SLS SELLAS Life Sciences Group Inc.

3.31
-0.06  -2%
Previous Close 3.37
Open 3.36
52 Week Low 1.455
52 Week High 10.89
Market Cap $22,236,249
Shares 6,717,900
Float 6,710,914
Enterprise Value $16,822,471
Volume 107,288
Av. Daily Volume 203,063
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Upcoming Catalysts

Drug Stage Catalyst Date
Galinpepimut-S and nivolumab
Malignant pleural mesothelioma (MPM)
Phase 1
Phase 1
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Galinpepimut-S and Keytruda (pembrolizumab)
Solid tumors
Phase 1/2
Phase 1/2
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Galinpepimut-S
Acute Myeloid Leukemia (AML)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Nelipepimut-S and GM-CSF (VADIS)
Ductal Carcinoma in Situ (DCIS)
Phase 2
Phase 2
Phase 2 initial data released March 18, 2020.
NeuVax in combination with Herceptin
Breast cancer - 1+/2+
Phase 3
Phase 3
Phase 3 trial planned.

Latest News

  1. NEW YORK, July 31, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $9.2 million through the private placement of up to 2,744,078 shares of its common stock and accompanying warrants to purchase an aggregate of 2,744,078 shares of common stock at a combined purchase price of $3.335 per share and accompanying warrant. The warrants will be exercisable immediately at an exercise price of $3.30 per share…

    NEW YORK, July 31, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $9.2 million through the private placement of up to 2,744,078 shares of its common stock and accompanying warrants to purchase an aggregate of 2,744,078 shares of common stock at a combined purchase price of $3.335 per share and accompanying warrant. The warrants will be exercisable immediately at an exercise price of $3.30 per share and will expire five years from the effective date.  The closing of the private placement is expected to occur on August 4, 2020 and is subject to the satisfaction of certain customary closing conditions set forth in the securities purchase agreements.

    Maxim Group LLC is acting as the sole placement agent for the transaction.

    The shares of common stock and warrants described above have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the shares of common stock and the shares issuable upon exercise of the warrants.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About SELLAS Life Sciences Group, Inc.

    SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS' lead product candidate, galinpepimut-S (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 or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS' second product candidate, nelipepimut-S (NPS), is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following standard of care.

    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 anticipated timing for closing the private placement, the Company's plans for further development of and regulatory plans for GPS, including the timing of clinical results, the potential for GPS as a drug development candidate, plans for further development of and regulatory plans for NPS, statements regarding the outcome of discussions with the FDA regarding NPS and statements about the Company's strategy and plans for out-licensing NPS. 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 associated with the COVID-19 pandemic and its impact on the Company's clinical plans and business strategy, risks and uncertainties associated with immune-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 13, 2020 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 Contacts

    Adam Holdsworth

    PCG Advisory

    646-862-4607

    Investor Relations

    SELLAS Life Sciences Group, Inc.

    917-438-4353

    Primary Logo

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  2. NEW YORK, NY / ACCESSWIRE / June 3, 2020 / The Virtual Summer Summit will take place on June 9th-12th, connecting 47 presenting small and microcap companies with distinguished investors from around the globe. A full list of issuers are listed below along with webcasting links to view presentations.

    Company

    Ticker

    Webcasting Link

    ACCO Brands Corporation

    ACCO

    Participating in meetings only

    Alimera Sciences, Inc.

    ALIM

    https://www.webcaster4.com/Webcast/Page/2038/35019

    Annovis Bio

    ANVS

    https://www.webcaster4.com/Webcast/Page/2038/35035

    AquaBounty Technologies, Inc.

    AQB

    https://www.webcaster4.com/Webcast/Page/2038/35133

    Arch Therapeutics, Inc.

    ARTH

    https://www.webcaster4.com/Webcast/Page/2038/35130

    Artelo Biosciences…

    NEW YORK, NY / ACCESSWIRE / June 3, 2020 / The Virtual Summer Summit will take place on June 9th-12th, connecting 47 presenting small and microcap companies with distinguished investors from around the globe. A full list of issuers are listed below along with webcasting links to view presentations.

    Company

    Ticker

    Webcasting Link

    ACCO Brands Corporation

    ACCO

    Participating in meetings only

    Alimera Sciences, Inc.

    ALIM

    https://www.webcaster4.com/Webcast/Page/2038/35019

    Annovis Bio

    ANVS

    https://www.webcaster4.com/Webcast/Page/2038/35035

    AquaBounty Technologies, Inc.

    AQB

    https://www.webcaster4.com/Webcast/Page/2038/35133

    Arch Therapeutics, Inc.

    ARTH

    https://www.webcaster4.com/Webcast/Page/2038/35130

    Artelo Biosciences, Inc.

    ARTL

    https://www.webcaster4.com/Webcast/Page/2038/35016

    Avalon Adv Materials

    AVLNF

    https://www.webcaster4.com/Webcast/Page/2038/35132

    Bellicum Pharmaceuticals

    BLCM

    https://www.webcaster4.com/Webcast/Page/2038/35045

    C-Bond Systems

    CBNT

    https://www.webcaster4.com/Webcast/Page/2038/35029

    Endra Life Sciences

    NDRA

    https://www.webcaster4.com/Webcast/Page/2038/35129

    Energy Focus, Inc.

    EFOI

    https://www.webcaster4.com/Webcast/Page/2038/35027

    Equillium

    EQ

    https://www.webcaster4.com/Webcast/Page/2038/35188

    Exro Technologies Inc.

    EXROF

    https://www.webcaster4.com/Webcast/Page/2038/35052

    GreenPower Motor Company

    GPV

    https://www.webcaster4.com/Webcast/Page/2038/35185

    Hecla Mining Company

    HL

    Participating in meetings only

    Heidrick & Struggles International, Inc.

    HSII

    https://www.webcaster4.com/Webcast/Page/2038/35053

    Helius Medical Technologies

    HSDT

    https://www.webcaster4.com/Webcast/Page/2038/35021

    Heritage Global Inc

    HGBL

    https://www.webcaster4.com/Webcast/Page/2038/35131

    Ideal Power

    IPWR

    https://www.webcaster4.com/Webcast/Page/2038/35031

    IMAC Holdings, Inc.

    IMAC

    https://www.webcaster4.com/Webcast/Page/2038/35146

    Lincoln Educational Services

    LINC

    https://www.webcaster4.com/Webcast/Page/2038/35028

    MailUp Group

    MAIL

    https://www.webcaster4.com/Webcast/Page/2038/35047

    Marrone Bio

    MBII

    https://www.webcaster4.com/Webcast/Page/2038/35033

    Medexus

    MDP.V

    https://www.webcaster4.com/Webcast/Page/2038/35128

    Medicenna Therapeutics

    TSX: MDNA

    https://www.webcaster4.com/Webcast/Page/2038/35034

    Milestone Scientific

    MLSS

    https://www.webcaster4.com/Webcast/Page/2038/35125

    My Size, Inc.

    MYSZ

    https://www.webcaster4.com/Webcast/Page/2038/35024

    Nephros

    NEPH

    https://www.webcaster4.com/Webcast/Page/2038/35014

    NewAge Beverage

    NBEV

    https://www.webcaster4.com/Webcast/Page/2038/35141

    Nova Leap Health Corp

    NLH

    https://www.webcaster4.com/Webcast/Page/2038/35042

    Oblong Inc.

    OBLG

    https://www.webcaster4.com/Webcast/Page/2038/35025

    OncoSec Medical Incorporated

    ONCS

    https://www.webcaster4.com/Webcast/Page/2038/35011

    Oragenics

    OGEN

    https://www.webcaster4.com/Webcast/Page/2038/35043

    PDS Biotechnology Corporation

    PDSB

    https://www.webcaster4.com/Webcast/Page/2038/35018

    Safeguard Scientifics, Inc.

    SFE

    https://www.webcaster4.com/Webcast/Page/2038/35143

    SELLAS Life Sciences Group, Inc.

    SLS

    Participating in meetings only

    ShiftPixy

    PIXY

    https://www.webcaster4.com/Webcast/Page/2038/35032

    Sigma Labs, Inc.

    SGLB

    https://www.webcaster4.com/Webcast/Page/2038/35153

    Sono-Tek Corporation

    SOTK

    https://www.webcaster4.com/Webcast/Page/2038/35022

    Timber

    Private

    https://www.webcaster4.com/Webcast/Page/2038/35017

    Tinybeans Group Limited

    TNY.AX

    https://www.webcaster4.com/Webcast/Page/2038/35046

    Tonix Pharmaceuticals Holding Corp.

    TNXP

    https://www.webcaster4.com/Webcast/Page/2038/35044

    TransGlobe Energy

    TGA

    https://www.webcaster4.com/Webcast/Page/2038/35051

    Trxade Group, Inc.

    MEDS

    https://www.webcaster4.com/Webcast/Page/2038/35123

    Ur-Energy Inc.

    URG

    https://www.webcaster4.com/Webcast/Page/2038/35030

    VIQ Solutions, Inc.

    VQS.V

    https://www.webcaster4.com/Webcast/Page/2038/35145

    Western Magnesium

    MLYF

    https://www.webcaster4.com/Webcast/Page/2038/35050

    About the Investor Summit

    The Investor Summit Group (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. Having produced successful conferences over the past 5 years, the upcoming event will be the 2nd virtual edition added to our growing portfolio where hundreds of high-quality meetings between executives and investors will take place over 4 days. We pride ourselves on building community and providing a platform for our industry and look forward to launching new features at the upcoming Summer Summit such as virtual roundtable discussions and a stock pitch session to promote networking in a virtual format.

    To register for the upcoming Investor Summit, visit our website at www.investorsummitgroup.com

    Media Partner: Investor Brand Network, www.InvestorBrandNetwork.com

    News Compliments of ACCESSWIRE

    FOR MORE INFORMATION

    Please visit: www.investorsummitgroup.com
    Or, contact Cassandra Miller at

    SOURCE: The Investor Summit Group

    View source version on accesswire.com:
    https://www.accesswire.com/592484/47-Public-Companies-to-present-at-the-Summer-Virtual-Investor-Summit-on-June-9th-12th

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  3. NEW YORK, May 22, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today announced that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") virtually due to the public health impact of the coronavirus (COVID-19) pandemic and to prioritize the health and well-being of meeting participants.

    The Annual Meeting will be held in a virtual-only format on Tuesday, June 9, 2020, at 8:30 a.m., Eastern Time. The date and time of the Annual Meeting, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive…

    NEW YORK, May 22, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today announced that it will hold its 2020 Annual Meeting of Stockholders (the "Annual Meeting") virtually due to the public health impact of the coronavirus (COVID-19) pandemic and to prioritize the health and well-being of meeting participants.

    The Annual Meeting will be held in a virtual-only format on Tuesday, June 9, 2020, at 8:30 a.m., Eastern Time. The date and time of the Annual Meeting, as disclosed in the previously distributed Notice of the Annual Meeting and Definitive Proxy Statement (the "Notice and Proxy Statement"), has not changed.

    Stockholders of record and registered beneficial owners as of the close of business on April 13, 2020 will be able to vote and ask questions during the meeting through the online platform. Online access to the Annual Meeting will begin at 8:15 a.m. Eastern Time. Stockholders will not be able to attend the Annual Meeting in person.

    SELLAS encourages stockholders to vote and submit their proxies in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.

    Attending the Virtual Annual Meeting

    Stockholders of record as of April 13, 2020 can attend the meeting by accessing  www.meetingcenter.io/257687071 and entering the 15-digit control number found on their proxy card, voting instruction form, notice of internet availability of proxy materials, or email previously received. Stockholders may vote during the Annual Meeting by following the instructions available on the meeting website during the meeting.

