Q4 2021 Altimmune Inc Earnings Call
Ladies and gentlemen, please stand by your alter immune conference call will begin momentarily. Once again. Please stand by your conference call will begin momentarily. Thank you Pete.
Operator: Ladies and gentlemen, please stand by. Your Altimmune conference call will begin momentarily. Once again, please stand by. Your conference call will begin momentarily. Thank you for your patience and please continue to hold. [music] Music playing [music] Good day, ladies and gentlemen, and welcome to the Altimmune, Inc. full year-end Q4 earnings conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require operator assistance, please press star, then zero on your touchtone telephone.
Patients said, please continue to hold.
[music].
Good day, ladies and gentlemen, and welcome to the Ulta Beauty, Inc. Full year and Q4 earnings conference call. At this time all participants are in listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require operator assistance. Please press star then zero on new Touchstone.
Telephone as a reminder, this call is being recorded I would now like to introduce your host for today's conference Richard Eisenstadt, Chief Financial Officer at all to me and Rich you may begin.
Operator: As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Rich Eisenstadt, Chief Financial Officer at Altimmune. Rich, you may begin.
Rich Eisenstadt: Thank you, Jonathan. And good morning, everyone. Thank you for participating in Altimmune's full year and fourth quarter 2021 earnings conference call. Members of the Altimmune team joining me on the call today are Vipin Garg, our Chief Executive Officer; Scott Roberts, our Chief Scientific Officer; and Scott Harris, our Chief Medical Officer. Following the prepared remarks, we will hold a question and answer session. A press release with our full year and fourth quarter 2021 financial results was issued this morning and can be found in the investor relations section of the company's website.
Thank you Jonathan and good morning, everyone. Thank you for participating in <unk> full year and fourth quarter 2021 earnings conference call members of the Ultimate team joining me on the call today are different guard, our Chief Executive Officer, Scott Roberts, Our Chief Scientific Officer, and Scott Harris, Chief Medical Officer.
Following the prepared remarks, we will hold a question and answer session. A press release with our full year and fourth quarter 'twenty 'twenty. One financial results was issued this morning and can be found on the Investor Relations section of the company's website.
Rich Eisenstadt: Before we begin, I would like to remind everyone that remarks about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995, cautioning that these forward-looking statements are subject to risks and uncertainties that can cause actual results to differ materially from those indicated, including those related to COVID-19 and its impact on our business operations, clinical trials, and results of operations. For a discussion of some of the risks and factors that could affect the company's future results, please see the risk factors and other cautionary statements contained in the company's filings with the SEC.
He began I would like to remind everyone that remarks about future expectations plans and prospects prospects constitute forward looking statements for purposes of the safe Harbor.
Under the private Securities Litigation Reform Act of 1995.
<unk> cautions that these forward looking statements are subject to risks and uncertainties that could cause.
Cause actual results to differ materially from those indicated including those related to COVID-19 and its impact.
Impact on our business operations clinical trials and results of operations for.
For a discussion of some of the risks and factors that could affect the company's future results. Please see the risk factors and other cautionary statements contained in the company's filings with the FTC.
Rich Eisenstadt: I would also direct you to read the forward-looking statement disclosure in our earnings press release issued this morning and now available on our website. Any statements made on this conference call speak only as of today's date, Tuesday, March 15th, 2022, and the company does not undertake any obligation to update any of these forward-looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this conference call is being recorded and will be available for audio replay on Altimmune's website.
It also direct you to read the forward looking statement disclosure in our earnings press release issued this morning, and now available on our website.
These statements made on this conference call speak only as of today's date Tuesday March 15th 2022, and the company does not undertake any obligation to update any of these forward looking statements to reflect events or circumstances that occur on or after today's date. As a reminder, this conference call is being recorded.
And will be available for audio replay also means website with that I will now turn the call over to Dr. Vipin Garg, Chief Executive officer of Alchemy.
Rich Eisenstadt: With that, I will now turn the call over to Dr. Vipin Garg, Chief Executive Officer of Altimu. Thank you, Richard, and good morning, everyone! We appreciate you joining us today for a discussion of our year-end and fourth quarter 2021 financial results and business updates. 2021 was a very productive year for the company as we achieved a key phase one data set in the development of how a lead product candidate can be dutized.
Thank you, Jeff and good morning, everyone.
We appreciate you joining us today for a discussion of our yearend and fourth quarter 2021 financial results and business update.
2021 was a very productive year for the company.
We achieved a key phase one data set in the development of our lead product candidate when we do diet.
Vipin Garg: We announced positive data from a 12-week, phase 1, placebo-controlled, single and multiple ascending dose trial in volunteers with obesity and overweight that showed a mean weight loss of 10.3% was achieved with a 1.8 mg once-weekly subcutaneous dose, with no serious or severe treatment-emergent adverse events or Discontinuations for Adverse Events. Furthermore, this favorable tolerability profile was achieved without the need for dose titration. We also demonstrated a greater than 90% reduction in liver fat content in subjects with hepatic steatosis, with liver fat decreasing below the limit of detection after only six weeks of treatment in the fourth quarter of 2021.
We announced positive data from a 12 week phase one placebo controlled single and multiple ascending dose trial in volunteers with obesity and overweight that showed a mean weight loss of 10.3% was achieved with the one eight milligram once weekly.
Subcutaneous dose.
With no serious or severe treatment emergent adverse events.
Discontinuation is put adverse events.
Motorola.
This favorable at this favorable tolerability profile was achieved without the need for dose titration.
We also demonstrated a greater than 90% reduction in liver fat content.
In subjects with hepatic steatosis with liver fat decreasing below the limit of detection after only six weeks of treatment.
In the fourth quarter of 2021.
Vipin Garg: We announced that we initiated a 12-week Phase 1B trial of panbidutide in subjects with non-alcoholic fatty liver disease, or NAFLD. That trial is ongoing at multiple sites in the United States with Dr. Stephen Harrison, a renowned expert in the field of fatty liver and liver diseases, serving as the principal investigator.
We announced that we initiated a 12 week phase one b trial, a family do died in subjects with non alcoholic fatty liver disease or mass L. D.
That trial is ongoing at multiple sites in the United States with Doctor Stephen Harrison.
Now an expert in the field of Nash and liver diseases, serving as the principal investigator.
Vipin Garg: Enrollment in this trial is over 90% complete, and a data readout is expected in the third quarter of 2022. Additionally, we initiated a 12-week extension to this trial, which when combined with the first trial will allow subjects to receive treatment for up to 24 weeks. This will enable comparison to the weight loss achieved with semaglutide and trizepatide at the six-month time point. We expect to report this important readout in the fourth quarter of 2022.
And Goldman and this trial is over 90% complete.
And the data readout is expected in the third quarter of 2022.
In addition, the.
We initiated a 12 week extension to this trial.
Which when combined with the first trial.
Allow subjects, who received treatment for up to 24 weeks.
This will enable comparison to debate last achieved with semi blue died and present. The died at the six month time point.
We expect to report this important readout in the fourth quarter of 2022.
I'll need to see a good year.
Vipin Garg: Early this year, we received IND clearance from the FDA to evaluate panbidutide for obesity, and we are preparing to commence enrollment in the 48-week phase to momentum trial of family do-touch in obesity later this month. The name reflects the rapidity of weight loss and Altimmune's firm commitment to the treatment of obesity.
<unk> die and we just see buying D clearance from the F D. A.
To evaluate when we do diet for obesity and.
