Q4 2023 TRACON Pharmaceuticals Inc Earnings Call
Operator: Copyright 2020, New Thinking Allowed Foundation. Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals fourth quarter and year-end 2023 Earnings 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 be given at that time.
Okay.
Good day, ladies and gentlemen, and welcome to the Tracon Pharmaceuticals fourth quarter and year end 2023 earnings conference call. At this time all callers are in a listen only mode. After the Speakers' prepared remarks, we will conduct a question and answer session and instructions will be given at that time.
Operator: 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, our development plan and strategies, potential cost savings and other benefits deliverable through our Product Development Platform, or PDP, ability to enter into additional license agreements, and expectations regarding Invis Fulbinab treatments continuing to generate a double digit, as described in our filings made with the Securities and Exchange Commission, including Form 10-K for the year ended December 31st, on Form 10-Q, you are cautioned not to place undue reliance on these forward-looking statements unless required by applicable law. We disclaim any obligation to update such statements.
During today's call, we will be making certain forward looking statements, including statements regarding expected timing of clinical trials and results.
Glitch free activities financing financing opportunities.
Element planning strategies potential cost savings and other benefits deliver at bolstering our product development platform or P. D P.
The Lady to enter into additional license agreements and expectations regarding <unk>.
Inflow in the past.
Hope Nab treatments continuing to generate a double digit.
Objective response rate. These statements are subject to risks.
And 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 31st 2023, and subsequent report.
On forms 10-Q, you are cautioned not to place undue reliance on these forward looking statements unless required by applicable law, we disclaim any obligation to update such statements.
Charles P. Theuer: Now, I would like to turn the call over to Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. Dr. Theuer, please begin. Good afternoon, and thank you for joining TRACON's fourth quarter and year-end 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 review the financial results for the three and 12 months ending December 31, 2023. Finally, we will conclude by taking your questions.
Now I would like to turn the call over to Doctor Charles sure President and CEO of <unk>.
On Pharmaceuticals Doctor Stuart please begin.
Yeah.
Good afternoon, and thank you for joining <unk> fourth quarter and year end 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.
Review the financial results for the three and 12 months ended December 31, 2023. Finally, we will conclude by taking your questions.
Charles P. Theuer: I'll begin with an update on our continued progress with the ongoing Phase 2 and VASARC pivotal trial. In December, we reported updated 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 15 percent by investigator review and 8.7 percent by blinded independent central review, or four responses. ENVA monotherapy was generally well-tolerated without a single drug-related serious adverse event.
I'll begin with an update on our continued progress with the ongoing phase II <unk> pivotal trial.
In December we reported updated interim safety and efficacy data from 46 patients in cohort C of single agent <unk> treatment.
The objective response rate and the initial 46 patients treated with single agent and vote was 15% by investigator review and eight 7% by blinded independent Central review or four responses.
And the mono therapy was generally well tolerated without a single drug related serious adverse events.
Charles P. Theuer: Importantly, the median duration response by central review is greater than six months. We are on track to complete accrual of the ENVISARC PIVL trial later this quarter and expect to report updated response data shortly thereafter and prior to the end of this quarter. As a reminder, in order to statistically exceed the 4% objective response rate of Votrien, the only FDA-approved treatment for patients with refractory UPS or MFS, the primary endpoint in NVSARC must show objective responses in nine out of 80 patients or an 11.25% objective response rate confirmed by central review. The median duration response of greater than six months is a key secondary.
Importantly, medium duration of response by Central review was greater than six months.
We are on track to complete accrual of the <unk> pivotal trial later this quarter and.
And expect to report updated response data shortly thereafter and prior to the end of this quarter.
As a reminder, in order to statistically exceed the 4% objective response rate of Vouchering.
The only FDA approved treatment for patients with refractory <unk> or MFS. The primary end point in <unk> must show objective responses in nine out of 80 patients or an 11.25% objective response rate confirmed by Central review.
Median duration of response of greater than six months as a key secondary endpoints.
Charles P. Theuer: Our goal in ENVASARG 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 the nine response. As a reminder, we have received Fast-Track designation for ENVA in the sarcoma subtypes of UPS and NFS 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 Envisar. These regulations provide important advantages that might expedite regulatory review of ENVA.
