0000950170-24-097142 | 10-Q | XBRL Viewer

Financings	6 Months Ended
Jun. 30, 2024
Text Block [Abstract]
Financings	2. Financings 2022 Equity Distribution Agreement On August 12, 2022, the Company entered into an Equity Distribution Agreement, or the Equity Distribution Agreement, with Piper Sandler & Co., or Piper Sandler, pursuant to which the Company can offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Piper Sandler as its sales agent in an "at the market offering." Piper Sandler will receive a commission of 3.0% of the gross proceeds of any common stock sold under the Equity Distribution Agreement. During the three and six months ended June 30, 2024 and 2023, there were no sales of the Company's common stock under the Equity Distribution Agreement.

Stock-Based Compensation (Tables)

6 Months Ended

Jun. 30, 2024

Stock-Based Compensation Expense on All Employee and Non-Employee Awards

The Company recognized stock-based compensation expense on all employee and non-employee awards as follows:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
(in thousands)	2024		2023		2024		2023
Research and development	$	2	$	180	$	13	$	356
General and administrative		99		734		260		1,468
Stock-based compensation expense	$	101	$	914	$	273	$	1,824

Fair Value of Stock Options Assumptions Using Black-Scholes Option Valuation Model

For the three and six months ended June 30, 2024 and 2023, the fair value of stock options was estimated on the date of grant using a Black-Scholes option valuation model with the following assumptions:


	For the Six Months Ended June 30,
	2024	2023
Risk-free interest rate	4.09%	3.51 – 3.87%
Expected life in years	5.04-5.27	5.06 – 6.25
Expected volatility	114.65 -170.50%	89.69 – 95.63%
Expected dividend yield	—%	—%

Stock Option Activity under Stock Option Plan

Stock option activity under the Company’s stock option plans for the six months ended June 30, 2024 was as follows:


(in thousands, except share and per share data)	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding, December 31, 2023		46,589		$	268.50	7.64		$	—
Granted		10,289			13.29
Exercised		-			-
Cancelled		(26,641	)		283.08
Outstanding, June 30, 2024		30,237		$	168.81		7.46	$	—
Options exercisable, June 30, 2024		17,743		$	250.45		6.10	$	—
Options available for future grant, June 30, 2024		145,745

CONDENSED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 2,463	$ 6,062
Receivables	4	1
Prepaid expenses and other current assets	2,211	2,198
Total current assets	4,678	8,261
Property and equipment, net	0	2
Total assets	4,678	8,263
Current liabilities:
Accounts payable	365	616
Accrued expenses	542	1,340
Total current liabilities	907	1,956
Total liabilities	907	1,956
Commitments and contingencies
Stockholders' equity
Common stock $0.001 par value; 5,000,000 shares authorized, 1,601,252 shares issued and outstanding at June 30, 2024 and at December 31, 2023	2	2
Additional paid-in capital	922,346	922,072
Accumulated deficit	(918,577)	(915,767)
Total stockholders' equity	3,771	6,307
Total liabilities and stockholders' equity	$ 4,678	$ 8,263

Financings - Additional Information (Details) - USD ($) $ in Thousands		3 Months Ended		6 Months Ended
	Aug. 12, 2022	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Debt Instrument [Line Items]
Aggregate offering price					$ 92
Equity Distribution Agreement [Member]
Debt Instrument [Line Items]
Stock issued during period		0	0	0	0
Aggregate offering price	$ 50,000
Percentage Of Commission On Gross Proceeds From Sale Of Common Stock	3.00%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

- Definition

Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering.

+ References + Details

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (1,129)	$ (8,773)	$ (2,810)	$ (18,821)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Stock-Based Compensation

6 Months Ended

Jun. 30, 2024

Text Block [Abstract]

Stock-Based Compensation

The Company recognized stock-based compensation expense on all employee and non-employee awards as follows:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
(in thousands)	2024		2023		2024		2023
Research and development	$	2	$	180	$	13	$	356
General and administrative		99		734		260		1,468
Stock-based compensation expense	$	101	$	914	$	273	$	1,824

The Company granted an aggregate of 6,288 stock options during the three months ended June 30, 2024, with a weighted-average grant date fair value of $9.72 per share, and granted an aggregate of 4,133 stock options during the three months ended June 30, 2023, with a weighted-average grant date fair value of $54 per share. The Company granted an aggregate of 10,289 stock options during the six months ended June 30, 2024, with a weighted-average grant date fair value of $11.76 per share, and granted an aggregate of 24,567 stock options during the six months ended June 30, 2023, with a weighted-average grant date fair value of $58.5 per share.