    Participating, Voting Electronically and Submitting Questions at the Virtual Annual Meeting

    Stockholders of Record

    Stockholders of record will be able to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting, without advance registration. The two items of information needed to access the live webcast of the meeting are the following:

    The 15-digit control number found on the proxy card, voting instruction form, notice of internet availability of proxy materials, or email previously received

    Meeting password: SLS2020

    Beneficial Owners

    Beneficial stockholders as of April 13, 2020 who hold shares through an intermediary, such as a bank, broker or nominee, and who want to attend the Annual Meeting, must register in advance to participate in the Annual Meeting, vote electronically and submit questions during the live webcast of the meeting. To register in advance, beneficial stockholders must obtain a legal proxy from the bank, broker or other nominee that holds their shares giving them the right to vote the shares and must forward a copy of the legal proxy along with their email address to Computershare Trust Company, N.A. ("Computershare").

    Requests for registration should be directed to Computershare by email at no later than 5:00 p.m. Eastern Time, on June 4, 2020. Stockholders will receive a confirmation of their registration and instructions on how to attend the meeting by email after Computershare receives registration materials.

    Questions

    Stockholders may submit questions in advance of the Annual Meeting by emailing the  question, along with proof of ownership, to prior to 8:30 a.m. Eastern Time on June 8, 2020. Stockholders may also submit questions during the Annual Meeting through the online platform in accordance with the instructions above. The Company will, subject to time constraints, answer all questions that are pertinent to the business of the Annual Meeting and will give priority to questions submitted in advance.

    The proxy materials, including the proxy card and Notice of Internet Availability of Proxy Materials, previously distributed along with the Notice and Proxy Statement, will not be updated to reflect the change in location and may continue to be used to vote shares in connection with the Annual Meeting.

    About SELLAS Life Sciences Group, Inc.

    SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS' lead product candidate, galinpepimut-S (GPS), is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS' second product candidate, nelipepimut-S (NPS), is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following standard of care. For more information on SELLAS, please visit www.sellaslifesciences.com.

    Investor Contacts
    Adam Holdsworth
    PCG Advisory
    646-862-4607


    SELLAS Life Sciences Group, Inc.
    Investor Relations
    917-438-4353

    Source: SELLAS Life Sciences Group 

    Primary Logo

    View Full Article Hide Full Article
    • Independent Data Monitoring Committee (DMC) to Review and Evaluate Patient Safety and Efficacy Data for Pivotal Phase 3 Trial of Galinpepimut-S in Patients with Acute Myeloid Leukemia in Second Remission
    • Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center to serve as DMC Chair
    • Thomas Fleming, Ph.D., Professor and former biostatistics department chair of the University of Washington, Member of the Fred Hutchinson Cancer Research Center, Special Government Employee for the FDA, and a regular member of FDA Advisory Committees to serve as Lead Biostatistician on DMC

    NEW YORK, May 18, 2020 (GLOBE NEWSWIRE) -- SELLAS…

    • Independent Data Monitoring Committee (DMC) to Review and Evaluate Patient Safety and Efficacy Data for Pivotal Phase 3 Trial of Galinpepimut-S in Patients with Acute Myeloid Leukemia in Second Remission
    • Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center to serve as DMC Chair
    • Thomas Fleming, Ph.D., Professor and former biostatistics department chair of the University of Washington, Member of the Fred Hutchinson Cancer Research Center, Special Government Employee for the FDA, and a regular member of FDA Advisory Committees to serve as Lead Biostatistician on DMC

    NEW YORK, May 18, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today announced the formation of the Independent Data Monitoring Committee (DMC) for its pivotal Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2). 

