Exhibit 99.1
SELLAS Life Sciences Provides Business Update and Reports Third Quarter 2022 Financial Results
– Cash Position of $21.3 Million as of September 30, 2022 –
– Hosting Phase 3 REGAL Study Update Webcast Today at 8:30 a.m. ET –
NEW YORK, 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, today provided a business update and reported its financial results for the quarter ended September 30, 2022.
“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) 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 SELLAS@kcsa.com.
For interested individuals unable to join the live event, an archived version of the webcast will also be available on SELLAS’ Investor Relations site: https://www.sellaslifesciences.com/investors/.
About SELLAS Life Sciences Group, Inc. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) 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 or in combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing 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.
Keytruda® is a registered trademark of Merck & Co., Inc., Rahway, N.J., USA (known as MSD outside the United States and Canada) and is not a trademark of SELLAS. The manufacturer of this brand is not affiliated with and does not endorse SELLAS or its products.
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 clinical development of GPS and GFH009 for various cancer indications, including the timing of commencement and completion of, and data from, clinical trials therefor, the potential for GPS and GFH009 as drug development candidates for various cancer indications, alone and in combination with other therapeutic agents. 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, risks and uncertainties associated 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 31, 2022 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
Allison Soss
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1267
Media Contacts
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 516.779.2630
SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
| Licensing revenue | | $ | — | | | $ | — | | | $ | 1,000 | | | $ | 7,600 | |
| Operating expenses: | | | | | | | | |
| Cost of licensing revenue | | — | | | — | | | 100 | | | 200 | |
| Research and development | | 4,282 | | | 4,541 | | | 14,422 | | | 12,281 | |
| Acquired in-process research and development | | — | | | — | | | 10,000 | | | — | |
| General and administrative | | 2,864 | | | 2,436 | | | 8,982 | | | 8,794 | |
| Total operating expenses | | 7,146 | | | 6,977 | | | 33,504 | | | 21,275 | |
| Operating loss | | (7,146) | | | (6,977) | | | (32,504) | | | (13,675) | |
| Non-operating income (expense), net: | | | | | | | | |
| Change in fair value of warrant liability | | 2 | | | 30 | | | 39 | | | (29) | |
| Change in fair value of contingent consideration | | 11 | | | (140) | | | 126 | | | (403) | |
| Interest income | | 111 | | | 2 | | | 159 | | | 6 | |
| Total non-operating income (expense), net | | 124 | | | (108) | | | 324 | | | (426) | |
| Net loss | | $ | (7,022) | | | $ | (7,085) | | | $ | (32,180) | | | $ | (14,101) | |
| | | | | | | | |
| Per share information: | | | | | | | | |
| Net loss per common share, basic and diluted | | $ | (0.34) | | | $ | (0.45) | | | $ | (1.70) | | | $ | (0.92) | |
| Weighted-average common shares outstanding, basic and diluted | | 20,562,351 | | | 15,874,076 | | | 18,932,571 | | | 15,344,210 | |
SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
| | | | | | | | | | | |
| September 30, 2022 | | December 31, 2021 |
| |
| ASSETS | | | |
| Current assets: | | | |
| Cash and cash equivalents | $ | 21,348 | | | $ | 21,355 | |
| Restricted cash and cash equivalents | 100 | | | 100 | |
| Prepaid expenses and other current assets | 1,157 | | | 1,589 | |
| Total current assets | 22,605 | | | 23,044 | |
| Operating lease right-of-use assets | 961 | | | 723 | |
| Goodwill | 1,914 | | | 1,914 | |
| Deposits and other assets | 521 | | | 594 | |
| Total assets | $ | 26,001 | | | $ | 26,275 | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY | | | |
| Current liabilities: | | | |
| Accounts payable | $ | 2,127 | | | $ | 2,144 | |
| Accrued expenses and other current liabilities | 4,570 | | | 2,640 | |
| Operating lease liabilities | 356 | | | 198 | |
| Acquired in-process research and development payable | 5,500 | | | — | |
| Total current liabilities | 12,553 | | | 4,982 | |
| Operating lease liabilities, non-current | 680 | | | 610 | |
| Warrant liability | 1 | | | 40 | |
| Contingent consideration | 170 | | | 296 | |
| Total liabilities | 13,404 | | | 5,928 | |
| Commitments and contingencies | | | |
| Stockholders’ equity: | | | |
| Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; no shares issued and outstanding at September 30, 2022 and December 31, 2021 | — | | | — | |
Common stock, $0.0001 par value; 350,000,000 shares authorized, 20,588,247 and 15,895,637 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 2 | | | 2 | |
| Additional paid-in capital | 183,378 | | | 158,948 | |
| Accumulated deficit | (170,783) | | | (138,603) | |
| Total stockholders’ equity | 12,597 | | | 20,347 | |
| Total liabilities and stockholders’ equity | $ | 26,001 | | | $ | 26,275 | |
Exhibit 99.2
SELLAS Life Sciences Announces Update on Phase 3 REGAL Clinical Trial Evaluating Lead Asset, Galinpepimut-S, in Acute Myeloid Leukemia
– Overall Survival Observed in Pooled Patient Data to Date Leads to Changes in Statistical Analysis Plan: Interim Analysis Now at 60 Events and Final Analysis Now at 80 Events –
– 3D Medicines to Participate in REGAL Clinical Trial, Which Will Trigger Significant Milestone Payments to SELLAS –
NEW YORK, NY, 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, today announced important updates relating to its ongoing Phase 3 open-label registrational clinical trial (the REGAL study) for galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients who have achieved complete remission following second-line salvage therapy (CR2 patients).
