Q3 2022 Ensysce Biosciences Inc Earnings Call

November 16, 2022

[music].

Operator 2: Good morning, and welcome to the Ensysce Biosciences, Inc. corporate update call. As a reminder, this conference is being recorded. Your hosts today are Dr. Lynn Kirkpatrick, Chief Executive Officer, Dr. Bill Schmidt, Chief Medical Officer, and Dave Humphrey, Chief Financial Officer. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

Operator: Good morning, and welcome to the Ensysce Biosciences, Inc. corporate update call. As a reminder, this conference is being recorded. Your hosts today are Dr. Lynn Kirkpatrick, Chief Executive Officer, Dr. Bill Schmidt, Chief Medical Officer, and Dave Humphrey, Chief Financial Officer. Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates, or other information that might be considered forward-looking. While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

Good morning, and welcome to the insights Biosciences incorporated corporate update call.

This conference is being recorded.

Your hosts today are Dr. Linda Kirkpatrick, Chief Executive Officer, Dr. Bill Schmidt, Chief Medical Officer, and Dave Humphrey Chief Financial Officer.

Before we begin the formal presentation I would like to remind everyone that statements made on the call and webcast may include predictions estimates or other information that might be considered forward looking.

While these forward looking statements represent our current judgment on what the future holds they are subject to risks and uncertainties that could cause actual results to differ materially.

Cautioned not to place undue reliance on these forward looking statements, which reflect our opinions only as of the date of this presentation.

Operator 2: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Forms 10-Q and 10-K for more complete discussion of these factors and other risks, particularly under the heading Risk Factors. At this time, I'd like to turn the call over to Chief Executive Officer, Dr. Lynn Kirkpatrick. Lynn.

Operator: Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions. You should also review our most recent Forms 10-Q and 10-K for more complete discussion of these factors and other risks, particularly under the heading Risk Factors. At this time, I'd like to turn the call over to Chief Executive Officer, Dr. Lynn Kirkpatrick. Lynn.

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward looking statements in light of new information or future events.

Throughout today's discussion we will attempt to present some important factors relating to our business that may affect our predictions.

You should also review our most recent forms 10-Q and 10-K for a more complete discussion of these factors and other risks, particularly under the heading risk factors.

At this time I would like to turn the call over to Chief Executive Officer, Dr. Linda Kirkpatrick Lynn.

Lynn Kirkpatrick: Thank you, operator, and good morning, everyone. Thank you for joining us. I am pleased to welcome you to today's corporate update conference call. Although some of you are familiar with Ensysce, I've historically kicked off these calls, spending a few minutes reviewing our technology platforms and overall company focus for those of you new to our story. First, we are a clinical-stage biotech company using sophisticated chemistry to improve drug safety and performance. Our technology platforms, TAP and MPAR, are designed to improve delivery and reduce abuse and overdose of prescription drugs with the goal of creating new classes of prescription medicines that are intended to be both powerful and safe. Our first effort is to bring to market the next-generation analgesics for strong pain relief. I will review our two technology platforms to offer background before we review recent clinical trial results.

Thank you operator, and good morning, everyone. Thank you for joining us I'm pleased to welcome you to today's corporate update conference call.

Although some of you are familiar with insight I have historically kept off these calls spending a few minutes reviewing our technology platforms and overall company focus for those of you new to our story.

First we are a clinical stage biotech company using sophisticated chemistry to improve drug safety and performance.

Our technology platforms tap and empower are designed to improve delivery and reduce abuse and overdose of prescription drugs with a goal of creating new classes of prescription medicines that are intended to be both powerful and safe.

Our first effort is to bring to market. The next generation GZIP for strong pain relief.

I will review, our two technology platforms to offer background before we review recent clinical trial results.

Lynn Kirkpatrick: TAP stands for Trypsin-Activated Abuse Protection. TAP is simply a chemical modification that makes a drug inactive until it is swallowed and reaches a small intestine, where it's exposed to an enzyme called trypsin. Trypsin is only found in the small intestine, where it is responsible for digesting the proteins and meats we eat. This exposure to trypsin allows our own body to turn on our TAP drugs by starting the release process. TAP allows us to deliver medicines orally, and we refer to it as sophisticated chemistry since we can use the chemical modification to fine-tune how quickly or slowly a drug is released. TAP can be applied to most types of medicines to either make them safer or actually perform better. We have applied TAP to opioid products in an attempt to reduce recreational drug abuse. Our second technology platform, MPAR, stands for Multi-Pill Abuse Resistance.

Tap stands for trips and activate it abuse protection.

Tap is simply a chemical modification that makes a drug in active until I, just swallowed and reaches the small intestine, where it's exposed to an enzyme called trips it.

Triptan is only found in the small intestine, where it is responsible for digesting the proteins and meat we eat.

This exposure to trips and allows our own body to turn on our top drugs by starting to release process.

Tap allows us to deliver medicines orally and we referred to it as sophisticated chemistry since we can use the chemical modification to fine tune how quickly or slowly a drug is released.

Tap can be applied to most types of medicines to either make them safer or actually performed better.

We have applied tap to opioid products in an attempt to reduce recreational drug abuse.

Okay.

Our second technology platform and par stands for multi pell abuse resistance.

Lynn Kirkpatrick: MPAR is a smart overdose protection technology designed to be combined with our TAAP program, prodrugs to prevent patients or abusers from overdosing. MPAR turns off the release of the active ingredient in an overdose situation. This protection from oral overdose is designed to activate only when more than the prescribed dose is taken. As mentioned, we have applied these transformative technologies initially to opioid products to produce the next generation analgesic to treat severe pain. Now I stress severe pain, which is what an opioid is indicated for. There are many types of pains where opioids are not appropriate and not the focus of our current program. As an example, there are those individuals who may require an opioid to control pain on a limited basis after major surgeries such as hip or knee replacement.

Empire.

Is the smart overdose protection technology designed to be combined with our tap program pro drugs to prevent patients or abusers from overdosing.

Tap turns off the release of the active ingredient in an overdose situation.

This protection from oral overdose is designed to activate only when more than the prescribed doses taken.

Okay.

As mentioned, we have applied these transformative technologies initially to opioid products to produce the next generation analgesics to treat severe pain.

Not always stress severe pain.

Okay.

Which is what an opioid is indicated for.

There are many types of pains, where opioids are not appropriate and not the focus of our current programs.

