NEW YORK, Could 14, 2020 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Firm”), a late-stage medical biopharmaceutical firm centered on the event of novel most cancers immunotherapies for a broad vary of most cancers indications, right now reported monetary outcomes for the primary quarter of 2020 and offered a enterprise replace.
“The primary quarter of 2020 introduced unprecedented instances with the onset of the COVID-19 world pandemic. Our key priorities are to deal with the well being and security of our sufferers, investigators, staff and different stakeholders in addition to diligently executing our enterprise operations. We have now been lucky to have the ability to proceed to progress our medical growth program for galinpepimut-S (GPS), together with our Part Three REGAL examine in acute myeloid leukemia (AML), our Part half of basket examine together with pembrolizumab (KEYTRUDA®), and our Part 1 trial together with nivolumab (Opdivo®) in malignant pleural mesothelioma (MPM) regardless of the uncertainty and disruption attributable to the pandemic. Our actions across the REGAL examine, together with these for added website activations in the US and Europe, have continued unabated. Screening is constant within the basket examine and dosing of enrolled sufferers is constant within the MPM Part 1 examine,” mentioned Angelos Stergiou, MD, ScD h.c., President and Chief Government Officer of SELLAS. “Moreover, we’re persevering with our enterprise growth efforts to pursue out-licensing alternatives for additional medical growth of nelipepimut-S (NPS).”
First Quarter 2020 and Current Pipeline Highlights
Galinpepimut-S (GPS) Program
- In April 2020, SELLAS introduced the formation of the Steering Committee for its Part Three REGAL medical trial of GPS in sufferers with AML who’ve achieved full remission after second-line anti-leukemic remedy (CR2). The Steering Committee presently consists of three members: Dr. Hagop Kantarjian, MD, Professor and Chair of the Division of Leukemia at The College of Texas MD Anderson Most cancers Heart, and Principal Investigator at MD Anderson for the multi-center Part Three REGAL examine and Chair of the REGAL Steering Committee; Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology on the H. Lee Moffitt Most cancers Heart and member of the SELLAS Scientific Advisory Board; and Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies on the Texas Oncology – Baylor Charles A. Sammons Most cancers Heart.
- In February 2020, SELLAS introduced constructive follow-up knowledge from its Part half of examine of GPS in CR2 AML sufferers. The ultimate knowledge present a median general survival (OS) of 21.Zero months, at a median follow-up of 30.eight months, in sufferers receiving GPS in comparison with 5.Four months in sufferers handled with greatest commonplace care (p-value < 0.02). GPS remedy continued to be well-tolerated all through the examine.
- In February 2020, SELLAS introduced the enrollment of the primary affected person in an investigator-sponsored medical trial of GPS together with Bristol-Myers Squibb’s anti-PD-1 remedy, nivolumab (Opdivo®), in sufferers with MPM.
- In January 2020, SELLAS introduced that it commenced affected person screening for its pivotal Part Three REGAL examine of GPS in sufferers with AML in CR2.
Nelipepimut-S (NPS) Program
- In March 2020, SELLAS introduced preliminary antigen-specific immune response knowledge from a Part 2 randomized investigator-sponsored trial of NPS together with granulocyte-macrophage colony-stimulating issue (GM-CSF) in ladies with ductal carcinoma in situ (DCIS) of the breast who’re HLA-A2+ or A3+ constructive, specific HER2 at IHC 1+, 2+, or 3+ ranges, and are pre- or post-menopausal. Preliminary knowledge present an 11-fold enhance in a CD8 cytotoxic T-lymphocytes immune response in sufferers who obtained a single dose of NPS in comparison with baseline. The ultimate knowledge is being additional analyzed by the Nationwide Institute of Well being, MD Anderson Most cancers Heart and the examine principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the Dana-Farber/Brigham and Ladies’s Most cancers Heart, and will likely be introduced at an upcoming medical convention.
- In March 2020, SELLAS introduced that last outcomes from the efficacy and security knowledge evaluation of the Part 2b impartial investigator-sponsored medical trial of the mix of trastuzumab (Herceptin®) +/- NPS concentrating on HER2 low-expressing breast most cancers affected person cohorts, together with sufferers with triple detrimental breast most cancers (TNBC), had been not too long ago printed within the peer reviewed journal, Medical Most cancers Analysis. With regard to the TNBC affected person cohort, the info evaluation reveals:
– Illness-free survival (DFS) landmark charge at 24 months for sufferers handled with NPS plus trastuzumab (n=53) was 92.6% in comparison with 70.2% for these handled with trastuzumab alone (n=44), a clinically and statistically vital enchancment.
– There was a statistically vital discount of 71.9% (p=0.01) within the frequency of clinically detected recurrences in sufferers handled with the mix (NPS plus trastuzumab) versus trastuzumab alone.
– The mix was usually well-tolerated and there have been no clinicopathologic variations between the examine teams.
- In February 2020, SELLAS introduced that it had finalized the design and plan for a Part Three registration-enabling examine of NPS together with trastuzumab for the therapy of sufferers with TNBC within the adjuvant setting after commonplace therapy, following suggestions from a Sort C evaluate with the FDA. SELLAS is actively pursuing out-licensing alternatives to fund and conduct the long run medical growth of NPS.
Current Company Highlights
- In April 2020, SELLAS retained PCG Advisory Inc., a number one investor relations and digital methods agency, to function an advisor for investor relations and strategic communications.
