Financing of $5.8 Million at a 25% premium will help advance the clinical development of MiNK-215, an armored-FAP-CAR-iNKTGKCC, LLC joins as a new investor with Katie Chudnovsky appointed as a Board Observer NEW YORK, May 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-mediat ...

NEW YORK, April 30, 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 that the Company will release its first quarter 2024 financial results before the market opens on Tuesday, May 14, 2024. MiNK executives will host a conference call and webcast ...

MiNK-215 eliminated MSS colorectal cancer liver metastases in human organoid modelsMiNK-215 exhibits potent anti-tumor activity through multiple mechanisms including immune activation NEW YORK, April 08, 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 ann ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40908 MiNK Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Securities registered pursuant to Section 12(b) ...

MiNK Therapeutics Fourth Quarter and Year-End 2023 Results [Overview and Strategic Highlights](index=1&type=section&id=Overview%20and%20Strategic%20Highlights) MiNK Therapeutics advanced its iNKT cell programs in 2023, progressing agenT-797 to Phase 2 for gastroesophageal cancers and forming a key research partnership for TCR-based therapies - The company primarily focuses on advancing its lead program, **agenT-797**, in indications with promising proof-of-concept data[3](index=3&type=chunk) - A Phase 2 study of **agenT-797** for gastroesophageal cancers has been initiated, with initial data expected later in the year[3](index=3&type=chunk)[7](index=7&type=chunk) - A research collaboration with ImmunoScape was established to accelerate the development of **TCR-based therapies** for solid tumors[3](index=3&type=chunk)[6](index=6&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) MiNK advanced agenT-797 to Phase 2 for gastroesophageal cancers, showed high survival in ARDS, and progressed MiNK-215 with preclinical efficacy in NSCLC [AgenT-797 in Solid Tumors](index=1&type=section&id=AgenT-797%20in%20Solid%20Tumors) A Phase 2 investigator-sponsored trial for **agenT-797** in second-line gastroesophageal cancers is actively enrolling patients, evaluating a combination therapy regimen - A Phase 2 trial (NCT06251973) for second-line gastroesophageal cancers has launched and is actively enrolling patients[7](index=7&type=chunk)[8](index=8&type=chunk) - The trial is led by Dr. Yelena Janjigian at Memorial Sloan Kettering Cancer Center and supported by Stand Up To Cancer[8](index=8&type=chunk) - The combination therapy includes **agenT-797**, Agenus' **botensilimab** (CTLA-4), **balstilimab** (anti-PD-1), ramucirumab, and paclitaxel[8](index=8&type=chunk) [AgenT-797 in Acute Respiratory Distress Syndrome (ARDS)](index=1&type=section&id=AgenT-797%20in%20Acute%20Respiratory%20Distress%20Syndrome%20(ARDS)) A Phase 1/2 study of **agenT-797** in ARDS demonstrated high survival rates and reduced secondary infections, with plans for further advancement in viral ARDS - A Phase 1/2 study published in Nature Communications demonstrated clinical activity in severe acute respiratory distress[7](index=7&type=chunk)[8](index=8&type=chunk) - Survival rates exceeded **70%** for patients on mechanical ventilation and over **80%** for those on VV ECMO, significantly higher than the **10%** control group survival[8](index=8&type=chunk) - **AgenT-797** treatment led to an over **80% decrease** in secondary bacterial and fungal infections in the highest dose cohort[8](index=8&type=chunk) [Research and Preclinical Programs](index=1&type=section&id=Research%20and%20Preclinical%20Programs) MiNK is expanding its early-stage pipeline via a collaboration with Immunoscape for TCR-based therapies and advancing preclinical candidate **MiNK-215** for NSCLC with IND-enabling activities underway - The collaboration with Immunoscape aims to accelerate **TCR-based therapies** development against novel targets in T cells and iNKT cells for solid tumors[6](index=6&type=chunk)[9](index=9&type=chunk) - Preclinical efficacy data for **MiNK-215** presented at ASGCT 2023 showed activity in NSCLC models[17](index=17&type=chunk) - IND-enabling activities and supportive financing discussions for **MiNK-215** are currently underway[17](index=17&type=chunk) [Manufacturing Progress](index=2&type=section&id=Manufacturing%20Progress) MiNK Therapeutics maintains internal, FDA-cleared, automated, and closed-system manufacturing for its allogeneic iNKT cells, supplying ongoing clinical trials - The company continued internal manufacturing of its **allogeneic iNKT cells** to supply ongoing