UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
_______________________________
(Exact name of registrant as specified in its charter)
_______________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices) (Zip Code)
(
(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 |
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.
On November 9, 2023, MiNK Therapeutics, Inc. announced its financial results for the quarter ended September 30, 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.
(d) Exhibit
The following exhibit is furnished herewith:
99.1 Press Release dated November 9, 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: November 9, 2023 | By: | /s/ Christine M. Klaskin |
| Christine M. Klaskin | ||
| Principal Financial Officer | ||
EXHIBIT 99.1
MiNK Therapeutics Reports Third Quarter 2023 Results
- MiNK presents first-of-a-kind data with allogeneic iNKTs, agenT-797, showing durable clinical benefit in solid tumor cancers and persistence >6 months without toxic pre-conditioning.
- AgenT-797 demonstrates potential beyond cancer, with improved survival in severe respiratory distress. MiNK plans for expansion in autoimmune and inflammatory diseases.
- Conference Call on Thursday, November 9, 2023, at 8:30 a.m. ET.
NEW YORK, Nov. 09, 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 reported financial results for the third quarter 2023. MiNK executives will host a conference call and webcast at 8:30 a.m. ET to discuss the results and to provide a corporate update.
"This quarter we made important advancements across our iNKT cell platform, including new data that demonstrated the long-term persistence and clinical benefits of iNKTs in heavily pretreated solid tumor cancer patients,” said Dr. Jennifer Buell, President and Chief Executive Officer. “We’ve also progressed our innovative engineered programs, including CARs and TCRs, and made substantial strides expanding our internal cGMP manufacturing, a critical capability to making these novel cells accessible to a broad patient population.”
AgenT-797 has shown promising results in patients with late-stage metastatic cancer, including NSCLC, testicular, appendiceal, and gastric cancers, refractory to traditional therapies. More than 30% of these patients experienced disease stabilization or biomarker responses, and a patient with gastric cancer achieved a durable clinical response. This is especially significant, considering agenT-797’s administration does not require HLA matching or toxic pre-conditioning, setting a new standard in the field of cell therapy.
A randomized phase 2 clinical trial of agenT-797 +/- standard of care chemotherapy +/- Agenus’ botensilimab/balstilimab in patients with 2L gastric cancer is on track to launch this year. The trial will be externally funded and led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center.
Financial Results
We ended the third quarter with a cash balance of $6.4 million as compared to $10.6 million at June 30, 2023, and $19.6 million at December 31, 2022. Cash used in operations for the three and nine months ended September 30, 2023, was $4.2 million, and $12.7 million, respectively, compared to $5.6 million and $14.4 million for the same periods in 2022.
Net loss for the nine-months ended September 30, 2023 was $17 million, or $0.50 per share, compared to net loss for the same period in 2022 of $20.2 million or $0.60 per share.
| Summary Consolidated Financial Information | |||||||||||||||
| Condensed Consolidated Balance Sheet Data | |||||||||||||||
| (in thousands) | |||||||||||||||
| (unaudited) | |||||||||||||||
| September 30, 2023 | December 31, 2022 | ||||||||||||||
| Cash and cash equivalents | $ | 6,399 | $ | 19,636 | |||||||||||
| Total assets | 7,462 | 21,472 | |||||||||||||
| Other Financial Information | |||||||||||||||
| (in thousands) | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Cash used in operations | $ | 4,209 | $ | 5,615 | $ | 12,727 | $ | 14,436 | |||||||
| Non-cash operating expenses (income) | $ | 993 | $ | (1,989 | ) | 2,643 | $ | (348 | ) | ||||||
| Condensed Consolidated Statements of Operations Data | |||||||||||||||
| (in thousands, except per share data) | |||||||||||||||
| (unaudited) | |||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 3,427 | 6,150 | 12,179 | 17,303 | |||||||||||
| General and administrative | 1,796 | 1,838 | 5,242 | 5,757 | |||||||||||
| Operating loss | 5,223 | 7,988 | 17,421 | 23,060 | |||||||||||
| Other income, net | (107 | ) | (1,656 | ) | (422 | ) | (2,838 | ) | |||||||
| Net loss | $ | 5,116 | $ | 6,332 | $ | 16,999 | $ | 20,222 | |||||||
| Per common share data, basic and diluted: | |||||||||||||||
| Net loss | $ | (0.15 | ) | $ | (0.19 | ) | $ | (0.50 | ) | $ | (0.60 | ) | |||
| Weighted average number of common shares outstanding, basic and diluted | 34,498 | 33,757 | 34,293 | 33,628 | |||||||||||
Conference Call
United States (New York): 646-968-2525
USA & Canada: 888-596-4144
Conference ID: 8819822
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/uns7ovrj/.
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 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, 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 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