Q4 2019 Earnings Call
[music].
Greetings and welcome to the Q Biopharma fourth quarter and fiscal year 2019 earnings call. At this time, all participants are in listen only mode.
A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press Star Zero honor telephone keypad as a reminder, this conference is being recorded.
I would now like turn the conference over to our hosts.
Actually Robinson of Investor Relations. Thank you may begin.
Thanks, Diego and good afternoon, everyone. Thank you for joining us on today's investor and analyst update call.
Joining me on the call today, or Dan Siri, Q, Biopharma CEO Dr., New series, President and Chief Scientific Officer, Dr., Ken <unk>, acting Chief Medical Officer, and carry out until our Vice President Finance and principal accounting and Finance officer before we begin I would like to remind you that during today's call the company will be make.
Forward looking statements various remarks at the company makes during this call about the company's future expectations plans and prospects constitute forward looking statements for purposes of the private Securities Litigation Reform Act of 1995 actual resorts results may vary a different differ materially from those indicated by these forward looking.
Statements as it relates <unk> as a result, various important factors, including those discussed and the risk factor section of the company's annual form 10-K report filed with the FCC on March 12, 2020, as well as other filings made by the company to the FCC from time to time, which can be accessed on the Edgar database at Www ASCII.
<unk> Dot Gov.
Addition, any forward looking statements.
Represents the company's views only as of today March 17th 2020, and should not be relied upon as representing the company's views as of any subsequent date well the company may elect to update these forward looking statements and there any at some future point the company's specifically disclaims any obligation to do so even if the companies use change.
These forward looking statements should not be relied upon as representing the company's views as of any state subsequent to today.
Be advised that today's call is being recorded and webcast I would like now like to turn the call over to Q Biopharma CEO dampen Siri Dan.
Yeah, Thanks, Ashley and good afternoon, everyone and thanks for joining us for a review of our progress in recent accomplishments [laughter] Oh, we hope everyone joining us on how the call today is safe and well during these challenging times with Corona <unk> Corona virus situation.
As a reminder, there is a slide deck that accompanies this call, which is directly control by those listening and we will remind you of which slide were on as we as we proceed.
The slides were presenting today as well as a recording of our call will be available on our website for the next 90 days also the Q senior management team will be available via email provided on our website for questions not addressed during today's call.
Slide three shows our agenda for the call today.
I will first provide an overview and update of our key accomplishments and will be followed by Dr., Ken P. After our acting Chief Medical Officer, Who'll provide additional details and status update our ongoing phase one Q O one.
Monotherapy dose escalation in expansion study in advanced or metastatic human papilloma virus or HPV positive head and neck cancer.
Following dR.P. Atas update Dr., a knee surgery, our president and Chief Scientific Officer will further described the progress of our platform conveys a competitive differentiation of our I O L. Two based Q1 hundred series and highlight our pipeline, including Q1 or two K. Ras.
Yes that.
As well as the Q2 hundred and Q3 hundred programs ladder in a collaborative partnership with Merck.
Our progress with all of these programs highlights focused execution towards platform validation, especially through the ongoing phase one trial with Q1 on one.
Following the nation's update carry animal our Q Biopharmas principal accounting and financial Officer will review, our current financial status and I'll, then provide concluding remarks, followed by a Q in a session.
On slide four.
We show the current state of our evolving pipeline [laughter]. Our lead Q1 hundred series is designed to selectively did deliver in engineered I L. Two directly to tumor specific T cells, thereby avoiding systemic activation and aisle to related toxicities.
The modularity of this series allows us to target diverse tumors by utilizing different epitopes as well as distinct HL eylea else to explain expanded global patient reach.
Our lead program within the Q1 hundred series is Q1 all one.
It addresses a significant unmet medical need and human papilloma virus, or HPV, driven driven apathy helio cancers, such as head and neck squamous cell carcinoma.
Despite recent gains made by adoptive cell therapies and checkpoint inhibitors new approaches in this field are needed that are not constrained by the challenges in deficiencies presented by current modalities.
We believe our immune to step platform provides the key advantages of ready to use off the shelf biologics for selective and controlled modulation of targeted.
Disease relevant T cells directly in the patient's own body.
Without the need for ex vivo expansion or manipulation.
As previously mentioned Ken will provide further details regarding the progress of clinical development for this promising program.
In addition to Q1 on one we're developing Q1 or two which incorporates the willms tumor one or WT, one T cell epitope target WT, one expressing solid in hematological cancers in patients expressing a chile able to or a 24, the latter being highly.
He represented an Asian populations.
We will define the target of Q1 or three in the near future [noise].
Excuse me.
I see Q1 hundred series Weve also establish the Q2 hundred series focused on cell surface signaling module, such as C D or full one bbl, which is in early discovery stages for treating chronic infectious diseases.
The application of Immunostatus in chronic infectious diseases is presently being evaluated by our collaborators at the Albert Einstein College of Medicine.
In addition to these programs we've made a promising progress with our Q3 hundred series focused on modulation of Cdfour T cells in the auto immune diseases. As a reminder, this is the focus of our collaboration with Merck, who recently presented data from this important program at the antigen specific immune.
