Form 8-K - Current report
2024年11月14日 - 9:00PM
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): November 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 November 14, 2024, MiNK Therapeutics, Inc. announced its financial results for the quarter ended September 30, 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: November 14, 2024 | By: | /s/ Christine M. Klaskin |
| | | Christine M. Klaskin |
| | | Principal Financial Officer |
| | | |
EXHIBIT 99.1
MiNK Therapeutics Reports Third Quarter 2024 Results and Business Update
NEW YORK, Nov. 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 third quarter 2024. MiNK will host a conference call and webcast at 8:30 a.m. ET.
“Our progress this quarter reflects MiNK’s commitment to advancing effective and scalable therapies in cancer and immune-mediated diseases,” said Jennifer Buell, PhD, Chief Executive Officer of MiNK Therapeutics. “We have continued to expand our iNKT cell therapy platform and partnerships to address high-need areas, recently showcasing the versatility of iNKT cells in two presentations at SITC. Our clinical programs are advancing with the ongoing Phase 2 study in second-line and later-stage gastric cancer, with initial data anticipated early next year. These developments underscore our momentum in delivering impactful treatments for patients.”
Recent Business Updates:
- Board Appointment: Dr. Robert Kadlec, a recognized authority in biodefense, pandemic preparedness, and public health strategy, has joined MiNK’s Board of Directors. Dr. Kadlec’s expertise in public health and biodefense will support MiNK’s iNKT cell platform in addressing critical infectious diseases.
- Research Collaboration: MiNK and Autonomous Therapeutics, a pioneer in disease-activated RNA medicines, entered into a research collaboration to target and treat metastatic tumors. The collaboration combines Autonomous’ encrypted RNA™ (encRNA) technology with MiNK’s iNKT cell therapies, MiNK-215 and agenT-797, with the goal of developing therapies to effectively target metastatic cancer cells.
- SITC 2024 Presentations: Two poster presentations at the Society for Cancer Immunotherapy (SITC) 2024 Annual Meeting highlighted the potential of iNKT cell therapies in advancing cancer treatment:
- AgenT-797 demonstrated enhanced activity of checkpoint inhibitors and bispecific engagers in combination.
- PRAME-targeted TCR iNKT cell therapy showcased the potential to address limitations of traditional T cell therapies in targeting solid tumors such as NSCLC, ovarian cancer, melanoma, and sarcoma. Preclinical studies indicate that PRAME-TCR-iNKTs can specifically target and kill tumor cells.
- Solid Tumor Clinical Program: AgenT-797 is advancing in an enrolling Phase 2 trial in second-line and later-stage advanced gastroesophageal cancer at Memorial Sloan-Kettering Cancer Center, with results expected at a major conference in early 2025.
- Graft-versus-Host Disease (GvHD) Program: MiNK is advancing initiation of Phase 1 trial with external financial support to investigate agenT-797 for the treatment of GvHD, in collaboration with leading research institutions in the U.S. and EU for dosing to start in 2025.
Financial Results
MiNK ended the quarter with a cash balance of $6.3 million reflecting cash used in operations for the three and nine months ended September 2024 of $3 million and $7.8 million, respectively, reduced from $7.8 million and $12.7 million, for the same period in 2023.
Net loss for the three and nine months ended September 30, 2024, was $1.8 million, or $0.05 per share, and $8.3 million, or $0.22 per share, respectively. This compares to $5.1 million, or $0.15 per share, and $17 million or $0.50 per share, for the same periods in 2023.
| Summary Consolidated Financial Information |
| | | | | |
| Condensed Consolidated Balance Sheet Data |
| (in thousands) |
| (unaudited) |
| | | | | | | | |
| | September 30, 2024 | | December 31, 2023 | | | | |
| | | | | | | | |
| Cash and cash equivalents | $ | 6,328 | | | $ | 3,367 | | | | | |
| Total assets | | 7,375 | | | | 4,552 | | | | | |
| | | | | | | | |
| | | | | | | | |
| Other Financial Information |
| (in thousands) |
| (unaudited) |
| |
| | Three months ended September 30, | | Nine months ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | | | | | | | |
| Cash used in operations | $ | 2,995 | | | $ | 4,209 | | | $ | 7,828 | | | $ | 12,727 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| Condensed Consolidated Statements of Operations Data |
| (in thousands, except per share data) |
| (unaudited) |
| | | | | | | | |
| | Three months ended September 30, | | Nine months ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | | | | | | | |
| Operating expenses: | | | | | | | |
| Research and development | $ | 541 | | | $ | 3,427 | | | $ | 4,930 | | | $ | 12,179 | |
| General and administrative | | 1,163 | | | | 1,796 | | | | 3,505 | | | | 5,242 | |
| Change in fair value of related party note | | 181 | | | | - | | | | 350 | | | | - | |
| | | | | | | | |
| Operating loss | | 1,885 | | | | 5,223 | | | | 8,785 | | | | 17,421 | |
| | | | | | | | |
| Other income, net | | (78 | ) | | | (107 | ) | | | (464 | ) | | | (422 | ) |
| | | | | | | | |
| Net loss | $ | 1,807 | | | $ | 5,116 | | | $ | 8,321 | | | $ | 16,999 | |
| | | | | | | | |
| Per common share data, basic and diluted: | | | | | | | |
| Net loss | $ | (0.05 | ) | | $ | (0.15 | ) | | $ | (0.22 | ) | | $ | (0.50 | ) |
| Weighted average number of common shares outstanding, basic and diluted | | 39,534 | | | | 34,498 | | | | 37,115 | | | | 34,293 | |
Conference Call
Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada)
Conference ID: 5606166
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/ukmiq8bo/.
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 potential, anticipated benefit, plans and timelines of iNKT cells and encrypted RNA, as well as the collaboration between MiNK and Autonomous Therapeutics. 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, Form 10-Q and the S-1 Registration Statement 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 and Autonomous undertake 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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MiNK Therapeutics (NASDAQ:INKT)
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