Alaunos Therapeutics, Inc. (NASDAQ:TCRT) Q4 2022 Earnings Call Transcript

Alaunos Therapeutics, Inc. (NASDAQ:TCRT) Q4 2022 Earnings Call Transcript March 7, 2023

Operator: Good day, and thank you for standing by. Welcome to the Alaunos Therapeutics Fourth Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Danielle Dudgeon with Stern IR. Please go ahead.

Danielle Dudgeon: Good morning, and welcome to Alaunos Therapeutics fourth quarter and full year 2022 financial results conference call and audio webcast. Earlier this morning, Alaunos issued a press release announcing financial results for the three months and full year ended December 31, 2022. We encourage everyone to read today’s press release, as well as the Alaunos annual report on Form 10-K for the quarter ended December 31, 2022, which was filed with the SEC this morning. The company’s press release and annual report will also be available one the Alaunos’ website at alaunos.com. In addition, this conference call is being webcast through the Investor Relations section of the company’s website, and will be archived there for future reference.

Please note that certain information discussed on today’s call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 7, 2023. Actual results could differ materially from those stated or implied by the forward-looking statements made today due to risks and uncertainties associated with the company’s business. Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law.

With me today are Kevin Boyle Senior, Chief Executive Officer; Drew Deniger, Vice President of Research and Development; Abhi Srivastava, Vice President of Technical Operations; and Mike Wong, Vice President of Finance. With that said, I would like to turn the call over to Kevin.

Kevin Boyle Senior: Thank you, Danielle. Good morning, and thank you for joining us today for an update on the exciting progress we are making here at Alaunos. 2022 was a transformational year for Alaunos Therapeutics, as we achieved several meaningful corporate milestones including advancing our library TCR-T cell program into the clinic and subsequently achieving our first objective clinical response. We are a highly focused company, committed to leading the scientific development of T-cell receptor therapies to revolutionize solid cancer treatment and improve patient outcomes. I’m extremely proud of our team’s work and realizing the promise of our novel technologies and R&D efforts with clinical execution. We believe TCR-T targeting high frequency driver mutations is potentially the most promising advanced immunotherapy to kill solid tumors.

We are proud to be on the leading edge of cell therapy. We are the first company to demonstrate an objective clinical response in a patient with a solid tumor using a non-viral TCR-T cell therapy. We are encouraged and motivated by the significant interest these results have since generated among physicians, patients, investors, potential partners and other key stakeholders. Every day, multiple patients are reaching out to inquire into our clinical study from across the country. This growing momentum provides a tremendous foundation for the year ahead. We have been hard at work to ensure that we can meet our TCR-T Library Phase 1/2 program milestones in 2023. In the fourth quarter, we filed an IND amendment for the trial. As part of this amendment, we made several critical enhancements to our enrollment and manufacturing processes.

First, we combined our treatment and screening protocols, streamlining enrollment, making it easier for both patients and physicians. Second, we are no longer required to retest the patient’s tumor mutation if more than six months has passed between screening and treatment, which will allow for faster accrual. We are confident that these driver mutations will be retained as they are at the core of the cancer. Lastly, we added cryopreservation to our manufacturing process. Cryo reduces the manufacturing process time from 30 days to 26 days, while simultaneously increasing flexibility for patient scheduling and treatment. As we look ahead, cryopreservation also allows us to open additional trial sites outside of Texas. And yes, contrary to the common belief of many , there is a big world outside of this great state.

In this expansive IND amendment, we again added to our industry leading TCR library for use against solid cancers with two new TCRs targeting frequent mutations and HLAs. This addition effectively doubles our eligible patient pool for the study with now more than 10% of all patients screened for our trial at MD Anderson matching a library TCR. Taken together, we are confident that these changes will enable us to increase the pace of enrollment in our trial, allowing us to become Phase 2 ready by the end of the year. I’d like to talk about our TCR-T Library Phase 1/2 trial and what this year will look like as we move towards Phase 2 readiness. As you will recall, this is a basket trial targeting driver mutations across six solid tumor indications, non-small cell lung, colon, endometrium, pancreas, ovary and bile duct cancers.

