Q3 2022 Theriva Biologics Inc Earnings Call

Good day and welcome to the parent easy yeah.

Biologics formularies synthetic biologics 2022 third quarter operational highlights and financial results.

Today's conference is being recorded at this time I would like to turn the conference over to Mr. Chris Calabresi Lifesize advisors relationship manager. Please go ahead Sir.

Thank you operator, and good morning, everyone. Welcome to the theory of a biologics 2022 third quarter Investor Conference call, leading the call today will be Steven Shallcross, Chief Executive and Chief Financial Officer of theory of a biologics documenting all guests Guy out general director of to read of a biologics European subsidiary.

Dr. Frank did borrow chief operating officer, and Dr. Vince wage or head of corporate and product development. After the Riva Biologics are also on the call and will be available to answer questions. During the Q&A session.

The reason biologics issued a press release last evening, which provided operational highlights included the financial results the third quarter ending September 30th 2022.

We used can be found in the investors section of the company website at Www Dot so rebel bio dotcom together with the quarterly report on Form 10-Q for the quarter ended September 30th 2022, which we filed last night with the Securities and Exchange Commission. In addition.

The to the phone line. This call is being streamed live via webcast, which will be archived on the company website www.

Got the Riva bio dot com for 90 days.

During this call certain forward looking statements regarding the rebuilt biologics in D C and 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.

These estimates and similar expressions.

Statements are based on current beliefs expectations and assumptions.

Okay.

Okay.

Subject to a number of risks and uncertainties, including those set forth in the theory of a biologic filings with the SEC many of which are difficult.

Ultra predict no forward looking statements can be guaranteed and actual results may differ materially from such statements.

On this call is provided only as of the date of this call I have to read the biologics undertakes no obligation to update any forward looking statements 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.

Thanks, Chris Good morning, everyone and I appreciate you, taking the time to join us on our call today.

We are very pleased to be speaking with you today is three of a biologics a unifying new brand for the company. It reflects our rapidly increasing momentum as a leading multinational developer of innovative differentiated therapies for cancer and related diseases.

Along with a new name logo and corporate website. The company began trading on the NYSE under the ticker T O VX and October 13th.

Today, I'll present, an update on our progress and well defined path forward, which we believe will drive shareholder value and long term success.

In the third quarter of 2022, we accelerated the clinical advancement of three of his oncology focused portfolio dedicating our primary resources to our lead clinical candidate B C. N O. One of systemically administered Alkalotic adenovirus designed to selectively replicate within the tumor.

We model the tumor matrix and increase tumor immunogenicity.

We also reported positive clinical data and have now initiated the second cohort of the phase one b to a clinical trial of syn for our product designed to prevent potentially fatal adverse outcomes in patients who undergo allogeneic hematopoietic cell transplant or H D T to treat EBITDA.

Logic cancers.

In addition, preclinical pipeline expansion activities during the third quarter concentrated in optimizing the C. N 11, and exploring related political virus candidates incorporating our novel Human Shield technology, which is designed to protect systemically administered high political viruses from.

The host immune system.

We believe the albumin shield technology may facilitate repeated administration of athletic virus therapy.

Increasing their efficacy and potentially allowing our pipeline programs to be used in standard treatment cycles that are well established in cancer chemotherapy.

Overall, we're extremely pleased with our progress to position <unk> three that the forefront of athletic virus development.

With a focused portfolio in an unexpected financial runway into the first quarter of 2024, we are well positioned to deliver on a number of value enhancing milestones.

I'm now excited to share with you the details of our pipeline progress starting with our lead program be Seattle what.

Building on the positive results of our phase one studies, we have designed barrage of multinational phase II clinical study.

Evaluating intravenous V C N O one in newly diagnosed metastatic pancreatic cancer patients.

Treated with first line standard of chemotherapy, namely genocide of being in that Paclitaxel.

The revised clinical trial is a randomized controlled multicenter open label Phase two study that's expected the world enroll up to 92 adults at sites across the U S, Spain and Germany.

In one treatment arm.

Patients will receive 10 side of being in that Paclitaxel standard of care chemotherapy, and then a second treatment arm patients will receive B C. N O. One administered seven days prior to Gen side of Nab Paclitaxel.

Two doses of V C N O one will be administered approximately three months apart.

