Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) Q1 2023 Earnings Call Transcript

Syros Pharmaceuticals, Inc. (NASDAQ:SYRS) Q1 2023 Earnings Call Transcript May 10, 2023

Syros Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $-0.85, expectations were $-1.09.

Operator: Good morning, and welcome to Syros Pharmaceuticals’ First Quarter 2023 Financial Results Conference Call. [Operator Instructions]. This call is being webcast live on the Investors and Media section of Syros’ website at www.syros.com. 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 Syros.

Karen Hunady: Thank you. This morning, we issued a press release announcing our first quarter 2023 financial results and business update. The full release is available on the Investor and Media section of Syros’ website at www.syros.com. We will begin the call with prepared remarks by Dr. Nancy Simonian, our Chief Executive Officer; Dr. David Roth, our Chief Medical Officer; and Jason Haas, our Chief Financial Officer. We will then open the call for questions. Christian Stevens, our Chief Development Officer; Dr. Eric Olson, our Chief Scientific Officer; and Conley Chee, our Chief Commercial Officer, are also on the call and will be available for Q&A. Before we begin, I would like to remind everyone that the statements we make on this conference call will include forward-looking statements.

Actual events or results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties and other factors, including those set forth in the Risk Factors section of our annual report on Form 10-K and our quarterly report on Form 10-Q that we filed this morning and any other filings that we may make with the SEC in the future. 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. I would now like to turn the call over to Nancy.

Nancy Simonian: Thank you, Karen. Good morning, everyone, and thank you for joining us today. 2023 is off to a strong start as we focus on clinical execution and move closer to our goal of delivering new standards of care for the frontline treatment of hematologic malignancies. Today, we will be sharing progress with you across our programs in MDS, AML and APL. We are excited about our continued progress on enrollment in our SELECT-MDS-1 trial, and we remain on track to complete enrollment of the 190 patients in the fourth quarter of this year and to announce pivotal complete response data from SELECT-MDS-1 trial in the third quarter of 2024. We recently amended the protocol for the SELECT-MDS-1 trial to include overall survival as a key secondary endpoint.

The primary endpoint of the trial remains complete response in 190 patients. By including overall survival as a key secondary endpoint, we have the potential to convert an accelerated approval based on CR to a full approval based on OS, if warranted, using an efficient one trial design. Importantly, this amendment does not impact the timing of our pivotal CR data from SELECT-MDS-1. David will provide additional details on the amended protocol shortly. Turning to our efforts in AML, following promising data from the safety lead-in, we initiated the randomized portion of the Phase II trial last quarter. We continue to expect initial data from this trial in the fourth quarter of this year followed by additional data in 2024. We also remain on track to provide an update on the dose confirmation study of 2101 in APL as was the next steps on a registration pathway in the second half of this year.

Taken together, these upcoming milestones lay the groundwork for multiple catalysts over the upcoming 12 to 18 months in which we will progress and turn over cards on each of our lead programs and move closer to our ultimate goal of delivering effective, well-tolerated and convenient therapies to targeted patient populations in need of better options. We believe MDS, AML and APL each represent significant market opportunities in the frontline setting, which we are well positioned to address through our own commercial efforts in the United States. With that, I’d like to turn the call over to David to provide a more detailed update on our ongoing clinical programs. David?

David Roth: Thank you, Nancy. Today, I will focus on the amended protocol for the SELECT-MDS-1 Phase III trial, which is evaluating the combination of tamibarotene and azacitidine in newly diagnosed higher-risk MDS patients with RARA overexpression, which we believe represents approximately 50% of patients with higher-risk MDS. As a reminder, the study is a double-blind placebo-controlled trial evaluating tamibarotene plus azacitidine versus placebo plus azacitidine. As Nancy mentioned, we recently amended the study protocol to include overall survival as a key secondary endpoint, while continuing to use complete response as the primary endpoint for potential approval. Recent FDA’s feedback continues to support our use of complete response rate as an appropriate primary efficacy endpoint for either full or accelerated approval with supporting data on durability of complete response and CR rate will remain the primary endpoint in our study.

That said, if tamibarotene receives accelerated approval, the addition of overall survival as a key secondary endpoint in the same study could allow SELECT-MDS-1 to also confirm clinical benefit to support full approval in the future, potentially avoiding the need for a separate confirmatory study. The use of a single randomized controlled trial to support potential accelerated approval and subsequent conversion to a full approval, if needed, is also consistent with recently issued draft FDA guidance on the clinical trial consideration to support accelerated approval of oncology therapeutics. This one-trial approach offers many advantages over a separate confirmatory trial, allowing us to include the 190 patients enrolled to support the primary CR endpoint to also support the confirmatory endpoint.

This ensures consistency of the patient population that support the primary and secondary analyses since they are all enrolled in the same protocol at the same sites by the same instigators and with identical eligibility criteria. It also provides the FDA assurances that we are well underway with the delivery of our confirmatory data to provide them with increased confidence when evaluating our primary endpoint data for regulatory decision-making. In addition to this being a more efficient way to confirm clinical benefit, a one-trial design has additional advantages for potentially speeding the delivery of confirmatory data and limiting trial-related costs and expenses. Under the amended protocol, SELECT-MDS-1 will enroll a total of 550 newly diagnosed higher-risk MDS patients, including the initial 190 patients supporting the primary endpoint to power the study for key secondary endpoint.

Importantly, and as Nancy mentioned, we continue to expect that we will complete enrollment of the initial 190 patients necessary to support approval either accelerated or full using a CR endpoint in the fourth quarter of this year and then report pivotal CR data in the third quarter of 2024. As we discussed last quarter, in January 2023, the FDA granted Fast Track designation to tamibarotene for the treatment of higher-risk MDS. This designation provides us with several advantages, including priority review time lines and further underscores the critical need for new treatment options for this patient population, a group that has been underserved by available therapies. Again, the existing standard of care hypomethylating agents offer only a 17% complete response rate and a median survival of 18.6 months and no more therapies beyond HMAs have been approved since 2006.

Turning to our study of tamibarotene in AML. We’ve previously announced that we had initiated the randomized portion of the study in newly diagnosed unfit AML patients with RARA overexpression. Like higher-risk MDS, AML represents a significant unmet medical need. Of the patients diagnosed with unfit AML, approximately 1/3 do not respond to upfront treatment with ven/aza, and a majority of those with initial responses ultimately relapse. These patients have a very poor prognosis with median overall survival rates of only 2.4 months. As we announced late last year in the safety leading portion of SELECT-AML-1, the triplet combination of tamibarotene and ven/aza demonstrated an 83% CR/CRI rate with a rapid onset of action and no evidence of increased toxicity relative to historical data with ven/aza, including rates of myelosuppression.

These data underscore the potential of tamibarotene in combination with existing standard of care to deliver improved outcomes to the approximately 30% of AML patients who are positive for RARA overexpression. As a reminder, the randomized portion of the trial is designed to evaluate the safety and efficacy of tamibarotene in combination with ven/aza — compared to ven/aza in approximately 80 newly diagnosed unfit AML patients with RARA overexpression randomized 1:1 with a composite CR rate or the CR/CRI rate as the primary endpoint. We continue to remain on track to report initial data in the fourth quarter of this year with additional data expected in 2024. Lastly, I’ll turn to 2101, our novel oral form of arsenic trioxide, or ATO, which is currently being evaluated in an ongoing dose confirmation study for the frontline treatment of acute promyelocytic leukemia.

The current standard treatment regimen with intravenous ATO creates a significant burden for patients, involving up to 140 treatment infusions, each over 2 to 4 hours for nearly a year. We believe 2101 has the potential to offer a reduced treatment burden by providing patients an all oral regimen that is effective, while also increasing access and reducing heath care cost and utilization. We look forward to providing an update on the dose confirmation study in the second half of this year to describe the planned development path and timing for further evaluation of 2101 in a registration-enabling study in APL. With that, I would like to turn the call over to Jason to review our first quarter financial results. Jason?

Jason Haas: Thank you, David. Now turning to our first quarter financial results. We recognized $3 million in revenue in the first quarter of 2023, consisting entirely of revenue recognized under our collaboration with Pfizer. Syros recognized $5.5 million of revenue in the first quarter of 2022, consisting of $5.1 million in revenue recognized under our collaboration with Pfizer and $400,000 under our collaboration with Incyte. R&D expenses were $28.8 million in the first quarter of 2023 as compared to $25.2 million for the first quarter of 2022. This increase was primarily due to the advancement of the company’s late-stage clinical programs. Based on our current operating plans, we expect that our future R&D expenses relating to our drug discovery stage programs will continue to be reimbursed by our collaboration partners.

G&A expenses were $7.4 million in the first quarter of 2023 as compared to $6.9 million for the first quarter of 2022. The increase relates to supporting the advancement of our late-stage clinical programs. We reported a net loss for the first quarter of $23.8 million or $0.85 per share compared to a net loss of $25.1 million or $3.99 per share for the same period in 2022. Cash, cash equivalents and marketable securities as of March 31, 2023, were $166 million as compared with $202 million on December 31, 2022. We believe our current cash position will be sufficient to fund our anticipated operating expenses and capital expenditure requirements into 2025, which is beyond Phase III data from the SELECT-MDS-1 trial and initial data from the randomized portion of the SELECT-AML-1 trial.

With that, I will turn the call over to the operator for questions.

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Q&A Session

Operator: [Operator Instructions]. Your first question is from Phil Nadeau from TD Cowen.

Operator: The next one is from Ed Tenthoff from Piper Sandler.

Operator: Your next question is from Jason Butler from JMP Securities.

Operator: [Operator Instructions]. The next question is from Mark Breidenbach from Oppenheimer.

Operator: Thank you. There are no further questions at this time. I will now hand the call back to Nancy for closing remarks.

Nancy Simonian: Thank you, operator, and thank you, everyone, for joining us today and for your continued support at Syros. Please reach out to us with any further questions, and have a great day.

Operator: Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect.