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Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
GlobeNewswire News Room· 2024-06-03 12:00
Core Insights - Replimune Group, Inc. presented promising clinical data for its RP1 and RP2 programs at the 2024 ASCO Annual Meeting, highlighting their potential in treating hard-to-treat tumor types [1][2] Group 1: RP1 Clinical Trial Results - The IGNYTE clinical trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma showed an overall response rate (ORR) of 32.7% with durable responses lasting over six months, and a median duration of response exceeding 36 months [3][4] - Among patients with primary resistance to prior anti-PD-1 therapy, the ORR was 34%, while those who progressed on prior anti-PD-1 combined with anti-CTLA-4 therapy had an ORR of 27.3% [3] - The safety profile of the combination therapy was favorable, with generally transient grade 1/2 adverse events indicating systemic immune activation [3][5] Group 2: RP2 Clinical Trial Results - RP2, administered alone or in combination with nivolumab in metastatic uveal melanoma patients, demonstrated an ORR of 29.4% and a disease control rate (DCR) of 58.8% [6] - The safety profile of RP2 was favorable, with evidence of immune cell infiltration and increased PD-L1 expression in tumors [6] - Replimune is finalizing a protocol for a registration-directed study based on the encouraging results observed in a historically challenging patient population [6] Group 3: Future Plans and Regulatory Pathway - The company is on track to submit a biologics license application (BLA) for RP1 to the FDA in the second half of 2024 [4] - A Phase 3 confirmatory study (IGNYTE-3) has been agreed upon with the FDA and is expected to be initiated prior to the BLA submission [4]
Replimune to Present at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
globenewswire.com· 2024-05-23 21:00
WOBURN, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced multiple presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago from May 31-June 4, 2024. The Company has two abstracts selected for oral presentation, including an updated presentation of investigator- assessed 12-month data from the IGNYTE ...
Replimune(REPL) - 2024 Q4 - Annual Report
2024-05-16 12:14
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...
Replimune(REPL) - 2024 Q4 - Annual Results
2024-05-16 12:08
Exhibit 99.1 Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update Woburn, MA, May 16, 2024 – Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2024 and provided a business update. "We have exciting milestones in the coming months, including sharing the investigator-a ...
Replimune Reports Fiscal Fourth Quarter and Year Ended 2024 Financial Results and Provides Corporate Update
Newsfilter· 2024-05-16 12:00
Core Insights - Replimune Group, Inc. is advancing its lead product candidate RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma, with a 12-month primary analysis expected in Q2 2024 and a Biologics License Application (BLA) submission anticipated in the second half of 2024 [1][2][4] Clinical Development Updates - The company has successfully completed a Type C meeting with the FDA, confirming alignment on Chemistry, Manufacturing and Controls (CMC) plans for the BLA submission [3][4] - Enrollment of the first patients in the Phase 3 confirmatory trial (IGNYTE-3) for RP1 is expected to begin in the second half of 2024 [1][5] - Positive six-month follow-up data from the IGNYTE clinical trial indicated efficacy and safety of RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma [4] Financial Performance - As of March 31, 2024, the company reported cash, cash equivalents, and short-term investments of $420.7 million, down from $583.4 million a year earlier, primarily due to cash utilized in operating activities [9] - Research and development expenses for the fourth quarter were $42.6 million, and $175.0 million for the fiscal year, compared to $37.9 million and $126.5 million, respectively, in the previous year [10] - The net loss for the fourth quarter was $55.1 million, with a total net loss of $215.8 million for the fiscal year, compared to $49.2 million and $174.3 million in the prior year [11] Upcoming Milestones - The company plans to present several abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, including data on RP1 and RP2 in various cancer types [3][4] - The Phase 2 clinical trial of RP2 in hepatocellular carcinoma is expected to initiate in the second half of 2024 [8]
Replimune(REPL) - 2024 Q3 - Quarterly Report
2024-02-08 13:09
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of inc ...