And we are preparing to commence enrollment.
In the 48 week phase III momentum trial of family do doubt in obesity later this month.
The name reflects the rapidity of weight loss and alter immune firm commitment to the treatment of obesity.
Vipin Garg: An interim analysis is planned to assess changes in body weight after 24 weeks of treatment, with data expected in the fourth quarter of 2022. This means that we expect to have 24-week readouts on weight loss from two separate clinical trials of Pambidutide in 2022, looking to other studies in 2022. We recently initiated a 12-week trial to characterize the effects of family dutite on glucose control in subjects with type 2 diabetes as a follow-on to our recently completed First in Human Phase I trial, where we demonstrated excellent maintenance of glucose control in subjects with prediabetes, with a concomitant decrease in insulin resistance.
An interim analysis is planned to assess changes in body weight. After 20 weeks of treatment, Saudi after 24 weeks of treatment.
With data expected in the fourth quarter of 2022.
This means that we expect to have 24 week readout on weight loss from two separate clinical trials of fans who died in 2022.
Looking to other studies in 2022.
We recently initiated a 12 week trial to characterize affects our family do die on glucose control.
In subjects with type two diabetes type two diabetes as a follow on to our recently completed first in human phase one trial.
Maybe demonstrated excellent maintenance of glucose control in subjects with pre diabetes.
<unk> com and a decrease in insulin resistance.
You had also completing a phase one drug drug interaction trial.
Valuate any potential interactions a family do tied with commonly used drugs.
The results of both of these trials are expected in the middle of 2022 .
Finally.
Vipin Garg: We are also completing a phase one drug-drug interaction trial to evaluate any potential interactions of pambidutide with commonly used drugs. The results of both of these trials are expected in the middle of 2022. Finally, [inaudible] We anticipate the launch of a 52-week biopsy-driven phase 2 national trial in the fourth quarter of 2022, based on the remarkable effects of pambidotide on liver fat reduction in our first inhuman clinical trial. We expect robust effects on Nash, histology, and other clinical endpoints, turning to Hep T cell.
We anticipate the launch of a 52 week biopsy driven phase III Nash trial in the fourth quarter of 2022.
Based on the remarkable effects of friendly do tight on liver fat reduction in our first in human clinical trial.
We expect robust effects on Nash histology and other clinical endpoints.
Turning to have T cell.
Vipin Garg: Enrollment in our Phase II clinical trial in chronic hepatitis B subjects is ongoing, with study readout expected in the first half of 2023. We are excited about the progress of Pembidutide and Heftycell and the data we have generated so far.
Enrollment in our phase II clinical trial in chronic hepatitis b subjects is ongoing.
Studied readout expected in the first half of 2023.
We are excited about the progress of N V do dive in Hep D cell.
And the data we have generated so far.
Vipin Garg: We expect 2022 to be an important year for Altimmune, with three major readouts representing significant potential value drivers for the company. With that, I will now turn the call over to our Chief Medical Officer, Dr. Scott Harris, to discuss our data and clinical plan.
We expect 2020 to be an important year for ultimately.
With three major readouts, representing significant potential value drivers for the company.
With that I.
I will now turn the call over to our Chief Medical Officer.
Doctors, Scott Harris to discuss our data and clinical plan.
Scott.
Thank you Ben and good morning, everyone.
Scott Harris: Thank you, Vipin, and good morning, everyone. As Vipin mentioned, we are on the verge of completing enrollment in our Phase 1b NAPLD clinical trial of Penta-Dutide. The trial was designed to assess the effects of panfidutide on liver fat in subjects with obesity or overweight with NAFLD, defined as a 10% or greater liver fat content as measured by MRI-PDFS. Approximately 72 non-diabetic and diabetic subjects are being randomized one-to-one to one-to-one to pendidutide 1.2 mg, 1.8 mg, 2.4 mg or placebo over 12 weeks of
As Vipin mentioned, we're on the verge of completing enrollment in our phase <unk> clinical trial of <unk>.
The trial was designed to assess the effects of Panther do tied on liver fat and subjects with obesity, we're overweight with natural D defined as a 10% or greater liver fat content.
Measured by MRI P D S F.
Approximately 72, non diabetic and diabetic subjects are being randomized one to one to one to one to <unk>. One two milligrams, one eight milligrams 2.4 milligrams or placebo over 12 weeks of treatment.
Scott Harris: The primary endpoint of this trial is the reduction in liver fat by MRI-PDFF, but a key secondary endpoint is weight loss at the end of 12 weeks of treatment, as we believe that obesity is the key driver of NAFLD and NASH. As Vipin mentioned, we expect data readout from this trial in the third quarter of 2022. Based on the results of our recently completed Phase 1 clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss in these subjects after 12 weeks of treatment.
The primary endpoint of this trial is the reduction in liver fat by MRI P. DFS, but a key secondary endpoint is weight loss at the end. So end of 12 weeks of treatment as we believe that obesity is the key driver of natural D and Nash.
As Vipin mentioned, we expect the data readout from this trial in the third quarter of 2022.
Based on the results of our recently completed phase one clinical trial, we expect to achieve a robust reduction in liver fat content and again show a significant weight loss and these subjects after 12 weeks of treatment.
Scott Harris: We have also initiated a 12-week extension for subjects who complete the initial 12 weeks of treatment. This will permit subjects to receive treatment for up to 24 weeks and allow us to compare the weight loss achieved by penvadutide to the weight loss achieved by semaglutide and terzepatide after 24 weeks of treatment.
We have also initiated a 12 week extension for subjects, who complete the initial 12 weeks of treatment.
This will permit subject to receive treatment for up to 24 weeks and allow us to compare the weight loss achieved but kind of a do tied to the weight loss achieved by <unk> insurance appetite after 24 weeks of treatment.
Scott Harris: Next, let me talk about the Phase 2 Momentum Trial of PEMBA-DUTA in obesity, in which we expect to commence enrollment later this month. We expect this important trial to enroll approximately 320 non-diabetic subjects with either overweight or obesity and at least one obesity-related complication. Subjects will be randomized one-to-one, the one-to-one to receive either 1.2 milligrams, 1.8 milligrams, 2.4 milligrams, 1.2 milligrams, 10 to do tied, work placebo, and minister weekly for 48 weeks. The primary endpoint of the momentum trial is the relative or percent change in body weight at 48 weeks compared to baseline, with additional readouts including metabolic and lipid profiles Cardiovascular Measures and Glucose Homeostasis
Next let me talk about the phase III momentum trial of <unk> in obesity, and which we expect to commence enrollment later this month.
We expect this important trial will enroll approximately 320, non diabetic subjects with either overweight or obesity with at least one obesity related complications.
Subjects will be randomized one to one to one to one to receive either one two milligrams or one eight milligrams two four milligrams tens of do Todd or placebo administered weekly for 48 weeks.
The primary endpoint of the momentum trial is the relative 4% change in body weight at 48 weeks compared to baseline.
With additional readouts, including metabolic and lipid profiles cardiovascular measures and glucose homeostasis.
Scott Harris: Dr. Lua Ran from Weill Cornell Medical School, a leading authority on obesity and obesity clinical trials, serving as the principal investigator. An interim analysis is planned to assess changes in body weight after 24 weeks of treatment with an expected readout in the fourth quarter of 2022 and a 48-week readout in the middle of 2023. During the fourth quarter of 2021, we also completed six-month and nine-month toxicology studies of pendidotide in rats and non-human primates.
