Q2 2021 Evelo Biosciences Inc Earnings Call

[music].

For me and welcome to the valid Biosciences conference call to discuss the second quarter 2021 financial results and business highlights at this time all participants are in listen only mode for the formal remarks, we'll open the call up for your questions. Please be advised of this call is being recorded at the company's request.

At this time I'd like to turn the call over to Jessica Cotrone of of Belo. Please proceed.

Operator: At this time, I'd like to turn the call over to Jessica Cutrone of Avelo. Please proceed.

Thank you. This morning, the issued a press release the outlines the topics we plan to discuss today. This release is available at www dot of Velo bio dot com under the investors tab today in our call Center.

Jessica Cutrone: Thank you. This morning, we issued a press release that outlines the topics we plan to discuss today. This release is available at www. EveloBios.com under the Investors tab. Today on our call, Simba Gill, Chief Executive Officer, Mark Plinio, Chief Commercial Officer, and Jonathan Zung, Chief Development Officer, will review our recent business highlights and second quarter 2021 financial results. Before we begin, I would like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about our objectives and anticipated clinical milestones, the impact of any of our product candidates, and the timing and results of any clinical studies should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

The Mcgill Chief Executive Officer, Mark plenty of Chief Commercial Officer, and Jonathan Zhang Chief Development Officer will review, our recent business highlights for the second quarter of 2021 financial results.

Before we begin I would like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about.

Objectives, and anticipated clinical milestone of the impact of any of our product candidate and the timing of the results of any clinical studies should be considered forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, such forward looking statements are intended to be subject to the safe Harbor protection provided.

Jessica Cutrone: Such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. However, actual results could differ materially from those indicated by the forward-looking statements due to the impact of many factors. Participants are directed to the risk factors set forth in Evelo's quarterly report on Form 10-Q for the quarter ended June 30, 2021, and the company's other filings with the Securities and Exchange Commission. Any forward-looking statements made today speak only to Avelo's operations as of today. Avelo disclaims any duty to provide updates to its forward-looking statements, even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Simba.

Added by the Reform Act actual results could differ materially from those indicated by the forward looking statements due to the impact of many factors participants are directed to the risk factors set forth in the Dallas quarterly report on form 10-Q for the quarter ended June 30th 2021 and the company's other filings with the securities.

Our of Beans Commission.

Any forward looking statements made today speak only 2 of those operations as of today of Ela disclaims any duty to provide updates to its forward looking statements. Even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Simba.

Thank you Jessica.

Simba Gill: Thank you, Jessica. Good morning, everyone, and thank you for joining us to review our progress during the second quarter. We wanted to begin by recapping the fundamentals of our platform and the small intestinal axis, or syntax. It has long been understood that the gut plays a central role in regulating health, inflammation, and immunity throughout the body. Evelo's focus is discovering how to make medicines that capture the potential of the gut to treat disease and promote good health.

Good morning, everyone and thank you for joining us to review of progress during the second quarter.

We wanted to begin by recapping the fundamentals of our platform and the.

The small intestinal axis or syntax.

It has long been understood that the got plays a central role in regulating health.

Inflammation and immunity throughout the body.

If those focus is discovering how to make medicines the capture of the potential of the gut to treat disease and the agenda good health.

Simba Gill: Over the last few years, we have made fundamental discoveries that have confirmed the central governing role of the gut is the biology of syntax, the small intestinal axis. This control system for systemic immunity, centered in the gut, can be targeted to make medicines that act at a distance from within the gut without entering the body. The announcement from Ceres last week about the lack of efficacy of Sphere 287, a microbiome therapeutic in people with ulcerative colitis, has raised questions about the prospects for Avelo's Syntax medicines. We want to address this directly and highlight that there is no bearing from this serious announcement at all on syntax, platform, or products.

Over the last few years, we have made fundamental discoveries that have confirmed the central governing role of the gut is.

For the biology of the syntax the small intestinal axis.

This control system for systemic immunity centered in the GAAP can be targeted to make mentioned, but just the distance from within the gut without entering the body.

The announcement from series last week about.

Lack of efficacy of SER 287 of microbiome therapeutic and people with ulcerative colitis.

Has raised questions about the prospects for our bellows syntax mentioned.

We want to address this directly and highlight but there is no bearing from series of announcements at all.

On the syntax platform of products.

Most importantly, there is no overlap either of mechanism of action for therapeutic intent.

Simba Gill: Most importantly, there is no overlap either of mechanism or action or therapeutic intent. The superficial view that these approaches are somehow linked by having to do with the gut and microbes hides the complete difference in scientific principles that have from the beginning led us away from complex ecosystem biology of live biotherapeutic products which seek to replace a disease-causing microbiome with a healthy microbial ecosystem. The series approach is fundamentally different to Avelo's focus on syntax, unlike Ceres or indeed the broad microbiome field.

The superficial view that these approaches of somehow linked by having to do with the gut microbes.

About the height of the complete different and scientific principles, but from the beginning led us away from complex ecosystem biology of life, biotherapeutic products, which seek to replace the disease, causing microbiome with healthy microbial ecosystem.

The theories of approach is fundamentally.

The different to embellish focus on syntax.

Unlike series or indeed, the broad microbiome field.

There is no intent nor actual modification of the microbiome ease of pre clinically or clinically with the syntax medicines.

The other impacts product candidates.

Ah well defined non life preparations of single strains of microbes and the extracellular vehicles.

Simba Gill: There is no intent nor actual modification of the microbiome either preclinically or clinically with Syntax Medicine. Rivelo Syntax product candidates are well-defined, non-live preparations of single strains of microbes and their extracellular vesicles. The mechanism of action is clear.

The mechanism of action is clear.

The physical structure is recognized by the syntax sensing system.

Sales in the small intestine, which then leads to a triggering the pharmacological.

Around the body without the need for the drug to leaps of God.

These effects are independent of anything to do with the microbial ecosystem in the colon.

The central point is that the Belo syntax product candidates of physical drugs not live biotherapeutic.

Simba Gill: Their physical structure is recognized by the syntax sensing system, cells in the small intestine, which then leads to the triggering of pharmacological signals around the body without the need for the drug to leave the gut. These effects are independent of anything to do with the microbial ecosystem in the colon. The central point is that Abelosyntax product candidates are physical drugs, not live biotherapeutic products. They act directly on target cells with an entirely new mechanism of action that enables systemic efficacy without systemic absorption.

Signaled ex the act directly on target cells with an entirely new mechanism of action that enables systemic efficacy without the systemic absorption.

From a pharmaceutical and patient value point of view. This is the core of advance of syntax medicines.

The positive data from 5 cohorts in clinical studies with Edp 18, 15, and over 300 people have shown inflammation resolving effects across the major types of inflammation th 1 th 2 and th 17.

While the consistently observing safety and Tolerability.

The ability of Edp 18, 15 comparable to placebo.

These cover psoriasis, atopic dermatitis and human experimental models.

Early phase clinical results, we're always open for the reasonable question of whether they are robust and reproducible.

Simba Gill: From a pharmaceutical and patient value point of view, this is the core advance of Syntax Medicines. Positive data from five cohorts in clinical studies with EDP 1815 in over 300 people have shown inflammation-resolving effects across the major types of inflammation, Th1, Th2, and Th17, while consistently observing safety and tolerability of EDP1815 comparable to placebo. These cover psoriasis, atopic dermatitis, and human experimental models. However, early phase clinical results were always open to the reasonable question of whether they were robust and reproducible.

This is why the emphasis on repeated studies with Edp 18, 15 is so important not just 1 but 5 positive outcomes have shown beyond a reasonable doubt that edp 18, 15 is active in humans and the syntax works as we propose it does concordant with hundreds of preclinical.

Experiments.

The data are remarkable revealing a whole new concept and how a naturally occurring drug.

Throughout the body via an external century system, rather than having to flood the body with foreign substances.

Another critical scientific that's the differentiator.

It's worth of microbes the under life Index medicines come from.

The microbes of isolated from the total surfaces, but line the interest in of human donors not from stool.

This is centrally important as these rat mucosal microbes are the ones that have adapted to interact.

Simba Gill: This is why the emphasis on repeated studies with EDP1815 is so important. Not just one, but five positive outcomes have shown, beyond reasonable doubt, that EDP1815 is active in humans and that Syntax works as we propose it does, concordant with hundreds of preclinical experiments.

With and to be recognized by the human host cells.

This is where we believe the pharmacology comes from.

They are quite distinct set of microbes from the relatively undifferentiated mass. The grows every day to form stool.

And they also quite distinct in the Mexican.

