UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2022

☐ 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 001-38326

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 Stock, par value $0.001 per share		CWBR		Nasdaq Capital Market

Indicate by check mark whether the registrant: (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. Yes ☑ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☑ 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 ☑

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑

As of November 4, 2022, the registrant had outstanding 2,906,926 shares of common stock.

COHBAR, INC.

FORM 10-Q

For the Quarterly Period Ended September 30, 2022

		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	12
Item 3	Quantitative and Qualitative Disclosures About Market Risk	18
Item 4	Evaluation of Disclosure Controls and Procedures	18

	PART II – OTHER INFORMATION

Item 1	Legal Proceedings	19
Item 1A	Risk Factors	19
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	40
Item 3	Defaults Upon Senior Securities	40
Item 4	Mine Safety Disclosures	40
Item 5	Other Information	40
Item 6	Exhibits	41

	SIGNATURES	42

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

CohBar, Inc.

Condensed Balance Sheets

	As of
	September 30, 2022			December 31, 2021
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	4,211,379		$	4,992,145
Investments		14,128,120			21,253,866
Vendor receivable		-			173,499
Prepaid expenses and other current assets		683,359			527,380
Total current assets		19,022,858			26,946,890
Property and equipment, net		174,773			260,612
Intangible assets, net		18,389			19,309
Other assets		76,596			69,620
Total assets	$	19,292,616		$	27,296,431

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	257,317		$	371,993
Accrued liabilities		92,487			196,020
Accrued payroll and other compensation		196,695			754,314
Note payable, net of debt discount and offering costs of $0 and $8,723 as of September 30, 2022 and December 31, 2021, respectively		-			366,277
Total liabilities		546,499			1,688,604

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, 2022 and December 31, 2021, respectively		-			-
Common stock, $0.001 par value, Authorized 12,000,000 shares; Issued and outstanding 2,906,926 shares as of September 30, 2022 and 2,877,985 as of December 31, 2021		2,907			2,878
Additional paid-in capital		111,855,921			110,339,011
Accumulated deficit		(93,112,711	)		(84,734,062	)
Total stockholders’ equity		18,746,117			25,607,827
Total liabilities and stockholders’ equity	$	19,292,616		$	27,296,431

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

CohBar, Inc.

Condensed Statements of Operations

(unaudited)

	For The Three Months Ended September 30,						For The Nine Months Ended September 30,
	2022			2021			2022			2021

Revenues	$	-		$	-		$	-		$	-

Operating expenses:
Research and development		1,037,111			1,634,063			3,730,319			6,906,510
General and administrative		1,433,699			1,777,000			4,735,402			5,720,043
Total operating expenses		2,470,810			3,411,063			8,465,721			12,626,553
Operating loss		(2,470,810	)		(3,411,063	)		(8,465,721	)		(12,626,553	)

Other income (expense):
Interest income		78,902			1,226			97,274			4,366
Interest expense		-			(7,562	)		(1,479	)		(32,547	)
Amortization of debt discount and offering costs		-			(4,359	)		(8,723	)		(28,733	)
Total other income (expense)		78,902			(10,695	)		87,072			(56,914	)
Net loss	$	(2,391,908	)	$	(3,421,758	)	$	(8,378,649	)	$	(12,683,467	)
Basic and diluted net loss per share	$	(0.82	)	$	(1.61	)	$	(2.90	)	$	(6.09	)
Weighted average common shares outstanding - basic and diluted		2,903,403			2,129,686			2,890,723			2,081,318

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

CohBar, Inc.

Statements of Changes in Stockholders’ Equity

(unaudited)

	Three and Nine Month Periods Ended September 30, 2022
						Additional						Total
	Common Stock					Paid-in-			Accumulated			Stockholders’
	Number			Amount		Capital			Deficit			Equity
Balance, December 31, 2021		2,877,986		$	2,878	$	110,339,011		$	(84,734,062	)	$	25,607,827
Stock-based compensation		-			-		456,423			-			456,423
Sale of common stock in ATM, net		21,404			21		200,603			-			200,624
Net loss		-			-		-			(3,261,773	)		(3,261,773	)
Balance, March 31, 2022		2,899,390		$	2,899	$	110,996,037		$	(87,995,835	)	$	23,003,101
Stock-based compensation		-			-		434,956			-			434,956
Net loss		-			-		-			(2,724,968	)		(2,724,968	)
Balance, June 30, 2022		2,899,390		$	2,899	$	111,430,993		$	(90,720,803	)	$	20,713,089
Stock-based compensation		-			-		390,062			-			390,062
Issuance of common stock for ESPP plan		5,604			6		25,019			-			25,025
Sale of common stock in ATM, net		1,948			2		9,915			-			9,917
Payout for fractional shares retired as a result of reverse stock split 1:30		(16	)		-		(68	)		-			(68	)
Net loss		-			-		-			(2,391,908	)		(2,391,908	)
Balance, September 30, 2022		2,906,926		$	2,907	$	111,855,921		$	(93,112,711	)	$	18,746,117

	Three and Nine Month Periods Ended September 30, 2021
					Additional					Total
	Common Stock				Paid-in-		Accumulated			Stockholders’
	Number		Amount		Capital		Deficit			Equity
Balance, December 31, 2020		2,037,251	$	2,038	$	87,743,403	$	(69,258,286	)	$	18,487,155
Stock-based compensation		-		-		320,444		-			320,444
Exercise of employee stock options		20,797		21		958,826		-			958,847
Exercise of warrants		1,563		2		67,534		-			67,536
Net loss		-		-		-		(4,038,344	)		(4,038,344	)
Balance, March 31, 2021		2,059,611	$	2,061	$	89,090,207	$	(73,296,630	)	$	15,795,638
Stock-based compensation		-		-		957,558		-			957,558
Sale of common stock, net		16,037		16		621,806		-			621,822
Net loss		-		-		-		(5,223,365	)		(5,223,365	)
Balance, June 30, 2021		2,075,648	$	2,077	$	90,669,571	$	(78,519,995	)	$	12,151,653
Stock-based compensation		-		-		681,835		-			681,835
Issuance of common stock for ESPP plan		589		1		16,813		-			16,814
Exercise of employee stock options		5,333		5		157,295		-			157,300
Exercise of warrants		46,804		47		2,021,893		-			2,021,940
Sale of common stock, net		39,226		39		2,262,925		-			2,262,964
Net loss		-		-		-		(3,421,758	)		(3,421,758	)
Balance, September 30, 2021		2,167,600	$	2,169	$	95,810,332	$	(81,941,753	)	$	13,870,748

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

CohBar, Inc.

