Q3 2020 Evelo Biosciences Inc Earnings Call

[music].

Good morning, and welcome to the other by Sciences third quarter 2020 financial and operating results conference call at this time all participants.

Operator: Good morning, and welcome to the Avelo Biosciences 3rd Quarter 2020 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode.

No listen only mode.

Operator: Following the formal remarks, we will open up the call for your questions. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn it over to Jessica Catron of Avelo. Please proceed. Thank you, operator. Good morning, everyone.

Following the formal remarks, we will open up the call to your questions.

Jessica Catron: This morning we issued a press release that outlines the topics we plan to discuss today. This release is available at www.elobio.com under the Investors tab. Today on our call, Cynda Gill, Chief Executive Officer, Mark Bodmer, President of R&D and Chief Scientific Officer, and Duncan McHale, Chief Medical Officer, will review our third quarter 2020 financial results and recent business highlights. Before we begin, I'd 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 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.

Jessica Catron: Participants are directed to the risk factors set forth in Avelo's quarterly report on Form 10-Q for the quarter ended June 30, 2020, 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.

Cause the other filings with the Securities and Exchange Commission any forward looking statements made today speak only two <unk> operations as of today Avila disclaims any duty to provide update to it's forward looking statements. Even if subsequent events caused the companies use to change. It is now my pleasure to pass the call over to Simba.

Simba: It is now my pleasure to pass the call over to Simba. Thank you, Jessica. Good morning, everyone, and thanks for joining us to review our third quarter and recent progress. 2020 continues to be a transformational year for Avelo, and we have now shown that we can harness syntax to resolve inflammation after oral delivery of EDP1815 in humans. These data underpin our development program.

Thank you Jessica good morning, everyone and thanks for joining us to review a third quarter and recent progress.

2020 continues to be a transformational yet for <unk> and we have now shown that we can harness syntax to resolve inflammation after oral delivery of Edp 18, 15 and humans.

These data underpin on development programs.

The <unk> team and our partners have consistently executed on a research and clinical plans, including through the COVID-19 pandemic and because of this we are poised to deliver six data readouts over the next three to nine months and psoriasis atopic dermatitis COVID-19.

Simba: The Avelo team and our partners have consistently executed on our research and clinical plans, including through the COVID-19 pandemic. Because of this, we are poised to deliver six data readouts over the next three to nine months in psoriasis, atopic dermatitis, COVID-19, and triple negative breast cancer. These readouts will inform our understanding of our current product candidates and programs but also provide important insights about our entire platform, which continues to evolve and expand.

<unk> and triple negative breast cancer.

These readouts will not only inform our understanding of our current product candidates and programs, but also provide important insights about our entire platform, which continues to evolve and expand.

Long term, we aim to capture the full breadth and depth of targeting syntax across different biology's and diseases.

Marx team in research and development continue to explore enhance and expand applications of syntax base mentioned and he will tell you more about this later on the call.

Simba: Long-term, we aim to capture the full breadth and depth of targeting syntax across different biologies and diseases. Mark's team in research and development continue to explore, enhance, and expand the applications of syntax-based medicines, and he will tell you more about this later on the call. With an eye to 2021 and beyond, we are making significant progress towards bringing these critical therapies to patients with inflammatory diseases and cancer who have a need for safe, effective, convenient, and affordable treatments. And with that, I'll pass the call over to Duncan to discuss our clinical highlights. Thank you, Simba, and good morning, everyone.

With an eye to 2021 and beyond we're making significant progress towards bringing these critical therapy to patients with inflammatory diseases and cancer, who have a need for safe effective convenient and a photo affordable therapies.

And with that I'll pass the call over to Duncan to discuss Ah clinical highlights.

Thank you timber and good morning, everyone case name today to discuss how we've continued to execute are clinical plans across the entire portfolio over the past quarter.

Before updating you on the progress we've made in our technical programs I wanted to briefly mention the key opinion later event. We hosted last week, we talked to Benjamin East is board certified dermatologist Ah needing clinical investigator.

The focus of the event was the containment landscape unmet need and opportunity for Edp, 18, 15, and both psoriasis and atopic dermatitis.

And his presentation factories made three key points patient.

Patients with mild moderate psoriasis and a top determine titus have a serious disease with a significant impact on the quality of life.

Dermatologist and patients alike are dissatisfied with existing therapies from the inconvenience and poured here and some topical treatments.

Duncan: I'm pleased to be able today to discuss how we've continued to execute our clinical plans across the entire portfolio over the past quarter. Before updating you on the progress we have made in our clinical programs, I wanted to briefly mention the Key Opinion Leader event we hosted last week with Dr. Benjamin East, a board-certified dermatologist and leading clinical investigator. The focus of the event was the treatment landscape, unmet need, and opportunity for EDP1815 in both psoriasis and atopic dermatitis. In his presentation, Dr. East made three key points.

Through to the expense risk a need for injections of the biologic agents.

He highlighted the need for safe well tolerated affordable and efficacious all treatment.

Which could be used as monotherapy for miles all the way through to the severe disease as well as in combination with current therapies in the severe disease setting.

Based on the preclinical and clinical research to date. He felt edp 18, 15 could potentially fit this profile offering an effective safe and convenient option to patients and thus filling an immense treatment gap.

Potentially ADP 18, 15 has also been catching the attention of the dermatology community more generally earlier.

Earlier today my colleague Douglas Maslin clinical lead of immunology that valor presented data from our phase won't be clinical trial and multiple psoriasis at the European Academy of Dermatology, and venereology or V Virtual Congress.

Duncan: Patients with mild to moderate psoriasis and atopic dermatitis have a serious disease with a significant impact on their quality of life. Dermatologists and patients alike are dissatisfied with existing therapies, from the inconvenience and poor adherence of topical treatments through to the expense, risk, and need for injections of the biologic agent. He highlighted the need for safe, well-tolerated, affordable, and efficacious oral treatment which could be used as monotherapy from mild all the way through to severe disease as well as in combination with current therapies in the severe disease sector. Based on the preclinical and clinical research to date, he felt EDP1815 could potentially fit this profile, offering an effective, safe, and convenient option to patients, and thus filling an immense treatment gap.

Our poster the selected as one of eight Adv's key stories and highlighted at a virtual press conference at the event. This morning.

Now with regard to the clinical programs as you know any of this month, we started a phase two dose ranging trial in marlton motor psoriasis, a dose our first patients.

Just to remind you that.

