Q1 2024 Enanta Pharmaceuticals Inc Earnings Call
Operator: Please see the complete disclaimer at https://sites.google.com Have a great day! Good afternoon, and welcome to Enanta Pharmaceuticals' Fiscal First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode; there will be a question and answer session at the end of the prepared remarks. Please be advised that this call is being recorded. I would now like to turn the call over to Jennifer Vera, Investor Relations. Please go ahead.
Okay.
Good afternoon, and welcome to <unk> Pharmaceuticals fiscal first quarter financial results Conference call. At this time all participants are in a listen only mode. There will be a question and answer session at the end of the prepared remarks. Please be advised that this call is being <unk>.
Recorded I would now like to turn the call over to Jennifer Viera Investor Relations. Please go ahead.
Jennifer Vera: Thank you, Operator, and thanks to everyone for joining us this afternoon. The news release with our fiscal first quarter financial results was issued this afternoon and is available on our website. Making remarks on today's call are Dr. Jay Lulai, President and Chief Executive Officer, and Paul Mellott, our Chief Financial Officer. Dr. Scott Roddinghouse, our Chief Medical Officer, and Dr. Tara Keefer, our Chief Product Strategy Officer, will be available during the Q&A portion of this call. Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements. A description of these risks is in our most recent form, 10-K, and our other periodic reports filed with the SEC. Enanta does not undertake any obligation to update any forward-looking statements made during this call. With that said, I'd like to turn the call over to Dr. Jay Lulai, President and CEO. Jay?
Jennifer Viera: Thank you operator, and thanks to everyone for joining us. This afternoon. The news release with our fiscal first quarter financial results was issued this afternoon and is available on our website, making remarks on today's call are Dr. Jay <unk>, President and Chief Executive Officer, and Paul Mellett.
Jennifer Viera: Our Chief Financial Officer, Dr. Scott Rottinghaus, our Chief Medical Officer, and Dr. Guitar, Kiefer, our chief product strategy officer will be available during the Q&A portion of this call.
Jennifer Viera: Before we begin with our formal remarks, we want to remind you that we will be making forward looking statements, which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially.
Jennifer Viera: Really from those statements a description of these risks is in our most recent Form 10-K, and our other periodic reports filed with the SEC.
Dr. Jay: Ananda does not undertake any obligation to update any forward looking statements made during this call with that I'd like to turn the call over to Dr. Jay <unk>, President and CEO Jay.
Dr. Jay Lulai: Thank you, Jennifer, and good afternoon, everyone. In the first quarter of 2024, Enanta began an important year, which has the potential to advance our programs in both virology and immunology and drive value across the company. Through our recent expansion into immunology, our mission continues to center around the development of small molecule treatments for indications of high unmet need. And we are leveraging our drug discovery capabilities to bolster our pipeline for near and long-term value creation. Today, I'll provide an overview of our progress during the first quarter, beginning with our Respiratory Syncytial Virus, or RSV, program, and then segue into our new immunology program targeting chronic spontaneous urticaria, or CSU. RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in infants, children, and other high-risk populations, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease, or asthma.
Jay: Thank you Jennifer and good afternoon, everyone.
Dr. Jay: In the first quarter of 2024, and then to begin an important year, which has the potential to advance our programs in both virology in immunology and drive value across the company.
Dr. Jay: Through our recent expansion into immunology, our mission continues to center around the development of small molecule treatments for indications of high unmet need and we are leveraging our drug discovery capabilities to bolster our pipeline for near and long term value creation.
Dr. Jay: Today I'll provide an overview of our progress during the first quarter, beginning with our respiratory syncytial virus or RSV program.
Dr. Jay: And then segue into our new immunology program targeting chronic spontaneous urticaria or CSU.
Dr. Jay: RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in infants children and other high risk populations, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease or asthma.
Dr. Jay Lulai: Despite the availability of vaccines and prophylactic monoclonal antibodies, the uptake has been low, and breakthrough infections will still occur. The current rate for adult RSV vaccine adoption is estimated to be only 11% of the eligible population. Further, both strategies for pediatric prophylaxis, the maternal vaccine, and monoclonal antibodies provide short-term passive immunity for infants and only shift the infant's first infection to the next season.
Dr. Jay: Despite the availability of vaccines and prophylactic monoclonal antibodies.
Dr. Jay: Take has been low and breakthrough infections will still occur.
Dr. Jay: Current rate for adult RSV vaccine adoption is estimated to be only 11% of the eligible population.
Dr. Jay: Further both strategies for pediatric prophylaxis, the maternal vaccine and monoclonal antibodies provide short term passive immunity for entrance and only shift the entrance first infection to the next season.
Dr. Jay Lulai: Because of this significant need for safe and effective treatments, our goal is to develop an oral, best-in-class treatment for RSV through our broad development program, which includes Zelicaprivir, an N-protein inhibitor formerly known as EDP-938, and EDP-323, an L-protein inhibitor. Both have fast-track designation from the FDA. Our conviction in our approach to RSV is rooted in the core mechanism of our molecule's replication inhibition. We believe both Zelicapavir and ADP-323 have robust potential as monotherapies, but we're also excited by the opportunity to combine them and potentially broaden the treatment window or addressable patient population. Selicapavir, the only N-protein inhibitor in clinical development, is currently being studied in two Phase 2 studies of high-risk patient populations, RSV-PEDS and RSV-HR. RSV-PEDS is a randomized, double-blind, placebo-controlled study in hospitalized and non-hospitalized pediatric RSV patients. Aged between 28 days and 36 months.
Dr. Jay: Because of the significant need for safe and effective treatments. Our goal is to develop an oral best in class treatment for RSV.
Dr. Jay: Broad development program, which includes Zelie cap rate, there and N protein inhibitor, formerly known as Edp 938, and Edp three to three and al protein inhibitor.
Dr. Jay: Both have fast track designation from the FDA.
Dr. Jay: Our conviction in our approach to RSP is rooted in the core mechanism of our molecules replication inhibition. We believe both zelie cap of ear and ADP <unk> three have robust potential as mono therapies, but we're also excited by the opportunity to combine them and potentially broaden.
Dr. Jay: The treatment window or addressable patient populations.
Salary cap of your the only N protein inhibitor in clinical development is currently being studied in two phase two studies of high risk patient populations, RSV peds and RSV HR.
Dr. Jay: RSV peds as a randomized double blind placebo controlled study in hospitalized and non hospitalized pediatric RSV patients aged 28 days to 36 months.
Dr. Jay Lulai: It is a two-part study of approximately 90 patients. The objective of the first part is to evaluate Zelicapavir's safety and pharmacokinetics in multiple ascending doses to select the optimal dose for each age group. In the second part, the objective is to evaluate Zilliqap Avir's antiviral activity at the selected optimal dose.
Dr. Jay: It is a two part study of approximately 90 patients.
Dr. Jay: The objective of the first part is to evaluate Zelie cap of your safety and pharmacokinetics and multiple ascending doses.
Dr. Jay: The optimal dose for each age group and the second part the objective is to evaluate zelie cap of yours any viral activity at the selected optimal dose.
Dr. Jay Lulai: Symptom scores will be assessed throughout the treatment duration. RSV-PEDS was designed as a smaller study that would allow us to demonstrate a trend toward improved virology metrics for Zelikapavir and to also move forward expeditiously into registrational studies. RSVHR is a randomized, double-blind, placebo-controlled study in adults with RSV infection who are at high risk of complications, including adults over 65 years of age or individuals with asthma, congestive heart failure, or chronic obstructive pulmonary disease, known as COPD. Approximately 180 patients will be treated with 800 milligrams of Zelicapavir or placebo for five days and evaluated over a 28-day period thereafter. RSVHR's primary endpoint is time to resolution of RSV lower respiratory tract disease symptoms, as assessed by the Respiratory Infection Intensity and Impact Questionnaire or RIIQ Symptom Score Scale.
Dr. Jay: <unk> scores will be assessed throughout the treatment duration.
Dr. Jay: RSV Peds was designed as a smaller study that would allow us to demonstrate a trend toward improved virology metrics for <unk> and to also move forward expeditiously into Registrational studies.
