UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended SeptemberJune 30, 20172019

 

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)

 

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 StockCWBRNasdaq Capital Market

Indicate by check mark whether the registrantregistrant: (1) 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)., and (2) has been subject to such filing requirements for the past 90 days. YesþNo ☐

 

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). YesþNo ☐

 

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“emerging growth company"company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filerAccelerated filerþ
Non-accelerated filerþSmaller reporting companyþ
 (Do not check if a smaller reporting company)þEmerging growth companyþ

 

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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐        Noþ

 

As of November 9, 2017August 5, 2019, the registrant had outstanding39,395,83742,861,422 shares of common stock.

 

 

 

 

 

COHBAR, INC.

FORM 10-Q

For the Quarterly Period Ended SeptemberJune 30, 20172019

 

  

Page


Number

 PART I – FINANCIAL INFORMATION 
   
Item 1Financial Statements1
   
Item 2Management’s Discussion and Analysis of Financial Condition and Results of Operations11
   
Item 3Quantitative and Qualitative Disclosures About Market Risk15
   
Item 4Evaluation of Disclosure Controls and Procedures15
   
 PART II – OTHER INFORMATION 
   
Item 1Legal Proceedings

16

  
Item 1ARisk Factors16
   
Item 2Unregistered Sales of Equity Securities and Use of Proceeds16
   
Item 3Defaults Upon Senior Securities16
   
Item 4Mine Safety Disclosures16
   
Item 5Other Information16
   
Item 6Exhibits

17

   
 SIGNATURES18

 

 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

CohBar, Inc.

Condensed Balance Sheets

 

  As of 
  September 30, 2017  December 31, 2016 
  (unaudited)    
ASSETS      
Current assets:      
Cash $2,314,928  $3,257,458 
Investments  8,027,314   5,428,962 
Subscription receivable  -   522,326 
Prepaid expenses and other current assets  113,296   110,822 
Total current assets  10,455,538   9,319,568 
Property and equipment, net  184,269   230,512 
Intangible assets, net  23,693   - 
Other assets  40,465   36,810 
Total assets $10,703,965  $9,586,890 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $575,340  $103,294 
Accrued liabilities  175,273   132,780 
Accrued payroll and other compensation  147,065   447,641 
Note payable, net of debt discount of $0 and $59 as of September 30, 2017 and December 31, 2016, respectively  -   205,201 
Total liabilities  897,678   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 September 30, 2017 and December 31, 2016, respectively  -   - 
Common stock, $0.001 par value, Authorized 75,000,000 shares;        
Issued and outstanding 39,295,754 shares as of September 30, 2017 and 34,807,881 as of December 31, 2016  39,296   34,808 
Additional paid-in capital  31,176,283   23,072,702 
Accumulated deficit  (21,409,292)  (14,409,536)
Total stockholders’ equity  9,806,287   8,697,974 
Total liabilities and stockholders’ equity $10,703,965  $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 September 30,  For The Nine Months Ended September 30, 
  2017  2016  2017  2016 
             
Revenues $-  $-  $-  $- 
                 
Operating expenses:                
Research and development  2,316,454   1,056,429   4,883,868   2,646,125 
General and administrative  549,505   598,507   2,124,601   1,753,008 
Total operating expenses  2,865,959   1,654,936   7,008,469   4,399,133 
Operating loss  (2,865,959)  (1,654,936)  (7,008,469)  (4,399,133)
                 
Other income (expense):                
Interest income  5,954   3,142   12,359   7,072 
Interest expense  (1,102)  (1,886)  (3,587)  (5,643)
Amortization of debt discount  -   (49)  (59)  (147)
Total other income  4,852   1,207   8,713   1,282 
Net loss $(2,861,107) $(1,653,729) $(6,999,756) $(4,397,851)
Basic and diluted net loss per share $(0.07) $(0.05) $(0.19) $(0.13)
Weighted average common shares outstanding - basic and diluted  38,809,942   33,416,874   36,829,669   32,878,254 
  As of 
  June 30,
2019
  December 31,
2018
 
  (unaudited)    
ASSETS      
Current assets:      
Cash $3,813,679  $5,722,342 
Investments  13,014,754   16,460,426 
Prepaid expenses and other current assets  543,626   260,630 
Total current assets  17,372,059   22,443,398 
Property and equipment, net  463,050   520,740 
Intangible assets, net  19,693   20,233 
Other assets  56,793   56,793 
Total assets $17,911,595  $23,041,164 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities:        
Accounts payable $194,420  $1,142,735 
Accrued liabilities  548,119   351,813 
Accrued payroll and other compensation  289,907   667,661 
Total current liabilities  1,032,446   2,162,209 
Notes payable, net of debt discount and offering costs of $766,238 and $986,163 as of June 30, 2019 and December 31, 2018, respectively  3,136,262   2,916,337 
Total liabilities  4,168,708   5,078,546 
         
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, 2019 and December 31, 2018, respectively  -   - 
Common stock, $0.001 par value, Authorized 75,000,000 shares; Issued and outstanding 42,861,422 shares as of June 30, 2019 and 42,578,208 as of December 31, 2018  42,861   42,578 
Additional paid-in capital  59,627,205   57,868,593 
Accumulated deficit  (45,927,179)  (39,948,553)
Total stockholders’ equity  13,742,887   17,962,618 
Total liabilities and stockholders’ equity $17,911,595  $23,041,164 

 

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

 

2

1

 

CohBar, Inc.

Condensed Statements of Cash FlowsOperations

(unaudited)

 

  For The Nine Months Ended September 30, 
  2017  2016 
Cash flows from operating activities:      
Net loss $(6,999,756) $(4,397,851)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation  49,502   41,273 
Stock-based compensation  1,180,835   524,118 
Amortization of debt discount  59   147 
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets  (2,474)  5,967 
Accounts payable  472,046   214,334 
Accrued liabilities  42,493   (11,769)
Accrued payroll and other compensation  (300,576)  20,417 
Net cash used in operating activities  (5,557,871)  (3,603,364)
         
Cash flows from investing activities:        
Purchases of property and equipment  (3,259)  (67,011)
Capitalized patent costs  (23,693)  - 
Payment for security deposit  (3,655)  (6,601)
Purchases of investments  (16,707,352)  (8,662,205)
Proceeds from redemptions of investments  14,109,000   12,073,000 
Net cash (used in) provided by investing activities  (2,628,959)  3,337,183 
         
Cash flows from financing activities:        
Proceeds from exercise of warrants  2,404,993   741,046 
Repayment of note payable  (205,260)  - 
Proceeds from exercise of compensation options  -   731,085 
Proceeds from exercise of employee stock options  19,825   2,600 
Proceeds from private offering, net  5,024,742   - 
Net cash provided by financing activities  7,244,300   1,474,731 
         
Net (decrease) increase in cash  (942,530)  1,208,550 
Cash at beginning of period  3,257,458   4,803,687 
Cash at end of period $2,314,928  $6,012,237 
         
Supplemental disclosure of cash flow information:        
Cash paid:        
Income taxes paid $2,057  $1,300 
Interest paid $29,007  $- 
  For The Three Months Ended
June 30,
  For The Six Months Ended
June 30,
 
  2019  2018  2019  2018 
             
Revenues $-  $-  $-  $- 
                 
Operating expenses:                
Research and development  1,418,426   1,832,459   2,790,274   4,513,442 
General and administrative  1,539,305   1,315,316   2,995,502   2,228,404 
Total operating expenses  2,957,731   3,147,775   5,785,776   6,741,846 
Operating loss  (2,957,731)  (3,147,775)  (5,785,776)  (6,741,846)
                 
Other (expense) income:                
Interest income  87,488   8,048   181,893   19,008 
Interest expense  (77,837)  (73,207)  (154,818)  (74,616)
Amortization of debt discount and offering costs  (109,962)  (103,179)  (219,925)  (105,244)
Total other (expense) income  (100,311)  (168,338)  (192,850)  (160,852)
Net loss $(3,058,042) $(3,316,113) $(5,978,626) $(6,902,698)
Basic and diluted net loss per share $(0.07) $(0.08) $(0.14) $(0.17)
Weighted average common shares outstanding - basic and diluted  42,799,486   40,261,670   42,717,950   39,969,738 

 

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

2

CohBar, Inc.

Statements of Changes in Stockholders’ Equity

(unaudited)

  Three and Six Month Periods Ended June 30, 2019 
        Additional     Total 
  Common Stock  Paid-in  Accumulated  Stockholders’ 
  Number  Amount  Capital  Deficit  Equity 
Balance, December 31, 2018  42,578,208  $42,578  $57,868,593  $(39,948,553) $17,962,618 
Stock based compensation  -   -   763,659   -   763,659 
Exercise of employee stock options  94,530   95   151,506   -   151,601 
Exercise of warrants  50,000   50   57,450   -   57,500 
Net loss  -   -   -   (2,920,584)  (2,920,584)
Balance, March 31, 2019  42,722,738  $42,723  $58,841,208  $(42,869,137) $16,014,794 
Stock based compensation  -   -   664,164   -   664,164 
Exercise of employee stock options  138,684   138   121,833   -   121,971 
Net loss  -   -   -   (3,058,042)  (3,058,042)
Balance, June 30, 2019  42,861,422  $42,861  $59,627,205  $(45,927,179) $13,742,887 

  Three and Six Month Periods Ended June 30, 2018 
     Additional     Total 
  Common Stock  Paid-in  Accumulated  Stockholders’ 
  Number  Amount  Capital  Deficit  Equity 
Balance, December 31, 2017  39,439,505  $39,440  $31,822,161  $(24,242,688) $7,618,913 
Stock based compensation  -   -   978,708   -   978,708 
Exercise of employee stock options  249,309   249   146,189   -   146,438 
Exercise of warrants  267,333   267   588,232   -   588,499 
Debt Discount on notes  -   -   711,310   -   711,310 
Net loss  -   -   -   (3,586,585)  (3,586,585)
Balance, March 31, 2018  39,956,147  $39,956  $34,246,600  $(27,829,273) $6,457,283 
Stock based compensation  -   -   808,470   -   808,470 
Sale of common stock  2,186,855   2,187   19,397,672   -   19,399,859 
Deferred offering costs  -   -   (95,805)  -   (95,805)
Exercise of employee stock options  277,374   277   242,442   -   242,719 
Exercise of warrants  6,982   7   3,484   -   3,491 
Debt Discount on notes  -   -   542,080   -   542,080 
Net loss  -   -   -   (3,316,113)  (3,316,113)
Balance, June 30, 2018  42,427,358   42,427   55,144,943   (31,145,386)  24,041,984 

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

 

3

CohBar, Inc.

Condensed Statements of Cash Flows

(unaudited)

 

  For The Six Months Ended June 30, 
  2019  2018 
Cash flows from operating activities:      
Net loss $(5,978,626) $(6,902,698)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  70,651   34,312 
Stock-based compensation  1,427,823   1,787,178 
Amortization of debt discount  210,170   100,953 
Amortization of debt issuance costs  9,755   4,290 
Discount on investments  (3,328)  - 
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets  (282,996)  (142,974)
Accounts payable  (948,315)  275,652 
Accrued liabilities  196,306   77,490 
Accrued payroll and other compensation  (377,754)  204,200 
Net cash used in operating activities  (5,676,314)  (4,561,597)
         
Cash flows from investing activities:        
Purchases of property and equipment  (12,421)  - 
Patent costs  -   1,739 
Purchases of investments  (26,924,000)  (15,062,528)
Proceeds from redemptions of investments  30,373,000   7,126,461 
Net cash provided by (used in) investing activities  3,436,579   (7,934,328)
         
Cash flows from financing activities:        
Debt issuance costs  -   (57,288)
Proceeds from the Controlled Equity Offering, net  -   19,304,054 
Proceeds from exercise of warrants  57,500   591,990 
Proceeds from notes payable  -   3,902,500 
Proceeds from exercise of employee stock options  273,572   389,158 
Net cash provided by financing activities  331,072   24,130,414 
         
Net (decrease) increase in cash  (1,908,663)  11,634,489 
Cash at beginning of period  5,722,342   2,823,450 
Cash at end of period $3,813,679  $14,457,939 
         
Non-cash investing and financing activities:        
Warrants issued in connection with note payable $-  $1,253,390 
         
Supplemental disclosure of cash flow information:        
Cash paid for:        
Income taxes $1,300  $2,057 

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

 


COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 1 - Business Organization and BasisNature of PresentationOperations

 

CohBar, Inc. (“CohBar”CohBar,” “its” or the “Company”) is an innovativea clinical stage biotechnology company and a leader in the research and development of mitochondria based therapeutics (MBTs), ana novel and emerging class of drugs withtherapeutics that have 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), obesity, type 2 diabetes mellitus (T2D), fibrotic diseases, cancer, atherosclerosis, cardiovascular disease, atherosclerosis and neurodegenerative diseases such as Alzheimer’s disease.