Our goal with <unk> is to demonstrate that <unk> has the potential to be both safer and more efficacious in both treated.
Drug with a black box warning for fatal liver toxicity.
Based on data from trials of other checkpoint inhibitors and refractory Ups's MFS were targeting a 15% response rate for single agent Edinburg.
Furthermore, we plan to approach the FDA to discuss the BLA filing strategy as soon as we determined nine responses.
As a reminder, we have received fast track designation for <unk> in the sarcoma subtypes of UBS NFS that have progressed on one or two prior lines of therapy.
<unk> received orphan drug designation in soft tissue sarcoma based on activity observed in <unk>.
These designations provide important advantages that might expedite regulatory review of anthem.
Charles P. Theuer: The ENVIRSARC study is designed to provide safety and efficacy data in the refractory sarcoma subtypes of UPS and MFS. We also have a strategy to pursue the approval of Enva in frontline SARCOM. Doxorubicin is the most common approved therapy used for the treatment of newly diagnosed sarcoma patients.
Infrastructure is designed to provide safety and efficacy data in the refractory sarcoma subtypes that UBS in MFS.
We also have a strategy to pursue the approval of Denver in frontline sarcoma.
Dr. <unk> is the most common approved therapy used for the treatment of newly diagnosed sarcoma patients.
Charles P. Theuer: We therefore plan to initiate a trial of ENVA and doxorubicin in the frontline setting for common sarcoma subtypes, including UPS and MFS, following the completion of enrollment in the pivotal ENVASARC trial and prior to the expected BLA submission, subject to positive results from ENVASARC. The goal of that trial will be to determine the subtypes of sarcoma that best respond to the combination of EN Assuming positive results in the MSR pivotal trial, 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 progression-free survival as the endpoint. This trial would be expected to enroll patients with UPS and MFS, as well as other sarcoma subtypes expected to respond to therapy with ENVA and doxorubicin.
We therefore plan to initiate a trial and the <unk> in the frontline setting of the common sarcoma subtypes, including UBS and MFS. Following the completion of enrollment in the pivotal <unk> trial.
And prior to the expected BLA submission subject to positive results from <unk>.
The goal of that trial will be to determine the subtypes of sarcoma that best respond to the combination of <unk> and doxorubicin.
Assuming positive results in the <unk> pivotal trial, 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 a single agent doxorubicin.
Dr <unk> with Edinburgh with progression free survival as the endpoint.
This trial would be expected to enroll patients with UBS and MFS as well as other sarcoma subtypes expected to respond to therapy with <unk> and Dr. Servicer.
Charles P. Theuer: 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 ENVA-SARC for potential accelerated approval of ENVA and refractory SARC. 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 revenues anticipated upon 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 BLA. Now, we will turn to our DNA Damage Repair Inhibitor, TRC-102, a program that is financially supported through a cooperative research and development agreement with the National Cancer Institute. The NCI is sponsoring an ongoing, randomized, phase 2 trial assessing TRC-102 in stage 3, non-squamous, non-small cell lung cancer in combination with chemoradiation.
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 <unk> for a potential accelerated approval even in refractory sarcoma.
It is important to understand the sales potential in sarcoma and we're at parity pricing is not solely the forecasted $200 million in peak annual revenues anticipated following approval in refractory <unk> PFS and MFS arc.
Our clinical development strategy is designed to create the opportunity for <unk> to broadly benefit patients with sarcoma in the frontline adjuvant and neo adjuvant settings by seeking supplemental BLA.
Okay.
We will now turn to our DNA damage repair inhibitor Trc, one or two.
A program 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 trc, one or two in stage III non squamous non small cell lung cancer in combination with chemo radiation.
Charles P. Theuer: The two-arm trial will enroll 78 patients to assess the benefit of adding TRC-102 to current standard of care treatment of hemotrexid, cisplatin, and radiation therapy, followed by consolidative value-mapped maintenance treatment. The primary endpoint of the trial is progression-free survival, and the trial is designed to detect an improvement in progression-free survival at one year from 56% to 75%. 12 sites are now open for enrollment in the US, and the final results are expected in 2025.
The two arm trial will enroll 78 patients to assess the benefit of adding Trc, one or two.
