Replimune Reports Fiscal Fourth Quarter and Year-Ended 2021 Financial Results and Provides Corporate Update
Added complete response as an independent primary endpoint in registration-directed CERPASS study in CSCC and held Type B meeting with FDA to discuss the IGNYTE study in anti-PD1 failed melanoma
Dosed first patient with
Data update on lead programs to be provided during virtual investor event on June 3, 2021
Strengthened management team to prepare for potential commercial launch and enable further later stage development
Ended fiscal year 2021 with approximately
“We have made good progress advancing our programs over the quarter and look forward to providing a data update with
- Expanded management team with key hires to prepare for the transition to a commercial company. The Company hired
Sushil Patel, Ph.D. as Chief Commercial Officer, arriving from Genentechwhere he was the head of their global oncology franchise for lung cancer, skin cancer and rare / agnostic tumor types, and previously the lifecycle leader in lung cancer for the multi-billion-dollar checkpoint blockade drug Tecentriq®. In addition to hiring Dr. Patel, the Company also appointed Tanya Lewisas Chief Development Operations Officer. Ms. Lewis’s past accomplishments include successful negotiations related to registration trial designs, approval, and/or commercialization of XPOVIO®, VELCADE®, VARUBI®, INTEGRILIN® and ZEJULA®.
- Announced plans to amend the CERPASS clinical trial protocol to add complete response (CR) rate as an additional independent primary endpoint. The amendment is based on the depth and durability of responses and the manageable safety profile seen in patients with non-melanoma skin cancers treated with
RP1in combination with Opdivo® to date. Under the modified clinical trial protocol for CERPASS, Replimuneplans to add CR rate as an additional independent primary endpoint, in addition to overall response rate (ORR), and to reduce target enrollment from 240 patients to 180 patients. Secondary endpoints will continue to include duration of response, progression-free survival (PFS), and overall survival (OS). Replimuneplans to submit the amended protocol to the FDA by the end of this quarter and is maintaining its guidance to expect primary data read out in 2022.
- Held Type B meeting with the FDA to discuss the regulatory pathway for
RP1in combination with Opdivo® (nivolumab) in anti-PD1 failed melanoma. Replimunerecently held a Type B meeting with the FDA to discuss the design of the currently enrolling 125-patient registration-directed cohort of patients with anti-PD1 failed melanoma in the IGNYTE clinical trial. The FDA expressed that while a randomized controlled clinical trial would always be preferred for registration, if the clinical data is sufficiently compelling in this patient population with no clear standard of care, then the data could be submitted to the FDA for review under the accelerated approval pathway. The FDA also indicated that a randomized confirmatory trial would be needed as is required under the accelerated approval process.
- Presented new biomarker and pre-clinical data for
RP1and RP2, at the 2021 American Association for Cancer Research(AACR) Annual Meeting. The data presented continues to confirm potent anti-tumor activity and activation of robust systemic immune activation by RP1and RP2.
- Virtual Investor Event to be held on
Thursday, June 3, 2021. The Company will host a virtual investor event to present updated data from its Phase 2 skin cancer cohorts combining RP1with Opdivo and data from its Phase 1 study of RP2alone and in combination with Opdivo. The event will include presentations by the management team and Mark Middleton, Professor of Experimental Cancer Medicine in the Department of Oncology, consultant Medical Oncologist at the Oxford Cancer and Hematology Centre and Head of the Department of Oncologyat the University of Oxford.
RP1batches produced and filled at state-of-the-art manufacturing facility. Release testing is underway for the first GMP RP1batches produced at its 63,000-square-foot manufacturing facility in Framingham, MA, that was built to support the commercialization of all of its products. Technology transfer for RP2has also commenced and is expected to complete in the next quarter.
Program Highlights and Upcoming Milestones
RP1in combination with Libtayo® (cemiplimab) in CSCC: CERPASS, the Company’s Phase 2, global, randomized, controlled, registration-directed clinical trial continues to actively enroll patients and remains on track for a primary data read out in 2022. RP1in combination with Opdivo in anti-PD-1 failed melanoma: The Company’s 125-patient cohort in the IGNYTE Phase 2 clinical trial of RP1in combination with Opdivo, continues to actively enroll patients and remains on track to report the primary data read out in 2022. RP1in combination with Opdivo in melanoma and non-melanoma skin cancers (NMSC): Following a positive Phase 2 data update in October 2020and enrollment of the initial melanoma cohort (including anti-PD1 naïve and anti-PD1 failed patients) being complete, the Company continues to enroll its 45-patient cohort evaluating RP1in combination with Opdivo in NMSC. The Company plans to provide an update on these programs at its June 3rd investor event. RP1in anti-PD1 failed NSCLC: The first patient in the cohort of 30 anti-PD1 failed NSCLC patients treated with RP1combined with Opdivo has been dosed, and the Company expects to report initial data in the second half of 2021. RP1as monotherapy in solid organ transplant recipients with CSCC: The Company is currently enrolling a 30 patient Phase 1b clinical trial (ARTACUS) assessing the safety and efficacy of RP1in liver and kidney transplant recipients with CSCC. Enrollment in this immuno-compromised population has been hampered by COVID 19, but as the effects of the pandemic reduce the Company expects recruitment to increase. Early data from this clinical trial is intended to be presented in the second half of 2021. RP1in combination with Opdivo in MSI-H/dMMR tumors: The Company continues to expect to be able to decide whether to pursue RP1for MSI-H/dMMR tumors into registration-directed development by the end of 2021. RP2alone and in combination with Opdivo: Following positive data with RP2given as monotherapy that were presented in October 2020, the Company is actively enrolling a 30-patient cohort evaluating RP2in combination with Opdivo. Updated data from this clinical trial, including an update on patients treated with RP2monotherapy and initial data with RP2in combination with Opdivo will be presented at the upcoming June 3rd investor event. RP3alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial evaluating RP3alone and in combination with anti-PD1 therapy in solid tumor patients is actively enrolling and the Company remains on track to report initial data in the second half of 2021.
- Target evaluation for new indications is currently underway: The Company remains on track to disclose part of its initial development plans for
RP2and/or RP3in less immune responsive tumor types at the upcoming June 3rd investor event.
Financial Fiscal Quarter Four and Year End Highlights:
- Cash Position: As of March 31, 2021, cash, cash equivalents and short-term investments were $476.3 million, as compared to $168.6 million as of March 31, 2020. This increase was primarily related to $372.5 million in net proceeds from financing activities offset by an increase in cash utilized in operating activities in advancing our expanded clinical development plan.
Based on the current operating plan,
Replimunebelieves that existing cash and cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements into the second half of 2024.
- R&D Expenses: Research and development expenses were $16.2 million for the fourth quarter and $56.8 million for the fiscal year ended March 31, 2021, as compared to $11.2 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2020. This increase was primarily due to clinical expenses driven by the company's lead programs, expansion into additional studies, operating our dedicated manufacturing facility and related increased personnel costs. Research and development expenses included $2.0 million in stock-based compensation expenses for the fourth quarter and $5.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2021.
- G&A Expenses: General and administrative expenses were $6.0 million for the fourth quarter and $23.2 million for the fiscal year ended March 31, 2021, as compared to $5.2 million for the fourth quarter and $17.4 million for the year ended March 31, 2020. The increase was primarily driven by personnel related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the fourth quarter and $6.0 million in stock-based compensation expenses for the fiscal year ended March 31, 2021.
- Net Loss: Net loss was $21.5 million for the fourth quarter and $80.9 million for the fiscal year ended March 31, 2021, as compared to a net loss of $15.8 million for the fourth quarter and $52.6 million for the fiscal year ended March 31, 2020.
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy
Libtayo® is a registered trademark of Regeneron.
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of
Opdivo® is a registered trademark of Bristol-Myers Squibb Company.
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 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, the potential impact of COVID-19 on our operations and milestones, 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
202.930.4762 x 409
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
|Statement of Operations|
|Research and development||$||56,754||$||38,761|
|General and administrative||23,201||17,437|
|Total operating expenses||79,955||56,198|
|Loss from operations||(79,955||)||(56,198||)|
|Other income (expense):|
|Research and development incentives||2,807||3,084|
|Interest expense on finance lease liability||(2,242||)||(1,185||)|
|Interest expense on debt obligations||(818||)||(734||)|
|Loss on extinguishment of debt||(913||)||-|
|Other (expense) income||(665||)||(16||)|
|Total other (expense) income, net||(915||)||3,573|
|Net loss attributable to common stockholders||$||(80,870||)||$||(52,625||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(1.75||)||$||(1.54||)|
|Weighted average common shares outstanding, basic and diluted||46,248,969||34,261,548|
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents and short-term investments||$||476,302||$||168,555|
|Total stockholders' equity||498,728||183,718|
Replimune Group Inc