Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals Third Quarter 2023 Earnings Conference Call.

[Operator Instructions] 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 envafolimab 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 Theuer, President and CEO of TRACON Pharmaceuticals. Dr.

Theuer?.

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, will discuss our financial results for the 3 and 9 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 ENVASARC 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 investigator 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 prespecified futility rule and ENVA monotherapy was generally well tolerated.

Importantly, median duration of response by central review is greater than 6 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 ENVASARC 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 Votrient, the only FDA-approved treatment for patients with refractory UPS or MFS, the primary endpoint in ENVASARC must show objective responses in 9 out of 80 patients or an 11.25% objective response rate confirmed by central review.

Median duration response of greater than 6 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 Votrient, 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 9 responses.

As a reminder, we have received Fast Track designation for ENVA in the sarcoma subtypes of UPS and MFS that have progressed on 1 or 2 prior lines of therapy and received orphan drug designation in soft tissue sarcoma based on activity observed in ENVASARC.

These designations provide important advantages that might expedite regulatory review and commercialization of ENVA. ENVASARC 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 in 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 to enroll 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 or 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 of 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 II trial assessing TRC102 in Stage 3 non-squamous non-small 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 consolidated durvalumab maintenance treatment. The primary endpoint of the trial is PFS, and the trial is designed to detect an improvement in PFS at 1 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 1/3 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 the 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 at TRACON by running trials using our in-house team. Turning now to an update on the arbitration work from I-Mab.

As you may remember, we collected $22 million from I-Mab 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 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..

Thank you, Charles, and good afternoon, everyone. Collaboration revenue was $0 and $9 million for the 3 and 9 months ended September 30, 2023, compared to $0 for the comparable periods of 2022.

The increase in revenue for the 9-month period is related to the prespecified $9 million termination fee for the TJ4309 license in conjunction with the previously announced arbitration outcome with I-Mab.

TRACON's research and development expenses were $2.3 million and $10.8 million for the 3 and 9 months ended September 30, 2023, compared to $4.1 million and $10 million for the comparable periods of 2022.

The decrease in the 3-month period was due to enrollment only in cohort C of ENVASARC with the corresponding termination of cohort D of the ENVASARC pivotal trial.

General and administrative expenses were $1.3 million and $5.5 million for the 3 and 9 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 3 months ended September 30, 2023, and our net loss was $4 million for the 9 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 3 and 9 months ended September 30, 2023, due to the arbitration award being collected in the third quarter. Included in the $22 million arbitration award was the $9 million prespecified termination fee payable by I-Mab under the TJ4309 agreement, which we recognized 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..

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 ENVASARC 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 nondilutive capital.

Thank you for your time and attention, and we are now available to answer your questions..

[Operator Instructions] Our first question comes from the line of Ed White from H.C. Wainwright..

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?.

So I think, yes, there are two important datasets, 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 6 responses by investigator review for those who 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 central review with the additional patients to recover to the endpoint of the study, which is a low double-digit response rate..

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 the development of the drug?.

Now it's a great question. I think the key focal point right now is really focusing on ENVASARC. So our focus right now is completing the enrollment of ENVASARC, 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 envafolimab in, for instance, the frontline setting is predicated on achieving that response rate in the current ENVASARC trial..

Okay. 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 was signed this year, you wouldn't record revenue until next year?.

Excellent question. So our expectation is to license the platform to one or more companies and to receive revenue in the same time frame. Nondilutive capital is a basis for licensing the know-how that enables a company to really become a CRO-independent company as we are and see some significant savings.

So we both expect the license to one or more companies to happen this year, but also we expect the nondilutive capital that would accompany that license to come in this year as well. So I appreciate the question..

And last question, if I may..

Yes..

With the cash of $7.8 million, what is your cash runway?.

So our runway right now is into 2024, with the expectation that by consummating a license deal or deals and additional nondilutive capital will push us further into 2024 based on the deals being consummated..

[Operator Instructions] At this time, I would now like to turn the conference back over to Dr. Theuer for closing remarks..

Thank you very much. We appreciate your time and attention, and look forward to speaking with you again next quarter..

This concludes today's conference call. Thank you for participating. You may now disconnect..