    The DMC is comprised of an independent group of medical, scientific and biostatistics experts and is responsible for reviewing and evaluating patient safety and efficacy data for the Company's Phase 3 REGAL clinical trial. The DMC will review study data at regular intervals in order to ensure the safety of all patients enrolled in the study. The Committee will also monitor the quality and overall conduct and ensure the validity, scientific and clinical merits of the study, including each site's compliance with the requirements specified in the study protocol. The DMC is charged with assessing such actions in light of an acceptable benefit/risk profile for GPS and will also make applicable recommendations regarding the clinical trial to SELLAS.

    "Our REGAL clinical trial is the only Phase 3 study focused on remission prolongation through maintenance post-CR2 therapy, a significant and growing unmet medical need. As such, it is critically important to maintain the highest levels of integrity for this pivotal study. With the formation of the DMC, comprised of highly regarded and experienced physicians and biostatisticians who will confer with the respected physicians on the Steering Committee recently announced, we believe that we have brought together world class experts to monitor and guide this critical study which has the potential to extend the life of AML patients in CR2," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS.  "Furthermore, the DMC will be able, at its sole discretion, to directly and independently liaise with the U.S. Food and Drug Administration (FDA) in order to discuss potential early unblinding and discontinuation of the study in case of reliable evidence of safety and clinically significant positive efficacy of GPS.  We believe that this further strengthens the integrity and conduct of our REGAL study."

    The Data Monitoring Committee currently consists of four members:

    • Moshe Talpaz, M.D., Associate Director of Translational Research and Associate Chief of the Division of Hematology/Oncology at the University of Michigan Comprehensive Cancer Center and Chair of the REGAL Data Monitoring Committee
    • Thomas Fleming, Ph.D., Professor and former department chair of the University of Washington Department of Biostatistics, Member of the Fred Hutchinson Cancer Research Center, former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID, Special Government Employee for the FDA, and for more than 25 years, a regular member of several FDA Advisory Committees
    • Miguel-Angel Perales, M.D., Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center (MSKCC)
    • Stephane de Botton, M.D., Head of the Hematology Department at the Gustave Roussy Cancer Campus in Paris, France

    Dr. Moshe Talpaz, commented, "I look forward to working together with the other esteemed members of the Data Monitoring Committee on SELLAS' important pivotal Phase 3 REGAL study. While significant progress has been made over the last few years in putting AML patients into a second remission, the survival benefit has not yet improved correspondingly.  Because those patients are by definition in a remission, risk and benefit must be very carefully balanced and it is of great scientific interest to me to be a part of that process, as GPS may have the potential to prolong survival, as the Chair of the independent data monitoring committee for the study focused specifically on that patient population."

    "It is a privilege to contribute to safeguarding the interests of study participants and to protecting the integrity of a trial of such importance in enhancing our understanding about the effects of interventions in AML patients in complete remission," added Dr. Fleming.

    The Company previously reported initial data from the Phase 2a study of GPS in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival (OS) in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy (p = 0.0175). The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of GPS in AML patients who achieved first complete remission (CR1) also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

    The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators' choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

    For further information on enrolling in the REGAL study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT04229979.

    About SELLAS Life Sciences Group, Inc.

    SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS' lead product candidate, GPS, is licensed from MSKCC and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS' second product candidate, nelipepimut-S (NPS), is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes triple negative breast cancer patients, following standard of care. 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 Company's plans for clinical development of for GPS, including the timing of clinical results, and the potential for GPS as a drug development candidate. 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 associated with the COVID-19 pandemic and its impact on the Company's clinical plans and business strategy, immune-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 13, 2020 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 Contacts
    Adam Holdsworth
    PCG Advisory
    646-862-4607


    SELLAS Life Sciences Group, Inc.
    Investor Relations
    917-438-4353


    Source: SELLAS Life Sciences Group

    Primary Logo

    View Full Article Hide Full Article
  4. NEW YORK, May 14, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today reported financial results for the first quarter of 2020 and provided a business update.