We are actively enrolling patients at MD Anderson with any one of these six cancers based on matching both a specific mutation and HLA combination to a TCR that is available in our library. As a result of the most recent IND amendment, our TCR library now consists of 12 TCRs, five KRAS, six TP53 and one EGFR. In December, we successfully dosed the third patient in the trial. This patient was diagnosed with pancreatic cancer with a tumor expressing HLA-A11, and KRAS-G12V mutation matching one of the TCRs within our TCR library. The patient was treated at the second dose level with 58 billion TCR-T cells. As with the first two patients, patient three had a manageable safety profile with no DLTs or ICANS observed. The flexibility of our platform is astonishing with the first three patients on the study representing three distinct indications being treated with three different TCRs. As we treat additional patients, we believe that presenting safety and efficacy data on multiple patients at the same time is the most credible, clinically meaningful and industry standard practice.

And we look forward to sharing additional patient three data with other patient results later this year. We will remain flexible on what venues we use to provide patient updates, when we provide updates and how many patients will be included in each update based on what is in the best interest of the company. In total, we anticipate treating between 12 and 15 patients in the Phase 1 portion of the trial. With three patients having been dosed in 2022, we are confident that our growing patient pipeline and manufacturing capacity will support treating the remaining balance of patients this year. Our resolve and commitment to developing the best-in-class TCR-T cell therapies has been strengthened by the growing momentum we are seeing in the patient and physician interest in our trial.

Now before I hand the call over to Drew, I’ll briefly speak to our financial position. In December, we completed a follow-on offering where we raised approximately $15 million in gross proceeds despite the most challenging market conditions facing the biotech industry over the past five years. As responsible stewards of the company, the Board carefully evaluated all available financing options and firmly believes that this was the right decision to allow the company to continue to advance our pioneering science. For perspective, in 2022, only 58 follow on financings were completed compared to over 200 in the years prior. As one of the few companies to close the financing at market terms without issuing warrants, the promise of our science and technology was recognized by investors.

The additional cash has allowed us to extend our runway into the fourth quarter and should enable us to accelerate the enrollment of patients and the manufacturing of clinical products to generate additional meaningful clinical data this year. Now let me hand the call over to Drew to highlight our ongoing R&D efforts and discuss where we see opportunities to explore next generation TCR-T cell therapies to further deepen clinical responses. Drew?

Drew Deniger: Thank you, Kevin. I’m excited to share today that we were pushing full speed ahead in our R&D efforts. We continue to ramp up our Hunter TCR discovery platform to increase the number of patients, who can benefit from TCR-T cell therapy. We are generating foundational data from the translational assessments in our treated patients. And we are using the translational data to guide our next generation TCR-T cell endeavors that will fuel our pipeline for the long-term. Let me start with Hunter. We continue to strongly believe that Hunter is at the cutting edge of innovation and has significant advantages over traditional TCR discovery methods. We have been very successful in identifying novel exclusively owned mutation reactive TCRs and are emboldened to increase throughput and focus on high value targets.

Our TCRs are sourced from T-cells infiltrating the tumor expressing the driver mutation in the natural context of HLA. We can then use the TCR to add to the library for the benefits of another patient who has the same target. At the 2022 SITC conference, we presented proof-of-concept data supporting Hunter’s ability to evaluate hundreds of thousands of HLAs mutations and TCR combinations in a high throughput setting with our proprietary technology. As Kevin referenced, in the fourth quarter, we added two new TCRs to our library targeting frequent driver mutations and HLAs. The addition of these two TCRs has had a major impact on the potential addressable market for our TCR-T program effectively doubling. We are pleased to show now a greater than a 10% match rate and the patient prescreening process.

The addition of these new TCRs is a prime example of our two pronged library expansion strategy. On one hand, we are working to add more HLAs to the existing KRAS, TP53 and EGFR mutations in the library, which we did by adding DR07 to KRAS G12V. On the other hand, we are adding new mutations within our targeted gene families, which we did with TP53 R273C. This year we expect to grow the library of 15 TCRs. And over time, we imagine that the library could be above 40 TCRs to expand the number of patients that could potentially benefit from our TCR-T cell therapy. We believe Alaunos is uniquely situated to effectively deliver more than one PCR to a patient on a commercial scale, which we call Multiplexing. From a therapeutic perspective, multiplexing is advantageous because the more targets we attack, the better chances we have of achieving long term durable remission of cancer.

