Q2 2023 Theriva Biologics Inc Earnings Call

Ladies and gentlemen, good morning, and welcome to the give up Biologics, Inc. 2023 second quarter earnings Conference call.

At this time all participants are in a listen only mode.

Brief question answer session will follow the formal presentation.

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As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host Chris Calabrese from lifestyle to wireless. Please go ahead.

Thank you operator, and good morning, everyone. Welcome to the theory of the Biologics second quarter 2023, Investor Conference call, leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of the read the biologics.

Dr. <unk> General director of theory of a biologic European subsidiary and Dr. Vince wait your head of corporate and product development of three of them are biologics are also on the call and will be available to answer questions. During the Q&A session.

Biologics issued a press release this morning, which provided operational highlights included the financial results for the second quarter ending June 32023 press release can be found in the investors section of the company website at Www Dot the Riva bio dot com together with our quarterly report on Form 10-Q.

For the quarter ended June 30th 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 dot for Riva bio dot com for 90 days.

During this call certain forward looking statements regarding theories of biologics and <unk> 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. 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 theory with biologics filings with the SEC many of which are difficult to predict no forward looking.

As 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 and to read the 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.

Yeah.

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 second quarter of 2023, we continue to drive forward, our oncology focused focused portfolio.

With our extended cash runway into the fourth quarter 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 P. C N O one.

As a reminder, V C N O. One is a systemically administered politically adenovirus designed to selectively replicate within the tumor the grade the tumor matrix and increase tumor immunogenicity.

We believe these multiple modes of action possession position V. C. N O one for optimized tumor killing across several indications and in combination with different types of therapies.

Our confidence in B C. N O. One is built on our strong clinical foundation is V. C. N O. One has been administered to more than 90 patients. So far and diverse indications that include pancreatic ductal adenocarcinoma or <unk> head and neck squamous cell carcinoma.

The rectal cancer ovarian cancer and retinoblastoma.

<unk> has been awarded orphan drug designation in the U S and Europe for the treatment of pancreatic cancer and in the U S for retinoblastoma, providing additional opportunities for regulatory engagement and if approved market exclusivity.

The potential use of V C N O one to enable and enhance the use of chemotherapy and immune checkpoint inhibitors and otherwise refractory solid tumors is a strategic focus for three of them that may provide multiple opportunities in areas of high therapeutic need.

I am pleased today to report recent highlights from our ongoing programs evaluating <unk> in different indications in combination with chemotherapy immune checkpoint inhibitors in car T cells.

First enrollment is accelerating and barrage, our multinational phase two b clinical trial evaluating intravenous V. C. N of one in combination with standard of care chemotherapy Gen side of being that Paclitaxel as a first line therapy for patients with <unk>.

The first patients in study sites in Spain have received their second doses of V. C. N O one and U S sites have dosed their first patients in the trial.

Repeated dosing of V. C. N O. One if effective is expected to enable dosing and more standardized treatment cycles and potentially improved treatment outcomes.

Second survival data for patients treated with <unk> hundred one in combination with immune checkpoint inhibitor <unk> 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 the DCNR, 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 b C N O one checkpoint inhibitor combination.

And third the University of Pennsylvania continues to enroll and treat patients in their investigator sponsored trial administering V. C. N O. One with you car T missile cells in ovarian and pancreatic cancer patients.

Initial data from this trial were presented at the Silicon Valley Conference in June highlighting the feasibility of administering V. C. N O one with your car T missile cells to treat solid tumors.

Car T cell therapies have had limited efficacy against solid tumors to date and we look forward to further data from this study to determine if he sees no one can improve patient outcomes with these powerful immunotherapies.

Looking ahead, we intend to meet with the FDA in the second half of 2023 to discuss the development pathway for V. C. N O one as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.

As we continue to explore the potentially broad synergistic clinical benefit of V. C. N O. One we remain committed to pursuing new alkalotic virus candidates to leverage our novel of human Shield technology, which is designed to protect systemically administered uncle lytic viruses from the host immune system and <unk>.

They facilitate repeated administration of uncle letting virus therapies. This may enable our pipeline of programs to be used in standardized treatment cycles that are well established and cancer chemotherapy and immunotherapy.

Additionally, as part of our oncology focused portfolio.

In addition to exploring the potential clinical benefits of V. C. N O one of different solid tumor indications, we continue to screen and enroll patients in the second cohort of the phase one b two way clinical trial of Syn for which we expect to complete in the first quarter of 2024.

As a reminder, <unk> four is designed to prevent potentially fatal adverse outcomes in patients who undergo allogeneic hematopoietic cell transplant or H C T to treat hematological cancers.

I will now provide further detail and how these programs to continue to position three the at the forefront of alkylating virus development, starting with our lead program B C N O one.

