Q1 2021 Pieris Pharmaceuticals Inc Earnings Call
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Greetings and welcome to the Paris Pharmaceuticals, Q1 earnings call.
At this time all participants are in a listen only mode of <unk>.
<unk> and answer session will follow the formal presentation.
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As a reminder of this conference is being recorded.
I would now like to turn the conference over to your host Tom Byrne Vice President Finance. Please go ahead.
Thank you.
Good morning, everyone and thank you for joining us for our first quarter of 2021 conference call on corporate update on the call today, we have Steve Yoder, our president and CEO, who will provide of corporate overview and outlook on our pipeline. He took Hoffman, our chief scientific officer, and Shane <unk>, our 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 of our website at Www Dot 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 the purest, including statements relating to the timing of progress of our clinical trials and preclinical programs, our partnerships and our financial position and acts.
The results for events may differ materially from those expressed or implied by such forward looking statements.
Factors 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 and fears undertakes no obligation to update any statements to reflect future events or circumstances.
I will now turn the call over to Steve.
Well, Thank you Tom and thank you to everyone for joining us today for our 2021 first quarter earnings call. The.
Last few months have been very productive and marked by significant accomplishments as we advanced our proprietary and partnered pipeline and leverage the existing and new alliances to materially bolster our balance sheet.
Putting the past few weeks into perspective, we have generated $46 million in cash flow two milestone achievement equity investments by partners Astrazeneca see Jan and the addition of the new partner, while also securing the drug supply for a key combination study for our most advanced I O assets.
We can and will continue to use partnerships and the power of non diluted funding mechanisms to reach significant corporate inflection points.
Purists is the proprietor of of class of next generation therapeutic polypeptides called N T K ones and we are focusing the development of any K ones in two areas, one inhaled delivery for respiratory disease and to the specifics in immuno oncology.
The first share some exciting updates for my respiratory pipeline and I'm pleased to begin by announcing that patient dosing with Prs of 60 has begun and the first part of the global Phase Iia study.
Perez of 60 is an IL four receptor alpha antagonist, we're developing for moderate to severe asthma in collaboration with Astrazeneca and it's our lead respiratory program the.
The first part of this two part study is evaluating the safety and pharmacokinetics of the dry powder formulation of <unk> 60 in moderate asthmatics controlled on standard of care of asthma therapy over four weeks.
The second part of the study will then evaluate the efficacy safety and pharmacokinetics of Prs of 60 in moderate uncontrolled asthmatics over four weeks the primary endpoint.
Endpoint of the study will be F E V one improvement compared to placebo.
Last quarter, we announced the achievement of of 13 million dollar milestone payment in connection with the initiation of this clinical study alongside of the $10 million equity investment from Astrazeneca in connection with the restructuring of certain financial terms for P. R. S of 60 in the manner that does not impact the overall.
Value split of the asset between Paris, and Astrazeneca. We are pleased with Astrazeneca is commitment to this program and to this collaboration more broadly which also includes for discovery stage programs that are currently under active collaboration.
In addition to our partnered respiratory programs. We are also developing a number of proprietary programs and look forward to sharing additional details, including R&D plans, but one of these respiratory programs later this year.
Looking beyond our respiratory franchise I would now like to discuss the progress we have made in our immuno oncology pipeline.
Our immuno oncology pipeline is concentrated around our expertise in for one BB based bi specifics.
We remain enthusiastic about four of them on B b as a target which is an immune cell co stimulatory receptor that is over expressed on activated T cells and natural killer cells in particular, and whose activation drives improved metabolic fitness of the cells. We.
We have designed our for won't be the based bi specifics with the objective of agonizing for won't be be locally to leverage its benefits, while overcoming systemic and off target side effects that have plagued systemically active for lumpy the agonists.
We were the first company to bring of for won't be based by specific into the clinic, which is now progressing into phase III and we have the number of for won't be based by specific programs following that lead.
Syndrome of US Alpha also known as Prs 343, or Synroc is there a lead for one BB clinical program.
As of for one b be hurt you by specific that we have tested in two phase one studies.
Last month, we presented clinical data update from the phase one monotherapy study of Sandra Hay day, a C are disclosing additional clinical benefit at the highest dose, including an additional confirmed durable partial response three additional patients with stable disease as best response and overall.