	For the Six Months Ended June 30,
	2024	2023
Risk-free interest rate	4.09%	3.51 – 3.87%
Expected life in years	5.04-5.27	5.06 – 6.25
Expected volatility	114.65 -170.50%	89.69 – 95.63%
Expected dividend yield	—%	—%

Stock option activity under the Company’s stock option plans for the six months ended June 30, 2024 was as follows:


(in thousands, except share and per share data)	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding, December 31, 2023		46,589		$	268.50	7.64		$	—
Granted		10,289			13.29
Exercised		-			-
Cancelled		(26,641	)		283.08
Outstanding, June 30, 2024		30,237		$	168.81		7.46	$	—
Options exercisable, June 30, 2024		17,743		$	250.45		6.10	$	—
Options available for future grant, June 30, 2024		145,745

At June 30, 2024, total unrecognized compensation costs related to unvested stock options outstanding amounted to $0.3 million. The cost is expected to be recognized over a weighted-average period of 1.82 years.

Cover Page - shares	6 Months Ended
Cover Page - shares	Jun. 30, 2024	Aug. 13, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Document Quarterly Report	true
Document Transition Report	false
Entity Registrant Name	Alaunos Therapeutics, Inc.
Entity Central Index Key	0001107421
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Trading Symbol	TCRT
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Common Stock, Shares Outstanding		1,601,252
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity File Number	001-33038
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	84-1475642
Entity Address, Address Line One	2617 Bissonnet Street
Entity Address, Address Line Two	Suite 225
Entity Address, City or Town	Houston
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77005
City Area Code	346
Local Phone Number	355-4099

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Additional Paid In Capital	Accumulated Deficit
Balance at Dec. 31, 2022	$ 38,555	$ 2	$ 919,180	$ (880,627)
Balance (in shares) at Dec. 31, 2022		1,602,738
Stock-based compensation	1,824		1,824
Issuance of common stock, net of expenses	92		92
Issuance of common stock, net of expenses, (in shares)		1,442
Net loss	(18,821)			(18,821)
Balance at Jun. 30, 2023	21,650	$ 2	921,096	(899,448)
Balance (in shares) at Jun. 30, 2023		1,604,180
Balance at Mar. 31, 2023	29,509	$ 2	920,182	(890,675)
Balance (in shares) at Mar. 31, 2023		1,604,180
Stock-based compensation	914		914
Net loss	(8,773)			(8,773)
Balance at Jun. 30, 2023	21,650	$ 2	921,096	(899,448)
Balance (in shares) at Jun. 30, 2023		1,604,180
Balance at Dec. 31, 2023	6,307	$ 2	922,072	(915,767)
Balance (in shares) at Dec. 31, 2023		1,601,252
Stock-based compensation	274		274
Net loss	(2,810)			(2,810)
Balance at Jun. 30, 2024	3,771	$ 2	922,346	(918,577)
Balance (in shares) at Jun. 30, 2024		1,601,252
Balance at Mar. 31, 2024	4,798	$ 2	922,244	(917,448)
Balance (in shares) at Mar. 31, 2024		1,601,252
Stock-based compensation	102		102
Net loss	(1,129)			(1,129)
Balance at Jun. 30, 2024	$ 3,771	$ 2	$ 922,346	$ (918,577)
Balance (in shares) at Jun. 30, 2024		1,601,252

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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- Definition

Equity impact of the value of new stock issued during the period. Includes shares issued in an initial public offering or a secondary public offering.

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- Definition

Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest.

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+ Details

Organization - Additional Information (Details) - USD ($) $ in Thousands	Jul. 17, 2024	Jan. 31, 2024	Aug. 14, 2023	Jun. 30, 2024	Mar. 31, 2024	Dec. 31, 2023	Jun. 30, 2023	Dec. 31, 2022
Cash, cash equivalents and restricted cash				$ 2,464		$ 6,062	$ 18,317	$ 52,996
Accumulated deficit				$ 918,577	$ 918,900	$ 915,767
Common stock, shares authorized				5,000,000		5,000,000
Common stock, shares outstanding				1,601,252		1,601,252
Strategic advisor name			Cantor
Pre Stock Split Shares Authorized	34,666,667	520,000,000
Post Stock Split Shares Authorized	5,000,000	34,666,667
Stockholders' Equity, Reverse Stock Split	The Third Charter Amendment became effective on July 17, 2024.	The Second Charter Amendment became effective on January 31, 2024.
Common Stock [Member]
Common stock, shares outstanding				1,601,252
Common stock reserved for future issuance				175,476

Stock-Based Compensation - Stock Option Activity Under Stock Option Plan (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Number of Shares
Beginning Balance			46,589
Granted	6,288	4,133	10,289	24,567
Cancelled			(26,641)
Ending Balance	30,237		30,237		46,589
Options exercisable, at end of period	17,743		17,743
Options available for future grant	145,745		145,745
Weighted Average Exercise Price
Beginning Balance			$ 268.5
Granted			13.29
Cancelled			283.08
Ending Balance	$ 168.81		168.81		$ 268.5
Options exercisable, at end of period	$ 250.45		$ 250.45
Weighted Average Contractual Term (Years)
Outstanding, period			7 years 5 months 15 days		7 years 7 months 20 days
Options exercisable, at end of period			6 years 1 month 6 days
Aggregate Intrinsic Value
Outstanding, at beginning of period			$ 0
Outstanding, at end of period	$ 0		0		$ 0
Options exercisable, at end of period	$ 0		$ 0