The phase two trial is evaluating three doses of Edp $2 15 versus placebo and approximately 225 patients over 16 week treatment period.

The primary endpoint is the main reduction in psoriasis area and severity index or Pozzy school.

In addition to key secondary endpoints, including the physicians Global assessment, Nathan severity school and arrange a patient reported outcomes.

This longer dosing period of 16 weeks will give us a better understanding of the potential clinical benefit the ADP 18, 15 could bring to patients with psoriasis.

Interim results from this trial are expected by mid 2021 and.

Duncan: The potential of EDP1815 has also been catching the attention of the dermatology community more generally. Earlier today, my colleague, Dr. Douglas Maslin, Clinical Lead of Immunology at Advelo, presented data from our Phase 1b clinical trial in mild type psoriasis at the European Academy of Dermatology and Venereology, or EADV, Virtual Congress. Our poster was selected as one of EADV's key stories and highlighted at a virtual press conference at the event this morning. Now, with regard to the clinical programs... As you know, earlier this month we started our Phase 2 dose-ranging trial in mild to moderate psoriasis and dosed our first patient. Just to remind you,

And the date to regenerate may enable us to advance into confirmatory Registrational studies following meetings with health authorities in the U S. Angela.

So now moving to atopic dermatitis.

In October we completed the enrollment of a code of patients with mild moderate atopic dermatitis and our phase won't be trial of EDTA 10 15.

This cohort is evaluating Edp, 18, 15, and enteric capsules versus placebo and 24 patients over 56 day treatment period.

The primary endpoint safety and Tolerability and will be our first cohort evaluating dosing beyond 28 days.

We will also be evaluating arrange a secondary endpoints, including markers of atopic dermatitis like the eczema errands severity index or easy school, and the scoring atopic dermatitis or score at school.

In addition, we're also collapsing arrange a patient reported outcomes, including the dermatology life quality index and the proprieties numerical rating school.

We expect to report data in the first quarter of 2021.

Atopic dermatitis is the most common chronic inflammatory skin disease and affects an estimated 10% of adults at 25% of children worldwide.

Duncan: The Phase II trial is evaluating three doses of EDP1815 versus placebo in approximately 225 patients over a 16-week treatment period. The primary endpoint is the mean reduction in psoriasis area and severity index, or PASI score, along with key secondary endpoints including the physician's global assessment, lesion severity score, and a range of patient-reported outcomes.

Typically presented to the Reds intensely itchy rash and although it's often sort of as a pediatric condition. Many will continue to have symptoms throughout their lives.

And as we know from our ongoing psoriasis trial and his patients in Cape emulated continue to reinforce.

Dermatological diseases extend far beyond individual lesions will flare ups that can be treated with simple topical treatments.

[noise] atopic dermatitis is no different and his doctor is discussed it is associated with a substantial physical and psychosocial beds and on both patients and their families.

Just as we think about the ongoing development of our product candidates, we're committed to providing a treatment option.

Duncan: This longer dosing period of 16 weeks will give us a better understanding of the potential clinical benefit that EDP1815 could bring to patients with psoriasis. Interim results from this trial are expected by mid-2021, and the data we generate may enable us to advance into confirmatory registrational studies following meetings with health authorities in the U.S. and Europe. Now, moving to Atopic Dermatitis.

Improved quality of life as well as improving independent measures of disease.

Moving now it's COVID-19.

Patients continue to do with Scooted into a two COVID-19 trials Ah.

Phase two trial in partnership with Rutgers University in the U S and.

In a phase two three trial called tactic E sponsored by the Cambridge University hospitals NHS Foundation Trust.

And led by Adam Books Hospital in Cambridge U K.

That was the result of the very an infection rates that have occurred with the pandemic, we've experienced slower than expected enrollment early on in both of the studies.

Now I expect to report data from both trials in the second quarter 2002, one.

Duncan: In October, we completed the enrollment of a cohort of patients with mild to moderate atopic dermatitis in our Phase 1B trial of UDP1815. This cohort is evaluating EDP1815 in enteric capsules versus placebo in 24 patients over a 56-day treatment period. The primary endpoint is safety and tolerability, and we'll be our first cohort evaluating dosing beyond 28 days. We will also be evaluating a range of secondary endpoints, including markers of atopic dermatitis, like the eczema error in severity index, or EZ score, and the scoring of atopic dermatitis, or SCORAD score. In addition, we're also collecting a range of patient-reported outcomes, including the Dermatology Life Quality Index and the Pruritus Numerical Rating Score. We expect to report data in the first quarter of 2021.

In order to expedite patient recruitment and expand access to potential therapies for COVID-19, New trial sites are being open for Staticky.

Over the past few months.

It has become increasingly care at the COVID-19 will continue to severely impact of global communities. Even is tremendous advances are made towards preventing infections and treating the virus.

<unk> 15 has the potential to be truly differentiated treatment for COVID-19.

With a goldilocks type activity observed preclinical.

Whereby hyper information is resolved.

Whilst mechanisms responsible for the antiviral activity are preserved.

When combined with the favorable Tolerability of Edp 18, 15 observed in a phase one trial.

Suggest it's really differentiated potential to treat COVID-19.

Either alone or in combination with other treatments.

And the data from these trials will also provide important learnings as we evaluate future opportunities and viral diseases and other indications involving hyper information.

If the data from these trials the positives we plan to engage in discussions with global regulatory authorities to determine inappropriate at registration COVID-19.

So now tenants oncology as we discussed and pray up prior earnings calls, we have focused our ADP 15, or three trial on patients who triple negative breast cancer.

We have continued to recruit into this cohort and will report the new data from a phase two trial at the 2020, San Antonio breast, Kansas impose you to be held virtually from December the eighth to the 11th.

Duncan: Atopic dermatitis is the most common chronic inflammatory skin disease and affects an estimated 10% of adults and 25% of children worldwide. It typically presents as a red, intensely itchy rash, and although it's often thought of as a pediatric condition, many will continue to have symptoms throughout their lives, as we know from our ongoing psoriasis trial and as patients and key opinion leaders continue to emphasize.

With that I will turn the call over to Mark to discuss our preclinical back.

Okay.

As you could with busy with a wide range of products development of the clinical results come about so typically iceberg.

I said, we are delving deeper and deeper into the potential of engaging with swollen festival axis syntax to create this extraordinary new clothes reflective stripes or of affordable medicines.

Major topic of my remarks today is would you form of syntax medicines.

