Form 8-K - Current report
May 14 2024 - 7:30AM
Edgar (US Regulatory)
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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 14, 2024
_______________________________
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, $0.00001 par value per share | INKT | The 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 14, 2024, MiNK Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2024. 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:
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 14, 2024 | By: | /s/ Christine M. Klaskin |
| | | Christine M. Klaskin |
| | | Principal Financial Officer |
| | | |
EXHIBIT 99.1
MiNK Reports First Quarter 2024 Results
- Completed $5.8 million private placement financing at 25% premium
- Upcoming presentation of agenT-797 in severe respiratory distress at the American Thoracic Society (ATS)
- AACR presentation reported MiNK-215 eliminated MSS colorectal cancer liver metastases in human organoid models
NEW YORK, May 14, 2024 (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 announced results for the first quarter 2024. MiNK executives will host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide a corporate update.
“This quarter we made significant strides across our iNKT cell programs, as we remain focused on generating clinical data from our lead program, agenT-797, strengthening our financial position, and advancing our innovative next-generation therapies,” said Dr. Jennifer Buell, Chief Executive Officer, and President of MiNK. “The $5.8 million capital infusion will enable us to accelerate the advancement of MiNK-215 into the clinic, which we believe has exciting potential to address significant unmet needs in solid tumor cancers, as demonstrated by the pre-clinical data we recently presented at AACR.”
Business Updates:
- MiNK successfully closed a private placement financing (PIPE) agreement, raising $5.8 million with a new investor. The proceeds will accelerate the clinical entry of MiNK-215, an investigational IL-15 armored fibroblast activation protein (FAP)-targeting CAR-iNKT cell therapy, currently in IND enabling studies with a filing planned for 2025.
- Yekaterina ("Katie") Chudnovsky, an accomplished attorney, venture investor, and dedicated patient advocate, has been appointed as a Board Observer at MiNK.
Clinical Program Updates:
- AgenT-797 in Gastroesophageal Cancers: Phase 2 investigator-sponsored trial, led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center, has been actively enrolling since February 2024. The trial assesses the combination of agenT-797 with Agenus' botensilimab, balstilimab, and standard of care chemotherapy with initial results expected later this year (NCT06251973).
- ATS Annual Meeting Presentation: A poster presentation at the upcoming ATS Annual Meeting on May 21, 2024, will highlight the clinical efficacy of agenT-797 in treating respiratory distress, particularly focusing on a complex case involving severe COVID-19 complications in a renal transplant patient.
- Abstract Title: Persistent SARS-CoV-2 Viremia, COVID-19 Associated Acute Respiratory Distress Syndrome, Severe Coagulopathy and Massive Hemoptysis in a Renal Transplant Patient on Veno-Venous Extracorporeal Membrane Oxygenation
- Abstract Number: P439
- Date and Time: May 21, 2024, 11:30 a.m. – 1:15 p.m. PST
MiNK-215 Development:
- Data presented at the AACR Annual Meeting in April 2024, presented robust preclinical data showing MiNK-215’s effectiveness against MSS colorectal cancer liver metastases. The therapy demonstrated significant tumor elimination capabilities through immune activation, tumor stroma remodeling, and enhanced tumor killing. Plans are in place to fast-track the IND filing to early 2025.
Financial Results
We ended the quarter with a cash balance of $5.8 million. Cash used in operations for the three months ended March 31, 2024 was $2.5 million compared to $4.4 million for the same period in 2023. Net loss for the first quarter of 2024 was $3.8 million, or $0.11 per share, compared to $5.7 million, or $0.17 per share, for the first quarter of 2023.
| Summary Consolidated Financial Information |
| | | | |
| Condensed Consolidated Balance Sheet Data |
| (in thousands) |
| (unaudited) |
| | | | |
| | March 31, 2024 | | December 31, 2023 |
| | | | |
| Cash and cash equivalents | $ | 5,817 | | | $ | 3,367 | |
| Total assets | | 6,894 | | | | 4,552 | |
| | | | |
| | | | |
| Other Financial Information |
| (in thousands) |
| (unaudited) |
| | Three months ended March 31, |
| | | 2024 | | | | 2023 | |
| | | | |
| Cash used in operations | $ | 2,542 | | | $ | 4,366 | |
| Non-cash expenses | | 650 | | | | 967 | |
| | | | |
| | | | |
| | | | |
| Condensed Consolidated Statements of Operations Data |
| (in thousands, except per share data) |
| (unaudited) |
| | | | |
| | Three months ended March 31, |
| | | 2024 | | | | 2023 | |
| | | | |
| Operating expenses: | | | |
| Research and development | | 2,550 | | | | 4,194 | |
| General and administrative | | 1,280 | | | | 1,660 | |
| | | | |
| Operating loss | | 3,830 | | | | 5,854 | |
| | | | |
| Other income, net | | (17 | ) | | | (168 | ) |
| | | | |
| Net loss | $ | 3,813 | | | $ | 5,686 | |
| | | | |
| Per common share data, basic and diluted: | | | |
| Net loss | $ | (0.11 | ) | | $ | (0.17 | ) |
| Weighted average number of common shares outstanding, basic and diluted | | 34,643 | | | | 33,967 | |
| | | | |
Conference Call
Dial-in numbers: 646-307-1963 (U.S. – NY), 800-715-9871 (U.S. & Canada)
Conference ID: 7888464
Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at https://investor.minktherapeutics.com/events-and-presentations and via https://edge.media-server.com/mmc/p/vc5onn9q.
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/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.
Forward Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797, MiNK-215, and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797 alone and in combination with anti-PD-1, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Investor Contact
917-362-1370
investor@minktherapeutics.com
Media Contact
781-674-4428
communications@minktherapeutics.com
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