Q4 2022 Theriva Biologics Inc Earnings Call

Greetings and welcome to the revamped biologics.

2022 full year operational highlights and financial results conference call. At this time, all participants are in a listen only mode.

<unk> and answer session will follow the formal presentation, if anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded I will now turn the conference over to Chris Calabrese with let's say advisors. Thank you you may begin.

Thank you operator, and good morning, everyone. Welcome kits of Riva Biologics full year 2022, Investor Conference call, leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of three of the Biologics Dr. Mendell got Sky, All General director of the Riva Biologics European subsidiary Dr.

You borrow chief operating officer and Dr. Vince wait your head of corporate and product development of series of Biologics are also on the call and will be available to answer questions. During the Q&A session.

The biologics issued a press release this morning, which provided operational highlights and included the financial results for the full year ending December 31, 2022 depressed.

The press release can be found in the investors section of the company website at Www Dot three of a bio dotcom together with the annual report on Form 10-K for year ended December 31, 2022, which we plan to file today with the Securities and Exchange Commission or STC. In addition to the phone line. This call is being.

Streamed live via webcast, which will be archived on the company website www dot the Riva bio dot com for 90 days.

During this call certain forward looking statements regarding Saraiva biologics and V. C N 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 <unk>.

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 of a 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.

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.

Thank you Chris Good morning, and I appreciate everyone for taking the time to join us today.

During the full year of 2022 and the first few months of 2023, we continue to make significant progress across our oncology focused portfolio.

With a cash runway into the third quarter of 2024, we believe we are well positioned to execute on our corporate objectives and reach multiple value enhancing milestones throughout this year.

Our lead clinical candidate <unk> hundred one is a systemically administered oncologic adenovirus designed to selectively replicate within the tumor remodel the tumor matrix and increase tumor immunogenicity.

We dedicated our primary resources to V. C. N O one and have successfully initiated two clinical trials garage, our phase <unk> trial for patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma or P deck as well as the investigator sponsored phase one trial for patients with brain tool.

<unk>.

We have dosed the first patients and enrollment is ongoing for both of these newly initiated clinical trials.

With these studies, we look forward to building on the growing data did underscore vicino one's differentiated mechanism of action biological activity and synergistic clinical benefit observed in combination with standard of care chemotherapy.

The part of our oncology focused portfolio. We've also initiated the second cohort of the phase <unk> clinical trials and for which is designed to prevent potentially fatal adverse outcomes in patients who undergo L. Genetic meta pay iodic cell transplant H C T to treat hematologic.

Cancers.

In addition, our discovery team continues to identify new development candidates to leverage our novel every human Shield technology.

This proprietary technology is designed to protect systemically administered oncologic viruses from the host immune system.

We believe the albumin shield technology may facilitate repeated administration of oncologic virus therapies, increasing their efficacy and potentially allowing our pipeline programs to be used and standardized treatment cycles that are well established and cancer chemotherapy.

We expect 2023 to be an important year for the advancement of our clinical programs that you continue to position three are at the forefront of oncologic virus development.

On today's call, we will provide an update on recent activities and share details and how these programs align with our mission to address unmet needs for difficult to treat cancers.

Starting with our lead program D C N O life.

Yeah.

Building on the positive results of our phase one studies in January 2023, we dose the first patients in barrage of multinational phase two b clinical study evaluating intravenous V. C. N O one in newly diagnosed <unk> patients treated with first line standard of care chemotherapy, Gemcitabine and Nab packs.

Tactful.

The incidents of Piedad continues to rise and while it is one of the lowest survival or has one of the lowest survival rates among all cancer types efforts to improve upon the standard of care treatment have largely stalled.

We believe we see no one has the potential to address the urgent need for new treatment options.

The garage is a randomized controlled multicenter open label Phase two b trial that is expected to enroll up to 92 adults and approximately 25 sites across the U S and Europe .

In both the control arm and the treatment arm patients will receive gen side of being in Nab Paclitaxel standard of care chemotherapy in 28 day cycles.

In 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 that Paclitaxel treatment.

Primary endpoints for the trial include overall survival and <unk> 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.

This is an open label trial progress will be monitored very closely and steps to accelerate the clinical program may be implemented is supported by emerging data.

In addition to initiating the barrage pancreatic cancer trial, we continue to refine our clinical strategy and retinoblastoma.