Commitments and Contingencies - Additional Information (Details) - USD ($)						3 Months Ended		6 Months Ended
	Oct. 20, 2023	Aug. 14, 2023	Mar. 17, 2023	Aug. 17, 2015	Jan. 13, 2015	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023	Apr. 03, 2023	Oct. 22, 2019	Oct. 05, 2018	Aug. 24, 2004
Accrued Payments
Research and development expense						$ 180,000	$ 5,186,000	$ 306,000	$ 11,689,000
Royalty amount						0		0
Maximum royalty amount												$ 100,000,000
Revenues						4,000	4,000	6,000	4,000
Unspecified monetary damages			$ 3,200,000
Loss contingency, name of plaintiff			KBI Biopharma
Litigation expense	$ 1,000,000
MD Anderson Warrant [Member]
Accrued Payments
Number of warrants											22,222
Warrant exercise per share											$ 0.15
Warrant expiry date											Dec. 31, 2026
MD Anderson Agreement and Worldwide License [Member]
Accrued Payments
License agreement commencing date					Jan. 13, 2015
MD Anderson License and the Research and Development Agreement [Member]
Accrued Payments
Reimbursement of historical costs											$ 20,000,000
Quarterly expense incurred						0	200,000	0	400,000
Aggregate potential benchmark payments											36,500,000
Payments due prior to the first marketing approval											$ 3,000,000
CRADA Agreement [Member]
Accrued Payments
Agreement termination date		Oct. 13, 2023
Annual expense incurred						0	30,000.00	0	500,000
The University of Texas MD Anderson Cancer Center and The Texas A & M University System [Member]
Accrued Payments
Milestone maximum payment													$ 4,500,000
The University of Texas MD Anderson Cancer Center and The Texas A & M University System [Member] \| Royalty [Member]
Accrued Payments
Payment under license agreement						0	0	0	0
License Agreement with the National Cancer Institute [Member]
Accrued Payments
License expense						0	10,000.00	0	400,000
Collaboration Agreement with Solasia Pharma KK [Member]
Accrued Payments
Revenues						0	0	0	0
Collaboration Agreement with Solasia Pharma KK [Member] \| Royalty [Member]
Accrued Payments
Revenues						5,000	$ 4,000	6,000	$ 4,000
M D Anderson License and the Two Thousand Fifteen Research and Development Agreement [Member]
Accrued Payments
Clinical expenses						$ 0		$ 0
Intrexon Corporation [Member]
Accrued Payments
Annual license fee										$ 75,000		100,000
Expected additional milestones payable												52,500,000
Intrexon Corporation [Member] \| T-cell receptor [Member]
Accrued Payments
Maximum royalty amount												$ 100,000,000
Portion of income payable to related party												20.00%
Minimum [Member] \| MD Anderson License and the Research and Development Agreement [Member]
Accrued Payments
Research and development expense				$ 15,000,000
Maximum [Member] \| MD Anderson License and the Research and Development Agreement [Member]
Accrued Payments
Research and development expense				$ 20,000,000

Commitments and Contingencies

6 Months Ended

Jun. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

License Agreements

Exclusive License Agreement with Precigen

On October 5, 2018, the Company entered into an exclusive license agreement, or License Agreement, with PGEN Therapeutics, or PGEN, a wholly owned subsidiary of Precigen Inc., or Precigen, which was formerly known as Intrexon Corporation. Except where the context otherwise requires, the Company refers to PGEN and Precigen together as Precigen. Pursuant to the terms of the License Agreement, the Company had exclusive, worldwide rights to research, develop and commercialize (i) TCR products designed for neoantigens for the treatment of cancer, (ii) products utilizing Precigen’s RheoSwitch® gene switch, or RTS, for the treatment of cancer, referred to as IL-12 Products and (iii) CAR products directed to (A) CD19 for the treatment of cancer, referred to as CD19 Products, and (B) BCMA for the treatment of cancer, subject to certain obligations to pursue such target under the License and Collaboration Agreement effective March 27, 2015 between the Company, Precigen and ARES TRADING S.A., a subsidiary of Merck KGaA, as assigned by Precigen to PGEN. Under the License Agreement, the Company also had exclusive, worldwide rights for certain patents relating to the Sleeping Beauty technology to research, develop and commercialize TCR products for both neoantigens and shared antigens for the treatment of cancer, referred to as TCR Products.

The Company was responsible for all aspects of the research, development and commercialization and was required to use commercially reasonable efforts to develop certain products.

