Q3 2022 Enanta Pharmaceuticals Inc Earnings Call
Operator: Good afternoon and welcome to Enanta Pharmaceuticals for fiscal third quarter 2022 financial results conference call.
Good afternoon, and welcome to announce pharmaceuticals for fiscal third quarter 2022 financial results conference call.
Operator: At this time, all participants are in a listen-only mode.
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.
Operator: There will be a question and answer session at the end of the prepared remarks. Please be advised that this call is being recorded.
Please be advised that this call is being recorded.
Operator: I would like now to turn the call over to Jennifer Viera,
I would like now to turn the call over to Jennifer Viera Investor relation.
Jennifer Viera: Investor Relations.
Please go ahead.
Thank you operator.
Thanks to everyone for joining us this afternoon.
The news release with our fiscal third quarter 2022 financial results was issued this afternoon and is available on our website.
On the call today are Dr. J, Lullay, President and Chief Executive Officer, Paul Mellett, Our Chief Financial Officer, and other members of <unk> Senior management team.
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.
It 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-Q and other periodic reports filed with the SEC Anantha does not take 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 C E O J.
Jennifer Viera: Please go ahead.
Jennifer Viera: Thank you operator and thanks to everyone for joining us this afternoon.
Thank you Jennifer and good afternoon, everyone.
Our vision at Atlanta is to leverage our expertise in virology and liver disease to discover develop and deliver groundbreaking medicines as we've already done with the cap rate for your <unk>.
And Abbvie is maverick for hepatitis C virus.
Jennifer Viera: The news release with our fiscal third quarter 2022 financial results was issued this afternoon and is available on our website.
This quarter, we made important strides toward achieving another breakthrough medicine.
Jennifer Viera: On the call today are Dr. Jay Luly, President and Chief Executive Officer, Paul Mellett, our Chief Financial Officer and other members of Enanta's, senior management team.
Today I will start by detailing our recent positive data from the phase one trial of.
E D P 235 in healthy volunteers.
As a reminder, ETB to three five is our oral antiviral inhibitor of the Corona virus three C. L. Protease also known as the main protease or M Pro which is in clinical development for the treatment of COVID-19.
Edp 235 has fast track designation and is designed to be a once daily oral treatment without the requirement for return of are boosting.
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 from those statements.
Jennifer Viera: A description of these risks is in our most recent form 10-Q and other periodic reports filed with the SEC.
Our first in human randomized double blind placebo controlled phase one study enrolled healthy volunteers to evaluate the safety Tolerability and pharmacokinetics.
Jennifer Viera: Enanta does not undertake any obligation to update any forward-looking statements made during this call.
Jennifer Viera: I'd now like to turn the call over to Dr. Jay Luly, President and CEO.
Jennifer Viera: Jay?
Jay Luly: Thank you, Jennifer, and good afternoon, everyone.
Oral edp, three five and single and multiple ascending doses for seven days, along with the effect of food.
Jay Luly: Our vision at Enanta is to leverage our expertise, in virology and liver disease to discover, develop, and deliver groundbreaking medicines, as we've already done with Glicaprevir and Abbe's Maverick for hepatitis C virus.
Total of 72 subjects received at least one dose of Edp 235 or placebo.
Jay Luly: This quarter, we made important strides toward achieving another breakthrough medicine.
We're 40 subjects in the single ascending dose phase and 32 in the multiple ascending dose phase.
Jay Luly: Today, I will start by detailing our recent positive data from the Phase 1 trial of EDP-235, and Healthy Volunteers. As a reminder, EDP-235 is our oral antiviral inhibitor of the coronavirus 3CL protease, also known as the main protease, or MPRO, which is in clinical development for, the treatment of COVID-19. EDP-235 has fast-track designation and is designed to be a once-daily oral treatment without the requirement for ritonavir boosting. Our first in-human, randomized, double-blind, placebo-controlled Phase 1 study enrolled healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of oral EDP-235. Oral EDP-235 in single and multiple ascending doses for seven days along with the effect of, food. A total of 72 subjects received at least one dose of EDP-235 or placebo.
All sad and Mad cohorts enrolled eight participants who were randomized to receive edp 235 or placebo in a three to one ratio.
Jay Luly: There were 40 subjects in the single ascending dose phase and 32 in the multiple ascending dose phase. All SAD and MAD cohorts enrolled eight participants who were randomized to receive, EDP-235 or placebo in a three-to-one ratio. To optimize dose selections, the study evaluated a broad range of single and multiple doses in a fasted and fed state. The FAD phase included cohorts with doses of 50 mg, 100, 200, 400, and 800 mg fasted, and a 200 mg fed crossover cohort.
To optimize dose selection the study evaluated a broad range of single and multiple doses in a fasted and fed state.
Sad phase included cohorts with doses of 50 milligrams 100, 200, 408 hundred milligrams fasted and a 200 milligram fed crossover cohort. The Mad phase included cohorts with doses of 200 milligrams and 400 milligrams fasted and 400 milligrams and 800.
Jay Luly: The MAD phase included cohorts with doses of 200 mg and 400 mg fasted and 400 mg and 800 mg fed. Overall, EDP-235 was generally safe and well-tolerated in healthy subjects up to 400 mg for up to seven days. Adverse events were infrequent, with headache and gastrointestinal-related symptoms such as nausea and abdominal discomfort being the most commonly reported AEs during the MAD phase.
Milligrams fed.
Overall, Edp 235 was generally safe and well tolerated in healthy subjects up to 400 milligrams for up to seven days.
Adverse events were infrequent with headache, and gastrointestinal related symptoms, such as nausea, and abdominal discomfort being the most commonly reported aes during the Mad phase.
Jay Luly: The majority of AEs were mild, with the exception of three that led to study discontinuations. There was one moderate headache in the 400 mg fasted cohort, one severe headache in the 800 mg fed cohort, and one grade 3 ALT grade 2 AST elevation in the 800 mg fed cohort. The single subject with elevated ALT-AST had no other lab abnormalities, and no clinically significant lab abnormalities were observed in any other patients. Furthermore, all AEs were subsequently resolved.
The majority of Aes were mild with the exception of three that led to study discontinuation.
Was one moderate headache, and the 400 milligram fasted cohort.
One severe headache, and the 800 milligram fed cohort and one grade three a L. T grade to a S. T elevation in the 800 milligram cohort.
The single subject with elevated L. T. A S. T had no other lab abnormalities and no clinically significant lab abnormalities were observed in any other patients. Furthermore, all aes were subsequently resolved.
Jay Luly: EDP-235 exposure was enhanced with food administration of a standard meal and increased approximately proportionally with ascending single and multiple doses, with a half-life consistently ranging from 13 to 22 hours, resulting in a PK profile suitable for a once-daily dosing.
It would be two to three five exposure was enhanced with food administration have a standard meal and increased approximately proportionally with ascending single and multiple doses with a half life consistently ranging from 13 to 22 hours, resulting in a PK profile suitable for once daily dosing.
Jay Luly: Data demonstrated that EDP-235 had strong exposure multiples over the EC90, where EC90 is a measure of potency, namely the concentration of drug that results in 90% inhibition in vitro. Specifically, EDP-235, 200 mg taken once daily with food, resulted in mean trough plasma levels at steady state that were threefold and sixfold over the plasma protein-adjusted EC90 for the alpha variant and delta variant, respectively, while 400 mg resulted in levels that were sixfold and twelvefold over the plasma protein-adjusted EC90 for these respective variants.
Data demonstrated that Edp three five had strong exposure multiples over the EC 90, where you see 90 is a measure of potency, namely the concentration of drug that results in 90% inhibition in vitro.
Specifically Edp 235, 200 milligrams taken once daily with food resulted in mean trough plasma levels at steady state that were three fold and sixfold over the plasma protein adjusted <unk> 90 for the Alpha variant and Delta variant, respectively. While 400 milligrams result.
And levels that were six fold and 12 fold over the plasma protein adjusted E. C 90 for these respective variance he's target exposure multiples were achieved without the need for a return of air boosting and its associated drug drug interactions. Additionally.
Jay Luly: These target exposure multiples were achieved without the need for ritonavir boosting and its associated drug-drug interactions. Additionally, EDP-235 is projected to have four times higher drug levels in lung tissue compared to plasma, which would be expected to drive the 400 mg multiples to 24-fold and 48-fold over the EC90 for the alpha variant and the delta variant, respectively.
