Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update
16 Maggio 2024 - 2:00PM
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 fourth quarter and year ended March 31, 2024 and
provided a business update.
“We have exciting milestones in the coming months, including
sharing the investigator-assessed 12-month IGNYTE data at ASCO and
then the official primary analysis by independent central review
later in the second quarter,” said Sushil Patel, Ph.D., CEO of
Replimune. “Importantly, the design of our Phase 3 confirmatory
IGNYTE-3 clinical trial has been agreed with the FDA, with patient
enrollment planned to initiate in the second half of the year prior
to the submission of our BLA for RP1. We also completed a
successful Type C meeting with the FDA to align on our CMC plans
ahead of the intended BLA. These are all critical steps as we plan
for our next phase as a commercial stage company and, pending FDA
approval, prepare to bring our first oncolytic immunotherapy to
patients with advanced skin cancer.”
Corporate Updates
- The following abstracts, including two oral
presentations, will be presented at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting, May 31-June 4:
- Abstract #9517 (Rapid Oral Abstract Session): Efficacy and
safety of RP1 combined with nivolumab in patients with anti-PD-1
failed melanoma from the IGNYTE clinical trial.
- Abstract #9511 (Rapid Oral Abstract Session): Safety, efficacy,
and biomarker results from an open-label, multicenter, phase 1
study of RP2 alone or combined with nivolumab in a cohort of
patients with uveal melanoma.
- Abstract #TPS9604 (Poster Session): A randomized, controlled,
multicenter, phase 3 study of vusolimogene oderparepvec (VO)
combined with nivolumab vs treatment of physician’s choice in
patients with advanced melanoma that has progressed on anti–PD-1
and anti–CTLA-4 therapy (IGNYTE-3).
- Abstract #TPS4191 (Poster Session): An open-label, multicenter
study investigating RP2 oncolytic immunotherapy in combination with
second-line systemic atezolizumab combined with bevacizumab in
patients with locally advanced unresectable or metastatic
hepatocellular carcinoma.
- Abstract #TPS9614 (Poster Session): Trial in progress: A phase
1/2 study of Vusolimogene oderparepvec in primary melanoma (mel) to
reduce the risk of sentinel lymph node (SLN) metastasis.
- Manufacturing progress. The Company completed
a successful Type C meeting with the FDA that confirmed alignment
on our Chemistry, Manufacturing and Controls (CMC) plans to support
our IGNYTE anti-PD1 failed melanoma BLA submission in the 2H
2024.
Program Highlights & Milestones
RP1
- RP1 combined with Opdivo®
(nivolumab) in anti-PD1 failed melanoma
- The Company presented positive six-month follow up data by
investigator assessment (N=140) from the anti-PD1 failed melanoma
cohort of the IGNYTE clinical trial late last year. The Company is
on track to present the 12-month primary analysis by independent
central review in Q2 2024.
- The Company plans to enroll its first patient in the Phase 3
confirmatory IGNYTE-3 trial prior to submitting the RP1 BLA. The
Phase 3 trial design has been agreed to with the FDA and will be a
2-arm randomized 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.
- RP1 in solid organ transplant recipients with skin
cancers
- The Company presented data from the ARTACUS clinical trial of
RP1 monotherapy in solid organ transplant recipients with skin
cancers at the American Association of Cancer Research (AACR) 2024
Annual Meeting in April 2024. The data included 23 evaluable
patients with CSCC (n=20) and MCC (n=3).
- The data demonstrated an overall response rate (ORR) of 34.8%
(8 of 23 evaluable patients, including 5 complete responses and 3
partial responses).
- 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.
- The ARTACUS clinical trial continues to enroll patients.
- RP1 in combination with
Libtayo® (cemiplimab-rwlc) in
CSCC
- The CERPASS trial continues as planned to assess the time-based
endpoints of duration of response, progression free survival and
overall survival with greater maturity.
RP2
- RP2 in Uveal Melanoma
- The protocol for the registration-directed clinical trial of
RP2 combined with nivolumab in advanced uveal melanoma is near
final following input from the FDA.
