Q3 2024 Syros Pharmaceuticals Inc Earnings Call
Good morning and welcome to the Sirus Pharmaceutical, 3rd quarter, 2024 financial results conference call. At this time, all participants are in elicine-only mode.
Note that this call is being webcast live on the investors and media section of Seros website at www.seros.com
Speaker Change: Please be advised that today's call is being recorded. At this time, I would like to turn the call over to Karen Hunady, director of investor relations and corporate communications at Cero's. Please go ahead.
Karen Hunady: Thank you. This morning, we issued a press release announcing our third quarter 2024 financial results. The full release is available on the investors and media section of Ferris' website at www.seros.com.
Speaker Change: We will begin the call with prepared remarks by Conley Chee, our chief executive officer, Dr. David Roth, our chief medical officer, and Jason Haas, our chief financial officer.
Karen Hunady: We will then open the call for questions. Kristen Stevens, our Chief Development Officer, is also here on the call with us today and will be available for Q&A.
Speaker Change: Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward looking statements.
Speaker Change: Actual events or results could differ materialially from those expressed or implied by any forward-looking statements.
Speaker Change: as a result of various risks on certainties and other factors.
Speaker Change: including those set forth in the risk factor section of a quarterly report on Form 10Q that we filed this morning. Our annual report on Form 10K that we filed earlier in the year and any other filings that we may make with the OCC in the future.
Speaker Change: Any Forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward-looking statements.
Speaker Change: With that, I'd now like to turn the call over to Conley Chee, Conley?
Conley Chee: Thank you Karen.
Conley Chee: Good morning everyone and thank you for joining us.
Conley Chee: Throughout the third quarter and recent weeks, we continue to advance our mission to develop and deliver Tammy Baritine as a new standard of care for the frontline treatment of newly diagnosed higher risk MDS patients with raw-raging over expression.
Conley Chee: which we believe represents approximately 50% of the higher risk population.
Conley Chee: These are exciting times at Sarah's as we are nearing the pivotal data read out from our ongoing select MDS-1 phase 3 trial in mid-November.
Conley Chee: This is a significant milestone in our work, and one we expect will be transformative for a company. As you know, there remains a tremendous undmittened for higher risk MDS patients, whose disease is often progressive and associated with a poor prognosis.
Conley Chee: They're very few frontline therapies in late stage development and no new treatments beyond hypometallating agents have been approved in over a decade.
Conley Chee: The current standard of care is a site of e-in, is an HMA that has only demonstrated a 17% complete response rate, leaving significant unmet need.
Conley Chee: Patients of physicians are seeking new treatment options that can enhance clinical outcomes without compromising safety and tolerability.
Conley Chee: We believe Tammy Berking has the potential to alter the current treatment paradigm and provide patients with a well tolerated and convenient therapeutic option that can induce durable response and a better disease control.
Conley Chee: With approximately 9,000 higher risk MDS patients diagnosed in the U.S. each year, we believe there's a significant commercial opportunity for Tammy Barritine.
Conley Chee: By 2020, we've spent a total of market opportunity for higher risk MDS therapeutics in the US will be approximately $1.6 billion.
Conley Chee: And the market opportunity for Tammy Baratine in the US for patients with raw, raw, overexpression will be over $800 million.
Conley Chee: As we approach our pivotal data, we are working diligently to prepare for our first MDA filing and to launch Tammy Barritine in the U.S. through our own commercial efforts.
Conley Chee: Once approved, our goal is to move quickly to deliver Tammy Baritine to the thousands of higher risk MDS patients with a raw, raw, overexpression awaiting better treatment options.
Conley Chee: We're really looking forward to announcing our data in the coming weeks.
Speaker Change: With that, I'll turn it over to David to review our MDS program and upcoming milestones in greater detail. David?
David Roth: Thank you, Conley.
David Roth: We are encouraged by the progress we've made in advancing Tammy Baratine, our oral, selective RAR alpha agonist, as a potential new standard of care for higher risk MDS patients with RAR over expression and look forward to the upcoming data from the Select MDS One trial.
David Roth: As a reminder, select MDS1 is a global, randomized, double-blind placebo controlled trial, evaluating the combination of Tammy Baratine and AESA CIDA Dean compared to placebo when AESA CIDA Dean.
David Roth: The Trials Primary Efficacy Endpoint is completely sponsored or CR.
David Roth: Based on the analysis of the initial 190 enrolled patients, which together with supporting durability data can potentially serve as the basis for accelerated approval or full approval in the U.S.
David Roth: The trial will continue to enroll up to 550 patients for the key secondary endpoint of overall survival. And we're happy to report that global enrollment at over 130 sites continues to go very well.
David Roth: The primary endpoint of CR is an important and clinically meaningful efficacy endpoint due to its correlation with overall survival, as well as improvements in peripheral blood counts.
David Roth: Taking together the clinical benefits associated with achieving a CR are compelling and reinforce our confidence in the potential of our select MDS1 trial if successful to address significant unmet need.
David Roth: The Select MDS-1 Files passed a pre-specified futility analysis in the first quarter of 2024 based on the primary endpoint.
David Roth: These data, along with the favorable tolerability profile observed in previous trials, support our conviction in using the double-it strategy of Tammy Baritine plus A'sucitidine in higher risk MDS.
David Roth: We're excited for these patients who have waited years for new therapeutic advancements for their condition.
Speaker Change: We are often asked by investors how should we interpret the results that you're planning to share with us in mid-no-vember or what kind of outcome are you hoping for?
Speaker Change: We believe that a successful pivotal trial result is not only one that hits its primary endpoint, but one that offers a generally well-tell-rated safety profile.
Speaker Change: A positive trial would excite the medical community and will be met with enthusiasm by prescribers. In particular, no new treatments in front-line higher risk MDS beyond HMAs have been approved in over a decade.
Speaker Change: In our recent medical expert event held in June, and in additional conversations we've had with physicians, it was emphasized that a successful trial result that achieves our primary end point would be clinically meaningful and likely drive strong usage.
Speaker Change: They highlighted the challenges with existing therapies due to limited efficacy, the need for well-tallurated therapies that can be given over long periods of time and the exciting prospect for a first-ever targeted agent for use in this population.
Speaker Change: Based on these considerations, we believe Tammy Baritine correctly become a standard of care.
Speaker Change: As you can imagine, we're very excited to report these pivotal data in November, as they are expected to move us one step closer to bringing this potentially transformative drug to patients.
Speaker Change: I would now like to turn the call over to Jason, our Chief Financial Officer, to review our third quarter financial results.
Speaker Change: Jason?
Jason Haas: Thank you, David. Now turning to our third quarter financial results.
Jason Haas: We didn't recognize any revenue in the third quarter of 2024 as compared to recognizing revenue of $3.8 million in the third quarter of 2023.
Jason Haas: The decrease reflex last year's termination of cirrhosis collaboration agreement with Pfizer.
Jason Haas: R&D expenses were $20.5 million in the third quarter of 2024, as compared to $28.3 million in the third quarter of 2023.
Jason Haas: The decrease was primarily due to the reduction in external R&D, consulting, contract manufacturing, and every reduction in head counts and related expenses.
Jason Haas: Our R&D expenditures are now principally focused on the advancement of time of
Jason Haas: G&A expenses were $5.7 million in the third quarter of 2024, as compared to $7.8 million in the third quarter of 2023. The decrease was principally due to a reduction in headcount and related expenses, consulting and facilities expenses.
Jason Haas: We reported a net loss for the third quarter of 2024 of $6.4 million, or 16 cents per share, compared to a net loss of $40.1 million, or a dollar 43 per share for the same period in 2023.
Jason Haas: Cash and Cash Equivalence as a September 30th, 2024, were $58.3 million as compared with $79 million as of June 30th, 2024.
