AI Earnings Predictions for Replimune Group Inc. (REPL)

EX-99.1

2 tm2628395d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Replimune Reports Fiscal Second Quarter 2027 Financial Results and Provides Corporate Update

TUDRIQEV first delivered to patients for advanced melanoma on October 6th

More than 15 institutions have prescribed TUDRIQEV

Management will host a webcast today at 8:00 a.m. ET

Woburn, MA, October 28, 2026 – Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2026 and provided a business update.

In early October, the Company announced that TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, is now commercially available in the United States for use in combination with nivolumab for the treatment of adults with advanced melanoma. Healthcare providers began ordering TUDRIQEV for next day delivery immediately upon availability. The Company has more than a year of inventory on hand, produced at its in-house manufacturing facility.

“Melanoma takes nearly 8,500 lives in the U.S. every year, and for patients whose disease progresses after anti-PD-1 therapy, treatment options have been limited. TUDRIQEV is now available to patients in urgent need,” said Sushil Patel, Ph.D., CEO of Replimune. “The response from physicians has been enthusiastic and both oncologists and interventional radiologists are eager to bring TUDRIQEV into their practices. They value the broad label that lets them treat patients immediately after progression on a PD-1 based therapy. We are focused on reaching as many of these patients as possible.”

Program Highlights & Milestones

TUDRIQEV™ (vusolimogene oderparepvec-wtpg)

·Early launch off to a positive start. The Company has actively engaged with more than 70 percent of its initial 200 priority accounts to establish workflows and enable TUDRIQEV adoption. Leading melanoma institutions have rapidly placed TUDRIQEV on formulary and have started treating patients.

·Broad label supports use across a wide range of patients. TUDRIQEV is indicated in combination with nivolumab after progression on a PD-1-blocking antibody-based regimen, with no requirement for prior BRAF treatment, and can be injected into superficial, deep and visceral lesions, including lung and liver. Patients can be retreated if clinically appropriate.

·Rapid and broad payer coverage facilitated by NCCN guideline inclusion. Multiple payer policies have been published covering TUDRIQEV to label. TUDRIQEV has been listed in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation.

·IGNYTE-3 confirmatory study remains on track. The global Phase 3 trial assessing TUDRIQEV 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 is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

·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. 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.

Financial Highlights

·Cash Position: As of September 30, 2026, cash and cash equivalents were $307.8 million, as compared to cash, cash equivalents and short-term investments of $268.9 million as of fiscal year ended March 31, 2026. The increase in cash balance was a result of approximately net $141.0 million in proceeds from the Company's offering of common stock and pre-funded warrants in August 2026, as well as $15.0 million in proceeds from long-term debt from the initial draw down on tranche 4 in September 2026, partially offset by cash burn related to operating activities in advancing the company’s clinical development plans.

We expect that our existing cash and cash equivalents will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

·R&D Expenses: Research and development expenses were $34.4 million for the fiscal second quarter ended September 30, 2026, and $57.9 million for the fiscal second quarter ended September 30, 2025. This decrease was primarily due to a decrease in personnel related and other costs, as well as a decrease in direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development expenses included $4.9 million in stock-based compensation expenses for the fiscal second quarter ended September 30,

EX-99.1

2 tm2623208d1_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Replimune Reports Fiscal First Quarter 2027 Financial Results and Provides

Corporate Update

TUDRIQEV™

in combination with nivolumab receives FDA accelerated approval and will launch within 60 days

Michelle DiNapoli appointed as Chief Commercial Officer

Recently completed financing extends cash runway to support commercial launch and confirmatory trial

Woburn, MA, August 14, 2026 – Replimune Group, Inc. (Nasdaq: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended June 30, 2026 and provided a business update.

On August 6, 2026, the Company announced the U.S. Food and Drug Administration (FDA) has approved TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1 antibody-based regimen. The Company has begun launch preparations in the U.S. and anticipates having product in the market within 60 days. Replimune also recently completed a $150 million financing to support commercial launch and the ongoing IGNYTE-3 confirmatory trial.

The Company also announced today the appointment of Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. Ms. DiNapoli brings more than 25 years of biopharmaceutical experience commercializing innovative oncology therapies and building high-performing commercial organizations. She joins Replimune after a seven-year tenure at Deciphera Pharmaceuticals. At Deciphera, she built the U.S. sales force, led the U.S. Commercial organization, and scaled infrastructure to drive launch execution as the company grew from a single product to a multi-product organization. Prior to Deciphera, Ms. DiNapoli spent 16 years at Genentech in commercial leadership roles spanning breast, lung, and colorectal cancer franchises as well as cancer immunotherapy, developing deep expertise in market access, lifecycle management, and cross-functional execution.

“The FDA’s approval of TUDRIQEV is a defining milestone for Replimune and, more importantly, for the patients facing advanced melanoma, where the need for safe and effective treatment options remains significant,” said Sushil Patel, Ph.D., CEO of Replimune. “With this approval, we are now a fully integrated biotechnology company. We are completing the build out of our commercial infrastructure to enable a successful launch and bring TUDRIQEV to patients as quickly as possible.”

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

·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, expected to readout in 2030, is overall survival, and key secondary endpoints are progression free survival and overall response rate.

RP2

·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 June 30, 2026, cash, cash equivalents and short-term investments were $195.3 million, as compared to $268.9 million as of fiscal year ended March 31, 2026. 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 our current operating plan, we expect that our existing cash and cash equivalents and short-term investments, as of June 30, 2026, in addition to the $141.0 million of net proceeds from the issuance of our common stock in August 2026, will enable us to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, which includes scale up for the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

·R&D

Expenses: Research and development expenses were $49.3 million for the fiscal first quarter and $57.8 million for the fiscal first quarter ended June 30, 2025. This decrease was primarily due to a decrease in personnel related and other costs, as well as a decrease in direct research costs relating to the IGNYTE, ARTACUS and CERPASS studies. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal first quarter ended June 30, 2026.

·S,G&A

Exp

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.e618d017.1784721741.709d0d3

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.