Tolerance drug development summit in February of this year.
His presentation may be found on our web under presentations in events located yeah. It within the investors in media section of our website.
A nice will elaborate upon these various programs later.
During the call, but now I'd like to briefly highlight some of our important accomplishments.
[noise] core to our strategic execution was the initiation of dosing in September of 2019 for our first clinical study in patients with our lead program Q1 O. One which is exemplary of our aisle to based Q1 hundred series. This study is the first.
Is I'm sorry. This study is in a post first line patients with advanced metastatic HPV positive head and neck cancer.
As of today, we're proud to announce that we have fully enrolled cohorts one into.
And have dose the first two patients for cohort three with a third patient dosing anticipating in the coming week.
To date Q1 on one has been very well tolerated with several patients having gone through multiple dosing cycles and again, Ken will provide further details in a moment.
I'm also pleased to share that we recently published a manuscript in a pair of review journal of clinical cancer research detailing our preclinical research data for Q1 O. One underscoring the mechanistic biology, along with supporting Nvvault and in vitro analyses, which provides confidence and support for.
Progressing this molecule.
For those interested the article are can be found on our website with the U.R.L. embedded within the press release announcing the publication, which was a dated January 21st 2020.
Before I hand, the call over to can I'd like to thank and congratulate our development research teams for reaching these important milestones. In addition, we also anticipate that our preclinical work with Q1 out too and partnership with LG Chem and our auto immune collaboration with Merck a with the Q3 hundred series.
I will begin to demonstrate the potential breadth and scope of our platform technology across cancers in auto immune diseases.
Ken will now provide further details regarding our ongoing Q1 O one clinical trial can.
Since then and good afternoon, everyone I'd like to first again when the commentary on slide five regarding the quality of the 13 participating clinical centers and associated oncologists were very honored and humbled to have such a premier group of participating oncologist working with us to assess the.
Potential in Q1 on one for Indra addressing depressing unmet need of patients suffering from HPV, driven head and neck cancer.
Investigators enthusiasm for the Q1 on one concept is reflected in the fact that today, we have had over 80 patients participating in our pre screening process to determine their eligibility for the trial.
Recognizing that current therapies are not or are rarely curative, we put into place the system whereby patients on first line or second line therapy for HPV, driven head and neck cancer, our pre screen, but it's still fairly tight and confirmatory HCV status to determine.
Eligibility for future Q1 on one therapy.
The demonstrated demand of patients.
For pre screening underscores the significant unmet medical need in this indication.
Next on slide six it's a high level summary of the design of our ongoing phase one trial of Q1 on one.
As Dan mentioned, we're very pleased with our progress of dosing patients in this trial and our highly encouraged by observations today.
As a reminder, at the current trial as a monotherapy dose escalation study with a translational precision medicine approach designed to provide insights into safety mechanistic activity and potential anti tumor efficacy.
We are enrolling post first line patients with recurrent or metastatic head and neck squamous cell carcinoma, driven by HCV, specifically HPV 16.
This represents approximately 70% of all head and neck cancer is occurring in the hour Oropharyngeal region.
Accounting for an estimated 13500 patients annually in the U.S. alone.
This phase one trial is defined molecular inclusion criteria to clear include a head and neck cancer patients that are each el Nio to a one positive.
Tumors are confirmed to be driven by HPV 16.
Through the specific inclusion criteria, we're ensuring that only patients with the potential for clinical benefit are enrolled and treated.
Only signify signifying a precision medicine approach whereby each of our immuno stat drug candidates isn't tenant for patients with a specific molecular fingerprint.
[noise] patients receive Q1 on one once every three weeks via Ivy infusion unless there is in disease progression as evidenced via scan patients are scanned. Once every six weeks or every two cycles to evaluate tumor status.
The trial is a standard two parts study with the first part eight designed as a standard three by three monotherapy dose escalation. However, we've also provided the opportunity to dose up to nine patients in any given cohort, where we see evidence of clinical activity or P.D. effect.
This strategy allows us to further explore PK PD effects as well as well as bill supporting data for determining the most appropriate dose for the part B expansion.
Based on the escalation phase safety Pee Dee Ann efficacy data, we will accrue additional patients at that dose level. During the part b expansion phase to confirm the recommended phase two dose and a total of 20 patients.
Therefore in summary, both parts, a and B if the trial will evaluate the safety and Tolerability of Q1 on one.
Biologic activity and anti tumor response is also being followed.
Expansion cohort is designed to confirm the safety biologic activity in anti tumor activity at the effective dose in additional patients to provide further support and confidence as we move into later phases with more patients.
To evaluate on target activity, we're measuring several translational biomarker.
For the T cell expansion in blood and cytokine production by measuring antigen specific T cells.
Our anti tumor activity, we're looking for objective responses by resist criteria at six week intervals or after every two cycles of Q1 on one.
I'm very pleased to report that after initiating dosing cohort one in late September last year, we successfully moved forward and begin dosing cohort two in December and then initiated enrollment of cohort three over the past week.
We'd like to remind you that we started dosing cohort one and what we believe should be a low biologically active dose based on our preclinical modeling based on this modeling we believe that a clinically active dose may be achieved starting cohorts three or four.
