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spk00: Good day ladies and gentlemen and welcome to TRACON Pharmaceuticals third quarter 2023 earnings conference call. At this time all callers are in a listen-only mode. After the speaker's prepared remarks we will conduct a question and answer session and instructions will follow at that time. During today's call we will be making certain forward-looking statements including statements regarding expected timing of clinical trials and results, regulatory activities, financing opportunities, future expenses, and cash runway into 2024, our development plans and strategy, potential cost savings deliverable through our product development platform or PDP, ability to enter into additional licensing agreements, and expectations regarding the enfafolimab treatment continuing to generate a double-digit objective response rates. These statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2022, and subsequently quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, and unless required by applicable law, we disclaim any obligation to update such statements. Now, I'd like to turn the call over to Dr. Charles Thuwer, President and CEO of Tracon Pharmaceuticals. Dr. Thuwer?
spk03: Good afternoon, and thank you for joining Tracon's third quarter 2023 financial results and business update call. I will begin with an update on our pipeline and then review our recent activities. Following that, Scott Brown, our Chief Financial Officer, We'll discuss our financial results for the three and nine months ended September 30, 2023. Finally, we will conclude by taking your questions. I'll begin with an update on our continued progress with the ongoing NVISARC pivotal trial. In September, the Data Monitoring Committee reviewed interim safety and efficacy data from 46 patients in Cohort C of single-agent ENVA treatment. The objective response rate in the initial 46 patients treated with single agent ENVA was 13% by investigative review and 8.7% by blinded independent central review. The response rate assessed by central review, all of which were confirmed responses, more than satisfied the pre-specified futility rule, and ENVA monotherapy was generally well tolerated. Importantly, median duration of response by central review was greater than six months. The DMC recommended the study continue as planned, and since then, more than 20 additional patients have enrolled. We are on track to complete accrual of the MVSARC Pivotal Trial in the fourth quarter of 2023, and expect to release updated response rate data before the end of the year. As a reminder, in order to statistically exceed the 4% objective response rate of Votreant the only FDA-approved treatment for patients with refractory UPS or MFS, the primary endpoint in ENVASARC must show objective responses in nine out of 80 patients, or an 11.25% objective response rate, confirmed by central review. Meaning duration of response of greater than six months is a key secondary endpoint. Our goal in ENVASARC is to demonstrate that ENVA has the potential to be both safer and more efficacious than Votrien a drug with a black box warning for fatal liver toxicity. Based on data from trials of other checkpoint inhibitors in refractory UPS or MFS, we are targeting a 15% response rate for single-agent ENVA. Furthermore, we plan to approach the FDA to discuss a BLA filing strategy as soon as we determine nine responses. As a reminder, we have received fast-track designation for ENVA in the sarcoma subtypes of UPS and MFS that have progressed on one or two prior lines of therapy and received orphan drug designation in soft tissue sarcoma based on activity observed in ENVA-SARC. These designations provide important advantages that might expedite regulatory review and commercialization of ENVA. ENVA-SARC is designed to provide safety and efficacy data in the refractory sarcoma subtypes of UPS and MFS. We also have a strategy for the approval of ENVA and frontline sarcoma. Doxorubicin is the most common therapy used for the treatment of newly diagnosed sarcoma patients. We therefore plan to initiate a trial of ENVA and doxorubicin in the frontline setting of the common sarcoma subtypes, including UPS and MFS, following the completion of enrollment in the pivotal ENVASARC trial. The goal of that trial will be to determine the subtypes of sarcoma that best respond to the combination of ENVA and doxorubicin. Assuming positive results in the ENVASARC pivotal trial and potential accelerated approval of ENVA, we expect the FDA will require a randomized trial to demonstrate a survival benefit. We expect this potential Phase III post-approval trial will compare single-agent doxorubicin to doxorubicin with ENVA with PFS at the endpoint. This trial would be expected in real patients with UPS and MFS as well as other sarcoma subtypes shown to respond to therapy with ENVA and doxorubicin. We expect to discuss the design of a frontline trial with the FDA at the time of our expected pre-BLA meeting to review the expected submission of data from ENVASARC for potential accelerated approval of ENVA in refractory sarcoma. It is important to understand the sales potential in sarcoma with ENVA at parity pricing is not solely the forecasted $200 million in peak annual ENVA revenues anticipated following approval in refractory UPS and MFS. Our clinical development strategy is designed to create the opportunity for ENVA to broadly benefit patients with sarcoma in the frontline, adjuvant, and neoadjuvant settings by seeking supplemental BLAs. We will now turn to our DNA damage repair inhibitor, TRC102, that is financially supported through a cooperative research and development agreement with the National Cancer Institute. The NCI is sponsoring an ongoing randomized phase two trial assessing TRC102 in stage three non-squamous, non-smell cell lung cancer in combination with chemo radiation. The two-arm trial will enroll 78 patients to assess the benefit of adding TRC102 to current standard of care treatment of pemetrexed, cisplatin, and radiation therapy, followed by a consolidated drivalumab maintenance treatment. The primary endpoint of the trial is PFS, and the trial is designed to detect an improvement in PFS at one year, from 56% to 75%. Nine sites are open for enrollment in the U.S., and final results are expected in 2025. I will now shift from our pipeline update to discuss our product development platform of CRO independent research, which we call our PDP. We continue to expect to execute a license of our PDP to one or more companies this year, with the ideal partner being a company with an emerging pipeline who plans to conduct multiple trials. This offering would include our platform of advanced clinical trial management, data management, and safety reporting, that we expect would enable our collaborator to potentially conduct trials at a cost of less than one-third of what they may otherwise pay a CRO. A license of the PDP would be expected to allow a partner to run clinical trials as we do at TRACON for an estimated cost of approximately $100,000 per patient. As a typical CRO charges $300,000 or more per patient, the potential savings from licensing our PDP on a 100-patient trial could be up to approximately $20 million for a partner. In addition to the expected advantages of increased speed of trial execution and pace of enrollment, that we enjoy TRACON by running trials using our in-house team. Turning now to an update on the arbitration award from IMAP. As you may remember, we collected $22 million from IMAP in July in satisfaction of the arbitration award. of which $4.4 million were disputed and had been held in a client trust account by our attorneys predicated on discussions as to the amount of success-based deferred legal fees the firm was due. In September, we successfully received $2 million from the client trust in addition to the write-off of approximately $300,000 in invoices from the attorneys. This brings the total amount of net proceeds from the arbitration to $9.1 million, and the matter is now closed. At this time, Scott will provide an update on our financials.