Dr. Lu will run from the Wild Fornell Medical school, a leading authority in obesity and obesity clinical trials is serving as the principal investigator.
An interim analysis is planning to assess changes in body weight. After 24 weeks of treatment with an expected readout in the fourth quarter of 2022, and a 48 week readout in the middle of 2023.
During the fourth quarter of 2021, we also completed six month and nine month toxicology studies of <unk> in rats and nonhuman primates.
Scott Harris: These studies showed no significant findings, including no ALT or blood glucose elevations in either [inaudible]. The completed tox studies will support the upcoming 24-week NAPLD extension and 48-week obesity studies, as well as the advanced development of Pembedutide. Following completion of our Phase 1b trial in NAFLD, we are planning to initiate a 52-week biopsy-driven Phase 2-trial in the fourth quarter of 2022. We currently expect this trial to enroll approximately 250 non-diabetic and diabetic subjects. 5C proven NASH.
These studies showed no significant findings, including no L T where blood glucose elevations in either species.
The complete the Tox studies will support the upcoming 24 week Apple the extension and 48 week obesity studies as well as advanced development of <unk>.
Following completion of our phase one b trial and the Apple D. We are planning to initiate a 52 week biopsy driven phase III Nash trial in the fourth quarter of 2022.
We currently expect this trial to enroll approximately 250, non diabetic and diabetic subjects with biopsy proven Nash with subjects randomized one to one to one to receive one of two doses of <unk> or placebo.
Scott Harris: Subjects are randomized one-to-one-to-one to receive one of two doses of pentadutide or placebo. The key endpoints of the trial will be NASH resolution and fibrosis improvement. Finally, by the middle of the year, we expect to have the results of two phase one trials to evaluate the effects of Pentadutide on glucose control in diabetics and its potential for drug-drug interaction. We are rapidly building the Pentadutide Clinical Development Program and expect to have accrued safety data in over 200 subjects receiving one or more doses of Pentadutide in clinical trials by the fourth quarter of 2022.
The key endpoints of the trial will be Nash resolution and fibrosis improvement.
Finally by the middle of the year, we expect to have the results of two phase one trials to evaluate the effects of tend to do Todd on glucose control in diabetics and its potential for drug drug interactions.
We are rapidly building the <unk> clinical development program and expect to have accrued safety data in over 200 subjects, receiving one or more doses of <unk> in clinical trials by the fourth quarter of 2022.
I wanted to highlight the important effects of temp do tied on serum lipids in our first in human clinical trial, which could have important implications for cardiovascular risk.
Scott Harris: I want to highlight the important effects of 10 to do ties on serum lipids in our first human clinical trial, which could have important implications for cardiovascular risks. It is well established that NASH and NAPLD patients succumb most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction, stroke, and heart failure. Peptidutai Treatment for 12 weeks, resulting in reductions in total cholesterol, LDL cholesterol, and triglycerides that were comparable to those achieved by sex.
It's well established that Nash and natural D patients to come most often to the cardiovascular comorbidities associated with obesity, which include myocardial infarction stroke and heart failure.
<unk> treatment for 12 weeks resulted in reductions in total cholesterol LDL.
LDL cholesterol and triglycerides that were comparable to those achieved by <unk> and.
Scott Harris: In addition, lipidomic profiling demonstrated a pronounced reduction in a wide range of inflammatory lipids, such as glycerophospholipids and sphingolipids, including pheromides, that have been implicated in the pathogenesis of NASH. Atherosclerosis and metabolic syndrome [inaudible] We are also making continued progress in the enrollment of our Phase 2 clinical trial in patients with inactive chronic Hall noted that the virologic effects of hep T cell are being evaluated in chronically infected patients to enable the combination of hep T cell with novel direct acting antivirals as part of combination therapy for chronic hepatitis B.
In addition, lipid genomic profiling demonstrated a pronounced reduction in a wide range of inflammatory lipids, such as glycerol phospholipids and swingle lipids, including ceramide that've been implicated in the pathogenesis of Nash.
After a sclerosis and metabolic syndrome.
We are also making continued progress in the enrollment of our phase II clinical trial in patients with inactive chronic hepatitis b and are on target to read out the results of this trial in the first half of 2023.
Recall that virologic effects of Hep T cells are being evaluated in chronically infected patients to enable the combination of <unk> T cell with novel direct acting Antivirals as part of combination therapy for chronic hepatitis b.
Rich Eisenstadt: We are excited about the data that we have generated and expect to generate in 2022, which we plan to present at international meetings later this year. We are pleased to announce that Penta-Dutite abstracts have been accepted as oral presentations at the American Diabetes Association and European Association for the Study of Liver Disease Annual Meetings in June of this year. We hope to announce the publication of these study results in peer-reviewed journals in the near future.
We are excited about the data that we have Jennifer regenerated and expect to generate in 2022, which we planned to presented interim national meetings later this year.
We are pleased to announce the 10th or <unk> abstracts have been accepted as oral presentations at the American Diabetes Association and the European Association for the study of liver disease annual meetings in June of this year.
We hope to announce the publication of the study results in peer reviewed journals in the near future.
Rich Eisenstadt: I will now hand the call over to Rich Eisenstadt to give us an update on our full year and fourth quarter financial results. Thank you, Scott. For today's call, I'll be providing a brief update on Altimmune's full year and fourth quarter 2021 financial and operating results. More comprehensive information will be available in our Form 10-K, to be filed with the SEC later today. Altimune ended the fourth quarter of 2021 with approximately $190.3 million of cash, cash equivalents, and short-term investments compared to $216 million at the end of 2020.
I will now hand, the call over to Richard Eisenstadt to give us an update on our full year and fourth quarter financial results rich.
Thank you Scott.
Rich Eisenstadt: We continue to have sufficient cash to operate through 2023, including completing our Phase 2 trial of Pembidutide and Obesity and our planned Phase 2 trial in NASH. Turning to the income statement, revenue in the fourth quarter of 2021 was $3.3 million compared to $2.3 million in the fourth quarter of 2020. Our revenue for the quarter was primarily prior period rate adjustments received in the quarter for earlier government-funded research projects. Revenue for the full year 2021 was $4.4 million compared to $8.2 million in 2020.
For today's call I'll be providing a brief update on <unk> full year and fourth quarter 2021 financial and operating results.
Our comprehensive information will be available in our Form 10-K to be filed with the SEC later today.
<unk> ended the fourth quarter of 2021 with approximately $193 million of cash cash equivalents and short term investments.
<unk> $216 million at the end of 2020.
We continue to have sufficient cash to operate through 2023, including completing our phase III trial <unk> tied in obesity and our planned phase two trial in Nash.
Rich Eisenstadt: The decline in revenue between the years was primarily due to the decrease in revenue attributable to the T-COVID program, which was completed earlier in 2021. Research and development expenses were $20.2 million in the fourth quarter of 2021 compared to $9 million in the fourth quarter of 2020. The increase in R&D expense was primarily the result of increased costs related to the development of Pemphidutide and a non-cash recognition of the change in fair value of contingent consideration liability connected with the acquisition and development of Pemphidutide as we near the next milestone.
Turning to the income statement.
Revenue in the fourth quarter of 2021 was $3 $3 million compared to $2 3 million in the fourth quarter of 2020.
Our revenue for the quarter was primarily prior period rate adjustments received in the quarter for earlier government funded research projects.