Notably today, the six patients in cohorts wanting to have received a total of 14 infusions of Q1 on one three weeks apart with no evidence of cytokine release syndrome.
Also of note at the second cohort the moeller equivalent of while two in Q1 on one is calculated to be slightly higher than the mall, where equivalent of the approved dose of Proleukin, which is the wild type aisle to molecule.
As of today, one patient cohort, one and two patients in cohort to continue to be does as well as those that have recently been dose cohort three.
We are highly encouraged by our early progress and observations, including early evidence suggestive of biologic activity.
The it anecdotal and highly preliminary.
We are presently on schedule to evaluate the first thing TAPV results for cohorts wanting to in early Q2.
In addition to the ongoing monotherapy trial to one or one in HPV positive head and neck cancer. We show on slide seven that we are planning to initiate a concurrent study to evaluate Q1 on one in combination with an anti PD one antibody as frontline therapy for the same.
Indication in patients who are in shallow to a one positive.
Our intention is to continue moving forward with the monotherapy trial for post first line HPV positive refractory ore head metastatic head and neck cancer patients.
Enhance our patient reach by moving into first line patients in combination with Pembrolizumab were Keytruda, which is the current standard of care.
This is Ken combination study enables access the first line metastatic HPV positive head neck cancer patients to potentially enhance therapeutic benefit of anti PD one therapy.
We intend to commence this trial in Q3 or Q4 once we've confirmed the safety of Q1 on one in the phase one trial.
Furthermore, slide seven also shows that we have the option of evaluating Q1 on one in the neoadjuvant setting and patience newly diagnosed with localized head neck cancer.
And finally once we have established clinical proof of concept for Q1 on one head and neck squamous cell carcinoma, we may expand opportunistically into other age featuring PV HPV drain cancers for example, cervical cancer.
Before I hand, the phone overturned nish I want to acknowledge that Covance then the covert 19 crisis is straining health systems across the country.
Cancer centers are actively prioritizing patients.
As an active clinical investigator at Johns Hopkins myself I'm, taking part in these discussions as plans evolve dynamically.
I'm also having discussions with our principal investigators across the country daily to determine how each academic center is reacting and involving plan.
Today, we remain on track and anticipate no negative.
Pat.
Q1 on one is currently classified as a tier one important treatment and our patients are being prioritized for therapy.
Well this could change is the crisis unfolds, which could potentially slow our accrual our investigators remain optimistic that Q1 on one patients will remain a priority for accrual and treatment. In addition, we're also working with our sites to allow more flexibility in seeing patients with some.
Visits potentially being done by phone to minimize Cobiz 19 exposure.
I'll hand, the call over to a nice to discuss the other advances in our pipeline and platform.
Oh, Thanks, Ken and thank you to everyone listening and I'd like to begin here, what slide eight to reemphasize. The molecular framework of the Q1 hundred series. The two key signals on the Q1 hundred series consist of stabilized peptide age lay molecules to engage tumor specific T cells and rationally engine.
What I have two molecules that selectively add upon those T cells. The top down view of the ribbon diagram of the Q1 hundred series as shown here provides a good contextual perspective for the spatial engagement by T cells.
Two notable modifications to the I have two molecule are important for the specificity and selectivity. The first abrogated binding to the two receptor alpha sub unit to minimize effects on T regs, well regulatory T cells and the second reduced binding to the IMO two receptor beta sub unit such that the I have two activity.
He is most evident only when the antigen specific T cells adult to the specific peptide age late complex.
We believe this framework has important ramifications on the ensuing biological T cell response in the patient that as it maintained specificity and selectivity, while avoiding the systemic toxicity associated with indiscriminate I have two dependent activation of many different cell types slide nine exempt.
Defies, what we believed to be the superior differentiation between our I O. Two based Q1 hundred series and other trial to modalities.
As shown in the slide a different T cells upsets in the broad expression of the I'll do receptor sub units.
T Regs constituency expressed the highest affinity I have two receptor composed of the three sub units Alpha beta and gamma while most of the T. Effector cells expressed the odd to receptor beta and got most of units as shown in the left panel wild type aisle too, which is an approved drug is a potent activator of all team.
So this results in not only the dose limiting toxicities, but also enhances expansion of immunosuppressive T regs that I detrimental to the anti tumor immune response. Moreover, indiscriminate activation of the polyclonal effector T cell repertoire is not desirable since the boss numbers of these details have no relevance.
Well specificity for tumor antigens.
And that is an assumption we have to make the patients have prime Tonight that human T cell repertoire, then they could perhaps gain some benefit from the systemic therapy. This is the likely case with the minority of patient that can tolerate aisle to an exhibit clinical responses.
The middle battled here depicts the not alpha aisle to variance being developed by a number of pharmaceutical and biotech companies with the objective of only stimulating effector T cells and not T. Rex. However, the challenge here again is that the not alpha aisle to Varians would act indiscriminately upon all effector T cell.
What did the majority of these T cells are not directed towards the tumor. Moreover, we have to make the assumption that the patient must have a pre primed and expanded antitumor T cell repertoire to gain meaningful benefit in contrast that right banner highlights the Q1 hundred series, but in the I'll do is selectively focused on the tumor specific.