spk01: Thank you, Charles, and good afternoon, everyone. Collaboration revenue was $0 and $9 million for the three and nine months ended September 30, 2023, compared to $0 for the comparable periods of 2022. The increase in revenue for the nine-month period is related to the pre-specified $9 million termination fee for the TJ4309 license in conjunction with the previously announced arbitration outcome with IMAP. TRACON's research and development expenses were $2.3 million and $10.8 million for the three and nine months ended September 30, 2023, compared to $4.1 million and $10 million for the comparable periods of 2022. The decrease in the three-month period was due to enrollment only in Cohort C of Envisarc, with the corresponding termination of Cohort D of the Envisarc pivotal trial. General and administrative expenses were $1.3 million and $5.5 million for the three and nine months ended September 30, 2023, compared to $2.3 million and $12 million for the comparable periods of 2022. The decrease was due to lower legal expenses. Our net income was $10.8 million for the three months ended September 30, 2023, and our net loss was $4 million for the nine months ended September 30, 2023, compared to net losses of $6.4 million and $22.1 million for the comparable periods of 2022. We recorded other income of $13 million in the three and nine months ended September 30th, 2023, due to the arbitration award being collected in the third quarter. Included in the $22 million arbitration award was the $9 million pre-specified termination fee payable by IMAP under the TJ4309 agreement which we recognize as revenue in Q2 of this year. Turning to the balance sheet, at September 30, 2023, our cash, cash equivalents, and restricted cash totaled $7.8 million compared to $17.5 million at December 31, 2022. With that, I will turn the call back over to Charles.
spk03: Thank you, Scott. As you have heard, our corporate strategy is proceeding as planned. Allow me to recap two key expected events. First, later this quarter, we expect to report updated response rate data from the NVISARC pivotal trial. Second, later this quarter, we expect to license our unique product development platform to enable one or more companies to benefit from our capabilities and realize for themselves the substantial clinical trial time and cost savings we enjoy at TRACON, while allowing TRACON to generate non-dilutive capital. Thank you for your time and attention, and we are now available to answer your questions.
spk00: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Ed White from HC Wainwright.
spk02: Hi, Charles. Hi, Scott. Thanks for taking my questions. So just on the blinded independent central review that we've seen so far of 8.7%, is it possible for that number to go up based on the investigator review, meaning can some of the investigator review patients be converted to a BICR patient?
spk03: So I think, yeah, there are two important data sets, Ed, and thanks for your question. So within the initial 46 patients, that was the basis for the DMC review in September. To your point, there were six responses by investigator review. Four of those were confirmed by central review. It is possible that a patient in that database could subsequently become a response by central review. But I think more importantly is consideration of the next 20 plus patients that enrolled since that time. And that's really, I think, the focal point of the update we expect to provide later this year. And our goal in that case would be to see the response rate by center view with the additional patients to recover to the endpoint of the study, which is a low double-digit response rate.
spk02: And if you don't hit that low double-digit response rate, would you still proceed to the frontline study, or would you just... not proceed at all with development of the drug?
spk03: That's a great question. I think the key focal point right now is really focusing on NVISARC. So our focus right now is completing the enrollment of NVISARC, assessing the updated response rate data in the patients that have enrolled subsequent to the DMC review that was announced in September. And based on that, our expectation is to recover the double-digit response rate But further development of Envifolumab in, for instance, the frontline setting is predicated on achieving that response rate in the current Envisarc trial.
spk02: Okay. Thanks, Charles. And perhaps just a question on the PDP. How should we be thinking about the potential revenue from that? Would there be revenue generated if the license deal was signed this year, or is it possible that if a deal is signed this year, you wouldn't record revenue until next year?
spk03: Excellent question. So our expectation is to license the platform to one or more companies and to receive revenue in the same timeframe. Non-diluted capital is a basis for licensing the know-how that enables a company to really become a serial independent company as we are and see some significant savings. We both expect the license to one or more companies to happen this year, but also we expect the nuns of the capital that would accompany that license to come in this year as well. So appreciate the question.
spk02: Thank you, Charles. And a last question, if I may. Yeah. With the cash of $7.8 million, what is your cash runway?
spk03: So our runway right now is into 2024, you know, with the expectation that by consummating a license deal or deals, An additional non-dual capital would push us further into 2024 based on the deals being consummated.
spk02: Okay, great. Thanks for taking my questions.
spk03: Really appreciate the questions. Thank you, Ed. Always a pleasure.
spk00: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. At this time, I would now like to turn the conference back over to Dr. Thuer for closing remarks.
spk03: Thank you very much. We appreciate your time and attention and look forward to speaking with you again next quarter.
spk00: This concludes today's conference call. Thank you for participating. You may now disconnect.
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