In the third quarter for Roche received regulatory clearance from both the F. D. A N. The Spanish competent authority to proceed.

We've also received clarification queries from regulators in Germany, and we plan to respond to these very shortly.

We've also commenced site initiation visits in Spain, and we remain on track to dose the first patient in the fourth quarter of 2022.

Primary endpoints for this study include overall survival and safety and Tolerability.

Additional endpoints include progression free survival objective response rate and measures of bio distribution virus replication in immune response.

Since this is anticipated to be a two arm open label study we plan to monitor the study progress very very closely and try to accelerate the clinical program is supported by the emerging data.

In addition to initiating the variety pancreatic cancer trial, we've continued to refine our proposed clinical trial and retinoblastoma.

Since there is no regulatory guidance for the development of Retinoblastoma medicines, we have worked closely with key opinion leaders from well known treatment centers across the U S Europe Central and South America to confirm the optimal patient population and treatment line for <unk> trio B C N O one.

<unk> to treat vitreous seats in children with retinoblastoma.

We look forward to leveraging the orphan drug designation for <unk> in this indication to facilitate protocol discussions with the FDA and other regulatory agencies.

In addition to the planned company sponsored studies there are several investigators sponsored studies underway at world, leading oncology research institutions.

At this year's ESMO Congress, we presented initial data from our phase one investigator sponsored study evaluating the Seattle one in combination with their value map for patients with recurrent metastatic squamous cell carcinoma of the head and neck.

We are encourage by the acceptable safety profile seen in the sequential arm of this study as well as the biological activity observed in the head and neck cancer patients previously treated with anti PD L. One agents.

These data speak to the promise of V. C O one as a potential means of enhancing the efficacy of your immuno therapeutic agents in patients whose cancers have been unresponsive to these powerful cancer therapies.

Our investigator sponsored study with University of Leeds do evaluate D. C. N O one in patients with high grade brain tumors is currently recruiting patients with dosing the first patient expected in the fourth quarter of 2022.

This study is designed to determine whether systemically administered V. C. N O one can reach tumors in the brain.

Treatment of these tumors typically require surgery and or direct injection. Therefore successful delivery of V. C. N O. One did the brain after systemic administration could potentially transform the way these cancers are treated.

In parallel to our clinical studies with B C. N O. One we are keenly advancing our albumin shield technology platform.

Our albumin shield athletic viruses incorporate proprietary albumin binding domain and the viruses outer shell.

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

I N D. Enabling studies are being planned and we expect to begin. These studies following the completion of ongoing preclinical and CMC activities.

Look forward to building upon our foundation of compelling proof of mechanism data and continuing to advance our V. C. N 11 program through clinical development.

Finally, turning to sing for ore write backs in this.

Washington University has dosed the first patient in cohort two of our phase one b two a study of syn <unk> to prevent acute graft versus host disease in patients undergoing allogeneic <unk> T to treat hematologic cancers.

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

The study targets completion of eight participants who received <unk> four and four who receives both schiebel in each of the three sequential cohorts designed to compare different IV beta lactam antibiotics to treat fever following conditioning therapy.

Yes.

We reported in September progress to cohort two was permitted by an independent data safety monitoring committee. After a detailed review of safety and pharmacokinetic data from the first antibiotic cohort administering their pet them.

The second antibiotic cohort will evaluate the combination of <unk> four with Pip, Brazil in and takes it back to him.

We are very pleased with the continued advancement of Syn for as part of our oncology portfolio and we are grateful for the tremendous support from Doctor to Burkey and his team at Washington University together.

Together, we will continue to work towards reducing potentially fatal adverse outcomes, such as T Gvhd and allogeneic <unk> recipients.

In summary, we've made steady progress throughout the third quarter of 2022.

With a cash runway into the first quarter of 2024, we are well positioned to reach potentially transformational inflection points across our oncology focused pipeline.

Near and long term clinical milestones include.

The dosing of the first patient in barrage, our phase II study in patients with metastatic P deck in the fourth quarter of 2022.

The dosing of V C N O one and the first patient with high grade brain tumors at the University of Leeds in the fourth quarter of 2022.

Holding a pre IND meeting with the FDA for our planned clinical study in retinal both still know in early 2023 ahead of the anticipated study initiation in the second half of 2023 and completing the second cohort of our phase one b to a clinical study of Syn <unk> for the prevention of acute graft versus host disease.