With a five year survival rate of only 3%.

Metastatic P deck has one of the lowest survival rates among all cancers and is an indication that is ripe for innovation.

It is well established that the pdx tumor matrix is one of the key reasons for the overall poor therapeutic outcomes for these patients.

We believe you see no one has the potential to address the urgent need for new treatment options for patients with pediatric by degrading the tumor matrix in increasing tumor access by standard of care chemotherapy.

The initiation of dosing at U S sites and the variety of trial and the completion of the second <unk> doses for the first patient in Spain are important accomplishments that add to the strong momentum for V. C N O one development.

We are extremely encouraged by the reported safety profile. Following the second BCN dose, which was consistent with the safety profile observed for single doses of <unk> administered with standard of care chemotherapy in this and previous clinical trials.

More broadly the barrage trial will enable us to determine the feasibility of repeated dosing of ECL, one which could shift the paradigm to standardized treatment cycles.

Our well established in cancer chemotherapy, and immunotherapy and May lead to improved clinical outcomes for patients with <unk> and other solid tumors.

The brush trial is expected to enroll 92 patients and currently has four sites opened in the U S and eight sites open in Spain.

As a reminder reminder, and both the control arm and treatment arm of our phase <unk> trial patients will receive gen. Cytopenia Nab Paclitaxel standard of care chemotherapy in 28 day cycles.

And the treatment arm only patients will also receive systemically administered V. C. N 017 days prior to the first and fourth cycles of Gen side of being in Nab Paclitaxel treatment.

Primary endpoints for the trial include overall survival and V C N safety and Tolerability.

Additional endpoints include progression free survival objective response rate and measures of bio distribution V. C. N O 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 Verizon <unk> trial, we continue to work closely with key opinion leaders to refine our clinical strategy can retinoblastoma.

We look forward to schedule and conversations with regulatory agencies to discuss the development pathway for V. C. N O one as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.

We believe <unk> has the potential to treat beatrices in children with retinoblastoma, and we look forward to leveraging our orphan drug designation in the syndication to facilitate protocol discussion with the FDA and other regulatory agencies.

Since current clinical practice varies and there is no regulatory guidance specific the 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 V. C. N O. One is being explored in a number of investigator sponsored studies that are underway at leading oncology research institutions around the world.

As previously noted enrollment and treatment are ongoing in an investigator sponsored study at the University of Pennsylvania administering V. C. N O one with U Penn's hue car T niece ourselves.

In this study <unk> hundred one is ministered 14 days prior to the dose of <unk> car T missile cells in 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 two ovarian cancer patients and one pancreatic cancer patients could receive the scheduled doses of V. C N O one and Hugh Kirkey mutual cells.

The investigators noted that the combination was generally well tolerated, which highlights the feasibility of administering <unk> with your car T cells and supports the continued evaluation of V. C. N O. One in combination with immunotherapy products to treat solid tumors.

And a separate investigator sponsored study we are exploring the therapeutic potential the bcl one in combination with the brilliant mab 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 <unk>, one and to really map as well as the biological activity observed in head and neck cancer patients, who failed multiple previous lines of therapy, including treatment with anti PD.

One N PD L. One agents.

At the upcoming ESMO Congress in Madrid, Spain from October 22 to 24th this year investigators will present survival data from the ongoing phase one study, which will provide the first clinical insights into the feasibility of combining <unk> with an immune checkpoint inhibitor.

Furthermore, in collaboration with the University of Leeds, we're evaluating intravenous V. C. N O one in patients with high grade brain tumors were scheduled for surgical resection.

This phase one trial is designed to evaluate the ability of you seem to want to enter brain tumors following systemic administration.

The leaky vasculature of many brain tumors may provide an excellent opportunity for systemically administered V. C. N O one to enter the tumor where it may replicate and initiate tumor cell killing.

Stroy tumor stroma and stimulate an anti tumor immune response.

Successful systemic delivery of <unk> hundred one to brain tumors could provide a less invasive intervention and potentially transform the way. These cancers are treated.

The lead investigators have initiated dosing and are exploring protocol refinements that may help expand enrollment.

Additionally, enrollment in the phase one clinical study in collaboration with hospitals with hospital San shown today, Oh in Barcelona, Spain has extended its two additional patients.

The study is designed to evaluate the safety and Tolerability of <unk>, one in patients with interac yellow retinoblastoma refractory to systemic and are arterial or inter vittorio chemotherapy or radiotherapy.

We look forward to using these data in future discussions with regulatory agencies to refine the development pathway for V. C N O one and rattler about Soma.

Turning to our ongoing phase <unk> clinical trial of Syn <unk> or <unk> to prevent acute graft versus host disease or a gvhd in patients undergoing allogeneic <unk> T treatment for Hematological cancers.

