these estimates. The Company’s significant estimates and assumptions include the fair value of financial instruments, stock-based compensation and the valuation allowance relating to the Company’s deferred tax assets.

 

Investments

 

Investments consist of U.S. Treasury Bills of $1,157,982, which are classified as held-to-maturity, and Certificates of Deposit of $1,939,864. The Company determines the appropriate balance sheet classification of its investments at the time of purchase and evaluates the classification at each balance sheet date. All of the Company’s U.S. Treasury Bills and Certificates of Deposit mature within the next twelve months. Unrealized gains and losses are de minimis . As of June 30, 2017, the carrying value of the Company’s U.S. Treasury Bills approximates their fair value, due to their short-term maturities.

 

Deferred Offering Costs

 

The Company capitalizes amounts related to an equity offering in progress as of the balance sheet date as Deferred Offering Costs. As of June 30, 2017, the Company capitalized $35,154 of such costs in the accompanying condensed balance sheet.

 

Share-Based Payment

 

The Company accounts for share-based payments using the fair value method. For employees and directors, the fair value of the award is measured, as discussed below, on the grant date. For non-employees, fair value is generally valued based on the fair value of the services provided or the fair value of the equity instruments on the measurement date, whichever is more readily determinable, and re-measured on each financial reporting date until the service is complete. The Company has granted stock options at exercise prices equal to the higher of (i) the closing price of the Company’s common stock as reported on the OTCQX marketplace or (ii) the closing price of the Company’s common stock as reported by the TSX Venture Exchange on the date of grant.

   

5

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 3 - Summary of Significant Accounting Policies (continued)

 

The weighted-average fair value of options and warrants has been estimated on the date of grant using the Black-Scholes pricing model. The fair value of each instrument is estimated on the date of grant utilizing certain assumptions for a risk free interest rate, volatility and expected remaining lives of the awards. Since the Company has a limited history of being publicly traded, the fair value of stock-based payment awards issued was estimated using a volatility derived from an index of comparable entities. The assumptions used in calculating the fair value of share-based payment awards represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and the Company uses different assumptions, the Company’s stock-based compensation expense could be materially different in the future. In addition, the Company is required to estimate the expected forfeiture rate and only recognize expense for those shares expected to vest. In estimating the Company’s forfeiture rate, the Company analyzed its historical forfeiture rate, the remaining lives of unvested options, and the number of vested options as a percentage of total options outstanding. If the Company’s actual forfeiture rate is materially different from its estimate, or if the Company reevaluates the forfeiture rate in the future, the stock-based compensation expense could be significantly different from what the Company has recorded in the current period.

 

The weighted-average Black-Scholes assumptions are as follows:

 

    For the Three Months Ended
June 30,
    For Six Months Ended
June 30,
 
    2017     2016     2017     2016  
Expected life   8 years     6 years     7 years     6 years  
Risk free interest rate     2.14%     1.25%     2.12%     1.25%
Expected volatility     79%     79%     79%     79%
Expected dividend yield     0%     0%     0%     0%
Forfeiture rate     0%     0%     0%     0%

 

As of June 30, 2017, total unrecognized stock option compensation expense is $1,679,269, which will be recognized as those options vest over a period of approximately four years. The amount of future stock option compensation expense could be affected by any future option grants or by any option holders leaving the Company before their grants are fully vested.

 

Net Loss Per Share of Common Stock

 

Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period.  Diluted net earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. Potentially dilutive securities are excluded from the computation of diluted net loss per share as their inclusion would be anti-dilutive and consist of the following:

 

    As of June 30,  
    2017     2016  
Options     5,513,497       4,912,715  
Warrants     951,635       7,940,733  
Totals     6,465,132       12,853,448  

 

6

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 4 - Accrued Liabilities

 

Accrued liabilities consist of:

 

