Full Press Release Details
Replimune Reports Fiscal Third Quarter Financial
Results and Provides Corporate Update
Strengthened balance sheet raising gross $259
million through an upsized public offering in December, extending cash runway into H2 2025 and increasing operational and strategic flexibility
Topline data from the CERPASS registration-directed clinical trial
evaluating RP1 in cutaneous squamous cell carcinoma (CSCC) expected to be announced in Q3 2023 along with updates from ongoing RP1 skin
cancer cohorts including anti-PD1 failed non-melanoma skin cancer (CSCC predominant) and the RP1 monotherapy clinical trial in organ transplant
recipients with skin cancer
Achieved target enrollment of 125 patients in
the IGNYTE clinical trial cohort of RP1 combined with Opdivo (nivolumab) in anti-PD1 failed melanoma and in December presented
positive data from the first 75 patients followed for at least 6 months
Announced collaboration with Roche for signal
finding studies in RP2/3 in third-line (3L) colorectal cancer (CRC) and in first- and second-line (1L & 2L) hepatocellular carcinoma
Woburn, MA, February 9, 2023
- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio
of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2022
and provided a business update.
"We ended 2022 with a data update from our registration directed
IGNYTE cohort of RP1 in anti-PD1 failed melanoma that demonstrated impressive and clinically meaningful activity in a patient population
of major unmet need and with limited treatment options," said Philip Astley-Sparke CEO of Replimune. "As we turn the page to
2023, we believe this data has significantly de-risked our overall skin cancer franchise with RP1, and we look forward to providing additional
updates on all of our skin cancer programs, including topline primary analysis data from our registration-directed CERPASS clinical trial
evaluating RP1 in CSCC. As we prepare for a potential commercial launch we have made further key appointments to strengthen our commercial
team and are well financed to build a commercial capability in the US. With RP2/3 we look forward to commencing our Phase 2 clinical trials
and providing further updates from our Phase 1 program this year."
Program Highlights & Milestones:
These Phase 2 clinical trials are expected to initiate around mid-year.
Financial Highlights
Based on the current
operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2022, will
enable the Company to fund operations into the second half of calendar year 2025.
CERPASS is Replimune's registration-directed randomized, global
Phase 2 clinical trial to compare the effects of Libtayo (cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune's
investigational oncolytic immunotherapy RP1. The clinical trial recently completed enrollment and enrolled 211 patients with locally advanced
or metastatic cutaneous squamous cell carcinoma (CSCC) who are na ve to anti-PD-1 therapy. The clinical trial will evaluate complete
response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as assessed by independent review,
as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall survival (OS). The clinical
trial is being conducted under a clinical trial collaboration agreement with Regeneron and full commercial rights retained by Replimune.
Libtayo is a registered trademark of Regeneron.
IGNYTE is Replimune's multi-cohort Phase 1/2 trial of RP1 plus
nivolumab. The leading IGNYTE cohort is a 125-patient cohort in anti-PD1 failed cutaneous melanoma with registrational intent. This cohort
was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma.
The additional cohort is enrolling in non-melanoma skin cancers which includes both na ve and anti-PD1 failed CSCC. This trial is
being conducted under a collaboration and supply agreement with Bristol-Myers Squibb.
RP1 is Replimune's lead product candidate and is based on a proprietary
new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor
killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
RP2 and RP3 are derivatives of RP1 that express additional immune-activating
proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating
proteins CD40L and 4-1BBL, but does not express GM-CSF. RP2 and RP3 are 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.
Replimune Group, Inc., headquartered
in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel tumor-directed
oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone with payloads added to maximize
immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform has a unique dual local and systemic
mechanism of action (MOA) consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived
antigens and altering of the tumor microenvironment (TME) to ignite a strong and durable systemic response. This MOA is expected to be
synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform
has 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,
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
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.
Verge Scientific Communications
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| Three Months Ended December 31, | Nine Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 30,261 | $ | 19,353 | $ | 88,573 | $ | 57,809 | ||||||||
| General and administrative | 11,369 | 10,345 | 35,512 | 28,517 | ||||||||||||
| Total operating expenses | 41,630 | 29,698 | 124,085 | 86,326 | ||||||||||||
| Loss from operations | (41,630 | ) | (29,698 | ) | (124,085 | ) | (86,326 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 607 | 733 | 2,032 | 2,246 | ||||||||||||
| Investment income | 2,675 | 87 | 4,130 | 259 | ||||||||||||
| Interest expense on finance lease liability | (548 | ) | (555 | ) | (1,650 | ) | (1,670 | ) | ||||||||
| Interest expense on debt obligations | (941 | ) | - | (941 | ) | - | ||||||||||
| Other income (expense) | 147 | (241 | ) | (4,531 | ) | (849 | ) | |||||||||
| Total other income (expense), net | 1,940 | 24 | (960 | ) | (14 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (39,690 | ) | $ | (29,674 | ) | $ | (125,045 | ) | $ | (86,340 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.69 | ) | $ | (0.57 | ) | $ | (2.25 | ) | $ | (1.66 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 57,857,132 | 52,319,877 | 55,618,052 | 52,104,548 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| December 31, | March 31, | |||||||
| 2022 | 2022 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 616,374 | $ | 395,655 | ||||
| Working capital | 597,497 | 383,221 | ||||||
| Total assets | 678,550 | 461,192 | ||||||
| Total stockholders' equity | 595,345 | 411,229 |