Q1 2022 Matinas BioPharma Holdings Inc Earnings Call
Welcome to the Martinez Biopharma first quarter 2022 results conference call.
At this time all participants are in a listen only mode.
A question and answer session will follow the formal presentation.
A reminder, this conference is being recorded.
I would now like to turn the conference over to feed of Basel Investor Relations Representative for <unk> Biopharma you may begin.
Thank you good morning, everyone and thank you for joining the <unk> Biopharma first quarter 2022 results conference call.
This morning, we issued a press release with our financial results along with business updates. The release is available on the <unk> Biopharma website under the investors section.
Speaking on today's call will be Jerry Jabbour, Chief Executive Officer, Gary Dr. Terry Moskovitz, Chief Development Officer, Dr. Terry Ferguson, Chief Financial Officer, Chief Medical Officer, Sorry, and Keith Kucinski, Chief Financial Officer. We also have Mr. Thomas Hoover, Chief business Officer, who will be available to answer questions during our Q.
<unk> session.
At this time I would like to remind our listeners that remarks made during this call may state management's intentions hopes beliefs expectations or projections of the future is a forward looking statements and involve risks and uncertainties forward looking statements. On this call are made pursuant to the safe Harbor provisions of Federal Securities laws. These forward looking.
Or based on mid teens, Biopharma current expectations and actual results may differ materially as a result, you should not place undue reliance on any forward looking statements.
Some of the factors that could cause actual results to differ materially from those contemplated.
Statements are discussed in the periodic reports <unk> Biopharma files with the Securities and Exchange Commission.
Documents are available in the investors section of the company's website and on the SEC's website.
Archives of this call will be posted to the company's website also in the investors section. Following the company's prepared remarks, we will open the call for a question and answer session I will now turn the call over to Jerry.
Thank you Peter Good morning, everyone and thank you for taking the time to join us today.
This morning, we will review our 2022 first quarter financial results and provide a business update.
Despite an incredibly challenging market for biotech stocks, we have managed to make substantial progress across our business during 2022.
We continue to validate our disruptive LNC platform delivery technology by delivering consistent and compelling clinical and preclinical data and the advancement of our internal pipeline.
At the same time, our external collaborations focused on expanding the reach of our LNC platform also continued to yield new data and exciting new molecules to encapsulate.
Our recently announced partnership with Messenger RNA pioneer violent attack provides clear external validation for our LNC platform from a global pharmaceutical leader and.
And creates the opportunity for the oral administration of messenger, RNA vaccines, and other cutting edge therapeutics, which could potentially benefit hundreds of millions of patients.
Our own internal discovery programs built around preclinical data further validating the LNC delivery of nucleic acids. Another biological materials combined with our ongoing projects with Genentech at Gilead provide momentum as we seek to capitalize upon the significant potential for our proprietary.
Next generation drug delivery technology.
Joining me today to speak to all of the progress we have been able to make so far this year, our Dr <unk> and Dr. Ferguson.
And it's my pleasure to turn the call over to Terry Mcevoy.
Guidance through the updates on our clinical stage LNC assets.
Thanks, Jerry and good morning, everyone I'd like to begin by discussing some very exciting developments with the met 22 O three program, which is our oral LNC formulation of the broad spectrum fungicide <unk> drug amphotericin B.
I'm going to enact trial is a phase two evaluation of map 22, or three in HIV patients suffering from Cryptococcal meningitis, a deadly fungal disease.
With compelling data already demonstrated in the first three cohorts of this trial. We are currently enrolling patients in cohort four which began in late January of 2022.
Cohort four is studying an all oral regimen of map 22 or three during the 14 day induction period, followed by four additional weeks of oral consolidation therapy, with Matt 22 or three.
Cohort four is comprised of 40 patients unmet 'twenty two or three administered with Phi That's C and a control group of 16 patients receiving IV amphotericin B also administered with five S C.
As discussed previously this is an especially informative cohort of patients since patients in the med 22 O speak group do not receive any dose of IV amphotericin, and therefore represents a great opportunity to demonstrate the clinically meaningful impact that oral med 22.
Of course, we can have in treating these highly vulnerable patients.
We are very pleased to report that 50% of the patients for cohort four had been enrolled and that enrollment continues to meet our expectations.
Further all patients currently on active treatment are reported to be doing quite well, which is a very good sign at this point in the trial.