Dr. Jay: RSV HR is a randomized double blind placebo controlled study in adults with RSV infection, who are at high risk of complications, including the adults over 65 years of age where individuals with asthma congestive heart failure or chronic obstructive pulmonary disease known as COPD.
Dr. Jay: Yeah.
Dr. Jay: Approximately 180 patients will be treated with 800 milligrams of <unk> or placebo for five days and evaluated over a 28 day period thereafter.
Dr. Jay: RSV HR as primary endpoint is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the respiratory infection intensity and impact questionnaire.
Dr. Jay: Our.
Dr. Jay: Q symptom score at scale.
Dr. Jay Lulai: We will also be evaluating multiple secondary endpoints, including other clinical efficacy measures and antiviral activity, as well as pharmacokinetics and safety. In RSVHR, we are primarily looking to see a clinically meaningful improvement in time-to-symptom resolution. The goal of this proof of concept study in high-risk patients with community acquired RSV is to obtain directional efficacy data that would give us the confidence to move into phase three as efficiently as possible. Currently, both RSVP and RSVHR continue to enroll patients, and we have taken the necessary steps to set up the trials to achieve enrollment around the world as quickly as possible, with each study having a global footprint spanning at least 15 countries. We have been pleased to see a more normal RSV season in North America.
Dr. Jay: We will also be evaluating multiple secondary endpoints, including other clinical efficacy measures and antiviral activity as well as pharmacokinetics and safety.
Dr. Jay: And RSP HR, we are primarily looking to see a clinically meaningful improvement in time to symptom resolution.
Dr. Jay: The goal of this proof of concept study in high risk patients with community acquired RSV is to obtain directional efficacy data that would give us the confidence to move into phase III as efficiently as possible.
Dr. Jay: Currently both RSV peds, and RSV HR continue to enroll and we have taken necessary steps to set up the trials to achieve enrollment around the world as quickly as possible with each study, having a global footprint spanning at least 15 countries. We.
Dr. Jay: We have been pleased to see a more normal RSV season in North America based on current enrollment trends, we anticipate reporting topline data from RSV peds and the third quarter of 2024.
Dr. Jay Lulai: Based on current enrollment trends, we anticipate reporting top line data from RSV-PEDS in the third quarter of 2024. As for RSV-HR, we will provide additional guidance as the RSV season continues. Also ongoing in our RSV portfolio is the Phase 2a challenge study of EDP323, a highly potent L-protein inhibitor in development as a once-daily oral treatment for RSV. In this randomized, double-blind, placebo-controlled study, up to 114 adult subjects will be infected with RSV and then randomized one-to-one-to-one to receive once-daily dosing of either 600 milligrams of EDP-323, 200 milligrams of 323 with a loading dose of 600 milligrams on the first day, or placebo for five days.
Dr. Jay: For RSV HR, we will provide additional guidance as the RSV season continues.
Dr. Jay: Also ongoing in RSV portfolio as the Phase Iia Challenge study of Edp 323, a highly potent L protein inhibitor and development as a once daily oral treatment for RSV.
Dr. Jay: In this randomized double blind placebo controlled study up to 114 adult subjects will be infected with RSV and then randomized one to one to one to receive once daily dosing of either 600 milligrams of Edp 303, 200 milligrams of <unk> three with a loading dose.
Dr. Jay: Of 600 milligrams on the first day or placebo for five days.
Dr. Jay Lulai: Primary and secondary outcome measures include safety, changes in viral load measurements, and changes in symptoms from baseline. We advanced EDP-323 into the challenge study based on positive Phase 1 results in which the drug demonstrated favorable safety, tolerability, and pharmacokinetics in healthy volunteers, and we are on track to report data from the challenge study in the third quarter of 2024. Now I'll turn to our work in immunology, where pipeline expansion builds on our expertise in small molecule drug discovery and virology, a scientifically adjacent area. Our team is focusing on areas where there is a strong understanding of the underlying disease pathology, allowing us to target the root cause of the disease. Moreover, we are concentrating on indications with high unmet medical need and a clear clinical development path, including well-defined populations and biomarkers available for early signs of efficacy. We believe that we are well positioned to pursue immunologic indications and are excited to advance our new program in chronic spontaneous urticaria, or CSU, which is a severely debilitating chronic inflammatory skin disease. Clinical manifestations include hives, which is also called urticaria, or angioedema, which is characterized by pronounced deep tissue swelling, or both.
Dr. Jay: Primary and secondary outcome measures include safety changes in viral load measurements and changes in symptoms from baseline.
Dr. Jay: We advanced Edp 323 into the challenge study based on positive phase one results in which the drug demonstrated favorable safety Tolerability and pharmacokinetics in healthy volunteers and we are on track to report data from the challenge study in the third quarter of 2024.
Now I will turn to our work in immunology, where our pipeline expansion builds on our expertise in small molecule drug discovery and virology.
Dr. Jay: Typically adjacent area.
Dr. Jay: Our team is focusing on areas, where there is a strong understanding of the underlying disease pathology, allowing us to target the root cause of the disease.
Dr. Jay: Moreover, we are concentrating on indications with high unmet medical need and a clear clinical development path, including well defined populations and biomarkers available for early signs of efficacy.
Dr. Jay: We believe that we are well positioned to pursue immunologic indications that are excited to advance our new program in chronic spontaneous urticaria or CSU, which is a severely debilitating chronic inflammatory skin disease.
Dr. Jay: Clinical manifestations include hives, which is also called urticaria or angioedema, which is characterized by pronounced deep tissue swelling or both.
Dr. Jay Lulai: Patients with CSU also experience symptoms beyond the skin manifestations, including sleep disturbances, fatigue, irritability, anxiety, and depression. The disease can be severely disabling, significantly impair quality of life, and affect performance at work or school. CSU is typically a self-limiting disorder persisting for two to five years, although some reports estimate that more than half of the patients suffer for more than five years. It may also recur after months or years of full remission. CSU is estimated to affect 0.5% to 1% of the global population at any given time, and there is a substantial unmet need for an efficacious oral agent. The standard of care treatment for CSU is antihistamine. However, in approximately half the patients, symptom alleviation is not adequate, and there is a substantial unmet need for an efficacious oral agent as only a minority of cases are treated with one indicated biologic.
Dr. Jay: Patients with CSU also experienced sometimes beyond the skin manifestations, including sleep disturbances fatigue, irritability anxiety and depression.
Dr. Jay: Disease can be severely disabling significantly impaired quality of life and affect performance at work or school.
CSU is typically a self limiting disorder persisting for two to five years, although some reports estimate that more than half of the patients suffer for more than five years. It may also reoccur after months or years of full remission.
Dr. Jay: CSU is estimated to affect <unk>, 5% to 1% of the global population at any given time and there is a substantial unmet need for an efficacious oral agent.
Dr. Jay: Standard of care treatment for CSU is there any histamines. However in approximately half the patients symptom alleviation is not adequate.
Dr. Jay: A substantial unmet need for an efficacious oral agent that's only a minority of cases are treated with one indicated biologic give.
Dr. Jay Lulai: Given the high unmet need for CSU patients, the opportunity in Urticaria is significant. Our goal is to develop a best-in-disease oral kit inhibitor treatment to reduce the number of mast cells, which are the primary driver of the disease. As mast cells are implicated in multiple allergic diseases, we have the potential to study our kit inhibitor and additional indications. The strategy is supported by anti-kit monoclonal antibodies demonstrating potential best-in-disease efficacy in a Phase II clinical trial in CSU. Our prototype inhibitor exhibits potent inhibition of KIT in binding and cellular functional assays and is highly selective for KIT versus other kinases. We've observed favorable in vitro and in vivo ADME properties in our prototype, including a low potential for off-target tissue penetration, a long half-life, and low drug-drug interaction potential.
Dr. Jay: Given the high unmet need for CSU patients the opportunity in urticaria is significant.
Dr. Jay: Our goal is to develop a best in disease oral kitten inhibitor treatment to reduce the number of mast cells, which are the primary driver of the disease.
Dr. Jay: As Matt cells are implicated in multiple allergic diseases, we have the potential to study our kit inhibitor and additional indications.
Dr. Jay: This strategy is supported by anti kit monoclonal antibodies demonstrating potential best in disease efficacy in a phase III clinical trial in CSU.
