Analyst Conference Summary

biotechnology

conference date:March 21, 2023
for quarter ending: December 31, 2022 (fourth quarter, Q4)

Forward-looking statements

Overview: Pipeline development continues.

Basic data (GAAP):

Revenue was zero.

Net income, diluted, was negative $7.8 million, down sequentially from negative $6.3 million, and down from negative $5.8 million year-earlier.

EPS (earnings per share), diluted, was negative $0.23, down sequentially from negative $0.19, and down from negative $0.18 year-earlier (due to increased share count).

Guidance:

None.

Conference Highlights:

Dr. Jennifer Buell, President and CEO of MiNK said: "Our advancements have solidified MiNK's position as a leader in the iNKT cell therapy field, with a growing body of clinical data demonstrating the potential of iNKT cells alone and in combination with standard of care agents, as well as novel insights into their unique mechanisms of action. Additionally, we've made strides in our CAR-iNKT program. As we move into 2023, we are eager to build on this momentum and rapidly expand our solid tumor program, leveraging our strong foundation to accelerate the development of potentially life-saving therapies for patients." 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.

Five MiNK abstracts were reported at SITC on Nov. 8 to 12. MiNK also hosted an R&D day on November 10, 2022.

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 SITC 2022. Observed disease modulation of metastatic liver lesions in a patient with refractory rectal cancer and in highly refractory multiple myeloma. 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. More data will be presented at AACR on Apirl 18th. Also plans to expand to gastric cancer and NSCLC.

AgenT-797 showed improved survival activity, 70%, in viral ARDS (acute respiratory distress syndrome) with expanded clinical data updates planned 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. 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 $19.6 million, down sequentially from $24.2 million. $4.4 million cash used in operations.

Operating expenses were $8 million, consisting of: R&D $6 million; G&A $2 million. Other income $0 million.

Q&A:

Gastric cancer expansion cohort? Opportunistic because when PD-1 refractory, they have limited options. Could be monotherapy or with a PD-1. Could be developed rapidly as a monotherapy on top of standard of care. We are exploring other solid tumors, may announce more later.

Mink-413 timeline? Did critical manufacturing prep. Could be ready for IND enablement in 2024.

AACR update plan? Launched trial in March 2022, enrollment completed. Mix of patients, predominantly refractory to all prior therapies. Some tumor types more than other, which mostly results from limited opportunities for patients with these tumor types.

Lung cancer cohort? Patients will be mostly checkpoint refractory. Will share data signals at AACR.

Potential Botensilimab combo? At ASCO GI botensilimab appears to be bringing extraordinary benefit, including NSCLC. Preclinical studies showed benefit of combination with our therapy, including near complete tumor eradication. Also indication of preclinical effectiveness in liver cancer. Will talk more about this at AACR.

Clinical hold on competitor? They had a fatality, neuroblastoma patient, a neurovirus, resulted from lymphodepletion. We do not need lymphodepletion to administer our cells.

MiNK-215 combination, biomarkers? Model shows reversal of exhaustion. So we could select for biomarkers, but at first will not restrict, just measure them. So start broad, then possibly narrow.

BCMA therapies? They are very competitive, but patients still progress and display the BCMA antigen. We can address that with our iNKT product. Our BCMA is armored with IL-15. But we prioritized the FAT program. We are in discussions about partners for the BCMA program.

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