The D. S. M. B, we view, 50% enrolled patients is scheduled for the end of this month and as with past reviews will include a review of the overall safety as well as efficacy data from the cohort.
We do not anticipate making any announcement following the D. S. M. B V view, but enrollment in this open label cohort is anticipated to complete early in the third quarter of 2022 with reporting the topline data also anticipated in the third quarter of 2022.
Turning now to the regulatory strategy for them at 22 or three development program. We recently held a productive follow up clinical type C meeting with the FDA and have received written feedback concerning the confirmatory data required to support the submission of a new drug.
Haitian N D a format 'twenty two or three.
As reflected in the official minutes of the meeting.
FDA is now considering the potential registration of map 22, or three for both stepped down induction indication as well as a consolidation treatment indication based upon a single phase III confirmatory trial.
This pivotal registration trial will feature a non inferiority design comparing met 22 or three administered with five let's see with a control arm of IV Amphotericin also administered with by that see randomized two to one in favor of met 22 or three as induction followed by <unk>.
Holiday <unk> therapy in HIV patients with Cryptococcal meningitis.
Critical elements of the next three will include a primary endpoint of two week all cause mortality for an induction indication.
Our non inferiority margin of 10% translating into a total trial size of approximately 250 patients with 80% power and a key secondary endpoint, which may include meningitis relapse free survival time through 18 weeks.
A consolidation treatment in support of a single NDA filing for both induction and consolidation treatment with Matt 22, or three in patients with Cryptococcal meningitis.
This streamlined development pathway represents a meaningful improvement from customary requirements for an NDA filing, which traditionally requires two adequate and well controlled phase III trials for registration.
We plan to meet with FDA early in the third quarter of 2022 to finalize the trial design and we anticipate that the pivotal phase III registration trial will commence later in 2022, assuming the continued financial support of the National Institutes of health.
Looking outside of the United States. We are pleased to report that we recently submitted a formal request for scientific advice to the European medicines agency or EMA to facilitate a development and registration program in support of expanding the regulatory footprint for Matt 22, or three globally.
We anticipate receiving feedback on their package later this year.
Concurrent with the EMA process. The company remains in discussions with key third parties interested in obtaining rights to them at 22, or three and a global and regional basis.
As part of our lifecycle management program for them at 22 or three focused on unlocking the full clinical potential of map 22, or three as an oral and safe version of the most fungicide all antifungal drug available. The previously planned preclinical studies of map 22 or three in Canada.
The Auris and Mucormycosis had been initiated to support potential label expansion for <unk> 22, or three into the treatment of other invasive fungal infections.
We are excited to report today that preliminary data generated to date demonstrates that <unk> 22, or three is as effective as like the summer amphotericin b and protecting against mucor mycosis, a deadly invasive fungal infection.
Additional confirmatory studies in different strains of Macquarie mycosis or ongoing.
Further preclinical evaluation of map 22, or three against Candida Auris was initiated in April of this year and preliminary data is expected early in the third quarter of 2022.
Finally in anticipation of filing an NDA for <unk> 22, or three following conclusion of our planned phase III registration trial in Cryptococcal meningitis.
During the first quarter of 2022, the company selected and reached agreement with Thermo Fisher scientific to support scale up and manufacturing for Matt 22 or three.
Thermo Fisher scientific with more than 65 locations around the world provides integrated end to end capabilities across all phases of development, including a P. IV biologics viral vectors cgmp plasmids formulation clinical trial solutions logistics service.
<unk> and commercial manufacturing and packaging.
This is a significant step forward for them at 22, three and four our platform technology and we look forward to working alongside such a well respected and experienced partner to achieve our CMC objective.
I'd like to turn now to met 25 O. One our oral LNC delivered amikacin product under development initially for the treatment of non tuberculosis mycobacteria or N T M infections.
This program is focused on delivering the first and only oral aminoglycoside with the potential to treat both acute and chronic bacterial infection pulmonary and disseminated.
Our team has made significant progress to advance the program with several critical preclinical Tox studies that should enable the longer term dosing required for our planned phase two safety and efficacy trials.
In the meantime, we recently completed our clinical single ascending dose trial with our optimized Matt 25 O. One LNC formulation in healthy volunteers and we are pleased to be able to share our topline results with you. This morning.
Overall, the resort results from the trial confirmed earlier findings with the legacy formulation of map 25 to one at the same doses tested 200, 408 hundred milligrams, along with an additional higher dose of 1000 milligrams evaluated only in this study.
Overall, there were no serious adverse events or study discontinuation in the completed study.
No significant increases in adverse events were seen with men 25 O one generally or any associated with an increase in the med twenty-five O. One dose administered with the exception of diarrhea, which was mild to moderate in severity and not inconsistent with what we had seen at very high doses of other LNC for them.
Related small molecule drugs.
There was no evidence of any renal or OTO toxicity observed in the trial, which are the two most common toxicity seen with IV administered amikacin.
From a pharmacokinetic perspective, there was a relatively rapid absorption of map 25 O. One with oral administration with the time to maximum concentration of approximately two hours.
There were dose proportional increases in amikacin levels observed with increased dose demonstrating good absorption of drugs via oral delivery.
Porton Lee circulating plasma levels of amikacin with our LNC platform were significantly lower than IV administered amikacin, which is expected to translate to a more favorable safety profile.
We look forward to submitting and discussing these data with FDA and the cystic fibrosis Foundation as we plan next steps for our met twenty-five O One development program.
And anticipate being in a position to potentially commence of phase two phase two program in 2023 following completion of the ongoing and planned long term Tox studies with men 25 O one.
I'd like to now turn the call over to Dr. Terry Ferguson, who will discuss exciting developments with some of our external collaborations.
Terry I'd like to take a few minutes to update everyone on some of our external research collaborations and the substantial progress we've already made this year.
First we very recently received data from the second in vivo study of oral LNC room desk severe in mice infected with Sars cov two.
The study performed in collaboration with the National Institute of allergy and infectious diseases.
A I D.
And the department of Epidemiology at the University of North Carolina at Chapel Hill demonstrated that an oral LNC formulation of Rem density or significantly reduced viral lung caner titers as early as day to significantly improve lung congestion scores and significantly.
Improved COVID-19 associated weight loss, and a well established model of Sars Cov two.
We are still awaiting final histological analysis and will shortly be discussing next steps with the NIH and gilead.
These data are important for two reasons first the therapeutic efficacy against Sars Covid two of an oral formulation of <unk> itself.
And second the very encouraging early knockdown of long viral titers, something that might not otherwise be expected with conventional IV room disappear.
Next Bettina has also expanded its ongoing collaboration with Genentech to include a third compound a specialized antibody fragment for which <unk> will be creating for the optimized oral LNC formulation.
For <unk>. This is a particularly exciting project because it represents an opportunity to take advantage of the protection did lnc's provide and apply it to fragile biologics that would otherwise not be able to withstand the hostile environment of the Gi tract.
We anticipate that oral formulations of this compound.
We will enter preclinical testing in the next few months with potential results anticipated later in 2022.
Finally, I'd also like to provide some of my own perspectives on the <unk> collaboration.
For me one of the most exciting aspects of this program as how it builds on a very strong foundation of prior inhouse vaccine work with al and CS, which to date has not gotten a lot of external attention.
Our work with oral oral LNC amphotericin and amikacin, the ongoing collaborations with NIH and Gilead on oral <unk> engine intact, and developing oral formulations of difficult to deliver molecules.
All taken advantage of the unique capabilities of <unk>.
Intra cellular delivery.
The collaboration with bio <unk> Tec takes this a step further into the realm of delivering vaccines into the complex biological world of cellular and humoral interactions in the immune system.
Areas, where the <unk> have already shown.
Large body of in vivo vaccine work with proteins peptides, DNA plasmids, and even DNA protein complexes.
Successful oral immunization.
Robust antibody and cellular responses to LNC vaccines, both of which persist over time can be boosted with repeat administration and can be even further enhanced with adjuvant.
Systemic and mucosal responses following oral administration of <unk> in some instances the cellular responses were substantially stronger than with native infections.
A high degree of inhibition of viral replication and demonstrated enhancement of the antibody response to an LNC formulation of a commercial flu vaccine.
LNC vaccine delivery conduct be differentiated by flexible routes of administration, so Q R M by inhalation and world.
Enhanced mucosal and systemic responses with both humoral and cellular immunity.
Our breadth of effective vaccine payloads proteins peptides, DNA plasmids DNA protein complexes with potentially more to follow.
A delivery mechanism that is itself not immunogenic and not associated with resulting potential adverse reactions.
And the opportunity to create much more stable formulations.
When you combine this strong foundation of prior work with bio <unk> vast experience with mrna and.
Mrna vaccines.