- In February 2020, SELLAS introduced the appointment of Dragan Cicic, MD, as Senior Vice President, Medical Growth.
First Quarter 2020 Monetary Outcomes
Money Place: As of March 31, 2020, money and money equivalents totaled roughly $6.7 million, in comparison with $2.6 million as of March 31, 2019. Web money utilized in working actions was $6.eight million for the three months ended March 31, 2020, in comparison with $5.Zero million for the three months ended March 31, 2019. Web money offered by financing actions was $6.Three million for the three months ended March 31, 2020, which was attributable to $6.Zero million in web proceeds from a registered direct providing of shares of widespread inventory and warrants to buy widespread shares in a concurrent personal placement consummated in January 2020, and $0.Three million from the gathering of a inventory subscription receivable. In the course of the three months ended March 31, 2019, the Firm generated $2.2 million of web money from financing actions from the train of sure widespread inventory warrants.
R&D Bills: Analysis and growth bills had been $1.9 million for the primary quarter of 2020, as in comparison with $1.9 million for the three months ended March 31, 2019. Whereas comparatively unchanged from the earlier 12 months quarter, for the three months ended March 31, 2020 there was a $0.2 million enhance in medical trial bills, a $0.1 million enhance in manufacturing associated bills for GPS because of the Firm’s ongoing basket trial of GPS together with pembrolizumab and the Part Three REGAL examine of GPS as a monotherapy in AML, and a $0.1 million enhance in different analysis and growth bills, partially offset by a $0.2 million lower in personnel associated bills attributable to diminished headcount and a $0.2 million lower in licensing charges.
G&A Bills: Normal and administrative bills had been $2.2 million for the three months ended March 31, 2020, as in comparison with $2.5 million for the three months ended March 31, 2019. The $0.Three million lower was primarily attributable to a $0.Three million lower in authorized charges, a $0.2 million lower in accounting charges, and a $0.1 million lower in personnel associated bills attributable to diminished headcount. These decreases had been partially offset by a $0.2 million enhance in premiums for administrators and officers legal responsibility insurance coverage and a $0.1 million enhance in outsourced consulting and public firm prices.
Web Loss: Web loss attributable to widespread stockholders was $4.2 million for the primary quarter of 2020, or a primary and diluted loss per share attributable to widespread stockholders of $0.66, as in comparison with a web loss attributable to widespread stockholders of $5.Zero million for the primary quarter of 2019, or a primary and diluted loss per share attributable to widespread stockholders of $11.12.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage medical biopharmaceutical firm centered on the event of novel most cancers immunotherapeutics for a broad vary of most cancers indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Most cancers Heart and targets the WT1 protein, which is current in an array of tumor sorts. GPS has potential as a monotherapy or together to handle a broad spectrum of hematologic malignancies and strong tumor indications. SELLAS’ second product candidate, NPS, is a HER2-directed most cancers immunotherapy with potential for the therapy of sufferers with early stage breast most cancers with low to intermediate HER2 expression, in any other case often known as HER2 1+ or 2+, which incorporates TNBC sufferers, following commonplace of care.
For extra data on SELLAS, please go to www.sellaslifesciences.com.
This press launch accommodates forward-looking statements. All statements aside from statements of historic information are “forward-looking statements,” together with these regarding future occasions. In some circumstances, forward-looking statements may be recognized by terminology reminiscent of “plan,” “count on,” “anticipate,” “could,” “would possibly,” “will,” “ought to,” “challenge,” “consider,” “estimate,” “predict,” “potential,” “intend,” or “proceed” and different phrases or phrases of comparable that means. These statements embrace, with out limitation, statements associated to the Firm’s plans for additional growth of and regulatory plans for GPS, together with the timing of medical outcomes, the potential for GPS as a drug growth candidate, plans for additional growth of and regulatory plans for NPS, statements concerning the end result of discussions with the FDA concerning NPS and statements in regards to the Firm’s technique and plans for out-licensing NPS. These forward-looking statements are based mostly on present plans, targets, estimates, expectations and intentions, and inherently contain vital dangers and uncertainties. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements on account of these dangers and uncertainties, which embrace, with out limitation, dangers and uncertainties related to the COVID-19 pandemic and its affect on the Firm’s medical plans and enterprise technique, dangers and uncertainties related to immune-oncology product growth and medical success thereof, the uncertainty of regulatory approval, and different dangers and uncertainties affecting SELLAS and its growth applications as set forth beneath the caption “Danger Components” in SELLAS’ Annual Report on Kind 10-Ok filed on March 13, 2020 and in its different SEC filings. Different dangers and uncertainties of which SELLAS shouldn’t be presently conscious might also have an effect on SELLAS’ forward-looking statements and will trigger precise outcomes and the timing of occasions to vary materially from these anticipated. The forward-looking statements herein are made solely as of the date hereof. SELLAS undertakes no obligation to replace or complement any forward-looking statements to replicate precise outcomes, new data, future occasions, adjustments in its expectations or different circumstances that exist after the date as of which the forward-looking statements had been made.
Keytruda®, Opdivo® and Herceptin® are registered logos of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA, Bristol Myers Squibb and Genentech, Inc., respectively, and should not logos of SELLAS. The producers of those manufacturers should not affiliated with and don’t endorse SELLAS or its merchandise.
SELLAS Life Sciences Group, Inc.