In bone marrow transplant patients in the first quarter of 2024.

As you can see we positioned our company to deliver on a number of key value, creating milestones over the next six to 12 months.

By prioritizing our core clinical programs, we have the ability to efficiently utilize our current cash position, which carries us into the first quarter of 2024 to deliver on important clinical data and related milestones.

Now I'd like to turn briefly to our financial results for the three months ended September 32022.

General administrative expenses increased $2 4 million for the three months ended September 32022 from $1 $3 million for the three months ended September 32021. This.

This increase of 88% was primarily comprised of increased consulting and legal costs related to U V. C N acquisition.

The increase in the fair value of contingent consideration higher insurance cost audit fees and public relation expenses and D C and administrative expenses not included in the prior year.

The charge related to stock based compensation expense was $93000 for the three months ended September 32022, compared to $83000 for the three months ended September 32021.

Research and development expenses increased to $2 $6 million for the three months ended September 32022 from $2 million for the three months ended September 32021.

This increase the 30% is primarily the result of V. C. N research expense related to V. C. N O one not incurred in the prior year and to a lesser extent higher manufacturing expenses related to our phase one clinical trial in 'twenty.

We anticipate research and development expense to increase as we planned for and initiate enrollment for our garage phase II clinical trial for <unk> hundred one in <unk> and our proposed clinical trial retinoblastoma expand GMP manufacturing activities for VC and old one and continue supporting our B C and 11 at other preclinical this.

And discovery initiatives.

The charge related to stock based compensation expense was $28000 for the three months ended September 32022, compared to $19000 related to stock based compensation expense for the three months ended September 32021.

Other income was $161000 for the three months ended September 32022, compared to other income of $2000 for the three months of the 232021.

Other income for the three months ended September 32022 is primarily comprised of interest income of $170000 offset by an exchange loss of $9000.

Other income for the three months ended September 32021 was primarily comprised of interest income.

Cash and cash equivalents totaled $55 million as of September 32022, compared to $67 $3 million as of December 31, 2021.

In summary, we've had yet another quarter of great progress and we're very excited about three was renewed corporate strategy and path towards strategic growth.

We believe our own Ob programs could represent a generational leap forward for patients in need of better treatment options and we look forward to advancing V. C. N O one a decent 11 through clinical development.

In parallel we will continue to evaluate strategic opportunities that a lot value for our company and with that we're happy to take questions.

Thank you, Sir ladies and gentlemen, if you would like to ask a question. Please take note by pressing star one on your telephone keypad.

If you are using a speaker phone. Please make sure. Your mute function is turned off to allow your signal to reach our equipment.

Once again, please press star one to ask a question.

We will pause for just a moment to allow everyone an opportunity to signal.

Yeah.

We'll take our first question today from Jim Malloy of.

Alliance Global Partners. Please go ahead your line is open.

Good morning, Steve Thanks for taking my question and an update on the quarter.

And looking at the Oh through the <unk>.

The broad investigator sponsored trial pipeline.

And obviously these are great ways to.

The Ah <unk>.

The Shepherd capital, but sometimes it can be harder to control the timing how much influence do you guys have one I'm trying to impress upon the Isps.

The need to sort of move as expeditiously as possible well see to obviously, it's their trial.

Yes.

That's something that we are we actually have a lot of discussion around you know on a weekly basis.

I think the reality is you know.

The ball's in their court win when they take these programs forward, but I think the dialogue between the organizations that we're working with folks at HEICO.

Folks at Leeds folks that you've had.

I think we have an engagement that is.

Respected you know.

Quite nicely and that you know because of that dialogue I think both parties understand the importance of continued to advance these programs.

And to be quite honest.

It's really a great opportunity for the company because although we're.

Providing study drug for these these organizations typically fund these programs on their own and they provide their own staff to monitor the progress of the programs. So it's a nice way for us to continue to explore uses for <unk> for V. C. N O one while limiting how many resources we need to.

Commit internally it's.

It's something that again, we pay a lot of attention to and as we've seen from the head and neck trial. We've generated some some really interesting data that was presented in Paris recently, and there's still more data and it's specifically to come of that trial and survivability and we're looking.

Forward to that data coming out some time you know in the next probably six months or so.

Is that helpful for you.

It is indeed, thank you I appreciate that and then on the.

On the combo in pediatric retinoblastoma.

And in the U S.

In the garage for pediatric first line combo with chemo, we have orphan EU correctly, the orphans correct in those two.

That's correct and we're in the process of applying for orphan indication for <unk> in the U S as well.

Excellent and then how long is there a way to.

Obviously, you're guiding for a fourth.

Fourth quarter 'twenty three to start the <unk>.

No.

Trial.

As there are second half 'twenty three excuse me.

Is there is there a way to advance that I'm sure. There's a lot that goes into it you can't talk about in advance of that but is there a way to advance either that or.

<unk>.

I guess, that's the only one and the other one the University of Leeds is in I S. T. So that's that's at their discretion.

So I'm going to I'll hand, this over to Manila in a second to give you a little bit more color on how we're thinking about the retinoblastoma trial.

The reality of that is that there is no approved treatment for retinal blastoma in the U S. There's there's around 200, a little bit more patients here the same in the U U but the larger patient population is in South America.

India and in Asia.

And one of the things that we've learned is that there may be opportunities as we design. This trial to take advantage of those much larger patient populations to more quickly gather data maybe maybe I'll hand, this over the middle and he could talk about some of the findings there.

That we've learned as a result of some of the discussions that we have ongoing with key opinion leaders Michele.

Yeah sure sure Yeah.

Yeah. In fact, we are very actively working in the retina over most of our program, but we have a lot.

Laura because obviously the way US Retinoblastoma Street, that's changing and we need a careful monitoring of all the activities that have been.

All the payments that have been proposed and more recently, but right now we have had quite good contentious after having to speaking with you opinion leaders in Europe .

Also in Brazil, and India, and we are very clear in what we're trying to be the target population and also the treatment schedule, which is very important.

In fact, we have presented the quite rationally calibration.

One of our Clos.

Collaborations.

A very nice data showing that <unk> black the boutique and subtract that each quarterly you said 14 minutes, some patience and regular blastoma results on really a handset that antitumor activity, which is very interesting and it is very it looks quite specific optical mutation Bcl one next week.

As we presented in a scientific Congress.

From the International Society of pediatric oncology.

Okay.

So we are running a lot, but we are a good pathway. So we are right now.

Targeting that conversation with FDA.

The agreement of the key opinion leaders.

Around the world basically and we are very confident that the trial can be a real facts us industrial by Hong Kong flower ranking number some of it you guys have.

As indicated by a steep there's nowhere and approve a treatment for retinoblastoma and that could really.

Major milestone beginning in the field.

Yeah.

Maybe to follow up on that if I could please so you guys recently held a Monday I think was it.

Excellent Kols call on <unk> I guess, it was written out but yeah.

But over on the <unk> side for garage, how would you what's sort of the key takeaways you guys heard from the Monday Kols call.

Obviously I'm talking about the challenges in the market.

You can apply to the variety of trial.

Go ahead Michelle.

So basically.

The kols.

Really pressing because the highlighted a lot of things.

Got to cancer.

I am pretty happy with the inputs that we have that.

Conversation in fact.

They have highlighted that the ability of our product reach.

I think it's one of the key things in this trial.

I think that obviously there are challenges with our recruitment rate, but I think that the fact that we have a position with our rock first line in metastatic pancreatic cancer warrants add that we are going to have a good like we'd been rate. That's also the feeling that we have with <unk>.

Our engagements in our cryo blocking you asking Europe so.

I mean, I think the kols.

Really really.

Encouraging for us.

You've got the general perception of how our product contractual affect the industrial activity mechanistic kind of administration of check around what's really the right pathway. So we are happy with that.

Okay and then maybe final question for Stephen how would you characterize the Oh the.

The market for your partnership opportunities for.

For Sunoco for.

I know you've been obviously.

Correctly, I think moving away from snow before and focusing on <unk>.

Turning to partner partnered up how is that how is that effort going.

So historically, we've had discussion with interested parties on syn form.

And we've actually had some discussions with folks that have a franchise in the transplant arena.

So I guess the feedback we were given was that it would complement their portfolio of products for transplantation, whether it be blood cancers or or solid organ transplants.

But you know the feeling was that okay, let's let's overcome this this issue.

Whether or not.

Four.