Since there's no regulatory guidance for the development of Retinoblastoma medicines, we have worked closely with key opinion leaders from well known treatment centers across the Europe across the U S Europe Central and South America to confirm the optimal patient population and treatment line for inter Vittorio V. C. N O one to treat vitreous seed.

And children with retinoblastoma.

We look forward to leveraging the orphan drug designation for V. C. N of one in the syndication to facilitate protocol discussions with the FDA and other regulatory agencies.

Complementing our company sponsored studies there are several investigator sponsored studies underway at World, leading oncology research institutions and.

Collaboration with the University of Leeds, we're evaluating <unk> in patients with high grade brain tumors, who are scheduled for a surgical resection.

In January 2023, we dosed the first patient in the phase one trial, which will evaluate the ability of V. CFO want to entered brain tumors following systemic administration.

Patients with recurrent high grade primary brain tumors, typically have poor prognosis and often undergo one a more surgical interventions to remove their tumors.

The leaky vasculature of many brain tumors may provide an excellent opportunity for systemically administered <unk> to enter the tumor where it can replicate and initiate tumor cell, killing destroyed tumor stroma and stimulate.

And her tumor immune response.

Successful delivery of V C N O one to brain tumors. After systemic administration could provide a more effective and less invasive intervention and potentially transform the way. These cancers are treated.

Additionally, our investigator sponsored study our phase one clinical study in collaboration with hospital says Sean debate today, Oh in Barcelona, Spain is also ongoing.

The study is designed to evaluate the safety and Tolerability of <unk> in patients with inter ocular retinoblastoma refractory to systemic intra arterial or <unk> chemotherapy or radiotherapy.

Six patients had been treated with B C. N O. One the date in the enrollment period has been extended to include additional patients.

We plan to hold a meeting with the FDA in 2023 to discuss the clinical development and potential registration pathway from B C. N O one as an adjunct to chemotherapy in pediatric patients with advanced retinal Osama.

And a separate investigator study we are also exploring the therapeutic potential of V. C. N O. One in combination with fair value Mab for patients with recurrent metastatic squamous cell carcinoma of the head and neck.

We are encouraged by the data generated to date highlighted by the acceptable safety profile seen with sequential dosing of V. C. N O one and <unk> as well as the biological activity observed in head and neck cancer patients previously treated with anti PD L. One agents.

The results obtained to date speak to the promise of Bcl, one as a potential means of enhancing the efficacy of immuno therapeutic agents in patients whose cancers have been unresponsive to these powerful cancer therapies.

We will continue to explore collaboration and partnership opportunities to further advance V. Seattle one in this setting and we are also planning to percent additional efficacy and survival data from this study in the second half of 2023.

In parallel with our clinical studies for V. C. N. One we are keenly advancing our Ob discovery platform in albumin Shield technology.

Our proprietary albumin shield alkylating viruses incorporate an albumin binding domain and the viruses out of shelf.

This is designed to improve systemic delivery by enabling the virus ducote itself with host serum albumin to prevent inactivation by antiviral neutralizing antibodies.

We look forward to building pound or foundation of compelling proof of mechanism data generated with <unk>. You know one N V. C. N 11 develop to develop new albumin shield movies, incorporating additional therapeutic payloads.

Finally, turning to our ongoing phase <unk> clinical trial of Syn for ore write backs amazed to prevent acute graft versus host disease in patients undergoing allogeneic <unk> T treatment for hematologic cancers.

So before is intended to address key limitations of Lord spectrum antibiotics, or IV beta lactam antibiotics and potentially improved treatment outcomes with this important and widely used class therapeutics.

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

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 syn <unk> and four will receive placebo.

Dosing is now underway for the second cohort, which will evaluate since four in combination with pepper ceiling and taser backed him.

As we reported in September 2020 to progress to the second cohort was permitted by an independent safety monitoring Committee. After a detailed review of safety and pharmacokinetic data from the first antibiotic cohort administering mayor of Panama.

These data were recently presented at this years 2023 tandem meetings transplantation and cellular therapy meetings of a S. T C T and C I B M T.

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

With our collaborators at the Washington University, we plan to continue to explore the therapeutic potential of <unk> and its ability to reduce serious adverse events in patients with hematologic cancers undergoing allogeneic <unk> T.

