Q2 2022 Infinity Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, thank you for standing by welcome to the Infinity Pharmaceuticals conference call to discuss the company's second quarter 2022 financial results and business update my name is Joseph and I'll be your operator for today's call. At this time all participants are in a listen only mode.
It'll be a question and answer session to follow please be advised this call is being recorded at <unk> request now I would like to introduce your host for today's call Jayne Kauffman. Please go ahead.
Thank you Joseph and good afternoon, everyone welcome to today's call to discuss our recent business progress and review of our second quarter 2022 financial results and company highlights on the call with me today are Abilene Perkins, Chief Executive Officer, and Chair, Larry Bloch, President and Robert a Lora you June.
And your Chief Medical Officer will open up the call for Q&A following our remarks.
The press release issued today details our financial results and is available on our website at <unk> Dot com.
Note that during this call we may make forward looking statements about our future expectations and plans, including clinical clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and financial projections.
Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factors section of our annual report on Form 10-K for 2021 and in other filings, we make with the F. T C.
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise now I'd like to turn the call over to Abilene.
Thanks, Jay and thanks to everyone for joining us today to review <unk> second quarter 2022 business update.
Our goal and Infinity has long been to bring again listen to patients who need better treatment.
Especially those who have derived little to no benefit from the first generation of immuno oncology therapies.
To achieve this goal as we discussed on our most recent call last may we.
We are focused on expanding the clinical evaluation of again a listed in additional solid tumors.
To maximize its value for patients.
And thereby for shareholders and we are pursuing potential partnerships to enable this.
We have two objectives and partnering.
First to expand the development of again listed across a broad array of solid tumors with a partner who shares our belief and the magnitude of the analysts have opportunity.
And is willing to fund an extensive R&D program.
Actually combining again with the with perspective partners drugs to create differentiated treatment regimens.
Second to establish a partnership structure.
Enables the creation of meaningful value for infinity shareholders.
Since our last quarterly call, we have completed our mid year strategic review.
And we've made the decision that we put a partnership in place prior to initiating new clinical trials for a couple of key reasons.
One is that we are in discussions with multiple potential partners and.
And given the breadth of activity, we've seen with the analysts said, we have multiple development option.
As such collaborating with prospective partners on our again with the clinical development strategy. So that we can accommodate their input on the prioritization and design of new studies, including decisions on which combination drug partners to use is very constructive.
In addition, and importantly, given current market dynamics. It has allowed us to increase our 2022 year end cash guidance.
And extend our cash runway into 2024.
Prior to starting new studies, we are focusing on operational resources on our ongoing clinical trial, Mario one Mario three and Mario 275.
Clinical and translational data we have presented from these studies.
So that analysts it is a unique immuno oncology therapeutic candidate for three notable reasons.
One we have a first in class therapy with on target activity.
And translational data showing that again, Melissa reprograms macrophages in the tumor microenvironment reduces immune suppression and activates and anti cancer immune response.
To the clinical data with the analysts it has demonstrated prolonged progression free survival and extended overall survival over current standards of care in multiple indications.
Including in a randomized controlled trial that allows us to see the distinct contribution they began with it over its combination drug partners.
Three and very importantly, again, a list that has been shown to have an acceptable and manageable safety profile in combination with other drugs, including in two and three drug combination regimens.
Reflective of these key attribute today, we are pleased to report positive updated results from the Mario 275, two year overall survival analysis.
In patients with Europe , Yale cancer, whose tumors progressed after treatment with a platinum based chemotherapy regimen.
We continue to see very encouraging and durable evidence of survival benefit over the standard of care control arm in this study with no new safety signals during the extended period of treatment, which Rob will review in detail.
By the end of this year, we will also review updated PFS data from our Mario three trial in frontline triple negative breast cancer patients with both PD Lone high and PD, one low tumors.
Which meaningfully will be a full year more mature since our last data cut in October of 2021.
We are increasingly encouraged by the data across a wide range of indications lines of therapy in combination, which continue to show a consistent trend of improved outcomes for patients in areas of great unmet need that Rob will now review.
Rob.
Okay.
Thank you Ashleigh and good afternoon, everyone.
The strength of our data across multiple indications and treatment settings continue.
Continues to provide solid evidence that again Elisa highly specific small molecule inhibitor of <unk> kinase gamma has the potential to be a transformative therapy immuno.
