Press Release
Replimune Reports Fiscal Second Quarter Financial Results and Provides Corporate Update
Raised gross proceeds of approximately $287 million through October upsized public offering; strengthened balance sheet allows for additional clinical trials, initial build of commercial infrastructure
“In October, we released clinical data with our second product candidate,
Recent Events and Corporate Updates
- Presented updated clinical data with
RP1 combined with Opdivo in melanoma and non-melanoma skin cancer (NMSC). The updated data from the Phase 1 expansion ofRP1 in combination with Opdivo and the Phase 2 cohorts in melanoma and NMSC showed eight of eleven patients with CSCC have achieved response (5 CR) with one patient currently assessed as stable disease at their first scan who remains on treatment. Five of 16 patients (87.5% with advanced visceral disease) with anti-PD-1 failed melanoma have achieved response, four of whom had also previously failed ipilimumab. A further patient is a surgical CR remaining tumor free currently more than 5 months from surgery and a further stable disease patient remains on treatment. Further responses have been observed in angiosarcoma and in anti-PD1 failed mucosal melanoma. All responses have been durable with only one patient with CSCC and one patient with any type of melanoma having progressed after response. Treatment has continued to be well tolerated and remains ongoing in many of the patients.RP1 is an enhanced potency oncolytic immunotherapy that expresses a GALV-GP R- fusogenic protein and GM-CSF.
The Company has been selected to participate in the SITC 2020Virtual Press Conference being held onMonday, November 9, 2020 at7:45 AM ET where the principal investigator will discuss the Company’s poster titled “An Open-label, multicenter, Phase 1/2 clinical trial ofRP1 , an enhanced potency oncolytic HSV, combined with nivolumab: Updated results from the skin cancer cohorts”.
- Presented single agent data from Phase 1 trial evaluating
RP2 in heavily pre-treated patients. The data presented demonstrated compelling monotherapy clinical activity in patients with immune insensitive tumor types. Nine patients were treated with single agentRP2 . One patient (with mucoepidermoid carcinoma) has an ongoing complete response and two other patients (with uveal melanoma and esophageal cancer) have ongoing partial responses. All three of these responses are durable; ongoing at between eight and 11 months from the first dose.RP2 was observed to be well-tolerated with side effects consistent withRP1 . Following from this single agent data, enrollment of patients being treated withRP2 combined with Opdivo is currently underway.RP2 is an enhanced potency oncolytic immunotherapy which expresses an anti-CTLA-4 molecule, intended to improve on the safety and efficacy profile of systemic antibody approaches to targeting CTLA-4.
- Clinical trials authorization (CTA) accepted by the MHRA for
RP3 . The CTA forRP3 , Replimune’s third product candidate, which in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4 also expresses CD40L and 4-1BBL, has been accepted by theMedicines and Healthcare Products Regulatory Agency (MHRA) in theUnited Kingdom allowing initiation of the Phase 1 clinical trial withRP3 alone and combined with anti-PD1 therapy, which is expected to initiate by the end of 2020.RP3 , in addition to maximizing so-called Signal 1 (antigen presentation), is intended to also maximize Signal 2 (immune co-stimulation) and Signal 3 (the production of inflammatory cytokines, stimulated by CD40L and 4-1BBL). - Extended cash runway into the second half of 2024. In
October 2020 , the Company raised gross proceeds of approximately$287 million through a public offering of common stock and pre-funded warrants. The Company believes that the existing cash, cash equivalents and short-term investments atSeptember 30, 2020 , together with the proceeds raised in October, will enable the Company to conduct additional clinical trials including potentially registration-directed clinical development ofRP2 and/orRP3 , build initial commercial infrastructure, and to fund overall operations into the second half of 2024. - Announced new appointment to the Board of Directors. In October, the Company announced the appointment of
Tanya Lewis to the Board of Directors. The appointment adds deep strategic expertise in developing and executing regulatory strategies. - Completed manufacturing facility to support late-stage development and commercialization. The 63,000-square-foot state-of-the-art facility in
Framingham, MA provides multi-product manufacturing capabilities for the Company’s product candidates with sufficient capacity to support full commercialization. The facility is now fully operational and technology transfer activities forRP1 complete. GMP batch production is underway with product expected to be released for use in 2021. - COVID-19 potential impact on milestones: Enrollment into our clinical trials, such as the Company’s clinical trial of
RP1 in solid organ transplant patients with CSCC, representing a highly immunocompromised patient population, has been slower than expected, which the Company attributes to the global pandemic. As the clinical sites continue to evaluate their capacity to treat patients, the Company could see additional impact on the pace of enrollment in the final quarter of 2020 and the first half of 2021 across its clinical trial programs.
Program Highlights
RP1 in combination with Libtayo® in cutaneous squamous cell carcinoma (CSCC): The Company is actively enrolling patients into its 240-patient, registration-directed Phase 2, randomized, controlled, global clinical trial.
