Replimune Reports Fiscal Fourth Quarter and Year-Ended 2022 Financial Results and Provides Corporate Update
May 19 2022 - 8:00AM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel class
of tumor-directed oncolytic immunotherapies, today announced
financial results for the fiscal fourth quarter and year ended
March 31, 2022 and provided a business update.
“We have ended the fiscal year in a very strong
position from which to execute on our vision to establish our
products as a cornerstone of immuno-oncology regimens and we look
forward with these firm foundations in place to a potentially
transformative 12-month period ahead,” said Philip Astley-Sparke
CEO of Replimune. “Updated data in anti-PD1 naïve cutaneous
squamous cell carcinoma (CSCC) and anti-PD1 failed melanoma
continue to support our two registration-directed clinical trials
in these settings. We are maintaining guidance that we expect to
complete enrollment into our registration directed CERPASS clinical
trial in CSCC mid-year and to release top line data in early 2023.
Further, we expect to release initial directional data from our
registration directed IGNYTE clinical trial in anti-PD1 failed
melanoma in late 2022. Launch scale manufacturing has been
established and commercial planning to establish a major skin
cancer franchise is advancing. With RP2/3 we have announced an
exciting mid stage program in colorectal cancer (CRC),
hepatocellular carcinoma (HCC) and head and neck cancer (SCCHN)
where an expedited path to potential approval in some settings may
be feasible. Finally, we have a strong cash position to drive value
through multiple major data catalysts.”
Corporate Updates
- Provided data update for RP1
in its skin cancer programs at a virtual investor event in March
2022.
- IGNYTE anti-PD1 naïve NMSC cohort of patients treated with RP1
combined with Opdivo® (nivolumab) (n=32; recruitment complete): The
overall response rate (ORR) in CSCC increased to 65%, compared to
60% at the June 2021 update with the complete response rate (CRR)
unchanged at 47%. Updated response rates in BCC, MCC and
angiosarcoma were 25%, 75% and 67% respectively with multiple
complete responses documented, indicating the potential utility of
RP1 in additional NMSCs beyond CSCC.
- IGNYTE anti-PD1 failed and anti-PD1 naïve melanoma cohort of
patients treated with RP1 combined with Opdivo (n=36; recruitment
complete): The ORR in anti-PD1 naïve cutaneous melanoma remained at
62.5%. The ORR in cutaneous melanoma patients who had previously
failed anti-PD1 or both anti-PD1 and anti-CTLA-4 (n=16) was
reported to have risen to 37.5%, an improvement from the 31% ORR
reported in the June 2021 update, including two complete
responses.
- IGNYTE anti-PD(L)-1 failed NMSC cohort of patients treated with
RP1 combined with Opdivo (n=12; recruitment ongoing): The initial
early ORR data in this group was 33.3% with responses having been
observed in anti-PD(L)-1 failed CSCC, MCC and angiosarcoma,
including one complete response as of the cutoff date. Other
patients who remain on study with a shorter follow up also showed
tumor shrinkage. The Company believes the clear activity of RP1
combined with Opdivo in anti-PD(L)-1 failed NMSC represents a new
potential therapeutic option for these patients and supports the
broader potential for RP1 in skin cancers, including those with
anti-PD(L)-1 failed disease.
- Phase 1b/2 ARTACUS clinical trial of RP1 monotherapy in solid
organ transplant recipients with skin cancer (n=6; recruitment
ongoing): Initial data with RP1 monotherapy in solid organ
transplant patients demonstrated a similar safety profile to that
observed in patients who are not immune suppressed, with initial
clinical activity having been seen. Two of the first six patients
enrolled (33%) had so far achieved a response, with one complete
response and one partial response.
- Provided detailed strategy and clinical development
plan for RP2/3 at a virtual investor event in March 2022.
- The Phase 2 development plan for RP2/3
is intended to target tumor types in large underserved markets,
including where liver metastases are common, as well as patients
with primary liver cancer, and patients with early disease where
the objective of treatment would be to increase the rate of cure.
This includes the development of RP2/3 in combination with current
standards of care (SOC), including immunotherapy, chemotherapy and
radiation, and in settings following the current SOC.The following
indications for signal finding single arm Phase 2 clinical trials
were identified which meet these criteria:
- Locally advanced (LA) and 1L recurrent SCCHN in combination
with chemoradiation, or SOC chemotherapy and anti-PD1 therapy,
respectively. The Company’s objective is to also expedite the
initiation of a randomized controlled registration directed program
in LA SCCHN.
- 1L and 2L hepatocellular carcinoma (HCC) in combination with
SOC immunotherapy and anti-PD1/L1 therapy respectively.
- 3L micro-satellite stable colorectal cancer (CRC) in
combination with anti-PD1 therapy.
- Additional signal finding work is also intended in other
indications.
- The RP2/3 Phase 2 program is expected
to initiate around the calendar year end.
- The decision as to whether RP2 or RP3
will be used in these clinical trials will be made later in the
calendar year, following generation and analysis of further
clinical data with RP2 and RP3 in their respective ongoing Phase 1
clinical trials.
Upcoming Milestones
CERPASS – Registration-directed Phase 2
clinical trial in CSCC
- RP1 in combination with
Libtayo® (cemiplimab-rwlc) in
CSCC: The Company is actively enrolling patients in a
registration-directed, global, randomized, controlled, 180-patient
Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with
Libtayo vs. Libtayo alone in patients with advanced CSCC. The
Company expects to complete enrollment in mid-year 2022 with top
line data expected to be available in Q1 2023.
IGNYTE – Multi-cohort Phase 2 clinical
trial of RP1 combined with Opdivo
- Anti-PD1 failed melanoma
cohort: The Company continues to enroll patients in the
125-patient cohort of the IGNYTE Phase 2 clinical trial in patients
with anti-PD1 failed melanoma. The Company continues to expect to
report initial directional data from the first 75 patient with six
months follow up in late 2022.
RP2 and RP3
- RP2 alone and in combination
with Opdivo in difficult-to-treat cancers: After fully
enrolling patients in the RP2 monotherapy (n=9) and combination
with Opdivo (n=30) cohorts in the Phase 1 clinical trial with RP2
(data presented in Nov 2020 and Nov 2021), a further cohort of
Phase 1 patients with tumor types of particular interest
(gastro-intestinal [GI] cancers, breast cancer, lung cancer, head
and neck cancer and uveal melanoma) was opened, with the first
patients having been enrolled and from which initial data is
expected towards the end of the year.
- RP3 alone and in combination
with Opdivo in difficult-to-treat cancers: The Company
completed enrollment in the initial part of its Phase 1 clinical
trial with RP3 alone. Following determination of the recommended
Phase 2 dose (RP2D), enrollment into the cohort of patients dosed
with RP3 combined with Opdivo has recently commenced. This cohort
will focus on enrolling patients with GI cancers, breast cancer,
lung cancer and head and neck cancer. Initial data for this
combination cohort is expected towards the end of the year.
Additional patients will also be dosed as monotherapy.
Financial Highlights
- Cash
Position: As of March 31, 2022, cash, cash
equivalents and short-term investments were $395.7 million, as
compared to $476.3 million as of March 31, 2021. The
decrease was primarily related to cash utilized in operating
activities in advancing the Company’s expanded clinical development
plan.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 body.
- R&D
Expenses: Research and development expenses
were $21.7 million for the fourth quarter and $79.5
million for the fiscal year ended March 31, 2022, as
compared to $16.2 million for the fourth quarter
and $56.8 million for the fiscal year ended March
31, 2021. This increase was primarily due to clinical expenses
driven by the Company's lead programs, expansion into additional
studies, operating our dedicated manufacturing facility and related
increased personnel costs. Research and development expenses
included $2.1 million in stock-based compensation
expenses for the fourth quarter and $8.6 million in
stock-based compensation expenses for the fiscal year
ended March 31, 2022.