To current standard of care treatment of Pemetrexed, cisplatin and radiation therapy.
By consolidated value map maintenance treatment.
The primary endpoint of the trial is progression free survival.
And the trial is designed to detect an improvement in progression free survival at one year from 56% to 75%.
12 sites are now open for enrollment in the U S and the final results are expected in 2025.
Charles P. Theuer: I will now shift from our pipeline update to discuss our Product Development Platform, or PDP, for CRO-independent research. We executed a license of our PDP for an upfront payment of $3 million in November of last year to a biotech company that recognized the value of internalizing its clinical operations to reap the benefits of CRO-independent clinical trial implementation that we enjoy at TRACON. The license of the PDP is expected to allow them 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.
I will now shift from our pipeline update to discuss our product development platform or PDP of CRO independent research.
We executed a license of our PDP for an upfront payment of $3 million in November of last year to a biotech company that recognize the value of internalizing its clinical operations to reap the benefits of zero independent clinical trial implementation that we enjoy at Tracon.
The license of the PDP is expected to allow them to run clinical trials as we do at Tracon for.
For an estimated cost of approximately $100000 per patient.
As a typical CLO charges $300000 or more per patient.
Charles P. Theuer: The potential savings from licensing our PDP on a 100-patient trial could be up to approximately $20 million for our 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, as we have noted in the past. We expect to further supplement our CAST position through opportunities for non-dilutive capital enabled through our CRO's independent PDP, which we believe positions us as one of the most efficient clinical development organizations. We expect to continue to leverage our platform in two ways that provide for potential non-dilutive capital to TRACON. First, we plan to continue to evaluate drug candidates where TRACON performs clinical trials at a lower fixed cost compared to a CRO but still at a premium to our costs using a pay-for-performance model. This is an alliance structure we have used in the past, for example, with Johnson & Johnson.
Potential savings from licensing our PDP on a 100 patient trial could be up to approximately $20 million for our partner.
In addition to the expected advantages of increased speed of trial execution and pace of enrolment that we enjoy tracon, but running trials using our in house team.
As we have noted in the past we expect to further supplement our cash position through opportunities for non dilutive capital enabled through our CRO independent PDP.
That we believe positions us as one of the most efficient clinical development organizations.
We expect to continue to leverage our platform in two ways that provide for potential non dilutive capital to tracon.
First we plan to continue to evaluate drug candidates, where trade count performance clinical trials at a lower fixed cost compared to our CFO.
But still at a premium to our cost using a pay for performance model.
This isn't aligned structure, we used in the past for example, with Johnson <unk> Johnson.
Charles P. Theuer: Second, we plan to continue to execute non-transferable licenses to our PDP, whereby we are paid to share our proprietary capabilities and know-how to enable another company to independently internalize clinical operations and use these new capabilities to avoid contracting with CROs to execute clinical trials. As has been the experience at TRACON, we believe such an investment could result in substantial time and cost savings for our partners. We believe that over time, our PDP has earned strong credibility as a compelling solution for companies who wish to become CRO independent and reap the rewards of conducting trials faster, at higher quality, and at lower cost compared to trials typically contracted to CROs. At this time, Scott will provide an update on our finances. Thank you, Charles, and good afternoon, everyone.
Second we plan to continue to execute non transferable licenses to our PDP, whereby we're paid to share our proprietary capabilities and knowhow.
To enable another company to independently internalized clinical operations and.
And use these new capabilities to avoid contracting with zero is to execute clinical trials.
As has been the experience of trade Cod, we believe such an investment to result in substantial time and cost savings for our partner.
We believe that over time, our PDP has earned strong credibility as a compelling solution for companies, who wish to become independent and reap the rewards of conducting trials faster at higher quality and at lower cost compared to trials typically contracted to see arrows.
At this time, Scott will provide an update on our financials.
Thank you Charles and good afternoon, everyone.
Scott B. Brown: Revenue was $3 million and $12 million for the three and 12 months ended December 31, 2023, compared to zero for the comparable periods of 2022. The increase in revenue for the three-month period is related to the PDP license for $3 million. And the increase in the 12-month period is due to the pre-specified $9 million termination fee for the TJ409 license in conjunction with the previously announced arbitration outcome with IMF. TRACON's research and development expenses were $1.5 million and $12.3 million.
