Analyst Conference Summary

biotechnology

conference date: March 21, 2024 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues to make progress, but needs more funding.

Basic data (GAAP):

Revenue was zero.

Net income, diluted, was negative $5.5 million, down sequentially from negative $5.1 million, and up from negative $7.8 million year-earlier.

EPS (earnings per share), diluted, was negative $0.16, up sequentially from negative $0.15, and up from negative $0.23 year-earlier.

Guidance:

None.

Conference Highlights:

Dr. Jennifer Buell, President and CEO of MiNK said: "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. 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." Reitterated Mink's fully integrated capabilities including manufacturing. Remains financially prudent. Looking for partners for combination therapies.

More data will be presented in April for AgenT-797. In November 2023 at SITC Mink presented AgenT-797 data showing "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."

Mink continues to build knowledge about iNKT cells. Seeing several biomarkers of immunological activation, including cytokines. Looking for persistent resistance to tumors; has shown 797 persists for at least 6 months.

AgenT-797 launched an investigator-sponsored Phase 2 trial in 2L gastric cancer in Q4 2023, at Memorial Sloan Kettering, funded by non-dilutive grants. Will include 797 with standard of care chemo, plus 797 + chemo + bot/bal. Accrued initial cohort and have some early promising patient responses.

AgenT-797 showed improved survival activity, 70%, in viral ARDS (acute respiratory distress syndrome) with expanded clinical data updates for ATS on May 21, 2023. Enrollment completed. Viral ARDS has no approved effective therapies. AgenT-797 has been identified as selectable for funding by DARPA, with contract negotiations underway. Mink plans for expansion into autoimmune and inflammatory diseases. "Poised" for a clinical trial for viral ARDS that is externally funded. More data will be presented at a conference in 1H 2024.

Expansion of manufacturing capability for AgenT-797 has been completed. This is the first known example of native iNKT manufacturing. Cleared by FDA for end-to-end iNKT production.

MiNK-215, a novel FAP-CAR-iNKT, and MiNK-413, a differentiated FAP allogeneic armored-BCMA-CAR-iNKT, presented preclinical data at ASGCT in Q2 2023. MiNK-215 IND filing planned for 2024, pending financing. FAP is often found on cancer cells but rarely on healthy cells.

MiNK signed a collaboration agreement with Immunoscape to accelerate development of TCR-based therapies.

Mink Therapeutics ended the quarter with a cash balance of $3.4 million, down sequentially from $6.4 million. $3.0 million cash used in operations. In Q1 2024 received $5 million from a convertible note from Agenus.

Operating expenses were $5.5 million, consisting of: R&D $3.3 million; G&A $2.2 million. Other expense $0 million.

Q&A selective summary:

Phase 2 study combinations? The data set includes iNKTs alone; with bot/bal; and chemo agents. The standard-or-care chemo typically has very little activity. Will share early data in 2H 2024. Will talk to FDA about forward path with the data. Did not include a chemo-alone arm, as much data is available on that, but would likely do that in a registrational trial.

Prior lines of therapy in Phase 2? The minimum is one prior line, but most will have just that one line.

Quest for cash? We only spent about $16 million in 2023. This year we have external financing for our trials and to expand discovery. We would like more cash, possibly by: a strategic collaboration, which we have multiple discussions on; a regional partner for research and development; talking to investors as well.

Gastric trial timing? Aggressive timeline, no staggering patients, based on unmet need argued by the investigator. Enrollment going quickly. She said she has patients lined up for the trial. Believes will conclude enrollment in 1H 2024. The investigator will report the data.

Still working on a ARDS trial, looking for financial support. Expects to announce the trial in 2024. A relatively small trial could generate data that would then allow for a pivotal trial. Will provide more detail when the contract is executed. Government is one possible funder.

Ready with trial design for immunomodulation indication; waiting for partner/funding.

A MSS colorectal cancer study will be externally funded, 797+bot/bal. This is a big indication. iNKTs can help with liver metastases in this indication. Should launch 1H 2024.

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