Looking ahead with a focused clinical development portfolio and expected financial runway into the third quarter of 2024, we are well positioned to reach potentially transformational inflection points, which include <unk>.

Planning to complete enrollment for a for a variety of the phase II clinical trial of <unk>, one and <unk> by early 2024.

Holding a pre IND meeting with the FDA in the second half of 2023 to discuss the clinical development and potential registration pathway for V. C. N O one as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma.

<unk> additional data from the study at V. C. N O one in combination with gorilla humira in patients with recurrent metastatic squamous cell carcinoma of the head and neck in the second half of 2023 and completed in the second cohort of our phase <unk> clinical study of Syn <unk> for the prevention of acute graft versus host disease and bone marrow transplant.

Transplant patients in the first quarter of 2024.

Yeah.

Now I'd like to briefly turn to our financial results for the full year ended December 31 2022.

General and administrative expenses increased to $9 $9 million for the year ended December 31, 2022 from $6 $5 million for the year ended December 31 2021.

This increase of approximately 58% is primarily comprised of increased expense related to the fair value of contingent consideration higher insurance costs additional salary and benefits related to new head count public relations expense and V. C. N O administrative expenses not included in the prior year offsets.

By a decrease in consulting and legal costs related to the <unk> acquisition.

If the charge related to stock based compensation expense was $400000 for the year ended December 31, 2022 compared to $300000 for the year ended December 31 2021.

Research and development expenses increased to $11 $7 million for the year ended December 31, 2022 from $7 $8 million for the year ended December 31 2021.

This increase of approximately 50% is primarily the result of increased clinical trial expenses related to V. C. N O one not incurred in the prior year offset by lower clinical and manufacturing expenses related to our phase <unk> clinical trials in 'twenty and expenses related to our phase one.

B to a clinical trial of Syn for.

El generic HGT recipients.

We anticipate research and development expense to increase as we continue to enroll in our farage phase II clinical trial of <unk> in our ongoing phase one clinical trial of retinoblastoma.

Ban GMP manufacturing activities for V. C N O one and continue supporting our V C and 11 in other preclinical and discovery initiatives.

Research and development expenses also include a charge related to noncash stock based compensation expense of $112000 for the year ended December 31, 2022 compared to $76000 for the year ended December 31, 2021.

Other income was $471000 for the year ended December 31, 2022 compared to other income of $6000 for the year ended December 31 2021.

Other income for the year ended December 31, 2022 is primarily comprised of interest income of $501 $12000 offset by an exchange loss of $41000.

Other income for the year ended December 31, 2021 was primarily comprised of interest income.

Cash and cash equivalents totaled $41 $8 million as of December 31, 2022, compared to $67.3 million as of December 31, 2021.

This is expected to provide a runway as we discussed earlier into the third quarter of 2024.

Following a very strong.

Year, where execution allowed us to make tremendous progress in 2022.

We have now set the stage for a meaningful 2023.

We remain focused on driving our key programs forward and we'll continue to evaluate strategic opportunities that drive shareholder value and long term success.

With that we're happy to take some questions.

Yeah.

Thank you as he would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question. Kim You May Press Star two if he would like to remove your question from the queue and for participants using speaker equipment. It may be necessary to pick up your handset before pressing.

Mr Keyes.

Our first question is from James Boy with Alliance Global. Please proceed.

Hey, guys. Thank you very much for taking the questions I had a question on the.

Yeah.

In head and neck squamous cell.

We can anticipate in data in second half 2023, and look at that phase one investigator sponsored trial could you walk through sort of expectations of what we should be looking for.

But any.

Any thoughts on what the number of patients will be treated at that point.

Sure I'll, let menel take take that question. There. There are 20 patients in that study you want to give an overview of the design and what we could expect to see one efficacy and survival data come out.

Yes. This is Ty I was targeting 28th 118, Okay. And finally included two different cohorts are were combined into work product with a duopoly Matt would you say anti PDL one antibody after failure of the patients have had them like carcinoma previous lines of anti PD one therapy.

Basically the main goal of the trial, obviously sable, we just have to throw the ability of the combination but also to evaluate if the premium would be San Juan was able to overcome COVID-19 before she starts to PD. One antibody, we published last year in ESMO meeting in Paris, all the data related to the safety of the trial, which has demonstrated to be.