Condensed Statements of Cash Flows

(unaudited)

	For The Nine Months Ended September 30,
	2022			2021
Cash flows from operating activities:
Net loss	$	(8,378,649	)	$	(12,683,467	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		86,759			107,735
Stock-based compensation		1,281,441			1,959,837
Amortization of debt discount		8,350			27,513
Amortization of debt issuance costs		373			1,220
Discount on investments		40,746			(2,501	)
Changes in operating assets and liabilities:
Vendor receivable		173,499			-
Prepaid expenses and other current assets		(155,979	)		(396,615	)
Accounts payable		(114,676	)		579,329
Accrued liabilities		(103,533	)		(986,129	)
Accrued payroll and other compensation		(557,619	)		(340,345	)
Net cash used in operating activities		(7,719,288	)		(11,733,423	)

Cash flows from investing activities:
Purchases of property and equipment		-			(6,398	)
Patent costs		-			(2,359	)
Payment for security deposit		(6,976	)		(2,217	)
Purchases of investments		(46,810,000	)		(22,345,994	)
Proceeds from redemptions of investments		53,895,000			34,634,000
Net cash provided by investing activities		7,078,024			12,277,032

Cash flows from financing activities:
Proceeds from ESPP plan		25,025			16,814
Proceeds from the At-the-Market Offering, net		210,541			2,884,786
Proceeds from exercise of warrants		-			2,089,476
Repayment of promissory notes		(375,000	)		(365,000	)
Proceeds from exercise of employee stock options		-			1,116,147
Reverse Stock Split Fractional Share Payout		(68	)		-
Net cash (used in) provided by financing activities		(139,502	)		5,742,223

Net decrease in cash and cash equivalents		(780,766	)		6,285,832
Cash and cash equivalents at beginning of period		4,992,145			2,894,575
Cash and cash equivalents at end of period	$	4,211,379		$	9,180,407

Supplemental disclosure of cash flow information:
Cash paid for income taxes	$	-		$	1,332
Cash paid for interest	$	114,411		$	89,908

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 Nature of Operations

CohBar, Inc. (“CohBar,” “its” or the “Company”) is a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases with limited to no treatment options.

The Company’s primary activities include utilizing its MITO+ platform to identify and develop novel peptide analogs, the research and development of its pipeline, securing intellectual property protection for its discoveries and assets, managing collaborations and clinical trials with contract research organizations (“CROs”) and raising capital to fund the Company’s operations. 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, private placements, the exercise of outstanding warrants and stock options and the issuance of debt instruments.

The Company is monitoring the COVID-19 pandemic, which continues to rapidly evolve, and has taken steps to mitigate the potential impacts on its business. The extent to which the pandemic may impact the Company’s business, preclinical studies and its clinical trial will depend on future developments, which are highly uncertain and cannot be predicted with confidence. The Company has modified its business practices by restricting nonessential travel, implementing a partial work from home policy for its employees and instituting safety protocols for its lab to enable essential on-site work to continue. The Company expects to continue to take actions that are in the best interests of its employees and business partners. Due to the uncertainty surrounding the pandemic, the Company’s visibility into the duration of these actions is limited.

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, 2021, included in the Company’s Annual Report on Form 10-K (the “2021 Form 10-K”), filed with the SEC on March 29, 2022. The interim unaudited condensed financial statements should be read in conjunction with those audited financial statements included in the 2021 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 nine month periods ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, or any other period.

Note 2 – Liquidity and Management’s Plans

Pursuant to the requirements of Accounting Standard Codification (“ASC”) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.

As of September 30, 2022, the Company had working capital and stockholders’ equity of $18.5 million and $18.7 million, respectively. During the nine months ended September 30, 2022, the Company incurred a net loss of $8.4 million and utilized cash of $7.7 million in its operating activities. Based on the cash and investments on hand as of September 30, 2022 of approximately $18.3 million, current budget assumptions and projected cash burn, 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 but it anticipates it will be dependent on additional investment capital to fund its operating expenses in subsequent quarters.

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 2 – Liquidity and Management’s Plans (continued)

Future capital requirements will depend on many factors, including the timing of spending on research and development, potential success of the Company’s research and development efforts, the sentiment of the capital markets at the time capital is required or pursued, amongst other things.

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/or other operations until such time as additional capital becomes available. Such limitation of the Company’s activities would allow it 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 would be successful. There is no assurance that, in the event the Company requires additional financing, such financing will be available at terms acceptable to the Company, if at all.

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.

Reverse Stock Split

On September 23, 2022, the Company effected a reverse stock split of its Common Stock at a ratio of 1-for-30. No fractional shares were issued in connection with the reverse stock split. Stockholders of record who would have otherwise been entitled to receive a fractional share received a cash payment in lieu thereof. All information presented in the accompanying unaudited condensed consolidated financial statements, unless otherwise indicated herein, reflects a 1-for-30 reverse stock split of the Company’s outstanding shares of Common Stock, and unless otherwise indicated, all such amounts and corresponding conversion price or exercise price data set forth herein have been adjusted to give effect to such reverse stock split.

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.

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 3 - Summary of Significant Accounting Policies (continued)

Investments

Investments as of September 30, 2022 and December 31, 2021 consist of U.S. Treasury Bills, which are classified as held-to-maturity, totaling $14.1 million and $21.3 million, respectively. 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 subsequent twelve months from the date of purchase. Unrealized gains and losses were de minimus. As of September 30, 2022 and December 31, 2021, the carrying value of the Company’s U.S. Treasury Bills approximates their fair value due to their short-term maturities.

Common Stock Purchase Warrants

The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) provide the Company with a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement) provided that such contracts are indexed to the Company’s own stock. The Company 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 shares (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 a private offering. The Company evaluated these warrants 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 balance sheets as of September 30, 2022 and December 31, 2021.

