Q4 2023 Rani Therapeutics Holdings Inc Earnings Call
Okay.
Speaker Change: Welcome to the Ronnie Therapeutics fourth quarter, and full year 2023 financial results and corporate update conference call. At this time, all participants are in a listen only mode.
Speaker Change: Following managements prepared remarks, we will hold a Q&A session to ensure that we had ample time to address everyones questions. During the Q&A session. We would ask for a limit of one question and one follow up question per person to ask a question at the time. Please press star followed by one one on your Touchtone phone as a reminder, this call.
Is being recorded today Wednesday March 20th 2024, I would now like to turn the conference call over to <unk> Patel at Gilmartin Group. Please go ahead.
Dilip Patel: Thank you operator, joining us on the call today from Ronny Therapeutics, our Chief Executive Officer to lot Enron VP of clinical development, Arvind or dollar and Chief Financial Officer fly Sanford.
Operator: During this conference call management will make forward looking statements that are subject to risks uncertainties and assumptions such as but not limited to those discussed in the risk factors section of the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K, and quarterly reports on Form 10-Q, which identive.
Operator: By the specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.
Operator: These statements may include without limitation statements regarding product development and clinical trials product potential market sizes platform progress platform potential certain business strategies capital resources financing plans or operating performance.
Operator: So our results and the timing of events could differ materially from those projected in such forward looking statements.
Lot Enron: With that I turn the call over to lot Enron, Chief Executive officer of Ronnie Therapeutics to lot.
Lot Enron: Thank you.
Lot Enron: I'm delighted to share the highlights of Ronnie Therapeutics strong performance in 2023 during which the company achieved numerous milestones in the development of its pipeline programs and high capacity oral delivery device.
Lot Enron: Ronnie Therapeutics is a clinical stage biotech company that has developed a platform technology for the oral administration of biologics with bioavailability comparable to a subcutaneous injection the.
Lot Enron: <unk> platform is designed to address any therapeutic area, where biologics are used.
Lot Enron: Our current focus is on immunology and endocrinology with discovery efforts underway in obesity and other therapeutic areas and drug modalities.
Speaker Change: During today's call I will start by reviewing the important milestones that Rodney has achieved throughout the past year.
Speaker Change: Then oven there will provide her perspective on the recent data we shared last month on our team on 11, we are highly encouraged by this data and this is now our third successfully completed phase one trial using our Ronnie pill technology.
Survive: And then finally survive will provide an update on our financial position for the fourth quarter and full year 2023.
Speaker Change: I will now begin the call by highlighting one of our biggest achievements over the past year and that is our positive phase one results for <unk> hundred 11, and orally administered as thinking about Biosimilar as a reminder, that youre thinking about biosimilar used in our <unk> hundred 11 program is supplied by sell through on a global biopharmaceutical company.
Speaker Change: Ronnie <unk> entered into a long term supply agreement at the beginning of 2023. This partnership was expanded to include in Abilene Humira Biosimilar in the middle of 2023 and.
Speaker Change: In both cases <unk> has the right of first negotiation to acquire commercial rights to each program. After the completion of the respective phase one studies.
Speaker Change: Last month, we announced positive results of the completed phase one trial for <unk> 111, we were very excited by those results as Archie 111 achieved high bioavailability in humans.
Speaker Change: In addition, it was well tolerated with no serious adverse events.
Speaker Change: We believe this is a large potential opportunity is currently <unk> is only available as a subcutaneous injection and is marketed in the United States by Janssen as Laura for the treatment of moderate to severe plaque psoriasis active psoriatic arthritis moderate to severe crohn's disease and moderate to severe.
Sort of colitis, all of which have large unmet medical needs for an oral treatment.
Speaker Change: As for the potential commercial opportunity sales for <unk> were approximately $7 billion in the United States and approximately $10 9 billion worldwide in 2023.
Moving onto our additional programs Ronny announce our second deal with <unk> for an adult <unk> biosimilar for the <unk> hundred five program in the middle of last year.
Speaker Change: This was the first announced partnership for a program involving the <unk> are high capacity device that is designed to deliver up to 200 micro liters of liquid payload with high bioavailability.
Speaker Change: Last fall Ronny announced successful oral delivery of Humira, <unk> AC and our preclinical study.
The preclinical study track the serum concentrations of ethylene <unk> following the oral administration of the enteric coated Ronnie <unk> HC capsule containing 11 milligrams of Humira or Abilene Moab, two <unk> for canine models.
Speaker Change: The <unk> <unk> successfully delivered at only Moab and all subjects. Further we have completed preclinical studies with additional antibody and peptide molecules in the REIT April HC.
Speaker Change: Overall, we are pleased with the progress we have made to date with our high capacity pill. As we believe this will be at the forefront of our clinical development programs moving forward.
Speaker Change: And finally, another potential area, we believe <unk> can make an impact is the obesity market in December 2023, Ronny announced preclinical data demonstrating that the trans enteric delivery of an <unk> credit Tri agonist of <unk>, CIP and glucagon elicited rapid weight loss in <unk>.
Speaker Change: Animal study.
Speaker Change: Preclinical data supported the potential for the <unk> platform to enable oral delivery of multiple obesity treatment.
Speaker Change: Considering the obesity market is expected to exceed $100 billion by 2030, we are highly enthusiastic about the potential for our Ronnie pill to make an impact in this therapeutic area.
Speaker Change: Overall, we believe that the progress we have made in 2023 reflects our commitment to our vision of making oral biologics a reality across a wide variety of indications with that let me now turn the call over to Arvind <unk> dollar to discuss our clinical updates in more detail.
Arvind: Thank you Paula good afternoon, everyone. My name is <unk> I am VP of clinical development at Ronnie Therapeutics.
Arvind: Delighted to provide a high level overview of the exciting data from our phase one study that I think 111, showing for the first time oral delivery of a monoclonal antibody.
Speaker Change: This was a single center open label Phase One study of Ipi 111 conducted in Australia. This study evaluated the safety Tolerability and pharmacokinetics of RG 111 in healthy volunteers.
Speaker Change: Study enrolled 20 participants each in RT 111, 0.5 milligram.
Speaker Change: 75 milligram dose groups, and 15 participants and Este Lauder 0.5 milligram subcutaneous injection coupe.