Revenue for the full year of 2021 was $4 4 million compared to $8 $2 million in 2020.
The decline in revenue between the years was primarily due to the decrease in revenue attributable to Covid program, which was completed earlier in 2021.
Research and development expenses were $22 million in the fourth quarter of 2021 compared to $9 million in the fourth quarter of 2020.
The increase in R&D expense was primarily the result of the increased costs related to the development of kind of to do tide and a noncash recognition of the change in fair value of contingent consideration liability connected with the acquisition development of deep tied as we near the next milestone.
Rich Eisenstadt: As a reminder, we will owe one last development milestone of $3 million, payable in common shares of the company, within 60 days following the dosing of the first patient in a phase 2 trial of pemvodutide. Research and development expenses were $74.5 million for full year 2021, compared to $49.8 million in the prior year. The increase in R&D expenses was primarily the result of ad COVID related development costs, including the expensing of payments made to Lonza for the construction of a manufacturing suite.
As a reminder, we will one last development milestone and a $3 million.
Payable in common shares of the company within 60 days following dosing of the first patient in our phase II trial proceed Todd <unk>.
Research and development expenses were $74 $5 million of full year 2021, compared to $49 $8 million in the prior year the.
The increase in R&D expense was primarily the result of add COVID-19 related development costs, including the expensing of payments made to launch the construction of a manufacturing suite.
Rich Eisenstadt: We terminate our agreement with Lanza at the end of 2021. The increase in R&D expenses is also attributable to development activities for Pemvidutide. Note that as a result of terminating the Alonzo Agreement in connection with the discontinuation of ADCOVID, we recorded an impairment loss of $3.3 million in the fourth quarter of 2021 and $11.4 million for the full year of 2021 associated with assets previously capitalized in connection with the construction of the Alonzo Manufacturing Suite.
We terminated our agreement with bonds at the end of 2021.
The increase in R&D expense is also attributable to development activities for <unk>.
Note that as a result of the termination of Alonza agreement in connection with the discontinuation of <unk>, we recorded an impairment loss of $3 $3 million in the fourth quarter of 2021, and 11 4 million for the full year of 2021 associated with assets previously capitalized in connection with the construction.
Lots of manufacturing suite.
Rich Eisenstadt: This represents the full cost of that asset that had previously been capitalized. General and administrative expenses remain generally consistent at $3.8 million in the fourth quarter of 2021, as compared to $4.1 million in the same period in 2020. For the full year 2021, general and administrative expenses were $15.4 million versus $13.2 million for the full year 2020.
This represents the full cost of that asset that had previously been capitalized.
General and administrative expenses remained generally consistent at $3 8 million in the fourth quarter of 2021 as compared to $4 $1 million in the same period in 2020.
For the full year 2021 general and administrative expenses were $15 4 million versus $13 2 million for full year 2020.
Rich Eisenstadt: The increase was primarily due to increased stock compensation expense and additional labor-related costs in 2021 associated with a full year of staff added in 2020 to support our clinical program. Net loss for the three months ended December 31, 2021, was $23.9 million, or $0.57 net loss per share, compared to $10.6 million, or $29.9 million, since net loss per share for the fourth quarter of 2020. The difference in net loss is primarily attributable to higher research and development expenses and lower contract revenues.
The increase was primarily due to increased stock compensation expense and additional labor related costs in 2021 associated with a full year of staff added in 2020 to support our clinical programs.
Net loss for the three months ended December 31, 2021 was $23 $9 million or <unk> 57.
Net loss per share compared to $10 6 million or 29.
Net loss per share for the fourth quarter of 2020.
The difference net loss is primarily attributable to the higher research and development expenses and lower contract revenue.
Rich Eisenstadt: Net loss for the year ended December 31, 2021 was $97.1 million, or $2.35 net loss per share, compared to $49 million, or $1.91 net loss per share, for the year ended December 31, 2020. The increase in net loss is primarily attributable to higher research and development expenses in 2021 associated with Pemba-Dutai and our now discontinued vaccine programs and the recognition of the Lonson impairment loss at COVID. I will now turn it back over to Vipin for his closing remarks. Thank you, Rich, operator.
Net loss for the year ended December 31, 2021 was $97 $1 million or $2 35, net loss per share compared to $49 million or $1 91 net loss per share for the year ended December 31 2020.
The increase in net loss is primarily attributable to higher research and development expenses in 2021 associated with <unk> tied in our now discontinued vaccine programs and the recognition of the loss of impairment loss.
At Covid.
I'll now turn it back over to Vipin for his closing remarks.
Thank you operator.
Operator: That concludes our formal remarks, and we would like to open the line to take questions. Could you please explain the Q&A procedure to the audience? Sure. Ladies and gentlemen, if you have a question at this time, please press star and then one on your touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue, please press the pound key.
That concludes our formal remarks, and we would like to open the lines to take questions could you. Please instruct the audience on the Q&A procedure.
Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Seamus Fernandez from Guggenheim. Your question. Please.
Operator: Our first question comes from the line of Seamus Fernandez from Guggenheim. Your question, please. Oh, great. Thanks for the question, guys. So just a couple of clarifications, maybe first and foremost, it sounds like the recruitment probably was impacted by COVID to some degree. You know, so the 12-week data we'll see from the Phase 1B NAPLID study in the third quarter. Can you just maybe give us a general sense of what we'll see in that data, just because I think some of the data was a little bit broken up in the Australia study for phase one A
Oh, great. Thanks for the question guys. So just a couple of clarifications, maybe first and foremost it sounds like.
The recruitment probably was impacted by Covid to some degree.
Sure.
For the 12 week data, we will see from the phase <unk> study.
In the third quarter.
Can you just maybe give us a general sense of what will.
In that data just because I think some of the data was a little bit broken up.
And in the Australia study for the Phase III.
Maybe you could just give us a sense of the.
There.
What we're going to see in those data and.
And what will be incorporated into it and then second you did clarify that the 24 week.
The extension to 20.
The study.
It has been approved and will be executed will all of the patients actually.
That were recruited in the study be incorporated into that.
Four we update and then just finally on the obesity study can you just clarify is it most likely that this that the obesity study the interim will actually read out more more likely in the first quarter of next year for investors, but perhaps you'll have or be evaluating.
Those data internally I, just want to make sure that we get the timelines correct.
Absolutely good morning, Seamus and thank you for your questions.
Operator: So maybe you could just give us a sense of what we're going to see in the data and what will be incorporated into it. And then second, you did clarify that the 24 week that was really an extension to 24 weeks in that study has been approved and will be executed. Will all of the patients actually that were recruited in the study be incorporated into that 24 week update? And then, just finally, on the obesity study, can you just clarify, is it most likely that the obesity study, the interim results will actually read out more likely in the first quarter of next year for investors, but perhaps you'll have or be evaluating those data internally? I just want to make sure that we get the timeline correct. Thanks. Absolutely. Good morning, Seamus.
Scotch had is do you want to take this.
Vipin Garg: And thank you for your questions. Scott Harris, do you want to take this? Yeah, hi, Seamus.
Yes, Hi, Seamus thanks for your questions.
Scott Harris: And thanks for your question. First, regarding the 12-week readout in the third quarter of 2023, we're going to focus, at this time, on the primary readouts, which will be liver fat reduction, weight loss, and adverse events, particularly GI adverse events in laboratory data. Those will be the focus of the readout. There may be other readouts provided as well, but I'd like us to concentrate on those.