 

The Company’s primary activities include the research and development of its MBT pipeline, securing intellectual property protection for its discoveries and assets, 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.options and the issuance of debt instruments. 

 

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, 2016,2018, included in the Company’s Annual Report onForm 10-K (the “2016“2018 Form 10-K”), filed with the SEC on March 31, 2017.18, 2019. The interim unaudited condensed financial statements should be read in conjunction with those audited financial statements included in the 20162018 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 ninesix month periods ended SeptemberJune 30, 20172019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017,2019, or any other period.

 

Note 2 - Liquidity and Management’s Liquidity Plans

 

As of SeptemberJune 30, 2017,2019, the Company had working capital and stockholders’ equity of $9,557,860$16,339,613 and $9,806,287,$13,742,887, respectively. During the ninesix months ended SeptemberJune 30, 2017,2019, the Company incurred a net loss of $6,999,756.$5,978,626 and used $5,676,314 in its operating activities. 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 Factors such as these and the Company’s projected cash burn raised substantial doubt about its ability to continue as a going concern for at least one year from the issuance of these financial statements. However, management has substantial latitude as to the timing and investments on hand asamount of September 30, 2017 the expenses it incurs and such latitude and control of those expenditures alleviated the substantial doubt. 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 activitiesand/or other operations until such time as additional capital becomes available. Such limitation of the Company’sits 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 willwould 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 accounting principles generally accepted in the United States of America (“U.S. GAAPGAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the dates of the financial statements and the reported amounts of revenue and expenses during the periods presented.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.

 

Concentrations of Credit Risk

The Company maintains deposits in a financial institution which is insured by the Federal Deposit Insurance Corporation (“FDIC”). At various times, the Company has deposits in this financial institution in excess of the amount insured by the FDIC. The Company has not experienced any losses in such accounts and believes it is not exposed to any significant credit risk.

Investments

 

As of September 30, 2017, investments consistedInvestments consist of U.S. Treasury Bills of $4,042,990,$13,014,754, which are classified as held-to-maturity, and Certificates of Deposit of $3,984,324.held-to-maturity. 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 mature within the next twelve months. Unrealized gains and losses arede minimisminimus. As of SeptemberJune 30, 2017,2019, the carrying value of the Company’s U.S. Treasury Bills approximates their fair value.value due to their short-term maturities.

Deferred Offering CostsCommon Stock Purchase Warrants

 

The Company capitalizes amounts related to anclassifies as equity offering in progress as of the balance sheet date as Deferred Offering Costs. During the nine months ended September 30, 2017,any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company incurred $132,338with a choice of offering related costs.net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) providing that such contracts are indexed to the Company’s own stock. The related offering closedCompany classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside the Company’s control), or (ii) give the counterparty a choice of net-cash settlement or settlement in July 2017shares (physical settlement or net-share settlement). The Company assesses classification of its common stock purchase warrants and other free-standing derivatives at each reporting date to determine whether a change in classification between assets, liabilities and equity is required.  The Company’s free-standing derivatives consist of warrants to purchase common stock that were issued in connection with its notes payable and private offering. The Company evaluated these costs were recorded as a reduction in additional paid-in capitalwarrants to assess their proper classification using the applicable criteria enumerated under U.S. GAAP and determined that the common stock purchase warrants meet the criteria for equity classification in the accompanying condensed balance sheets.sheets as of June 30, 2019 and December 31, 2018.

 

6

Capitalization of Patent Costs

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

The Company capitalizes the costsNote 3 - Summary of its patents which consists of legal and filing fees related to the prosecution of patent filings. The patents will be amortized using the straight-line method over the estimated remaining lives of the patents which is 20 years from the initial filing of the patent. Amortization for the nine months ended September 30, 2017 wasde minimis to the condensed financial statements.Significant Accounting Policies (continued)

 

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 dates until the service is complete.determinable. 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 marketplaceby Nasdaq or (ii) the closing price of the Company’s common stock as reported by the TSX Venture Exchange as determined by the board of directors, with input from management on the date of grant.

5

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 3 - Summary Upon exercise of Significant Accounting Policies (continued)an option or warrant, the Company issues new shares of common stock out of its authorized shares.

 

The weighted-average fair value of options and warrants has been estimated on the grant date of grantor measurement date using the Black-Scholes option-pricingpricing model. The fair value of each instrument is estimated on the grant date of grantor measurement date utilizing certain assumptions for a risk-free interest rate, volatility and expected remaining lives of the awards. SinceThe risk-free interest rate used is the Company hasUnited States Treasury rate for the day of the grant having a limited historyterm equal to the life of being publicly traded,the equity instrument. Beginning with the current year, the fair value of stock-based payment awards issued was estimated using a volatility derived from the Company’s share price. Prior to the current year, the Company had a limited history of being publicly traded and estimated the fair value of stock-based payment awards 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 September 30, For Nine Months Ended September 30, For the Three Months Ended
June 30,
  For Six Months Ended
June 30,
 
 2017 2016 2017 2016 2019  2018  2019  2018 
Expected life 5 years 4 years 6 years 5 years  6.25 years   5 years   6.25 years   5 years 
Risk free interest rate 1.92% 1.03% 1.99% 1.10%  2.19%  2.70%  2.21%  2.63%
Expected volatility 81% 79% 80% 79%  76%  81%  76%  81%
Expected dividend yield 0% 0% 0% 0%  0%  0%  0%  0%
Forfeiture rate 0% 0% 0% 0%  0%  0%  0%  0%

 

As of SeptemberJune 30, 2017,2019, total unrecognized stock basedoption compensation expense was $2,087,473is $5,957,615, which will be recognized as that equity veststhose options vest over a period of approximately fivefour years. The amount of future stock option compensation expense could be affected by any future equityoption grants or by any option holders leaving the Company before their grants are fully vested.


COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 3 - Summary of Significant Accounting Policies (continued)

 

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 September 30, 
  2017  2016 
Options  5,598,497   4,652,497 
Warrants  4,569,688   8,056,418 
Totals  10,168,185   12,708,915 

6

  As of June 30, 
  2019  2018 
Options  7,741,814   5,886,272 
Warrants  4,907,223   5,039,205 
Totals  12,649,037   10,925,477 

 

COHBAR, INC.Recent Accounting Pronouncements

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)In July 2018, the FASB issued ASU No. 2018-09, “Codification Improvements” (“ASU 2018-09”). These amendments provide clarifications and corrections to certain ASC subtopics including, but not limited to, the following:Income Statement - Reporting Comprehensive Income – Overall (Topic 220-10),Debt - Modifications and Extinguishments (Topic 470-50),Distinguishing Liabilities from Equity – Overall (Topic 480-10),Compensation - Stock Compensation - Income Taxes (Topic 718-740) andFair Value Measurement – Overall (Topic 820-10). The majority of the amendments in ASU 2018-09 is effective in annual periods beginning after December 15, 2018.The adoption of ASU 2018-09 did not have a material impact on the financial statements contained herein.

 

Note 4 - Accrued Liabilities

 

Accrued liabilities consist of:

 

 As of As of  As of As of 
 September 30, 2017  December 31, 2016  June 30,
2019
  December 31,
2018
 
Lab services & supplies $32,608  $87,100  $119,029  $103,766 
Professional fees  140,165   17,760 
Consultant fees  2,500   2,500 
Professional & other fees  42,274   16,048 
Interest  -   25,420   386,816   231,999 
Total accrued liabilities $175,273  $132,780  $548,119  $351,813 


COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

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 (i) a lease agreement for a shared laboratory facilityspace leased on a month-to-monthmonth-to month basis that is part of a shared facility in Menlo Park, California.California, and (ii) a one-year lease agreement for office space in Fairfield, New Jersey, which expires in September 2019.

 

Rent expense was $57,428$85,190 and $41,343$70,356 for the three months ended SeptemberJune 30, 20172019 and 2016,2018, respectively. Rent expense was $169,237$170,379 and $116,378$140,712 for the ninesix months ended SeptemberJune 30, 20172019 and 2016,2018, respectively.

 

Note 6 - Stockholders’ Equity

 

Private Offering

During the quarter ended September 30, 2017, the Company completed a private offering for total net proceeds of approximately $5.02 million (“Private Offering”), of which 289,334 units were sold to officers and directors. The Company issued an aggregate of 3,438,053 units at a price of $1.50 per unit. Each unit consists of one share of the Company’s common stock and one common stock purchase warrant (see “Warrants”).

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 rulesAs of the TSX-Venture Exchange (or “TSX-V”) provide that the maximum number ofJune 30, 2019, there were 1,289,106 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 authorizedremaining available for issuance under the 2011 PlanPlan.

During the six months ended June 30, 2019, the Company granted stock options to a total of 7,171,540, which is equalemployees and non-employee directors to 20% of the number ofpurchase 2,579,000 shares of the Company’s common stock outstandingwith grant date prices that ranged between $1.72 to $3.15 per share. The stock options have terms of ten years and are subject to vesting based on the datecontinuous service of the amendment.awardee over periods ranging between zero and four years. The stock options have an aggregate grant date fair value of $3,266,611.

 

The stock options granted during the six months ended June 30, 2019, included an option to purchase 430,000 shares of common stock that contained service and performance conditions to be met for those options to begin vesting. The option holder had to be continuously employed to meet the service condition and attain certain funding milestones over a two-year period to satisfy the performance condition.

During the six months ended June 30, 2019, stock options to purchase 233,214 shares of common stock were exercised for cash proceeds of $273,572.

The Company recorded stock-based compensation as follows:

  For the Three Months Ended
June 30,
  For the Six Months Ended
June 30,
 
  2019  2018  2019  2018 
Research and development $237,331  $337,730  $510,142  $1,111,389 
General and administrative  426,833   470,740   917,681   675,789 
Total $664,164  $808,470  $1,427,823  $1,787,178 

The following table represents stock option activity for the six months ended June 30, 2019:

        Weighted Average    
  Stock Options  Exercise Price  Fair Value  Contractual  Aggregate 
  Outstanding  Exercisable  Outstanding  Exercisable  Vested  Life (Years)  Intrinsic Value 
Balance – December 31, 2018  5,488,282   4,384,294  $2.10  $1.32  $1.32   5.80  $- 
Granted  2,579,000   -   -   -   -   -   - 
Exercised  (233,214)  -   -   -   -   -   - 
Cancelled  (92,254)  -   -   -   -   -   - 
Balance – June 30, 2019  7,741,814   4,540,410  $2.15  $1.45  $1.45   6.27  $2,768,087 

7

9

 

 

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. In August 2017, the Company issued warrants to purchase 180,000 shares of the Company’s common stock to two consultants as compensation for consulting services they will provide the Company over a five-year period. Pursuant to applicable policies of the TSX-V, the shares issuable under the warrantswill be counted against the limit of shares authorized for issuance under the 2011 Plan, notwithstanding that the warrants were not issued under the 2011 Plan. After giving effect to this limitation there were 1,241,793 shares remaining available for issuance under the 2011 Plan at September 30, 2017.

During the nine months ended September 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 nine months ended September 30, 2017.

During the nine months ended September 30, 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, are subject to vesting over periods of three and four years and have an aggregate grant date fair value of $269,416.

