SLS SELLAS Life Sciences Group Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): December 10, 2024

 

SELLAS Life Sciences Group, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-33958		20-8099512
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(I.R.S. Employer Identification No.)
		7 Times Square, Suite 2503 New York, NY 10036
		(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (646) 200-5278

  

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, $0.0001 par value per share	SLS	The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

ITEM 7.01

REGULATION FD DISCLOSURE.

 

On December 10, 2024, SELLAS Life Sciences Group, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the triggering of an interim analysis to be conducted by the Independent Data Monitoring Committee (“IDMC”) in its Phase 3 REGAL trial of galinpepimut-S (“GPS”) in acute myeloid leukemia (“AML”). A copy of the Press Release is included as Exhibit 99.1 hereto and is incorporated by reference herein.

 

Additionally, on December 10, 2024, the Company hosted a webcast to review the process leading up to the IDMC meeting and the potential outcomes of the REGAL interim analysis. The webcast is available athttps://viavid.webcasts.com/starthere.jsp?ei=1697841&tp_key=5e3028bd5c, and the transcript of the webcast is included as Exhibit 99.2 hereto.

 

The information disclosed under this Item 7.01, including Exhibits 99.1 and 99.2 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

 

The Press Release and transcript contain forward-looking statements. Such forward-looking statements can be identified by the use of the words “expect,” “believe,” “will,” “anticipate,” “estimate,” “plan,” “project” and other words of similar import. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. 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 the Company 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 filings with the U.S. Securities and Exchange Commission. Other risks and uncertainties of which the Company is not currently aware may also affect the Company 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. The Company 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.

 

 

ITEM 9.01

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release, dated December 10, 2024.
99.2		SELLAS Life Sciences Group, Inc. Transcript of the Webcast, dated December 10, 2024.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	SELLAS Life Sciences Group, Inc.
Date: December 10, 2024	By:	/s/ John T. Burns
		Name:	John T. Burns
		Title:	Senior Vice President, Chief Financial Officer

 

 

 

Exhibit 99.1

 

SELLAS Life Sciences Triggers Interim Analysis in Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia

 

-

Study Reaches Pre-Specified Threshold of 60 Events (Deaths) Initiating the Interim Analysis –

 

-

REGAL Independent Data Monitoring Committee to Perform Interim Analysis in January 2025 -

 

-

Company to Host Webcast Call Today at 9:00 am ET

 

NEW YORK, December 10, 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 announced that the pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC).

 

The IDMC will conduct a thorough review of the current REGAL data, and the interim analysis will provide an assessment of efficacy, futility as well as safety of GPS.

 

“This is an exciting and very important milestone in our efforts to bring forward a new potential treatment option for AML patients,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Our mission at SELLAS is to develop novel therapies that prolong patients’ lives, and the outcome of the interim analysis will hopefully bring us closer to the potential of adding GPS as a powerful ally in the battle against AML. Today, we are here thanks to the unwavering support of our shareholders, dedication of our clinical investigators and the resilience of our patients and their families. The IDMC will now carefully review and analyze all the data and have scheduled a meeting in January to review results to date. We are extremely grateful to everybody who have contributed to the REGAL study, and we look forward to sharing the IDMC’s feedback and recommendations as soon as they become available.”

 

The Company will host a call today to review the process leading up to the IDMC meeting and the potential outcomes of the REGAL interim analysis.

 

To access the webinar, please use the following information:

 

Date:	Tuesday, December 10, 2024
Time:	9:00 a.m. Eastern Time
Webcast:	SELLAS GPS REGAL

 

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 the 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) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.

 

 

About the GPS Phase 3 REGAL Study

 

REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.

 

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, including the REGAL study and the timing of future milestones related thereto. 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

 

Media Contact

 

Michael Fitzhugh

LifeSci Communications

mfitzhugh@lifescicomms.com

 

 

 

Exhibit 99.2

 

 

 

 

 

 

C O R P O R A T E P A R T I C I P A N T S

 

Angelos M. Stergiou, MD, ScD hc, President and Chief Executive Officer, SELLAS Life Science Group

 

P R E S E N T A T I O N

 

Operator

 

Greetings and welcome to the SELLAS Life Sciences Group Corporate Update Call.

