SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) is a late-stage clinical biopharmaceutical company at the forefront of developing novel therapies for a broad range of cancer indications. With a focus on innovative immunotherapies and targeted small molecule inhibitors, SELLAS is making strides in addressing some of the most challenging cancer types, including acute myeloid leukemia (AML) and peripheral T-cell lymphomas (PTCL).

The company’s comprehensive pipeline is anchored by two lead product candidates: galinpepimut-S (GPS), a cancer immunotherapeutic agent, and SLS009, a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Both of these investigational therapies have demonstrated promising results in clinical trials, positioning SELLAS to potentially transform the treatment landscape for various cancer patients.

Company Background

SELLAS Life Sciences Group, Inc. was founded in 2017, focusing on the development of novel therapeutics for a broad range of cancer indications. In December 2020, the company entered into an exclusive license agreement with 3D Medicines Inc., a China-based biopharmaceutical company, for the development and commercialization of GPS and its next generation heptavalent immunotherapeutic GPS across all therapeutic and diagnostic uses in Greater China. This agreement has resulted in SELLAS receiving $10.5 million in upfront payments and certain technology transfer and regulatory milestones.

In March 2022, SELLAS further expanded its portfolio by entering into an exclusive license agreement with GenFleet Therapeutics Shanghai, Inc. This agreement granted the company rights to develop and commercialize SLS009 across all therapeutic and diagnostic uses worldwide, except for Greater China. SELLAS successfully completed a Phase 1 dose-escalating clinical trial for SLS009 in mid-2023, reporting positive safety and efficacy data.

Galinpepimut-S (GPS): Targeting the WT1 Antigen in Hematological and Solid Tumors

GPS, SELLAS’ lead immunotherapeutic agent, is a peptide-based vaccine that targets the Wilms Tumor 1 (WT1) antigen, which is present in over 20 different cancer types. This innovative approach has garnered significant attention, as WT1 is considered one of the most promising tumor-associated antigens for cancer immunotherapy.

SELLAS is currently conducting a pivotal Phase 3 clinical trial, the REGAL study, evaluating GPS as a maintenance therapy for patients with AML who have achieved second complete remission (CR2) following successful completion of second-line antileukemic therapy. The REGAL study, which completed enrollment in March 2024, is designed to assess the ability of GPS to prolong overall survival in this patient population. The Independent Data Monitoring Committee (IDMC) recently conducted a prespecified risk-benefit assessment of unblinded data from the study and recommended that the trial continue without modifications. The IDMC is scheduled to convene again in June 2024 to review additional efficacy and safety data, with the interim analysis expected by the fourth quarter of 2024.

GPS has also been granted Orphan Drug Designations by the FDA and the European Medicines Agency (EMA) for the treatment of AML, malignant pleural mesothelioma, and multiple myeloma, as well as Fast Track designations from the FDA for these indications. In a landmark achievement, the FDA has recently granted Rare Pediatric Disease Designation (RPDD) to GPS for the treatment of pediatric AML, making it eligible for a Priority Review Voucher upon marketing approval.

SLS009: A Highly Selective CDK9 Inhibitor with Promising Efficacy and Safety

SLS009, SELLAS’ second lead candidate, is a novel and highly selective CDK9 inhibitor with the potential to address a wide range of hematological and solid tumors. CDK9 activity has been shown to correlate negatively with overall survival in numerous cancer types, making it an attractive therapeutic target.

SELLAS has reported positive results from the Phase 2a clinical trial of SLS009 in patients with relapsed/refractory (r/r) AML who had failed or did not respond to treatment with venetoclax-based therapies. The study demonstrated an overall response rate (ORR) of 50% in the 30 mg twice-weekly (BIW) cohort, exceeding the targeted 20% ORR. Notably, a 100% response rate was observed in patients with the ASXL1 gene mutation, a biomarker associated with poor prognosis in myeloid diseases. These findings have led SELLAS to expand the ongoing study to include additional cohorts focused on ASXL1 mutated AML and myelodysplasia-related molecular abnormalities.