Immuno oncology.
The consistently positive clinical results, we have observed with a gander listen.
Paired with the translational medicine data demonstrating it in catalysts the reprograms macrophages.
Microenvironment and enhances immune activation are very encouraging.
Important to note that we have observed evidence of clinical benefit in both PDL, one negative tumors and tumors resistant to immune checkpoint inhibitors to patient populations underserved by checkpoint inhibitors today.
I would now like to review the positive updated results from Mario 275 randomized placebo controlled study in second line platinum resistant metastatic <unk> cancer.
Patients were randomized to treatment with either of Ghana with a questionable about Warner volt Mab plus placebo.
Last year, we provided the one year landmark survival data demonstrating that 59% of the patients were alive on the analyst first of all about tripping on prepay.
To 32% on the whole amount below.
We're pleased to share that we continue to see very encouraging and durable evidence a survival benefit in this study.
With 45% of patients on the again Alyssa plus the whole Mab arm alive at the two year landmark compared to 24% of patients, although the volt map control arm.
This benefit was also seen in the PDL, one negative tumors subgroup with 38% of those patients alive at two years on the analyst the placebo arm versus only 17% on the control arm.
Additionally, there were no new safety signals observed during the extended period.
Hi.
These results are important for several reasons.
First survival is the gold standard for treatment benefit oncology and we are observing durable long term survival benefit and a group of patients with few treatment options once their treatments become platinum reached their tumors become platinum resistant.
Second we are observing this impressive magnitude of benefit in a can.
<unk> study in which patients received the Gan Alyssa in combination with our highly relevant standard of care, Ebola that allowing us to see the benefit of adding again alyssa over novo about mono therapy.
And lastly, the positive data from Mario 275, and Euro few cancer.
<unk> PDL one negative tumors. This consistent with the positive results and PD, one negative T N B C. We reported last year and the San Antonio breast cancer Symposium.
These updated Mario 275 results support multiple potential opportunities for Ghana with a combination in Europe , new cancer indications and will play an important role in our conversations with potential partners about future development paths, we're getting on with it and your T O cancer.
Regarding our other important phase two study with.
Plan to provide an update on Mario three P. M. D. C data later this year.
This will be an important uptake since it will provide us the opportunity to convert.
Berm the continued durability of the encouraging P. F results. The <unk> results in both PDL, one positive and PD, one negative T N B C with a data cut approximately one year later than that news for <unk> 2021.
Now I'll turn the call over to Larry to review the second quarter financials.
Larry.
Thank you Rob.
The teams remained very disciplined and pressing good fiscal stewardship, which resulted in extending our cash runway into 2024.
And then in the second quarter 2022, it's India total cash of $56 6 million compared to $80 7 million at December 31, 2021.
Research and development expense for the second quarter of 2022 was $8 $8 million.
Compared to $8 million at the same period in 2021.
The increase was primarily related to higher compensation expense, mostly due to new hires during the period an increase in consulting expense, partially offset by a decrease in clinical development expenses.
In general and Administrate expense was $3 5 million for the second quarter of 2022.
As well as the second quarter of 2021.
Net loss for second quarter, 2022 was 12 million or basic and diluted loss per common share of <unk> 13.
Compared to a net loss of $11 3 million or basic and diluted loss per common share of <unk> 13.
Also in the same period of 2021.
I'll now provide updated financial guidance for 2022.
Net loss for 2022 is expected to range from 40% to $50 million, which is an improvement of $5 million.
In 2022 year end cash is expected to range from 35 million to $45 million, which is an improvement of $10 million.
If these financial guidance does not include additional financing or business development activities.
We are well positioned to execute our strategic initiatives and look forward to continuing to update you on our progress.
At this time, we can open the call up for questions operator.
At this time I'd like to remind everyone in order to ask a question press star and the number one on your telephone keypad.
Your first question comes from the line of Ted <unk>. Your line is open.
Great. Thank you very much.
Thanks for the update.
Wanted to get a sense for what needs remains to be done.
With respect to preparation for Mary or four.
Whether the partnership is a gating.
Giving event, just because whether or not you would want to buy them from a potential partner.
Our CNBC makes us first it makes the most sense for the first pivotal indication. Thanks.
