Analyst Conference Summary

biotechnology

conference date: November 9, 2023 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2023 (third quarter, Q3)

Forward-looking statements

Overview: Good preclinical data, but running out of cash. However, its controlling company, Agenus, is well-funded.

Basic data (GAAP):

Revenue was zero.

Net income, diluted, was negative $5.1 million, up sequentially from negative $6.2 million, and up from negative $6.3 million year-earlier.

EPS (earnings per share), diluted, was negative $0.15, up sequentially from negative $0.18, and up from negative $0.19 year-earlier.

Guidance:

None.

Conference Highlights:

Dr. Jennifer Buell, President and CEO of MiNK said: "This quarter we made important advancements across our iNKT cell platform, including new data that demonstrated the long-term persistence and clinical benefits of iNKTs in heavily pretreated solid tumor cancer patients. We've also progressed our innovative engineered programs, including CARs and TCRs, and made substantial strides expanding our internal cGMP manufacturing, a critical capability to making these novel cells accessible to a broad patient population." We have accomplished a lot with minimal cash flow, yet expects cash use to decrease as external financing comes in. In discussion with strategic partnerships to strengthen the balance sheet through regional partnerships, R&D collaboration, and manufacturing services.

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 will launch a 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.

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.

Expansion of manufacturing capability for AgenT-797 has been 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 FAP allogeneic armored-BCMA-CAR-iNKT, presented preclinical data at ASGCT in Q2 2023. 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 $6.4 million, down sequentially from $10.6 million. $4.2 million cash used in operations.

Operating expenses were $5.2 million, consisting of: R&D $3.4 million; G&A $1.8 million. Other expense $0.1 million.

Q&A selective summary:

SITC data v. typical cell therapy, etc.? Median PFS is quite compelling, given the patients failed all prior therapy lines and were quite sick. It is remarkable persistence, especially given no pretreatment.

Your CAR iNKT therapies? It has shown potentially best in class preclinical activity. We are looking at partnerships to advance the BCMA, but it is ready for an IND. FAP-CAR-iNKT is on track for IND filing in 2024.

Cell expansion? When we infuse 1 billion cells, will be about 15% of your white blood cell account. Continue to be detected for at least 6 months, but we don't have clinical data on where they go, or if they are dividing actively in the body.

Partnership discussions? We have experience from Agenus is developing partnerships. We have a remarkable ability to discover new targets here and engineer new iNKTs. We are in active discussions with companies that need innovation and have an appetite for our potential products. These could be regional specific. This should support bringing technologies to the clinic more rapidly, and in combinations with other agents. More externally financed trials are being actively discussed at this time.

Acute graft v. host disease? We expect to introduce 797 for that indication this year.

We are working on combining TCR expession with iNKT cells.

Many i/o failures we see today seem to be from the microenvironment. iNKT, together with checkpoings, appear to be able to overcome this. We don't attack the immune system with lymphodepletion, which is an advantage over other cell therapies. We are following persistence, which will help us to decide when to re-dose.

Testicular cancer? Compelling, durable response. The patient who dropped from the trial wanted to spend more time with family, but we are following. Will expand into a Phase 1b.

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