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 September 30,  For Nine Months Ended September 30, 
  2017  2016  2017  2016 
Research and development $441,629  $89,526  $584,589  $264,270 
General and administrative  126,242   101,290   596,246   259,848 
Total $567,871  $190,816  $1,180,835  $524,118 

The following table represents stock option activity for the nine months ended September 30, 2017:

        Weighted Average  Aggregate 
  Stock Options  Exercise Price  Fair Value  Contractual  Intrinsic 
  Outstanding  Exercisable  Outstanding  Exercisable  Vested  Life (Years)  Value 
Balance – December 31, 2016  4,652,497   1,908,883  $0.92  $0.41  $0.41   8.24  $- 
Granted  1,116,000   -   -   -   -   -   - 
Exercised  (16,250)  -   -   -   -   -   - 
Cancelled  (153,750)  -   -   -   -   -   - 
Balance – September 30, 2017  5,598,497   3,006,807  $1.02  $0.64  $0.64   6.92  $12,910,289 

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 SeptemberJune 30, 2017:2019:

 

      Weighted
Average
 Weighted     Weighted 
Exercise  Number  Remaining Average  Number  Average 
Price  Outstanding  Contractual Term Exercise Price  Exercisable  Exercise Price 
                
$0.05   72,876  4.51 years $0.05   72,876  $0.05 
$0.26   1,024,810  6.53 years $0.26   1,008,112  $0.26 
$0.73   1,475,687  7.12 years $0.73   1,045,278  $0.73 
$1.00   313,124  7.81 years $1.00   186,457  $1.00 
$1.10   10,000  8.35 years $1.10   4,584  $1.10 
$1.17   70,000  8.12 years $1.17   36,250  $1.17 
$1.22   125,000  8.35 years $1.22   52,083  $1.22 
$1.50   40,000  8.42 years $1.50   15,833  $1.50 
$1.55   1,456,000  8.44 years $1.55   424,500  $1.55 
$2.02   85,000  9.86 years $2.02   27,500  $2.02 
$2.40   926,000  9.34 years $2.40   133,334  $2.40 
Totals   5,598,497         3,006,807     

Grant Price  Weighted Average  Total  Number  Weighted Average Remaining Contractual 
From  To  Exercise Price  Outstanding  Exercisable  Term 
$0.26  $2.02  $0.89   3,299,604   3,281,062   4.06 years 
$2.10  $4.60  $2.46   3,737,335   850,980   9.15 years 
$5.30  $8.86  $6.60   704,875   408,368   8.86 years 
         Totals   7,741,814   4,540,410     

 

Warrants

 

In January 2017, a totalDuring the six months ended June 30, 2019, warrants to purchase 50,000 shares of 926,588the Company’s 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 nine months ended September 30, 2017, 4,695,846 unexercised warrants expired.$57,500.

 

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

        Weighted Average    
  Warrants  Exercise Price  Fair Value  Contractual  Aggregate 
  Outstanding  Exercisable  Outstanding  Exercisable  Vested  Life (Years)  Intrinsic Value 
Balance – December 31, 2018  4,964,205   4,907,223  $2.39  $2.39  $1.14   2.27  $- 
Granted  -   -   -   -   -   -   - 
Exercised  (50,000)  -   -   -   -   -   - 
Cancelled  (6,982)  -   -   -   -   -   - 
Balance – June 30, 2019  4,907,223   4,907,223  $2.40  $2.40  $1.11   1.80  $1,175,115 

 

During the ninesix months ended September 30, 2017, the Company issued 3,438,053 warrants as part of the Private Offering. Each warrant can be exercised at any time prior to June 30, 2020 for the2019, warrants to purchase of one share6,982 shares of the Company’s common stock at an exercise price of $2.25.expired and were cancelled.

 

During the nine months ended September 30, 2017, the Company issued warrants to two consultants. The warrants are exercisable any time prior to August

Note 7 2022 for the purchase of an aggregate of up to 180,000 shares of common stock at an exercise price of $1.99 per share.

9

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 6 - Stockholders’ Equity (continued)Non-Cash Expenses

 

The following table represents warrant activity fordetails the nine months ended September 30, 2017:

        Weighted Average  Aggregate 
  Warrants  Exercise Price  Fair Value  Contractual  Intrinsic 
  Outstanding  Exercisable  Outstanding  Exercisable  Vested  Life (Years)  Value 
Balance – December 31, 2016  6,681,051   6,618,551  $1.74  $1.74  $0.41   0.98  $- 
Issued  3,618,053   3,618,053  $2.24  $2.24  $1.04   2.86   - 
Exercised  (1,033,570)  -   -   -   -   -   - 
Cancelled  (4,695,846)  -   -   -   -   -   - 
Balance – September 30, 2017  4,569,688   4,554,063  $1.85  $1.86  $0.92   3.46  $8,212,130 

Note 7 - Related Party TransactionsCompany’s non-cash expenses included in the accompanying condensed statements of operations:

 

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 September 30, 2017 and 2016. During each of the nine months ended September 30, 2017 and 2016, payments to each Director totaled $31,500. As of September 30, 2017, and December 31, 2016, no amounts were owed to either Director.

  For the Three Months Ended June 30,  For the Six Months Ended June 30, 
  2019  2018  2019  2018 
Operating expenses:            
Stock based compensation $664,164  $808,470  $1,427,823  $1,787,178 
Depreciation & amortization  36,028   17,073   70,651   34,312 
Subtotal $700,192  $825,543  $1,498,474  $1,821,490 
                 
Other expense:                
Amortization of debt discount  105,085   98,977   210,170   100,953 
Total non-cash  expenses $805,277  $924,520  $1,708,644  $1,922,443 

 

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.

In October 2017, 80,083 stock options were exercised for cash proceeds of $100,392, and 20,000 warrants were exercised for cash proceeds of $45,000.

 

In October 2017,No such events occurred subsequent to the Company entered into a one-year lease agreement for office space in New Jersey at a costdate of $13,080 per annum.

the financial statements.

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 onForm 10-K for the year ended December 31, 20162018 (the “2016“2018 Form 10-K”). All references to the thirdsecond quarter mean the three-month period ended June 30, 2019, and all references to the first ninesix months of 20172019 and 2016 are to2018 mean the three and nine monthsix-month periods ended SeptemberJune 30, 20172019 and 2016,2018, 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 therapeuticprojections about our business, our potential of mitochondria based therapeutics, plans and expectations regarding ourCB4209 and CB4211and initiation of clinical trials,drug candidates, 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 inherentthose discussed 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 inthis report under the section entitled “Risk Factors” found in Item 1A of Part I of the 20162018 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 innovativea clinical stage 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), obesity, type 2 diabetes mellitus (T2D), fibrotic diseases,cancer, atherosclerosis, cardiovascular disease, atherosclerosis and neurodegenerative diseases such as Alzheimer’s disease.