T cells and because of that rational engineering. The I'll do component has little to no effect on T regs or irrelevant Lorne Kumer effector T cells.
The core molecular structure possesses the key signals needed to prime and expand the right T cells, especially in patients where such populations will not optimal expand this allows us to address several key aspects of a desirable antitumor T cell response, one the ability to focus I'll do or the T cells that matter.
To enable priming, an activation of the desirable T cells and three accomplish all of the above while not compromising patient safety.
Slide 10 highlights our immuno oncology development strategy to exploit the fullest potential of the Q1 hundred framework Q1 to one provides us with the foundational proof of concept in an indication of unmet medical need.
Furthermore, Q1 to one is positioned to potentially de risk the Io to based Q1 hundred series as noted before it key strength of the immunoassay platform as modularity and flexibility that allows us to target different tumor antigens, along with distinct a Chile ilias for global patient populations.
This is evident from a current ongoing work with Q1 O two and beyond where we have focused on tumor antigens like Williams deal, one or WT, one NK RASK and have initiated programs with additional ilias. Besides age related to these include actually a 24 and a 11 both being down.
Permanent in Asia, which was the primary impetus for a LG Chem partnership for the first three programs. We've made strong progress with our Q1 or two programs and have generated pilot data demonstrating ex vivo expansion of human T cells. These data would expect accepted for presentation at the Keystone advances.
In cancer immunotherapy meeting in March and at a CR in April Unfortunately in light of the current Corona virus situation. Both these meetings have been canceled we will look forward to other avenues and forums to disclose these promising datasets.
We've also evolved the platform called Neal Stat, which greatly accelerates our scalability in generating new clinical candidate the nearest that framework, specifically increases up productivities and efficiencies both from a time and cost perspective. Furthermore, the newest our platform enhances our versatility by allowing us.
Target multiple tumor antigens, including both translational modifications and personalize Neoantigens, let me move on to slide 11 to talk a bit more about any of that platform.
The key advancement here is the fact that we can generate the entire Q1, the 100 Sealy scaffold without any specific peptide attached to the H. fillet molecule. This is in contrast to our current immunoassay platform, whereas where were the H T cell epitope is an integral part of the munis dot meaning it is incorporated into.
To the molecule as a fusion protein at the time of synthesis, Neil stats synthesize without a peptide epitope instead the peptide epitope is attached subsequently using sophisticated attachment chemistry as shown in the current feed to the other examples of three different peptides bound to the Neo started scaffold. This advance allows us to generate the core generics.
Scaffold for any actually Ilene via a single cell line and then use the same product conjugate to different tumor antigens to expand our reach the fact that only a single scaffold needs to be generated will save us significant resources in both the time and cost but generation of clinical grade material. We've generated early proof of <unk>.
Concept supporting the biological activity of molecules generated via the neo start platform and that's disclosed these foundational data during a recent talk at the World vaccine and immunotherapy Congress meeting in December 2019 in San Francisco.
Finally in my last few minutes I'd like to share with you. The early results off a collaboration with Merck in the development of immune starts for the treatment of autoimmune diseases Slide 12 depicts the importance of immune homeostasis and how selective modulation via they munis that platform may help restore immune balance while much of the data.
We've discussed has been on selective enhancement event that human T cells. Mccann says the same principle essentially in reverse applies to autoimmune diseases, where in selective targeting of the pathogenic auto reactive T cells can be accomplished unit using immuno regulatory segment.
For this program as shown in slide 13, we generated in immuno starts using the human H. late last two molecule h. an idea over a one or deal for which is associated with type one diabetes. The immuno start molecule as shown in the left banner was made with a known epitope of pro insulin I know and and.
Auto antigen in type one diabetes, along with the native PD, one like in molecule for selective down regulation of pro insulin reactive T cells. This immune established tested for its ability to reduce expansion of pro incidents specific T cells from two different type one diabetes donors.
As shown in the graph on the right. The T cells can be expanded with the pathogenic peptide stimulation as represented by the yellow and Blue bar graphs. However, in the presence of the pro insulin in munis that this robust expansion to significantly reduce.
As a control and irrelevant got 65 peptide in munis that had no effect on diesel expansion got 65 is another auto antigen in type one diabetes. We then examined this relationship in vivo by using H., an idea for transgenic mice, which expressed the same human h. an idea for molecule as shown in the following slide 40.
Team Dfour transgenic mice can be immunized to generate T cells and this experiment they were immunized with the pro insulin peptide and then epitope from hemoglobin, then or age a which is a flu virus protein. The less panel shows that T cells to both engines can be generated after immunization as measured by interferon Gamma L.
Spot responses that are indicative of antigen specific T cells.
Black Lions show pro insulin specific T cells, while dotted blue lines, so hemoglobin in specific T cells or AJ.
The same experiment was performed in mice treated with the pro insulin immunostatus as shown in the right panel as you can see the pro incident in munis that selectively inhibited the pro insulin specific T cells shown in red while having no effect on the Flus Hs specific T cells. These results support two key conclusions one that they meet.
