Q3 2019 Earnings Call
At this time all participants are in listen only mode. There will be a question and answer session. At the end of this call. Please God bless that today's call is being recorded.
No look to turn conference over to Dr., Lu said that the Wolf head of Investor relation and corporate Communications. Please proceed.
Thank you Charlie.
Good afternoon, and thanks for joining us on todays conference call.
Oh you. This afternoon, we issued a press release, which outlines our food four to 29, chief financial results and several other topics that we plan to discuss today.
Release is available on the Investor section of our website at Www Dot.
Stops in logic, TX Dot com.
Joining me on the cool several members of some logic senior management, including me for Brennan, President and Chief Executive Officer, Richard Reese, Our new Chief Medical Officer, Scopes Levy, Chief Scientific officer aggressive below whose recently joined US adventure in Chief Financial Officer.
Equal will provide an update on recent events, Greg will briefly summarize all financial results for the quarter I'm Richard will provide more detail about how soon be 18, 91 program, which we just opened to clinical trial.
Following the prepared remarks, we'll open up the cold question.
As we begin I'd like to remind everyone that comments today may include forward looking statements made on to private Securities Litigation Reform Act at 99 coupon.
Forward looking statements include without limitation statements other than statements of historical facts regarding the potential synergies platform to develop so teachings to address a wide range diseases, including cancer inborn errors of metabolism, and inflammatory and immune disorders, the future development of synthetic biologic met.
And the approach to illustrate 'cause taking to discover and develop novel therapeutics using synthetic biology, and the expected timing of Silajdzic's clinical trials and available to keep increasing.
Actual results could differ materially from those contained in any forward looking statement as a result, various factors, including those described under the heading forward looking statements and Silajdzic's press release for movies today or under the heading risk factors. Instead logics, most recent Form 10-Q or links to filings with the actions.
So in logic cautions you not to place undue reliance on any forward looking statement now I'd like to to the color between.
Hi, good good afternoon, everyone and thank you for joining us on our quarterly update you discuss financial results for the term cautious 2019 and provide an update on our program coming milestones.
It's been a busy summer with data read that she's technical trials and the initiation of our first oncology program.
We've learned a great deal, including where we can best apply our platform and resources and they continue to be excited about the potential in the first attach a classic medicine.
Our mission is to develop new types of medicine that can address dynamic and complex diseases.
You think synthetic biology tools and techniques, we engineered non pathogenic eco language. So she was like one or more tear accusing assumptions missing or damaged in patients with disease.
And did you sell senses in response with environments, and we engineered Turkey six functions into our synthetic biologic medicines with hope you see uncontrolled, which enable them to provide the herpetic function when and where they are needed.
Equal what I need to preach currently forms the basis for our synthetic biology platform conferred specific advantages over other bacterial strain.
It has been used to that probiotic for decades and had a good safety record.
We understand had to engineer book, Turkey take any additional safety functions into its Gino and.
At combination dysfunction as needed.
Finally, it's relatively easy to grow at large quantities and we can demonstrate that it can be successfully formulated at this solid powder, while retaining viability in activity unimportant commercial consideration for certain of our southeast medicine.
In July we reported positive data from our randomized placebo controlled phase 128, clinical study and liquid formulation CNB 16 18.
Hi can be 60, 18, syntactic biotic medicine, we've engineered to consume feel now need commonly known as fee from the G. I tracked for the treatment of Pheno Keaton urea a PK you.
In Teekay, you patient, whose ability to metabolites he compromised elevated blood levels that this metabolites can lead to series cognitive impairments.
The only available on the medicine for this disease coupon results in a Turkey percent reduction Im glad to see ended 20 to Turkey presented patients with PK, you who respond.
Our goal is to develop a C oral treatment for patients with T.K. you that can be used by all patients regardless of age or disease type.
The data we disclosed in a press release and subsequently presented at an academic meeting in September .
Demonstrated that the bacteria assumption I have to start into human Gee I track.
And we could measure metabolite blood and urine.
These days had demonstrated that those engineered pathways for active and consuming fee acumen.
Based on modeling derived from the relationship of dietary feet restriction on blood fee lowering our data suggested that we hire active Jos a symbiotic see 18, we can achieve cynically relevant let's see reductions in Teekay you patients.
Prior to proceeding with an efficacy study to confirmed let's see rejection, we needed to switch from a liquid formulation, which requires storage at minus 82 was solid oral preparation that it's stable at room temperature.
We're currently evaluating the tolerability in activity up and you saw that formulation of CNB 60, 18 in a bridging study in healthy volunteers.
