Q4 2020 Pieris Pharmaceuticals Inc Earnings Call
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Greetings and welcome to the <unk> Pharmaceuticals, Inc. Earnings Conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation.
Anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
Please note this conference is being recorded.
I'll now turn the conference over to your host Tom you may begin.
Thank you.
Good morning, everyone and thank you for joining us for our year end 2020 conference call on corporate update.
On the call today, we have Steve Yoder, our president and CEO, who will provide a corporate overview and outlook on our pipeline keto Kaufmann, our chief Scientific officer, and Shane <unk>, our SVP and head of translational science, who will be available for Q&A.
You can access the press release released this morning on the Investor Relations page on our website at Www Dot Paris Dot com.
Before we begin I'd like to caution that comments made during this conference call may contain forward looking statements involving risks and uncertainties regarding the operations and future results of operations of puris, including statements relating to the timing and process progress of our clinical trials and preclinical programs.
Our partnerships on our financial position and actual results or events may differ materially from those expressed or implied by such forward looking statements.
Actors that might cause such differences are described in our filings with the SEC, including our annual quarterly and current reports.
The information being presented is only accurate as of today <unk> undertakes no obligation to update any statements to reflect future events or circumstances.
I will now turn the call over to Steve.
Thank you Tom and thank you to everyone for joining us today for 2020 year on earnings call.
It's been a busy and exciting past few days, including this morning's update within on Astrazeneca collaboration, but before diving into those updates as well as a recap of some of last year's highlights and an outline of our future plans I would like to simply remind everyone that we are building a proprietary and partnered pipeline of large molecules called.
Anti kilen proteins, which are engineered versions of naturally occurring proteins called Liberal K ones.
K ones are small specific binding proteins with good drug like properties.
We're currently focused in two areas inhaled anti calin proteins to treat respiratory diseases locally and.
And by specifics designed to activate the immune system of cancer patients locally.
In both cases, the local or focused approach that Eddie Kilen proteins offer is intended to drive superior outcomes for patients compared to systemically active agents.
Beginning with our respiratory franchise I first we will provide an update on P. S O 60, or a Z D. One 402.
And IL four receptor alpha antagonist, we are developing for moderate to severe asthma in collaboration with Astrazeneca.
We are pleased to have announced earlier today the achievement of the 13 million U S. Dollar milestone payment in connection with the initiation of the Phase Iia study for this program.
In this global two part Phase Iia study Prs on 60 will be evaluated at up to three dose levels and an inhaled dry powder formulation versus placebo.
The first part of the study will evaluate the compound and approximately 45 moderate asthmatics controlled on standard of care asthma therapy over four weeks to establish the safety and pharmacokinetics of the dry powder formulation.
The second part of this study will assess its efficacy safety and pharmacokinetics and up to three arms, plus a placebo arm and up to 360 moderate uncontrolled asthmatics with a blood eosinophil count of greater than or equal to 150 cells per micro liter and fractional exhaled nitric oxide or <unk>.
You know greater than or equal to 25 parts per billion.
Patients will be dosed and monitored over four weeks with F. E V. One improvement compared to placebo as the primary endpoint.
The initiation of this trial is a significant milestone for our respiratory franchise. This program remains a high priority one for peers and we look forward to continuing our collaboration with Astrazeneca on this program and sharing the phase Iia results next year.
Additionally, we recently amended our agreement with Astrazeneca to restructure certain commercial terms for Prs was 60 by adjusting various milestones and royalty provisions well fundamentally maintaining the overall value split between the two companies Inc.
Connection with the Amendment Astrazeneca is also making a 10 million U S dollar equity investment in Paris. We believe this investment further strengthens our joint vision for the future of inhaled biologics and demonstrates Astrazeneca is ongoing commitment to our alliance Bill.
Beyond this lead respiratory program, we have several other inhaled respiratory programs in development. There for discovery stage programs that are part of the five program collaboration with Astrazeneca and there are multiple fully proprietary programs. We are developing outside our partnership with Astrazeneca. We have continued to make progress.
On our proprietary programs and we envision disclosing program details, including any plans for one of those programs later this year.