Speaker Change: In this study <unk> 111, deliver <unk> biosimilar and a dose proportional manner. The AUC is for the two zero point.
Speaker Change: Five milligram groups were quite comparable.
Speaker Change: Nothing in a bioavailability up 84%, Yeah, Ronny route of administration compared to the second group.
Speaker Change: In addition, oral Archie 111 demonstrated a higher C Max and as shown on T. Max compact it will stick and imagine the liver.
Speaker Change: By sub Q injection.
Speaker Change: Moving on to safety and Tolerability.
Speaker Change: <unk> was well tolerated by all participants in the 2011 groups and no serious adverse events were observed in this study.
Speaker Change: There was no meaningful difference in the incidence of antidrug antibodies, yes.
Speaker Change: Rounded out of delivery compared to Soliris sub Q injection.
Speaker Change: Additionally, no participants reported difficulty swallowing pills and capsules remanent paths from all participants.
Speaker Change: Overall, we are very pleased with the data that are Iranian tons delivered to get them at biosimilar antibody in healthy volunteers without any serious adverse events and this high bioavailability.
Speaker Change: With RG 111, we aim to have a product that is highly differentiated as compared to other oral and injectable options currently being commercialized or in development.
Speaker Change: Whilst a lot of us disruptive been launched it's patchy 75 scores early in the treatment are not as high as more recent entrants.
Speaker Change: This is something we intend to address with a differentiated loading dose regimen for <unk> 111.
Speaker Change: The reason a loading dose is critical is that new psoriasis patients typically start therapy in the middle of a serious flare up.
Speaker Change: Justifies the use of a biologic ultimately, though most patients will transition to maintenance dosing and after review we believe there is a potential to improve on the lora here as well.
Speaker Change: We plan to explore a dosing regimen that begins with a 30 day daily loading dose followed by just three pills at the beginning of each month when maintenance.
Speaker Change: Furthermore, currently approved oral therapy like a tesla and subject to have show, nor passing 75 scores as compared to the more recent injectable biologic.
Neil or oral therapies have the potential to improve outcomes. However, those require or are being studied for daily or twice daily dosing.
Speaker Change: Therefore, we believe that RG 111 has the potential to provide patients with the efficacy of our monoclonal antibody with a dosing schedule that has not been achieved by other oral therapies.
Speaker Change: Now I would like to pass the call over to survive satisfied our chief financial Officer to review our financials.
Speaker Change: <unk>.
Speaker Change: Thank you <unk>.
Speaker Change: In addition to our financial results summarized in the press release that was issued earlier today.
Speaker Change: I will briefly share some key financial highlights on this call.
Speaker Change: You can also find additional information in our Form 10-K for the year ended December 31 2023.
Speaker Change: Now turning to our balance sheet cash.
Speaker Change: Cash cash equivalents and marketable securities as of December 31, 2023 totaled $48 5 million.
Speaker Change: Compared to $98 5 million as of December 31, 2022.
Speaker Change: We expect our current cash cash equivalents.
Speaker Change: And marketable securities to be sufficient to fund our operations into 2025.
We recognize the need to raise additional capital to support our operations from 2025 and beyond.
Speaker Change: We plan to raise additional capital through equity offering.
Speaker Change: That financing and potential non dilutive.
Speaker Change: Ensing fees from pharma partners.
Speaker Change: For our operating results for the fourth quarter and year ended December 31 2023.
Speaker Change: Research and development expenses for the fourth quarter and full year of 2023 were $11 6 million.
And $39 6 million respectively.
Speaker Change: <unk> to $10 4 million and $36 6 million.
Speaker Change: For the same periods in 2022, respectively.
Speaker Change: We have sufficiently manage our operating costs and even with the challenge of limited capital doing 2023.
Speaker Change: We successfully completed the phase one clinical study for RG 111, and.
And significantly advance development of the <unk>.
Speaker Change: <unk>, which is expected to be ready for clinical studies in the second half of this year.
Speaker Change: General and administrative expenses for the fourth quarter and full year 2023 were $5 8 million.
Speaker Change: In $26 5 million respectively.
Speaker Change: Compared to $7 1 million and $26 8 million for the same periods in 2022, respectively.
Speaker Change: The G&A expenses for.
Speaker Change: For the full year 2023 decreased by zero point $3 million.
Speaker Change: <unk> to the prior year due to our cost containment measures and.
Speaker Change: And it includes noncash expenses of approximately $12 9 million for the full year of 2023.
Speaker Change: Compared to $9 8 million in 2022, which is primarily stock based compensation.
Speaker Change: Net loss for the fourth quarter and full year 2023 was $14 1 million and.
Speaker Change: And $67 9 million, respectively, compared to $17 3 million.
Speaker Change: And $63 3 million for the same periods in 2022, respectively.
Speaker Change: The net loss includes non cash stock based compensation expense of $4 5 million for the fourth quarter and 19.0 million for the full year of 2023.
Speaker Change: Compared to $4 5 million and $15 8 million for the same periods in 2022.
Speaker Change: <unk>.
Speaker Change: That concludes the financial section and I will turn the call back over to Taylor for closing comments.
Taylor: Thank you <unk>.
Taylor: Overall I am exceptionally pleased by the results of our <unk> hundred 11 study that Rins are reviewed earlier.
Taylor: To our knowledge. This is the first clinical evidence of oral delivery of a monoclonal antibody with such high bioavailability.
Taylor: We believe these results provide validation that our platform can transform injectable large molecules into convenient oral pills.
Taylor: In addition, we are proud to announce that we have now dose the Ronnie pill over 230 times in human subjects and three clinical studies without observing any serious adverse events related to the platform.
Taylor: <unk> platform has the potential to combine the efficacy specificity and long half life of a monoclonal antibody with the convenience of dosing flexibility of a pill.
Taylor: The combination of the two could create products that we believe are as of now impossible to replicate with any other oral formulation.
Taylor: Ronnie intends to identify additional opportunities where there is a potential to create better products in terms of efficacy safety and dosing schedule as compared to the originator.
Taylor: In closing we are proud to have built a world class leadership team at Ronnie and I would like to thank everyone at the company for their efforts this past year and so far in 2024.
Taylor: I'd also like to thank all of our stakeholders for your continued support of Ronnie and for helping us move closer to our vision of making oral biologics a reality.
Speaker Change: With that I will now open the call up for questions operator, and thank you.
Speaker Change: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to join your question. Please press Star one again, please standby what we compile the Q&A roster and we do ask that you limit yourself to one question and one follow up and one moment Bob first question.
Speaker Change: And our first question comes from Olivia Brayer from Cantor Fitzgerald. Your line is now open.
Olivia Brayer: Hey, good afternoon, guys. Thank you for the question.
Olivia Brayer: Are you guys with respect to negotiating the terms of the development path forward with poultry on and how are you thinking about cost sharing with a partner versus first moving forward with the <unk> 111 program alone and then I've got a quick follow up on that on obesity.
Speaker Change: Yes, great questions Hi, Olivia so in terms of the negotiations there ongoing there is not much I can say about that.
Speaker Change: We're in the middle of it.
Speaker Change: And if we were to go this alone versus doing it with.
Speaker Change: A partner like <unk> I think in the case of a partnership we would expect the cost to be borne by the partner going forward and if we were to do this by ourselves I think which will be excited to do given the color that are when they are provided.
Speaker Change: We would look to bring in additional capital to support the program through through our phase two a repeat dose study to show the higher pass score in the first 12 weeks.
Speaker Change: All right.
Speaker Change: Apologize I'm, sorry, a follow up question to that.
A quick follow up question and then I've got a question on obesity, but.
Speaker Change: Can you comment on whether or not they are officially opted in.
Speaker Change: There was that that window has passed right that was at the end of February if I'm not mistaken that's.
Speaker Change: Correct I cannot comment on that unfortunately.
Speaker Change: Okay, and then on obesity, how big of a strategic priority is that program at this point and just considering some of the recent developments in that space, where do you think your pill could realistically fit into that commercial market. Yes, absolutely. So it is one of the highest priorities for us as a company and we've been working on this for years now.
Speaker Change: Looking at potential opportunities I think I've said publicly what we would like to do is create like we're doing with <unk> hundred 11.
Speaker Change: A dosing schedule that would be very difficult to replicate with any other oral technology.
Speaker Change: And while getting the same kind of discontinuation rates and.
Speaker Change: Safety efficacy profile of the Injectables.
Speaker Change: And so to that end, we're looking at maybe one generation ahead technologies that are showing.
Speaker Change: Even better tolerability than the first generation strictly the <unk> IP.
Speaker Change: No.
Speaker Change: Drugs.
Speaker Change: And looking at dosing schedules that could be once a month or once every couple of weeks.
So that's the plan.
Speaker Change: The strategy around it and it is a top priority for us and I think whats exciting about Ronnie's technology is that its from our perspective, the future proof whether it's.
Speaker Change: Muscle preservation drugs or combinations thereof. This ism.
Speaker Change: Oral auto injector swallow the auto injector. So it doesn't really matter I think we've demonstrated this now over 15 drugs pre clinically in three phase ones. It doesn't really matter what you put in <unk>. So we shouldnt be able to deliver it with bioavailability that similar to an injection.
Speaker Change: Okay, great. Thank you guys I appreciate it.
Speaker Change: And thank you.
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from Edward Nash from Canaccord Genuity. Your line is now open.
Edward NASH: Hi, Good afternoon, guys and thanks for taking my question wanted to now that 102 is going to be entering phase. Two this year could you maybe just talk.
Edward NASH: Talk a little bit about the size of that trial and design.
Speaker Change: Absolutely I'll turn that over to sorry, Ed was there another question.
Speaker Change: Okay great.
Speaker Change: Urban there maybe you can jump in and provide the color on our two one or two.
Yes sure.
Speaker Change: Yes.
Urban: So we're planning to.
Urban: <unk> enrolled 25 subjects.
Urban: And we plan to have two groups in the study one or.
Urban: Two and one or will be using a tale ethical Erica.
Urban: And the study is.
Urban: Of eight weeks of duration and we're just going to look at the biomarkers that correlate well with the.
Urban: BMD.
Speaker Change: Okay and would that be the only phase two that you would need to do before moving into a bigger trial.
Speaker Change: We would need to do a bigger trial this is Jeff.
Jeff: Startup of dose finding proof of concept type of study that we wanted to do before we do a bigger study.
Speaker Change: Got it okay perfect. Thank you.
Speaker Change: Thanks, Ed.
Speaker Change: And thank you.
Speaker Change: And one moment our next question.
Speaker Change: Okay.
And our next question comes from Julian Harrison from BT AIG. Your line is now open.
Julian Harrison: Hi, Thank you for taking my questions on the obesity front I'm wondering if you could talk more about how teekay advantages enabled by Randy pill could maybe translate to potential benefits on efficacy tolerability are both in the context of Incretin based therapies and then maybe beyond <unk> based therapies I'm curious if you've given any thoughts.
Julian Harrison: Some of the emerging classes in obesity.
Julian Harrison: Such as Amazon analogs, Exxon receptor ligand traps CB one inhibitors as the example.
Speaker Change: Absolutely Hi, Julien.
Speaker Change: So in terms of PK safety efficacy and I would also add Cogs in there.
Speaker Change: If I can.
Julien: In terms of efficacy the drugs work really well so I don't think changing the benchmark unless you change the <unk> you put into the pill or into the injectable are going to make a material difference based on the modality, but safety and Tolerability there is a potential there.
I think it was Eli Lilly with their Mojo data they've put out a time based course of when the Aes popped up in patients and it was right when they were getting a new dose. So at the beginning of a new cycle. It seemed like there was.
Spike in Aes that showed up so with the Ronnie pill, if you move to daily dosing in the induction phase similar to what were thinking about doing in the early goings of RG 100 weapon for our patients you can smooth those curves out so that the peaks and troughs.
Julien: <unk> away and you have a more linear progression in the escalation of the dose.
Julien: While we don't have the data yet we will have to run a study with one of those drugs to find out we feel like based on the literature that there is a potential to improve the tolerability of.
Julien: And in platinum based therapy, so that brings us kind of your second question, which is.
Julien: If you look at amylin based therapies.
