Alaunos Therapeutics Inc (TCRT) 2021 Q3 法說會逐字稿

Greetings. Welcome to the Ziopharm Oncology Third Quarter 2021 Earnings Conference Call. (Operator Instructions)

Please note, this conference is being recorded. I will now turn the conference over to your host, Alex Lobo, Stern Investor Relations. Thank you. You may begin.

Thank you. Good afternoon, and welcome to Ziopharm Oncology's Third Quarter 2021 Financial Results Conference Call and Audio Webcast. With me today are Kevin Boyle Senior, Ziopharm's Chief Executive Officer; and Raffaele Baffa, Ziopharm's Chief Medical Officer and Executive Vice President of Research and Development.

Earlier this afternoon, Ziopharm issued a press release announcing financial results for the 3 months ended September 30, 2021. We encourage everyone to read today's press release as well as Ziopharm's quarterly report on Form 10-Q for the third quarter 2021, which has been filed with the SEC. The company's press release and quarterly report will also be available on Ziopharm's website at ziopharm.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 are accurate only as of the date of this live broadcast, November 8, 2021. Actual results could differ materially from those stated or implied by these forward-looking statements 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 that said, I would like to now turn the call over to Kevin Boyle. Kevin, you may begin.

Thank you, Alex, and welcome, everyone, to Ziopharm's Third Quarter 2021 Earnings Call. When I joined Ziopharm just over 2 months ago, I promised to be transparent with shareholders and share my observations and perspectives at the next opportunity. Today, I'd like to do that and highlight some of our recent accomplishments and lay out my vision for the next year. A month ago, we made the decision to strategically restructure the organization and focus our efforts on advancing our differentiated TCR-T cell platform. As a result, we took immediate action to rightsize the organization with a focus on generating clinical data while maintaining a robust R&D discovery engine. I'm impressed by the quality, dedication and resiliency of our team at Ziopharm, and I'm confident we possess the internal capabilities to advance our innovative scientific research into the clinic.

We appreciate the importance of generating clinical data to validate our TCR-T platform and are making excellent progress in that regard. We realized the fastest way to the clinic was not to rely on an external contract manufacturer but to operationalize our in-house cGMP clinical production unit or CPU. I am very proud to announce that we completed the necessary engineering and process qualification runs in October at our CPU.

The Ziopharm team did an excellent job working together in a cross-disciplinary manner to accomplish this important step. We remain committed to begin treating patients in the first half of 2022. Our TCR-T platform is predicated on a robust research and development lab and team based in Houston. The R&D team is working on several different programs. First, we continue to support the lead program, our TCR-T library trial and are working to incorporate additional TCRs into this IND. Second, we are advancing the development of our membrane-bound IL-15 program and expect to have further updates on future calls. Third, we have devoted significant resources to generating our own TCR discovery platform.

These activities will allow us to generate our own intellectual property and have exclusive use of the TCRs we identify. I'm impressed by the breadth and depth of our R&D team and TCR-T platform, which holds the potential to meaningfully improve the lives of cancer patients. I will let Raffaele take a deeper dive into our upcoming TCR-T library study, but I want to elaborate briefly on our rationale for this program.

Our TCR-T library platform is enabled by our versatile, nonviral Sleeping Beauty technology combined with our extensive library of TCRs. This gives us an advantage as we can target multiple solid tumor indications within this single trial. This enables a timely and cost-effective approach to potentially identifying several indications that could benefit from our TCR-T platform and give us multiple paths forward once we have generated this initial data set. This is critical to our go-forward strategy, and we are focused on dosing our first patient in this study.

I would now like to turn the call over to Raffaele, our Chief Medical Officer, to provide an update across our manufacturing, clinical and R&D efforts that will support our future growth and bring value to our stakeholders. Raffaele?

Thank you, Kevin. This past quarter, we have continued to make progress across all our manufacturing, development programs and R&D activities. And like Kevin said, all of us at Ziopharm are committed to execution and generating clinical data in the next year.