    As of     As of  
    June 30,
2017
    December 31, 2016  
Lab services & supplies   $ 6,080     $ 87,100  
Professional fees     50,031       17,760  
Consultant fees     2,500       2,500  
Interest     13,542       25,420  
Other     9,700       -  
Total accrued liabilities   $ 81,853     $ 132,780  

 

Note 5 - Commitments and Contingencies

 

Litigations, Claims and Assessments

 

The Company may from time to time be a party to litigation and subject to claims incident to the ordinary course of business. As the Company grows and gains prominence in the marketplace it may become a party to an increasing number of litigation matters and claims. The outcome of litigation and claims cannot be predicted with certainty, and the resolution of these matters could materially affect the Company’s future results of operations, cash flows or financial position. The Company is not currently a party to any legal proceedings.

 

Operating Lease

 

The Company is a party to a lease agreement for a shared laboratory facility leased on a month-to-month basis in Menlo Park, California.

 

Rent expense was $56,595 and $40,640 for the three months ended June 30, 2017 and 2016, respectively. Rent expense was $111,810 and $75,035 for the six months ended June 30, 2017 and 2016, respectively.

 

Note 6 - Stockholders’ Equity

 

Stock Options

 

The Company has an incentive stock plan, the Amended and Restated 2011 Equity Incentive Plan (the “2011 Plan”), and has granted stock options to employees, non-employee directors and consultants from the 2011 Plan. Options granted under the 2011 Plan may be Incentive Stock Options or Non-statutory Stock Options, as determined by the Administrator at the time of grant. The rules of the TSX-Venture Exchange (or “TSX-V”) provide that the maximum number of shares which can be reserved under a stock option plan is equal to 20% of the number of shares of the issuer which are outstanding on the date the plan is approved by stockholders. On June 15, 2017 the Company’s stockholders approved an amendment to the 2011 Plan to increase the number of shares authorized for issuance under the 2011 Plan to a total of 7,171,540, which is equal to 20% of the number of shares of the Company’s common stock outstanding on the date of the amendment.

 

7

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 6 - Stockholders’ Equity (continued)

 

In January 2016 the Company issued a warrant to purchase 125,000 shares of the Company’s common stock to an investor relations firm as partial compensation for consulting services it would provide the Company over a two year period. Pursuant to applicable policies of the TSX-V, the shares issuable under the warrant will be counted against the limit of shares authorized for issuance under the 2011 Plan, notwithstanding that the warrant was not issued under the 2011 Plan. After giving effect to this limitation there were 1,506,793 shares remaining available for issuance under the 2011 Plan at June 30, 2017.

 

During the six months ended June 30, 2017, the Company granted stock options to employees to purchase 1,031,000 shares of the Company’s common stock at an exercise price of $2.40 per share. The options have terms of ten years. Of the 1,031,000 stock options granted, 300,000 are subject to vesting based on continuous service over periods between zero and four years from the date of grant. The balance of the grant, or 731,000 shares, has performance-based vesting conditions and will be valued at the time the milestones are reached. The stock options have an aggregate grant date fair value of $528,580. Subsequent to the issuance, the Company cancelled 105,000 stock options during the six months ended June 30, 2017.

 

In February 2017, 16,250 stock options were exercised for cash proceeds of $19,825 and the Company cancelled 48,750 stock options.

 

The Company recorded stock based compensation as follows:

 

    For the Three Months Ended
June 30,
    For Six Months Ended
June 30,
 
    2017     2016     2017     2016  
Research and development   $ 76,267     $ 103,537     $ 142,960     $ 174,744  
General and administrative     122,184       106,118       470,004       158,557  
  Total   $ 198,451     $ 209,655     $ 612,964     $ 333,301  

 

The following table represents stock option activity for the six months ended June 30, 2017:

 

