Q1 2023 Theriva Biologics Inc Earnings Call
Speaker 1: Greetings and welcome to the 3 of the Biologics, 2023 First Quarter Operational Highlights and Financial Results. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone who requires operator assistance during the conference, please press star zero on your telephone keypad.
Speaker 1: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Chris Calibriz of Life Side Advisors. Thank you, Chris. You may begin.
Speaker 2: Thank you operator and good morning everyone. Welcome to the Reva Biologics first quarter of 2023 Investor Conference call. Leading the call today will be Steven Shaupcross, Chief Executive and Chief Financial Officer of the Reva Biologics. Dr. Mannell Kiskayo, General Director of the Reva Biologics, European subsidiary.
Speaker 2: and Dr. Vince Weich here, head of corporate and product development of Sariva Biologic, are also on the call and will be available to answer questions during the Q&A session. Sariva Biologic issued a press release this morning, which provided operational highlights and included financial results for the first quarter ending March 31st, 2023.
Speaker 2: The press release can be found in the investor section of the company website at www.thorivabio.com together with the quarterly report on Form 10Q for the quarter ended March 31, 2023, which we plan to file today with the Securities and Exchange Commission or SEC.
Speaker 2: In addition to the phone line, this calls being stream live via webcast, which we archived on the company website www.serivabio.com for 98.
Speaker 2: During the call, certain forward-looking statements regarding cerebrobiologics and VCN bioscience's current expectations and projections about future events will be made. Generally, the forward-looking statements can be identified by terminology such as may, should, expects, anticipates, intends, plans, believes, estimates, and similar expressions.
Speaker 2: results may differ materially from such statements. The information on this call is provided only as the date of this call. And the REVA Biologics undertakes no obligation to update any forward-looking statements contained on this conference call on account of new information, future events, or otherwise expect except as required.
Speaker 2: by law. With that, I'd like to turn the call over to Steve. Please, thanks Chris, and good morning. I appreciate everyone taking the time to join us today.
Speaker 2: I'd like to begin by reiterating our deep commitment to advancing our organization and addressing unmetandies for difficulty to treat cancers.
Speaker 2: In the first few months of 2023, we continue to make steady progress across our oncology folks portfolio and remain on track to reach multiple value enhancing milestones. With cash runway into the third quarter of 2024, we believe we're well positioned to execute on our corporate objectives. As a reminder, our lead clinical candidate, we see an online.
Speaker 2: types of therapies providing multiple mechanisms of tumor killing.
Speaker 2: Building on strong phase one clinical data, we are advancing verage our phase 2B trial for patients with newly diagnosed metastatic pancreatic ductile endocursinoma or PDEC, and we are pleased with the progress today.
Speaker 2: Enrollment and dosing are also underway for the Phase I trial, the BC-01 and patients with brain tumors, and we're preparing to engage with regulatory agencies to discuss the development and potential registration pathway for BC-01 as an adjunct to chemotherapy and pediatric patients with advanced retinoblastoma.
Speaker 2: This part of our oncology focus portfolio in addition to exploring the potential clinical benefits of BCN01 and different solid tumor indications, we continue to screen patients and enroll them in the second cohort of the phase 1B2A clinical trial of CIN4, which we expect complete in the first quarter of 2024.
Speaker 2: As a reminder, SYN4 is designed to prevent potentially fatal outcomes in patients who undergo L-genetic hematopoietic cell transplant, HCT, to treat hematologic cancers.
Speaker 2: In parallel, we've taken important steps to identify new candidates through our OV Discovery Platform, which is designed to protect systemically administered oncologic viruses from the host immune system and may facilitate repeated administration of oncologic virus therapies touch.
Speaker 2: increasing their efficacy and potentially allowing their pipeline programs to be used in standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy.
Speaker 2: With this brief introduction, I will now provide an update on recent activities and share details on how these programs continue to position Tereva at the forefront of oncolytic virus development, starting with our lead program, BCN01.
Speaker 2: It is well known that PDAC has one of the lowest survival rates among all cancers and despite the growing incidence, efforts to improve upon the standard of care chemotherapy treatments have largely stalled.
Speaker 2: We believe UCN-01 has the potential to address the urgent need for new treatment options for patients with PDAC.
Speaker 2: Enrollment and dosing are underway in Barrage, the multinational phase-to-be clinical study evaluating intravenous VC-01 in newly diagnosed PDAC patients treated with first-line standard to care chemotherapy, gen-side-of-beat and NAPACS tax.