Additionally, E. D. P 235 is projected to have four times higher drug levels in lung tissue compared to plasma which would be expected to drive the 400 milligram multiples to 'twenty four fold and 48 fold over the EC 94, the alpha variant and the Delta variant respectively.
Jay Luly: This is significant because an antiviral drug's potency and exposure level often translates to clinical efficacy.
This is significant because an antiviral drugs potency and exposure level, often translates to clinical efficacy E.
Jay Luly: EDP-235's preclinical and clinical profiles suggest the potential for a best-in-class antiviral treatment for SARS-CoV-2 infection.
D P. Two three fives preclinical and clinical profile suggest the potential for a best in class antiviral treatment for Sars Cov two infection.
Jay Luly: We plan to finalize a Phase II protocol in alignment with the FDA and initiate the study during the fourth quarter of this year.
We plan to finalize the phase III protocol and alignment with the FDA and initiate the study during the fourth quarter of this year.
Jay Luly: Looking at the COVID-19 landscape, there continue to be infections globally due to new variants, and the BA5 variant reportedly can circumvent much of the immunity arising from prior COVID infection or vaccination.
Looking at the COVID-19 landscape there continue to be infections globally due to the new variants in the VA five variant reportedly can circumvent much of the immunity arising from private prior COVID-19 infection or vaccination.
Jay Luly: This highlights the urgent need for convenient, easily prescribed antiviral COVID treatments for patients, potentially even beyond high-risk patients.
This highlights the urgent need for a convenient easily prescribed anti viral COVID-19 treatments for patients potentially even beyond high risk patients.
Jay Luly: ADP235 has the potential to fill this need, as it is designed to be used once daily without ritonavir boosting, and easily prescribed quickly without the need to assess drug-drug interactions associated with ritonavir.
Edp 235 has the potential to fill this need as it is designed to be used once daily without ritonavir boosting and easily prescribed quickly without the need to assess drug drug interactions associated with retarded here, we believe a one pill once a day antiviral treatment regimen with Edp two three.
Jay Luly: We believe a one-pill, once-a-day antiviral treatment regimen with ADP235 can enable a true test-to-treat model, to facilitate rapid treatment of COVID infections.
Three five could enable a true test to treat model to facilitate rapid treatment of COVID-19 infections.
Jay Luly: Beyond COVID-19 and continuing with our industry-leading respiratory virology treatment portfolio, we are also advancing our respiratory syncytial virus, or RSV, program. RSV is another virus that represents an important unmet need, as it can result in severe respiratory infection, and is associated with significant morbidity and mortality in children, the elderly, and the immune-compromised.
Beyond COVID-19, and continuing with our industry, leading respiratory virology treatment portfolio. We are also advancing our respiratory syncytial virus or RSV program.
RSP is another virus that represents an important unmet need as it can result in severe respiratory infection and is associated with significant morbidity and mortality in children, the elderly and the immune compromised.
Jay Luly: Further, there are no targeted treatments or vaccines available.
There are no targeted treatments or vaccines available.
Jay Luly: Our robust RSV program includes ADP938, the most advanced N-protein inhibitor in clinical development today, as well as ADP323, a potent L-protein inhibitor. We are confident in the potential of ADP938, which has fast-track designation from the FDA.
Our robust RSV program includes Edp 938, the most advanced N protein inhibitor in clinical development today as well as Edp 323, a potent L protein inhibitor.
We are confident in the potential of Edp 938, which has fast track designation from the F. D. A.
Jay Luly: We are evaluating ADP938 high-risk populations in ongoing and planned clinical studies, including pediatric patients, adult hematopoietic cell transplant recipients, and high-risk adults, all of which have significant unmet need.
We're evaluating Edp 938 high risk populations in the ongoing and planned clinical studies, including in pediatric patients adult hematopoietic cell transplant recipients and high risk adults all of which have significant unmet need.
Jay Luly: Last quarter, we announced data from RSVP, a Phase IIb trial in otherwise healthy adults with community-acquired RSV infection. In this low-risk population, which had mild, self-resolving upper respiratory tract infection, ADP938 did not meet the primary endpoint of reduction in total symptom score compared to placebo or the secondary antiviral endpoints. However, we were pleased to observe a statistically significant difference in the number of subjects, achieving undetectable RSV RNA at the end of treatment with ADP938, making this the only study that has reported a statistically significant antiviral effect in an otherwise healthy adult population with community-acquired RSV.
Last quarter, we announced data from RSV P. A phase two b trial in otherwise healthy adults with community acquired RSV infection, and this low risk population, which had mild self resolving in upper respiratory tract infection. Edp 938 did not meet the primary endpoint of reduction in total symptom score.
Compared to placebo or the secondary antiviral endpoints. However.
However, we were pleased to observe a statistically significant difference in the number of subjects achieving undetectable RSV RNA at the end of treatment with Edp 938, making this the only study that has reported a statistically significant antiviral effect in an otherwise healthy adult population with community.
Wired RSV.
Jay Luly: Even though patients were treated within 48 hours of symptom onset, a key observation in this study was that the viral load and symptoms had already peaked and were declining at the time of the first dose, indicating RSV infection resolves quickly in this otherwise healthy population.
Even though patients were treated within 48 hours of symptom onset a key observation in this study was that the viral load and sometimes had already peaked and were declining at the time of the first dose, indicating RSV infection resolved as quickly in this otherwise healthy population.
Jay Luly: Importantly, ADP938 demonstrated a favorable safety profile in a data set, that now includes approximately 500 subjects exposed to the drug.
Importantly, edp 938 demonstrated a favorable safety profile and a data set that now includes approximately 500 subjects exposed to the drug.
Jay Luly: We continue to believe that RSV antiviral treatment, including EDP-938, has the greatest potential to show optimal efficacy in high-risk populations, as these patients have reduced RSV immunity, which manifests in a higher and longer duration of viral load and greater disease severity, allowing a bigger window to realize the full potential of EDP-938. Moving forward, our broad clinical development plan is focused on evaluating EDP-938 in populations with the greatest unmet need, namely those who are at high risk for severe disease.
We continue to believe that RSV anti viral treatment, including Edp 938 has the greatest potential to show optimal efficacy in high risk populations. As these patients have reduced RSV immunity, which manifests any higher and longer duration of viral load and greater disease severity, allowing a bit.
Her window to realize the full potential of Edp 938.
Moving forward, our broad clinical development plan is focused on evaluating edp 938, and populations with the greatest unmet need, namely those who are at high risk for severe disease are ongoing studies include RSV Peds, a phase two study in pediatric RSV patients.
Jay Luly: Our ongoing studies include RSV-PEDS, a Phase II study in pediatric RSV patients, and RSV-TX, a Phase IIb study in adult hematopoietic cell transplant recipients with RSV.
And RSP T X the fees to be study in adult hematopoietic cell transplant recipients with RSV. Both are expected to recruit beyond 2022 subject to the reemergence of RSV and broader populations at pre COVID-19 levels.
Jay Luly: Both are expected to recruit beyond 2022, subject to the reemergence of RSV in broader populations at pre-COVID levels.
Jay Luly: Also in the fourth quarter of this year, we're planning to initiate another Phase IIb study in high-risk adults, including the elderly and those who have asthma, COPD, or congestive heart failure. We believe EDP-938 has the potential to deliver a potent oral antiviral treatment for all populations at high risk from RSV infection.
Also in the fourth quarter of this year, we're planning to initiate another phase <unk> study in high risk adults, including the elderly and those who have asthma COPD or congestive heart failure.
We believe Edp 938 has the potential to deliver a potent oral antiviral treatment for all populations at high risk from RSV infection.
Jay Luly: Our robust RSV antiviral portfolio also includes EDP-323, a novel oral therapeutic targeting the RSV-L protein RNA polymerase. We believe EDP-323 has the potential to be a standalone treatment, or it may be used in combination with other agents, such as EDP-938, to potentially broaden the treatment window or range of addressable RSV patient populations. EDP-323 is supported by preclinical data that demonstrates strong oral absorption and good plasma exposure across different species. Importantly, EDP-323 has sub-nanomolar in vitro potency against both major subtypes of RSV, RSV-A and RSV-B, and is not expected to have cross-resistance to other classes of inhibitors.
Our robust RSV any viral portfolio also includes edp three Q3, a novel oral therapeutic targeting the RSV L protein RNA polymerase.
We believe Edp 323 has the potential to be a standalone treatment or it may be used in combination with other agents such as edp 938 to potentially broaden the treatment window or range of addressable RSV patient populations.
<unk> three is supported by preclinical data that demonstrates strong oral absorption and good plasma exposure across different species.
Importantly, ATP 323 has suddenly animal or in vitro potency against both major subtypes of RSV RSV.
That's V a and RSV b and is not expected to have cross resistance to other classes of inhibitors. We plan to initiate a phase one study of Edp 323 in the fourth quarter of this year.
Jay Luly: We plan to initiate a Phase I study of EDP-323 in the fourth quarter of this year.
Jay Luly: We also continue to pursue our respiratory discovery program in human metapneumovirus, or HMPV, a virus that is similar to RSV in that it impacts a number of vulnerable populations, including the elderly, adults with underlying pulmonary disease, and those who are immune compromised. We're continuing lead optimization of potent nanomolar HMPV inhibitors and plan to select a clinical candidate in the first half of 2023.
We also continue to pursue our respiratory discovery program in human Metapneumovirus or H M. P. V. A virus that is similar to RSV and the impacts a number of vulnerable populations, including the elderly adults with underlying pulmonary disease and those who are immune compromised we're.
In lead optimization of potent animal or H M. P V inhibitors and plan to select a clinical candidate in the first half of 2023.
Jay Luly: Turning to hepatitis B, we remain committed to developing a combination regimen as a functional cure for chronic HPV patients, as we believe the ultimate cure for this infection will involve combination therapy.
Turning to hepatitis B, we remain committed to developing a combination regimen is a functional cure for chronic HBV patients as we believe the ultimate cure for this infection will involve combination therapy or.
Jay Luly: Our commitment is based on the continued high unmet need for this disease, which is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer, the second leading cause of cancer deaths in the world.
Our commitment is based on the continued high unmet need for this disease, which is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer. The second leading cause of cancer deaths in the world last quarter. It easel final data from two of our phase one B study.
Jay Luly: Last quarter at ESL, final data from two of our Phase I-B studies of EDP-514 were presented. EDP-514 is our HPV core inhibitor with fast-track designation, which is shown to be safe and potent in two different chronic HPV patient populations, those who have high viral load, whom we refer to as viremic patients, and those who are on treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as nuke-suppressed patients.
Use of Edp 514 were presented.
D. P 514 is our HBV core inhibitor with fast track designation, which is shown to be safe and potent in two different chronic HBV patient populations, those who have high viral load, whom we refer to as viremia patients and those who are on treatment with a nucleoside reverse transcriptase inhibitor, whom we were.
Prior to his nuc suppressed patients based on these data we remain convinced that Edp 514 has the potential to be a best in class core inhibitor for HBV.
Jay Luly: Based on these data, we remain convinced that EDP-514 has the potential to be a best-in-class, core inhibitor for HPV. We believe that a core inhibitor such as EDP-514 will ultimately be an important component, of a successful combination regimen.
We believe that our core inhibitors, such as Edp 514 will ultimately be an important component of a successful combination regimen, we continue to evaluate internal and external opportunities for additional candidates to develop in combination with edp 514, and a nuc to create a triple drug regimen.
Jay Luly: We continue to evaluate internal and external opportunities for additional candidates to, develop in combination with EDP-514 and a nuke to create a triple drug regimen.
Before moving to the financials I wanted to address briefly our ongoing patent litigation in which we are seeking damages for pfizer's infringement of our issued 95, three patent and the manufacturer use and sale of its COVID-19, antiviral packs love it.
Jay Luly: Before moving to the financials, I want to address briefly our ongoing patent litigation, in which we are seeking damages for Pfizer's infringement of our issued 953 patent and the manufacture, use, and sale of its COVID-19 antiviral, Paxlovid.
Jay Luly: We recognize the importance of Paxlovid's availability for patients, and we do not intend, to seek an injunction or take other action in this litigation to impede the production, sale, or distribution of Paxlovid.
We recognize the important of Pac Slovenes availability for patients and we do not intend to seek an injunction or take other action in this litigation to impede the production sale or distribution of Pac slogan and finally in this lawsuit we are taking steps to ensure that we will be fairly compensated for our intellectual property.
Jay Luly: And filing this lawsuit, we are taking steps to ensure that we will be fairly compensated, for our intellectual property.
Jay Luly: Importantly, our 953 patent is completely separate from the patent estate covering our, discovery of EDP-235 and our ongoing antiviral discovery work for coronaviruses. Indeed, we have a growing 3CL protease inhibitor patent estate, including several issued U.S, patents, one of which covers EDP-235.
Importantly, our 95 three patent is completely separate from the patent estate covering our discovery of Edp 235, and our ongoing antiviral discovery work for Corona viruses. Indeed, we have a growing three C. L protease inhibitor patent to state, including several issued U S patents, one of which cut.
Or is Edp 235. These patents described compounds built on an independent and distinct chemical scaffold from the one described in the 95, three patent and in Pfizer's patents for <unk>.
Jay Luly: These patents describe compounds built on an independent and distinct chemical scaffold, from the one described in the 953 patent and in Pfizer's patents for Paxlovid.
Jay Luly: At this point, I'd also like to take the opportunity to welcome our new chief medical officer,
This point I'd also like to take the opportunity to welcome our new Chief Medical Officer, Dr. Scott Rottinghaus, who joins an answer today.
Jay Luly: Dr. Scott Rottinghaus, who joins ANATA today. Scott is an infectious disease-trained physician who has more than 20 years of experience in, a broad range of therapeutic areas. He joins us from Alexion, now a part of AstraZeneca, where he was vice president, head of clinical, development, hematology, and nephrology. He has also held positions at Pfizer, where he worked on trials of a DNA vaccine for influenza, and on studies of anti-infectives, and continued to practice as an attending physician and assistant clinical professor in infectious diseases at Yale School of Medicine. His experience also includes multiple NDA and MAA submissions and FDA advisory committee, participation.
Scott is an infectious disease trained physician, who has more than 20 years of experience in a broad range of therapeutic areas. He joins us from Alexia on now a part of Astrazeneca, where he was vice president head of clinical development Hematology and nephrology.
He has also held positions at Pfizer, where he worked on trials of a DNA vaccine for influenza and on studies of anti Infectives and continued to practices and attending physician in assistant clinical professor in infectious diseases at Yale School of Medicine.
His experience also includes multiple NDA and MAA submissions and FDA Advisory Committee participation. We're very excited to have Scott join us as we advance our antiviral development programs.
Jay Luly: We're very excited to have Scott join us as we advance our antiviral development programs.
Jay Luly: Finally, I'd like to wrap up by highlighting our near-term milestones.
Finally, I'd like to wrap up by highlighting our near term milestones.
Jay Luly: We are thrilled with our Phase 1 results of EDP-235 and look forward to advancing the, COVID-19 program into a Phase 2 study in the fourth quarter of this year.
We are thrilled with our phase one results of Edp 235, and look forward to advancing the COVID-19 program into a phase two study in the fourth quarter of this year.
Jay Luly: We're also on track to begin a new Phase 2 RSV study in high-risk adults in the fourth, quarter of this year.
We're also on track to begin a new phase two RSV study in high risk adults in the fourth quarter of this year and last we're excited to initiate a phase one study for Edp 323, our RSV L inhibitor in the fourth quarter of this year as well as nominated clinical candidate for human Metapneumovirus and the first half.
Jay Luly: And last, we're excited to initiate a Phase 1 study for EDP-323, our RSV-L inhibitor, in the fourth quarter of this year, as well as nominate a clinical candidate for human metapneumovirus in the first half of 2023.
Half of 2023.
Jay Luly: With that, I'll turn the call over to Paul to discuss the financials.
With that I'll turn the call over to Paul to discuss the financials Paul.
Paul Mellett: Paul?
Paul Mellett: Thank you, Jay.
Thank you Jay.
I'd like to remind everyone that a natural reports on a September 30 fiscal year schedule today.
Paul Mellett: I'd like to remind everyone that Enanta reports on a September 30th fiscal, year schedule.
Today, we are reporting results for our third quarter ended June 30th 2022.
Paul Mellett: Today we are reporting results for our third quarter ended June 30th, 2022. For the quarter, total revenue was $19.5 million and consisted of royalty revenue earned on, AbbVie's Global Maverick Net Product Sales. This compares to total revenue of $21.6 million for the same period in 2021. Royalty revenue was calculated on 50% of Maverick sales at a royalty rate for the quarter of 10% after adjustments for certain contractual discounts, rebates, and set-offs, which are now approximately 2% of AbbVie's total reported, HCV product sales.
The quarter total revenue was $19 5 million and consisted of royalty revenue earned on at least global Maverick net product sales.
This compares to total revenue of $21 6 million for the same period in 2021.
Royalty revenue was calculated on 50% of Maverick sales at a royalty rate for the quarter of 10% after adjustments for certain contractual discounts rebates and set offs, which are now approximately 2% of Abbvie has total reported HCV product sales.
Can review, our royalty tier schedule in our 2021 Form 10-K.
Paul Mellett: You can review our royalty tier schedule in our 2021 Form 10-K. Moving on to our expenses, for the three months ended June 30th, 2022, research and development, expenses totaled $39.1 million compared to $47 million for the same period in 2021. The decrease was primarily due to timing of our clinical trials year-over-year.
Moving onto our expenses. The three months ended June 32020 to research and development expenses totaled $39 1 million compared to 47 million for the same periods in 2021.
The decrease was primarily due to timing of our clinical trials a year over year.
Paul Mellett: General and administrative expense for the quarter was $12.9 million compared to $8.4, million for the same period in 2021. The increase was due to an increase in head count and compensation expense.
General and administrative expense for the quarter was $12 9 million compared to $8 4 million for the same period in 2021.
The increase was due to an increase in head count and compensation expense.
Paul Mellett: Finanza recorded an income tax benefit of $0.4 million for the three months ended June 30th, 2022, due to the release of a state tax reserve during the period, compared to a tax benefit of $9.4 million for the three months ended June 30th, 2021, when we had the benefit of federal net loss carrybacks available under the CARES Act of 2020. Finanza is still due a refund of $28.7 million for the tax losses carried back in 2021 to offset taxable income in prior years.
NASA recorded an income tax benefit of <unk> 4 million. The three months ended June 30th 2022, due to the release of the state taxes or during the period.
Compared to a tax benefit of $9 4 million for the three months ended June 30th 2021, when we had the benefit of federal net loss carry backs are available under the cares Act of 2020.
And that is still due a refund of $28 7 million the tax losses carried back in 2021 to offset taxable income in prior years.
Paul Mellett: Net loss for the three months ended June 30th, 2022, was $31.7 million, or a loss of $1.53 per, diluted common share, compared to a net loss of $24 million, or a loss of $1.19 per diluted common share, for the corresponding period in 2021. Finanza ended the quarter with approximately $292.7 million in cash and marketable securities. We expect that our current cash, cash equivalents, and short-term and long-term marketable securities, as well as our ongoing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs for the next two years.
Net loss for the three months ended June 32022 was $31 7 million or a loss of $1 53 per diluted common share.
Compared to a net loss of $24 million or a loss of $1 19 per diluted common share for the corresponding period in 2021.
And then at the ended the quarter with approximately $292 7 million in cash and marketable securities.
We expect that our current cash cash equivalents and short term and long term marketable securities as well as our ongoing royalty revenue.
Continue to be sufficient to meet the anticipated cash requirements of our existing business and development programs for the next two years.
Paul Mellett: Further financial details are available in our press release and will be available in our, quarterly report on Form 10-Q when filed.
Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed.
Paul Mellett: I'd now like to call back to the operator
And now I'd like to turn the call back to the operator and open up the lines for questions operator.
Operator: and open up the lines for questions.
Operator: Operator?
Thank you well now begin the question and answer session.
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Operator: Thank you.
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If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.
Operator: We'll now begin the question and answer session.
At this time, we will pause momentarily to assemble our roster.
Operator: To ask a question, you may press, star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys.
Our first question comes with that.
<unk> <unk> with Jefferies.
Operator: If, at any time, your question has been addressed and you would like to withdraw your question, please press star then 2.
Please go ahead.
Operator: At this time, we will pause momentarily to assemble our roster.
Operator: Our first question comes with Akash Tiwadi with Jeffrey.
Clayton: Please go ahead.
Hi, this is calling for a cost.
Clayton: Hi.
Yeah.
First we've seen the FDA approved vaccine on preclinical and also <unk>.
The antibody market based on preclinical data could you talk about the potential for an accelerated path.
Antivirals and secondly can you go over here.
On to design in terms of patients.
Points, given the lower event rates, we're seeing with <unk>.
How do think about.
And an accrual when can we expect edp two to three five entered the market. Thank you.
Okay.
Hello can you.
I'll repeat the question.
Yes.
Can you hear me a little better.
Yes, sorry about that.
Could you repeat the question.
Clayton: This is Clayton for Akash.
Yes definitely so this is clarke on for Josh Thanks for taking our questions first we've seen the FDA approved vaccines on preclinical data and also pull regeneron monoclonal antibody off the market based on preclinical data could you talk about the potential for an accelerated path to approval with Covid Antivirals and secondly can you go over your current thought.
Clayton: Thank you for taking our question.
Clayton: First, we've seen the FDA-approved vaccine on preclinical data and also preclinical data, runs monoclonal antibody off the market based on preclinical data.
Clayton: Could you talk about the potential for an accelerated path to approval with COVID antivirals?
Clayton: And, secondly, can you go over your thoughts on phase two design in terms of patient population, and vaccine points given the lower event rates we're seeing with COVID-19?
What's on phase two design in terms of patient population and endpoint.
Clayton: And, finally, how do you think about trial size and accrual time?
Given the lower event rates, we're seeing with omicron, how do you think about trial design, our trial size and powering and accrual times when can we expect edp 235 to enter the market. Thank you.
Clayton: When can we expect EDP-235 to enter the market?
Clayton: Thank you.
Clayton: Hello, can you repeat the question?
Hi, there.
Thanks.
Clayton: Yes.
For the question. This is a J blue light and.
Clayton: Can you hear me a little better?
And I apologize for the connection the operator's line keeps dropping out on us So we're coming into a cell phone I hope.
Clayton: Yes.
Clayton: Sorry about that.
Paul can Tim.
Clayton: Could you repeat the question?
Clayton: No worries.
Tim Harris here.
Clayton: Yeah, definitely.
Okay.
Clark: So, this is Clark on for Akash.
I think the vaccines and the antibodies are very different than the Antivirals I think once you.
Clark: Thanks for taking our question.
Clark: First, we've seen the FDA-approved vaccines on preclinical data and also pull Regeneron, monoclonal antibody off the market based on preclinical data.
Demonstrated you're basically looking for Jenny.
Generation of a species that is has reactivity against the virus.
Clark: Could you talk about the potential for an accelerated path to approval with COVID antivirals?
Ken wants.
Once you do that with a vaccine or an antibody it's easy to kind of look at the neutralizing.
Capabilities of <unk>.
That entity.
Antiviral developments just is just different so I don't expect there to be the same sort of correlate of.
Short path.
That would accelerate things.
Clark: And, secondly, can you go over your current thoughts on phase two design in terms of patient, population and endpoint?
And with regards to the patient population that's something that we're.
Sorting out the whole I would say the whole.
Clark: Given the lower event rates we're seeing with Omicron, how do you think about trial design, or trial size and powering and accrual times?
Design.
Thinking through the phase two and three in this area. It is dynamic it's changing now.
The vaccination state of people is changing both being vaccinated and then suddenly.
Having immunity wear off either because.
The vaccine has had sort of a sharp been short lived and or the booster or the.
The variance have abated.
The vaccine so.
Again, we're in the process of.
Designing having our.
Clark: When can we expect EDP-235 to enter the market?
Interactions with the FDA and plan to finalize those interactions and start a phase two.
Clark: Thank you.
Jay Luly: Hi there.
Later this year in the fourth quarter, so stay tuned on the front of it.
Jay Luly: Thanks for the question.
Trial design and that once we've wrapped up those interactions as well as our subsequent studies, but I think the plan would be to try to.
Wrap up the phase two and hopefully be in phase three next year and then we'll have to see what the environment of the of the virus looks like in terms of how we.
Schedule and size of that trial.
Were you able to hopefully you're able to hear the answer to the question. Yes. We were thank you alright. Good okay. Thank you I'm holding my breath here.
Jay Luly: This is Jay Lulai.
Next question please.
The question. The next question comes with Voip.
Ed with GMP Securities. Please go ahead.
Jay Luly: And I apologize for the connection.
Hi, Thanks for taking the questions I had a few for 235.
Jay Luly: The operator's line keeps dropping out on us, so we're coming in through a cell phone.
The 401 lung to plasma ratio that you guys are talking about for total drug or is that is that using.
The total amount of drug that's in the plasma or is it just the free non protein bound drug and then the ISI RV poster you had last year. There was an EC 90 of 33, nanomole or what's that corrected for serum protein binding.
Yeah. So.
The question regarding the four to one ratio it was total drug.
We measure total drug in the plasma and told her drug in the blood. So in the plasma so our total drug in the lung and total drug in the in the plasma so it's.
It's measured in the same way so it does it accounts for.
Trying to think of the right way the ratio would be the same either way you calculated it whether you adjusted for the plasma.
Our adjusted for binding in one tissue and the other it would be the same sort of adjustment the ratio wouldn't change.
Got it and then.
With regards to I am sorry, what was the other question.
The poster from ISI RV meeting last over 33 90 Yep.
It was not it was not a plasma adjusted that was and I think it was in human airway epithelium.
<unk> was that that cell line at the time, yeah. So that was not adjusted net.
Okay, and I had a couple on the a question on the on the headache, I guess any characterization you can make does it onset early does it resolve or persist or does it come on later in the treatment course, thank you.
It resolved I don't recall exactly when it came on but any headaches.
That were observed.
Resolved so.
Okay. Thank you.
Youre welcome.
Jay Luly: I hope people can hear us here.
The next question comes with Brian's Corny with Baird. Please go ahead.
Jay Luly: You know, I think the vaccines and the antibodies are very different than the antivirals.
Jay Luly: I think once you've demonstrated you're basically looking for, you know, generation of a species, that has reactivity against the virus.
Jay Luly: And once you do that with a vaccine or an antibody, it's easy to kind of look at the neutralizing capabilities of that entity.
Hey, good afternoon, thanks for taking my questions.
No its reported it as a low rate in trials, but it seems like the past a little bit rebound.
Kratos is pretty common colleagues from asking rents have seen how it as much as 50% obviously saw it we saw bottoms rebound on and just thoughts on.
What do you think this is is that a <unk> PK issue do you think they don't have enough 20.
24 hour coverage do you think five days.
Could it be a potential resistance issue and just how do you think your edp 235 in sort of your program development could could try to focus on it.
Ensuring that.
You've mitigated in your program.
Jay Luly: Antiviral developments is just different.
Sure.
Jay Luly: So I don't expect there to be the same sort of, correlative short path that would accelerate things.
Jay Luly: And with regards to the patient population, it's something that we're sorting out.
Thanks, you cut out there at least at our Hinton in the beginning of the question, but I think I've been intuited, what it was so the.
Jay Luly: I would say the whole design, thinking through the phase two and three in this area, it is dynamic, it's changing.
Jay Luly: The vaccination state of people is changing, both being vaccinated and then suddenly having immunity wear off either because the vaccine has sort of been short lived and or the booster or the variants have evaded the vaccine.
Jay Luly: So again, we're in the process of designing, having our interactions with the FDA and plan to finalize those interactions and start a phase two later this year in the fourth quarter.
Jay Luly: So stay tuned on the front of trial design in that, once we've wrapped up those interactions, as well as subsequent studies.
Jay Luly: But I think the plan would be to try to wrap up, the phase two and hopefully be in phase three next year.
Jay Luly: And then we'll have to see what the environment, of the virus looks like in terms of how we schedule and size that trial.
It's it doesn't appear to be a resistance issue, there's no sign of resistance with regards to <unk> treatment.
I assume.
Well.
This is Jeff.
Hypothesis right now it could be that tax.
<unk> to profit from longer dosing.
That's one possibility.
I think the other.
Has to do at dose pack slope it does have a.
The short half life, even though there is a return of your boosting involved.
And our clinical half life is longer.
Once a day so.
That.
Having good PK characteristics.
It can only help you the.
The other characteristic of 235 is that it has good tissue partitioning and potentially into tissues that could be a reservoir of virus.
And so we think that.
A molecule like Edp 235, with with very good PK once daily dosing nice long half life good exposure.
Polls and good tissue targeting.
<unk> help.
Potentially.
The virus.
Where it might be hiding in to help with that so.
That's one of the things that we're hoping to.
Find out in future studies.
The duration of treatment of five days versus seven or something longer.
No one really knows.
The answer to that other than five days with Pac slowed.
Isn't isn't that bad can you do better.
With a better molecule that has different characteristics. That's the possibility that we'll be exploring in the future does that help.
Yeah, that's very helpful. And then if I could just throw.
Another quick question there on the LTE elevation.
So I was just wondering if you could discuss the Nia al for Edp 235, as the end organ Tox liver here and just I know in the protease inhibitors experience there is sort of.
Not uncommon in a L T elevations on our Rebecca stickley distinct from liver injury I just wonder if you if you have any idea.
No we haven't.
At all.
Yeah, we typically don't.
Describe our preclinical safety findings if any.
Other than with the F D a.
Okay. Thanks, Brett.
Youre welcome.
The next question comes with Eric Joseph with JP Morgan.
Please go ahead.
Jay Luly: Were you able, hopefully you were able, to hear the answer to the question.
Hi, Good afternoon. This is Peter on for Eric Thanks for taking the questions for Mark just wanted to get a sense if there's any alternative mechanisms.
19 viral lifecycle that you'd be looking to target co target with ADP.
Glad to have just more of a potent efficacy profile.
And then for the second question just what are your current thoughts on the relationship between viral infection and COVID-19 has there been a consensus reached by the scientific community on this and is there any utility in your view and using reduction in viral load as a registrational endpoint.
Yes, Im sorry, you broke up on parts of both questions, but I think the the first question was are there other mechanisms that we're thinking of in Covid other than.
Protease did was that the question.
Yeah, just any other mechanisms that exist today.
Or would you look to maybe look at a combination.
Pathway or a combination approach upfront yesterday.
Okay.
You cut out right there, but the sort of the short answer is there are other mechanisms.
We're looking.
Looking at a couple of other ones in house.
Again, not lacking any confidence in 235 against the Covid World as we know it now but.
Just sort of doubling down with our strengths in.
<unk> protease <unk>.
And about the future and if the virus were to take any twists and turns.
Maybe there would be the need for combinations in the future.
Again, no sign of that offering a benefit now but we're.
But were worth it.
Long term here.
So since the beginning of the pandemic, we've been working on multiple different mechanisms in house.
The second one.
I heard the tail end of the question I thought it was asking it did was it possible to have a virology endpoints in registration it was that the question.
Yeah, just one other thing.
Cody.
Our biologic endpoint in Covid.
Well you know, it's a little confusing.
In part because <unk> severe.
It seems to have good data in terms of.
You know prevention of hospitalization and death.
In patient populations, but yet it hasn't demonstrated an effect on viral load reduction yet other mechanism such as protease inhibitor.
He has a demonstrated viral load reduction.
So it's.
It's a little bit.
It's not the only thing it's not the only thing that you can measure that matters and in fact now the viral load reductions that you sometimes see.
And Covid when you do see them are fairly <unk>.
Modest I think that's in part based on the area that you can readily sample which is through.
Nasal pharyngeal swab.
So you know where that goes in terms of endpoints I think you wanted it certainly if you can demonstrate an antiviral effect or a trend.
Wherever you can look for it.
But beyond that.
That doesn't always appeared to be.
Necessary.
And I would put nukes in that category or at least room desk severe.
That's helpful. Great very helpful and just thinking about.
