SELLAS Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Update
SELLAS Life Sciences Group (NASDAQ: SLS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. The IDMC recommended continuing the Phase 3 REGAL study in AML without modifications, with interim analysis expected by Q4 2024.
2. Positive preliminary data from the Phase 2a trial of SLS009 in r/r AML, showing ORRs of 33%, 50%, and 100% in different cohorts.
3. SLS009 received EMA Orphan Drug Designations and FDA Rare Pediatric Disease Designations.
4. $21 million raised in August 2024 at a premium to market.
5. Q2 2024 financial results: R&D expenses $5.2M, G&A expenses $2.4M, net loss $7.5M ($0.13 per share).
6. Cash position: $9.1M as of June 30, 2024, bolstered by the subsequent $21M offering.
Il gruppo SELLAS Life Sciences (NASDAQ: SLS) ha riportato i risultati finanziari del secondo trimestre 2024 e ha fornito un aggiornamento aziendale. Punti chiave includono:
1. L'IDMC ha raccomandato di continuare lo studio di Fase 3 REGAL in AML senza modifiche, con un'analisi intermedia prevista per il quarto trimestre del 2024.
2. Dati preliminari positivi dal trial di Fase 2a di SLS009 in AML r/r, mostrando ORR del 33%, 50% e 100% in diversi cohort.
3. SLS009 ha ricevuto le designazioni di farmaco orfano dall'EMA e le designazioni per malattie pediatriche rare dalla FDA.
4. Raccolti 21 milioni di dollari ad agosto 2024 a un premio rispetto al mercato.
5. Risultati finanziari del secondo trimestre 2024: spese per R&D 5.2M di dollari, spese G&A 2.4M di dollari, perdita netta di 7.5M di dollari (0.13 dollari per azione).
6. Posizione di cassa: 9.1M di dollari al 30 giugno 2024, potenziata dall'offerta successiva di 21M di dollari.
El grupo SELLAS Life Sciences (NASDAQ: SLS) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los puntos clave incluyen:
1. El IDMC recomendó continuar el estudio de Fase 3 REGAL en AML sin modificaciones, con un análisis intermedio esperado para el cuarto trimestre de 2024.
2. Datos preliminares positivos del ensayo de Fase 2a de SLS009 en AML r/r, mostrando ORRs del 33%, 50% y 100% en diferentes cohortes.
3. SLS009 recibió designaciones de medicamento huérfano de la EMA y designaciones de enfermedad pediátrica rara de la FDA.
4. Se recaudaron 21 millones de dólares en agosto de 2024 a una prima respecto al mercado.
5. Resultados financieros del segundo trimestre de 2024: gastos de I+D 5.2M, gastos G&A 2.4M, pérdida neta de 7.5M (0.13 dólares por acción).
6. Posición de efectivo: 9.1M de dólares al 30 de junio de 2024, reforzada por la posterior oferta de 21M de dólares.
SELLAS 생명 과학 그룹 (NASDAQ: SLS)은 2024년 2분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. IDMC는 AML의 3상 REGAL 연구를 수정 없이 계속할 것을 권장했으며, 중간 분석은 2024년 4분기에 예상됩니다.
2. SLS009에 대한 2a상 시험의 긍정적인 초기 데이터가 r/r AML에서 33%, 50%, 100%의 ORR을 보였습니다.
3. SLS009는 EMA 고아 약물 지정을 받고 FDA 희귀 소아 질병 지정을 받았습니다.
4. 2024년 8월에 시장보다 프리미엄을 붙여 2,100만 달러를 모금했습니다.
5. 2024년 2분기 재무 결과: R&D 비용 520만 달러, G&A 비용 240만 달러, 순손실 750만 달러 (주당 0.13달러).
6. 현금 위치: 2024년 6월 30일 기준 910만 달러, 이후 2,100만 달러 모집으로 강화되었습니다.
Le groupe SELLAS Life Sciences (NASDAQ: SLS) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur la société. Les faits saillants incluent:
1. Le IDMC a recommandé de continuer l'étude de Phase 3 REGAL dans l'AML sans modifications, avec une analyse intermédiaire prévue d'ici le quatrième trimestre 2024.
2. Données préliminaires positives de l'essai de Phase 2a de SLS009 dans l'AML r/r, montrant des ORR de 33 %, 50 % et 100 % dans différents cohortes.
