Replimune Reports Fiscal First Quarter Financial Results and Provides Corporate Update
Updated complete and durable response data in
Initial data with
A broad Phase 2 program with
Cash at 30 June of
“The data we presented in June continues to demonstrate the depth and durability of responses observed with
Recent Events and Corporate Updates
- Presented data at June Virtual Investor Event that continues to indicate the durable efficacy of
RP1and RP2. During the event, Replimuneprovided a data update from the Phase 2 cohorts of RP1in combination with Opdivo in patients with melanoma and CSCC and other non-melanoma skin cancers and from the RP2Phase 1 monotherapy cohort in patients with difficult-to-treat cancers. In addition to these updates, Replimunepresented initial data with RP2in combination with Opdivo. The RP1data presented showed compelling depth and durability of response with RP1that strongly supports the ongoing studies with registrational intent in CSCC and anti-PD-1 failed melanoma. The RP2monotherapy and combination data presented also showed compelling activity in patients with immune insensitive tumors and with anti-PD-1 failed disease.
- Announced intention to initiate a development program in patients with liver metastases from various cancer types. In June, the Company announced its intention to initiate a development program for patients with liver metastases from various cancer types based on preliminary data in which durable clinical responses have been observed following treatment with
RP1in combination with Opdivo and RP2alone and in combination with Opdivo. The Company also intends to further evaluate whether RP2and/or RP3will be used in this program and present the detailed development plan in the first quarter of 2022.
RP1batches produced and filled at state-of-the-art manufacturing facility. Work to compare these batches to the contract manufactured material used in the Company’s clinical studies is ongoing. RP1batches produced and filled at the Company’s 63,000-square-foot manufacturing facility in Framingham, MA, will be released once comparability work has been completed. Technology transfer and process development work for RP2and RP3are underway in readiness for bringing the facility on-line to support all of the Company’s clinical development activities.
CERPASS – Registration directed Phase 2 clinical trial in CSCC
RP1in combination with Libtayo® (cemiplimab) in CSCC: The Company continues to actively enroll patients in CERPASS, its registration directed, global, randomized Phase 2 study of RP1in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company recently submitted an amended protocol to the U.S. Food and Drug Administration(FDA) adding complete response (CR) rate as an independent primary endpoint, in addition to overall response rate (ORR), and with a reduction in sample size from 240 patients to 180 patients. The Company expects to complete enrollment in time for the primary data read-out to be triggered in late 2022.
IGNYTE – multi cohort Phase 2 clinical trial of
- Anti-PD-1 failed melanoma cohort: The Company’s 125-patient cohort in the IGNYTE Phase 2 clinical trial of
RP1in combination with Opdivo continues to actively enroll patients. While the Company still expects to release data from this cohort in late 2022, in order to document sufficient durability of response, an important secondary endpoint of the study, the timing of the primary analysis upon which a filing is intended to be made is expected to be extended by approximately 6 months from year end 2022.
- Non-melanoma skin cancer (NMSC) cohort: The Company has enrolled 29 of the 30-patient PD-1 naïve cohort of
RP1in combination with Opdivo in non-melanoma skin cancers and continues to enroll patients with anti-PD-1 failed NMSC. The Company expects to provide initial data from the anti-PD-1 failed patients in the first quarter of 2022.
- Anti-PD(L)-1 failed non-small cell lung cancer (NSCLC) cohort: Dosing is underway in a 30-patient cohort of
RP1in combination with Opdivo in anti-PD(L)-1 failed NSCLC. A planned amendment to the IGNYTE protocol also includes modifications to the patient eligibility criteria which are expected to enhance enrollment into the trial. The Company now plans to provide initial data from this cohort in the first quarter of 2022.
- MSI-H/dMMR tumor cohort: Due to development challenges in the anti-PD-1 naïve setting, the Company has decided to not pursue
RP1with Opdivo for the treatment of anti-PD-1 naïve patients with MSI-H/dMMR tumors, but instead amend the clinical trial protocol to enroll patients with anti-PD-1 failed disease. This complements other cohorts in the clinical trial where patients with anti-PD-1 failed disease of other tumor types are being enrolled.
ARTACUS – Phase 1b/2 clinical trial of
- The Company is currently enrolling its clinical trial assessing the safety and efficacy of
RP1in liver and kidney transplant recipients with CSCC. The protocol has recently been amended to now enroll up to 65 patients with potentially registrational intent. The Company now expects to present initial data from this clinical trial in the first quarter of 2022. RP2alone and in combination with Opdivo in difficult-to-treat cancers: The Company has fully enrolled the initial 30-patient cohort evaluating RP2combined with Opdivo in difficult-to-treat cancers. The Company remains on track to provide updated data from this program in the second half of 2021. The Company intends to expand this clinical trial to provide further signal confirmation for the treatment of patients with liver metastases from various tumor types. A protocol amendment to facilitate the expansion is expected to be made in the third quarter of 2021. RP3alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial evaluating RP3alone in solid tumor patients is actively recruiting patients. Initial data from this cohort of the Phase 1 trial is now expected to be presented in the first quarter of 2022. In addition to this cohort, the Company expects to begin enrolling a cohort evaluating RP3in combination with anti-PD-1 therapy in solid tumor patients by the end of 2021, with focus on patients with lung, breast and gastrointestinal cancers including colorectal cancer. RP2and/or RP3in patients with liver metastases from a range of tumor types: Based on the observation of the clinical responses in patients with liver metastases from a range of difficult-to-treat tumor types following treatment with RP1in combination with Opdivo and RP2alone and in combination with Opdivo, the Company plans to initiate a clinical development program with RP2and/or RP3with particular focus on patients with liver metastases from a range of prevalent cancer types. The Company expects to initiate a multi-tumor type Phase 2 clinical program with RP2and/or RP3in these patients around mid-year 2022. The details of this development program, including tumor types and setting, are intended to be disclosed in first quarter of 2022.
*Program Highlight dates are on a calendar-year basis.
- Cash Position: As of June 30, 2021, cash, cash equivalents and short-term investments were $458.3 million, as compared to $476.3 million as of
March 31, 2021. This decrease was primarily related to 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, excluding any confirmatory trial required by the FDA or other regulatory body.
- R&D Expenses: Research and development expenses were $18.6 million for the first quarter ended
June 30, 2021, as compared to $12.2 million for the first quarter ended June 30, 2020. 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 $2.5 million in stock-based compensation expenses for the first quarter ended June 30, 2021.
- G&A Expenses: General and administrative expenses were $8.8 million for the first quarter ended June 30, 2021, as compared to $5.7 million for the first quarter ended June 30, 2020. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $3.8 million in stock-based compensation expenses for the first quarter ended June 30, 2021.
- Net Loss: Net loss was $27.3 million for the first quarter ended June 30, 2021, as compared to a net loss of $17.5 million for the first quarter ended June 30, 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 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, 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
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
|Three Months Ended
|Research and development||$||18,554||$||12,157|
|General and administrative||8,827||5,676|
|Total operating expenses||27,381||17,833|
|Loss from operations||(27,381||)||(17,833||)|
|Other income (expense):|
|Research and development incentives||788||686|
|Interest expense on finance lease liability||(558||)||(561||)|
|Interest expense on debt obligations||-||(284||)|
|Other (expense) income||(252||)||(28||)|
|Total other (expense) income, net||70||340|
|Net loss attributable to common stockholders||$||(27,311||)||$||(17,493||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.53||)||$||(0.44||)|
|Weighted average common shares outstanding, basic and diluted||51,910,331||39,862,319|
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents and short-term investments||$||458,331||$||476,302|
|Total stockholders' equity||479,024||498,728|
Replimune Group Inc