Dr. Jay: Our prototype inhibitor exhibits potent inhibition of kit and binding and cellular functional assays and is highly selective for kit versus other kinases.
Dr. Jay: We've observed favorable in vitro and in vivo add me properties in our prototype, including a low potential for off target tissue penetration, a long half life and low drug drug interaction potential we plan to announce a development candidate for <unk> This year.
Dr. Jay Lulai: We plan to announce a development candidate for CSU this year. We are very excited about our pipeline growth in immunology and are pursuing additional targets with plans to introduce a second immunology program this year. With that, I'd like to conclude by highlighting our upcoming milestones. We look forward to reporting results from our Phase 2a Challenge Study of EDP-323 in the third quarter of 2024. And, assuming the season continues to be a normal RSV season in the Northern Hemisphere, we anticipate reporting data from the RSV-PEDS Phase 2 study of Zelicapavir in the third quarter of 2024.
Dr. Jay: Very excited about our pipeline growth in immunology and are pursuing additional targets with plans to introduce a second immunology program. This year.
Dr. Jay: With that I'd like to conclude by highlighting our upcoming milestones.
Dr. Jay: We look forward to reporting results from our Phase Iia Challenge study of Edp 323 in the third quarter of 2024.
Dr. Jay: And assuming the season continues to be a normal RSP season in the northern Hemisphere, we anticipate reporting data from the RSV Peds phase III study of salary cap of here in the third quarter of 2024.
Dr. Jay Lulai: Further, we plan to identify a clinical candidate for our CSU program this year. And finally, we plan to announce a second immunology program in 2024. Now, I'll turn the call over to Paul to discuss our financials. Paul?
Dr. Jay: Further we plan to identify a clinical candidate for our CSU program. This year and finally, we plan to announce a second immunology program in 2024.
Dr. Jay: Now I'll turn the call over to Paul to discuss our financials Paul.
Paul Mellott: Thank you, Jay. I'd like to remind everyone that Enanta reports on the September 30th fiscal year schedule. Today, we are reporting results for our fiscal first quarter ended. 312. 313. 312. 312, order. Total revenue was $18 million and consisted of royalty revenue earned on Abbey's Global Maverick Net Product Sale.
Paul Mellett: Thank you Jay I would like to remind everyone that in annual reports on a September 30 fiscal year schedule.
Paul Mellett: Today, we are reporting results for our fiscal first quarter ended December 31 2023.
Paul Mellett: For the quarter total revenue was $18 million and consisted of royalty revenue earned on <unk> Global <unk> net product sales. This.
Paul Mellott: This compares to total revenue of $23.6 million for the same period in 2020. As a reminder, 54.5% of Enanta's ongoing royalties from Abbey's Net Sales of Maverick that are included in our revenue are being paid over to OMERS, the royalty buyer, in our April 2023 royalty sale transaction. For financial reporting purposes, the sale transaction was treated as debt, with the upfront purchase payment to us of $200 million recorded as a liability
Paul Mellett: This compares to total revenue of $23 6 million for the same period in 2022.
Paul Mellett: As a reminder, 54, 5% of <unk> ongoing royalties from Abbvie net sales of Maverick.
Paul Mellett: Are included in our revenue are being paid over to owners the royalty buyer in our April 2023 royalty sale transaction.
Paul Mellett: For financial reporting purposes, the sale transaction was treated as debt with the upfront purchase payment to us of 200 million recorded as a liability.
Paul Mellott: As such, we continue to record 100% of the royalties earned as revenue and will then amortize the debt liability proportionately as 54.5% of the cash royalty payments are paid to homeowners until a cap of 1.42 times the purchase payment, at which point 100% of the cash royalty payments will be retained by Enanta. Non-cash interest expense of the debt will be recorded in Enanta's consolidated statement of operations, based on an imputed interest Interest expense was $3.4 million for the three months.
Paul Mellett: As such we continue to record 100% of the royalties earned as revenue will then amortize the debt liability proportionately is 54, 5% of the cash royalty payments are paid to owners.
Paul Mellett: Till a cap of 142 times the purchase payment has met after which point, 100% of the cash royalty payments will be retained by <unk>.
Non cash interest expense the debt will be recorded in in <unk> consolidated statement of operations based on an imputed interest rate.
Paul Mellett: Interest expense was $3 4 million for the three months ended December 31 2023.
Paul Mellett: Moving on to our other expenses for the three months ended December 31, 2023 research and development expenses totaled $36 4 million compared to $40 9 million for the same period in 2022.
Paul Mellott: December 31, 2020. Moving on to our other. The three months ended December 31, 2020, research and development expenses totaled $36.4 million, compared to $40.9 million for the same period.
Paul Mellett: The decrease was primarily due to a decrease in costs associated with our COVID-19 program.
Paul Mellett: As we previously announced that our plans to pursue any future COVID-19 efforts would be in the context of our collaboration.
Paul Mellett: General and administrative expense for the quarter was $16 5 million compared to $12 7 million for the same period in 2022.
Paul Mellott: The decrease was primarily due to a decrease in costs associated with our COVID-19 program, as we previously announced that our plans to pursue any future COVID-19 efforts would be in the context of a collaboration. General and administrative expense for the quarter was $16.5 million, compared to $12.7 million for the same period in 2022.
Paul Mellett: This increase was primarily due to an increase in stock compensation expense and an increase in legal expenses related to the Companys patent infringement suit against Pfizer.
Paul Mellett: Other income net totaled <unk> 9 million.
Paul Mellett: <unk> recorded an income tax benefit of <unk> 6 million for the three months ended December 31, 2023 for interest earned on a pending $28 million federal income tax refund.
Paul Mellott: This increase was primarily due to an increase in stock compensation and an increase in legal expenses related to the company's patent infringement suit against Pfizer. Other income net totaled $0.9 million. Enanta recorded an income tax benefit of $0.6 million for the three months ended December 31, 2023 for interest earned on a pending $28 million federal income tax refund, compared to an income tax benefit of less than $0.1 million for the three months into December 31, 2022. Net loss for the three months ended December 31, 2023 was $33.4 million, or a loss of $1.58 per diluted common share, compared to a net loss of $29 Enanta ended the quarter with approximately $337 million in cash and marketable security.
Paul Mellett: Compared to an income tax benefit of less than <unk> 1 million for the three months ended December 31 2022.
Paul Mellett: Net loss for the three months ended December 31, 2023 was $33 4 million or a loss of $1 58 per diluted common share compared to a net loss of $29 million or a loss of $1 39 per diluted common share for the corresponding period in 2022.
Paul Mellett: <unk> ended the quarter with approximately $337 million in cash and marketable securities.
Paul Mellett: We expect that our current cash cash equivalents and short term marketable securities as well as our ongoing retained portion of royalties will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs through fiscal 2027.
Paul Mellett: Further financial details are included in our press release and will be available in our report on Form 10-Q, one filed.
Speaker Change: I would now like to turn the call back to the operator and open up the lines for questions operator.
Speaker Change: 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.
Paul Mellott: We expect that our current cash, cash equivalents, and short-term marketable securities, as well as our ongoing retained portion of royalty..., will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs through fiscal 2027. Further financial details are included in our press release and will be available in our report on Form 10-Q-1 file. I'd now like to turn the call back to the operator and open up the lines for questions, operator. And thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Okay.
Speaker Change: And one moment by first question and our first question comes from Roy Buchanan from JMP. Your line is now open.
Hey, Thanks for taking the questions I just had a few on valley cap are there.
First one on the RSVP readout, presumably and <unk> I guess.
Brian Skorney: Although the negative scenario, where you don't see any virological effects.
Brian Skorney: Is it conceivable that you just wind down the program stop RSV HR or would you still see.
Brian Skorney: Chr readout.
Brian Skorney: And then in that same scenario and I think the challenge trial for <unk> three is highly positive.
Operator: Please stand by while we compile the Q&A roster. And one moment for our first question, and our first question comes from Roy Buchanan from JMP. Your line is now open. Hey, thanks for taking the questions. I just had a few on Zeli Kapovir.
Brian Skorney: Potentially look to immediately combine the two.
Brian Skorney: Agents and I had a follow up thanks.
Speaker Change: Thanks Ray.
Speaker Change: So.
Starting with the challenge study.
Speaker Change: 323.