Could possibly be systemically absorbed and interfere with the antibiotic used after conditioning and this more fragile patient population as we've described so the first cohort of that that study has been completed we've reported that data out in September and the trial.

And the outcome of that trial was what we expected. So now we're actually going to the next cohort.

Where the.

Syn for enzyme.

<unk> has the ability to degrade Pip taser, though.

So this will be key. So then once this trial wraps up I think we'll have a very very strong.

Data package not only what we generate from this ongoing trial, but who has previously been able to demonstrate in the original phase III trial for the prevention of C. Diff in a M. R. A.

To re approach potentially interested parties. So it's definitely on our radar.

We're really happy with how this trial is performing and the Doctor <unk> and his team at wash, you've just done a tremendous job in the trial design and how it uses three antibiotics increasing.

And level of the type of activity, we expect to see.

With with the use of our backs amazed I don't know Vince do you have any other comments on that perhaps.

No I think that's all.

A reasonable assessment, we've got to get the data to really consolidate in this indication but.

I will say that the interest in prevention and in these indications say compared to other indications is extremely high and entrenched in the therapeutic.

But rationale for this disease. Unlike other things other conditions related potentially to infection.

In bone marrow transplant. It is well established you moss to prevent mass prevent a gvhd moss prevent clustered <unk> prevent CRE infections, because they can be thankful.

There's no question that prevention is key so it's a much better indication for us as far as taking ports. These products I'll also say that there was an FDA and CDC workshop not too long ago that we participated in and it was good to see that the FDA and the CDC I'm, making a joint effort to understand how to prevent.

These are hospital acquired infections and of which.

Clearly you know for us is in that space.

And we were one of the participants and I think what great takeaway from that was something that people in industry, New maybe people at the FDA and CDC didn't which is the need is tremendous to prevent hospital acquired conditions cost acquired infection things related to antibiotic use.

Such as with what we're trying to address with you know a full but I don't think that the FDA and the CDC understood. The challenge of getting clinical trials done in those indications and the cost of moving the ball.

So that's a positive outcome that we on the corporate side of the company. So we're able to impart that not just not just.

Three of us less synthetic but other companies working in this space, we're able to say listen.

This is an important.

Problems, we're addressing but we need to work out a way to make these studies.

Can more easily.

And get to our approvals faster.

Yes.

Excellent. Thank you then one actually one last question what is the garage stand for on the <unk> trial.

Do you guys come up with that name of the trial.

Okay go ahead Michelle.

So basically as anticipated by Steve we have already gotten approval from the Spanish authorities and safety perceived from FDA.

In September so we are initiating sites in Spain and in fact, there is already sites already in shape.

Ready to recruit patients so we spec rigs within patients very soon and definitively before ending up this year and we are also finalizing how it.

Our arms works through Macquarie race by Germany with parties that are basically classical question on plan associated with the manufacturing a product that we are very familiar with because obviously we have been previously asked the same question is have we already happy to provide <unk> to this question. So we respect that.

Germany tried to be open slightly late now that probably.

Yes.

And the Spain, but very soon.

In fact.

All that machinery Ravi <unk> Ravi.

Can you size, how really excited by this program in fact.

The investigator meetings that we have come back that we have.

Hi.

Our meeting in Paris that has been very successful with researchers from all different areas, where we're trying to be come back that express really excitement about this trial because it generates a unique opportunity.

Our product combines different mechanism of action in a single product and that generated a lot of interest in order to see if we can really have a bigger impact on the survival of patients with pancreatic cancer, which is obviously really a unmet need.

Someone else, who I think also the question.

I think it was also the name the name of it also was picked by it really means to change course.

That's what we're trying to change the course of pancreatic cancer, but also it's a kind of a global name and you could think about it as virus adenovirus, Jim side have been sort of the way we thought about it so it actually works pretty well.

Sure.

Great Okay sorry.

Misunderstanding.

Yeah.

Thank you. It appears we have no further questions at this time I would like to turn the call back over to Mr. Shallcross for any additional or closing remarks.

Thank you Lynn and thank you to everyone for taking the time to join our call today.

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

And finally on this veterans day, we'd like to thank those who have served to protect our great great country.

Once again, thank you for joining us and we look forward to keeping you updated on our progress and have a great weekend.

Okay.

Thank you, ladies and gentlemen that will conclude today's conference call. Thank you for your participation you may now disconnect.

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