Let's start framework can be deployed to selectively dampen order reactive T cells and to that this can be accomplished without compromising protective immunity as evident with the several good AJ specific T cells. In this case current therapeutic approach has deployed broader immune suppression for treatment of auto immune diseases. This.
Tact runs the risk of making the patient susceptible to infections and malignancies. The world today. Unfortunately as evident from the current Corona virus infections is best served wherein individuals and patients are not broadly immuno compromised to dress symptoms of chronic autoimmune and inflammatory diseases to that end.
Selective modulation via innovative approaches such as the munis that platform may provide superior benefit.
In conclusion, and as I've stated in prior presentations, the immuno stat and by extension the Neil's that platform address a fundamental an important immunological problem, which is how does one maintain selectivity and specificity of a desirable immune response without breaching patient safety or creating toxicities.
We believe our approach built upon rational protein engineering, which is bolstered by supporting datasets may offer unique solution to patients suffering from Kansas autoimmune diseases and threats from chronic pathogenic infections with that I'll now turn the call over to Kevin to review our financial results Kerry. Thank you in nish.
On slide 15, I'd like to provide our financial results for the fourth quarter and so you're ending.
2019.
We finished the year with approximately $59.4 million in cash and cash equivalents.
61 million in total assets and working capital of approximately 49.4 million.
During the fourth quarter 2019, we extended our cash runway with $33.3 million from our aftermarket equity offerings to Stifel, Nicholas and company, who actually that sales agent.
During 2019, we received approximately $49 million in total net of commissions paid to Stifel from these sales agreements, which has positioned us about the progress our munis that platform in 2020.
Revenue generated from a collaboration with Merck and LG Chem in the fourth quarter of 2019, and 2018 was 1 million and $331000 respectively.
Research and development expenses were 6.9 million for the quarter ended December 31, 2019, as compared to 7.3 million for the same period in 2018.
This decrease in research and development expenses due primarily to me decrease in drug substance manufacturing costs as a full clinical supply for the Q1 on one phase one monotherapy trial was manufactured during 2018.
The decrease in manufacturing cost was offset in part by clinical trial expenses incurred during the fourth quarter of 2019.
General and administrative expenses by 3.11 million for the quarter ended December 31, 2019, as compared to 5.3 million for the same carried in 2018.
This decrease in general and administrative expenses was primarily due to a decrease in stock based compensation expenses and legal and accounting fees incurred in the fourth quarter of 2019.
Revenue generated from a collaboration with Merck and how do you can for the full year ended December 20, or 31, 2019, and 2018 was approximately 3.5 million and 1.1 million respectively.
Research and development expenses were 27.5 million for the full year ending December 31, 2019, compared with 28.5 million for the full year in 2018.
This decrease in research and development expenses is due primarily to a reduction in headcount and operational efficiencies realized during 2019.
General and administrative expenses were 12.7 million for the full year ending December 31, 2019, as compared to 11.3 million for the full year in 2018.
The increase in general and administrative expenses was primarily due to an increase in headcount and legal fees related to our patent filings and 2019.
Q bio pharma continues to be well positioned to support the development of our immuno stepped platform associated pipeline, including the clinical development of Q1 on one based upon our forecast which includes further build out of our ongoing clinical studies. Our current cash position is estimated to take us into the second quarter of 2021.
I'll now turn the call back over to Dan for closing remarks, Dan.
Hi, Thanks Kerry.
Since our last call we've made significant progress across the platform and have achieved our stated priority goals and objectives for moving our platform and associated programs forward as shown in slide 16.
We are now strategically very well positioned with our lead program Q1, or one currently in a clinical phase one dose escalation trial.
This program as exemplary of the aisle to based Q1 hundred series and as such supporting data from these studies represent potential therapeutic validation for our patients as well as substantial de risking in value inflection for our shareholders.
With Q auto one now being dose that what could be biologically active and clinically relevant levels. We believe we're very well positioned to establish Q biopharma as a differentiated leader in immuno therapy space as a potentially disruptive breakthrough therapeutic platform.
Our key accomplishments as a covered during this call. Our noted on slide 16, and I'd now like to provide some guidance on the upcoming 2020 milestones are.
These include.
In the second quarter of this year, we expect to obtain PK PD results from the early cohorts from the ongoing phase one do you want on clinical trial also in the second quarter of this year, we're guiding to select and announce a the target for Q1 O three.
In the second half we expect to evaluate.
Pinnacle responses and our ongoing phase one Q on on trial via resist criteria.
We expect to initiate a trial with a the PD one inhibitor pembrolizumab in frontline HPV positive head and neck squamous cell carcinoma.
And also in the second half were planning to initiate and extend I N D, enabling activities for Q1 or two.
We expect to generate data supporting the premise of our neo stat platform.
For enhancing a productivities inefficiencies as well as support Manufacturability.
And we expect to develop datasets to identify potential clinical candidates from our Q3 hundred series as an east just reviewed.
For treating auto immune diseases in collaboration with Merck.
With that I'd like to thank our employees for their hard work and commitment to advancing our platform forward and bringing our first drug to patients in need.
I'd also like to thank our shareholders in our your continued support in helping us realize Q biopharmas potential we look forward to providing further updates as we continue to advance our programs and thank you for your continued support.