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. The Company accounts for performance-based share payments by measuring the fair value of the grant when the performance criteria are deemed probable and recognizing the associated expense at that time. The Company has granted stock options at exercise prices equal to the closing price of the Company’s common stock as reported by The Nasdaq Capital Market, with input from management on the date of grant. Upon exercise of 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 or measurement date using the Black-Scholes pricing model. The fair value of each instrument is estimated on the grant date or measurement date utilizing certain assumptions for a risk-free interest rate, volatility and expected remaining lives of the awards. The risk-free interest rate used is the United States Treasury rate for the day of the grant having a term equal to the life of the equity instrument. The volatility percentage used was derived from the Company’s share price equal to the expected term of the option grant. 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.

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 3 - Summary of Significant Accounting Policies (continued)

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

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2022			2021			2022			2021
Expected life	6.25 years			6.25 years			6.25 years			6.25 years
Risk free interest rate		3.06	%		0.91	%		2.03	%		1.05	%
Expected volatility		92	%		91	%		92	%		91	%
Expected dividend yield		0	%		0	%		0	%		0	%
Forfeiture rate		0	%		0	%		0	%		0	%

As of September 30, 2022, total unrecognized stock option compensation expense was $4.6 million, 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 September 30,
	2022		2021
Options		332,551		372,154
Warrants		1,178,169		493,358
Totals		1,510,720		865,512

Recent Accounting Pronouncements

There were no recently issued accounting standards not yet adopted which would have a material effect on the Company’s consolidated financial statements or related disclosures.

Note 4 - Commitments and Contingencies

Litigation, Claims and Assessments

The Company may from time to time be 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 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.

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 4 - Commitments and Contingencies (continued)

Operating Leases

The Company is a party to (i) a lease agreement for laboratory space leased on a month-to month basis that is part of a shared facility in Menlo Park, California and (ii) a one-year lease agreement for office space in Fairfield, New Jersey, which expires in September 2023.

Rent expense was $0.1 million for each of the three-month periods ended September 30, 2022 and 2021. Rent expense was $0.3 million for each of the nine-month periods ended September 30, 2022 and 2021.

Note 5 - Stockholders’ Equity

Authorized Capital

The Company has authorized the issuance and sale of up to 17.0 million shares of stock, consisting of 12.0 million shares of common stock having a par value of $0.001 and 5.0 million shares of Preferred Stock having a par value of $0.001 per share. As of September 30, 2022 and December 31, 2021, there were no shares of Preferred Stock outstanding and there were no declared but unpaid dividends or undeclared dividend arrearages on any shares of the Company’s capital stock.

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. As of September 30, 2022, there were 0.1 million shares remaining available for issuance under the 2011 Plan.

During the nine months ended September 30, 2022, stock options to purchase 19.4 thousand shares of common stock were granted at a weighted average exercise price of $10.42 per share. The stock options have a term of ten years and are subject to vesting based on continuous service of the awardee over a period of four years. The stock options have an aggregate grant date fair value of $0.2 million.

During the nine months ended September 30, 2022, stock options to purchase 53.2 thousand shares of common stock with a weighted average exercise price of $56.39 expired, were cancelled and returned to the option pool for future issuance.

The Company recorded stock-based compensation as follows:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2022		2021		2022		2021
Research and development	$	17,639	$	23,362	$	64,048	$	200,092
General and administrative		372,423		658,473		1,217,393		1,759,745
Total	$	390,062	$	681,835	$	1,281,441	$	1,959,837

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 5 - Stockholders’ Equity (continued)

The following table represents stock option activity for the nine months ended September 30, 2022:

						Weighted Average
	Stock Options					Exercise Price				Fair Value		Contractual		Aggregate
	Outstanding			Exercisable		Outstanding		Exercisable		Vested		Life (Years)		Intrinsic Value
Balance – December 31, 2021		366,411			204,230	$	51.30	$	47.40	$	47.40		6.27	$	-
Granted		19,367			278		10.42		10.42		4.53		6.27		-
Exercised		-			-		-		-		-		-		-
Cancelled		(53,227	)		-		-		-		-		-		-
Balance – September 30, 2022		332,551			197,585	$	49.08	$	43.12	$	43.12		6.27	$	-

The following table summarizes information on stock options outstanding and exercisable as of September 30, 2022:

Grant Price				Weighted Average		Total		Number		Weighted Average Remaining Contractual
From		To		Exercise Price		Outstanding		Exercisable		Term
$	6.00	$	60.60	$	34.41		270,963		138,680	7.46 years
$	63.00	$	138.00	$	82.13		46,821		44,138	5.46 years
$	159.00	$	265.80	$	193.28		14,767		14,767	5.60 years
					Totals		332,551		197,585

Warrants

During the nine months ended September 30, 2022, 9.6 thousand warrants to purchase 9.6 thousand shares of common stock at a weighted average exercise price of $114.33 expired and were cancelled.

The following table summarizes information on warrants outstanding and exercisable as of September 30, 2022:

						Weighted Average
	Warrants					Exercise Price				Fair Value		Contractual		Aggregate
	Outstanding			Exercisable		Outstanding		Exercisable		Vested		Life (Years)		Intrinsic Value
Balance – December 31, 2021		1,187,803			1,187,664	$	31.35	$	31.35	$	15.90		4.38	$	-
Granted		-			-		-		-		-		-		-
Exercised		-			-		-		-		-		-		-
Cancelled		(9,634	)		-		-		-		-		-		-
Balance – September 30, 2022		1,178,169			1,178,169	$	30.67	$	30.67	$	17.83		3.66	$	-

Note 6 - Employee Stock Purchase Plan

The Company has an Employee Stock Purchase Plan (“ESPP”) in which it purchases shares with the amounts accumulated during the offering period from employee directed payroll deferrals. Purchases of the Company’s common stock are equal to 85% of the closing market price of its common stock on the first day or last day of the offering period, whichever is lower. During the nine months ended September 30, 2022, 5.6 thousand shares were issued under the ESPP for $25.0 thousand of employee compensation deferrals. As of September 30, 2022, 10.5 thousand shares are available for future issuance under the ESPP.