Mechanism of action and pharmacological function.

The value of of our pipeline of syntax medicines lies in the differences not the similarities the other microbiome approaches.

Simba Gill: The data are remarkable, revealing a whole new concept in how a naturally-occurring drug can work throughout the body via an external sensory system, rather than having to flood the body with foreign substances. Another critical scientific differentiator is where the microbes that underlie the synthetic medicines come from. The microbes are isolated from mucosal surfaces that line the intestine of human donors, not from stool.

Yeah.

The <unk> scientific discoveries, which differ from the mainstream microbiome.

I am field have been integrated the create a pipeline of product kinds of thoughts with the potential to be of significant advance in the development of medicines.

1 use of single microbes, which are 2 isolated from the the mucosa rather than stool.

Free.

Work non life.

For microbes produce extracellular vehicles, which are pharmacologically active.

5 they have direct action on herself in the duck.

Simba Gill: This is centrally important as these rare mucosal microbes are the ones that have adapted to interact with and be recognized by their human host cells. This is where we believe the pharmacology comes from. They are a quite distinct set of microbes from the relatively undifferentiated mass that grows every day to form stool, and they are also quite distinct in their mechanism of action and pharmacological function.

And sixth play all of this together syntax enable systemic efficacy and safety.

Of non absorbed drugs.

So yes, once way of working with microbes in the gut our approach is completely unique.

I'd like to now turn to 1 particular feature of the clinical profile.

Safety and Tolerability are critical parameters for both adults and children.

Children with diseases, such as psoriasis and atopic dermatitis.

Our products have the potential to have a differentiated profile given that they are orally delivered gut restricted and systemically acting.

Simba Gill: The value of our pipeline of syntax medicines lies in the differences, not the similarities to other microbiome approaches. Six scientific discoveries which differ from the mainstream microbiome field have been integrated to create a pipeline of product candidates with the potential to be a significant advance in the development of medicine.

The studies to date have shown ETP 18, 15 to be well tolerated.

And with the safety profile comparable to placebo.

This is important the clinicians and to the people with these diseases.

A reminder, also the inflammatory diseases, including psoriasis and atopic dermatitis, a systemic not local diseases.

Simba Gill: Use of single microbes, which are 2. isolated from the mucosa, rather than stool. 3. They work non-live.

At ETP 18, 15th is designed to treat systemic inflammation topical treatments do not treat systemic effects.

We have several additional clinical readouts across atopic dermatitis, and psoriasis with Edp, <unk> 15 and <unk>.

The D P 18.60.

Simba Gill: 4. Microbes produce extracellular vesicles which are pharmacologically active. Five, they have direct action on host cells in the gut. And six, pulling all of this together, syntax enables systemic efficacy and safety of non-absorbed drugs. So, yes, whilst we are working with microbes in the gut, our approach is completely unique. I'd like to now turn to one particular feature of the clinical profile. Safety and tolerability are critical parameters for both adults and children with diseases such as psoriasis and atopic dermatitis.

The 7 which Jonathan will tell you about.

The research and development teams continue to explore ways to enhance and extend the applications of syntax medicines of.

Of note is the previously announced preclinical data for our first extra cellular vehicle product candidate for.

For inflammation, which is on track to enter clinical development next year.

Evs have the potential to drive even greater efficacy than seen with a whole microbe programs.

Execution of our vision requires the highest kind of the team and I'm pleased that we continue.

The to attract tremendous talent 2 of valor.

We recently appointed Martin linear as of Ellis Chief Commercial officer.

Mark brings significant sales and marketing leadership 2 of <unk>.

Including experience launching blockbuster products for inflammatory diseases, such as percentage of biologic.

Being approved for the treatment of both psoriasis and arthritic conditions.

I'd now like to turn the call over to Mark who will provide a bit more color on the himself his role as the Belo and how he will help us enable broad global access of our medicines the benefit the lives of.

Simba Gill: Our products have the potential to have a differentiated profile given that they are orally delivered, gut restricted, and systemically acting. Studies to date have shown EDP1815 to be well tolerated and with a safety profile comparable to placebo. This is important to clinicians and to people with these diseases.

Billions of people worldwide.

<unk>.

Thank you Sandra.

I'm thrilled to be here. This morning, I joined of L. O for 3 main reasons for.

The company's innovative scientific platform, which I believe has the potential to transform the treatment of inflammatory diseases.

Yeah.

Second the opportunity to apply this novel science to address areas of immense unmet need where new oral medicines that are effective.

Simba Gill: A reminder also that inflammatory diseases, including psoriasis and atopic dermatitis, are systemic, not local diseases. EDP1815 is designed to treat systemic inflammation, while topical treatments do not treat systemic effects.

It's well tolerated and affordable could meaningfully impact the lives of billions of people.

And third the opportunity to work closely with the phenomenal team with the.

Simba Gill: We have several additional clinical readouts across atopic dermatitis and psoriasis with EDP 1815 and EDP 1867, which Jonathan will tell you about. The research and development teams continue to explore ways to enhance and extend the applications of syntax medicines. Of note is the previously announced preclinical data for our first extracellular vesicle product candidate for inflammation, which is on track to enter clinical development next year. EVs have the potential to drive even greater efficacy than seen with whole microprograms. Execution of our vision requires the highest caliber team, and I'm pleased that we continue to attract tremendous talent to Avelo. We recently appointed Mark Plonio as Avella's Chief Commercial Officer.

And expertise to turn of big vision into reality.

Today I'd like to focus on the vast unmet need that we're seeking to address.

As Simba alluded to there are more than 1 billion people worldwide suffering from classic inflammatory diseases.

Diseases, with which we are all too familiar.

<unk> like psoriasis, atopic dermatitis, rheumatoid arthritis, and inflammatory bowel disease.

While each of these diseases presents differently all are characterized by systemic inflammation.

And all have a significant negative impact on People's lives.

Our.

Amir of clinical programs are focused on demonstrating the impact of syntax medicines in the treatment of psoriasis and atopic dermatitis.

People living with psoriasis or atopic dermatitis are underserved by existing option.

Especially those with mild and moderate disease.

Innovation, including oral therapy, primarily has been.

Our initiatives on the moderate to severe population.

Despite such innovation. It is estimated that in the United States less than 8% of people with psoriasis in less than 2% of people with atopic dermatitis have received these treatments.

Safety Tolerability and high costs are significant barriers to treatment.

With many people, especially those with mild and moderate disease opting for marginally effective topical treatments.

Mark Plinio: Mark brings significant sales and marketing leadership to Avelo, including experience launching blockbuster products for inflammatory diseases such as Cosentix, a biologic which has been approved for the treatment of both psoriasis and arthritic conditions. I'd now like to turn the call over to Mark, who will provide a bit more color on himself, his role at Avelo, and how he will help us enable broad global access to our medicines to benefit the lives of billions of people worldwide. Mark. Thank you, Sremba.

Or no treatment at all.

Take for example, atopic dermatitis for <unk>.

There has been limited innovation and currently there are no oral therapies available.

People suffering from milder.

Ben spoke out of it atopic dermatitis suffer from very painful itchy skin lesions that are highly visible they.

They reported a significant impact on their quality of life and experienced a significant psychosocial burden, which has been shown to be greater than the impact of diabetes.

Cardiovascular disease, and even some cancers.

These people also suffer from a number of other comorbidities, such as asthma and allergies.

Despite the high level of suffering there remains a very large treatment gap for the more than 20 million atopic dermatitis sufferers in the U S alone.

Mark Plinio: I'm thrilled to be here. I joined Evelo for three main reasons. First, the company's innovative scientific platform, which I believe has the potential to transform the treatment of inflammatory disease. Second, the opportunity to apply this novel science to address areas of immense unmet need, where new oral medicines that are effective, safe, well-tolerated, and affordable could meaningfully impact the lives of billions of people. And third, the opportunity to work closely with a phenomenal team with the capabilities and expertise to turn a big vision into reality.

Most of these people are treated with topical that are time intensive and inconvenient to.

The other mother of low compliance and address only the outward dermatologic manifestations of disease.

Leaving the systemic inflammation that characterizes this condition entirely untreated.

Dialogic therapy used in less than 2% of people with atopic dermatitis is not without its own limitations.

To admit including administration by injection the potential for immuno suppression and high cost.

Simply put there remains of significant need for oral medicines that are effective safe well tolerated and affordable for the more than 200 million people suffering from atopic dermatitis globally.

Mark Plinio: Today, I'd like to focus on the vast unmet need that we're seeking to address. As Simba alluded to, there are more than 1 billion people worldwide suffering from inflammatory diseases. Diseases with which we are all too familiar, like psoriasis, atopic dermatitis, rheumatoid arthritis, and inflammatory bowel disease. While each of these diseases presents differently, all are characterized by systemic inflammation, and all have a significant negative impact on people's lives.

And the more than 50 million people impacted by psoriasis around the globe.

Which is why we have chosen to focus our initial efforts are improving care for these patients.

This creates a unique opportunity for <unk> to improve care for a significant population of suffers especially those with mild.

Mild to moderate disease, who remain underserved.

Our syntax targeted therapies, we have the potential to deliver effective.

<unk>, well tolerated and affordable oral therapies that treat a number of inflammatory conditions across multiple arms of the immune system.

And this is exactly what we.

To do I.

I joined developed to help fulfill this vision specifically to create a business model that allows us to translate the tremendous potential of syntax into medicines that are affordable and accessible to people worldwide.

Mark Plinio: Our initial clinical programs are focused on demonstrating the impact of syntax medicines in the treatment of psoriasis and atopic dermatitis. People living with psoriasis or atopic dermatitis are underserved by existing treatments, especially those with mild and moderate. Innovation, including oral therapy, primarily has been focused on the moderate to severe population.

As we begin to build the commercial organization, we will challenge the traditional pharma business.

The internal.

And the way people think about drug pricing and in the way technology in other channels are used to provide care and deliver medicines for people suffering from diseases.

Mark Plinio: Despite such innovation, it is estimated that in the United States, less than 8% of people with psoriasis and less than 2% of people with atopic dermatitis have received these treatments. Safety, tolerability, and high cost are significant barriers to treatment, with many people, especially those with mild and moderate disease, opting for marginally effective topical treatments or no treatment at all. Take, for example, atopic dermatitis, for which there has been limited innovation, and currently, there are no oral therapies available.

So that every person who can benefit from of syntax space medicine is able to receive it.

This is core to our vision and I look forward to the.

The small ahead.

We'll provide additional details on our commercial strategy as we advance our programs through the clinic and begin preparing for our next steps.

Now over to Jonathan to provide an update on our clinical progress and future milestone.

Thank you Mark and good morning, everyone a simple <unk>.

Attunity during the third quarter, we anticipate readouts from our ongoing Edp 18, 15 phase II and phase <unk> trials in psoriasis.

The phase II trial is evaluating the safety and efficacy of 3 different doses of <unk> versus placebo and individuals with mild and moderate sort of.

Mark Plinio: People suffering from mild or moderate atopic dermatitis suffer from very painful, itchy skin lesions that are highly visible. They report a significant impact on their quality of life and experience a significant psychosocial burden, which has been shown to be greater than the impact of diabetes, cardiovascular disease, and even some cancer. These people also suffer from a number of other comorbidities, such as asthma and allergies.

Following daily dosing for 16 weeks.

The trial has been designed to evaluate the efficacy and safety of Edp, $18.15 and to select the appropriate doses for the phase III program the <unk>.

While aims to confirm the safety and Tolerability of the ETP 18, 15 and to demonstrate.

The straightened confirm effects on a number of clinical efficacy endpoints in psoriasis.

The primary endpoint is the mean percentage change in the psoriasis area of severity index surpasses the score at week 16.

Mark Plinio: Despite the high level of suffering, there remains a very large treatment gap for the more than 20 million atopic dermatitis sufferers in the U.S. alone. Most of these people are treated with topicals that are time-intensive and inconvenient to administer, have low compliance, and address only the outward dermatologic manifestations of the disease, leaving the systemic inflammation that characterizes this condition entirely undetectable. Biologic therapy used in less than 2% of people with atopic dermatitis is not without its own limitations, including administration by injection, the potential for immunosuppression, and high cost.

Secondary endpoints include a number of physician measures such as past the 50 <unk>.

Demonstrate 95 body surface area of BSA and the physician global assessment PGA times, PSA along with different patient reported outcomes such as the dermatology life quality index, the <unk> and the psoriasis symptom inventory for <unk>.

In parallel to our phase 2.

2 trial, we have an ongoing phase 1 b trial in individuals with mild to moderate psoriasis that is evaluating tablet and capsule dosage forms containing a higher concentration of drug.

We will use the totality of the results from the phase 2 and phase <unk> trials to further understand the potential of edp 18th.

<unk> seen in psoriasis and to select an appropriate dosage form for Edp $18.15 for the next phase of clinical trials.

Mark Plinio: Simply put, there remains a significant need for oral medicines that are effective, safe, well-tolerated, and affordable for the more than 200 million people suffering from atopic dermatitis globally and the more than 50 million people affected by psoriasis around the world. This is why we have chosen to focus our initial efforts on improving care for these patients. This creates a unique opportunity for Avelo to improve care for a significant population of sufferers, especially those with mild to moderate disease who remain underserved.

Moving onto atopic dermatitis, we continue to be very excited about our EVP of <unk> atopic dermatitis program and we will begin the phase III trial this quarter.

As a reminder, in our phase 1 b trial in a cohort of people with mild and moderate atopic dermatitis trial participants were dose for 56 days with Edp 18, 15 or placebo.

The data showed consistent improvements in percentage change from baseline compared to placebo for 3 clinical.

Sales for us the eczema area and severity index easy Iga times PSA score at.

Mark Plinio: With our Syntax-Targeted Therapies, we have the potential to deliver effective, safe, well-tolerated, and affordable oral therapies that treat a number of inflammatory conditions across multiple arms of the immune system. And this is exactly what we intend to do.

7 out of 16 or 44% of trial participants treated with <unk> achieved an outcome of the 50% of greater improvement from baseline in easy score easiest.

Mark Plinio: I joined DEVELOP to help fulfill this mission, specifically to create a business model that allows us to translate the tremendous potential of Syntax into medicines that are affordable and accessible to people worldwide. As we begin to build the commercial organization, we will challenge the traditional pharma business in the way people think about drug pricing and the way technology and other channels are used to provide care and deliver medicines to people suffering from diseases so that every person who can benefit from a syntax-based medicine is able to receive it. This is core to our vision, and I look forward to the opportunity ahead.

Split day by day, 7 day, compared with zero percent in the placebo group.

The phase II trial will be a 12 week double blind placebo controlled multiple cohort trial in individuals with mild moderate or severe atopic dermatitis. This will allow us to more fully understand the potential.

Benefits of Edp, $18.15 across a range of disease severity.

All trial participants who complete the 12 week study will be eligible to enroll into an open label extension study, where they will all receive ETP 18 for 15.

Approximately 198 participant.

<unk> will be randomized to receive edp, 18th for 15, and 66 participants will be randomized to receive the matching placebo.

Mark Plinio: We will provide additional details on our commercial strategy as we advance our programs through the clinic and begin preparing for our next step. Now, over to Jonathan to provide an update on our clinical progress and future milestones. Thank you, Mark, and good morning, everyone.

Participants will receive either 1 capsule once daily 2 capsules once daily for 1 capsule twice daily the.

Trial will be conducted in North America the U.

Canada, along with Europe.

The primary endpoint will be the main difference between E. D. P. A T 15 of placebo and the percentage change from baseline and easy score at week 12.

Secondary endpoints will include a number of investigator Iga and BSA, along with patient reported out.

Jonathan Zung: As Simba shared, during the third quarter, we anticipate readouts from our ongoing EDP1815 phase 2 and phase 1B trials in psoriasis. The Phase II trial is evaluating the safety and efficacy of three different doses of EDP1815 versus placebo in individuals with mild and moderate psoriasis following daily dosing for 16 weeks. The trial is designed to evaluate the efficacy and safety of EDP1815 and to select the appropriate doses for the Phase III program.

The us such as the <unk>, it's using the daily peak pruritus numerical rating scale and the patient oriented ex <unk> measure or poem.

We anticipate reporting results from this trial in the third quarter of 2022, which will be used to support the dose selection for the phase III atopic dermatitis program.

Outcome, our phase 1 b trial of E. D. P 18, 67, and a cohort of individuals with moderate atopic dermatitis is ongoing.

The trial participants are being dosed for 56 days with the 14 day follow up we.

We anticipate results from this trial in the fourth quarter of the sheer.

As a reminder.

18, 67 is from a different genus to ETP 18, 15 and has been rendered non live by gamma irradiation.

Jonathan Zung: The trial aims to confirm the safety and tolerability of EDP1815s and to demonstrate and confirm effects on a number of clinical efficacy endpoints in psoriasis. The primary endpoint is the mean percentage change in the psoriasis area severity index, or PASI score, at week 16. Secondary endpoints include a number of physician measures such as PASI-50, PASI-75, Body Surface Area BSA, and the Physician Global Assessment PGA x BSA, along with different patient-recorded outcomes such as the Dermatology Life Quality Index, the LQI, and the Psoriasis Symptom Inventory, or PSI.

D. P..18, 67 has demonstrated robust anti inflammatory activity in preclinical models of th 2 biology.

And moving to Evs.

As Simba mentioned at the beginning of this call ETP 29, 39 is our lead microbial extracellular vesicle product candidate for inflammation, we anticipate initiating a clinical trial in 2022.

We will share more about this program next quarter with that I will hand, it over to Simba.

Thank you Jonathan.

As you heard we have a number of milestones expected over the next 6 to 12 months.

In Q3 of 2021, we expect data from our phase II dose ranging trial of Edp 18, 15 in psoriasis.

We would also expect.

Data from the phase 1 B trial of Edp 18, <unk> in psoriasis in cohorts with tablets and capsules dosage forms containing more concentrated drug and we will begin the phase 2 trial of Edp 18, 15 in atopic dermatitis.

In Q4 of 2021.

Jonathan Zung: In parallel to our Phase 2 trial, we have an ongoing Phase 1B trial in individuals with mild and moderate psoriasis that is evaluating tablet and capsule dosages containing higher concentrations of drugs. We will use the totality of the results from the Phase 2 and Phase 1b trials to further understand the potential of EDP1815 and psoriasis, and to select an appropriate dosage form for EDP1815 for the next phase of Moving on, we discuss atopic dermatitis.

We expect interim data from the phase 1 b trial of Edp 18, 67% in atopic dermatitis and in 2022, we will initiate clinical development of our first inflammatory extracellular visco product candidate Edp 2939.

And we expect data from the phase II trial.

Of the Edp 18, 15 in atopic dermatitis in the third quarter of 2022.

Yeah.

I wanted to conclude by thanking the abele of team and our partners in the midst of the pandemic. We have continued to execute successfully across all areas, including clinical development.

Manufacturing and supply chain.

And to advance of research platform and our pipeline.

We've continued to grow and to build value of capabilities and expertise.

We are now all physically working of labs and offices and highly focused on delivering on our next sets of data.

This has been a.

Kelly half period, and we're very proud of the results we have produced.

And for the resilience for the choose a great spirit of our team.

I'd now like to turn the call over to the operator for questions.

Jonathan Zung: We continue to be very excited about our EDP 1815 atopic dermatitis program, and we'll begin the phase 2 trial this quarter. As a reminder, in our Phase 1b trial, in a cohort of people with mild and moderate atopic dermatitis, trial participants were dosed for 56 days with EDP1815 or placebo. The data showed consistent improvements in percentage change from baseline compared to placebo for three clinical scores, the Eczema Area and Severity Index EASY, IgA times BSA, and SCOREP.

Thank you and the reminder to ask the question you'll need the press star 1 on your telephone.

<unk> please.

Kate please standby, while we compile the Q&A roster. Our first question comes from Matthew Harrison with Morgan Stanley. Your line is open.

Great. Good morning, this is vikram on for Matthew.

2 questions from our side.

The first we were just wondering how you plan to manage.

The placebo rate in the.

The atopic.

The atopic dermatitis study do you expect to start in the third quarter with 18.15, and also I just wanted to see what sort of.

Safeguards you have in place to kind of manage any impact from the pandemic for the study.

Okay.

Hi, Vic.

The good day for me, let me take those in reverse order.

Jonathan Zung: Seven out of 16, or 44%, of trial participants treated with EDP1815 achieved an outcome of a 50% or greater improvement from baseline in the EASY score, EASY 50 by day 70, compared with 0% in the placebo score. The Phase II trial will be a 12-week, double-blind, placebo-controlled, multiple-cohort trial in individuals with mild, moderate, or severe atopic dermatitis. This will allow us to more fully understand the potential benefits of EDP1815 across a range of disease severities.

So for the pandemic.

First of all as I.

Concluded in my prepared remarks, we've already had experience of recruiting very successfully through the pandemic.

Both in atopic dermatitis and psoriasis.

And 1 of the keys to.

From our historical success, we're applying to the forward plans for atopic dermatitis, which is to have multiple sites and multiple geographies and to be very close to all of those sites and that will obviously mitigate.

Against any potential issues, because obviously, if the pandemic has different.

Realities of.

At different times in different geography, so we've got multiple geographies across the U S and across the Europe.

And we're very close to all of the relevant sites, Jonathan who is leading our.

Clinical development for us.

Obviously taken our capabilities for the next level sort.

The feeling very confident that we will recruit on schedule.

With the atopic derma.

On the types of sites for the first study and then on the second question on the first let me hand, it over the John Yeah. So for the first question in terms of the placebo response of the way. We designed the study is the study will have a 2 week lead in automotive the answer patients some of the patients. So we'll look at we'll look at their incoming.

Jonathan Zung: All trial participants who complete the 12-week study will be eligible to enroll in an open-label extension study where they will all receive EDP 1815. Approximately 198 participants will be randomized to receive EDP 1815, and 66 participants will be randomized to receive the matching placebo. Participants will receive either one capsule once daily, two capsules once daily, or one capsule twice daily. The trial will be conducted in North America, the U.S., and Canada, along with Europe.

Z score there'll be automotive answer.

For 2 weeks.

Then get another easy measurements, and then they'll be randomized to either active or placebo. So that's how we're looking to <unk>.

Managed satisfy.

Great understood and my second question was on the.

So Ryan this program.

I'm just wondering how.

In the third quarter of this year.

And the you mentioned that Youre going to have the data from the phase <unk> study and also from data from the phase 1 b cohorts for the tablets and capsules could you just walk us through.

Those are different datasets going to kind of come together to help you formulate your plan.

Plans for for the Phase III study.

Yes, So let me say 1 overarching comment and then it kind of I'll hand over to Jonathan to give you a bit more detail. So we will release all of the data together that's the way all of the data is coming together, we expect the late third quarter, we will be ready to do that.

Jonathan Zung: The primary endpoint will be the mean difference between EDP1815 and placebo and the percentage change from baseline in the EASY score at Week 12. Secondary endpoints will include a number of investigator, IGA, and BSA, along with patient-reported outcomes, such as the DLQI, itch using the Daily Peak Paritis Numerical Rating Scale, and the Patient-Oriented Eczema Measure, or POEM. We anticipate reporting results from this trial in the third quarter of 2022, which will be used to support the dose selection for the Phase 3 atopic dermatitis program.

So just.

To repeat.

The question for everybody else is a benefit of Vikram constraint. It's important we're released the phase II data together with the phase <unk> data looking at.

Increased concentration.

Tablets and capsules.

And then Jonathan any additional comments sure. So as we think about the phase 2 trial.

We will be looking at the 3 cohorts, which are evaluating different dosing regiments.

And looking at those in terms of pads. The 50 pads. The 75 responses along with patient reported outcomes will guide us in terms of next steps around dose selection and how.

Trial forward.

Great. Thank you.

Thank you Vikram.

And our next question comes from Kristen <unk> with Cantor Fitzgerald of your line is open.

Hi, everybody. This is Rick on for Kristen I just have a couple.

Jonathan Zung: Our Phase 1b trial of EDP1867 in a cohort of individuals with moderate atopic dermatitis is ongoing. Trial participants are being dosed for 56 days with a 14-day follow-up. We anticipate results from this trial in the fourth quarter of this year. As a reminder, EDP1867 is from a different genus than EDP1815 and has been rendered non-live by gamma irradiation

How we machines for you this morning first of all.

When youre looking to.

The phase 2 atopic dermatitis trial, when you are looking to move into now the mild moderate and severe.

The difference severities, how are you thinking about maybe targeting specific percentage.

A quest of patients the fall into these categories is that something youre looking at.

And how are you thinking about baseline inclusion exclusion criteria based on what you observed in the phase <unk> trial.

Yeah, Great question, so in terms of that study.

Jonathan Zung: EDP1867 has demonstrated robust anti-inflammatory activity in preclinical models of Th2 biology. And moving to EVs, as Simba mentioned at the beginning of this call, EDP2939 is our lead microbial extracellular vesicle product candidate for inflammation. We anticipate initiating a clinical trial in 2022. We will share more about this program next quarter. With that, I will hand it over to you.

We're looking to enroll in <unk>.

We've got a.

Plans are in place to maintain the percentages will probably enroll about 65% of the participants from the moderate and the 10% to 15% each of the mild and severe.

So that will give us a good range of patients that we're studying.

And Rick 1 important point.

Is embedded in your question.

Anticipate the potential for Edp $18.15 to have meaningful activity across all 3 groups mild moderate and severe as we think forward to the ultimate.

Goal of the program.

Yeah.

Simba Gill: Thank you, Jonathan. As you heard, we have a number of milestones expected over the next 6 to 12 months. In Q3 of 2021, we expect data from a Phase II dose-ranging trial of EDP1815 in psoriasis. We will also expect data from the Phase 1B trial of EDP1815 in psoriasis in cohorts with tablet and capsule dosage forms containing more concentrated drug. And we will begin the Phase 2 trial of EDP1815 in atopic dermatitis.

Thank you and maybe just 1 more.

How did the increased costs.

Accretion preliminary work that you've been doing in the psoriasis side as well as the ongoing study of cohorts kind of influence the design of.

Of the trial design relative to the different capsule combinations.

Yeah.

Hasn't hasn't had any.

Any impact in the the way we think about the overall clinical development plan is to get that data now. So that's part of the data that will be released at the end of third quarter, and then that will inform them of what we do in the next wave of studies. So the goal of the existing clinical trials as Johnson was saying is true.

Determine optimum dose.

And the optimal formulation of the concentration of we'll get that data from the ongoing studies in psoriasis and then that will inform of what we do next.

Simba Gill: In Q4 of 2021, we expect interim data from the Phase 1b trial of EDP1867 in atopic dermatitis, and in 2022, we will initiate clinical development of our first inflammatory extracellular vesicle product candidate, EDP2939, and we expect data from the Phase 2 trial of EDP1815 in atopic dermatitis in the third quarter of 2022.

Okay. Thank you all very much.

Thanks for you.

Our next question comes from Chris Howerton with Jefferies. Your line is open.

Great.

Thank you very much for taking the questions. Obviously I'm really excited for all of the data readout for the upcoming up.

So I guess.

Maybe I I feel like maybe we could get a little more information on the totality of the readout with respect of psoriasis in the third quarter I think Jonathan you're certainly.

Great.

Addressed of feature of the different dosing cohorts within the phase 2.

But the part that I feel was not answered was the idea of the 2 different formulations and then I think the other concept as well as in terms of kind of the dosing frequency.

Simba Gill: I wanted to conclude by thanking the Abello team and our partners. In the midst of the pandemic, we have continued to execute successfully across all areas, including clinical development, manufacturing, and supply chain, and to advance our research platform and our pipeline. We continue to grow and to build develop capabilities and expertise. We are now all physically working in our labs and offices and highly focused on delivering on our next sets of data.

So how does that fit into the comments that simple.

Made at the beginning with respect to.

How the how this therapeutic modality works.

And certainly some of the features.

Some of the ecological approaches that are out there.

Sure. So the phase II study design.

The design to basically demonstrate the efficacy.

Efficacy in.

Of the 18th 2015.

Simba Gill: This has been a particularly hard period, and we are very proud of the results we have produced and of the resilience, fortitude, and great spirit of our team. I'd now like to turn the call over to the operator for questions.

As you think about the phase <unk> studies. The 2 studies that we're looking at the cohorts of tablets and capsules. That's the really understand the performance of each of those dosage forms.

In the psoriasis patient population that we would then use 2 inch.

Future studies in the whether there's a switch between capsules and tablets. So that that's a pretty straightforward approach that were looking at.

Operator: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Matthew Harrison on Morgan Stanley. Your line is open.

That would inform us as we think about our phase III program next steps post the phase III, which dosage form we would bring forward, whether it's the capsule or the.

Tablet and Chris just to expand on that a little bit too to the reference versus the first.

Vikram: Great. Good morning. This is Vikram.

Hello.

And though we lost you.

Vikram: On behalf of Matthew, two questions from our side. First, we were just wondering how you plan to manage the placebo rates in the atopic dermatitis study you expect to start in the third quarter with 1815, and also just wanted to see what sort of a safeguard you have in place to kind of manage any impact from the pandemic on this study. Hi Vikram, good to hear from you.

For.

Some of this MRI.

You may continue.

Okay great.

Well. So this is Chris howerton the.

I was I guess I'm wondering Jonathan if we can just understand.

Maybe is it is it simple of as the different formulations.

You do have different efficiencies with respect to C. M. C. N N C activities or is there a punitive clinical benefit of Warner either of the different formulations and you know I guess the added an implicit question on top of that is debt.

Simba Gill: Let me take those in reverse order. So for the pandemic, first of all, as I concluded in my prepared remarks, we've already had experience recruiting very successfully through the pandemic, both in atopic dermatitis and psoriasis. And one of the keys to our historical success is applying to the forward plans for atopic dermatitis, which is to have multiple sites in multiple geographies and to be very close to all of those sites. And that will obviously mitigate against any potential issues because, obviously, the pandemic has different realities at different times in different geographies. So we've got multiple geographies across the U.S. and across Europe, and we're very close to all of the relevant sites.

That.

Obviously, we're going to learn a lot of information from the specific phase 2 b study in psoriasis, but you know how can we better understand whether or not you know, let's say the tablet formulation would enhance those results what would be the information to help you make that determination.

Stan.

Again at this time please standby.

In Asia again at this time, we're experiencing technical difficulties. Please standby.

The Mama Caroline.

Okay.

And you may resume.

Greg Hi, this is simba, we got disconnected for some reason so.

I'm not sure what happened that debt.

Hello, everybody.

I'm not sure where we lost.

Jonathan Zung: Jonathan, who's leading clinical development for us, has obviously taken our capabilities to the next level. So we're feeling very confident that we will recruit on schedule with the atopic dermatitis study. And then on the second question. On the first question, let me hand it over to Jonathan.

Well you lost the battle.

Yeah can you hear me now survey of reported yet.

Okay great.

Fantastic Yeah. So I think you kind of right, where I think you were about to address.

How that may or may not relate to your comments with respect the different ecological approaches in.

And then I.

I actually pressed on the point just lag so when I have the.

Jonathan Zung: Yeah, so for the first question in terms of the placebo response, the way we've designed the study is that the study will have a two-week lead-in on emollients for patients. So the patients will look at their incoming EZ score. They'll be on emollients for two weeks.

Podium is that you know the I guess I would love a little more information Jonathan with respect to the actual of tablets and capsules. You know is it as simple as debt each of the different formulations has different C. N N C efficiencies and that's really the focus of.

Vikram: They'll then get another EZ measurement, and then they'll be randomized to either active or placebo. So that's how we're looking to manage that effect. Great, understood. And my second question was about just so Riaz's program.

The understanding that or is there a period of clinical benefit of 1 or either of the formulations with respect to either of the concentration.

Or the dosing frequency.

Okay.

Thanks, Chris.

Just on the on the fundamental question of what's really centers in our mind around the platform.

Key point is.

As I said the mic.

For the wrong there is no linkage to the ecosystem based approach of so the intention here is not the colonized the microbial ecosystem.

Vikram: I'm just wondering how... In the third quarter of this year, you mentioned that you were going to have data from the Phase 2B study and also data from the Phase 1B cohorts for the tablets and capsules. Could you just walk us through how those different data sets are going to kind of come together to help you formulate your plans for the Phase 3 study? Yeah, so let me say one overarching comment and then I'll hand over to Jonathan again to give you a bit more detail.

The goal is to make sure there is as much exposure as possible for the active pharmacological.

Agents.

At the right place.

For the right period of time in that for the different things that we're looking at cost of the phase II and the phase 1 b.

All focused on the core point is that the.

Platform is based upon recognition of structural motifs.

For breakfast sentiment of the vehicle and so we need to get enough.

Vikram: So, we will release all of the data together. That's the way all of the data is coming together. We expect late in the third quarter we'll be ready to do that. So, just to repeat the question for everybody else is benefit Vikram because I think it's important, increased concentration, in tablets and capsules. And then, Jonathan, any additional comments? Sure. So, as we think about the Phase 2 trial, you know, we'll be looking at the three cohorts which are evaluating different dosing regimens. And, you know, looking at those in terms of PASI 50 and PASI 75 responses along with patient-reported outcomes will guide us in terms of, you know, next steps around dose selection and how we move forward.

The optimize the amount of the micrographs of income support from the public cells in the small intestinal access from the different things we're looking at the.

Investigating those those differences throughout the.

Maybe to expand on that in terms of the second part of the question, yes in terms of the.

My credit part of the question I mean, we're evaluating the tablets and capsules to understand if there is the difference between them in terms of the delivery of the drug.

In the psoriasis patients and then obviously, we would use the data from those 2 cohorts of the then determine next steps of 1 formulation is.