<unk> now like to open the line open to questions operator.
Thank you.
At this time of conduct our question and answer session. If he would like to ask a question. Please press star one on your telephone keypad confirmation tone, what indicate that your line is in the question Q.
The press Star too if you would like to remove your question from the Q4 participants do you think speaker equipment. It may be necessary to pick up your had your headset before pressing the star keys.
Our first question comes from Stephen Wiley with Stifel. Please state your question.
Yeah. Good afternoon, thanks for taking the questions.
And all the while the progress.
[noise] just a quick question regarding some of the PD data that we might be seeing next quarter I know that you talk about.
Proportion of antigen specific cdthree positive T cells as as being one of the key biomarkers and presumably you'll be counting as a function of.
It was treatment biopsies.
I guess would the understanding that that that the confidence intervals around these counts are obviously subject.
Inherent heterogeneity of sampling, but just curious as to what proportion of antigen specific cdafs you would like to see in these whose treatment biopsies I know in some of the preclinical data that was recently published that you mentioned I think there was an observation that you solve more than 50%.
End of of tumor infiltrating being characterized as such so I'm just kind of curious if you could maybe give us maybe a lower bound you're hoping to see in.
In the PD dinner.
Yeah, Steve. Thanks for your question. This is a nation I'll take that on as you well noted the.
The fact that one can see expansion of antigen specific T cells is mechanistic proof that the platform and the molecule is doing what is intended to do.
What has been not formally establishing set in stone odd quantitative numbers. However, what we do know from experience in immunotherapy, both from Kansas cancer related and infections immunity related is to look at the qualitative aspects, which is what is the phenotype of.
The tumor specific diesel repertoire are they express, saying a effect of molecules inside all kinds of they positive for silent side to let the granules all of those in the preclinical setting, which you referred to in the recent papers, Steve is what we saw to confirm and demonstrate in that city.
Duration, but the Tcone tumor model, we did indeed see a robust infiltrate into two men in high percentages as you noted, but I think more to us would be to qualify the president of the seed the T cells in patient samples, but importantly to make sure that their qualitatively of the effect of phenotype.
Hi, but we would desire, including these sorts of Mark as interferon Gamma TNF Alpha positive for some of the side to let the gradual mark as indicative that they have all the right bearings off important tumor killing T cell.
Okay. So it'll be the counts in the context of functionality.
[noise] exactly will take both into account exactly right.
Okay, maybe just a question for Dan I know that you've been exclusive with Merck on AI front for a while now and I think that.
Period of exclusivity is perhaps now over I guess.
Yes.
[noise] Didnt, just whether or not you expect AI to kind of become a focal point of BD activity, you're going forward and maybe you can kind of speak to some of perhaps the initial conversations you had around enthusiasm for being able to selectively dampened our reactive T cells without the broad base.
Immuno suppression that in each referenced in his opening statements. Thanks.
Sure appreciate the question and it's it's an important question for our business model, we're focusing our resources principally in the immuno oncology space presently so obviously, having a AI as a potential monetizable class of assets is important as we go forward.
As you characterize that Merck had the they well let me be explicitly definitive here Merck has an exclusive license to two indications they've disclosed in their recent presentation. One of those indications as type one diabetes were not.
Able to disclose the other indication presently.
They were early on when this was basically a thought experiment and their capital helped us a establish the dataset that showed the potential of this platform for addressing auto immune disease. So we had agreed when we entered the relationship for a two year forbearance that we would not communicate.
Any of the datasets publicly ought to potential.
Additional partners that forbearance period has now expired. So we are free to talk to other companies and those discussions have.
Recently been engaged upon and we're having quite a bit of interest I'm looking at that platform as well as what we're doing in the immuno oncology space. So it is important to our overall growth as a company to have a class of assets that we could view as a a partner double group, while we focus on our core strengths which is.
Protein engineering and the Io sector.
Great. Thanks for taking the questions.
Thank you.
Our next question comes from Boris Peaker with Cowen and company. Please state your question.
Oh My first question is on just the Q1 to one dose ranging studies now normally in oncology and traditional approaches to ramp up the maximum tolerated dose and then just those expand at that level. Further I'm. Just curious in this particular scenario with aisle to being the active component what is the dose ranging strategy how far do you want it.
Those are and the thoughts on the dose expansion.
Hi, Yeah. This is Ken Thanks for the question you know what where what we believe is because of our delivery method of our attenuated aisle to we don't necessarily expect it to see a I don't too tight.
Type toxicity, and we are actually we may not see a dose limiting toxicity, which is why we built in using a basie an approach to be able to as we see PV effects at various dose levels.
Span those dose levels up to nine patients. So that we can better understand if we're not seeing toxicity.
What is the dose that we should pick up to move forward in the expansion phase. So we've sort of built in two approaches one is the standard three by three or can we see it a dose limiting toxicity and we're prepared to go up to you know.
Eight or nine cohorts, if we need to but we're also our thinking we might not see that and you know we don't want to it sort of dose indefinitely. So thats why weve built in this these extra patients that we can use add to it study at various.
Lower dose levels does that make sense.
Got it okay.
