MiNK Therapeutics, Inc. (NASDAQ:INKT) Q4 2022 Earnings Call Transcript

MiNK Therapeutics, Inc. (NASDAQ:INKT) Q4 2022 Earnings Call Transcript March 21, 2023

Operator: Good morning, and welcome to MiNK Therapeutics’ Fourth Quarter and Full Year 2022 Conference Call and Webcast. All participants will be in a listen-only mode until the question-and-answer session. Please note, this event is being recorded. If anyone has any objections, you may disconnect at this time. I will now turn the call over to Zack Armen, Head of Investor Relations at MiNK.

Zack Armen: Thank you, and thank you all for joining us today. Today’s call is being webcast and will be available on our website for replay. I’d like to remind you that this call will contain forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans as well as time lines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. Joining me today on the call are Dr. Jennifer Buell, President and Chief Executive Officer; and Christine Klaskin, Principal Financial and Accounting Officer. Now I’d like to turn the call over to Dr. Buell to highlight our progress in 2022 and plans for the year ahead.

Jennifer Buell: Thank you so much, Zack. Good morning, everyone. Thanks for joining our fourth quarter and full year 2022 earnings call. It’s a great pleasure to be with you today and to share an update on the progress of our company. And I’m really excited and proud to share that our dedication to advance the field of cell therapy has yielded a quite exciting and differentiated results in 2022 and set us up for a very active 2023. We’ve made important strides in advancing iNKT cells, our platform and generating critical data in research as well as in the clinic, some of which we’ve already presented publicly and more of which will be coming your way this year. Recall that agenT-797, our lead product advancing in the clinic is an allogeneic, unmodified or naked iNKT cell.

These cells have shown promise as a monotherapy as well as in combination with approved anti-PD-1 KEYTRUDA or OPDIVO in clinical trials, and these are trials in patients that are heavily pretreated with solid tumor cancers. We’re excited to present an update on this progress at the upcoming AACR meetings next month. And we’ll also be announcing our plans for developing iNKT solid tumor cancers, such as non-small cell lung cancer and relapsed refractory gastric cancer in collaboration with world leaders in these diseases. These data build upon our earlier presentation at the Society of Immunotherapy for Cancer or SITC conference in Boston last November. We also detailed our findings in our inaugural R&D Day last November, where we reported on our lead program, and we showed that it can be demonstrated tolerably alone and in combination with commercially approved anti-PD-1.

We demonstrated that we could dose patients tolerably up to 1 billion cells per dose without lymphodepletion and with no observations of cytokine release syndrome CRS or neurotoxicity. These data enable development flexibility to deliver the benefit of these cells without toxicity observed with first-generation cell therapies. Furthermore, we concluded our Phase I study of 797, or allo-iNKTs in patients with viral ARDS. We reported 70% survival, which compares favorably in hospital control and CDC data of survival rates of 10% to 22%. Even more compelling were the observations of a reduction in secondary infections that are oftentimes fatal in patients in the ICU. We’ve submitted these data to a top-tier journal and expected publication this year.

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Now these results in patients with viral ARDS have generated great interest from government and public financing and private financing opportunities. We’re currently in discussions to externally finance the development of iNKT cells in acute infections and associated fatal consequences like respiratory distress, an indication for which there are no approved therapies. We’ll be providing more updates on the advancement of these discussions this year. The development of allo-iNKTs and indications outside of oncology is only made possible through the manufacturing productivity that our team has made. MiNK address the limitation of the use of cell therapy products beyond oncology and in infections in many ways. First, we focused on the development of iNKT cells, which have shown promise in treating viral infections and respiratory illnesses.

By using iNKT cells, we can avoid some of the limitations associated with traditional cell therapies, such as the need for matching donors and recipients, the use of lymphodepletion and the limitations of cost and scalability. We’ve addressed this. We’ve invested in a high throughput manufacturing technology, which allows for the rapid production of large quantities of iNKT cells, generating billions of cells from a single donor and thousands of doses per donor. Our process is now FDA cleared for implementation into our clinical trials without external dependency. Our manufacturing approach is designed to make iNKT cell therapy more accessible to patients and to improve the scalability of cell therapies overall. As we continue to make progress in our clinical programs, we’re also making important advancements and deepening our understanding of the novel mechanisms of action of iNKT cells and their unique advantages over available cell therapies.

At the end of last year, we presented data elucidating the long-hypothesized mechanism of iNKT cells that underscore their potential as a highly effective living medicine for patients with cancer. Specifically, our scientists demonstrated that iNKTs have the killing power of NK cells and the memory of T cells. They activate dendritic cells. These are signalers that help the immune system recognize tumors. We’ve shown that iNKTs also kill M2 macrophages. M2 macrophages are immunosuppressive cells that constrain the body’s ability to fight tumors. And we also reported that iNKTs can restore the tumor killing capacity of exhausted T cells. This is a very important mechanism in which CD8+ T cells become exhausted and lose their tumor fighting capability.

And as we reported at SITC last year, iNKTs can overcome this mechanism and reinvigorate exhausted CD8+ T cells restoring their killing capacity. These mechanisms help to explain some of the early signals of benefit that we’ve observed in solid tumor cancers. Additionally, our research team has made important progress on our pipeline, including the development and advancement of MiNK-215. MiNK-215 is an armored IL-15-FAP-CAR-iNKT designed to target the tumor stroma and modulate the tumor microenvironment to increase tumor killing capability. Targeting FAP, which is fibroblast Activation Protein, with CAR iNKTs, these are chimeric antigen receptor in variant natural killer T cells can benefit patients in several ways. FAT is a protein that’s found in high levels on the stroma of many evasive solid tumor cancers, but is absent in most normal tissues.

By targeting FAP-CAR-iNKT, we could specifically seek out and destroy cancer cells that express FAP while leaving healthy cells intact. Moreover, FAP is known to play a key role in promoting tumor growth and metastatic disease, and FAP inhibit the body’s immune response against cancer. So, by targeting FAP with CAR-iNKT is possible to overcome these barriers of resistance and activate a potent immune response against cancer. So, in summary, targeting FAP with CAR-iNKTs can provide a highly specific and effective approach to fighting cancer while minimizing damage to any healthy tissues and boosting the body’s natural immune defense. The molecule is an IND-enabling studies for the submission planned in 2024. Now we are in dynamic markets and a unique time where fiscal responsibility and prudence will be critical to delivering the value of our science and the potential of our technology for patients with cancer.

Partnering remains core to our strategy to fully leverage the potential of our platforms and products quickly. And these include public and private collaborations. At MiNK, we’ll focus our internal efforts on deepening our data sets and select solid tumor cancer indications where iNKTs can complement available and approved standard-of-care and we believe expands the benefit of available therapies to patients with specific tumor types and will further elucidate our development plans with the data release at the upcoming AACR conference. We will continue to leverage our research productivity and exciting findings outside of oncology through strategic curation. I will now turn the call over to Christine to go over our financials.

Christine Klaskin: Thank you, Jenn. We ended the fourth quarter 2022 with a cash balance of $19.6 million as compared to $38.9 million at December 31, 2021. Cash used in operations for the year and fourth quarter ended December 31, 2022, was $18.9 million and $4.4 million, respectively. This compares to $12.8 million and $1.7 million for the same period in 2021. This increased funding was related to the internalization of our cGMP manufacturing of agenT-797 for clinical trial supply, which has increased our production and results in decreased supply cost prospectively. Net loss for the quarter ended December 31, 2022, was $7.8 million or $0.23 per share compared to a net loss for the same period of 2021 of $5.8 million or $0.18 per share. Net loss for the year was $28.0 million or $0.83 per share compared to $30.2 million and $1.16 per share for the year ended December 31, 2021. Thank you. We’ll now turn the call over for questions. Operator?

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Q&A Session

Operator: Our first question comes from the line of Emily Bodnar from H.C. Wainright. Please proceed.

Emily Bodnar: Hi, good morning. Maybe for without like specifically talking about data, can you just comment on what may be for gastric cancer for an expansion cohort? And are gastric along the only indications you’re planning to evaluate? Or is just the first and then you kind of will look to see if there’s any others after that? And are they going to be combination cohorts or monotherapy cohorts? Thanks.

Jennifer Buell: Emily, thanks for your question. So, we are currently focused on expanding data sets and indications where we are quite enthusiastic about the result gastric and lung are opportunistic for two reasons: One, when patients are refractory to anti-PD-1 therapy, there are very limited treatment options for them. And that includes in patients that are PD-1 refractory with lung cancer, the patients are treated with docetaxel, 9% response rates. And there’s an enormous opportunity to expand benefit. We also see quite a bit of complementarity by adding ourselves into this setting, either alone or in combination with approved PD-1s. These indications enable a path forward where we may be able to develop the product quite rapidly as a monotherapy on top of available standard-of-care.

So those are the two that we’ve about and will deepen the discussion following our data presentation at AACR on some other areas where we’ll be continuing to explore the benefits of iNKTs in different solid tumor cancers.

Emily Bodnar: Okay. Makes sense. And maybe can you just reiterate the time lines for when you might have MiNK-413 enter the clinic?

Jennifer Buell: MiNK-413 are armored BCMA-CAR. We’ve brought that through the critical gating items for manufacturing for master cell bank. And this product could be ready for IND enablement in 2024.

Operator: Our next question comes from the line of Kalpit Patel from B. Riley. Please proceed.

Kalpit Patel: Good morning, and thanks for taking my question. Maybe starting with expectations for the AACR update, can you give us a sense of how many patients’ worth of data we should expect there? And then maybe what proportion of those patients would have lung cancer or gastric cancer?

Jennifer Buell: Thanks for your question, Kalpit. We’ll have to hold responding until you see the data set. But just a reminder, what we have spoken about is we launched the trial in March and had completed accrual for the Phase I dose escalation and preliminary expansion. So, it is a Phase II, the Phase I solid tumor study. It does have a mix of patients, predominantly those who are refractory to all prior therapy. So, these are late-line patients. They are a standard Phase I cohort with some operational enrichment for certain tumor types, which you may see some enhanced representation of specific tumor types in the cohort, most of which is a measure of the limited therapeutic options for patients at this stage in development. But our cohort, we completed accrual to it at the beginning of the year. So those will be presenting as much data as possible from that cohort by the time of the data presentation at AACR.

Kalpit Patel: Okay. And then in the planned expansion cohorts for lung cancer, are the patients going to be primarily checkpoint naive? Or are you going to include both checkpoint naive and checkpoint refractory patients in that study?