Brian Skorney: First one on the RSVP readout, presumably in 3Q, I guess, you know, under the negative scenario where you don't see any virological effect. Is it conceivable that you just wind down the program, stop RSVHR, or would you still see the RSVHR readout? And then, in that same scenario, and if the challenge trial for 323 is highly positive, would you potentially look to immediately combine the two agents? Thanks, Roy. This is Jay.
Speaker Change: We're also on track.
Speaker Change: For Q3.
Speaker Change: It's a very potent <unk> inhibitors as you know I know.
Speaker Change: But what about the.
Data.
Speaker Change: Yes.
Speaker Change: The potency given the PK given the huge multiples we drive.
Over the protein adjusted <unk> 90.
Speaker Change: We're we're very hopeful that it should show.
Speaker Change: Efficacy.
Speaker Change: Comparable to sell a cathode here the question of getting into combination studies.
Speaker Change: Right away.
Dr. Jay Lulai: So starting with the challenge study, 323 is also on track for Q3. It's a very potent L inhibitor, as you know, I know, you know, a lot about the data. And given the potency, given the PK, given the huge multiples we drive over the protein-adjusted EC90, we're very hopeful that it should show efficacy comparable to Zelicafavir. The question of getting into combination studies right away is an interesting one, but I think we'll probably be most interested in fully characterizing Single Agent Efficacy for both Delicapivir and 3, 2, 3 in the real world and then contemplating combinations, of course, in parallel.
Speaker Change: It's an interesting one but I think we will probably.
Speaker Change: The most interested in.
Speaker Change: Fully characterizing.
Speaker Change: Single agent efficacy for both Delhi cap, a year and 323.
Speaker Change: And real World and then contemplate combinations of course in parallel.
Speaker Change: You could be scouting out some of the combinations and challenge study.
Speaker Change: First shadowing that but I think we wouldn't want to slow down.
Speaker Change: Single agent characterization.
Speaker Change: <unk>.
Speaker Change: Of three to three.
Speaker Change: The Peds study again.
Speaker Change: We are.
Speaker Change: We're on track for Q3.
Speaker Change: You are asking an interesting question.
Speaker Change: It doesn't show anything what would you do with HR and a different patient population.
Speaker Change: I think you've got to look at.
Dr. Jay Lulai: You could be scouting out some of the combinations and challenge studies, you know, foreshadowing that, but I think we wouldn't want to slow down single-agent characterization of 323 The PEADS study, again, was, We're on track for Q3. You know, you're asking an interesting question. If PEDS didn't show anything, what would you do with HR?
Speaker Change: Facts and circumstances around any clinical trial result in one patient population done under one set of conditions and then make.
Speaker Change: Good judgments as to how it might or might not relate to a different clinical trial in a different patient population under a different set of circumstances. So.
Just need to look at data.
Dr. Jay Lulai: You know, different patient populations; I think you've got to look at the facts and circumstances around any clinical trial result in one patient population done under one set of conditions and then, you know, make good judgments as to how it might or might not relate to a different clinical trial on a different patient population under a different set of circumstances. So we just need to look at data. So that's my thought on that. Okay, great. Presumably, HR is not too far behind.
That's my thought on that.
Speaker Change: Okay, great, presumably HR is not too far behind.
Speaker Change: And then just a follow up I wonder if the only catheter here.
You can put a dollar value on the two markets that peds and the HR just in your view what do you think is a rough dollar value. Thank you.
Speaker Change: Well there are no established therapeutics in this market. So I think there's a great.
Speaker Change: Opportunity to build.
Speaker Change: The first opportunity for an RSV treat.
Dr. Jay Lulai: Just a follow-up question, I wondered for Zelikapivir if you could put a dollar value on the two markets, the PEDS and the HR. Just in your view, what do you think is a rough dollar value? Thank you. Um, well, you know, there are no established therapeutics in this market, so I think there's a great opportunity to build the first opportunity for an RSV treatment ever in each of those patient populations and yet other high-risk patient populations. I'm not going to, you know, be able to give you an exact dollar amount, but it's a billion dollars. It's got to be a billion-dollar market opportunity. It has a billion on it, let's just say that.
Speaker Change: Treatment ever in each of those.
Patient populations and yet other high risk pay.
Speaker Change: Patient population.
Speaker Change: I'm not going to be.
Speaker Change: Are you able to give you a.
And the exact dollar amount, but it's really it's got to be a $1 billion.
Speaker Change: Our market opportunity has $1 billion on it let's just say that.
Speaker Change: Directionally is probably the bigger piece of that although.
Speaker Change: I think.
Speaker Change: There is more data and information on RSV impedes than there is in adults and so.
Speaker Change: We're also not going to underestimate what the adult market.
Speaker Change: Could ultimately look like clearly there's been a lot of.
Speaker Change: Interest in that space.
Operator: And PEDS is probably the bigger piece of that. Although, I think, you know, there's more data and information on RSV in PEDS than there is in adults. And so, we're also not going to underestimate what that adult market could ultimately look like. Clearly, there's been a lot of interest in that space in promoting vaccine opportunities for the elderly. And they're doing quite well, you know, in prophylaxis, even though only a small portion of the eligible patient population is getting vaccinated and everybody else, which is the overwhelming majority of people, isn't getting vaccinated and would still be susceptible to infections. And even some of the vaccinated people, you know, could be getting breakthrough infections. So give us more time to see how that market evolves a little bit, and work up the final bits on a potential product profile.
Speaker Change: And promoting vaccine opportunities for elderly.
Speaker Change: And.
Speaker Change: And they're doing quite well in prophylaxis, even though only a small part.
Speaker Change: <unk> of the eligible patient population is getting.
Speaker Change: Vaccinated and everybody else, which is the overwhelming majority of people arent getting vaccinated.
Speaker Change: And would still be susceptible to infections and even some of the vaccinated people could be getting breakthrough infections. So.
Speaker Change: Give us more time to.
Speaker Change: Two.
See how that market evolves to a little bit the word Cup final.
Speaker Change: On a potential product profile.
Speaker Change: Where we are.
Speaker Change: We're encouraged by.
Speaker Change: And our position.
Speaker Change: <unk> in the field.
Operator: But we're very encouraged by our position in the field, the, you know, sort of leadership position we have in our portfolio and also the fact that there are no approved drugs on the market, and a huge unmet need. So it's a good opportunity. Okay, thank you. You're welcome. And thank you. And one moment for our next question, and our next question comes from Rowana Ruiz from Lyric. Your line is now open.
Speaker Change: The.
Speaker Change: Sort of the leadership position, we have an RFC portfolio.
Speaker Change: And also the fact that there are no approved drugs on the market huge unmet need.
Speaker Change: That's a good opportunity.
Speaker Change: Okay. Thank you.
Speaker Change: Youre welcome.
Yes.
Speaker Change: And thank you.
Speaker Change: One moment for our next question.
Marianna Ruiz: And our next question comes from marijuana Ruiz from Leerink. Your line is now open.
Rowana Ruiz: Great afternoon, everyone. So a question about your CSU program. So could you walk us through some of the elements that excited you about this indication over other similar immunology indications? And I was curious, what additional optimization might you try to be working on to get to a final candidate that could be deemed the best in disease? And I have a follow-up after that. Okay, well, I'll handle part of that question, and then I'll let Tara Keefer, Head of Product Strategy, talk about the other part. So with regard to, you know, the optimization, I think we showed some data at J.P. Morgan on a prototype molecule, which we think is far along in terms of our optimization profile. We're still making lots and lots of molecules, continuing to tweak bits and pieces.
Marijuana Ruiz: Great afternoon, everyone. So a question on your CSU program. So could you walk us through some of the elements that excited you about this indication over other similar immunology indications and I was curious what additional optimization might you try to be working on to get to a final candidate.
Marijuana Ruiz: That could be deemed like best in disease, and I have a follow up after that.
Marijuana Ruiz: Okay.
Marijuana Ruiz: Well.
Speaker Change: I'll handle part of that question and then ill, let Tara keefer.
Tara Keefer: That's a product strategy can you talk about.
Tara Keefer: So with regards to the optimization I think.
Tara Keefer: We showed some data at Jpmorgan on a prototype molecule, which we think is.