- S,G&A
Expenses: Selling, general and administrative
expenses were $10.3 million for the fourth quarter
and $38.8 million for the fiscal year ended March
31, 2022, as compared to $6.0 million for the fourth
quarter and $23.2 million for the year ended March
31, 2021. The increase was primarily driven by personnel related
costs, including sales and marketing personnel associated with
pre-launch planning and the initial build of the Company’s
commercial infrastructure. Selling, general and administrative
expenses included $3.7 million in stock-based
compensation expenses for the fourth quarter and $15.7
million in stock-based compensation expenses for the fiscal
year ended March 31, 2022.
- Net Loss: Net
loss was $31.7 million for the fourth quarter
and $118.0 million for the fiscal year ended March
31, 2022, as compared to a net loss of $21.5 million for
the fourth quarter and $80.9 million for the fiscal year
ended March 31, 2021.
About CERPASSCERPASS 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 is enrolling 180 patients
with locally advanced or metastatic cutaneous squamous cell
carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical
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
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.
About IGNYTEIGNYTE is Replimune’s
multi-cohort Phase 1/2 trial of RP1 plus Opdivo®. There are 4 tumor
specific cohorts currently enrolling in this clinical 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 clinical trial of approximately
30 patients with melanoma. The additional cohorts are in
non-melanoma skin cancers which includes both naïve 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.
About RP1RP1 is Replimune’s lead
product candidate and is based on a proprietary new strain of
herpes simplex virus engineered and genetically armed to maximize
tumor killing potency, the immunogenicity of tumor cell death, and
the activation of a systemic anti-tumor immune response.
About RP2 & RP3RP2 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. 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.
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 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.
Investor Inquiries Chris
BrinzeyICR Westwicke339.970.2843chris.brinzey@westwicke.com
Media InquiriesLissette
SteeleVerge Scientific Communications202.930.4762 x
409lsteele@vergescientific.com
|
Replimune Group, Inc.Condensed
Consolidated Statements of Operations(Amounts in
thousands, except share and per share
amounts)(Audited) |
|
|
|
Year Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
79,545 |
|
|
$ |
56,754 |
|
Selling, general and administrative |
|
|
38,769 |
|
|
|
23,201 |
|
Total operating expenses |
|
|
118,314 |
|
|
|
79,955 |
|
Loss from operations |
|
|
(118,314 |
) |
|
|
(79,955 |
) |
Other income (expense): |
|
|
|
|
Research and development incentives |
|
|
3,170 |
|
|
|
2,807 |
|
Investment income |
|
|
390 |
|
|
|
916 |
|
Interest expense on finance lease liability |
|
|
(2,223 |
) |
|
|
(2,242 |
) |
Interest expense on debt obligations |
|
|
- |
|
|
|
(818 |
) |
Loss on extinguishment of debt |
|
|
- |
|
|
|
(913 |
) |
Other (expense) income |
|
|
(1,059 |
) |
|
|
(665 |
) |
Total other income (expense), net |
|
|
278 |
|
|
|
(915 |
) |
Net loss attributable to
common stockholders |
|
$ |
(118,036 |
) |
|
$ |
(80,870 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(2.26 |
) |
|
$ |
(1.75 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
52,212,269 |
|
|
|
46,248,969 |
|
|
|
|
|
|
|
Replimune Group, Inc.Condensed
Consolidated Balance Sheets(Amounts In thousands,
except share and per share
amounts)(Audited) |
|
|
|
March 31, |
|
March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
395,655 |
|
|
$ |
476,302 |
|
Working capital |
|
|
383,221 |
|
|
|
469,200 |
|
Total assets |
|
|
461,192 |
|
|
|
543,098 |
|
Total stockholders' equity |
|
|
411,229 |
|
|
|
498,728 |
|
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