Is superior to the other.

Okay.

Okay. All right that's great. Thank you so much for taking the questions and obviously like I said look forward to the coming months.

Hi, Christine.

Thank you for your next question comes from Matthew Luchini with BMO capital. Your line is open.

Hi, good morning, Thanks for taking the question and thank you for the update.

So first.

On the.

Simba Gill: And our next question comes from Kristen Kluska with Cancer Fixed Urals. Your line is open.

The atopic dermatitis study.

It seems like the.

How should we interpret the inclusion of severe the patients in the past the company has.

Rick: Hi everybody, this is Rick speaking on behalf of Kristen. I just have a couple of questions for you this morning. First of all, when you're looking to move into now these mild, moderate, and severe different severities, how are you thinking about maybe targeting specific percentages of patients to fall into these categories?

The sort of really emphasize the strategic focus of mild to moderate disease.

Just wondering if the.

This is the prelude to perhaps pushing into more severe patients.

In this indication and relatedly on the on an atopic dermatitis can you just remind us.

We.

Where you see the potential advantages of $18.67 relative to $18.15 recognized that the different microbe, but it's the.

Rick: Is that something you're looking at? And what are you thinking?

At the end of the day at the site.

For the efficacy story at that perhaps the potential for better concentration of much lower dosing.

Rick: How are you thinking about baseline inclusion and exclusion criteria based on what you observed in the Phase 1B trial?

Everything works out where does how does these 2 product profiles kind of.

Shape.

Relative to 1 another.

Jonathan Zung: Yeah, great question. So, in terms of that study, we're looking to enroll, and we've got plans in place to maintain the percentages. So we'll probably enroll about sixty-five percent of the participants in the moderate condition and then ten to fifteen percent each in the mild and severe. So, you know, that will give us a good range of patients that have been studied. And Rick, one important point, which is embedded in your question: we anticipate the potential for EDP1815 to have meaningful activity across all three groups, mild, moderate, and severe, as we think forward to the ultimate. Thank you. And maybe just one more.

Hi, Matt.

The answer the question on the let Mark answer the question of about 18.67. So the first of all just to reemphasize the unmet need for patients with atopic dermatitis.

There are about 20 million patients in the U S alone with a.

Topics on the types of from hundreds of millions of patients around the world.

For the major.

ARIA.

For the patient unmet need is in patients with moderate amount of disease.

There are no oral safe well tolerated.

Portable and effective drugs available so.

It's a massive area of unmet need.

And syntax space mentioned of uniquely positioned to solve that in the past.

Exactly the profile of what we expect.

Well, we'll know soon over the next year or so in atopic dermatitis the.

We expect to see if we get that profile again confirming.

The safety Tolerability, obviously, you have something that total convenient.

And if we can generate the efficacy and obviously, we will make sure to my previous comments that we're delivering on the affordable basis.

We expect we will have <unk> treatment for that huge population.

And severe disease.

To your question we believe.

We have the possibility of important impact even in the severe patient population and atopic dermatitis, there is unmet need and there's plenty of room for improved drugs and.

Rick: How did the increased concentration preliminary work that you've been doing on the psoriasis side, as well as the ongoing study of cohorts, kind of influence the design of the trial design relative to the different capsule combinations? hasn't had any impact on that the way we're thinking about the overarching clinical development plan is to get that data now, so that's part of the data that we'll release at the end of the third quarter, and then that will inform what we do in the next wave of studies.

Yes, we are we are keen to explore what might be able to do that as well.

The study will provide initial data.

Because of the census.

As to how much impact and we haven't message would be of patient population.

So thats that question I'll, let mark Bob mounts for the question on <unk> hundred 67.

Hey, Matt small share Im going also.

So some of the strategic land then of specific way of ex.

<unk> hundred 67% and 18 sustain the claim that we made at the outset.

Rick: So the goal of the existing clinical trials, as Johnson was saying, is to determine the optimum dose and the optimum formulation and concentration, and we'll get that data from the ongoing studies in psoriasis, and then that will inform what we do next. Okay, thank you all very much.

For the aspiration to make.

The single strains of normalized now we see the maturing of the derived from the cobalt preparations of the X percentage of the vehicles, which assets directly in the cost of the sensory system of pharmacological effects was a fairly substantial claim to be able to do something with the new type of medicine total new modality that hadn't been.

Made before we never assumed that the first drug we picked.

Chris Howerton: Our next question comes from Chris Howerton with Jeffries. Your line is open. Great. Thank you very much for taking the questions. Obviously, I'm really excited for all

Wouldn't necessarily have the benefits of more any more of that you would.

If you are starting again with small molecules of antibodies with gene therapy of whatever modality. So our strategy from the outset was to pick multiple microbes of workout experimentally and clinically what.

Chris Howerton: Great Thank you very much for taking the questions. Obviously, I'm really excited for all the data readouts that you have coming up. So, I guess, you know, maybe I feel like maybe we could get a little more information on the totality of the readout with respect to psoriasis. In the third quarter, Jonathan, you certainly addressed the features of the different dosing cohorts within phase two, but the part that I feel was not answered was the idea of the two different formulations, and then I think the other concept as well is in terms of kind of the dosing frequency, you know, so how does that fit into the comments that Simba made at the beginning with respect to, you know, how this therapeutic modality works and certainly some of the Sure.

So all of the force the pharmaceutical types, we're going to be we've actually got pretty lucky with the EPA <unk> getting a lot of positive data going.

Going in but were nominated for <unk> 15 company with syntax Medicine company. So the breadth of the biology and.

The follicle from up.

<unk>.

The bulk of drugs was importance of Edp $18.67 for.

Sales into that as by the way do the extracellular vesicles GDP 18, 67 is another new coastal we derive microbe derived from the different pump the microbe, let's touch on non likely distinct.

And it has been.

Repeatedly robust.

Structure in and preclinical studies of not going to make particular comparisons of Edp $18.15 on that because of the entourage quite answer the questions about which is better if you like the.

Both good Edp, aged 67 has been very robust in preclinical studies. The other thing which is emerging we haven't talked much about this.

Jonathan Zung: So the Phase 2 study, you know, is designed to basically demonstrate the efficacy of 1815. As for the Phase 1B studies, the two studies that we're looking at, the cohorts of tablets and capsules, that's to really understand the performance of each of those dosage forms in the psoriasis patient population that we would then use to inform future studies, you know, whether there is a switch between capsules and tablets. So that's a pretty straightforward approach that we're looking at.

The publicly is the.

Price of these microbial preparations and the skew that Culp, Inc. Extracellular visa growth appear to have in common this broad inflammation resolving pharmacology, apparently without thinking of suppressive effects for other types of side effects with differences.

And the details of the molecular targeted mechanisms of action that is very interesting because if we can get diversity of induction of the effects for common broad spectrum of inflammation resolution activity that puts this whole platform at the very powerful.

Jonathan Zung: And then that would inform us, you know, as we think about, you know, our Phase 3 program, next steps post-phase 2, which dosage form we would bring forward, whether it's the capsule or the tablet. And Chris, just to expand on that a little bit, to the reference versus.

Physician, so they're with us.

Some of those 2 characteristics 1 is that the strategy how do we make these medicines as 1 of the best ones are going to be I don't know specific characteristics of Edp $18.67 in comparison with Edp $18.15, and we see them as being.

Simba Gill: Simba, we lost you. Uh, well, this is...

For a complementary in the in the clinic.

Chris Howerton: Okay, great. Well, so this is Chris Houghton.

We'll just broadened the base of what we're able to go to clinically as we think about diseases beyond dermatological.

Chris Howerton: I guess I'm wondering, Jonathan, if we can just understand maybe it is simple as the different formulations, you know, have different efficiencies with respect to CM&C activities, or is there a punitive clinical benefit of one or any of the different formulations? And, you know, I guess the added and implicit question on top of that is that, obviously, we're going to learn a lot of information from the specific Phase IIb study in psoriasis, but, you know, how can we better understand whether or not, you know, let's say the tablet formulation would enhance those results? What would be the information to help you make that determination?

Okay. Thanks, and then just really quickly on the <unk> brought us.

That youre going to have a bunch of data all being presented at the same time later this quarter.

How much of the.

The kind of go forward.

Strategy.

Do you expect to be able to communicate concurrent with data or do you see that as being something that youll have to work out after and if so why.

At what point would you expect to be able to communicate.

And we expect we'll be able to give meaningful guidance.

And so on the go forward strategy. So the idea is that we do a meaningful analysis of the data across the 3 cohorts and that should guide on what we do next and a very clear way and Thats, what we would expect to announce.