Furthermore, SLS009 has been granted Orphan Drug Designations by the FDA and the EMA for the treatment of AML and PTCL, as well as Rare Pediatric Disease Designations from the FDA for the treatment of pediatric AML and acute lymphoblastic leukemia (ALL). These regulatory designations underscore the potential of SLS009 to address significant unmet medical needs in these challenging cancer indications.

In addition to the ongoing AML trial, SLS009 is also being evaluated in pediatric solid tumors and leukemia models through the NCI Pediatric Preclinical In Vivo Testing (PIVOT) program, with data expected in the fourth quarter of 2024.

Leveraging Strategic Partnerships and Regulatory Milestones

SELLAS has strategically partnered with 3D Medicines, a leading biopharmaceutical company in China, for the development and commercialization of GPS in Greater China. This collaboration has the potential to expand the global reach of GPS and generate significant milestone payments and royalties for SELLAS. However, in December 2023, SELLAS commenced a binding arbitration proceeding against 3D Medicines regarding the trigger and payment of certain milestone payments due to the company.

Additionally, SELLAS’ successful achievement of several regulatory designations, including Orphan Drug Designations and Rare Pediatric Disease Designations, has further bolstered the company’s pipeline. These designations not only provide development and commercial advantages but also open the door for potential revenue streams through the sale of Priority Review Vouchers, which have historically commanded values exceeding $100 million per voucher.

Financials

SELLAS has demonstrated its ability to raise capital to support the advancement of its clinical programs. In 2024, the company successfully completed several equity financing transactions, including a $19.5 million registered direct offering priced at a premium to market in August 2024. These fundraising efforts have strengthened SELLAS’ balance sheet, providing the necessary resources to continue executing on its strategic priorities.

For the fiscal year 2023, SELLAS reported no revenue, a net loss of $37,340,000, operating cash flow (OCF) of -$31,410,000, and free cash flow (FCF) of -$36,910,000. In the most recent quarter (Q3 2024), the company again reported no revenue, with a net loss of $7,108,000, OCF of -$7,806,000, and FCF of -$7,806,000. The decreases in net income, OCF, and FCF were primarily attributable to ongoing research and development expenses for the company’s lead product candidates, GPS and SLS009.

SELLAS operates primarily in the United States and does not disclose performance by geographic markets.

Liquidity

As of September 30, 2024, SELLAS reported cash and cash equivalents of $21.03 million and restricted cash of $0.1 million. The company’s debt-to-equity ratio stands at 0.036, with a current ratio and quick ratio both at 2.26. While the company’s cash position is sufficient to fund its current planned operations in the near term, SELLAS will likely require additional financing to support the ongoing development and potential commercialization of its product candidates. The company does not have any disclosed available credit lines.

Navigating the Challenges and Opportunities in the Oncology Landscape

The biopharmaceutical industry, particularly in the oncology space, is inherently complex and competitive. SELLAS faces several challenges, including the inherent risks associated with drug development, potential delays in clinical trials, regulatory uncertainties, and intense competition from other innovative therapies.

However, the company’s focus on targeting unmet medical needs, its diversified pipeline, and the promising data generated from its clinical trials have positioned SELLAS as a promising player in the oncology landscape. The company’s unique approach to cancer immunotherapy and selective small molecule inhibition, coupled with its strategic partnerships and regulatory achievements, have the potential to drive significant value for shareholders.

Conclusion

SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company that is at the forefront of developing innovative therapies for a broad range of cancer indications. With its lead product candidates, GPS and SLS009, SELLAS is poised to potentially transform the treatment paradigm for patients suffering from devastating diseases like AML and PTCL.

The company’s commitment to addressing unmet medical needs, its diversified pipeline, and its strategic partnerships and regulatory milestones have positioned SELLAS as a promising investment opportunity in the dynamic oncology sector. As the company continues to navigate the challenges and capitalize on the opportunities in the industry, investors will closely monitor SELLAS’ progress and the potential impact of its groundbreaking therapies on the lives of cancer patients worldwide.

Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.