Now turning from a respiratory franchise I will now give an update on our immuno oncology pipeline, which is focused on a target known as four one b b or C. D 137, which is an immune cell co stimulatory receptor that is expressed on activated T cells and natural killer cells in particular.
<unk> is a leader in the form on B B space.
And our data driven belief in this target underpins most of what we're doing in immuno oncology are.
Our localized four won't be agonism approach was designed to overcome the challenges that systemically active four won't be agonists have faced in the clinical setting rendering them ineffective in achieving suitable therapeutic window.
We believe our four won't be based bi specifics can open up that window and take advantage of the biology fundamentals of four one b b.
What makes four wouldn't be so special is that its activation is believed to provide a critical signal that leads to increased T cell proliferation, cytotoxicity and cytokine secretion and enhance T cell memory, among other effects, which collectively helped to mediate effective and durable anti tumor activity.
Our lead program with international non proprietary name syndrome, a fuss Alpha which you all know is Prs 343 and from here on often referred to as Synroc is a forgone BB her to buy specific and the first tumor targeted for lumpy be agonist to have entered clinical trials.
It was engineered specifically to take advantage of the potential of four O M. B b, while avoiding off tissue toxicity limitations clinical data, we have generated which are based on our monotherapy dose escalation study and a combination dose escalation study with a Tesla lids, a map to centric provided under a drug supply agreement.
Roche.
They have demonstrated clinical benefit linked to biomarker evidence indicative of a four one b be driven mechanism of action and not only the syndrome demonstrate clinical activity, but it does so with an acceptable safety and Tolerability profile.
Most recently, we presented results from both studies at the 'twenty 'twenty European Society for medical oncology or ESMO virtual Congress. The results confirmed that syndrome provides durable clinical benefit including a durable confirmed complete response in heavily pretreated patients across multiple her too.
Positive tumor types the observed clinical benefit coincides with significant expansion of CDA T cells observed in longitudinal biopsies of responders and a substantial increase of soluble four wouldn't be b in the active dose cohorts demonstrating four won't be be activation.
Data presented at ESMO included several patients from the highest dose cohort cohort 13, B, which is an 18 milligram per kilogram dose dosed Q2 weekly.
Those patients who had only recently enrolled in the study as of the conference cutoff date and had not yet reached the first radiological assessment under resist criteria at.
At ACR on April 10th we will present additional clinical benefit and safety data for these patients as well as additional biomarker data across all active dose cohorts.
Our objective increases in presenting additional data is to lay further foundation for our phase two trial plans, including the development of syndrome in both the her two high and her two low settings.
As announced last year, we intend to build on the positive clinical activity, we observed with <unk> syndrome in the her two high setting that is I H C to plus and ish positive as well as I H C. Three plus two a study of cinema in gastric cancer patients in combination with second line standard of care tackling.
Taxable and Ram Macero map for this study Lilly is supply in rabbits here, a mab under a drug supply agreement.
Given the clinical activity, we observed in monotherapy in heavily pretreated patients.
Positive safety profile and the fundamental underpinnings of four won't be biology that drive T cell proliferation cytotoxicity in memory. We are encouraged that the prospect of syndrome offering a meaningful treatment option to her two positive patients in what has become a very dynamic space and.
Turning beyond the her two high gastric cancer setting.
We are also excited to be exploring the combination of Sandro with two Kaiser to cat nib for her to low gastric cancer patients and we have recently signed a trial collaboration with C. Jen who will supply to cat nib for this study.
Based on centers motive action and data we have been generating we believe the her two low setting is an area where sooner it could be particularly differentiated the combination of Cinderella. Two cabinet is intended to address a high unmet medical need in her two low expressing gastric cancer patients, who do not respond to traditional her to targeted therapies.
Preclinical studies, we generated in collaboration with CJ and show that to Cat Nib sooner.
Synergizes with Sandra to enhance four won't be be mediated immune cell stimulation.
This effect was observed across a range of her two expressing cell lines not just IH see three plus but also IEC, two plus and one plus cell lines regarded as her two low including those where syndrome had limited single agent activity.