All of the ruble benefit syndrome has shown a clear dose response and a for won't be be driven mode of action and clinical benefit was observed in patients with cold tumors as well as those with her to low expressing tumors.
Sandra has shown an acceptable safety profile at all doses tested with no dose limiting toxicities the.
These findings provide the rationale for advancing this asset into a phase II trial in her two expressing gastric cancer of tumor type that continues to derive benefit from the immuno modulator therapies as recently demonstrated by the keynote eight of 11 clinical study outcome, which led to the approval of pad, but lets the bad one attitude. The first line standard.
Of care Trastuzumab and chemotherapy.
The dose dependent activity, we are seeing with FINRA supports our recommended phase two dose which consists of the two cycle loading dose at 18 milligrams per kilogram on the Q2 weekly regimen.
Followed by an eight Mig per kilogram Q2 weekly regimen in subsequent cycles.
As a reminder, the phase two study will be a two arm study the.
The first arm will evaluate syndrome in her two high gastric cancer in combination with rabbits, ceramide and Paclitaxel with Lilly supplying ran the serum at no cost of Puris is part of the trial collaboration agreement.
We expect to begin enrolling this 20 patient study arm later this summer focusing on the U S and South Korea, where gastric cancer has a high prevalence.
We are setting a high bar for go no go in a planned interim analysis of this study to ensure that we remain competitive with the evolving treatment landscape and we will be looking at a composite of the efficacy measures, including durability and safety. In addition to objective response rate or or or.
We are setting the or our target at a minimum of 50% at this interim analysis, which is higher than the 28% over our benchmark established by Rab of serum <unk> and Paclitaxel and takes into consideration potential emerging standard of care.
And it's the bar, we believe we can achieve given the activity we've observed with the sender to date and the complimentary motive action in this combination.
We believe that setting stringent criteria for advancement of our proprietary assets will help to ensure prudent and judicious use of our corporate resources and that achieving these criteria can translate into meaningful value for patients and shareholders.
The second the arm of the study will enroll 20 patients with her two low gastric cancer and we'll evaluate cintra in combination with two cabinet, which will be supplied by our partner see Gen at no cost to Paris.
In addition to the data we generated collaboratively with sea Gen that showed synergy between two cat nib, and Sandra and enhancing of for want of B b mediated immune cell activation.
The the data where we presented at this year's ACR Conference also support that syndrome is active in the her two low tumor setting as we observed clinical benefit in multiple her two locations receiving syndrome as of mono therapy, coupled with the pharmacodynamic data the demonstrate for <unk>.
On BB agonism in these her two locations. We believe it is encouraging that when paired with the cat Nib syndrome may show clinical benefit in the setting where many other her two targeting drugs have shown only minimal activity.
Or too low gastric cancer, therefore presents a high unmet medical need and is the sizable market opportunity.
And as in the her two high arm of this study we are setting a high bar for success for the her too low on looking at the same composite of other efficacy measures, including durability and safety in addition to or are here.
Here, we believe that achieving at least a 40% or are would be a significant improvement over the 28 per cent or are demonstrated by standard of care of Rem misfire on IV Paclitaxel in light of the marginal activity of other agents tested in this setting.
We are excited the study this novel combination regimen with sea Gen, who made of 13 million U S dollar strategic equity investment in Paris in collaboration and in connection with the amendment of our existing immuno oncology collaboration agreement last quarter.
As we are making the necessary preparations for the start of the phase two study of syndrome. We are also working hard alongside our partner Servier and anticipation of advancing Prs 344, which is a for one be the PD L. One by specific into phase. One later this year.
Last month, we also presented preclinical data for 344 at ACR, demonstrating superiority to the combination of PD L. One and for one BB targeting molecules as a reminder, we hold exclusive commercialization rights for Prs 344 in the United States and we will receive royalties on ex U S.
Sales by Servier for this program.
<unk> is also responsible for further development of Prs $3 50 to an undisclosed immuno oncology by specific that is also part of our collaboration.
Finally, we also recently entered into a license and collaboration agreement granting Boston Pharmaceuticals exclusive worldwide rights to Prs 342 of preclinical for won't be the G. P. C. Three of immuno oncology by specific.
