Press Release
Replimune Reports Second Fiscal Quarter Financial Results and Provides Corporate Update
“It has been a very productive and exciting period for Replimune,” said
Recent Business Highlights and Upcoming Events
RP1 – Presented initial data from the Phase 1/2 clinical trial ofRP1 alone and in combination with Opdivo atSITC 2019. The data presented demonstrated thatRP1 used alone and in combination with Opdivo is well tolerated and showed clear anti-tumor efficacy in target tumor types that provides strong support for Replimune’s ongoing and planned development programs in melanoma and CSCC. This clinical trial is being conducted under a clinical trial collaboration and agreement withBristol Myers Squibb (BMS) for the supply of Opdivo.
RP1 – Initiated the registration-directed Phase 2 clinical trial ofRP1 in combination with Libtayo in CSCC. This multi-center, randomized, controlled clinical trial is intended to enroll approximately 240 patients with CSCC. The clinical trial’s primary objective is to compare the response rate following treatment withRP1 in combination with Libtayo to the response rate achieved with Libtayo alone. Libtayo is anFDA -approved anti-PD-1 therapy developed by Regeneron andSanofi for the treatment of patients with metastatic or locally-advanced CSCC who are not candidates for curative surgery or radiation. This clinical trial is being conducted under the Company’s collaboration agreement with Regeneron, whereby the Company and Regeneron will split equally development and supply costs. Recruitment into this clinical trial is expected to take approximately 18 to 24 months.
RP1 – Recruitment ongoing in the Phase 2 part of the Phase 1/2 trial ofRP1 in combination with Opdivo. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts of patients with melanoma, non-melanoma skin cancers, metastatic bladder cancer and microsatellite instability high (MSI-H) tumors.
- RP1 – New clinical trial planned of
RP1 as monotherapy in organ transplant recipients with CSCC. CSCC represents a significant unmet medical need in organ transplant recipients where it is the most prevalent tumor type in a population at higher risk for malignancy in general, and where anti-PD-1 therapy provides a significant risk of rejection of the transplanted organ.The U.S. Food and Drug Administration (FDA ) has accepted the protocol for this clinical trial under the Company’s previously accepted Investigational New Drug Application forRP1 . The clinical trial is intended to enroll approximately 30 patients and assess the safety and efficacy ofRP1 in liver and kidney transplant recipients with recurrent CSCC.Replimune expects to initiate the clinical trial in the first quarter of 2020.
RP1 – Additional clinical trial intended ofRP1 in combination with an anti-PD-1 therapy in anti-PD-1 refractory melanoma patients. Based on the clinical efficacy data to date withRP1 in melanoma, the Company has decided to conduct a new clinical trial ofRP1 in combination with an anti-PD-1 therapy in anti-PD-1 refectory melanoma patients. Discussions are underway to determine the particular anti-PD-1 therapy to be used. The trial is expected to begin enrollment in 2020.
RP2 – Initiation of the Phase 1 clinical trial ofRP2 alone and in combination with Opdivo.RP2 is based onRP1 but additionally expresses a genetically encoded anti-CTLA-4 antibody-like molecule. The addition of anti-CTLA-4 is intended to block the inhibition of the initiation of immune responses otherwise caused by CTLA-4. The clinical trial is designed to assess the safety, tolerability and to determine the optimal dose ofRP2 alone and in combination with Opdivo and is being conducted under a clinical trial collaboration and agreement with BMS for the supply of Opdivo.
RP3 – The Phase 1 clinical trial ofRP3 alone and in combination with an anti-PD1 therapy remains on track to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands (CD40L and 4-1BBL) in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4.
- Build-out of Replimune’s manufacturing facility to support late-stage development and commercialization remains on schedule. The 63,000-square-foot facility in
Framingham, MA is intended to provide multi-product manufacturing capabilities for Replimune’s Immulytic product candidates. The capacity of this facility will be sufficient to support full commercialization of the Company’s product candidates. An occupancy certificate for the facility has been obtained and technology transfer is underway.
Financial Highlights
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Based on its current operating plan,
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 use of cash, our advancement of our clinical trials, results of our clinical trials, our goals to develop and commercialize our product candidates, our plans to establish our own in-house manufacturing capabilities, our proposed scientific presentations, 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 establishing, equipping, and operating our planned 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, 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
Replimune Contact
617.233.6988
pamela@replimune.com
Investor Inquiries
Westwicke, an
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
917.548.1582
agoldenberg@vergescientific.com
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Research and development | $ | 8,168 | $ | 4,962 | $ | 15,625 | $ | 8,898 | ||||||||
General and administrative | 4,074 | 2,142 | 7,524 | 4,085 | ||||||||||||
Total operating expenses | 12,242 | 7,104 | 23,149 | 12,983 | ||||||||||||
Loss from operations | (12,242 | ) | (7,104 | ) | (23,149 | ) | (12,983 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Research and development incentives | 620 | (77 | ) | 1,241 | 361 | |||||||||||
Investment income | 567 | 664 | 1,254 | 891 | ||||||||||||
Interest expense | (195 | ) | - | (195 | ) | - | ||||||||||
Change in fair value of warrant liability | - | (2 | ) | - | (5,452 | ) | ||||||||||
Other income | 111 | 58 | 202 | 678 | ||||||||||||
Total other income (expense), net | 1,103 | 643 | 2,502 | (3,522 | ) | |||||||||||
Net loss | $ | (11,139 | ) | $ | (6,461 | ) | $ | (20,647 | ) | $ | (16,505 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.35 | ) | $ | (0.26 | ) | $ | (0.65 | ) | $ | (1.11 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 31,675,323 | 24,574,239 | 31,668,414 | 14,831,266 |
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
(Unaudited)
September 30, | March 31, | ||||||
2019 | 2019 | ||||||
Cash and cash equivalents | $ | 53,298 | $ | 25,704 | |||
Short-term investments | 56,581 | 109,107 | |||||
Research and development incentives receivable | 2,337 | 2,474 | |||||
Prepaid expenses and other current assets | 5,796 | 3,696 | |||||
Property, plant and equipment, net | 3,528 | 12,159 | |||||
Deferred offering costs | - | - | |||||
Research and development incentives receivable - long term | 1,212 | - | |||||
Long term prepaid rent | 15,072 | - | |||||
Right of use - operating lease | 4,873 | - | |||||
Right of use - financing lease | 7,105 | - | |||||
Restricted cash | 1,636 | 1,186 | |||||
Total assets | $ | 151,438 | $ | 154,326 | |||
Accounts payable | $ | 7,965 | $ | 7,084 | |||
Accrued expenses and other current liabilities | 3,352 | 2,801 | |||||
Deferred rent, net of current portion | - | 24 | |||||
Financing obligation | - | 6,561 | |||||
Operating lease liabilities - current | 631 | - | |||||
Financing lease liabilities - current | 34 | - | |||||
Long term debt, net of debt discount | 9,659 | - | |||||
Operating lease liabilities - non current | 4,384 | - | |||||
Financing lease liabilities - non current | 4,772 | - | |||||
Total liabilities | 30,797 | 16,470 | |||||
Total stockholders' equity (deficit) | 120,641 | 137,856 | |||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 151,438 | $ | 154,326 | |||
Source: Replimune Group Inc