Q2 2020 Earnings Call
Good afternoon, and welcome to answer Pharmaceuticals fiscal second quarter financial results Conference call.
At this time, all participants Arnie listen only bode.
There will be a question and answer session at the end of the prepared remarks.
You see it finds that this call is being recorded Oh now like to turn the call over to Jennifer Vera Senior Director Investor Relations. Thank you. Please go ahead.
Jay R. Luly: We're planning to add a substantial number of sites in Europe. If we can complete enrollment for the study in the Northern Hemisphere next winter, we would expect to have data in the third calendar quarter of 2021. As a reminder, RSVP is a randomized, double-blind, placebo-controlled study of EDP-938 designed to enroll approximately 70 subjects up to the age of 75 years, randomized to receive either 80 mg of EDP-938 or placebo for 5 days. The primary objective of this study is to evaluate the effect of EDP-938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period. Antiviral efficacy will be evaluated as a secondary endpoint. Obviously, the COVID-19 pandemic currently has an impact on any respiratory disease study.
Thank you operator, and thanks to everyone for joining us. This afternoon. The news release with our fiscal second quarter of financial results was.
They should this afternoon and is available on our website on the call today is Doctor Jay Lou Lie President and Chief Executive Officer, Paul Mallet, Our Chief Financial Officer in other members of Atlantis Senior management team before we begin with our formal remarks, we want to remind you that we will be making forward.
Which may include our plans and expectations with respect to our research and development pipeline and financial projections, all of which involves certain assumptions in risks beyond our control that could cause our actual developments and results to different materially from these statements.
Jay R. Luly: In RSVP, we're in the process of modifying our protocol to do testing to exclude the presence of COVID-19 in any potentially eligible patient with RSV. We continue to collaborate with Cepheid to use its real-time PCR machines, which can now test for RSV, Flu A, Flu B, and COVID-19. These are the machines that we've used at our North American testing sites, and we're in the process of getting additional machines set up at the Southern Hemisphere site.
Description of these risks is in our most recent form 10, Q. and other periodic reports filed with the S.C.C. an enter does not undertake any obligation to update any forward looking statements made during this call I'd now like to turn the call over to Doctor, Jay Little lie President and C.E.O.J.
Thank you Senator good afternoon every one.
Jay R. Luly: We're also on track to initiate two additional Phase 2 studies, one in pediatric patients and one in adult transplant patients by the end of this year, concurrent with the RSVP study. Fortunately, today, it appears the health effects of COVID-19 in children have not been as severe as in adults, and we anticipate parents will continue to take ill children to the doctor, even if the pandemic continues into the winter RSV season in the Northern Hemisphere. And given their immune-suppressed condition, we would hope that transplant patients would be on high alert for respiratory illness and be willing to participate in a clinical study. However, we recognize there could potentially be more challenges for the transplant study, depending upon how the pandemic moves later in the fall.
I could take a moment to acknowledge the extraordinary times, we are experiencing during the cold in 19 pandemic.
Oh, it's also with those who are directly affected.
Grateful for the heroic efforts of caregivers first responders and many others, who are making great sacrifice each for the common good as we navigate through the worst weeks this crisis.
Safety and wellbeing of our employees is Paramount we will continue to prioritize it as we move forward.
Under thank our employees further on wavering dedication to our mission Green These files for several weeks.
In a period of great upheaval, one uncertainty their commitment has allowed us to maintain continuous business operations and momentum that will enable us to execute on our business plans and milestone goals to the best possible extent.
Jay R. Luly: Regarding the third respiratory virus in our portfolio, we introduced our discovery program for human metapneumovirus, also known as HMPV, at the beginning of the year. HMPV is a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in COPD, asthma, and immune-compromised patients. In fact, it's the second most common cause of lower airway infection in Children Less Than 5 Years of Age behind RSV, and accounts for more than 20,000 hospitalizations in this age group each year.
Given the circumstances.
Squabble healthcare crisis that strengthened our resolve to advance novelty therapies friend, but needs and our core expertise in both by raunchy and respiratory diseases positions an answer to be part of the solution for club in 19 and other emerging viral threats.
To that end all start by highlighting the newest disease program and our respiratory virus pipeline, mainly code, but 19.
As you know in mid March we announced that we initiated a program to discover direct acting antiviral drugs candidates for the treatment of patients in fact in the cupboard 19.
Jay R. Luly: HNPV also presents a significant health challenge in the elderly and immunocompromised individuals, with more than 100,000 hospitalizations annually. We continue to perform optimization of our current nanomolar HMPV inhibitor leads as we work toward identifying our first clinical candidate for this indication. I'll now move to our portfolio of products focused on the treatment of liver-related conditions. First, let me update you on our Clinical Stage Hepatitis B program with EDP514, our Novel Class II HPV Core Inhibitor. Last month, we announced that we are pausing further recruitment in Part 2 of our Phase 1a, 1b study of EDP514 in new suppressed HPV patients in North America, which initiated earlier this quarter. NucSuppress refers to patients with chronic HPV infection that is being suppressed with nucleoside reverse transcriptase treatment, the current standard of care.
Based on our proven track record in biology at her capabilities and respiratory diseases. We believe we can leverage hard core competency used to discover a potential treatment for cope with 19.
That said, we are leveraging our experience and takes in a two pronged approach for covert 19 discovery efforts.
Not only are we testing compounds for her antiviral compound library for potential activity against the virus.
We are using our background and expertise some <unk> antiviral mechanisms to discover new candidates treat codes 19.
We've mobilized survivor, all Justin chemist did begin this discovery program, which involves finding leads and ultimately candidates.
Among other mechanisms of interest and initial focus for us or Sars code to produce inhibitors.
User direct acting any by roles.
It's not a simple endeavor, but this is what a NASA.
And what is that as well.
Will continue to update our code in 19 efforts in the coming quarters.
Jay R. Luly: We plan to enroll a total of 24 subjects among three escalating dose cohorts with study drug administered for 28 days. We're regularly evaluating the circumstances around this study and are hoping to resume enrollment within the next couple of months, depending upon whether enough of our clinical sites are able to open. Given FDA guidance on the conduct of clinical trials during the COVID-19 pandemic and its emphasis on the safety of trial participants and integrity of clinical trial data, conducting short-term trials in patients with chronic disease during the pandemic is not practicable nor recommended. As such, we'll continue to follow regulatory guidance to determine when it is safe to resume the study.
Well now turn to our lead respiratory virus program DDP 938, the respiratory some social virus where aristide.
To remind everyone R.S.B. is a severe respiratory infection associated with significant morbidity and mortality N.N. fence.
Elderly an immune compromised adults at a condition for which there is currently no safe and effective therapy.
Each year in the United States, approximately 57000 children below age five and 177000 older adults are hospitalized for ours fee.
14000 died from this respiratory infection.
We've completed the R.S.P.C.'s and in the United States that are on track with plans to move our fees to be study known as R.S.V.P. to the southern hemisphere.
Jay R. Luly: We're also pleased to be on track to initiate our Phase 1B study this quarter in HPV patients who are not on therapy and who have high levels of the virus in their blood, which are also referred to as vireme. We're optimistic about this study moving forward in viremic patients, given that our sites are in Hong Kong and Taiwan, both areas where COVID-19 appears to be under better control than in Western countries and where there is a large unmet need for HPV treatment. As a reminder, this study will assess the impact of EDP-514 on viral load in patients, not on other HPV therapy. We are excited about this study because we expect it will produce our next clinical data readout, which we are targeting around year end. I'll now move to EDP-305, our Farnesoid X-receptor, or FXR egg, in development for both PBC and non-alcoholic steatohepatitis, or NASH. First, let me focus on our efforts in primary biliary cholangitis, or PBC.
Given uncertainties created by the spread of coping 19 in that region are also keeping her north American sites ready for reactivation, the fall and winter R.'s P.C.'s and we're planning to add substantial number of sites in Europe.
If we can complete enrollment for this study in the northern Hemisphere next winter, we would expect to have data in the third calendar quarter of 2021.
It's a reminder, R.C.P. user randomized double blind placebo controlled study of eating P. 938.
To enroll approximately 70 subjects up to the age from 75 years randomized to receive either 80 milligrams of P.D.P. 938 or placebo for five days.
The primary objective of this study is to evaluate the effect of eating P. 938 on the progression of R.S.V. in section by assessment of clinical symptoms measured over the course of the 14 days study observation period.
Antiviral after because he will be evaluated as a secondary endpoint.
Obviously covert 19 pandemic currently has an impact on any of respiratory disease studies.
R.S.P.P., where in the process is modifying our protocol to do testing to exclude the presence of coping 19 in any potentially eligible patient with R.C.
We continue to collaborate with <unk>.
Jay R. Luly: Earlier today, we announced data from our Phase 2a Intrepid study. Intrepid was a 12-week, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and efficacy of ADP305 in subjects with PBC, with or without an inadequate response to ursodeoxycholic acid. The primary endpoint of the study was to evaluate the proportion of subjects with at least 20% reduction in ALP from pre-treatment value, or normalization of ALP, at week 12. In the intent-to-treat, or ITT, analysis, treatment with 1 and 2.5 mg of EDP-305 resulted in 45% and 46% ALP responses, respectively, compared to 11% in placebo. These response rates, while numerically higher than placebo, were not statistically significant. However, in an analysis of the subjects who completed study treatment with no missing values at week 12, the proportions of ALP responders in the 1 mg and 2.5 mg arms showed specifically significant response rates of 50 and 62%, respectively, compared to 11% in placebo.
It's real time, P.C.R. machines, which can now towns for R.S.B. flew a we'd be and 19.
You said the machines that we've used that are north American tests game sites, where in the process of getting additional mistreating set up from the southern hemisphere sites.
We're also on track to initiate two additional things to studies, one in pediatric patients and one in adult transplant patients by the end of this year concurrent with the R.S.P.P. study.
Fortunately today that appears the health effects of coping 19, and children have not been as severe 810 adults. We anticipate parents will continue to take ill children to the doctor even in the <unk>. If the pandemic continues into the winter or a ski season.
Hemisphere.
And given their immune suppressed condition, we would hope to transplant patients will be on high alert for respiratory illness, it'd be willing to participate in a clinical study.
However, we recognize there are potentially more challenges for the transplant study depending upon how the pandemic moods later in the fall.
Regarding the third respiratory virus and our portfolio. We introduce started discovery program for human better Pneumo virus also known as H.M.P.D. at the beginning of the year.
H.M.P.D. is a pathogen that causes upper and lower respiratory tract infection send young children and the elderly as well as N.C.O.P.D. asthma and immune compromised patients.
Jay R. Luly: Key secondary objectives were to evaluate the safety and tolerability of EDP-305, as well as changes from baseline in the liver enzymes ALT, AST, or GGT. Data from the full ITT population showed statistically significant reductions in absolute amounts of these key biomarkers compared to placebo at 1 milligram and 2.5 milligrams of EDP-305. A statistically significant difference in the percent changes from baseline of these key biomarkers at week 12 was also observed in both EDP-305 arms compared to placebo. In terms of safety, EDP-305 was generally well tolerated in subjects with PBC, with the majority of treatment-emergent adverse events, or TEAEs, being mild to moderate. The most common TEAEs included pruritus, gastrointestinal-related symptoms, headache, and insomnia.
In fact, it's the second most common cause at the lower airway.
Infection in children less than five years of age behind doors feet that counts for more than 20000 hospitalization send this age group each year.
It shouldn't be the also presents a significant health challenges and the elderly and immunocompromised individuals.
With more than 100000 hospitalizations annually.
The continued to perform optimization of our current Nanomolar H.M.P.B. inhibitor leads as we work toward identifying our first clinical candidate for this syndication.
Oh now moved to our portfolio products focused on the treatment to deliver related conditions.
First let me update you on or clinical stage hepatitis B. program with the P.D.P. five one for our novel class to H.P.V. Corps inhibitor.
Last month, we announced that we are at pausing further recruitment and part two of our phase one a one be studying E.D.P. five one for nuke suppressed H.P.D. patients in North America, which initiated earlier this quarter.
Nukes across the first the patience with chronic H.P.D. infection that is being suppressed with nuclear side reverse transcriptase treatment. The current standard of care.
Jay R. Luly: These TEAEs are consistent with the safety profile observed across more than 400 subjects exposed to EDP-305 for up to 12 weeks. The incidence of treatment discontinuation due to poritis intrepid was approximately 3% for the 1 milligram EDP-305 treatment group, 18% for the 2.5 milligram treatment group, and 0% for the placebo treatment group.
Plan to enroll a total of 24 subjects among three escalating those cohorts with studied drug dazed for 28 days.
We're regularly evaluating the circumstances around this study in are hoping to resume enrollment within the next couple of months, depending upon whether or not for third clinical sites are able to open.
Given F.D.A. guidance on the conduct of clinical trials during the covert 19 pandemic and it's emphasis regarding the safety of trial participants and integrity of clinical trial data.
Jay R. Luly: While we did not meet the primary endpoint for PBC in the ITT analysis, we plan to use these data to help inform our development of EDP305 for NAC. Specifically, we are encouraged that the lower dose of one milligram achieved better tolerability in terms of pruritus without significantly reducing the number of ALP responders and while still having statistically significant effects on key biomarkers of target engagement. We see this as helpful information for the intermediate doses of 1.5 milligrams and 2 milligrams that we plan to use in our Argon 2 study in NASH patients. We believe the dose of 1.5 mg or 2 mg in NASH could potentially achieve an efficacy and tolerability profile comparable to that of the 1.0 mg dose in PBC.
Conducting short term trials and patience with chronic disease during the pandemic is not practicable nor recommended.
As such will continue to follow regulatory guidance to determine what is it safe to museums study.
They're all pleased to be on track to initiate or phase one Beast study this quarter and H.P.D. patients who are not on therapy and it would have high levels of the virus and their blood. We're also referred to as by reading it.
Optimistic about this study moving forward and by remake patience, given that our sights or in Hong Kong and Taiwan, most areas, where covert 19 appears to be under better control than in western countries, and where there is a large hadn't met need for each meeting treatment.
Reminder.
He will assess the impact the BDP five one for on viral load and patients.
On other H.B.B. therapies.
We were excited about this study because we expect it will produce our next clinical data read out, which we are targeting for around your hand.
Jay R. Luly: For more information on the intrepid study, please see the slide deck that we will post on our website after this call. Rather than conducting further dose selection studies with EDP305 and PBC, a disease for which there is already an approved second-line FXR agonist therapy and for which generic fibrates are showing benefit in some studies, we intend to focus our future efforts with EDP305 on that. We see NASH as a disease where FXR agonists like EDP305 have the potential to be important components of drug combinations designed to give maximum benefit to patients.
Well now moved to eating P., three o., five or <unk> or F.X.R., Agnes and development for both P.B.C. and non alcoholic Seattle hepatitis We're Nash.
The first let me focus on our efforts in primary Billy Erie, Colin <unk>, where P.D.C.
Earlier today, we announced data from her face to a intrepid study.
<unk> said 12 week randomized double blind placebo controlled study evaluating the safety Tolerability pharmacokinetics and Africa, C.M.U.D.P., three o., five and subjects with P.B.C. with or without an inadequate response, there are so deoxi <unk>.
Jay R. Luly: In our NASH program, we remain focused on evaluating EDP305 and Argon2, a phase 2b, randomized, double-blind, placebo-controlled, 72-week study in approximately 340 subjects with biopsy-proven NASH. While we were ready to begin dosing Argon2 on schedule in March, we decided to pause recruitment and dosing in the study due to the ongoing COVID-19 pandemic. We did this having in mind the safety of our clinical trial participants as well as the resource constraints of clinical trial sites. As a reminder, the primary endpoint of Argon 2 will be improvement of fibrosis without worsening of NASH, or Nash Resolution Without Worsening Fibrosis. We plan to use doses of 1.5 milligrams and 2 milligrams, which we selected to provide strong target engagement and a balanced profile in terms of efficacy and tolerability. Argonne 2 will include a 12-week interim analysis to generate dose information more quickly for potential combinations with other mechanisms.
The primary endpoint of this study was to evaluate the proportion of subjects with at least 20% reduction in L.P. from pre treatment value.
Normalization of the L.P., Yeah, we 12.
And he intends to treat where I.T.T. analysis treatment with one and two and a half milligrams of P.D.P. three o. five resulted in 45% and 46% L.P. responses, respectively compared to 11% and placebo.
He's response rates fall numerically higher than placebo, we're not statistically significant.
However, in an analysis of the subjects, who completed study treatment with no missing value. We 12, the proportions of A.L.P. responders and the one milligram and two and a half milligram arms <unk> heuristically significant response rates of 50, and 62%, respectively compared to 11% and placebo.
T secondary objectives were to evaluate the safety and tell her ability a V.D.P. three o. five as well as changes from baseline and deliver enzymes L.P.A.S.T.
Where G.G.T.
Data from the full I.T.T. population showed statistically significant reductions in absolute amounts of these t. bio markers compared to placebo at one milligram in two and a half milligrams a P.D.P. 305.
Statistically significant difference in the per cent changes from baseline of these key Biomarkers that week 12 was also observed in both P.D.P. three o. five arms or two placebo.
Jay R. Luly: We're hopeful that we'll be able to resume this trial within the next couple of months, depending upon whether enough of our clinical trial sites for this study are able to open up in the context of the COVID-19 pandemic. Also, in our NASH program, we are developing EDP297, our follow-on FXR candidate. We're excited about the compelling preclinical data we have previously shared that demonstrate the high potency and tissue targeting characteristics of EDP-297 compared to other FXR agonists in development.
In terms of safety 80, P., three or five with generally well tolerated in subjects with P.B.C.
The majority of treatment emerges adverse events or T.E., eight ease being mild to moderate.
Most common P.E.V.'s included <unk>.
Restaurant test an old related symptoms headache and insomnia.
These T.E.D.E.'s were consistent with the safety profile observed across more than 400 subjects exposed to 80 P. three apply for up to 12 weeks.
No incidents of treatment discontinuation due to parade of some traffic was approximately 3% for the one milligram P.D.P. three o. five treatment group.
Jay R. Luly: Subject to a determination that it is safe to initiate the Healthy Volunteer Study at the trial site in Europe in the context of COVID-19, we now plan to initiate a Phase I study of EDP-297 later in the third quarter, which would likely produce a readout in the second quarter of 2021. Beyond our pipeline, I'd like to take a moment to comment on MAVRID, our treatment for hepatitis C developed in collaboration with AbbVie. AbbVie recently announced that it is experiencing lower new patient volumes for hospital-based treatments in several international markets where hospitals are limiting access to non-emergency, non-COVID-19 patients. If the COVID-19 pandemic continues for a prolonged period, we expect this to adversely affect AbbVie's Maverick sales during that period.
Teen percent for the 2.5 milligrams treatment group and zero percent the placebo treatment group.
Well, we did not meet the primary and point for P.B.C.N.B.I.T.T. analysis, we plan to use these data, helping swarm or development of P.D.P. three o. five for Nash.
Specifically, we are encouraged that the lower dose of one milligram achieve better tolerability in terms of <unk> without significantly reducing the number of L.P. responders and while still having statistically significant effects on t. biomarkers target engagement.
See this is helpful information.
The intermediate doses of 1.5 milligrams and two milligrams that we plan to use in our Oregon to study Nash patients. We believe the dose at 1.5 milligrams for two milligrams isn't Nash could potentially achieve and advocacy intolerability profile comparable to that of the 1.0 milligram dose.
N.P.B.C.
Jay R. Luly: However, we also expect that those sales will likely shift to subsequent periods since there is no expectation that existing infections will decline materially other than by eventual treatment. We also note that AbbVie has now guided that it expects its calendar 2020 HCV sales to be approximately $2.3 billion. It's also worth noting that the CDC guidelines issued in April 2020 now recommend that all adults ages 18 to 75 be tested for the hepatitis C virus.
For more information on the Intrepids study. Please see this slide deck. They we will post on our website. After this call.
Rather than conducting further days selection studies with P.D.P., three o., five and P.B.C. a disease for which there was already in approved second line F.X.R. Agnes therapy, and for which generic fibrates are showing benefit from some studies, we intend to focus our future efforts with.
P.D.P. three o. fired on Nash.
You know Asher said disease, where I'm sorry, I you know, it's like 80, P. three o. five have the potential to be important components of drug combinations designed to give maximum benefit to patients.
Jay R. Luly: In closing, I'd like to point to a few key takeaways. Despite the challenging backdrop of COVID-19, which could have effects we don't currently expect. Enanta remains well positioned to execute on our business plans and advance our growing pipeline of novel therapies for respiratory viruses and liver disease. The unusual combination of our strong balance sheet and ongoing royalty revenue allows us to capitalize on the opportunities ahead and to advance our wholly owned pipeline independent of capital market conditions.
In our Nash program, we remain focused on evaluating E.D.P. three or five in Oregon to a phase to be randomized double blind placebo controlled 72 weeks study in approximately 340 subjects with biopsy proven mash.
While we were ready to begin devastating Oregon too on schedule March we decided to pause recruitment and don't seen in the study due to the ongoing cobin 19 pandemic.
We did this having in mind the safety of our clinical trial participants as well as resource constraints of clinical trial sites.
As a reminder, primer endpoint of our down to will be improvement in fibrosis without worsening of Nash and or Nash resolution without worsening fibrosis.
Jay R. Luly: We are on track with several milestones. First, our Phase 1B study of EDP514 in viremic hepatitis B patients is slated to begin this quarter. Second, we are planning to initiate our first in-human study of EDP297 for NASH next quarter. Regarding our RSV program, our two Phase II studies in pediatric patients and adult transplant patients are still on track to begin in the fourth quarter. Finally, we are advancing our RSVP study in the Southern Hemisphere, also keeping our Northern American sites ready for reactivation for the upcoming fall and winter RSVP. And later this year, we're planning to add a substantial number of sites in Europe. Assuming we can complete the study in the next Northern Hemisphere season, we would expect to have RSVP top-line data in the third calendar quarter of 2021.
Plan to use services at 1.5 milligrams and two milligrams, which we selected to provide strong target engagement any balanced profile in terms of advocacy and tell her ability.
Are going to include at 12 week interim analysis to generate dose information work quickly for potential combinations with other mechanisms in there.
We're hopeful that we'll be able to resume nice trial within the next couple of months, depending upon whether enough of her clinical trials sites for this study are able to open up on the context of the covert 19 pandemic.
Also in our Nash program, we are developing E.D.P. 297 or follow on F.X. our candidate.
We're excited about the compelling pre clinical data we have previously shared that demonstrate the high potency and tissue targeting characteristics. The P.D.P. 297 compared to other effects are Agnes some development.
Paul J. Mellett: Overall, we are in a very solid position with several opportunities in place. With that, I will now turn the call over to Paul to discuss our financials for the quarter.
Subject to a determination that it is safe to initiate the healthy volunteers study at the trial site that Europe in the context of the code bit 19, we now plan to initiate the phase one study a V.D.P. 297 later in the third quarter, which would likely produce a readout on the second quarter of 2020.
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 second fiscal quarter ended March 31, 2020. For the quarter, total revenue was $27.6 million and consisted entirely of royalty revenue earned on AVI's global HCV product sales. This compares to total revenue of $39.6 million for the same period in 2019. AbbVie has stated that its lower HCV sales were due to a decline in treated patient volumes in select international markets and increased competition affecting pricing and market share within the U.S. managed Medicaid segment.
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Yonder pipeline I'd like to take a moment commented on moderate like treatment for hepatitis C. developed in collaboration with Abby.
That'd be recently announced that it is experiencing lower do patient volumes of hospital based treatments and several international markets were hospitals are limiting access to non emergency non coated 19 patience.
You have to call. The 19 pandemic continues for prong period expect us to adversely affect abbey's maverick sales during that period.
However, we also expect to throw sales will likely shift to subsequent periods. Since there is no expectation that existing infections will decline mitt materially.
Paul J. Mellett: Royalty revenue for the quarter was calculated on 50% of Maverick sales at a royalty rate of 10% after adjustments for certain contractual discounts and rebates, which historically have been approximately 1.6% of AVI's total reported ATV product sales. As a reminder, our royalties are calculated on a calendar year basis. Therefore, royalties for our fiscal second quarter ending March 31 are calculated at the lowest royalty rate tier for our fiscal year. You can review our royalty tier schedule in our 2019 Form 10-K. Moving on to our expenses, for the three months ended March 31, 2020, research and development expenses totaled $32.6 million, compared to $34.2 million for the same period in 2019. The decrease was primarily due to a decrease in clinical trial expenses due to the timing of costs in the prior year for Phase II studies in NASH and PBC.
Then by eventual treatment.
We also noticed that Abby has now guided that it expects its calendar 2020, H.C.D. sales you approximately 2.3 billion.
It's also worth noting that the C.D.C. guidelines issued in April 2020, now recommend that all adults ages 18 to 75.
Tested for hepatitis C. virus.
And closing I'd like to point to a few key take waves.
Challenging backdrop of covert 19.
Which could have effects, we don't currently at stocked.
Into remains well positioned to execute on our business plans and a bouncer growing pipeline of novel therapies for respiratory viruses and I'll ever diseases.
Unusual combination of our strong balance sheet and ongoing royalty revenue allows us to capitalize on the opportunities ahead and to advance are wholly owned pipeline independent of capital market conditions.
We're on track with several milestones.
First or phase one b. study of eating P. 514, and five remake hepatitis b. patients slated to begin this quarter.
Paul J. Mellett: General and administrative expense for the quarter was $6.9 million, compared to $6.8 million for the comparable quarter in 2019. Enter recorded an income tax benefit of $3.9 million for the three months ended March 31, 2020, compared to an income tax benefit of $3.2 million for the same period in 2019. In the current quarter, we recorded an income tax benefit driven by our pre-tax loss and increased research and development tax credits. In the prior year, Enanta recorded an income tax benefit despite reporting a pre-tax income due to tax deductions from employee stock award related activity during the quarter. The net loss for the three months ended March 31, 2020, was $6 million, or a loss of $0.30 per diluted common share, compared to net income of $4.1 million, or $0.20 per diluted common share, for the corresponding period in 2019.
Second we were planning to initiate our first in humans study EVD P. 297 for Nash next quarter.
Regarding our our speed program or two phase two studies and pediatric patients and adult transplant patients are still on track to begin and the fourth quarter.
Finally, we are advancing R.R.S.T.P. study in the southern Hemisphere also keeping our northern Northern American sorry, it's ready for reactivation for the upcoming fall and winter ours season.
Later this year, we're planning to add a substantial number of sites in Europe.
So I mean, we can complete the study and then next to northern Hemisphere season, we would expect to have R.S.P.P. tough wind data and the third calendar quarter of 2021.
Over all we were in a very solid position with several opportunities in place.
Without I will now turn the call over to Paul to discuss or financials for the quarter ball.
Thank you J.
I'd like to remind everyone that an answer reports on September 30th fiscal year schedule.
Today, we are reporting results for our second fiscal quarter ended March 31 2020.
So the quarter total revenue was 27.6 million.
Paul J. Mellett: Enanta ended the quarter with approximately $435 million in cash and marketable securities, an increase of approximately $35 million from our 2019 fiscal year-end balance of $400 million. We expect that these cash resources, as well as our continuing royalty revenue, will be sufficient to meet our anticipated cash requirements for the foreseeable future. Further financial details are available in our press release and will be available in our quarterly report on Form 10-Q when filed. I'd now like to turn the call back to the operator and open up the lines for questions. Operator?
Consisted entirely of royalty revenue earned on abbey's global H.T.V. product sales.
Compares to total revenue was 39.6 million for the same period and 2019.
As he has stated that is slower H.T.V.'s sales were due to a decline and treated patient volumes and select international markets and increased competition affecting pricing in market share within the U.S. managed Medicaid segment.
Royalty revenue for the quarter, miscalculated and 50% of Mavericks sales.
Guilty rate is 10% after adjustments for certain contractual discounts and rebates, which historically has been approximately 1.6%.
These total reported H.T.B. product sales.
As a reminder.
Operator: Ladies and gentlemen, at this time, if you would like to ask a question, please press star, then the number 1 on your telephone keypad. Again, to ask a question, please press star, then the number 1. Your first question is from the line of Yasmeen Rahimi with Roth Capital Partners. Hi, team.
<unk> are calculated on a calendar year basis, therefore royalties for our fiscal second quarter ending March 31 are calculated to lowest royalty rate here for our fiscal year.
You can review our royalty tear schedule in our 2019 form 10 k.
Yasmeen Rahimi: Thank you for all the updates. I have two questions for you. The first one is, can you kindly shed some light on why the intrepid study may have missed its primary endpoint? Is there any reason that maybe you could have recruited more severe PBC patients that could have contributed? Or we also noticed that the placebo response was higher than we had hoped for. Any color in that regard could be helpful for us.
Moving onto our expenses.
Three months ended March 31, 2020 research and development expenses totaled 32.6 million compared to 34.2 million for the same period in 2019.
The decrease was primarily due to a decrease in clinical trial expands to visit timing of costs and the prior year for phase two studies and gnashing P.D.C.
General in administrative expenses for the quarter was 6.9 million compared to 6.8 million comparable quarter and 2019.
Jay R. Luly: And then the second question is, can you give us an update on where you are in regards to your antiviral development against SARS-CoV-2? How much progress has been made since the announcement was made a few weeks ago? And thank you so much for taking our questions.
An enter recorded an income tax benefit of 3.9 million for the three months ended March 31, 2020, compared to an income tax benefit of 3.2 million for the same period and 2019.
In the current quarter, we recorded an income tax benefit driven by our pre tax laws and increased research and development tax credits.
Jay R. Luly: Thanks, this is Jay. Why don't I take the COVID question, and I'll ask Natalie to... and talk about the Intrepid Quest. So, on the COVID side of things, as you know, we announced our program and, in the March timeframe, after kind of watching the coronavirus start to pick up, it became pretty clear that it was very different from other coronaviruses, which we hadn't paid that much attention to. SARS-1 sort of burned out on its own, and MERS, you know, really, Transcribed by https://otter.a So it isn't really a sort of a global threat. But as we all know now, in spades, COVID seems to be behaving very differently. So we mobilized the team just several weeks ago, and, you know, I've been taking this As some have a multi-pronged approach, our first approach is just getting key things from our library up and ready for testing. As you know, we've worked on lots of different viruses over the years. Within each virus, we've worked on lots of different mechanisms against each virus. And within each mechanism, we often have multiple different structural classes of molecules and so forth.
Prior year, an enter recorded an income tax benefit despite reporting it pretax income due to tax deductions from employee stock award related activity during the quarter.
Net loss for the three months ended March 31, 20, 26 million or a loss of 30 cents per diluted common share.
Intranet income, a 4.1 million or 20 cents per diluted common share for the corresponding period and 2019.
An end to end of the quarter was approximately 435 million in cash and marketable securities and increase of approximately 35 million for my 2019 fiscal year round balance for 400 million.
We expect that these cash resources as well as our continuing royalty rather than okay, we'll be sufficient to meet our anticipated cash requirements for the foreseeable future.
Further financial details are available in our Presley's and will be available in a quarterly report on foreign 10, Q. when filed.
Now like to turn the call back to the operator and open up the lines of questions operator.
Ladies and gentlemen at this time, if you'd like to ask a question. Please press start that'd be number one on your telephone keypad again to ask a question. Please press start sending number wine.
The first question if on the line of gas men Rahimi with Rod capital partner.
Hi team. Thank you all the update two questions yeah with the first 20 can you claim.
Jay R. Luly: So we've got a pretty robust library for, selection of molecules for testing the many different chemotypes. So we've mobilized that external effort and I would say it's certainly still going on. There's a backlog of testing at a lot of these facilities who can handle the BL-3 conditions required for SARS-CoV-2, but we're going through that, so that's, you know, a little bit more of a passive activity. We hope we might find an interesting chemical launching point. If we do, it saves us that much time, but also not leaving anything to chance where we're taking on sort of a direct targeted approach just like we do with all of our viruses where we unpack the virus, figure out where key vulnerabilities might be, and then we, Dr. Joseph, Thomas Yip, Brian Abrahams, Brian Skorney, Douglas Buchanan, Roanna Ruiz, Luke Herrmann, Hannah Adeoye, Tara Kieffer, Unknown Executive, Jasmeen Rahimi, Jay Olson, Jennifer Viera, Amy Luly, Scott Rottinghaus, Enanta Pharmaceuticals Inc.
I'm light online why the Entropic Daddy May have my son, it's primary endpoint.
Is there any reason that maybe you could have recruited more severe P.B.C.P. <unk> I could contribute war. We also noticed that the plus humor response is higher than we had hoped for any color in that regards could be helpful. For us and then the second question you can you give us an update on where.
You are in regards to your antiviral developing against Sars Coby cue how much progress has been made just since D. announcement announcement was made a few weeks ago and thank you. So much for taking your question.
Thanks, Yeah. This is true.
Why don't I take the code would question and all out now to lead to.
Jay R. Luly: Classical, if you will, drug discovery initiatives have started. It started on multiple different targets. Among them, we like proteases, which is probably not a surprise based on our legacy in hepatitis C. And, you know, chemistry and biology have ensued. So, it's been just a short number of weeks and under, you know, the difficult constraints of, you know, the COVID backdrop. But, you know, the teams are, again, highly mobilized and afoot. So, you know, we don't have any breaking results to report this quarter, but we'll be giving updates, you know, as the year progresses. Don't all of you want to comment on the intrepid?
Talk about the Intrepid question.
So on the <unk> side of things, because you know, we announced or program and.
And the March time frame.
Kind of watching in the Corona virus start to pick up and it it became pretty clear that it was very different than other current of viruses, which we hadn't paid that.
Attention to Sars one.
Sort of burned out on its own and murders you know really.
Unknown Executive: Sure. Thank you for your question, Yasmeen.
<unk> went away, it's still Pops up now and then but only in regions.
Unknown Executive: So maybe a few considerations I can point you out. The choice of the endpoint, as you can notice, we used the proportion of patients with more than 20% reduction, which for a proof of concept study of 12 weeks was setting up the primary endpoint as a high bar. So I think it's important just to point that out.
And and people who have close proximity to camels. So it it it isn't really a sort of a global a threat, but since we all know now.
Spades koban seems to be behaving very differently.
So we immobilize, though.
The team just several weeks ago.
And you know I've been taking notes.
And some have a multi prong approach. Her first approach was just getting key things from or a library.
Unknown Executive: If we look at the change over time for ALP, we had a nice reduction over time that was statistically significant. So I believe that, you know, there's a few considerations that I can comment on missing the endpoint here. There's probably a lack of power in the study. We decided a while back to [inaudible] You are right to absolutely point out the fact that we have a higher placebo effect than other studies, and I think the other consideration in a small sample size was the fact that we had a little bit higher rate of discontinuation than we anticipated as we calculated our sample size and power. That could have also contributed to missing the endpoint. From a numerical standpoint, we have a nice difference even from the placebo, and I think given the small sample size and the randomization ratio that we had for 3 to 1, one subject can make a huge difference as far as expressing a significant p-value. So this is what I can share today. We obviously will be looking further into the entire dataset, and I hope to bring more color to the results.
Oh and ready.
For testing as you know we've worked on lots of different viruses over the years within each virus, we've worked on lots of different mechanisms.
Against each virus seven within each mechanism, we often have multiple different structural classes of molecules and stuff. So we've got.
The robots library for.
Selection of molecules for testing in many different from the time, so we mobilize that external effort and.
Let's say, it's certainly still it's still going on there's a backlog of.
<unk>.
These facilities, who can handle the B.L. three conditions required for Sars codes too, but we're we're we're going through that so that's.
You know a little bit more of a passive activity. We we hope we might find it interesting chemical launching point, if we do it it saves us that much time.
But also not leaving anything to chance. We're we're taking on a sort of a direct targeted approach just like would be with all of her viruses, where we <unk>.
Unpack the virus figure out a were keep on her abilities might be.
And then we.
To identify you know certain targets and then optimize you know quietly ideally highly potent.
Unknown Executive: Thank you, Natalie, and thank you, Jay, for the color. Your next question is from the line of Brian Skorney with Bayard.
Safe convenient to use in this case world drugs for for treatment so that.
Operator: How's it going?
Luke P. Herrmann: Thanks for, this is Luke on for Brian, thanks for taking the call.
Was more classical we will drug discovery initiative started it started on multiple different targets.
Luke P. Herrmann: all. We were wondering
Luke P. Herrmann: Looking at the COVID clinical plan down the road.
Jay R. Luly: have other programs in there, at the multi-patient severity level with prophylactic mild to moderate and severe patients. How has that framed your outlook on entering clinical development in the future? Thanks.
Among them, we like pretty soon so it's probably not a surprise based on our legacy and and hepatitis C.
And you know chemistry, and biology has been sued so it's.
It's been just a short number of weeks and under you know sort of difficult constraints of no the Kobe backdrop, but.
Jay R. Luly: Yeah, I think you know, like any new indication? This is certainly a new indication for people to confront. It's going to be it's going to evolve over time, but certainly, you know, in the early days of crisis mode.
The teams are again highly mobilized and an output so.
You know, we don't have any breaking results to report this quarter, but we'll be getting updates yeah, you're progressive.
Jay R. Luly: People are getting treated at late stages of infection, perhaps too late, you know, by then. COVID has progressed from an upper airway disease into a lower airway disease; we get a lot of inflammation going on cytokine storms and other things, complications. And it's certainly not ideal. And, you know, to look at an antiviral in late stage disease is asking an awful lot of any agents, including all the ones that have been tested to date. We can see why people are doing it, and it makes good sense.
Not all you want to comment on the <unk>.
Sure. Thank you for your question, Yes mean, so maybe a few consideration they can point to the choice of <unk> you can Moody's we used to proportion of patient <unk> more than 20 per cent prediction reach for proof of concept studios 12 weeks was a sitting it's you know.
<unk> and part of it <unk>. So I think it's gone just too much is that if we look at the change all the time for H.P., We had a nice we did send over time there was such a sticky significant so I believe that's you know does a few consideration that I can.
Jay R. Luly: You don't have anything else, and you're in crisis mode. So while people are waiting for other kinds of more optimized products to come along, waiting for the possibility of vaccines, that's about all you can do. We're obviously not participating in vaccine discovery or development, and we're actually not. I'm looking toward entering into, you know, patients when they're further advanced in their disease. I think, You know, we're sort of thinking a little bit about RSV, and if you sort of imagine where the puck may eventually go, it's really headed toward, you know, ultimately, it'd be great to get to a state where patients present, perhaps not unlike they do in our RSVP study. They're symptomatic for a few days; they come in, they walk into a clinic, and they can get tested.
Oh come on and missing the endpoint here, there's clubby not Oh, well just studies, we decided to wind bike to.
<unk> do equipment, because we figure that that's pulling dead, yet sufficient that that could I've had to a median phones, we and number 68 subject.
You a right to up to the T. point that decided that we have a higher price is always take a then oh, that's a steady finishing P.O.'s or a consideration in a small sample size was decided that yeah. They didn't beat high rates of discontinuation that we anticipated as we calculate.
Oh sample size and Paula.
That we that was the country P.D. to missing <unk> point.
Jay R. Luly: There's a rapid diagnostic test available. Obviously, we've been doing this for a while now in our RSVP study. And then, if it lights up COVID, you would ideally treat in one direction. If it lights up RSV, you treat in another direction. If it lights up the flu, you treat it in another direction. And so, you know, we're probably a ways off, we and others, before COVID can be managed that way. But I think that's an aspiration in terms of where we would like to, you know, ultimately really make an impact if we're able to. So, I think the longer term, and we've been saying this for quite a while in RSV, it's all about getting patients diagnosed early and getting them on drugs early.
<unk> Oh, we have a nice difference even from the placebo and I think given you know desmona synthesized and then let the musician <unk> that we had for 321.
One subject can make a huge difference as far as <unk>. She said I can share today, we have you seen a we'd be looking further to the entire Denis it and I hope to <unk> to to do we sent.
Thank you not only in pens are trying to put a color.
Jay R. Luly: And if you really want to change the course of human respiratory viral infection, that's the most likely best way to do it. I think that's appreciated now with COVID. The challenge to date has been, you know, testing and also just managing the crisis at the back end of the disease. But hopefully, we'll get to a more stable plateau where the course of patient management can shift to a better direction.
You're welcome.
Her next question if I'm the line of Brian's corny with the back yard.
Hi, How's it going thanks for this Luke on for Brian. Thanks for taking the call we were wondering.
Looking at the coded critical planned on the road have other programs in there.
T patient <unk> prophylactic mild to moderate instead of your patience.
How is that <unk> outlook on entering clinical development in the future. Thanks.
Yeah I think.
Jay R. Luly: Management can shift in a better direction. Thank you so much.
You know like any.
Operator: You're welcome.
Any new indication. This is certainly a new indication what people to confront.
Operator: Again, to ask a question, please press star 1 on your telephone keypad. Again, that is star 1. Your next question is from the line of Akash Tewari with Wolf Research. Hi, this is Andrew Newton on behalf of Akash. First on RSV, both J&J and Reviral are assessing combo approaches using an F inhibitor as well as an L or an N inhibitor due to some synergistic effects and to combat any potential
It's going to be it's going to evolve over time. So certainly you know in early days of crisis mode.
People are getting treated late stages of instruction, perhaps too late you know by then.
Cobin has progressed from an upper airway disease into a lower airway disease, we get a lot of inflammation got where you know undecided kind storms and other things complications and it's certainly not ideal and you know to look at an anti viral.
Andrew Newton: Transcription by Transcription Outsourcing, LLC.
Late stage disease is asking an awful lot of any regions, including all the ones that put them.
Andrew Newton: Would you ever consider a combination approach in later trials? And then secondly, we know Enanta has a history of success with protease inhibitors, and we recently saw Pfizer identify some.
Tested today.
We can see why.
Will are doing it but makes good sense, we don't have anything else when you're in crisis smoke. So while people are waiting for other kinds of more optimized the products come a long waiting for the possibility of vaccines. That's about all you can do.
Andrew Newton: Unidentified Coronavirus C3L Inhibitor with Nanomolar Affinity
Jay R. Luly: Would be some of the theoretical pros and cons to targeting this protease in COVID versus some of the other antiviral MOAs like nukes?
Jay R. Luly: Sure. So let me let me take your first question first.
Jay R. Luly: So I think, you know, we at the very beginning of our RSV program, we had sort of a clinging slight. We could have started with entry inhibitors or nukes, or, you know, in our case, we went to the nucleoprotein approach and other mechanisms. The mechanism that we actually pushed to the side initially in favor of the one that we're working on with EDP938, was the fusion approach, or the so-called F-protein. So people obviously got excited with the F-protein approach, first with synergist, a monoclonal antibody targeted against it. We think that makes a great deal of sense in prophylaxis, where the drug, in this case, a monoclonal antibody, can be present before the virus, and it's perfectly set up to be there on time and to block entry. That said, if you've got an ongoing, pretty active infection where viruses have already entered a lot of cells, a good deal of viral infection involvement.
Where obviously not participating in vaccine discovery or development when we're we're actually not.
I'm looking toward.
Entering into you know patience one there further progressed in there disease I think.
<unk> you know, we're sort of thank you know it a little bit about.
Like R.S.V.
You sort of imagine where the puck may eventually go.
It's it's really headed toward you know ultimately it'd be great state where.
Patients present, perhaps not on like they do and R.R.S.V.P. study. They are symptomatic for a few days they come in.
Walk into the clinic, they can get tested.
There's a rapid diagnostic test available obviously, we've been doing this for for Awhile now in our R.C.P. study and then if if it lights up a covert you you would ideally tree in one direction, if it lights up R.S.B. treat in another direction.
Jay R. Luly: The fear is that maybe a little bit late for fusion inhibitors to have maximum impact, particularly if you're as they progress in time from the time of infection. So we targeted a non-fusion approach using an inhibitor, and it turns out that that many of the reasons that you want to use. Unknown Speaker 05.0.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.1.
Flew you treat in another direction. So you know, we're probably away so off we and others before co. Good can be managed that way.
But I think that's the an aspiration in terms of where we would like to.
You know ultimately really make an impact if we.
So.
I think the longer and we've been saying this for quite awhile.
Has to be it's all about getting patients getting patients diagnosed early and getting them on drug early and if you really want to change the course of human respiratory viral infection. That's the most likely best way to to do it I think.
Jay R. Luly: Super High Barrier. So, we've demonstrated that pre-clinically and have shown all the virology data, you know, along those lines. So, you know, whereas I could see why a fusion inhibitor, which by the way, fusion inhibitors in our hand, in contrast to a molecule like EDP938, actually have an incredibly low barrier to resistance. And so from a virologic perspective, it makes a good deal of sense if you have a fusion inhibitor approach to try to add something else to it, because you can see resistance mutations popping up very readily So I would say a fusion inhibitor is more likely to need something like an N, but an N may not need a fusion inhibitor.
Appreciated probably now with Kobe challenge.
The date has been you know testing and and also just managing the crisis at the back end is good but.
Hopefully, we'll get two or more stable a plateau, where the course patient management can can shift in a better direction.
They they do so much.
Welcome.
Again to ask a question. Please press star one on your telephone keypad again that is starve line.
Your next question based on the line of <unk> with <unk> research.
Hi, this is standardized on for costs first on R.S.V.J., and J. and revival, our assessing combo approaches using an f. inhibitor as well as an l. oriented and inhibitor.
Jay R. Luly: Of course... You know, we can't rule out that as good of a benefit as we're seeing with N, that if we added something else onto it, we might see even greater efficacy than we've already seen. That's a possibility, and to that end, we are working on other approaches to RSV such that we might find a mechanism that could be even better than an N or one that may marry well within in terms of optimizing efficacy to, you know, even higher levels. So that's our thought on that. In terms of the...
<unk> effects and to combat any potential resistance to one and the way how do you think you're monotherapy approach would compare to those kind of results in regards to safety or efficacy and would you ever consider a combo approach in later trials and then secondly, we go into the history of successive protease inhibitors, and we recently saw Pfizer identified.
<unk> inhibitor with Nanomolar affinity what do you think would be some of the theoretical pros and cons to targeting this protease encoded versus some of the other antiviral m. always like nukes.
Jay R. Luly: The P.I. for SARS that has been identified. Well, I've already mentioned, you know, we like direct acting antivirals as approaches here. There are lots of ways that you could think about going after this, but protease is, you know, likely or could well be, anyway, an important target vulnerability in the virus. So I suspect, you know, we and others will be working on those, and Enanta's a pretty good protease inhibitor shop, and it just makes a great deal of sense for us not to ignore it. You know, nukes are not necessarily uninteresting. They have, they can have liabilities, as you know, and so there's a question of really fine-tuning the profile such that you have a good safety profile and good pharmacokinetics in addition to having just an antiviral effect because, you know, optimization may be required there. But I would say, you know, any of the direct acting antiviral targets are of interest at this early stage of our understanding of how the virus really works.
Sure.
I need to take the first question first so I think you know we we.
The very beginning of R.R.'s P. program, we had sort of a clean slate, we could have started with a entry inhibitors or nukes or.
You know in our case, we went through the nuclear protein approach and and other mechanisms.
The mechanism that we actually pushed to the side initially.
In favor of the one that we're working on with P.D.P. 938.
What is that fusion approach, where the the so called F. Crazy. So people, obviously got excited with the a f. protein approach first with send a just a monoclonal antibody targeted against that we think that makes a great deal sense in profile access where the drug in this case.
Monoclonal antibody can be present before the virus.
And it's perfectly set up to be there on time and to block entry.
That's sad.
If you've got a.
An ongoing pretty active in section where.
Viruses already entered a lot of salt you have it.
A good deal of viral infection involvement. This here is that maybe a little bit late for fusion and others have maximum impact, particularly if you were.
Jay R. Luly: Awesome. Thank you. You're welcome.
Jennifer Viera: There are no further questions. I will turn the call back over to Jennifer. Thank you everyone for joining us today. If you have additional questions, feel free to give us a call in the office. Take care. This concludes today's conference call. Thank you for participating. You may now disconnect.
Getting patience as they progress in in time from the time of infection. So we we targeted the non fusion approach using an inhibitor.
And it turns out that.
Many of the reasons that you want to use a combination is to thwart the possibility of resistance.
Turns out that are a molecule eating p. 938, and then this mechanism as a very high barrier to resistance.
Super high barriers so.
And we've demonstrated that preclinically and have shown halted by rolling three data you know along those lines. So you know, whereas I could see why the fusion inhibitor, which by the way fusion inhibitors on our hands in contrast to molecule like even P. 938.
Actually have an incredibly low barrier to resistance.
And so from a viral logic perspective that makes a good deal in the sense. If you have a fusion inhibitor approach to try to add something else to it because you can see resistance mutation popping up very readily in the lab and very quickly and patients who who have been done with a fusion inhibitors. So.
Operator: ??? ???
I would say a fusion inhibitor more likely to need something like N.N. button and may not need to be.
Better.
Of course.
No. We we can't rule out ever that it's a good of a benefit is where the same within that if we've added something else onto it that we might even greater Africa's. We then we've already seen that's a possibility to data and we are working on other approaches to ours.
Such that we might find that mechanism that could be even better than on n. or one that may marry well with in terms of optimizing advocacy too you know even higher levels. So that's that's our our thought on that in terms of the.
The P.I.
Toward Sars that has.
Then identified well I've already mentioned you know we like <unk> approaches here, there's lots of ways that you could think about going after this but <unk>.
Likely or could well be anyway, a an important target.
Vulnerability and the then the virus so I suspect.
We and others will be working on those in answer is a pretty good <unk> competitors shop, and we just makes a great deal of sense for us to to not ignore.
You know nukes or not necessarily uninteresting.
They have.
Maybe they can have liabilities.
No. So there it's a question of really fine tuning the profile such that you have a good seafood profile and good Pharmaco kinetics.
And to having testing antiviral sucks because.
The mistakes and maybe required there, but I I would say you know any of the direct acting in by rolled targets.
Or of interest, but this early super understanding of how the virus is really picky.
[noise] awesome. Thank you.
Welcome.
There are no further questions I will turn to call back over to Jennifer.
Thank you everyone for joining us today, if you have additional question feel free to give us a call in the office.
Yeah.
Basically today's conference call. Thank you for participating you may now disconnect.
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