Replimune(REPL) - 2024 Q2 - Quarterly Report
2023-11-07 22:03
PART I FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's analysis, market risk, and internal controls [Condensed Consolidated Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) The company reported a **net loss of $109.6 million** for the six months ended September 30, 2023, driven by increased R&D, maintaining **$496.8 million in cash and investments** Condensed Consolidated Balance Sheets (Unaudited) | | September 30, 2023 (Thousands USD) | March 31, 2023 (Thousands USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | **$75,996** | **$146,590** | | Short-term investments | **$420,765** | **$436,796** | | Total current assets | **$508,175** | **$592,603** | | Total assets | **$562,398** | **$646,591** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | **$39,832** | **$33,825** | | Total liabilities | **$97,226** | **$91,299** | | Accumulated deficit | **$(595,087)** | **$(485,488)** | | Total stockholders' equity | **$465,172** | **$555,292** | Condensed Consolidated Statements of Operations (Unaudited) | | Three Months Ended Sep 30, 2023 (Thousands USD) | Three Months Ended Sep 30, 2022 (Thousands USD) | Six Months Ended Sep 30, 2023 (Thousands USD) | Six Months Ended Sep 30, 2022 (Thousands USD) | | :--- | :--- | :--- | :--- | :--- | | Research and development | **$49,101** | **$28,834** | **$89,538** | **$58,312** | | Selling, general and administrative | **$14,730** | **$12,745** | **$29,941** | **$24,143** | | Loss from operations | **$(63,831)** | **$(41,579)** | **$(119,479)** | **$(82,455)** | | Net loss | **$(60,044)** | **$(43,102)** | **$(109,599)** | **$(85,355)** | | Net loss per common share | **$(0.90)** | **$(0.79)** | **$(1.65)** | **$(1.57)** | Condensed Consolidated Statements of Cash Flows (Unaudited) | | Six Months Ended Sep 30, 2023 (Thousands USD) | Six Months Ended Sep 30, 2022 (Thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | **$(92,178)** | **$(66,665)** | | Net cash provided by investing activities | **$20,044** | **$5,351** | | Net cash provided by financing activities | **$1,543** | **$39,945** | | Net (decrease) increase in cash | **$(70,594)** | **$(17,018)** | - The company is a **clinical-stage biotechnology firm** focused on developing **oncolytic immunotherapies** to treat cancer, subject to risks common to **early-stage biotech companies**, including the need for **significant additional capital** and **regulatory approval** for its **product candidates**[24](index=24&type=chunk)[25](index=25&type=chunk) - The company has a **Loan and Security Agreement** with **Hercules Capital, Inc.** for a **term loan facility** of up to **$200.0 million**, with an initial **$30.0 million** borrowed in October 2022[39](index=39&type=chunk) - Collaboration agreements are in place with **Bristol-Myers Squibb (BMS)**, **Regeneron**, **Roche**, and **Incyte** for the supply of combination therapies in various clinical trials[83](index=83&type=chunk)[86](index=86&type=chunk)[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's **oncolytic immunotherapy platform**, highlighting increased R&D expenses, higher net loss, and strong liquidity of **$496.8 million** expected to fund operations into late 2025 [Overview](index=25&type=section&id=Overview) This section provides an overview of Replimune's clinical-stage oncolytic immunotherapy platform and lead product candidates - **Replimune** is a **clinical-stage biotechnology company** developing a portfolio of **oncolytic immunotherapies** based on its **proprietary RPx platform**, which uses an engineered strain of **herpes simplex virus 1 (HSV-1)**[113](index=113&type=chunk)[115](index=115&type=chunk) - The lead **product candidate**, **RP1**, is in a registration-directed **Phase 2 trial (CERPASS)** for **cutaneous squamous cell carcinoma (CSCC)**, with a **Biologics License Application (BLA)** submission expected in Q2 2024, assuming positive data[116](index=116&type=chunk) - The **IGNYTE trial** for **anti-PD-1 failed cutaneous melanoma** has completed enrollment of 140 patients, with a **BLA** submission planned for Q3 2024 based on this trial[118](index=118&type=chunk) - The pipeline includes **RP2** and **RP3**, which are being evaluated in various tumor types like **hepatocellular carcinoma (HCC)** and **colorectal cancer (CRC)** in collaboration with partners such as **Roche** and **BMS**[122](index=122&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20operations) This section details the company's operating results, highlighting changes in research and development and selling, general and administrative expenses Comparison of Operating Results (Three Months Ended Sep 30) | | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (Thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | **$49,101** | **$28,834** | **$20,267** | | Selling, general and administrative | **$14,730** | **$12,745** | **$1,985** | | Loss from operations | **$(63,831)** | **$(41,579)** | **$(22,252)** | | Net loss | **$(60,044)** | **$(43,102)** | **$(16,942)** | - R&D expenses increased by **$20.3 million** for the three months ended Sep 30, 2023, primarily due to increased **clinical trial site and patient enrollment** for **RP1**, higher **manufacturing efforts**, and an **$8.2 million** increase in **personnel-related costs**[157](index=157&type=chunk)[158](index=158&type=chunk)[160](index=160&type=chunk) - SG&A expenses increased by **$2.0 million** for the three months ended Sep 30, 2023, mainly due to a **$1.1 million** increase in **personnel costs** from hiring for **pre-launch planning** and building **commercial infrastructure**, and a **$0.9 million** increase