 

At this time all participants are in a listen-only mode. Before we begin, please note that today’s call contains forward-looking statements, the accuracy of which depends on future events outside SELLAS’ control and therefore could cause actual results to differ materially from those forward-looking statements. The forward-looking statements are made as of the date of this call only. Additional information regarding the risks and uncertainties and other important factors, any of which could cause SELLAS’ actual results to differ from those contained in these forward-looking statements can be found under the section titled Risk Factors in SELLAS’ annual report on Form-10-K filed on March 28, 2024, and in other SEC filings.

 

With that, I would like to turn the call over to Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS. Please go ahead Angelos.

 

Dr. Angelos M. Stergiou

 

Good morning.

 

Today, I am excited to share a significant milestone in our galinpepimut-S,GPS, journey, an accomplishment that underscores our unwavering commitment to advancing the fight against leukemia. We have just reached the interim analysis trigger, 60 events, in our pivotal Phase 3 REGAL study, a step that brings us closer to the potential of adding GPS as a powerful ally in the battle against this devastating disease.

 

This achievement is made possible through the strength, resilience, and partnership of many. We extend our deepest gratitude to the patients and their families, who are at the heart of this journey. Their courage inspires us daily and drives our dedication to making a meaningful difference in their lives and the lives of countless others.

 

We also honor the outstanding efforts of the principal investigators and the clinical study teams who work tirelessly to make this study a reality. Their expertise and unwavering commitment to quality and compassion reflect the values we hold at the core of our Mission here at SELLAS.

 

Our SELLAS team’s exceptional work in bringing this study to fruition has been nothing short of remarkable. Each milestone reached is a testament to our passion and commitment to creating impactful solutions in oncology. I wholeheartedly want to thank our employees who are integral in our Mission and without whose diligence and tireless work, our clinical programs would not be possible.

 

ViaVid has made considerable efforts to provide an accurate transcription. There may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference call. This transcript is being made available for information purposes only.

 

1-888-562-0262 1-604-929-1352 www.viavid.com

 

 

 

 

And, of course, I want to thank you, our shareholders, who have supported our cause over the years. On behalf of all our dedicated employees and our Board, I want to express my gratitude for your continued support and confidence in our Company, a matter that I neither take lightly, nor for granted.

 

As I have stated over the years, we are confident that by staying true to our Mission, working diligently, and executing our strategic initiatives, we will unlock significant value for our shareholders as well as patients and physicians.

 

Now, let me review with you what lies ahead for GPS and the REGAL study and potential outcomes as we proceed towards the expected IDMC meeting next month in January.

 

As a reminder, REGAL is a Phase 3 open-label registrational clinical trial of GPS in AML patients who have achieved complete remission following second-line salvage therapy, CR2 patients. The primary endpoint of the trial is the overall survival.

 

The Independent Data Monitoring Committee, or IDMC, is an independent multidisciplinary group consisting of clinicians and a biostatistician with extensive collective experience in managing patients with acute myeloid leukemia and in conducting and monitoring randomized clinical trials.

 

The primary role of the IDMC is to routinely assess participants’ safety, evaluate the safety and efficacy data by intervention group, and monitor the overall conduct of the study to ensure the trial’s validity and scientific integrity. The IDMC Charter provides for specified reviews of safety, efficacy, and futility in addition to the interim and final analyses.

 

The IDMC will meet next month and, in particular, will focus on efficacy, futility and safety analyses following the activation of prespecified 60 event for interim analysis.

 

We enrolled 126 patients into the REGAL study. Since the REGAL study is event-driven, the required rate of events defined as patients’ deaths, for the interim analysis, represents 48% of the study population. For the final analysis, an event rate of 63%, or 80 events, will be required.

 

Our Independent Statistical Center reviews the statistical analysis plan for the IDMC and prepares and distributes open and closed session reports to all IDMC members. While this is an open-label study, the randomization list and summary of data by treatment regimens are not provided to SELLAS.

 

The Independent Statistical Center, EMMES Company, will now perform further analyses, summarize and tabulate the totality of the data and provide Kaplan Meier plots and any other analyses that may be required by the IDMC to the Committee. Independent statisticians need to provide the data to the IDMC at least five days prior to their meeting. A conservative version of the O’Brien-Fleming monitoring boundary will be used at the 60 event interim analysis that preserves the strength of evidence to declare statistical significance at both the interim and final analyses in this 80 event trial. We have previously provided guidance as to what we need to observe at the 80 event final analysis to declare statistical significance with an estimated Hazard Ratio for Overall Survival of approximately 0.636.