Note 7 – At-the-Market Offering

In May 2020, the Company entered into an At-the-Market Offering Sales Agreement (the “ATM”) with Virtu Americas, LLC as sales agent. During the nine months ended September 30, 2022, the Company sold 23.4 thousand shares of its common stock under the ATM program for proceeds of $0.2 million, net of commissions. As of September 30, 2022, a balance of approximately $5.0 million remains in the Company’s ATM program.

COHBAR, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 8 – Non-Cash Expenses

The following table details the Company’s non-cash expenses included in the accompanying condensed statements of operations:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2022		2021		2022		2021
Operating expenses:
Stock-based compensation	$	390,062	$	681,835	$	1,281,441	$	1,959,837
Depreciation & amortization		21,716		34,594		86,759		107,735
Subtotal	$	411,778	$	716,429	$	1,368,200	$	2,067,572

Other expense:
Amortization of debt discount		-		4,174		8,350		27,512
Subtotal	$	-	$	4,174	$	8,350	$	27,512

Total non-cash expenses	$	411,778	$	720,603	$	1,376,550	$	2,095,084

Note 9 – Promissory Notes

During the nine months ended September 30, 2022, the Company repaid a promissory note, held by a director of the Company, totaling $0.5 million in principal and interest.

During the nine months ended September 30, 2021, the Company paid $0.1 million in principal and interest for two promissory notes that matured.

Note 10 – 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.

Subsequent to September 30, 2022, the Company negotiated a buyout of a previously issued purchase order. The buyout, in the amount of approximately $1.2 million, related to materials and manufacturing services that were expected to be delivered in the quarter ending December 31, 2022. A portion of the buyout relates to raw materials that could be used at a later date, the timing of which is not determinable at this time. The Company will recognize the $1.2 million charge on the aforementioned buyout during the quarter ending December 31, 2022.

Subsequent to September 30, 2022, the Company sold unused equipment for net proceeds of approximately $0.1 million.

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, 2021 (the “2021 Form 10-K”). All references to the third quarter mean the three-month period ended September 30, 2022, and all references to the first nine months of 2022 and 2021 mean the nine-month periods ended September 30, 2022 and 2021, 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 about our business, our potential 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, those discussed in this report under the section entitled “Risk Factors” in Item 1A of Part I of the 2021 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 a clinical stage biotechnology company leveraging the power of the mitochondria and the peptides encoded in its genome to develop potential breakthrough therapeutics targeting chronic and age-related diseases with limited to no treatment options. Our novel approach is built on the key insights of our founders that certain mitochondrially encoded peptides produce effects that are not limited to local regulation within the mitochondria and may have important roles to play in critical systemic biological pathways. Many of these effects are quite distinct from traditional mitochondrial function such as energy production and metabolism, involving diverse processes including inflammation, fibrosis and cell signaling.

We believe we have achieved a leading position in exploring the mitochondrial genome and its utility for the development of novel therapeutics, including world-renowned expertise in mitochondrial biology, a broad intellectual property estate with more than 65 patent applications filed, key opinion leaders and disciplined drug discovery and development processes. Our proprietary processes of identifying nucleic acid sequences encoding native peptides in the mitochondrial genome, developing and optimizing novel analogs of these natural mitochondrial derived peptides (“MDPs”), as well as developing and conducting proprietary screens to identify and characterize the activities of these peptides are referred to as our Mito+ platform. We are using our Mito+ platform to identify and develop novel modified versions of natural peptides, which we call analogs, to treat a variety of serious conditions, with a focus on chronic diseases involving inflammation and fibrosis. We believe that the mitochondrial genome may be transformative in the field of drug discovery and that our novel peptide analogs may become a new and major class of drugs with broad therapeutic application. We are currently advancing a pipeline of novel peptide analogs through varying stages of development: CB5138-3 for idiopathic pulmonary fibrosis (“IPF”), CB4211 for the treatment of nonalcoholic steatohepatitis (“NASH”) and obesity, and several preclinical and discovery-stage programs.

Our Programs

●

CB5138-3: In 2021, we nominated our second clinical candidate, CB5138-3, a first-in-class therapeutic under development for the treatment of idiopathic pulmonary fibrosis and other fibrotic diseases. Our CB5138-3 product candidate has shown positive preclinical results, with significant anti-fibrotic and anti-inflammatory properties in models of IPF. In addition, we believe CB5138-3 has the potential to provide a better safety profile than currently approved IPF drugs, which are poorly tolerated with significant gastrointestinal and/or skin toxicity. This program is currently in IND-enabling studies. We have been working to improve the formulation to address injection site reactions seen in earlier toxicology studies. We plan to file an Investigational New Drug (“IND”) Application in the second half of 2023, dependent on identifying a suitable formulation. We expect to begin a first-in-human study shortly thereafter, subject to availability of additional resources.

●

CB4211: Our most advanced clinical candidate, CB4211, is a first-in-class therapeutic under development for the treatment of NASH and obesity. In August 2021, we released positive topline data from our Phase 1a/1b clinical study of CB4211. The Phase 1b stage of this study was designed to assess the safety, tolerability, and activity of CB4211 in obese subjects with nonalcoholic fatty liver disease. The study met its primary endpoint as CB4211 was well-tolerated and appeared safe with no serious adverse events. The evaluation of the exploratory endpoints in the Phase 1b portion of the trial showed significant reductions from baseline in key biomarkers of liver damage, ALT and AST, and in glucose levels in the CB4211 group compared to placebo after four weeks of treatment, with a trend towards lower body weight. We believe the positive clinical data from our CB4211 trial is an important validation of our overall approach to drug discovery, serving as a proof point that novel analogs of peptides encoded in the mitochondrial genome can impact systemic biological pathways in humans while having an attractive safety and tolerability profile. We intend to partner this program before moving forward with further development.

