cntx-20230331

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________________

FORM 10-Q

___________________________________

(Mark one)


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

For the quarterly period ended March 31, 2023


			o			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: 001-40654

CONTEXT THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

___________________________________


Delaware			86-3738787
(State of other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification Number)

2001 Market Street, Suite 3915, Unit #15

Philadelphia, Pennsylvania 19103

(Address of principal executive offices, including zip code)

(267) 225-7416

(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	CNTX	The Nasdaq Stock Market LLC

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 ý No o

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

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 Act).Yes o No ý

The number of shares of common stock outstanding at May 5, 2023 was 15,966,053 shares.


			Page
NOTE REGARDING FORWARD-LOOKING STATEMENTS			3

PART I – FINANCIAL INFORMATION			6
Item 1. Financial Statements (unaudited):			6
Condensed Consolidated Balance Sheets			6
Condensed Consolidated Statements of Operations			7
Condensed Consolidated Statement s of Changes in Stockholders’ Equity			8
Condensed Consolidated Statements of Cash Flows			9
Notes to the Unaudited Condensed Consolidated Financial Statements			10
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations			18
Item 3. Quantitative and Qualitative Disclosures About Market Risk			25
Item 4. Controls and Procedures			25

PART II – OTHER INFORMATION			26
Item 1. Legal Proceedings			26
Item 1A. Risk Factors			26
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			26
Item 3. Defaults Upon Senior Securities			26
Item 4. Mine Safety Disclosures			26
Item 5. Other Information			26
Item 6. Exhibits			27
Signatures			28


	March 31, 2023		December 31, 2022
	(Unaudited)		(Note 3)
Assets
Current assets:
Cash and cash equivalents	$	29,768,990	$	35,497,445
Prepaid expenses and other current assets	2,116,737		2,356,213
Total current assets	31,885,727		37,853,658
Operating lease right-of-use asset	29,892		51,967
Property and equipment, net	24,375		27,568
Other assets	26,188		32,750
Total assets	$	31,966,182	$	37,965,943
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	1,210,261	$	936,330
Accrued expenses and other current liabilities	1,991,442		2,216,169
Operating lease liability - current	31,669		55,078
Total current liabilities	3,233,372		3,207,577
Total liabilities	3,233,372		3,207,577
Commitments and contingencies (Note 8)
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding	—		—
Common stock, $0.001 par value; 100,000,000 shares authorized; 15,966,053 shares issued and outstanding at March 31, 2023 and December 31, 2022	15,966		15,966
Additional paid-in capital	79,115,541		78,832,779
Accumulated deficit	(50,398,697)		(44,090,379)
Total stockholders' equity	28,732,810		34,758,366
Total liabilities and stockholders' equity	$	31,966,182	$	37,965,943


	Three months ended March 31,
	2023		2022
Operating expenses:

Research and development	$	4,534,676	$	1,351,495
General and administrative	2,131,872		2,091,467
Loss from operations	(6,666,548)		(3,442,962)
Interest income	355,542		5,864
Other income (expense)	2,688		(1,239)
Net loss	$	(6,308,318)	$	(3,438,337)
Net loss per common share, basic and diluted	$	(0.40)	$	(0.22)
Weighted average shares outstanding, basic and diluted	15,966,053		15,966,053


	Three Months Ended March 31, 2023
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
Balance at January 1, 2023	15,966,053	$	15,966	$	78,832,779	$	(44,090,379)	$	34,758,366
Share-based compensation expense	—	—		282,762		—		282,762
Net loss	—	—		—		(6,308,318)		(6,308,318)
Balance at March 31, 2023	15,966,053	$	15,966	$	79,115,541	$	(50,398,697)	$	28,732,810


	Three Months Ended March 31, 2022
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
Balance at January 1, 2022	15,966,053	$	15,966	$	77,510,809	$	(29,254,440)	$	48,272,335
Fair value of warrants issued for services	—	—		345,530		—		345,530
Share-based compensation expense	—	—		214,958		—		214,958
Net loss	—	—		—		(3,438,337)		(3,438,337)
Balance at March 31, 2022	15,966,053	$	15,966	$	78,071,297	$	(32,692,777)	$	45,394,486