Which we expect to compete at the end 2019.
We were selected dose level for a phase two efficacy study of the solid formulation in T.K., you patients, which we expect to initiate into first half of 2020 .
In August we announced a topline data from our faith wouldn't be to age into custody SNB tentwenty in patients with roasted an elevated ammonia.
The data demonstrated that can be 10 tranche was well tolerated at a dose a fight by tend to do that and three times Davey.
However in contrast data obtained in standard preclinical models of high parameter media in both mice and rats.
The tentwenty treatment did not meet to lowering of blood ammonium patients.
We believe that these days I reflect on this program under difficult indication and not the platform as a whole.
They tell us.
Strain designed to work in the call on was active as evidenced by the production of the nitrate biomarker, but the mechanism Archie production did not result in lowering of ammonia in humans.
Based on the data we discontinued our student be Tentwenty program.
Our near term trend for GE IP programs will focus resources on development of soon be 16, 18, and other applications with validation biology.
As part of the process of learning about the potential up our platform through clinical trials as our first strains.
We've been building capabilities required to develop or syntactic biotic platform.
In addition to establishing the clinical and regulatory functions to carry out clinical studies.
We have developed in house profit development and manufacturing of both solid and they put presentation of our synthetic biologic medicines, which isn't able Jeff to generate clinical trial materials for ongoing trial, just seem be 16, 18, and our first oncology program Cindy 18 91.
This summer we established to correct collaboration with Gingko, Bioworks has exponentially grown our capabilities and synthetic biology, and providing access to their extensive library, a potential therapeutic jeans bio informatics and in industrial scant operation to enable the generation screening and I say of candidates.
Strains.
All of this one able us to news more rapidly to optimize and advanced the most active versions of each candidate synthetic biologic medicine in clinical trials.
This closure, we also made several appointments to support our clinical programs and our platform development.
In September I was absolutely delighted to welcome Dr., Richard we like our new Chief Medical Officer.
Richard had over 15 years of experience in the pharmaceutical industry. Most recently as VP of clinical development as an item where he led clinical development project in several areas across I'm not Adams rare disease portfolio.
Prior to that he was head of translational clinical science it into research unit at Lexia, but he was responsible for the clinical development strategy all compounds from discovery to proof of concepts.
Stepping in to take over the running a too cynical triad Richard has already made significant impact, particularly on my life.
I asked him to introduce himself and provide more information on our clinical plans for CNB 18, 91 later in this call.
We've also been fortunate to convince Micah featured she joins in logic full time and head of regulatory affairs. After a short skin to the consultant with us.
Michael is especially to the industry with more than 25 years of experience and shooting hands on preclinical and clinical regulatory strategy developments from pre Yankee application to drug approval.
Most recently he would head of regulatory Faired, Merrimack Pharmaceuticals, where he led the regulatory strategy, resulting in the proof of ONIVYDE for the treatment of metastatic pancreatic cancer.
Our recent addition to Scott's research team Dr. Diarists around who joins us as head of synthetic biology, most recently from Multifoods', but prior to that from Kiko Bioworks.
His years of synthetic biology experience to intimate knowledge of can cook capability to operations will be instrumental in helping us to strengthen our relationship with backing for partners.
Last but not leads we're lucky to be joined by Greg below the we can keep decade interim Chief financial officer, probably conducted search for a permanent replacement, Greg. It's a co founder Stanford Advisory and another investment that life Sciences industry.
He has served as CFO , a separate public and private he held companies, where he managed finance accounting corporate communications human resources I T facility legal IP and business development functions I.
I hand, the call over to hit that summarizing our financial results for the quarter. Greg. Thanks, If it's a pleasure to be here and good afternoon, everyone earlier today, we released our financial results for the third quarter ended September 32019, and I'm pleased to review those highlights of the results with you now.
Revenues in the third quarter of 2019 were <unk> point $3 million as compared to 1.8 million for the corresponding period in 2018.
The revenue for both periods is associated with our collaboration with Abbvie to develop a synthetic biotic medicine for the treatment of inflammatory bowel disease.
The decrease in revenue was primarily the result of the achievement of a 2 million dollar milestone under a September 2018 amendment to our Abbvie agreement of which 1.8 million was recognized in revenue in the quarter ended September 32018.
Total operating expenses for the third quarter of 2019 were $14.4 million compared to $13.3 million. So the same period in 2018.
For the three months ended September 32019, we reported a consolidated net loss of $13.3 million or 39 cents a share as compared to a consolidated net loss of $10.7 million or 43 cents per share for the corresponding period into.
