8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  May 11, 2023

_______________________________

MiNK Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware	001-40908	82-2142067
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

149 Fifth Avenue, Suite 500

New York, New York 10010

(Address of Principal Executive Offices) (Zip Code)

(212) 994-8250

(Registrant's telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 $0.00001 per share	INKT	NASDAQ Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 2.02. Results of Operations and Financial Condition.

On May 11, 2023, MiNK Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2023. In connection with the announcement, the Company issued a press release, which is being furnished as Exhibit 99.1 to this current report on Form 8-K.

The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibit

The following exhibit is furnished herewith:

99.1	Press Release dated May 11, 2023
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	MiNK Therapeutics, Inc.
Date: May 11, 2023	By:	/s/ Christine M. Klaskin
		Christine M. Klaskin
		Principal Financial Officer

EX-99.1

EXHIBIT 99.1

MiNK Therapeutics Reports Corporate Update and First Quarter 2023 Financial Results

• agenT-797, an allo-iNKT cell therapy, shows clinical responses in heavily pre-treated solid tumor cancers when administered with anti-PD-1 and persists without lymphodepletion.
• Initiating phase 1/2 expansion studies in NSCLC and gastric cancer, with majority costs planned for external, non-dilutive grant funding.
• MiNK to present an update on the novel FAP-CAR-iNKT IND-enabling program at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting.
  

NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today provided a corporate update and reported financial results for the first quarter 2023.

“This quarter we have achieved significant progress across our iNKT cell platform. Our lead program, agenT-797, has shown pioneering data in advanced solid cancers at AACR and we have launched expansion studies in anti-PD-1 refractory NSCLC and gastric cancer”, said Dr. Jennifer Buell, President and CEO at MiNK. “We are proud to remain the most clinically advanced allo-iNKT company with robust manufacturing capabilities and a novel pipeline of next generation therapies, including our novel FAP-CAR-iNKT.”

Allogeneic iNKT cell therapy (agenT-797) showed clinical benefit and tolerable safety across a range of heavily pre-treated solid tumor cancers at AACR 2023.

• A durable partial response (PR) was observed in a patient with metastatic gastric cancer who had no response to prior anti-PD-1 alone or in combination with standard chemotherapy. The patient received agenT-797 (4.3x10⁶ cells/kg) in combination with anti-PD-1 and achieved a 42% tumor reduction that continued beyond 9 months.
• Durable disease stabilization and biomarker responses were also observed in anti-PD-1 refractory NSCLC and testicular cancers.
• iNKT cells can be administered without lymphodepletion, persist for >~8 weeks, and generate and mobilize immune cells into the tumor for cancer cell destruction.
• A tolerable safety profile was observed up to 1x10⁷ cells, with no neurotoxicity, dose-limiting toxicities, or severe cytokine release syndrome (> grade 3).
• MiNK expands trials in NSCLC and launches an independent trial in metastatic gastric cancer led by Dr. Yelena Janjigian, Chief of GI Oncology at Memorial Sloan Kettering.
  • AgenT-797 will be administered in combination with standard chemotherapy with and without immune checkpoint inhibitors. The study is planned to be externally funded by non-dilutive grant funding.
  • MiNK will supply trial with its in-house manufacturing capability, currently producing 5,000 doses/year with rapidly expanding capacity.
    

Upcoming Presentations:

• MiNK continues to advance next generation CAR-iNKT programs and will present new data on allogeneic FAP-CAR-iNKT, MiNK-215, at American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 19^th.
  

Title: Development of an Allogeneic FAP-CAR iNKT Cell Therapy to Modulate the Immunosuppressive Stroma and Improves Anti-Tumor Immunity Against Non-Small Cell Lung Carcinoma
Presenting Author: Dr. Shannon Boi
Date/Time: May 19^th, 2023, 12:00-2:00 pm ET
Abstract number: 1488

• Dr. Terese Hammond, West Region Medical Director at Sound Critical Care, to present clinical data from phase 1/2 study of agenT-797 in viral ARDS at American Thoracic Society (ATS) Annual Meeting (Abstract Number: 10725) on May 21^st.
  

First Quarter 2023 Financial Results

We ended the first quarter 2023 with a cash balance of $14.9 million as compared to $19.6 million at December 31, 2022. Cash used in operations for the quarter ended March 31, 2023, was $4.4 million, compared to $4.2 million for the same period in 2022.

Net loss for the quarter ended March 31, 2023, was $5.7 million or $0.17 per share, compared to a net loss for the first quarter of 2022 of $7.8 million or $0.23 per share.

Summary Consolidated Financial Information
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
	March 31, 2023			December 31, 2022
Cash and cash equivalents	$	14,892		$	19,636
Total assets		16,589			21,472
Other Financial Information
(in thousands)
(unaudited)
	Three months ended March 31,
		2023			2022
Cash used in operations	$	4,366		$	4,196
Non-cash expenses		967			813
Condensed Consolidated Statements of Operations Data
(in thousands, except per share data)
(unaudited)
	Three months ended March 31,
		2023			2022
Operating expenses:
Research and development		4,194			5,277
General and administrative		1,660			2,097
Operating loss		5,854			7,374
Other expense (income), net		(168	)		403
Net loss	$	5,686		$	7,777
Per common share data, basic and diluted:
Net loss	$	(0.17	)	$	(0.23	)
Weighted average number of common shares outstanding, basic and diluted		33,967			33,504

Forward Looking Statements

This release contains forward-looking statements. You can identify these forward-looking statements by the fact they use words such as “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “intend,” “plan,” “believe,” “will,” “potential,” “opportunity,” “future” and other words and terms of similar meaning and include statements that they do not relate strictly to historical or current facts. In particular, these statements relate to, among other things, the mechanism of action, efficacy and safety of our iNKT technology and therapeutic candidates, business strategy, our research and development plans, our product development efforts, funding and partnering opportunities, future operating plans, results, objectives, expectations, and intentions. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. Therefore, we caution investors such statements need to be evaluated in light of all the information contained in our filings with the SEC on our Annual Report on Form 10-K, among others. Furthermore, the statements speak only as of the date of this document, and we undertake no obligation to update or revise these statements, except as required by law.

Conference Call and Webcast

MiNK will host a conference call and webcast to discuss its first quarter 2023 financial results and business updates today, Thursday, May 11^th, 2023, at 8:30 AM ET. The webcast is available on the events and presentations page of the company website and at https://edge.media-server.com/mmc/p/4c4qmbci). The conference ID is 8437743. To access live by phone, call 646-307-1963 (USA-NY) or 800-715-9871 (USA & Canada).

About MiNK Therapeutics

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/. Follow us on Twitter @MiNK_iNKT.

Contact

Alexa Buffa
781-674-4428
communications@minktherapeutics.com

Investor relations
Zack Armen
917-362-1370
investor@minktherapeutics.com

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