                Weighted Average        
    Stock Options     Exercise Price     Fair Value     Contractual     Aggregate  
    Outstanding     Exercisable     Outstanding     Exercisable     Vested     Life (Years)     Intrinsic Value  
Balance – December 31, 2016     4,652,497       1,908,883     $ 0.92     $ 0.41     $ 0.41       8.24     $ -  
Granted     1,031,000       100,000       2.40       2.40       6.25       6.25       -  
Exercised     (16,250 )     -       -       -       -       -       -  
Cancelled     (153,750 )     -       -       -       -       -       -  
Balance – June 30, 2017     5,513,497       2,745,159     $ 0.98     $ 0.59     $ 0.59       6.73     $ 3,805,494  

 

8

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 6 - Stockholders’ Equity (continued)

 

The following table summarizes information on stock options outstanding and exercisable as of June 30, 2017:

 

            Weighted   Weighted           Weighted  
Exercise     Number     Average Remaining   Average     Number     Average  
Price     Outstanding     Contractual Term   Exercise Price     Exercisable     Exercise Price  
                               
$ 0.05       72,876     4.76 years   $ 0.05       72,876     $ 0.05  
$ 0.26       1,024,810     6.78 years   $ 0.26       978,507     $ 0.26  
$ 0.73       1,475,687     7.38 years   $ 0.73       953,048     $ 0.73  
$ 1.00       313,124     8.06 years   $ 1.00       166,457     $ 1.00  
$ 1.10       10,000     8.53 years   $ 1.10       3,959     $ 1.10  
$ 1.17       70,000     8.37 years   $ 1.17       31,875     $ 1.17  
$ 1.22       125,000     8.60 years   $ 1.22       44,271     $ 1.22  
$ 1.50       40,000     8.67 years   $ 1.50       13,333     $ 1.50  
$ 1.55       1,456,000     8.69 years   $ 1.55       353,750     $ 1.55  
$ 2.40       926,000     9.59 years   $ 2.40       127,083     $ 2.40  
Totals       5,513,497                   2,745,159          

 

Warrants

 

In January 2017, a total of 926,588 common stock purchase warrants were exercised for aggregate cash proceeds of $1,853,176. Additional proceeds in the amount of $522,326 were received in January 2017 from warrants exercised in December 2016. During the six months ended June 30, 2017, 4,695,846 unexercised warrants expired.

 

In January and February 2017, consultants to the Company exercised a total of 106,982 warrants for aggregate cash proceeds of $29,491.

 

As of June 30, 2017, the Company had 951,635 warrants outstanding and exercisable to purchase common stock. Such warrants have a weighted average exercise price of $0.39, a weighted average remaining contractual life of 6.01 years and an aggregate intrinsic value of $1,291,950.

 

Note 7 - Related Party Transactions

 

Two of the Company’s directors, Pinchas Cohen and Nir Barzilai, provide consulting services to the Company pursuant to agreements that provide for annual compensation to each director of $42,000. Each agreement provides for an annual service term and can be extended by mutual consent of both parties. The service terms under the agreements expired in 2015. The Company continues to compensate Dr. Cohen and Dr. Barzilai for their ongoing services under the terms of the original agreements. Payments of $10,500 were made to each Director during each of the three months ended June 30, 2017 and 2016. During the six months ended June 30, 2017 and 2016, payments to each Director totaled $21,000. As of June 30, 2017 and December 31, 2016, no amounts were owed to either Director.

 

9

 

 

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 8 - Subsequent Events

 

Management has evaluated subsequent events to determine if events or transactions occurring through the date on which the condensed financial statements were issued require adjustment or disclosure in the Company’s condensed financial statements.

 

On July 14, 2017, the Company issued and sold an aggregate of 3,438,053 units at a price of $1.50 per unit for total proceeds of approximately $5.16 million. Each unit consists of one share of the Company’s common stock and one common stock purchase warrant. Each warrant can be exercised at any time prior to June 30, 2020 for the purchase of one share of the Company’s common stock at an exercise price of $2.25.

 

In August 2017, the Company granted stock options to two consultants to purchase a total of 85,000 shares of the Company’s common stock. The stock options have an exercise price of $2.02 per share and are exercisable during a ten year term, subject to vesting over periods of three and four years.