Let me start by highlighting the progress we have made and announced the cGMP manufacturing facility in Houston, Texas. We have built and are opening our own cGMP clinical production unit, CPU. Commissioning of the facility as well as the safety process validation were completed in the second quarter. And we recently completed engineering and process qualification round in the CPU. We are committed to having a similar manufacturing capability operational to support the first patient dosing in the first half of 2022. Once operationalized, we expect to begin dosing patients in our Phase I/II TCR-T library study in the first half of 2022. As Kevin mentioned, our TCR-T library study is a basket trial that we will evaluate patients across 6 solid tumor indications: lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers.

Last month, we opened our screening study at the MD Anderson Cancer Center, and we are actively screening patients that will be enrolled on the Phase I/II treatment study, based on matching new antigen TCR, HLA bearing that are available in our TCR-T library. Patients will then be infused with autologous T cells that have been engineered to express T cell receptors using our Sleeping Beauty transposon/transposase technology and that are reactive against such imitated neoantigen.

The Phase I dose-finding portion of the study will evaluate patients at one of the dose levels. We believe that our adaptive trial design is an optimal approach to advancing our TCR-T library forward as it will allow us to rapidly and cost effectively, first, identify the recommended Phase II dose and then develop a tumor-agnostic therapies across multiple indications. This give us the opportunity to move quickly in one or more registrational trial, match to the genetic profile of the patient's cancer cells, as we seek to translate our research and development engine into meaningful clinical progress.

As you may recall, earlier this year at the ACR Annual Meeting, we shared exciting preclinical data on our multiple TCRs. On Saturday, at the annual 2021 conference of the Society of Immunotherapy of Cancer, SITC, we will provide an update on these TCRs, with unique specificity targeting recurrent TP53 and KRAS substitution in frequent HLA haplotypes. These data will further demonstrate the strong science beyond our TCFD program.

Finally, to round up our go-forward strategy, we are continuing to qualify and validate new TCRs to further expand the potential utility and applicable patient population for our TCR-T library. On this subject, we plan to file an IND in the next few months to include 4 additional TCRs into our upcoming TCR-T library trials. Furthermore, we have developed an innovative platform with internal resources including genomics, bioinformatics and cellular immunology to generate and validate (inaudible) TCR-T targets that are exclusively owned by us.

I would now like to turn the call back over to Kevin to review the financial results for the quarter. Kevin?

Thank you, Raffaele. For the third quarter of 2021, we reported a net loss of approximately $22.7 million or an $0.11 net loss per share compared to a net loss of approximately $20.3 million or a $0.10 net loss per share for the third quarter of 2020. Research and development expenses totaled approximately $14.5 million for the third quarter 2021 compared to approximately $14 million for the same period in 2020, an increase of 4%. General and administrative expenses were approximately $8.2 million for the third quarter 2021 compared to approximately $6.4 million for the third quarter of 2020.

Total operating expenses for the third quarter of 2021 were approximately $22.7 million compared to approximately $20.3 million for the same period in 2020, an increase of 12%. Cash and cash equivalents, as of September 30, 2021, were approximately $91.7 million. Given our current development plans and continued cost management efforts, we anticipate our cash runway will extend into the second quarter of 2023. That concludes our financial statements.

But before we open the call to questions, I'd like to close by saying that we are committed to building a leading TCR-T company. We have created an organization that is appropriately capitalized and staffed for success. Over the next year, we will remain focused on transforming the innovative scientific research we have developed into clinical progress. We have made excellent progress on operationalizing our in-house manufacturing facility. And with existing cash sufficient to fund our operations into the second quarter of 2023, we are confident in our ability to enter the clinic with our TCR-T library program and generate meaningful clinical data in 2022. With these clear and achievable strategic priorities in place, our entire team, here, at Ziopharm, is focused on execution as we aim to bring value to our stakeholders and improve the lives of cancer patients.