<unk> extra cellular vehicles actuarial extra rooms with like this are hugely exciting new frontier for our platform, which I'll tell you more about shortly.

Duncan: Dermatological diseases extend far beyond individual lesions or flare-ups that can be treated with simple topical treatment. Atopic dermatitis is no different, and, as Dr. East discussed, it is associated with a substantial physical and psychosocial burden on both patients and their families. Thus, as we think about the ongoing development of our product candidates, we are committed to providing a treatment option that improves quality of life as well as improves independent measures of disease. Moving now to COVID-19. Patients continue to be recruited into our two COVID-19 trials, a Phase II trial in partnership with Rutgers University in the U.S., and a Phase 2-3 trial called Tactic E sponsored by the Cambridge University Hospitals NHS Foundation Trust and led by Adam Brooks Hospital in Cambridge, UK. Now, as a result of the varying infection rates that have occurred with the pandemic, we've experienced slower-than-expected enrollment early on in both of the studies.

It was one of those do holds we're looking at your microbes to learn about the range of therapeutic utility of touch with all the distinct strange AVP 18, 67 is a good example of this.

We're looking at new formulations, optimizing drug concentration disposal windows, which are critical for getting the most of them are products.

We're looking at your inflammation in preclinical bubbles syntax modulate soon us information without needed to get drugs across the blood brain Barrio solving one of the most pressing problems in CNS Brook development and we're looking at metabolism, where we see effects of our agents on visceral fat inflammation benefits to metabolic.

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So can you a context extra sudden vehicles I'm gonna check you on a quick tour a full breakthroughs, but it'll take them us from our origins was a microbiome company.

Where we are all today.

The first breakthrough was based on looking directly at the interactions of microbes with ourselves with the cost rather than attempting to fix microbial ecology, but let us for the efficacy of single strains of microbes and got around the complex challenges all trying to modify the microbiome itself.

Duncan: And we now expect to report data from both trials in the second quarter of 2021. In order to expedite patient recruitment and expand access to potential therapies for COVID-19, new trial sites are being opened for Taptakee. Over the past few months, it has become increasingly clear that COVID-19 will continue to severely impact our global communities, even as tremendous advances are made toward preventing infections and treating the virus.

The second breakthrough was the discovery type of action of these single strange was the small intestine, which has a very low microbial conference and not the code on with its trillions of microbes. We coined that's small intestine Alexis or syntax. This is more of a branding with the scientific that's submission.

Of the control network, but radiates throughout the body from the small intestines.

Drugs target and engage.

This turns out to be consistent with a long standing observation, but people who've had a total colectomy have normal and you do a logical method bullock functions. They have no code on so they lack those trillions of microbes.

Physiologically normal healthy lifespans.

Duncan: EDP1815 has the potential to be a truly differentiated treatment for COVID-19, with Goldilocks-type activity observed preclinically, whereby hyperinflammation is resolved, whilst mechanisms responsible for the antiviral activity are preserved. When combined with the favorable tolerability of EDP1815 observed in our Phase I trial, it suggests a truly differentiated potential to treat COVID-19, either alone or in combination with other treatments, and the data from these trials will also provide important learnings as we evaluate future opportunities in viral diseases and other indications involving hyperinflammation. If the data from these trials are positive, we plan to engage in discussions with global regulatory authorities to determine an appropriate path to registration for COVID-19. So now I'm turning to oncology.

First of all I'm interested in is actually some time ago, a close family member one is one of those people with no Cola.

And it also turns out that the microbes with interesting properties came up from the chemo up stuff that grows in the code on every day, but from the railroad microbes, but living in the mucosal surfaces.

<unk>.

The third bright through was realization that all drugs did not need to be alive to be effective we discovered that the efficacy of our products will still bear with a bacteria. We're not living it's turned out to be a general profit to your medicines targeting syntax and it took us the EDTA King 60 setup, which has got me irradiated by so dead.

Design real quick benefits to this.

To providing formal proof of animals and humans that we were making pharmacological agents rather than microbiome drugs.

On the fourth breakthrough is today's extension of our platform to extra Sunday the vehicles.

Certain types of bacteria, mostly grab negative naturally shed extra rooms, generally cold extracellular vehicles or E vs. Ivy's, a lipid vehicles, which contained various elements of the parent bacterium.

The volume about 1000 times smaller.

Mark: As we discussed in prior earnings calls, we have focused our EDP-1503 trial on patients with triple negative breast cancer. We've continued to recruit into this cohort, and we'll report new data from our Phase 1-2 trial at the 2020 San Antonio Breast Cancer Symposium, to be held virtually from December 8th to the 11th. With that, I will turn the call over to Mark to discuss our preclinical work. Thanks, Malcolm.

There is a literature on bacterial eevees, including experimental even though modulation by objection in animal models.

There was no literature on some stomach imido modulation, but <unk> to live with bacterial E V. S and yes that is exactly what we see those depends affects a pharmaceutical preparations a bacterial eevees from single strange delivered orally.

This discovery gives us a view proprietary dog microbial modality poorly deliberate since touch medicines.

Trying to help with the same preclinical models, both inflammation and oncology.

Mark: As you've heard, we're busy with a wide range of products, development, and clinical results. And that's for Pippa B. Einsberg. As I said, we are delving deeper and deeper into the potential of engaging the small intestinal axis syntax to create this extraordinary new class of effective, safe, oral, and affordable medicine. A major topic of my remarks today is a new form of Syntax Medicines, bacterial extracellular vesicles, or bacterial exosomes, if you like. This is a hugely exciting new frontier for our platform, which I'll tell you more about shortly, as well as new forms. We are looking at new microbes to learn about the range of therapeutic utility of taxonomically distinct strains. EDP1867 is a good example of this.

All working through engagement with a small intestinal access to send signals around the body with north detected distribution with B B's outside the got pre clinically.

And they have that effective mice, Ah doses, which I'll buy white.

Least a thousand and up to 100000 times lower than whole microbes.

<unk> seen Edp 29, 39 on a recent pipeline charts as an option furniture, Canada.

This is an easy which is an advanced preclinical in manufacturing development.

And all color Judy we recently discovered the bacterial strain, which my T V's would that be true or activity advice with <unk> with anything we've previously seen with either checkpoints have a table or a whole microbe, whether it all hams or in the literature.

D and preclinical chuba bubbles is as effective after all the administration as all reported it for tomorrow immune stimuli actors, that's a high ball, which is all it on C V Beach.