in **sales and marketing costs**[161](index=161&type=chunk) Comparison of Operating Results (Six Months Ended Sep 30) | | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (Thousands USD) | | :--- | :--- | :--- | :--- | | Research and development | **$89,538** | **$58,312** | **$31,226** | | Selling, general and administrative | **$29,941** | **$24,143** | **$5,798** | | Loss from operations | **$(119,479)** | **$(82,455)** | **$(37,024)** | | Net loss | **$(109,599)** | **$(85,355)** | **$(24,244)** | [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20capital%20resources) This section discusses the company's cash position, operating cash flow, and projected liquidity runway - As of September 30, 2023, the company had **cash, cash equivalents, and short-term investments** of **$496.8 million**[173](index=173&type=chunk) - Net cash used in **operating activities** was **$92.2 million** for the six months ended September 30, 2023, compared to **$66.7 million** for the same period in 2022, primarily due to a higher **net loss**[175](index=175&type=chunk)[177](index=177&type=chunk) - Based on the current **operating plan**, existing cash is expected to fund operations and **capital expenditure requirements** into the **second half of 2025**[185](index=185&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable for this reporting period - Not applicable[209](index=209&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - The **Chief Executive Officer** and **Chief Accounting Officer** concluded that the company's **disclosure controls and procedures** were effective as of September 30, 2023[211](index=211&type=chunk) - There have been no changes in **internal control over financial reporting** for the three months ended September 30, 2023, that have materially affected, or are reasonably likely to materially affect, **internal controls**[213](index=213&type=chunk) PART II OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, and exhibits related to the company's operations [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[216](index=216&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including early-stage product development, clinical trial uncertainty, regulatory approval challenges, competition, financial losses, and the need for additional capital [Risks Related to Product Development](index=43&type=section&id=Risks%20related%20to%20product%20development) This section outlines risks associated with early-stage product development, clinical trial outcomes, and platform dependency - All **product candidates** are in early stages of development and may not receive **regulatory approval** or become commercially viable; **preclinical and early clinical trial results** are not predictive of later-stage outcomes[220](index=220&type=chunk)[222](index=222&type=chunk) - Development of **product candidates** in combination with **third-party drugs** (e.g., **anti-PD-1 therapies**) presents challenges, including reliance on supply and the regulatory status of those drugs[229](index=229&type=chunk)[232](index=232&type=chunk) - An underlying problem with the **proprietary RPx platform** could adversely affect the entire pipeline, as all current **product candidates** are based on this platform[234](index=234&type=chunk) [Risks Related to Regulatory Approval](index=47&type=section&id=Risks%20related%20to%20regulatory%20approval) This section addresses risks concerning the lengthy and unpredictable regulatory approval process and potential post-marketing restrictions - The **regulatory approval process** is lengthy, unpredictable, and the company may never obtain approval for its **product candidates**; even if approved, the indications may be limited[237](index=237&type=chunk)[240](index=240&type=chunk) - **Undesirable side effects** could delay or prevent **regulatory approval**, result in a more restrictive label, or lead to post-marketing restrictions[242](index=242&type=chunk) - The company is subject to **ongoing regulatory review** even after approval, which can result in significant expense and limit how products are manufactured and marketed[253](index=253&type=chunk) [Risks Related to Commercialization](index=53&type=section&id=Risks%20related%20to%20commercialization) This section covers risks related to market competition, lack of commercial infrastructure, and challenges in achieving market acceptance and reimbursement - The company faces **significant competition** from other biopharmaceutical companies that may have greater resources and develop products more quickly[268](index=268&type=chunk) - The company currently lacks a **commercial infrastructure** and may be unable to establish effective marketing, sales, and distribution capabilities, which could limit revenue[273](index=273&type=chunk) - Successful commercialization depends on achieving broad **market acceptance** and securing **adequate reimbursement** from government and private payors, which is uncertain[280](index=280&type=chunk)[284](index=284&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=58&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20need%20for%20additional%20capital) This section highlights risks from the company's limited operating history, continuous net losses, and the necessity for additional financing - The company has a **limited operating history**, has incurred **net losses since inception**, and anticipates substantial and increasing **net losses** for the foreseeable future[291](index=291&type=chunk) - The company will require **additional financing** to achieve its goals, and failure to obtain this capital could force it to **delay, limit, or terminate** its **development