Thousand 18.
Research and development expenses were $10.6 million for the three months ended September 32019, when compared to $9.9 million for the corresponding period in 2018.
The increase in expense was primarily due to increased clinical development costs for our CNB 161 a program.
Turning to the balance sheet send logic ended the third quarter of 2019 with cash and cash equivalents as well as short and long term investments of $138.7 million.
So based on our current operating plan, we anticipate that our existing cash and cash equivalents will fund our operations through 2021.
So in summary, we have the balance sheet strength to advance our ongoing clinical programs throughout important data readouts in 2020 and to accomplish our near and midterm goals as we continue to develop our platform and pipeline.
Thanks, I will now turn the call back FIFA.
Thanks, Greg.
Using a micro that's the basis for letting medicines provides certain additional adoption of other cell type.
As we've shown in our Cindy 16, 18 studies, we can exploit this special relationships that human have with bacteria NRG I track, where well protected from the immune system microbes have the potential to affect systemic biology.
Our second Fusin administration, we are evaluating.
Simulated by historical observation of tumor immune responses in patients with cancer and concurrent bacterial infections is the administration of bacteria interest Chew Bernie.
We are exploiting this route of administration with our first immuno oncology program.
On that note, let me hand over to Richard to provide more detail on our plans for development of Cindy 80, 91 and to give you a sense of fluctuation to synoptic Richard great.
Thanks before.
That's a great deal my career development treatments for rare diseases.
And I'm fortunate enough to have worked in a number of successful products.
Which are now helping patients in meaningful ways.
That's been larger I'm, particularly excited by the potential to develop a whole new class of drugs.
Well I synthetic biology.
Purposeful engineering of microbes.
Oh, well ultimately impact like larger patients and their families.
I'd also like a company's approach of rational design.
And the L. potential drug development principles to programs.
Finally, it is clear that's in logic is really the leader in this new field.
And is building the necessary capabilities to rapidly Trentwood this platform.
Into therapies have the potential to provide meaningful clinical benefit for patients.
It's been fun to roll up nicely you forget.
On details.
And to say that some logic as what the my expectations on excitement.
It's a bit of an understatement.
I'm also not lytro deeper carried on both jobs over these last few months.
I look forward to updating you on a PK your programs in future calls.
Today, I would like to provide more detail in our plan for soon be taking 91.
Well John for potential to help to significant proportion of patients.
Who do not respond to currently available immunotherapies.
As Lisa mentioned, we have initiated the first clinical trial to evaluate Arsone hundred I always approach immune oncology.
Soon be taking 91.
Which is designed to activate the immune system in advanced solid tumors removed from once.
Not responsive to checkpoint inhibitors.
[noise] soon be 80, 91 is an engineered strain of equal I know that produces some quick identify the amount of loss rate we're sitting here.
It pulled agonists the steering pathway, which plays a critical enrollment production.
Just one interferon.
And initiation of anti tumor responses via activation of antigen presenting cells or sbcs.
There are several key differences between our approach and others in this area.
Particularly small molecule string.
Cindy 18, 91 can be delivered directly into the tumor.
Well it remains active for several days to stimulate a local immune response.
In contrast to naked agonists, let's turn to how short half lives.
Cdrs and wonder directly into tumor resonant apc's.
When they in Gulf soon be 91, as these innate immune cells naturally sense and in Gulf bacteria.
This process, resulting in a highly efficient activation of the student pathway.
One interfere in response.
And apc's, well sparing other so apart so just T cells.
We're staying activation may be detrimental throughout the country.
We believe its longer availability and directed to whoever has unique tourist synthetic biology platform among many other approaches.
In addition for bacterial Chelsea using for larger synthetic paddick approach.
There's also able to stimulate him make immune system.
Several other mechanisms potentially adding to the magnitude.
Well the overall immune response.
These two key features staying estimation, primarily Olin apc's.
An affirmation of additional immune pathways.
I wouldn't be 80 91 in our opinion.
He truly differentiated first in class immuno oncology agent.
Let me provide an overview of our clinical plans.
The phase one clinical trial is an open label to arm dose escalation studies in patients with cutrone. If we are accessible advanced metastatic solid tumors for lymphomas.
The studies primary objectives are to evaluate the safety of intra Tumoral administration.
We couldn't be a do 91.
Now wishing her maximum tolerated dose as monotherapy in our one.
And to establish a suitable for administration in combination with a checkpoint inhibitor has a liver ma'am.