As an example, there are those individuals who may require an opioid to control pain on a limited basis after major surgeries, such as hip or knee replacement.

Lynn Kirkpatrick: Whereby controlling pain in these situations appropriately may prevent one from developing chronic pain and needing opioids long term. The CDC has just released guidelines for the clinical practice of prescribing opioids, recognizing the need for these medications for severe pain when other therapies are contraindicated or likely to be ineffective. We do know that in circumstances such as severe traumatic injuries or invasive surgeries, having pain is inevitable, but we feel suffering from severe pain should be optional, and that is the role for PF-614. We also know past opioid use has led to a crisis, yet our TAP and MPAR technologies have been developed to address and reduce both abuse and overdose of these prescription pain products, something that other marketed abuse-deterrent formulations of opioids have failed to achieve.

Their pump whereby controlling pain in these situations appropriately may prevent one from developing chronic pain and needing opioids long term.

Okay.

The C. D. C has just released guidelines for the clinical practice of prescribing opioids, recognizing the need for these medications for severe pain. When other therapies are contra educated are likely to be an ineffective.

We do know that in circumstance stances, such as severe traumatic injuries or invasive surgeries.

Having pain is inevitable, but we feel suffering from severe pain should be optional and that is a role for P. F 614.

We also know past opioid use as the last true led to a crisis, yet our tap and then park technologies have been developed to address and it would reduce both abuse and overdose of these prescription pain products.

That other market abuse deterrent formulations of opioids have failed to achieve.

Lynn Kirkpatrick: It is important to note that although we are focused on developing our lead product, PF-614, both our TAP and MPAR technologies can be applied to many more prescription drugs, therefore providing us with ongoing opportunities. As our pipeline shows, we have applied TAP chemical modification to a number of opioids as well as drugs to treat ADHD. We have a discovery program focused on novel TAP agents for treatment of opioid use disorder. Our main focus today is to update you on our lead program, PF-614, an oxycodone TAP product, which is designed to replace OxyContin in the marketplace. TAP has received Fast Track status for use in chronic pain from the FDA, demonstrating that the agency feels PF-614 may fulfill an unmet therapeutic need.

It is important to note that although we are focused on developing our lead product <unk> 614.

Both our top and Empire technologies can be applied to many more prescription drugs, they're providing us with ongoing opportunities.

How's the pipeline shows we have applied top chemical modification to a number of opioids as well as drugs to treat ADHD.

And we have a discovery program focused.

Our novel Tap agents for treatment of opioid use disorder.

Our main focus today is to update you.

And our lead program P of six one floor.

And Oxycodone tap product.

Which is designed to replace oxy cotton in the marketplace.

Tap has received fast track status for use in chronic pain from the F. D. A demonstrating that the agency feels P. A six one for maybe for Phil.

Unmet therapeutic need.

Lynn Kirkpatrick: We continue to make significant strides in bringing our lead product to market, and we recently reported that PF-614 was shown to be bioequivalent to commercially available OxyContin, an outcome that may provide a shortened path to registration and commercialization through the 505(b)(2) regulatory process. For those unfamiliar, bioequivalence is the clinical comparison of two dosage forms or active ingredients, showing that they provide similar blood concentration levels, therefore resulting in the same therapeutic effect. In other words, the data from this study means that PF-614 will be as effective in treating severe pain as OxyContin. The advantages of PF-614, however, is that PF-614 has a longer half-life, meaning pain relief should last longer than OxyContin and possibly be a true twice-a-day pain medication. Additionally, excuse me.

We continue to make significant strides in bringing a lead product to market and we recently reported the P. A six foot four was shown to be bio equivalent commercially available oxycontin and outcomes that may provide a shortened paths to registration and commercialization.

Through the five Oh I'd be two regulatory process.

For those unfamiliar.

Bioequivalence is the clinical comparison of two dosage forms are active ingredient showing that they provide similar blood concentration levels, therefore, resulting in the same therapeutic effect.

In other words the data from this study means that P. M 614 will be as effective in treating severe pain as oxycontin.

The advantages of PFS six of them for however.

Is that P. M. Six infor has a longer half life, meaning pain relief should last longer than oxycontin, and possibly be a true twice a day pain medications.

Additionally.

Excuse me.

Lynn Kirkpatrick: We believe PF-614 has superior abuse-deterrent properties and also can be supplied with overdose protection, as with our PF-614-MPAR product. Our extensive early discovery programs provided us with over 100 patents issued in 25 countries. We have built a strong team to assist in achieving the milestones we have set for each program, and we have been advancing our lead products through clinical development in an attempt to bring our lead programs to market as quickly as possible. Just this week on Monday, we announced we received guidance from the FDA that an acute pain indication may be appropriate for PF-614.

We believe P. M 614 has saberi superior abuse deterrent properties and also can be supplied with overdose protection as with their P. F six import Empire product.

Our extensive early discovery programs provided us with over 100 patents issued and 25 countries. We have built a strong team to assist in achieving the milestones we have set for each program and we have been advancing our lead products through.

Nicole development in an attempt to bring our lead programs to market as quickly as possible.

Just this week on Monday, we announced we received guidance from the FDA that in acute pain indication may be appropriate for P. F 604.

Lynn Kirkpatrick: While not binding, the FDA guidance is encouraging and states that our proposed clinical development approach of conducting at least two adequate and well-controlled clinical trials in two different pain models, comparing PF-614 to placebo and to another immediate release or IR opioid such as IR oxycodone, appears to be reasonable to support a new drug application for PF-614 for an acute pain indication. Now, this guidance is important since the development path for an acute pain indication should be less costly and have a shorter path to commercialization than that for chronic pain. The FDA advice letter also provided additional guidance with respect to the non-clinical studies and the clinical trials we have planned.

While not finding the F D. A guidance is encouraging and states that our proposed clinical development approach of conducting at least two adequate and well controlled clinical trials in two different pain models comparing P. F 6142, placebo and two another immediate release or I.

Our opioid such as IR oxycodone appears to be reasonable to support a new drug application.

Or P F 6144 in acute pain indication.

Now this guidance is important since the development path for an acute pain indications should be less costly than have a shorter path to commercialization than that.

For chronic pain.

The F D. A advice letter also provided additional guidance with respect to the non clinical studies and the clinical trials we have planned.