We are highly encouraged that roughly one in five of our patients match to more than one TCR in our library right now. Multiplexing TCP is therefore a unique opportunity for us in the near term. We expect the number of patients with single and multiple matches to continue to grow as we expand the library and given the pace of our Hunter successes, we believe we can further weaponize TCR-T cells to benefit patients with driver mutations. Our non-viral Sleeping Beauty system enables us to build the library of TCRs quickly and cost effectively in a way that we believe no other company can. In addition to expanding the addressable market and reach of our TCR-T cell therapy through the TCR library, we are also using our translational data from the clinical trial to help guide our next generation TCR-T efforts.

We will make data driven decisions to address factors relevant for limiting exhaustion and maximizing the therapeutic potential of our TCR-T cells. We are delighted to say that we have detected persistence of our TCR-T cells in the peripheral blood without exhaustion markers such as PD-1. Further, we have observed effector cells and a diverse group of T-cell memory subsets, including team memory stem cells. Post-treatment biopsies have retained the targeted HLA in mutation, T-cells grown from post treatment biopsies contained TCR-T cells capable of responding to the appropriate driver mutation. And therefore our cells are making it to the tumor microenvironment and are functional. This is what we were hoping to see and are thrilled to have these translational data with the Sleeping Beauty TCR-T experience.

We continue to develop novel strategies that generate IP for the company and build upon our early successes while being supported by the translational assessments. We routinely engage with our Scientific Advisory Board chaired by Dr. Carl June, leading experts at MD Anderson and a host of other advisors, consultants and key opinion leaders on these topics who believe in the promise of our platform and support our trailblazing path. Given our demonstration of proof-of-concept, we are marching towards commercialization of the first ever driver mutation TCR-T cell therapy. Now let me turn the call over to Abhi to highlight the tremendous progress this team has been making in our manufacturing process. Abhi?

Abhi Srivastava: Thank you, Drew. As Kevin and Drew has discussed, we continue to be very excited about the progress we are making in our TCR-T library trial. Last year was a critical year for us, as we initiated several efforts to advance and accelerate our clinical program. I’d like to highlight three major efforts. First, we have successfully manufactured at cGMP suite, three (ph) patients’ product using three different TCRs in three different tumor indications. All three manufactured products had fantastic characteristics, relating to viability, purity and TCR positivity. Our manufacturing process works consistently for the TCR in our library, irrespective of mutations, part HLA’s. Second, we have doubled our manufacturing capacity by implementing new SOPs that allow for simultaneous production of multiple products in our GMP suite.

And third, we continue to invest to improve process development, further refining our manufacturing platform. In the fourth quarter of 2022, we worked to further optimize our manufacturing process to an IND amendment to move from fresh to cryopreserved cell products. Cryo enabled us to reduce the manufacturing process time from 30 to 26 days representing a 13% decrease. I’m happy to report that we have already implemented the cryo manufacturing process this year. This new process now provides us with greater flexibility for patients scheduling and treatment with the possibility to collect the patient’s phrases (ph) earlier in their treatment journey. We can then manufacture the drug product and cryopreserve it until the patient is ready for the infusion.

This is a good start and our long term goal is to further reduce the manufacturing time to 15 days. I’m so proud of our fully committed technical operations team and our universal TCR manufacturing platform. And I remain excited about the investment we are making in process development that will close the system, automate the process and decrease the cost while preparing us for Phase 2. I would now like to turn the call over to Mike Wong to review the financial results for the fourth quarter and full year. Mike?

Mike Wong: Thank you, Abhi. Allow me to review our financials for the three months ended December 31, 2022. For the fourth quarter of 2022, we reported a net loss of approximately $9.2 million or a $0.04 net loss per share compared to a net loss of approximately $11.8 million or a $0.05 net loss per share for the same period in 2021. Research and development expenses were approximately $5.6 million for the fourth quarter of 2022 compared to approximately $8.2 million for the fourth quarter of 2021, a decrease of 32%. The decrease was primarily due to reduced program related costs and lower employee related and consulting expenses. General and administrative expenses were approximately $2.9 million for the fourth quarter of 2022 compared to approximately $2.1 million for the fourth quarter of 2021, an increase of approximately $800,000, which was primarily due to higher legal and accounting expenses.