Which would be evaluated our true.
Exploratory endpoints when we put a preliminary assessment of disease response.
Appropriate for the given tumor type.
As long as valuation cellular and folks soluble pharmacodynamic response or markers in the tumor Im sure.
And dramatic from shouldn't be 80 91 of the tumor.
And our one patient cohorts will be treated with shouldn't be MP nine to one as monotherapy.
Escalating dose levels.
Patients enrolled and one may receive up to 421.
21 day cycle of soon be 80 91 monitor.
[noise] in cycle, one patients will receive an IP injection of soon be 18 91 into an eligible lesion on days, one hey in 15.
On cycle two through four patients will receive an injection at that point on day one.
So maximum tolerated dose or MTD.
Well be determined based on the fine dose limiting toxicity thresholds observed in cycle.
In our two.
Patient cohorts will begin at a time for lower dose and in our margin.
And we'll be treated with escalating doses will soon be 80 91 in combination with a fixed dose of a total Windsor ma'am.
Until the recommended phase two dose for the combination regimen is determined.
It was 11 amount will be administered on day, one or Beecher for plan cycles.
One two phase two dose burned to its determine.
Up to 20 additional patients may be a broadening our core.
I would characterize the safety profile shouldn't be a 91 in combination with a total works ma'am.
We will pause further details on clinical trials on.
Earlier this summer we announced her Pf Gary has cleared our R&D.
An earlier this month, we initiated our first line.
And are working hard to get several more sites online this year.
Well, it's too early to provide more specific timing.
We expect to have monotherapy data in 2020.
And well update as we get a better understanding.
[laughter] as already for enrollment into the site.
Thank you.
Let me turn the call back to Eva Thanks, Richard.
Well, that's an exciting stage in the complete development with two programs in clinical trials that represent very different clinical applications Everest in tech basket cap form.
Cindy 60, Eighteensix treatment to PK, you would see ministered at the solid oral product and Cindy 18, 91, our first immuno oncology program, which is administered by into tumor injection.
The two synthetic biologic medicines will continue to teach us about the strength of our platform and provide very different opportunities from a clinical development and visits perspective.
At this stage before people love to partner programs, where appropriate, particularly as partnerships provide necessary capabilities for developments, allowing us to focus on developing our platform and pipeline of wholly owned programs.
With approximately 139 million in cash and investments ended the third quarter, we haven't started financial sufficient to execute on our conductivity through 2021.
In the year ahead, we believe that we will gain additional insights into the potential if I program to treat human disease, and the promise of our platform across additional metabolic and oncology indications.
Look forward to updating you on our progress and future plans as we compete in Vsixty 18 bridging study at the end of 29 team.
In the new year, we also expect to provide more detail and how we feel engaging kinko's capabilities and the future development the pipeline as we advance several new programs.
I'd like to thank you all for joining US. This afternoon, we will now open the call for questions.
[noise] leasing did something if you had the question at this time. Please proceed as far the number one key on your Touchstone told US soon if your question has been answered all you wish to remove yourself from the Q Chris town keep our first question comes from the line Joseph Schwartz with SBB Leerink Your line smelting.
Hi, I'm jury park dialing in for Joseph Schwartz. Thank you for taking your questions.
My first question has to do with NBC.
I mean I'm for your bridging study in healthy volunteers I know the goal is to establish the maximum tolerated dose that was just wondering if you could please remind us <unk> like the number volunteers you have and what you remeasuring. The Biomarkers you will be looking for and how you will be analyzing the data and maybe if we could put into context by letting us know what.
You're hoping to see that would indicate that you could reach her target profile, a few lowering of 30% that would be very helpful.
Great. Thanks, so much jury asked the question so as I mentioned on prior calls the objectives that the breaching steadier, leading to a threefold firstly to identify the maximum tolerated dose of the solid oral formulation and because that's the kind of formulation that we think is commercially viable for later stages of development and feel free.
We will enroll cohorts of SK escalating doses and the courts will be eight patients per cohort six active in two placebo and will we will measure the same biomarkers that we measured in our prior phase. One study, we think that those biomarkers are at the appropriate ones to measure in vivo activity and we are able to device.
Nice precise assays that we taught us a loss in.
Good to study the liquid formulation. So we'll continue to kind of metric TCAM ha using the trace start that we used in phase one because we think we have a nice informative biomarker strategy. So that's kinda first objective.
The second objective was to really understand how we could.
And I stop ish, a first dose effect that was going to be favorable for patients and as you know with them and when we announce data from the prior study, but we observed with that there was some nausea and vomiting appeared to occur right around the time to the first dose that was you know easy worse on the first day in patients continued with dosing.
