Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update
2024年2月8日 - 10:00PM
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 third quarter ended December 31, 2023, and provided a
business update.
“The collective data for RP1 shows that it has the potential to
be a safe and effective treatment option for patients with a range
of different skin cancers in various treatment settings. We plan to
submit a BLA for the treatment of patients with anti-PD1 failed
melanoma in 2H 2024. Subsequently, we will explore the potential
for additional submissions based on the evolving data from our
multiple non-melanoma skin cancer studies,” said Philip
Astley-Sparke, CEO of Replimune. “We are excited about the data we
have seen to-date with RP2 including as monotherapy in very
difficult to treat tumors. Planning is underway for a clinical
trial in advanced uveal melanoma as a foundational study for
establishing a rare cancer franchise. Following the decision to
reprioritize our pipeline, we have extended our cash runway to fund
operations into 2H 2026, leaving us well positioned to bring our
lead product to market.”
Program Highlights & Milestones
RP1
- RP1 combined with Opdivo®
(nivolumab) in anti-PD1 failed melanoma
- The Company presented initial data from the full population
enrolled into the registration directed anti-PD1 failed melanoma
cohort from the IGNYTE clinical trial in December 2023. In the full
data set of 156 patients (140 patients from the
registration-directed expansion cohort and 16 anti-PD1 failed
cutaneous melanoma patients from the prior phase 2 cohort), had an
overall response rate (ORR) of 31.4% with a complete response rate
(CR) of 12% showing activity consistent with the prior snapshot of
91 patients. RP1 combined with nivolumab continues to be
well-tolerated, with mainly Grade 1-2 “on target” side effects,
observed.
- Following a Type C meeting with the U.S. Food and Drug
Administration (FDA), a confirmatory study design concept
consisting of a 2-arm randomized trial with physician’s choice of
treatment as a comparator arm in anti-PD1 failed melanoma patients
was agreed. The FDA requested that the Phase 3 confirmatory trial
be underway at the time of a BLA submission under the accelerated
approval pathway. The FDA also indicated that all patients should
be followed for at least 12 months and have undergone central
review by RECIST v1.1. A BLA submission for RP1 in combination with
nivolumab in anti-PD1 failed melanoma is planned for 2H 2024.
- CERPASS clinical trial of RP1 combined with
Libtayo® (cemiplimab-rwlc) in CSCC
- Following the initial report of the primary analysis data from
the CERPASS clinical trial in December 2023, it is intended that a
further analysis of the time-based endpoints of duration of
response (DOR), progression free survival (PFS) and overall
survival (OS) will be conducted when the data set has further
matured.
- RP1 in solid organ transplant recipients with skin
cancers
- Presented initial data from the ARTACUS clinical trial of RP1
monotherapy in solid organ transplant recipients with skin cancers
at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual
Meeting in November 2023. The data included 23 evaluable patients
with CSCC (n=20) and MCC (n=3).
- The data demonstrated an ORR of 34.8% and a CR of 21%.
- RP1 monotherapy was well tolerated, and the safety profile was
similar to non-immunocompromised patients with advanced skin
cancers (i.e. from the IGNYTE study). No immune-mediated adverse
events or evidence of allograft rejection were observed.
- RP1 combined with Opdivo in anti-PD1 failed
non-melanoma skin cancers (NMSC)
- Recruitment remains ongoing into the cohort of patients with
anti-PD1 failed NMSC. The Company provided a data from the first 30
patients with at least 6 months of follow up including patients
with CSCC, Merkel cell carcinoma (MCC), basal cell carcinoma, and
angiosarcoma in December 2023.
- The data showed that treatment with RP1 in combination with
nivolumab led to an ORR of 30% which is consistent with data from
the anti-PD1 failed melanoma cohort with approximately a third of
patients responding and 60% demonstrating clinical benefit. The
combination of RP1 and nivolumab was well tolerated in this patient
population with a safety profile consistent with the overall
experience seen with this treatment regimen to date.
RP2
- RP2 in second-line (2L) uveal melanoma
- The Company presented positive safety and efficacy data from a
cohort of metastatic uveal melanoma patients enrolled in the
open-label, multicenter Phase 1 study of RP2 as a single agent and
in combination with nivolumab at the 20th Annual International
Society for Melanoma Research Congress on November 8, 2023.
- Based on the data in this population, planning is underway for
a potentially registrational clinical trial of RP2 in advanced
uveal melanoma as a foundational study for establishing a rare
cancer franchise.
Financial Highlights
- Cash
Position: As of December 31, 2023, cash, cash
equivalents and short-term investments were $466.4 million, as
compared to $583.4 million as of March 31, 2023. The
decrease was primarily related to 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 December 31, 2023, will enable the Company to fund operations
into the second half of 2026.
- Debt: As of December 31, 2023, the debt
(net of discount) balance was $44.4 million, as compared
to $28.6 million as of March 31, 2023. The increase was
primarily related to the draw down of $15M in December 2023, at the
time of the closing of the second amendment to the loan and
security agreement with Hercules.
- R&D Expenses: Research and
development expenses were $42.8 million for the third
quarter ended December 31, 2023, as compared to $30.3
million for the third quarter ended December 31, 2022.
This increase was primarily due to increased clinical and
manufacturing expenses driven by the Company’s lead programs and
increased personnel expenses. Research and development expenses
included $3.8 million in stock-based compensation
expenses for the third quarter ended December 31, 2023.
- S,G&A Expenses: Selling, general and
administrative expenses were $13.7 million for the third
quarter ended December 31, 2023, as compared to $11.4
million for the third quarter ended December 31, 2022.
The increase was primarily driven by personnel related costs,
including sales and marketing personnel associated with pre-launch
planning and build of the Company’s commercial infrastructure.
Selling, general and administrative expenses included $4.5
million in stock-based compensation expenses for the third
quarter ended December 31, 2023.
- Net Loss: Net loss was $51.1
million for the third quarter ended December 31, 2023, as
compared to a net loss of $39.7 million for the third
quarter ended December 31, 2022.
About RP1RP1 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 intended to maximize tumor killing
potency, the immunogenicity of tumor cell death, and the activation
of a systemic anti-tumor immune response.
About RP2RP2 is a derivative of RP1,
Replimune’s lead product candidate that 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
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 portfolio of 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 StatementsThis 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 BrinzeyICR
Westwicke339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen
GoldenbergReplimune917.548.1582media@replimune.com
Replimune
Group, Inc.Condensed Consolidated Statements of Operations(Amounts
in thousands, except share and per share
amounts)(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended December 31, |
|
Nine Months
Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
42,847 |
|
|
$ |
30,261 |
|
|
$ |
132,384 |
|
|
$ |
88,573 |
|
Selling, general and administrative |
|
|
13,693 |
|
|
|
11,369 |
|
|
|
43,633 |
|
|
|
35,512 |
|
Total operating expenses |
|
|
56,540 |
|
|
|
41,630 |
|
|
|
176,017 |
|
|
|
124,085 |
|
Loss from operations |
|
|
(56,540 |
) |
|
|
(41,630 |
) |
|
|
(176,017 |
) |
|
|
(124,085 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Research and development incentives |
|
|
415 |
|
|
|
607 |
|
|
|
1,251 |
|
|
|
2,032 |
|
Investment income |
|
|
5,686 |
|
|
|
2,675 |
|
|
|
17,922 |
|
|
|
4,130 |
|
Interest expense on finance lease liability |
|
|
(540 |
) |
|
|
(548 |
) |
|
|
(1,626 |
) |
|
|
(1,650 |
) |
Interest expense on debt obligations |
|
|
(1,012 |
) |
|
|
(941 |
) |
|
|
(3,083 |
) |
|
|
(941 |
) |
Other income (expense) |
|
|
1,344 |
|
|
|
147 |
|
|
|
1,307 |
|
|
|
(4,531 |
) |
Total other income (expense), net |
|
|
5,893 |
|
|
|
1,940 |
|
|
|
15,771 |
|
|
|
(960 |
) |
Loss before income taxes |
|
$ |
(50,647 |
) |
|
$ |
(39,690 |
) |
|
$ |
(160,246 |
) |
|
$ |
(125,045 |
) |
Income tax provision |
|
|
473 |
|
|
|
- |
|
|
|
473 |
|
|
|
- |
|
Net loss |
|
$ |
(51,120 |
) |
|
$ |
(39,690 |
) |
|
$ |
(160,719 |
) |
|
$ |
(125,045 |
) |
Net loss per common share, basic and diluted |
|
$ |
(0.77 |
) |
|
$ |
(0.69 |
) |
|
$ |
(2.42 |
) |
|
$ |
(2.25 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
66,645,691 |
|
|
|
57,857,132 |
|
|
|
66,532,488 |
|
|
|
55,618,052 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Replimune Group, Inc.Condensed Consolidated Balance
Sheets(Amounts In thousands, except share and per share
amounts)(Unaudited) |
|
|
|
|
|
|
|
|
December
31, |
|
March
31, |
|
|
|
2023 |
|
2023 |
|
|
|
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
466,351 |
|
$ |
583,386 |
|
Working
capital |
|
|
440,514 |
|
|
558,778 |
|
Total
assets |
|
|
532,930 |
|
|
646,591 |
|
Total
stockholders' equity |
|
|
421,537 |
|
|
555,292 |
|
|
|
|
|
|
|
Replimune (NASDAQ:REPL)
過去 株価チャート
から 4 2024 まで 5 2024
Replimune (NASDAQ:REPL)
過去 株価チャート
から 5 2023 まで 5 2024