Replimune公佈第四財季業績，RP1黑色素瘤BLA獲FDA受理目標評審日為8月2日

EX-99.1
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tm2619129d1_ex99-1.htm
EXHIBIT 99.1

 

 

Exhibit 99.1

 

Replimune Reports
Fiscal Fourth Quarter and Year End 2026 Financial Results and Provides Corporate Update

 

Woburn, MA, June 29, 2026 – Replimune Group, Inc.
(Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced
financial results for the fiscal fourth quarter and year ended March 31, 2026 and provided a business update.

 

The Company recently announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination
with nivolumab for the treatment of advanced melanoma. The FDA considers this a complete, class 1 response with a goal date of August 2,
2026, and has notified the company to expect an advisory committee meeting in late July.

 

“The FDA’s acceptance of our RP1 BLA resubmission marks
a pivotal milestone in our mission to bring this important therapy to patients facing advanced melanoma, where the need for durable,
effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “We are working hard to ensure
we can provide access to RP1 as soon as possible pending an approval. We are equally pleased by the momentum across our clinical programs
including continued strong enrollment in our IGNYTE-3 trial of RP1 in advanced melanoma and our REVEAL trial of RP2 in metastatic uveal
melanoma.”

 

Program Highlights & Milestones

 

RP1 (vusolimogene oderparepvec)

 

•IGNYTE Trial (RP1 + Nivolumab)
 - 3-Year Overall Survival Analysis: In an oral presentation at the ASCO 2026 annual meeting,
 RP1 plus nivolumab demonstrated exceptional durability in anti-PD-1-failed melanoma patients,
 with 47.8% of all treated patients alive at 3 years and a median overall survival of 32.9
 months - including an 83.5% 3-year survival rate among responders - representing
 a rare and meaningful long-term benefit in a patient population with historically limited
 treatment options (Presentation).

•IGNYTE-3 Confirmatory Study:
 The global Phase 3 trial assessing RP1 in combination with nivolumab versus physician's choice
 in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies
 or are ineligible for anti-CTLA-4 treatment is actively enrolling. The primary endpoint of
 this trial is overall survival, and key secondary endpoints are progression free survival
 and overall response rate.

 

RP2

 

•Phase 1 First-in-Human Trial
 (RP2) - Final Data: In an oral presentation at the ASCO 2026 annual meeting, RP2 monotherapy
 and in combination with nivolumab demonstrated promising efficacy across multiple advanced
 solid tumor types, achieving a 19% objective response rate in both arms with durable responses
 (median duration not reached for monotherapy), while translational analyses confirmed the
 intended mechanism of transforming immunologically “cold” tumors into immune-inflamed
 environments with systemic T-cell activation, supporting advancement to a randomized Phase
 2/3 trial in metastatic uveal melanoma (Presentation).

•REVEAL Study: The registration-directed
 Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating
 RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately
 280 patients. The primary endpoints of the trial are overall survival and progression free
 survival, and key secondary endpoints are overall response rate and disease control rate.
 Phase 2/3 transition is expected in Q1 2027.

 

  

  

 

 

Financial Highlights

 

•Cash
 Position: As
 of March 31, 2026, cash, cash equivalents
 and short-term investments were $268.9 million,
 as compared to $483.8 million as of fiscal year
 ended March 31, 2025. The decrease in cash balance was a result of cash burn
 related to 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 will enable us to fund operations into the first quarter of calendar
2027, which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate
purposes and excludes any potential revenue.

 

•R&D
 Expenses: Research and development expenses were $52.3
 million for the fiscal fourth quarter and $221.2
 million for the fiscal year ended March 31,
 2026, as compared to $54.0 million for
 the fiscal fourth quarter and $189.4 million for the fiscal year ended
 March 31, 2025. This year over year increase was primarily due to an increase
 in personnel-related costs as we scaled operations in preparation for commercial launch of
 RP1, as well as consulting and facility-related costs. Research
 and development expenses included $4.1 million in
 stock-based compensation expenses for the fiscal fourth quarter and $16.7 million
 for the fiscal year ended March 31, 2026.

 

•S,G&A
 Expenses: Selling, general and administrative expenses were $21.0
 million for the fiscal fourth quarter and $98.7
 million for the fiscal year ended March 31,
 2026, as compared to $25.4 million for
 the fiscal fourth quarter and $72.2 million for
 the fiscal year ended March 31, 2025. Selling,
 general and administrative expenses included $4.1 million in
 stock-based compensation expenses for the fiscal fourth quarter and $15.5 million
 for the fiscal year ended March 31, 2026.

 

•Net
 Loss: Net loss was $73.7 million for
 the fiscal fourth quarter and $313.9 million for the fiscal year ended
 March 31, 2026, as compared to a net loss
 of $74.1 million for the fiscal fourth quarter
 and $247.3 million for the fiscal year ended March 31,
 2025.

 

About RP1

 

RP1 (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 RP2

 

RP2 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. 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 novel 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 intended to ignite local 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 then activate 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.

 

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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 status of the FDA review of our BLA for RP1 or potential
approval of such BLA, 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, the regulatory review process and timing of potential product approval,
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 the outcome of FDA’s review process, 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 a global pandemic and related public
health issues and the ongoing political and military conflicts, including trade 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 Brinzey

ICR Healthcare

339.970.2843

[email protected]

 

Media Inquiries

Arleen Goldenberg

Replimune

917.548.1582

[email protected]

 

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Replimune Group, Inc.

Consolidated Statements of Operations

(Amounts in thousands, except share and per
share amounts)

(Unaudited)

 

 
   
 Year Ended March 31, 

 
   
 2026  
 2025 

 
 Operating expenses: 
     
    

 
      Research and development 
 $221,184  
 $189,447 

 
      Selling, general and administrative 
  98,735  
  72,180 

 
           Total operating expenses 
  319,919  
  261,627 

 
 Loss from operations 
  (319,919) 
  (261,627)

 
 Other income (expense): 
     
    

 
      Research and development incentives 
  1,604  
  1,773 

 
      Investment income 
  13,625  
  21,120 

 
      Interest expense on finance lease liability 
  (2,063) 
  (2,118)

 
      Interest expense on debt obligations 
  (6,796) 
  (5,775)

 
      Other expense 
  (942) 
  (202)

 
           Total other income, net 
  5,428  
  14,798 

 
 Loss before income taxes 
 $(314,491) 
 $(246,829)

 
      Income tax (benefit) provision 
  (551) 
  468 

 
 Net loss 
 $(313,940) 
 $(247,297)

 
 Net loss per common share, basic and diluted 
 $(3.38) 
 $(3.07)

 
 Weighted average common shares outstanding, basic and diluted 
  92,803,711  
  80,564,147 

 

 

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Replimune Group, Inc.

Condensed Consolidated Balance Sheets

(Amounts in thousands, except share and per
share amounts)

(Unaudited)

 

 
   
 March 31, 2026  
 March 31, 2025 

 
   
 (in thousands) 

 
 Consolidated Balance Sheet Data: 
     
    

 
 Cash, cash equivalents and short-term investments 
 $268,889  
 $483,804 

 
 Working capital 
  220,891  
  433,518 

 
 Total assets 
  332,388  
  551,328 

 
 Total stockholders' equity 
  166,160  
  415,843 

 

 

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