It got fashion threat to dosing period that needs to be obvious question well what happens if you do it don't ramp where you gave lower doses and then gradually ramp up to the dose that you think you need to second objective of the study is going to be evaluating a dose ramp and the impact of kind of starting low and escalating the dose on on the Tolerability profile.
And then to turn objective, which we inform how we think it back formulation of a product for nature phases of development options might be available to us it to really understand the need for buffering and the impact of of ph on day activity of the product and that's kind of to the current objective. So we anticipate.
Having data from all three objectives I think all three are important as we think about setting ourselves up for success in subsequent phases of development and as soon as we think we have an answer and all three funds will be providing an update to the investment community.
Anything else Richard that you'd like to add there in terms of but I've outlined today to jury known all I think Uh huh.
Pretty clearly stated TV.
Goals.
Great Okay.
Does that answer your question Julia any follow on questions. There Yeah. That's very helpful. And then in your press release or I guess, sorry in your prepared remark I saw that this study will be completed by year end 19, I was just wondering if we could expect that data you'd be could just provide some more clarity on that because.
Like the data by year end as well or does that mean, you have to do analysis and that it's more likely to be like early 2020, because you plan to initiate your face PQ patients and what have 20.
Yes, I think either way, we feel we'll be able to meet that guidance rent initiating the phase two study and the study will be complete the ended the year. So it's hard for us to sometimes some things are coming in you're relying on external labs to analyze samples we team Thanksgiving and Christmas I feel Dod providing guidance for right now should the controlled fees I find it so close to holiday.
The time, it's really hard for us to call you know a single sample that needs to be repeated could push us into the you know the first quarter next year. So we'll be in the next couple of months I can say I think cast as something that hopefully I don't have to to dial back at a laser pointer.
But you know we're hopeful to get it hasn't got to study pieces in possible because we feel that getting into the PK patients again and demonstrating fee lowering its really going to be important for the program. So we want to make sure that we make progress quickly towards that goal.
Okay, great. Thank you at the my next question has to do with manufacturing I know you put a lot of NRG and thought into developing or second generation oral solid or formulation and I was just wondering are there additional updates you foresee implementing of in your future to either increase the potency or allow for better Tolerability <unk>.
It was higher and how those changes could be implemented entered into your trial do you have to do additional you know bridging studies to introduce new updates or is there an easier way to introduce the updates and stuff like clinic.
Yeah. So I think there a couple of as you know with the new platform company and with any program, we're going to be constantly evolving the platform and looking at better ways of doing things I think the changes fall into two buckets for me number one is formulation right now we're in this powder, we're looking at what that's going to look like eventually the commercial.
Presentation across you know our aim for this program is to have something an offering from year to year old too.
So it's possible that there'll be different presentations and formulations across that kind of.
And end users based on just the characteristics of that population. So for sure. We'll continue to scale up manufacturing and to get higher scale. It's as we move forward into later phases of development to do bigger tries and commit prepare for commercialization.
We'll continue to do you think the increase Kennedy quote unquote yields of the manufacturing that continue to look at formulation changes that will help us kind of and be more patient centric and provide option to patients in terms of what the product actually looks like at the end of the day.
I think the second bucket of changes will be things that we do to leverage our gingko partnership and I think I discussed when it seems that was really exciting to me when we established ticking a partnership it when we have biology and when we think that we have a product where we can really make a difference for patients being able to leverage through pushing the optimization inco can bring to.
They are on the genetics I think it's a really key driver for me off.
Establishing that partnership so we start to work on pipeline programs that will feed on future development programs and we've also started work on thinking ramp backup for programs that we think are really exciting like the PK program. So we're hoping to show some kind of data around how were thinking it bypassing the early part.
Next year, it's me alluded to in the script and we'll be providing you with some updates there but.
We think we have a really interesting.
Potential opportunity for patients with PK you. We think we have biomarkers that Ari informing us that were on the right path. We're hoping to update did that 16 18 product gets there, but we're also in parallel working on them Nexgen program seizing to the tool kit that we got access to with income.
Okay, great. Thank you that's very helpful I'll hop back into queue. Thanks.
Thanks Terry.
Your next question comes from the line that people much a mobile with Citi. Your line is now open.
Hi, This is the math odd for your call today, Thanks, very much for taking my question.
You mentioned that the the 18 anyone studies grinding they're looking at solid tumors and solve us, but I wonder is that going to be all commerce or having their down specific tumor types that you expect general.