 

In August 2017, the Company issued a total of 180,000 warrants to two consultants. The warrants have an exercise price of $1.99 and terms of five years.

 

10

 

 

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis is based upon our financial statements as of the dates and for the periods presented in this section. You should read this discussion and analysis in conjunction with the financial statements and notes thereto found in Part I, Item 1 of this Form 10-Q and our financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2016 (the “2016 Form 10-K”). All references to the second quarter and first six months of 2017 and 2016 are to the three and six month periods ended June 30, 2017 and 2016, respectively. Unless the context otherwise requires, “CohBar,” “we,” “us” and “our” refer to CohBar, Inc.

 

Special Note Regarding Forward-Looking Statements

 

This report, including the “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains forward-looking statements regarding future events and our future results that are based on our current expectations, estimates, forecasts, and projections. These include statements regarding the therapeutic potential of mitochondria based therapeutics, plans and expectations regarding our CB4209 and CB4211 candidate program , anticipated timing and results of IND-enabling activities, regulatory submissions and initiation of clinical trials, our capital resources and ability to fund our operations, our results of operations, the industry in which we operate and the beliefs and assumptions of our management. Words such as “expect,” “anticipate,” “target,” “goal,” “project,” “would,” “could,” “intend,” “plan,” “believe,” “seek” and “estimate,” variations of these words, and similar expressions are intended to identify those forward-looking statements. These forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, actual results may differ materially from those expressed in any forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, 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; and those risks discussed in the section entitled “Risk Factors” found in Item 1A of Part I of the 2016 Form 10-K, as supplemented or modified in our quarterly reports on Form 10-Q. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, whether as a result of new information, future events or otherwise, except as may be required by law.

 

Overview

 

We are an innovative biotechnology company and a leader in the research and development of mitochondria based therapeutics (MBTs), an emerging class of drugs with the potential to treat a wide range of diseases associated with aging and metabolic dysfunction, including obesity, fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), type 2 diabetes mellitus (T2D), cancer, atherosclerosis, cardiovascular disease, and neurodegenerative diseases such as Alzheimer’s.

 

MBTs originate from almost two decades of research by our founders, resulting in their discovery of a novel group of peptides called mitochondrial-derived peptides (MDPs) encoded within the genome of mitochondria, the powerhouses of the cell. These naturally occurring MDPs and related analogs have demonstrated a range of biological activity and therapeutic potential in pre-clinical models across multiple diseases associated with aging.

 

We believe CohBar is a first mover in exploring the mitochondrial genome for therapeutically relevant peptides, and have developed a proprietary MBT technology platform which uses cell based assays and animal models of disease to rapidly identify mitochondrial peptides with promising biological activity. Once identified, we deploy optimization techniques to improve the drug-like properties of our MBT candidates, enabling us to match the most biologically promising peptides to disease indications that have substantial unmet medical needs.

 

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In September 2016, we advanced two novel, optimized analogs of our MOTS-c MDP, CB4209 and CB4211, into IND-enabling studies as our lead MBT drug candidates with potential for treatment of fatty liver disease (NAFLD), Nonalcoholic steatohepatitis (NASH), obesity, and type 2 diabetes (T2D). To date, our founders and scientific team have discovered a large number of MDPs that have demonstrated a range of biological activities and therapeutic potential. Our ongoing research and development of our pipeline MDPs is focused on identifying and advancing novel improved analogs of those MDPs that have the greatest therapeutic and commercial potential for development into drugs.

 

We have financed our operations primarily with proceeds from sales of our equity securities, including our initial public offering (“IPO”), private placements, and the exercise of outstanding warrants and stock options. Since our inception through June 30, 2017, our operations have been funded with an aggregate of approximately $25.8 million, of which approximately $0.2 million was from a grant-funding organization and approximately $25.6 million was from the issuance of equity instruments.