Jason Haas: We believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into the third quarter of 2025. With that, I will turn the call over to the operator for questions.
Speaker Change: Thank you sir. Ladies and gentlemen, if you would like to ask a question, please press star, followed by one on your touchstone phone. You will then hear a three-tone prompt, I'm sorry. You will hear a prompt that your hand has been raised.
Speaker Change: and if you should wish to decline from the polling process, please press star followed by two. And if you are using a speaker phone, we do after you please lift the handset before pressing any keys. Please go ahead and press star one now if you do have any questions.
Speaker Change: First, we will hear from Ted Ben Hoff at Piper's Sandler. Please go ahead, Ted.
Speaker Change: Great, thank you very much and I appreciate you taking the question, excited for data coming up right away on the corner here. I just want to kind of re-emphasize this and maybe you can walk us back through what's the historical...
Speaker Change: is a controls our...
Speaker Change: in both on the label and then also most recent clinical experience. And how should we interpret the AML results?
Speaker Change: in terms of how they could give us a sense for what you could show in.
Speaker Change: Higher Risk and the F Thanks.
Speaker Change: Thanks, Ted, this is David, I'm happy to answer your question. So with respect to the AESA control data, the AESA label has a complete remission rate of 17%
Speaker Change: and that has been an accepted regulatory standard true.
Speaker Change: Use as a benchmark for the control.
Speaker Change: and Randomized Trial. There's been...
Speaker Change: Meta analyses with hundreds of trials looked at and they...
Speaker Change: C.R. Rape is the same. Obviously there's variation from trial to trial and in more recent trials we've seen some have reported up in the low 20% range.
Speaker Change: More recently I believe one of the trials had to see our rate in the control arm of 14% So we're very comfortable that something in the mid to high teams is likely going to be the type of C.R. rate one could anticipate.
Speaker Change: Also, if you look at some of the publications, the literature, for instance.
Speaker Change: The Summinal Paper, the Lancet Oncology Paper, that reported on the pivotal outcomes of the higher risk MDS population that is included as part of the package of data in the AESA label. You know, the duration of response.
Speaker Change: is, is rather short. I believe the Aza on had about a 3.2 month, you know, time for respawns duration compared to the control arm of three months, but that was also for a CR plus PR, not just CR.
Speaker Change: I keep in mind the time to onset of response phrase is typically relatively long. It could be anywhere in a four to five or four to six month range. So, you know, duration of therapy can be somewhat longer because it will take on that the better part of a half year to achieve your response.
Speaker Change: and last for several months and you may continue there after Christmas, and we still have some benefit. So those are the types of expectations for the A's of performance in the control. Now, if you can just please, I'm sorry, I didn't jot the note down what your second party or question was, I'm happy to answer that one.
Speaker Change: Well, that's really helpful and then second part was just in terms of looking at the
Speaker Change: How can we sort of infer from that to MDS if we even can?
Speaker Change: Yeah, so the AML experiment was really an experiment to see if we can leverage the apoptotic mechanism that we've seen when we've combined.
Speaker Change: Tammy Barrican and Azza with that of the Nettaclacks. The idea was that we have very high CRC alarm rates in CR rates with Tammy and Azza, and the Nettaclacks itself has a similarly high rate in the mid 60% range.
Speaker Change: in New Udigmost on today. And also by combining all three could we do even better. And we set up a randomized phase two to see whether we can push the envelope on that.
Speaker Change: and that. You know, the outcome of that study demonstrated that we're essentially maxed out on what one could achieve. So we don't review that as having any, you know.
Speaker Change: and the MDS trial is a totally different experiment.
Speaker Change: It's testing the doble of Tamian A's and the nonexlux is not a part of that experiment. And so we really don't see a relationship between the AMO outcome.
Speaker Change: and the Van der Glacau. You know, that said we still continue to see high responses in a Tammy based regimen that occur quickly and we did have some encouraging activity even in the context of that ML data set which included nice durations of response.
