Theriva Biologics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2023

There are 5 speakers on the call.

Operator

Ladies and gentlemen, good morning, and welcome to the Turgiva Biologics, Inc. 2023 Second Quarter Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

It is now my pleasure to introduce your host, Chris Calabrese from LifeSci Advisors, please go ahead.

Speaker 1

Thank you, operator, and good morning, everyone. Welcome to the 3rdiva Biologics' 2nd quarter 2023 investor conference call. Leading the call today will be Stephen Shallcross, Chief Executive and Chief Financial Officer of Theriva Biologics Doctor. Manel Piscayo, General Director of Theriva Biologics, European subsidiary and Doctor. Vince Wacher, Head of Corporate and Product Development of Cereva Biologics are also on the call We'll be available to answer questions during the Q and A session.

Speaker 1

Cereba Biologics issued a press release this morning, which provided operational highlights and included Financial results for the Q2 ending June 30, 2023. The press release can be found in the Investors section of the company website at www.zarevabio.com, together with the quarterly report on Form 10 Q for the quarter ended June 30, 2023, which we plan to file today with the Securities and Exchange Commission or SEC. In addition to the phone line, this call is being streamed live via webcast, which will be archived on the company website, www.tarevabio.com for 90 days. During this call, certain forward looking statements regarding Cereva Biologics and BCN Biosciences' 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 1

These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, including those set forth in Cereva Biologics' filings with the SEC, many of which are difficult to predict. No forward looking statements can be guaranteed and actual results may differ materially from such statements. The information on this call is provided only as of the date of this Call, Encoreva Biologics undertakes no obligation to update any forward looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. With that, I'd like to turn the call over to Steve. Steve?

Speaker 2

Thanks, Chris. Good morning, and I appreciate everyone taking the time to join us today. We're making tremendous progress With advancing our organization and addressing unmet needs for difficult to treat cancers and in the Q2 of 2023, We continue to drive forward our oncology focused portfolio. With our extended cash runway into the Q4 of 2024, We believe we're well positioned to execute on our corporate objectives and remain on track to reach multiple value enhancing milestones. Our primary efforts and resources are focused on pursuing multiple therapeutic opportunities for our lead clinical candidate VCN-one.

Speaker 2

As a reminder, VCN-one is a systemically administered oncolytic adenovirus designed to selectively replicate within the tumor, To grade the tumor matrix and increase tumor immunogenicity. We believe these multiple modes of action Our confidence in VCN-one is built on a strong clinical foundation as VCN-one has been administered to more than 90 patients so far And diverse indications that include pancreatic ductal adenocarcinoma or PDAC, head and neck squamous cell carcinoma, Colorectal cancer, ovarian cancer and retinal blastoma. VCN-one has been awarded orphan drug designation in the U. S. And Europe Market exclusivity.

Speaker 2

The potential use of BcN-one to enable and enhance the use of chemotherapy and immune checkpoint inhibitors In otherwise, refractory solid tumors is a strategic focus for Tareva that may provide multiple opportunities in areas of high therapeutic need. I'm pleased today to report recent highlights from our ongoing programs evaluating VCN-one in different indications Our multinational Phase 2b clinical trial evaluating intravenous VCN-one in combination with standard of care chemotherapy, gensitabine, nap Exotaxel is a first line therapy for patients with PDAC. The first patients at study sites in Spain have received their second doses of VCN-one and U. S. Sites have dosed their first patients in the trial.

Speaker 2

Repeated dosing of VCN-one, if effective, is expected to enable dosing in more standardized treatment cycles and potentially improve treatment outcomes. 2nd, survival data for patients treated with VCN-one in combination with the immune checkpoint inhibitor Durvalumab in patients with recurrent metastatic head and neck cancer will be presented at ESMO at the ESMO conference in October. Biochemical and mechanistic data presented last year demonstrated that VCN-one improved tumor immunogenicity In previous immunotherapy refractory patients and the upcoming presentation, we'll discuss and highlight Some of the first clinical outcomes data evaluating the feasibility of a VCN-one checkpoint inhibitor combination. And 3rd, the University of Pennsylvania continues to enroll and treat patients in their investigator sponsored trial administering VCN-one with Hu CAR T meso cells in ovarian and pancreatic cancer patients. Initial data from this trial were presented at the Silicon Valley Conference in June highlighting solid tumors to date and we look forward to further data from the study to determine if ECN-one can improve patient outcomes with these powerful immunotherapies.

Speaker 2

Looking ahead, we intend to meet with the FDA in the second half of twenty twenty three to Further, as we continue to explore the potentially broad synergistic clinical benefit of VCN-one, we remain committed to Systemically administered oncolytic viruses from the host immune system and may facilitate repeated administration of oncolytic virus therapies. This may enable our pipeline of programs to be used in standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy. Additionally, as part of our oncology focused portfolio, in addition to exploring the potential clinical benefits of VCN-one in different solid tumor indications, we continue to screen and enroll patients in the 2nd cohort of the Phase 1b2a clinical trial of SYN-four, which we expect to complete in the Q1 of 2024. As a reminder, SYN-four is designed to prevent potentially fatal adverse outcomes in patients who undergo hematopoietic Cell transplant or HCT to treat hematological cancers. I will now provide Further detail on how these programs continue to position Thuriva at the forefront of oncolytic virus development, starting with our lead program, VCN-one.

Speaker 2

With a 5 year survival rate of only 3%, metastatic PDAC has one of the lowest It is well established that the PDAC tumor matrix is one of the key reasons for the overall poor therapeutic outcomes for these patients. We believe VCN-one has the potential to address the urgent need for new treatment options for patients with PDAC by degrading the In the VIRAGE trial and the completion of the 2nd VCN-one doses for the first patients in Spain Our important accomplishments that add to the strong momentum for VCN-one development. We are extremely encouraged By the reported safety profile following the 2nd VCN dose, which was consistent with the safety profile observed for single doses of VCN-one administered with standard of care chemotherapy in this and previous clinical trials. More broadly, The VARAGE trial will enable us to determine the feasibility of repeated dosing of ECN-one, which could shift the paradigm to standardized treatment cycles that are well established in cancer chemotherapy and immunotherapy and may lead to improved clinical outcomes The VARAGE trial is expected to enroll 92 patients and currently has in 28 day cycles. In the treatment arm only, patients will also receive systemically administered VCN-one 7 days prior to the first and fourth cycles of gensitabine and nab paclitaxel treatment.

Speaker 2

Primary endpoints for the trial include overall survival and VCN safety and tolerability. Additional endpoints include progression free survival, Objective response rate and measures of biodistribution, VCN-one replication and immune response. Since this is an open label trial, Progress will be monitored very closely and steps to accelerate the clinical program may be implemented if supported by emerging data. In addition to advancing the VIRAGE PDEC trial, we continue to work closely with key opinion leaders to refine our clinical strategy retinal blastoma, we look forward to scheduling conversations with regulatory agencies to discuss the development pathway for VCN-one is an adjunct to chemotherapy and pediatric patients with advanced retinoblastoma. We believe intravitreal VCN-one has the potential treat beetroot seeds in children with retinoblastoma and we 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 retinoblastoma drug development. We are working with our key opinion leaders in the U. S, Europe and Central and South America to develop a potential treatment options for this difficult to treat cancer. In parallel with company sponsored studies, the potential utility of BCN-one is being explored in a number of investigator sponsored studies Treatment are ongoing at an investigator sponsored study at the University of Pennsylvania administering VCN-one with UPenn's In this study, VCN-one is administered 14 days prior to the dose of hucar T Measle Cells and the patients are carefully followed for safety and clinical outcomes. At the recent Silicon Valley Conference in June, the University of Pennsylvania investigators presented initial data from 2 ovarian cancer patients And one pancreatic cancer patient could receive the scheduled doses of VCN-one and huKurti measles cells.

