Q2 2024 Enanta Pharmaceuticals Inc Earnings Call
Okay.
Operator: Good afternoon, and welcome to Enanta Pharmaceuticals' fiscal second quarter financial results conference call. At this time, all participants are on 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 Viera, Investor Relations. Please go ahead.
Okay.
Good afternoon, and welcome to <unk> Pharmaceuticals fiscal second 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 Viera.
Jennifer Viera: The relations. Please go ahead.
Jennifer Viera: Thank you, operator. And thanks to everyone for joining us this afternoon.
Jennifer Viera: Thank you operator, and thanks to everyone for joining us this afternoon in the news release with our fiscal second quarter financial results was issued this afternoon and is available on our website.
Jennifer Viera: The news release with our fiscal second quarter financial results was issued this afternoon and is available on our website. Making remarks on today's call are Dr. Jay Luly, President and Chief Executive Officer, and Paul Mellett, our Chief Financial Officer. Dr. Scott Rottinghaus, our Chief Medical Officer, and Dr. Tara Kieffer, our Chief Product Strategy Officer, will be available during the Q&A portion of the call.
Jennifer Viera: Making remarks on today's call, our Doctor J, Lullay, President and Chief Executive Officer, and Paul Mellett, Our Chief Financial Officer, Dr. Scott Riding House, our Chief Medical Officer, and Dr. Guitar, Keefer, our chief product strategy officer will be available during the Q&A portion of the call.
Jennifer Viera: Before we begin with our formal remarks, we want to remind you that we will be making forward-looking statements. These statements may include our plans and expectations with respect to our research and development pipeline and financial projections. All of these statements involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those expressed. A description of these risks is in our most recent form, 10-K, and other periodic reports filed with the SEC.
Jennifer Viera: Before we begin with our formal remarks, we want to remind you that we will be making forward looking statements. These statements may include our plans and expectations with respect to our research and development pipeline and financial projections. All of these statements involve certain assumptions and risks beyond our control that could cause our actual developments and reserve.
Jay Olson: <unk> to differ materially from these statements a description of these risks is in our most recent Form 10-K and other periodic reports filed with the SEC Anantha does not undertake any obligation to update any forward looking statements made during this call I would now like to turn the call over to Dr. Jay <unk>, President and CEO.
Jennifer Viera: Enanta does not undertake any...
Jay R. Luly: Thank you, Jennifer, and good afternoon, everyone. Throughout 2024, Enanta has remained squarely focused on advancing our virology and immunology pipeline to bring important oral therapeutics to market. Our commitment to developing treatments for areas of high unmet need is driven by our mission to transform patients' lives with curative therapies, and we are determined to achieve our milestones to drive near and long-term shareholder value to fulfill this.
Dr. Jay: Hey.
Jay Olson: Thank you Jennifer and good afternoon, everyone.
Jay Olson: Around 2024, and that has remained squarely focused on advancing our virology in immunology pipeline to bring important oral therapeutics to market.
Jay Olson: Our commitment to developing treatments or areas of high unmet need is driven by our mission to transform patients' lives.
Jay Olson: Curative therapies, and we are determined to achieve our milestones to drive near and long term shareholder value to fulfill this mission.
Jay Olson: Our focus is critical as we approach meaningful inflection points with the potential to develop the first antiviral treatment for RSV.
Jay R. Luly: Our focus is critical as we approach meaningful inflection points with the potential to develop the first antiviral treatment for RSV. With that in mind, today I'll begin with an overview of our programs, beginning with our respiratory syncytial virus, or RSV, programs, and then discuss our immunology program for chronic spontaneous urticaria, or CSU. As a reminder, 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, asthma, or other high-risk conditions. Despite the availability of prophylactic options such as vaccines and monoclonal antibodies, there's a clear need for a Adoption of vaccines has been suboptimal, and breakthrough infections still occur.
Jay Olson: With that today I'll begin with an overview of our programs beginning with our respiratory syncytial virus or RSV programs, and then discuss our immunology program for chronic spontaneous urticaria or CSU.
Jay R. Luly: Additionally, pediatric monoclonal antibodies only provide passive immunity for a few months and not long-term protection against the infection. With this clear need, we have developed a broad clinical program that has the potential to enable multiple opportunities to treat RSV. [inaudible] most advanced clinical replication and, Zellicapavir, formerly known as EDP938, an N-protein inhibitor, as well as EDP323, an L-protein inhibitor. Philae Kapovir is currently being studied in high-risk patient populations in two Phase II studies, RSV-P and RSV-HR.
Jay Olson: As a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in infants.
Jay Olson: <unk> and other high risk populations, including the elderly and individuals with congestive heart failure chronic obstructive pulmonary disease.
Jay Olson: Or other high risk conditions.
Jay Olson: The availability of prophylactic options, such as vaccines monoclonal antibodies there is a clear need for a safe and effective oral RSV antiviral treatment.
Jay Olson: Adoption of vaccines has been sub optimal and breakthrough infections still occur.
Additionally, pediatric monoclonal antibodies only provide passive immunity for a few months.
Jay Olson: Long term protection against the infection.
Jay Olson: With this clear need we have developed a broad spectrum.
Jay Olson: Clinical program.
Jay Olson: It has the potential to enable multiple opportunities to treat our key.
Jay Olson: RFP pipeline.
Jay Olson: Most advanced clinical replication inhibitors.
Jay Olson: A recap of ear, formerly known as Edp nine create.
Jay Olson: In M protein inhibitor as well as edp three to three and al protein inhibitor.
Jay Olson: <unk> is currently being studied in high risk patient population from two phase III studies RSVP.
Jay Olson: RSV HR.
Jay R. Luly: RSVPs is a first-in-pediatrics, phase-two, randomized, double-blind, placebo-controlled study in hospitalized and non-hospitalized RSV patients aged 28 days to 36 months. The study, which will enroll approximately 90 patients, is being conducted in two parts. As this is a first in pediatric study, the objective of the first part is to evaluate the safety and pharmacokinetics of Zelicapavir at multiple ascending doses to select the optimal dose for each age group. The second part of the study will evaluate the antiviral activity of Zelicapavir at the selected dose, and virology and symptom scores will be assessed throughout the treatment.
<unk> is the first in pediatrics phase two randomized double blind placebo controlled study in hospitalized or non hospitalized RSV patients aged 28 days to 36 months.
Jay Olson: The study, which will enroll approximately 90 patients is being conducted in two parts.
Jay Olson: As this is the first in pediatric study the objective of the first part is to evaluate the safety and pharmacokinetics of <unk> and multiple ascending doses to select the optimal dose for each age group.
The second part of this study will evaluate the antiviral activity of salary cap of euro at the selected dose and virology in symptom scores will be assessed throughout the treatment duration.
Jay R. Luly: This study was designed as a small proof of concept in pediatric patients to show a trend toward improved virology metrics for selicapavir compared to placebo and to give confidence to move forward efficiently into larger registrational studies. The key objective of this study was to show improvement in virology endpoints in patients on Zilliqavivir compared to placebo, sufficient to allow us to advance into phase three. Currently, we have partially enrolled the last age cohort, 20 patients, in Part 2 of the study.
Jay Olson: This study was designed as a small proof of concept in pediatric patients to show a trend toward improved by realogy metrics for <unk> compared to placebo and to give confidence to move forward efficiently into larger Registrational studies.
Jay Olson: A key objective of this study is to show improvement in virology endpoints in patients on <unk> compared to placebo sufficient to allow us to advance to phase III.
Jay Olson: Currently we have fully enrolled the last age cohort two patients in part two of the study.
Jay R. Luly: As this cohort can only enroll patients 28 days to six months of age, the eligible population is narrower, and we will need to continue to recruit in the Southern Hemisphere. As we monitor the RSC season in the Southern Hemisphere, we anticipate reporting data from this study in the second half of 2024.
Jay Olson: This cohort can only enrolled patients 28 days to six months of age. The eligible population is narrower and we will need to continue to recruit in the southern hemisphere as we monitor the RSP season in the southern Hemisphere, we anticipate reporting data from that study in the second half of 2024.
Jay R. Luly: RSVHR is a phase two randomized double-blind placebo-controlled study of approximately 180 adults with RSV infection who are at high risk of complications, including the elderly, those with congestive heart failure, chronic obstructive pulmonary disease, or as. The primary endpoint for RSVHR is time to resolution of RSV lower respiratory tract disease symptoms, as assessed by the Respiratory Infection Intensity and Impact Questionnaire Symptom Scal Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics, and safety of Zelikapavir. The primary objective of this study was to show an improvement in time-to-symptom resolution.