 

Since inception, we have incurred significant operating losses. Our net losses were $4,138,649 and $2,744,122 for the six months ended June 30, 2017 and 2016, respectively. As of June 30, 2017, we had an accumulated deficit of $18,548,185. Our net losses may fluctuate significantly from quarter to quarter and from year to year. We expect to continue to incur operating losses as we continue research, discovery and pre-clinical development efforts on our current MBT candidates and any other MDPs, expand and protect our intellectual property portfolio, and hire additional development and scientific personnel. Our MBT drug target candidates are in early stages of investigational research. Candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect research and development expenses to increase in the coming quarters as we continue to advance our lead drug candidates into clinical studies and continue discovery, research and development efforts for our pipeline MDPs.

 

Based on current budget assumptions, the cash and investments on hand as of June 30, 2017, and the proceeds received from our private placement completed on July 14, 2017 (see Note 8 to our condensed financial statements included elsewhere in this document), we believe that we have sufficient capital to meet our operating expenses and obligations for the next twelve months from the date of this filing. However, if unanticipated difficulties or circumstances arise we may require additional capital sooner to support our operations. If we are unable to raise additional capital whenever necessary we may be forced to decelerate or curtail our research and development activities and delay planned FDA filings and clinical activities until such time as additional capital becomes available. Such limitation of our activities would allow us to slow our rate of spending and extend our use of cash until additional capital is raised. There can be no assurance that such a plan will be successful. There is no assurance that additional financing will be available when needed or that we will be able to obtain such financing on reasonable terms.

 

Financial Operations Review

 

Revenue

 

To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the near future. In the future, we will seek to generate revenue from product sales, either directly or under any future licensing, development or similar relationship with a strategic partner.

 

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Research and development expenses

 

Research and development expenses consist primarily of costs incurred for our research activities, including our drug discovery efforts, and the development of our product candidates, which include:

 

employee-related expenses including salaries, benefits, and stock-based compensation expense;
expenses incurred under agreements with third parties, including contract research organizations, or CROs, that conduct research and development and pre-clinical activities on our behalf, and the cost of consultants;
the cost of laboratory equipment, supplies and manufacturing MBT test materials; and
depreciation and other personnel-related costs associated with research and product development.

 

We expense all research and development expenses as incurred. We expect our research and development expenses will continue to increase in the remainder of the year ending December 31, 2017, as we continue our efforts to advance our lead MBT candidate program and to discover, evaluate and optimize other MDPs as potential MBT drug candidates.

 

General and administrative expenses

 

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. Other significant costs include legal fees relating to patent and corporate matters, and fees for accounting and consulting services. We anticipate that our general and administrative expenses will increase in the future to support continued research and development activities and the potential commercialization of our product candidates. These increases will likely include increased costs related to the hiring of additional personnel, and fees to outside consultants, lawyers and accountants, among other expenses.

 

Results of Operations

 

The following tables set forth our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative of financial results to be achieved in future periods.

 

    For The Three Months Ended June 30,     Change  
    2017     2016     $     %  
Operating expenses:                                
Research and development   $ 1,274,634     $ 852,596     $ 422,038       50 %
General and administrative     635,007       674,569       (39,562 )     (6 )%
Total operating expenses   $ 1,909,641     $ 1,527,165     $ 382,476       25 %

 

Comparison of Three Months Ended June 30, 2017 and 2016

 

Research and development expenses were $1,274,634 in the three months ended June 30, 2017 compared to $852,596 in the prior year period, an increase of $422,038, or 50%. The increase in research and development expenses was due primarily to a net increase of approximately $553,000 in expenses for laboratory supplies, MBT materials and other costs of IND-enabling activities associated with advancing our lead drug candidates into clinical studies, partially offset by a decrease of approximately $136,000 in salary, benefits and stock-based compensation relating to a bonus paid in the prior year quarter with no corresponding expense in the current year quarter and reduced headcount of scientific staff in the three months ended June 30, 2017 when compared to the same period in the prior year.

