Full Press Release Details
Fiscal First Quarter Financial Results and Provides Corporate Update
Updated complete and durable response data in
RP1 (vusolimogene oderparepvec) skin cancer cohorts support the ongoing registration directed development programs in CSCC and anti-PD-1
failed melanoma, with full accrual for both programs expected in mid-2022
Initial data with RP2 as monotherapy and in combination with Opdivo
(nivolumab) in patients with difficult-to-treat and anti-PD-1 failed cancers supports expanding the Phase 1 clinical trial to focus on
patients whose tumors have metastasized to the liver
A broad Phase 2 program with RP2 and/or RP3
with particular focus on patients with liver metastases from various prevalent cancer types is being designed with the detailed development
plan expected to be presented in the first quarter of 2022
Cash at 30 June of $458m with runway into second
Woburn, MA, August 6, 2021 - Replimune Group, Inc. (NASDAQ:
REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, today announced financial
results for the fiscal first quarter ended June 30, 2021 and provided a business update.
"The data we presented in June continues to demonstrate the depth
and durability of responses observed with RP1 and RP2, which we believe indicates the potential to provide new treatment options for a
range of difficult-to-treat cancers with clear unmet need, including for patients with anti-PD-1 failed disease," said Philip Astley-Sparke,
CEO of Replimune. "Beyond our evolving skin cancer franchise where we expect to complete accrual in our registration directed CERPASS
study in CSCC and in our registration directed cohort of patients with anti-PD-1 failed melanoma mid next year, we are designing a comprehensive
development plan with the goal of establishing our product candidates as a cornerstone of cancer treatment regimens, including in patients
with liver metastases. The detail behind these plans will be made available early next year."
Recent Events and Corporate Updates
CERPASS - Registration directed Phase 2 clinical trial in
IGNYTE - multi cohort Phase 2 clinical trial of RP1 combined
ARTACUS - Phase 1b/2 clinical trial of RP1 as monotherapy
in solid organ transplant recipients with skin cancers
*Program Highlight dates are
on a calendar-year basis.
Financial Highlights
current operating plan, Replimune believes that existing cash and cash equivalents and short-term investments will fund operating
expenses and capital expenditure requirements into the second half of 2024, excluding any confirmatory trial required
by the FDA or other regulatory body.
CERPASS is Replimune's registration-directed randomized, global
Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune's investigational oncolytic
immunotherapy RP1. The clinical trial will enroll 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)
who are na ve to anti-PD-1 therapy. The trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two
primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall
survival (OS) as its secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in
which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron
Libtayo is a registered trademark of Regeneron.
IGNYTE is Replimune's multi-cohort Phase 1/2 trial of RP1 plus
Opdivo . There are 4 tumor specific cohorts currently enrolling in this trial including a 125-patient extension cohort of RP1 combined
with Opdivo in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in
the same trial of approximately 30 patients with melanoma. The additional cohorts are studying RP1 in combination with Opdivo in non-melanoma
skin cancers which includes both na ve and anti-PD-1 failed CSCC, in microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1
failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers
Opdivo is a registered trademark of Bristol-Myers Squibb Company.
RP1 is Replimune's lead Immulytic product candidate and
is based on a proprietary new strain of herpes simplex virus engineered 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
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. RP2 and RP3 are intended to provide targeted and potent delivery 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 to develop the next generation of oncolytic immune-gene therapies for the treatment of cancer. Replimune is developing novel, proprietary
therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response
to the tumor antigens released. Replimune's Immulytic platform is designed to maximize systemic immune activation, in particular
to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating
proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and
other approaches to cancer treatment across a broad range of cancers. Replimune intends to progress these therapies rapidly through clinical
development in combination with other immuno-oncology products with complementary mechanisms of action as well as in standalone indications. 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, the potential impact of
COVID-19 on our operations and milestones, 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.
Westwicke, an ICR Company
Verge Scientific Communications
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per
| Three Months Ended June 30, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 18,554 | $ | 12,157 | ||||
| General and administrative | 8,827 | 5,676 | ||||||
| Total operating expenses | 27,381 | 17,833 | ||||||
| Loss from operations | (27,381 | ) | (17,833 | ) | ||||
| Other income (expense): | ||||||||
| Research and development incentives | 788 | 686 | ||||||
| Investment income | 92 | 527 | ||||||
| Interest expense on finance lease liability | (558 | ) | (561 | ) | ||||
| Interest expense on debt obligations | - | (284 | ) | |||||
| Other (expense) income | (252 | ) | (28 | ) | ||||
| Total other (expense) income, net | 70 | 340 | ||||||
| Net loss attributable to common stockholders | $ | (27,311 | ) | $ | (17,493 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.53 | ) | $ | (0.44 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 51,910,331 | 39,862,319 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| June 30, | March 31, | |||||||
| 2021 | 2021 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 458,331 | $ | 476,302 | ||||
| Working capital | 449,514 | 469,200 | ||||||
| Total assets | 523,724 | 543,098 | ||||||
| Total stockholders' equity | 479,024 | 498,728 |