Speaker 2

The investigators noted that the combination was generally well tolerated, which highlights the feasibility of administering VCN-one with UCAR T meso cells and supports the continued evaluation of ECN-one in combination with immunotherapy products to treat solid tumors. In a separate investigator's Thompson Spinaldi, we are exploring the therapeutic potential of VCN-one in combination with darolumab for patients with recurrent metastatic head and neck cancer. We are encouraged by the data generated to date Highlighted by the acceptable safety profile seen with the sequential dosing of VCN-one and durvalumab as well as the biological PD L1 agents. At the upcoming ESMO Congress in Madrid, Spain from October 20 through 24th This year, investigators will present survival data from the ongoing Phase 1 study, which will provide the first Furthermore, in collaboration with the Universio leads, we are evaluating intravenous VCN-one in patients with high grade brain tumors We're scheduled for surgical resection. This Phase 1 trial is designed to evaluate the ability of VCN-one to enter brain tumors Following systemic administration, the leaky vasculature of many brain tumors may provide an opportunity for systemically administered VCN-one to enter the tumor where it may replicate and initiate tumor cell killing, Successful systemic Delivery of VCN-one to brain tumors could provide a less invasive intervention and potentially transform the way these cancers are treated.

Speaker 2

The lead investigators have initiated dosing and are exploring protocol refinements that may help expand enrollment. Additionally, enrollment in the Phase 1 clinical study in collaboration with Hospital San Jean Dedeo in Barcelona, Spain has extended its 2 additional patients. The study is designed to evaluate the safety and We look forward to using these data in future discussions with regulatory agencies to refine the development pathway for VCN-one in retinal lymphoma. Turning to our ongoing Phase IbIIa clinical trial of SYN-four or ribaxamase to prevent acute graft versus host disease or AGVHD in patients undergoing allogeneic ACT treatment for hematological cancers. Symphora is intended to address key limitations of broad spectrum antibiotics or IV beta lekhem antibiotics and potentially improve treatment outcomes with this important and widely used class of therapeutics.

Speaker 2

The Phase 1b2a study is designed to assess the feasibility of using Symphora in the specific patient population and to provide Key information requested by the FDA regarding the safety and tolerability of SYN-four in patients with impaired intestinal barrier function. As a reminder, the study consists of 3 sequential cohorts designed to compare different IV beta lactam antibiotics to treat fever Following conditioning therapy, in each cohort, 8 patients will receive SYN-four and 4 will receive placebo. While the data remain blinded, an analysis suggests that SYN-four is well tolerated and was not observed in the blood samples of a majority Our second cohort is underway and is designed to evaluate SYN-four This cohort will provide important additional safety information, In particular, whether oral SYN-four has the potential to alter IV antibiotic levels in this patient population. With our collaborators at Washington University, we continue to explore the potential of Synfort to reduce potentially fatal adverse events related to IV antibiotic use in allogeneic HCT recipients, including AGVHD and Overgrowth in infection by pathological organisms such as C. Difficile and vancomycin resistant terracoxides.

Speaker 2

We are pleased with the progress of our clinical programs. As we continue to build On the growing data that underscores VCN-one's differentiated mechanisms of action, a key priority will be to identify new candidates to leverage the novel albumin shield technology and exciting additional technologies from our OB platform, which have tremendous potential for our pipeline. To this end, in May 2023, we appointed Doctor. Ramon Eleni, PhD, to Senior Vice President of Discovery. Ramon is an internationally recognized expert in oncolytic adenoviruses and as co founder of VCN Biosciences is uniquely suited to oversee the Riva's discovery and development pipeline.

Speaker 2

Ramon will At the ProCure program, at the Catalent Institute of Oncology or IKO and the OncoBell program of the Biomedical Research Institute, Abelvijie or ITABEL. We look forward to his guidance and strategic leadership in his new role. Additionally, we are grateful for the opportunity to strengthen our relationship with IKO and Ittobome, The leading research institutions and long term collaborators where our current OV technologies and products were invented and incubated. Overall, I'm confident that the company's strong cash position and upcoming catalyst provide a solid foundation Flooring opportunities to expand our pipeline through our OV discovery platform. We remain on track Complete enrollment for the Viroj program by the Q1 of 2024.

Speaker 2

Meet with the FDA to discuss the clinical development and potential registration pathway for BCN-one is an adjunct to chemotherapy in pediatric with advanced retinal blastoma before the end of the year and complete the 2nd cohort of our Phase 1b2a clinical study of Now I'd like to briefly turn to the financial results for the Q2 of June 30, 2023. General and administrative expenses increased to $2,700,000 for the 3 months ended June 30, 2023 from $1,500,000 the 3 months ended June 30, 2022. This increase of 80% is primarily comprised of increased Not included in the prior year, offset by a decrease in legal costs related to the VCN acquisition. The charge related to stock based compensation expense was $106,000 for the 3 months ended June 30, 2023 compared to $86,000 for the 3 months ended June 30, 2022. Research and development expenses decreased to $3,100,000 for the 3 months ended June 30, 2023 from approximately $3,500,000 for the 3 months ended June 30, 2022.

