Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update
03 Agosto 2023 - 9:00AM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of tumor-directed oncolytic immunotherapies, today
announced financial results for the fiscal first quarter ended June
30, 2023 and provided a business update.
“It was a productive quarter with positive updates for RP1 in
anti-PD1 failed melanoma and RP2 in uveal melanoma presented at
ASCO. The duration of responses are particularly impressive with
all responding patients in the anti-PD1 failed melanoma 75 patient
cohort presented late last year continuing without progression,”
said Philip Astley-Sparke, CEO of Replimune. “We now look forward
to presenting the top-line data from our registration-directed
CERPASS trial of RP1 in combination with Libtayo in cutaneous
squamous cell carcinoma (CSCC) as well as sharing an initial
snapshot from the full patient population in the IGNYTE clinical
trial cohort of RP1 combined with Opdivo in anti-PD1 failed
melanoma later in the year. Commercial preparations are
progressing, and in line with our ambition of establishing a major
skin cancer franchise, we are pleased to announce that we have
entered a cost sharing collaboration with Incyte to conduct a
clinical trial for the neoadjuvant treatment of CSCC with RP1 and
the oral PD-L1 inhibitor, INCB99280.”
Program Highlights & Milestones
RP1
- CERPASS clinical trial of RP1 combined with
Libtayo® in CSCC
- The trigger for the primary analysis from the
registration-directed CERPASS clinical trial occurred in late June
and data collection activities are nearly complete. Guidance for
the top line data disclosure has been updated from Q3 to early Q4
2023 as a result of the independent review read rate tracking
behind projections. Assuming positive data demonstrating overall
clinical benefit, the Company plans to submit a biologics license
application (BLA) for RP1 in Q1/2 2024, with the potential to
combine the filings for both the CERPASS clinical trial and the
IGNYTE anti-PD1 failed melanoma cohort.
- Announced Clinical Trial Collaboration with Incyte to
Evaluate RP1 and INCB099280 in CSCC
- Under the terms of the agreement, Incyte will initiate and
sponsor a clinical trial of INCB99280 (oral PD-L1 inhibitor) and
RP1 in approximately 40 patients with unresectable, high risk CSCC
in the neoadjuvant setting. Replimune will supply Incyte with RP1
for the study and share costs.
- RP1 combined with Opdivo® (nivolumab)
in anti-PD1 failed non-melanoma skin cancers
- Recruitment remains ongoing into the cohort of patients with
anti-PD1 failed non-melanoma skin cancers, including CSCC, with a
data update expected from the first 30 patients with at least six
months follow up in early Q4 2023.
- 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 American Transplant Congress (ATC) Meeting in June. These
data included 11 evaluable patients with cutaneous squamous cell
carcinoma (N=10) and Merkel cell carcinoma (N=1).
- The data demonstrated an overall response rate (ORR) of 27.3%,
with all responders achieving confirmed complete responses
(CR).
- RP1 monotherapy was well tolerated, and the safety profile was
similar to non-immunocompromised patients with advanced skin
cancers (IGNYTE study). No immune-mediated adverse events or
evidence of allograft rejection were observed.
- RP1 combined with Opdivo in anti-PD1 failed
melanoma
- Presented updated data from the ongoing IGNYTE clinical trial
at the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting in June. These data included the first 75 patients from the
anti-PD1 failed melanoma cohort combined with the 16 anti-PD1
failed melanoma patients from the prior all comers 30 patient
melanoma cohort (N=91 in total).
- The data demonstrated an overall response rate (ORR) of 37.4%,
with clinically meaningful activity across the range of anti-PD1
failed cutaneous melanoma settings enrolled, including in patients
with moderate-high tumor burden and with visceral disease.
- Systemic activity was seen in both injected and un-injected
lesions, with both responding with similar durability and kinetics,
including in un-injected visceral disease.
- RP1 continues to be generally well tolerated with safety data
showing predominantly ‘on target’ flu-like Grade 1-2 side effects
indicative of systemic immune activation. Grade 3 treatment related
events were rarely seen in the 91-patient group, with a range of
Grade 3 events in one patient each, and two Grade 3 events of
fatigue. There were two Grade 4 treatment related events (elevated
lipase, and cytokine release syndrome) and no treatment related
Grade 5 events.