Speaker 2: The trials expected to enroll up to 92 adults at up to 25 sites across the U.S. and Europe .
Speaker 2: We are encouraged by the enrollment today, which is a testament to both the engagement of our clinical trial sites and the intense commitment of our experienced clinical team.
Speaker 2: In both the control arm and treatment arm, patients will receive ginsotabine and napaxic taxol standard of care chemotherapy in 28 day cycles.
Speaker 2: In the treatment arm only, patients will also receive Systemically administered VC-01, seven days prior to the first and fourth cycles of Gen-Cyda Bean and NEPPEX attacks of treatment. Primary endpoints for the trial include overall survival and VC-01 safety and tolerability. Additional endpoints include progression for each survival, objective response rate,
Speaker 2: to work closely with key opinion leaders to refine our clinical strategy in retinal blastoma.
Speaker 2: We believe that for VTRIL, V101 has the potential to treat VTRC's in children with retinal blistoma, and we also look forward to leveraging our orphan drug designation in this indication to facilitate protocol discussions with the FDA and other regulatory agencies.
Speaker 2: Since current clinical practice varies and there is no regulatory guidance specific to retinal blood stoma drug development, we are working with our key opinion leaders in the US, Europe , and Central and South America to develop new potential treatment options for this difficult to treat cancer.
Speaker 2: Since current clinical practice varies and there is no regulatory guidance specific to retinal blodstoma drug development, we are working with our key opinion leaders in the US, Europe , and Central and South America to develop new potential treatment options for this difficult-to-treat cancer. In parallel with company-sponsored studies, we are working with our key opinion leaders in the US, Europe , and Central and South America to develop new potential treatment options
Speaker 2: the potential utility of VCN01 is being explored in a number of investigator-sponsored studies that are underway in leading oncology research institutions around the world.
Speaker 2: In collaboration with the University of Leeds, we are evaluating intravenous VCN01 in patients with high-grade brain tumours for scheduled presurgical resection.
Speaker 2: This phase one trial is designed to evaluate the ability of E.C. No. 1 to enter brain tumors following systemic administration.
Speaker 2: The leaky vascular of many brain tumors may provide an excellent opportunity for Systemically administered VC01 to enter the tumor where it may replicate and initiate tumor cell killing, destroy tumor stroma, instinulate, and anti-tumor immune response. Successful Systemic Delivery of VC01 to Breed Tumors could provide a
Speaker 2: with hospital San Juan Dadeo in Barcelona, Spain, has been extended to additional patients.
Speaker 2: The study is designed to evaluate the safety and tolerability of EC01 in patients with interocular retinoblastoma refractory to systemic inter arterial or intravitriol chemotherapy or radiotherapy.
Speaker 2: We plan to hold the meeting with the FDA in the second half of 2023 to discuss the clinical development and potential registration pathway for VCN-01 as an adjunct to chemotherapy and pediatric patients with advanced retinoblastoma.
Speaker 2: A separate investigator-sponsored study is exploring the therapeutic potential of VCN01 in combination with drivelumab for patients with recurrent metastatic squamous cell carcinoma of the head and neck.
Speaker 2: We are encouraged by the data generated today, highlighted by the acceptable safety profile seen with sequential dosing of VCN-01 and drevalumab, as well as biological activity observed in head and neck cancer patients who failed multiple previous lines of therapy In part N1 the
Speaker 2: including treatment with NIPD1 and PD-L1 agents. We are planning to present additional efficacy and survival data from the study in the second half of 2023, and we will continue to explore collaboration and partnering opportunities to advance VC-N01 indication.
Speaker 2: The potential to enable the use of immune checkpoint inhibitors in refractory or in sensitive cancer patients is a particularly compelling goal of BCN01 that may have valuable utility in a range of cancer indications.
Speaker 2: Turning to our ongoing Phase 1B2A clinical trial, CIN4, or rivaximase to prevent acute graft-versus-host disease, or AGVHD, in patients undergoing alginic HCT treatment for hematologic cancers.
Speaker 2: Sin4 is intended to address key limitations of broad spectrum antibiotics or IV beta-lactamin antibiotics and potentially improve treatment outcomes with this important and widely used class of therapeutics.
Speaker 2: The PASE-1B2A study is designed to assess the feasibility of using SYN4 in the specific patient population and to provide key information requested by the FDA regarding the safety and tolerability of SYN4 in patients with impaired intestinal barrier function. As a reminder, the study consists of three sequential cohorts designed...