Revenue was $3 million and $12 million for the three and 12 months ended December 31 2023.
Compared to zero for the comparable periods of 2022.
The increase in revenue for the three months period is it related to the PDP license for $3 million.
And the increase in the 12 month periods due to the pre specified $9 million termination fee.
For the T J <unk> licensed in conjunction with the previously announced arbitration outcome with imap.
<unk> research and development expenses were $1 5 million and $12 3 million.
Scott B. Brown: For the 3 and 12 months ended December 31, 2023, compared to $3.9 million and $13.9 million for the comparable periods of 2022, the decrease was due to enrollment only in Cohort C of NVSARC and the corresponding termination of Cohort D of the NVSARC Bipinal Trial. General and Administrative Expenses $1.1 million and $6.7 million for the three-and-twelve months ended December 31, 2021, compared to $2 million and $14 million for the comparable periods in 2022.
For the three and 12 months ended December 31, 2023, compared to $3 9 million and $13 9 million for the comparable periods of 2022.
The decrease was due to enrollment only in cohorts the of <unk> and the corresponding termination of cohort of.
The <unk> pivotal trial.
General and administrative expenses were $1 1 million and $6 7 million.
For the three and 12 months ended December 31 2023.
Compared to $2 million and $14 million for the comparable periods of 2022.
Scott B. Brown: The decrease was due to lower legal... Our net income was $0.4 million for the three months ended December 31st, 2023. And our net loss was $3.6 million for the 12-month end of December 31, 2015, compared to net losses of $7 million and $29.1 million for the comparable periods of 2022. We recorded other income of $13 million in the 12 months ended December 31, 2023 due to the Arbitration Award being collected in the third. Turning to the balance sheet, at December 31st, 2023, cash, cash equivalents, and restricted cash totaled $8.6 million, compared to $17.5 million on December 31. With that, I will turn the call back over to Scott. Thank you, Scott. As you have heard, our corporate strategy is proceeding as planned.
The decrease was due to lower legal expenses.
Our net income was <unk> 4 million for the three months ended December 31 2023.
And our net loss was $3 6 million for the 12 months ended December 31 2023.
Compared to net losses of $7 million and $29 1 million for the comparable periods in 2022.
We recorded other income of $13 million in the 12 months ended December 31 2023.
Due to the arbitration award being collected in the third quarter.
Turning to the balance sheet.
At December 31, 2023, our cash cash equivalents and restricted cash totaled $8 6 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 data from the <unk> pivotal trial.
Charles P. Theuer: Allow me to recap two key expected events. First, later this quarter, we expect to report updated response data from the NVSARC Pivotal trial. Second, we expect to continue to leverage our product development platform to generate non-dilutive capital through either an additional license or fees captured by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO, but still at a premium to our cost using a pay-for-performance model. Thank you for your time and attention, and we are now available to answer your questions. Thank you. To ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. One moment while we compile our Q&A. And our first question is going to come from the line of Soumit Roy, Jones Research. Your line is open. Please go ahead.
Second we expect to continue to leverage our product development platform to generate non dilutive capital through either an additional license.
Through fees capture.
Captured by replacing our CFO and executing clinical trials for partners at a lower cost compared to a CRO, but still at a premium to our cost using a pay per performance model.
Thank you for your time and attention and we are now available to answer your questions.
Thank you to ask a question at this time, Please press star one on your telephone.
For your name to be announced to withdraw your question. Please press star one again.
And that will become power Q&A roster.
And with your first question comes from the line of Sumit Roy with Jones Research. Your line is open. Please go ahead.
Soumit Roy: Hello everyone, and thank you for taking my question. In the ENVASAR trial, have you started doing some market research on what approval or response rate would really cause a proper adoption of this drug? There is a response rate to be greater than 20-25%, or physicians are willing to take on a lower response rate because of a better safety profile and faster infusion. Any color would be helpful.
Hello, everyone and thank you for taking my question.
Yes.
On the <unk> trial have you started doing.
Some market research on.
What would be the.
<unk>.
What approval rate our response rates would really cause it proper adoption of this drug.
Do you expect.
So responsive to be greater than 2025%, our physicians are willing to take on a lower response rate because of a better safety profile and better faster infusion any color would be helpful.
