Replimune Reports Fiscal Fourth Quarter and Year-Ended 2022 Financial Results and Provides Corporate Update
Enrollment in the CERPASS clinical trial with
Directional data from the first 75 patents with 6 months follow up from the IGNYTE clinical trial with
Phase 2 development plan for
“We have ended the fiscal year in a very strong position from which to execute on our vision to establish our products as a cornerstone of immuno-oncology regimens and we look forward with these firm foundations in place to a potentially transformative 12-month period ahead,” said
- Provided data update for
RP1in its skin cancer programs at a virtual investor event in March 2022.
- IGNYTE anti-PD1 naïve NMSC cohort of patients treated with
RP1combined with Opdivo® (nivolumab) (n=32; recruitment complete): The overall response rate (ORR) in CSCC increased to 65%, compared to 60% at the June 2021update with the complete response rate (CRR) unchanged at 47%. Updated response rates in BCC, MCC and angiosarcoma were 25%, 75% and 67% respectively with multiple complete responses documented, indicating the potential utility of RP1in additional NMSCs beyond CSCC.
- IGNYTE anti-PD1 failed and anti-PD1 naïve melanoma cohort of patients treated with
RP1combined with Opdivo (n=36; recruitment complete): The ORR in anti-PD1 naïve cutaneous melanoma remained at 62.5%. The ORR in cutaneous melanoma patients who had previously failed anti-PD1 or both anti-PD1 and anti-CTLA-4 (n=16) was reported to have risen to 37.5%, an improvement from the 31% ORR reported in the June 2021update, including two complete responses.
- IGNYTE anti-PD(L)-1 failed NMSC cohort of patients treated with
RP1combined with Opdivo (n=12; recruitment ongoing): The initial early ORR data in this group was 33.3% with responses having been observed in anti-PD(L)-1 failed CSCC, MCC and angiosarcoma, including one complete response as of the cutoff date. Other patients who remain on study with a shorter follow up also showed tumor shrinkage. The Company believes the clear activity of RP1combined with Opdivo in anti-PD(L)-1 failed NMSC represents a new potential therapeutic option for these patients and supports the broader potential for RP1in skin cancers, including those with anti-PD(L)-1 failed disease.
- Phase 1b/2 ARTACUS clinical trial of
RP1monotherapy in solid organ transplant recipients with skin cancer (n=6; recruitment ongoing): Initial data with RP1monotherapy in solid organ transplant patients demonstrated a similar safety profile to that observed in patients who are not immune suppressed, with initial clinical activity having been seen. Two of the first six patients enrolled (33%) had so far achieved a response, with one complete response and one partial response.
- IGNYTE anti-PD1 naïve NMSC cohort of patients treated with
- Provided detailed strategy and clinical development plan for
RP2/3at a virtual investor event in March 2022.
- The Phase 2 development plan for
RP2/3is intended to target tumor types in large underserved markets, including where liver metastases are common, as well as patients with primary liver cancer, and patients with early disease where the objective of treatment would be to increase the rate of cure. This includes the development of RP2/3in combination with current standards of care (SOC), including immunotherapy, chemotherapy and radiation, and in settings following the current SOC.
The following indications for signal finding single arm Phase 2 clinical trials were identified which meet these criteria:
- Locally advanced (LA) and 1L recurrent SCCHN in combination with chemoradiation, or SOC chemotherapy and anti-PD1 therapy, respectively. The Company’s objective is to also expedite the initiation of a randomized controlled registration directed program in LA SCCHN.
- 1L and 2L hepatocellular carcinoma (HCC) in combination with SOC immunotherapy and anti-PD1/L1 therapy respectively.
- 3L micro-satellite stable colorectal cancer (CRC) in combination with anti-PD1 therapy.
- Additional signal finding work is also intended in other indications.
RP2/3Phase 2 program is expected to initiate around the calendar year end.
- The decision as to whether
RP2or RP3will be used in these clinical trials will be made later in the calendar year, following generation and analysis of further clinical data with RP2and RP3in their respective ongoing Phase 1 clinical trials.
- The Phase 2 development plan for
CERPASS – Registration-directed Phase 2 clinical trial in CSCC
RP1in combination with Libtayo® (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 with top line data expected to be available in Q1 2023.
IGNYTE – Multi-cohort Phase 2 clinical trial of
- Anti-PD1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical trial in patients with anti-PD1 failed melanoma. The Company continues to expect to report initial directional data from the first 75 patient with six months follow up in late 2022.
RP2alone and in combination with Opdivo in difficult-to-treat cancers: After fully enrolling patients in the RP2monotherapy (n=9) and combination with Opdivo (n=30) cohorts in the Phase 1 clinical trial with RP2(data presented in Nov 2020and Nov 2021), a further cohort of Phase 1 patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer and uveal melanoma) was opened, with the first patients having been enrolled and from which initial data is expected towards the end of the year. RP3alone and in combination with Opdivo in difficult-to-treat cancers: The Company completed enrollment in the initial part of its Phase 1 clinical trial with RP3alone. Following determination of the recommended Phase 2 dose (RP2D), enrollment into the cohort of patients dosed with RP3combined with Opdivo has recently commenced. This cohort will focus on enrolling patients with GI cancers, breast cancer, lung cancer and head and neck cancer. Initial data for this combination cohort is expected towards the end of the year. Additional patients will also be dosed as monotherapy.
- Cash Position: As of March 31, 2022, cash, cash equivalents and short-term investments were $395.7 million, as compared to $476.3 million as of March 31, 2021. The decrease was primarily related to cash utilized in operating activities in advancing the Company’s 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 $21.7 million for the fourth quarter and $79.5 million for the fiscal year ended March 31, 2022, as compared to $16.2 million for the fourth quarter and $56.8 million for the fiscal year ended March 31, 2021. 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 $2.1 million in stock-based compensation expenses for the fourth quarter and $8.6 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.
- S,G&A Expenses: Selling, general and administrative expenses were $10.3 million for the fourth quarter and $38.8 million for the fiscal year ended March 31, 2022, as compared to $6.0 million for the fourth quarter and $23.2 million for the year ended March 31, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and the initial build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $3.7 million in stock-based compensation expenses for the fourth quarter and $15.7 million in stock-based compensation expenses for the fiscal year ended March 31, 2022.
- Net Loss: Net loss was $31.7 million for the fourth quarter and $118.0 million for the fiscal year ended March 31, 2022, as compared to a net loss of $21.5 million for the fourth quarter and $80.9 million for the fiscal year ended March 31, 2021.
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
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, 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)
|Research and development||$||79,545||$||56,754|
|Selling, general and administrative||38,769||23,201|
|Total operating expenses||118,314||79,955|
|Loss from operations||(118,314||)||(79,955||)|
|Other income (expense):|
|Research and development incentives||3,170||2,807|
|Interest expense on finance lease liability||(2,223||)||(2,242||)|
|Interest expense on debt obligations||-||(818||)|
|Loss on extinguishment of debt||-||(913||)|
|Other (expense) income||(1,059||)||(665||)|
|Total other income (expense), net||278||(915||)|
|Net loss attributable to common stockholders||$||(118,036||)||$||(80,870||)|
|Net loss per common share, basic and diluted||$||(2.26||)||$||(1.75||)|
|Weighted average common shares outstanding, basic and diluted||52,212,269||46,248,969|
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents and short-term investments||$||395,655||$||476,302|
|Total stockholders' equity||411,229||498,728|
Replimune Group Inc