Jay Olson: RSV HR is a phase II randomized double blind placebo controlled study of approximately 180 adults with RSV infection, who are at high risk of complications, including the elderly.
Jay Olson: With congestive heart failure, chronic obstructive pulmonary disease or asthma.
Jay Olson: The primary endpoint for RSV EHR. It is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the respiratory infection intensity and impact questionnaire symptom scale.
Jay Olson: Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo pharmacokinetics and safety of Zelie cap up here.
Jay Olson: The primary objective of this study is to show an improvement in time to symptom resolution.
Jay R. Luly: Given the study was designed to be a small phase two proof of concept study, it is powered based on a 50% reduction in symptom resolution. However, as there are no data showing a statistically significant effect on symptoms in the community-acquired RSV adult population with which to benchmark, this reduction likely represents a high bar. Therefore, directional efficacy data that is clinically meaningful would provide us with conviction to move directly into phase 3. Enrollment is progressing, and we will provide additional guidance on the RSVHR study as the Southern Hemisphere RSV season evolves.
Jay Olson: Given the study was designed to be a small phase two proof of concept study. It is powered based on a 50% reduction in symptom resolution.
Jay Olson: However, as there are no data showing a statistically significant effect on symptoms and community acquired RSV adult population with which to benchmark. This reduction likely represents the high bar. Therefore, a directional efficacy data that is clinically meaningful would provide us with conviction to move directly into.
The phase III.
Jay Olson: Enrollment is progressing and we'll provide additional guidance on the RSP EHR study is the southern hemisphere RSV season evolves.
Jay R. Luly: Also ongoing in our RSV portfolio is the Phase 2a Challenge Study of ADP-323, which is in development as a once-daily oral treatment for RSV. In this randomized, double-blind, placebo-controlled study, up to 114 healthy 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 EDP-323 with a loading dose of 600 milligrams on the first day, or a placebo for five days.
Jay Olson: Also ongoing in our RSP portfolio as the Phase Iia Challenge study of Edp 302, three which is under development as a once daily oral treatment for RSV.
Jay Olson: In this randomized double blind placebo controlled study up to 114 healthy 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 300, 232 hundred milligrams of Edp 3231.
Jay Olson: The loading dose of 600 milligrams on the first day or placebo for five days primary and secondary outcome measures include safety changes in viral load measurements and changes in symptoms from baseline to.
Jay R. Luly: Primary and secondary outcome measures include safety, changes in viral load measurements, and changes in symptoms from baseline. The development of EDP-323 is supported by positive phase one results in which the drug demonstrated favorable safety, tolerability, and pharmacokinetics in healthy volunteers. We anticipate reporting data from this challenge study in the third quarter of 2024. We believe either Zelicapavir or EDP-323 would be effective as monotherapy because they do not have cross-res
The development of Edp three Q3 is supported by a positive phase one results in which the drug demonstrated favorable safety Tolerability and pharmacokinetics in healthy volunteers, we anticipate reporting data from those challenge study in the third quarter of 2024.
Jay Olson: We believe either Zelie cap of your ore Edp three two to three would be effective as a monotherapy because they do not have cross resistance. We could also potentially use them in combination to broaden the treatment window or expand the eligible patient population to harder to treat patients.
Jay R. Luly: We could also potentially use them in combination to broaden the treatment window or expand the eligible patient population to harder-to-treat patients. Also in Respiratory Virology, data from SPRINT, our Phase 2 study of EDP-235, a 3-CL protease inhibitor, was presented in April at the ESCMID Conference, formerly known as ECMID. We are pleased to present this comprehensive data package in a scientific forum for the first
Jay Olson: Also in respiratory virology data from <unk>, our phase III study of Edp 235.
Jay Olson: <unk> protease inhibitor was presented in April Fps mid conference, formerly known as <unk>.
Jay Olson: We are pleased to present the comprehensive data package in a scientific forum for the first time.
Jay R. Luly: As a reminder, we will conduct any future COVID-19 work in the context of a collaboration. I'll now turn to our work in immunology, where we are concentrating on indications with a high unmet medical need and a clear clinical development path, including well-defined populations and biomarkers available for early signs of efficacy. Our first immunology indication is CSU, a severely debilitating chronic inflammatory skin disease that can continue for years before remission. Clinical manifestations include urticaria, commonly called hives, as well as angioedema, which is characterized by pronounced deep tissue swelling.
As a reminder, we will conduct any future COVID-19 work in the context of the collaboration.
Jay Olson: I'll now turn to our work in immunology, where 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.
Jay R. Luly: The disease can be severely disabling, significantly impair quality of life, and affect performance at work or school, as patients with CSU can experience symptoms beyond the skin manifestation, including sleep disturbances, fatigue, irritability, anxiety, and depression. CSU is estimated to affect 0.5 to 1% of the global population at any given time.
Jay Olson: Our first immunology indications CSU are severely debilitating chronic inflammatory skin disease, which can continue for years or remission.
Jay Olson: Clinical manifestations include urticaria, commonly called highs as well as angioedema, which is characterized by pronounced deep tissue swelling the.
Jay Olson: The disease can be severely disabling significantly impaired quality of life.
Jay Olson: <unk> performance at work or school as patients with CSU can experience, sometimes beyond the skin manifestations.
Jay Olson: Including sleep disturbances fatigue, irritability anxiety and depression.
Jay Olson: CSU is estimated to affect 0.5% to 1% of the global population at any given time.
Jay R. Luly: The standard of care for CSU is antihistamines, but in approximately half of patients, symptoms are not alleviated, and a minority of patients are treated with one indicated biologic. Consequently, there is a substantial unmet need for a new efficacious drug that can be conveniently dosed as an oral agent. Mast cells are the primary driver for disease in CSU, as well as being involved in multiple other allergic diseases. In our first immunology program, we are seeking to develop a best-in-disease oral kit inhibitor treatment that reduces the number of mast cells available to drive pathology in patients suffering from CSU. We are also encouraged by the potential to study kit inhibition and additional indications. Currently, our prototype KIT inhibitors in preclinical development demonstrate potent inhibition and are highly selective for KIT.
Jay Olson: The standard of care for CSU is any histamines, but an approximately half patients symptoms are not alleviated and a minority of patients are treated with one indicated biologic.
Jay Olson: Consequently, there is a substantial unmet need for new applications drug that can be conveniently dose as an oral agent.
Jay Olson: Marcellus or the primary driver for disease in CSU as well as being involved in multiple other allergic diseases and our first immunology program. We are seeking to develop a best in disease oral kit inhibitor treatment that reduces the number of mast cells available to drive pathology in patient suffering from <unk>.
Jay Olson: Hugh.
Jay Olson: We are also encouraged by the potential to study <unk> inhibition and additional indications.
Jay Olson: Currently our prototype kit inhibitors in preclinical development demonstrated potent inhibition and are highly selective for kit. We continue to optimize these lead surround potency selectivity and DM PK properties.
Jay R. Luly: We continue to optimize these leads around potency, selectivity, and DMPK properties, and we are on track to select a development candidate in the fourth quarter of 2024 and plan to move into the clinic shortly thereafter. We are excited about our pipeline growth into immunology and are confident in the team's ability to translate the learnings from our previous success with small molecule drugs to enable our development of a best in class disease therapeutic for CSU.
Jay Olson: And we are on track to select a development candidate in the fourth quarter of 2024 and plan to move into the clinic shortly thereafter.
Jay Olson: We are excited about our pipeline growth and immunology and are confident in the team's ability to translate the learnings from our previous success with small molecule drugs to enable our development of a best in disease therapeutic for CSU.
Jay R. Luly: We are also pursuing additional immunology targets and look forward to introducing a second program this year. Outside of our pipeline, I would also like to take a moment to welcome Matthew Kowalski as our chief legal officer, who joined last week. Matt is a strong addition to our team, as he brings more than 20 years of experience in the life sciences industry, handling corporate governance, Public Company Reporting, Intellectual Property, Financing, Business Development, and M&A Activities.
Jay Olson: We're also pursuing additional immunology targets and look forward to introducing a second program this year.