Lynn Kirkpatrick: As a result of the FDA guidance, we now intend to initially pursue clinical development of PF-614 for an acute pain indication while we continue with our chronic pain development program. We believe that the longer half-life of PF-614 compared to OxyContin may ultimately prevent acute pain from becoming chronic pain by better controlling severe pain on a day-to-day basis. Now for the primary purpose of our call today. While Dave will later touch on our recent financial results at a high level, I'm pleased to turn the call over to Dr. Bill Schmidt, our Chief Medical Officer, to review the recently reported positive data from our PF614-103 human abuse potential clinical study. Bill?

As a result of the FDA guidance, we now intend to initially pursue clinical development of P. F. C. It's one four for an acute pain indication.

We continue with our chronic pain development program.

We believe that the longer half life with P. F 614, compared to oxy cotton may ultimately prevent acute pain from becoming chronic pain by better controlling severe pain on a day to day basis.

Now for the primary purpose of our call today, well, Dave well later touch on our recent financial results at a high level I'm pleased to turn the call over to Dr. Bill Schmidt, Our Chief Medical Officer to review. The recently reported positive data from our P. F 6141 O three human abuse potential clinical <unk>.

Bill.

William Schmidt: Thank you, Lynn, and wonderful to be here this morning to discuss the continued progress we are making with our clinical program for the development of PF-614. I would like to begin by outlining the PF-614 nasal human abuse potential study, recently reported positive results just two weeks ago. Human abuse potential or HAP studies are a requirement by the FDA to show the drug has fewer desirable effects than products used by recreational drug users. In other words, we want our drug products to be effective medications for patients taking oxycodone-containing products but less desirable to recreational drug users. These are vital for obtaining abuse-deterrent labeling upon final approval. PF614-103 for liking. The primary measure drug liking. The secondary measure was whether the subjects felt the drug again.

Bill Schmidt: Thank you, Lynn, and wonderful to be here this morning to discuss the continued progress we are making with our clinical program for the development of PF-614. I would like to begin by outlining the PF-614 nasal human abuse potential study, recently reported positive results just two weeks ago. Human abuse potential or HAP studies are a requirement by the FDA to show the drug has fewer desirable effects than products used by recreational drug users. In other words, we want our drug products to be effective medications for patients taking oxycodone-containing products but less desirable to recreational drug users. These are vital for obtaining abuse-deterrent labeling upon final approval. PF614-103 for liking. The primary measure drug liking. The secondary measure was whether the subjects felt the drug again.

Thank you lindon.

Wonderful to be here. This morning to discuss the continued progress, we're making with our clinical program for the development of it.

I would like to begin by outlining the PFS, it's one for that.

Angel human abuse potential study.

We reported positive results for just two weeks ago.

Human abuse potential or Hap studies are a requirement by.

Straight to the drug.

He says fewer does that.

And then products used by recreational drug use.

Where do we want all of our drug products to be effective.

Sure.

Thanks Bruce.

The oxycodone containing products by recreational drug users.

These are vital for obtaining abuse deterrent labeling upon final approval.

Yeah.

Gosh 100 trees.

Six one porphyry.

<unk>.

Primary measure.

Go ahead Mike.

The secondary measure was whether the subject.

Drug again.

William Schmidt: Use of PF-614 was rated on a scale using visual analog or VAS. It measures both desirable and undesirable drug effects. Compared PF-614 to oxycodone by recreational users who were previously qualified to recognize a reference opioid product as something that they considered to be desirable or liked. The subjects received the following three treatments in a crossover fashion. Essentially, they received one treatment in each of the three treatments. The tests were conducted in a randomized double-blind manner following a fasting period of at least 8 hours. Powdered PF-614 from a 100 mg capsule or an equivalent opioid dose of crushed oxycodone HCl, or a placebo. They were placed in dark jars for the subjects. Then they were asked to rate how much they liked the test products.

Bill Schmidt: Use of PF-614 was rated on a scale using visual analog or VAS. It measures both desirable and undesirable drug effects. Compared PF-614 to oxycodone by recreational users who were previously qualified to recognize a reference opioid product as something that they considered to be desirable or liked. The subjects received the following three treatments in a crossover fashion. Essentially, they received one treatment in each of the three treatments. The tests were conducted in a randomized double-blind manner following a fasting period of at least 8 hours. Powdered PF-614 from a 100 mg capsule or an equivalent opioid dose of crushed oxycodone HCl, or a placebo. They were placed in dark jars for the subjects. Then they were asked to rate how much they liked the test products.

He was at 614 rated on it.

Bill using a visual analog reviewed.

It measures, both desirable and undesirable drug.

Kurt P F six one.

Oxycodone.

Oh Boy Recreation.

Lasers.

Where previously quote.

Can recognize for reference opioid product, it's something that they considered to be desirable or liked the tests.

Sure. The following three treatments in a crossover fashion.

Essentially they receive one treatment in each of the three.

The tests.

You're getting a randomized double blind manner, following fasting period of at least eight hours.

Powdered PFS 614 from a 100 milligram capsule or an equivalent opioid Joseph crushed oxycodone each.

Uh huh.

Okay.

Sure.

You replace them dark charged for the subjects treated.

And then they were asked to rate how much they liked the test products. The primary outcome measure maximum effect.

William Schmidt: The primary outcome measure, maximum effect for drug liking, recommended by the FDA in their guidance on assessment of abuse potential of drugs. This measure is known to correlate with the drug's abuse potential, establishing that opioid analgesics can be manipulated and abused through nasal inhalation. PF-614 has a much lower risk, showing a liking score for recreational drug use. PF-614, as Lynn explained, must be exposed to trypsin to release oxy. The only way that this happens with nasally administered drugs is for the user to swallow a portion of the nasally administered product. The study confirmed our hypothesis that a very low liking score for PF-614 should reduce the risk of diversion through nasal administration by those who use recreational drugs.

Bill Schmidt: The primary outcome measure, maximum effect for drug liking, recommended by the FDA in their guidance on assessment of abuse potential of drugs. This measure is known to correlate with the drug's abuse potential, establishing that opioid analgesics can be manipulated and abused through nasal inhalation. PF-614 has a much lower risk, showing a liking score for recreational drug use. PF-614, as Lynn explained, must be exposed to trypsin to release oxy. The only way that this happens with nasally administered drugs is for the user to swallow a portion of the nasally administered product. The study confirmed our hypothesis that a very low liking score for PF-614 should reduce the risk of diversion through nasal administration by those who use recreational drugs.

For drug liking.

Okay.

