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SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

NEW YORK, March 28, 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 full year ended December 31, 2023, and provided a corporate update.

“We are off to a strong start this year highlighted by progress in our late-stage pipeline, strong data from Phase 2a study of SLS009 in r/r AML, completing enrollment in Phase 3 REGAL study, positive feedback from the REGAL Steering Committee, and the recent FDA Fast Track Designation granted for SLS009 in r/r AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The data from the Phase 2a study of SLS009 in r/r AML patients resistant to venetoclax combination therapies achieved 50% response in the selected optimal dose regimen of 30 mg BIW and 100% response rate in patients with identified biomarkers to date. We were pleased to recently announce enrollment completion in the Phase 3 REGAL trial and we eagerly anticipate the Independent Data Monitoring Committee (IDMC) meeting in late April. We also reported Phase 1 data of SLS009 in AML at ESH demonstrating the first-ever complete response achieved in a relapsed/refractory AML patient through CDK9 inhibition monotherapy. We enter 2024 well-positioned to execute on our goals with the priority of reporting data from the Phase 3 REGAL trial of GPS in AML, additional data from our Phase 2a study of SLS009 in r/r AML, and topline data from the Phase 1b/2 study of SLS009 in PTCL by the end of the second quarter.”

Recent Highlights:

Completed enrollment in Phase 3 REGAL study: Reached planned enrollment of patients in the United States, Europe, and Asia, in accordance with the predetermined statistical analysis plan.

Phase 3 REGAL study in AML: The Steering Committee has reviewed the study as of the March 1, 2024 cutoff date, signaling potentially imminent interim analysis of the ongoing global Phase 3 registrational clinical trial (the REGAL study) of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients). The next IDMC meeting is expected in late April 2024.

Reported data from the Phase 2a Study of SLS009 in Relapsed/Refractory AML Patients: A total of 21 patients were enrolled in the study as of March 15, 2024, 10 in the 45 mg safety cohort and 11 in the 60 mg cohort (2 x 30 mg twice a week or 60 mg once a week). The response rate of 10% was achieved in the 45 mg (safety cohort), 20% in the 60 mg QW cohort, and 50% response rate in the 60 mg, 2 x 30 mg BIW, the optimal dose level cohort. Additionally, in the patients with identified biomarkers, a 100% response rate was observed to date at the optimal dose level and a 57% response rate across all the levels tested in patients with those biomarkers. The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed. The median survival rate has not been reached in any of the dose levels. The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.

Received $20.0 million of gross proceeds from a registered direct offering priced at-the-market under Nasdaq rules: On March 19, 2024, announced the closing of a $20.0 million registered direct offering with two institutional investors before deducting placement agent’s fees and related offering expenses. The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.

Presented Phase 1 Data in AML at the 2024 European School of Haematology (ESH): All key study objectives regarding pharmacokinetic, pharmacodynamic, safety, and clinical activity were met. Data showed that for the first time, a relapsed/refractory patient achieved complete remission (CR) with a CDK9 inhibitor monotherapy. The CR was achieved after three months of treatment and lasted 8 months with one-year survival at the latest assessment.

Publication in Oncotarget: The preclinical data published revealed the underlying mechanisms of action behind the anti-proliferative effects of SLS009, a highly selective CDK9 small molecule inhibitor, in various hematologic malignancies. The publication, entitled, “The pharmacodynamic and mechanistic foundation for the antineoplastic effects of GFH009, a potent and highly selective CDK9 inhibitor for the treatment of hematologic malignancies”, is available online.

Fast Track Designation: The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009, for the treatment of r/r AML. The Fast Track Designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

2024 Milestones:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

SLS009: highly selective CDK9 inhibitor

2023 Highlights:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

SLS009: highly selective CDK9 inhibitor

Financial Results for the Full Year 2023:

R&D Expenses: Research and development expenses for the year ended December 31, 2023, were $24.0 million, compared to $20.3 million for the year ended December 31, 2022. The increase was primarily due to an increase in clinical trial expenses related to the ongoing Phase 3 REGAL clinical trial and our clinical trials of SLS009, increase in clinical and regulatory consulting expenses due to the advancement of our clinical programs

Acquired In-Process Research and Development: There was no acquired in-process research and development for the year ended December 31, 2023, compared to $10.0 million during the year ended December 31, 2022 from the in-licensing of SLS009.

G&A Expenses: General and administrative expenses for the year ended December 31, 2023, were $13.9 million, as compared to $12.6 million for the year ended December 31, 2022. The increase was primarily due to personnel-related expenses and an increase in intellectual property related expenses.

Net Loss: The net loss was $37.3 million for the year ended December 31, 2023, or a basic and diluted loss per share of $1.34, as compared to a net loss of $41.3 million for the year ended December 31, 2022, or a basic and diluted loss per share of $2.13.

Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million. On January 8, 2024, the Company received gross proceeds of $9.0 million from a public offering. On March 19, 2024, the Company received gross proceeds of $20.0 million from a registered direct offering priced at-the-market under Nasdaq rules.

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 16, 2023 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)

    Year Ended December 31,  
      2023       2022    
Licensing revenue   $     $ 1,000    
           
Operating expenses:          
Cost of licensing revenue           100    
Research and development     24,007       20,268    
General and administrative     13,862       12,582    
Acquired in-process research and development           10,000    
Total operating expenses     37,869       42,950    
Loss from operations     (37,869 )     (41,950 )  
Non-operating income:          
Change in fair value of warrant liability     4       36    
Change in fair value of contingent consideration           296    
Interest income     525       317    
Total non-operating income     529       649    
Net loss   $ (37,340 )   $ (41,301 )  
           
Per share information:          
Net loss per common share, basic and diluted   $ (1.34 )   $ (2.13 )  
Weighted average common shares outstanding, basic and diluted     27,777,111       19,395,709    

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)

  December 31,
    2023       2022  
ASSETS      
Current assets:      
Cash and cash equivalents $ 2,530     $ 17,125  
Restricted cash and cash equivalents   100       100  
Prepaid expenses and other current assets   542       531  
Total current assets   3,172       17,756  
Operating lease right-of-use assets   858       874  
Goodwill   1,914       1,914  
Deposits and other assets   275       399  
Total assets $ 6,219     $ 20,943  
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY      
Current liabilities:      
Accounts payable $ 5,639     $ 3,357  
Accrued expenses and other current liabilities   7,650       6,286  
Operating lease liabilities   446       372  
Acquired in-process research and development payable         5,500  
Total current liabilities   13,735       15,515  
Operating lease liabilities, non-current   460       573  
Warrant liability         4  
Total liabilities   14,195       16,092  
Commitments and contingencies      
Stockholders’ (deficit) equity:      
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; 0 shares issued and outstanding at December 31, 2023 and 2022          
Common stock, $0.0001 par value; 350,000,000 shares authorized, 32,132,890 and 21,005,405 shares issued and outstanding at December 31, 2023 and 2022, respectively   3       2  
Additional paid-in capital   209,265       184,753  
Accumulated deficit   (217,244 )     (179,904 )
Total stockholders’ (deficit) equity   (7,976 )     4,851  
Total liabilities and stockholders’ (deficit) equity $ 6,219     $ 20,943  

 


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