Speaker Change: Relative to the control on things about nature and we also saw it.
Speaker Change: Rescue Responsives for Patients who had been on the conform.
Speaker Change: who initially had responses to Ven and Aza who then lost their response, just adding town into the regiment, while continuing Ven and Aza, enabled them to restore their complete mission. And at the time of our report, I believe one patient had been back out about a year at that point another about six months.
Speaker Change: and we're having weekend responses. So we really feel that those are very important to you. And the last comment I'll say about that trial result, which is important, has to do with safety.
Speaker Change: So as you know, we don't believe that Tammy and I are...
Speaker Change: Challenging. The regimen is generally well tolerated, easily administered, it's convenient. And we saw no evidence of added violence suppression, even in the backdrop of a regimen containing venevitaclacks. And for more perspective, that's a very important.
Speaker Change: and Alcom because it really just points to the tolerability of a Tony-based regimen.
Speaker Change: and the appropriateness for its use should our data support it.
Speaker Change: and a population like higher risk on DS, where patients are generally elderly, often have other medical conditions and comorbidities that make it complicated to give them challenging regimens.
Speaker Change: and the absence of added in my list of pressure and is really important in these patients because that's often the main problem they have at the beginning of their illness suffering from side-to-peans.
Speaker Change: and their complications. So, all told we're very excited about our MDS experiment coming to fruition in just a few weeks and we're really looking forward to sharing those outcomes with you.
Speaker Change: I appreciate all my color doing things. Yep, you're welcome.
Speaker Change: Thank you.
Speaker Change: Next question, will we from Phil Nado at TD Cowen? Please go ahead.
Speaker Change: Good morning, thanks for taking our question and let us reiterate what Ted said really exciting times.
Speaker Change: Welcome from to the data. I guess first question is, on that data release, can you give us some sense of what you'll be able to discover, presumably, see our rate in safety, but also how much durability data will you have and anything else that you might be able to put in that press release?
Speaker Change: Thanks again for that question. Again, just for anyone who's listening that doesn't have as much...
Speaker Change: and ConTech, I just want to repeat just to remind everybody. So this trial is a global randomized placebo controlled trial of Tammy, plus A's versus placebo, plus A's. Our primary endpoint is the complete admission rate, the CR rate.
Speaker Change: We're in mid November, we're planning to report the pivotal primary and point outcome of the CR rate across those two arms.
Speaker Change: and this is going to be evaluating the first 190 in roll patients but our study continues to enroll, we're targeting a total of 550 to support a future evaluation of the key secondary and point of survival over also.
Speaker Change: So one thing I will, on GoFase, we will not have over-all survival at the time of our top line, we didn't know that, so you should not anticipate hearing about that.
Speaker Change: and that's still an experiment in progress.
Speaker Change: But we do expect to have other secondary endpoints that are important for you to understand our CR results. So just like you're a suggesting, we will obviously have...
Speaker Change: Daydata around the duration of complete response.
Speaker Change: How quickly it occurs and at the time to complete response, we may have information as well about.
Speaker Change: We overall response rate, which may include other responses in addition to the CR like PR and human improvement. And importantly, and as I mentioned in my prior response, we're going to have safety data to share.
Speaker Change: And we think this is going to be critically important for you to appreciate. I know everyone is very focused on efficacy, but in this population safety is equally important.
Speaker Change: and I think that it's critical to look forward to hearing about that as well. These, again, are elderly patients often with other comorbidities and taking together, I think you're going to have a very solid understanding.
Speaker Change: of Hal Timmy Barrettine is working in these patients with a raw routine of expression and other risk-embeasts. So, again, looking forward to sharing it all with you.
Speaker Change: That's very helpful and then, in terms of the FDA filing, what do you need to do? Post the release of this primary and point data in order to file. Are there other?
Speaker Change: All the things that also have to be completed that are getting to the filing and secondarily, would you need to have a new pre-endie meeting with the FDA prior to filing?