In terms of the synergy at play here, we know that in general tyrosine kinase inhibitors have been shown pre clinically to upregulation or stabilized tumor cell surface her two expression.
One hypothesis behind the synergy we're observing is that two cat nib can impact her to stabilization on tumor cells, which can facilitate increased clustering of cidra on the tumor cell surface to further drive forward won't be cross linking and therefore enhanced activation of immune cells.
Not only does the her two low gastric cancer setting represent a sizeable market opportunity, but also it's an area where competitor drugs that showed benefit in her two high gastric cancer have not fared as well in the her two low setting we look forward to studying this combination and are pleased to be doing so with an existing supportive partner.
Not only is C J on providing to cut on it for this study, but they recently also made a 13 million U S dollar strategic equity investment in Paris in connection with the amendment of our existing immuno oncology collaboration agreement and we believe that this investment further strengthens our joint commitment to developing novel cancer therapies.
Together.
As we work on phase two initiation for these two studies, which we expect will begin this summer and will include a number of sites in South Korea, and the U S. We have dosed two of six intended patients and a small safety cohort that is progressing well and which employs the co diluted technique, we refined as <unk>.
Our efforts to remove the partial clinical hold which was lifted by FDA in January of this year.
Looking beyond syndrome, and our immuno oncology collaboration with sea. Gen. We are also working hard to advance Prs 344, a four won't be be PD L. One by specific under co development with Servier.
On April 10th we will present, what we believe are compelling preclinical data for 344 as part of a poster session at ACR the.
The presentation will showcase synergistic data, including in vitro data evaluating potential effects of combining <unk> and PDL, one and the effects of Prs 344 on CD eight T cell as well as dose dependent anti tumor response in in vivo preclinical models, we expect that the fee.
Phase one trial of Prs 344 will begin this year.
And as a reminder, purest holds exclusive commercialization rights for Prs 344 in the United States and we'll receive royalties on ex U S sales by Servier for this program.
Additionally, within our Saturday a collaboration we completed non G. L. P. Preclinical work for Prs $3 52, a pretty preclinical stage program addressing undisclosed targets for immuno oncology last year.
<unk> is fully responsible for further development of the program.
This concludes my prepared remarks, and I would now like to hand, the call back over to Tom to guide you through our year end 2020 financial results over to you Tom.
Thanks, Steve and good morning again, everyone.
Cash and cash equivalents totaled $70 4 million for the year ended December 31, 2020, compared to a cash cash equivalents and investment balance of $104 2 million for the year ended December 31 2019.
The decrease was primarily due to funding operating and capital expenses in 2020, partially offset by ATM proceeds and milestone achievements during the year.
The December 31, 2020, ending cash excludes the $13 million received from C. J on in March 2021.
The $23 million to be received from Astrazeneca in connection with the phase Iia study initiation and equity investment.
R&D expenses were $46 5 million for the year ended December 31, 2020 compared to $55 million for the year ended December 31 2019.
The decrease in R&D expenses was primarily due to lower clinical and manufacturing costs on her arm.
Immuno oncology programs.
In part due to the partial clinical hold and FINRA.
Lower manufacturing spending on Prs, <unk>, which is fully reimbursed from astrazeneca.
And lower travel related expenditures due to COVID-19 restrictions.
The overall decrease was partially offset by an increase in allocated facility cost due to the move to a new R&D facility and Halberg, most Germany in early 2020.
G&A expenses were $16 7 million for the year ended December 31, 2020, compared to $18 4 million for the year ended December 31 2019.
The decrease in G&A expenses was primarily due to lower personnel costs, lower audit and professional fees related to Sarbanes Oxley readiness.
And lower travel related expenditures due to COVID-19 restrictions.
These decreases were partially offset by higher allocated facility cost due to the move to the new R&D facility.
Our net loss attributable to common shareholders was $37 2 million or <unk> 68 cents per share loss for the year ended.
Remember 31 2020.
Compared to a net loss of $28 3 million or 56 cents per share loss for the year ended December 31 2019.
With that I'll turn the call back over to Steve.
Thanks, Tom.
I'd just like to conclude by saying that 2020 was a tough year for everyone to say, the least and I'm very proud of how our team adapted and stayed the course the challenges we faced last year made us a more resilient organization and I look forward to maintaining this mindset in 2021 and beyond this.
This year is already off to a good start.
With partner support in a number of clinical programs starts recently announced or anticipated.
S. A 60 is progressing through its next phase of development in this year, we will be advancing both the cinema and Prs 344 into the next phases of development.
We would now like to open the call for any questions that you might have.
Yeah.
And at this time, we'll be conducting a question and answer session.
I wanted to ask a question. Please press star one on your telephone keypad.
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One moment, please while we pull for questions.
Our first question is from Matt Phipps with William Blair. Please proceed with your question.
Good morning, Thanks for taking my questions and congrats on a minute agreements here.
Yeah.
I'm just curious if you guys have been able to glean any learnings from the recent dataset.
Our updates from competitor PD lone by for them to be by specific programs. It really it seems like our competitors are not able to reach a dose level, where they can fully inhibit the PDL one pathway.
And therefore may even look to combine with a separate PD one antibody. So really just curious if you guys have any reason to think that three or four for might be able to.
Still have good foreign BB agonism at a higher dose level to saturate the PD lone pathway and then.
I'm gleaning from maybe the.
Tumor types or things like that to go into what the drags on what you said.
Clinics.
Hey, Matt Steve here. Thanks for the question. It's a great question and we know a lot of people are focused on not just for won't be but for one BV PDL, one and we do believe it's a great example of a combination where the bi specific itself drives novel biology compared to a Cox.
He'll approach and where you're giving on this in this case, an antagonistic approach on one side and agonistic approach on another you have to really put a lot of thought into the design on the dosing schedule of the molecule and here I think this demonstrates our position of leadership a lot of the thought that's going on.
On the designing the molecule on how we can extract learnings from $3 43 in the clinical setting for 344 going forward and I would say before turning it over to Shane to get into some of those important nuances that you highlighted we believe that the data we're seeing in general out there from third party molecules in the clinic.
Confirm the rationale to pursue this combination and it does show the nuanced challenges of getting the right dosing schedule. Those dose levels of course, you have to work with the molecule you have and given the thought that we've put into the design of our molecule we feel really encouraged about.
The opportunity for a best in class approach and I'll, let Shane go into the details he was largely the brainchild behind the development of design of this molecule. So I would be remiss, if I didn't let him share that with you firstly.
Thanks, So shave over to you Mark for the question.
Yes, thanks, Steve so.
As you say you know there are some emerging data.
Steve mentioned, we see this as positive on the science that is further validation of confirming <unk> importance, but when it comes to the actual design of the molecule. There are a number of things you need to bear in mind, and we certainly consider things like the <unk> type of a molecule that we wanted to ensure that it would be.
We would have a completes a solid backbone. We spent a lot of time working on valency and the geometry of our molecules from our balance sheet perspective, we feel by balance is.
His best geometry, we wanted to hop on optimized flexible.
Formats that would allow a natural cleanups true to form and then other things like the actual affinity for the partners be it for BB or PDL, one as we've said many times, we feel on the Columbia side, you need to have a moderate affinity to really allow you to take advantage of a therapeutic window.
So we've gone for the offers some capacitors have gone through our highest end molecule and on that may impact the therapeutic window. They see we also saw a lot of price.
Particular epitope on for them to be we bind two so all in on as Steve said, we've been working in the form of BB space for a number of years, we've learned a lot from Prs 343, and all of those learnings can go into Prs 344, we feel we have the opportunity that with best in class play here.
Notwithstanding that we are we do feel the data coming out from competitors is supporting the general approach of targeting for MBP.
Okay, yeah. Thanks.
Shane.
On the.
Oh gosh.
Central combo, the newsletter combo with together why not also explore chemo in that combo. Just you know it seems like in gastric.
A lot of drugs in regimens really kind of need some chemo there to help slow down on the aggressive tumor.
Shane do you want to you want to answer that one as well.
Yes sure.
Martha.
