Analyst Conference Summary

biotechnology

conference date: August 13, 2024 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2024 (second quarter, Q2)

Forward-looking statements

Overview: Continues to make progress with clinical trials.

Basic data (GAAP):

Revenue was zero.

Net income, diluted, was negative $2.7 million, up sequentially from negative $3.8 million, and up from negative $6.2 million year-earlier.

EPS (earnings per share), diluted, was negative $0.07, up sequentially from negative $0.11, and up from negative $0.18 year-earlier.

Guidance:

Cash runway into 2025.

Conference Highlights:

Dr. Jennifer Buell, President and CEO of MiNK said: "MiNK is making significant strides in advancing our iNKT programs as we pioneer this next generation of cell therapies for patients. Our lead program, agenT-797, is moving forward in a Phase 2 study for second-line gastric cancer, and we are fast-tracking IND-enabling activities for our FAP-expressing CAR-iNKT therapy, MiNK-215. Additionally, the expanded findings presented at the ATS annual meeting underscore the significant potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients. We are committed to expanding the development of agenT-797 in a non-dilutive manner, particularly in the areas of ARDS and GvHD, where unmet needs are critical." Operating burn has been reduced more than 50% y/y; working on getting more external financial support.

Data was presented in April for AgenT-797.

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. Includes 797 with standard of care chemo, plus 797 + chemo + bot/bal. Accrued initial cohort and have some early promising patient responses. This is funded by Stand Up to Cancer. Initial data will be presented at an upcoming 2024 or early 2025 conference. First cohort of patients are now exceeding 3 to 6 months of follow-up and showing evidence of benefit.

AgenT-797 showed improved survival activity, from the Phase 2 trial, in viral ARDS (acute respiratory distress syndrome) with expanded clinical data updates at American Thoracic Society in May 2024. Expanding acess. Mink plans for expansion into autoimmune and inflammatory diseases. Poised for a clinical trial for viral ARDS that is externally funded. Data was published in Nature Communications in Q2 2024.

AgenT-797 Phase 1 trial in GvHD (graft v. host disease) should start in Q2 2024.

The $5.8 million investor cash raise in May 2024 is specifically for funding MiNK-215.

MiNK-215, a novel FAP-CAR-iNKT, presented preclinical data at AACR in MSS colorectal cancer liver metastases in April 2024. MiNK-215 IND filing planned for early 2025. FAP is often found on cancer cells but rarely on healthy cells.

MiNK-413, is a differentiated FAP allogeneic armored-BCMA-CAR-iNKT, in preclinical development.

Partnership with ImmunoScape is underway to develop T-cell receptors to tumor antigens. Our iNKT hosts should be ideal for these PCRs.

Mink Therapeutics ended the quarter with a cash balance of $9.3 million, up sequentially from $5.8 million. $2.3 million cash used in operations. In Q2 2024 completed a $5.8 million stock sale.

Operating expenses were $3.1 million, consisting of: R&D $1.8 million; G&A $1.1 million. Other expense $0.4 million.

Q&A selective summary:

GvHD funded externally? Yes.

Early gastic activity color? Hesitant to add details before conference, except that first cohort has better results than we would have expected without 797 in the combination.

Cohorts in gastric study? Translational endpoints are well known. Trying iNKTs as induction, and in addition to standard of care chemo, and with bot/bal plus chemo. So we will have data on each of those populations.

GvHD timeline? Excited to get underway, great preclinical data. Pediatric as well as adult. Trial should start enrolling in 2024, but could be as late as early 2025. Expect first data in 2H 2025.

Partnering is core to our strategy. Active discussions with possible partners, including outside the US.

ImmunoScape specific engagers? We did a lot of work with engagers. We believe we have a recipe for T-cell engager success. Including solid tumors. iNKT cells can enter tumors where T cells can't go.

Manufacturing 215? New investor to accelerate, will bolster our initial clinical profile. Our preclinical data shows it can penetrate metastatic liver disease. Manufacturing in house, optimizing the protocol, scale the cells without exhaustion.

Grant support for our programs shows the excitement. More discussions are underway. Interest is high from pharma groups that have cell therapy programs or are in the respiratory space. We hope to have more news later this year or early next year.

GVHD, allow for lines of prior therapy, dosing? We have been able to administer the cells beyond one dose. We have dosed over 80 patients, 1 billion cells is the likely target dose. We do not know if multiple doses will be necessary. We are open to other lines of therapy, but want a good reference group, a homogeneous population so we can advance quicly into Phase 2.

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