Speaker 2: While the data remained blinded, interim analysis suggests that SIN-4 is well-tolerated and was not observed in the blood samples of a majority of the available patients. Building on these results, our second cohort is underway and is designed to evaluate SIN-4 in combination with Purposellin and TASA-VAC-TAM. This cohort will provide important additional safety information in particular whether oral SIN-4 had the potential to alter IV antibiotic levels in this patient population.
Speaker 2: With our collaborators at Washington University, we continue to explore the potential of sin-for to reduce potentially fatal adverse events related to IV antibiotic use and LGNAHCT recipients, including AGVHD and overgrowth and infection by pathological organisms such as C. difficile and vancomycin resistant teracoxic.
Speaker 2: of mechanism data generated with VC-01 and VC-11 to develop new human shield candidates incorporating additional therapeutic payloads.
Speaker 2: Overall, I'm confident that the company's strong cash position and upcoming catalyst will provide a solid foundation for execution and value creation. We remain focused on driving our clinical programs forward and exploring opportunities to expand our pipeline through our OV Discovery platform.
Speaker 2: We were made on track to complete enrollment for Varage by early 2024. Hold the pre-IND meeting with the FDA in the second half of 2023 to discuss the clinical development and potential registration pathway for VC-01 is an adjunct to chemotherapy and pediatric patients with advanced retinoblastoma.
Speaker 2: present additional data from the study of BCN01 in combination with Duralumab in patients with recurrent metastatic screen of cell carcinoma of the head and neck in the second half of 2023. And complete the second cohort of our phase 1B2A clinical study of Sin4 for the prevention of acute graft-versus-host disease and bone marrow transplant.
Speaker 2: the three months ended March 31, 2023 from $1.7 million. Should the three months ended March 31, 2022.
Speaker 2: This increase of 29% is primarily comprised of increased expense related to the fair value of the contingent consideration, additional salary and benefits related to new headcount, audit fees, consulting fees, travel and VC and administrative expenses not included in the prior year, offset by a decrease in consulting and legal costs related to the VC and acquisition.
Speaker 2: The charge related to SOC-based compensation expense was $87,000 for the three months ended March 31, 2023, compared to $85,000 for the three months ended March 31, 2022. Research and development expenses increased to $3 million for the three months ended March 31, 2023, from approximately $2.6 million to the three months ended March 31, 2022.
Speaker 2: HTT recipients and decreased manufacturing expenses related to our Phase 1a clinical trial of SIN 20.
Speaker 2: We anticipate research and development expense to increase as we continue enrollment in our Virage Phase II clinical trial of VCN-01 in PDAC and our ongoing Phase I clinical trial in retinolosoma, expand GMP manufacturing activities for VCN-01, and continue supporting VCN-11 and other preclinical and discovery initiatives.
Speaker 2: $1,000 for the three months that had March 31, 2023 compared to other expense of $21,000 for the three months ended March 31, 2022.
Speaker 2: Other income for three months ended March 31, 2023's primarily comprised of interest income of $364,000 in exchange gain of $6,000.
Speaker 2: Other expense for the three months ended March 31, 2022, is primarily comprised of an exchange loss of $23,000 offset by interest income of $2,000. Cash and cash equivalents totaled $36.1 million as of March 31, 2023, compared to $41.8 million as of December 31, 2022.
Speaker 2: We remain deeply committed to improving patient outcomes for these very hard to treat cancers. And before we conclude today's call, I want to extend my sincere appreciation and gratitude for the foundational work that has brought us closer to delivering on our mission. I'd also like to thank the entire three of the team, our investors, and the many for participating and particularly our volunteers to share their inspiration and skills to contribute
Speaker 1: of own keypad. A confirmation tunnel indicate your line is in the question queue. You may press star 2 if you would like to remove your questions from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star keys. One moment please while we pull for questions.
Speaker 1: As a reminder to if you'd like to ask a question, please press star one.
Speaker 1: Our first question came from the line of James Malloy with Alliance Global Partners. Please proceed with your question.
Speaker 2: Thank you very much for taking my question. My apologies. I had it on mute there at first when I hit the star 1. On the VARAZ trial, when you anticipate...
Speaker 3: Looking for interim data here, fourth quarter of 23, I believe. Can you anticipate this trial concluding and top line data coming through?
Speaker 2: So Jim, as we previously disclosed, we plan to complete the enrollment by early 2024, so that's all 92 patients in. Enrollments currently are on target with our expectations. We expect that sometime by the end of the year we should have enough inpatient.