 

General and administrative expenses were $635,007 in the three months ended June 30, 2017 compared to $674,569 in the prior year period, a decrease of $39,562, or 6%. The decrease in general and administrative expenses was primarily due to a decrease in compensation relating to the timing of a bonus accrued in the prior year quarter with no corresponding expense in the current year quarter, which was partially offset by an increase in headcount and salary compensation in the current year quarter when compared to the same period of the prior year.

 

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    For The Six Months Ended June 30,     Change  
    2017     2016     $     %  
Operating expenses:                                
Research and development   $ 2,567,414     $ 1,589,696     $ 977,718       62 %
General and administrative     1,575,096       1,154,501       420,595       36 %
Total operating expenses   $ 4,142,510     $ 2,744,197     $ 1,398,313       51 %

 

Comparison of Six Months Ended June 30, 2017 and 2016

 

Research and development expenses were $2,567,414 in the six months ended June 30, 2017 compared to $1,589,696 in the prior year period, an increase of $977,718, or 62%. The increase in research and development expenses was due primarily to an approximately $1,005,000 net increase in expenses for laboratory supplies, MBT materials and other costs of IND-enabling activities, $46,500 in consulting fees, and a $37,800 increase in rent associated with the expansion of our laboratory facility in Menlo Park, California. The increase in research and development expenses was partially offset by a decrease of approximately $126,000 in salary, benefits and stock-based compensation relating to a bonus paid in the prior year period with no corresponding expense in the current year period and reduced headcount of scientific staff in in the six months ended June 30, 2017 when compared to the same period in the prior year. We expect research and development expenses to increase in the coming quarters as we continue to advance our lead drug candidates into clinical studies and continue to develop optimized MBT candidates.

 

General and administrative expenses were $1,575,096 in the six months ended June 30, 2017 compared to $1,154,501 in the prior year period, an increase of $420,595, or 36%. The increase in general and administrative expenses was primarily due to an increase of $52,200 in salary and benefit costs associated with the expansion of our general and administrative staff with the addition of our new Chief Executive Officer and Director of Investor Relations, an increase of $311,400 in stock based compensation due to option grants made in the current year period and a $38,100 increase in legal expenses associated with our legal compliance and certain filings for the protection of our intellectual property. We expect general and administrative expenses for the year ending December 31, 2017 to be higher in comparison to prior years as we continue to incur the costs associated with running a public company and expanding our intellectual property protection.

 

Liquidity and Capital Resources

 

As of June 30, 2017 we had a cash balance of $4,633,845. We maintain our cash in a checking and savings account on deposit with a banking institution in the United States. We also maintain a portfolio of short-term highly liquid securities investing in U.S. Treasury Bills and Certificate of Deposits. As of June 30, 2017, we had an investments balance of $3,097,846.

 

Cash Flows from Operating Activities

 

Net cash used in operating activities for the six months ended June 30, 2017 and 2016 was $3,238,860 and $2,407,424, respectively. The cash used in operations for the six months ended June 30, 2017 was primarily due to our reported net loss of $4,138,649 and a $286,309 decrease in accrued compensation related to the bonuses accrued at December 31, 2016 and paid in the current year, partially offset by $612,964 in stock-based compensation expense and a $653,716 increase in accounts payable associated with the timing of receipt of vendor invoices received at the end of the quarter. The cash used in operations for the six months ended June 30, 2016 was primarily due to our reported net loss of $2,744,122 partially offset by $333,301 in stock-based compensation expense in that period.

 

Cash Flows from Investing Activities

 

Net cash provided by investing activities in the six months ended June 30, 2017 and 2016 was $2,328,213 and $2,022,549, respectively. The cash provided by investing activities in both periods was due to the maturities of our investments in certificates of deposit and treasury bills as compared to the timing of purchases of those investments.