Preclinical data on all color <unk>, Canada called E. D. T 19, Oh wait will be presented the forthcoming meeting with the society for him you know serve you cancel this let's see.

Mark: We are looking at new formulations, optimizing drug concentration, dispersal, and dose, which are critical to getting the most from our product. We are looking at neuroinflammation in preclinical models. Syntax can modulate CNS inflammation without needing to get drugs across the blood-brain barrier, solving one of the most pressing problems in CNS drug development.

November and a couple of weeks time.

So we have a right to the next phase of these other platform taking origins into microbiome, so new level of drug development.

We sometimes jokes about a full side of having E V spots. The company name <unk> of course, there wasn't a full size, but we've had the good fortune that came from keeping open to ever Grace the possibilities of the extra ordinary potential drugs, but uhm syntax nope after supper.

Mark: And we're looking at metabolism, where we see effects of our agents on visceral fat inflammation and benefits for metabolic profile. To give you a context for extracellular vesicles, I'm going to take you on a quick tour of four breakthroughs that have taken us from our origins as a microbiome company to where we are today. The first breakthrough was based on looking directly at the interactions of microbes with host cells in the gut, rather than attempting to fix microbial ecology. That led us to the efficacy of single strains of microbes and got around the complex challenges of trying to modify the microbiome itself. The second breakthrough was the discovery that the site of action of these single strains was the small intestine, which has a very low microbial content and not the colon with its trillions of microbes. Thus, we coined the term small intestine axis or syntax. This is more than branding.

Thank you ma'am.

As I mentioned at the beginning of the call. We have six clinical readouts expected over the next three to nine months within a COVID-19 programs. We expect initial data from a phase two trial in partnership with Rutgers University as well as interim safety data and futility analysis from the face two three times.

Trial in the second quarter of 2021.

We also expect data from a phase one be trials of EVP 18, 15 and E. P. P 18, 57, and atopic dermatitis in the first quarter of 2021 and mid 2021, respectively.

And interim data from a phase two trial and mild to moderate psoriasis my mid 2021.

Finally, we will report additional data from a phase one two clinical trial of ADP 15, O three and triple make the breast cancer at the San Antonio Breast cancer Conference in December.

In addition.

As Mark mentioned, we look forward to sharing initial preclinical data for Edp 19 O eight Ah first extracellular vehicle candidate for oncology.

At the <unk> meeting and a couple of weeks. This is an incredibly exciting time for available.

We have now entered phase two clinical development ADP 18 15.

Advanced you can pipeline, a potential medicines, which could transform the calf millions of patients living with inflammatory disease and cancer worldwide.

Alongside the clinical development method, we continue to optimize our candidates.

Mark: It's a scientific definition of the control network that radiates throughout the body from the small intestine and that our drugs target and engage. This turned out to be consistent with a long-standing observation that people who've had a total colectomy have normal immune, neurological, and metabolic function. They have no colon, so they lack those trillions of microbes and live physiologically normal, healthy lifespans. I first got interested in this actually some time ago. A close family member of mine is one of those people with no colon.

Pru rigorous preclinical evaluation and testing and look forward to capitalizing on a growing knowledge to expand our platform.

Ah developments with microbial extra cellular vehicles expand our ability to harness syntax white excited to advance I E V programs into development.

We are progressing with significant momentum and moving closer and closer to delivering a broadly applicable new class and profile of medicine that is not only efficacious, but also safe and well tolerated already delivered and affordable.

We have accomplished a lot over the last quarter and this would not have been possible without the passionate commitment of our team so I'd like to think.

Mark: And it also turned out that the microbes with interesting properties came not from the kilo of stuff that grows in the colon every day but from the rarer microbes that live in the mucosal surfaces that line the gut. The third breakthrough was the realization that our drugs did not need to be alive to be effective. We discovered that the efficacy of our products was still there if the bacteria were not living. This turned out to be a general property of medicine's targeting syntax, and it led us to EDP 1867, which is gamma-irradiated, so it is dead by design.

And with that I will now open the call for questions.

As a reminder, ladies and gentlemen, if you have a question at this time. Please Bernstein my number one on your Touchtone telephone. If your question has been answered or you wish to remove yourself from the queue.

Please press the pound sign.

Our first question comes from the line of Chris Harrison with decorating your line or something.

Okay.

Yeah.

Mr. Howerton. If you found this on you. Please help me out.

You hear me now.

Yes, Sir we can hear yep.

Okay, sorry about that anyway, I was just saying congratulations on the corner and the progress and obviously some setting times coming forward. So I guess just a couple of questions for me one would be.

What is your I think there's been some kind of tantalizing increases in terms of narrow inflammation. The applicable any of that science for C. N. S disorders. So I'd be curious to know what your application grade 10, 15 might be in those types of medical indications.

Mark: There are clear benefits to this, in addition to providing formal proof in animals and humans that we were making pharmacological agents rather than microbiome drugs. And the fourth breakthrough is today's extension of our platform to extracellular vesicles. Certain types of bacteria, mostly gram-negative, naturally shed exosomes, generally called extracellular vesicles (EVs).

Secondly, if you can give us a little more color granularity on what we might expect in San Antonio breast cancer by the end of this here and and Triple your negative breast cancer is as you all know I follow the Immunomedic story for quite some time. So obviously <unk> has made a lot of noise in that space. So just curious to see.

Mark: EVs are lipid vesicles that contain various elements of the parent bacterium in a volume about 1,000 times smaller. There is a literature on bacterial EVs, including experimental immunomodulation by injection in animal models. There is no literature on systemic immunomodulation by orally-delivered bacterial EVs. And yet, that is exactly what we see, dose-dependent effects of pharmaceutical preparations of bacterial EVs from single strains delivered orally. This discovery gives us a new, proprietary, non-microbial modality of orally-delivered synthetax medicine, which has striking efficacy in preclinical models of both inflammation and oncology. It works through engagement of the small intestinal axis to send signals around the body.

See what we will learn from from your 15 O three programming and what the the updates might be specifically at that conference and then lastly, with respect to the X extra cellular vehicles, you know I guess what is the the drug product that you're envisioning, Karen I'm, sorry, if I missed and.

Missed it and what is the the purity of the drug substance or the the content themselves of the extra cellular vehicles and I think maybe I'll stuff there.

Okay, Chris Thanks, very much let me answer your question about the cancer conference to San Antonio Cancer Conference in December and then I'm Gonna pass over to Mark who I think can festival onto the E. V question can give you.

