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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): July 31, 2023
REPLIMUNE GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-38596 |
|
82-2082553 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification Number) |
500
Unicorn Park Drive
Suite 303
Woburn,
MA 01801
(Address of principal executive offices, including
Zip Code)
Registrant’s telephone number, including
area code: (781) 222-9600
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
|
REPL |
|
The Nasdaq Stock Market LLC
(Nasdaq Global Select Market) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this
chapter). Emerging growth company x
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 2.02 | Results of Operations and Financial Condition. |
On August 3, 2023, Replimune
Group, Inc. (the “Company”) issued a news release announcing its financial results for the first quarter ended June 30,
2023 and certain corporate updates. A copy of the news release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General
Instruction B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall
not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly stated by specific
reference in such filing.
| Item 7.01 | Regulation FD Disclosure |
On
July 31, 2023, the Company issued a news release announcing its entry into a clinical trial collaboration and supply agreement
with Incyte Corporation. A copy of the news release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information contained
in this Item 7.01 and in the accompanying Exhibit 99.2 shall not be incorporated by reference into any filing of the Company, whether
made before or after the date hereof, regardless of any general incorporation language in such filing, unless expressly incorporated by
specific reference to such filing. The information in this Item 7.01 and the accompanying Exhibit 99.2 shall not be deemed to be
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
| Item 9.01 | Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
|
REPLIMUNE GROUP, INC. |
|
|
|
Date: August 3, 2023 |
By: |
/s/ Philip Astley-Sparke |
|
|
Philip Astley-Sparke |
|
|
Chief Executive Officer |
Exhibit 99.1
Replimune
Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update
Topline
data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous
squamous cell carcinoma expected in early Q4 2023 and Biologics License Application submission anticipated in Q1/2 2024
Cost
sharing collaboration in cutaneous squamous cell carcinoma in the neoadjuvant setting entered into with Incyte
Data
snapshot for all 141 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma expected Q4 2023
RP2
and RP3 Phase 2 programs; third-line colorectal cancer clinical trial initated, first- and second-line hepatocellular carcinoma trials
expected to initiate this quarter; Phase 1 clinical trial update expected at year end
Strong
balance sheet with cash runway into H2 2025
Woburn,
MA, August 3, 2023 – 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 |
| o | 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 |
| o | 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 |
| o | 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 |
| o | 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). |
| o | The
data demonstrated an overall response rate (ORR) of 27.3%, with all responders achieving
confirmed complete responses (CR). |
| o | 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 |
| o | 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). |
| o | 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. |
| o | 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. |
| o | 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. |
| o | 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 |
| o | 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. |
| o | 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. |
| o | 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 |
| o | 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. |
| o | 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. |
| o | 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 |
| o | 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 |
| o | 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
CERPASS
CERPASS
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
IGNYTE
IGNYTE
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
RP1
RP1
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 & RP3
RP2
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
Brinzey
Westwicke,
an ICR Company
339.970.2843
chris.brinzey@westwicke.com
Media
Inquiries
Arleen
Goldenberg
Replimune
917.548.1582
media@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 | |
Exhibit 99.2
FOR IMMEDIATE RELEASE
Replimune and
Incyte Enter into Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB099280 in Patients with Cutaneous Squamous
Cell Carcinoma
Initial study in the neoadjuvant setting designed
to assess RP1 in combination with the small molecule, oral PD-L1 inhibitor, INCB99280
WOBURN, Mass. and WILMINGTON, Del., July 31, 2023 – Replimune
Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed
oncolytic immunotherapies, and Incyte (NASDAQ:INCY), a global biopharmaceutical company, today announced a clinical trial collaboration
and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small
molecule oral PD-L1 inhibitor.
“We are excited to enter into this collaboration with Incyte
to explore the use of RP1 prior to surgery as we believe that our tumor-directed oncolytic immunotherapies could have a great impact in
the neoadjuvant setting both in cutaneous squamous cell carcinoma (CSCC) and in other cancer types, given the high rates of complete responses
we’ve seen to date, and data indicating RP1 is generally very well tolerated” said Robert Coffin, Chief Research and Development
Officer of Replimune. “The unique potential of the RPx platform to induce a patient-specific anti-tumor immune response with an
off-the-shelf treatment speaks to the practicality and broad potential utility of the approach, and exploring its use with Incyte’s
oral PD-L1 inhibitor has the potential to improve the patient experience further.”
“We look forward to collaborating with Replimune on this study
evaluating INCB99280 and RP1 in patients with CSCC. Our oral PD-L1 program has shown promising safety and efficacy in early studies thus
far, and we look forward to adding to the growing body of evidence for INCB99280 and learning more about its potential to improve clinical
outcomes,” said Lance Leopold, M.D., Group Vice President, Clinical Development Hematology and Oncology, Incyte.
Under the terms of the agreement, Incyte will initiate and sponsor
the clinical trial of INCB99280 and RP1 in patients with high risk, resectable cutaneous squamous cell carcinoma (CSCC), with the clinical
trial expected to initiate in early 2024. Replimune will supply Incyte with RP1 for the study and share equally in the costs of the study.
About RP1
RP1 is Replimune’s lead oncolytic immunotherapy product
candidate and is based on a proprietary new strain of herpes simplex virus engineered for robust tumor selective replication 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 INCB99280
INCB099280 is a potent and selective small molecule oral PD-L1 inhibitor,
which has demonstrated promising clinical activity and safety in patients with solid tumors. INCB099280 is being evaluated in multiple
Phase 2 studies as monotherapy and in combination with other antitumor agents.
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.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary
therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.
Replimune 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 the design and advancement of our clinical trials, those of our collaboration partners
or the combined clinical trials with our collaboration partners, the timing and sufficiency of our clinical trial outcomes to support
potential approval of any of our RPx product candidates or those of, or combined with, our collaboration partners, our goals to develop
and commercialize our RPx product candidates alone or with our collaboration partners, patient enrollments in our planned clinical trials,
alone or with our collaboration partners, 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 RPx product candidates, alone or with
our collaboration partners, changes in laws and regulations to which we are subject, political and global macro factors, 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 and the actual results of our collaboration partners and/or the
combined results with our collaboration partners 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.
Incyte Forward-looking Statements
Except for the historical information set forth herein, the matters
set forth in this press release, including statements regarding the potential of INCB99280 and/or RP1 to treat patients with cuteaneous
squamos carcinoma or for any other indication, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte‘s current
expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments
in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful
or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of
subjects in clinical trials; determinations made by regulatory authorities; Incyte‘s dependence on its relationships with its collaboration
partners; the efficacy or safety of Incyte‘s products and the products of Incyte‘s collaboration partners; the acceptance
of Incyte‘s products and the products of Incyte‘s collaboration partners in the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; and other risks detailed from time to time in Incyte‘s reports filed with the Securities
and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2023.
Incyte disclaims any intent or obligation to update these forward-looking statements.
# # #
Replimune Contacts:
Media
Arleen Goldenberg
Replimune
media@replimune.com
Tel 917.548.1582
Investors
Chris Brinzey
Westwicke, an ICR Company
chris.brinzey@westwicke.com
Tel 339.970.2843
Incyte Contacts:
Media
Catalina Loveman
cloveman@incyte.com
Tel 302.498.6171
Investors
Greg Shertzer
gshertzer@incyte.com
Tel 302.498.4779
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Jul. 31, 2023 |
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REPLIMUNE GROUP, INC.
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DE
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Unicorn Park Drive
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