Full Press Release Details
Replimune Reports Fiscal Second Quarter Financial
Results and Provides Corporate Update
RP1; Full patient accrual in CERPASS registration-directed
clinical trial continues to be expected in mid-year 2022 with the primary data trigger expected in late 2022. Interim data in the IGNYTE
anti-PD1 failed registration directed melanoma cohort continues to be expected in late 2022
RP2; Updated monotherapy and combination data
with Opdivo (nivolumab) to be presented at SITC this month; Phase 1 protocol amendment expansion to add additional patients with liver
RP2/3; Detailed Phase 2 clinical development
program including patients with liver metastases to be presented in Q1 2022 along with initial RP3 Phase 1 monotherapy data
Cash at 30 September of ~$436m with runway
into second half of 2024
Woburn, MA, November 4, 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 second quarter ended September 30, 2021 and provided a
"Replimune continues to build towards a data rich 2022 where
we are expecting to reach multiple inflection points culminating in the primary data analysis trigger for our registration-directed randomized
controlled clinical trial with RP1 in cutaneous squamous cell carcinoma (CSCC) and the presentation of interim data from our registration
directed cohort in anti-PD1 failed melanoma from the IGNYTE clinical trial," said Philip Astley-Sparke, CEO of Replimune. "In
the first quarter of 2022 we will be presenting initial data in anti-PD1 failed non-melanoma skin cancers (NMSC) and in NMSC transplant
patients with single agent RP1, both including CSCC. Our objective is to establish a broad skin cancer franchise with RP1. In addition
to an update on RP2 at SITC 2021, we look forward to presenting data during 2022 from the expansion of our Phase 1 studies with RP2 and
RP3 with a focus on patients with liver metastases from prevalent tumor types. We also look forward to presenting a comprehensive Phase
2 development plan with RP2 and/or 3 in the first quarter of 2022, with study initiation intended around midyear, as we continue to make
progress towards positioning our programs as a cornerstone of cancer treatment."
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
Highlight dates are on a calendar-year basis.
Financial Highlights
Based on the 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
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 and Sanofi.
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 cohort 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 in non-melanoma skin cancers which includes both na ve and anti-PD-1 failed
CSCC, in anti-PD1 failed 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 Squibb Company.
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
the global coronavirus pandemic and the global economy 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.
Verge Scientific Communications
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands,
except share and per share amounts)
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 19,902 | $ | 14,050 | $ | 38,456 | $ | 26,207 | ||||||||
| General and administrative | 9,345 | 5,613 | 18,172 | 11,289 | ||||||||||||
| Total operating expenses | 29,247 | 19,663 | 56,628 | 37,496 | ||||||||||||
| Loss from operations | (29,247 | ) | (19,663 | ) | (56,628 | ) | (37,496 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 725 | 755 | 1,513 | 1,441 | ||||||||||||
| Investment income | 80 | 178 | 172 | 705 | ||||||||||||
| Interest expense on finance lease liability | (557 | ) | (562 | ) | (1,115 | ) | (1,123 | ) | ||||||||
| Interest expense on debt obligations | - | (286 | ) | - | (570 | ) | ||||||||||
| Other (expense) income | (356 | ) | (517 | ) | (608 | ) | (545 | ) | ||||||||
| Total other (expense) income, net | (108 | ) | (432 | ) | (38 | ) | (92 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (29,355 | ) | $ | (20,095 | ) | $ | (56,666 | ) | $ | (37,588 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.56 | ) | $ | (0.46 | ) | $ | (1.09 | ) | $ | (0.90 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 52,081,325 | 44,015,786 | 51,962,795 | 41,950,401 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per
| September 30, | March 31, | |||||||
| 2021 | 2021 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 435,771 | $ | 476,302 | ||||
| Working capital | 427,748 | 469,200 | ||||||
| Total assets | 503,464 | 543,098 | ||||||
| Total stockholders' equity | 457,412 | 498,728 |