    "The first quarter of 2020 brought unprecedented times with the onset of the COVID-19 global pandemic. Our key priorities are to focus on the health and safety of our patients, investigators, employees and other stakeholders as well as diligently executing our business operations. We have been fortunate to be able to continue to progress our clinical development program for galinpepimut-S…

    NEW YORK, May 14, 2020 (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 cancer immunotherapies for a broad range of cancer indications, today reported financial results for the first quarter of 2020 and provided a business update.

    "The first quarter of 2020 brought unprecedented times with the onset of the COVID-19 global pandemic. Our key priorities are to focus on the health and safety of our patients, investigators, employees and other stakeholders as well as diligently executing our business operations. We have been fortunate to be able to continue to progress our clinical development program for galinpepimut-S (GPS), including our Phase 3 REGAL study in acute myeloid leukemia (AML), our Phase 1/2 basket study in combination with pembrolizumab (KEYTRUDA®), and our Phase 1 trial in combination with nivolumab (Opdivo®) in malignant pleural mesothelioma (MPM) despite the uncertainty and disruption caused by the pandemic. Our activities around the REGAL study, including those for additional site activations in the United States and Europe, have continued unabated. Screening is continuing in the basket study and dosing of enrolled patients is continuing in the MPM Phase 1 study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Additionally, we are continuing our business development efforts to pursue out-licensing opportunities for further clinical development of nelipepimut-S (NPS)."

    First Quarter 2020 and Recent Pipeline Highlights

    Galinpepimut-S (GPS) Program

    • In April 2020, SELLAS announced the formation of the Steering Committee for its Phase 3 REGAL clinical trial of GPS in patients with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2). The Steering Committee currently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the multi-center Phase 3 REGAL study and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology - Baylor Charles A. Sammons Cancer Center.
    • In February 2020, SELLAS announced positive follow-up data from its Phase 1/2 study of GPS in CR2 AML patients. The final data show a median overall survival (OS) of 21.0 months, at a median follow-up of 30.8 months, in patients receiving GPS compared to 5.4 months in patients treated with best standard care (p-value < 0.02). GPS therapy continued to be well-tolerated throughout the study. 
    • In February 2020, SELLAS announced the enrollment of the first patient in an investigator-sponsored clinical trial of GPS in combination with Bristol-Myers Squibb's anti-PD-1 therapy, nivolumab (Opdivo®), in patients with MPM.
    • In January 2020, SELLAS announced that it commenced patient screening for its pivotal Phase 3 REGAL study of GPS in patients with AML in CR2. 

    Nelipepimut-S (NPS) Program

    • In March 2020, SELLAS announced preliminary antigen-specific immune response data from a Phase 2 randomized investigator-sponsored trial of NPS in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. Preliminary data show an 11-fold increase in a CD8 cytotoxic T-lymphocytes immune response in patients who received a single dose of NPS compared to baseline. The final data is being further analyzed by the National Institute of Health, MD Anderson Cancer Center and the study principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Women's Cancer Center, and will be presented at an upcoming medical conference.
    • In March 2020, SELLAS announced that final results from the efficacy and safety data analysis of the Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab (Herceptin®) +/- NPS targeting HER2 low-expressing breast cancer patient cohorts, including patients with triple negative breast cancer (TNBC), were recently published in the peer reviewed journal, Clinical Cancer Research. With regard to the TNBC patient cohort, the data analysis shows:
      -  Disease-free survival (DFS) landmark rate at 24 months for patients treated with NPS plus trastuzumab (n=53) was 92.6% compared to 70.2% for those treated with trastuzumab alone (n=44), a clinically and statistically significant improvement.
      -  There was a statistically significant reduction of 71.9% (p=0.01) in the frequency of clinically detected recurrences in patients treated with the combination (NPS plus trastuzumab) versus trastuzumab alone.
      -  The combination was generally well-tolerated and there were no clinicopathologic differences between the study groups.
    • In February 2020, SELLAS announced that it had finalized the design and plan for a Phase 3 registration-enabling study of NPS in combination with trastuzumab for the treatment of patients with TNBC in the adjuvant setting after standard treatment, following feedback from a Type C review with the FDA. SELLAS is actively pursuing out-licensing opportunities to fund and conduct the future clinical development of NPS.