RP1 in combination with Opdivo in melanoma, non-melanoma skin cancers, and MSI-H/dMMR tumors: Enrollment and accrual of the initial melanoma cohort (including anti-PD1 naïve and failed patients) was completed in the first half of 2020. The Company continues to enroll into a cohort of patients with non-melanoma skin cancers which has been expanded from 30 patients to 45 to include anti-PD1 failed patients. The Company is accumulating data from the MSI-H/dMMR (anti-PD1 naïve) cohort to inform a decision as to whether to pursue MSI-H/dMMR tumors into registration-directed development in 2021.
RP1 in combination with Opdivo in anti-PD-1 failed melanoma: The Company initiated recruitment into a new registration-directed 125-patient cohort in the Phase 2 clinical trial ofRP1 in combination with Opdivo in the first half of 2020 and continues to enroll patients.
RP1 in anti-PD1 failed patients with non-small cell lung cancer (NSCLC): The Company plans to initiate the 30 patient cohort of anti-PD1 refractory patients with NSCLC to theRP1 combined with Opdivo clinical trial later this year with the first patient expected to be dosed by the end of 2020 or in early 2021.
RP1 as monotherapy in solid organ transplant recipients with CSCC: A 30 patient Phase 1b clinical trial assessing the safety and efficacy ofRP1 in liver and kidney transplant recipients with recurrent CSCC is open for enrollment.
RP2 alone and in combination with Opdivo:RP2 is being evaluated in a Phase 1 clinical trial evaluating the safety and efficacy ofRP2 alone and combined with Opdivo. Following the monotherapy phase, enrollment is currently underway in a 30-patient expansion cohort in combination with Opdivo.
RP3 alone and in combination with anti-PD-1 therapy: The Phase 1 clinical trial remains on track to be initiated in 2020.
Financial Highlights
- Cash Position: As of September 30, 2020, cash, cash equivalents and short-term investments were $244.6 million, as compared to $168.6 million as of
March 31, 2020 . This increase was primarily related to $109.5 million in net proceeds from financing activities offset by cash utilized in operating activities largely associated with advancing our expanded clinical development plan.
In October the company closed on an offering of common stock and pre-funded warrants raising approximately$287 million in gross proceeds and received aggregate net proceeds of approximately$270 million after 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.
- R&D Expenses: Research and development expenses were $14.0 million for the second quarter ended
September 30, 2020 , as compared to $8.2 million for the second quarter endedSeptember 30, 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 $1.3 million in stock-based compensation expenses for the second quarter ended September 30, 2020.
- G&A Expenses: General and administrative expenses were $5.6 million for the second quarter ended September 30, 2020, as compared to $4.1 million for the second quarter ended September 30, 2019. The increase was primarily driven by personnel-related costs, professional fees, and facility expansion. General and administrative expenses included $1.5 million in stock-based compensation expenses for the second quarter ended September 30, 2020.
- Net Loss: Net loss was $20.1 million for the second quarter ended September 30, 2020, as compared to a net loss of $11.1 million for the second quarter ended September 30, 2019.
About
About
About
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 our expectations about the appointment of a new director, our expectation about the timing of the release of product from our manufacturing facility 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
Westwicke, an
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
917.548.1582
agoldenberg@vergescientific.com
Replimune
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended | Six Months Ended | ||||||||||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Research and development | $ | 14,050 | $ | 8,168 | $ | 26,207 | $ | 15,625 | |||||||||||||||
General and administrative | 5,613 | 4,074 | 11,289 | 7,524 | |||||||||||||||||||
Total operating expenses | 19,663 | 12,242 | 37,496 | 23,149 | |||||||||||||||||||
Loss from operations | (19,663 | ) | (12,242 | ) | (37,496 | ) | (23,149 | ) | |||||||||||||||
Other income: | |||||||||||||||||||||||
Research and development incentives | 755 | 620 | 1,441 | 1,241 | |||||||||||||||||||
Investment income | 178 | 567 | 705 | 1,254 | |||||||||||||||||||
Interest expense on finance lease liability | (562 | ) | (195 | ) | (1,123 | ) | (195 | ) | |||||||||||||||
Interest expense on debt obligations | (286 | ) | - | (570 | ) | - | |||||||||||||||||
Other income | (517 | ) | 111 | (545 | ) | 202 | |||||||||||||||||
Total other income, net | (432 | ) | 1,103 | (92 | ) | 2,502 | |||||||||||||||||
Net loss attributable to common stockholders | $ | (20,095 | ) | $ | (11,139 | ) | $ | (37,588 | ) | $ | (20,647 | ) | |||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.35 | ) | $ | (0.90 | ) | $ | (0.65 | ) | |||||||||||
Weighted average common shares outstanding, basic and diluted | 44,015,786 | 31,675,323 | 41,950,401 | 31,668,414 | |||||||||||||||||||
Replimune
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
(Unaudited)
2020 | 2020 | ||||||||||||
(in thousands) | |||||||||||||
Consolidated Balance Sheet Data: | |||||||||||||
Cash, cash equivalents and short-term investments | $ | 244,646 | $ | 168,555 | |||||||||
Working capital | 239,449 | 162,377 | |||||||||||
Total assets | 314,244 | 234,097 | |||||||||||
Total stockholders' equity | 261,390 | 183,718 | |||||||||||
Source: Replimune Group Inc