First regarding the 12 week read out in the third quarter of 2023, we're going to focus.
At this time, when the primary readouts, which will be liver fat reduction.
Loss adverse events, particularly Gi adverse events and laboratory data.
The focus of the readout there may be other readouts provided as well, but I liked us to concentrate on those you are correct.
Scott Harris: The 12-week data, the 12-week extensions of the NAFLD study were approved. This is a separate study from the parent study, and the patient is not automatically enrolled but has the option of enrolling. That depends on the various factors that exist at the time that the patient rolls over.
The 12 week data.
The 12 week extension to the naphtha <unk> study was approved.
This is a separate study.
To the parent study and the patient is not automatically enrolled.
It has the option of enrolling that depends on.
The various factors that exist at the time that the patient rolls over we are anticipating that most of the patients rolled rollover, but not all of the patients that's simply the way. It occurs in studies and that happens for a variety of reasons and right now we're still advising the streets that are 24 week readout, meaning the investments.
Scott Harris: We're anticipating that most of the patients will roll over, but not all of the patients. That's simply the way it occurs in studies, and it happens for a variety of reasons. And right now, we're still advising the street that our 24-week readout, meaning the NS, of the results of the interim analysis in that weight loss study over 24 weeks will still occur in 2022. Great, thank you. Thank you. Our next question comes from Yasmeen Rahimi on behalf of Piper Sandler. Your question, please. Good morning, team.
The results of the interim analysis and that weight loss study 24 weeks will still occur in 2022.
Great. Thank you.
Thank you. Our next question comes from the line of <unk> Rahimi from Piper Sandler Your question. Please.
Yasmeen Rahimi: I have a number of questions for you. Maybe the first place to start off is can you comment on how many patients at this junction have completed 12 weeks of treatment? I definitely appreciate you giving us guidance or insight that 90% is complete. So let's start there, and then I have a bunch of other questions.
Good morning team I have a number of questions for you maybe.
Maybe first place to start off can you comment on.
How many patients at this junction have completed 12 weeks of treatment.
Definitely appreciate your giving us guidance for arc or inside that 90% is complete so let's start there and then I have a bunch of other questions.
Vipin Garg: Right, Yas. Well, as we noted, we've accrued more than 90% of the qualified subjects needed to conduct the study who have been dosed or will be dosed shortly. And, you know, as I mentioned previously, we'll be on track to announce the results in the third quarter. That means that all the subjects will get to the finish line in order to announce the results.
Alright.
As well as we noted we've accrued more than 90% of the qualified subjects needed to conduct this study that had been dosed or will be dose shortly.
As mentioned previously we will be on track to announce results in the third quarter that means that all of the subjects will get to the finish line in order to announce the results I think thats more relevant than the number of patients that have completed.
Vipin Garg: I think that's more relevant than the number of patients that have completed. Okay, can you maybe comment on, since you're at about a 90% completion rate, whether the fraction of diabetic versus non-diabetics, which you guided previously was going to be 50-50, is coming in around your expectation, or do you think that maybe the fractions are slightly modified? If you could comment on that as well, please. Right, you know, it
Okay.
Can you maybe comment on since you are at about 90% completion rate, whether the fraction of diabetic versus non diabetics, but you guys had previously it was going to be 50 50.
Coming in around your expectation or do you think that maybe that fractions are slightly modified if you could comment on that as well. Please.
Vipin Garg: But I say that it's meeting our expectations of approximately 50-50. Okay, another question I have for you in regards to the interim analysis in the diabetes study, could you maybe help us understand, at the 24-week diabetes momentum study, what fraction of patients will be reported? Like, is this half of the population?
Right, it's always changing.
Say that it's meeting our expectations of approximately 50 50.
Ken.
Another question I have for you in regards to <unk>.
In regards to the interim analysis and the diabetes study could you maybe help us understand at the 24 week diabetes study what fraction of patients will be reported at this half of the population.
Scott Harris: Is this just any color you could give us at that 24-week time point on the size of the interim could be helpful? And whether the interim could show a statistical separation in weight loss? Right. Just to correct, I think you've got a little...
Yes.
Just any any color you can give us.
At that 24 week time point on the size of the interim could be helpful and whether the interim.
Slide show, a statistical separation and weight loss.
Right.
Just to correct I think you've got a little.
Confused on terms, it's an obesity study, it's not a diabetes study.
Scott Harris: Confused on terms? It's an obesity study, it's not a diabetes study, it's a study of non-diabetics. At the current time, on the 24-week readout that we're expecting to announce at the end of the year, we expect to report on 100% of the patients. And, you know, the current plan is to report the statistical significance of that. Okay. Yasmeen, if I could jump in here, one thing I would like to emphasize is that these obesity studies, unlike NASH, enroll very fast. Based on all of the analysis that we've done, we're learning that there are a lot of subjects out there who like to enroll in these studies.
Okay. My apologies, yes, no problem.
It actually is a study of non diabetics.
The current time on the 24 week readout that we're expecting to announce at the end of the year. We expect to report on a 100% of the patients and the current plan is to report out statistical significance at that time.
Okay. Yeah, and then you asked me if I could jump in here one thing I would like to emphasize that these obesity studies. Unlike Nash Danville very fast based on all of the analysis that we've done.
We're learning that there is lot of <unk>.
Subjects out there, who who'd like to enroll in the study. So we are expecting to enroll the study much faster than.
Vipin Garg: So we're expecting to enroll this study much faster than you typically see with NASH studies. So I think that will help us as we start this obesity study here in the next few weeks. Thank you, team.
You typically see with the Nash study, so I think that would help us.
As we start this this obesity study he had in next the next few weeks.
Vipin Garg: And then the last question, discontinuation rates; do you currently get notified in the NAFLD study if patients discontinue due to GIAEs or any other liver enzyme abnormalities? Can you comment on what you're seeing so far from the safety side of the drug? And I'm cautious of this because this is on a blinded basis. Thank you again for taking my long list of questions. Thank you.
Thank you Tim and then a last question.
Discontinuation rates do you get notified currently and then Apple study of patients discontinued due to Gi aes or <unk>.
Any other liver enzymes.
Normally they use can you comment on what youre seeing so far from the safety side of the drug and I'm cautious because this is on a blinded basis and thank you again for taking my long list of questions.
Scott Harris: Well, as you've acknowledged, you know, it's a blinded study, and as you recognize, it's best for study integrity to announce the results of any trust study on plan day, but I can confirm that we're extremely pleased with the safety profile so far in this study. Thank you, that your next question comes in line from Roger Song from Jeffries. Your question, please. Great. Thank you for taking our question. A couple from us.
Alright, well, thank you well as you've acknowledged it's a blinded study and as you recognize its best.
For study integrity to announce the results of any trial study on the planned date, but I can confirm that we're extremely pleased with the safety profile so far.
In this study.
Thank you.
Thank you. Our next question comes from the line of Roger song from Jefferies. Your question. Please.
Great. Thank you for taking our questions a couple from us so.
Roger Song: So, the first one is for the 24-week weight loss data from the face to obesity data. So, what is your expectation based on the face war A data? And related to that, do you expect a little bit higher baseline BMI compared to the previous face war? So, what is your expectation based on face war A data? So, what is your expectation based on face war A data? Right, thanks for the question, Roger. I'll take the second question first.
So first one is for the 24 week weight loss data.
So on the phase two <unk> data. So what is your expectation based on phase II data and related to that is do you expect a little bit higher baseline BMI compared to the previous phase one.