And add to this mix the strengths of the LNC platform itself.
And our own internal expertise in creating <unk> formulations that can potentially take intra cellular delivery in a whole new directions. You can begin to understand why this is such an exciting collaboration for us.
Throughout the course of this collaboration we will be learning a great deal.
Both the subtle nuances of creating LNC formulations for a variety of nucleic acids.
As well as refining techniques for successfully delivering them to different target tissues.
This additional knowledge will in turn establish a deeper and broader foundation for the LNC delivery of additional payloads to other targets, allowing us to both forge additional potential partnerships.
And to establish our own robust internal pipeline of nucleic acid or other therapies.
A full advantage of the unique capabilities of our LNC platform to package and deliver highly sensitive biologics, we're really looking forward to sharing additional updates on our progress during 2022 and beyond.
I will now turn the call over to our CFO , Keith Kaczynski, who will discuss our financial results.
Thanks, Terry and good morning, everyone.
Today, the company reported a net loss attributable to common shareholders of approximately $6 million or.
<unk> <unk> per basic and diluted share for the first quarter of 2022.
Compared to a net loss attributable to common shareholders of $5 $2 million.
Net loss of <unk> <unk> per share basic and diluted for the same period in 2021.
Research and development expenses were approximately $5 million in the first quarter of 2022 compared to approximately $3 $2 million in the same quarter of 2021.
The increase is due primarily to higher development expenses associated with the advancing associated with advancing our internal product candidates and higher people costs as organizational head count has grown year over year.
General and administrative expenses were approximately $2 $7 million in the first quarter of 2022 down from $3 1 million in the same period of 2021.
Cash cash equivalents and marketable securities at March 31, 2022, or approximately $43 9 million compared to $49 $6 million at December 31, 2021.
Based on current projections, we continue to believe that cash on hand is sufficient to fund planned operations through 2023.
I will now turn the call back over to Gerry.
Thank you Keith.
In summary.
<unk> effective and safe delivery of molecules and therapeutics is mission critical to the future of all medicines.
But especially so for nucleic acids and other biological materials.
Embodied in our LNC technology, we have a unique and differentiated true platform, which provides solutions to some of the significant challenges faced by other delivery modalities, including lipid nanoparticles and viral vectors.
We continue to generate impressive data across all our programs further validating our technology.
Our team has managed to keep its collective eye on the ball and adroitly executing our strategic plan under challenging conditions we.
We are extremely pleased with the positive impact our mat 22, or three has had on saving patients lives and we look forward to reporting additional confirmatory data from cohort four of enact in the coming months.
And also aligning ourselves with pharma Giants hungry for an effective delivery platform and the resultant competitive advantage. We are building a strong foundation across the board.
With a cash runway through 2023, we believe we are well positioned to take advantage of some of the numerous catalysts and milestones lining our path ahead over the next several months and quarters.
We're grateful to our investors for joining us on this exciting journey and we look forward to keeping everyone apprised as to our progress moving forward.
This concludes the end of our prepared remarks, and I will now turn the call back over to our operator, Peter to facilitate a question and answer session.
Thank you.
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One moment, please while the poll for questions.
Our first question is from Bert Hazlett with BD.
Please go ahead.
Thank you congratulations on all the progress very impressive I have a number of questions but.
Fairness to my colleagues on the phone I'll ask only one or two.
Come back to them.
So Jerry with the biotech and the movement toward a form of license agreements.
Without getting too far ahead of it.
Yourself or anybody could you just sell under general terms, which you would like to see in such an agreement just and then I have a couple on the 22 or three but love to hear that sure. So thanks.
Thanks for the question Bert obviously at a lot of attention on our relations shift like this specifically because of the visibility biotech brings.
Not only to the messenger RNA space, but now to our technology and so the foundation of this relationship again with science and so it was very very important for us with bio attack.
That they truly wanted to collaborate with us and so right now we are intently focused on that collaboration essentially letting them into our kitchen. The appropriate protections are in place there. So that they can fundamentally understand what we're doing and that's going to be central to then arriving at what we believe can be a deep and extensive relate.
<unk> shipped in the form.
I have a license agreement whether it begins with an option to license agreement with appropriate trigger points Theres plenty of precedent in this area both with delivery vehicles also in the vaccine space about what these relationships look like.
But our discussions have centered around both trying to get a fundamental understanding of just how broad. The relationship is are we talking about the entire field of messenger RNA are we talking about particular products. Those are very thoughtful complex discussions, but beginning from a shared interest in optimizing the value of our <unk>.