Covid in our cardio respiratory virus I was just wondering if there's any potential for an anti viral acute treatment approach and something like monkey boxes.
Wondering it does seem to hang around a little bit longer than regulatory excellence. It is something of interest for you guys.
I'm not sure I don't know.
Felipe vaccines will be.
Ultimately very helpful. There, but to the extent they are not we we have our eyes on any viruses, where vaccines leave a void so.
If there's a need we'll we would.
We would be thinking about it.
Okay very helpful. Thanks for taking the question.
Youre welcome.
Clark: Yes, we were.
The next question comes with Brian Abrahams with RBC capital markets.
Please go ahead.
Clark: Thank you.
Thanks. This is Steve on for Brian Thanks for taking our question.
Clark: Oh, good.
Clark: Good, thank you.
Or do you see 90 multiples for the Alpha and Delta strengthen with some difference between those strains can you comment on your expectation for multiples with the omicron variant and maybe whether you expect time to steady state or other PK parameters to be important for our current or future streams that might be faster replicating to assess efficacy or predict efficacy there. Thanks.
Yeah, sorry, I hate to do this to you, but part of the first part of the question broke up and part of the backend of it Ted.
Let me.
Ask you to repeat the beginning but I think the omicron I heard was the tailwind.
We have.
We have omicron studies in process right now we don't have the data we will get it later this year.
But just speaking about it in general.
When you're talking about protease.
The protease mutations.
Across all the different variants and even sub variance you know all the different variance of <unk> <unk>.
Concerned like home a crown and then you drill down and look at.
Whether it be a two or 212 or four or 4.6 or five.
The.
The protease itself is highly conserved.
And any mutations if they do occur.
Are.
Distal they're they're far away from the active side of the enzymatic activity, where our drug works.
And so.
It's important to actually for the viruses on survival is to not radically mutate that site. So what we what we've observed is up and down the line.
With every variant that we've tested.
First thing we do is look at biochemical.
Test for antibiotic inhibition and.
Very very tight data you can see some of that data in our slide deck.
So we we believes that.
For all the variance of concern the sub Varian said have followed in <unk>.
And very likely future variance.
By targeting the protease mechanism.
235.
We will continue to have very very strong activity and I apologize I missed the beginning of the question.
Well I think you've covered it there there was that was pretty comprehensive.
Thanks, Ed.
Great. Thank you.
Okay.
The next question comes with Ron <unk> relief with SBB Securities. Please go ahead.
Clark: I'm holding my breath here.
Great afternoon, everyone. So I was curious if you have any thoughts on whether an EUA filing for ADP to two five is still on the table for the FDA or at some point do you think it would be more strategic to go for a full NDA approval for the product.
Operator: Next question.
Well right now we don't know that an EUA is is not available I think it's going to be again as we get closer to that time, it's going to be facts and circumstances on the ground with regards to what the virus is doing but.
The F D a.
I'm not aware that they have given indication yet that for new drug therapies and antiviral category.
That it's.
But it's not available.
Got it thanks, and a quick one on RSV as well.
Have you heard any anything on the ground about the RSV infection rates in the northern and southern Hemispheres and how are you monitoring enrollment for your ongoing studies there.
Yeah. We're we're we're kind of between sort of traditional seasons I think next step would be.
I don't want to say hopefully.
But.
The next season would be northern hemisphere.
Starting later in the it's been very quiet in the northern Hemisphere.
Of late which is not unexpected generally speaking at this time of year. So.
As you get into late Q4, that's the traditional time.
When it would perk up again and so that's currently currently what we are.
Planning.
And expecting.
Got it helpful. Thanks.
Youre welcome.
Thank you once again, if you have a question. Please press star one.
Operator: The question, the next question comes with
Next question comes with Jay Olson with Oppenheimer. Please go ahead.
Operator: Floyd Buchanan with GMP security.
Floyd Buchanan: Please go ahead.
Hello, Hi, this is Charles on the line for Jade. Thanks for taking my question and congrats on the progress.
Maybe a follow up on the question previously.
Okay.
Sure, let me put more color on the discovery programs all COVID-19 is.
Is that more skeptical or more potent against emerging barriers.
Do you see the unmet need to combine edp 235, with another mechanism more with another molecule.
Yes.
Sure.
See no reason to combine now.
Then.
There is no signs of resistance as it relates to.
Patients who are treated with protease inhibitors.
It's a it's an acute treatment acute infection, you know, we're talking about five or so days and.
And so.
If you put lots of pressure on the drug which we do on the virus, which we do a trough we see great multiples of a very potent drug with a long half life and good tissue uptake so.
I don't see the need for it but as I've said before.
If a more serious variance came along.
Someday you May want you may want to have as many weapons as you could possibly happen. This is no different by the way than any virus. We've taken on when we went after Hep C. We went after multiple mechanisms.
Even though.
It looks like probably a couple would be enough, but you don't know it at the helm.
Bill until you're done you're always wondering same with Hep b same with RSP when we get into an area, we're going to mine as many different mechanisms until we know we don't need them.
As long as we possibly might in the future we want to be at the cutting edge with with everything that we can so.
I would say.
Edp, three five being sort of the cornerstone at <unk>.
We will continue to do.
Research on this and maybe someday combinations will be necessary.
Hopefully they want and hopefully to three five is all will ever need or any one lever needs.
Great. Thank you so much.
Youre welcome.
The next and final question comes with a crushed Hawaii with Jefferies. Please go ahead.
Hi, This is Clarke Jennifer Akash, thanks for taking our additional questions.
First could you comment on the potential cost for the trials for the Edp two to three five.
And secondly in your phase one healthy volunteer study for Edp 305, what percentage of patients reached <unk> 90, and can you comment on the PK variability across patients.
<unk>.
So <unk>.
You broke up on the tail end of the question again is quite frustrating at least at our and I Hope I Hope you can hear at year end.
<unk>.
So the cost I think at the end of the day, we'll we'll need to wait and see how we've sized the trials really hard to project on that until we see how big they are and thats going to be dependent on all kinds of design factors that we havent finalized yet with the agency so stay tuned.
Tuned on that I think the.
Generally speaking the concept on the on the face.
Two.
Piece would be fairly small and then we would have.
Into that.
Two the larger portion which would be registrational obviously.
And ultimately.
Keeping in mind.
All of that our ultimate plan.
As to be teaming up with a.
So a larger company that Ken.
That can more effectively.
To help with the global law.
Launch and distribution.
Of the drug.
So.
Say tuned on that front.
And then I missed I missed the other part of your question sorry.
Hello.
Oh, sorry, the second part of the question was.
In your phase one healthy volunteer study for Edp three five what percentage of patients reached <unk> 90, and can you comment on the PK variability across patients.
Okay.
I think I'll, let Tara I'll take that question.
Sure No problem Hi, Craig This is Cherokee for speaking so we actually saw pretty low variability in our phase one study it was about 15%.
And so we would expect down.
Down the road, we would have the vast majority greater than 95% of the patients above that eastern 90 value.
Great. Thank you.
Sure.
This concludes our question and answer session I.
Floyd Buchanan: Hi, thanks for taking the questions.
I would like now to turn the conference back over to Jennifer Viera for any closing remarks. Please go ahead.
Floyd Buchanan: I had a few for two, three, five.
Thank you everyone for joining us today serious apologies for the technical glitches. If you do have any follow up questions feel free to contact us by email or call me at the office. Thanks, again and have a great evening Goodbye.
Floyd Buchanan: The four to one lung to plasma ratio, that you guys are talking about for total drug, is that using the total amount of drug that's in the plasma or is it just the free non-protein bound drug?
Floyd Buchanan: And then in the ISIRV poster you had last year, there was an EC90 of 33 nanomolar.
Floyd Buchanan: Was that corrected for serum protein binding?
Jay Luly: Yeah, so the question regarding the four to one ratio, was total drug. We measured total drug in the plasma, and total drug in the blood.
Jay Luly: So in the plasma, so or total drug in the lung, and total drug in the plasma.
Jay Luly: So it's measured in the same way.
Jay Luly: So it does, it accounts for, trying to think of the right way.
Jay Luly: The ratio would be the same either way you calculated it, whether you adjusted for the plasma or adjusted for binding in one tissue and the other, it would be the same sort of adjustment.
