Analyst Conference Summary

biotechnology

conference date: August 6, 2020
for quarter ending: June 30, 2020 (second quarter, Q2)

Forward-looking statements

Overview: Continues to progress pipeline.

Basic data (GAAP):

Revenue was $3.2 million, up sequentially from $2.4 million, and up from $0.5 million year-earlier.

Net income was negative $17.2 million, flat sequentially from negative $17.2 million, and up from negative $19.5 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.38, up sequentially from negative $0.39, and up from negative $0.47 year-earlier.

Guidance:

Believes cash sufficient into 2022.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We completed enrollment in our Phase 2 trial of SY-1425, opened a new combination cohort in treatment-resistant breast cancer patients in our Phase 1 trial of SY-5609, and presented new preclinical data on SY-5609 in colorectal cancer that further highlights CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers. Looking ahead, the second half of 2020 promises to be an exciting time for Syros, with planned data readouts for SY-1425 in two RARA-positive AML patient populations and the first clinical data from the Phase 1 trial of SY-5609 in select solid tumor patients. These data will provide valuable insights that will help inform next steps and, hopefully, bring us closer to our vision of building an enduring company with medicines that provide a profound benefit for patients."

Syros specializes in using small molecules to control gene regulation.

All Q2 revenue were from the Incyte collaboration.

Lab based functions had been suspended due to the pandemic, but were restarted by the end of Q2.

SY-1425 completed enrollment in May 2020 in the ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia patients. Also same combination for newly diagnosed AML in patients who are not candidates for chemo. Should report data in Q4 2020. There is still high unmet medical need in AML. SY-1425 is an oral agent.

SY-5609, a oral CDK7 agent, is due to report Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in Q4 2020 from the dose-escalation portion of Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, and in patients with solid tumors of any histology that harbor Rb pathway alterations. Preclinical data presented at ASCO for colorectal cancer was encouraging, and supported use of PD biomarkers. A second Phase 1 study started in June 2020, in combination with fulvestrant, for HR-positive metastatic breast cancer patients who progressed after CDK4/6 inhibitor treatment.

In January 2020, Syros presented preclinical data showing that inhibiting cyclin-dependent kinase 7 and CDK12 result in different transcriptional effects at the 2020 Keystone Symposia Cancer Epigenetics: New Mechanisms and Therapeutic Opportunities.

In December 2019, Syros presented preclinical data demonstrating its discovery and validation of a novel fetal hemoglobin repressor, Nuclear Factor I X (NFIX) at the ASH Annual Meeting. Data showed that, when knocked down in primary cells and an erythroid cell line expressing adult hemoglobin, NFIX induced fetal hemoglobin in nearly 100% of cells and increased total fetal hemoglobin levels to 40%, exceeding levels that are associated with a functional cure in a subset of sickle cell disease patients.

In February 2020, Syros announced the closing of a $60 million senior secured loan facility with Oxford Finance, LLC. $20 million was drawn down at closing, and $40 million will be available across two tranches, subject to certain conditions and achievement of milest

In December 2019, Syros entered into a collaboration with Global Blood Therapeutics (GBT) for sickle cell disease and beta thalassemia. Under the agreement, Syros will identify therapeutic targets and discover drugs that induce fetal hemoglobin, and GBT will receive an option to obtain an exclusive worldwide license to develop, manufacture and commercialize products resulting from the collaboration. Syros received a $20 million upfront payment. GBT is obligated to fund up to approximately $40 million in research expenses for at least three years. Should GBT exercise its option under the agreement, Syros could receive up to $315 million in option exercise, development, regulatory, commercialization and sales-based milestones per product candidate resulting from the collaboration, in addition to mid- to high-single digit royalties on sales of products.

Cash and equivalents ended the quarter at $109 million, down sequentially from $122 million. Reflects a $20 million upfront payment from GBT collaboration.

Operating expenses were $19.9 million, comprised of $14.8 million for R&D and $5.1 million for administration. Loss from operations $16.7 million. Other expense $0.5 million.

Q&A summary:

Pandemic impact on trials? Nothing major, it is an oral drug for populations with high unmet medical need.

1425 R/R data goal? Has high unmet medical need. Precedent is agents approved with response rates 25% to 30%, duration 4 to 6 months, which shows the high unmet need.

5609 cohort number? Started enrollment in January. The trial is enrolling well, data will be reported in Q4.

1425 newly diagnosed strategy? AML landscape has been changing. But about 1/3 of patients don't respond to vanesa (sp? maybe venclextah). So could combo with something like vanesa.

The PD/PK relationships help inform which tumors we should focus on.

5609 is both more potent and more selective than 1365.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: