Press Release
Replimune Reports Third Fiscal Quarter Financial Results and Provides Corporate Update
Data expected to be presented at an investor event in
Data updates from the completed
Initial data from the ongoing study in anti-PD1 failed NMSC and from the ARTACUS trial, a Phase 1b/2 trial of
“We are looking forward to hosting an investor event next month to present on commercial strategy and
Corporate Updates
Replimune to host an investor event inMarch 2022 . The event will review updated data from completed IGNYTE cohorts in non-melanoma skin cancer (NMSC) and melanoma. In addition, the Company intends to present initial data from the ongoing study in anti-PD1 failed NMSC and from its ARTACUS trial, a Phase 1b/2 trial ofRP1 as monotherapy in solid organ transplant recipients with skin cancer. The Company will also provide a detailed overview of itsRP2/3 program including the Phase 2 development plan.- Presented updated
RP2 data at the 2021Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting. In November, the Company presented updated interim data from its ongoing Phase 1 trial ofRP2 alone and in combination with Opdivo® (nivolumab) that demonstrated the potential clinical utility ofRP2 in patients with hard-to-treat, anti-PD1 failed cancers, including durability of response, together with biomarker data demonstrating the ability ofRP2 to turn immunologically ‘cold’ tumors ‘hot.’
Upcoming Milestones
CERPASS – Registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC)
RP1 in 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) evaluatingRP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment in mid-year 2022 and the trigger for the primary data analysis to be six months thereafter.
IGNYTE – Multi-cohort Phase 2 clinical trial of
- Anti-PD-1 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 expects to release initial directional data from this cohort in late 2022.
- Non-melanoma skin cancer (NMSC) cohort: The Company continues to enroll patients with anti-PD-1 failed NMSC. The Company expects to provide initial data from this cohort in the first quarter of 2022.
- Anti-PD(L)-1 failed non-small cell lung cancer (NSCLC) cohort: Enrollment is open in a 30-patient cohort of RP1 in combination with Opdivo in anti-PD(L)-1 failed NSCLC patients, with initial data expected to be released in late 2022.
ARTACUS – Phase 1b/2 clinical trial of
- Enrollment continues in this 65-patient clinical trial with potential registrational intent, assessing the safety and efficacy of
RP1 in organ transplant recipients with skin cancer. The Company expects to present initial data from this clinical trial in the first quarter of 2022.
RP2 alone and in combination with Opdivo in difficult-to-treat cancers: The Company has initiated the expansion of the Phase 1 clinical trial ofRP2 in combination with Opdivo, with a focus on patients with liver metastases from various prevalent tumor types including patients with lung, breast and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.RP3 alone and in combination with Opdivo: The Company is enrolling patients in a Phase 1 clinical trial forRP3 , with initial data expected to be released in the first quarter of 2022. The Company expects to start enrolling patients to be treated withRP3 in combination with Opdivo this quarter, including patients with various prevalent tumor types such as lung, breast, head and neck cancer and gastrointestinal cancers. The Company expects to release initial expansion patient data in late 2022.RP2 and/orRP3 next stage development including in patients with liver metastases from a range of tumor types: The Company remains on track to initiate a broad Phase 2 clinical development program withRP2 and/orRP3 , intended to include a range of prevalent tumor types, including in patients with liver metastases, around mid-year 2022. Details of this plan remain on track to be presented in the first quarter of 2022.
Financial Highlights
- Cash Position: As of December 31, 2021, cash, cash equivalents and short-term investments were $420.2 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 the Company’s expanded clinical development plan.
Based on the current operating plan, Replimune believes that existing cash, 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 $19.4 million for the third quarter ended
December 31, 2021 , as compared to $14.3 million for the third quarter endedDecember 31, 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 $1.8 million in stock-based compensation expenses for the third quarter ended December 31, 2021. - G&A Expenses: General and administrative expenses were $10.3 million for the third quarter ended December 31, 2021, as compared to $6.0 million for the third quarter ended December 31, 2020. The increase was primarily driven by personnel-related costs, including sales and marketing personnel associated with pre-launch planning and initial build of the Company's commercial infrastructure. General and administrative expenses included $4.1 million in stock-based compensation expenses for the third quarter ended December 31, 2021.
- Net Loss: Net loss was $29.7 million for the third quarter ended December 31, 2021, as compared to a net loss of $21.8 million for the third quarter ended December 31, 2020.
About CERPASS
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
About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of
About
About
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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, our upcoming investor event, 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
Investor Inquiries
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
202.930.4762 x 409
lsteele@vergescientific.com
Condensed Consolidated Statements of Operations | ||||||||||||||||||||||
(Amounts in thousands, except share and per share amounts) | ||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||
Three Months Ended |
Nine Months Ended |
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2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||
Research and development | $ | 19,353 | $ | 14,322 | $ | 57,809 | $ | 40,529 | ||||||||||||||
General and administrative | 10,345 | 5,953 | 28,517 | 17,242 | ||||||||||||||||||
Total operating expenses | 29,698 | 20,275 | 86,326 | 57,771 | ||||||||||||||||||
Loss from operations | (29,698 | ) | (20,275 | ) | (86,326 | ) | (57,771 | ) | ||||||||||||||
Other income (expense): | ||||||||||||||||||||||
Research and development incentives | 733 | 550 | 2,246 | 1,991 | ||||||||||||||||||
Investment income | 87 | 116 | 259 | 821 | ||||||||||||||||||
Interest expense on finance lease liability | (555 | ) | (560 | ) | (1,670 | ) | (1,683 | ) | ||||||||||||||
Interest expense on debt obligations | - | (247 | ) | - | (817 | ) | ||||||||||||||||
Loss on extinguishment of debt | - | (913 | ) | - | (913 | ) | ||||||||||||||||
Other (expense) income | (241 | ) | (454 | ) | (849 | ) | (999 | ) | ||||||||||||||
Total other (expense) income, net | 24 | (1,508 | ) | (14 | ) | (1,600 | ) | |||||||||||||||
Net loss | $ | (29,674 | ) | $ | (21,783 | ) | $ | (86,340 | ) | $ | (59,371 | ) | ||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.57 | ) | $ | (0.44 | ) | $ | (1.66 | ) | $ | (1.34 | ) | ||||||||||
Weighted average common shares outstanding, basic and diluted | 52,319,877 | 49,382,213 | 52,104,548 | 44,436,680 | ||||||||||||||||||
Condensed Consolidated Balance Sheets | ||||||||||||||||
(Amounts In thousands, except share and per share amounts) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
2021 | 2021 | |||||||||||||||
Consolidated Balance Sheet Data: | ||||||||||||||||
Cash, cash equivalents and short-term investments | $ | 420,172 | $ | 476,302 | ||||||||||||
Working capital | 409,504 | 469,200 | ||||||||||||||
Total assets | 485,282 | 543,098 | ||||||||||||||
Total stockholders' equity | 437,509 | 498,728 |
Replimune Group Inc