Charles P. Theuer: Thanks for the question. Yeah, I think in order to answer your question, I think it's important to understand kind of where the treatment for refractory sarcoma stands. As an example, for diseases like, or subtypes like leiomyosarcoma and liposarcoma, there is a second line of... treatments approved like epirubicin that has a 1% response rate.
Hi, Sharon yes. Thanks for the question, Yes, I think in order to answer your question I think is important to understand kind of where the treatment for refractory sarcoma stands.
As an example for.
Diseases like our subtypes like Leiomyosarcoma LIFO sarcoma.
They're a second lineup.
<unk> approved like I guess Rubinsohn that has a 1% response rate.
Charles P. Theuer: In the case of UPS and MFS, since we've discussed the approved standard of care, Votrien has a 4% response rate. So based on our market research for achieving our target product profile, which is a 15% response rate, we actually expect significant adoption of the therapy. And you have to consider that a 15 percent response rate, for example, in refractory sarcoma is almost as high as the response rate for doxorubicin, which is about 17 percent in frontline sarcoma.
Case of UBS in MFS as we've discussed the approved standard of care <unk> has a 4% response rate.
So based on our market research of achieving our target product profile, which is a 15% response rate.
We actually expect significant adoption of the therapy.
And you have to consider that a 50% response rate for example, and refractory sarcoma is almost as high as the response rate for doxorubicin, which is about 17% and frontline sarcoma.
Charles P. Theuer: So I think when you think about sarcoma and response rates, it's a very different dynamic than some larger tumors where there have been much more significant advances in the standard of care. And I guess the bottom line to think about how slow progress has been in sarcoma is to consider the fact that Doxorubicin is still the most effective therapy across the board for sarcoma. It's a drug that was approved in 1975 and, as I mentioned, even in a frontline setting, it has only a 17% response rate. So, based on our market research and achieving our target product profile, we do feel that Envifolmab would be adopted by the investigators that are currently using it in the clinical trial, which is another advantage for us. The fact that we're enrolling this trial at 29 sites in the U.S. with almost every significant key opinion leader in the field, and they have experience with the drug, I think would also be a big positive in terms of potential adoption of the therapy commercially. That's really helpful.
So I think when you think about sarcoma and response rates, it's a very different dynamic than some larger tumors, where there had been much more significant advances in the standard of care.
And I guess the.
Bottom line to think about how slow progress has been in sarcoma is to consider the fact that the doxorubicin is still the most effective therapy across the board for sarcoma.
It's a drug that was approved a 1975 and as I mentioned, even in frontline setting only has a 17% response rate so.
So based on our market research and achieving our target product profile, we do feel that and before Matt would be adopted by the investigators that are currently using it and the clinical trial, which is another advantage for us. The fact that we're enrolling this trial 29 sites in the U S. With almost every significant key opinion leader in the field and they have experience with the drug.
I think it would also be a big positive in terms of potential adoption of the therapy commercially.
Great Thats really helpful second question on.
Charles P. Theuer: Second question on the discussion with the FDA on the BLA. Now that the trial has only one arm... What has been the conversation from before, if the FDA would like you to run a larger phase three trial with a control arm, or can this be filed? Yes, so our discussions with the FDA were to file the NVISARC data based on achieving the primary endpoint as a single-arm study with respect to accelerated approval. And the way the trial was designed initially, to be clear, there was a single arm with Envifolumab, which is currently Cohort C, and there was a combination of Envifolumab with Ipilimumab, which is Co Given we didn't see superior responses in Cohort D compared to Cohort C, we took down Cohort D in the study.
Discussion with FDA on the BLA.
Now that the trial has only one arm.
What has been the Congress from before if the FDA would like you to run a larger phase III trial with a control arm or is can this be filed.
Yes, so our discussion with the FDA were to file the <unk> data based on achieving the primary endpoint as a single arm study with respect to accelerated approval.
And the way the trial was designed initially to be clear there was a single arm of <unk> cohort C. Currently and there was a combination of combining into a format with Illumina Mab, which is cohort D is as you know.
Given we didn't see superior responses in cohort D compared to cohort C. We took down cohort in the study.
Charles P. Theuer: But to be clear, the opportunity for having cohort D in the study was potentially to have dual approval, but that would only have been achieved if Cohort D had clearly outperformed Cohort C and both of the cohorts had independently achieved the primary endpoint of an 11.25% response rate. So the fact that cohort D did not show increased activity doesn't change with respect to cohort C and the opportunity for approval based on achieving the primary end and the um... The upcoming data at the end of this quarter; could you give us any color on how many patient data will that be and what kind of details will be provided? Sure. Yeah, so we announced in December that we had enrolled in excess of 70 patients at that time, and our opportunity to provide updated response rate data is that we want to follow each enrolled patient for at least three months to give them the opportunity to respond to therapy.
But to be clear the opportunity for having cohort D. In this study was potentially tap dual approval.
But that would have only been achieved if cohort D had clearly outperformed cohort C and both of those cohorts had independently achieved the primary endpoint of 11, 5% response rate.
So the fact that <unk> did not show increased activity doesn't change with respect to cohort C.
And the opportunity for approval based on achieving the primary endpoint.
Alright.
And the.
The upcoming data at the end of this quarter could you give us any color on how many patient data will that be in.
What kind of details will be provided thank you sure. Yes. So we had announced in December that we enrolled in excess of 70 patients at that time and our opportunity for providing an updated response rate data is that we want to follow each enrolled patient for at least three months to give them the opportunity to respond to therapy. So at this time.
Charles P. Theuer: So, at this time, we would expect an update on approximately 70 patients, so that would be the additional patients beyond the 46 in December, to a total of potentially 70 or so patients in whom we would have at least the opportunity to evaluate for three months. And we would expect to update response rate and also duration of response to finish that thought show. Great. Thank you again.
We would expect an update on approximately 70 patients. So it would be in the additional patients beyond the <unk> 46 in December to a total of potentially 70 or so patients in whom we would have at least the opportunity to evaluate for three months.
Great.
Update response rate and also duration of response to finish that thought Sherman.
Great. Thank.
Operator: I appreciate your questions, gentlemen. Thank you. Thank you and one moment for our next question. Our next question is going to come from the line of Ed White with HC Wainwright. Your line is open, please go ahead. Hey, this is Steve on behalf of Ed.
Thank you again.
I appreciate your questions gentlemen, thank you.
Thank you and one moment for our next question.
Our next question is going to come from the line of Ed White with H C. Wainwright. Your line is open. Please go ahead.
Hey, this is Steve on for Ed.
Operator: So, first question. For the final data from the EndoSARC study, I think that... to be expected in mid-2024, and now it's the second half. So just wondering about the timing.
The first question.
The final data from the <unk> study I think that used to be expected in mid 2024, and now it's second half.
I'm just wondering about the timing.
Charles P. Theuer: Yeah, no, good question. So, as I mentioned, as part of the call, we do expect full accrual this quarter, which means that we should have response data by mid-year. You know, we mentioned the third quarter just because the other key endpoint for the trial is not just the objective response rate but also the duration of response, with the key endpoint being their immediate duration response of more than six months being the goal. So in order to have significant data for each patient being on trial for at least six months, given we expect full accrual this quarter, we feel that data would then be in the third quarter of 2024. Okay, yeah, that makes sense.
Yes, no. Good question, so as I mentioned.
As part of the call, we do expect full accrual this quarter.
Which means that we should have response data by mid year.
We mentioned third quarter, just because the other key endpoint for the trial is not just the objective response rate, but also duration of response.
With the key endpoint being there a median duration of response of more than six months being the goal. So in order to have significant data for each patient being on trial at least six months given we expect full accrual this quarter.
Feel that data would then be in third quarter of 2024.
Okay, yes that makes sense.
Charles P. Theuer: And then for your product development platform, do you have any deals that are being worked through right now? What would pricing for future deals look like? No, great question.
Then for your product development platform do you have any deals that are being worked through right now and.
How would pricing for future deals look like.
Charles P. Theuer: So, you know, I can't comment on specific potential transactions, but I would just reiterate the fact that, you know, we've clearly monetized the PDP in the past through one of two ways. One is through now licensing the actual technology through a non-transferable license that we accomplished in November, and that was for $3 million up front.
No great question, So I can't comment on specific potential transactions, but I would just reiterate the fact that you know.
We've clearly monetize the PDP in the past.
Two ways one is through now licensing the actual technology through a non transferable license that we accomplished in November.
And that was for $3 million upfront.
Charles P. Theuer: I think even more potentially substantial would be actually performing services for a company to replace a CRO and give them access to our in-house platform. And, you know, to make clear what that potential can mean to TRACON, you know, if it's a phase one study, and for example, we can do a 30 patient phase one study at $3 million. And we know Acira will typically charge $9 million or more. If we charge $9 million and guarantee the price so it won't be more, that's potentially $6 million in revenue to TRACON. If it's a bigger trial, let's say it's a 100-patient trial, we can do a TRACON for, say, $10 million, which is $100,000 a patient. But again, a CRO might bid that study at $300,000 a patient. Likely, the final cost to the potential partner company would be more than that. So we're talking about $30 million plus.
Yes, I think even more potentially substantial would be actually performing services for a company to replace a CFO and give them the access to our in house platform.
And to make clear what that potentially could mean to tracon. If it's a phase one study in <unk> and for example, we can do it 30 patient phase one study of $3 million.
And we know of Sierra will charge typically $9 million or more.
We charge 9 million guarantee the price so it won't be more of that as potentially $6 million in revenue to tracon.
If it's a bigger trial, let's say, it's a 100 patient trial that we can do a trade kind of say $10 million, which is $100000 of patient again its hero my bid that study of $300000 of patient likely.
Likely the final cost to the potential partner company, we'd be more than that so we're talking about a $30 million cost plus.
Charles P. Theuer: If we can go to that company and say, we'll guarantee the price at $30, knowing we can do it at $10, you can see that's substantial potential revenue for TRACON. So both those are opportunities for TRACON, and that gives you some idea of the potential economics around each of those potential opportunities. Okay, thank you. Thank you, Steve. Yeah, please.
If we can go to that company say will guarantee the price at 30, knowing we can do it at 10, you can see that substantial potential revenue for tracon. So both those are opportunities for tracon and that gives you some idea of the potential economics around each of those potential opportunities.
Yeah.
Okay. Thank you thank.
Thank you Steve can you provide that but yes.
Charles P. Theuer: Yeah, can you provide the cash runway and any cost-cutting and just how this is about SG&A going forward? Sure. So I think we've got it to mid this year, and I think, as you've seen, we have definitely decreased expenses related to two things. One is that they no longer have expenses related to arbitration, which was a significant expense the last two years. And second of all, we have, as I mentioned, almost fully enrolled the ENVASARC trial, so that will decrease expenses going forward as well. Potential revenue through licensing or leveraging the platform could result in further quarters in the future where we're actually income positive. And I would point out that we were net income positive both in quarter four and also in quarter three related to leveraging the platform.
Can you provide that cash runway and any cost cutting efforts.
And just how to think about SG&A going forward.
Sure John So I think we guided to mid this year and I think as you've seen we have definitely decreased as expenses I think related to two things. So one is that no longer have expenses related to the arbitration that was a significant expense. The last two years and second of all we have as I mentioned almost fully enrolled the <unk> trials, so that we will deal.
<unk> expenses going forward as well.
And potential revenue through licensing or leveraging the platform could result in further quarters in the future we're actually income positive.
Went out we were net income positive both in quarter, four and also quarter three related to leveraging the platform.
Charles P. Theuer: Alright, thank you very much. Thank you, Steve. Thank you. And again, if you would like to ask a question at this time, please press star one one on your telephone. One moment.
Alright, Thank you very much thank you Steve.
Thank you.
Ken if you would like to ask a question at this time. Please press star one on your telephone one moment.
Charles P. Theuer: I'm showing no further questions at this time, and I would like to turn the call over to Dr. Theuer for closing remarks. Well, many thanks for the questions, and thank you to the audience for your time and attention. And we look forward to updating you next quarter. Have a great day. This concludes today's conference call. Thank you for participating. You may now disconnect.
And Im showing no further questions at this time I would like to turn the conference back over to Dr. Stewart for closing remarks.
Well many thanks for the questions and thank you to the audience for your time and attention and we look forward to updating you next quarter have a great day.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
[music].
Okay.
[music].
Yes.
Yes.
[music].