Great. Thank you thanks for taking the questions.

Thanks very much thank you.

Operator: Again, at this time, please stand by. Again, at this time, we're experiencing technical difficulties. Please stand by; we'll resume momentarily.

Thank you. Our next question comes from Goldman.

Singh with JMP Securities. Your line is open.

Hi, Thanks for taking the questions from the thing.

And about the 16 of efficacy measurements like pad the 50.

For something in the phase III or is it for it out can we take a step back and discuss a little bit about what efficacy.

Simba Gill: Hi, this is Cinder. We got disconnected for some reason. I'm not sure what happened there, but hopefully everybody didn't notice. Chris, I'm not sure where we lost or where you lost that battery. Yeah, can you hear me now, Simba?

The measurements how they evolve.

Goldman from the week 6 of 8.

2 week 16, and and maybe you could help with the apply to what was previously shown with <unk>.

I think it was the sixth.

Chris Howerton: Are we talking? Yeah, absolutely. All right, fantastic. Yeah, so I think you cut off right where I think you were about to address, you know, how that may or may not relate to your comments with respect to the different ecological approaches. And then I actually pressed on the point, just like I have done, I guess I would love a little more information, Jonathan, with respect to the actual tablets and capsules.

To help us getting the idea of how the kind of set expectations for the upcoming readout and then 1 follow up question for Mike.

Yeah.

So.

Hi, Kevin.

On the first question, let me just start by reminding everybody about the.

The unmet need and what we're targeting.

And I know you know the scope and but I think just important to ground everybody. So.

First of all.

Psoriasis also massive patient population.

9 million people in the U S tens of millions of people globally.

Only about 8% of those patients receive innovative treatments today.

And of similar rate for atopic dermatitis, the majority of patients with moderate and mild surrounding states.

Im happy with current treatments.

<unk>.

With the <unk>.

Chris Howerton: Is it as simple as that each of the different formulations has different CMNC efficiencies, and that's really the focus of understanding that? Or is there a punitive clinical benefit to one or any of the formulations? Thanks, Chris.

Potent things again, the first of all safety and Tolerability of that is something that is extremely important to <unk>.

Patients and to the physicians treating them well.

No well tolerated oral drugs for the use in the moderate amount of population.

Right.

About new day.

Obviously from the oral convenient is much preferable.

To the injection and again affordability really matters.

So the efficacy.

Simba Gill: So, just on the fundamental question, which really centers in our minds around the platform, the key point is... As I said in my preparatory remarks, there is no linkage to ecosystem-based approaches. So the intention here is not to colonize the microbial ecosystem. The goal is to make sure there's as much exposure as possible to the active pharmacological agent at the right place for the right period of time, and that's what the different things that we're looking at across Phase II and Phase IB are focused on.

The important as.

As well the feedback we're getting from continuous discussion with physicians and the patients. It is we need to show that we have something plus or minus.

But as of passing 50 day level or better.

But if we do that together with the safety and Tolerability. We have an important mentioned that will make the big difference for patients.

So that's what we're aiming at.

To your specific question on.

What happens at 6 weeks et cetera.

The original phase 1.

1 piece of it wasn't a per week study.

What <unk> typically seen with drugs to treat psoriasis as it takes at least 16 weeks to see.

Part of the effect from the can go out longer than that and if you look at other drugs are being used in this area. So the expectation that we have.

As we've always communicated if you look at historical drugs that have been used and for US. This population is the extended duration of therapy should lead to deepening responses and potentially of blow the population of of responders as well and it's partly.

Simba Gill: So the core point is that the platform is based upon recognition of structural motifs on the microbes or the extracellular vesicle, and so we need to get enough and an optimized amount of the microbial extracellular vesicle to the target cells in the small intestinal axis. And the different things we're looking at are aimed at investigating those differences. Jonathan, maybe to expand on that in terms of the second part of the question

Use of the time it takes time for the skin to heal.

There's a variety of other things, but we expect the extended duration.

Lead to deeper effects and the strong website.

Great and then for the fee.

For atopic dermatitis trial, that's coming up the.

Just wanted to dig a little bit more into the moderate to severe.

The population maybe just.

Simba Gill: Yeah, in terms of the second part of the question, I mean, we're evaluating the tablets and capsules to understand if there is a difference between them in terms of the delivery of the drug to the psoriasis patients. And then obviously, we would use the data from those two cohorts to then determine next steps if one formulation is superior to the other. Okay, all right, that's cool. Great, thank you so much for taking the questions and, obviously, like I said, look forward to the next one.

Particularly thinking about the strategy with the patients that may be also on <unk>.

Can you is that still the case there'll be some of these things like this and how might you be controlling it. So the patients that are on the <unk> alone for example in the placebo arm.

Versus the combination is there any kind of controlling that.

The 40%.

Sent or so we're going to be moderate in the 10% to 15 in the severe how is that.

Yeah, Let me give it to John So driven for this study no patients will be on <unk>.

There'll be theyre excluded from from the study. So we're looking at patients that are not on biologics hasnt been on in another trial for.

Chris Howerton: Thank you. Our next question comes from Matthew Lucchini with BMO Capital. Your line is open.

Matthew Lucchini: Hi, good morning. Thanks for taking the questions and thank you for the update.

The time. So these will be patients that have active disease and again as you think about the population about 65% of that study will be in the moderate and then we will also be studying the extremes, meaning the mild patient population in the severe population the better understand the full potential of $18.15.

Matthew Lucchini: So first, on the Atopic Dermatitis Study. It seems like...

Simba Gill: How should we interpret the inclusion of severe In the past, the company has really emphasized the strategic focus on mild to moderate disease. This is the prelude to perhaps pushing into more severe patients. Can you just remind us where you see the potential advantages of 1867 relative to, You know, if everything works out, where does, how do these two products compare? Hi Matt.

Across the mild to moderate and the severe.

Thank you.

So the 1 other point I Should've mentioned total offices.

Reflecting just again in terms of duration of response.

The duration of treatment versus response rate as of yet.

The key thing obviously, we're looking at patient reported outcomes.

So we'll be looking at those and.

Those should improve over time, but I just wanted to and sales importance of those patient patient reported outcomes as well so looking at things and women's growth of manner, including sleep ex overall patient integrating DSI and so on a reported as well.

Mark Bodmer: I'll answer the first question and let Mark Bodmer answer the question about 1867. So first of all, just to re-emphasize the unmet need for patients with atopic dermatitis. There are about 20 million patients in the U.S. alone with atopic dermatitis and hundreds of millions around the world. The major area for patients with unmet need is in patients with moderate and mild disease where there are no oral, safe, well-tolerated, affordable, and effective drugs available.

Great. Thank you for that.

Thanks for thank you.

As a reminder, the ask a question you will need the press Star 1. Our next question comes from Joseph Thome with Cowen Your line is open.

Hi, there good morning, and thank you for taking my questions a couple of on the atopic dermatitis study.

I know it was just mentioned that patients cannot be on.

That type of.

The same time during the study but are all of the patients that are going to be enrolled biologic naive. So.

Could they have failed to play that previously and then.

If you could just let us know sort of what is the the dose on the capsule basis compared to what we saw in the phase 1 b is it the same dose.

Mark Bodmer: So it's a massive area of unmet need, and syntax-based medicines are uniquely positioned to solve that in that that's exactly the profile that we expect, will know soon, over the next year or so, in a couple of demonstrators that we expect to see. If we get that profile again, confirming safety tolerability, obviously, we have something that's all convenient, and if we can generate the efficacy, and obviously, we'll make sure to mark the nearest comments that we're delivering on an affordable basis, we expect we will have D-key treatment for that huge population.

So you're just giving them more frequently.

And then last question on the on the trial design there is a the IV dosing arm maybe what.

David I'll lead you to think that maybe the 2 times of day dosing.

Maybe maybe more beneficial accretion.

Yes, so in terms of in terms of the study.

Design, but I'll take the B IV for.

So as we as we think about it.

Not tested the drug in.

In the QD versus bid so we want to.

The stand the full breadth of the essentially dosing twice a day and as you think about the concentrations in the study we will be using the more concentrated material.

So we will be dosing 1 cohort with 1 capsule of day another cohort with 2 capsules of day, and then that final cohort will be IV, 1 capsule in the morning and the afternoon.

Mark Bodmer: In severe disease, to your question. We believe we will have the possibility of important impact even in the severe patient population. In atopic dermatitis, there is unmet need, and there's plenty of room for improved drugs, and yes, we are keen to explore what we might be able to do there as well, and the study will provide initial data that gives us a sense as to how much impact we can have in that severe patient population. So that's that question. I'll let Mark Bodmer answer the question about 1867. Hey guys, it's Mark here.