Tara Keefer: <unk>.
Tara Keefer: Far along in terms of our optimization profile.
Speaker Change: We're still making.
Speaker Change: Lots and lots of molecules continuing to tweak bits and pieces, but.
Dr. Jay Lulai: But obviously, among the things we're looking at is just really honing down potency, selectivity, making sure we've got good safety, and of course, our old friend pharmacokinetics, and hopefully once daily dosing. All of those kinds of things that we like to build into every one of our molecules. CSU is attractive.
Speaker Change: Obviously, among the things we're looking at is just really honing down.
Speaker Change: Let's see.
Speaker Change: Seal activity, making sure we've got good safety.
Speaker Change: And.
Speaker Change: And of course, our old trend pharmacokinetics, and hopefully once daily dosing.
Speaker Change: All of those kinds of things that wed like to built into every one of our molecules.
Speaker Change: CSU is attractive.
Dr. Jay Lulai: And maybe I'm already answering some questions, but we're not certainly limiting ourselves to that. I think it happened to be the first program that we announced in the area, but we're working on, you know, a few other things. We're piloting other programs, and getting involved. So you can expect that there will be a broader footprint, certainly, as our slide deck anticipates in the field. And we go about it in the way that we've done in a lot of our, well, pretty much all of our programs. We get the biology figured out and sorted. Really important to do that and try to figure out chemical matter that we can get into.
Speaker Change: And maybe I'm already answering some questions but.
Speaker Change: We're not certainly limiting ourselves.
Speaker Change: To that I think it happened to be the first program.
Speaker Change: That we've announced in the area.
Speaker Change: But we're working on.
Speaker Change: A few other things we're piloting other programs.
It involves.
Speaker Change: So you can you can expect that there will be a broader footprint certainly is our slide deck.
Speaker Change: <unk>.
Speaker Change: In the field and we go about it in the way that we've done.
And a lot of our well in pretty much all of our programs we get the biology.
Speaker Change: Figured out and sort of really important to do that try to figure out chemical matter that we can get into.
Dr. Jay Lulai: Make sure we've got strong commercial rationale in terms of the competitive landscape, potential product profiles, set all that stuff, start making molecules, get on the board, start filing intellectual property. And we tend to do all of that before we really announce the program. So suffice it to say that work is ongoing in other areas, and as the year rolls out, we'll come out with more. Does that answer your question?
Speaker Change: Make sure we've got strong commercial rationale in terms of competitive landscape potential product profile, we said all of that stuff start making molecules get on the boards.
Speaker Change: Finally in intellectual property and we tend to do all of that before we really announced the program. So suffice it to say that's ongoing in other areas.
As the year rolls out we'll come out with more.
To answer your question.
Dr. Jay Lulai: Yep, that helps. And I have a follow-up question on RSVP as well. So given the top line, what do you hope to see in terms of efficacy and safety results? And how might you use that data to inform a go or no-go decision for advancing to registrational trials? Maybe if I didn't give Cara the chance for the last question, I'll let her take this one. Sorry.
Speaker Change: Yes that helps.
Speaker Change: And I have a follow up on RSVP adds as well so given the topline coming.
Speaker Change: Do you have to see in terms of efficacy and safety results and how might you use that data to inform a go or no go decision for ethane to Registrational trials.
Speaker Change: Yes, maybe since I didn't give tara.
Speaker Change: So.
Speaker Change: And I'll, let her take this one sure.
Dr. Tara Keefer: So, Rowan, as you know, the RSVP study, first in piece, so doing some dose ranging and then looking at that optimal dose for virology as the primary endpoint in the second part of the study. We'll certainly look at other endpoints, clinical endpoints like symptoms, but, you know, with the size of the study, we'll primarily be looking at virology endpoints. And really, what we're hoping to see is some directional data and numerical trends in the virology endpoints that give us the confidence to, you know, take the program forward into a larger, more robust phase three program as we move forward. So that's really what we're looking to achieve in this kind of initial team study. I got it.
Speaker Change: Sure Yes.
Tara Keefer: Alright, so Brian as you know the RSVP study.
Tara Keefer: First in T cell doing some dose ranging and then looking at that optimal dose.
Tara Keefer: <unk>.
Speaker Change: And the second part of the study we will certainly look at other endpoints clinical endpoints like symptom.
Speaker Change: But with the size of the study.
Speaker Change: We will primarily be looking at virology endpoint and really what we're hoping to see some directional data numerical trend in <unk> endpoints that give us the confidence to take the program forward into a larger more robust phase III program.
Speaker Change: As we move forward so that's.
Speaker Change: Really what we're looking to achieve.
Speaker Change: Initial study.
Dr. Tara Keefer: Thanks, and thank you. And one moment for our next question. And our next question comes from Akash Tiwari from Jeffreys. Your line is now open. Hi, this is Stevie on behalf of Akash.
Speaker Change: Got it thanks.
Speaker Change: And thank you.
And one moment our next question.
Costa Worry: And our next question comes from a cost to worry from Jefferies. Your line is now open.
Costa Worry: Hi, This is Steven on for our costs. Thank you for taking our question.
Akash Tiwari: Thank you for taking your question. It doesn't seem like the Phase 2b RSVP study is powered to hit on symptoms or viral load reduction. So what would be a strong enough signal for you to move it into Phase 3?
Steven: It doesn't seem like the TB RSVP study is powered to hit on symptoms their viral load reduction so what would be a strong enough signal for you to move into phase III and then Additionally, how are you thinking about the oral from dusted your failure for Gilead does that change strategic value for your approach <unk> inhibitor at all thank you.
Dr. Tara Keefer: And then additionally, how are you thinking about the oral remdesivir failure for Gilead? Does that change the strategic value for your protease inhibitor at all? Thank you. Yeah, I can build on that for the RSVP piece. You know, we will again primarily be looking at virology, and I think, you know, there's not a lot of benchmarks in this area that we could point to or compare to. There is one data set out of a company called ArcBio where, in a phase three trial, they showed about a 0.6 log drop, and that did translate into an improvement, a statistically significant improvement in symptoms.
Speaker Change: Do you want to just tell them I can build on for the RSVP piece, yes.
Speaker Change: Yes, we will again, primarily be looking at biology, and I think.
Speaker Change: <unk>.
Speaker Change: Theres not a lot of benchmarks in this area that we could point to or compared to you.
Speaker Change: There is one dataset out of a company called arc bio Ware and phase III trials.
Speaker Change: So at about 1.6 log drop.
Speaker Change: And that then translate into an improvement statistically significant improvement.
Dr. Jay Lulai: So that is one sort of benchmark that we have, but again, you know, numerical trends and directional data showing that Zoletapivir is showing an improved trend in virology compared to placebo would give us the confidence to move forward into a phase three study. Again, we'll look at symptoms, and as you said, it is a small study, and the likelihood of seeing something on that certainly in a statistically significant way is probably not as high, but we'll look at that and see what we get. And the second part, I guess, relates to oral remdesivir for COVID. I mean, I guess our initial reaction was we, like everybody else, just got that news late yesterday afternoon. I think it simplifies the COVID landscape, which is one of the things that I think everybody who's involved in COVID, including us, who's interested in COVID, whether it's strategics or the government, they're trying to figure out what the competitive landscape is or what the arsenal of drugs is going to be available for COVID patients. And it seems like there's, you know, one fewer now. So that's that's going to help clarify things, I guess. You know, Shinogi is another one that's due to turn over a card pretty soon here.
Speaker Change: Yes.
Speaker Change: So that is the one sort of benchmark that we have but again numerical trends and directional data.
Speaker Change: Knowing that the only type.
Speaker Change: Type of areas.
Speaker Change: Showing an improved trend in urology compared to placebo would get us a comprehensive move forward into a phase III study.
Speaker Change: Then we will look at symptoms and as you said.
Speaker Change: It is a small study in.
Speaker Change: The likelihood of seeing something on that certainly in statistically significant way.
Speaker Change: It's probably not as.
Speaker Change: But we'll look at that and see what we get.
Speaker Change: And the second part I guess.
Speaker Change: Waits too.
Speaker Change: <unk> does severe.
Speaker Change: For Covid.
Speaker Change: I mean, I guess our initial reaction.
Speaker Change: Like everybody else just.
