Press Release
Replimune Reports Financial Results for the First Fiscal Quarter, Ended June 30, and Provides Development and Corporate Update
Completed initial public offering raising
Entered into strategic collaboration with
Signed lease for 63,000 sq. ft. manufacturing facility
“With the completion of our successful initial public offering,
Recent Business Highlights
- The investigational new drug (IND) application for
RP1 submitted with theU.S. Food and Drug Administration (FDA ) is progressing on track.Replimune submitted an amendment to the IND in early August to include the longer-term toxicology data previously requested by theFDA and expects to receive acceptance of the IND in the U.S. in the coming months. Replimune’s Phase 1/2 clinical trial withRP1 is currently ongoing in theUnited Kingdom , andReplimune plans to open the clinical trial in the U.S. later in the year. The first part of the clinical trial is testingRP1 initially alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors, and the second part of the clinical trial will testRP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers, under Replimune’s collaboration agreement withBristol-Myers Squibb (BMS).
- Entered into a strategic collaboration with
Regeneron Pharmaceuticals . In May,Replimune entered into an open-ended agreement with Regeneron that allows for clinical development of Replimune’s Immulytic product candidates in combination with Regeneron’s cemiplimab (REGN2810), an investigational PD-1 antibody, on a 50/50 cost sharing basis. The first clinical trial under this agreement is intended to be a randomized, controlled Phase 2 clinical trial ofRP1 combined with cemiplimab compared to cemiplimab alone in cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma, and while no drugs are currentlyFDA -approved for its treatment, cemiplimab has been filed with theFDA for approval based on encouraging data with cemiplimab in this disease.
- Entered into a collaboration with BMS. In February,
Replimune entered into a collaboration agreement withBristol-Myers Squibb under which BMS will provide toReplimune , at no cost, nivolumab, its anti-PD-1 therapy, for use in combination withRP1 in the ongoing Phase 1/2 clinical trial.
- Signed an agreement for the lease of a manufacturing facility to support late-stage development and commercialization.
Replimune signed an agreement in June for the lease of a 63,000-square-foot facility inFramingham, MA where the Company intends to establish world-class, multi-product manufacturing capabilities for its Immulytic product candidates. The facility is expected to be operational in the first half of 2020.
- Continued to build a strong leadership team. In June,
Replimune appointedDieter Weinand andHyam Levitsky to the Board of Directors. Mr. Weinand is the current President ofBayer Pharmaceuticals and serves on the board ofBayer AG . Dr. Levitsky is a pioneer in immuno-oncology research with expertise in multiple areas including adoptive T cell therapies, cancer vaccines, and immunomodulatory therapies for the treatment of hematologic malignances and solid tumors, and most recently served as Chief Scientific Officer of Juno Therapeutics prior to its acquisition byCelgene Inc.
- Successfully completed an Initial Public Offering (IPO). In July, the Company completed its IPO, raising approximately
$111 million in gross proceeds, before underwriting discounts and commissions and other offering expenses.Replimune intends to use the net proceeds to fund the development of multiple product candidates derived from its Immulytic platform into and through clinical trials, fund the fit-out and commissioning of its manufacturing facility, and general corporate expenses.
Guidance on Upcoming Events
RP1 – In the second half of calendar 2018, define the dose ofRP1 intended for future use and initiate dosing ofRP1 combined with nivolumab in a cohort of 12 advanced cancer patients with a range of solid tumors, in the second part of the Phase 1 stage of the ongoing Phase 1/2 study.RP1 – In the first half of 2019, initiate dosing of approximately 120 patients withRP1 in combination with nivolumab, in four defined indications: metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers.RP1 – In the first half of 2019, initiate a randomized, controlled Phase 2 clinical trial ofRP1 in combination with cemiplimab, compared to cemiplimab alone, in approximately 240 patients with CSCC.RP2 – In the first half of 2019, file an IND with theFDA and/or a CTA with the MHRA in theUnited Kingdom .RP2 is a version ofRP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody.- In the second half of calendar 2018, finalize the
RP3 product candidate to be progressed into clinical trials.RP3 is intended to additionally express immune co-stimulatory pathway activating ligands, with the goal of activating immune co-stimulatory pathways, in addition to blocking immune co-inhibition through CTLA-4.
Financial Highlights
Research and development expenses for the quarter ended
General and administrative expenses were
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, our goals to develop and commercialize our product candidates, our plans to establish our own in-house manufacturing capabilities, 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 obtain necessary funding, 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 set forth under the heading “Risk Factors” of our Quarterly Report on Form 10-Q for the first quarter ended June 30, 2018. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Replimune Contact
617.233.6988
pamela@replimune.com
Investor Inquiries
Westwicke Partners
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
917.548.1582
agoldenberg@vergescientific.com
Replimune Group, Inc. Condensed Consolidated Statements of Operations (Amounts in thousands, except share and per share amounts) (Unaudited) |
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Three Months Ended | ||||||||
June 30, | ||||||||
2018 | 2017 | |||||||
Operating expenses: | ||||||||
Research and development | $3,936 | $2,291 | ||||||
General and administrative | 1,943 | 885 | ||||||
Total operating expenses | 5,879 | 3,176 | ||||||
Loss from operations | (5,879) | (3,176) | ||||||
Total other income (expense), net | (4,165) | (376) | ||||||
Net loss | $ (10,044) | $ (3,552) | ||||||
Net loss per share attributable to common stockholders, basic and diluted | $ (2.02) | $ (0.71) | ||||||
Weighted average common shares outstanding, basic and diluted | 4,981,227 | 4,973,439 |
Replimune Group, Inc. Condensed Consolidated Balance Sheets (Amounts In thousands, except share and per share amounts) (Unaudited) |
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June 30, | March 31, | |||||||
2018 | 2018 | |||||||
Cash and cash equivalents | $12,910 | $17,583 | ||||||
Short-term investments | 39,119 | 43,968 | ||||||
Research and development incentives receivable | 2,251 | 2,389 | ||||||
Prepaid expenses and other current assets | 944 | 763 | ||||||
Property, plant and equipment, net | 443 | 370 | ||||||
Deferred offering costs | 1,344 | - | ||||||
Research and development incentives receivable - long term | 426 | - | ||||||
Restricted cash | 1,856 | 78 | ||||||
Total assets | $59,293 | $65,151 | ||||||
Accounts payable | $2,854 | $1,993 | ||||||
Accrued expenses and other current liabilities | 1,642 | 3,171 | ||||||
Deferred rent, net of current portion | 43 | 52 | ||||||
Warrant liability | 7,092 | 1,642 | ||||||
Total liabilities | 11,631 | 6,858 | ||||||
Convertible preferred stock | 86,361 | 86,361 | ||||||
Total stockholders' deficit | (38,699) | (28,068) | ||||||
Total liabilities, convertible preferred stock and stockholders’ deficit | $59,293 | $65,151 | ||||||
Source: Replimune Group Inc