Since <unk> is intended to address key limitations of broad spectrum antibiotics, or IV beta lactam antibiotics and potentially improved treatment outcomes with this important and widely used class of therapeutics.

The phase <unk> study is designed to assess the feasibility of using <unk> for in this specific patient population and to provide key information requested by the FDA regarding the safety and Tolerability of <unk> in patients with impaired intestinal barrier function.

As a reminder, the study consists of three sequential cohorts designed to compare different IV beta lactam antibiotics to treat fever following conditioning therapy.

And each cohort eight patients will receive <unk>, four and four who received placebo.

While the data remain blinded interim analysis suggests that's in four is well tolerated and was not observed in the blood samples of a majority of the available patients.

Our second cohort is underway and is designed to evaluate <unk> in combination with pepper sealant and tie it back to him.

With our collaborators at Washington University, we continue to explore the potential of syn <unk> to reduce potentially fatal adverse events related to IV antibiotics used in allogeneic, <unk> recipients, including a gvhd and overgrowth in infection by pathological organisms such.

C difficile and vancomycin resistant <unk>.

We are pleased with the progress of our clinical programs as.

As we continue to build on.

The growing data that underscores V C N O one's differentiated mechanisms of action are 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 Dr. Ramon Alimony ph D to senior Vice President of discovery.

Ramon is an internationally recognized expert in alcoholic adenoviruses and as co founder of V. C. N Biosciences is uniquely suited to oversee the revisit discovery and development pipeline.

Ramon will continue to serve as chair of the scientific Advisory Board and his head of the immuno therapy and viral therapy group at the procure program at the <unk> Institute of oncology our Iqos.

In the ankle Bell program of the Biomedical Research Institute Belge or Isabel.

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 Iqos.

M.

The leading research institutions and long term collaborators, where our current <unk> 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 for execution and value creation.

We remain focused on driving our clinical programs forward and exploring opportunities to expand our pipeline through our <unk> discovery platform.

We remain on track to complete enrollment for the variety.

Program by the first quarter of 2024.

Meet with the FDA to discuss the clinical development and potential registration pathway for <unk> as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma before the end of the year and complete the second cohort of our phase <unk> clinical study of Syn <unk> for the prevention of acute graft versus host disease and bone marrow.

Lance and patient.

In the first quarter of 2024.

Now I'd like to briefly turn to the financial results for the second quarter of June 32023.

General and administrative expenses increased to $2 $7 million for the three months ended June 32023 from $1 $5 million for the three months ended June 32022.

This increase of 80% is primarily comprised of increased expense related to the fair value of contingent consideration adjustment of <unk> $9 million, along with higher audit fees consulting fees travel and VC and administrative expenses not included in the prior year offset by a decrease in legal costs related to the V C.

Acquisition.

The charge related to stock based compensation expense was $106000 for the three months ended June 32023, compared to $86000 for the three months ended June 32022.

Research and development expenses decreased to $3 $1 million for the three months ended June 32023 from approximately $3 5 million for the three months ended June 32022.

This decrease of 10% is primarily the result of lower expenses related to our phase <unk> clinical trial of Syn for an allogeneic <unk> recipients phase one <unk> clinical trials in 'twenty and decreased manufacturing expenses related to our phase <unk> clinical trial of Syn <unk> 'twenty offset by increased clinical trial.

Expenses related to the C N O one.

We anticipate research and development expenses to increase as we continue enrollment nerve or Raj phase III clinical trial of <unk> in our ongoing phase one trial and retinoblastoma expand GMP manufacturing activities for <unk> and continue supporting our VC and 11 and other preclinical.

Coal and discovery initiatives.

The charge related to stock based compensation expense was $40000 for three months ended June 32023, compared to $27000 for the three months ended June 32022.

Other income was $377000 for the three months ended June 32023, compared to other expense of $17000 for the three months ended June 32022.

Other income for the three months ended June 32023 is primarily comprised of interest income of $381000 and an exchange loss of $4000.

Other income for the three months ended June 32022 is primarily comprised of interest income of $26000 and offset by an exchange loss of $9000.

Cash and cash equivalents totaled $34 $2 million as of June 32023, compared to $41 $8 million as of December 31, 2020 'twenty two.

We remain deeply committed to improve improving patient outcomes for these very 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 her 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.

Ladies and gentlemen, we will now be conducting a question and answer session.

If you would like to ask a question. Please press star and one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue.

You May press Star two if you would like to remove your question from the queue.

All participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

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.

Hi, Good morning, Thank you for taking my question.

I had a question on.

The <unk> the <unk>.

<unk>.

We are running.

The gut.

The <unk> the brain to or do you ever see leads which we anticipate.

Going down sort of three suite brain tumor phase one.

