Replimune Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update
Replimune Group (NASDAQ: REPL) announced financial results for Q2 2024 and provided corporate updates. The company completed a pre-BLA meeting with FDA and plans to submit BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via accelerated approval pathway by year-end. The IGNYTE-3 confirmatory trial enrolled its first patient in August.
Key financial metrics: Cash position of $432.1 million as of September 30, 2024, R&D expenses decreased to $43.4 million from $49.1 million YoY, and net loss improved to $53.1 million from $60.0 million YoY. The company expects current cash to fund operations into second half of 2026.
Replimune Group (NASDAQ: REPL) ha annunciato i risultati finanziari per il Q2 2024 e fornito aggiornamenti aziendali. L'azienda ha completato un incontro pre-BLA con la FDA e prevede di presentare la BLA per RP1 più nivolumab per il melanoma che ha fallito il trattamento anti-PD1 attraverso una procedura di approvazione accelerata entro la fine dell'anno. Il trial di conferma IGNYTE-3 ha arruolato il suo primo paziente ad agosto.
Principali metriche finanziarie: Posizione di cassa di $432,1 milioni al 30 settembre 2024, le spese in R&S sono diminuite a $43,4 milioni rispetto a $49,1 milioni dell'anno precedente e la perdita netta è migliorata a $53,1 milioni rispetto a $60,0 milioni dell'anno precedente. L'azienda si aspetta che la cassa attuale finanzi le operazioni fino alla seconda metà del 2026.
Replimune Group (NASDAQ: REPL) anunció resultados financieros para el segundo trimestre de 2024 y proporcionó actualizaciones corporativas. La compañía completó una reunión pre-BLA con la FDA y planea presentar la BLA para RP1 más nivolumab en melanoma resistente a anti-PD1 a través de una vía de aprobación acelerada para fin de año. El ensayo confirmatorio IGNYTE-3 inscribió a su primer paciente en agosto.
Métricas financieras clave: Posición de efectivo de $432.1 millones al 30 de septiembre de 2024, los gastos en I+D disminuyeron a $43.4 millones desde $49.1 millones en comparación con el año anterior, y la pérdida neta mejoró a $53.1 millones desde $60.0 millones en comparación con el año anterior. La compañía espera que el efectivo actual financie las operaciones hasta la segunda mitad de 2026.
레플리뮤 은 그룹 (NASDAQ: REPL)은 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공하였습니다. 이 회사는 FDA와의 사전 BLA 회의를 완료했으며, 연말까지 PD1 저항성 흑색종에 대한 RP1 및 니볼루맙의 BLA를 가속 승인 경로를 통해 제출할 계획입니다. IGNYTE-3 확인 시험은 8월에 첫 환자를 등록했습니다.
주요 재무 지표: 2024년 9월 30일 기준 현금 보유액은 $432.1백만, R&D 비용은 지난해 $49.1백만에서 $43.4백만으로 감소했으며, 순손실은 지난해 $60.0백만에서 $53.1백만으로 개선되었습니다. 이 회사는 현재의 현금이 2026년 하반기까지 운영자금을 지원할 것으로 예상합니다.
Replimune Group (NASDAQ: REPL) a annoncé les résultats financiers du deuxième trimestre 2024 et fourni des mises à jour sur l'entreprise. La société a terminé une réunion pré-BLA avec la FDA et prévoit de soumettre une BLA pour RP1 plus nivolumab dans le traitement du mélanome résistant au PD1 via un chemin d'approbation accélérée d'ici la fin de l'année. L'essai de confirmation IGNYTE-3 a recruté son premier patient en août.
Métriques financières clés : Position de liquidités de $432,1 millions au 30 septembre 2024, les dépenses en R&D ont diminué à $43,4 millions par rapport à $49,1 millions de l'année précédente, et la perte nette s'est améliorée à $53,1 millions contre $60,0 millions de l'année précédente. La société s'attend à ce que les liquidités actuelles financent les opérations jusqu'à la deuxième moitié de 2026.