I guess an extension of that question, maybe my second and last question is.
The data update that we anticipate for Q1 to one or the dose ranging study later this year, what should we be expecting in terms of efficacy.
[noise] well this is Ken Thanks again for that question you know that's obviously the big question and.
You know, we're hoping that we're going to see a clinical activity in the form that meet match it meets resist criteria.
As well as when we see that activity to see matching a PD a effects.
That's right.
Thank you very much for taking my questions.
Thanks bars.
Our next question comes from Mark Brides, and talk with Oppenheimer and company your question.
Hey, good afternoon, guys and I hope everyone staying healthy.
And then maybe I'll start with a quick one for you or possibly for Ken as well.
First of all is it safe to assume that the initial PK PD and biomarker data will be kind of delivered by our press release and conference call and given the absence of medical meetings and I'm curious if we're in a biomarker data you'll be specifically looking.
For any signs of he so energy and or exhaustion is that that we might get a into whether or not that's going on in that that initial read out.
Sure. So I'll take the first shot at this and welcome any share count if they want to add anything to it so regarding the forum.
Our means by which we'll communicate you are correct in lieu of the conference is being postponed or canceled we would likely communicate that via our own internal mechanisms, which would be potentially a press release conference call. We certainly put it on our web.
So we'll we'll be prudent on when we can when we gather that data and how best to disseminate the information.
Regarding the issue of looking at the phenotype of the T cell, that's part and parcel of what we're going to be evaluating as a knee stated we'll be looking at various markers.
Side analytic capability, but also their characteristic as to whether they're in energy or not.
Okay. That's helpful and maybe a quick follow up for a niche and looking at the architecture of Q3, a one I'm wondering if you can just walk us through the challenge is unique to building a class two NHC into an in munis that.
Manufacturing very different.
From from one of your Q1 hundred series products and does the newest that platform extend to the M. A C class two products.
There are compatibility there. Thank you.
Yeah. Thanks, Mark a great question actually on the very basic mechanistic and platform centric activities. So just so everybody is on the same page and Mark I just want to make sure people. Appreciate the Q1 hundred series is based of H. laid Clos, one, which mostly focuses on C D H and while as much.
Referred to the work that we've done with Merck Fools focus is a nature late Clos to which allows us to note target and drug selectively cdfour T cells in autoimmune diseases.
As we've known from historically, a class one has been easier to work with compared to cost, which lays and last year. When we had made the announcement that we had some are the proof of concept molecules using nature. They close to this was a significant leap forward in the field. So the Clos to designed for laws.
Very similar concept.
Mark in terms of protein engineering and expression, which is again built off in this integration of.
Again, a two plasmid system in mammalian chose an expression we continue to refine the cool framework and looking at other Optionalities there and that's an active bought off a collaboration with Merck in terms of the way the peptide is latched in its the there's no beta to him his last indirect.
Okay to the H. late class two beta chain.
Peptide lends a different than h. late class ones, we spend a lot of time looking at the engineering components as well as a spatial organization to come up with this first prototype in what you're seeing the activity.
Moving onto the neo start side of things, we again made a lot of progress for the news Dot scaffold with data Lake lost one using the core Q1 hundred base series.
Which deploys Io too as well as big class when nationally and the future.
Thinking as we continue to learn more about the newest that is is to deploy that and understand the applications with close to that experiments so far as being a thought experiment, but they intentions in the future again to.
Build off a protein engineering expertise to explore that in the future at some point as well that allows US then do them to modulate both of the level of CD force across a autoimmune diseases, but also bringing back some of those nuances for cancer immunotherapy and infectious diseases as well.
Okay. Thanks, very much for the clarity and thanks for taking question.
Sure. Thank you Mark Mark.
Our next question comes from Ren Benjamin with JMP Securities. Please state your question.
Hey, good afternoon, guys. Thanks for taking the questions and congrats on all the progress.
I guess just to maybe start off with the combination study in front line can you can you talk can you give us some thoughts on how that trial will be designs. How many patients are you thinking about just a straight combo are there others.
Sequences of of the administration of the drugs that you're thinking about and and you know on on top that have you thought about a potential combination with chemo radiation, especially in a setting like head and neck.
Yeah, Hey, Thanks for that question. Obviously this is Ken so the trial is we've initially designed it is a is a three by starting out as a three by three dose escalation.
We intend to like start with ER, our third dose level and then ramp up.
To fight to make sure we have a safety and then we'll do a classic expansion. So we're really actually looking only looking for a total of 20 patients I'm in the initial.
20 patient static ethic, given dose level once we reach it as we start as we do that first trial and then.
We are what I think he yet about changing cequent say, we're giving the two drugs together and then basically we have thought about and have talked about of course, adding a doing that further trial down the way with chemo.
As more data is learned about pembro with chemo and but we haven't put that on our sort of list yet because we want to see what we're going to get from the combo study footwear clearly thinking about it.
Got it thanks, and then I guess just a broader question just given your platform in combating and addressing T cell energy and I guess, there have been recent articles as well, suggesting that infectious diseases, such as Corona may in fact impact T cell energy I wanted to.
Yet your thoughts on.