<unk> there are other things that are on the horizon or maybe right here right now showing much better tolerability and so thats top of mind for us when we think about selecting a partner and a program to bring onto the running till there is tremendous interest in the obesity space to use the <unk> fell by a number of potential partners.
Julien: The the thing for US is to find something that works today and will be competitive tomorrow.
Julien: And we're in trials and obviously when we get to commercial and then finally I think maybe dovetails with what I. Just said we are absolutely looking at the next generation, we're going to take a portfolio approach to obesity, but I don't think theres going to be one drug that can address the entire $100 billion category and I think youll see over time and all of you.
Julien: As analysts will do this youll start to bifurcate this into sub categories.
Julien: Patients maybe with lower.
Julien: Our weight loss requirements, but maybe they have other adverse events.
Julien: People, who will self pay and then there is the morbidity obese, where youre competing maybe with the ruling y or a gastric sleeve and then finally finally I should say.
Julien: I mentioned Cogs I think that what some companies are doing to make oral therapies, while they generate great data they have to increase the dose by 200 ex <unk>.
Julien: Compared to an injectable and Theres, a cogs issue with that.
Julien: That may be at Cogs in production and it's just a waste of drug when theres. So many patients that want to get onto these therapies. So I'm skeptical of those in the near term maybe the production issues will be solved over the next four or five years, but I have a feeling that as much as we can produce as an industry of these obesity drugs there'll be patients who want to take.
Julien: So I think there's a really good fit in this market for Ronnie pill that can take an injectable dose and get injectable efficacy with with.
Dosing schedules as I said that you can't do with.
Julien: With a small molecule approach with an oil.
Speaker Change: Very helpful. Thank you.
Speaker Change: Thank you for the questions.
Speaker Change: And thank you.
Speaker Change: And one moment and one moment our next question.
Speaker Change: And our next question comes from John Vanda Motion from Zacks. Your line is now open.
Speaker Change: Alright, Thank you and Hello, Todd.
Speaker Change: Good afternoon.
Speaker Change: Starting out with a question on just assuming that sultry on.
Speaker Change: Signs a deal with you and then funds 101, how will your focus shift for.
Speaker Change: <unk> for the rest of your pipeline if that happens.
Todd: It's a good question I mean, we've been talking about obesity assets. So it's hard to describe something that we don't have in the pipeline right now, but I think we would we are putting a lot of focus on.
Todd: Im making a selection there.
Todd: And that would be a place too.
Todd: Invest capital and then Theres Archie 105 Humira remains.
Todd: A very popular drug amongst clinicians and patients.
Todd: And despite the biosimilars coming into the market. There is just not a lot of differentiation there so bringing a TNF alpha oral and perhaps a once a week. So it's something that we're thinking about in that in that space would be a really exciting products I think.
Speaker Change: Yes and.
Speaker Change: And as we think about Ronnie pill and kind of.
Speaker Change: Getting to.
Speaker Change: Later stages manufacturing stages I know you guys were working on some some automated processes for manufacturing how's that coming along and.
Speaker Change: Will you be using that for.
Speaker Change: Four clinical stage product.
Speaker Change: Yes, great question, we do need to automate and we've made incredible strides over the last year, we have a fully dedicated in house automation team. That's taking every step of the manufacturing process for the Ronnie pill and turning it into something that doesn't require an operator, that's fully automated and then ultimately will string.
Speaker Change: All of those pieces of equipment together to make a fully automated end to end line.
Speaker Change: As I said, we've made good progress we're shooting for a demonstration or pilot line.
Speaker Change: That can deliver in the low thousands of pills per day and the goal is to have this ready for our phase three studies, we don't need it for the phase ones and phase twos, we have the capacity already to support those studies.
Speaker Change: But we would like to have that in place and then of course be able to work with the with our CBS CMO partner that does mass scale production and scale that up so that we can make 50 or 100000 pills per day per line, which is what we'll need to do in order to commercialize any of these problems.
Okay, and one more if I may I was doing some research on Biosimilars I was just looking at the rate of new Biosimilars that are out there I think there were about nine approved in the last 12 months, what do you think about.
Speaker Change: The environment for more Biosimilars to come you know it started off pretty slowly about a decade ago, especially in the U S. What are your thoughts about this and kind of the maybe.
Speaker Change: Legislative environment for.
Speaker Change: Accelerated growth of Biosimilars.
Speaker Change: Right I think.
Speaker Change: There's a couple of points here the first is that everyone.
Speaker Change: From Congress to patients clinicians payers should want biosimilars because exclusivity from patents is good because it allows for innovation, but you don't want to keep prices for an old drug high artificially forever. So we need biosimilars, but we also need to I think as in not just our industry, but the health care industry.
Speaker Change: History writ large needs to look at rebates, how things are paid for.
Speaker Change: And I think the Amgen example of the two prices they gave for Humira, Humira, Biosimilar and which one had uptake.
Speaker Change: Says a lot about how the PVM and payer market works or doesn't work if I can say that.
Speaker Change: I think that there's going to be more biosimilars coming in but the only thing. They can compete on this price and you also see like Humira or abbvie, making humira unbranded that could play well with patients and clinicians, it's really hard to say what I love about Ronnie is that we're not going to be playing even though we may use a biosimilar is our drug substance and our final drug.
Speaker Change: We're not a biosimilar company, we're making novel products out of making bio betters. If you will our novel products out of a biosimilar. So dosing schedules are different we're shooting for with <unk> hundred 11, as an example, getting better near term efficacy faster passey scores and then potentially even elevating in the maintenance phase.
Speaker Change: <unk> referenced.
Speaker Change: The efficacy we think there is some potential there. So we're really looking for those opportunities not just doing a one for one replacement where it's just the pill. So that is profound we think in and of itself.
Speaker Change: So I think as it relates to Ronnie that's kind of how we look at this whether theres more whether theres fewer it doesn't really impact our strategy.
Speaker Change: Okay, great. Thanks, a lot I appreciate it thanks John.
Speaker Change: And thank you and if you would like to ask a question that is star one one again, if you would like to ask a question that is star 111 moment for questions.
Speaker Change: And I am showing no further questions I would now like to turn the call back over to Taylor for closing remarks.
Taylor: Thank you Justin.
Taylor: This concludes our fourth quarter and full year 2023 financial results and corporate update conference call.