Under the terms of that agreement Pieris received an upfront payment of $10 million and there's further entitled to receive up to around 350 million U S dollars in milestone payments tiered royalties up to low double digits on sales of the treatment if successfully approved and commercialized.
And the share of certain subsequent sub licensing revenue.
Paris will collaborate with Boston Pharmaceuticals to advance the program towards the 90 submission.
Aston Pharmaceuticals has a strong leadership team and proven track record of developing a broad range of assets, including oncology and we look forward to the advancement of this novel next generation bi specific which follows in the.
Localized for one BB agonism motive action of syndrome.
So in conclusion.
With our focused investments in center of both of Us of Alpha and our partnerships with Servier. The sea Gen. In Boston Pharmaceuticals, we have placed our immuno oncology by specifics pipeline on solid footing and we look forward to the progression of multiple assets into the clinical stage beyond syndrome, driven by material ongoing investments.
By these partners.
This concludes my prepared remarks, and I would now like the hand, the call back over to Tom to guide you through our first quarter 2021 financial results over the Utah.
Thanks, Steve and good morning again, everyone.
Cash and cash equivalents totaled $66 8 million for the quarter ended March 31, 2021, compared to a cash and cash equivalents balance of 74 million for the call.
Order ended December 31 2020.
The increase was due to the 13 million dollar U S.
$13 million received from CJ in March 2021, offset by our operating cash needs.
The quarter ending cash balance excludes $23 million received from Astrazeneca in April.
And $10 million to be received for Boston Pharmaceuticals on.
On a pro forma basis quarter end cash and cash equivalents would have been approximately of $100 million, which ensures that we are well positioned to execute on our strategic plans into 2023.
R&D expenses were $16 6 million for the quarter ended March 31 2021.
<unk> to $12 8 million for the quarter ended March 31 2020.
The increase reflects higher spending on preclinical activities for our proprietary respiratory pipeline and manufacturing costs for our of immuno oncology programs, while maintaining flat spending on other non project related R&D costs.
G&A expenses were $4 1 million for the quarter ended March 31, 2021, compared to $4 4 million for the quarter ended March 31 2020.
This decrease reflects more one time costs incurred in 2020 related to the move to our new R&D facility in Alberta, Most Germany.
Partially offset by.
By higher consulting expenses in the current quarter.
Net loss was $4 2 million or of seven loss per share for the quarter ended March 31, 2021, compared to a net loss of $3 6 million or seven loss per share for the quarter ended March 31 2020.
With that I'll turn the call back over to you Steve.
Thanks, Tom and as I Trust, you all would agree.
These last few months have been of productive time at peers, particularly with respect to our leveraging of new and existing partnerships and we look forward to building on our momentum.
Thanks to our business development activities, we have added $46 million to our balance sheet to a mix of non diluted funding and focused strategic equity Stakes from two existing partners. We remain committed to this business model.
We look forward to keeping you updated on our progress as we drive towards achieving key inflection points throughout the year I want to thank you for joining us on the call today, and we would now like to open the call to your questions. Thank you.
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One moment, please while we poll for questions.
Our first question today is from more of a thought of Evercore. Please proceed with your question.
Hi, guys. Thanks for taking my questions I have a few today if I may one for the asthma trial would you have an internal readout of the part one I know of Quintiles says it'll be unblinded review of so I'm just trying to understand can we talk to you about part one perhaps even if it's not a press release and also would you be able to announce that you're now for.
I'm really progressing to part two and that dose level. Three was included would that be of formal announcements should we expect that or not and perhaps also if you could spell out for us what is that bar that you have to clear to include that third dose and to move to phase three and finally, just quickly if you could remind us of the choice of <unk>.
<unk> selection I notice, it's Australia on the Ukraine site and trying to understand we should expect U S sites to be up as well when you get the part two thank you.
Okay.
Hey, Omar Thanks for the questions all focused on 60 clinical study design and that's that's great I can try to take all of those one of the time.
So yes, you noted Omar there is there's two parts of the study there's the part one of efficacy phase, which is up to three dose safety phase sorry, which is up to three doses and then there is the part two.