Collective technologies for the benefit of patients. So we believe that it's going to look very much like an option to license or a license agreement. The biggest questions now our breath of exclusivity how closely you're ever going to work together what is in our ability to take things that we learned as a result of this.
Duration to apply them in other areas of nucleic acid thats, especially important for <unk>.
And so.
In looking at some of the.
The delivery deals that have been done just in the last six months without naming them specifically there are pretty easy to find.
If you Google them. It would consist of sort of the normal upfront payments a variety of triggers development milestones.
And then.
Royalties associated with sales of the product the real wildcard here is is just how much.
Does does biotech want to control the field of messenger RNA and I think there is obviously a great deal of value associated with something like that and are truly exclusive relationship given the multitude of areas that you can take messenger RNA vaccines, so that remains to be seen.
Very encouraged by the spirit of discussions.
Which really began at the highest levels between Uber and myself quite a while ago that spirit has continued and we're working as you saw.
To finalize that no no update on timing and we won't be commenting on it.
More broadly other than on today's call, but hopefully that gives you a sense of how it could be framed.
So very helpful. Good luck with all of that.
And then a couple on 'twenty two or three.
Cohort four is pretty meaningful as you mentioned.
In the opening remarks, there's a number of you did with an all oral induction and consolidation.
Hum.
Could you just benchmark safety and efficacy readouts.
Be upcoming for that and then with regard to the Registrational process. Thank you for the additional color congratulations on all that.
Is there a way to win and are quoting there on on the safety side of things and then is there an ability to harmonize the process with the EMA during your discussions or.
A lot there in those questions. So I'll shift it back over to you after those.
Great. Thanks, Thanks, Bert Alright, so let's take them one at a time cohort four as you point out really is a big cohort I mean, obviously, we're thrilled with the results from cohort two where there was an Ivy League.
But when you are talking about an all oral regimen of <unk> 22, or three you are removing any doubt about the impact of IV amphotericin on efficacy during the induction period. So cohort four is a big one very pleased with what we've seen so far Dr. <unk> reporting that all patients are doing well and so the next readout for that really will be.
The announcement of data the full dataset from cohort four which we continue to anticipate will occur in Q3 of this year, so right around the corner.
Going to get a look at really what was now the fully envisioned complete enact study where you're getting that look at both transition from IV to oral therapy and then what is the patient experience with an all oral regimen of <unk> 22, or three so figure right smack in Q3 there.
Exactly when in Q3, it's hard to predict based upon enrollment, but that continues to move along well, but thats a big data point certainly for our program.
Certainly will help continue to occur.
Courage FDA.
To work with us in a way that makes this this.
Drug available to patients as soon as reasonable under the circumstances, but thats a big data point for us in Q3, when we look and then you asked a question on safety and can we differentiate.
That's a big deal so safety and convenience of administration or two big wins and that's just within the induction period, but youre also with with the way that we can encapsulate and deliver amphotericin Youre also positioning it to be for the potential to be used in a way that it could never in the past.
So youre also optimizing and extending the potential use of the most broad spectrum antifungal drug beyond deduction. So yes, we want to win on safety, we want to win on convenience, we want to win on health economics getting people out of the hospital sooner, we know that that's a valuable sort of point for payers.
And then certainly we want to broaden the opportunity for physicians and patients to have the benefit of being able to use the broadest spectrum drug which in and of itself chemically as not as susceptible to the development of resistance, which means it really can be used for a long period of <unk>.
Time.
Because of the way it really attacks the fungus and then to go to the third.
Point I'll ask Dr. <unk> to just to chime in here on our strategy with FDA and EMA. She spent an incredible amount of time, putting together, even a more comprehensive package for EMA required for FDA and she and her team did that and just under two months. So she is in best position to sort of.
Talk about synergies and how you harmonize that and how we're approaching expanding the global footprint of this drug.
Thanks, Jerry and thanks for your question. So just to follow on it it is exactly our strategy as as you've indicated in your question to harmonize the regulatory and global footprint of our development program.
So with the timing of the start of Phase III. Later this year, we are able to get that very important feedback from the European regulatory authorities to gain alignment on what a registration trial.
Would need to be in order to support global registration and we believe that the timing lines up very well across both FDA and EMA that will allow us to really optimize the design of this phase III trial to meet both both regions regulatory requirements.