 

In the closed sessions of the January IDMC meeting, the IDMC will discuss unblinded data from the REGAL trial, including information about the relative efficacy and safety of interventions. To ensure that the IDMC will be fully informed to fulfill its primary mission of safeguarding the interest of participating patients, the IDMC will have access to unblinded data for its assessment of safety, futility and efficacy.

 

Following the closed session, an open session will be held which allows SELLAS and the IDMC an opportunity to discuss the trial-related matters, and, if warranted, for the IDMC to request additional information deemed relevant to executing their responsibilities. The database will also be further cleaned to assure any queries are resolved, as simple as assuring patients’ ages have been correctly entered to concomitant medication and dates when CRs were recorded, the survival dates, and so forth.

 

ViaVid has made considerable efforts to provide an accurate transcription. There may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference call. This transcript is being made available for information purposes only.

 

1-888-562-0262 1-604-929-1352 www.viavid.com

 

 

 

 

The open session is the only portion of the IDMC meeting during which SELLAS representatives may participate and only blinded data will be discussed during the open session.

 

After IDMC’s discussion with SELLAS during that open session, IDMC will have a second closed session without SELLAS present. Following the second closed session, SELLAS representatives will be invited to rejoin the meeting to receive verbal recommendations from the Chair of the IDMC. These recommendations will address trial monitoring and will specify whether to continue the trial without modification, continue with modification, or discontinue the trial.

 

Now, in case of a recommendation to discontinue the trial, the decision would be based on results from either the futility analysis, indicating that GPS did not show a positive effect in the REGAL AML patients, or due to exceptional efficacy already seen at the interim analysis, where GPS has shown an exceptional efficacy benefit in the REGAL study.

 

We, as the study sponsor, hope that the IDMC will recommend stopping the study due to exceptional efficacy observed at this interim analysis already or proceeding to the final study analysis at 80 events.

 

To further clarify around the final 80 events, if the recommendation would be to proceed to 80 events, this may indeed indicate that GPS extends survival to reach statistical significance, and would be a very encouraging recommendation, because the IDMC will perform a futility analysis in the expected January meeting instead of discontinuing the study in January for futility.

 

I’m merely providing the above thoughts to help you understand the potential outcomes as we are proceeding towards next month’s IDMC meeting.

 

As per the IDMC Charter and alignment with regulators, if the IDMC recommends stopping the study for efficacy and recommends unblinding, no action will be taken until SELLAS communicates this recommendation to the FDA and receives its input.

 

To be clear, SELLAS will inform the public, as we have done in the past, of the IDMC recommendation as soon as it is available to us along with any relevant information.

 

As part of our commitment to maintaining the integrity of the trial, we will provide a full update once the trial is complete and the data is unblinded, unless otherwise guided by the IDMC or regulatory agencies.

 

In conclusion, as we move forward, our resolve is stronger than ever. This milestone fuels our hope and ambition to bring innovative treatments to those who need them most. We are optimistic and committed about what lies ahead and remain dedicated to achieving our goals. Together, we are making strides toward a brighter future.

 

Thank you for your trust, support, and shared vision for a world where hope for leukemia patients is within reach.

 

On behalf of our SELLAS family, I would like to wish you and your loved ones at this time, Happy Holidays, Merry Christmas and a Happy, Healthy and Successful New Year. Thank you.

 

ViaVid has made considerable efforts to provide an accurate transcription. There may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference call. This transcript is being made available for information purposes only.

 

1-888-562-0262 1-604-929-1352 www.viavid.com

 

 

v3.24.3

Cover	Dec. 10, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 10, 2024
Entity File Number	001-33958
Entity Registrant Name	SELLAS Life Sciences Group, Inc.
Entity Central Index Key	0001390478
Entity Tax Identification Number	20-8099512
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	7 Times Square
Entity Address, Address Line Two	Suite 2503
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10036
City Area Code	646
Local Phone Number	200-5278
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	SLS
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

---