MiNK Reports Fourth Quarter and Year-End 2023 Results
MiNK Therapeutics, Inc. (INKT) announced significant advancements in allogeneic iNKT cell therapies for cancer and immune-mediated diseases. Key highlights include the launch of a Phase 2 trial in gastroesophageal cancers, positive clinical data in solid tumors and ARDS, collaboration with Immunoscape, and financial results for Q4 and full-year 2023.
Positive
MiNK Therapeutics, Inc. made substantial progress in 2023 with its allogeneic iNKT cell programs.
The company expanded its pipeline and established key partnerships, such as with ImmunoScape.
MiNK announced the launch of a Phase 2 trial in gastroesophageal cancers for agenT-797.
Positive clinical data was published in Nature Communications and Oncogene, showcasing the efficacy of allo-iNKTs.
The company's Phase 1/2 study in ARDS patients demonstrated promising survival rates and immunologic properties.
MiNK entered into a collaboration agreement with Immunoscape to develop TCR-based therapies for solid tumors.
Financially, MiNK ended 2023 with a cash balance of $3.4 million and received $5 million under a convertible note agreement with Agenus Inc.
The company reported a net loss of $22.5 million for the year ended December 31, 2023.
Negative
MiNK Therapeutics, Inc. reported a net loss of $22.5 million for the year ended December 31, 2023.
Cash used in operations for the twelve months ended December 31, 2023, was $15.8 million, compared to $18.9 million for the same period in 2022.
The company's total stockholders' equity (deficit) was -$18.1 million as of December 31, 2023.
Operating expenses for research and development were $15.5 million for the year ended December 31, 2023.
MiNK's net loss per share was $0.65 for the year ended December 31, 2023.
From an oncology research perspective, the progression of MiNK Therapeutics' agenT-797 into a Phase 2 trial for gastroesophageal cancers is a pivotal development. Gastroesophageal cancers represent a therapeutic area with high unmet medical needs and current treatment options are limited. The innovative approach of combining allo-iNKTs with botensilimab and other agents could potentially offer a new paradigm in cancer immunotherapy. The reported clinical activity in solid tumors, along with the strategic collaboration with Immunoscape to develop TCR-based therapies, indicates a forward-thinking approach to oncology treatment that could have significant implications for patient outcomes and the competitive landscape.
Examining the financial health of MiNK Therapeutics, the reduction in net loss from $28 million in 2022 to $22.5 million in 2023 is noteworthy, as it suggests improved operational efficiency or cost containment measures. However, the company's cash position decreased significantly from $19.6 million to $3.4 million year-over-year, raising concerns about its ability to sustain operations without additional funding. The $5 million received under the convertible note agreement with Agenus Inc. post year-end provides a temporary cushion, but it underscores the need for careful monitoring of the company's cash burn rate and the pursuit of strategic financing options to support its clinical programs and manufacturing progress.
Looking at the broader implications of MiNK's clinical data published in Nature Communications, the reported survival rates in ARDS patients treated with agenT-797 are remarkable, especially when compared to the in-hospital control group's survival rate. This suggests a potential breakthrough in ARDS treatment, a condition with a historically high mortality rate. The data indicating a significant reduction in secondary infections is equally compelling, as it highlights the dual therapeutic potential of agenT-797 in both immune modulation and infection control. The decision to advance agenT-797 in viral ARDS through an externally funded trial is a strategic move that may optimize resources while addressing a critical area of respiratory care.
03/21/2024 - 07:00 AM
Launched and enrolling Phase 2 trial of allo-iNKTs with botensilimab/balstilimab and chemotherapy in second-line gastroesophageal cancers Announced collaboration with Immunoscape for development of TCR-based therapies Published clinical data in Nature Communications and Oncogene demonstrating clinical activity of allo-iNKTs, agenT-797, in solid tumors and severe acute respiratory distress NEW YORK, March 21, 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 fourth quarter and full-year 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.
“In 2023, MiNK made significant strides in advancing our allogeneic iNKT cell programs, contributing to a growing body of clinical data that underscores the unique advantages of iNKTs and their pivotal role in immunity,” said Dr. Jennifer Buell, Chief Executive Officer and President at MiNK. “We expanded the scope of our pipeline, solidifying key partnerships such as our research agreement with ImmunoScape. As we move forward, our primary focus remains on advancing our lead program, agenT-797, particularly in indications where we have observed promising proof-of-concept data. We are pleased to announce the progression of this program into a Phase 2 study in gastroesophageal cancers and we anticipate sharing initial trial data later this year.”