Good question.
Certainly I can answer.
It's a good question on again, we we've taken an approach to gastric cancer and that we want to we want to explore different regimens and.
What we are what we would say is there's a lot of rationale for combining <unk> three for three with Sandra we see.
On.
The dramatic increase in T cell activation went to come combination. We also would remind you.
As a single agent, we're seeing really nice activity with Prs 343.
No.
We do feel combining those two agents certainly makes a lot of science I would also say that with our other arm and the gastric trial. We are exploring chemotherapy. So we've got one on which is lucky nuts, ROM paclitaxel and on arm, which will look at.
On to Cop net so I would say, we're covering our bases. There we do feel that with regards to the sooner on PURA <unk> III, the sidra combination, which to cut net theres a strong.
Biological rationale we've got some really nice preclinical data on building on the clinical data, we've seen as a monotherapy or on our agents, we feel that there's a real opportunity here.
Yeah, and I would just add to change a very thoughtful answer that we certainly are exploring the chemo regimen in combination with her two positive cancer and that's also because of the standard of care being Ram Taxol and that allows for an efficient enrollment on top of standard of care.
It's not for fear of any toxicity that we wouldnt add a chemo regimen on top of two cabinet right now we feel it's following the biology based on data we generated in house and with the collaborative efforts of CGM and we look forward to moving both of them forward in parallel.
Great questions, Matt Thanks.
And if I could just sneak one last one on that for Tom can you say where the.
Cash now gets you from a kind of a runway standpoint.
Sure Matt.
We haven't really guided beyond.
Saying that we have more than 12 months of cash, but certainly this puts us in a really good position.
To to run these phase II trials for Sandra.
<unk>.
Get to Readouts on those.
Certainly you get to a readout on the recently initiated.
Phase Iia trial for Prs, <unk> and and go forward with the.
344 study as well as getting that into the clinic along with.
And on a number of earlier.
Earlier stage.
Discovery programs that are made on partnered and that's on the rehab proprietary as well so.
And I think we're well positioned now with with some of the traditional cash that's coming on over the last couple of days.
Alright, thanks to them.
Sure.
Okay.
Yeah.
Right and it seems as if we have reached the end of the question and answer session and I will now turn the call over to Stephen.
On actually I do I'm, sorry, I do see Matt Phipps from William Blair again ran another question. Please proceed with your question.
Oh, yeah, Yeah, that's going on at least for it but.
So I know you guys can't say too much on on those six out of trial, but you know Quinn trials Gov list.
Mid next year with the primary completion.
What should what can we look for for updates I know you guys have to work with me on this but will we know when it reaches through the first part of the trial or will you be able to provide some updates as it goes.
Yeah, Matt I'm happy to happy to take the question, it's nice to have a nice dialogue with you today.
But no no worries.
Look we have to rely on as you said with a Z on the disclosure strategy across the you know the duration of the trial, we clearly talked about the enrollment criteria for subjects for part one versus part two you can see that for part one they're moderate asthmatics controlled on standard of care that they don't have to.
The type two phenotype versus for the epic because he part that is moderate on control that have the classic T to phenotype with the E O in the Pheno cutoffs.
So I think you know we're encouraged to say that we think enrollment of part one.
You know should be should be straightforward, okay with all the caveats that we're still in a COVID-19 world out there, but I would like to think that that can go forward efficiently with the multiple sites, we have up and running.
And we would like to be able to talk about getting through that stage gate.
In a timely manner, that's our expectation and that's our hope and so that's something that hopefully we can be able to comment on later in the year.
And we will work with easy to be able to do that on a way that meets their corporate communication strategy. So that's what I would hope to be able to do on the way to announcing the overall efficacy data, which would be absolutely next year.
Great Alright, thanks, guys.
Alright. Thanks.
Alright.
Okay.
Thank you.
No.
No other questions I guess, so I'm happy just to thank everyone for your attention today and your continued support of Paris, and we certainly look forward to keeping you updated on all of our progress. Thanks again for joining the call on have a great day.
This concludes today's conference and you may disconnect your lines at this time.
Thank you for your participation.
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