Jay Olson: Beyond our pipeline I would also like to take a moment to welcome Matthew Kowalski as our Chief Legal Officer, who joined last week, Matt is a strong addition to our team as he brings more than 20 years of experience in the life Sciences industry handling corporate governance public company reporting and <unk>.
Jay Olson: Actual property financing business development and M&A activities.
Jay R. Luly: At Enanta, he will lead all legal and compliance activities for the company and provide strategic guidance and corporate governance oversight. With that said, I'd like to conclude by highlighting our upcoming milestones. We anticipate reporting data from the Phase 2a challenge study of EDP-323 in the third quarter and reporting data from the Phase 2 pediatric study of Zelikapivir in the second half of this year. Furthermore, we plan to identify a clinical candidate for our CSU program in the fourth quarter, and finally, we also plan to announce a second immunology program this year. Now I'll turn the call over to Paul to discuss our finances. Paul? Thank you.
Jay Olson: It announced that he will lead all legal and compliance activities for the company and provide strategic guidance and corporate governance oversight.
Jay Olson: With that I'd like to conclude by highlighting our upcoming milestones, we anticipate reporting data from the phase Iia Challenge study of Edp three three in the third quarter and reporting data from the phase II pediatric study of Zyla cap up here in the second half of this year.
Jay Olson: Further we plan to identify a clinical candidate for our CSU program in the fourth quarter and finally, we also plan to announce a second immunology program. This year.
Jay Olson: Now I'll turn the call over to Paul to discuss our financials Paul.
Paul J. Mellett: Thank you, Jay. I would like to remind everyone that Enanta reports on a September 30th fiscal year schedule. Today, we are reporting results for our fiscal second quarter ended March 31st, 2024. For the quarter, total revenue was $17.1 million and consisted of royalty revenue earned on AbbVie's Global Maverick Net Product sale. This compares to total revenue of $17.8 million for the same period in 2023. As a reminder, our royalties are calculated on a calendar year basis.
Paul J. Mellett: Jay I would like to remind everyone that in answer reports on a September 30 fiscal year schedule.
Paul J. Mellett: Today, we are reporting results for our fiscal second quarter ended March 31 2024.
Paul J. Mellett: For the quarter total revenue was $17 1 million and consisted of royalty revenue earned on as these global Maverick net product sales.
Paul J. Mellett: This compares to total revenue of $17 8 million for the same period in 2023.
Paul J. Mellett: As a reminder, our royalties are calculated on a calendar year basis, therefore royalties for our fiscal first quarter ending December 31, or calculated at 12% the highest royalty rate for the year and royalties for our fiscal quarter ending March 31 are calculated at 10% our lowest royalty.
Paul J. Mellett: Therefore, royalties for our fiscal first quarter ending December 31 were calculated at 12%, the highest royalty rate for the year, and royalties for our fiscal quarter ending March 31 are calculated at 10%, our lowest royalty tier.
Paul J. Mellett: Tier.
Paul J. Mellett: [inaudible] 54.5% of Enanta's ongoing royalties from Average Net Sales of Maverick that are included in our revenue are being paid 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. As such, we continue to record 100% of the royalties earned as revenue and will then amortize the debt liability at 54.5% of the cash royalty payments paid to owners through June 30, 2032, subject to a cap of 1.42 times the purchase payment, after which point 100% of the cash royalty payments will be retained by Enanta. Interest expense for the debt will be recorded in Enanta's consolidated statement of operations based on an imputed interest rate. For the three months ended March 31, 2024.
Paul J. Mellett: Of note.
Paul J. Mellett: 54, 5% of <unk> ongoing royalties from <unk> net sales of Maverick that are included in our revenue are being paid to <unk> the royalty buyer and our April 2023 healthy 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 J. Mellett: As such we continue to record 100% of the royalties earned as revenue and will then amortized amortize the debt liability at 54, 5% of the cash royalty payments are paid to almost through June 32032 subject to a cap of 142 times the purchase payment.
Paul J. Mellett: After which point, 100% of the cash royalty payments will be retained by <unk>.
Paul J. Mellett: Interest expense for the debt will be recorded in an analyst consolidated statement of operations based on an imputed interest rate.
Paul J. Mellett: Interest expense was $2 6 million for three months ended March 31 2024.
Paul J. Mellett: Moving on to other expenses, for the three months ended March 31, 2024, research and development expenses totaled $35.6 million, compared to $43.5 million for the same period in 2023. The decrease was primarily due to a decrease in costs associated with our COVID-19 program, although as we previously announced that plans to pursue any future COVID-19 efforts would be in the context of a collaboration.
Paul J. Mellett: Moving on to other expenses for the three months ended March 31, 2020 for research and development expenses totaled $35 6 million compared to $43 5 million for the same period in 2023.
Paul J. Mellett: The decrease was primarily due to a decrease in costs associated with our COVID-19 program as we previously announced that plans to pursue any future COVID-19 efforts would be in the context of our collaboration.
Paul J. Mellett: This is partially offset by increased costs associated with our RSE program and our recently announced immunology program. General and administrative expense for the quarter was $14.2 million compared to $13.8 million for the same period in 2023. This increase was primarily due to an increase in legal expenses related to a patent infringement lawsuit against Pfizer. Additionally, the company recorded an income tax benefit of $0.4 million for the three months ended March 31, 2024, for interest earned on a pending $28 million federal income tax refund, compared to an income tax expense of less than $0.1 million for the three months ended March 31, 2023.
Paul J. Mellett: This was partially offset by increased costs associated with our RSV program, and our recently announced immunology programs.
Paul J. Mellett: General and administrative expense for the quarter was $14 2 million compared to $13 8 million for the same period in 2023.
Paul J. Mellett: This increase was primarily due to an increase in legal expenses related to a patent infringement lawsuit against Pfizer.
Paul J. Mellett: <unk> recorded an income tax benefit of <unk> 4 million for the three months ended March 31, 2024 for interest earned and a pending $28 million of federal income tax refunds compared to an income tax expense of less than <unk> 1 million for the three months ended March 31 2023.
Paul J. Mellett: The net loss for the three months ended March 31, 2024 was $31.2 million, or a loss of $1.47 per diluted common share, compared to a net loss of $37.7 million, or a loss of $1.79 per diluted common share, for the corresponding period in 2023. At this fiscal year midpoint, we are updating our expense guidance. We now expect our research and development expenses to be between $125 million and $145 million, and our general and administrative expenses to be between $50 million and $60 million.
Paul J. Mellett: Net loss for the three months ended March 31, 2024 was $31 2 million or a loss of $1 47 per diluted common share.
Paul J. Mellett: To a net loss of $37 7 million or a loss of $1 79 per diluted common share for the corresponding period in 2023.
Paul J. Mellett: At this fiscal year midpoint, we are updating our expense guidance.
Paul J. Mellett: We now expect our research and development expense to be between $125 million and $145 million and our general and administrative expense to be between $50 million and $60 million.
Paul J. Mellett: The research and development expense increase reflects the impact of our new immunology program, as well as additional efforts to accelerate our RSV clinical study. The general and administrative expense increase is due to additional stock compensation expense and costs associated with pursuing our patent infringement lawsuit, leaving us at the end of the quarter with approximately $300 million cash and marketable security. We expect that our current cash, cash equivalents in short-term marketable securities, as well as a retained portion of ongoing royalties, will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs through the third quarter of fiscal 2027.
Paul J. Mellett: The research and development expense increase reflects the impact of our new immunology program as well as additional efforts to accelerate our RSV clinical studies.
Paul J. Mellett: The general and administrative expense increase is due to additional stock compensation expense and cost associated with pursuing our patent infringement lawsuit.
Paul J. Mellett: And then at the ended the quarter with approximately 300 million of cash and marketable securities.
Paul J. Mellett: We expect that our current cash cash equivalents and short term marketable securities as well as our retained portion of ongoing royalties will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs through the third quarter of fiscal 2027.
Paul J. Mellett: 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 I'll open up the lines for questions. Operator.
Paul J. Mellett: Further financial details are included in our press release and will be available on our report on Form 10-Q, one files.
Speaker Change: I'd now like to turn the call back to the operator and open up the lines for questions operator.
Operator: 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.
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 withdraw. Your question. Please press star. One again, please standby will be compile the Q&A roster and one moment for our first question.
Operator: Please stand by while we compile the Q&A roster and one moment for our first question. And our first question comes from Akash Tiwari from Jeffreys. Your line is now open.