Alright, Thanks for the question Roger I'll take the second question first yes.
Scott Harris: Yes, we expect that the average BMI in the obesity study will be approximately 35, heavier than in the phase one study. And, you know, right now, we're focusing on where the weight loss is going to be at the end of the year. And the trajectory of the study shows that we should be beating the weight loss achieved by semaglutide and interzepatide in about one year for 48-week time points. Got it. Okay, great.
We expect that the average BMI in the obesity study will be approximately 35.
Here then in the phase one study.
<unk>.
Right now.
We're focusing on where the weight loss is going to be at the end of the year.
The trajectory of this study shows that we should be.
Beating the weight loss achieved by some angle the title insurers appetite about one year or 48 week time point.
Got it okay, great. Thank you and then for the.
Scott Harris: Thank you. Um, and then for the, uh, phase two, 52 week NASH study, you say you will start in for Q, maybe just, uh, a true related question is one: what kind of data do you expect from phase one, the 12 weeks? study to trigger you to make the Gonovo decision, and I realize you have this extension 24 week data also around the same time for you to do. You need to wait for that data before you start the phase 252 week national study. Right. Thanks, Roger.
Phase 252 week Nash study.
See you will start for Q.
Maybe just two.
The related question is one what kind of data you expect around the pace of <unk>.
That a triggering event.
To trigger you to make that go no go decision and.
Realized you have this extension 24 week data also around the same time for Q do you need to weigh that data before you start the phase two a 52 week Nash study.
Scott Harris: Well, the first question pertained to the kind of data that we would need from that 12-week NAPLD study. And, you know, we expect to replicate the data that we saw in our phase one study, where we saw remarkable reductions in liver fat, and that would lead us then to move ahead with the committed NASH study. And to answer the second part of your question, no, we would not wait for the 24-week data. We would make the decision based on the 12-week data.
Alright, Thanks, Roger will the first question pertains to the kind of data that we would need from that 12 week now for this study.
And.
We expect to replicate.
The data that we saw in our phase one study, where we saw remarkable reductions in liver fat and that would lead US then to move ahead with the committed Nash study in earnest.
The second part of your question no we would not wait for the 24 week data, we would make the decision on the 12 week data.
Great and thank you for the time, maybe just a last one sorry for the long list as well. So you mentioned you.
Scott Harris: Great, thank you for the comment. I already completed a six-month and a nine-month toxicology study. Just curious, any additional GLP talks you need to support a potential chronic use label? Scott Roberts, do you want to take that?
<unk> already completed a six months and the nine months toxicity toxicology study just curious any additional GOP talks you need to support potential product can use label.
Scott Roberts do you want to think that.
Scott Roberts: [inaudible] Vipin, I can answer that question. Yeah, no, absolutely, yeah, go ahead. Yeah, yeah, Roger, the answer is no. Our Toxicology Program is complete. We've been given the go-ahead by the FDA to conduct studies for upwards of or greater than 48 to 52 weeks. And our program is complete at this point. And I would emphasize the safety that was seen in those studies, with no unexpected events, no ALT elevations, no glucose deviations; it was a very clean study, and we expect that excellent toxicology safety study to extend to human studies as well. Excellent. Thank you. That's all for now.
Vipin I can answer that question is yes, no absolutely. Yeah go ahead, Sean yes, yes.
The answer is no.
<unk> talked to apology program is complete we have been given the go ahead by the FDA to conduct studies and upwards or greater than 48 to 52 weeks and our program is complete at this point I would emphasize the safety that was seen in those studies.
With no unexpected.
No Joe <unk> elevations.
Glucose deviations it was a very clean study and we expect the excellent toxicology safety study to extend to human studies as well.
Excellent. Thank you that's helpful. Thank.
Thank you.
Thank you. Our next question comes from the line of John <unk> with JMP Securities. Your question. Please.
Operator: Thank you. Thank you. Our next question comes from the line of John Wolleben from JMP Securities.
Hey, Thanks for the update and taking the questions for me just wanted to confirm whether or not youre using a short titration period to get to the two four milligram dose in the <unk> study. We're running now and then also do you. If so do you plan on using that as well and there'll be study will be starting soon.
Operator: Your question, please? Hey, thanks for the update and taking the questions. A couple for me: just wanted to confirm whether or not you're using a short titration period to get to the 2.4 milligram dose in the NAFLD study you're running now and then also do you, if so, do you plan on using that as well in the obesity study you'll be starting soon? Right.
Right.
Scott Harris: So the answer is yes, Jonathan, as you know, we are not when emphasized using titration at the 1.2 or 1.8 milligram dose because the safety and tolerability profile of those compounds were excellent in the phase 1 study without titration. At the 2.4 milligram dose, we did see some GI adverse events, and they occurred typical for JLP at the ones in the first two weeks. Consequently, we saw the rationale here of titrating in order to affect better tolerability at just the 2.4 milligram dose.
So the answer is yes, Jonathan as you know we are not I don't want emphasize using titration at the $1 two or one eight milligram doses safety and Tolerability profile of those compounds were excellent in the phase one study without titration.
The two four milligram dose we did see some gi adverse events when they occurred typical for <unk> ones in the first two weeks. So consequently, we saw the rationale here.
Trading in order to effect better Tolerability adjusted the two four milligram dose and.
Scott Harris: And we thought that it was worthwhile to pursue the 2.4 milligram doses at this time because the potential that we could be leaving efficacy on the table by moving from that dose based on the number of patients that we dosed in the phase one study. If we do not see Uh... better results at the 2.4 that we saw at the 1.8, the likelihood is that we would not pursue that dose going forward, but at the current time, we are planning to carry the 2.4 dose into both the NAFLD study, the 12-week NAFLD study, and the 48-week obesity study.
And we thought that it was worthwhile to pursue the two four milligram doses.
At this time because of the potential that we could be leaving efficacy on the table by moving from that dose based on the number of patients that we dosed in the phase one study.
If we do not see.
Better results of the two point for.
We saw the one eight the likelihood is that we would not pursue that dose going forward, but at the current time, we are applying to carry the $2 four dose into both the Napoli study the 12 week Napoli study.
The 48 week obesity study.
Got it and then maybe taking a step back I know, we didn't see any of hyperglycemia in the phase one study and I'm wondering what are your thoughts mechanistically on why we arent or why we won't or is that something you think may pop up with longer dosing in more patients.
Scott Harris: Got it. And then maybe taking a step back, I know we didn't see any hyperglycemia in the phase 1a study. I'm wondering, you know, what are your thoughts mechanistically on why we aren't or why we won't?
Scott Harris: Or is this something you think may pop up with longer dosing and more patients? Yeah, we don't think it's going to appear Jonathan, you know, go back to the preclinical studies we did in diabetic mice. The glucose control that was actually achieved in that study was actually better than semaglutide. We think in humans that at a minimum, glucose control will be maintained because of the balance, which is one-to-one between the GLP-1 agonism and the glucagon agonism, and they'll balance each other out in glucose control.
Yeah, We don't think it's going to appear Jonathan I'll go back to the preclinical studies, we did in diabetic mice.
Glucose control that was actually achievement study was actually better than tobacco Todd.
We think in humans.
At a minimum glucose control being maintained because the balance which is one to one between the <unk> agonism in the glucagon agonism and will balance each other out and glucose control as we saw in the phase One study we had no perturbations fasting blood sugar.