3. SLS009 a reçu les désignations de médicament orphelin de l'EMA et les désignations de maladies pédiatriques rares de la FDA.
4. 21 millions de dollars ont été levés en août 2024 à une prime par rapport au marché.
5. Résultats financiers du deuxième trimestre 2024 : dépenses R&D 5,2 M$, dépenses G&A 2,4 M$, perte nette 7,5 M$ (0,13 $ par action).
6. Position de trésorerie : 9,1 M$ au 30 juin 2024, renforcée par l'offre subséquente de 21 M$.
Die SELLAS Life Sciences Group (NASDAQ: SLS) hat die finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Unternehmensupdate bereitgestellt. Wichtige Highlights sind:
1. Das IDMC empfahl, die Phase 3 REGAL-Studie bei AML ohne Änderungen fortzusetzen, mit einer Zwischenanalyse, die bis zum vierten Quartal 2024 erwartet wird.
2. Positive vorläufige Daten aus der Phase 2a-Studie von SLS009 bei r/r AML, die ORRs von 33 %, 50 % und 100 % in verschiedenen Kohorten zeigen.
3. SLS009 erhielt die EMA-Hochrisiko-Arzneimittelbezeichnung und die FDA-Hochrisikopädiatrische Erkrankungsbezeichnung.
4. Im August 2024 wurden 21 Millionen Dollar zu einem Aufschlag zum Markt gesammelt.
5. Finanzielle Ergebnisse des 2. Quartals 2024: F&E-Ausgaben 5,2 Millionen Dollar, G&A-Ausgaben 2,4 Millionen Dollar, Nettoloss 7,5 Millionen Dollar (0,13 Dollar pro Aktie).
6. Liquiditätsposition: 9,1 Millionen Dollar zum 30. Juni 2024, verstärkt durch das nachfolgende Angebot von 21 Millionen Dollar.
- Phase 3 REGAL study in AML continuing without modifications, with interim analysis expected by Q4 2024
- Positive preliminary data from Phase 2a trial of SLS009 in r/r AML, with ORRs up to 100% in certain cohorts
- SLS009 granted EMA Orphan Drug Designations and FDA Rare Pediatric Disease Designations
- $21 million capital raise completed at a premium to market in August 2024
- Decreased R&D and G&A expenses compared to the same period in 2023
- Reduced net loss compared to Q2 2023 ($7.5M vs $8.8M)
- Net loss of $7.5 million for Q2 2024
- Continued cash burn, with only $9.1 million in cash and cash equivalents as of June 30, 2024
Insights
SELLAS Life Sciences' Q2 2024 results show promising developments, particularly in their clinical programs. The company's cash position of
The preliminary data from SELLAS' Phase 2a trial of SLS009 in r/r AML is particularly intriguing. An ORR of 33% and 50% in the 60 mg QW and 30 mg BIW cohorts, respectively, is promising for this difficult-to-treat population. The 100% ORR in patients with ASXL1 mutations is remarkable and warrants further investigation. The median overall survival of 5.4 months at the 45 mg QW dose, compared to the expected 2.5 months with standard care, suggests a potential survival benefit. The expansion into AML with myelodysplasia-related changes could broaden the drug's applicability. However, we must await more mature data to fully assess SLS009's efficacy and safety profile in AML.
SELLAS is strategically positioning itself in the competitive AML market with its dual-pronged approach using GPS and SLS009. The recent regulatory designations for SLS009, including Orphan Drug Designations from the EMA for AML and PTCL and Rare Pediatric Disease Designations from the FDA for pediatric AML and ALL, could provide market exclusivity and expedited review processes. These designations, coupled with the promising early clinical data, enhance SLS009's market potential. The continuation of the Phase 3 REGAL study for GPS without modifications is a positive signal, with the interim analysis expected in Q4 2024 potentially serving as a significant catalyst for the company's valuation. The expanded indications and pediatric applications for SLS009 could open up additional market opportunities, diversifying SELLAS' potential revenue streams.
- Announced Independent Data Monitoring Committee’s (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: Interim Analysis Anticipated by Q4 2024 -
- Reported Positive Preliminary Data from the Phase 2a Trial of SLS009 in r/r AML Demonstrating to Date Overall Response Rate (ORR) of
- SLS009 Granted EMA Orphan Drug Designations and U.S. FDA Rare Pediatric Disease Designations –
-
NEW YORK, Aug. 13, 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 reported financial results for the second quarter ended June 30, 2024, and provided a corporate update.