 

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 genomemitochondrial genome. Some of mitochondria, the powerhouses of the cell. Thesethese naturally occurring MDPs and relatedtheir analogs have demonstrated a range of biological activity and therapeutic potential in pre-clinicalresearch models across multiple diseases associated with aging.

 

We believe CohBar is a first mover in exploringare focused on building our organization, enhancing our scientific and management teams and their capabilities, planning and strategy, raising capital and the mitochondrial genome for therapeutically relevant peptides,research 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 propertiesdevelopment of our MDPs. Our research efforts have focused on discovering and evaluating our MDPs for potential development as MBT candidates, enabling usdrug candidates. We seek to match the most biologically promising peptides to disease indications thatidentify and advance research on MDPs with superior potential for yielding an MBT drug candidate, and ultimately a drug, for which we have substantial unmet medical needs.a strong intellectual property position.

 

11

In September 2016, we advanced two novel, optimized analogs of our MOTS-c MDP, CB4209 and CB4211, into IND-enabling studies as ourOur lead MBT drug candidates withcandidate for the potential for treatment of NASH and obesity is CB4211, a novel optimized analog of the MOTS-c MDP. In July 2018, we announced the initiation of a Phase 1a/1b clinical study of CB4211. The double-blind, placebo-controlled clinical study is designed to initially assess the safety, tolerability, and pharmacokinetics of CB4211 following single and multiple-ascending doses in healthy subjects. The final Phase 1b stage of the study, which has not yet started, is designed to assess the safety, tolerability, and activity of CB4211 in obese subjects with non-alcoholic fatty liver diseases (NAFLD). Assessments will include changes in liver fat assessed by MRI-PDFF, body weight, and biomarkers relevant to NASH and obesity. Our


In November 2018, we announced the temporary suspension of our Phase 1 clinical study of CB4211 to address mild but persistent injection site reactions. These injection site reactions, which were observed in the Phase 1a dose escalation part of the study, were generally seen as painless bumps at the injection site that can be felt under the skin, but in most cases would be otherwise undetectable. We believe, based on the data accumulated, that some of the administered dose of CB4211 remained localized in the tissue at the injection site, thereby causing these bumps to occur. In May 2019, we received regulatory feedback for our plan to address this issue and in June 2019 we resumed the trial. While we anticipate receiving topline data in the second or third quarters of 2020, we cannot predict with certainty when such data will be available.

To date, our founders and scientific team have also 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, a debt offering, public sales of our securities, and the exercise of outstanding warrants and stock options. Since our inception through SeptemberJune 30, 2017,2019, our operations have been funded with an aggregate of approximately $30.7$56.3 million from the sale and issuance of equity instruments.instruments and debt.

 

Since inception, we have incurred significant operating losses. Our net losses were $6,999,756$5,978,626 and $4,397,851$6,902,698 for the ninesix months ended SeptemberJune 30, 20172019 and 2016,2018, respectively. Our net losses included $1,708,644 and $1,922,443 of non-cash expenses for the six months ended June 30, 2019 and 2018, respectively. Our net losses excluding non-cash expenses were $4,269,982 and $4,980,255 for the six months ended June 30, 2019 and 2018, respectively. As of SeptemberJune 30, 2017,2019, we had an accumulated deficit of $21,409,292.$45,927,179. We expect to continue to incur significant expenses and operating losses over the next several years. Our net losses may fluctuate significantly from quarter to quarter and from year to year. We anticipate incurring increasing expenses from IND-enabling activities for our lead programs, continuedas we advance CB4211 through the clinic, and as we conduct pre-clinical development of our pipeline MDPs,other research peptides, continue development of our MBTs and from the expansion and protection ofseek to expand our intellectual property portfolio.

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.

Research and Development Expenses

Our research and development programs include activities in support of the clinical development of our lead MBT candidate program, CB4211, as well as the operation of our platform technology related to the discovery and development of new MBTs, evaluation of newly discovered MDPs, design of novel improved analogs, evaluation of their therapeutic potential, and optimization of their characteristics as potential MBT drug development candidates. Depending on factors of capability, cost, efficiency and intellectual property rights, we conduct our research programs independently at our laboratory facility, pursuant to contractual arrangements with CROs or under collaborative arrangements with academic institutions.


The success of our research programs and the timing of those programs and the possible development of research peptides into drug candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing or estimated costs of the efforts that will be necessary to complete research and development of a commercial drug. We are also unable to predict when, if ever, we will receive material net cash inflows from our operations. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainty of:

establishing an appropriate safety profile with toxicology studies;
successfully designing, enrolling and completing clinical trials;
receiving marketing approvals from applicable regulatory authorities;
establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
obtaining and enforcing patent and trade secret protection for our product candidates;
launching commercial sales of the products, if and when approved, whether alone or in collaboration with others; and
maintaining an acceptable safety profile of the products following approval.

A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that product candidate.

Research and development activities are central to our business model. Most of 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 costs to increase for the foreseeable future as our product candidate development programs progress. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through commercialization. There are numerous factors associated with the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development programs and plans.

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 and directors and officers insurance.

Results of Operations

The following table sets 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 
  2019  2018  $  % 
Operating expenses:            
Research and development $1,418,426  $1,832,459  $(414,033)  -23%
General and administrative  1,539,305   1,315,316   223,989   17%
Total operating expenses $2,957,731  $3,147,775  $(190,044)  -6%


Comparison of Three Months Ended June 30, 2019 and 2018

Research and developmentexpenses were $1,418,426 in the three months ended June 30, 2019 compared to$1,832,459 in the prior year period, a decrease of $414,033. The decrease in research and development expenses was primarily due to lower clinical and pre-clinical costs of $588,168 related to the timing of those expenses and the temporary clinical suspension in the current year quarter and a decrease of $77,327 in peptide synthesis services due to the timing of those costs. These decreases were partially offset by an increase of $355,510 in expenses associated with our research programs focused on continuing our development of peptides. We expect research and development expenses to increase in the coming quarters as we continue to advance our lead MBT candidate program through our clinical trial and evaluate and optimize other MDPs as potential MBT drug candidates into clinical studiescandidates.

General and continue discovery,administrativeexpenses were $1,539,305 in the three months ended June 30, 2019 compared to $1,315,316 in the prior year period, an increase of $233,989. The increase was due to a $104,297 increase in legal fees primarily related to costs associated with the protection of our intellectual property, an $82,397 increase in recruiting costs related to our search for a new Chief Executive Officer, and a $74,625 increase in directors’ fees due to the appointment of new directors and changes in board compensation. We expect general and administrative expenses for the year ending December 31, 2019 to be higher in comparison to the prior year.

  For The Six Months Ended
June 30,
  Change 
  2019  2018  $  % 
Operating expenses:            
Research and development $2,790,274  $4,513,442  $(1,723,168)  -38%
General and administrative  2,995,502   2,228,404   767,098   34%
Total operating expenses $5,785,776  $6,741,846  $(956,070)  -14%

Comparison of Six Months Ended June 30, 2019 and 2018

Research and development expenses were $2,790,274 in the six months ended June 30, 2019 compared to $4,513,442 in the prior year period, a decrease of $1,723,168, or 38%. The decrease in research and development efforts forexpenses was primarily due to $1,646,265 of costs incurred in the prior year period which related to timing of our pipeline MDPs.pre-clinical and clinical activities during such period.

 

BasedGeneral and administrativeexpenses were $2,995,502 in the six months ended June 30, 2019 compared to $2,228,404 in the prior year period, an increase of $767,098, or 34%. The increase was due to a $241,891 increase in stock-based compensation primarily related to new grants made in the current year period, a $135,397 increase in recruiting costs related to our search for a new Chief Executive Officer, a $120,625 increase in directors fees due the appointment of new directors and to the changes in board compensation and a $100,580 increase in legal fees primarily related to costs associated with the protection of our intellectual property.

Liquidity and Capital Resources

As of June 30, 2019, we had a cash balance of $3,813,679. We maintain our cash in a checking and savings account on current budget assumptionsdeposit 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. As of June 30, 2019, we had an investments balance of $13,014,754.

As ofJune 30, 2019, we had working capital and stockholders’ equity of $16,339,613 and $13,742,887, respectively. During the six months ended June 30, 2019, we incurred a net loss of $5,978,626. We have not generated any revenues, have incurred net losses since inception and do not expect to generate revenues in the near term. Factors such as these and our projected cash burn raised substantial doubt about our ability to continue as a going concern for at least one year from the issuance of these financial statements. However, we have substantial latitude as to the timing and investments on hand asamount of September 30, 2017, wethe expenses incurred and such latitude and control of those expenditures alleviated the substantial doubt. 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 activitiesand/or other operations 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 however, thereraised. 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.

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. These 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.

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We expense all research and development expenses as incurred. We expect our research and development expenses will continue to increase in future periods, 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 September 30,  Change 
  2017  2016  $  % 
Operating expenses:            
Research and development $2,316,454  $1,056,429  $1,260,025   119%
General and administrative  549,505   598,507   (49,002)  (8%)
Total operating expenses $2,865,959  $1,654,936  $1,211,023   73%

Comparison of Three Months Ended September 30, 2017 and 2016

Research and development expenses were $2,316,454 in the three months ended September 30, 2017 compared to $1,056,429 in the prior year period, a $1,260,025 increase. The increase in research and development expenses was due primarily to a net increase of approximately $880,000 in costs related to our IND-enabling activities associated with advancing our lead drug candidates into clinical studies, purchases of laboratory supplies and expenses related to our efforts to develop optimized MBT candidates, and a $352,000 increase in stock-based compensation relating to the cost of new grants and the revaluation of options granted to consultants that are revalued at each balance sheet date.

General and administrativeexpenses were $549,505 in the three months ended September 30, 2017 compared to $598,507 in the prior year period, a $49,002 decrease. The decrease in general and administrative expenses was primarily due to a decrease in professional fees in the current quarter as we capitalized legal costs associated with our patents and the incurrence of a recruiting fee in the prior year quarter. This decrease was offset by an increase in stock-based compensation costs related to new grants.

  For The Nine Months Ended September 30,  Change 
  2017  2016  $  % 
Operating expenses:            
Research and development $4,883,868  $2,646,125  $2,237,743   85%
General and administrative  2,124,601   1,753,008   371,593   21%
Total operating expenses $7,008,469  $4,399,133  $2,609,336   59%

Comparison of Nine Months Ended September 30, 2017 and 2016

Research and development expenses were $4,883,868 in the nine months ended September 30, 2017 compared to $2,646,125 in the prior year period, a $2,237,743 increase. The increase in research and development expenses was due primarily to a net increase of approximately $1,885,000 in expenses related to our IND-enabling activities associated with advancing our lead drug candidates into clinical studies, purchases of laboratory supplies and expenses related to our efforts to develop optimized MBT candidates along with a $320,000 increase in stock based compensation relating to the costs of new grants and the revaluation of options granted to consultants that are revalued at each balance sheet.

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General and administrativeexpenses were $2,124,601 in the nine months ended September 30, 2017 compared to $1,753,008 in the prior year period, a $371,593 increase. The increase in general and administrative expenses was primarily due to an increase of approximately $336,000 in stock-based compensation. This increase was due to option grants made in the current year period and recognition of an entire period of stock compensation costs in the current year as compared to a partial period of recognition in the prior year due to the timing of the grants. 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 September 30, 2017 we had a cash balance of $2,314,928 and short-term investments of $8,027,314. We maintain our cash in a checking and savings account on deposit with a banking institution in the United States. Our investments are maintained in a portfolio of short-term highly liquid securities investing in U.S. Treasury Bills and Certificate of Deposits.

Cash Flows from Operating Activities

 

Net cash used in operating activities for the ninesix months ended SeptemberJune 30, 20172019 and 20162018 was $5,557,871$5,676,314 and $3,603,364,$4,561,597, respectively. The cash used in operations for the ninesix months ended SeptemberJune 30, 20172019 was primarily due to our reported net loss of $6,999,756, partially offset by $1,180,835 in stock based compensation expense$5,978,626 and an increase of $472,046the decrease in accounts payable of $948,315 due to the timing of invoices receivedpayments made during the quarter.current year period, partially offset by $1,427,823 in stock-based compensation. The cash used in operations for the ninesix months ended SeptemberJune 30, 20162018 was primarily due to our reported net loss of $4,397,851,$6,902,698, partially offset by $524,118$1,787,178 in stock basedstock-based compensation expense and anthe $275,652 increase of $214,334 in accounts payable duerelated to the timing of invoices received during the quarter.for our clinical trials.