Replimune Group (NASDAQ: REPL) hat die finanziellen Ergebnisse für das zweite Quartal 2024 bekannt gegeben und Unternehmensupdates bereitgestellt. Das Unternehmen hat ein Pre-BLA-Meeting mit der FDA abgeschlossen und plant, bis Ende des Jahres den BLA für RP1 plus Nivolumab im Falle von anti-PD1-resistentem Melanom über einen beschleunigten Zulassungsweg einzureichen. Die bestätigende IGNYTE-3-Studie hat im August ihren ersten Patienten rekrutiert.
Wichtige finanzielle Kennzahlen: Geldposition von $432,1 Millionen zum 30. September 2024, die F&E-Ausgaben sind im Vergleich zum Vorjahr von $49,1 Millionen auf $43,4 Millionen gesunken, und der Nettoverlust hat sich im Vergleich zum Vorjahr von $60,0 Millionen auf $53,1 Millionen verbessert. Das Unternehmen erwartet, dass das aktuelle Bargeld die Operationen bis zur zweiten Hälfte des Jahres 2026 finanzieren wird.
- Cash position increased to $432.1 million from $420.7 million in March 2024
- Net loss improved to $53.1 million from $60.0 million YoY
- R&D expenses decreased to $43.4 million from $49.1 million YoY
- Strong clinical data with 33.6% overall response rate in melanoma trial
- 21.6 months median duration of response from response initiation
- Increased SG&A expenses to $15.5 million from $14.7 million YoY
Insights
The Q2 financial results reveal a mixed picture. While
The upcoming BLA submission for RP1 in melanoma treatment represents a important milestone. The
The clinical data for RP1 plus nivolumab shows encouraging efficacy in a difficult-to-treat population. Key highlights include
The initiation of IGNYTE-3 confirmatory trial and planned RP2 studies in uveal melanoma and HCC demonstrates pipeline expansion. The positive reception at ESMO and SITC conferences suggests growing clinical interest in this novel oncolytic immunotherapy approach.
- Completed Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) and remain on track to submit a BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year
- IGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) in advanced melanoma underway with first patient enrolled in August
- Presented late-breaking abstracts at ESMO and SITC featuring the IGNYTE trial primary analysis showing clinical activity with RP1 plus nivolumab in anti-PD1 failed melanoma
WOBURN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2024 and provided a business update.
“I am incredibly proud of our progress as we rapidly approach the submission of our BLA for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “The IGNYTE data was presented at major medical meetings and was well received by the oncology community, who noted the importance of the systemic activity demonstrated and the continuing need for additional treatments for patients with advanced melanoma. As a team, we have been focused on our ongoing preparation for commercialization, including building our field teams, completing important market research and developing our market access teams, among many other activities to ensure we are well positioned to reach as many physicians and patients as possible.”
Program Highlights & Milestones
RP1
- RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma
- In September, the Company completed a pre-BLA meeting with the FDA confirming plans to submit a BLA for RP1 for the treatment of anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year.
- The IGNYTE-3 confirmatory trial of RP1 in advanced melanoma is underway with first patient enrolled in August. This clinical trial is a 2-arm randomized Phase 3 trial with a defined list of physician’s choice treatment options as the comparator arm in advanced melanoma patients who progressed on anti-PD1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment.
- Late-breaking abstracts presented at ESMO and SITC shared the primary analysis from the IGNYTE trial.
- The primary analysis reiterated the positive top line results presented in June and confirmed the 12-month overall response rate was
33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. - In addition, new data shared showed activity across all clinical subgroups, including patients who had prior anti-PD1 and anti-CTLA-4 (ORR
27.7% ) and for those who had primary resistance to anti-PD1 (ORR35.9% ) by modified RECIST 1.1. - Median duration of response from response initiation was 21.6 months and median duration of response from treatment initiation was 27.6 months.
- Initial biomarker data shows increased CD8+ T cell and PD-L1 expression post treatment in
50% of the tested biopsies. The increase in gene expression signature, associated CD8+ T cells and inflammatory cytokines further highlight the potential of RP1 plus nivolumab to generate a potent anti-tumor response.
- The primary analysis reiterated the positive top line results presented in June and confirmed the 12-month overall response rate was
RP2
- RP2 in Uveal Melanoma
- Study start-up activities are underway for a registration-directed study of RP2 in metastatic uveal melanoma in patients who are immune checkpoints inhibitor-naïve. The study plans to enroll the first patient in a randomized trial of RP2 in combination with nivolumab vs. ipilimumab and nivolumab, or nivolumab for those ineligible for ipilimumab in the first quarter of 2025.