Jay Luly: The ratio wouldn't change.
Jay Luly: And then, with regards to, I'm sorry, what was the other question?
Floyd Buchanan: A poster from ISIRV meeting last year.
Floyd Buchanan: Oh, the 3390.
Floyd Buchanan: Yep.
Jay Luly: Yeah, it was not, it was not plasma adjusted.
Jay Luly: That was in, I think it was in human airway epithelial, cells with that, that cell line at the time.
Jay Luly: Yeah, so that was not adjusted.
Jay Luly: Okay, and I had a couple on the, or a question on the, on the headache.
Floyd Buchanan: I guess, any characterization you can make?
This conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Floyd Buchanan: Does it onset early?
Floyd Buchanan: Does it resolve or persist?
Jennifer Viera: Thank you, everyone, for joining us today.
Floyd Buchanan: Or does it come on later in the treatment course?
Jennifer Viera: Serious apologies for the technical glitches.
Jay Luly: Thank you.
Jennifer Viera: If you do have any follow-up questions, feel free to contact us by email or call me at the office.
Jay Luly: It resolved.
Operator: You may now disconnect.
Jennifer Viera: Thanks again, and have a great evening.
Jay Luly: I don't recall exactly when it came on, but, you know, any headaches, that were observed, you know, resolved.
Jennifer Viera: Goodbye.
Jay Luly: So.
Operator: This conference is now concluded.
Floyd Buchanan: Okay, thank you.
Operator: Thank you for attending today's presentation.
Jay Luly: You're welcome.
Operator: The next question comes with Brian Scorney with Bayard.
Operator: Please go ahead.
Brian Scorney: Hey, good afternoon.
Brian Scorney: Thanks for taking the questions.
Brian Scorney: I know it's reported as a low rate in trials, but it seems like the patch a little bit rebound in practice is pretty common.
Okay.
Brian Scorney: Currently, some estimates have seen how it does much as 50%.
Brian Scorney: Obviously, we saw Biden rebound on it.
Brian Scorney: Just thoughts on what you think this is.
Brian Scorney: Is it a PAX loaded PK issue?
Brian Scorney: Do you think they don't have enough 24 hour coverage?
[music].
Brian Scorney: Do you think five days isn't enough?
Brian Scorney: Could it be a potential resistance issue?
Brian Scorney: And just how do you think EDP 235 and sort of your program development could, could try to focus on ensuring this you mitigate it in your program?
Jay Luly: Sure.
Jay Luly: Thanks.
Jay Luly: You cut out at least at our hint on the beginning of the question, but I think I've, been to what it was.
Jay Luly: So the.
Jay Luly: It's it's doesn't appear to be a resistance issue.
Jay Luly: There's no sign of resistance with regards to PAX loaded treatment.
Jay Luly: So I I assume.
Jay Luly: Well, this this is just, you know, hypothesis right now.
Jay Luly: It could be that, PAX loaded could profit from longer dosing.
Jay Luly: That's one possibility.
Jay Luly: But I think the other has to do it does.
Jay Luly: PAX loaded does have a short half life, even though there's return of your boosting involved.
Jay Luly: And our clinical half life is longer once a day.
Jay Luly: So, you know, that having good PK characteristics can only help you.
Jay Luly: The the other characteristic of 235 is that it has good tissue partitioning, and potentially into tissues that could be a reservoir of virus.
Jay Luly: And so we think that, you know, a molecule like EDP 235 with with very good PK, once daily dosing nice long half life, good exposure multiples and good tissue targeting could help potentially find the virus where it might be hiding and help with that.
Jay Luly: So that's one of the things that we're hoping to find out in future studies. The duration of treatment of five days versus seven or something longer.
Jay Luly: No one really knows the answer to that other than five days with PAX loaded.
Jay Luly: You know, isn't isn't that bad.
Jay Luly: Can you do better with a better molecule that has different characteristics?
Jay Luly: Now, that's the possibility that we'll be exploring in the future.
Jay Luly: Is that how.
Jay Luly: Hi.
Brian Scorney: Yeah, that's very helpful.
Brian Scorney: And then if I could just throw another quick question there on the ALT elevation.
Brian Scorney: So, I was just wondering if you've discussed the NOAA L4EDT235 as the end organ tox liver here.
Brian Scorney: And just I know in the protease inhibitors experience, there's sort of not uncommon ALT elevations that are mechanistically distinct from liver injury.
Jay Luly: I just wonder if you have any idea.
Jay Luly: Yeah, we haven't.
Jay Luly: Yeah, we typically don't describe our preclinical safety findings, if any, other than with the FDA.
Jay Luly: Okay.
Brian Scorney: Thanks, Chip.
Jay Luly: Yep, you're welcome.
Operator: The next question comes with Eric Joseph with JPMorgan.
Operator: Please go ahead.
Hannah Ong: Hi, good afternoon.
Hannah Ong: This is Hannah Ong for Eric.
Hannah Ong: Thanks for taking the questions.
Hannah Ong: Just a few from us.
Hannah Ong: Just wanted to get a sense if there's any alternative mechanisms in the COVID-19 viral life cycle that you'd be looking to target, like co-target with EDP235 to have just more of a potent efficacy profile up front.
Hannah Ong: And then for the second question, just what are your current thoughts on the relationship between viral infection and COVID-19?
Hannah Ong: Has there been a consensus reached by the scientific community on this?
Hannah Ong: And is there any utility, in your view, in using reduction in viral load as a registration endpoint?
Jay Luly: Yeah, I'm sorry.
Jay Luly: You broke up on parts of both questions, but I think the first question was, are there other mechanisms that we're thinking of in COVID other than protease?
Hannah Ong: Was that the question?
Hannah Ong: Yeah, just any other mechanisms you're interested in, and would you look to maybe look at a combination pathway or combination approach up front just so you have that efficacy profile?
Hannah Ong: Okay, you cut out right there.
Jay Luly: But the short answer is, you know, there are other mechanisms.
Jay Luly: We're, you know, looking at a couple of other ones in-house.
Jay Luly: Again, not lacking any confidence in 235 against the COVID world as we know it now, but, you know, just sort of doubling down with our strengths in protease, thinking about the future and if the virus were to take any twists and turns, maybe there would be the need for combinations in the future.
Jay Luly: Again, no sign of that offering benefit now, but we're thinking, you know, long-term here.
Jay Luly: So since the beginning of the pandemic, we've been working on multiple different mechanisms in-house.
Jay Luly: The second one, I heard the tail end of the question.
Jay Luly: I thought it was asking, you know, was it possible to have a virologic endpoint in registration?
Hannah Ong: Was that the question?
Hannah Ong: Yeah, just what is the utility of a virologic endpoint in COVID currently?
Jay Luly: Well, you know, it's a little confusing in part because, you know, remdesivir, It seems to have good data in terms of prevention of hospitalization and death in patient populations, but yet it hasn't demonstrated an effect on viral load reduction.
Jay Luly: Yet other mechanism, such as protease inhibitor, has demonstrated viral load reduction.
Jay Luly: So it's a little bit – it's not the only thing that you can measure that matters.
Jay Luly: And, in fact, the viral load reductions that you sometimes see in COVID when you do see them are fairly modest.
Jay Luly: I think that's in part based on the area that you can readily sample, which is through, you know, a nasal pharyngeal swab.
Jay Luly: So, you know, where that goes in terms of endpoints, I think you want to – certainly, if you can, demonstrate an antiviral effect or a trend wherever you can look for it.
Jay Luly: But beyond that, that doesn't always appear to be necessary.
Jay Luly: And I would put nukes in that category, or at least remdesivir.
Jay Luly: Is that helpful?
Hannah Ong: Okay, great.
Hannah Ong: Very helpful.
Hannah Ong: Yeah.
Hannah Ong: And just thinking about outside of COVID and outside of respiratory viruses, just wondering if there's any potential for an antiviral acute treatment approach in something like monkeypox, considering it does seem to hang around a little bit longer than respiratory infections?
Jay Luly: Is this something of interest for you guys?
Jay Luly: I'm not sure.
Jay Luly: I don't know.
Jay Luly: You know, hopefully, vaccines will be ultimately very helpful there.
Jay Luly: But to the extent they're not, we have our eyes on any viruses where vaccines leave a void.