Speaker Change: Got that news.
Speaker Change: Yesterday afternoon.
Speaker Change: I think it simplifies the COVID-19 landscape, which is one of the things that I think.
Speaker Change: Everybody who's involved in Covid, including us.
Speaker Change: Everybody, who is interested in COVID-19, whether it's strategic for the government.
Speaker Change: Trying to figure out what the competitive landscape is or what the arsenal of drugs is going to be available for COVID-19 patients and it seems like there is.
Speaker Change: One fewer now so thats.
Speaker Change: That's going to help clarify things I guess.
Speaker Change: Shionogi is another one that's due to turnover a card.
Speaker Change: Pretty soon here.
Dr. Jay Lulai: I guess there's a question about what Pfizer is doing with their follow-on molecule. We haven't, we haven't seen that they've advanced it. But so a question mark there that will hopefully get sorted here in the nearer term. And then we'll have a more complete. I'd like to start with a brief overview of what that competitive landscape looks like, which is, again, important for anybody who would be making funding decisions going forward. Our plan, as we've stated a few times before, is to only pursue 235 in the context of a collaboration. Okay, understood. Thank you so much.
Speaker Change: I guess first question about what's Pfizer doing with their follow on molecule. We haven't we haven't seen that they've advanced it.
Speaker Change: So a question Mark there that will hopefully get sorted here in the nearer term.
Speaker Change: Ken.
Ken: Well have a more complete.
Ken: View of what that competitive landscape looks like which is again important for anybody who would be making funding decisions going forward. Our plan is.
Ken: We've stated a few times before.
Ken: As to.
Ken: The only pursue three five in the context of a collaboration.
Speaker Change: Okay understood. Thank you so much that was very helpful.
Dr. Jay Lulai: That was very helpful. You're welcome. Eh, thank you.
Speaker Change: Youre welcome.
Speaker Change: Thank you.
Operator: And one moment for our next question. And our next question comes from Eric Joseph from J.P. Morgan. Your line is now open. Oh, thanks. Eric, I'm sorry, you're sounding a little low there. I'm sorry, can you hear me now?
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from Eric Joseph from Jpmorgan. Your line is now open.
Eric William Joseph: Thanks, just a quick.
Eric William Joseph: Eric I'm, sorry, you're sounding a little low there.
Eric William Joseph: I'm sorry can you hear me now.
Eric William Joseph: Yes, sir. Okay, thanks for taking the question. Just your 3Q guidance for reading out the RSVP, does that anticipate full accrual of your target of 90 patients? If you sort of end up tracking under that goal after this season, do you go ahead with the readout, or do you perhaps sort of push out timelines a bit?
Eric William Joseph: Yes, Sir.
Eric William Joseph: Okay.
Speaker Change: Thanks for taking the question just your <unk> guidance for reading RSVP does that anticipate full accrual.
Speaker Change: Your target of 90 patients.
Speaker Change: If you can sort of end up tracking under that goal. After this season. You go ahead with the readout or do you, perhaps sort of push out timelines a bit.
Dr. Jay Lulai: I think we're still targeting to, you know, at least hit the target enrollment. That's the plan. That's plan A.
Speaker Change: No I think we're still targeting to at least hit the target enrollment.
Speaker Change: The plan that's plan a.
Dr. Jay Lulai: And to report report data on the full set in Q3. Okay, great. And I'm sorry if I missed it earlier, but can you just comment a little bit on just how accrual is taking place with RSV high risk and sort of how much further behind it might be from Full of Cruel or how much further behind basically our readout from that study is tracking relative to RSVP. Thank you. Yeah, so, quarter after quarter, I've been asked, you know, which study do you think is going to come out? And I could never answer the question.
Speaker Change: Their report.
Speaker Change: Report data on the full set in Q3.
Speaker Change: Okay, great and I'm, sorry, if I missed it earlier, but can you just comment a little bit on <unk>.
Speaker Change: Just how accrual is.
Speaker Change: Taking place with our.
Speaker Change: RSV high risk and sort of how much further behind it might be.
Speaker Change: From a full accrual or how much how much further behind basically a readout from that study is tracking relative to RSVP. Thank you.
Speaker Change: Yes so.
Quarter after quarter.
Speaker Change: When asked which which study do you think is going to read out.
Speaker Change: I could never answered the question.
Dr. Jay Lulai: Because, you know, especially when we targeted a goal of Q3 for data. But, you know, as a, I think at the JPMorgan conference, as we get a little further into this season, we'll have a better sense of it and should be able to make a call. And, you know, clearly today we're making that call. It looks like Pete is.., is the one that will.
Speaker Change: Especially when we target a nickel of Q3 for data.
Speaker Change: But.
Speaker Change: Yes.
Speaker Change: So I think at the JP Morgan conference as we get a little further in the seasonal or better.
A better sense of it it should be able to make a call and clearly today, we're making that call. It looks like piece is.
Speaker Change: As is.
Speaker Change: Is the one that will.
Dr. Jay Lulai: In terms of the HR, you know, how far behind is it? I think we just have to, you know, continue the recruitment for that. Obviously, I think we're going to need to go to the Southern Hemisphere and continue on beyond the Northern Hemisphere season.
Speaker Change: In terms of the HR.
Speaker Change: How far behind Us that I think we just got to continue.
Speaker Change: Continue the recruitment and that obviously I think we're going to need to go to the southern hemisphere.
Speaker Change: Continue on beyond the northern hemisphere season.
Dr. Jay Lulai: And we'll just give updates as we go once we have a, you know, good, more crisp target guidance to provide if we will. But we did see a, And to remind you, it's a, you know, it's a larger study than peds, right? So it's roughly twice the size, and it started later than peds, but we did see a nice uptick in this Northern Hemisphere season.
Speaker Change: We'll just give updates.
Speaker Change: As we go once we have a.
Speaker Change: Good.
Speaker Change: Chris target guidance to provide it we will.
Speaker Change: But we did see.
Speaker Change: And to remind you of.
Speaker Change: It's a larger studies.
Speaker Change: Then peds right. So it's roughly twice the size.
Speaker Change: And it started later than peds.
Speaker Change: We but we did see a nice uptick in the northern hemisphere.
Season.
Dr. Jay Lulai: It was really gratifying to see that. So we've got over 100 sites now; we're in over 15 countries. You know, we've got a pretty big catcher's mitt on now, and it's, you know, it's just all about execution and hoping, you know, that the trends towards normalcy, you know, continue. But that's been, again, something that we've seen this COVID season, in terms of when it started and the shape of the season and everything else. This is the first season we've seen like this in years.
Speaker Change: That was really gratifying to see that so we've got over 100 sites now are an over <unk>.
Speaker Change: 15 countries.
Speaker Change: We've got a pretty big catchers met on now.
Speaker Change: And then.
Speaker Change: It's just all about execution.
Speaker Change: And hoping.
Speaker Change: The trends towards normalcy.
Speaker Change: Continue but.
Speaker Change: Thats been again something.
Speaker Change: You've seen this COVID-19 season in terms of when it started in the shape of the season and everything else.
Speaker Change: This is the first season, we've seen in years.
Dr. Jay Lulai: Okay, great. That's helpful. Maybe one follow-up question, if you have clear evidence of, what seems to be clear evidence of, Reducing viral load in RSVPs, can you talk a little bit about steps to running an efficacy study in the pediatric population?
Okay, Great. That's helpful. Maybe one follow up if I could.
Speaker Change: If you have a clear what needs to be clear evidence of.
Speaker Change: Reducing viral load in RSVP.
Speaker Change: Can you talk a little bit about gating steps running an efficacy study in the pediatric population is that dependent on results from RSV high risk. Thank you.
Dr. Jay Lulai: Is that dependent on results from RSV-Pyris? No, I mean, I can let Scott comment on that, but, you know, they're just very different patient populations, Scott. Sorry, Scott Ridinghouse.
Speaker Change: No I mean, I can let Scott comment on that.
Speaker Change: They're just very different patient populations.
Speaker Change: Yes, sorry, Scott Rottinghaus, it's different patient populations, and we would feel comfortable moving forward in pediatrics with positive results from our pediatric study.