- RP2 in hepatocellular carcinoma (HCC)
- A Phase 2 clinical trial with RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is actively screening patients.
Financial Highlights
- Cash Position: As of September 30, 2024, cash, cash equivalents and short-term investments were
$432.1 million , as compared to$420.7 million as of fiscal year ended March 31, 2024. The increase in cash balance was directly related to the PIPE financing in June, offset by cash utilized in operating activities in advancing the Company’s clinical development plans.
Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of September 30, 2024 will enable the Company to fund operations into the second half of 2026 which includes scale up for the commercialization of RP1 in skin cancers and for working capital and general corporate purposes.
- R&D Expenses: Research and development expenses were
$43.4 million for the fiscal second quarter ended September 30, 2024, as compared to$49.1 million for the fiscal second quarter ended September 30, 2023. This decrease was primarily due to the wind down of the CERPASS and IGNYTE Phase II studies, as well as the deprioritization of development efforts on RP3. Research and development expenses included$4.1 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2024.
- S,G&A Expenses: Selling, general and administrative expenses were
$15.5 million for the fiscal second quarter ended September 30, 2024, as compared to$14.7 million for the fiscal second quarter ended September 30, 2023. Selling, general and administrative expenses included$4.6 million in stock-based compensation expenses for the fiscal second quarter ended September 30, 2024. - Net Loss: Net loss was
$53.1 million for the fiscal second quarter ended September 30, 2024, as compared to a net loss of$60.0 million for the fiscal second quarter ended September 30, 2023.
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About RP2
RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
Westwicke, an ICR Company
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) | |||||||||||||||
Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 43,448 | $ | 49,101 | $ | 86,420 | $ | 89,538 | |||||||
General and administrative | 15,468 | 14,730 | $ | 29,863 | 29,941 | ||||||||||
Total operating expenses | 58,916 | 63,831 | 116,283 | 119,479 | |||||||||||
Loss from operations | (58,916 | ) | (63,831 | ) | (116,283 | ) | (119,479 | ) | |||||||
Other income (expense): | |||||||||||||||
Research and development incentives | 408 | 443 | 846 | 836 | |||||||||||
Investment income | 5,394 | 6,049 | 10,106 | 12,235 | |||||||||||
Interest expense on finance lease liability | (531 | ) | (542 | ) | (1,065 | ) | (1,086 | ) | |||||||
Interest expense on debt obligations | (1,438 | ) | (955 | ) | (2,864 | ) | (2,070 | ) | |||||||
Other income (expense) | 2,028 | (1,409 | ) | 2,433 | (35 | ) | |||||||||
Total other income (expense), net | 5,861 | 3,586 | 9,456 | 9,880 | |||||||||||
Loss before income taxes | $ | (53,055 | ) | $ | (60,245 | ) | $ | (106,827 | ) | $ | (109,599 | ) | |||
Income tax provision | $ | — | $ | (201 | ) | $ | — | $ | — | ||||||
Net loss | $ | (53,055 | ) | $ | (60,044 | ) | $ | (106,827 | ) | $ | (109,599 | ) | |||
Net loss per common share, basic and diluted | $ | (0.68 | ) | $ | (0.90 | ) | $ | (1.45 | ) | $ | (1.65 | ) | |||
Weighted average common shares outstanding, basic and diluted | 78,570,135 | 66,582,280 | 73,903,650 | 66,475,577 |
Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited) | |||||
September 30, 2024 | March 31, 2024 | ||||
(in thousands) | |||||
Consolidated Balance Sheet Data: | |||||
Cash, cash equivalents and short-term investments | $ | 432,059 | $ | 420,668 | |
Working capital | 398,845 | 393,229 | |||
Total assets | 498,202 | 487,722 | |||
Total stockholders' equity | 381,459 | 374,508 |
FAQ
What was Replimune's (REPL) cash position in Q2 2024?
What was the overall response rate for REPL's RP1 plus nivolumab in melanoma trial?
When does Replimune (REPL) expect to submit BLA for RP1?