Analyst Conference Summary

biotechnology

conference date: May 11, 2023
for quarter ending: March 31, 2023 (first quarter, Q1)

Forward-looking statements

Overview: Good early clinical results, but very low on cash.

Basic data (GAAP):

Revenue was zero.

Net income, diluted, was negative $5.7 million, up sequentially from negative $7.8 million, and up from negative $7.8 million year-earlier.

EPS (earnings per share), diluted, was negative $0.17, up sequentially from negative $0.23, and up from negative $0.23 year-earlier (due to increased share count).

Guidance:

None.

Conference Highlights:

Dr. Jennifer Buell, President and CEO of MiNK said: "This quarter we have achieved significant progress across our iNKT cell platform. Our lead program, agenT-797, has shown pioneering data in advanced solid cancers at AACR and we have launched expansion studies in anti-PD-1 refractory NSCLC and gastric cancer. We are proud to remain the most clinically advanced allo-iNKT company with robust manufacturing capabilities and a novel pipeline of next generation therapies, including our novel FAP-CAR-iNKT." iNKT cells can overcome some of the negative issues with CAR T therapies with multiple mechanisms of action. Mink will focus on its leading indications internally, other research results will be pursued through collaborations.

Believes this is the most flexible cell therapy in development. More MINK-215 data will be reported on May 19, 2023 at ASGCT for lung cancer. AgenT-797 of ARDS new data will be presented at ATS on May 21, 2023. Then more in 2H 2023. Expects to have a fully donor independent manufacturing process by next year. This makes capital costs very low for a cell therapy company.

AgenT-797 alone or in combo with Keytruda or Opdivo in solid tumors and multiple myeloma showed encouraging signs of safety and activity in the ongoing Phase 1 trial. Enrollment completed. Data was presented at AACR in Q2 2023. A durable partial response (PR) was observed in a patient with metastatic gastric cancer who had no response to prior anti-PD-1 alone or in combination with standard chemotherapy. The patient received agenT-797 in combination with anti-PD-1 and achieved a 42% tumor reduction that continued beyond 9 months. These were very sick, refractory patients. Durable disease stabilization and biomarker responses were also observed in anti-PD-1 refractory NSCLC and testicular cancers. Mink has 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. Showed early signals of benefit without lymphodepletion or neurotoxicity. Also plans to expand to gastric cancer and NSCLC at Memorial Sloan Kettering funded by non-dilutive grants.

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.

Expansion of manufacturing capability for AgenT-797 was completed. This is the first known example of native iNKT manufacturing. Cleared by FDA.

MiNK-215, a novel FAP-CAR-iNKT, and MiNK-413, a differentiated allogeneic armored-BCMA-CAR-iNKT, had preclinical data presented at SITC 2022. MiNK-215 IND filing planned for 2024. FAP is often found on cancer cells but rarely on healthy cells.

MiNK-413, a differentiated allogeneic armored-BCMA-CAR-iNKT, had preclinical data presented at SITC 2022.

Mink Therapeutics ended the quarter with a cash balance of $14.9 million, down sequentially from $19.6 million. $4.4 million cash used in operations.

Operating expenses were $ million, consisting of: R&D $ million; G&A $ million. Other income $0 million.

Q&A:

NSCLC study details? Advancing into a Phase 1b trial. Taking patients on standard of care that is not active, adding onto that.

Testicular cancer plans? That study will continue, it is a rare cancer, so only enrolling an occasional patient to continue to study.

Multiple/combination dosing? Seeing benefit in both monotherapy and a more rapid path to registration when added to standard of care. Will start adding multiple dosing, probably at week 6 or 8.

Viral ARDS program? Data at pulmonary conference in Washington DC this year. ACS May 21. Cells can be administered in ICU and emergency settings by that type of doctor. Showed 70% survival benefit. Critically ill patients tolerated the cells well. Saw no cytokine release. We are negotiating with non-dilutive sources to continue trials.

215 and 413, develop on your own or partner? Partnering is core to our strategy. Working on partnering to allow rapid expansion. Look for near term announcements. We are well-positioned to move through the IND prep and into the clinic.

Reponsive gastric cancer patient, any idea why? Increased TCR clonality and diversity. MSI high tumors are usually responsive to PD1, but not this patient, until our therapy was added. Appears INKT cells are resistant to suppression that sometimes stops PD1 T cell responses.

Increased dosing? We are confident in our dose level, mainly now looking at multiple doses, but may explore higher doses to have in the data package.

Sees MiNK-413 as a major advance, but given the competitive BCMA landscape, looking for partners. Will file an IND in 2024, probably in the middle to second half of the year.

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