Taylor: You again, everyone for joining us this afternoon.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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Welcome to the Ronnie Therapeutics fourth quarter, and full year 2023 financial results and corporate update conference call. At this time, all participants are in a listen only mode.
Speaker Change: Following managements prepared remarks, we will hold a Q&A session to ensure that we have ample time to address everyones questions. During the Q&A session. We would ask for a limit of one question and one follow up question per person to ask a question at a time. Please press star followed by one one on your Touchtone phone as a reminder, this call is.
Raj Patel: Being recorded today Wednesday March 22024, I would now like to turn the conference call over to <unk> Patel at Gilmartin Group. Please go ahead.
Dilip Patel: Thank you operator, joining us on the call today from Ronny Therapeutics, our Chief Executive Officer to lot Enron VP of clinical development, Arvind or dollar and Chief Financial Officer fly Sanford.
Operator: During this conference call management will make forward looking statements that are subject to risks uncertainties and assumptions such as but not limited to those discussed in the risk factors section of the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K, and quarterly reports on Form 10-Q, which identify.
Operator: The specific factors that may cause actual results or events to differ materially from those described in these forward looking statements.
Operator: These statements may include without limitation statements regarding product development and clinical trials product potential market sizes platform progress platform potential certain business strategies capital resources financing plans or operating performance.
Operator: Actual results and the timing of events could differ materially from those projected in such forward looking statements.
Lot Enron: With that I turn the call over to lot Enron, Chief Executive officer of Ronnie Therapeutics to lot.
Lot Enron: Thank you.
Ron Enron: I am delighted to share the highlights of Ronnie Therapeutics strong performance in 2023 during which the company achieved numerous milestones in the development of its pipeline programs and high capacity oral delivery device.
Ron Enron: <unk> Therapeutics is a clinical stage biotech company that has developed a platform technology for the oral administration of biologics with bioavailability comparable to subcutaneous injection the.
Ron Enron: <unk> platform is designed to address any therapeutic area, where biologics are use our current focus is on immunology and endocrinology with discovery efforts underway in obesity and other therapeutic areas and drug modalities.
Speaker Change: During today's call I will start by reviewing the important milestones that Ronnie has achieved throughout the past year, then oven. There will provide her perspective on the recent data we shared last month on our team on 11, we are highly encouraged by this data and this is now our third successfully completed phase one trial using our Ronnie.
Speaker Change: Technology.
Speaker Change: And then finally survived will provide an update on our financial position for the fourth quarter and full year 2023.
Speaker Change: I will now begin the call by highlighting one of our biggest achievements over the past year and that is our positive phase one results for Archie 111, an orally administered is thinking about a biosimilar as a reminder, that youre speaking about a biosimilar use in our RT <unk> hundred 11 program is supplied by <unk>, a global biopharmaceutical company.
Speaker Change: Ronnie <unk> entered into a long term supply agreement at the beginning of 2023. This partnership was expanded to include in Abilene <unk> Biosimilar in the middle of 2023 and.
Speaker Change: In both cases <unk> has the right of first negotiation to acquire commercial rights to each program. After the completion of the respective phase one studies.
Speaker Change: Last month, we announced positive results of the completed phase one trial for <unk> hundred 11, we were very excited by those results as Archie 111 achieved high bioavailability in humans in.
Speaker Change: And it was well tolerated with no serious adverse events.
Speaker Change: We believe this is a large potential opportunity as currently with <unk> is only available as a subcutaneous injection and is marketed in the United States by Janssen has to Laura for the treatment of moderate to severe plaque psoriasis active psoriatic arthritis moderate to severe crohn's disease and moderate to severe <unk>.
Speaker Change: Sort of colitis, all of which have large unmet medical needs for an oral treatment.
Speaker Change: As for the potential commercial opportunity sales for <unk> were approximately $7 billion in the United States and approximately $10 9 billion worldwide in 2023.
Speaker Change: Moving onto our additional programs Ronny announce our second deal with South Korea on for in Abilene <unk> Biosimilar for the <unk> hundred five program in the middle of last year.
Speaker Change: This was the first announced partnership for a program involving the Ronnie pill HC. Our high capacity device that is designed to deliver up to 200 micro liters of liquid payload with high bioavailability.
Speaker Change: Last fall Ronny announced successful oral delivery of Humira by the Ronnefeldt HC and a preclinical study.
Speaker Change: The preclinical study track the serum concentrations of Adalimumab. Following the oral administration of the enteric coated Ronnie <unk> HC capsule containing 11 milligrams of Humira or Abilene Moab, two <unk> for canine models.
Speaker Change: The <unk> <unk> successfully delivered at only Moab and all subjects. Further we have completed preclinical studies with additional antibody and peptide molecules in the radical HC.
Speaker Change: Overall, we are pleased with the progress we have made to date with our high capacity pill. As we believe this will be at the forefront of our clinical development programs moving forward.
Speaker Change: And finally, another potential area, we believe our writing Perl can make an impact is the obesity market in December 2023, Ronny announced preclinical data demonstrating that the trans enteric delivery of an <unk> credit Tri agonists of G. L. P. One G IP and glucagon elicited rapid weight loss in <unk>.
Speaker Change: Animal study.
Speaker Change: Preclinical data supported the potential for the Ronnie pill platform to enable oral delivery of multiple obesity treatment considering the obesity market is expected to exceed $100 billion by 2030, we are highly enthusiastic about the potential for our Ronnie pill to make an impact in this therapeutic area or.
Speaker Change: We're all we believe that the progress we have made in 2023 reflects our commitment to our vision of making oral biologics a reality across a wide variety of indications with that let me now turn the call over to Arvind deller to discuss our clinical updates in more detail.
Arvinder Dhalla: Thank you Paula good afternoon, everyone. My name is Arlinda Gallo I am VP of clinical development at Ronnie Therapeutics I'm delighted to provide a high level overview of the exciting data from our phase one study with <unk> hundred 11, showing for the first time.
Arvinder Dhalla: Delivery of our monoclonal antibody via the Ronnie pill.
Arvinder Dhalla: This was a single center open label Phase One study of Ipi 111 conducted in Australia.