Dr. Scott Roddinghouse: It's different patient populations, and we'd feel comfortable moving forward in pediatrics with positive results from our pediatric study. Okay, great. Thanks for taking the questions. You're welcome, and thank you. And one moment for our next question. And our next question is from Jay Olson, of SMAOPCO. Your line is now open. Hi, this is John on the line for Jay.
Speaker Change: Okay, great. Thanks for taking the questions.
Speaker Change: Youre welcome.
Speaker Change: And thank you.
Speaker Change: And one moment our next question and our next question is Jay Olson from Opco. Your line is now open.
Speaker Change: Hi, This is John align for Jade Thanks for taking the question and congrats on progress.
Jay Olson: Thanks for taking the question and congratulations on the progress. There will be two questions from us. First, on the RSV program. Just for a moment, if you decide to move the program into a pivotal study, I'm just wondering how you think about the adoption of the RZ vaccine in your target patient population and whether you would maybe exclude patients who recently took this vaccine? Or would there be some other reason?
John: Let me two questions from US first on the RSV program.
John: Just for debt to cap, if you decided to move the program into a pivotal study.
John: Just wondering how are you thinking about the adoption of <unk> vaccine anywhere.
John: Targeted patient population.
John: Would you maybe excludes patients who recently took less vaccine where there are some other.
Dr. Scott Roddinghouse: thoughts around that for the moment. And I have another question for the CSU program. Scott, do you want to take the other seat?
John: Thoughts around that.
John: For the moment.
Speaker Change: Another question for them.
Speaker Change: To your program.
Dr. Scott Roddinghouse: Yeah, for sure. So from a vaccine perspective, obviously, the coverage of vaccines is going to be far from 100%, and they're not 100% effective. So, you know, we still see the market and the clinical opportunity persisting there, so that's the first important point. And then, in terms of a putative phase three study in pediatrics, We envision including patients broadly, including patients who break through on vaccine or nurse sebum ab, so we again envision broad studying patients in pediatrics. You had it.
Scott you want to take the RSC, yes for sure.
Speaker Change: So from a vaccine perspective.
Speaker Change: Obviously, the coverage of vaccines is going to be far from 100% and theyre not 100% efficacious. So we still see the market in the clinical opportunity persist in there. So that's the first important point and then in terms of a putative phase III study in.
Speaker Change: Tricks.
Speaker Change: We envision including patients broadly.
Speaker Change: Including patients who breakthrough on vaccine or <unk>, So we again envision.
Speaker Change: Broadly studying patients in pediatrics.
Dr. Tara Keefer: That's helpful. And with the CSU program, I'm just wondering your thoughts on how you would position the oral kit inhibitor in the QDM treatment landscape for CSU. And that's like recent BDK inhibitors that are positively, So just wondering if you think that's kind of a good benchmark for efficacy you are shooting for. Thanks. Hi, this is Tara.
Speaker Change: Okay that does help.
Speaker Change: So and.
Speaker Change: For the <unk> program I'm just wondering.
Speaker Change: Sure.
Speaker Change: How would you consider in the oral kit inhibitor in GBM.
Speaker Change: <unk> landscape for PSU.
Speaker Change: That's like recent PTK inhibitor read out positively.
Speaker Change: So just wondering if you think that's kind of a good benchmark for efficacy you are shooting for.
Speaker Change: Yeah.
Terrorism: Hi, This is terrorism, yes, thanks for the question.
Dr. Tara Keefer: Yeah, thanks for the question. I guess the way we look at the CSU landscape is by looking broadly at all the different mechanisms. If you think about the standard of care being antihistamines, and only 50% of the patients really being controlled on that, very few of those go on to get the only indicated biologic, which is Zolaire. The data coming through from the BTK inhibitors, which are an oral option in development, you know, those studies did read out positive. I would kind of put their efficacy to be somewhat similar to Zolaire in that camp.
Terrorism: I guess the way we look at the CSU landscape is.
Terrorism: Broadly at all the different mechanisms. If you think about the standard of care being anti Histamines and only 50% of the patients really being controlled on that.
Terrorism: A few of those go on to get the only indicated biologic, which is the layer.
Terrorism: The the data coming through from that.
Terrorism: <unk> inhibitors, which are an oral option in development.
Terrorism: Those studies did readout positive I would kind of.
Put their efficacy to be somewhat similar to <unk> in that camp.
Dr. Tara Keefer: What we're excited about from a kit inhibitor perspective is the data that was generated through an antibody program in phase two, where they saw some of the best efficacy in this disease so far. And that's really the benchmark we're looking towards and hoping to replicate that data with an oral option. So that's sort of how we're seeing this evolve.
Terrorism: We're excited about from a kit inhibitor perspective is the data that was generated.
Terrorism: Through an antibody program in phase two where they.
Terrorism: They have seen some of the best efficacy in this disease so far.
Terrorism: And Thats really the benchmark, we're looking towards and helping to replicate that data with an oral option.
Terrorism: So that's sort of how we're seeing this evolve.
Dr. Tara Keefer: You know, obviously, we'll continue to watch as the data comes out, hoping to provide additional efficacy over and above what a BTK inhibitor might provide. Yeah, that's maybe a quick follow-up on the last part. I think there are some side effects for the antibody approach, maybe including the hair color change or some change in blood cells.
Terrorism: Obviously, we will continue to watch as the data comes out and helping to provide additional efficacy over and above what a PTK inhibitor might might provide.
Speaker Change: Yeah, maybe a quick follow up on the last part I think there are some like the side effects for antibody approach may be including the <unk>.
Speaker Change: Colored sense, where it's kind of a change in blood cells. So do you think the Oro kit inhibitor may have some bankers with safety as well.
Dr. Tara Keefer: So do you think the oral kit inhibitor may have some advantage in safety as well? Yeah, so there are certainly known side effects, on-target side effects for kit inhibitors. Overall, the antibody has had a good safety profile. Most of the AEs were mild or moderate, and they resolved. The ones that are known on target that you mentioned in terms of neutropenia, there were generally mild hematologic impacts, and the neutropenia sort of stabilized after a short time period of a week or two of dosing.
Yes. So there are certainly known side effects on target side effects for kit inhibitors. Overall, the antibody has had a good safety profile most of the aes were mild or moderate to be resolved.
Speaker Change: The ones that are unknown on target that you mentioned in terms of neutropenia.
Speaker Change: They were generally mild hematologic impact and the new Japan has sort of stabilized.
Speaker Change: After a short time period of a week or two of dosing and so what we did find out it didn't get worse with longer dosing and so it seems quite manageable at least at the levels that they are observing so.
Dr. Tara Keefer: And so, you know, what we did find out is that it didn't get worse with longer dosing, and so it seems quite manageable, at least at the levels that they're observing so far in the clinic. It was not associated with infections, at least in the trials with SPARSO, and so we're obviously keeping an eye on it, but we don't think that will be a limitation. Okay, I got it. Thank you so much, and thank you. And one moment for our next question, and our next question comes from Brian Skorney from Baird. Your line is now open. Hey guys, thanks for taking the question. This is Charlie on for Brian.
Speaker Change: So far in the clinic.
Speaker Change: They were not associated with infection.
Speaker Change: At least in the trials with bar, though and so we're obviously keeping an eye on it but we don't think that will be a limitation.
Speaker Change: Okay got it thank you so much.
Speaker Change: Okay.
Speaker Change: And thank you.
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from Brian <unk> from Baird. Your line is now open.
Speaker Change: Hey, guys. Thanks for taking the question. This is Charlie on for Brian Just a couple quick ones here. We were wondering if you could give us some more color on how severe symptoms are and how long RSV tends to last.
Brian Skorney: Just a couple quick ones here. We were wondering if you could give us some more details on how severe symptoms are and how long RSV tends to last. And we're thinking about pediatric and high-risk patients relative both to each other and to low-risk adults, such as those that were enrolled in the RSVP trial. And then secondly, just, you know, you spoke about antibodies and CSU. Just wondering, is this a main focus for you guys in terms of designing the specificity of your lead candidates, and do you consider that a bar for you to reach, and how else are you thinking about that?
Charlie: Thinking about pediatric in high risk patients relative to each other and to low risk adults.
Charlie: Such as those that were enrolled in the RSVP trial, and then secondly, just.
Charlie: You spoke to antibodies in CSU just wondering is this.