In consideration of the licenses and other rights granted by Precigen, the Company was required to pay Precigen an annual license fee of $0.1 million, reimburse Precigen for certain historical costs, pay Precigen milestones up to an additional $52.5 million for each exclusively licensed program upon the achievement of certain milestones, and pay Precigen tiered royalties up to a maximum royalty amount of $100.0 million in the aggregate. The Company was also obligated to pay Precigen 20% of any sublicensing income received by us relating to the licensed products. The Company was responsible for all development costs associated with each of the licensed products.

Precigen was obligated to pay the Company royalties up to a maximum royalty amount of $100.0 million. No royalty amounts were incurred during the three and six months ended June 30, 2024.

On April 3, 2023, the Company entered into the Amended and Restated Exclusive License Agreement with Precigen, or the A&R License Agreement, which restated and amended the License Agreement in full. Under the A&R License Agreement, the Company still has exclusive, worldwide rights to research, develop and commercialize TCR products designed for neoantigens or driver mutations for the treatment of cancer and non-exclusive rights to use non-driver mutation TCRs. The Company further maintains its exclusive, worldwide rights for certain patents relating to the Sleeping Beauty technology to research, develop and commercialize TCR products for both neoantigens and shared antigens for the treatment of cancer, referred to as TCR Products.

The Company remains solely responsible for all aspects of the research, development and commercialization of the exclusively licensed products for the treatment of cancer. The (i) products utilizing Precigen’s RheoSwitch® gene switch, or RTS, for the treatment of cancer, referred to as IL-12 Products and (ii) CAR products directed to (A) CD19 for the treatment of cancer, referred to as CD19 Products, and (B) BCMA for the treatment of cancer, subject to certain obligations to pursue such target under the License and Collaboration Agreement effective March 27, 2015 between the Company, Precigen and ARES TRADING S.A., a subsidiary of Merck KGaA, as assigned by Precigen to PGEN are no longer exclusively licensed to the Company. The Company is no longer obligated to use commercially reasonable efforts for the exclusively licensed products. The A&R License Agreement further eliminates any royalty or milestone obligations to Precigen, with an annual license fee of $75 thousand due on the anniversary of the A&R License Agreement effective date. Precigen is no longer obligated to pay the Company royalties on the net sales derived from the sale of Precigen's CAR products.

License Agreement and 2015 Research and Development Agreement —The University of Texas MD Anderson Cancer Center

On January 13, 2015, the Company, together with Precigen, entered into a license agreement, or the MD Anderson License with MD Anderson (which Precigen subsequently assigned to PGEN). Pursuant to the MD Anderson License, the Company, together with Precigen, holds an exclusive, worldwide license to certain technologies owned and licensed by MD Anderson including technologies relating to novel CAR T-cell therapies, non-viral gene transfer systems, genetic modification and/or propagation of immune cells and other cellular therapy approaches, Natural Killer, or NK Cells, and TCRs.

On August 17, 2015, the Company, Precigen and MD Anderson entered into the 2015 R&D Agreement to formalize the scope and process for the transfer by MD Anderson, pursuant to the terms of the MD Anderson License, of certain existing research programs and related technology rights, as well as the terms and conditions for future collaborative research and development of new and ongoing research programs. The rights and obligations of Precigen under the 2015 R&D Agreement were assigned to the Company pursuant to the Fourth Amendment to 2015 R&D Agreement which was entered into on September 19, 2019 (the “Fourth Amendment”) with an effective date of October 5, 2018. The activities under the 2015 R&D Agreement are directed by a joint steering committee comprised of two members from the Company and one member from MD Anderson.

As provided under the MD Anderson License, the Company provided funding for research and development activities in support of the research programs under the 2015 R&D Agreement for a period of three years and in an amount of no less than $15.0 million and no greater than $20.0 million per year. On November 14, 2017, the Company entered into an amendment to the 2015 R&D Agreement, extending its term until April 15, 2021. In connection with the execution of the 2019 R&D Agreement described below, on October 22, 2019, the Company amended the 2015 R&D Agreement to extend the term of the 2015 R&D Agreement until December 31, 2026 and to allow cash resources on hand at MD Anderson under the 2015 R&D Agreement to be used for development costs under the 2019 Research and Development Agreement, or the 2019 R&D Agreement, which the Company entered into on October 22, 2019, with MD Anderson, pursuant to which the Company agreed to collaborate with respect to the TCR program. The Company did not incur clinical costs from MD Anderson related to the 2015 R&D Agreement for the three and six months ended June 30, 2024.