The scientific background behind what we're doing in your information on why we're excited about it.

And if if we need more clarity on the clinical and euro dumping could give you our initial sports that.

So on.

The San Antonio breast cancer breast cancer conference, what we've basically said is that we.

We'll report base of that on roughly.

20 patients who are in the existing combination study <unk>.

With Keytruda to.

To your point on <unk>.

Mark: We've not detected the distribution of EVs outside the gut preclinically, and they have their effects in mice at doses which are, by weight, at least 1,000 and up to 100,000 times lower than whole microbes. You've seen EDP2939 on our recent pipeline charts as an anti-inflammatory candidate. This is an EV, which is an advanced preclinical and manufacturing development. In oncology, we recently discovered a bacterial strain that makes EBs with anti-tumor activity in mice that surpasses anything we have previously seen with either a checkpoint inhibitor or a whole microbe, whether in our hands or in the literature. Indeed, in preclinical tumor models, it is as effective after oral administration as our reported intratumoral immune stimulators. That's a high bar that this oily-dosed EV meets.

We see that level of response as well as other relevant data from patients as essentially the bar, Chris. So if we see something in the order of 25% to 30% response rate.

Then we have something that could be very interesting to take forward.

Uhm.

And so we'll be reporting out on that and in 20 patient importantly, it's not competitive with <unk> as you know Chris it's something that's complimentary the way we look at the current world of I O is essentially three pillows, obviously checkpoints many of them now uhm have.

Remove the break that is applied to the immune system by T myself.

Things like <unk>, the subtle approaches that increase exposure to answer a neat new action in a tuba microenvironment in what way.

Able to do based on the preclinical early clinical data with Edp 15 O three and on next wave of programs. They don't <unk> is to activate.

The innate and subsequently the adaptive immune system systems with something that is already delivered and something that appears to be very safe and well tolerated. So it's a very nice thick with other things that are going on in the I R World.

Mark: Preclinical data on our oncology candidate, called EDP1908, will be presented at the forthcoming meeting of the Society for Immunotherapy of Cancer, the SOCI, in mid-November in a couple of weeks' time. Thus, we have arrived at the next phase of the Avelo platform, taking our origins in the microbiome to a new level of drug development. We sometimes joke about our foresight at having E.V. at the start of a company name, Evelo.

So that's what will be reporting how Joan.

And as I said, if we see something similar to trigger it'll be in terms of response rate that's something very very interesting would in principle support potentially going into late stage clinical trials.

Obviously, if we see something at a low level Uhm then it potentially is still interesting in terms of supporting activation of systemic community consistent with what I've. Just described so that's what we're waiting for that let me pass over to mall, who can talk about maybe a suggest month do the E V respond.

And then you can respond on Euro Inflammatories anything you don't get to Duncan can talk about new or and try and finish.

Sure Polka small care.

Simba: Of course, there was no foresight, but we've had the good fortune that came from keeping open to ever greater possibilities of the extraordinary potential of drugs that act on syntax. Now back to syntax. Thank you, Mark. As I mentioned at the beginning of the call, we have six clinical readouts expected over the next three to nine months. Within our COVID-19 programs, we expect initial data from our phase two trial in partnership with Rutgers University, as well as interim safety data and futility analysis from the phase two, three Tactic E trial in the second quarter of 2021. We also expect data from our Phase 1b trials of EDP1815 and EDP1867 in atopic dermatitis in the first quarter of 2021 and mid-2021, respectively, and interim data from a Phase II trial in mild to moderate psoriasis by mid-2021.

Hi.

Hi, the Coke product is a a natural component to be patient of tricks, we'll call. We normally throw away because the extra side of the vehicles shedful the bacteria into the medium uhm, so rather than harvest themselves, regardless of medium and we purify it by a mixture of centralization.

Filtration, it's it's fairly straightforward I'm gonna answer your questions about content.

Regulatory contacts go I suspect that's part of what you have in mind.

And asking it and we have discussed these questions with regular to your policy as opposed to the U S. M. B U K with <unk> positive.

It comes because they recognize.

So the extra cellular vehicles.

<unk> all will likely to depart all the types of products that will order using at the clinic.

His whole microbes, so actually the preclinical development requirements. We have four E vs. At the moment don't look to be any different from the microbes, which is hugely beneficial because as you'll recall, we haven't had to do preclinical toxicology testing because he's a natural products.

Or we delivered the requirements for purity, a completely different than it would be for instance, if we were making a lot maybe an extra so I've been trying to inject it intravenously or by some other principle parental route.

So this is a permissive path so these.

Simba: Finally, we will report additional data from a Phase 1-2 clinical trial of EDP-1503 in triple negative breast cancer at the San Antonio Breast Cancer Conference in December. In addition, as Mark mentioned, we look forward to sharing initial preclinical data for EDP-1908, our first extracellular vesicle candidate for oncology, at the CITSE meeting in a couple of weeks. This is an incredibly exciting time for Envelo.

Things that are that's the scientists for the microbes one other comment about the drug policy. So if if we look at.

<unk> presentation, which is whether it's essentially the cost and scale issue will come it's pretty similar E. D's as it is to the whole microbes. So that you may be a little bit higher so we have a training let me.

Spell requirements. It it just changes downstream processing a bit I've been concept.

So the E Bay's basically grab parts of the macromolecular content with a pair of arterial it's not a one for one marching are we doing a logo mixed with a moment to try I'm trying to look up and of course, you know we gotta have all the data showing but.

Simba: We have now entered Phase 2 clinical development of EDP1815 and are advancing a pipeline of potential medicines which could transform the care of millions of patients living with inflammatory disease and cancer worldwide. Alongside the clinical development effort, we continue to optimize the candidate through rigorous preclinical evaluation and testing, and look forward to capitalizing on our growing knowledge to expand our platform. A development with microbial extracellular vesicles expands our ability to harness syntax, and we're excited to advance EV programs into development. We are progressing with significant momentum and moving closer and closer to delivering a broadly applicable new class and profile of medicine that is not only efficacious but also safe and well-tolerated, orally delivered, and affordable. We have accomplished a lot over the last quarter, and this would not have been possible without the passion and commitment of our team, whom I'd like to thank.

Some some proteins are more highly representative E V versus the bacteria and the other way round and we're looking at glycolipid some of.

The rest and you know the.

The differences, we're seeing in the efficacy.