Speaker Change: Our main focus for you guys in terms of how you're designing the specificity of your lead candidates and you consider that a bar for you to reach and how else are you thinking about that thank you.
Dr. Scott Roddinghouse: Thank you. So I'll jump in on the RSV question. You know, the kids that we've been enrolling are typical kids, often with their first episode of RSV infection, and they have symptoms typically pushing two weeks, longer than you'd expect to see in young healthy adults given their immune naivety.
Speaker Change: So I'll jump in on the RSV question.
Speaker Change: Sure.
Speaker Change: The kids that we have been enrolling our typical kids often with their first episode of RSV infection and they they have symptoms typically pushing two weeks longer than you would expect to see in and young healthy adults given there.
Speaker Change: Immune idea of it so that's kind of the length of symptoms 10 to 14 days and again.
Dr. Scott Roddinghouse: So that's kind of the length of symptoms, 10 to 14 days. And again, severity varies in our study, you know, the sorts of symptoms that can often get you hospitalized, so fairly severe. And in adults.
Speaker Change: Severity varies in our study.
Speaker Change: The sorts of symptoms that can often get you hospitalized so fairly severe.
Dr. Scott Roddinghouse: Again, the high-risk adults that we're enrolling in our study, patients with COPD, CHF, again, have a more severe symptomatic profile, again, a couple of weeks in most cases, so that's, I think the general severity and length of that disease, if that helps. And I'm sorry, could you repeat your question on CSU? Yeah, and that's very helpful. Thank you for RSV. But for CSU, we were just wondering how you're thinking about designing the specificity and thinking about the antibody that you mentioned earlier. Is that kind of your goal in terms of the specificity of your molecules?
Speaker Change: <unk>.
Speaker Change: With adults again, the high risk adults that were enrolling in our in our study patients with COPD CHF again have a a more severe symptomatic profile again.
Speaker Change: A couple of weeks in most cases, so thats I think as the general severity and length of that disease.
Speaker Change: If that helps.
And I'm, sorry could you repeat your question.
Speaker Change: CSU.
Speaker Change: Yeah.
Speaker Change: That's very helpful. Thank you on RSV, but for CSU. We're just wondering how youre thinking about designing the specificity and thinking about the antibody that you mentioned earlier is that kind of your goal in terms of the specificity of your molecules.
Dr. Tara Keefer: Yeah, so the goal of the program is to have something that's potent against kit. And so we've looked at that preclinically in both binding and cellular function assays, and we see nanomolar activity there, and then it's highly selective against kit versus other kinases. We shared some preliminary data for that a few weeks ago, and you know, showing good selectivity. We continue to optimize the compounds that we have and study them for selectivity, but that is the goal. Thank you. Bye-bye. And thank you. And if you would like to ask a question, that is star 11. Again, if you would like to ask a question, that is star 11.
Speaker Change: Yes, so I mean, the goal of the program is to have something that's potent kit and so we've looked at that pre clinically in both binding and cellular function assays, and we see nanomole or activity there and then to be highly selective against kit versus other kinases.
Speaker Change: We shared some preliminary data.
Speaker Change: Or is that a few weeks ago.
Sean: Yes, Sean.
Sean: We continue to optimize the compounds that we have and studied inventory productivity, but that is the goal yes.
Speaker Change: Thank you.
Speaker Change: Okay.
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 one one and one moment for our next question and our next question comes from Ed Arce from H C. Wainwright. Your line is now open.
Operator: And one moment for our next question. And our next question comes from Ed Arce from H.C. Wainwright. Your line is now open. Hi, everyone.
Ed Arce: Thank you for the questions. This is Thomas Yip asking a couple of questions for Ed. So for the new immunology program that is to be unveiled later this year, I'm just trying to figure out what some expectations that you have for now, whether it be for a large disease or a small disease or something along the line of the new kid inhibitor program in terms of a large market and then lastly, you know, a large unmet need as well. Yeah, so we're primarily targeting chronic spontaneous urticaria with this molecule as a primary indication.
Ed Arce: Hi, everyone. Thank you for taking my questions. This is Thomas.
Ed Arce: Couple of questions for Ed.
Ed Arce: So for the new Immunology program.
Ed Arce: Yes.
Ed Arce: <unk>.
Ed Arce: This year.
Ed Arce: I'm just trying to figure out.
Ed Arce: Some expectations.
Ed Arce: For now would it be for a large seasonal smart be ceased for something along the lines of the new program.
Ed Arce: In terms of launch Mark there.
Ed Arce: And then last for me.
Ed Arce: Lots of unmet need as well.
Speaker Change: Yes, so we're primarily targeting chronic spontaneous urticaria with this molecule as the primary indication.
Dr. Jay Lulai: I'm sorry, were you talking about a future to be announced program? Yes, the second immunology program to be announced this year. Yeah, I mean, we're trying to be very thoughtful about it going after, you know, good markets, right?
Speaker Change: I'm sorry.
Speaker Change: Talking about our future.
Speaker Change: To be announced program.
Speaker Change: We are talking about.
Speaker Change: Yes.
Speaker Change: And the larger program.
Speaker Change: Yes.
Speaker Change: Sure.
Speaker Change: Yes, I mean.
Speaker Change: To be very thoughtful about it going after.
Speaker Change: Good.
Speaker Change: Good market is good.
Dr. Jay Lulai: Good markets in areas where we think a small molecule could make an important impact. But beyond that, you know, we're rolling out the program, who will announce the results when we announce them. I mean, I think some of the things we think about in selecting programs, obviously, having a good market opportunity, something that has a high unmet medical need, and, ideally, programs where there's a clear clinical path and biomarkers or early signs of efficacy that we can get early on in the program. And really understanding the underlying disease, the cause of the disease, and having confidence in the target and mechanism are some of the criteria we look at.
Speaker Change: Good markets in areas, where we think a small molecule could make a.
Speaker Change: An important impact.
Speaker Change: But beyond that.
Speaker Change: Yes.
Speaker Change: We will announce.
Speaker Change: Well announce the program when we when we announced it I think some of the things, we think about and selecting programs, obviously, having a good market opportunity something that has a high unmet medical need.
Speaker Change: Ideally programs, where there is a clear clinical path and biomarkers or early signs of efficacy that we can get early on in the program.
Speaker Change: And really understanding the kind of underlying disease cause of the disease and having confidence in the target and mechanism.
Speaker Change: Our.
Speaker Change: Some of the criteria we look at.
Paul Mellott: Got it. Thank you for the additional color. And then this question, one financial question, first of all, just to try to confirm, last quarter for fiscal year 2024, OPEX guidance, R&D 100 to 120, and then G&A 45 to 50, just trying to figure out whether that's still on target for this fiscal year. Yeah, that is still our targeted spend at this point.
Speaker Change: Got it.
Speaker Change: Thank you for the additional color.
Speaker Change: And then this question one financial question.
Speaker Change: Paul.
Paul Mellett: Just trying to confirm.
Paul Mellett: Last quarter.
Paul Mellett: For fiscal year, 2024, Opex guidance RMB 100 <unk>.
Paul Mellett: G&A 45 to 50.
Paul Mellett: Just trying to figure out whether thats still on target for this fiscal year.
Speaker Change: Yes that is still our targeted spend at this point yet.
Paul Mellott: All right, fantastic. Thank you again for the kind questions. And thank you. And I am showing no further questions. I would now like to turn the call back over to Jennifer Vera for closing remarks. Thank you, everyone, for joining us today. If you have additional questions, please feel free to contact us either by email or call the office. Thanks so much, and have a good night. This now concludes today's conference call. Thank you for participating. You may now disconnect.
Speaker Change: Alright.
Speaker Change: Great.
Speaker Change: Thank you again for taking my questions.
Speaker Change: Thank you.
Speaker Change: And thank you and I'm showing no further questions I would now like to turn the call back over to Jennifer Viera for closing remarks.
Jennifer Viera: Thank you everyone for joining us today, if you have additional questions. Please feel free to contact us either by email or call. The office. Thanks, So much and have a good night.
Speaker Change: This now concludes today's conference call. Thank you for participating you may now disconnect.
Jennifer Vera: Conservation Department of State Office of the National Research on Alcohol Education Office of the National Research on Alcohol Administration
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