Because of the face which would look at the one is the primary end point, we have not disclosed specific communication planning for the progression from part one of the part two but as I had mentioned before it's my personal desire and assuming the Astrazeneca is fine was that I assume that they would be is that we intend to be able to.
We intend to be able to announce when we have or that we have progressed from part one and the part two which I would anticipate pending the enrollment as planned debt that would be sometime later this year. So that's something that we hope to be able to talk about even though I would not expect a formal press release around any data disclosures, but then we could.
Talk about that for sure.
As far as the doses that would be used in the the part one is a progression of part two there is a certain amount of staging that is allowed such that if one were to clear. The first two doses. One could then move into the efficacy phase.
Rather than wait for all three so that's some nuances and design that we still will consider but we don't necessarily have to clear all three doses before moving into the efficacy phase at the lower doses and then as far as the sites. As you noted we are currently leveraging efficiency and regulatory.
<unk> and site readiness, we have been very very accustomed to working in Australia with phase one and phase one b with Prs of 60. So we're focused there on also in the Ukraine and we're looking at multiple additional geographies and several other sites. It's a global study, we havent disclosed the specific strategy.
In the U S yet, but certainly interactions with the FDA are certainly contemplated before too long.
Thank you very much.
Yeah.
The next question is from Matt Phipps of William Blair. Please proceed with your question.
Good morning, Thanks for taking my questions and congrats on the business development activity in the quarter.
You know I guess, where given where you guys have gotten with Sandra and.
The data generated with the way this first for M. D V by specific and now what's been kind of get pretty competitive space.
The looking for bigger picture on how you can leverage that info into the rest of your pipeline and then and then specifically for kind of the the PDL one.
The group of these.
But the specifics we've had a couple of other companies start to give some disclosures are on their programs.
Wondering what you might have taken from that that can help with the development of <unk> of $3 40 for the.
In combination with obviously of what you've learned from center.
Sure Matt. Thanks. Thanks, so much there's a lot of things we could talk through there I mean, firstly what did the data for.
From cintra speak to the opportunity with sooner of itself.
In the gastric cancer space in particular, and we can talk about that then you also mentioned the broader of learnings of Sandra throughout the rest of our pipeline and then specifically looking at the PD L. One for won't be be bi specific approach, where there are a number of other.
Programs that have recently moved into clinical stage and some of them already reported some initial data. So I can just frame that at a high level and then I'd like true Shane to go through that in the little bit more detail and when we first think about the the the cinryze for cintra sake looking at the opportunity in the.
In her two expressing tumors.
Let's let's not forget that we have what I think is pretty compelling impressive single agent activity, coupled with a very good safety and tolerability profile and the I don't want that to get lost on people because for them on BB agonism can be a very sharp knife and we've seen that coupled with the dose response and I think of great set of P.
The correlates that will help us to have helped us to zero in on a what we think is a very thoughtful R. P. T D.
And when we consider the single agent activity the relevance of Immunotherapies in gastric cancer and the ability to play on both the her two high space and the her two low space the latter being far less dynamic than the her two positive space, we really like those those nuances of bringing of for won't be be bi specific into the.
This field and if you think about the biology at stake. This is the only to our knowledge the only her to engaging agent that leverages. The adaptive immune space. It also brings innate immunity to it with NK cells, but compared to bi specifics compared to novel payloads compared the macrophage biology this is different and.
If we think about what for won't be B does which is to drive the improved metabolic fitness of T cells and immune cells. In general. This is something we think could lead to meaningful differentiated opportunity and there will be learnings and learnings from this into how we think about positioning the for won't be B P. D O arm based by specific as well as I think helping boss.
The <unk> pharmaceuticals on the positioning of the G. P C three for won't be bi specific.
Shane can maybe go a little deeper on some of the nuances in the her to hide for too low.
Including the bars that we announced today on the O R. R as well as why we feel really enthusiastic about our specific for won't be B P. D. All of them by specific which we really put a lot of thought into designing for potentially.
Best in class opportunity, there, so I'm going to hand, it over to Shane to go a little bit deeper.
Thanks, Dave and thanks, Mark for the question. So maybe just going back for your question in terms of.