The material is is more concentrated so if you think about that phase <unk> study, we were dosing 10 capsules in this particular study.

We'll get to equivalent number of using the current dosage form and dosing regimen.

Great and then on the are these all biologic naive patients that will be entering the baseline.

There'll be buy up yes, they will be about biologic naive.

The participants yes.

Okay, great. Thank you.

Thanks for.

And at this time from showing no further questions I'd like to turn the call back over to Simba Gill for any closing comments.

Thanks, very much everybody and this obviously as you've heard from some of the questions of very exciting time.

Mark Bodmer: I'm going to answer in a first of all a strategic way and then a specific way about EPA 1867 and 1815. The claim that we made at the outset for the aspiration to make single strains of non-live, now we see that mucosally derived, microbial preparations of Rx-percent of the vesicles which acted directly in the gut on the sensory system to have pharmacological effects was a fairly substantial claim to be able to do something with a new type of medicine, total new modality that hadn't been made before.

Study.

The clinical data Readouts coming up.

Building on the.

Barry.

The multiple clinical cohorts that we've shown historically so I. Appreciate your continued interest in the Delavan, we'll keep you updated over the next.

Couple of months and beyond thanks, very much of them.

This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.

Uh huh.

[music].

Okay.

Yes.

[music].

Mark Bodmer: We never assumed that the first drug we picked would necessarily have the benefits we wanted any more than you would if you were starting again with small molecules or antibodies or gene therapy or whatever modality. So our strategy from the outset was to pick multiple microbes and work out experimentally and clinically what the best pharmacophores or pharmaceutical types were going to be. We've actually gotten pretty lucky with EDP 1815, getting a lot of positive data going in, but we're not an EDP 1815 company; we're a Syntax Medicine Company. So the breadth of the biology and the pharmacological structure of the drugs was important. So EDP 1867 flows into that, as do, by the way, the extracellular vesicles.

Mark Bodmer: EDP 1867 is another mucosally derived microbe derived from a different part of the microbe. It's taxonomically distinct, and it has been repeatedly robust in pre-clinical studies. I'm not going to make particular comparisons with EDP 1815 on that because I don't want to answer the question because I can't tell you which is better if you like. They're both good, but EDP 1867 has been very robust in pre-clinical studies. The other thing which is emerging, and we haven't talked much about this publicly, is that various of these microbial preparations and actually their cognate extracellular vesicles appear to have in common this broad inflammation-resolving pharmacology, apparently without immunosuppressive effects or other types of side effects with differences in the details of the molecular targeted mechanisms of action.

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Mark Bodmer: That is very interesting because if we can get diversity of induction of the effects for common broad-spectrum inflammation resolution activities, that puts this whole platform into a very powerful position. So just to sum up, there are two characteristics.

Matthew Lucchini: One is the strategy, how do we make these medicines, what are the best ones going to be, and then those specific characteristics of EDP 1857 in comparison with EDP 1815. We see them as being very complementary in the clinic and will broaden the base of what we're able to go to clinically as we think about diseases beyond dermatology. Thanks, and then just really quickly on, given that you're going to have a bunch of data all being presented at the same time later in this quarter.

Matthew Lucchini: How much of the kind of go forward strategy at www.ncbi.nlm.nih.gov. Now we expect we'll be able to give meaningful guidance on the go-forward strategy. So the idea is that we do a meaningful analysis of the data across the three cohorts and that should guide what we do next in a very clear way, and that's what we would expect to announce. Thank you. Thanks for taking the time to answer.

Simba Gill: Thank you. Our next question comes from Gobind Singh with JMP Securities. Your line is open.

Gobind Singh: I think you're taking the questions. So just thinking about the Can we take a step back and discuss a little bit about what, www.microsoft.com, www.ncbi.gov Yeah, so... Hi Kevin, so on the first question, let me just start by reminding everybody about the unmet need and what we're targeting. And I know you know this, Govind, but I think it's just important, again, to ground everybody. So, first of all, psoriasis is also a massive patient population, about 9 million people in the U.S., tens of millions of people globally.

Gobind Singh: Only about 8% of those patients receive innovative treatments today. In a similar way to atopic dermatitis, the majority of patients with moderate and mild psoriasis are unhappy with current treatments. With the important things, again, being first of all safety and tolerability, that is something that is extremely important to patients and to the physicians treating them. There are no well-tolerated oral drugs that are used in that moderate and mild population right now.

Simba Gill: Obviously, being oil convenient is much preferable to the injection, and again, affordability really matters. So, efficacy is very important as well. The feedback we're getting from continuous discussion with physicians and with patients is that we need to show that we have something plus or minus that is as good as a passive 50 level or better. But if we do that, together with safety and tolerability, we have an important medicine that will make a big difference for patients.

Simba Gill: And so Amy had, to your specific question on..., what happens at six weeks, etc. The original Phase 1 B study was a three-week study, and what one typically sees with drugs to treat psoriasis is it takes at least 16 weeks to see a plateau effect, and it can go out longer than that if you look at other drugs that have been used in this area.

Simba Gill: So the expectation that we have, and we've always communicated, if you look at historical drugs that have been used in psoriasis populations, is that extended duration of therapy should lead to deepening responses and potentially a broader population of responders as well. And that's partly due to the fact it takes time for the skin to heal, and there's a variety of other things, but we expect extended curation will lead to deeper effects and stronger effects.

Simba Gill: Right, and then for the phase 2 atopic dermatitis trial, that's, a little bit more into the moderate to severe population, maybe just particularly thinking about the strategy with the patients that may be also due. Can you, is that still the case? There'll be some things like this, and how might you be controlling it for the patients that are on. Is there any kind of control in that about 40% or so are going to be moderated? and the severe? How is that?

Gobind Singh: Yeah, let me give it to John. So, Govind, for this study, no patients will be on DUPI, so they're excluded from the study, so we're looking at patients that are not on biologics, haven't been on another trial for a period of time, so these will be patients that have active disease, and again, as you think about the population, about 65% of that study will be in the moderate, and then we'll also be studying the extremes, meaning the mild patient population and the severe population to better understand the full potential of 1815 across the mild, the moderate, and the severe.

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Gobind Singh: But then one other point I should have mentioned earlier, just as in terms of duration of response, duration of treatment versus response rate. So the other key thing we're obviously looking at is patient-reported outcomes, and we'll be looking at those, and again, those should improve over time, but I just wanted to emphasize the importance of those patient-reported outcomes as well. So looking at things in an integrated manner, including sleep, itch, overall patient-integrated feeling, USI, and so on, are important as well. Thank you. Thank you. Thank you. As a reminder, to ask a question, you'll need to press star 1. Our next question comes from Joe Thome with Cowan. Your line is open.

Joe Thome: Good morning, and thank you for taking my questions. A couple on the atomic thermotypist study. I know I just mentioned that patients cannot be on Dupli-Med at the same time during the study, but are all the patients that are going to be enrolled in the study biologic nave? So, you know, could they have failed Dupli-Med previously? And then if you could just let us know sort of what the dose is on a capsule basis compared to what we saw on the... 1B. Is it the same dose? Are you just giving it more frequently?

Jonathan Zung: And then last question on the trial design, there is a dosing arm. Maybe what data led you to think that maybe this was two times a day dosing, um, maybe, maybe more. Yeah, so in terms of the study design, but I'll take the BID first. So as we think about it, you know, we have not tested the drug in QD versus BID, so we want to understand the full breadth of potentially dosing twice a day.

Jonathan Zung: As you think about the concentrations in the study, we'll be using the more concentrated material. So we'll be dosing one cohort with one capsule a day, another cohort with two capsules a day, and then that final cohort will be BID, one capsule in the morning and the afternoon. The material is more concentrated, so if you think about that phase 1B study, we were dosing 10 capsules. In this particular study, we'll get to equivalent numbers using the current dosage form and dosing regimen. Great. And then on the other hand, are these all biological naive patients that will be entering? They will be biologically naive participants, yes.

[music].

Jonathan Zung: And at this time, I'm showing no further questions. I'd like to turn the call back over to Simba Gill for any closing comments.

Simba Gill: Thanks very much, everybody. This is obviously, as you've heard from some of the questions, a very exciting time for us with lots of clinical data readouts coming up building on very positive results across multiple clinical cohorts that we've shown historically. So I appreciate your continued interest in Novello and we'll keep you very updated over the next couple of months and beyond.

Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone have a wonderful day.

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