The term of the MD Anderson License expires on the last to occur of (a) the expiration of all patents licensed thereunder, or (b) the twentieth anniversary of the date of the MD Anderson License; provided, however, that following the expiration of the term of the MD Anderson License, the Company, together with Precigen, shall then have a fully-paid up, royalty free, perpetual, irrevocable and sublicensable license to use the licensed intellectual property thereunder. After ten years from the date of the MD Anderson License and subject to a 90-day cure period, MD Anderson will have the right to convert the MD Anderson License into a non-exclusive license if the Company and Precigen are not using commercially reasonable efforts to commercialize the licensed intellectual property on a case-by-case basis. After five years from the date of the MD Anderson License and subject to a 180-day cure period, MD Anderson will have the right to terminate the MD Anderson License with respect to specific technology(ies) funded by the government or subject to a third-party contract if the Company and Precigen are not meeting the diligence requirements in such funding agreement or contract, as applicable. MD Anderson may also terminate the agreement with written notice upon material breach by the Company and Precigen, if such breach has not been cured within 60 days of receiving such notice. In addition, the MD Anderson License will terminate upon the

occurrence of certain insolvency events for both the Company and Precigen and may be terminated by the mutual written agreement of the Company, Precigen, and MD Anderson.

2019 Research and Development Agreement—The University of Texas MD Anderson Cancer Center

Under the 2019 R&D Agreement, the Company and MD Anderson will, among other things, collaborate on programs to expand the Company's TCR library and conduct clinical trials. The activities under the 2019 R&D Agreement are directed by a joint steering committee comprised of two members from the Company and one member from MD Anderson.

The Company will own all inventions and intellectual property developed under the 2019 R&D Agreement and the Company will retain all rights to all intellectual property, patentable or not, for oncology products manufactured using non-viral gene transfer technologies under the 2019 R&D Agreement, including the Company's Sleeping Beauty technology. The Company has granted MD Anderson an exclusive license for such intellectual property to develop and commercialize autologous TCR products manufactured using viral gene transfer technologies and any products outside the field of oncology and a non-exclusive license for allogenic TCR products manufactured using viral-based technologies.

Under the 2019 R&D Agreement, the Company agreed, beginning on January 1, 2021, to reimburse MD Anderson up to a total of $20.0 million for development costs under the 2019 R&D Agreement, after the funds from the 2015 R&D Agreement are exhausted. In addition, the Company will pay MD Anderson royalties on net sales of its TCR products. The Company is required to make performance-based payments upon the successful completion of clinical and regulatory benchmarks relating to its TCR products. The aggregate potential benchmark payments are $36.5 million, of which only $3.0 million will be due prior to the first marketing approval of the Company's TCR products. Thce royalty rates and benchmark payments owed to MD Anderson may be reduced upon the occurrence of certain events. The Company also agreed to sell its TCR products to MD Anderson at preferential prices and will sell the Company's TCR products in Texas exclusively to MD Anderson for a limited period of time following the first commercial sale of the Company's TCR products. For the three and six months ended June 30, 2024 the Company did not incur clinical expenses from MD Anderson related to the 2019 R&D Agreement, compared to $0.2 and $0.4 million for the three and six months ended June 30, 2023.

The 2019 R&D Agreement will terminate on December 31, 2026 and either party may terminate the 2019 R&D Agreement following written notice of a material breach. The 2019 R&D Agreement also contains customary provisions related to indemnification obligations, confidentiality and other matters.

In connection with the execution of the 2019 R&D Agreement, on October 22, 2019, the Company issued MD Anderson a warrant to purchase 22,222 shares of the Company's common stock, which is referred to as the MD Anderson Warrant. The MD Anderson Warrant has an initial exercise price of $0.15 per share, expires on December 31, 2026, and vests upon the occurrence of certain clinical milestones. As of June 30, 2024, the milestones have not been met.

License Agreement with the NCI

On May 28, 2019, the Company entered into a patent license agreement, or the Patent License, with the NCI. Pursuant to the Patent License, the Company held an exclusive, worldwide license to certain intellectual property to develop and commercialize patient-derived (autologous), peripheral blood T-cell therapy products engineered by transposon-mediated gene transfer to express TCRs reactive to mutated KRAS, TP53 and EGFR neoantigens. In addition, pursuant to the Patent License, the Company held an exclusive, worldwide license to certain intellectual property for manufacturing technologies to develop and commercialize autologous, peripheral blood T-cell therapy products engineered by non-viral gene transfer to express TCRs, as well as a non-exclusive, worldwide license to certain additional manufacturing technologies. On May 29, 2019, January 8, 2020, September 28, 2020, April 16, 2021, May 4, 2021 and August 13, 2021 the Company amended the Patent License to expand its TCR library to include additional TCRs reactive to mutated KRAS and TP53 neoantigens licensed from the NCI.

On October 27, 2023, the Company provided the NCI the requisite notice of its intent to terminate the Patent License, effective December 26, 2023. The Company discovered multiple proprietary TCRs targeting driver mutations through its hunTR TCR discovery platform, including many of the same KRAS and TP53 mutations licensed from the NCI.

For the three and six months ended June 30, 2024, the Company did not incur expenses to the NCI under this agreement, compared to $0.01 and $0.4 million for the three and six months ended June 30, 2023.