programs**[297](index=297&type=chunk) - All **product candidates** are in early stages of development and may never receive **regulatory approval** or become commercially viable; the company has a history of **losses** and expects them to continue[220](index=220&type=chunk)[291](index=291&type=chunk) - The company's ability to commercialize its products depends on successfully transitioning **manufacturing** to its **in-house facility** and maintaining relationships with **third-party suppliers** and **collaborators** like **BMS** and **Regeneron**[218](index=218&type=chunk)[319](index=319&type=chunk) - The company faces risks related to protecting its **intellectual property** and potential **infringement claims** from third parties, such as the recently settled matter with **Amgen** which now requires **royalty payments**[303](index=303&type=chunk)[311](index=311&type=chunk) - The company will require **additional financing** to achieve its goals, and failure to obtain necessary capital could force delays or termination of **product development** or commercialization efforts[297](index=297&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[407](index=407&type=chunk) [Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company has indicated that this section is not applicable - Not applicable[408](index=408&type=chunk) [Mine Safety Disclosure](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company has indicated that this section is not applicable - Not applicable[409](index=409&type=chunk) [Other Information](index=77&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this period - None[410](index=410&type=chunk) [Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including employment agreements and CEO/CFO certifications - Exhibits filed include **employment agreements**, **stock option agreements**, and **CEO/CFO certifications** required under **Sections 302 and 906** of the **Sarbanes-Oxley Act**[412](index=412&type=chunk)
Replimune(REPL) - 2024 Q1 - Quarterly Report
2023-08-03 12:11
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the quarter ended June 30, 2023 [Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, and cash flows, reporting a net loss of $49.6 million for the quarter ended June 30, 2023 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets to $603.9 million from $646.6 million at the end of the previous quarter, primarily due to a reduction in cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | March 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $106,481 | $146,590 | | Short-term investments | $432,619 | $436,796 | | **Total Assets** | **$603,891** | **$646,591** | | Total current liabilities | $32,242 | $33,825 | | **Total Liabilities** | **$89,862** | **$91,299** | | Accumulated deficit | $(535,043) | $(485,488) | | **Total Stockholders' Equity** | **$514,029** | **$555,292** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2023, the company reported a net loss of $49.6 million, or ($0.75) per share, compared to a net loss of $42.3 million, or ($0.78) per share, for the same period in 2022 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | | Research and development | $40,437 | $29,478 | | Selling, general and administrative | $15,211 | $11,398 | | **Total operating expenses** | **$55,648** | **$40,876** | | Loss from operations | $(55,648) | $(40,876) | | Investment income | $6,186 | $343 | | **Net loss** | **$(49,555)** | **$(42,253)** | | Net loss per common share | $(0.75) | $(0.78) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $48.6 million for the three months ended June 30, 2023, a significant increase from $33.5 million in the prior-year period, primarily due to a higher net loss Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(48,588) | $(33,455) | | Net cash provided by investing activities | $7,361 | $5,315 | | Net cash provided by financing activities | $1,105 | $32,522 | | **Net (decrease) increase in cash** | **$(40,109)** | **$6,297** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's clinical-stage biotechnology business, its liquidity assessment, and significant collaboration and loan agreements - The company is a clinical-stage biotechnology firm focused on tumor-directed oncolytic immunotherapies, acknowledging risks like the need for **additional capital** and **regulatory approval**[23](index=23&type=chunk)[24](index=24&type=chunk) - Despite recurring losses and an accumulated deficit of **$535.0 million**, the company expects existing cash to fund operations for at least **12 months** from the issuance date[25](index=25&type=chunk) - In October 2022, the company secured a Loan Agreement with Hercules Capital for up to **$200.0 million**, with an initial draw of **$30.0 million**, and an amendment in June 2023[38](index=38&type=chunk)[39](index=39&type=chunk) - Collaboration agreements include receiving nivolumab from BMS for RP1 and RP2 trials, and a cost-sharing agreement with Regeneron for the Phase 2 CERPASS trial, with reimbursements completed in June 2022[84](index=84&type=chunk)[86](index=86&type=chunk)[94](index=94&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical program advancements for RP1, RP2, and RP3, increased operating expenses, and liquidity, projecting cash to fund operations into the second half of 2025 [Overview](index=24&type=section&id=Overview) Replimune, a clinical-stage biotech, is advancing its oncolytic immunotherapy candidates RP1, RP2, and RP3, with key RP1 data readouts anticipated in Q4 2023 and new Phase 2 collaborations initiated - Topline data for the registration-directed CERPASS trial (RP1 in CSCC) is now expected in **early Q4 2023**, a revision from Q3 2023 due to slower