Arvinder Dhalla: Study evaluated the safety Tolerability and pharmacokinetics of RT 111 in healthy volunteers. The study enrolled 20 participants each in RT 111, 0.5 milligram and 0.75 milligram dose groups and 15 participants and Este Lauder 0.5 milligram.
Arvinder Dhalla: Cutaneous injection coupe.
Arvinder Dhalla: In this study <unk> 111 delivered let's take an EMR biosimilar and a dose proportional manner.
Arvinder Dhalla: These for the two 0.5 milligram groups were quite comparable.
Arvinder Dhalla: One thing and a bioavailability up 84%, Yeah, Ronny route of administration compared to the subclinical.
Arvinder Dhalla: In addition, oral Archie 111 demonstrated a higher C Max and as shown on T. Max compact <unk> deliver.
Arvinder Dhalla: By sub Q injection.
Arvinder Dhalla: Moving on to safety and Tolerability <unk> 11 was well tolerated by all participants in the two rte burned 11 groups and no serious adverse events were observed in this study.
Arvinder Dhalla: There was no meaningful difference in the incidence of antidrug antibodies that.
Arvinder Dhalla: Rounding out of delivery compared to Soliris sub Q injection.
Arvinder Dhalla: Additionally, no participants reported difficulty swallowing that any pills and capsules remanent pass from all participants.
Arvinder Dhalla: Overall, we are very pleased with the data that ironical delivered to get them a biosimilar antibody in healthy volunteers without any serious adverse events and then high bioavailability.
With RG 111, we aim to have a product that is highly differentiated as compared to other oral and injectable options currently being commercialized or in development.
Whilst a lot of a disruptive been launched it's passing 75 scores early in the treatment are not as high as more recent entrants.
Arvinder Dhalla: This is something we intend to address with a differentiated loading dose regimen for Archie 111.
Arvinder Dhalla: The reason loading doses critical is that new psoriasis patients typically start therapy in the middle of a serious player app, which justifies the use of a biologic.
Arvinder Dhalla: Ultimately, though most patients will transition to maintenance dosing and after review we believe there is a potential to improve on the lora here as well.
Arvinder Dhalla: We plan to explore a dosing regimen that begins with a 30 day daily loading dose followed by just three pills at the beginning of each month for maintenance.
Arvinder Dhalla: Furthermore, currently approved oral therapy like a Tesla and predictable have shown lower pass through 75 scores as compared to the more recent injectable biologic.
Arvinder Dhalla: Nila oral therapies have the potential to improve outcomes. However, those require or are being studied for daily or twice daily dosing.
Arvinder Dhalla: Therefore, we believe that RG 111 has the potential to provide patients with the efficacy of our monoclonal antibody with a dosing schedule that has not been achieved by other oral therapy.
Speaker Change: Now I would like to pass the call over to survive satisfied our chief financial Officer to review our financials. Thank you.
Thank you our vendor in.
Speaker Change: In addition to our financial results summarized in the press release that was issued earlier today.
Speaker Change: I will briefly share some key financial highlights on this call.
Speaker Change: You can also find additional information in our Form 10-K for the year ended December 31 2023.
Now turning to our balance sheet cash.
Speaker Change: Cash cash equivalents and marketable securities as of December 31, 2023 totaled $48 5 million.
Compared to $98 5 million as of December 31, 2022.
Speaker Change: We expect our current cash cash equivalents.
Speaker Change: And marketable securities to be sufficient to fund our operations into 2025.
Speaker Change: We recognize the need to raise additional capital to support our operation for 2025 and beyond.
Speaker Change: Plan to raise additional capital through equity offerings.
Speaker Change: Debt financing and potential non dilutive licensing fees from pharma partners.
Speaker Change: For our operating results for the fourth quarter and year ended December 31 2023.
Research and development expenses for the fourth quarter and full year of 2023 were $11 6 million.
Speaker Change: And $39 6 million respectively.
Speaker Change: <unk> to $10 4 million and $36 6 million.
Speaker Change: For the same periods in 2022, respectively.
Speaker Change: We have sufficiently manage our operating costs and even with the challenge of limited capital during 2023.
Speaker Change: We successfully completed the phase one clinical study for <unk> 111, and significantly advance development of the Ronnie pill, AP, which is expected to be ready for clinical studies in the second half of this year.
Speaker Change: General and administrative expenses for the fourth quarter and full year 2023 were $5 8 million.
Speaker Change: And $26 5 million respectively.
Speaker Change: Compared to $7 1 million and $26 8 million for the same periods in 2022 were effectively.
Speaker Change: The G&A expenses for the full year 2023 decreased by zero point $3 million compared to the prior year due to our cost containment measures.
Speaker Change: And it includes noncash expenses of approximately $12 9 million for the full year of 2023.
Speaker Change: Compared to $9 8 million in 2022, which is primarily stock based compensation.
Speaker Change: Net loss for the fourth quarter and full year 2023 was $14 1 million and.
Speaker Change: And $67 9 million, respectively, compared to $17 3 million.
Speaker Change: And $63 3 million for the same periods in 2022, respectively.
Speaker Change: The net loss includes non cash stock based compensation expense of <unk> 5 million for the fourth quarter and 19.0 million for the full year of 2023.
Speaker Change: Compared to $4 5 million and $15 8 million.
Speaker Change: The same periods in 2022, respectively.
Speaker Change: That concludes the financial section and I will turn the call back over to Todd for closing comments.
Todd: Thank you survive.
Todd: Overall I am exceptionally pleased by the results of our <unk> hundred 11 study that arvin, they're reviewed earlier.
Todd: To our knowledge. This is the first clinical evidence of oral delivery of a monoclonal antibody with such high bioavailability.
Todd: We believe these results provide validation that our platform can transform injectable large molecules into convenient oral pills.
Todd: In addition, we are proud to announce that we have now dosed the Ronnie pill over 230 times in human subjects in three clinical studies without observing any serious adverse events related to the platform the.
Todd: <unk> platform has the potential to combine the efficacy specificity and long half life of a monoclonal antibody with the convenience of dosing flexibility of a pill.
Todd: The combination of the two could create products that we believe are as of now impossible to replicate with any other oral formulation Ronny.
Todd: <unk> intends to identify additional opportunities where there is a potential to create better products in terms of efficacy safety <unk> dosing schedule as compared to the originator.
Todd: In closing we are proud to have built a world class leadership team at Ronnie and I would like to thank everyone at the company for their efforts this past year and so far in 2024 I'd also like to thank all of our stakeholders for your continued support of Ronnie and for helping us move closer to our vision of making oral biologics a reality.
Speaker Change: With that I will now open the call up for questions operator, and thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster and we do ask that you limit yourself to one question and one.
Speaker Change: Follow up and one moment for our first question.
Speaker Change: And our first question comes from Olivia Brayer from Cantor Fitzgerald. Your line is now open.
Olivia Brayer: Hey, good afternoon, guys. Thank you for the question.
Olivia Brayer: Are you guys with respect to negotiating the terms of the development path forward with poultry on and how are you thinking about cost sharing with a partner versus first moving forward with the <unk> 111 program alone and then I've got a quick follow up on the on obesity.
Speaker Change: Yeah, Great question Tyler via so in terms of the negotiations they are ongoing there's not much I can say about that.
Speaker Change: Where we're in the middle of it.
Speaker Change: And if we were to go this alone versus doing it.
Speaker Change: A partner like <unk> I think in the case of a partnership we would expect the costs to be borne by the partner going forward and if we were to do this by ourselves I think which will be excited to do given the.
Speaker Change: Color that arguably are provided.
Speaker Change: We would look to bring in additional capital to support.
Speaker Change: The program through through our phase two a repeat dose study to show the higher passey score in the first 12 weeks.
Speaker Change: Right.
Speaker Change: I apologize was there a follow up question to that.
Speaker Change: Yes, a quick follow up question and then I've got a question on obesity, but.
Speaker Change: Can you comment on whether or not they are officially opted in because I think there was that that window has passed right that was at the end of February if I'm not mistaken that's correct I cannot comment on that unfortunately.
Okay, and then on obesity, how big of a strategic priority is that program at this point and just considering some of the recent developments in that space, where do you think your pill could realistically fit into that commercial market. Yes, absolutely. So it is one of the highest priorities for us as a company and we've been working on this for years now.
Speaker Change: Looking at potential opportunities.
I think I've said publicly what we would like to do is create like we're doing with Archie 111, a dosing schedule.
Speaker Change: Schedule that would be very difficult to replicate with any other oral technology.
Speaker Change: And while getting the same kind of discontinuation rates and safety efficacy profile of the Injectables.
Speaker Change: And so to that end, we're looking at maybe one generation ahead technologies that are showing.
Speaker Change: Even better tolerability than the first generation strictly the <unk> IP.
Speaker Change: Drugs.
Speaker Change: And looking at dosing schedules that could be once a month or once every couple of weeks.
Speaker Change: So that's the plan and the strategy around it and it is a top priority for us and I think what's exciting about Ronnie technology is that its for our perspective future proof whether it's.
Speaker Change: Muscle preservation drugs or combinations thereof. This isn't.
Speaker Change: Oral auto injector swallow the auto injector. So it doesn't really matter I think we've demonstrated this now over 15 drugs pre clinically in three phase ones. It doesn't really matter what you put in <unk>. So we shouldn't be able to deliberate with bioavailability that similar to an injection.
Speaker Change: Okay, great. Thank you guys I appreciate it thank you.
Speaker Change: Thank you.
And one moment our next question.
Speaker Change: And our next question comes from Edward Nash from Canaccord Genuity. Your line is now open.
Hi, Good afternoon, guys and thanks for taking my question wanted to now that 102 is going to be entering phase two this year could you maybe just.
Edward Hamilton Nash: Talk a little bit about the size of that trial and design.
Speaker Change: Absolutely I'll turn that over to sorry, Ed was there another question.
Speaker Change: Okay great.
Urban there maybe you can jump in and provide the color on our two you wanted to.
Urban: Yes sure.
Urban: So we're planning to.
Enrol 25 subjects per arm and we plan to have two groups in the study one or <unk>.
Urban: Two and one or will be using a tale ethical Erica.
Urban: And the study of.
Urban: Of eight weeks of duration and we're just going to look at the Biomarkers that may as they correlate quite well with the.
BMD.
Speaker Change: Okay would that be the only phase two that you would need to do before moving into a bigger trial.
Speaker Change: We would need to do a bigger trial this is Jeff.
Jeff: Sort of a dose finding proof of concept type of spending that we wanted to do before we do a bigger study.
Speaker Change: Got it okay perfect. Thank you.
Speaker Change: Thanks, Ed.
Speaker Change: And thank you.
Speaker Change: And one moment our next question.
Speaker Change: Okay.
Speaker Change: And our next question comes from Julian Harrison from BT AIG. Your line is now open.
Julian Reed Harrison: Hi, Thank you for taking my questions on the obesity front I'm wondering if you could talk more about how teekay advantages enabled by Randy Pelican, maybe translate to potential benefits on efficacy tolerability are both in the context of <unk> based therapies and then maybe beyond <unk> based therapies I'm curious if you've given any thoughts.
Julian Reed Harrison: Some of the emerging classes in obesity.
Julian Reed Harrison: Such as Amazon analogs axon receptor ligand traps CB one inhibitors as an example.
Speaker Change: Absolutely Hi, Julien.
Speaker Change: So in terms of PK safety efficacy and I would also add Cogs in there.
If I can.
Julien: In terms of efficacy of the drugs work really well so I don't think changing the benchmark unless you change the ingress and Cretins you put into the pill or into the injectable are going to make a material difference based on the modality, but safety and Tolerability there is a potential there.
Julien: I think it was Eli Lilly with their Manganaro data they put out a time based course of when the Aes popped up in patients and it was right when they were getting a new dose. So at the beginning of a new cycle. It seemed like there was a.
Julien: Mike.
Julien: Is that showed up so with Irani pill, if you move to daily dosing in the induction phase similar to what were thinking about doing in the early goings of Archie 111 for a patient you can smooth those curves out so that the peaks and troughs.
Julien: Go away and you have a more linear progression in the escalation of the dose.
Julien: And while we don't have the data yet we will have to run a study with one of those drugs to find out we feel like based on the literature that there is a potential to improve the tolerability.
Julien: Oven and platinum based therapy, so that brings us kind of your second question, which is.
Julien: When you look at Amylin based therapies <unk> <unk>. There are other things that are on the horizon or maybe right here right now showing much better tolerability and so that's top of mind for us when we think about selecting a partner and a program to bring onto the Ronnie So there's tremendous interest in the obesity space.
Julien: <unk> fell by a number of potential partners.
Julien: The the thing for US is to find something that works today and will be competitive tomorrow.
Julien: When we're in trials and obviously when we get to commercial and then finally I think it maybe dovetails with what I. Just said we are absolutely looking at the next generation, we're going to take a portfolio approach to obesity, but I don't think theres going to be one drug that can address the entire $100 billion category and I think youll see over time and all of you.
Julien: As analysts will do this you'll start to bifurcate this into sub categories of patients maybe with lower.
Julien: Our weight loss requirements, but maybe they have other adverse events. There is there are people who will self pay and then there is the morbidity obese, where youre competing with you with the ruin y or a gastric sleeve and then finally finally I should say.
Julien: I mentioned caused I think that what some companies are doing to make oral therapies, while they generate great data they have to increase the dose by 200 ex <unk>.
Julien: Compared to an injectable and Theres, a cogs issue with that.
Julien: That may be at Cogs in production and it's just a waste of drug when theres. So many patients that want to get onto these therapies. So I'm skeptical of those in the near term maybe the production issues will be solved over the next four or five years, but I have a feeling that as much as we can produce as an industry of these obesity drugs there'll be patients who want to take.
Julien: So I think there's a really good fit in this market for Ronnie pill that can take an injectable dose and get injectable efficacy with with.
Julien: Dosing schedules as I said that you can't do with it.
Julien: With a small molecule approach with an oil.
Speaker Change: Very helpful. Thank you yeah, absolutely. Thank you for the questions.
Speaker Change: And thank you.
Speaker Change: And one moment.
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from John Vanda Motion from Zacks. Your line is now open.
Speaker Change: Alright, Thank you and Hello, Todd.
Good afternoon.
Speaker Change: Running out with a question on just assuming that sultry on.
Speaker Change: Signs a deal with you and then funds 111, how will your focus shift.
Speaker Change: For the rest of your pipeline if that happens.
Todd: It's a good question I mean, we've been talking about obesity asset. So it's hard to describe something that we don't have in the pipeline right now, but I think we would we are putting a lot of focus.
Todd: Im making a selection there.
Todd: And that would be a place too.
Todd: Invest capital and then Theres Archie 105 Humira remains.
Todd: A very popular drug amongst clinicians and patients.
Todd: And despite the biosimilars coming into the market, there's just not a lot of differentiation there so bringing a TNF alpha oral and perhaps a once a week hill is something that we're thinking about in that in that space would be a really exciting product I think.
Yes and.
Todd: And as we think about Ronnie pill and kind of.
Todd: Getting to.
Todd: Later stages manufacturing stages I know you guys were working on some some automated processes for manufacturing how's that coming along and.
Todd: Will you be using that for.
Todd: For for our clinical stage product.
Speaker Change: Yes, great question, we do need to automate and we've made incredible strides over the last year, we have a fully dedicated in house automation team Thats, taking every step of the manufacturing process for the Ronnie pill and turning it into something that's doesn't require an operator, that's fully automated and then ultimately you will string.
Speaker Change: All of those pieces of equipment together to make a fully automated end to end line.
Speaker Change: As I said, we've made good progress we're shooting for a demonstration or pilot line.
That can deliver in the low thousands of pills per day and the goal is to have this ready for our phase three studies, we don't need it for the phase ones and phase II, we have the capacity already to support those studies.
Speaker Change: But we would like to have that in place and then of course be able to work with with a Cvs CMO partner that does mass scale production and scale that up so that we can make 50 or 100000 pills per day per line, which is what we'll need to do in order to commercialize any of these problems.
Speaker Change: Okay, and one more if I may I was doing some research on Biosimilars and I was just looking at the rate of new Biosimilars that are out there I think they were about nine approved in the last 12 months, what do you think about the.
Speaker Change: The environment for more Biosimilars to come you know it started off pretty slowly about a decade ago, especially in the U S. What are your thoughts about this and kind of the maybe.
Speaker Change: Legislative environment for.
Speaker Change: Accelerated growth of Biosimilars.
Speaker Change: Right I think that there is a couple of points here. The first is that everyone in from Congress to patients clinicians payers should want biosimilars because.
Speaker Change: 270 from patents is good because it allows for innovation, but you don't want to keep prices for an old drug high artificially forever. So we need biosimilars, but we also need to I think as in not just our industry, but the health care industry writ large needs to look at at rebates, how things are paid for.
Speaker Change: And I think the Amgen example of the two prices they gave for Humira for their Humira, Biosimilar, and which one had uptake.
Speaker Change: Says a lot about how the PVM and payer market works at or it doesn't work if I can say that.
Speaker Change: I think that there's going to be more biosimilars coming in but the only thing. They can compete on price and you also see like humira or abbvie, making humira unbranded that could play well with patients and clinicians, it's really hard to say what I love about Ronnie is that we're not going to be playing even though we may use a biosimilar is our drug substance and our final drug <unk>.
Speaker Change: Product, we're not a biosimilars company, we're making novel products out of making bio betters. If you will our novel products out of a biosimilar. So dosing schedules are different we're shooting for with <unk> hundred 11, as an example, getting better near term efficacy faster passey scores and then potentially even elevating in the maintenance phase is arguably.
Speaker Change: <unk> referenced.
Speaker Change: The efficacy we think there's some potential there. So we're really looking for those opportunities not just doing a one for one replacement where it's just the pill, though that is profound we think in and of itself.
Speaker Change: So I think as it relates to Ronnie that's kind of how we look at this whether theres more whether theres fewer it doesn't really impact our strategy.
Speaker Change: Okay, great. Thanks, a lot I appreciate it thanks John.
Speaker Change: And thank you and if you would like to ask a question that is star one one again, if you would like to ask a question that is star 111 moment for questions.
Speaker Change: And I am showing no further questions I would now like to turn the call back over to Taylor for closing remarks.
Taylor: Thank you Justin.
Taylor: This concludes our fourth quarter and full year 2023 financial results and corporate update conference call. Thank you again, everyone for joining us this afternoon.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.