2023 Highlights
AgenT-797 in Solid Tumors
Announced the launch of a Phase 2 investigator-sponsored trial in gastroesophageal cancers, led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center (NCT06251973 ). Supported by Stand Up To Cancer, this trial is actively enrolling and evaluating the combination of agenT-797 (allo-iNKTs), Agenus' botensilimab (a novel Fc-enhanced CTLA-4 inhibitor), along with balstilimab (anti-PD-1), ramucirumab, and paclitaxel. These data aim to provide invaluable insights into the clinical activity and development pathway for this difficult disease, where there are currently no curative therapies available. AgenT-797 in Acute Respiratory Distress (ARDS)
MiNK's Phase 1/2 study in patients with moderate to severe ARDS was published in Nature Communications . The study reports survival rates exceeding 70% among patients on mechanical ventilation and surpassing 80% among those receiving VV ECMO support. These results stand in stark contrast to the 10% survival rate observed in the in-hospital control during the same period. Moreover, demonstrating its immunologic properties, agenT-797 showcased a significant reduction in secondary bacterial and fungal infections, with an over 80% decrease in pneumonia cases within the highest dose cohort. Looking ahead, MiNK remains committed to addressing critical unmet needs in respiratory care. The company is poised to advance agenT-797 in patients with viral ARDS through a predominantly externally funded, large platform trial. Research Programs
MiNK entered into a collaboration agreement with Immunoscape, aimed to accelerate the development of TCR-based therapies against novel targets in T cells, iNKT cells, and other modalities for solid tumor cancers. MiNK-215 preclinical efficacy was presented at the American Society of Gene and Cell Therapy (ASGCT) 2023 annual meeting that showed MiNK-215’s activity in non-small cell lung cancer (NSCLC) models. MiNK-215 IND enabling activities are underway to support clinical advancement; supportive financing discussions are underway. Manufacturing Progress
MiNK continued internal manufacturing of its allogeneic iNKT cells, through an FDA cleared, automated and closed-system process. MiNK is supplying product for its ongoing clinical trials. Financial Results
We ended the year with a cash balance of $3.4 million . Since year-end we received $5 million under our convertible note agreement with Agenus Inc. Cash used in operations for the three and twelve months ended December 31, 2023, was $3.0 million , and $15.8 million , respectively, compared to $4.4 million and $18.9 million for the same periods in 2022.
Net loss for the year ended December 31, 2023 was $22.5 million , or $0.65 per share, compared to net loss for the same period in 2022 of $28 million or $0.83 per share.
Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) December 31, 2023 2022 Cash and cash equivalents $ 3,367 $ 19,636 Total assets 4,552 21,472 Total stockholders' equity (deficit) (18,055 ) (401 ) Other Financial Information (in thousands) (unaudited) Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Cash used in operations $ 3,025 $ 4,431 $ 15,752 $ 18,867 Non-cash expenses 1,167 706 3,810 358 Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development 3,311 5,812 15,490 23,115 General and administrative 2,189 2,077 7,431 7,834 Operating loss 5,500 7,889 22,921 30,949 Other expense (income), net (41 ) (120 ) (463 ) (2,958 ) Net loss $ 5,459 $ 7,769 $ 22,458 $ 27,991 Per common share data, basic and diluted: Net loss $ 0.16 $ 0.23 $ 0.65 $ 0.83 Weighted average number of common shares outstanding, basic and diluted 34,558 33,806 34,360 33,673
Conference Call
Dial in numbers: 646 - 307-1963 (U.S. – NY), 800-715-9871 (U.S. & Canada)
Conference ID: 1391457
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/xa2m5uy7 .
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, MiNK-215, 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 investor@minktherapeutics.com Media Contact communications@minktherapeutics.com
What Phase trial did MiNK Therapeutics, Inc. announce the launch of in gastroesophageal cancers?
MiNK Therapeutics, Inc. announced the launch of a Phase 2 investigator-sponsored trial in gastroesophageal cancers, led by Dr. Yelena Janjigian.
What survival rates were reported in MiNK's Phase 1/2 study in patients with ARDS?
MiNK's Phase 1/2 study in patients with moderate to severe ARDS reported survival rates exceeding 70% among patients on mechanical ventilation and surpassing 80% among those receiving VV ECMO support.
What collaboration agreement did MiNK enter into for the development of TCR-based therapies?
MiNK entered into a collaboration agreement with Immunoscape for the development of TCR-based therapies against novel targets in T cells, iNKT cells, and other modalities for solid tumor cancers.
What was MiNK Therapeutics, Inc.'s net loss for the year ended December 31, 2023?
MiNK Therapeutics, Inc. reported a net loss of $22.5 million for the year ended December 31, 2023.
What was the cash balance of MiNK Therapeutics, Inc. at the end of 2023?
MiNK Therapeutics, Inc. ended 2023 with a cash balance of $3.4 million.