What you'll see a family such a post there shortly between the whole microbe <unk> E V. Maybe due to differences in culture I suspect it's much it's more to do with the pharmacodynamics O B a b E V. It's ability to get some of the targets. So that's that's why we all with that answers your question.

Yeah, and I'm, sorry, Mark, but maybe it's just a very brief clarification in it's basically it's a lie alkalies product in a capsule is that the dosage one.

Yes, sorry, okay. Okay. Yeah. So it's a lot less pollock. It takes a lie optimizations the same way the microbes, though we're looking at all the same formulation questions would be easy. So we all with the microbes are actually transfer that technology strike over their differences and dismiss them. Some loyal polarization excipient, some things, but it's fundamentally the same process.

Okay, Alright, well alright that briefing on <unk>, Yeah, [laughter] Fructify Chick <unk>. This extraordinary to take back the weapons for years ago, Yeah, we totally but we were able to we're gonna reduce it to something like that so it's it's it's really frustration or well, we'll talk more about some of the scientific details behind this in the coming months as well, it's it's it's really.

It's it's it's a new world.

Operator: And with that, I'll now open the call for questions. As a reminder, ladies and gentlemen, if you have a question at this time, please press star and the number one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound sign.

All the neuro inflammation the key point.

It was actually the one I made.

A moment ago on me for the path, Nicole, but the activity of the microbes in the small intestine bypass is the need to cross the blood brain barrier, because some taxes more with textile access does it for US we have put a lot of these days in the public domain or some of it.

Operator: Our first question comes from the line of Chris Howerton with Jeffrey. Your line is open. Mr. Howerton, if your phone is on mute, please unmute.

File collaborators.

At the Mayo clinic, we can clear inflammatory cells in the central nervous system that she can take spinal cord sections, you see you see it very clearly and that's.

Chris Howerton: Yes, sir, we can hear you. Sorry about that. Anyway, I was just saying congratulations on the quarter and the progress and, obviously, some exciting times coming forward. So I guess just a couple questions for me. One would be, you know, what is your application for 1815? I think there's been some kind of tantalizing increase in terms of neuroinflammation and the applicability of that science for CNS disorders. So I'd be curious to know what your application for 1815 might be in those types of medical indications. Secondly, could you give us a little more color or granularity on what we might expect in San Antonio breast cancer by the end of this year and in Tripoli and negative breast cancers. As you all know, I've followed the immunomatics story for quite some time, so obviously, Trudelvy has made a lot of noise in that space.

That's a profound statement Betsy that statement alone would be enough to base, an entire company on with with the prospects for doing something uhm there are companies say.

That would be based on.

The mental ideas about how you can get pharmacological activity in the central nervous system. That's what we do it hasn't been called about mainstream development, yet, but it has been a significant part of what we've been doing Creek clinically you ask the questions specifically in contact with D. D. P. H M 15, actually the preclinical models the ones where.

We've seen some differentiation in deep Ah robustness and maximum efficacy of different microbes and so we have two other microbes, which actually have superior pharmacology in the preclinical models E. D. P. A T T E. K 215 works part of this basic anthropometer after the ZIP with these others give us more <unk>.

Chris Howerton: I'm just curious to see what we will learn from your 1503 program and what the updates might be specifically at that conference. And then lastly, with respect to the extracellular vesicles, you know, I guess, what is the drug product that you're envisioning, Karen? I'm sorry if I missed it. And what is the purity of the drug substance or the content itself of the extracellular vesicles? and I think maybe I'll stop there.

System for robust activity, we'll we'll we'll we'll talk about that more as.

As things develop so interestingly as we go.

Out some core inflammation to your information I'd actually I mentioned metabolisms were looking somebody inflammatory aspects of that's a bullet control, we're starting to see some some some degree of differentiation amongst all product candidates, but we didn't save just looking at core classical.

Simba: Okay Chris, thanks very much. Let me answer your question about the cancer conference, the San Antonio Cancer Conference in December and then I'm going to pass over to Mark who I think can first of all answer the EV question, can give you.., the scientific background behind what we're doing in neuroinflammation and why we're excited about it, and if we need more clarity on the clinical in neuro, Dante could give you our initial thoughts there. So on the San Antonio Breast Cancer Conference what we've basically said is that we will report data there on roughly 20 patients who are in the existing combination study with Keytruda. To your point on Tredelvi.

<unk>.

Okay. So I'll I'll look at that.

Okay, well, that's I mean honestly just very exciting obviously, all the work you're doing in the back in and of course, we have an accent in your clinical catalyst upcoming too. So anyway. Thanks for taking the questions and great to see the progress.

Thanks, Chris.

Yeah.

Thank you and our next question comes from the line of Joseph down with Allen and company and that is open.

The first one is on the atopic dermatitis programs when we see data from 18, 15, and 18 67 next year.

Can you just remind us how you're thinking about moving forward and the indication.

If both look good would you move both forward or or would you make a decision before kind of further committing and the indication and then.

With the data from the COVID-19 studies. It just looks effective here do you believe there's a role for 18 15 in other.

Simba: We see that level of response, as well as other relevant data from patients, as essentially the bar, Chris. So if we see something in the order of 25% to 30% response rate, then we have something that could be very interesting to take forward. And so we'll be reporting on that in 20 patients. Importantly, it's not competitive with Tredelvi.

Pulmonary viral conditions and will this be an area of focus outside of Covid, if the day to look strong.

Thanks, [laughter] so on the first question.

Stretchy has always been to look at different microbes.

Which ah differentiated in terms of for example in the inflammatory space, how that driving inflammation resolution and.

Ah different in other ways like to manufacturing linked to behavior.

In the small intestine and the duck.

That's why I would take 815, and 18 57 forward so that different but.

Simba: As you know, Chris, it's something that's complementary to the way we look at the current world of I.O. There are essentially three pillars, obviously checkpoints. Many of them now have removed the break that is applied to the immune system by tumor cells. Things like Tredelvia, and there are several approaches there, increase exposure to neoantigen in a tumor microenvironment. What we are able to do based on my preclinical and early clinical data with the EDP-1503 and our next wave of programs in oncology is to activate. [inaudible] And as I said, if we see something similar to Tredelby in terms of response rate, that's something very, very interesting and would, in principle, support potentially going to later stage clinical trials. Obviously, if we see something at a lower level, then it potentially is still interesting in terms of supporting activation of systemic immunity consistent with what I've just described.

But the both very potent and resolving inflammation in preclinical models.

The the way, we sometimes refer to it as like looking at antibodies, which both targeting the same diseases work on different mechanisms in different pathways.