Hi to FDA and their guidance on this stuff.

Drugs.

This measure is known to correlate with the drugs potential.

Okay.

Establishing that.

Opioid adults.

Can be manipulated and abused through nasal inhalation P. S 614 has a much lower risk of Shaw.

Taking school.

Recreational drug use.

Yes, just one for US then explained must be exposed to Crimson.

But he released arc.

And the only way to do it.

With with Nasally administered drugs is for the user to swallow a portion of the nasally administered product.

The study confirmed our hypothesis that have very low likelihood.

One four should reduce the risk of them.

Diversion through nasal administration by those who use recreational drugs.

William Schmidt: I note that the FDA previously excused us from having to do intravenous abuse liability studies since PF-614 will never see trypsin in the blood and hence will never be converted to oxycodone. The top-line results from the study, which compared intranasal administration of PF-614 powder to crushed oxycodone immediate-release tablets, were recently announced and showed that PF-614 has a significantly lower peak and significantly less appeal to take the drug again in non-dependent recreational opioid users. In this particular trial, specifically, the primary endpoint for the study, drug liking at this moment, was measured up to 24 hours after dosing using the VAS scale. In the study, PF-614 had significantly lower peak drug liking when compared with intranasal crushed IR or immediate-release oxycodone. The p-value was 0.0123 using the full 26-subject population.

Bill Schmidt: I note that the FDA previously excused us from having to do intravenous abuse liability studies since PF-614 will never see trypsin in the blood and hence will never be converted to oxycodone. The top-line results from the study, which compared intranasal administration of PF-614 powder to crushed oxycodone immediate-release tablets, were recently announced and showed that PF-614 has a significantly lower peak and significantly less appeal to take the drug again in non-dependent recreational opioid users. In this particular trial, specifically, the primary endpoint for the study, drug liking at this moment, was measured up to 24 hours after dosing using the VAS scale. In the study, PF-614 had significantly lower peak drug liking when compared with intranasal crushed IR or immediate-release oxycodone. The p-value was 0.0123 using the full 26-subject population.

I note that the FDA previously excuse us from having to do intravenous abuse liability studies with PFS. It's one four will never see a tripling in the blood and hence will never be converted to oxycodone.

The topline results from the study, which compared intranasal administration that takes six months for powder to crushed oxycodone immediate release tablets were recently announced and showed that PFS. It's one four has a significantly lower.

Peak.

And significantly less appeal to take drug again, and non dependent recreational opioid users.

No.

Okay.

So in this particular trial.

And specifically the primary endpoint for the study drug liking at this moment with measured up to 24 hours after dosing using the D E F scale.

In the study.

Before.

Secondly, lower peak drug liking when compared with intranasal crushed by our or immediate release Oxycodone.

P value was 0.01.

Q3, using the full 26 subject population that's highly significant.

William Schmidt: That's highly significant. Analyzing a smaller group of subjects that were administered, called the first period analysis, showed a similarly strong difference between PF-614 in 8 subjects and crushed immediate-release oxycodone in 10 subjects. Value of 0.0175. Even with the smaller group of subjects, it's statistically significant. Where we asked subjects if they want to, this pretty significant difference with a lower wish to take PF-614 again versus crushed immediate-release oxycodone with a P less than 0.0001. Also using the smaller period analysis. Highly significant value in the small group of subjects speaks to the difference between PF-614 and oxycodone for those who wish recreationally.

Bill Schmidt: That's highly significant. Analyzing a smaller group of subjects that were administered, called the first period analysis, showed a similarly strong difference between PF-614 in 8 subjects and crushed immediate-release oxycodone in 10 subjects. Value of 0.0175. Even with the smaller group of subjects, it's statistically significant. Where we asked subjects if they want to, this pretty significant difference with a lower wish to take PF-614 again versus crushed immediate-release oxycodone with a P less than 0.0001. Also using the smaller period analysis. Highly significant value in the small group of subjects speaks to the difference between PF-614 and oxycodone for those who wish recreationally.

<unk>, a smaller group of subjects.

Okay.

Were administered called.

Called the first period analysis showed a similarly strong difference between PFS 614, and eight subjects and crushed immediate release Oxycodone 10 subjects.

0.0175, even with the smaller group of subjects, it's statistically significant.

Yeah.

Good with the SEC.

Weighted where we ask subjects if they.

Just want to.

Okay.

Yes.

It could be significant difference with a lower wished to take pictures, one four again versus crushed immediate release oxycodone.

With a P.

Less than a 0.0001 also using a smaller.

Its period analysis.

Highly significant value in the small group of subjects speaks to the difference between PFS six one port and Oxycodone for those who wish.

Recreationally.

William Schmidt: These results are findings that showed that PF-614 failed to release oxycodone, and we believe this demonstrates that PF-614 may provide unique advantages when compared with current. During the last quarter, H2 study, PF614-104 at the oral abuse potential of PF-614 and subject dosing is continuing. This study is designed to test and confirm that PF-614 may have less potential for drug liking versus immediate-release oxycodone at equivalent drug doses when taken orally. The PF614-104 study will examine the desirability of three doses of PF-614 versus equivalent and placebo in recreational drug users. Eligible subjects in this study will receive five treatments, one treatment per period, in a randomized double-blind crossover manner.

Bill Schmidt: These results are findings that showed that PF-614 failed to release oxycodone, and we believe this demonstrates that PF-614 may provide unique advantages when compared with current. During the last quarter, H2 study, PF614-104 at the oral abuse potential of PF-614 and subject dosing is continuing. This study is designed to test and confirm that PF-614 may have less potential for drug liking versus immediate-release oxycodone at equivalent drug doses when taken orally. The PF614-104 study will examine the desirability of three doses of PF-614 versus equivalent and placebo in recreational drug users. Eligible subjects in this study will receive five treatments, one treatment per period, in a randomized double-blind crossover manner.

These results are.

Windings that showed the 614.

All of them to release Oxycodone and we believe this demonstrates the Pea at 614 may provide unique advantages when compared with Kurt.

Yeah.

During the last quarter.

Second half study.

Do you have six one for dash one O four.

If the oral abuse potential P. S. Its one four and subject dosing is continuing this study is designed to test them confirm that PFS 614 may have less potential for drug liking versus immediate release oxycodone at equivalent drug doses when taken orally.

The <unk> four dash one O four study will examine the desirability of three doses of PFS 614.

Versus.