clinical trials[10](index=10&type=chunk) - The manufacturing process is **FDA-cleared**, **automated**, and utilizes a **closed-system**[10](index=10&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) MiNK ended 2023 with **$3.4 million** cash, secured an additional **$5 million** post-year-end, and reduced its full-year net loss to **$22.5 million** due to decreased R&D spending and improved operational efficiency [Key Financial Position (Balance Sheet)](index=2&type=section&id=Key%20Financial%20Position%20(Balance%20Sheet)) As of December 31, 2023, MiNK's cash and cash equivalents were **$3.4 million**, a significant decrease from **$19.6 million** in 2022, with total assets also declining, though **$5 million** was received post-year-end via a convertible note - Ended 2023 with a cash balance of **$3.4 million** and received an additional **$5 million** after year-end under a convertible note agreement with Agenus Inc[11](index=11&type=chunk) Balance Sheet Summary (in thousands USD) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,367 | $19,636 | | Total assets | $4,552 | $21,472 | | Total stockholders' equity (deficit) | $(18,055) | $(401) | [Statement of Operations](index=3&type=section&id=Statement%20of%20Operations) For full year 2023, MiNK reported a net loss of **$22.5 million** (**$0.65 per share**), an improvement from **$28.0 million** in 2022, primarily due to decreased R&D expenses from **$23.1 million** to **$15.5 million** Statement of Operations Summary (in thousands USD, except per share data) | | Year ended Dec 31, 2023 | Year ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $15,490 | $23,115 | | General and administrative | $7,431 | $7,834 | | **Operating loss** | **$22,921** | **$30,949** | | **Net loss** | **$22,458** | **$27,991** | | **Net loss per share** | **$0.65** | **$0.83** | [Cash Flow](index=2&type=section&id=Cash%20Flow) MiNK demonstrated improved cash management, with cash used in operations decreasing to **$15.8 million** for full year 2023 from **$18.9 million** in 2022, and **$3.0 million** for Q4 2023 from **$4.4 million** in Q4 2022 Cash Used in Operations (in thousands USD) | Period | 2023 | 2022 | | :--- | :--- | :--- | | Q4 | $3,025 | $4,431 | | Full Year | $15,752 | $18,867 |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-40908 MiNK Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-2142067 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission File Number: 001-40908 MiNK Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 82-2142067 (State or other jurisdiction of incorporation or organization) 149 Fifth Avenue Suite 500 New ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for the quarter ended March 31, 2023, show a decrease in cash and total assets compared to year-end 2022, with a net loss of $5.7 million, an improvement from the $7.8 million loss in the same period of 2022, while cash flow from operations remained negative and the accumulated deficit grew to $116.6 million [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2023, the company's total assets were $16.6 million, a decrease from $21.5 million at the end of 2022, primarily due to a reduction in cash and cash equivalents, with total liabilities also decreasing to $11.3 million from $12.7 million, and the total stockholders' deficit increasing significantly to $4.5 million from $0.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $14,892 | $19,636 | | Total current assets | $15,522 | $20,405 | | Total assets | $16,589 | $21,472 | | Total current liabilities | $11,250 | $12,683 | | Due to related parties | $9,720 | $9,081 | | Total stockholders' deficit | $(4,476) | $(401) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2023, the company reported a net loss of $5.7 million, or ($0.17) per share, compared to a net loss of $7.8 million, or ($0.23) per share, for the same period in 2022, with the reduced loss driven by lower research and development and general and administrative expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Research and development | $4,194 | $5,277 | | General and administrative | $1,661 | $2,097 | | Operating loss | $(5,854) | $(7,374) | | Net loss | $(5,686) | $(7,777) | | Basic and diluted net loss per common share | $(0.17) | $(0.23) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) The company's total stockholders' deficit increased from $0.4 million at December 31, 2022, to $4.5 million at March 31, 2023, primarily due to the net loss of $5.7 million for the quarter, partially offset by stock-based compensation and other equity transactions - The total stockholders' deficit grew to **$4,475,781** as of