SELLAS Life Sciences Reports First Quarter 2024 Financial Results and Provides Corporate Update
SELLAS Life Sciences (SLS) announced its Q1 2024 financial results, highlighting significant clinical and financial milestones. The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL study without modifications and confirmed the completion of patient enrollment. Positive Phase 2 data for SLS009 in AML patients showed a 100% response rate in those with the ASXL1 mutation at a 30 mg BIW dose. Financially, R&D expenses decreased to $5.1 million, while G&A expenses rose slightly to $4.5 million. The net loss narrowed to $9.6 million, with cash reserves at $18.4 million.
- IDMC recommended continuation of Phase 3 REGAL study without modifications.
- Completion of patient enrollment in Phase 3 REGAL study.
- Positive Phase 2 data for SLS009 showing 100% response rate in AML patients with ASXL1 mutation.
- Expansion of SLS009 cohort for ASXL1 mutation patients.
- Research and development expenses decreased to $5.1 million from $7.2 million.
- Net loss reduced to $9.6 million from $11.1 million.
- Cash position of $18.4 million as of March 31, 2024.
- General and administrative expenses increased to $4.5 million from $4.1 million.
- Net loss of $9.6 million for Q1 2024.
- Decreased headcount and licensing fees contributing to reduced R&D expenses.
- One-time severance charge in the first quarter of 2024.
Insights
The financial results for the first quarter of 2024 indicate some positive trends for SELLAS Life Sciences. The company's R&D expenses decreased to
However, G&A expenses slightly increased to
The company's cash position of
The Phase 3 REGAL study in AML and the Phase 2 data of SLS009 are highly significant for SELLAS Life Sciences. The IDMC's recommendation to continue the REGAL study without modifications speaks to the promising efficacy and safety profile of Galinpepimut-S (GPS). This is a key development, as AML is a challenging disease with limited treatment options and any progress here could have substantial implications for patients and the company's future valuation.
The Phase 2 data of SLS009 showing a 100% response rate in r/r AML patients with the ASXL1 mutation at a 30 mg BIW dose is particularly encouraging. The ASXL1 mutation is associated with poor prognosis and this high response rate could position SLS009 as a breakthrough therapy. Additionally, the favorable safety profile supports the drug's potential in a broader range of indications.
From a medical and clinical perspective, these results are promising and suggest that SELLAS Life Sciences is on a strong path towards developing effective treatments for hard-to-treat cancers.
The completion of enrollment in the Phase 3 REGAL study and positive Phase 2 data for SLS009 provide significant market potential for SELLAS Life Sciences. As the biotech sector is highly driven by clinical trial outcomes, these milestones could enhance the company's market position and investor confidence. The focus on AML, a market with high unmet medical needs, offers substantial growth opportunities.
The favorable data on SLS009, especially the high response rate in patients with the ASXL1 mutation, could attract attention from potential partners and investors. The announcement of upcoming data in the second and third quarters of 2024 also sets the stage for potential stock price catalysts, making it an interesting period for stakeholders.
In summary, the company's strategic focus on advancing its drug pipeline in areas with significant unmet needs could drive long-term value, although investors should be mindful of the inherent risks and uncertainties associated with clinical trials and regulatory approvals.
- Announced Independent Data Monitoring Committee’s (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: IDMC to Reconvene in June -
- Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S -
- Announced Positive Phase 2 Data of SLS009 Demonstrating
NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.
“SELLAS had a very productive and successful first quarter of 2024,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We reported strong preliminary data from the Phase 2a study of SLS009 in r/r AML showing high anti-leukemic activity in the selected optimal dose regimen of 30 mg BIW, including a
Dr. Stergiou continued: “We are also excited with the ongoing progress in the Phase 3 REGAL study of GPS. Based on its recent efficacy and safety assessment, the IDMC recommended the trial continue without modification. We look forward to the next IDMC meeting, scheduled for June, during which the Committee will review data from all enrolled 127 patients and the most recent information regarding the number of events required for triggering the interim analysis. Furthermore, with the recent financing, we were able to strengthen our balance sheet as we expect further significant catalysts throughout 2024.”
Pipeline Highlights
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: Reached planned enrollment of patients in the United States, Europe, and Asia, following the predetermined statistical analysis plan. The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC scheduled its next meeting in June 2024 to review the safety and efficacy data from all enrolled 127 patients.
SLS009: highly selective and specific CDK9 inhibitor
Announced Positive Phase 2 Data of SLS009 in r/r AML: The preliminary data showed
IP Protection: Based on the SLS009 efficacy data in r/r AML patients with ASXL1 mutation, SELLAS filed a provisional patent application. The ASLX1 mutations are associated with poor prognosis in all myeloid diseases, owing to the reduced response to the current treatment options.
Phase 1b/2 clinical trial in combination with BTK inhibitor, Brukinsa® (zanubrutinib), in r/r DLBCL: GenFleet Therapeutics (Shanghai), Inc. entered into a clinical trial collaboration and supply agreement with BeiGene Switzerland GmbH and dosed the first patient in March 2024. The trial is an open-label single-arm multicenter Phase 1b/2 study to be conducted in two parts. In the Phase 1b portion, 6-18 patients will be enrolled and in the Phase 2 portion, approximately 45 patients will be enrolled. This study is being conducted in China and is funded by GenFleet which intends to focus on DLBCL as its lymphoma target with SLS009.
National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
Financial Results for the First Quarter 2024:
R&D Expenses: Research and development expenses for the quarter ended March 31, 2024 were
G&A Expenses: General and administrative expenses for the first quarter of 2024 were
Net Loss: The net loss was
Cash Position: As of March 31, 2024, cash and cash equivalents totaled approximately
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China. For more information on SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program and the timing for achievement of milestones. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
| Three Months Ended March 31, | |||||||
| 2024 | 2023 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 5,111 | $ | 7,174 | |||
| General and administrative | 4,534 | 4,107 | |||||
| Total operating expenses | 9,645 | 11,281 | |||||
| Loss from operations | (9,645 | ) | (11,281 | ) | |||
| Non-operating income: | |||||||
| Change in fair value of warrant liability | — | 2 | |||||
| Interest income | 79 | 182 | |||||
| Total non-operating income | 79 | 184 | |||||
| Net loss | $ | (9,566 | ) | $ | (11,097 | ) | |
| Per share information: | |||||||
| Net loss per common share, basic and diluted | $ | (0.21 | ) | $ | (0.47 | ) | |
| Weighted-average common shares outstanding, basic and diluted | 44,812,996 | 23,547,562 | |||||
SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
| March 31, 2024 | December 31, 2023 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 18,415 | $ | 2,530 | |||
| Restricted cash and cash equivalents | 100 | 100 | |||||
| Prepaid expenses and other current assets | 2,986 | 542 | |||||
| Total current assets | 21,501 | 3,172 | |||||
| Operating lease right-of-use assets | 747 | 858 | |||||
| Goodwill | 1,914 | 1,914 | |||||
| Deposits and other assets | 272 | 275 | |||||
| Total assets | $ | 24,434 | $ | 6,219 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 7,407 | $ | 5,639 | |||
| Accrued expenses and other current liabilities | 6,542 | 7,650 | |||||
| Operating lease liabilities | 488 | 446 | |||||
| Total current liabilities | 14,437 | 13,735 | |||||
| Operating lease liabilities, non-current | 313 | 460 | |||||
| Total liabilities | 14,750 | 14,195 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity (deficit): | |||||||
| Preferred stock, | — | — | |||||
| Common stock, | 5 | 3 | |||||
| Additional paid-in capital | 236,489 | 209,265 | |||||
| Accumulated deficit | (226,810 | ) | (217,244 | ) | |||
| Total stockholders’ equity (deficit) | 9,684 | (7,976 | ) | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 24,434 | $ | 6,219 | |||
FAQ
What did the IDMC recommend for SELLAS Life Sciences' Phase 3 REGAL study?
What were the results of the Phase 2 study for SLS009 in AML patients?
How did SELLAS Life Sciences' research and development expenses change in Q1 2024?
What were SELLAS Life Sciences' general and administrative expenses for Q1 2024?
What was SELLAS Life Sciences' net loss for Q1 2024?
What is SELLAS Life Sciences' cash position as of March 31, 2024?