Yeah. That's a great question, maybe I'll hand that went over to richer it's too.
To address the specific inclusion exclusion criteria.
Sure.
French would be all commerce book will have to a fail.
Conventional treatment, including checkpoint inhibitors.
And then we'll be solid tumors.
Infomercial.
Traditional phase one.
Cutaneous.
Traditional phase one criteria were you're here or there.
Forget protector Farrell.
Correct and its GTC accessible tumors as well some month as another criterion. So we're not enrolling patients with deep visceral tumors. There has to be at least one cutaneous T accessible tumor that can be injected to end to qualify for that study.
Got it and that kind of gets to my follow up question.
How big is there any conclusions on the defies the diameter Timur as well as cutaneous location you just mentioned.
At my I'm trying to we oppose the thing now what we're talking and my understanding is they have to meet the criteria of measurable per the resist criteria, which I believe he is one centimeters once I wish I knew it does is the minimum area. The injectable tumor has to be a minimum side to enable but the volume of injections very very small us about.
Not going to be limitation, the inclusion of the injectable tomorrows meaty based on the measurable criteria per week.
Yeah, rather listen our resist and lyric, yes, so depending on the tumor type.
Got it so theres no upper bound to the size that with the met and question.
Correct, Yes, yes, there's no offer bombed.
Yes, as we've said visceral tumors or where it will not be included.
Or tumors close to.
Yes arteries or other.
Nerves.
Be excluded also.
Got it that makes sense and then.
Steve You mentioned that perhaps you could clarify the injection will go into the same location for each dose or will you be I mean, I guess as the tumor maybe you respond well you'd be change you know location that go with that response.
Correct. So the first we choose an injectable lesion so long as it meets the criteria for being an injectable lesion. Each visit we will continue to use the same lesion, but we have built in flexibility that at that tumor regressions, obviously, we sell dashing our preclinical work in in our preclinical tox that we get tumor regressions if that has.
And in the tenant with the primary vision ended criterion protocol that the investigation can choose second tumor that meets the criteria injectable. If they don't say patients don't have the second tumor that meets the criteria for injectable think would continue with the monitoring phases of the study or with the checkpoint inhibitor, depending on each arm of the trial.
They're in does that make sense.
Yes that makes perfect sense. Thank you very much for taking my question.
My pleasure.
Your next question comes from the line rather than sell direct to H.C. Wainwright. Your line is now open.
Hi, This is bolland dialing in for Raman Thanks for taking my question.
I just wanted to talk to a little bit about 16, 18, and its clinical development cost maybe you can tell those little bit about how much is the next stage of clinical development for 16 18 likely to cost on what form. It is a slated to take maybe you can also oh elaborate a little bit on your learnings from from your biomarker modeling work into this program.
Yes, so I think as a financial partner to the Copart to that question I, maybe ask Greg to address the finance apart in terms of the impact on the runway and Denville will address the modeling questions separately that works, okay, sure and and not to make anyone's life difficult in terms of very much.
Those but it's not our approach.
Our practice to give guidance specifically to programs.
As you know there are.
General cost that we sign when we look at a CR Rowan there'll be some variation around them a specifically what our financial guidance is and will continue to be is that we have cash on the balance sheet sufficient to support not only 16, 18, but 18 91 as well as our other initiatives new programs platform development.
Through 2021.
I think just to jump to the second part to the question and just to Echo you know Gregg said, you know with feast didn't we'd need rare diseases are interesting ones for us is as well as the patient need and the unmet needs and generally try fights in development costs tend to be under on the lower end.
In terms of the question for the modeling what we've shown and jumping on to kick us off and then jump in with Richard add any details I overlooked by what we know it that the bacteria consuming team landing in the G. I tracked him rates measure that consumption. If you assume that one mole seen lounging consumed by bacteria.
It's the same as one mold fee lounging excluded from the diet as a piece with PK you you can start to make a nice relationship between the activity of the bacteria and impact on Black sea lowering.
So thats kind of the underlying assumption to all of our modeling and that's kind of what we're basing our decision criteria on as we think about you know how good this needs to be to move to the next phase of development.
So Richard anything you want to add there in terms, how we think about modeling and yeah. I know I think yeah, I mean, that's exactly right or goal here.
If you use the modeling to helpless predict.
You know or how much could fortune will take time.
To affect fee levels in the Sherman and there are nextera energy or next.
He is to show free lowering.
Next year as as we move on into the next study.
Does that answer your question.