 

Cash Flows from Financing Activities

 

Net cash provided by financing activities in the six months ended June 30, 2017 and 2016 was $2,287,034 and $1,211,222, respectively. Net cash provided by financing activities in the six months ended June 30, 2017 was due to the exercise of warrants and employee stock options, which was partially offset by payment to the Alzheimer’s Drug Discovery Foundation of $102,630, representing the first installment of a note obligation associated with a grant from that organization and $35,154 of deferred offering costs associated with our private placement completed on July 14, 2017 (see Note 8 to our condensed financial statements included elsewhere in this document). Cash provided by financing activities in the amount of $1,211,222 in the six months ended June 30, 2016 was primarily due to the exercise of compensation options issued to the agents in our IPO, resulting in proceeds of $496,376, and the exercise of common stock purchase warrants resulting in proceeds of $712,246.

 

Contractual Obligations

 

The Company is a party to a lease agreement for a shared laboratory facility leased on a month-to-month basis in Menlo Park, California.

 

Rent expense was $56,595 and $40,640 for the three months ended June 30, 2017 and 2016, respectively. Rent expense was $111,810 and $75,035 for the six months ended June 30, 2017 and 2016, respectively. The increases in rent expense were primarily due to an expansion of our laboratory facilities in January 2017.

 

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Item 3.    Quantitative and Qualitative Disclosures About Market Risk

 

As a smaller reporting company as defined by the rules and regulations of the SEC, we are not required to provide this information.

 

Item 4.    Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this report, we conducted an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (“Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded as of the end of the period covered by this report that our disclosure controls and procedures were not effective due to a material weakness. 

 

The material weakness relates to our having one employee assigned to positions that involve processing financial information, resulting in a lack of segregation of duties so that all journal entries and account reconciliations are reviewed by someone other than the preparer, heightening the risk of error or fraud. If we are unable to remediate the material weakness, or other control deficiencies are identified, we may not be able to report our financial results accurately, prevent fraud or file our periodic reports as a public company in a timely manner. Due to our small size and the early stage of our business, segregation of duties may not always be possible and may not be economically feasible. We have limited capital resources and have given priority in the use of those resources to our research and development efforts. As a result, we have not been able to take steps to improve our internal controls over financial reporting during the quarter ended June 30, 2017. However, we continue to evaluate the effectiveness of internal controls and procedures on an on-going basis. As our operations grow and become more complex, we intend to hire additional personnel in financial reporting and other areas. However, there can be no assurance of when, if ever, we will be able to remediate the identified material weaknesses.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended June 30, 2017 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1.    Legal Proceedings

 

We may from time to time be a party to litigation and subject to claims incident to the ordinary course of business. As we grow and gain prominence in the marketplace we may become a party to an increasing number of litigation matters and claims. The outcome of litigation and claims cannot be predicted with certainty, and the resolution of these matters could materially affect our future results of operations, cash flows or financial position. We are not currently a party to any legal proceedings.

 

Item 1A.    Risk Factors

 

A description of the risks associated with our business, financial conditions and results of operations is set forth in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and filed with the SEC on March 31, 2017. There have been no material changes to these risks during the six months ended June 30, 2017.

 

Item 2.    Unregistered Sale of Equity Securities and Use of Proceeds

 

Sales of Unregistered Securities

 

None.

 

Item 3.    Defaults Upon Senior Securities

 

None.

 

Item 4.    Mine Safety Disclosures

 

None.

 

Item 5.    Other Information

 

None.

 

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Item 6.    Exhibits

 

Exhibit Number   Description
10.1*   First Amendment to Amended and Restated 2011 Equity Incentive Plan.
31.1   Certification of Principal Executive Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2   Certification of Principal Financial Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1   Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS   XBRL Instance Document
101.SCH   XBRL Taxonomy Extension Schema Document
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document
101.LAB   XBRL Taxonomy Extension Label Linkbase Document
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document

 

*    Management contract or compensatory agreement or arrangement in which our directors or executive officers may participate.

 

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on.

 

  COHBAR, INC.
     
Date: August 14, 2017 By: /s/ Jeffrey F. Biunno
    Jeffrey F. Biunno
    Chief Financial Officer, Treasurer and Secretary
    (Principal Financial Officer)

 

 

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