Syros Pharmaceuticals, Inc.

Good day and welcome to the Q3 2022 Cirrus Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker, Ms. Karen Honody, Director of Corporate Communications and Investor Relations. Please go ahead.

Thank you. This morning, we issued a press release announcing our third quarter 2022 financial results and a broader business update. The release is available on the Investor and Media section of the CEROS website at www.ceros.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. Kristen 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. Thank you, Karen. Good morning, everyone, and thank you for joining us today.

The third quarter was transformative for CIRA. In September, we announced the concurrent close of our merger with Time Technologies and our oversubscribed PIPE financing. Together, these transactions netted approximately $190 million, providing us the necessary cash to continue investing in the clinical development of our late stage targeted hematology programs while also supporting initial launch readiness. Our goal has always been to build Cirrus into a commercial company. With this additional capital, we believe we are an important step closer to achieving this foundational vision and ultimately to delivering our portfolio of medicines to people living with cancer. Now I'll turn to the initial data we announced this morning from the safety-leading portion of our ongoing phase one trial, evaluating SY5609. As David will review shortly, these data provide further evidence that CDK7 inhibition is a potentially important therapeutic approach for treating pancreatic cancer, one of the most devastating and difficult to treat malignancies, as well as other difficult to treat tumor types. We're encouraged by 5609's emerging safety profile, both as a single and combination agent, and by the clinical activity we've observed in pancreatic cancer, with several patients achieving stable disease and one patient achieving a confirmed partial remission. We've yet reached a maximum tolerated dose as a single agent or in combination, and given the emerging exposure response relationship plan to continue dose escalation with both single-agent 5609 and in the doublet combination with gemcitabine. At the same time, we've always said that data from this Phase I trial, evaluated in the context of our own strategic priorities, will inform the best course for further development of this program. While we believe there is a strong rationale to advance 5609 in pancreatic cancer, as well as in other difficult to treat solid tumors, we believe this will be best done in the hands of a partner who has the resources to maximize the opportunity both in pancreatic cancer as well as additional combination regimens in tumor types. To that end, we plan to explore partnership opportunities while we continue to dose Escalate. We look forward to providing an update at the appropriate time in the future. Importantly, we are excited to continue to support Roche's ongoing arm, evaluating 5609 in combination with a kesalizumab in patients with BRAF mutant colorectal cancer in their Phase 1, 1B intrinsic trial. Turning to our hematology portfolio, as you know, tamiberitine is our selective and potent oral RA or ALTA agonist, which has the potential to offer a new standard of care to be approximately 50% of MDS and 30% of AML patients who are positive for RARA gene overexpression. We are currently evaluating camiberitin in two clinical trials. Select MDS1, a pivotal phase three trial in higher risk MDS patients, and select AML1, a phase two trial in newly diagnosed unfit AML patients. As we announced in a press release last week, We will be sharing initial data from the safety leading portion of the Select AML-1 trial at the ASH Annual Meeting in early December. We are highly encouraged by the initial clinical activity observed in this study to date. We initiated both the Select MDS-1 and Select AML-1 trials based on the belief that temibarotene in combination with hypomethylating agents alone and with venetoclax has the potential to improve clinical outcomes for MDS and AML patients with RARA overexpression. We previously reported Phase II data with temiberitone and azacitidine in newly diagnosed unfit AML patients with RARA overexpression, which showed a high CR-CRI rate with a rapid onset of action. And now we are excited by the early data from Select AML-1 trials, which, together with the data from our prior Phase II trials, support the potential for Tamiviridine to augment existing standards of care and meaningfully improve outcomes for both AML and higher-risk MDS patients. We look forward to presenting updated data from the Select AML-1 trial at ASH and request that you save any questions on data from our trial until our presentation on December 10th. Looking ahead, we continue to expect data from the Pivotal Select MDS-1 trial in late 2023 or early 2024, and to initiate the randomized portion of the Select AML-1 Phase 2 trial with data expected in 2023 or 2024. In addition, we are making good progress in our ongoing dose confirmation trial of FY2101, our novel oral form of arsenic trioxide, or ATO, for the treatment of frontline patients with acute promyelocytic leukemia, or APL. We are on track to identify the optimal dose to advance into our planned phase three trial, which we expect to initiate in the second half of next year. And as we announced on our based on feedback from both the FDA and EMA, we believe we will be able to use a single registration trial to support the approval of 2101 in both the United States and Europe. We are excited by the potential of each of our product candidates and confident in our ability to execute with excellence across each of our ongoing clinical studies. And we are grateful for the support of our new and existing investors, which we believe will enable us to bring forward these new medicines that redefine the standard of care for patients with difficult-to-treat tumors. We look forward to our upcoming catalyst and continuing to work towards our mission of making a profound difference in patients' lives. I would now like to turn the call over to David. David?