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 MARCH 31, 2022


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

COMMISSION FILE NUMBER 001-39202

Annovis Bio, Inc.

(Exact name of registrant as specified in its charter)

Delaware		26-2540421
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

1055 Westlakes Drive, Suite 300

Berwyn, PA 19312

(Address of registrant’s principal executive offices)

(610) 727-3913

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class		Trading Symbol		Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share		ANVS		New York Stock Exchange

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.

The number of outstanding shares of the registrant’s common stock as of May 2, 2022 was: 8,163,923.

PART I – FINANCIAL INFORMATION		Page


Item 1.	Financial Statements	3

	Balance Sheets as of March 31, 2022 (Unaudited) and December 31, 2021	3

	Statements of Operations for the Three Months Ended March 31, 2022 and 2021 (Unaudited)	4

	Statements of Changes in Stockholders’ Equity for the Three Months Ended March 31, 2022 and 2021 (Unaudited)	5

	Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021 (Unaudited)	6

	Notes to Financial Statements (Unaudited)	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15

Item 3.	Quantitative and Qualitative Disclosure About Market Risk	19

Item 4.	Controls and Procedures	19


PART II – OTHER INFORMATION


Item 1.	Legal Proceedings	20

Item 1A.	Risk Factors	20

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	20

Item 3.	Defaults Upon Senior Securities	20

Item 4.	Mine Safety Disclosures	20

Item 5.	Other Information	20

Item 6.	Exhibits	21

	Signatures	22


	March 31,		December 31,
	2022		2021
		(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	42,668,838	$	45,686,014
Prepaid expenses and other current assets		627,902		315,464
Total current assets		43,296,740		46,001,478
Total assets	$	43,296,740	$	46,001,478
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	928,997	$	688,074
Accrued expenses		327,435		818,440
Total current liabilities		1,256,432		1,506,514
Total liabilities		1,256,432		1,506,514
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock - $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding		—		—
Common stock - $0.0001 par value, 35,000,000 shares authorized and 8,163,923 and 8,100,570 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively		816		810
Additional paid-in capital		76,659,912		73,220,361
Accumulated deficit		(34,620,420)		(28,726,207)
Total stockholders’ equity		42,040,308		44,494,964
Total liabilities and stockholders’ equity	$	43,296,740	$	46,001,478


	Three Months Ended
	March 31,
	2022		2021
Operating expenses:
Research and development	$	2,809,791	$	2,389,583
General and administrative		3,104,071		839,627
Total operating expenses		5,913,862		3,229,210

Operating loss		(5,913,862)		(3,229,210)
Other income:
Interest income		19,649		197
Grant income		—		29,340
Total other income		19,649		29,537

Loss before income taxes		(5,894,213)		(3,199,673)
Income tax expense (benefit)		—		—
Net loss	$	(5,894,213)	$	(3,199,673)
Basic and diluted loss per common share	$	(0.72)	$	(0.46)
Weighted average number of common shares outstanding, basic and diluted		8,157,445		6,920,622


				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders'
	Shares	Amount		Capital		Deficit		Equity
Three Months Ended March 31, 2022
Balance, December 31, 2021	8,100,570	$	810	$	73,220,361	$	(28,726,207)	$	44,494,964
Exercise of stock options	63,353		6		4,607		—		4,613
Stock-based compensation expense	—		—		3,434,944		—		3,434,944
Net loss	—		—		—		(5,894,213)		(5,894,213)
Balance, March 31, 2022	8,163,923	$	816	$	76,659,912	$	(34,620,420)	$	42,040,308

Three Months Ended March 31, 2021
Balance, December 31, 2020	6,891,608	$	689	$	21,779,340	$	(14,239,075)	$	7,540,954
Exercise of stock options	3,868		1		3,016		—		3,017
Cashless exercise of warrants	51,644		5		(5)		—		—
Stock-based compensation expense	—		—		23,977		—		23,977
Net loss	—		—		—		(3,199,673)		(3,199,673)
Balance, March 31, 2021	6,947,120	$	695	$	21,806,328	$	(17,438,748)	$	4,368,275


	Three Months Ended March 31,
	2022		2021
Cash flows from operating activities:
Net loss	$	(5,894,213)	$	(3,199,673)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		3,434,944		23,977
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(312,438)		(317,473)
Accounts payable		240,923		482,709
Accrued expenses		(491,005)		535,592
Net cash used in operating activities		(3,021,789)		(2,474,868)
Cash flows from financing activities:
Proceeds from exercise of stock options		4,613		3,017
Net cash provided by financing activities		4,613		3,017
Net decrease in cash and cash equivalents		(3,017,176)		(2,471,851)
Cash and cash equivalents, beginning of period		45,686,014		8,074,658
Cash and cash equivalents, end of period	$	42,668,838	$	5,602,807


			Fair Value Measurement at
			March 31, 2022
	Carrying Value		Level 1		Level 2		Level 3
Cash and cash equivalents	$	42,668,838	$	42,668,838	$	—	$	—


			Fair Value Measurement at
			December 31, 2021
	Carrying Value		Level 1		Level 2		Level 3
Cash and cash equivalents	$	45,686,014	$	45,686,014	$	—	$	—


Exhibit Number		Description of Exhibit

3.1		Amended and Restated Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to Form 8-K filed February 6, 2020.)

3.2		Amended and Restated Bylaws of the Registrant. (Incorporated by reference to Exhibit 3.2 to Form 8-K filed February 6, 2020.)

31.1		Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1		Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2		Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


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Signature	Title	Date

/s/ MARIA MACCECCHINI	President and Chief Executive Officer (principal	May 4, 2022
Maria Maccecchini	executive officer)

/s/ JEFFREY MCGROARTY	Chief Financial Officer (principal financial and	May 4, 2022
Jeffrey McGroarty	accounting officer)


	March 31,		December 31,
	2022		2021
Prepaid clinical trial expenses	$	258,361	$	232,752
Prepaid insurance		313,119		29,111
Prepaid expenses		46,557		43,736
Security deposits		9,865		9,865
	$	627,902	$	315,464

SEC Form 10-Q filed by Annovis Bio Inc.