Replimune Reports Fiscal Second Quarter Financial Results and Provides Corporate Update
Cash at 30 September of
“Replimune continues to build towards a data rich 2022 where we are expecting to reach multiple inflection points culminating in the primary data analysis trigger for our registration-directed randomized controlled clinical trial with
Recent Events and Corporate Updates
Replimuneto present three ‘Trial-In-Progress’ posters and a poster including new data with RP2at the 2021 Society for Immunotherapyof Cancer’s (SITC) 36th Annual Meeting. The Company is scheduled to present four posters at SITC being held November 10-14, 2021. Included in these posters will be a data update from its 30-patient Phase 1 clinical trial evaluating RP2alone and combined with Opdivo in difficult-to-treat cancers.
CERPASS – Registration directed Phase 2 clinical trial in CSCC
RP1in combination with Libtayo® (cemiplimab) in CSCC: The Company is actively enrolling patients in CERPASS, its registration directed, global, randomized controlled Phase 2 clinical trial of RP1in combination with Libtayo vs. Libtayo alone in 180 patients with advanced CSCC. The Company expects to complete enrollment such that the primary data analysis is expected to be triggered in late 2022.
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 continues to expect to release interim data from this cohort in late 2022 but, as previously disclosed, in order to document sufficient durability of response, an important secondary endpoint of the study, the primary analysis is expected to be triggered in mid-year 2023.
- Non-melanoma skin cancer (NMSC) cohort: The Company has completed enrollment of 30-patients with anti-PD-1 naïve NMSC and continues to enroll patients with anti-PD-1 failed NMSC. The Company remains on track to provide updated data from the anti-PD1 naïve patients and 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 RP1 in combination with Opdivo in anti-PD(L)-1 failed NSCLC. A recently filed amendment to the IGNYTE protocol includes modifications to the patient eligibility criteria which are expected to enhance enrollment into this cohort of the clinical trial. The Company had planned to provide initial data from this cohort in the first quarter of 2022. However, the changes made to facilitate enrollment are not expected to take effect in time to meet prior guidance and initial data is now expected to be released later in 2022.
ARTACUS – Phase 1b/2 clinical trial of
- The Company continues to enroll patients in this 65-patient clinical trial, with potential registrational intent, assessing the safety and efficacy of
RP1in liver and kidney transplant recipients with skin cancers, including CSCC. The Company remains on track 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 remains on track to provide a data update from the Phase 1 clinical trial in patients treated as monotherapy with RP2and RP2combined with Opdivo at SITC in the fourth quarter of 2021. The Company has filed an amendment to expand this trial to, in particular, provide data in patients with liver metastases from various prevalent tumor types with a focus on patients with lung, breast and gastrointestinal cancers including colorectal cancer. RP3alone and in combination with anti-PD-1 therapy: The Company is enrolling patients in its Phase 1 clinical trial with RP3, with initial monotherapy data expected to be presented in the first quarter of 2022. The Company expects to start enrolling patients to be treated with RP3in combination with anti-PD-1 therapy early in the new year, including patients with liver metastases from various prevalent tumor types such as lung, breast, head and neck cancer and gastrointestinal cancers including colorectal cancer. RP2and/or RP3next stage development with focus on patients with liver metastases from a range of tumor types: The Company remains on track to initiate a broad clinical development program with RP2and/or RP3, intended to include a range of prevalent tumor types with focus on patients with liver metastases, around mid-year 2022. Details of this plan are intended to be presented in the first quarter of 2022.
*Program Highlight dates are on a calendar-year basis.
- Cash Position: As of September 30, 2021, cash, cash equivalents and short-term investments were $435.8 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,
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 $19.9 million for the second quarter ended
September 30, 2021, as compared to $14.1 million for the second quarter ended September 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 $2.2 million in stock-based compensation expenses for the second quarter ended September 30, 2021.
- G&A Expenses: General and administrative expenses were $9.3 million for the second quarter ended September 30, 2021, as compared to $5.6 million for the second quarter ended September 30, 2020. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $4.1 million in stock-based compensation expenses for the second quarter ended September 30, 2021.
- Net Loss: Net loss was $29.4 million for the second quarter ended September 30, 2021, as compared to a net loss of $20.1 million for the second quarter ended September 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 the global coronavirus pandemic and the global economy 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)
|Three Months Ended
||Six Months Ended
|Research and development||$||19,902||$||14,050||$||38,456||$||26,207|
|General and administrative||9,345||5,613||18,172||11,289|
|Total operating expenses||29,247||19,663||56,628||37,496|
|Loss from operations||(29,247||)||(19,663||)||(56,628||)||(37,496||)|
|Other income (expense):|
|Research and development incentives||725||755||1,513||1,441|
|Interest expense on finance lease liability||(557||)||(562||)||(1,115||)||(1,123||)|
|Interest expense on debt obligations||-||(286||)||-||(570||)|
|Other (expense) income||(356||)||(517||)||(608||)||(545||)|
|Total other (expense) income, net||(108||)||(432||)||(38||)||(92||)|
|Net loss attributable to common stockholders||$||(29,355||)||$||(20,095||)||$||(56,666||)||$||(37,588||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.56||)||$||(0.46||)||$||(1.09||)||$||(0.90||)|
|Weighted average common shares outstanding, basic and diluted||52,081,325||44,015,786||51,962,795||41,950,401|
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|Consolidated Balance Sheet Data:|
|Cash, cash equivalents and short-term investments||$||435,771||$||476,302|
|Total stockholders' equity||457,412||498,728|
Replimune Group Inc