    Recent Corporate Highlights

    • In April 2020, SELLAS retained PCG Advisory Inc., a leading investor relations and digital strategies firm, to serve as an advisor for investor relations and strategic communications.
    • In February 2020, SELLAS announced the appointment of Dragan Cicic, MD, as Senior Vice President, Clinical Development.

    First Quarter 2020 Financial Results

    Cash Position: As of March 31, 2020, cash and cash equivalents totaled approximately $6.7 million, compared to $2.6 million as of March 31, 2019. Net cash used in operating activities was $6.8 million for the three months ended March 31, 2020, compared to $5.0 million for the three months ended March 31, 2019. Net cash provided by financing activities was $6.3 million for the three months ended March 31, 2020, which was attributable to $6.0 million in net proceeds from a registered direct offering of shares of common stock and warrants to purchase common shares in a concurrent private placement consummated in January 2020, and $0.3 million from the collection of a stock subscription receivable. During the three months ended March 31, 2019, the Company generated $2.2 million of net cash from financing activities from the exercise of certain common stock warrants.

    R&D Expenses: Research and development expenses were $1.9 million for the first quarter of 2020, as compared to $1.9 million for the three months ended March 31, 2019. While relatively unchanged from the previous year quarter, for the three months ended March 31, 2020 there was a $0.2 million increase in clinical trial expenses, a $0.1 million increase in manufacturing related expenses for GPS due to the Company's ongoing basket trial of GPS in combination with pembrolizumab and the Phase 3 REGAL study of GPS as a monotherapy in AML, and a $0.1 million increase in other research and development expenses, partially offset by a $0.2 million decrease in personnel related expenses due to reduced headcount and a $0.2 million decrease in licensing fees.

    G&A Expenses: General and administrative expenses were $2.2 million for the three months ended March 31, 2020, as compared to $2.5 million for the three months ended March 31, 2019. The $0.3 million decrease was primarily due to a $0.3 million decrease in legal fees, a $0.2 million decrease in accounting fees, and a $0.1 million decrease in personnel related expenses due to reduced headcount. These decreases were partially offset by a $0.2 million increase in premiums for directors and officers liability insurance and a $0.1 million increase in outsourced consulting and public company costs.

    Net Loss: Net loss attributable to common stockholders was $4.2 million for the first quarter of 2020, or a basic and diluted loss per share attributable to common stockholders of $0.66, as compared to a net loss attributable to common stockholders of $5.0 million for the first quarter of 2019, or a basic and diluted loss per share attributable to common stockholders of $11.12.

    About SELLAS Life Sciences Group, Inc.

    SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapeutics 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 or in combination to address a broad spectrum of hematologic malignancies and solid tumor indications. SELLAS' second product candidate, NPS, is a HER2-directed cancer immunotherapy with potential for the treatment of patients with early stage breast cancer with low to intermediate HER2 expression, otherwise known as HER2 1+ or 2+, which includes TNBC patients, following standard of care.

    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 Company's plans for further development of and regulatory plans for GPS, including the timing of clinical results, the potential for GPS as a drug development candidate, plans for further development of and regulatory plans for NPS, statements regarding the outcome of discussions with the FDA regarding NPS and statements about the Company's strategy and plans for out-licensing NPS. 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 associated with the COVID-19 pandemic and its impact on the Company's clinical plans and business strategy, risks and uncertainties associated with immune-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 13, 2020 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.

    Keytruda®, Opdivo® and Herceptin® are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, Bristol Myers Squibb and Genentech, Inc., respectively, and are not trademarks of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

    Investor Contacts
    Adam Holdsworth
    PCG Advisory
    646-862-4607

    Investor Relations
    SELLAS Life Sciences Group, Inc.
    917-438-4353

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