- The Company remains on track to announce snapshot data for all
patients (N=141) in Q4 2023 by which point all patients will have
had at least 6 months follow up, prior to the per protocol primary
analysis at 12 months post the last patient enrolled.
RP2 and RP3
- RP2 combined with nivolumab in uveal melanoma
- Presented updated data from an ongoing Phase 1b trial of RP2 at
the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting in June. To date 17 patients have been treated with RP2 as
monotherapy (N=3) or in combination with nivolumab (N=14) to date,
with enrollment of uveal melanoma patients into this clinical trial
now being complete.
- In uveal melanoma, four of the 14 evaluable patients have thus
far responded to treatment (28.6%), including metastatic tumors in
the liver and bone. The final three of 17 patients remain on
treatment, but currently have insufficient follow-up data to
determine response outcome as of the cut-off date. Three of the
four responses are ongoing at 9, 12 and 21 months, including for
patients with liver and bone metastases, with the fourth patient
having progressed at 15 months.
- The safety profile as monotherapy and in combination with
nivolumab was generally well tolerated with no additive adverse
events observed.
- RP2 and RP3 Phase 2 program
- RP2 and RP3 in combination with atezolizumab and bevacizumab in
third-line colorectal cancer (CRC)
- Two signal finding cohorts of 30 patients each will be enrolled
in collaboration with Roche. The first cohort will enroll patients
to be treated with atezolizumab combined with bevacizumab and RP2
and the second cohort with atezolizumab and bevacizumab and RP3.
The Company believes that data with both RP2 and RP3 in CRC will
allow the comparative efficacy of RP2 and RP3 to be evaluated in a
particularly difficult to treat patient population. This clinical
trial has now been initiated.
- RP3 in combination with atezolizumab and bevacizumab in first
(1L) and second-line (2L) hepatocellular carcinoma (HCC)
- Two signal finding cohorts of 30 patients each will be enrolled
in collaboration with Roche. The first cohort will enroll 1L
patients treated with SOC atezolizumab combined with bevacizumab
and RP3, and the second cohort will enroll patients who have
progressed on 1L immunotherapy (including
atezolizumab/bevacizumab), and will be treated with atezolizumab
combined with bevacizumab and RP3. This clinical trial is expected
to initiate this quarter.
- RP3 in combination with standard of care therapy in squamous
cell carcinoma of the head and neck (SCCHN)
- A two-cohort clinical trial is planned, with the first cohort
of 100 patients with locally advanced disease being randomized to
receive either standard of care (SOC) cisplatin chemotherapy
combined with radiation or RP3 combined with chemotherapy and
radiation followed by adjuvant nivolumab therapy. The second,
signal finding cohort, will enroll 30 patients with recurrent or
metastatic SCCHN with low PDL1 levels (CPS<20) who will be
treated with chemotherapy (carbopltin and paclitaxel), nivolumab
and RP3. Due to the the global shortage of cisplatin and
carboplatin, initiation of this study is currently on hold until
sufficient supplies of these agents are available.
- RP2 and RP3 Phase 1 program
- Accrual in the Phase 1 program is expected to materially
complete in Q3 2023. Any additional Phase 2 development programs
not already announced which are driven by data from the full Phase
1 data and other opportunistic considerations are expected to be
disclosed by year end.
Corporate Update
- Announced the appointment of new member to Board of
Directors
- The Company appointed Veleka R. Peeples-Dyer, strategic
enterprise leader and former Chair of the North American Food and
Drug practice and Co-Chair of the Global Regulatory Group at Baker
McKenzie, to the Company’s Board of Directors effective June 1,
2023. The appointment strengthens the Company’s board as it
prepares for the anticipated commercialization of its leading
pipeline of oncolytic immunotherapies, beginning with the potential
2024 commercial launch of RP1.
Financial Highlights
- Cash
Position: As of June 30, 2023, cash, cash
equivalents and short-term investments were $539.1 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 expended clinical development
plans.Based on the current operating plan, the Company believes
that existing cash, cash equivalents and short-term investments, as
of June 30, 2023, will enable the Company to fund operations into
the second half of calendar year 2025.