Thanks for the question Ted Yes, we have made the decision that a strategic partnership.
Should be in place prior to initiating studies, we continue to advance the preparation for those studies, but as you would imagine given the number of different settings for which we've had encouraging activity with the analysts and the number of different partners. We're speaking with there are different views on how different.
Parties might prioritize and so we think it's very important to be able to incorporate prospective partners and the ultimate decision of who we partner with such that we're working on the studies that together, we've decided should be prioritized first so partnership comes first then the initiation.
<unk> studies.
But we are in parallel advancing advancing readiness for for the studies.
Perfect. Thank you.
Thank you.
Your next question comes from the line of Robyn car.
Your line is open.
Yeah.
Hi, Thanks for taking my question. So I guess I'll follow up with that just first say congratulations on the second year of data for Mario 275, that's impressive.
I guess this is three parts I apologize so number one.
It sounds like the partner will want to have a lot of control and spent a lot of money in multiple different tumor types.
Is a buy out rather than a partnership on the table because I feel like that's something we've seen more recently.
And the second question would be.
The discussions youre, having with these partnerships, especially since what is the gating factor for them are they waiting for like a follow up dataset like for this dataset for Mario or what are the things. They are looking for to fill more comfortable with their strategy here and I think the third which is sort of tangential maybe for Larry.
He is like you know how do you think about given the new.
Health care Forum.
How are companies thinking about that in terms of bringing things in where you may actually want small molecules and where you may actually want to go after frontline sort of like we're talking about rather than going lately.
Try to put these three things together, so M&A versus partnership.
Gating factors for a partnership deal and then how does health care reform are price reform factor it. Thanks.
Thanks, Robin So I'll take the first few and then turn it over to Larry.
With respect to what type of a partnership we'd be open to and whether we consider M&A. We really are focused on the two goals that we have so the two goals are expanding the development of the Gan analysts said, we believe it has the data to date have suggested it has a potential for very broad impact for patients and that's our number one.
One goal is to.
Realize that potential and number two to do it in a structure that allows meaningful value creation for our shareholders and there are a lot of different deal structures that could accommodate that so where we're considering everything and will come down in the final analysis on which of the options that we have we think best achieve those two goals. So we're not taking anything off.
Off the table.
With respect to gaining there is nothing thats gating right now none of our conversations have partners waiting for for example, additional data were building all of our conversations are building off of the data that we've presented to date, it's nice when it continues to mature nicely as we found.
Presenting today with Marriott to 75, but but waiting for additional maturation of the data is not gating. It's just.
Conversations that we're going through with the parties on what clinical development strategies and plans might makes sense in those conversations all have.
Their own cadence, so theres nothing thats.
Our stage gate for those.
And I'll, let Larry talk about how.
Health care reform might influence desk I'd say in general we think some of the aspects of reform like capping out of pocket costs is a plus but more globally concerned about any government price controls that could limit funds flow into the industry and therefore limit our innovation and I think.
You were asking Larry for something more specific about how it might.
Translate into what lines of therapy are of greatest interest so Larry.
Yes, so just to emphasize the fact that we do think there is some.
The benefit and obviously and costs associated with.
The.
The new legislation.
We are we are focused on.
First in class best in class medications.
Those are non triple expense and so anything that limits reimbursement.
Excessively is going to have a negative impact at least in the margin on.
On innovative new medicines, and having just gone through this.
First couple of rounds of Covid I think we all appreciate how important is to have access to cutting edge technologies. When it comes to medical challenges and that certainly includes the.
Everyone colleges that we're focused on.
It doesn't fundamentally effects are.
As a first order prioritization of our of our clinical studies, because we really think the most important thing for US is to is to follow the data.
So as Robert said.
We started off in the later lines.
With the <unk> one patients.
Patients who had fourth.
Hence line prior therapies.
And move towards the second line with Mario 275, and with Mario three TWC in the frontline and while there is.
We think that the greatest benefit can be had by having patients getting first access two gigawatts of this part of the initial.
Regimen, we think theres, a broad potential across multiple indications and lines of therapy, and so having having invested in gigawatts of development from.
The labs through the phase two closed what we've had it's really now about focusing on following the data which is.
Clinical.
Translational as well as the prequel that we generated in the <unk>.
Reimbursement landscape is really tertiary concern for us.