March 31, 2023, from a deficit of **$401,303** at the end of 2022[13](index=13&type=chunk) - The main drivers for the change in equity were the net loss of **$5.7 million** and stock-based compensation expenses of **$0.9 million**[13](index=13&type=chunk)[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $4.4 million for the first quarter of 2023, slightly higher than the $4.2 million used in the same period of 2022, with the company's cash and cash equivalents decreasing by $4.7 million during the quarter, ending at $14.9 million Cash Flow Highlights (in thousands) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,366) | $(4,196) | | Net cash used in investing activities | $(14) | $0 | | Net cash (used in) provided by financing activities | $(334) | $1 | | Net decrease in cash and cash equivalents | $(4,744) | $(4,200) | | Cash and cash equivalents, end of period | $14,892 | $34,688 | [Notes to Unaudited Interim Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Key notes highlight the company's business as a clinical-stage biopharmaceutical firm focused on iNKT cell therapies, with a history of losses and an accumulated deficit of $116.6 million, but believes its current cash of $14.9 million is sufficient for over a year, detailing significant related-party transactions with its parent company, Agenus, for services and IP, and a legal contingency involving a default judgment from the Walloon Region for approximately $2.3 million - The company is a clinical-stage biopharmaceutical company developing allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies for cancer and immune-mediated diseases[19](index=19&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$116.6 million**. Management believes its cash balance of **$14.9 million** is sufficient to fund operations for more than one year[20](index=20&type=chunk) - The company has significant related-party transactions with its parent, Agenus, including an Intercompany Services Agreement and an IP License Agreement. As of March 31, 2023, **$9.7 million** was due to Agenus[37](index=37&type=chunk)[38](index=38&type=chunk)[41](index=41&type=chunk) - The company faces a default judgment from the Belgium Walloon Region seeking repayment of a **~$2.3 million** advance. The outstanding liability is recorded in other current liabilities[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=13&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing its iNKT cell therapy platform, led by its most advanced candidate, agenT-797, which has shown encouraging activity in solid tumors and viral ARDS, with operating expenses decreasing in Q1 2023 compared to Q1 2022 due to the timing of clinical trials, and the company ending the quarter with $14.9 million in cash, believing it has sufficient liquidity for more than one year, with potential future funding from partnerships, financing, or its parent company, Agenus - The lead product candidate, agenT-797, is an allogeneic, native iNKT cell therapy being evaluated in a Phase 1 trial for solid tumor cancers, with encouraging activity observed[50](index=50&type=chunk) - AgenT-797 also showed an encouraging survival benefit of **70%** in a Phase 1 trial for viral acute respiratory distress syndrome (ARDS)[52](index=52&type=chunk) - The company is advancing a pipeline of engineered iNKT programs, including MiNK-215 (FAP-CAR-iNKT) and MiNK-413 (BCMA-CAR-iNKT), with IND-enabling activities underway in 2023[54](index=54&type=chunk) Operating Expense Comparison (in millions) | Expense Category | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $4.2 | $5.3 | -21% | | General & Administrative | $1.7 | $2.1 | -21% | - The company had a cash and cash equivalents balance of **$14.9 million** as of March 31, 2023, which is believed to be sufficient to satisfy liquidity requirements for more than one year[67](index=67&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=18&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not required for smaller reporting companies, and therefore no information is provided - As a smaller reporting company, MiNK Therapeutics is not required to provide this disclosure[77](index=77&type=chunk) [Item 4. Controls and Procedures](index=18&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Principal Executive Officer and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of March 31, 2023, with no material changes to the company's internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[78](index=78&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[79](index=79&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=19&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[82](index=82&type=chunk) [Item 