And then the answer to your question is it's gonna be Devil in the details and let's see what the data is obviously, it's 18 15 drives potent responses and atopic dermatitis, we're going to move it forward aggressively.

And will still continue to see what happens with 18 67.

So we have to see the day to joke, but at the moment, we've got somewhat of an embarrassment of riches and having to very potent anti inflammatory agents the work on different mechanisms.

So we'll see what the data reveals lab.

18, 15, if we see a response.

In Covid as your question suggests it's very broad utility.

And a number of other viral infections pulmonary I'm beyond because the core driver.

Of the of the theory as to why we're looking at 18 15 and Covid as you know juror is to resolve the hyper information that causes progression to serious COVID-19.

And that same principle of hyper information is relevant to a number of other viral infections, including influenza for example, which is still killing significant numbers of people in the world as you know in a number of other areas. So yes, absolutely we'll look into other areas. If we see posted results from COVID-19.

Simba: So that's what we're waiting for there. Let me pass over to Mark, who can talk about maybe I'd suggest Mark do the EV response first, and then you can respond to neuro-inflammation, and if there's anything you don't get to, Duncan can talk about neuro-inflammation. Sure, Hello Chris, Mark here. So the drug product is a natural component of the fermentation. Actually, it's the part we normally throw away because the extracellular vesicles are shed from the bacteria into the medium, and so rather than harvesting the cells, we harvest the medium, and we purify it by a mixture of segregation and filtration. It's fairly straightforward.

Great. Thank you very much in Nebraska.

Thanks Roger.

Thank you and our next question comes from the line of Matt Matthew Luchini with Emo capital My concern is open.

Hi, This is chen on for a Mac ear congrats on the progress.

Just two questions for me.

Could you guys provide some color on what you guys are doing in terms of the trial.

Like the test how many sites are being added and when they're coming along I'm coming on line and does that mean, there can you change and just wrapping makeup of the studying some way.

Hi, Jane good good to hear your voice uhm so.

Let me, let me step back a little bit now I'll answer your question directly gym. So you know obviously.

Mark: I'm going to answer your questions about purity and content in a regulatory context because I suspect that's part of what you have in mind in asking it and we have discussed these questions with regulatory authorities both in the US and in the UK with very positive outcomes because they recognized, the extracellular vesicles were part of or likely to be part of the types of products that we are already using in the clinic as whole microbes. So actually the preclinical development requirements we have for EVs at the moment don't look to be any different for the microbes which is hugely beneficial because as you'll recall we haven't had to do preclinical toxicology testing and because these are natural products orally delivered the requirements for purity are completely different than they would be for instance if we were making a mammalian exosome and trying to inject it intravenously or by some other parenteral root.

The World of COVID-19 is complex and unpredictable what we've been doing to essentially set ourselves up for.

Rapid an accelerated recruitment is exploring opening up new sites not just in the U K, but absolutely and other geographies and we have multiple discussions ongoing right. Now is you know this is part of the UK platform study led by Addenbrooke, we're working very closely with them, but it's that study.

So I don't think it's appropriate for me to say more right now other than we are looking to expand sites not just in the U K, but also internationally in some of the obvious areas, where it could be 19.

Continues to be.

Significant and I expect we'll be able to say more than not too distant future.

Got it and my other question is could you remind us how that is.

Right, it's tile help accelerate development in a E.

Yeah sure Duncan do you want to take that one.

Sure I think the question.

Obviously, there's a lot of planning that we will be able to take from the <unk> 15 psoriasis program for a topic dermatitis I think.

Mark: So there's a permissive path for these, things that are the same as for the microbes. One other comment about the drug product itself: if we look at dose yield per liter fermentation, which is where the essentially the cost and scale issue will come, it's pretty similar for the EVs as it is for the whole microbes. It actually may be a little bit higher, so we haven't changed our manufacturing scale requirements; it just changes downstream processing a bit. And then content, so the EVs basically grab parts of the macromolecular content of the parent bacterium.

In short all of the safety Tolerability daiquiri very likely to just extrapolate completely across these are very similar populations from that perspective also from the dais response data combined with our faith won't be co. What is currently ongoing will provide.

North a lot of information actually about the the dose as well so we'll be able to take the safety tolerability.

That does not to see learning from psoriasis.

Applies to a Catholic dermatitis.

Got it that's helpful. Thank you.

And as a reminder, ladies and gentlemen, if you'd like to ask a question at this time please.

Mark: It's not a one-for-one matching, and we're doing a lot of omics at the moment to try and try and look at that, but of course, you know we get a hairball of data showing that some proteins are more highly represented in the EV versus the bacterium and the other way around, and we're looking at glycolipids and the rest. And you know the differences we're seeing in the efficacy, which you'll see in the CITSE poster shortly, between the whole microbe and the EV, maybe due to differences in content. I suspect it has more to do with the pharmacodynamics of the EV and its ability to get to the target.

And the number one on your Touchtone telephone.

I'm not showing any further questions I'm not in the call back over for clothes at Walmart.

Thanks, very much everyone for continued attend.

Attention to what we're doing this you heard on today's call. This is incredibly exciting time, both in terms of the clinical Readouts, we're moving forward.

As well as progress in terms of advancing the platform with our extra cellular vehicles as well as progress in other areas of disease in biology.

I appreciate the continued attention to avella, we look forward to keep you updated as we go forward. Thank you very much.

Mark: So that's where we are with that. I hope that answers your question. Yeah, and I'm sorry, Mark, but maybe just a very brief clarification. It's basically, it's a lyophilized product in a capsule. Is that the dosage form? Yes, sorry. It's a lyophilized product. It takes lyophilization the same way that microbes do.

Ladies and gentlemen does that include the program you know disconnect. Thank you for participating everyone have a great day.

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Mark: We're looking at all the same formulation questions with the EVs that we are with the microbes and actually transferring the technology straight over. There are differences in dispersants and lyophilization excipients and things, but it's fundamentally the same process. Okay. Well, very exciting. The brief thing I'll make is very exciting. Actually, it's extraordinary if you think back to four years ago and how we were able to reduce it to something like this. It's really transformational.

Mark: We'll talk more about some of the scientific details behind this in the coming months as well. It's a new world. On neuroinflammation, the key point there is actually the one I made a moment ago during the formal part of the call, that the activity of the microbes in the small intestine bypasses the need to cross the blood-brain barrier because the small intestinal axis does it for us.

Mark: And we haven't put a lot of this data in the public domain, although some of it has been published by our collaborators at the Mayo Clinic. We can clear inflammatory cells from the central nervous system, just as you can take spinal cord sections. You see it very clearly. And that's a profound statement.

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Mark: Actually, that statement alone would be enough to base an entire company on the prospects of doing something. And there are companies that are actually based on fundamental ideas about how you can get pharmacological activity in the central nervous system, and that's what we do. It hasn't been part of our mainstream development yet, but it has been a significant part of what we've been doing pre-clinically. You asked the question specifically in the context of EDP 1815; actually, the preclinical models are ones where we've seen some differentiation in the robustness and maximum efficacy of different microbes, and so we have two other microbes which actually have superior pharmacology in the preclinical models for EDP 1815.

Mark: EDP 1815 works, part of its basic anti-inflammatory activity, but these others give us more consistent or robust activity. We'll talk about that more as things develop. So interestingly, as we go out from core inflammation to neuroinflammation, and actually, I mentioned metabolism, as we look at some of the inflammatory aspects of metabolic control, we're starting to see some degree of differentiation amongst our product candidates that we didn't see just looking at core classical inflammatory molecules. Okay, well, that's, I mean, honestly, just very exciting, obviously all the work you're doing in the back, and then Thanks, Chris.

Chris Howerton: Thank you. And our next question comes from the line of Joseph Stone with Cowan & Company. Your line is open.

Operator: The first one is on the atomic dermatitis programs. When we see data from 1815 and 1867 next year, can you remind us how you're thinking about moving forward in the indication? If both look good, would you move both forward, or would you make a decision before any kind of further commitment in the indication?

Simba: And then with the data from the COVID-19 studies, if this looks effective here, do you believe there's a role for 1815 and others for more information on pulmonary viral conditions, and will this be an area of focus outside of COVID if the data looks strong? Thanks, Joe. So on the first question, a strategy has always been to look at different microbes, which are differentiated in terms of, for example, in the inflammatory space, how they're driving inflammation resolution and are different in other ways, linked to manufacturing, linked to behavior in the small intestine and the gut. And that's why we're taking 1815 and 1867 forward. So they're different, but they're both very potent in resolving inflammation in preclinical models. The way we sometimes refer to it is, it's like looking at antibodies that target the same diseases but work on different mechanisms and different pathways.

Simba: And then the answer to your question is, it's going to be the devil in the details, and let's see what the data is. Obviously, if 1815 drives potent responses in atopic dermatitis, we're going to move it forward aggressively, and we'll still continue to see what happens with 1867. So we have to see the data, Joe, but at the moment, we've got somewhat of an embarrassment of riches in having two very potent anti-inflammatory agents that work on different mechanisms. So we'll see what the data reveals about that. On 18-15, if we see a response in COVID, as your question suggests, it's got very broad utility in a number of other viral infections, pulmonary and beyond, because the core driver of the theory as to why we're looking at 1815 and COVID, as you know, Joe, is to resolve the hyper-inflammation that causes progression to serious COVID-19. And that same principle of hyper-inflammation is relevant to a number of other viral infections, including influenza, for example, which is still killing significant numbers of people around the world, as you know, and in a number of other areas.

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Simba: So, absolutely, we'll look into other areas if we see positive results in COVID-19. Great, thank you very much and congratulations again. Thanks a lot, Ken. Thank you, and our next question comes from the line of Matthew Lucchini with BMO Capital Markets. Your line is open.

Operator: Hi, this is Jin speaking on Matthew's behalf. Congratulations on the progress. Just two questions for me. Could you guys provide some color on what you guys are doing in terms of the trial sites expansion? Like how many sites are being added and when they're coming along, coming online?

Jin: And does that mean there's going to be a change in the geographic makeup of the study in some way? Hi Jen, good to hear your voice. Let me step back a little bit, and I'll answer your question directly, Jim. So, you know, obviously, the world of COVID-19 is complex and unpredictable. What we've been doing to essentially set ourselves up for rapid and accelerated recruitment is exploring opening up new sites, not just in the UK but absolutely in other geographies.

Simba: And we have multiple discussions ongoing right now. As you know, this is part of a UK platform study led by Addenbrookes. We're working very closely with them, but it's their study. So I don't think it's appropriate for me to say more right now other than we are looking to expand sites. Not just in the UK but also internationally in some of the obvious areas where COVID-19 continues to be significant, and I expect we'll be able to say more in the not-too-distant future.

Jin: Got it. And my other question is, could you remind us how the Phase II psoriasis trial helped accelerate development in AD? Yeah, sure. Duncan, do you want to take that one?

Duncan: Sure. Thanks, Jim, for the question. Obviously, there are a lot of learnings that we will be able to take from the EDP1815 psoriasis program for atopic dermatitis. I think, in short, all of the safety tolerability data is very likely to just extrapolate completely across these very similar populations from that perspective. Also, the dose response data combined with our Phase 1B cohort that's currently ongoing will provide an awful lot of information about the dose as well. So we'll be able to take the safety tolerability and, in fact, dose efficacy learnings from psoriasis and apply those to atopic dermatitis.

Duncan: Got it. That's helpful. Thank you. And as a reminder, ladies and gentlemen, if you'd like to ask a question at this time, please press star and the number one on your touchtone telephone. I'm not showing any further questions.

Operator: I'll turn the call back over to the speaker for closing remarks. Thank you very much, everyone, for your continued attention to what we're doing. As you heard on today's call, this is an incredibly exciting time both in terms of the clinical readouts we're moving forward with, as well as progress in terms of advancing the platform with our extracellular vesicles, as well as progress in other areas of disease and biology. So I appreciate the continued attention to Avelo, and we look forward to keeping you updated as we go forward.

Simba: Thank you very much. Ladies and gentlemen, this does conclude the program. You may now disconnect. Thank you for participating. Everyone have a great day. [inaudible] For more information on our workshops, please visit www.ilo.org This video was made possible in partnership with The National Science Foundation This video was made possible in partnership with The National Science Foundation [inaudible] [inaudible] Music Music Music Music Music Music Music Music Music Music Music Music Music Music Music This video was made possible in partnership with The National Science Foundation www.nfc.nlm.nl www.nfc.nlm.nl www.nfc.nlm.nl www.nfc.nlm.nl www.nfc.nlm.nl www.nfc.nlm.nl www.nfc.nlm.nl [inaudible] A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by A film by, Copyright © 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.

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