And to just add on to that Bert I mean at the end of the day.
There is really a dual purpose to everything we're doing here I mean fundamentally we understand that in a safe an oral version of amphotericin you have the potential for a broad reach not just with cryptococcal meningitis, but for all invasive fungal infections. So everything here is about positioning this drug to optimize its potential.
And being the key agent in the treatment of all invasive fungal infections and we know you based upon the data that the prevalence of these invasive fungal infections, including Cryptococcal meningitis are higher outside of the U S. So.
It was it was a necessary approach for us whether we were going to completely hold onto this asset ourselves and build a global franchise or response to the interest comments and questions of parties, who are interested in taking this drug in commercializing it and developing it outside the U S that we have.
Those necessary inputs to be able to inform strategic discussions so harmony as key FDA has been a great Foundation. The EMA now has the full data package will engage in those discussions in the third and fourth quarter of this year with the idea that we do want total alignment here because it will help us and our partner opt.
<unk> the value of this drug.
Thanks for all that I'll hop back in the queue. Thanks.
Thank you ladies and gentlemen.
If you would like to ask a question. Please press star one on your telephone keypad.
We have the question from.
Bert Hazlett with BTG. Please go ahead.
The next steps for 25 or one then.
The phase two for MTM infection can can start when maybe I missed that in your comments and then I.
You've mentioned previously Jerry about planning for other indications.
Do you have any evolution with regard to 20 501 with regard to indications beyond MTM.
Sure I'll, let Dr. <unk> handle the first part of that question and it really has to do.
With putting in place sort of the long term Tox studies with Terry why don't you shed some light on what's necessary to sort of put us in position to start phase III.
Sure. So we are currently in the middle of a very important Tox studies that will allow us to treat patients through 90 days, which really would cover the treatment duration based on our preliminary thoughts for our phase III development program. So based on the current timelines, we anticipate meeting with the FDA.
At the end of this year or early next year to share with them our phase II development program get alignment on study design and be in a position to initiate a phase II trial in probably quarter to quarter three of next year.
And then Bert just to talk about planning for other indications I mean, the reality of amikacin from a profile perspective, it's not dissimilar.
And its broad spectrum nature from the way amphotericin is viewed in the antifungal space Amikacin is a very broad spectrum aminoglycoside, which has impacted.
Impacting the efficacy against for example, both Gram negative and Gram positive infections.
<unk> was a natural place for us to start because of the preclinical data that was generated in MTM by the by Dr. Mannino and his colleagues and working with your gene Bermudez and others.
So it made sense to stay on that path, particularly with the support of the cystic fibrosis Foundation, who is eagerly looking for a solution that a drug like our case can't fill and so there is first sorted the unique profile of our ability to encapsulate amikacin and get it directly to the lung it's going to broaden the potential uses in the NT.
Market, but then you don't have to look far to see the graveyard of drugs that have been attempted to be developed for the treatment for example of Gram negatives.
Utis and things like that we're trying to be.
Careful with how we resource these programs and how we advance them sensitive to utilizing as much as possible non dilutive funds. The team continues to evaluate how we brought in into indications outside MTM, that's actually something thats planned for the second half of this year, but if you historically look at aminoglycoside.
And their potential for the treatment of other disseminated bacterial infections. The data are there you just haven't been able to really use amikacin for those before because of the toxicity profile. So the pathway is there. The logic is they are the indications are there and thats something that will be focused on.
As we move this program forward closer towards phase two in MTM. It's also something that we're talking to third parties about who recognize the potential further first oral aminoglycoside, so and routine. This we're in a little bit of a unique position.
Certainly not resource starved Barbara resource conscious I think we've done a good job of utilizing non dilutive funds to advance both our clinical stage assets, we want to continue to do that and then as much as possible.
Expand those indications at the right time with the right resources Thats all part of our plan.
Okay.
Thank you for that.
<unk> program as well.
And you are making material progress broadly on the LNC collaborations.
Excuse me.
Want to make sure we don't.
Okay short trip to LNC Rem that severe.
One asked us just.
Okay.
The Covid pandemic is gone.
The number of different ways as we all know, but with what urgency should we be thinking about the.
The advancement of LLC that severe and just one last one.
How should we think about your plans on evolving the antibody fragment program and other efforts with Genentech is that data.
Going to be published press released just would love to get a sense of of how we should understand that the potential evolution of that.
Research agreement. Thank you.
Thanks, Barry I appreciate the questions and glad you brought both of these up because these relationships are important but they also share a certain similarity.
When you work with the 800 pound Gorilla is youre not always in control of how data is discussed and disseminated. So in terms of when things will be announced and published we obviously.
Much as we can practically within the confines of what we believe.
We need to disclose legally where sort of bound by what they want to do in terms of data announcements, but lets take each of those in turn with Gilead. I mean, you just heard on their call. The other day that they believe in.
In the future of oral <unk> severe so.
We do and are cognizant of the fact that they are approaching that in a number of different ways. They do have.
Develop sort of a prodrug of <unk> its not <unk> to be clear that they have also studied in preclinical models at UNC ours actually is.
The oral version of <unk>, which obviously has regulatory advantages as you think about streamline development pathways. So the enthusiasm is there I mean for us we need the full dataset from UNC and NIH, we're still waiting on the history, we will reengage with Gilead at that time, although they have already seen the data generated to date.
And it goes beyond just how we think about Rem density or in the fight against COVID-19, the oral delivery efficient delivery of an anti viral has broad implications. So for us it's sort of a dual path. We certainly are interested in continuing to engage with gilead and really optimizing the potential ramp that severe has as an oral actual.
<unk> has as an oral drug and so we will do that but for a platform company with this sort of proof of concept demonstration of an antiviral intracellular delivery of an oral antiviral as big so it checks a number of boxes, we would expect at some point that this data will be published.
And that's something that remains under discussion with Gilead.
<unk> is not dissimilar in the sense that we've already got a small molecule and then ASO, which we've successfully encapsulated in delivered gen.
Genentech is really looking at this holistically so they really want to see the data across all of these programs.
On one hand that requires a little bit of patience on the other hand I like the fact.
That at least to our mind, they're looking at this as a true platform and how it could solve a lot of their delivery challenges and just having now the opportunity to move from small molecules to an ASO and now too to an antibody.
His progress it as well, it's expanding the breadth.
We already have received.
These materials from Genentech the team alongside everything else. We're doing is slotting. These in for formulation activities in the next few months. Our plan is to prepare those get those back to genentech.
Run through there in.
In vitro models and then we do expect that there would be data available later this year, how and when that's presented obviously is subject.
To genentech and our obligations of confidentiality, but in our experience good data finds a way.
To be made public and so that's the confidence that we have that's the way our team is approaching this in and just this collection, whether its genentech, whether it's gilead, whether it's <unk>, whether it's our own clinical stage assets.
Everything we've announced so far over the last year has demonstrated our ability to do this successfully thats not a guarantee that everything will ever do will work, but we have to like how things are lining up and with each step we take with each of these relationships and with our own programs. We're showing that this LNC platform, we think can be a real.
Difference maker in the delivery field.
Thanks for all that just one quick follow up do you expect this collaboration with Genentech to evolve maybe in.
<unk> way that you are seeing things move more rapidly with the <unk> collaboration is that the goal here or.
Couple of quick one.
It's absolutely a golf Bert.
So you have different goals when you start different collaborations it was a great proof of concept I think the <unk> Tec has brought as sort of a stamp of approval from a big pharma, we'd love to get to that point with Genentech and anything else. It's about does it maximize the value that our technology brings the relationship with Genentech is broad.
A number of different molecules so yes.
One key for us is generating the data necessary to I would say.
Better formalize, especially from a financial perspective, our relationship with Genentech for the present time, we're sort of content with continuing to generate great data.
And in our experience and the experience of our board of directors ultimately that leads to.
Suddenly becoming very interested in controlling that so we'll continue to do our part under these collaborations we do think that that has great potential for us to become a more cemented relationship.
How and when is what remains to be seen.
Terrific. Thanks for all that.
Thank you.
Ladies and gentlemen, we have reached the end of the question and answer session.
And now I would like to turn the call back to Jerry Jabbour for closing remarks.
Peter Thanks, very much and thanks to all our valued and loyal investors who've been following us and were thrilled with the progress we've been able to make during 2022 very cognizant of the market, we're operating in but intent on continuing to check boxes deliver on our corporate strategy and lineup milestones and catalysts over.
The balance of this year and early next year, which we think will put us in position for people to better recognize the value of having a differentiated drug delivery platform. We hope you have a great day and look forward to keeping you apprised of our progress take care.
Thank you.
This concludes today's conference.
Disconnect your lines at this time, thank you for your participation.