Speaker Change: Obviously, we will have completed pulling in all of the data that has been thoroughly corroborated and validated. So when you hear about the information, you can assume it's perfect.
Speaker Change: I know that we're all working hard toward that end.
Speaker Change: and then you know there are the routine regulatory interactions, there's nothing unusual that we need to do just to go through and make sure everything's buttoned down. We made great progress toward that objective and one I can say is we'll be working as hard as possible and as quickly as possible to get that submission.
Speaker Change: in good order, so I'm about to reuse as efficient and straightforward as possible.
Speaker Change: Perfect, thanks for taking our questions and we look forward to the day.
Speaker Change: Thank you. Next question will be from Jason Butler at GMT Citizens. Please go ahead.
Jason Butler: Hi, thanks for taking the questions and let me add my...
Jason Butler: and Conley Chee, you know excited to see the data very soon. And if you maybe just talk about the commercial work that you're doing and we'll do over the month following the release of results if they're positive, you know, getting ready for commercial launch of Temi, Farrot Cine and MBS, thanks.
Speaker Change: Thanks for watching!
Jason Haas: Yeah, thanks Jason for the question, Conley Gears.
Conley Chee: Yeah, our team has been working for Roathley for last year or so preparing for the launch and we have a very detailed plan.
Conley Chee: going forward to ensure that we have brought access to our drugs and we can get it to patients. We've already been conducting a lot of activity I would say, prior to data, post-stata, we will be accelerating a lot of that work as well. I would say comes in the several buckets.
Conley Chee: First, sort of market awareness and ensuring that there's education around Robo Biology and the effects of overexpression. We are continuing to size up the field force and looking at our infrastructure and how we'll build that to support our commercial opportunity.
Conley Chee: And then lastly, the brand plan and obviously ensuring that there's manufacturing milestones are being hit so that we have drugs at launch and also our diagnostic to ensure that that's readily available for patients as well as physicians.
Speaker Change: Great thanks for taking the question.
Speaker Change: Thank you. Next question will be from Lee Akkan at Brookline Capital Market. Please go ahead.
Lee Akkan: Thank you and good morning. So two questions, the first on Tammy Barricine, is there any plan?
Lee Akkan: 2, Edom Medical Meeting, or some sort of presentation to show more of the detail of the data from the recent AML results. And my second question is...
Lee Akkan: Something from the past, 56-09. I know it's been on the back burner, but if there's any thoughts or plans for how that could.
Speaker Change: and we'll see you next week. We'll see you next week.
Speaker Change: Thanks, I'll take the first one and maybe not aware of the we did present.
Speaker Change: of the complete data outcome from the AML after so-home meeting.
Speaker Change: which happened shortly after our data disclosure. So I think that should be available and we're happy to address any questions you may have about that if you haven't had a chance to look at that yet.
Speaker Change: and the state of thinking, yes, I do have those data apologies. Okay, yeah, not no problem. And then for the second one about 56 and 90, oh, um...
Speaker Change: I'll turn that one out to it. Conley.
Conley: Yeah, I can trip in on that one. Yeah, 56 or nine is a tremendous asset with high potential. And we believe could be the best in class, CDK seven.
Conley: I think you know with this asset there's this tremendous potential across multiple tumors.
Conley: and to fully prosecute all of this potential, it's better suited in the hands of a larger farm company that has the resources to do that and so we continue to look for a business development opportunities for that asset.
Conley: Thank you.
Speaker Change: Thank you. At this time we have no other questions for the stirred, I will turn to call back over to Mr. Conley Chee.
Conley Chee: Okay, thank you operator and thank you everyone for joining and for continuing support of Syros, it's a very exciting time here for us and potentially for the thousands of higher risk MDS patients waiting for a better treatment option.
Conley Chee: As always, please reach out to the team if you have any further questions and have a great Halloween.
Speaker Change: Thank you. Thank you. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask to cheer please disconnect your lines.