The potential to build out of pipeline beyond oncology and auto immune either by yourselves or with potential partners have you guys. You know looked into that at all and kind of what your thoughts are regarding.
The platform and infectious disease.
Yes, thanks rent this as a nation that it's a great question is something we have thought about that is there is a direct.
Potential application for the platform Platonic infectious disease as you've referred to in fact, a lot of early pilot experiments prototype being the molecules themselves utilize known virus epitopes, including ones from CMV in some some of this data as a part of the recent paper that we just published that.
As mentioned earlier that we continue to work in chronic infectious diseases in collaboration with the investigators at the Albert Einstein College of Medicine. As you specifically look at cases for decent exhaustion or a reversal of diesel energy, including possibly some early data that is evident from the current Macau.
But 19 situation. We think we have an opportunity here, we've had focused and deliberate discussions internally. We've had some early discussions with some external partners. Whether this is a core part of the strategy to make sure that a potential if a disruptive got them. Like this is just not limited to current capacity, but in fuel.
Yeah, we're able to really deployed this in a meaningful manoj for patients for benefit across diseases, particularly on the infectious side.
[noise] perfect. Thanks for taking the questions.
Thank you Aaron.
Our next question comes from Matt, who Kumar with Baird. Please state your question.
[noise] Omega Thanks for taking my question, so starting with the question Ken.
It's another observation there were highly encouraging from the one on one dose escalation to date are there any specific observations you can kind of 0.2 as being particularly encouraging.
Yes, thanks for the question.
At this point everything I'm I'm observing of course is is anecdotal and preliminary.
But what I can't say is that I'm isn't and colleges.
And what my investigators are also seeing is that we're really pleased that patients remain on trial in RV actively dose even as some of these lower doses are and that suggests to us.
That's very intriguing to say the least and that's all I can say at this point, but I really am a and we all are encouraged by what we're seeing.
Okay and also actually what has been the first line therapy for patients in the trial going it has it been PD, one blockade something else that our mix of the too.
So I am <unk>. Thanks for the question when I can tell you is that all the patients to date have received both a platinum based <unk>.
Chemotherapy as well as checkpoint.
At the so they've received both.
Okay, Great and then one last question on the cash when weighted to Q 21, what level of clinical development for 101 and other programs is that right away as said.
Yeah, So I'll take a shot at NASS carry to elaborate if it needs to elaboration.
So madu the current forecast is based on our ongoing activities in terms of a 101 monotherapy.
Dose escalation as well as the potential for expansion cohorts, we up to the nine patients and it includes the combination study.
And it also incorporates the.
Existing partnerships that we have in terms of both on immuno oncology with LG, Chem, which as our partner for Asia on one or one or through one or two in one or three and includes let's just say the.
Base level of activity, we have now in auto immune if that's moving towards the potential of of Canada elected that would go internally within.
Merck so far auto immune to expand that would either increase our burn radar it would require an additional partnership.
Okay, and I'll squeeze one last one in thinking about the one or one program and other H.L.A. illegal.
What's signal would it take for you to go to LG Chem to work like building a one on one molecule the uses.
Each of lay a wheel type that somebody to a one.
Sure.
As he is doing to some other that's a that's a key focus of the Q1 or two program a wet with WT, one we have prosecuting a too.
As well as a may 24, which is the dominant one of the dominant leaders in Asia.
And there's a the the optionality an opportunity of going for targeting one to one which is the HBV specificity on other racially leaders is still very much on the table and I think as the reason data asked us to emerge from the clinic. That's a discussion that is very much alive and.
It's an area of focus for our partnership.
Alright, thanks very much.
Thank you thank you Amanda.
Our next question comes from Tom Shrader with BP I Ji. Please state your question.
Hi, This is going very quick Tom Thanks for taking my question I just have a couple for Q3 year, one what type Oh type one diabetes patient population you think your approach will be more relevant here.
[noise] Coverity. This is it nish so as we think about the specificity is a visa obviously you know in early stages, where the repertoires relatively still narrow or even see repos that about risk individuals where you can track b cells and selectively modulate this specificity in particular.
As being tracked in both at risk and de Wendy patients and we believe that is a suite window in terms of if they think about strategies for disease intervention or disease interception before you know Frank late stages of hypoglycemia that maybe there is significant opportunity in the patient population.
That's helpful. Thanks, and for Q1 or one curious to know what are the other indications where you could expand that program.
So thanks for that question, they're most obvious is cervical cancer, but it's really any HPV driven cancer. For example, anal cancer in peanuts cancer are both are tend to be HPV driven so.
Really we could have it should work in any HCV driven cut cancer and <unk> again, the other three big ones are cervical eight all penile.
Got it thanks article and congrats on the partner.
Thank you.
Thank you.
Thank you that concludes the question and answer session I'll turn it back to dampen sorry for closing remarks. Thank you.
Okay. Thank you Diego and we want to thank everyone for your attention on the call today, and particularly in lieu of Ah all of the.
Activity and focus on the Corona virus situation. So really appreciate your attention and are they stay safe and look forward to providing you with additional updates during the quarter upcoming quarter. Thank you very much.
Thanks. This concludes todays conference all parties may disconnect have a great evening.