Speaker 2

This decrease of 10% It's primarily the result of lower expenses related to our Phase IbIIa clinical trial of SYN-four in allogeneic HCT Key recipients, Phase 1a clinical trial SYN-twenty and decreased manufacturing expenses related to our Phase 1a clinical trial SYN-twenty, offset by increased clinical trial expenses related to VCN-one. We anticipate research and development expenses to Increase as we continue enrollment in our VARAGE Phase 2 clinical trial of VCN-one in PDAC and our ongoing Phase 1 trial in The charge related to stock based compensation expense was $40,000 for the 3 months ended June 2023 compared to $27,000 for the 3 months ended June 30, 2022. Other income was 377 dollars for the 3 months ended June 30, 2023 compared to other expense of $17,000 for the 3 months ended June 30, 2022. Other income for the 3 months ended June 30, 2023 is primarily comprised of interest income of $381,000 and an exchange loss of $4,000 Other income for the 3 months ended June 30, 2022 is primarily comprised of interest income of 26,000 dollars and offset by an exchange loss of $9,000 Cash and cash equivalents totaled $34,200,000 of June 30, 2023 compared to $41,800,000 as of December 31, 20, 2022.

Speaker 2

We remain deeply committed to improving patient outcomes for these very, very hard to treat cancers. And before we conclude today's 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 3 of the team, our investors and the many people who have been supportive along the way, including our patients and their families. With that, we're happy to take some questions.

Operator

Ladies and gentlemen, Ladies and gentlemen, we will wait for a moment while the question queue assembles. Our first question comes from the line of James Molloy with Alliance Global Partners. Please go ahead.

Speaker 3

Hi, good morning. Thank you for taking my question. I had a question on the ISTs That are running. We've got the pancreatic, the brain tumor you ever see leads. When should we anticipate So, Safa, going down sort of 3, so brain tumor Phase 1, the combo with CAR T, ovarian and pancreatic and The Phase 1 with Infinzi or head and neck, when should we anticipate, I guess, interim looks for these intentionally, I know it's hard to judge for an IST.

Speaker 3

It wouldn't be reasonable to think you might be looking at top line data on these trials.

Speaker 2

Okay. So thanks, Jim. Let me take the first stab at that. So going down the line, The UPenn study, which we're incredibly excited about, is ongoing and they have not given us a deadline on How long that trial will continue? We know they continue to enroll patients.

Speaker 2

As I mentioned, the Silicon Valley Conference, they presented some data. We believe that there are some additional conferences that are coming up this fall that further data will be presented at. Again, it's a function of how quickly they can attract the right patients to enroll in their The retinal blastoma study, we've kept that open in Spain. And that's important to continue to gather as much data as possible ahead of our meeting with regulatory authorities, including the FDA. I think it's the possibility of closing that trial perhaps as soon as The end of this year, early next year, that's probably the time line.

Speaker 2

And once that trial is concluded, we'll update everybody On the additional data that's been generated, the LEAD study, that one, Again, we don't have a firm deadline. We continue to have discussions with the investigators, and we continue to look ways to Make enrollment easier for patients to participate. As you may or may not have heard, The U. K. Health system has been feeling a little bit of pressure from budgetary issues and staffing.

Speaker 2

So the investigators continue to address that. And again, when we have an update On the timing, we'll certainly bring everybody up to speed with that. And then finally, we're really excited About the head and neck cancer trial, as we said in the presentation here today, the survival and efficacy data is going to be At the ESMO conference in Madrid in October, it's the 20th through 24th. We don't have a meeting date yet And more than the date is going to be presented, but that's going to be a, I think, a real opportunity to highlight How VCN-one could be used in combination with checkpoint inhibitors, particularly in patients that have failed previous rounds with checkpoint inhibitors and became refractory to those treatments. So that's Sort of all I have right now.

Speaker 2

And again, we'll continue to update everybody as we have more firm deadlines. Is that helpful for you?

Speaker 3

It is indeed. And I had heard that, yes, the UK is They're cutting funding and sort of shutting down programs, so they feel like they can't get them completed in a reasonable amount of time. Is the University of Leeds IST and Brain Tumor, one of these that's potentially looking at that?

Speaker 2

The study itself is funded. It's the staffing issues at the hospitals where I think they're feeling some pressure. But again, we're in communication with the with the investigator and we continue to look for ways to enhance the opportunity for patients to be enrolled in that trial.

Speaker 3

Okay. Maybe on Veraj then just to clarify, enrollment completed Q1 of 'twenty four, which is excellent, on track with expectations. When we get is there an interim look anticipated on that in the current year? And then I think I've got Q4 of 'twenty three, but maybe I made that up. And then where would you anticipate potentially top line data for the VIRAGE trial so wrapping that trial and taking next steps?

Speaker 2

So first and foremost, the primary endpoint of that Trial is overall survival. And assuming that the trial is completely enrolled by the Q1 of next year, Arguably, that data will start presenting itself sometime probably in 2025. Now having said that, we have multiple Secondary endpoints that will help us evaluate before then whether or not the drug is performing As expected and maybe as soon as the end of this year going into next year, we could possibly have A good indication of overall response. How we convey that information to the market is yet To be determined, because depending on what those data say, we may be well positioned To first have a discussion with regulatory authorities before we make that data public. So although it could be an opportunity for us to have such a communication, more importantly, I think the fact that we could have an opportunity to go in front of regulatory authorities to figure out how we could expedite The clinical development of the asset would be equally important.

Speaker 2

So stay tuned, I guess, is the answer.

Speaker 3

Okay. And as an open label trial, obviously, you have the opportunity to release data as You deem it worthy of release, correct?

Speaker 2

Again, I would not suggest that we plan to release that data Before we had a chance to analyze it and first have a discussion with regulatory authorities. Think that wouldn't be fair to the trial, the participants and our ability to sort of chart the path Forward and from a clinical development point of view.

Speaker 3

And maybe last couple of questions. Apologize if I missed it on the call. On VCN11, is the IND on track for Q3 this year?

Speaker 2

Manel, you want to talk about CN11 and other development initiatives?

Speaker 4

Yes, I can do that perfectly. So we are working right now with basically the manufacturing part of BCN11. We don't have a formal deadline for this year for this product yet. In fact, our research and development team is working very actively with DISHEN11 and also with different candidates right now. We have announced the incorporation of Ramon Alemany during this year and that has been a real boost for all our discovery activities.

Speaker 4

So for V-eight eleven, yes, we are advancing, but we are not yet in the phase of applying for IMPD formally. We are working on that, But we need to still some work to do before that. And we are also developing, as I said, a new candidate that can be really, really promising. So I think that probably In the next month, we are going to have some additional things to show you, but that's still a bit there,

Speaker 1

Got it.

Speaker 3

Understood. Thank you. I may have made up the IND there on my end. And then maybe last question. On the SYN-four and SYN-twenty, I know that We've long discussed potentially partnering these programs.

Speaker 3

How realistic is The opportunity to partner them, I know that you still look to get some data from them to perhaps make the product look better. What is a realistic Expectation as an outsider, we should have thinking about a potential partnership for either 2020 or 4?

Speaker 2

I think it's realistic to certainly expect a potential partnership with either one of those assets. And as I've said on previous calls, although there's folks that We've had discussions with, we continue to have discussions with until we have something committed And over the line, we're not going to talk any further about that.

Speaker 3

Understood. Thank you very much for taking the questions.

Operator

Thank For the questions, I would now hand the conference over to Stephen Shallcross for closing comments.

Speaker 2

Thank you, Ryan. Thanks again everyone for taking the time to join us today. We remain focused on driving our key programs as we've talked about And we'll continue to evaluate strategic opportunities that could in fact further drive shareholder value and long term success. Once again,

Operator

The conference of Teriva Biologics Inc. Has now concluded. Thank you for your participation. You may now disconnect your lines.

Powered by Quartr
Earnings Conference Call
Theriva Biologics Q2 2023
00:00 / 00:00