The primary endpoint of the REGAL study is overall survival (OS). The trial was originally designed using certain assumptions regarding OS for both the GPS treatment arm and the control arm receiving best available treatment (BAT) which are reflected in the protocol and statistical analysis plan (SAP) for the study. A review of preliminary data to date, which was pooled (i.e., GPS arm plus control arm) and which remains blinded as to treatment arm, suggests that the median OS in the pooled study population is likely considerably longer, by approximately two-fold, than originally anticipated and upon which the SAP was based. Accordingly, the overall duration of the REGAL study is now expected to be longer than initially predicted.
Following consultation with members of the Independent Data Monitoring Committee for the REGAL study and AML key opinion leaders, as well as the recommendations of the Company’s biostatistics experts, SELLAS is implementing changes to the SAP and protocol for the REGAL study as follows:
•The total targeted enrollment in the study will increase from 116 patients to a range of 125 to no more than 140 patients.
•The targeted number of events (deaths) for the interim analysis will be reduced to 60 from 80 and is currently expected to occur in late 2023 or early 2024.
•The targeted number of events (deaths) for the final analysis will be reduced to 80 from 105 and is currently expected to occur by the end of 2024.
•Statistical significance would be achieved by an estimated hazard ratio (HR) for OS of 0.636, corresponding to an OS of 12.6 months versus eight months for GPS versus BAT, respectively.
The Company has developed these changes using a conservative application of the O’Brien-Fleming statistical theory, which is suitable when regulatory approval is expected to be based predominantly on results from a single clinical trial and when mortality is the primary endpoint. The Company has notified the U.S. Food and Drug Administration of these changes through a filing to the investigational new drug application (IND) for GPS.
Additionally, SELLAS’ development and commercialization partner for the Greater China territory, 3D Medicines (3DMed), has agreed to participate in the REGAL trial through the inclusion of approximately 20 patients from the Greater China territory. Such participation by 3DMed is possible due to the increase in the target patient enrollment in the study and will trigger significant milestone payments, which SELLAS expects to receive in the first half of 2023. If the REGAL study meets its primary endpoint for efficacy and the Chinese regulatory authorities determine that the REGAL data is sufficient for approval in China, GPS could potentially reach the market in Greater China much earlier than had been anticipated by SELLAS and 3DMed when the parties entered into the license agreement providing rights to 3DMed, triggering additional regulatory and commercialization milestones and royalties for SELLAS.
“The review of the pooled blinded dataset from the REGAL study shows that the entire trial population has a longer than originally expected OS duration,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The causative reason for this result remains unknown and could be attributed to many factors, including the potential for, and extent of, increased clinical benefit accorded by the active GPS arm as well as an evolving treatment landscape and potentially better care for the patients receiving BAT. However, without unblinding the study, it is currently impossible to confirm or refute any of the possibilities. Upon examining the pooled blinded dataset, we worked expeditiously with our biostatisticians and other clinical advisors to refine our SAP, taking into account the observed longer OS, which has resulted in a reduction of the number of events needed for the interim and final analyses while maintaining a similar hazard ratio.”
“Furthermore, our team has agreed on a path forward with our partner 3DMed to allow for 3DMed to participate in the REGAL trial and to enroll Chinese patients in a Phase 3 study much earlier than anticipated. This has been made possible by the refinements we are making for the REGAL study. Assuming a statistically significant and clinical beneficial outcome of the REGAL study, as well as agreement by the Chinese regulatory authorities that such data is sufficient for approval in China, GPS may become available to patients in China far earlier than originally thought, which would be a positive outcome for patients in need of better AML therapies,” continued Dr. Stergiou.
Phase 3 REGAL Study Update Virtual Investor Event
SELLAS will hold a virtual investor event today, November 14, 2022, at 8:30 a.m. ET at which the Company will discuss these updates. The event will be facilitated by SELLAS management, including the Company’s 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 SELLAS@kcsa.com.
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, 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 and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing 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 global clinical development of GPS 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, risks and uncertainties associated 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 31, 2022 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
Allison Soss
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1267
Media Contacts
Raquel Cona / Michaela Fawcett
KCSA Strategic Communications
Email: SELLAS@kcsa.com
Phone: 212.896.1276