The combo with car T for ovarian and pancreatic.

The phase one with the Infinity head and neck.

When should we anticipate I guess.

Interim looks for these essentially.

It's hard to judge for an ISP.

What would be reasonable to think you might be looking at topline data on these trials.

Hey, Thanks, Jim Let me take the first stab at that so going down the line.

The U Penn study, which we're incredibly excited about.

<unk> is ongoing and they have not given us a deadline on <unk>.

How long that will that trial will continue we know they continue to enroll patients 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 <unk> again, it's a function of how quickly.

They can attract the right patients to enroll in their study and ultimately the data that's presented but so far we're very encouraged by what we're seeing.

In terms of the results that have been generated to date with you pen.

The Retinoblastoma study we've kept that open in.

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 that's probably the timeline.

And once that trials 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 way ways too.

Make enrollment easier for patients to participate as you may or may not have heard.

The UK health system has been feeling a little bit of a pressure from budgetary issues and staffing.

So the investigators continue to.

Address that.

And again, when we have an update on the timing certainly bring.

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 in the presentation here today, the survival and efficacy data is going to be presented at the ESMO conference in mid Dread in October .

It's the 20th through the 24th we don't have a meeting date yet.

More than the date is going to be presented but that's going to be a.

I think a real opportunity.

Highlight how VC you don't want to be used in combination with checkpoint inhibitors, particularly in patients that have failed <unk>.

This rounds with checkpoint inhibitors and became a refractory to those treatments.

As we have more firm deadlines is that is that helpful for you.

I had heard that you had the U K is.

They're cutting funding sort of shutting down programs that they feel like they can't.

Get them completed in a reasonable amount of time as the University of Leeds I S T and in brain tumor one of them is essentially looking at that.

The study itself has funded it's the staffing issues at the hospitals.

Where I think they are feeling some pressure.

But again, we're in we're in communication with the investigator and we continue to look for ways to <unk>.

Enhance the opportunity for patients to be enrolled in that trial.

Okay, maybe I'll garage, then just to clarify enrollment completed first quarter 2014 is excellent on track with expectations.

In.

When we get is there an interim look anticipate on that in the current year and then.

I think I've got fourth quarter, 'twenty, three but maybe maybe I made that up and then where would you anticipate potentially topline data for the garage trial and sort of wrapped in that trial and thinking next steps.

So first and foremost the primary endpoint of that trial is overall survival.

And assuming that the trial is completely enrolled by the first quarter of next year.

Arguably that data will start presenting itself sometime probably in 25 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 day to 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.

Have.

An opportunity to go in front of regulatory authorities to figure out how we can expedite the clinical development of the asset.

B.

Equally important.

So stay tuned I guess is the answer.

Okay.

And there is an open label trial. When obviously you have an opportunity to release data as Regina and worthy of release of correct again.

I would not I would not suggest that we plan to release that data.

Before we had a chance to.

To analyze it and have a discussion with regulatory authorities I 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.

Yeah.

And then maybe a last last couple of questions I apologize if I missed it on the call as you said 11 as the A&D on track with third quarter. This year.

And now you want to talk about D C and 11 and our other development initiatives.

Oh, yes, I can do that for funding. So we are working right now.

The amount of packaging box, what do you see any lag on we don't have a formal deadline for this year for this product yet in fact, our.

Short term development teams are working very actively with 11% also with different candidates right now.

We have announced that the incorporation of Romo now remain range. This year and that has been a real boost for all of our discovery activities.

Or are we hitting a lot of yes, we are advancing but we are not yet in the face of.

Flying for IMTT, formerly we're working on that but we need to still work to do before that and we are also developing.

A new candidate that can be a really really promising so I think that probably in the next months.

Here are some additional things to show you that.

Just get a little bit differently.

Got it understood. Thank you.

And maybe I may just made up the idea there on my end.

And maybe last question.

On the <unk> hundred 20, I know that.

If you're long discussed potentially partnering.

These are these these.

Grams, how realistic is the is the opportunity to partner them I know that you're still looking to get some data from them.

Make the make the product better.

What is a realistic.

The expectation is and I would say, we should have thinking about a potential partnership for either <unk> or 'twenty or Oh four.

I think it's.

It's realistic to certainly expect a potential partnership with either one of those assets.

And.

As I have said on previous calls, although there's 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.

Okay.

Understood. Thank you very much for taking the questions.

Thank you.

Ladies and gentlemen, if you wish to ask a question Please press star and one.

As there are no further questions I will now hand, the conference over to Steven Shallcross for closing comments.

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 today and we will continue to evaluate strategic opportunities that could in fact further drive shareholder value and long term success. Once again, thanks again for joining us today, and we look forward to keeping you up.

David on our progress.

Okay.

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

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