We will now open the call to questions. Hillary?

(Operator Instructions)

Our first question is from Alethia Young of Cantor Fitzgerald.

This is Emily on for Alethia. I'm just curious what the gating factors are to starting the Phase I plus II study now that you've made the progress with the in-house manufacturing? And then maybe also just comment on, now that you've done the restructuring, how do you kind of expect your operating expenses to change in the fourth quarter and maybe in 2022 as well?

Great. Thanks, Emily. I'll start with the second one first. With regards to cash burn, we anticipate that our burn going forward will be less than $15 million a quarter. And so that's something that we will be reporting on our cash burn going forward as well. And some of the cash is associated with repaying the term loan that was put in place as well as we look in the future horizon. And so those terms of the term loan are spelled out into our 10-Q. But we do have a nice reduction in our cash burn while remaining the appropriate size team to execute on our goals.

Now with regards to treating patients in our trial, it's important that we have the all clear on our IND from the FDA. So the FDA review is probably the most important part to the next step along with screening and enrolling patients. Raffaele, anything you'd like to add to that?

Just as I said earlier, that we already started screening patients -- actively screening patients. So the -- we are already screening patients that can be involved in the Phase I/II treatment study.

Our next question is from Arthur He of H.C. Wainright.

This is Arthur in for RK. So I guess I just want to follow up on the TCR-T trial. Could you give us more color to see how -- what else need to be complete to be qualified before you guys are starting to dose the first patient in that trial?

Raffaele, do you want to reiterate what we said before to Emily.

Exactly. We are waiting for the FDA review. And as Kevin mentioned earlier -- and we are already screening patients that can be enrolled on the trial. Now you have to keep in mind that the frequency of the mutations in the HLA haplotypes, where we are selecting these patients and we are ready to start enrolling patients very soon, I would say, but in the first half of, definite, 2022.

Okay. And congratulations on the manufacturing part, I just want to know, for those manufacturing part, it's most likely more for the clinical trial? Or how about for the commercial manufacturing? What's your plan on that part?

Yes. Thank you. It's -- for the clinical part that we have our manufacturing capabilities. On the commercial side, that's quite a number of years away from right now, and we have not communicated what our strategy will be at that point.

Our next question is from Thomas Flaten of Lake Street Capital Markets.

I was just curious, following the restructuring that you had, have there been any retention strategies put in place to keep the staff that's left behind? Have there been any other unforeseen departures? I'm just curious what impact that has had on the remaining staff.

Yes. Thanks, Thomas. We did put in incentive stock option grant to make sure that we are all aligned with regards to creating value for our shareholders, and at the same time, motivating and incentivizing our team. And so we -- that has been well received by the team and everybody has been working very hard, very much aligned. And we have not had any resignations that come as a surprise. So we're very excited with the retention of our team, and it's a core team. We're very strategic with who we ended up keeping. And I just reiterate the strength of the team that we have, the resiliency of the team and the amount of effort and deliverables that are coming out of this team is quite impressive and really well positioned to get this clinical trial up and running and enrolling patients here in the first half of next year.

I apologize if I missed this, but with respect to the IND clearance, are you anticipating adding new TCRs to the IND prior to clearance? Or will that be kind of an ongoing rolling exercise that you go through as you identify new TCRs?

Raffaele, why don't you speak to that?

Yes. So I wouldn't put a time line or a time connection with the submission, but we are planning, rolling -- adding TCR in a rolling manner, not only for the 4 dimension earlier but additional TCR that will come in the next year.

Great. And then finally...

I wouldn't need to link together though. Go ahead.

Got it. No, no, understood. And then just one final question. Any word out of the NCI on how things are going over there.

So I believe that Raffaele and team will be visiting the NCI later this week as part of the SITC visit and -- but we don't have any update right now to share with regards to the NCI.

We have reached the end of the questions-and-answer session. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a great day.