●

CB5064 Analogs: Our discovery efforts have identified CB5064 Analogs, a family of peptides that are agonists of the apelin receptor. By utilizing the protective apelin signaling pathway, our CB5064 Analogs have the potential to address a variety of unmet medical needs such as our initial target of Acute Respiratory Distress Syndrome (“ARDS”). We believe our CB5064 Analogs could be effective in ARDS from a variety of different causes, such as bacterial or viral pneumonia, including COVID-19 associated ARDS. In a preclinical mouse model of ARDS, treatment with CB5064 Analogs reduced fluid accumulation in the lungs and a corresponding broad reduction in levels of key pro-inflammatory cytokines secreted into the lung fluid, when compared to treatment with a placebo control.

●

Discovery Efforts: Our discovery efforts have resulted in the identification of multiple unique and previously unidentified peptides encoded within the mitochondrial genome. Many of these natural sequences and their novel analogs have demonstrated various degrees of biological activity in cell based and/or animal models relevant to a wide range of diseases. Our research efforts have identified and focused on certain of these novel analogs that have demonstrated greatest therapeutic potential. We plan to further explore these peptide families for the potential treatment of a variety of diseases, subject to resource availability and the requirements of our more-advanced programs.

Business Overview

We have financed our operations primarily with proceeds from sales of our equity securities, including our initial public offering, private placements of our securities, public sales of our securities and the exercise of outstanding warrants and stock options, as well as through a debt offering. Since our inception through September 30, 2022, our operations have been funded with an aggregate of approximately $97.3 million from the sale and issuance of equity instruments and debt.

Since inception, we have incurred significant operating losses. Our net losses were $8.4 million and $12.7 million for the nine months ended September 30, 2022 and 2021, respectively. We incurred $1.4 million and $2.1 million in non-cash expenses during the nine months ended September 30, 2022 and 2021, respectively. Our net losses excluding non-cash expenses were $7.0 million and approximately $10.6 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, we had an accumulated deficit of $93.1 million. Although we anticipate incurring expenses consistent with prior periods, our net losses may fluctuate significantly from quarter to quarter and from year to year and are subject to the ongoing COVID-19 pandemic, the timing of our preclinical activities, clinical trial expenses and other factors.

Reverse Stock Split

On September 23, 2022, we executed a reverse stock split of our Common Stock at a ratio of 1-for-30. No fractional shares were issued in connection with the reverse stock split. Stockholders of record who would have otherwise been entitled to receive a fractional share received a cash payment in lieu thereof. In response to their non-compliance notification on May 10, 2022, and as a result of the reverse stock split, we received notification from The Nasdaq Stock Market Listing Qualifications Staff on October 7, 2022, that we are now in compliance with its minimum bid price requirement and the matter has been closed.

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

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 (“CROs”) that conduct research and development and preclinical activities on our behalf and the cost of consultants;

●

the cost of laboratory equipment, supplies and manufacturing MDP and proprietary analog test materials; and

●

depreciation and other personnel-related costs associated with research and product development.

We record all research and development expenses as incurred.

Our Research Programs

Our research and development programs include activities in support of our continuing evaluation of CB5138-3 in IPF and CB4211 in NASH and obesity, as well as the operation of our platform technology related to the discovery and development of additional novel analogs, evaluation of newly discovered natural sequences, design of novel improved analogs, evaluation of their therapeutic potential and optimization of their characteristics as potential drug development candidates. Depending on factors of capability, cost, efficiency and intellectual property rights, we conduct our research programs at our laboratory facility, or externally, 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:

●

developing appropriate manufacturing processes and formulations;

●

establishing an appropriate safety profile with toxicology studies;

●

obtaining appropriate regulatory approval for conducting clinical trials;

●

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;

●

receiving desirable payor reimbursement and formulary access for potential drugs that are approved and commercially launched; 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 potential drug 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 we incur costs related to our IND-enabling studies and potential initial clinical costs for that program, which are dependent on identifying a suitable formulation for our CB5138-3 program, in addition to general program costs and the discovery, evaluation and optimization of novel analogs as potential drug candidates. 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 may 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. We anticipate that our general and administrative expenses will remain relatively constant in the year ending December 31, 2022.

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 September 30,				Change
	2022		2021		$			%
Operating expenses:
Research and development	$	1,037,111	$	1,634,063	$	(596,952	)		-37	%
General and administrative		1,433,699		1,777,000		(343,301	)		-19	%
Total operating expenses	$	2,470,810	$	3,411,063	$	(940,253	)		-28	%

Comparison of Three Months Ended September 30, 2022 and 2021

Research and development expenses were $1.0 million in the three months ended September 30, 2022 compared to $1.6 million in the prior year period, a decrease of $0.6 million, or 37%. The decrease in research and development expenses was primarily due to a decrease of $0.6 million associated with the timing of our research programs focused on continuing the development of our peptides.

General and administrative expenses were $1.4 million in the three months ended September 30, 2022 compared to $1.8 million in the prior year period, a decrease of $0.4 million, or 19%. The decrease in general and administrative expenses was primarily due to a $0.3 million decrease in stock-based compensation costs.

	For The Nine Months Ended September 30,				Change
	2022		2021		$			%
Operating expenses:
Research and development	$	3,730,319	$	6,906,510	$	(3,176,191	)		-46	%
General and administrative		4,735,402		5,720,043		(984,641	)		-17	%
Total operating expenses	$	8,465,721	$	12,626,553	$	(4,160,832	)		-33	%

Comparison of Nine Months Ended September 30, 2022 and 2021

Research and development expenses were $3.7 million in the nine months ended September 30, 2022 compared to $6.9 million in the prior year period, a decrease of $3.2 million, or 46%. The decrease in research and development expenses was primarily due to a decrease of $2.2 million associated with the timing of our research programs focused on continuing the development of our peptides and a $1.1 million decrease in clinical trial costs due to the timing of those expenses. Though we expect research and development expenses to increase in the coming quarters as we incur the costs of the IND-enabling studies and potential clinical trial costs for CB5138-3, and continue evaluating and optimizing other potential drug candidates, the extent of that increase is unknown at this time and subject to change based on successful outcomes of our studies and our ongoing formulation development for CB5138-3, the amount of capital available to us and the uncertainties related to the COVID-19 pandemic.

General and administrative expenses were $4.7 million in the nine months ended September 30, 2022 compared to $5.7 million in the prior year period, a decrease of $1.0 million, or 17%. The decrease in general and administrative expenses was primarily due to $1.0 million decrease in compensation costs and stock-based compensation costs primarily due to the departure of our former CEO in the prior year period. We anticipate that our general and administrative expenses will remain relatively constant in the year ending December 31, 2022.

Liquidity and Capital Resources

As of September 30, 2022, we had cash, cash equivalents and investments totaling $18.3 million. We maintain our cash in a checking and savings account on deposit with a banking institution in the United States. During the nine months ended September 30, 2022, the Company incurred a net loss of $8.3 million and utilized cash of $7.7 million in its operating activities

On May 27, 2020, we entered into an At-the-Market Offering Sales Agreement (the “ATM”) with Virtu Americas, LLC, as sales agent. In connection with the ATM, we filed a prospectus supplement on March 29, 2022, pursuant to which we may currently sell shares of common stock with an aggregate offering price of up to $5.0 million.

During the nine months ended September 30, 2022, we sold approximately 23.4 thousand shares of our common stock under our ATM program for proceeds of $0.2 million, net of commissions.

Pursuant to the requirements of Accounting Standard Codification (“ASC”) 205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

Based on the cash and investments on hand as of September 30, 2022 of approximately $18.3 million, current budget assumptions and projected cash burn, 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 but we anticipate we will be dependent on additional investment capital to fund our operating expenses in subsequent quarters.

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/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. There can be no assurance that such a plan would be successful. There is no assurance that, in the event we require additional financing, such financing will be available at terms acceptable to us, if at all.

Cash Flows from Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2022 and 2021 was $7.7 million and $11.7 million, respectively. The cash used in operations for the nine months ended September 30, 2022 was primarily due to our reported net loss of $8.4 million and a decrease in accrued payroll and other compensation of $0.6 million, partially offset by stock-based compensation of $1.3 million. The cash used in operations for the nine months ended September 30, 2021 was primarily due to our reported net loss of $12.7 million, partially offset by stock-based compensation and a decrease in accrued liabilities due to the timing of those payments.

Cash Flows from Investing Activities

Net cash provided by investing activities was $7.1 million in the nine months ended September 30, 2022 and was primarily due net redemptions of investments during the period. Net cash provided by investing activities was $12.3 million in the nine months ended September 30, 2021 and was primarily due to net redemptions of investments during the period.

Cash Flows from Financing Activities

Net cash used in and provided by financing activities in the nine months ended September 30, 2022 and 2021 was $0.1 million and $5.7 million, respectively. Cash used in financing activities in the nine months ended September 30, 2022 was due to the repayment of promissory notes partially offset by the proceeds received from sales under our ATM program and proceeds received from our Employee Stock Purchase Plan. Cash provided by financing activities in the nine months ended September 30, 2021 was due to proceeds received from the sale of common stock under our ATM program and the exercise of stock options and warrants partially offset by the repayment of promissory notes.

Contractual Obligations

We are a party to (i) a lease agreement for laboratory space leased on a month-to month basis that is part of a shared facility in Menlo Park, California and (ii) a one-year lease agreement for office space in Fairfield, New Jersey, which expires in September 2023.

Critical Accounting Estimates

Management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies disclosed are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

During the nine months ended September 30, 2022, there were no material changes to our critical accounting estimates or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2021.

Recent Accounting Pronouncements

See Note 3 to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for more information.

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

In accordance with Rule 13a-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end of the period covered by this Quarterly 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 effective as of the end of the period covered by this report.

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 September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

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

Summary of Risk Factors

An investment in our common stock involves various risks, and prospective investors are urged to carefully consider the matters discussed in the section titled “Risk Factors” prior to making an investment in our common stock. These risks include, but are not limited to, the following:

●

we are an early-stage biotechnology company and may never be able to successfully develop marketable products or generate any revenue. We have a limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations;

●

we have had a history of losses and no revenue;

●

the outbreak of SARS-CoV-2, which causes COVID-19, and the ongoing COVID-19 pandemic, could adversely impact our business, including our clinical trials and preclinical studies;

●

if we fail to demonstrate efficacy or safety in our research and clinical trials, our future business prospects, financial condition and operating results will be materially adversely affected;

●

if any future clinical trials are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of any approved products;

●

if we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline;

●

our future success depends on key members of our scientific team and our ability to attract, retain and motivate qualified personnel;

●

we may seek to establish development and commercialization collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans;

●

we may not be successful in our efforts to identify or discover potential drug development candidates;

●

we may not be successful in our efforts to develop commercially viable formulations for our product candidates;

●

our research and development plans will require substantial additional future funding which could impact our operational and financial condition. Without the required additional funds, we will likely cease operations;

●

even if we are able to develop our potential drugs, we may not be able to obtain regulatory approval, or if approved, we may not be able to generate significant revenues or successfully commercialize our products, which will adversely affect our financial results and financial condition, and we will have to delay or terminate some or all of our research and development plans, which may force us to cease operations;

●

if we do not maintain the support of qualified scientific collaborators, our revenue, growth and profitability will likely be limited, which would have a material adverse effect on our business;

●

we expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing. These third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or preclinical testing;

●

we contract with third parties for the manufacture of our peptide materials for research and preclinical testing and expect to continue to do so for any future product candidate advanced to clinical trials and commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our research peptide materials, product candidates or medicines, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our research, development or commercialization efforts;

●

we may not be able to develop drug candidates, market or generate sales of our products to the extent anticipated. Our business may fail, and investors could lose all of their investment in our Company;

●

interim and preliminary or topline data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data;

●

we expect to expand our drug development and regulatory capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations; and

●

the use of any of our products in clinical trials may expose us to liability claims, which may cost us significant amounts of money to defend against or pay out, causing our business to suffer.

We operate in an environment that involves a number of risks and uncertainties. The risks and uncertainties described in this Quarterly Report on Form 10-Q are not the only risks and uncertainties that we face. Additional risks and uncertainties that presently are not considered material or are not known to us, and therefore are not mentioned herein, may impair our business operations. If any of the risks described in this Quarterly Report on Form 10-Q actually occur, our business, operating results and financial position could be adversely affected.

Risks Related to Our Financial Position and Need for Additional Capital

We have had a history of losses and no revenue.

