Replimune Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update
REPL 11.12.2024
Drug:RP1-vusolimogene-oderparepvec RP1
Drug:RP2-UNKNOWN RP2
Diseases:anti-PD1 failed melanoma
Diseases:Uveal Melanoma
Date of Upcoming Event:2024-08-01
Name of Upcoming Event:ESMO
Date of Upcoming Event:2024-11-01
Name of Upcoming Event:SITC
About Gravity Analytica
Recent News
- 01.21.2025 - Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
- 01.13.2025 - 43rd Annual J.P. Morgan Healthcare Conference
- 01.10.2025 - Replimune Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Recent Filings
- Completed Pre-Biologics License Application (BLA) meeting with the
U.S. Food and Drug Administration (FDA) and remain on track to submit a BLA forRP1 plus nivolumab in anti-PD1 failed melanomavia the accelerated approval pathway beforethe end of the year
- IGNYTE-3 confirmatory trialof
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 showingclinical activitywith
RP1 plus nivolumab in anti-PD1 failed melanoma
“I am incredibly proud of our progress as we rapidly approach the submission of our BLA for
Program Highlights & Milestones
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, and 32.9% 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 (ORR 35.9%) 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.
- In September, the Company completed a pre-BLA meeting with the FDA confirming plans to submit a BLA for
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 ofRP2 in combination with nivolumab vs. ipilimumab and nivolumab, or nivolumab for those ineligible for ipilimumab in the first quarter of 2025.
- Study start-up activities are underway for a registration-directed study of
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.
- A Phase 2 clinical trial with
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 endedMarch 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
- R&D Expenses:Research and development expenses were
$43.4 million for the fiscal second quarter endedSeptember 30, 2024 , as compared to$49.1 million for the fiscal second quarter endedSeptember 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 onRP3 . Research and development expenses included$4.1 million in stock-based compensation expenses for the fiscal second quarter endedSeptember 30, 2024 .
- S,G&A Expenses:Selling, general and administrative expenses were
$15.5 million for the fiscal second quarter endedSeptember 30, 2024 , as compared to$14.7 million for the fiscal second quarter endedSeptember 30, 2023 . Selling, general and administrative expenses included$4.6 million in stock-based compensation expenses for the fiscal second quarter endedSeptember 30, 2024 . - Net Loss:Net loss was
$53.1 million for the fiscal second quarter endedSeptember 30, 2024 , as compared to a net loss of$60.0 million for the fiscal second quarter endedSeptember 30, 2023 .
About
About
About
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
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| Three Months Ended | Six Months Ended | ||||||||||||||
| 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 | |||||||||||
| (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 | |||
Replimune Group Inc