And placebo and recreational drug users.

Eligible subjects in this study will receive five treatments one treatment for a period in a randomized double blind crossover manner.

William Schmidt: order of exposure of each treatment will be mixed. The primary endpoint to assess treatment. The secondary endpoint to evaluate whether the subjects would take the drug again. We are looking forward to reporting the data from this trial, expected in H1 2023. To reiterate that these are important milestones, key to gain labeling for PF-614. Help us and the users to achieve PF-614. Lynn?

Bill Schmidt: order of exposure of each treatment will be mixed. The primary endpoint to assess treatment. The secondary endpoint to evaluate whether the subjects would take the drug again. We are looking forward to reporting the data from this trial, expected in H1 2023. To reiterate that these are important milestones, key to gain labeling for PF-614. Help us and the users to achieve PF-614. Lynn?

Order of exposure of each treatment will be mixed.

The private.

Again to assess.

Treatment.

These secondary.

Anyway, whether the subjects would take drug again.

We're looking forward to reporting the data from this trial expected in the first half of 2023.

To reiterate with you.

Our important miles.

Keys for Gannett.

Labeling for PFS 614.

Help us.

And it is those two.

To achieve.

You have six one.

Yeah.

Okay.

Linda.

Okay.

Yeah.

Okay.

Lynn Kirkpatrick: Thank you, Bill. I'd like to again say how pleased we are with the positive top-line results of the nasal HAP study. I know Dr. Schmidt's line was poor, so I'd like to repeat some of the data, specifically the top-line results from this study, which compared the intranasal administration of PF-614 powder to crushed OxyContin oxycodone immediate-release tablets that was recently announced. These top-line results showed that PF-614 had significantly lower peak drug liking and significantly less appeal to take drug again in non-dependent recreational opioid users, where we had a total of 26 subjects. Specifically, the primary endpoint of the study, drug liking at this moment, was measured up to 24 hours after dosing using the Visual Analog Scale, VAS scale.

Thank you Bill I'd like to again say, how pleased we are with the positive topline results of the nasal Hap studies I know Dr. Smith language poor so I'd like to repeat some of the data specifically the topline results from this study when compared which compared the intranasal administration of PFS six one for powder.

Two crushed oxy cotton oxycodone immediate release tablet that was recently announced.

These topline results showed that PFS 614 had significantly lower peak drug liking and significantly less appeal to take drug again in non dependent recreational opioid users.

Wherever we had a total of 26 subjects.

Specifically the primary endpoint of the study drug liking at this moment was measured up to 24 hours after dosing using the visual assessment scale vast scale as mentioned in this study.

Lynn Kirkpatrick: As mentioned in the study, PF-614 powder produced significantly lower drug liking when compared with intranasal crushed IR oxycodone with a P-value of 0.0133 using the full 26 subject population. Furthermore, analyzing a smaller group of subjects following their exposure to the first drug they were administered, called the first period analysis, a similarly strong difference was noted between PF-614 in 8 subjects and crushed IR oxycodone in 10 subjects with a P-value of 0.0175, even with this small cohort of subjects. Similar findings were noted with the second endpoint we evaluated, where we asked subjects if they liked the drug enough to want to take the drug again.

Six one for powder produce significantly lower drug liking liking when compared with intranasal crushed IR oxycodone with a P value of point.

Zero.

133, using the full 26 subject population.

Furthermore, analyzing a smaller group of subjects following their exposure to the first drive they were administered called the first period analysis. A similarly strong difference was noted between T. A 614 and eight subjects and crushed.

IR Oxycodone and 10 subjects with a P value of zero.

0.0175, even with the small cohort of subjects.

Similar findings were noted.

The second endpoint, we evaluated where we asked subjects if they like the drug enough to want to take the drug again.

Lynn Kirkpatrick: The study showed a statistically significant difference with a lower wish to take PF-614 again versus crushed IR oxycodone with a P value of, which was even lower, at 0.0001. Also using a smaller group of subjects in the first period analysis. Such a highly significant value in a small group of subjects speaks to the difference between PF-614 and oxycodone for those who wish to use drug recreationally. During the last quarter, we also initiated a second human abuse potential study, which we designate PF614-104, to evaluate the oral abuse potential of PF-614 in subjects. Subject dosing is continuing.

The study showed a statistically significant difference with a lower wish to take P. M 614, again, I guess versus crushed IR oxycodone with a P value, which was even lower at 0.0001.

Also using a smaller group of subjects in the first period in Ireland.

Such a highly significant value in a group a small group of subjects speaks to the difference between he of 614 and Oxycodone for those who wish to use drugs recreationally.

[laughter].

During the last quarter, we also initiated a second human abuse potential study, which we designate P. M 6141, or four to evaluate the oral abuse potential appear six and four in subjects.

And subject dosing is continuing this study is designed to test and confirmed that P. F 614 will have less potential for drug liking versus again immediate release oxycodone adequate equivalent doses.

Lynn Kirkpatrick: This study is designed to test and confirm that PF-614 will have less potential for drug liking versus, again, immediate-release oxycodone at equivalent dosages when taken orally. We are looking forward to reporting the data from this trial, and we expect data to be released in H1 2023. We'd like to reiterate why these HAP studies are important milestones. They are key for gaining abuse-deterrent labeling for PF-614. The studies help us further understand the tendencies for drug abusers to like the effects achieved after taking PF-614, either orally or nasally, compared to that of similar products, for example, crushed OxyContin. I will now briefly comment on the initial clinical data from our overdose protection product, PF-614-MPAR, that we reported in May.

When taken orally.

We're looking forward to reporting the data from this trial and we expect.

Data to be released in the first half of 2023.

We'd like to reiterate why these types of studies are important milestone.

Our key for gaining abuse deterrent labeling for P. F. Six one for the studies help us further understand the tendencies for drug abusers to like the effects achieved after taking P. M. Six one for either orally or nasally compared to that of similar products.

Example, crushed oxy cotton.

I will now briefly comment on the initial clinical data from an overdose protection product P. F. Six went for Empire that we reported in May.

Lynn Kirkpatrick: We believe that this data for the PF-614 MPAR study, where we combined PF-614 and the trypsin inhibitor nafamostat, provided the first evidence of a product that would protect from an overdose. The results also provided the first human data to show PF-614, when absorbed into the bloodstream, does not convert to oxycodone, supporting our contention that attempts to abuse PF-614 by direct injection should be unsuccessful. We are continuing the PF-614 MPAR study to fine-tune our drug product profile.

We believe that this data for the PFS six one.

P. F 604, empower study where are we combined two of six and four and the Triptan inhibitor in Afghanistan provided the first evidence of a product that would prove.

But from an overdose.

The results also provided the first human data to show P. A six foot four when absorbed into the bloodstream does not convert oxycodone and supporting our contention that attempts to abuse P. F 614.

Direct injection should be successful.

We are continuing the P. F 604, empower study to fine tune, our drug product profile additional data from this part of the study is expected before the end of this year and will allow us to test the con snapped up overdose protection by delivering increasing doses appear six one for empower in the.

Lynn Kirkpatrick: Additional data from this part of the study is expected before the end of this year and will allow us to test the concept of overdose protection by delivering increasing doses of PF-614 MPAR in the final Part 3 of the study in H1 2023. During the quarter, we announced that this study is being undertaken in partnership with Quotient Sciences using their integrated Translational Pharmaceutics platform for the clinical testing of PF-614 MPAR. Our findings from this study are important because the MPAR combination technology is the first approach we expect may prevent all four forms of abuse, injecting, chewing, inhaling, and importantly, oral overdose. Looking ahead at the milestones for the remainder of the year, I summarize them as follows.

Final part three of this study in the first half of 'twenty to 'twenty three.

During the quarter, we announced that this study is being undertaken in partnership with quotient sciences using their integrated translational pharmaceutics platform for the clinical testing appears six cents for empower.

Our findings from this study are important because.

Cause the M. Part combination technology is the first approach we expect may prevent all four forms of abuse injecting chewing inhaling and importantly oral overdose.

Looking ahead at the milestones for the remainder of the year.

I summarize them as follows.

Lynn Kirkpatrick: We expect to report data from the oral human abuse potential study, PF-614-104, during H1 2023. We expect the full data from PF-614 MPAR part two to be reported before the end of this year, 2022, and data from the final part three of the study in the first part of next year. I will now welcome our CFO, Dave Humphrey, for a short financial summary. Dave?

We expect to report data from the oral human abuse potential study P. A six foot four one O four during the first half of 'twenty to 'twenty three.

We expect the full data from P. F six one floor and part part too.

Be reported before the end of this year 2022 and data on the final part three of the study in the first part.

Next year.

I will now welcome our CFO , Dave Humphrey for a short financial summary, Dave.

Dave Humphrey: Thanks, Lynn. As of September 30, remaining funding available from federal grants included $3.3 million to support our OUD research program and another $2.6 million to support the third part of the ongoing phase 1 clinical trial evaluating the MPAR platform. With this non-dilutive government grant funding and our September 30 cash balance of $4.5 million, we are on track to advance the development of our highly unique TAP and MPAR technologies through the end of this year. I'll now turn the call back to Lynn for closing remarks and questions. Lynn?

Thanks Lynn.

As of September 30th remaining funding available from federal grants included $3 $3 million to support our <unk> research program and another $2.6 million to support the third part of the ongoing phase one clinical trial evaluating the empower platform.

With this non dilutive government grant funding and our September 30th cash balance of $4 5 million.

We're on track to advance the development of our highly unique tap and Empire technologies through the end of this year.

I'll now turn the call back to <unk> for closing remarks and questions.

Lynn Kirkpatrick: Thanks, Dave. Before I turn the call over to the operator for Q&A, I wanna take a moment and acknowledge all our company constituents as we forge ahead on our mission to provide patients in severe pain a unique therapeutic option. Developing any new drug involves a complicated and sometimes torturous path, and we are pleased that the FDA has provided us its recent feedback that will allow us to finalize our path toward commercialization in the coming months. We believe our recent clinical data that we highlighted today point to the potential for PF-614 to be a safer pain medication and a highly novel option for those who experience severe pain. Operator, we will now take questions.

Thanks, Dave.

Before I turn the call over to the operator for Q&A I wanted to take a moment and acknowledge all our company constituents as we forge ahead on our mission to provide patients and severe pain a unique therapeutic option.

Developing any new drug involves the complicated and sometimes torturous path and we're pleased that the FDA has provided us. Its recent feedback that will allow us to finalize our path toward commercialization in the coming months.

We believe our recent clinical data that we highlighted today point to the potential for P. S. Four to be a safer pain medications and a highly novel option for those who experience severe pain.

Operator, we will now take questions.

Operator 2: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question today, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Once again, that's star one. Thank you. Thank you. Our first question is from the line of Thomas Flaten with Lake Street Capital Markets. Please proceed with your questions.

Operator: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question today, please press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Once again, that's star one. Thank you. Thank you. Our first question is from the line of Thomas Flaten with Lake Street Capital Markets. Please proceed with your questions.

Thank you at this time, we'll be conducting a question and answer session.

If you'd like to ask a question today. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.

You May press star two if you'd like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

One moment, please while we poll for questions once again Thats star one thank you.

Okay.

Thank you. Our first question is from the line of Thomas Flaten with Lake Street Capital. Please proceed with your questions.

Thomas Flaten: Good morning. I appreciate you guys taking the questions. Hey, Lynn. I was wondering if you could provide some context for the interaction you had with FDA that generated the guidance around the acute indication. You know, what was the question you were asking? Were you surprised by the outcome? I'm just hoping you can kind of set the stage for how we ended up with that press release you put out this week.

Good morning. Appreciate you guys, taking the questions I was wondering if you could provide some context for the interactions <unk> had with FDA that generated the guidance around the acute indication you know what was the question you were asking what are you surprised by the by the outcome I'm just hoping you can kind of set the stage for how we ended up with that press release, you put out this week.

Lynn Kirkpatrick: Sure. Thanks, Thomas. We have been interacting with the agency now for almost a year and considering various options for PF-614 in an attempt to understand how we may be able to bring PF-614 to the market in a, I guess, a more direct path. As you know, with the COVID and supply chain issues, a lot of things have been delayed. In order to potentially expedite some of the activity, we had asked the agency whether an acute pain indication may be appropriate, which potentially would have a reduced timeline for us, both for the non-clinical activities as well as the clinical path. We began our discussion about December of last year.

Sure and thanks Thomas.

We have been interacting with the agency now for almost a year.

And considering various options for P. F 614 in an attempt to understand how we may be able to bring P of 614 to the market and a.

I guess a.

More direct path as you know with me.