Very mild and we can also those are the highest those when combining sequentially our product with anti PD L. One and at ESMO. We also disclose that all the biological data obtained from a b trial, where we have demonstrated the replication capability of the virus, but also the.

Capability for the virus to shifting more logical environment off just your March to express more immuno logically.

Stein Mart tariffs that got Warren to our eventual berth our prognosis.

We are collecting right now the short way for bipolar data.

And that's going to be interesting because we have seen interesting things and we expect 2% be state that property at ESMO.

And in 2023 that you're trying to be a in the last part of September of 'twenty three each.

Its an international meeting needs to be held in Madrid in Spain. So we expect to do a release at that point of old desk or viability of these data we have at the mine.

I promise you trying to <unk> pricing.

Yeah.

And so they can I think you mentioned.

Peter as well.

Any updates on gone beyond in PNG.

Sorry could you repeat it.

Yeah.

Yes, I'm sorry, I believe in the past you had spoken about trying a combination with keytruda as well in this patient population.

Yes.

Okay.

Yeah.

Well, that's definitely something that we could ever Lake we have already depot with combining with anti PD L. One can say 10 anti PD, one antibody and obviously wary about weighting based on the results that we obtained from this trial and we have a better understanding of the final conclusions whereabout awaiting different possibilities to move these programs.

And obviously the combination with anti PD, one antibodies could be an option yes.

Okay.

Great. Thank you and then maybe a last question on the <unk> trial.

Can you walk through how do you.

I believe Steven you said, you anticipate enrollment completing first half of 'twenty four.

And.

And what should we anticipate there in that interim look in late 'twenty three.

So maybe I'll I'll start this one off so based on our projections, we expect to have the trial enrolled by early.

2024, but as you recall the study design is quite creative although it's a controlled study. It's also open label and.

As we all know from the eyes of the regulators overall survivability is absolutely. The most important endpoint. However, we're going to have the ability to look at response rates real time for this this the patients enrolled in this trial and the expectation is that sometime by the <unk>.

End of this year, we hope to have enough patients enrolled and have collected enough data for us too.

Get a good indication of whether or not we're observing the same types of response rates that we saw in our phase one study.

If the data look very compelling then we will have options to go back and talk to the regulatory authorities to figure out how we could advance this trial much more rapidly and there are a lot of options on the table, which could possibly include converting this to a pivotal a pivotal or possibly either.

In making it a registration trial with additional.

Data monitoring you know on the back end I mean, all those around the table, it's ultimately going to come down to the data.

Okay.

Okay. The last question on VC and 11 the Nexgen.

Optimized for IV administration can you walk through the timing.

Okay.

The expectations for VC and 11 please.

Yeah, maybe <unk>, you could take that as well in and discuss where we're kind of not only evaluating VC 11, but sort of our other product candidates <unk> 12, and 13 as we not only advance that program, but look for opportunities to.

To further enhance the payloads of the viruses for additional therapeutic benefit.

Yes, so basically I said it probably you remember we discussed the ACD technology platform technology that we can apply to different products and that's what we are doing right. Now. So our scientists are very actively right now and working in different and payload to buy <unk>.

What's the best combination of genetic modification to the product can.

Let's say you cooperate to have IV.

All our properties, we know very well that that'd be C&I lending can be perfect. When it goes.

I don't have systemic administration after our davita in defined systemic administration models in animals, and that's really really great and encouraging data because that's something that hasn't been describe it never before for other adenovirus and but we are seeing if that's a probably we can even incorporated.

Panel.

Properties through the virus to really be a much more active in the.

Antitumor all Amelia Okay. So that's why we have not only be seen 11 as indicated by a steep but different candidates that we are able to wait and in parallel and that's why our hour recommendation right. Now is that we probably are going to have a final decision on whats the contract we are going to move into the clinic.

During this year.

Great. Thank you for taking the questions.

We have reached the end of our question and answer session I would like to turn the conference back over to Steve for closing comments.

Thank you Shari and thank you to everyone for taking the time to join us today.

We remain very deeply committed to improving patient outcomes for these very hard to treat cancers, and we look forward to providing updates on our progress as we continue forward once again I'd like to thank our shareholders the entire team and the many people who have supported us along the way, including our patients their families.

Once again, thank you for joining us today, and we look forward to future updates.

Thank you. This will conclude today's conference you may disconnect. Your lines at this time and thank you for your participation.

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