On November 14, 2022 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, reported its financial results for the quarter ended September 30, 2022 (Press release, Galena Biopharma, NOV 14, 2022, View Source [SID1234623988]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"As announced this morning, we look forward to executing on our revised protocol and statistical analysis plan (SAP) for the Phase 3 registrational REGAL study of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) as well as evaluating the next steps for our ovarian cancer program for GPS in combination with PD1 inhibitors following our release last week of the promising final top-line data from our Phase 1/2 study of GPS in combination with pembrolizumab (Keytruda). We are pleased with the preclinical in vitro study results received in the third quarter for GFH009 in neuroendocrine prostate cancer (NEPC), other solid tumors and AML which will help guide our planning for a Phase 2 clinical program for GFH009 in 2023. In addition, we presented data at the 2022 SOHO Meeting, which highlighted bioequivalence data for GFH009 formulations, allowing us to explore a range of dosing strategies and prepare for dosage and administration, and are looking forward to two poster presentations at the upcoming 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December," stated Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
"These activities in the third quarter and early fourth quarter are laying the groundwork for the continued advancement in 2023 for both of our clinical programs," added Dr. Stergiou.
Pipeline Updates:
GPS: Wilms Tumor-1 (WT1) targeting peptide immunotherapeutic
•Phase 3 REGAL Study: SELLAS is holding a virtual investor event today at 8.30 am ET to discuss refinements to the protocol and SAP for the REGAL study and the participation of 3D Medicines Inc., SELLAS’ licensee for the development and commercialization of GPS in China, Hong Kong, Macau and Taiwan, in the REGAL study. Webcast information for the update call can be found below.
•Phase 1/2 Study with Keytruda: On November 10, 2022, SELLAS announced confirmatory top-line data showing survival and clinical benefits based on the final analysis of the Phase 1/2 clinical trial of GPS in combination with pembrolizumab (Keytruda) in patients with WT1+ relapsed or refractory platinum-resistant advanced ovarian cancer.
•First Patient Dosed in 3DMed Phase 1 Clinical Trial in China: In October 2022, SELLAS announced that 3D Medicines dosed the first patient in its Phase 1 clinical trial in China of GPS.
GFH009: small molecule, highly selective CDK9 inhibitor
•Preclinical Results: In August 2022, SELLAS announced results from preclinical in vitro studies in solid tumor cell lines, including NEPC, and AML cell lines demonstrating significant anti-tumor effects and cancer cell growth inhibition in selected cell lines.
•Phase 1 Clinical Trial Protocol Amendment: In July 2022, SELLAS announced that a second, once-a-week dose cohort has been added in its ongoing Phase 1 clinical trial in both the United States and China, beginning at the higher dose level of 30 mg.
Corporate Updates:
•New Board Member: In August 2022, SELLAS appointed Katherine Bach Kalin to its Board of Directors. Ms. Kalin’s healthcare industry experience spans pharmaceuticals, diagnostics, medical devices and digital health.
Financial Results for the Third Quarter 2022:
Licensing revenue: There was no licensing revenue for the third quarter of 2022 or 2021. There was $1.0 million in licensing revenue for the nine months ended September 30, 2022, which related to approval by Chinese regulatory authorities of an investigational new drug application by 3D Medicines. This compares to $7.6 million for the nine months ended September 30, 2021.
R&D Expenses: Research and development expenses for the third quarter of 2022 were $4.3 million, compared to $4.5 million for the same period in 2021. The decrease was primarily due to the timing of start-up fees and drug supply purchases in the prior year related to the Company’s ongoing Phase 3 REGAL clinical trial of GPS in AML patients. Research and development expenses were $14.4 million for the first nine months of 2022, compared to $12.3 million for the same period in 2021. The increase was primarily due to an increase in clinical trial expenses related to the REGAL study and personnel related expenses due to increased headcount.
Acquired In-Process Research and Development: There was no acquired in-process research and development for the third quarter of 2022. Acquired in-process research and development was $10.0 million for the first nine months of 2022, resulting from the in-licensing of GFH009. There was no acquired in-process research and development during the same periods in 2021.
G&A Expenses: General and administrative expenses for the third quarter of 2022 were $2.9 million, as compared to $2.4 million for the same period in 2021. The increase was primarily due to personnel related expenses due to increased headcount. General and administrative expenses were $9.0 million for the first nine months of 2022, compared to $8.8 million for the same period in 2021. The increase was primarily due to personnel related expenses due to increased headcount, which were partially offset by a decrease in amortization expense associated with the capitalized contract acquisition costs of the 3D Medicines license agreement.
Net Loss: Net loss was $7.0 million for the third quarter of 2022, or a basic and diluted loss per share of $0.34, compared to a net loss of $7.1 million for the same period in 2021, or a basic and diluted loss per share of $0.45. Net loss was $32.2 million for the first nine months of 2022, or a basic and diluted loss per share of $1.70, compared to a net loss of $14.1 million for the same period in 2021, or a basic and diluted loss per share of $0.92.
Cash Position: As of September 30, 2022, cash and cash equivalents totaled approximately $21.3 million.
Webcast Information for Phase 3 REGAL Study Update
The Company will host a virtual investor event on its Phase 3 REGAL clinical trial of GPS in patients with AML today at 8:30 a.m. ET. The event will be facilitated by SELLAS management, including SELLAS’ President and CEO, Angelos Stergiou, MD, ScD h.c., and Dragan Cicic, MD, Senior Vice President, Clinical Development, who will be joined by leading cancer researcher, M. Yair Levy, M.D., Director of Hematologic Malignancies Research at the Baylor University Medical Center, and member of the REGAL Steering Committee.
To attend the live video webcast, please register or email KCSA Strategic Communications at [email protected].
For interested individuals unable to join the live event, an archived version of the webcast will also be available on SELLAS’ Investor Relations site: View Source