He covered and supply chain issues a lot of.

Things have been delayed.

And in order to potentially expedite some of the activity we had ask the agency whether in acute pain indication may be appropriate.

Okay.

Which potentially would have a reduced timelines for us both for the non clinical activities as well as the clinical path.

We began our discussion about December of last year, we had additional questions for the agency last March and we were very pleased with our back and forth that they have agreed that a potential clinical development path for PFS 614 in acute pain as well as chronic pain would be.

Lynn Kirkpatrick: We had additional questions for the agency last March, and we were very pleased with our back and forth that they have agreed that a potential clinical development path for PF-614 in acute pain as well as chronic pain would be appropriate. This will allow us now to move really build on the answers, identify specifically the clinical program we intend to utilize over the next few years and hopefully bring the product to market, more quickly than we could in the acute pain space.

Appropriate. So this will allow us now to move really hum build on the answers.

Identify specifically the clinical program, we intend to utilize over the next few years and hopefully bring the product to market more quickly than we could in the acute pain space.

Thomas Flaten: Great. Did they render an opinion about the chronic pain indication, or was this specifically to get them to agree to acute, just to confirm?

Great and did they render an opinion about the chronic pain indication or was this specifically to get them to agree to acute just to confirm.

Lynn Kirkpatrick: Yes. We'd always intended, and we still intend to, develop PF-614 because it is an extended-release product in the acute pain space or in the chronic pain space. This was specifically to address whether or not it might be appropriate for this type of agent, which has a delayed onset and an extended release profile to be used for acute pain. Really the CDC guidelines that has broken pain down really into three subcategories now, acute, sub-acute, and chronic, defines where our clinical trials may be most appropriate.

Yes, we'd always intended and we still intend to.

It's developed P. A $6 four because it is an extended release product in the acute pain space or in the chronic pain space, but this was specifically to address whether or not it might be appropriate for.

This type of agent, which has a delayed onset on an extended release profile to be used for acute pain and really the CDC guidelines that has broken paying down really into three subcategories now acute sub acute and chronic defines where our clinical.

<unk> may be most appropriate.

Thomas Flaten: Got it. In terms of upcoming interactions with FDA to move towards an acute development plan, what's on the horizon there? I'm assuming you're gonna wait till you have the HAP studies done and be able to report those out. Can you kinda lay out for us what happens next?

Got it and in terms of upcoming interactions with FDA to move towards an acute development plan, what's the what's on the horizon, there I'm, assuming you're going to wait till you have the Hap studies done and be able to report those out but can you kind of layout for us what happens next.

Lynn Kirkpatrick: Well, we're currently meeting with our clinical advisory board to continue the discussions of exactly what our clinical programs will be so we can develop our protocols. We anticipate providing those to the agency next year and discussing them. As they indicated, 2 well-controlled studies, and for acute pain you do need to do both a bony and a soft tissue study, would be considered appropriate for an NDA in this indication. We will be discussing those protocols with the agency in the coming months.

Well where were currently meeting with our clinical advisory Board to continue the discussions are exactly what our.

Clinical programs will be so we can develop our protocols, we anticipate providing those to the agency next year and discussing them and as they indicated two well controlled studies and for acute pain, you do need to do both of bony and a soft tissue study will wood.

Be considered appropriate for an NDA in this indication so we will be discussing those protocols with the agency in the coming months.

Thomas Flaten: Final question, if I might. Any adjudication on the 505(b)(2) question, or was that not part of the discussion most recently with FDA?

And then final question if I might.

Any adjudication on the 505 two question or is that not part of the discussion most recently with FDA.

Lynn Kirkpatrick: Good question. No, these questions were submitted much longer before we had the data, but that will be, certainly, in our upcoming discussions, Tom.

Good question no. They these questions were submitted much much longer before we had the data but that will be our certainly in our upcoming discussions.

Lynn Kirkpatrick: Good question. No, these questions were submitted much longer before we had the data, but that will be, certainly, in our upcoming discussions, Tom.

Thomas Flaten: Understood. I appreciate you guys taking the question. Thanks so much.

Understood I appreciate you guys, taking the questions. Thanks, so much.

Yeah.

Operator 2: Our next question is from the line of Hunter Diamond with Diamond Equity. Please proceed with your question.

Operator: Our next question is from the line of Hunter Diamond with Diamond Equity. Please proceed with your question.

Our next question is from the line of Hunter Diamond with Diamond equity. Please proceed with your questions.

Hunter Diamond: Hello. Congratulations on the quarter so far. I was wondering, in terms of the recent top-line results for intranasal administration of PF-614, can you explain why the field data supports advantages over currently marketed products?

Hello.

Congratulations on the quarter. So far I was wondering in terms of the recent top line results for Intranasal administration of PFS 615 can you say why the field data supports advantages over currently marketed products.

Lynn Kirkpatrick: Bill, would you like to take that question?

Bill would you like to take that question.

William Schmidt: Sure. It's 614, and we compared this directly to crushed oxycodone HCl, which would be known commercially as Roxicodone. We used equivalent opioid equivalent doses of both products. When the subjects snorted the Roxicodone product, they got the expected rush that you'd expect from doing intranasal insufflation of an opioid product. They liked it. Some even hit 100 on the 1-to-100 scale in terms of how much they liked it and whether they would take the drug again. Those who insufflated placebo, and this was all on a double-blind basis. They didn't know what they were getting. It just looked like white powder. Those who insufflated placebo had very neutral scores. It indicated that they neither liked it nor disliked it. It didn't have aversive properties.

Bill Schmidt: Sure. It's 614, and we compared this directly to crushed oxycodone HCl, which would be known commercially as Roxicodone. We used equivalent opioid equivalent doses of both products. When the subjects snorted the Roxicodone product, they got the expected rush that you'd expect from doing intranasal insufflation of an opioid product. They liked it. Some even hit 100 on the 1-to-100 scale in terms of how much they liked it and whether they would take the drug again. Those who insufflated placebo, and this was all on a double-blind basis. They didn't know what they were getting. It just looked like white powder. Those who insufflated placebo had very neutral scores. It indicated that they neither liked it nor disliked it. It didn't have aversive properties.

Sure.

614, and we compared this directly to crush Oxycodone C L.

Which would be known commercially as walks you can put on.

We used equivalent grade equivalent doses of both products.

When the subjects snorted the Roxy.

Roxy code on products, they got the expected rushed but expect from doing it.