 

Cash Flows from Investing Activities

 

Net cash provided by investing activities was $3,436,579 in the six months ended June 30, 2019, and was due to the timing of redemptions of our investments in certificates of deposit and treasury bills. Net cash used in investing activities was $7,934,328 in the ninesix months ended SeptemberJune 30, 2017 was $2,628,959. The cash used in investing activities2018, and was due to the timing of the purchases of our investments in certificates of deposit and treasury bills as compared to the timing of the maturities of those investments. Net cash provided by investing activities in the nine months ended September 30, 2016 was $3,337,183 which was primarily due to net proceeds from redemptions of investments totaling $3,410,795, offset by $67,011 in purchases of property and equipment for our lab.bills.

 

Cash Flows from Financing Activities

 

Net cash provided by financing activities in the ninesix months ended SeptemberJune 30, 20172019 and 20162018 was $7,244,300$331,072 and $1,474,731,$24,130,414, respectively. Cash provided by financing activities of $7,244,300 in the ninesix months ended SeptemberJune 30, 20172019 was primarily due to $5,024,742 in net proceeds received in the private offering we completed during the three months ended September 30, 2017 and the exercise of warrants and employee stock options, which was offset by the repayment of a debt obligation to the Alzheimer’s Drug Discovery Foundation of $205,260.options. Cash provided by financing activities of $1,474,731 in the ninesix months ended SeptemberJune 30, 20162018 was primarily due to the exercisereceipt of Compensation Options resulting innet proceeds totaling $19,304,054 from our Controlled Equity Offering, $3,902,500 from the issuance of $741,046promissory notes and $981,148 from the exercise of commonwarrants and stock purchase warrants resulting in proceeds of $731,085.options.

 

Contractual Obligations

We are a party to (i) a lease agreement for a laboratory facility. The laboratory space is leased on a month-to-monthmonth-to month basis andthat is part of a shared facility in Menlo Park, California.California and (ii) a one-year lease agreement for office space in Fairfield, New Jersey, which expires in September 2019.

 

Rent expense was $57,428$85,190 and $41,343$70,356 for the three months ended SeptemberJune 30, 20172019 and 2016,2018, respectively. Rent expense was $169,237$170,379 and $116,378$140,712 for the ninesix months ended SeptemberJune 30, 20172019 and 2016,2018, respectively.

 

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Off-Balance Sheet Arrangements

 

We did not have any off-balance sheet financing arrangements at June 30, 2019.

 

Item 3.Quantitativeand Qualitative Disclosures About Market Risk

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.Controls and Procedures

Item 4. Evaluation of Disclosure Controls and Procedures

 

AsIn accordance with Rule 13a-15 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(the “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 reportQuarterly Report on Form 10-Q, our management evaluated, with the participation of our Chief Executive Officer and our Chief Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) under the Exchange Act). Based upon their evaluation of these disclosure controls and procedures, our management, including the Chief Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures were not effective due to a material weakness.as of the end of the period covered by this report.

 

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. 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 did not take steps to improve our internal controls over financial reporting during the quarter ended September 30, 2017.

Subsequent to September 30, 2017 we hired additional financial staff and plan to remediate the material weakness in the future by implementing procedures for segregation of duties among our financial staff to ensure that journal entries and account reconciliations are reviewed by someone other than the preparer. Notwithstanding the foregoing, there can be no assurance that we will be successful in remediating the identified material weakness. 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.

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 SeptemberJune 30, 20172019 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

Item 1. Legal Proceedings

 

We may from time to time be 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 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

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 onForm 10-K for the fiscal year ended December 31, 20162018 and filed with the SEC on March 31, 2017.18, 2019. There have been no material changes to these risks during the ninethree months ended SeptemberJune 30, 2017.2019.

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

 

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

Sales of Unregistered Securities

 

On July 14, 2017, the Company completed a private placement in which it issued and sold to accredited investors an aggregate of 3,438,053 units at a price of $1.50 per unit realizing net proceeds of approximately $5.02 million. Officers and directors of the Company purchased an aggregate of 289,334 units in the offering. 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 common share of the Company’s stock at an exercise price of $2.25.None.

 

On August 7, 2017, the Company issued warrants to two consultants as compensation for consulting services they will provide the Company over a five-year period. The warrants are exercisable any time prior to August 7, 2022 for the purchaseUse of an aggregate of up to 180,000 shares of common stock at an exercise price of $1.99 per share.Proceeds from Registered Securities

 

The private placements described above were completed pursuant to the exemptions from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506(b) promulgated thereunder.None.

Item 3.Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities

 

None.

Item 4.Mine Safety Disclosures

Item 4. Mine Safety Disclosures

 

None.

Item 5.Other Information

Item 5. Other Information

 

None.

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Item 6. Exhibits

The following exhibits are filed herewith and this list is intended to constitute the exhibit index.

 

Exhibit Number Description
4.110.1 Form of Warrant issued July 14, 2017 (incorporatedInterim Chief Executive Officer Agreement Extension, dated April 6, 2019, by and between Philippe Calais and CohBar, Inc. – Incorporated by reference fromto Exhibit 4.1 to the Company’s10.1 of our Current Report on Form 8-K filed with the Commission on July 18, 2017).April 11, 2019.
10.110.2 Form of Unit SubscriptionExecutive Employment Agreement, dated July 14, 2017 (incorporatedMay 6, 2019, by and between CohBar, Inc. and Steven B. Engle. – Incorporated by reference fromto Exhibit 10.1 to the Company’s Current10.2 of our Quarterly Report on Form 8-K10-Q filed with the Commission on July 18, 2017).May 8, 2019.
10.3Addendum to the Executive Employment Agreement, dated November 27, 2013, by and between CohBar, Inc. and Jeffrey F. Biunno.
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

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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:  November 14, 2017August 9, 2019By:/s/ Jeffrey F. Biunno
  Jeffrey F. Biunno
  Chief Financial Officer, Treasurer and Secretary
  (Principal Financial Officer)

 

 

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