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 August 9, 2022, MiNK Therapeutics, Inc. announced its financial results for the quarter ended June 30, 2022. 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 August 9, 2022 | |
| 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: August 9, 2022 | By: | /s/ Christine M. Klaskin |
| Christine M. Klaskin | ||
| Principal Financial Officer | ||
EXHIBIT 99.1
MiNK Therapeutics Reports Corporate Update and Second Quarter 2022 Financial Results
- Novel stromal-CAR-iNKT shows activity in solid tumors; FIH planned for 2023
- Clinical presentation of AgenT-797 in solid tumors, myeloma, and ARDS planned for 2H2022
- Under the leadership team of Dr. Joy Zhou, completed internal cGMP production of AgenT-797 with expansion capacity to treat >700,000 patients/year
- AgenT-797 for the treatment of infections and viral ARDS identified as selectable for funding by DARPA; contract negotiations underway
NEW YORK, Aug. 09, 2022 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc., 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 second quarter 2022 and provided a corporate update.
“We are on track to present clinical data updates from our lead program, AgenT-797, an allo-iNKT cell therapy, administered alone and in combination with KEYTRUDA® or OPDIVO® this year1,” said Dr. Jennifer Buell, President and Chief Executive Officer of MiNK. “We are also excited to present data on our novel pipeline of CAR-iNKTs, including a differentiated, stromal-CAR-iNKT program in solid tumors and a novel armored BCMA-CAR-iNKT designed to be delivered without toxic lymphodepletion; all enabled by our fully internalized cGMP manufacturing and our star team.”
1KEYTRUDA® (pembrolizumab) is a registered trademark of Merck and OPDIVO® (nivolumab) is a registered trademark of Bristol Myers Squibb
Business Progress:
- Enrollment advancing in clinical trials of AgenT-797 alone or in combo with FDA-approved PD-1 (KEYTRUDA or OPDIVO) in solid tumors and multiple myeloma. Encouraging signs of safety and clinical activity at doses from 10x106 to 100x106 cells. No evidence of cytokine release syndrome or neurotoxicity. Early observations of disease modulation metastatic liver lesions in a patient with refractory rectal cancer and highly refractory multiple myeloma. Expansion plans in solid tumor cancers where auto-iNKTs have shown benefit, including but not limited to tumors of the lung, liver, bladder, and kidney are underway.
- Successful completion of in-house cGMP production of allogeneic iNKTs. Under the leadership team of Dr. Joy Zhou, MiNK completed internal cGMP production of AgenT-797 with expansion capacity to treat >700,000 patients/year in a fully integrated semi-closed automated manufacturing process.
- AgenT-797 revealed early signals of clinical activity in viral ARDS with expanded clinical data updates planned for 2H2022. Early data support development opportunity in viral ARDS, an indication with no approved effective therapies. AgenT-797 has been identified as selectable for funding by DARPA, with contract negotiations underway.
- Expanded MiNK leadership team appointment Dr. Joy Zhou, as Vice President Head of CMC. Dr. Zhou oversees the company’s CMC operations, bringing over 20 years of biologics and cell therapy product development industry experience from discovery through commercialization and post-commercialization. Dr. Zhou has held various leadership positions at Pfizer, JNJ and Takeda including as the Head of Takeda Cell Therapy Product Development. She received her Ph.D. in Pharmaceutical Chemistry from the University of Kansas.
- IND enabling studies underway for next-generation iNKT programs including a differentiated pipeline of novel CAR-iNKTs and iNKT-engagers. Data presentations planned for a novel, differentiated, stromal-CAR-iNKT program in solid tumors and a novel armored BCMA-CAR-iNKT designed to be delivered without toxic lymphodepletion.
Near-term Milestones (2H22):
- Clinical data updates on AgenT-797 in solid tumors, myeloma, and viral ARDS planned for 2H2022.
- Plan to present data on a novel, differentiated, stromal-CAR-iNKT program in solid tumors and potential differentiation of a novel armored BCMA-CAR-iNKT designed to be delivered without toxic lymphodepletion.
- Expert on discovery and development of novel immune modulating therapies, CSO Dr. Marc Van Dijk, will speak on MiNK’s novel iNKT platform and engineering capabilities at the CAR-Summit in Boston on September 19th.
Fourth Quarter and Full Year 2021 Financial Results
We ended the second quarter 2022 with a cash balance of $29.8 million as compared to $38.9 million at December 31, 2021.
Cash used in operations for the six-months and second quarter ended June 30, 2022, was $8.8 million, and $4.6 million respectively, compared to $7.6 million and $3.4 million for the same periods in 2021.
Net loss for the quarter ended June 30, 2022, was $6.1 million or $0.18 per share, compared to a net loss for the same period of 2021 of $6.3 million or $0.26 per share. Net loss for the six months ended June 30, 2022, was $13.9 million, or $0.41 per share compared to $10.2 million and $0.42 per share for the six months ended June 30, 2021.
| Summary Consolidated Financial Information | ||||||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| June 30, 2022 | December 31, 2021 | |||||||||||||||
| Cash and cash equivalents | $ | 29,847 | $ | 38,889 | ||||||||||||
| Total assets | 31,117 | 40,242 | ||||||||||||||
| Total stockholders' equity | 13,690 | 23,776 | ||||||||||||||
| Other Financial Information | ||||||||||||||||
| (in thousands) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cash used in operations | $ | 4,626 | $ | 3,420 | $ | 8,822 | $ | 7,629 | ||||||||
| Non-cash expenses | $ | 829 | $ | 2,390 | 1,642 | 2,748 | ||||||||||
| Condensed Consolidated Statements of Operations Data | ||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,876 | 3,585 | 11,153 | 6,682 | ||||||||||||
| General and administrative | 1,822 | 868 | 3,919 | 1,463 | ||||||||||||
| Change in fair value of convertible affiliated note (non-cash) | - | 1,160 | - | 475 | ||||||||||||
| Operating loss | 7,698 | 5,613 | 15,072 | 8,620 | ||||||||||||
| Other expense (income), net | (1,585 | ) | 722 | (1,182 | ) | 1,561 | ||||||||||
| Net loss | $ | 6,113 | $ | 6,335 | $ | 13,890 | $ | 10,181 | ||||||||
| Per common share data, basic and diluted: | ||||||||||||||||
| Net loss | $ | (0.18 | ) | $ | (0.26 | ) | $ | (0.41 | ) | $ | (0.42 | ) | ||||
| Weighted average number of common shares outstanding, basic and diluted | 33,619 | 24,177 | 33,562 | 24,177 | ||||||||||||
Conference Call:
Tuesday August 9th, 11:00 AM ET
Dial-in numbers: (646) 307-1963 (US-NY) or (800) 715-9871 (US & CA)
Event ID: 1395557
Webcast:
A 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/gcf72sva
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, please visit https://minktherapeutics.com/.
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, business strategy, our research and development plans, our product development efforts, funding and partnering opportunities including government funding 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.