Form 8-K - Current report
13 August 2024 - 1:00PM
Edgar (US Regulatory)
0001840229 False 0001840229 2024-08-13 2024-08-13 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
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): August 13, 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 August 13, 2024, MiNK Therapeutics, Inc. announced its financial results for the quarter ended June 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: August 13, 2024 | By: | /s/ Christine M. Klaskin |
| | | Christine M. Klaskin |
| | | Principal Financial Officer |
| | | |
EXHIBIT 99.1
MiNK Reports Second Quarter 2024 Results and Business Update
- Expanded Access to AgenT-797 in Severe ARDS Reinforces Clinical Efficacy; Data Highlighted at ATS 2024 Annual Meeting
- Phase 2 Study in 2L Gastric Cancer Advances; Early Clinical Data to be Presented at Upcoming Medical Conference
- Phase 1 Study in GvHD on Track for Activation in 2Q 2024
NEW YORK, Aug. 13, 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 second 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.
"MiNK is making significant strides in advancing our iNKT programs as we pioneer this next generation of cell therapies for patients," said Dr. Jennifer Buell, CEO of MiNK Therapeutics. "Our lead program, agenT-797, is moving forward in a Phase 2 study for second-line gastric cancer, and we are fast-tracking IND-enabling activities for our FAP-expressing CAR-iNKT therapy, MiNK-215. Additionally, the expanded findings presented at the ATS annual meeting underscore the significant potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients. We are committed to expanding the development of agenT-797 in a non-dilutive manner, particularly in the areas of ARDS and GvHD, where unmet needs are critical."
Business Updates:
- In May 2024, MiNK successfully closed a private placement financing (PIPE) agreement, raising $5.8 million at a 25% premium to a new investor. Increased efficiency and progress of externally funded trials enable cash runway into 2025.
Clinical Programs:
- Acute Respiratory Distress (ARDS): Expanded access to agenT-797 in ARDS has deepened observations of clinical benefit. MiNK’s recent presentation at the American Thoracic Society (ATS) 2024 annual meeting highlighted the activity of agenT-797 in treating ARDS. In a clinical case involving a renal transplant patient with severe COVID-19-induced respiratory distress, agenT-797 led to rapid cytokine reduction, successful extubation, and rapid discharge after just a single dose. These results underscore the potential of agenT-797 for severe respiratory conditions in immune-compromised patients. MiNK is committed to advancing agenT-797 in ARDS through a predominantly externally funded, large-scale platform trial.
- 2L Gastric Cancer: A Phase 2 Investigator-Sponsored Study of agenT-797 is progressing rapidly at Memorial Sloan Kettering Cancer Center (NCT06251973). The study’s swift advancement and early signals of activity highlight the promising potential of agenT-797 in treating challenging cancers, with initial data at an upcoming conference.
- MiNK is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for 2Q 2024. This study aims to explore the potential of agenT-797 in mitigating GvHD, a severe and life-threatening complication following allogeneic stem cell transplantation. The unique immunomodulatory properties of iNKT cells offer a novel therapeutic approach to controlling GvHD by reducing inflammation and promoting immune tolerance - furthering MiNK’s commitment to the application of agenT-797 beyond cancer.
Preclinical Programs Advancing:
- MiNK-215 is an investigational IL-15 armored fibroblast activation protein (FAP) targeting CAR-iNKT cell therapy, that has demonstrated robust preclinical activity in solid tumor cancers, including MSS colorectal cancer liver metastases, and non-small-cell-lung cancer. Plans are in place to fast-track the IND filing to early 2025.
Financial Results
MiNK ended the quarter with a cash balance of $9.3 million reflecting cash used in operations for the quarter of $2.3 million, reduced from $2.6 million for the first quarter 2024.
Net loss for the three and six months ended June 30, 2024, was $2.7 million, or $0.07 per share, and $6.5 million, or $0.18 per share, respectively. This compares to $6.2 million, or $0.18 per share, and $11.9 million, or $0.35 per share, for the same periods in 2023.
| Summary Consolidated Financial Information | | | | |
| | | | | | | | | |
| Condensed Consolidated Balance Sheet Data | | | | |
| (in thousands) | | | | |
| (unaudited) | | | | |
| | | | | | | | | |
| | June 30, 2024 | | December 31, 2023 | | | | | |
| | | | | | | | | |
| Cash and cash equivalents | $ | 9,314 | | | $ | 3,367 | | | | | | |
| Total assets | | 10,324 | | | | 4,552 | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Other Financial Information | | | | | |
| (in thousands) | | | | |
| (unaudited) | | | | |
| | Three months ended June 30, | | Six months ended June 30, | |
| | | 2024 | | | | 2023 | | | | 2024 | | | | 2023 | | |
| | | | | | | | | |
| Cash used in operations | $ | 2,291 | | | $ | 4,151 | | | $ | 4,833 | | | $ | 8,517 | | |
| Non-cash operating expenses | | 491 | | | | 683 | | | | 1,141 | | | | 1,650 | | |
| | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
| Condensed Consolidated Statements of Operations Data | | | | |
| (in thousands, except per share data) | | | | |
| (unaudited) | | | | |
| | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, | |
| | | 2024 | | | | 2023 | | | | 2024 | | | | 2023 | | |
| | | | | | | | | |
| Operating expenses: | | | | | | | | |
| Research and development | $ | 1,840 | | | $ | 4,558 | | | $ | 4,389 | | | $ | 8,752 | | |
| General and administrative | | 1,062 | | | | 1,785 | | | | 2,343 | | | | 3,445 | | |
| Change in fair value of related party note | | 169 | | | | - | | | | 169 | | | | - | | |
| | | | | | | | | |
| Operating loss | | 3,071 | | | | 6,343 | | | | 6,901 | | | | 12,197 | | |
| | | | | | | | | |
| Other income, net | | (369 | ) | | | (146 | ) | | | (386 | ) | | | (314 | ) | |
| | | | | | | | | |
| Net loss | $ | 2,702 | | | $ | 6,197 | | | $ | 6,515 | | | $ | 11,883 | | |
| | | | | | | | | |
| Per common share data, basic and diluted: | | | | | | | | |
| Net loss | $ | (0.07 | ) | | $ | (0.18 | ) | | $ | (0.18 | ) | | $ | (0.35 | ) | |
| Weighted average number of common shares outstanding, basic and diluted | | 37,142 | | | | 34,409 | | | | 35,892 | | | | 34,189 | | |
| | | | | | | | | |
Conference Call
Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada).
Conference ID: 4021545
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/gwzqgg8t/.
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, 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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