Cooperative Research and Development Agreement (CRADA) with the NCI

On January 9, 2017, the Company entered into a Cooperative Research and Development Agreement, or the CRADA, with the NCI. The purpose of this collaboration was to advance a personalized TCR-T approach for the treatment of solid tumors. Using the Company's Sleeping Beauty technology, the NCI would analyze a patient’s own cancer cells, identify their unique neoantigens and TCRs reactive

against those neoantigens and then use the Company's Sleeping Beauty technology to transpose one or more TCRs into T cells for re-infusion. Research conducted under the CRADA was under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, in collaboration with the Company's researchers.

On August 14, 2023, the Company announced that it had provided the requisite notice to terminate the CRADA, pursuant to its terms, effective October 13, 2023, in light of the Company’s exploration of strategic alternatives.

The Company did not record expenses under the CRADA for the three and six months ended June 30, 2024, compared to $0.03 and $0.5 million for the three and six months ended June 30, 2023.

Patent and Technology License Agreement—The University of Texas MD Anderson Cancer Center and the Texas A&M University System

On August 24, 2004, the Company entered into a patent and technology license agreement with MD Anderson and the Texas A&M University System, which the Company refers to, collectively, as the Licensors. Under this agreement, the Company was granted an exclusive, worldwide license to rights (including rights to U.S. and foreign patent and patent applications and related improvements and know-how) for the manufacture and commercialization of two classes of organic arsenicals (water- and lipid-based) for human and animal use. The class of water-based organic arsenicals includes darinaparsin.

Under the terms of the agreement, the Company may be required to make additional payments to the Licensors upon achievement of certain milestones in varying amounts which, on a cumulative basis could total up to an additional $4.5 million. In addition, the Licensors are entitled to receive royalty payments on sales from a licensed product and will also be entitled to receive a portion of any fees that the Company may receive from a possible sublicense under certain circumstances. During the three and six months ended June 30, 2024 and 2023, the Company did not incur any milestone expenses or royalty expenses on sales under this agreement.

Collaboration Agreement with Solasia Pharma K.K.

On March 7, 2011, the Company entered into a License and Collaboration Agreement with Solasia Pharma K. K., or Solasia, which was amended on July 31, 2014 to include an exclusive worldwide license and amended on October 14, 2021 to revise certain payment schedule details, or, as so amended, the Solasia License and Collaboration Agreement. Pursuant to the Solasia License and Collaboration Agreement, the Company granted Solasia an exclusive license to develop and commercialize darinaparsin in both intravenous and oral forms and related organic arsenic molecules, in all indications for human use.

As consideration for the license, the Company is eligible to receive from Solasia development- and sales-based milestones, a royalty on net sales of darinaparsin, once commercialized, and a percentage of any sublicense revenue generated by Solasia. Solasia will be responsible for all costs related to the development, manufacturing and commercialization of darinaparsin. The Company’s licensors, as defined in the Solasia License and Collaboration Agreement, will receive a portion of all milestone and royalty payments made by Solasia to the Company in accordance with the terms of the Solasia License and Collaboration Agreement with the licensors, as described above.

In June 2022, Solasia announced that darinaparsin had been approved from relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the three months ended June 30, 2024 and 2023, the Company earned collaboration revenue of $0 and $0 and earned royalty revenues of $5 thousand and $4, respectively, of royalty revenues on net sales under the Solasia License and Collaboration Agreement. During the six months ended June 30, 2024 and 2023, the Company earned collaboration revenue of $0 and $0 and earned royalty revenues of $6 thousand and $4, respectively, of royalty revenues on net sales under the Solasia License and Collaboration Agreement.

KBI Biopharma Litigation

On March 17, 2023, KBI Biopharma, Inc., or KBI, filed a complaint against the Company in the District Court of Harris County, Texas, 165th Judicial District, asserting breach of an Amended and Restated Master Services Agreement between the Company and KBI relating to the development of an autologous gene modified T-cell therapy product, or the KBI Agreement. KBI was primarily seeking unspecified monetary damages in excess of $3.2 million. On May 1, 2023, the Company filed an answer generally denying all of KBI’s allegations and asserting affirmative and other defenses as well as counterclaims for breach of the KBI Agreement and conversion. On October 20, 2023, the Company entered into an agreement with KBI to settle all claims asserted by KBI against the Company and the Company's counterclaims against KBI at issue in the litigation for $1.0 million.

CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	6 Months Ended
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	Jun. 30, 2024	Jun. 30, 2023
Cash flows from operating activities:
Net loss	$ (2,810)	$ (18,821)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	3	1,395
Amortization of financing costs	0	1,339
Stock-based compensation	274	1,824
Decrease in the carrying amount of right-of-use assets	0	947
Gain on modification of lease	0	(245)
Loss on disposal of equipment	0	10
Change in operating assets and liabilities:
Receivables	(3)	0
Prepaid expenses and other current assets	(13)	342
Deposits	0	41
Accounts payable	(251)	90
Accrued expenses	(798)	(2,095)
Lease liabilities	0	(1,182)
Other liabilities, non-current	0	(28)
Increase (decrease) in:
Net cash used in operating activities	(3,598)	(16,383)
Cash flows from investing activities:
Purchases of property and equipment	0	(196)
Proceeds from the disposal of property and equipment	0	38
Net cash used in investing activities	0	(158)
Cash flows from financing activities:
Proceeds from the issuance of common stock	0	92
Repayment of long-term debt	0	(18,105)
Debt extinguishment	0	(125)
Net cash used in financing activities	0	(18,138)
Net decrease in cash, cash equivalents and restricted cash	(3,598)	(34,679)
Cash, cash equivalents and restricted cash, beginning of period	6,062	52,996
Cash and cash equivalents, end of period	2,464	18,317
Supplementary disclosure of cash flow information:
Cash paid for interest	$ 0	$ 2,063

Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options, granted	6,288	4,133	10,289	24,567
Weighted-average grant date fair value	$ 9.72	$ 54	$ 11.76	$ 58.5
Unvested Stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation costs related to unvested restricted stock outstanding	$ 0.3		$ 0.3
Expected recognition period			1 year 9 months 25 days

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

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+ Details

Organization

6 Months Ended

Jun. 30, 2024

Accounting Policies [Abstract]

Organization

Overview

Alaunos Therapeutics, Inc., which is referred to herein as “Alaunos,” or the “Company,” is a clinical-stage oncology-focused cell therapy company that was historically involved in the development of adoptive TCR therapies, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. The Company is leveraging its proprietary, non-viral Sleeping Beauty gene transfer platform and its novel cancer mutation hotspot TCR library to design and manufacture personalized cell therapies that target neoantigens arising from common tumor-related mutations in key oncogenic genes, including KRAS, TP53 and EGFR.

The Company’s operations to date have consisted primarily of conducting research and development and raising capital to fund those efforts.

As of June 30, 2024, there were 1,601,252 shares of common stock outstanding and an additional 175,476 shares of common stock reserved for issuance pursuant to outstanding stock options and warrants.

On August 14, 2023, the Company announced a strategic reprioritization of its business and wind down of its TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, the Company has significantly reduced its workforce and continues working to reduce costs in order to extend its cash runway. The Company continues to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. The Company has engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process. Separately, the Company is evaluating several potential opportunities including evaluating its own internal obesity program.

The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business.

The Company has operated at a loss since its inception in 2003 and has no recurring revenue from operations. The Company anticipates that losses will continue for the foreseeable future. As of June 30, 2024, the Company had approximately $2.5 million of cash and cash equivalents. The Company’s accumulated deficit at June 30, 2024 was approximately $918.9 million. Given its current development plans and cash management efforts, the Company anticipates cash resources will be sufficient to fund operations into the third quarter of 2024. The Company’s ability to continue operations after its current cash resources are exhausted depends on future events outside of the Company's control, including its ability to obtain additional financing or to achieve profitable results, as to which no assurances can be given. If adequate additional funds are not available when required, or if the Company is unsuccessful in entering into partnership agreements for further development of its product candidates, management may need to curtail its development efforts and planned operations to conserve cash until sufficient additional capital is raised. There can be no assurances that such a plan would be successful.

Based on the current cash forecast and the Company's dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, management has determined that the Company's present capital resources will not be sufficient to fund its planned operations for at least one year from the issuance date of the condensed financial statements, and substantial doubt as to the Company's ability to continue as a going concern exists. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of expenses could vary materially and adversely as a result of a number of factors.

Basis of Presentation

The accompanying unaudited interim condensed financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. The unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on April 1, 2024, or the Annual Report.

The results disclosed in the statements of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the full fiscal year 2024.

Use of Estimates

The preparation of condensed financial statements in conformity with GAAP requires management 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 condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company regularly

assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known.

Reverse Stock Splits

On January 31, 2024, the Company filed a Second Amended and Restated Certificate of Incorporation or (the Second Charter Amendment) with the Secretary of State of the State of Delaware in order to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-15 or the Reverse Split. The Second Charter Amendment decreased the number of authorized shares of common stock from 520,000,000 to 34,666,667. The Second Charter Amendment does not affect the par value of the Company’s common stock or change the number of authorized shares or par value of the Company’s preferred stock. The Second Charter Amendment became effective on January 31, 2024.

On July 17, 2024, the Company filed a Third Amended and Restated Certificate of Incorporation or Third Charter Amendment with the Secretary of State of the State of Delaware in order to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-10 or the Second Reverse Split, collectively the Reverse Splits. The Third Charter Amendment decreased the number of authorized shares of common stock from 34,666,667 to 5,000,000. The Third Charter Amendment does not affect the par value of the Company’s common stock or change the number of authorized shares or par value of the Company’s preferred stock. The Third Charter Amendment became effective on July 17, 2024.