Scott Harris: As we saw in the phase one study, we had no perturbations of fasting blood sugar, and we had no perturbations of hemoglobin A1C, and we think that's going to continue as well, not only in non-diabetics but diabetics as well. And as we reported previously, because of the weight loss that was induced in these patients, we actually saw a decrease in insulin resistance, which means that during the course of a trial with weight loss, blood sugars are going to decrease over time, especially in diabetic patients.
Had no perturbations of hemoglobin, a one C and we think that's going to continue as well not only in non diabetics, the diabetics as well and as we reported previously.
Because of the weight loss that was introduced in these patients.
Actually saw a decrease in insulin resistance, which means that during the course of the trial with weight loss blood sugars are going to decrease over time, especially in diabetic so.
Scott Harris: To summarize, we're very bullish on the ability of this drug to maintain glucose control. We are, as Vipin mentioned, doing a committed study in diabetics, and we'll have those results in the middle of the year, but we think the results will continue to demonstrate the control of blood sugar that we saw in non-diabetics. It has certainly been impressive so far, and I'm looking forward to all the data this year. Thanks for taking the question. Thank you. Our next question comes from the line, Mayank Mamtani from B. Riley Securities. Your question, please. Good morning, team.
To summarize we're very bullish on the ability of this drug to maintain glucose control.
Our as Vipin mentioned doing a committed study in diabetics and we'll have those results in the middle of the year, but we think the results will continue to demonstrate the controlled blood sugar that we saw in the non diabetics.
It's certainly been impressive so far and im looking forward to all the data this year, thanks for taking the questions.
Thank you. Our next question comes from the line of Matt.
<unk> <unk> from B Riley Securities Your question. Please.
Mayank Mamtani: Thanks for taking our questions, and welcome, Rich, to these calls. So maybe just to clarify on previously asked questions, first on the six and nine-month toxicology study, can you remind us the highest dose you've given to those non-human primates and rodents, and what's the safety margin you're working with? And then on the DDI study, just curious what background therapies are being looked at. Any chance you have GLP-1 combination with that?
Good morning team, thanks for taking our questions and welcome rich to these guys. So maybe just to clarify on previously asked questions.
<unk> done the six to nine month toxicology study can you can you remind us the highest.
<unk> gone in.
And those are non.
<unk> and diamonds in rodents, and what's the safety margin Youre working with and then on the DDI study.
Just curious what that gun Televisa had been that bad.
Do you have.
Scott Harris: And the reason I ask is, as you know, Novartis is looking to combine their next-generation molecules with GLP-1. So I'm just curious if, from a safety package standpoint, what sort of information you're kind of putting together from the preclinical and the DDI studies you just have. Oh, thanks, Mayank.
<unk>.
The combination of that and then.
Can I ask is lower that is looking to combine.
Yeah.
Next generation molecules with <unk> I'm just curious.
From a safety package standpoint, what sort of information you were kind of putting together from the preclinical and the DDI study goes down.
Scott Harris: I'm going to answer the toxicology questions, but your voice is a bit muted, and I'm not sure I understood the second question about combining with GLP1. So when we get to that, I'm going to ask you to repeat that. I don't have the highest doses of GLP1 in the toxicology studies. In front of me, I will tell you that there was a more than adequate safety margin between the toxic kinetic levels and the serum levels at the toxicologic doses or drug, any human doses. That margin was more than adequate.
Thanks, Mike I'm going to answer the toxic quality two questions, but your voice is a bit muted and I'm not sure I understood. The second question about combining with GOP. One so when we get to that I'm going to ask you to repeat that.
I don't have.
The highest doses of <unk> one of the toxicology studies in front of me I will tell you that there was a more than adequate safety margin.
Wendy.
<unk> kinetic levels with the serum levels.
At the toxicological doses of drug and the human doses margin was more than adequate.
But could you repeat the second question. Please.
Scott Harris: But could you repeat the second question, please? Yeah, sorry about that. I hope you can hear me fine now. So the question was about the DDI study. What background type is that you're looking at?
Yes, sorry about that I hope you can hear me find now so the question was on the DDI study.
Background therapy that uses.
Looking at and any chance.
Mayank Mamtani: And any chance you're looking at also a GLP1 sort of combination where, and the reason I ask is, no one orders them, as you may have seen at that NASHTAC presented some data on combining the next one of the next generation of ILM unlock with the GLP1. I'm just curious. What sort of background therapies are you looking at as far as the DDI? And if you have any plans to do head to head studies longer term against, you know, there's a bit of an or semi-gluten type.
Youre looking at also.
One sort of combination there.
And the reason I ask is no were not as <unk> as you may have seen at NASDAQ.
And did some data on combining their next one of their next generation of Ireland and lodged with the <unk>. So I'm just curious.
What sort of background therapy that youre looking at in spite of the DDA.
And if you have any plans to do head to head study longer term against.
There is a bit delayed.
Similar to date.
Right.
Mayank Mamtani: Right. So the first part of the question regarding the DDI studies, it's pretty much a checkbox exercise that is expected by FDA to be working in this class. And it's not actually at the level of cytokines, Mayank, because these are peptides and not expected to have cytokine or transporter interaction.
So the first part of the question regarding to the DDI studies, it's pretty much a checkbox exercise, which is expected by FDA to be working in this class.
And it's not actually at the level of cytokines Miami.
Because these are peptides and unexpected upside the coroner transporter interactions.
Scott Harris: But it's actually the hypothetical, and I emphasize that term, effects of GLP-1s on gastric emptying and then for the absorption of drugs. And pretty much the same substrates are used in all of these studies representing different solubility and absorptibility classes of drugs, and that's what we're putting into the trial. But I want to emphasize that none of the long-acting GLP-1s have had any effects on gastric emptying or on drug interactions, and we would be extremely surprised if we saw any effect like that.
But it's actually the hypothetical not emphasize that term.
The effects of.
GOP warrants on gastric emptying and then for the absorption of drugs.
And pretty.
Pretty much the same substrates are used in all of these studies.
Representing different solubility and absorbed stability classes of drugs and that's what we're putting into the trial, but I want to emphasize that none of the long acting <unk>, one so that any effects on gastric emptying.
Were on drug interactions and we would be extremely surprised if.
We saw that effect and we're not doing this study because of any concern we're doing it out of what we perceive to be a regulatory obligation.
Scott Harris: And we're not doing this study because of any concern. We're doing it out of what we perceive to be a regulatory obligation. Regarding the second part of your question, it's pretty clear that you can only achieve about 15% weight loss with GLP-1 monotherapy. And in order to achieve the levels of weight loss that are seen with bariatric surgery, GLP-1 has to be combined with another drug.
Regarding the second part of your question.
You know, it's pretty clear that you can only get to about 15% weight loss with <unk> monotherapy.
And in order to achieve the levels of weight loss.
That are seen with bariatric surgery <unk>, one has to be combined with another drug that's been the emphasis and I would emphasize in that regard we have combination therapy, because we're adding glucagon to GOP, one and we think that thats the optimal AGGY.
Scott Harris: That's been the emphasis, and I would emphasize in that regard that we have combination therapy because we're adding glucagon to GLP-1, and we think that that's the optimal agonist or candidate or other molecule or compound to add to GLP-1 because of the synergy of GLP-1 and glucagon with GLP-1 reducing appetite, but glucagon driving energy expenditure. If you look at drugs such as the amylin compound that... Novo has or the addition of G.I.P., which is Gers-Appetite, they mainly work by suppressing appetite.