independent review read rates[113](index=113&type=chunk) - Snapshot data for all **141 patients** in the IGNYTE trial (RP1 in anti-PD-1 failed melanoma) is on track for **Q4 2023**, with evaluation for potential dual launch with CERPASS[115](index=115&type=chunk) - Phase 2 development for RP2 and/or RP3 is progressing with signal-finding studies in collaboration with **Roche** (for CRC and HCC) and **BMS** (for SCCHN)[124](index=124&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) The company's net loss increased to $49.6 million for the quarter ended June 30, 2023, from $42.3 million in the prior-year period Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $40,437 | $29,478 | $10,959 | | Selling, general and administrative | $15,211 | $11,398 | $3,813 | | **Total operating expenses** | **$55,648** | **$40,876** | **$14,772** | - Increased RP1 program costs resulted from more clinical trial sites, higher patient enrollment, increased data management, and reduced cost-sharing from Regeneron[162](index=162&type=chunk) - SG&A expenses rose due to a **$2.8 million** increase in personnel costs and a **$1.3 million** increase in other variable costs, including pre-launch sales and marketing programs[165](index=165&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company had $539.1 million in cash, cash equivalents, and short-term investments, with management believing these funds are sufficient to support operations into the second half of 2025 - As of June 30, 2023, the company held **$539.1 million** in cash, cash equivalents, and short-term investments[170](index=170&type=chunk) - Net cash used in operating activities increased to **$48.6 million** for the quarter, up from **$33.5 million** in the prior-year period, primarily due to a higher net loss[172](index=172&type=chunk)[173](index=173&type=chunk) - Based on the current operating plan, existing cash resources are expected to fund operations into the **second half of 2025**[179](index=179&type=chunk)[294](index=294&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company states that this section is not applicable to its business at this time - The company has determined this item is **not applicable**[203](index=203&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the Chief Executive Officer and Chief Accounting Officer, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2023 - As of June 30, 2023, the CEO and Chief Accounting Officer concluded that the company's disclosure controls and procedures were **effective**[204](index=204&type=chunk) - No material changes to internal control over financial reporting occurred during the quarter[206](index=206&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers other required disclosures, including legal proceedings, risk factors, and exhibits [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not currently a party to any **material legal proceedings**[209](index=209&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks, including uncertainties in clinical development, regulatory approval, reliance on third parties, capital needs, competition, and intellectual property challenges - The company's product candidates are in early development and may never receive **regulatory approval** or become commercially viable[213](index=213&type=chunk) - The company has a history of net losses, anticipates increasing future losses, and will require **additional financing** to achieve its objectives[284](index=284&type=chunk) - Development and commercialization depend on successful collaborations with partners like **BMS** and **Regeneron** for checkpoint blockade therapy supply[222](index=222&type=chunk)[312](index=312&type=chunk) - Risks exist in transferring manufacturing to the new in-house facility, including potential delays, higher expenses, and failure to achieve anticipated efficiencies[334](index=334&type=chunk) - The company is involved in an inter partes review petition with the USPTO challenging an **Amgen Inc. patent**, which could impact its freedom to operate[304](index=304&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=75&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period covered by the report - The company reports **None** for this item[400](index=400&type=chunk) [Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports that this item is not applicable - The company reports **Not applicable** for this item[401](index=401&type=chunk) [Mine Safety Disclosure](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) The company reports that this item is not applicable - The company reports **Not applicable** for this item[402](index=402&type=chunk) [Other Information](index=75&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed in this section - The company reports **None** for this item[403](index=403&type=chunk) [Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the 10-Q, including the First Amendment to the Loan and Security Agreement with Hercules Capital and a Separation Agreement with former CFO Jean Franchi - Exhibit 10.1 is the **First Amendment to the Loan and Security Agreement** with Hercules Capital, dated June 28, 2023[405](index=405&type=chunk) - Exhibits 10.2 and 10.3 are the **Separation Agreement** and **Consulting Agreement** with former CFO Jean Franchi, dated May 18, 2023[405](index=405&type=chunk)
Replimune(REPL) - 2023 Q4 - Annual Report
2023-05-18 12:10
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...
Replimune(REPL) - 2023 Q3 - Quarterly Report
2023-02-09 13:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38596 REPLIMUNE GROUP, INC. (Exact name of registrant as specified in its charter) Delaware 82-2082553 (State or other ...