“We are pleased with our second-quarter performance marked by significant advancements in our development efforts and clinical programs,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “The initial Phase 2a dataset from the SLS009 trial in AML showed early signs of treatment efficacy across all cohorts exceeding the targeted ORR of at least
Dr. Stergiou continued: “As for our Phase 3 REGAL study of galinpepimut-S (GPS) in AML, we were pleased to report that based on recent efficacy and safety assessment, the IDMC has recommended trial continuation without modifications. The committee projects that the 60 events will occur by the fourth quarter which will trigger the interim analysis. We remain confident in the positive trajectory of both GPS and SLS009 and we look forward to the interim results from the Phase 3 REGAL study, as well as additional data from the Phase 2 trial of SLS009 in AML.”
Pipeline Highlights
Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic
Phase 3 REGAL study in AML: The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study in June and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024.
SLS009: highly selective and specific CDK9 inhibitor
Completed Enrollment in Phase 2a Trial of SLS009 in r/r AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Except for one, all patients in this Phase 2a trial had adverse risk AML (
Announced Positive Initial Phase 2 Data of SLS009 in r/r AML: The preliminary data showed the overall response rate (ORR) of
Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients.
National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for r/r AML and r/r PTCL.
Financial Results for the Second Quarter 2024:
R&D Expenses: Research and development expenses for the quarter ended June 30, 2024 were
G&A Expenses: General and administrative expenses for the second quarter of 2024 were
Net Loss: The net loss was
Cash Position: As of June 30, 2024, cash and cash equivalents totaled approximately
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.
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 LIFE SCIENCES GROUP, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share data) (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 5,186 | $ | 5,923 | $ | 10,297 | $ | 13,097 | ||||||||
| General and administrative | 2,435 | 3,127 | 6,969 | 7,234 | ||||||||||||
| Total operating expenses | 7,621 | 9,050 | 17,266 | 20,331 | ||||||||||||
| Loss from operations | (7,621 | ) | (9,050 | ) | (17,266 | ) | (20,331 | ) | ||||||||
| Non-operating income: | ||||||||||||||||
| Change in fair value of warrant liability | — | 2 | — | 4 | ||||||||||||
| Interest income | 151 | 208 | 230 | 390 | ||||||||||||
| Total non-operating income | 151 | 210 | 230 | 394 | ||||||||||||
| Net loss | $ | (7,470 | ) | $ | (8,840 | ) | $ | (17,036 | ) | $ | (19,937 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per common share, basic and diluted | $ | (0.13 | ) | $ | (0.31 | ) | $ | (0.33 | ) | $ | (0.77 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 57,630,506 | 28,347,920 | 51,221,752 | 25,961,001 | ||||||||||||
| SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share and per share data) (Unaudited) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,147 | $ | 2,530 | ||||
| Restricted cash and cash equivalents | 100 | 100 | ||||||
| Prepaid expenses and other current assets | 3,055 | 542 | ||||||
| Total current assets | 12,302 | 3,172 | ||||||
| Operating lease right-of-use assets | 633 | 858 | ||||||
| Goodwill | 1,914 | 1,914 | ||||||
| Deposits and other assets | 270 | 275 | ||||||
| Total assets | $ | 15,119 | $ | 6,219 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,331 | $ | 5,639 | ||||
| Accrued expenses and other current liabilities | 5,183 | 7,650 | ||||||
| Operating lease liabilities | 531 | 446 | ||||||
| Total current liabilities | 12,045 | 13,735 | ||||||
| Operating lease liabilities, non-current | 161 | 460 | ||||||
| Total liabilities | 12,206 | 14,195 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 5 | 3 | ||||||
| Additional paid-in capital | 237,188 | 209,265 | ||||||
| Accumulated deficit | (234,280 | ) | (217,244 | ) | ||||
| Total stockholders’ equity (deficit) | 2,913 | (7,976 | ) | |||||
| Total liabilities and stockholders’ equity (deficit) | $ | 15,119 | $ | 6,219 | ||||
FAQ
What were SELLAS Life Sciences' (SLS) key financial results for Q2 2024?
What progress did SELLAS (SLS) report for its SLS009 drug candidate in Q2 2024?
What is the status of SELLAS' (SLS) Phase 3 REGAL study as of Q2 2024?
How much capital did SELLAS (SLS) raise in August 2024?