- R&D Expenses: Research and
development expenses were $40.4 million for the first
quarter ended June 30, 2023, as compared to $29.5
million for the first quarter ended June 30, 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 $3.3 million in stock-based compensation
expenses for the first quarter ended June 30, 2023.
- S,G&A Expenses: Selling, general and
administrative expenses were $15.2 million for the first
quarter ended June 30, 2023, as compared to $11.4
million for the first quarter ended June 30, 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 $5.5
million in stock-based compensation expenses for the first
quarter ended June 30, 2023.
- Net Loss: Net loss was $49.6
million for the first quarter ended June 30, 2023, as
compared to a net loss of $42.3 million for the first
quarter ended June 30, 2022.
About CERPASSCERPASS is Replimune’s
registration-directed randomized, global Phase 2 clinical trial to
compare the effects of Libtayo® (cemiplimab-rwlc) alone versus a
combination of Libtayo and Replimune’s investigational oncolytic
immunotherapy RP1. The clinical trial recently completed enrollment
and enrolled 211 patients with locally advanced or metastatic
cutaneous squamous cell carcinoma who are naïve to anti-PD-1
therapy. The clinical trial will evaluate complete response rate
and overall response rate as its two independent primary efficacy
endpoints as assessed by independent review, as well as secondary
endpoints including duration of response, progression-free
survival, and overall survival. The clinical trial is being
conducted under a clinical trial collaboration agreement with
Regeneron and full commercial rights retained by Replimune. Libtayo
is a registered trademark of Regeneron.
About IGNYTEIGNYTE is Replimune’s multi-cohort
Phase 1/2 trial of RP1 plus nivolumab. There are 3 tumor specific
cohorts currently enrolling in this clinical trial including a
125-patient cohort in anti-PD1 failed melanoma with registrational
intent. 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-PD1 failed CSCC,
and in anti-PD1 failed microsatellite instability high, or
MSI-H/dMMR tumors. This trial is being conducted under a
collaboration and supply agreement with Bristol-Myers Squibb.
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 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, but does not express GM-CSF. 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 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.
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 BrinzeyWestwicke, an
ICR Company339.970.2843chris.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 June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
$ |
40,437 |
|
|
$ |
29,478 |
|
General and administrative |
|
|
15,211 |
|
|
|
11,398 |
|
Total operating expenses |
|
|
55,648 |
|
|
|
40,876 |
|
Loss from operations |
|
|
(55,648 |
) |
|
|
(40,876 |
) |
Other income (expense): |
|
|
|
|
Research and development incentives |
|
|
393 |
|
|
|
851 |
|
Investment income |
|
|
6,186 |
|
|
|
343 |
|
Interest expense on finance lease liability |
|
|
(544 |
) |
|
|
(552 |
) |
Interest expense on debt obligations |
|
|
(1,115 |
) |
|
|
- |
|
Other income (expense) |
|
|
1,374 |
|
|
|
(2,019 |
) |
Total other income (expense), net |
|
|
6,294 |
|
|
|
(1,377 |
) |
Net loss attributable to common stockholders |
|
$ |
(49,354 |
) |
|
$ |
(42,253 |
) |
Income tax provision |
|
|
201 |
|
|
$ |
- |
|
Net loss |
|
$ |
(49,555 |
) |
|
$ |
(42,253 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.75 |
) |
|
$ |
(0.78 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
66,367,702 |
|
|
|
54,211,446 |
|
|
|
|
|
|
|
|
|
|
|
Replimune Group, Inc.Condensed
Consolidated Balance Sheets(Amounts In thousands,
except share and per share
amounts)(Unaudited) |
|
|
|
|
|
|
|
June 30, |
|
March 31, |
|
|
|
2023 |
|
|
|
2023 |
|
|
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
Cash, cash equivalents and short-term investments |
|
$ |
539,100 |
|
|
$ |
583,386 |
|
Working capital |
|
|
517,800 |
|
|
|
558,778 |
|
Total assets |
|
|
603,891 |
|
|
|
646,591 |
|
Total stockholders' equity |
|
|
514,029 |
|
|
|
555,292 |
|
|
|
|
|
|
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