Our operating cash burn for the fourth quarter of 2022 was approximately $7.1 million compared to approximately $15.1 million in the fourth quarter of 2021, a decrease of approximately $8 million or 53%. And now, I will review the results for the full year ended December 31, 2022. For the year ended December 31, 2022, we reported a net loss of approximately $37.7 million or $0.17 net loss per share, compared to a net loss of approximately $78.8 million or $0.37 net loss per share for the year ended December 31, 2021, an impressive year-over-year reduction of 52%. Collaboration revenue was approximately $2.9 million for the year ended December 31, 2022 compared to approximately $400,000 for the year ended December 31, 2021. The increase in collaboration revenue was primarily due to the achievement of sales based milestones of darinaparsin in Japan, which was largely offset by a 1 time research and development expense that I’ll touch on shortly.

Research and development expenses were approximately $25 million for the year ended December 31, 2022 compared to approximately $49.6 million at the year ended December 31, 2021, a decrease of 50%. The decrease in research and development expenses was primarily due to reduced program related costs and lower employee related and consulting expenses. These decreases were partially offset by a 1 time $2.5 million milestone payment to MD Anderson for darinaparsin. For the year 2022, general and administrative expenses were approximately $13.1 million compared to approximately $27.6 million for the year ended December 31, 2021, a decrease of 52%. The decrease in general and administrative expenses was primarily due to lower employee related and professional services expenses.

As of December 31, 2022, Alaunos had approximately $53 million in cash balances, which includes restricted cash of approximately $13.9 million serving as collateral for our outstanding debt. Our operating cash burn for the year ended December 31, 2022 was approximately $29.2 million compared to approximately $61.5 million for the year ended December 31, 2021, a decrease of approximately $32.2 million or 52%, reflecting the full year impact of our cost reduction efforts and our focus on being good stewards of capital. Based on our current operating plans, we expect our operating cash flows excluding debt service costs for 2023 to be between approximately $35 million to $40 million. We expect to have sufficient cash resources to fund research and development programs and operations into Q4 of 2023.

I want to highlight some of the work we are doing on the corporate side to further build upon our growing momentum. Alaunos is the leader in TCR-T targeting driver mutations. And as we look to further solidify this presence and raise our profile among the industry and media, we recently engaged 6 Degrees, an established public relations firm specializing in and serving the biotech industry. Our innovative technology and exciting clinical program remain on the cutting edge of research in the TCR and solid tumor space and we look forward to engaging with and building relationships with media audiences. In addition to 6 Degrees, we recently engaged additional investor relations resources to cultivate existing and develop new investor relationships.

I would now like to turn the call to Kevin for closing remarks.

Kevin Boyle Senior: Thank you, Mike. As we look to the year ahead, we are dedicated to revolutionizing how solid tumors are being treated using our disruptive technology and the clinical, manufacturing and research teams are committed to this objective. Through the groundwork we have laid in our recent IND amendment, where we added additional TCRs and transition to cryopreservation, we will greatly enhance patient throughput and treatment flexibility for our TCR-T library Phase 1/2 trial. We remain confident the positive momentum we have built among patients and physicians will lead to even greater accomplishments as we expect to treat the remaining balance of patients in the Phase 1 portion of our TCR-T library trial, share additional patient data and become Phase 2 ready by the end of the year.

Looking beyond 2023, we envision being in the Phase 2 stage of our existing IND. Our IND enables us to conduct multiple independent indication specific Phase 2 trials simultaneously. Often times, certain TCRs may be associated with specific cancer types. For instance, non-small cell lung cancer commonly has EGFR and KRAS mutations. So we may expect to enroll lung cancer patients with predominantly these TCRs. Colon cancer on the other hand is associated with KRAS and TP53 mutations, which could be a second Phase 2 trial. Over time, we expect to initiate multiple Phase 2 trials across several solid tumor indications. As we believe our TCR-T cell therapy has applicability across a broad range of solid tumor types. To our knowledge, we are the only company taking this type of unique approach, utilizing a TCR library targeting driver mutations against solid tumors.

