Replimune Reports Third Fiscal Quarter Financial Results and Provides Corporate Update
RP1: Initial data in new indications expected in 2021 in anti-PD1 failed NSCLC, anti-PD1 failed CSCC and CSCC solid organ transplant recipient patients; further updates expected to be provided across all studies
RP2: Initial data to be reported in 2021 in combination with Opdivo in Phase 1 all comers study
RP3: First patient dosed; initial single agent data expected to be reported in 2021
Commercial-scale facility operational; GMP manufacturing underway
“It has been a productive start to 2021,” said
- Commenced GMP Manufacturing in completed state of the art facility. The Company has completed buildout of its 63,000-square-foot state-of-the-art manufacturing facility in
Framingham, MA, which will support late-stage development and full commercialization of all of its products. GMP production is underway with the first RP1batch having been filled. RP2tech-transfer is scheduled to commence this quarter.
- Extended cash runway into the second half of 2024. In October, the company closed on an offering of common stock and pre-funded warrants raising approximately
$287 millionin gross proceeds and received aggregate net proceeds of approximately $270 millionafter deducting underwriting discounts, commissions, and other offering expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. Based on its current operating plan, Replimuneexpects that its cash, cash equivalents and short-term investments of $493.3 millionas of December 31, 2020will fund its operating expenses and capital expenditure requirements into the second half of 2024.
- Potential impact of COVID-19 on milestones: Enrollment into the Company’s clinical trials, in particular the clinical trial of
RP1in solid organ transplant patients with CSCC, which represents a highly immune-compromised patient population, has been slower than expected, which the Company attributes to the global pandemic. While mitigation plans have been and are being implemented, as the clinical trial sites continue to evaluate their capacity to enroll patients into clinical trials, the Company could see additional impact on the pace of enrollment across its clinical trial programs.
Program Highlights and Upcoming Milestones
RP1in combination with Libtayo® in CSCC: The Company is actively enrolling patients into its global registration-directed Phase 2, randomized, controlled, clinical trial. The Company remains on track to report the primary data read out in 2022. RP1in combination with Opdivo in anti-PD-1 failed melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort Phase 2 clinical trial of RP1in combination with Opdivo in the first half of 2020 and continues to enroll patients. The Company remains on track to report the primary data readout in 2022. RP1in combination with Opdivo in melanoma and non-melanoma skin cancers (NMSC): In October 2020, Replimuneprovided positive Phase 2 data updates in melanoma and NMSC which demonstrated deep and durable responses to RP1combined with Opdivo, including in anti-PD1 failed melanoma that continues to support the Company’s ongoing registration-directed development in this setting and in CSCC. Enrollment of the initial melanoma cohort (including anti-PD1 naïve and anti-PD1 failed patients) was completed in the first half of 2020 with the NMSC cohort now being expanded from 30 to 45 patients to also include 15 patients with anti-PD1 failed disease. RP1in anti-PD1 failed NSCLC: The Company has opened for recruitment a new cohort of 30 anti-PD1 failed NSCLC patients treated with RP1combined with Opdivo and expects to report initial data from this cohort 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 assessing the safety and efficacy of RP1in liver and kidney transplant recipients. Although the company recently dosed the initial patient, the study continues to be particularly impacted by COVID-19 due to the immune suppression that solid organ transplant patients receive and mitigation steps are therefore being taken to aid enrollment. Initial 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 is accumulating data from the MSI-H/dMMR (anti-PD1 naïve) cohort. Based on the data, the Company expects to be able to decide whether to pursue MSI-H/dMMR tumors into registration-directed development by the end of 2021. RP2alone and in combination with Opdivo: RP2is being evaluated in a Phase 1 clinical trial alone and combined with Opdivo in advanced solid tumor patients. In October 2020, Replimunepresented positive data from the single agent RP2portion of the clinical trial that showed deep and durable responses, including in patients with immune insensitive tumor types. Following the monotherapy phase, enrollment is currently underway in a 30-patient cohort in combination with Opdivo. Updated data from this clinical trial, including initial data with RP2in combination with Opdivo, is expected to be presented mid-year. RP3alone and in combination with anti-PD-1 therapy: Replimuneinitiated dosing in its Phase 1 clinical trial of RP3in December 2020. The Phase 1 clinical trial is designed to evaluate RP3alone and combined with anti-PD1 therapy in advanced solid tumor patients. Initial data is expected to be presented in the second half of 2021.
- Targeted evaluation for new indications is currently underway: An analysis of the solid tumor space is currently underway to define the later stage clinical development pathway initially intended for
RP2and/or RP3. This is from the perspective that RP2and RP3are intended to target less immune responsive tumor types, and follows from initial promising data having been generated with single agent RP2, including in immune non-responsive tumor types. The details of this initial development plan are intended to be announced mid-year.
- Cash Position: As of December 31, 2020, cash, cash equivalents and short-term investments were $493.3 million, as compared to $168.6 million as of
March 31, 2020. This increase was primarily related to $371.7 million in net proceeds from financing activities offset by cash utilized in operating activities largely associated with advancing our expanded clinical development plan.
- R&D Expenses: Research and development expenses were $14.3 million for the third quarter ended
December 31, 2020, as compared to $11.9 million for the third quarter ended December 31, 2019. 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 $1.5 million in stock-based compensation expenses for the third quarter ended December 31, 2020.
- G&A Expenses: General and administrative expenses were $6.0 million for the third quarter ended December 31, 2020, as compared to $4.7 million for the third quarter ended December 31, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.6 million in stock-based compensation expenses for the third quarter ended December 31, 2020.
- Net Loss: Net loss was $21.8 million for the third quarter ended December 31, 2020, as compared to a net loss of $16.2 million for the third quarter ended December 31, 2019.
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 advancement of our clinical trials, our plans to initiate new clinical trials, 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
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|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|Research and development||$||14,322||$||11,948||$||40,529||$||27,573|
|General and administrative||5,953||4,716||17,242||12,240|
|Total operating expenses||20,275||16,664||57,771||39,813|
|Loss from operations||(20,275||)||(16,664||)||(57,771||)||(39,813||)|
|Other income (expense):|
|Research and development incentives||550||951||1,991||2,192|
|Interest expense on finance lease liability||(560||)||(834||)||(1,683||)||(1,029||)|
|Interest expense on debt obligations||(247||)||-||(817||)||-|
|Loss on extinguishment of debt||(913||)||-||(913||)||-|
|Other income (expense)||(454||)||(192||)||(999||)||10|
|Total other income (expense), net||(1,508||)||475||(1,600||)||2,977|
|Net loss attributable to common stockholders||$||(21,783||)||$||(16,189||)||$||(59,371||)||$||(36,836||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.44||)||$||(0.46||)||$||(1.34||)||$||(1.13||)|
|Weighted average common shares outstanding, basic and diluted||49,382,213||34,877,944||44,436,680||32,742,148|
|Condensed Consolidated Balance Sheets|
|(Amounts In thousands, except share and per share amounts)|
|Consolidated Balance Sheet Data:
|Cash, cash equivalents and short-term investments||$||493,272||$||168,555|
|Total stockholders' equity||516,195||183,718|
Replimune Group Inc