	March 31,
	2023	2022
Stock options	2,165,646	1,180,222
Warrants	5,860,000	5,860,000
	8,025,646	7,040,222


			March 31, 2023
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Financial assets
Cash equivalents (Money Market Accounts)	$	2,150,810	$	2,150,810	$	—	$	—


	March 31, 2023		December 31, 2022
Compensation and benefits	$	215,050	$	770,055
Research and development costs	1,629,014		1,358,707
Professional fees	103,131		3,951
Other	44,247		83,456
Total	$	1,991,442	$	2,216,169


	Outstanding	Exercise price		Expiration dates
Issued in connection with 2021 IPO	250,000	$	6.25	October 2026
Issued in connection with 2021 private placement	5,250,000	$	6.25	June 2027
Issued in 2022 for consulting services	360,000	$	10.00	December 2027
	5,860,000


	2023	2022
Expected stock price volatility	91.85%	86.86%
Risk-free interest rate	3.88%	1.91%
Expected term (in years)	6.08	6.03
Expected dividend yield	—	—


	Number of Shares	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (years)
Outstanding at January 1, 2023	1,341,504	$	3.27	8.9
Granted	824,142	$	0.84
Forfeited	—	$	—
Outstanding at March 31, 2023	2,165,646	$	2.35	9.1
Vested and exercisable at March 31, 2023	526,574	$	4.43	8.3
Vested and expected to vest at March 31, 2023	2,165,646	$	2.35	9.1


	Three months ended March 31,
	2023		2022		$ Change		% Change
ONA-XR	$	2,088,763	$	861,311	$	1,227,452	143	%
CTIM-76	2,085,275		80,971		2,004,304		2,475	%
Personnel-related costs	345,255		352,340		(7,085)		(2)	%
Other research and development	15,383		56,873		(41,490)		(73)	%
	$	4,534,676	$	1,351,495	$	3,183,181	236	%


	Three months ended March 31,
	2023		2022
Cash used in operating activities	$	(5,728,455)	$	(3,820,281)
Cash used in investing activities	—		(34,999)
Cash used in financing activities	—		(102,071)
Net decrease in cash, cash equivalents and restricted cash	$	(5,728,455)	$	(3,957,351)


						CONTEXT THERAPEUTICS INC.



			By:			/s/ Martin Lehr
						Martin Lehr
						Chief Executive Officer (Principal Executive Officer)



			By:			/s/ Jennifer Minai-Azary
						Jennifer Minai-Azary
						Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)


Exhibit No.			Exhibit Description
3.1			Amended & Restated Certificate of Incorporation of Context Therapeutics Inc. (incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K (File No. 001-40654), as filed with the SEC on October 22, 2021).
3.2			Amended and Restated Bylaws of Context Therapeutics Inc. (incorporated by reference to Exhibit 3.2 to the Company's Current Report on Form 8-K (File No. 001-40654), as filed with the SEC on October 22, 2021).
10.1#			Amendment No. 1, dated March 20, 2023, to that certain Research Collaboration and License Agreement, dated April 6, 2021, between Context Therapeutics LLC and Integral Molecular, Inc. (incorporated by reference to Exhibit 10.23 to the Company's Annual Report on Form 10-K (File No. 001-40654), as filed with the SEC on March 22, 2022)
10.2			Termination Agreement of the Clinical Trial Collaboration and Supply Agreement, dated March 21, 2023 between Context Therapeutics Inc. and Berlin-Chemie AG - Menarini Group (incorporated by reference to Exhibit 10.24 to the Company's Annual Report on Form 10-K (File No. 001-40654), as filed with the SEC on March 22, 2022)
31.1*			Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
31.2*			Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
32.1*+			Certification Pursuant to 18 U.S.C. Section 1350 of principal executive officer and principal financial officer.
101*			The following financial statements from Context Therapeutics Inc.’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023, formatted in Inline XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets; (ii) Condensed Consolidated Statements of Operations; (iii) Condensed Consolidated Statements of Changes in Stockholders’ Equity; (iv) Condensed Consolidated Statements of Cash Flows; and (v) Notes to the Condensed Consolidated Financial Statements.
104*			Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 hereto)

SEC Form 10-Q filed by Context Therapeutics Inc.