Huawei: And our first question comes from a cost to Huawei from Jefferies. Your line is now open.
Kathy: Hi, this is Kathy on behalf of ACOSH. So I had a question for the RCPs. Since RCPs isn't explicitly powered to hit on viral loads or symptoms, what will you be looking at in terms of the data to inform your design for Phase 3, and as such, how should we think about gauging efficacy or safety, and then how much of a read-across do you believe the data will have for RCHR, and then are you expecting a symptom benefit of, like, one or two days? Thank you.
Huawei: Hi, This is Kathy on for our cash so I had a question for RSVP.
Kathy: Since RCP isn't explicitly powered to hit on viral load your symptoms what will you be looking at in terms of the data to inform your design for phase III and as such how should we think about gauging efficacy or safety and then how much of a read across do you believe the data will have for RSV HR and then are you expecting a symptom benefit.
Speaker Change: Like one or two days thank you.
Jay R. Luly: Thanks for the question. This is Jay. I think I'll...hand over to Tara Kieffer to talk about how we were going to be viewing the data set coming out of PEDS. Tara? Sure.
Speaker Change: Thanks for the question. This is Jay I think al.
Speaker Change: Handed over to Tara Keefer.
Tara Lynn Kieffer: To talk about.
Tara Lynn Kieffer: We weren't going to be viewing the data set coming out of peds sure sure.
Tara Lynn Kieffer: Sure. Yeah, so the RCP study is our proof-of-concept Phase 2 study in pediatrics. So we have to think about it a little bit differently than our adult study in Phase 2, because this is the first time that we're dosing children in this young age range of 28 days to three years. So we have to first confirm the safety profile and the dose. And so the study was done in two parts. In part one, the primary endpoint was safety and PK, and it was done in a dose-assessing fashion. And we select the optimal dose from that part, which has been studied in part two. And in that part, the primary objective is to look at the virology endpoint. Unknown Speaker...
Tara Lynn Kieffer: So the RCT study is our proof of concept phase II study in pediatrics.
Tara Lynn Kieffer: Think about it a little bit differently than our adult study in phase two because this is the first time that we're dosing children and MS. Young age range of 28 days to three years.
Tara Lynn Kieffer: So we have to first confirm the safety profile and the dose.
Tara Lynn Kieffer: And so the study has been done in two parts part one the primary endpoint is safety and PK.
Tara Lynn Kieffer: And then in the dose.
Tara Lynn Kieffer: Does this lending fashion and we select the optimal dose from that part which has been studied in say in part two.
And that part the primary objective is to look at the virology endpoints.
Tara Lynn Kieffer: So we're primarily looking for improvement in virology endpoints between patients on 938 or Zolcaprevir and placebo, with directional data that would give us the confidence to move into a phase three study. We'll look at a number of different virology endpoints. We'll also look at the clinical endpoints as well, but primarily, we'll be looking at virology. You know, it's hard to give a specific threshold or a bar in terms of what we're looking at because there's not a lot of data out there on RSV for naturally acquired RSV in children.
Tara Lynn Kieffer: So we're primarily looking for improvements.
Tara Lynn Kieffer: In virology endpoints between the patients on 93, eights or cap Revere and turbo.
Tara Lynn Kieffer: With directional data that would give us the confidence to move into a phase III study.
Tara Lynn Kieffer: So we'll look at a number of different virology endpoints will also look at the clinical endpoints as well.
Tara Lynn Kieffer: But primarily it will be looking at their LNG.
Tara Lynn Kieffer: It's hard to give a specific threshold or a bar in terms of what we're looking at.
Tara Lynn Kieffer: Because there is theres not a lot of data out there in RFP or naturally acquired.
Tara Lynn Kieffer: But there's one study that we can point to from a company called ArcBio that did a phase three study in pediatrics in China, and they did show a 0.6 log drop at day four, a statistically significant effect in virology. And they also, in that same study, demonstrated an improvement in symptoms. So we're not able to really give any kind of a bar that we're looking for, but we're really interested in the totality of the data and showing those trends and directional data that would give us the confidence to move into a larger, more well-powered study to tease out these.
Tara Lynn Kieffer: <unk>.
Tara Lynn Kieffer: One study.
Tara Lynn Kieffer: That we can point to from a company called arc bio that did a phase III study in pediatrics in China.
They did show eight six log drop at Dave for a statistically significant effect in biology, and then also in that same study demonstrated an improvement in symptoms.
Speaker Change: So we're not able to really give any kind of a bar that we're looking for but.
Speaker Change: We're really interested in the totality of the data and so showing those trends and directional data that would give us the confidence to move into a larger.
Speaker Change: Well powered study to able to.
Speaker Change: Tease out these effects.
Operator: Any questions?
Speaker Change: Got it.
Speaker Change: Okay.
Eric William Joseph: And thank you. And one moment for our next question, and our next question comes from Eric Joseph from J.P. Morgan. Your line is now open.
Speaker Change: And thank you.
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.
Jay R. Luly: Great, thank you. Just a couple of questions related to the immunology program, I guess for this KIT development candidate. Can you talk a little bit about your strategic plans with respect to clinical development there? I guess to the extent you might be seeking a strategic partner at some point along the way, is there a certain sort of Ertl's, and then secondly, just noting that you're looking to expand into or expand with a second immunology program. Can you give us a bit of a preview there in terms of either the Target you may be pursuing, or are you perhaps doubling down on kit? Thanks very much.
Eric William Joseph: Great. Thank you.
Eric William Joseph: Just a couple of questions related to the immunology program I guess for the kits development candidate.
Can you talk a little bit about your strategic plans with respect to clinical development. There I guess to the extent you might be seeking.
Eric William Joseph: Our strategic partner at some point along the way.
Is there a certain sort of.
Eric William Joseph: Hurdles.
Eric William Joseph: Kind of milestones you would want to see clear at first and then secondly, just noting that year.
Looking to expand into or expanding with a second immunology program can you give us a bit of a preview there in terms of either.
Eric William Joseph: Target you might be pursuing are you, perhaps doubling down on kit thanks very much.
Jay R. Luly: Thanks, Eric. This is Jay.
Eric William Joseph: Thanks, Eric This is Jay so were.
Jay R. Luly: So we're We're working up a few different approaches in parallel to, you know, figure out which we might prioritize, you know, going forward. So it's a little early to be discussing that. I think you asked where we are Doubling down on kids. We have one major kit program now.
Jay Olson: We're working up a few different approaches.
Jay Olson: Parallel.
Jay Olson: Two.
Jay Olson: Figure out, which we might.
Jay Olson: <unk> going forward, so it's a little early.
Jay Olson: To be.
Jay Olson: To be discussing how do you think you asked where are we.
Jay Olson: Doubling down on kit.
Jay R. Luly: I think we're looking to broaden beyond that. And so we'll provide more details as the year progresses and after we've generated more data in-house, made more molecules in-house, filed intellectual property, and so forth. So stay tuned on that front. Unknown Speaker, With regard to, I wasn't quite sure on the first part of your question; you were talking about strategic partnering.
Jay Olson: I mean, we have one major kit program now I think we're looking to.
Jay Olson: Broaden beyond that.
Jay Olson: And so we'll provide more details as the year progresses.
After we've generated more data in house made more molecules in house.
Jay Olson: Filled intellectual property and so forth so stay tuned on that front.
Jay R. Luly: I mean, our plan, just in a nutshell, initially, at least is to, again, identify the candidate in the fourth quarter; we're going to be aiming to get it into the clinic, hopefully rapidly thereafter. And then, you know, phase one, I think, should be fairly straightforward and healthy. The nice thing is that with this mechanism, you can get sort of surrogate readouts of target engagement by looking at tryptas
Jay Olson: With regards to it.
Jay Olson: I wasn't quite sure on your first part of your question you were talking about strategic partnering.
Jay Olson: Our plan just in a nutshell initially at least is too high.
Jay Olson: Again identify the candidate in the fourth quarter, we're going to be aiming to get it.
And to the clinic.
Jay Olson: Hopefully rapidly thereafter.
Jay Olson: And then.
Jay Olson: Phase one I think should be fairly straightforward and healthy is a nice thing.
Jay Olson: As with this mechanism you can get.
Sort of surrogate readout.
Jay Olson: <unk> targeting.