Jay Luly: So if there's a need, we would be thinking about it.
Hannah Ong: Okay, very helpful.
Hannah Ong: Thanks for the question.
Jay Luly: You're welcome.
Operator: The next question comes with Brian Abraham with RBC Capital Markets.
Operator: Please go ahead.
Steve Hung: Thanks.
Steve Hung: This is Steve Hung from Brian.
Steve Hung: Thanks for taking our question.
Steve Hung: You shared EC90 multiples for the alpha and delta strains.
Steve Hung: And with some difference between those strains, can you comment on your expectation for multiples with the Omicron variant?
Steve Hung: And maybe whether you expect time to study state or other PK parameters to be important for current or future strains that might be faster replicating to assess efficacy or predict efficacy there.
Steve Hung: Thanks.
Jay Luly: Yeah, I'm sorry.
Jay Luly: I hate to do this to you, but part of the first part of the question broke up and part of the back end of it did.
Jay Luly: I'll ask you to repeat the beginning, but I think the Omicron I heard was the tail end.
Jay Luly: We have Omicron studies in process right now.
Jay Luly: We don't have the data.
Jay Luly: We'll get it, you know, later this year.
Jay Luly: But just speaking about it in general, when you're talking about protease, the protease mutations across all the different variants and even sub-variants, you know, all the different variants of concern like Omicron, and then you drill down and look at whether it's BA2, or 4 or 4.6 or 5, the protease itself is highly conserved.
Jay Luly: And any mutations, if they do occur, are distal. They're far away from the active site of the enzymatic activity where our drug works.
Jay Luly: And so that's important actually for the virus's own survival, is to not radically mutate that site.
Jay Luly: So what we've observed is up and down the line, with every variant that we've tested, first thing we do is look at biochemical tests for enzymatic inhibition and very, very tight data. You can see some of that data in our slide deck.
Jay Luly: So we believe that for all the variants of concern, the sub-variants that have followed and very likely future variants, that by targeting the protease mechanism, 235 will continue to have very, very strong activity.
Jay Luly: And I apologize, I missed the beginning of the question.
Steve Hung: But I think you covered it there.
Steve Hung: That was pretty comprehensive.
Steve Hung: Thanks.
Steve Hung: Good.
Steve Hung: Great, thank you.
Operator: The next question comes with Roanna Ruiz with SVB Security.
Operator: Please go ahead.
Roanna Ruiz: Great afternoon, everyone.
Roanna Ruiz: So I was curious if you have any thoughts, on whether an EUA filing for ADP-235 is still on the table for the FDA, or at some point, do you think it would be more strategic to go for a full NDA approval for the product?
Jay Luly: Well, right now, we don't know that an EUA is not available.
Jay Luly: I think it's gonna be, again, as we get closer to that time, it's gonna be facts and circumstances on the ground with regards to what the virus is doing.
Jay Luly: But the FDA, I'm not aware that they've given indication yet, that for new drug therapies in the antiviral category, that it's not available.
Roanna Ruiz: Got it, thanks.
Roanna Ruiz: And a quick one on RSV as well.
Roanna Ruiz: I was curious, have you heard anything on the ground, about the RSV infection rates in the northern and the southern hemispheres, and how are you monitoring enrollment for your ongoing studies there?
Jay Luly: Yeah, well, we're kinda between sort of traditional seasons.
Jay Luly: I think next up would be, I don't wanna say hopefully, but the next season would be northern hemisphere starting later in the, it's been very quiet in the northern hemisphere of late, which is not unexpected, generally speaking at this time of year.
Jay Luly: So, as you get into late Q4, that's the traditional time, when it would perk up again.
Jay Luly: And so that's currently what we're planning and expecting.
Roanna Ruiz: Got it, helpful, thanks.
Jay Luly: You're welcome.
Jay Luly: Thank you.
Operator: Once again, if you have a question, please press star one.
Operator: The next question comes with Jay Olson with Oppenheimer.
Operator: Please go ahead.
Chong: Oh, hi, this is Chong on the line for Jay.
Chong: Thanks for taking our question and congrats, on the progress.
Chong: Just maybe a follow-up on a question asked previously.
Chong: Can you share a little bit more color on the discovery program from COVID-19 and is that more specific or more potent against emerging variants?
Chong: And where do you see the need to combine EDP-235 with another mechanism or with another molecule?
Chong: Thank you.
Jay Luly: Sure.
Jay Luly: We see no reason to combine now.
Jay Luly: Again, there's no signs of resistance as it relates, to patients who are treated with protease inhibitors.
Jay Luly: It's an acute treatment, acute infection. You know, we're talking about five or so days.
Jay Luly: And so, if you put lots of pressure on the drug, which we do, or on the virus, which we do, you know, a trough, we see great multiples of a very potent drug with a long half-life and good tissue uptake.
Jay Luly: So, don't see the need for it.
Jay Luly: But as I said before, you know, if a more serious variant came along, someday you may want to have as many weapons as you could possibly have.
Jay Luly: And this is no different, by the way, than any virus we've taken on.
Jay Luly: When we went after Hep-C, we went after multiple mechanisms, even though it looked like probably a couple would be enough.
Jay Luly: But you don't know until you're done, you're always wondering.
Jay Luly: Same with Hep-B, same with, RSV.
Jay Luly: When we get into an area, we're going to mine as many different mechanisms until we know we don't need them.
Jay Luly: As long as we possibly might in the future, we want to be at the cutting edge with everything that we can.
Jay Luly: So, I would say, you know, EDP-235 being sort of the cornerstone at Enanta, you know, we'll continue to do research in this.
Jay Luly: And maybe someday combinations will be necessary.
Jay Luly: You know, hopefully they won't.
Jay Luly: And hopefully EDP-235 is all we'll ever need or anyone will ever need.
Chong: Great.
Jay Luly: Thank you so much.
Chong: You're welcome.
Operator: The next and final question comes with Akash Tiwadi with Jefferies.
Operator: Please go ahead.
Clark Danford: Hi, this is Clark Danford Akash.
Clark Danford: Thanks for taking our additional questions.
Clark Danford: First, could you comment on the potential costs for the trials for the EDP-235?
Clark Danford: And secondly, in your Phase 1 Healthy Volunteer Study for EDP-235, what percentage of patients reached
Clark Danford: EC90?
Clark Danford: And can you comment on the PK variability across patients?
Clark Danford: Thank you.
Jay Luly: So, you broke up on the table onto the question, and it's quite frustrating, at least at our end.
Jay Luly: I hope you can hear it here.
Jay Luly: So, the cost, I think at the end of the day, we'll need to wait, and see how we've sized the trials.
Jay Luly: It's really hard to project on that until we see how big they are.
Jay Luly: And that's going to be dependent on all kinds of design factors that we haven't finalized yet with the agency.
Jay Luly: So, stay tuned on that.
Jay Luly: I think the I think, generally speaking, the concept on the Phase 2 piece would be fairly small, and, then we would, you know, head into the larger portion, which would be registrational, obviously.
Jay Luly: And ultimately, you know, keeping in mind all of that, our ultimate plan is to be teaming, up with a, you know, larger company that can more effectively help with the, you know, global launch and distribution of the drug.
Jay Luly: So, you know, stay tuned on that front.
Jay Luly: And then I missed the other part of your question, sorry.
Clark Danford: Hello?
Clark Danford: Oh, sorry.
Clark Danford: The second part of the question was, in your Phase 1 Healthy Volunteer Study for EDP-235, what percentage of patients reached EC90?
Clark Danford: And can you comment on the PK variability across patients?
Tara Kieffer: I think I'll let Tara take that question.
Tara Kieffer: Sure, no problem.
Tara Kieffer: Hi, Clark.
Tara Kieffer: This is Tara Kieffer speaking.
Tara Kieffer: So, we actually saw pretty low variability in our Phase 1 study. It was about 15%. And so, we would expect down the road, we would have the vast majority, greater than 95% of the patients above that EC90 value.
Tara Kieffer: Great, thank you.
Clark Danford: Sure.
Operator: This concludes our question and answer session.
Jennifer Viera: I would like now to turn the conference back over to Jennifer Varela for any closing remarks.
Jennifer Viera: Please go ahead.