Agonist or Canada, or other molecule or compound.
So the GOP, one because of the synergy of <unk>, one and glucagon with GOP, one reducing appetite, but glucagon driving energy expenditure. If you look at drugs such as <unk>.
The amylin compound.
Novo House.
The addition of <unk>, which is true separately, they mainly work by suppressing appetite.
Scott Harris: So we have a much greater opportunity to affect weight loss and other metabolic improvement by making that combination with GLP-1 and glucagon. I believe there might have been a third part of the question, and I'm not sure I hit it. Mayank, if you want to ask it, I'm happy to answer. May I give my PR mute?
So we have a much greater opportunity to affect weight loss and other metabolic improvements by making that combination with <unk>, one and glucagon I believe there might've been a third part of the question on I'm not sure. It hit my Ark, if you want to ask what I'm happy to answer it.
You might be on mute.
I apologize and thank you for that detailed color, yes. The third part of the question was on.
Mayank Mamtani: I apologize. And thank you for that detailed color. The third part of the question was about any long-term plans to generate head-to-head data versus terzapatide or semaglutide and whether you think you would need that, you know, from a regulatory or commercial standpoint. Yeah, we don't think at this time that that will be needed. It certainly isn't in our current plans right now.
And any longer term plans to generate head to head data versus the data Center group.
And if you think you would need that.
From a regulatory and commercial standpoint.
Yes, we don't think at this time that that will be needed. It certainly it's not in our current plans right now we could discuss that in the future.
Got it and final question on the Naphthalene just quickly how many subjects have suddenly rolled over.
Scott Harris: We could discuss that in the future. Got it. And final question on NAFWA, just quickly, how many subjects have currently rolled over, in case you have that information? And then I know you commented on the relative difference in the inclusion criteria for Phase I and then Phase I-B on MRI, PDFF, and weight levels. Can you also comment on age groups, like what's, if any, differences between, you know, what sort of age groups and maybe sex of these patients that could be helpful to know for the investors?
In case, you have that information and then I know you commented on the relative.
The difference in the inclusion criteria for our phase one and phase one b.
<unk> weight levels.
Also comment on age group like what if any differences on what side of age groups and maybe.
Six.
These patients that that could be.
For Danone putting list.
Scott Harris: Yeah. Regarding the rollover, I'd rather focus on where we're going to be, which is going to be on a readout on the 24-week data from the extension in the fourth quarter. The age, I believe, is coming in where we expected, which is typically in the mid-40s for a trial like this, but I don't have that information directly in front of me right now.
Regarding the rollover I would rather focus and where we're going to be which is going to be on a readout on the 24 week data from the extension in the fourth quarter.
The age I believe is coming in where we expected which is typically in the mid <unk> for a trial like this but I don't have information directly in front of me right now.
Okay. Thanks for taking our questions.
Scott Harris: Okay, thanks for taking our questions. Thank you. Our next question comes from the line of Patrick Trucchio from H.C. Wainwright.
Thank you. Our next question comes from the line of Patrick <unk> from H C. Wainwright Your question. Please.
Patrick Trucchio: Your question, please. Thanks. Good morning, everyone. Just a quick follow-up on the interim analysis in the Momentum program. I'm wondering if you can discuss the expectations in terms of the side effects and tolerability, and particularly around the GI side effects and the potential discontinuation rate in the program that you could see at that time.
Thanks, Good morning, everyone. Just a quick follow up on the interim analysis and the momentum program I'm wondering if you can discuss the expectations in terms of the side effects and tolerability and particularly around the Gi side effects.
Potential discontinuation rate in the program that you could see at that time, and then secondly, just with the key phase two readouts expected. This year on <unk> tied I'm wondering what your latest thoughts are on timing of potential partnering of the program for phase III or if you could potentially bring this program forward.
Scott Harris: And then secondly, just with the key phase two readouts expected this year on Pembidu's side, I'm wondering what your latest thoughts are on timing a potential partnership of the program for phase three, or if you could potentially bring this program forward in National BC on your own. Thanks, Patrick. I'll answer the first question, and then I'll turn to Vipin to answer the second question. We're very confident about the side effect profile that we have with our drugs.
Now do you see on your own.
Thanks, Patrick I'll answer the first question and then I'll turn to <unk> to answer the second question.
We're very confident about the side effect profile that we have with our drug.
Scott Harris: As we've emphasized before, the most meaningful declaration of tolerability is whether the patient discontinues treatment. And that's the one metric that can be compared across all studies because otherwise, thank you very much. It's called patient-reported outcome, which is very highly dependent on conditions, investigators, and the patients, and a number of other things.
As we've emphasized before the most meaningful declaration.
Tolerability is whether the patients discontinued <unk>.
Treatment and Thats, the one metric that can be compared across all studies because otherwise.
What's called patient reported outcomes, which are very hardly dependent on conditions investigators in the <unk>.
Patients in a number of other things.
Scott Harris: So focusing on the discontinuation rates, as you mentioned, we didn't have any discontinuation rates for adverse events in our phase one study. As I noted, we're trying to focus our data communications on the planned readout date. And I don't want to get into discontinuation rates that we're... that may be occurring during the trial right now. What I would say and emphasize is that you are not going to be able to do this. You are not going to be able to do it.
So focusing on the discontinuation rates.
Mentioned we.
We didn't have any discontinuation rates for adverse events in our phase one study.
Noted.
All right.
We're trying to focus our data communications on the planned readout dates and I don't want to get into the discontinuation rates that were.
That may be occurring during the trial right now what I would say and emphasize that we're extremely pleased with the safety profile of the compounds that we've seen so far in the clinical trial.
Vipin Garg: You're not going to be able to do it, but we're extremely pleased with the safety profile of the compounds that we've seen so far in the clinical trial. And with that, I'll turn the second question over to Vipin. Yeah, thanks, Patrick. Look, as we have said all along, our goal is to continue to generate a very compelling data package. And that's exactly what we're doing. But it's very hard to tell you exactly when the timing of a potential strategic transaction might be.
And with that I'll turn the second question over to Vipin.
Yeah. Thanks, Patrick.
Vipin Garg: But we think as we progress into 2022, we've got a lot of Studies Now or would want to evaluate the asset and do some sort of strategic transaction. So we'll keep everybody posted on that, but we need to focus on generating this data and really increasing the value of the asset as we go into 2023. Yep, that's helpful. Thank you very much. Thank you. This does conclude the question and answer session of today's program.
Look as we have said all along that our goal is to continue to generate a very compelling data package and thats exactly what we are doing it.
It's very hard to tell you exactly what the timing of its potential.
The <unk> transaction might be but.
Think as we progress into 2022, we've got a lot of studies that will be reading out all of those will increase the value of the asset. We think it's a very compelling asset a number of companies out there would want to partner with us.
Well I would want to.
Evaluate the asset and do some sort of strategic transaction. So we'll keep everybody posted on that but we need to focus on generating this data and really.
Increase the value of the asset as we as we go into 2023.
Yeah. That's helpful. Thank you very much.
Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to vipin for any further remarks.
Vipin Garg: I'd like to hand the program back to Vipin for any further remarks. Thank you, everyone, for participating today. We appreciate this opportunity to share our results and outlook with you. And thank you for your continued interest. Have a wonderful day. Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day, music playing music playing
Thank you everyone for participating today, we appreciate this opportunity to share our results and outlook with you and.
And thank you for your continued interest have a wonderful day.
Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
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