We have generated substantial accumulated losses since our inception. We have not generated any revenues from our operations to date and do not expect to generate any revenue in the near future. As a result, our management expects the business to continue to experience negative cash flow for the foreseeable future. We can offer no assurance that we will ever operate profitably or that we will generate positive cash flow in the future.

Until we can generate significant revenues, if ever, we expect to satisfy our future cash needs through equity or debt financing. We will need to raise additional funds, and such funds may not be available on commercially acceptable terms, if at all. If we are unable to raise funds on acceptable terms, we may not be able to execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated requirements. This may seriously harm our business, financial condition and results of operations. In the event we are not able to continue operations, investors will likely suffer a complete loss of their investments in our securities.

We are an early-stage biotechnology company and may never be able to successfully develop marketable products or generate any revenue. We have a limited relevant operating history upon which an evaluation of our performance and prospects can be made. There is no assurance that our future operations will result in profits. If we cannot generate sufficient revenues, we may suspend or cease operations.

We are an early-stage company. Our operations to date have been limited to organizing and staffing our Company, business planning, raising capital, identifying MDPs for further research, developing our intellectual property portfolio, performing research on identified MDPs and our novel analogs and progressing our most advanced drug candidate into and through clinical studies. We have not generated any revenues to date. All of our novel peptide analogs are in the concept, research or early clinical stages. Moreover, we cannot be certain that our research and development efforts will be successful or, if successful, that our novel peptide analogs will ever be approved by the FDA. Typically, it takes 10 to 12 years to develop one new medicine from the time it is discovered to when it is available for treating patients, and longer timeframes are not uncommon. Even if approved, our products may not generate commercial revenues. We have no relevant operating history upon which an evaluation of our performance and prospects can be made. We are subject to all of the business risks associated with a new enterprise, including, but not limited to, risks of unforeseen capital requirements, failure of potential drug candidates either in research, preclinical testing or in clinical trials, and failure to establish business relationships and competitive advantages against other companies. If we fail to become profitable, we may be forced to suspend or cease operations.

The outbreak of SARS-CoV-2, which causes COVID-19, and the ongoing COVID-19 pandemic, could adversely impact our business, including our clinical trials and preclinical studies.

Public health crises such as pandemics or similar outbreaks could adversely impact our business. In response to the global COVID-19 pandemic, we have modified our business practices by restricting nonessential travel, implementing a partial work from home policy for our employees and instituting safety protocols for our lab to enable essential on-site work to continue. We continue to monitor the impact of COVID-19 on ongoing activities at our external research and development partner sites.

Timely enrollment in our clinical trials is dependent upon global clinical trial sites, which may be adversely affected by global health matters, such as pandemics. These and any additional delays in our clinical trials could increase our development costs, delay or prevent the availability of topline data expected to be available from the trial, delay our product development and regulatory submission process, result in the termination of the trial or make it difficult to raise additional capital.

As a result of the COVID-19 outbreak, or similar pandemics, we may experience disruptions that could severely impact our business, clinical trials and preclinical studies, including:

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delays or difficulties in recruiting, enrolling and retaining patients in our clinical trials;

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delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

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disruptions in the supply chain and the manufacture or shipment of both drug substance and finished drug product for our product candidates for preclinical testing and clinical trials;

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delays in the ability to initiate certain preclinical studies in a timely fashion due to shortages in the availability of suitable animals for such studies;

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delays or disruptions in non-clinical experiments and investigational new drug application-enabling good laboratory practice standard toxicology studies due to unforeseen circumstances in the supply chain;

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increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine or not accepting home health visits;

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diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

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interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (particularly any procedures that may be deemed non-essential), which may impact the integrity of subject data and clinical study endpoints;

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interruption or delays in the operations of the FDA and comparable foreign regulatory agencies, which may impact approval timelines;

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limitations on employee resources that would otherwise be focused on the conduct of our preclinical studies and clinical trials, including because of sickness of employees or their families, the desire of employees to avoid contact with large groups of people, an increased reliance on working from home or mass transit disruptions;

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interruption of, or delays in receiving, supplies of our product candidates from our contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems; and

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reduced ability to engage with the medical, investor and partnering communities due to the cancellation of conferences scheduled throughout the year.

In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic and the resulting impact on economic activity, including rising interest rates and inflation. As COVID-19 transitions from a pandemic to an endemic disease, we are uncertain about its ongoing effect on both domestic and worldwide economic activity, which may continue to be unpredictable. As a result, we may face difficulties raising capital through sales of our common stock or other equity-linked securities, and any such sales may be on unfavorable terms to us and potentially dilutive to existing stockholders.

The extent to which the pandemic may impact our business, clinical trials and preclinical studies will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the emergence of novel variants of SARS-CoV-2, the impact of vaccinations and vaccination rates, travel restrictions and actions to contain the virus or treat its impact, such as social distancing and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. For example, primarily due to COVID-19 related restrictions and disruption, we have experienced delays in shipping raw materials to our partners in China, which has delayed certain of our investigational new drug application-enabling activities.

If we fail to demonstrate efficacy or safety in our research and clinical trials, our future business prospects, financial condition and operating results will be materially adversely affected.

The success of our research and development efforts will greatly depend on our ability to demonstrate efficacy of our novel peptide analogs in non-clinical studies, as well as in clinical trials. Non-clinical studies involve testing potential drug candidates in appropriate non-human disease models to demonstrate efficacy and safety. Regulatory agencies evaluate these data carefully before they will approve clinical testing in humans. If certain non-clinical data reveals potential safety issues or the results are inconsistent with an expectation of the potential drug’s efficacy in humans, the program may be discontinued or the regulatory agencies may require additional testing before allowing human clinical trials. This additional testing will increase program expenses and extend timelines. We may decide to suspend further testing on our potential drugs if, in the judgment of our management and advisors, the non-clinical test results do not support further development.

Moreover, success in research, preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and non-clinical testing. The clinical trial process may fail to demonstrate that our potential drug candidates are safe for humans and effective for indicated uses. This failure would cause us to abandon a drug candidate and may delay development of other potential drug candidates. Any delay in, or termination of, our non-clinical testing or clinical trials will delay the filing of an investigational new drug application and new drug application with the FDA or the equivalent applications with pharmaceutical regulatory authorities outside the United States and, ultimately, our ability to commercialize our potential drugs and generate product revenues. In addition, our Phase 1a/1b trial of CB4211, our most advanced drug candidate, involved, and we expect that our other early clinical trials will involve, small patient populations. Because of these small sample sizes, the results of these early clinical trials, including the topline data from our CB4211 Phase 1a/1b trial, may not be indicative of future results.

Risks Related to Discovery, Development and Commercialization

If any future clinical trials are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of any approved products.

We cannot predict whether we will encounter problems with our planned or future clinical trials that will cause regulatory agencies, institutional review boards, or us to suspend or delay a trial. For example, in November 2018, we announced the temporary suspension of the Phase 1a/1b clinical trial for CB4211 in order to address injection site reactions, and we resumed the trial in June 2019. In November 2019, we announced the completion of the Phase 1a portion of the clinical trial and the commencement of the recruiting phase of the final Phase 1b stage of the study. However, in March 2020, we announced a delay in the completion of this trial due to a pause by some of our clinical research organization partners in all of their activities related to the study in response to developments relating to the COVID-19 pandemic. While we announced the resumption of our Phase 1b study in July 2020, our clinical activities could be delayed again in the future. Additionally, the FDA’s review of any prior or future submissions related to completed, ongoing, or planned clinical trials of our product candidates, or future information requests from the FDA could result in the delay or suspension of any ongoing or planned clinical trials to address any concerns.

Clinical trials and clinical data collection protocols can be delayed for a variety of reasons, including:

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unanticipated consequences of the formulation of the product candidate requiring us to pause the trial to investigate alternative formulations;

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the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials;

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discussions with the FDA regarding the scope or design of our clinical trials and clinical data collection protocols;

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delays or the inability to obtain required approvals from institutional review boards or other responsible entities at clinical sites selected for participation in our existing or future clinical trials;

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adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;

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the amendment of clinical trial or data collection protocols to reflect changes in regulatory requirements and guidance or other reasons, as well as subsequent re-examination of amendments of clinical trial or data collection protocols by institutional review boards or other responsible bodies; and

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the need to repeat or conduct additional clinical trials as a result of inconclusive or negative results, failure to replicate positive early clinical data in subsequent clinical trials, failure to deliver an efficacious dose of a product candidate, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol, an unacceptable study design or other problems.

In addition, a clinical trial or development program may be suspended or terminated by us, institutional review boards, the FDA or other responsible bodies due to a number of factors, including:

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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

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inability to resume a suspended trial in a timely manner, which we cannot predict with certainty, if at all;

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unforeseen safety issues or any determination that a trial presents unacceptable health risks;

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inability to deliver an efficacious dose of a product candidate; and

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lack of adequate funding to continue the clinical trial.

If the results of our clinical trials are not available when we expect or if we encounter any delay in the analysis of data from our clinical trials, we may be unable to conduct additional clinical trials on the schedule we anticipate. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any delays in completing a clinical trial could increase our development costs, delay or prevent the availability of topline data expected to be available from the trial, delay our product development and regulatory submission process or make it difficult to raise additional capital.

If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our products may be delayed and, as a result, our stock price may decline.

From time to time, we estimate the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we may publicly announce the expected timing of some of these milestones. All of these milestones are and will be based on numerous assumptions, including timely performance by our contract research organizations (“CROs”) and other vendors, positive clinical and preclinical results, our ability to develop commercially viable formulations for our product candidates, the addition of a corporate partner for our CB4211 program, and sufficient funding from partnering and general fundraising. The actual timing of these milestones can vary dramatically compared to our estimates, in some cases for reasons beyond our control. If we do not meet these milestones as publicly announced, or at all, our revenue may be lower than expected, the commercialization of our products may be delayed or never achieved and, as a result, our stock price may decline.

Our future success depends on key members of our management and scientific teams and our ability to attract, retain and motivate qualified personnel.

Recruiting and retaining qualified senior management and scientific, clinical, and operations management and personnel will be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biopharmaceutical companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

We are highly dependent on our key management and scientific teams, including our Chief Executive Officer and Chief Financial Officer who are employed “at will,” meaning they may terminate the employment relationship at any time. We do not maintain “key person” insurance for any of the key members of our team. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives. We have in the past and may in the future continue to experience changes in our executive management team resulting from the departure of executives or subsequent hiring of new executives, which may be disruptive to our business. For example, Kenneth Cundy resigned from his role of Chief Scientific Officer effective March 31, 2022. Any changes in business strategies can create uncertainty, may negatively impact our ability to execute our business strategy quickly and effectively and may ultimately be unsuccessful. The impact of hiring new executives may not be immediately realized.

We rely on consultants and advisors from time to time, including drug discovery and development advisors, to assist us in formulating our research and development strategy. Agreements with these advisors typically may be terminated by either party, for any reason, on relatively short notice. In addition, our consultants and advisors, including our founders, may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

We may seek to establish development and commercialization collaborations, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our potential drug development programs and the potential commercialization of our drug candidates will require substantial additional cash to fund expenses. We may decide to collaborate with biopharmaceutical companies in connection with the development or commercialization of our potential drug candidates. For example, we intend to partner CB4211 before moving forward with further development of this program. There is no guarantee that we will be able to establish a partnership for the CB4211 program on favorable terms, if at all. If we are unable to establish such a partnership, our CB4211 program may be delayed or terminated, which may cause our stock price to decline or otherwise result in adverse effects on our business.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive collaboration agreement will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the expected efficacy, safety and tolerability of the subject product candidate, the design or results of clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential reimbursement rates for such product candidates, the potential of competing products, the strength of our data supporting the mechanism of action of the subject product candidate, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative product candidates or technologies for similar disease indications on which to collaborate, and whether such alternative collaboration project could be more attractive than one with us for our product candidate.

There are a limited number of large biopharmaceutical companies with whom we could potentially collaborate, and collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on a timely basis, on acceptable terms or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.

We may not be successful in our efforts to identify or discover potential drug development candidates.

A key element of our strategy i

SEC Form 10-Q filed by CohBar Inc.