cntx-20240930

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 September 30, 2024


			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 November 4, 2024 was 74,998,312 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 Statements 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			19
Item 3. Quantitative and Qualitative Disclosures About Market Risk			29
Item 4. Controls and Procedures			29

PART II – OTHER INFORMATION			30
Item 1. Legal Proceedings			30
Item 1A. Risk Factors			30
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			30
Item 3. Defaults Upon Senior Securities			30
Item 4. Mine Safety Disclosures			30
Item 5. Other Information			30
Item 6. Exhibits			31
Signatures			32


	September 30, 2024		December 31, 2023
	(Unaudited)		(Note 3)
Assets
Current assets:
Cash and cash equivalents	$	84,801,556	$	14,449,827
Prepaid expenses and other current assets	1,269,265		1,597,384
Total current assets	86,070,821		16,047,211
Property and equipment, net	14,893		15,524
Operating lease right-of-use lease assets	244,135		—
Total assets	$	86,329,849	$	16,062,735
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	1,028,667	$	2,383,016
Accrued expenses and other current liabilities	1,199,205		1,808,699
Operating lease liabilities - current	104,160		—
Total current liabilities	2,332,032		4,191,715
Operating lease liabilities - non-current	140,200		—
Total liabilities	2,472,232		4,191,715
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; 200,000,000 and 100,000,000 shares authorized at September 30, 2024 and December 31, 2023, respectively; 74,998,312 and 15,966,053 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	74,998		15,966
Additional paid-in capital	175,219,405		79,909,644
Accumulated deficit	(91,436,786)		(68,054,590)
Total stockholders' equity	83,857,617		11,871,020
Total liabilities and stockholders' equity	$	86,329,849	$	16,062,735


	Three months ended September 30,				Nine months ended September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development	$	16,825,198	$	4,485,223	$	20,182,960	$	12,480,836
General and administrative	1,876,230		1,695,272		5,430,518		5,658,575
Loss from operations	(18,701,428)		(6,180,495)		(25,613,478)		(18,139,411)
Interest income	1,243,687		290,440		2,236,188		939,256
Other (expense) income	(2,152)		15,369		(4,906)		5,830
Net loss	$	(17,459,893)	$	(5,874,686)	$	(23,382,196)	$	(17,194,325)
Net loss per common share, basic and diluted	$	(0.22)	$	(0.37)	$	(0.46)	$	(1.08)
Weighted average shares outstanding, basic and diluted	80,481,053		15,966,053		50,578,115		15,966,053


	Nine Months Ended September 30, 2024
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
Balance at January 1, 2024	15,966,053	$	15,966	$	79,909,644	$	(68,054,590)	$	11,871,020
Share-based compensation expense	—	—		240,007		—		240,007
Net loss	—	—		—		(3,667,797)		(3,667,797)
Balance at March 31, 2024	15,966,053	15,966		80,149,651		(71,722,387)		8,443,230
Sale of common stock and prefunded warrants, net of offering costs of $5,234,020	59,032,259	59,032		94,699,715		—		94,758,747
Share-based compensation expense	—	—		157,037		—		157,037
Net loss	—	—		—		(2,254,506)		(2,254,506)
Balance at June 30, 2024	74,998,312	74,998		175,006,403		(73,976,893)		101,104,508
Share-based compensation expense	—	—		213,002		—		213,002
Net loss	—	—		—		(17,459,893)		(17,459,893)
Balance at September 30, 2024	74,998,312	$	74,998	$	175,219,405	$	(91,436,786)	$	83,857,617

	Nine Months Ended September 30, 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
Share-based compensation expense	—	—		283,103		—		283,103
Net loss	—	—		—		(5,011,321)		(5,011,321)
Balance at June 30, 2023	15,966,053	15,966		79,398,644		(55,410,018)		24,004,592
Share-based compensation expense	—	—		254,949		—		254,949
Net loss	—	—		—		(5,874,686)		(5,874,686)
Balance at September 30, 2023	15,966,053	$	15,966	$	79,653,593	$	(61,284,704)	$	18,384,855


	September 30,
	2024	2023
Stock options	3,259,615	2,238,609
Warrants	5,860,000	5,860,000
	9,119,615	8,098,609


			September 30, 2024
	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)	$	84,304,470	$	84,304,470	$	—	$	—


	September 30, 2024		December 31, 2023
Compensation and benefits	$	627,400	$	652,804
Research and development costs	458,271		1,084,009
Professional fees	23,776		63,393
Other	89,758		8,493
Total	$	1,199,205	$	1,808,699


	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
Issued in connection with 2024 private placement	5,482,741	$	0.001	No expiration
	11,342,741


	2024	2023
Expected stock price volatility	95.52%	91.98%
Risk-free interest rate	4.13%	3.86%
Expected term (in years)	6.00	6.00
Expected dividend yield	—	—


	Number of Shares	Weighted Average Exercise Price Per Share		Weighted Average Remaining Contractual Term (years)	Aggregate Intrinsic Value
Outstanding at January 1, 2024	2,164,031	$	2.20	8.4	$	260,688
Granted	1,230,604	$	1.51
Forfeited	(135,020)	$	1.30
Outstanding at September 30, 2024	3,259,615	$	1.97	8.4	$	1,715,314
Vested and exercisable at September 30, 2024	1,383,123	$	2.77	7.5	$	519,934
Vested and expected to vest at September 30, 2024	3,259,615	$	1.97	8.4	$	1,715,314


	Three Months Ended September 30,
	2024		2023		$ Change		% Change
ONA-XR	$	—	$	(17,363)	$	17,363	(100)	%
CTIM-76	1,431,387		4,191,008		(2,759,621)		(66)	%
CT-95	4,008,841		—		4,008,841		*
CT-202	11,016,442		—		11,016,442		*
Personnel-related costs	349,414		295,323		54,091		18	%
Other research and development	19,114		16,255		2,859		18	%
	$	16,825,198	$	4,485,223	$	12,339,975	275	%


	Nine Months Ended September 30,
	2024		2023		$ Change		% Change
ONA-XR	$	—	$	1,904,088	$	(1,904,088)	(100)	%
CTIM-76	4,659,764		9,599,509		(4,939,745)		(51)	%
CT-95	4,008,841		—		4,008,841		*
CT-202	11,016,442		—		11,016,442		*
Personnel-related costs	470,771		928,330		(457,559)		(49)	%
Other research and development	27,142		48,909		(21,767)		(45)	%
	$	20,182,960	$	12,480,836	$	7,702,124	62	%


						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)

SEC Form 10-Q filed by Context Therapeutics Inc.