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NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company, announced that its immunotherapeutic agent, Galinpepimut-S (GPS), has been granted Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric acute myeloid leukemia (AML). This designation is for serious or life-threatening diseases affecting fewer than 200,000 people in the U.S., primarily individuals under 18.
The company's President and CEO, Angelos Stergiou, MD, ScD h.c., expressed that the FDA's recognition underscores the urgent need for new treatments for AML, especially in younger patients who may respond better to immune system-mediated therapies like GPS. The RPDD reflects the potential of GPS, which has shown clinical benefits in adult AML patients, to extend to pediatric cases.
AML has a notably poor prognosis in pediatric patients who relapse or do not respond to initial treatments. Current statistics indicate a 5-year overall survival rate of 33% for all relapsed pediatric AML patients, with even lower rates for those with short remission periods or who do not achieve remission after initial chemotherapy. GPS has previously demonstrated a median overall survival of 67.6 months in adult AML patients, with particularly favorable outcomes in younger adults.
The RPDD could lead to a Priority Review Voucher (PRV) for SELLAS if the FDA approves a New Drug Application for GPS. PRVs can accelerate the review process for subsequent marketing applications and may be sold; recent sales have been around $100 million each.
SELLAS is also developing another candidate, SLS009, for AML. This small molecule CDK9 inhibitor has shown promising response rates, particularly in patients with unfavorable prognostic factors.
The information in this article is based on a press release statement from SELLAS Life Sciences Group, Inc.
In other recent news, SELLAS Life Sciences Group has extended its lease agreement for its Times Square Tower headquarters through September 2026, maintaining its annual rent without changes. The company also secured Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for its drug SLS009, highlighting its potential for treating pediatric acute myeloid leukemia and pediatric acute lymphoblastic leukemia. SELLAS's Phase 1 trial of SLS009 demonstrated a 36.4% response rate in peripheral T-cell lymphoma patients, while the Phase 2a trial achieved a 57% overall response rate in acute myeloid leukemia patients.
In financial developments, SELLAS is set to raise approximately $21 million through a registered direct offering, with Maxim Group LLC serving as the placement agent. The funds will support the company's ongoing research and development efforts. SELLAS has also received Orphan Drug Designation from the European Medicines Agency for SLS009, intended for the treatment of relapsed/refractory peripheral T-cell lymphomas. These are among the recent developments for SELLAS Life Sciences Group.
InvestingPro Insights
SELLAS Life Sciences Group's recent FDA designation for its immunotherapeutic agent, Galinpepimut-S (GPS), comes at a critical time for the company. According to InvestingPro data, SELLAS has a market capitalization of $80.42 million, reflecting its status as a small-cap biopharmaceutical company focused on developing novel cancer therapies.
The company's financial position presents a mixed picture. An InvestingPro Tip highlights that SELLAS holds more cash than debt on its balance sheet, which could provide some financial flexibility as it advances its clinical programs. This is particularly important given the capital-intensive nature of drug development, especially for rare pediatric diseases like acute myeloid leukemia (AML).
However, investors should note that SELLAS is not currently profitable, with an adjusted operating income of -$34.8 million over the last twelve months as of Q2 2023. This aligns with another InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. This is not uncommon for early-stage biopharmaceutical companies investing heavily in research and development.
The stock's performance has been volatile, with a year-to-date price total return of 17.92% as of the latest data, but a one-year return of -3.85%. This volatility is typical of biotech stocks, especially as they approach key regulatory milestones like the recent Rare Pediatric Disease Designation.
For investors considering SELLAS, it's worth noting that InvestingPro offers 9 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable in assessing the potential impact of the FDA designation on SELLAS's future prospects.
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