Jay Olson: Target engagement by looking at Tryptase changes.
Jay R. Luly: So that'll help a lot, you know, having the biomarker available to us. And then, you know, the clinical development. CSU, I think is actually, you know, pretty straightforward. So, we would be thinking about progressing to a fairly straightforward proof-of-concept study. It's a defined, accessible, and large patient population. So, hopefully, we won't have the, you know, seasonal trends that we experience in RSV. And, you know, we're looking very much forward to progressing that first program in immunology and then, you know, again, bringing on additional targets and mechanisms as time goes on. Can I just say?
Jay Olson: So that will help.
A lot having the biomarker available to us and then.
Jay Olson: The clinical development.
Jay Olson: In.
Jay Olson: CSU I think is actually.
Jay Olson: Pretty straightforward so.
Jay Olson: We would be thinking about progressing to a fairly straightforward proof of concept study.
Jay Olson: It's a defined accessible in large patient populations. So.
Jay Olson: We hopefully won't have the.
Jay Olson: The seasonal trends that we experienced in RSV.
Jay Olson: And.
Jay Olson: And are looking very much forward to progressing that.
Jay Olson: First program in Immunology and then.
Jay Olson: Again, bringing on additional.
Jay Olson: Targets and mechanisms says as time goes on.
Tara Lynn Kieffer: Can I just add one thing to that, Jay, the biomarker that Jay mentioned we can monitor in phase one in healthy volunteers is serum triptase. You know, there's a lot of data, excuse me, out there generated from some of the monoclonal antibodies against kits from cell decks that have nicely been able to show a tight correlation with impacts on that biomarker and ultimate clinical outcomes. So I think, you know, it's something that can really be risked by the program early on in those phase one studies.
Speaker Change: Can I just add one thing to that Jay is the biomarker, but Jay mentioned, we can monitor in phase one in healthy volunteers is tryptase tryptase.
Speaker Change: There is a lot of data excuse me out there generated from some of the monoclonal antibodies against kits.
Speaker Change: Sel Dex that have.
Speaker Change: Nicely.
<unk> been able to show a tight correlation with impacts from that biomarker and ultimate clinical outcome. So I think it's something that really can derisk. The program early on in those phase one studies.
Operator: That's great. Thanks for taking the time to ask the question. You're welcome.
Speaker Change: That's great. Thanks for taking the questions.
Speaker Change: Youre welcome and thank you.
Operator: And one moment for our next question, and our next question comes from Ed Arce from HC Wainwright. Your line is now open.
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from Ed Arce from H C. Wainwright. Your line is now open.
Thomas Yip: Hi, good afternoon, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for taking our questions. So first, can you outline what your estimate of the patient population breakdown between the Northern and Southern Hemisphere to date, both for the RSVP study and also for the HR study?
Antonio Eduardo Arce: All right. Good afternoon, everyone. This is Thomas Yip asking a couple questions for Ed. Thank you for taking my questions.
Thomas Yip: So first.
Thomas Yip: Alright.
Thomas Yip: What's your estimate.
Thomas Yip: Patient population breakdown between the northern and southern Hemisphere.
Thomas Yip: Right.
Thomas Yip: Both for the RSVP study and also for the HR study as well.
Thomas Yip: Are you making reference to numbers of sites? You say patient population, but are you talking about markets? Are you talking about clinical trial conduct?
Thomas Yip: Are you, making reference to numbers of sites.
You say patient population, but are you talking about markets or are you talking about clinical trial conduct.
Thomas Yip: More on clinical trial conduct, so perhaps the number of sites, so both the number of sites or the number of patients enrolled, just a four-part sandwich.
Thomas Yip: More on the clinical trial conduct so perhaps the number of sites. So both the number of sites or the number of patients enrolled.
Thomas Yip: Our ballpark sandwich.
Jay R. Luly: Yeah, I don't have the exact figures in front of me. We have I mean, maybe Scott, maybe I'll just let you amplify on that.
Thomas Yip: Yes.
Thomas Yip: Don't have the exact.
Thomas Yip: Figures in front of me we have.
Thomas Yip: I mean, maybe Scott maybe I'll, just let you amplify on that yes sure. Thanks Jay.
Scott T. Rottinghaus: Yeah, sure. Thanks, Jay.
Scott: So we've enrolled patients in both northern and southern hemispheres, and both the pediatric and the high risk studies, including in.
Scott: The current season ongoing in the south so I don't have the exact numbers in front of me either but we are continuing to enroll actively in both of those studies and as Jay mentioned on the call in the pediatric study in particular were down to the last cohort in enrolling in the south.
Scott T. Rottinghaus: So we've enrolled patients in both the northern and southern hemispheres in both the pediatric and the high-risk studies, including in, you know, the current season ongoing in the South. So I don't have the exact numbers in front of me either, but we are continuing to actively enroll in both of those studies. And as Jay mentioned on the call, in the pediatric study in particular, we're down to the last cohort and enrolling in the South.
Jay R. Luly: Yeah, I think directionally, maybe you're quite right, the Northern Hemisphere is, without question, more highly represented in terms of clinical trial sites than the Southern Hemisphere. I mean, we're in many different European countries, many different North American countries, we're in Asia. In the Southern Hemisphere, we're in South Africa, we're in Brazil, we're in Argentina, New Zealand, Australia, not as large a footprint in the southern hemisphere, but nonetheless, we're hoping to make good progress on enrollment in that and wrap this up as soon as possible.
Scott: But I think Directionally, maybe you are.
Scott: The northern Hemisphere beyond question, it's more highly represented in terms of clinical trial sites than the southern hemisphere.
And many different European countries, many different north American countries were in Asia.
Scott: In the southern Hemisphere, we're in.
Scott: We're in South Africa, we're in Brazil, we're in Argentina.
Scott: <unk> Australia.
Not not as larger footprint in the southern hemisphere, but.
Scott: But.
Scott: But nonetheless, we're hoping to make.
Scott: Good progress on enrollment in that.
Scott: Rep. This.
Scott: Wrap this up is.
Scott: As soon as possible.
Operator: Understood. And as a follow-up on that, can you remind us how much overlap there is between the Southern Hemisphere RSV season and the flu season? And also, to that point, for the HR study, do you expect the study to complete enrollment kind of in line with the conclusion of the Southern Hemisphere RSV season?
Scott: Understood.
Speaker Change: A follow up on that.
Speaker Change: Can you remind us how how much overlap there, but trade in the southern hemisphere RSV season than a new season and also do you expect.
Speaker Change: To that point.
Our study.
Speaker Change: Pat.
Speaker Change: To complete enrollment.
Speaker Change: <unk>.
Speaker Change: In line with the conclusion of the southern Hemisphere.
Speaker Change: Our spring season.
Operator: Was the first question about overlap with the flu season?
Speaker Change: What's the first question about overlap with the flu season.
Operator: Yes, but how much overlap is there between the orange species and the blue species? I mean,
Speaker Change: Yes, how much overlap there between the RSV season in the flu season.
Jay R. Luly: I mean, generally, they're somewhat correlated, but even in any given year, they can deviate a little bit one way or the other flu could come on a little earlier or a little later come on twice. RSV has been, and flu, but especially RSD, have been substantially impacted by the pandemic years in terms of just, you know, only more recently, starting to settle down into what we would call more normal seasonality. Um, so I think, Again, we follow, we track the R species and do so much more closely than the flu.
Speaker Change: I mean generally there are somewhat correlated but.
Speaker Change: Even in any given year.
Speaker Change: They can they can deviate a little bit one way or the other flu could come on a little earlier or a little later come on twice.
Speaker Change: RSP has been.
Speaker Change: And flu, but especially RSP have been substantially.
Speaker Change: Impacted by the pandemic.
Speaker Change: Years in terms of just only more recently starting to settle down into what we would call more normal seasonality.
Speaker Change: So I think.
Speaker Change: So again, we follow it we track.
Speaker Change: <unk> is a much more closely than than flu.
Speaker Change: As it relates to HR.
Jay R. Luly: As it relates to HR, my guess is we'll need to come back to the Northern Hemisphere, given that we again have a much stronger footprint there. We made excellent strides in the Northern Hemisphere this year. That's why, especially in the United States, It was a very nice season for us. So we may need some of that as well. Well, again, we'll be tracking this and reporting progress later this summer, you know, when we're well into the Southern Hemisphere season, and we'll be able to forecast a little bit better based on, you know, more current data. But that's my expectation.
Speaker Change: My guess is we will need to come back to the northern hemisphere.
Speaker Change: Given that we again have just much stronger footprint. There we made excellent strides in the northern hemisphere.
This year, that's why especially in the United States.
It was it was a very nice season for us so.
Speaker Change: We may need.
Speaker Change: We may need some of that as well will again will be tracking this and reporting progress.
Speaker Change: Later this summer when we're well.
Speaker Change: Into the southern Hemisphere season, and we will be able to forecast a little bit better based on.
Speaker Change: More current.
Speaker Change: Data.
Speaker Change: But that's my expectation.
Thomas Yip: Okay, understood. Thank you again for the kind of questions, and we look forward to the progress and as it can happen this year.
Speaker Change: Okay understood. Thank you and with careful what's kind of your questions and we look forward to the progress in the second half of this year.
Operator: You're welcome. And thank you. And one moment for our next question. And our next question comes from Roy Buchanan from Citizens JMP. Your line is now open.
Speaker Change: Thank you Youre welcome.
Speaker Change: Thank you.
Speaker Change: And one moment for our next question.
Speaker Change: And our next question comes from Roy Buchanan from citizens JMP. Your line is now open.
Douglas Royal Buchanan: Thanks for taking the question. Just a couple on RSV. Jay, for the RSVHR, I think I heard you say that it was powered for a 50% reduction in symptoms, and it's probably a high bar. Just wondering where that conclusion about it being a high bar comes from. I think in the challenge trial, you had a 75% reduction in symptoms. And are you just interpolating between that and RSVP, or is there something else you're seeing in the trial?
Douglas Royal Buchanan: Hey, Thanks for taking the question just a couple on RSV Jade for the RMB HR.
Douglas Royal Buchanan: I think I heard you say that.
Douglas Royal Buchanan: Powered for a 50% reduction.
Douglas Royal Buchanan: The reduction in symptoms and this is probably a high bar just wondering where that.
Douglas Royal Buchanan: I guess conclusion about it being a high bar comes from I think Chad.
Douglas Royal Buchanan: Challenge trial, you had a 75% reduction in symptoms and are you just interpolating between that and RSVP or is there something youre seeing in the trial.
Jay R. Luly: Yeah, so to be clear, we're talking about time to resolution of symptoms. So it's different than in the challenge where we're looking at the number of days improvement in time to resolution of symptoms versus placebo. I mean, I can give you a little color on that.
Speaker Change: Yes, so to be clear, we're talking about time to resolution of symptoms.
Speaker Change: So it's different than in the challenge we're looking at.
Speaker Change: The number of days improvement in time to resolution of symptoms versus placebo.
Speaker Change: I can give a little color on that.
Jay R. Luly: I think, for example, with the flu, in a placebo study, and Tara can correct me if I'm wrong, there's about a four day time period for time to resolution, and Tamiflu will shorten that by a day. So it's a three day time resolution, so it's a one day shortening, out of four days, that's a 25% improvement in Time to Resolution. And so,
Speaker Change: I think for example with flu.
Speaker Change: And a placebo study.
Speaker Change: <unk> can correct me, if I'm wrong news about a four day.
Speaker Change: Time period for time to resolution.
Speaker Change: Tamiflu.
Speaker Change: We'll shorten that by a day.
Speaker Change: So it's a three day time resolution <unk>.
Speaker Change: So one day shortening.
Out of four days, that's a 25%.
Improvement in time to resolution.
Speaker Change: And so.
Speaker Change: Yes.
Jay R. Luly: The way this was powered with HR, and in order to keep it a relatively small study of only just under 200 patients, it was powered on a 50% effect; had we powered it on a 25% effect, the study would be even much larger. So it's that fine balance of running a phase two study that is enabling a pivotal trial while keeping it at a manageable size. And we felt with a couple of hundred patients, even though it's a high bar to reach stat second the way it was powered, we should be able to make good decisions based on clinically meaningful improvements. And again, shortening time to resolution of symptoms by one or more days would be clinically meaningful.
Speaker Change: The way this was powered with HR.
Speaker Change: And in order to keep it a relatively small study of only just under 200 patients. It was powered on a 50% effect.
Speaker Change: Had we powered it on a 25% the fact that the study would be even much larger so it's a fine balance of running.
Phase II study that is enabling of a pivotal trial.
Speaker Change: Keeping it at a manageable size and.
Speaker Change: We felt with a couple of hundred.
Speaker Change: Patients, even though it's a high bar to reach stats second on the way it was powered.
Speaker Change: We should be able to.
Make good decisions based on clinical clinically meaningful.
Speaker Change: Improvements in again.
Speaker Change: Shortening.
Speaker Change: Shortener.
Speaker Change: Time to.
Speaker Change: Resolution of sometimes by one or more days.
Speaker Change: It would be clinically meaningful.
Jay R. Luly: Okay, makes sense. And then for the 3-2-3 challenge, what are you hoping to see there? You know, we've said many times that Zelicapavir data is probably the best in class. Are you expecting to see something similar? Do you need to see something similar? Just help us think about that.
Speaker Change: Okay makes sense and then for the <unk> three challenge, but what are you hoping to see there.
Speaker Change: We've said many times is that like half of their data is probably best in class.
Speaker Change: Are you expecting to see something similar or do you need to see something similar.
Speaker Change: Help us think about that thanks.
Jay R. Luly: Yeah, you know, silly kappa beer does set a high bar. You know, the mechanism is an end protein inhibitor. It is about the best challenge study data that any book company has ever put on the boards. So it does represent a high bar.
Speaker Change: Yes.
Speaker Change: Selling catheter beer does set a high bar.
Speaker Change: The mechanism is an N protein inhibitor.
Speaker Change: It is about the best Challenge study data in companies that are put on the boards. So it does represent a high bar that said <unk> three is another mechanism as the preliminaries inhibitor.
Jay R. Luly: That said, 3,2,3 is another mechanism. It's a polymerase inhibitor. It's a picomolar polymerase inhibitor, so it's super potent. Can we replicate the same best-in-class data that we saw with Zelicapavir? You know, we'll see. Hopefully, yes. Unknown Speaker, It's hard to do much better.
Speaker Change: It's a piker molar preliminaries inhibitor, so it's super potent.
Speaker Change: Can we replicate the same best.
Speaker Change: Best in class data that we saw was early cap of your.
Speaker Change: We will see hopefully yes.
Jay R. Luly: I think we want to be in the same range to declare it as a strong player in the field. But you know, based on every bit of data that we have pre-clinically in our phase one data, which showed good safety, tolerability, wonderful exposures after QD dosing, And again, very, very strong virology. We've set it up about as best as we can. We're running it at the same clinical site as we ran the Zilliqap Avir trial. So. You know, we'll see. So we should have data for that in Q3, next next quarter.
Speaker Change: It's hard to do much better I think we want to be in the same range to declared as a as a strong.
Speaker Change: Player.
Speaker Change: In the field, but based on.
Speaker Change: Every bit of data that we have pre clinically in our phase one data, which showed good safety and tolerability.
Speaker Change: Wonderful exposures after QD dosing.
Speaker Change: And again very very strong virology.
Speaker Change: We have set it up about as best as we can we're running it.
Speaker Change: At the same clinical site as we ran as early cap of your trial. So.
Speaker Change: We will see so we should have.
Speaker Change: Data for that.
Speaker Change: In Q3.
Speaker Change: Next next quarter.
Speaker Change: Okay. Thank you.
Speaker Change: Youre welcome.
Speaker Change: Thank you.
Operator: And one moment for our next question, and our next question comes from Roanna Ruiz from Lyrinc Partners. Your line is now open.
Speaker Change: And one moment our next question.
Brian Corey Abrahams: And our next question comes from <unk> from Leerink Partners. Your line is now open.
Nick Gassick: Hey, this is Nick Gassick on behalf of Roanna. Thanks for taking your questions. Maybe first on RSV. Could you give us a sense of how close you are to completing enrollment in the younger age cohort of RSVP? Maybe how long you think it could take to analyze and ultimately share the data afterwards?
Brian Corey Abrahams: This is Matt gasich onto <unk>. Thanks for taking our questions. Maybe first on RFP could you give us a sense of how close you are to completing enrollment of the younger age cohort of RSVP leads maybe how long do you think it could take to analyze.
Brian Corey Abrahams: Ultimately share the data accurate.
Jay R. Luly: Yeah, again, so there are two parts to the study. Part one is completed in all age cohorts. Part two of this study is done in the older age cohorts, and we're down to the final cohort of 20 patients. It's the youngest children from age 28 days to six months, and we've been actively recruiting that cohort. So, you know, we're in the home stretch, and we just. Unfortunately, you know, our pool of patients is now only one sixth of what it was based on age groups.
Speaker Change: Yes again.
Speaker Change: So there are two parts to this study.
Speaker Change: Part one is completed and all age cohorts.
Speaker Change: Part two of this study is done.
Speaker Change: <unk>.
Speaker Change: Older age cohorts and we're down to the final cohort of 20 patients since the youngest children from age 28 days to six months and we've been actively recruiting that cohort so.
Speaker Change: We're in the homestretch.
And.
Speaker Change: We just.
Unfortunately, we can with our pool of patients is now only one six.
Speaker Change: Of what it was based on age groups. So it's a narrower pool.
Jay R. Luly: So it's a narrower pool, and they, you know, any older children, we really have to we can't enroll in the study anymore. So we're just really zeroed in, focused on getting the remaining young children to fill out this cohort.
Any older children.
Speaker Change: We really have to we can't enroll.
Speaker Change: And the study anymore. So we're just really zeroed in focused on getting the remaining.
Speaker Change: Young children to fill out this cohort.
Nick Gassick: Got it. Thanks, Jay.
Speaker Change: Got it thanks, Jay and then maybe on CSU.
Speaker Change: Curious what are you hoping to see in.
Speaker Change: In a future phase one for your <unk> inhibitor in terms of safety, maybe how should we think about frequency of administration for this asset once daily twice daily how should we think about that.
Jay Olson: Well we're still.
Jay Olson: Finally as seen the candidate again, we are targeting to have be finalized.
Jay Olson: In Q4, but suffice it to say.
Jay Olson: We're very much zeroed in on QD.
Jay Olson: Dosing.
Jay Olson: We've made molecules that are very potent very selective.
Jay Olson: We're optimizing DM PK.
Jay Olson: Profiles tissue distribution.
Jay Olson: Number of other sorts of parameters like that to make it the kind of candidate that we.
Jay Olson: Typically bring forward so.
Jay Olson: We've already shown data on a on a strong prototype.
Jay Olson: And we continue to the chemist are very busy.
Speaker Change: Well not just chemists.
Speaker Change: <unk> done all the.
Speaker Change: The biology people, who are doing the characterization and our DM PK and safety team are working very very diligently on this so we would be aiming.
Nick Gassick: And then maybe on CSU, I'm curious, you know, what are you hoping to see in a future phase one for your oral kit inhibitor in terms of safety? Maybe how should we think about frequency of administration for this asset? Is it once daily, twice daily? How should we think about that?
Speaker Change: For acuity candy.
Speaker Change: Candidate that would be.
The best safety profile, we can provide as well as.
Okay.
Good potency and selectivity.
That's helpful. Thank you.
Speaker Change: Yes.
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: Hi, This is Luke on for Brian.
Luke: For Edp three to three can you remind us of your current thoughts on potentially entering a phase <unk> in otherwise healthy adults as opposed to starting with the higher risk in pediatric populations like you've done with solid cap of here and would you wait for RSVP their RSV EHR data to make this decision.
Speaker Change: Yes, that's a good question I mean, the short answer is we won't do another RSV study in otherwise healthy adults. They just we found out from our RSVP trial.
Speaker Change: That there the otherwise healthy folks just resolve the.
Speaker Change: Self resolve the infection so quickly on their own.
Speaker Change: So they're really not in need.
Yes.
Speaker Change: Therapy.
Speaker Change: We would only focus on high risk patient populations.
Jay R. Luly: Um, well, we're still, you know, finalizing the candidate. Again, we were targeting to have the finalists in Q4.
Speaker Change: Yeah.
Speaker Change: We're hoping to have an abundance of data.
Speaker Change: Sure.
Speaker Change: In the second half.
Speaker Change: We will have $3 three data will have peds data.
We will be able to look at the totality of the information and figure out how.
Speaker Change: Best to position.
Jay R. Luly: But suffice it to say, we're very much zeroed in on QD dosing. You know, we've made molecules that are very potent or very selective. We're optimizing DMPK profiles, tissue distribution, a number of other sorts of parameters like that to make it the kind of candidate that we typically bring forward. So we've already shown data on a strong prototype, and we continue to; the chemists are very busy. Well, not just chemists, but the chemists and all the biology people who are doing the characterization, and our DMPK and safety team are working very, very diligently on this. So we would be aiming for a QD candidate that would have the best safety profile we can provide as well as good potency and selectivity.
Speaker Change: Three to three so.
For us it's been about bringing another strong mechanism.
Operator: You're welcome. 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.
Speaker Change: Forward, we've been working on this.
Speaker Change: From the beginning I guess, we've been working on it for a few years now to bring forward, another differentiated asset and RSV and that could.
Speaker Change: Give us the potential for.
Speaker Change: Doing combination therapy down the road and particularly hard to treat patient populations.
Speaker Change: Potentially it could help.
Speaker Change: Widen the treatment window, where we too.
Speaker Change: So after a patient with two drugs rather than one so it's just.
Speaker Change: Just part of our strategy overall to try to build a leadership position.
Speaker Change: RSV is a therapeutics company.
Speaker Change: And the more the more sort of cards, we have to play.
Speaker Change: I think we can come up with ways to.
Speaker Change: To leverage.
Speaker Change: Another asset over time, so the key is getting it up to a strong threshold on the challenge study data first.
Speaker Change: Great. Thank you.
Brian Peter Skorney: Yeah, that's a good question. I mean, the short answer is, we won't do another RSV study in otherwise healthy adults. They just, we found out from our RSVP trial that otherwise healthy folks just resolve the self-resolve the infection so quickly on their own. So they're really not in need of therapy.
Speaker Change: And thank you.
Speaker Change: Okay.
Speaker Change: And one moment our next question.
Speaker Change: Okay.
And our next question comes from Lisa Baker from <unk>. Your line is now open.
Speaker Change: Hi, This is <unk> on for Lisa.
Speaker Change: I have a question on the <unk> T program what doses.
Speaker Change: <unk> are you testing in phase Iia Human Challenge study.
Speaker Change: Yes so.
Speaker Change: We're looking at a couple of different dose regimens. So the first is <unk>.
Speaker Change: 600 milligrams straight across for five days.
Speaker Change: The other is 600.
Speaker Change: Milligram loading dose on day, one followed by 200 milligrams on each subsequent day.
Speaker Change: It's kind of like.
Speaker Change: And antibiotics, they do that sometimes to give you a loading dose on day, one and then a lower maintenance dose for a few days.
Speaker Change: Thereafter, so we just put both of them in.
Speaker Change: And.
Speaker Change: I think in theory either.
Speaker Change: Based on calculations and modeling either has.
Speaker Change: A good chance of demonstrating the activity we want.
Speaker Change: One obviously is a lower dose and has different cost of goods ramifications et cetera et cetera. So we're just.
Speaker Change: The challenge study is just such a wonderful way.
Speaker Change: Way to tease all of those kinds of questions out because you don't have to wait for the season, you can just affect human volunteers lung cohorts up every few weeks.
Speaker Change: Dose them so.
Speaker Change: Does that does that answer your question.
Speaker Change: Yeah. That's helpful. Thank you I have a second question on the <unk>.
Speaker Change: Thanks again.
Speaker Change: The case against Pfizer, because lucky if I just said that.
Speaker Change: Fixed a little bit doesn't infringe the patent because.
Speaker Change: I believe it has high plateau.
Speaker Change: Now described in New York.
Speaker Change: So if you can comment on that.
Speaker Change: Yes.
Speaker Change: Really can't get.
Speaker Change: And to the discussion on our ongoing patent litigation.
Speaker Change: The only the only thing I can say is that.
Speaker Change: Assuming that were to go to trial.
Speaker Change: We would expect to trial.
Speaker Change: At the end of the year.
Speaker Change: Okay.
Speaker Change: Thank you that's helpful.
Speaker Change: Youre welcome.
Speaker Change: And thank you.
Speaker Change: 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.
Speaker Change: And one moment our next question.