Sorry can I just ask a quick follow up that I think all of us are wondering.
Obviously some of the combinations you are talking about those drugs will go off patent eventually right. So.
And Europe , a pill versus like an antibody therapeutics.
The question becomes are you seeing any discuss discussions any changes toward pills versus biologics and that is a broader question. It was really give a lot of.
Clarity, we're all asking that question and then.
With pills in biologics you can't co formulate some times. So that's another question like are there any ideas around how you Keith.
Keep that revenue stream longer than a nine year revenue stream I'm, just curious because none of us have any insight into those two things and maybe you don't either I don't know.
Well, let me start Robin with that because there are a number of advantages to pills and.
Rob I may ask you to.
I will ask you to follow up as well.
The advantages are of course.
Especially with again, a listen it's a very simple once a day oral administration. It's also very helpful for doctors in managing patient care, because if there is any need for it.
Dose reduction or a drug holiday, that's much easier to do with small molecules and antibody.
And the cost of manufacturing is of course, much lower so theres a lot of treatment advantages and cost of manufacturing advantages to small molecules.
And so we found that that's a real plus for again alissa.
Rob do you want to elaborate on why you see as a treating physician advantage just small molecules and then we can wrap up with any implications for health care reform.
Oh sure.
No I think you bring up some great points.
Okay.
Okay.
Okay.
Thank you Mark.
Things like that but I think it's great.
Ladies.
Sure.
It might be efficient.
Rob Youre breaking up a bit.
Oh, sorry.
Can you hear me now volatile it little better.
Okay sorry.
I think that.
One of the most important factors in patient convenience, particularly patients with cancer.
Going too.
Do things at home with your family and work and things like that I think having the flexibility of an oral drug youre not having to come into an infusion area. We.
Ours in line to get your infusion.
There is an ability to have very flexible follow up with your physician you can make can easily dose changes either even though with a phone you can call. Your physicians say I'm, having this in this problem physician can say oh hold your pills into ICU or something like that so I think there's a great deal of flex.
<unk> ability with an oral molecule from a patient perspective.
So that all speaks robin to the value and there's a lot of value to small molecules and at the end of the day pricing should be reflective of value and then of course, there are lower cost of manufacturing. So we think those are all pluses in the overall healthcare reform.
So just in terms of the.
Policy level at the federal and even the.
International level is the small molecules as well as emphasizing about the convenience for patients in many settings outside of the first world.
Refrigeration can be.
Hey.
Kindred to patient access.
Infusion can obviously be a hindrance to patient access and so when we're talking about global health.
Including oncology small molecules are clearly the gold standard.
Yes.
Thank you.
Yeah.
Your next question comes from the line of Qatar.
Your line is open.
Good afternoon. This is Andy on for Culp at.
<unk> for taking questions, maybe one on the regulatory side preparing for Registrational studies, you've previously mentioned that it can be beneficial to have one company kind of driving the regulatory process and having to take place in parallel to you any potential BD activity.
To get a sense of where you guys are currently at <unk> in terms of aligning with regulatory agencies on the key endpoints and design for Registrational studies.
Yes. Thank you for the question so in light of our decision to finalize the clinical development strategy. The prioritization of studies and the design of those studies.
Until we've put a strategic partnership in place, obviously and naturally will peak FDA feedback after we've received and incorporate a potential partner.
So.
Got it.
While it has long been our policy that we don't discuss any ongoing regulatory interactions. In this case I can tell you that we have not yet sought regulatory feedback on a registration study.
That's helpful. Thank you.
Youre welcome.
Thank you.
At this time I'm showing no further questions I would like to turn the call back over to ethylene for closing remarks.
Thank you Joseph and thank you to everyone for joining US today, we're very fortunate to be with developing a promising therapy with the potential to improve the quality and length of life for people with cancer, we remain committed to realizing the value of the Gan Elisa for the benefit of patients and a result, bringing value to shareholders.
To think the infinity team, our investigators our trial sites as well as our investors and most importantly, the people participating in our clinical studies and their families who have all played integral world and advancing our work to bring better treatments to patients. We look forward to updating you on our progress in the coming months.
And thank you for your continued support.
Have a nice night.
This concludes the conference call and you may now disconnect.
Yeah.
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Oh.
Yes.
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