Syros Takes The Road Less Traveled In Gene Control, Awaits Windfall From Diverse Indications

The rising popularity of gene control is unconcerning to Syros Pharmaceuticals Inc SYRS, a company where the top line depends on its leadership in the space. 

“Just because this has been a really exciting new area of biology and medicines, there are much earlier-stage companies that are preclinical or discovery stage that are in this space,” CEO Nancy Simonian recently told Benzinga. “But I think we really are the leading company and don’t have another company right now that’s likely to have a big impact on our stock.”

By Simonian's assessment, Syros stands apart in its progress, as no rival has reached clinical stages; in its analysis of large, noncoding gene regions to identify disease-causing alterations; and in its development of chemical libraries to manipulate levels of gene expression.

The Pipeline

Syros' competitors, as far as Simonian is concerned, are outside the gene control space and are taking different approaches to cure the same indications. Syros’ advantage is in its platform, which provides broad optionality in products, she said.

“One of the things about our platform is that it’s applicable across a broad range of diseases, so what that allows us to do is leverage our platform in strategic partnerships outside of our core therapeutic area to broaden the reach of our platform to benefit patients."

Although focused on oncological indications, Syros also explores monogenic diseases like sickle cell disease and recently launched a target discovery collaboration with Incyte Corporation INCY for myeloproliferative neoplasms.

The five-year-old company has five programs in preclinical or discovery stages and two in clinical development. SY1425 is a Phase 2 selective retinoic acid receptor alpha agonist targeting hematologic malignancies and SY1365 is a Phase 1 selective CDK7 inhibitor for treatment-resistant ovarian and breast cancers. The latter recently posted positive preclinical data for pretreated ovarian cancer and is expected to have dose-escalation data ready in the fourth quarter.

“We think both of them are really promising and that they are both first-in-class and have the opportunity to address very significant, unmet medical need,” Simonian said.

What Syros Is Watching

While competition is of marginal concern to Syros, the company is keeping an eye on a number of other environment-altering factors. Regulatory change from the U.S. Food and Drug Administration and European Medicines Agency is of primary concern.

“On that score, it’s been ... very positive in terms of overall outlook in that regulators have really demonstrated that they are willing to work with companies to figure out how to get innovative medicine faster to patients,” Simonian said, noting a “favorable regulatory climate” in both cancer and monogenic diseases.

The CEO is also following changes around reimbursement policies and the system by which drugs are valued and priced.

“That’s an area of continued watching, but I think that for innovative products that are making transformative benefits to patients, I continue to see that there will be a path to ways to be able to provide the return that’s necessary to companies to continue to innovate on new medicines,” she said.

The Balance Sheet

Syros pursued a secondary stock offering earlier this year and subsequently secured $20 million from the Incyte collaboration; the financing provides Syros with runway through 2020, the CEO said. Considering these channels, Simonian said she's comfortable with Syros' cash position, particularly as the company nears multiple opportunities for value inflection.

The biotech plans to present data from the clinical programs in the fourth quarter and will also name a new development candidate from its preclinical programs at some point this year. The latter will advance to the clinic with an investigational new drug application in 2019, Simonian said.

SY1425 is in two different patient populations in combinations, and SY1365 is in the dose escalation phase of the trial, Simonian said. 

"We are in a good cash position knowing that we have cash into 2020."

Related Links:

Exclusive: Moleculin CEO Says Acute Myeloid Leukemia Candidate Could Be 'Remarkable'

Eyenovia CEO Talks Temporary Distraction Of IPO, Pipeline Opportunity