Yeah, absolutely on the Oh I'd be collaboration is pretty intriguing might we see any lead candidates to be formula designated or advanced into clinical studies and 2020 maybe.
Yeah were and.
Because I'd be it the decision maker, we all think Threed interesting collaboration spina great win for US continues to be very healthy multiple targets. Obviously in that collaboration that we are unable to disclose and also you know our progress we'll be able to disclose when we achieved milestones, but other than that I'm afraid it remains at low pay so.
Got it going well is I think all we can we can say jade.
Okay, Great I think I might not actually for the next one. So this is in regards to gingko by awards. So maybe you can.
<unk> about five you on this collaboration and maybe what kind of therapeutic area, you're working on any lead candidates that would be disclosed from this initiative.
Yes, so the gingko collaboration is a really great one for us because it allows us to access stays at the RF content biology infrastructure and capabilities that would be very challenging for us to build internally the company if our side it automation its high throughput it all up there kind of I T engage management infrastructure.
We say about the collaboration that where the architects under the builders. So if we have a the idea for strain comes from US because we believe we kinda understand the biology into diseases, we tend to pursue we'll come up with an idea about frequency lumpy design strain to consume feeling we think this unmet need and PK you would could be a good opportunity for our platform.
We work with our gingko partner to think about all the various enzymes and pathway that exist within the microbial world that consume penile name, we will initiate technical development plan together for a we assigned specific performance criteria of swap that need to achieve based on our understanding of disease allergy and translation they.
They will screen multiple genes come up but some small test candidate for us to test and we'll continue to his racing in that way.
I think it as he mentioned on the call we haven't spoken about the specific data yet, but early in the new year will provide more visibility to specifically, but we're working on with gingko, but so far it's been a great working relationship that we've really enjoyed kind of getting up to speed and starting to work with them.
Scott I know, you're leading a lot of the work is there anything there that you'd like to add to what you said, yes.
I guess I just wanted to make the point that this is by no means a CR ROE type relationship and the interactions and collaborations is really bi directional and.
We.
We value their intellectual input into the projects very very much and.
I just had a very high level, we've had conversations where we propose an application and they have knowledge of that particular pathway that may be relevant to this application from some of that the work they've done a industrial application in the past so it's.
It really expands our intellectual bandwidth as well.
Okay. That's great for me thanks, so much.
My pleasure.
Your next question comes from the line Mark Freedom back with Oppenheimer. Your line is now open.
Okay. My question I, just got one on on its related to the new solid formulation for 16 18.
I'm trying to get a sense for for the kinetics.
Animation would be for it for these lyophilized bacteria and if thats compatible with your expected transit time of the bacteria through the G. I tried I mean, if we're trying to keep them all in small intestine do we have to worry about some sort of delay or like before they would wake up.
There are lot outflows state.
Come on that thank you.
Yes, absolutely.
Bacteria are pretty intriguing to me, but they're pretty amazing they never cease to amaze in terms of the speed of how they had they come back to life seem to the bacteria double equal like double every 20 minutes. So everything is on them, but shorter time scale compared to kind of human minutes and human years.
We have shared some days on the lie Oh in any hps and in my showing that the pro find in terms of the kinetic is super imposed a bomb the liquids. So in those models, it's been very rapid and it appears to function in vivo very similar to the liquid product with no lag required for close on code kind of waking up.
And we will measured led TCPA into breaching steady so we'll be able to share similar types of data with you from humans, but based on everything we've seen so far in both the IBSD system and in some of the pre clinical models, you lie appears to be and interchangeable with the liquid.
Product is that fair to say, yes.
Bob out exactly.
Alright, thanks for clarifying and thanks for taking the questions.
Thanks Mark.
Your next question comes from the like Ted Tenthoff with Piper Jaffray. Your line is now open.
Great. Thank you very well hold to come from.
I was wondering.
Her worker.
Yes.
Everything else, maybe jumps out either in addition to PD one PDL one.
Targets for potential combination for example, Sterne Agee. Thank you.
Yeah. That's that's a great question, Chris Youve the benefits of being asked at 50 I was only following along on Twitter. So [laughter] I didnt get much. It did the real time. So I think you know some and things ISO certainly looking across the spectrum of all of the data that we shared there was certainly a lot of intriguing support for nation.
Activation in the nation unanimous in in cancer, and I think some pretty nice stays in terms of responders across kind of various programs and approaches Tunis immune activation I felt that there was some really nice data for intra tumoral approaches that may overcome some of the hesitancy that's been there to days with with.
T routes of administration I think both of those things increase my conviction in CNB 18 91.
I think the final parts of your question is really around kind of combinations and is there a no the way to think about needs immune activation other than the kind of traditional elusive monotherapy and combination with checkpoint inhibitors and I certainly some intriguing days at that combination with for instance, radiotherapy chemotherapy.
And you know it has given us food for talked I think it's too early to say that anything is active and into hopper, yet, but certainly I think some provocative data that permit we may actually has and further ability to differentiate and can.
We have had some interesting conversations with oncologists and around that but well also continue ideas that said that you have 10 I know you.
That's very closely.
Well I have another quick question cubicles took a thinking about.
For a more garden workers and influencing Cardinal fall on the device side that they make access through this role in Israel.
Okay.
Something that too.
Injections. Thanks.
Yeah, I think that's another great question my belief is that there's no tumor the body thats not accessible with interventional radiology, but our initial studies going to be limited to cutaneous key accessible tumor that's really just because we can monitor safety local information more easily than you kind of its something that seek visceral tumor I think look to below their programs like the reps.
The new data and it was an oncolytic virus given into too many deigned to did a really broad set of tumors from you very deep VIX rhodesians two cutaneous accessible one so I really don't see that theres, an impediment from a ability to accept these tumors with the right interventional radiology and especially centers.
I think devices Theres. Some really nice went that there were like Quadras Hughes and some of those that helped in terms of distribution within tumors that we havent evaluated yet, but certainly we continue to have talks with investigators and radiologists to really work at Fox to best approach of accessing some with these tumors, but so far the.
Feedback that we've received is that radiology guidance sweetie enables pretty much any tumor to be to be access.
Wrapping up going like intracranial, but certainly any mr. older or soft tissue team, but can be accessed it.
You want to say something yes, certainly we've also spoken to many investigators who would be interested in endoscopic bronchus Scopic assistance Scopic administration of.
Of.
Ascend biotic as well so I think the future possibilities in terms of moving away.
Solely from an IP approach is something we're really interested in doing.
Great makes a lot of a sense and Arbor Realty kirker compare more progress over the.
Listen programs as well so thanks for taking the current Tonight.
Again, ladies and gentlemen, if you have a question at this time. Please press Star then the number one key on your Touchtone Tolson. Your next question comes from the lineup Tom Shrader, we'd be TRG. Your line is now open.
Hey, this is Julian off for Tom Thanks for taking my questions. Just have a couple on 18 on your one first and dose escalation or are you keeping the amount of sting agonist or decade copies per bacteria generally constant.
Here is how strong of a dollar you have on this and if you're keeping a constant in your phase. One can you briefly talk about how you arrived at the current cost strict currently being tested.
Yes, sure. So so I'll answer that and in terms of we and the dose escalation will be and in comedy formally farming units are lifestyles and because we integrate within the genome. It's not expressed on a plasma so and that's pretty constant per lives. Every lives. So we'll have the same genetics essentially so were.
Able to escalate just based on the number of life sales across the cohorts. So it's a little difference to may be some of the other viral vectors another and bacterial vectors for gene therapy that you may coverage Julien, we really integrate says that we have good control over the quote unquote potency and we measure dose based on the number of a glide.
Cells and so that's kind of how we have we seen thinking about that does that does that answer your question.
It does thanks, that's helpful. And then for my second question I was just wondering if you could talk about any biomarkers that are uniquely indicative of thing pathway engagement and will you be collecting data on any of these in the monotherapy surgery a phase one.
Yeah, Great question on my hand, you over to Scott who to onto that when fee Julien Yeah, we'll be doing.
Biopsies and fine needle aspiration, pretreatment and that day and we have a.
Biomarker analysis, which will include Q PCR and Nanostring, what we're really interested in looking for is the.
Immediate downstream targets, such thing activation, which is going to be type one interferon production signatures.
In that pathway and.
We are.
Believe we have an idea on what fold elevations, we're going to want to see both from our preclinical modeling and.
Some of the word from other Sting agonist that had been done in humans in the field. So.
We'll have a biomarker plan that will hopefully be able to help us.
Demonstrate target in engagements in the context that this study and.
I would be remiss, if I didnt remind everyone that this is a phase one study and ultimately the primary endpoint is safety here.
Great Yeah. Good. Good addition, Scott Thanks for that reminder.
Thanks, very much appreciate the color.
Thanks Julien.
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Thank you Charlie we'd like to thank you for joining us on today's call them. We look forward to updating you on progress across our developing pipeline in the coming months will be available. Later today is there any follow up question good night.
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