What do we see for BP of excites us on how can we leverage will receive it Sandra.
To really position those other programs, we're bringing through so with regard to what we see with FINRA.
No.
The power of for BBB is very evident in our clinical trial as you know it was the translation heavy trials, where we mandate paired biopsies that allowed us to take care of luck into the tumor microenvironment and see what was happening and we see real nice really nice dose dependent decrease in CDA T cells. The Steve said this is true.
Our mind, the only or two targeted agent that is is the.
As shown to be driving expansion of T cells in the tumor microenvironment. We also have developed a very useful biomarker and soluble for BP, which can be tracked in the blood of patients index demonstrates target engagement on our form BB mechanism of action and.
Very important for us those PD carloads are are also correlation with clinical benefits. So we're seeing patients kind of the expansion of CD eight T cells on the expansion of for MBP gaming clinical benefit from our agents as Steve said the monotherapy activity.
As to our minds very compelling.
What's also compelling is that were driving that for BB agonism and of her two low staffing as well and that has really allowed us to.
Go for this two armed gastric.
For study.
And in terms of the.
The first arm there, we will combine with round the surmount paclitaxel, we've set of or 50.
50% of Gray search and we believe that's achievable based on not very unique mechanism of action, which will complement the bulging of the the <unk>.
Chemotherapy and the.
Vascular normalization that will come west for a mature market in terms of what else have we learned from from the study well we've learned that we can combine with two cut net.
The way with with <unk>.
Our preclinical data showing the we can drive strong for BB agonism.
Uh huh.
Fairly low her two receptor density and when we look forward into the other studies, we're certainly bringing all of that biomarker data warehouse, we know what to expect from a tumor microenvironment perspective, we know that we can drive the NK population, we can drive sort of talks.
The T cells and therefore, it has allowed us with regard to Prs three for four to setup.
On a very very nice biomarker strategy, there as well in terms of how are the however.
Are we feeling the buys while others are doing will certainly we failed us for Bebe is very relevant of the data coming out from capacity were trials.
Is also confirming that so we will use all of the data that we've generated all of the knowledge, we have of foreign BB too.
How about how the smart design, there, but in terms of.
In terms of PDL, one for BP in particular, we've certainly developed the molecule, which we believe.
How is the other.
Compelling.
Activity profile based on what we shared us ACR this year on.
We look forward to taking that into the clinic later this year as Steve said, we've also got the Boston Pharmaceuticals collaboration where we bring the.
For the GPC three molecule forward all of the biomarker assays, we've setup for sidra are certainly relevant there.
We will collaborate very closely with Boston farmers, who ensure that Dr. Clinical trial design takes full advantage of them.
Thanks for the class.
Just one follow up we've had I think at least two competitors in the PD lone but for me the space has to pick a record of two dose kind of below what you would expect the saturate.
The PD L. One.
The receptor or at least for inhibit that pathway.
Do you think $3 44, we'll be able to overcome that or do you think it's okay to kind of fall in the middle.
Dose range on the the PD L. One side.
Yes, so to your question on on the.
Forwards and the.
Recommended phase two dose of the of the competitor molecules on the safety profile as the day of observed in the clinic, we certainly ought to be aware of the fact that of PDL on foreign BB by specific is going to be very potent we see of pre clinically.
It drives T cells.
And two of proliferative burst and also really changes of phenotype. So it's going to be very powerful by specific in terms of our molecule. We certainly go on with a moderate affinity for Bebe agonist, which we feel is appropriate for activating the pathway.
We have to wait for the clinic to read out to see where with US what that plays out like from a safety perspective in terms of do you need to saturates the checkpoint the arm here well preclinical data, which suggests noss preclinical data would suggest that you can gas very strong activation.
Of the.
The T cell compartment without saturation the the.
The checkpoint arm, so I would say that there's there's opportunities to go forwards without saturation of the arm in terms of therapeutic window. There may be small nuances between the different different people's approaches, but in essence, we of select a reduction of the clinic.
Thanks for that.
There are no additional questions at this time I would like to turn the call back the Steve Yoder for closing remarks.
Okay, well I just want to thank everyone again for your attention and for your continued support of Paris I wish you all the great day. Thank you for participating today.
This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.
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