As we continue to build a long term potential of TCR-T cell therapies from Alaunos, we are actively developing next generation treatments, which hold the potential to deepen clinical responses through combination approaches and multiplexed TCR-T cell therapies. We are working to conduct translational assessments of treated patients to guide these next-gen approaches. In the near-term, our membrane-bound IL-15 TCR-T cell therapy program is advancing towards an IND, which we anticipate submitting later this year. We remain very optimistic about our Hunter TCR discovery platform, which is firing on all cylinders. By expanding the library with proprietary TCRs, we increased the addressable market and the number of patients that might benefit from our single or multiplex TCR-T cell therapies.

It is truly astonishing what this platform is capable of and I look forward to what the future holds for Hunter. In sum, bolstered by the early and encouraging clinical results, we believe 2023 will prove to be an exciting year filled with promise and progress for Alaunos as we advance our pipeline of innovative TCR therapies. I want to express my deepest gratitude to our patients, shareholders and employees for their support as we continue our mission to improve the lives of patients with solid tumors. We will now open the call to questions. Michelle?

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Q&A Session

Operator: Thank you. Our first question comes from the line of Prakhar Agrawal with Cantor. Your line is open. Please go ahead.

Prakhar Agrawal: Hi. Thanks for taking my questions and congrats on 4Q. So Kevin and team, my first question, have there been additional patients dose in patient number three in Q4 given enrollment progress as a key focus for the company. So appreciate any color here. And just to confirm that you have the green light from the FDA on the specific enhancements to the IND and there are no further regulatory approvals required? And I had a couple of follow ups.

Kevin Boyle Senior: Prakhar, good morning. Good to hear from you. With regards to patient enrollment, as we said, we are very excited about the progress that is being made and the interest in this trial stemming from our first objective clinical response. We are not going to report on a patient by patient basis, but we’re going to look for the right venue to provide further updates on number of patients treated and the data associated with that. But we’re feeling quite confident based on the interest that has grown and the excitement around the response and the data that we’ve seen thus far out of the first three patients. And with regards to the IND amendment in the fourth quarter where we added two additional TCRs and made certain enhancements in the clinical trial design to further facilitate and accelerate the enrollment, there are no outstanding questions from the IND, which is really shown our unique trial design and the relationship with the agency the fact that we have had multiple IND amendments with very minimal comments.

So this is a unique trial design for sure, one that we believe is a differentiator for this company in quite a positive way and very excited about these driver mutations benefiting cancer patients.

Prakhar Agrawal: Got it. Thank you. And the second question, the opportunity for multiplex TCR was noted in the press release and the comments for patients who are matching for more than one TCR. So maybe if you can expand on how this will be — this could be implemented in the trial? Will it be a separate IND? And if you can expand on the scientific rationale for a multiplex TCR? Thank you.

Kevin Boyle Senior: Absolutely. I’ll let Drew comment on that.

Drew Deniger: Yeah. Prakhar, good morning. Thank you for the question. We’re very excited about the potential for multiplexing’s out of its TBD for now. But we’re excited to see that roughly one in five of our patients that matched one of the TCRs, on our prescreening process have more than one match. So we do think that this is something that’s feasible for us. We think that through our Sleeping Beauty non-viral system, we have a unique position to deliver more than one TCR. And then to your point about the rationale, just going back to more than one target at a given time has more than one chance to affect the cancer. So we’re excited about that. And we’re looking forward to bringing in IL-15 as our — in the second half of this year for an IND amendment, maybe even potentially adding that to multiplexing in the long-term.

Prakhar Agrawal: Got it. Thank you.

Operator: Thank you. And one moment for our next question. Our next question comes from the line of Yale Jen with Laidlaw. Your line is open. Please go ahead.

Yale Jen: Good morning, and thanks for taking the questions. My first question is that in terms of you characterized the TCR sales that has certain characteristics. Could you elaborate more in terms of whether those aspects are functional or — and then I have a follow-up as well?