Asian of an opioid product they liked it.

Some even hit a 100 to 100 scale in terms of how much locked it and whether they would take the drug again.

Those who insulated placebo and this is all on a blind basis. They didn't know what they were getting just like white powder, those who instigated placebo had very neutral.

Scores indicate that they neither liked it more disliked it didn't have a virtue of properties. When we got to <unk> 61 for the lightning scores were let's say very muted.

William Schmidt: When we got to PF-614, the liking scores were, let's say, very muted. They were substantially less than the scores that any of the individuals had recorded when they had snorted authentic oxycodone HCl. When we looked at this again for take drug again, the scores were also on PF-614 side compared to the oxycodone HCl side. We believe that this is because they actually received exposure to less oxycodone derived from PF-614 when they snorted, because the only parts that they will convert to oxycodone is what they swallow down the back of their throat. Previous studies have shown that that's only about percent of what goes up their nose.

Bill Schmidt: When we got to PF-614, the liking scores were, let's say, very muted. They were substantially less than the scores that any of the individuals had recorded when they had snorted authentic oxycodone HCl. When we looked at this again for take drug again, the scores were also on PF-614 side compared to the oxycodone HCl side. We believe that this is because they actually received exposure to less oxycodone derived from PF-614 when they snorted, because the only parts that they will convert to oxycodone is what they swallow down the back of their throat. Previous studies have shown that that's only about percent of what goes up their nose.

They were substantially less than the scores that any of that.

Individuals had recorded when they had Florida.

Oxycodone C L.

When we look at this and for take drug again, the sportswear also.

It's one four side compared to Oxycodone Hcl side.

We believe that this is because they actually receive exposure to less oxycodone derived from $6 four when they snorted because the only part.

It will convert to oxycodone, they swallow them back in their throat.

Previous studies have shown that that's the only about percent of what goes up their nose.

William Schmidt: It would be the equivalent of taking, say, a 100 mg tablet of oxycodone, which would be an enormous dose, but put it in another perspective, 40 mg, which was the actual dose of oxycodone HCl. If you reduce that to 4 mg, so that's 4% of the dose of oxycodone, probably wouldn't engender very much liking or take drug again. It's probable that the recreational user would be looking for something else if they really wanted to get high. That's what we showed in this study, that given an alternative, would not take PF-614 again and look for some other drug product.

Bill Schmidt: It would be the equivalent of taking, say, a 100 mg tablet of oxycodone, which would be an enormous dose, but put it in another perspective, 40 mg, which was the actual dose of oxycodone HCl. If you reduce that to 4 mg, so that's 4% of the dose of oxycodone, probably wouldn't engender very much liking or take drug again. It's probable that the recreational user would be looking for something else if they really wanted to get high. That's what we showed in this study, that given an alternative, would not take PF-614 again and look for some other drug product.

So it would be the equivalent of taking a let's say.

The 100 milligram tablet.

Z code on would you be I mean, once it goes but put it in another person or.

<unk> 40 milligrams, which was the actual dose of Oxycodone H C L.

If you can reduce that to.

Milligrams per cent.

Well most of Oxycodone.

Probably wouldn't engender very much liking or probably again.

It's probable that the recreation user would be looking for somebody else.

They really wanted to get high and so that's what we showed in this study that given an alternative would not take PFC swung for again.

For some other drug product.

Hunter Diamond: Great. Thank you. Can you provide some color on how investors view the acute pain indication for PF-614? Sort of, what exactly is the speed to market? I mean, I kind of understand the overall market opportunity. What's the speed here to market?

Great. Thank you and can you provide some color on how investors should view the acute pain indication for PFS. So of course sort of what exactly is the speed to.

Mark and it was I mean, I kind of understand the overall market arbitrage, what's the speed to market.

Yes.

Lynn Kirkpatrick: Thanks, Hunter. The advantage of us moving into the acute pain space means that we are not required to undertake some of the non-clinical studies which are required for chronic pain, where they take up to 2 years to complete, some of the carcinogenicity studies. That is eliminated from our development path. Additionally, in the chronic pain space, we would be required to have subjects exposed to PF-614 for up to a year. The clinical development path is also reduced. We have not identified our ultimate timelines to date. We hope to provide more clarity, but we believe this opportunity, although on a market basis is a smaller market, it will be adding to the overall market when we are able to commercialize both for acute as well as chronic pain, and initially bring the product to market more quickly.

Thanks Hunter.

This is the advantage of us moving into the acute pain space. It means that we are not required to undertake some of the non clinical studies, which are required for chronic pain with it take up to two years to complete some of the carcinogenicity studies.

That is eliminated from our development path. Additionally, in the chronic pain space, we would be required to have subjects exposed to P. F 614 for up to a year.

So the clinical development path is also reduced.

We have not identified.

Identified our ultimate timelines to date, we hope to provide more clarity, but we believe this opportunity although on a market basis is a smaller market it will be adding to the overall market. When we are able to commercialize.

Both for acute as well as chronic pain and initially bring the product to market more quickly. So we're anticipating a cigna.

Lynn Kirkpatrick: We're anticipating a significant reduction in time and cost, and we'll be providing more guidance on our expected commercialization date, probably in the coming months.

Significant reduction in time and cost and we'll be providing more guidance on our expected commercialization date.

Probably in the coming months.

William Schmidt: Thank you so much. Appreciate it.

Bill Schmidt: Thank you so much. Appreciate it.

Thank you so much I appreciate it.

Operator 2: Thank you. At this time, I would now like to turn the call back over to Dr. Kirkpatrick for her closing remarks.

Operator: Thank you. At this time, I would now like to turn the call back over to Dr. Kirkpatrick for her closing remarks.

Thank you.

At this time I would now like to turn the call back over to Dr. Kirkpatrick for closing remarks.

Lynn Kirkpatrick: Thank you, operator, and I would like to thank each of you for joining our earnings conference call today. I look forward to continuing to update you on our ongoing progress in the coming year. I wish everyone a lovely holiday season and look forward to updating you in our next call. Thank you very much.

Thank you operator, and I would like to thank each of you for joining our earnings conference call. Today I look forward to continuing to update you on our ongoing progress in the coming year I wish everyone. A lovely holiday season, and look forward to updating you.

In our next call. Thank you very much.

Operator 2: Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Operator: Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.

Thank you. This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.

Q3 2022 Ensysce Biosciences Inc Earnings Call

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