- RP2 in Hepatocellular Carcinoma (HCC)
- The Phase 2 clinical trial with RP2 in anti-PD1/PD-L1
progressed HCC of RP2 combined with atezolizumab and bevacizumab is
expected to initiate in 2H 2024.
Financial Highlights
- Cash
Position: As of March 31, 2024, cash, cash
equivalents and short-term investments were $420.7 million, as
compared to $583.4 million as of fiscal year 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 March 31, 2024 will enable the Company to fund
operations into the second half of 2026.
- Debt: As of March 31, 2024, the debt (net
of discount) balance was $44.8 million, as compared to $28.6
million as of March 31, 2023. The increase was primarily
related to the draw down of $15 million 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 $42.6 million for the fourth
quarter and $175.0 million for the fiscal year
ended March 31, 2024, as compared to $37.9
million for the fourth quarter and $126.5
million for the fiscal year ended March 31, 2023. 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 $3.2 million in stock-based compensation
expenses for the fourth quarter and $14.7 million in
stock-based compensation expenses for the fiscal year
ended March 31, 2024.
- S,G&A Expenses: Selling, general and
administrative expenses were $16.2 million for the fourth
quarter and $59.8 million for the fiscal year
ended March 31, 2024, as compared to $15.0
million for the fourth quarter and $50.6 million for
the year ended March 31, 2023. 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 $4.7 million in
stock-based compensation expenses for the fourth quarter
and $19.4 million in stock-based compensation expenses
for the fiscal year ended March 31, 2024.
- Net Loss: Net loss was $55.1
million for the fourth quarter and $215.8
million for the fiscal year ended March 31, 2024, as
compared to a net loss of $49.2 million for the fourth
quarter and $174.3 million for the fiscal year
ended March 31, 2023.
About RP1RP1 (vusolimogene oderparepvec) is
Replimune’s lead product candidate and is based on a proprietary
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 based on a proprietary 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)(Audited) |
|
|
|
|
|
|
|
Year Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
174,963 |
|
|
$ |
126,527 |
|
Selling, general and administrative |
|
|
59,810 |
|
|
|
50,553 |
|
Total operating expenses |
|
|
234,773 |
|
|
|
177,080 |
|
Loss from
operations |
|
|
(234,773 |
) |
|
|
(177,080 |
) |
Other income
(expense): |
|
|
|
|
Research and development incentives |
|
|
1,920 |
|
|
|
2,914 |
|
Investment income |
|
|
23,356 |
|
|
|
10,006 |
|
Interest expense on finance lease liability |
|
|
(2,163 |
) |
|
|
(2,197 |
) |
Interest expense on debt obligations |
|
|
(4,497 |
) |
|
|
(1,963 |
) |
Other income (expense) |
|
|
771 |
|
|
|
(5,676 |
) |
Total other income (expense), net |
|
|
19,387 |
|
|
|
3,084 |
|
Loss before
income taxes |
|
$ |
(215,386 |
) |
|
$ |
(173,996 |
) |
Income tax
provision |
|
|
408 |
|
|
|
288 |
|
Net
loss |
|
$ |
(215,794 |
) |
|
$ |
(174,284 |
) |
Net loss per
common share, basic and diluted |
|
$ |
(3.24 |
) |
|
$ |
(2.99 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
66,569,894 |
|
|
|
58,213,010 |
|
|
|
|
|
|
Replimune
Group, Inc.Condensed Consolidated Balance
Sheets(Amounts In thousands, except share and per
share amounts)(Audited) |
|
|
|
|
|
|
|
March
31, |
|
March
31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
Cash, cash
equivalents and short-term investments |
|
$ |
420,668 |
|
|
$ |
583,386 |
|
Working
capital |
|
|
393,229 |
|
|
|
558,778 |
|
Total
assets |
|
|
487,722 |
|
|
|
646,591 |
|
Total
stockholders' equity |
|
|
374,508 |
|
|
|
555,292 |
|
Grafico Azioni Replimune (NASDAQ:REPL)
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Da Ago 2024 a Set 2024
Grafico Azioni Replimune (NASDAQ:REPL)
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Da Set 2023 a Set 2024