No fractional shares were issued in connection with the Reverse Splits. Stockholders of record who would otherwise have been entitled to receive fractional shares as a result of the Reverse Splits received a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing sales price per share of the common stock (as adjusted for the Reverse Splits) on the Nasdaq Capital Market on January 31, 2024 and July 17, 2024.

All share and per share amounts of common stock, options, warrants, and restricted stock in the accompanying financial statements and notes thereto have been retroactively adjusted for all periods presented to reflect the Reverse Splits as if it had occurred at the beginning of the earliest period presented.

CONDENSED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
CONDENSED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Income Statement [Abstract]
Revenues	$ 4	$ 4	$ 6	$ 4
Operating expenses:
Research and development	180	5,186	306	11,689
General and administrative	990	3,045	2,607	6,213
Gain on lease modification	0	(245)	0	(245)
Total operating expenses	1,170	7,986	2,913	17,657
Loss from operations	(1,166)	(7,982)	(2,907)	(17,653)
Other income (expense):
Interest expense	0	(1,068)	0	(1,921)
Other income, net	37	277	97	753
Other income (expense), net	37	(791)	97	(1,168)
Net loss	$ (1,129)	$ (8,773)	$ (2,810)	$ (18,821)
Net loss per share , basic	$ (0.71)	$ (5.49)	$ (1.75)	$ (11.78)
Net loss per share , diluted	$ (0.71)	$ (5.49)	$ (1.75)	$ (11.78)
Weighted average common shares outstanding, basic	1,601,252	1,598,650	1,601,252	1,598,258
Weighted average common shares outstanding, diluted	1,601,252	1,598,650	1,601,252	1,598,258

Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands		6 Months Ended
	Dec. 18, 2018	Jun. 30, 2024	Jun. 30, 2023
Eden Biocell [Member]
Related Party Transaction [Line Items]
Payments to fund long-term loans to related parties	$ 10,000
Additional loans committed	$ 25,000
Dune Lake Capital [Member]
Related Party Transaction [Line Items]
Consulting service amount		$ 0	$ 25

Net Loss Per Share - Potentially Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share (Details) - shares	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	175,476	247,921
Warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	145,239	152,815
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	30,237	90,725
Unvested Restricted Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive securities excluded from computation of earnings per share, amount	0	4,381

Organization (Policies)	6 Months Ended
Organization (Policies)	Jun. 30, 2024
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited interim condensed financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. The unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on April 1, 2024, or the Annual Report. The results disclosed in the statements of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results to be expected for the full fiscal year 2024.
Use of Estimates	Use of Estimates The preparation of condensed financial statements in conformity with GAAP requires management 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 condensed financial statements and the reported amounts of revenues and expenses during the reporting period. Although the Company regularly assesses these estimates, actual results could differ from those estimates. Changes in estimates are recorded in the period in which they become known.
Reverse Stock Split	Reverse Stock Splits On January 31, 2024, the Company filed a Second Amended and Restated Certificate of Incorporation or (the Second Charter Amendment) with the Secretary of State of the State of Delaware in order to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-15 or the Reverse Split. The Second Charter Amendment decreased the number of authorized shares of common stock from 520,000,000 to 34,666,667. The Second Charter Amendment does not affect the par value of the Company’s common stock or change the number of authorized shares or par value of the Company’s preferred stock. The Second Charter Amendment became effective on January 31, 2024. On July 17, 2024, the Company filed a Third Amended and Restated Certificate of Incorporation or Third Charter Amendment with the Secretary of State of the State of Delaware in order to effect a reverse stock split of the Company’s common stock at a ratio of 1-for-10 or the Second Reverse Split, collectively the Reverse Splits. The Third Charter Amendment decreased the number of authorized shares of common stock from 34,666,667 to 5,000,000. The Third Charter Amendment does not affect the par value of the Company’s common stock or change the number of authorized shares or par value of the Company’s preferred stock. The Third Charter Amendment became effective on July 17, 2024. No fractional shares were issued in connection with the Reverse Splits. Stockholders of record who would otherwise have been entitled to receive fractional shares as a result of the Reverse Splits received a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing sales price per share of the common stock (as adjusted for the Reverse Splits) on the Nasdaq Capital Market on January 31, 2024 and July 17, 2024. All share and per share amounts of common stock, options, warrants, and restricted stock in the accompanying financial statements and notes thereto have been retroactively adjusted for all periods presented to reflect the Reverse Splits as if it had occurred at the beginning of the earliest period presented.

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Jun. 30, 2024	Dec. 31, 2023
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	5,000,000	5,000,000
Common stock, shares issued	1,601,252	1,601,252
Common stock, shares outstanding	1,601,252	1,601,252

Warrants - Additional Information (Details) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Fair Value Assumptions Expected volatility Rate Maximum	170.50%	95.63%
Fair Value Assumptions Risk Free Interest Rate Maximum		3.87%
Aggregate offering price		$ 92
Risk-free interest rate	4.09%