Salarius expects early cohort data readouts for Seclidemstat later in 2020
Salarius Pharmaceuticals announced that its CEO David Arthur, issued an open letter to Salarius' stockholders following the completion of the reverse merger with Flex Pharma, Inc. The letter read in part, "We are thrilled to have completed the merger with Flex Pharma and to have begun trading on Nasdaq with the new trading symbol "SLRX". This represents the culmination of many years of hard work, dedication, and innovation from talented people, and we are proud of what we have accomplished. Following the reverse merger, Salarius' stockholder base is now comprised of a combination of former Flex Pharma stockholders, former unit holders of Salarius Pharmaceuticals, LLC, and new stockholders. The purpose of this letter is to provide each of you with an overview and update on Salarius Pharmaceuticals, Inc. and our plan for building stockholder value by advancing clinical programs. Salarius' development trajectory is on course and we look forward to your support as we work toward developing novel treatments for patients who need them the most...The Food and Drug Administration has already granted our lead drug candidate, Seclidemstat, both Orphan Drug and Rare Pediatric Disease designations, conferring certain regulatory benefits and commercial advantages upon a potential FDA approval. If proven efficacious with a benefit-risk profile that the FDA judges to be positive and supportive of approval, Seclidemstat could qualify to receive a pediatric priority review voucher, which the FDA awards to companies developing a drug or biologic that targets a rare pediatric disease. If received, this voucher adds significant value to our Seclidemstat program. PRVs can be sold to other qualifying companies and based on 2017-2018 selling prices, a PRV has a value ranging between $80 million and $150 million. Our Ewing Sarcoma program is progressing in a Phase 1 clinical trial that is currently in the dose escalation phase, and we expect to establish the maximum tolerable dose in early-2020. We then expect to commence dose expansion with the potential for reporting early cohort data later in 2020. We are also developing Seclidemstat for adults with advanced solid tumor cancers. We recently began enrolling a Phase 1 dose escalation/dose expansion study in advanced solid tumors, including but not limited to, breast, ovarian and prostate cancer patients. Early cohort data readouts are also expected in 2020...We believe stockholder value is created by reporting clinical data showing patient benefit in response to Seclidemstat. To that end, our timeline for releasing clinical data and reaching possible inflection points is largely unchanged. In June 2019, Salarius was a private company executing a clinical plan to potentially report early patient cohort data in 2020. Two months later, we are a public company listed on Nasdaq executing that same clinical plan to potentially report early patient cohort data in 2020."