Speaker 2: enrolled that will give us the opportunity to evaluate the data and make some determinations on whether or not the trial and the patients in the trial are responding as we expect them to respond. At that point in time, that will give us the opportunity to, if we're seeing that robust response, to have discussions with the public about the
Speaker 2: longer the better because obviously that would mean that patients are living longer. But we will have, in our opinion, a real good feel perhaps as soon as the end of the year on whether or not we're seeing the response rate that we observed or something close to it in the Phase 1 trial.
Speaker 3: How goes the expectation for the
Speaker 3: Actually, how do you pin the IST trials? Any updates there? And when you just be getting data potential from those trials, I know they're out of your hands a little bit.
Speaker 2: So, you're correct on that. First, the LEADS trial, we have the first patient dosed there in the process of recruiting still. Recently, there were some proposed protocol amendments that would give the sponsor some additional flexibility.
Speaker 2: to improve the enrollment rate, so that's ongoing and we have no specific timeline on when that study will conclude and at what point we'll actually have the data. That effort is totally in their hands.
Speaker 2: The UPEN study similarly, we know that they're dosing patients. We have no specific data on exact numbers and what they're observing in terms of response rate.
Speaker 2: We would expect that sometime in the middle or going into the third quarter this year that we would have a communication and it's also possible that UPenn, which they are again controlling the study,
Speaker 3: may perhaps present some of that data at a public forum. How often is communication between you guys and the ISTs? And again, I know ISTs are outside of your hands, but what's sort of the schedule of these updates? And you mentioned potentially second half of this 23. Is there is set
Speaker 3: board meeting or panel meeting to
Speaker 3: board meeting or panel meeting to coordinate efforts on these trials.
Speaker 2: trial, for example, we've been in active discussions with them because that data is being prepared to be released sometime in the third quarter at an upcoming conference. So in that case, the discussions with the PI are pretty active and pretty regular.
Speaker 3: So, again, it depends on the trial and how aggressively the enrollments are progressing. Understood. And then on CINN04, I think you've made it clear, I think in the previous calls you're looking to partner continues development beyond sort of the Phase 1, V2A.
Speaker 3: Now that you're currently working on, how would you characterize the partnership environment for CNO4 currently?
Speaker 2: There is interest. We have had inbound interest. Again, these things take time to play out. Once we have something that's more definitive, we certainly will communicate that to everybody.
Speaker 2: Do you think it's something that's likely a 2023 or is it still too early to even put a timeline on it? I can't put a timeline. I mean, this environment is very tricky nowadays. You get a lot of interest. You have discussions. And there are a lot of reasons why something moves at the rate it does. And...
Speaker 2: Again, we're doing everything we can to actively engage with interested parties across our whole portfolio of products. When we have something more definitive, we'll obviously again communicate that.
Speaker 2: Again, we're doing everything we can to actively engage with interested parties across our whole portfolio of products. When we have something more definitive, we'll obviously again communicate that. Outstanding, thank you very much for taking the questions.
Speaker 4: Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question. Hi, guys. This is Chad on for Jason. Thanks for taking the question. For the retinoblastoma program, I know it's
Speaker 4: you know, those meetings with the FDA are coming up, but do you anticipate if you can speak on it, if this could be a registrational trial, if you guys maybe go with a P2 or P2-3, or would you need, do you think, an additional study after that?
Speaker 2: So the bottom line is we won't know until we have a discussion with the FDA. But maybe, Manel, if you want to give a little bit more color about some of the discussions we've had with the KOL and how we're moving forward. Yeah, exactly. Yes, as anticipated by Steve, that's something that's going to be very dependent on.
Speaker 5: on our interaction with FDA, obviously.
Speaker 5: We are working very intensively, having some very interesting discussions with key opinion leaders, both here in the US and in Europe with the top investigators, but also with some physicians involved in treatment of this disease in low and medium income countries.
Speaker 5: because in that geographical area, it's where retinoblastoma is much more abundant and the patients normally are not diagnosed as soon as it could be, for instance, in the US. And that gives us a opportunity to really impact with our treatment in that population that otherwise it's orphaned off.
Speaker 5: that it's going to be probably more in the line of a global health system, let's say. But again, that's something that we should discuss with FDA. We have very nice ideas, I think, to discuss and we are getting support for these ideas from the QP
Speaker 2: Thanks again to everyone for taking the time to join us today. We remain focused on driving our key programs forward and will continue to evaluate strategic opportunities that we believe will help further drive our shareholder value in long-term success. Once again, thanks for joining us and we look forward to future updates.
Speaker 1: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.
Speaker 6: So.
Speaker 6: The C.