Salarius Pharmaceuticals CEO Issues Letter to Stockholders
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’ 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. We believe in our science, vision and clinical programs that are poised to generate data validating our approach. Additionally, prior to entering into the merger agreement with Flex Pharma, our technology, pipeline, clinical plan, market opportunity, finances, and management team were reviewed carefully by Flex Pharma. Flex Pharma selected Salarius based on due diligence and discussions with nearly 40 other companies, which we believe provides substantial third-party validation for our business.
In short, Salarius is a cancer-focused biotechnology company developing treatments for patients who need them the most. Today, that includes active clinical development programs dedicated to delivering new therapeutic options for:
- Patients with Ewing Sarcoma, a rare and devastating bone and soft-tissue cancer that mostly afflicts children and young adults for which no approved targeted therapies are currently available. Unfortunately, the standard of care treatment for these children and young adults currently is adult chemotherapy, radiation and often disfiguring surgeries.
- Patients with advanced solid tumors, such as prostate, breast, and ovarian cancers who have not responded to or are no longer responding to standard of care treatments and are seeking new potential treatments.
Our lead drug candidate or potential medicine, Seclidemstat, is an oral tablet with a targeted, disease-specific mechanism of action, unlike toxic chemotherapy.
Our technology targets the epigenetic causes of cancer. Epigenetics is the study of the regulatory system that controls how genes are turned “on” or “off.” In certain cancers, the proteins that regulate gene expression become dysregulated and incorrectly turn genes “on” or “off,” which in some cases leads to cancer progression. Drugs that are able to safely modify the activity of these epigenetic regulators may correct the gene changes that are driving the disease. The field of epigenetics is maturing, and with a differentiated drug candidate in two clinical studies, Salarius has the potential to become a leader in this exciting area of cancer research.
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 (MTD) 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.
Importantly, in 2016, Salarius was granted a
We are committed to advancing Seclidemstat toward potential
In terms of upcoming financial disclosures, we plan to file a Form 8-K/A within the next few months that will contain certain interim and pro forma financial information relating to the merger of the two companies. Going forward, we will report our quarterly and year-end financial results, as required, on a typical filing schedule for public companies, including our results for the third quarter ended
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
Our top priority is the continued execution of our clinical trials and as such, patient enrollment and efficient clinical operations remain our top focus. We look forward to providing updates on our progress and we invite you to visit our website at salariuspharma.com for more information.
We thank you for your current support and for your continued support as we strive to deliver maximum value for you, our stockholder, and deliver potential new medicines for the many patients and their families fighting cancer.
Chief Executive Officer
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to: the potential for Seclidemstat to target the epigenetic dysregulation underlying Ewing sarcoma and advanced solid tumors including, but not limited to, prostate, breast, and ovarian cancers; expected timing and results of clinical studies; Salarius’ development trajectory; third-party validation for Salarius’ business; changes in the field of epigenetics and Salarius’ potential in such field; the likelihood of Seclidemstat qualifying to receive a pediatric priority review voucher (PRV) and the potential value of such PRV; Seclidemstat’s
Source: Salarius Pharmaceuticals