Speaker Change: And our next question comes from Jay Olson from Oppenheimer. Your line is now open.
Jay Olson: Well, hi, Jay Thanks for providing the update and taking the questions.
Jay Olson: On the immunology program what are the most important differentiators youre looking for with your oral kit inhibitor candidate versus other.
Jay Olson: Oral <unk> inhibitors in development.
Jay Olson: How are you thinking about positioning of kit inhibitors versus other ores.
Jay Olson: Oral therapies for CSU, such as PTK inhibitors.
Jay Olson: Thanks, Thanks for the questions Yeah ill, let Terry speak to that sure Hi, Jay.
Terry: I think some of the data that's been generated from the monoclonal antibodies against kit that would be from from.
Terry: From Sel Dex and then an earlier program with Jasper have indicated that this target inhibiting this target has some of the best in disease efficacy at least from the phase III trials that have been have been run. So yes. It gives us confidence in the target and what we're really hoping for our program is to match.
Terry: Or even exceed potentially that efficacy with a good safety profile just with an oral route of administration.
Speaker Change: That's the goal of our program as you mentioned, there's other companies working on this as well. They are all early they are all preclinical.
At the moment, there's really only preclinical data at the moment, so it's hard to see.
Speaker Change: What I would say what would be differentiated but I can tell you. What our program is looking to achieve and that would be something that is able to be dose QD orally.
Speaker Change: Something that is very potent against kit, but selective and so.
Speaker Change: <unk>.
Speaker Change: Leading to a good safety profile and just balancing that.
Speaker Change: That potency and selectivity, so that the efficacy and safety profile.
Speaker Change: Could potentially be.
It's something that you would have as best in class.
Speaker Change: And then I would just say that the oral inhibitors, maybe more tunable I think this is something that remains to be proven in the clinic, but.
Speaker Change: Whether they're able to be in.
Speaker Change: Dosed and tuned more finely than a monoclonal antibody you can certainly.
Speaker Change: Have a little bit more.
Speaker Change: Yeah.
Speaker Change: Flexibility over that so I think remains to be determined but one potential.
Speaker Change: Strategy as well.
Speaker Change: Okay, great. Thank you and then can you just talk about how you're thinking about additional indications and your development plan beyond CSU.
Speaker Change: Sure you mean for the kit inhibitor, yes.
Speaker Change: Yes.
Speaker Change: Yeah. So.
The reason that we're interested in kit is.
Speaker Change: He is a key driver for mast cells, and we know that <unk> have been implicated in a number of <unk>.
Speaker Change: Indications so certainly.
Speaker Change: Chronic inducible urticaria or some new is something Thats also been studied with this target and there are some good data from the monoclonal antibody here.
Or is it a philip it's off a J. This is also another indication would be interested in.
Speaker Change: Pn as well and even potentially agonize something that one can think about with these types of inhibitors.
Speaker Change: Okay, Great. That's super helpful. Thanks for taking the questions.
Speaker Change: Mhm.
Speaker Change: And thank you.
Speaker Change: And I am showing no further questions I would now like to turn the call back over to Jennifer Viera for closing remarks.
Jay R. Luly: We would only focus on high-risk patient populations. And, you know, we're hoping to have an abundance of data here, you know, in the second half. You know, we'll have 3-2-3 data, we'll have PEDS data; we'll be able to look at the totality of the information and figure out how best to position 3-2-3. So, for us, it's been about bringing another strong mechanism forward. We've been working on this, you know, from the beginning. I guess we've been working on it for a few years now to bring forward another differentiated asset in RSV.
Jay R. Luly: And that could, you know, give us the potential for doing combination therapy down the road in particularly hard-to-treat patient populations; potentially, it could help widen the treatment window where we go after a patient with two drugs rather than one. So it's just part of our strategy overall to try to build a leadership position and RSV as a therapeutics company. And the more the more sort of cards we have to play, I think we can come up with ways to, you know, leverage another asset over time. So, the key is getting it up to a strong threshold on the challenge study data first.
Operator: and thank you. And one moment for our next question, and our next question comes from Liisa Bayko from EVR. Your line is now open.
Seema: Hi, this is Seema speaking on behalf of Liisa. I have a question about the 3-2-3 program. What doses of 3-2-3 are you testing in phase 2a human talent study?
Jennifer Viera: Thank you operator, and thanks to everyone for joining US today. If you have additional questions. Please feel free to contact us by email or call the office and have a great night.
Jay R. Luly: Yeah, so we're looking at a couple of different dose regimens. So the first is 600 milligrams straight across for five days. The other is a 600 milligram loading dose on day one, followed by 200 milligrams on each subsequent day. It's kind of like, in antibiotics, they do that sometimes to give you a loading dose on day one and then a lower maintenance dose for a few days thereafter.
Jay R. Luly: So we just put both of them in, and I think, in theory, either, at least based on calculations and modeling, either has a good chance of demonstrating the activity we want. One, obviously, is a lower dose and has different cost of goods ramifications, etc, etc.
Jay R. Luly: So we're just, the challenge study is just such a wonderful way to tease all those kinds of questions out because you don't have to wait for the season. You can just, in fact, find volunteers, line cohorts up every few weeks, and those. Does that answer your question? Yeah.
Seema: Yeah, that's helpful. Thank you. I had a second question on the patent in the case against Pfizer because last year Pfizer said that Paxilovid doesn't infringe the patent because Paxilovid has a tri-fluorogroup, which is not described in your patent. So could you comment on that?
Jay R. Luly: Yeah, I really can't get into the discussion of our ongoing patent litigation. Unknown Speaker, The only thing I can say is that, assuming that it were to go to trial, we would expect a trial around the end of the year.
Operator: 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. And one moment for our next question. And our next question comes from Jay Olson from Oppenheimer. Your line is now open.
Jay Olson: Oh, hi Jay. Thanks for providing the update and taking the questions. On the immunology program, what are the most important differentiators you're looking for in your oral kit inhibitor candidate versus other oral kit inhibitors in development? And how are you thinking about positioning oral kit inhibitors versus other oral therapies for CSUs such as BTK inhibitors?
Tara Lynn Kieffer: Thanks. Thanks for the question, Jay. I'll let Tara know.
Tara Lynn Kieffer: So I think, you know, some of the data that's been generated from the monoclonal antibodies against KIT, that would be from CELDEX and then an earlier program with JASPER, have indicated that this target, inhibiting this target, has some of the best disease efficacy, at least from the phase two trials that have been run. And so, you know, it gives us confidence in the target. And what we're really hoping for with our program is to match or even potentially exceed that efficacy with a good safety profile, just with an oral route of administration. So that's the goal of our program. You know, as you mentioned, there are other companies working on this as well.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Tara Lynn Kieffer: They're all early, they're all preclinical. At the moment, there's really only preclinical data at the moment, so it's hard to, you know, sort of say what would be differentiated. But I can tell you what our program is looking to achieve.
Tara Lynn Kieffer: And that would be, you know, something that is able to be dosed QD orally, something that is very potent against kit but selective. And so, you know, leading to a good safety profile and just balancing that potency and selectivity so that the efficacy and safety profile could potentially be something that you would have as best in class. And then I would just say that oral inhibitors may be more tunable.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Tara Lynn Kieffer: I think this is something that remains to be proven in the clinic, but you know, whether they're able to be dosed and tuned more finely than a monoclonal antibody, you can certainly have a little bit more flexibility over that. So I think it remains to be determined, but one potential strategy as well.
Jay Olson: Okay, great. Thank you. And then can you just talk about how you're thinking about additional indications in your development plan beyond CSU?
Tara Lynn Kieffer: Sure you mean for the kit inhibitor? Yes. Yeah, so.
Tara Lynn Kieffer: You know, the reason that we're interested in KIT is that it obviously is a key driver for mast cells. And we know that mast cells have been implicated in a number of different indications. So certainly, chronic inducible urticaria or Sindu is something that's also been studied with this target, and there's some good data from the monoclonal antibodies here. EOE or eosinophilic esophagitis is also another indication we'd be interested in. PN as well, and potentially asthma is something that, you know, one could think about with these types of inhibitors.
Tara Lynn Kieffer: Okay, great. That's super helpful. Thanks for taking the time to ask the question.
Operator: 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, operator. And thanks to everyone for joining us today. If you have additional questions, please feel free to contact us by email or call the office. Have a great night.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: [music].