1A. Risk Factors](index=19&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - No material changes have occurred to the risk factors described in the 2022 Form 10-K[83](index=83&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=19&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details the use of proceeds from its October 2021 initial public offering, where net proceeds were approximately $39.8 million, and as of March 31, 2023, approximately $24.9 million of these proceeds have been used for the development of agenT-797, working capital, and other general corporate purposes - The company received net proceeds of approximately **$39.8 million** from its IPO in late 2021[86](index=86&type=chunk) - As of March 31, 2023, approximately **$24.9 million** of the net IPO proceeds have been used for development of agenT-797 and general corporate purposes[87](index=87&type=chunk) [Item 6. Exhibits](index=20&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files [Signatures](index=21&type=section&id=Signatures) The report is duly signed by Jennifer S. Buell, Ph.D., President and Chief Executive Officer, and Christine M. Klaskin, Treasurer, on May 11, 2023

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40908 MiNK Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) (State or other jurisdiction of incorporation or ...

Financial Data and Key Metrics Changes - The net loss for Q4 2022 was $7.8 million or $0.23 per share, compared to a net loss of $5.8 million or $0.18 per share in Q4 2021 [9] - The net loss for the full year 2022 was $28.0 million or $0.83 per share, an improvement from a net loss of $30.2 million or $1.16 per share in 2021 [9] - Cash balance at the end of Q4 2022 was $19.6 million, down from $38.9 million at the end of Q4 2021 [41] Business Line Data and Key Metrics Changes - The company has made significant advancements in its clinical programs, particularly with its lead product, agenT-797, which has shown a 70% survival rate in patients with viral ARDS, compared to control rates of 10% to 22% [4] - MiNK-215, an armored IL-15-FAP-CAR-iNKT, is in IND-enabling studies with submission planned for 2024 [7] Market Data and Key Metrics Changes - The company is focusing on expanding its data sets and indications for solid tumor cancers, particularly non-small cell lung cancer and relapsed refractory gastric cancer, where there are limited treatment options for patients [43] - The company is exploring opportunities in acute infections and respiratory distress, indicating a potential for external financing to support development in these areas [31] Company Strategy and Development Direction - The company aims to deepen its understanding of iNKT cells and their mechanisms, focusing on solid tumor cancers where iNKT therapies can complement existing treatments [40] - Strategic collaborations are a core part of the company's strategy to leverage its platforms and products effectively [61] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the advancements in cell therapy and the potential for iNKT cells to address significant unmet medical needs in oncology and beyond [35] - The company is committed to fiscal responsibility and is actively seeking partnerships to enhance its development capabilities [61] Other Important Information - The company has invested in high-throughput manufacturing technology, allowing for rapid production of iNKT cells, which enhances scalability and accessibility for patients [37] - iNKT cells have shown promise in treating viral infections, which could expand the application of cell therapies beyond oncology [58] Q&A Session Summary Question: Expansion cohort for gastric cancer - Management indicated that gastric cancer is one of the initial indications being evaluated, with plans for further exploration based on data presented at AACR [10][11] Question: Data expectations for AACR update - The company completed accrual for a Phase I solid tumor study and will present as much data as possible from that cohort at AACR [45][67] Question: Combination therapies with Botensilimab - Management discussed the potential for combining iNKT cells with Botensilimab, highlighting preclinical data showing enhanced efficacy in solid tumors [18][49] Question: Safety of allogeneic versus autologous iNKT therapies - Management clarified that their approach does not require lymphodepletion, which differentiates their product from others that have faced safety challenges [73] Question: Timelines for MiNK-413 - MiNK-413 is expected to be ready for IND enablement in 2024, with ongoing discussions about its development [66]