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Syros Pharma Reports Second Quarter 2017 Financial Results And Highlights Accomplishments And Upcoming Milestones

8/10/2017 7:32:50 AM

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Initiated Phase 1 Clinical Trial for SY-1365, Its First-in-Class CDK7 Inhibitor, Adding a Second Clinical-Stage Program to Syros’ Pipeline

Presented Preclinical Data Supporting Rational Combination Strategy for SY-1425, Including Ongoing Clinical Development in Combination with Standard-of-Care Therapy and Planned Future Development in Combination with Anti-CD38 Therapy

Announced Cancer Discovery Publication Highlighting Platform as New Approach for Stratifying Patients with Potential to Lead to Improved Treatment

On Track to Present Initial Phase 2 Clinical Data for SY-1425 in Fourth Quarter of 2017

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, today reported financial results for the quarter ended June 30, 2017 and provided an update on recent accomplishments and upcoming events.

“Syros made significant progress during the second quarter by dosing the first patient in our Phase 1 clinical trial of SY-1365 and driving toward the planned initial data readout from our Phase 2 trial of SY-1425 in the fourth quarter,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “We presented data at key medical meetings supporting our rationale for the ongoing and planned future development of SY-1425 as both a monotherapy and combination agent in defined subsets of AML and MDS patients. We also presented data on our identification of 14 new drug targets for triple negative breast cancer and our discovery of key genes controlling the autoimmune response in lupus. The depth of our programs, from discovery to development, is a testament to the promise of our gene control platform to generate a sustainable pipeline across a range of diseases to support our long-term goal of building an enduring company that makes a profound difference for patients.”

Syros also announced that Kyle Kuvalanka, Chief Operating Officer, has resigned effective September 22, 2017. Syros has initiated a search to appoint a chief financial officer.

“Kyle has been instrumental in charting our strategic course and maturing Syros into a publicly-traded entity with robust investor support and sufficient funding to enable operations through key inflection points,” said Dr. Simonian. “The Syros team and our board of directors thank Kyle for his many contributions, and we wish him much success in the future.”

Upcoming Milestones

  • Syros expects to report initial clinical data from its ongoing Phase 2 clinical trial of SY-1425, an oral first-in-class selective retinoic acid receptor alpha (RARa) agonist, in the fourth quarter of 2017. The Phase 2 trial is assessing the safety and efficacy of SY-1425 as a monotherapy in four acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patient populations, as well as in combination with azacitidine, a standard-of-care therapy, in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. All patients in the trial are prospectively selected using biomarkers for high expression of RARA or IRF8, which are genes associated with the RARA pathway.
  • Syros expects to report preliminary clinical data from its ongoing Phase 1 clinical trial of SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in 2018. The Phase 1 trial is evaluating the safety and tolerability of SY-1365 in patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

Recent Platform and Pipeline Highlights

  • In July 2017, Syros published data providing the foundation of its clinical development strategy for SY-1425 in Cancer Discovery, a peer-reviewed journal of the American Association of Cancer Research (AACR), supporting the ongoing Phase 2 clinical trial of SY-1425. The publication highlights Syros’ discovery of subsets of AML and MDS patients with altered regulation of the RARA gene, which was shown in preclinical studies to be predictive of response to SY-1425. The findings underscore the promise of Syros’ gene control platform to provide a new approach for stratifying patients with the potential to lead to improved treatment for defined subsets of patients.
  • In June 2017, Syros presented preclinical data on SY-1425 at the European Hematology Association (EHA) 22nd Congress. The data demonstrate the synergistic activity of SY-1425 with standard-of-care AML and MDS therapies and targeted anti-CD38 therapies, strengthening the rationale for ongoing and planned future clinical investigation of SY-1425 as both a monotherapy and combination agent. Additional preclinical data presented at EHA elucidate SY-1425’s mechanism of action, demonstrating that SY-1425 regulates genes associated with the proliferation of AML cells and normal myeloid differentiation.
  • In June 2017, Syros presented on its discovery of key genes controlling the autoimmune response in lupus in a late-breaking oral presentation at the 17th Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS). Using its proprietary gene control platform, Syros discovered alterations in regulatory regions of the genome in T cells from patients with systemic lupus erythematosus (SLE), revealing genes critical for activating T cells and driving disease. These findings provide important biological insights that could lead to the identification of novel drug targets and therapeutic approaches to treat SLE.
  • In May 2017, Syros dosed the first patient in a Phase 1 clinical trial of SY-1365, its first-in-class selective CDK7 inhibitor, in patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.
  • In May 2017, Syros presented new preclinical data further detailing the mechanism of action of SY-1425 in an oral plenary session at the AACR Hematologic Malignancies: Translating Discoveries to Novel Therapies conference. These data demonstrate that SY-1425 represses genes known to be associated with the proliferation of AML cells, while activating genes critical for driving normal cell differentiation.
  • In May 2017, Syros presented new data demonstrating the power of its gene control platform to identify novel drug targets at the IMPAKT 2017 Breast Cancer Conference. Using its platform to systematically analyze regulatory regions of the genome, Syros identified 14 new drug targets for triple negative breast cancer across a range of druggable target types.
  • In April 2017, Syros presented new data on its clinical and preclinical development programs at the AACR Annual Meeting. These data showed:
  • High IRF8 expression is predictive of response to SY-1425 in preclinical models of AML, supporting the utilization of this biomarker in the ongoing trial;
  • SY-1365 induces anti-proliferative and pro-apoptotic effects, including complete regressions, in solid tumor cell lines and preclinical models of difficult-to-treat transcriptionally dependent solid tumors; and
  • Selective inhibition of cyclin-dependent kinase 12 (CDK12) and cyclin-dependent kinase 13 (CDK13) exhibits distinct transcriptional changes and anti-proliferative effects in subsets of ovarian and breast cancer cells compared with the relatively indiscriminate effects of pan-CDK and selective CDK9 inhibitors, supporting Syros’ rationale for optimizing selective CDK12 and CDK13 inhibitors that may be suitable for clinical development.

Recent Corporate Highlights

  • In June 2017, Syros announced the appointment of Srinivas Akkaraju, M.D. Ph.D., to its board of directors.
  • In April 2017, Syros completed a private financing with a select group of existing and new institutional investors, raising approximately $35 million in gross proceeds through the sale of 2,592,591 shares of its common stock at a purchase price of $13.50 per share.

Second Quarter 2017 Financial Results

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