Press Release
Replimune Reports Fourth Fiscal Quarter and Year 2019 Financial Results and Provides Corporate Update
“This past fiscal year has been incredibly productive for
Recent Business Highlights and Upcoming Events
RP1 – Initiated the Phase 2 part of the Phase 1/2 clinical trial ofRP1 in combination with nivolumab. In the Phase 2 part of the clinical trial,RP1 in combination with nivolumab is being tested in four 30-patient cohorts of patients with melanoma, non-melanoma skin cancers (NMSC), metastatic bladder cancer and microsatellite instability-high (MSI-H) tumors. Enrollment inthe United States and theUnited Kingdom is now open in the melanoma, NMSC and bladder cancer cohorts, and enrollment in the MSI-H cohort will open as soon as a protocol-required MSI-H patient is evaluable from Phase 1. The patients enrolled into the melanoma cohort will either be treatment naïve or have received one prior systemic therapy, including anti-PD1 and/or anti-CTLA-4 therapy, and the patients enrolled into the other three cohorts will all be naïve to anti-PD1 therapy. Efficacy and biomarker data will be evaluated within each tumor-type cohort.RP1 – Data from the Phase 1 part of the Phase 1/2 clinical trial ofRP1 alone and in combination with nivolumab is expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of this ongoing clinical trial tested single-agentRP1 by direct injection into a single superficial or nodal tumor and by imaging-guided injection into a single visceral tumor in patients with advanced heavily pre-treated cancers who have failed available therapy, with the goal of defining the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients, who have failed available therapy, then receivedRP1 at the recommended Phase 2 dose in combination with nivolumab at standard clinical doses. This clinical trial is being conducted under a clinical trial supply agreement withBristol Myers Squibb (BMS) for the supply of nivolumab.RP1 – Opening of the Phase 2 clinical trial ofRP1 in combination with cemiplimab is expected in the near term. The registration directed randomized controlled Phase 2 clinical trial will enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination withRP1 , under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy that was approved by theU.S. Food and Drug Administration (FDA ) for the treatment of locally recurrent and metastatic CSCC.RP 2 – Phase 1 clinical trial ofRP2 as a single agent and in combination with nivolumab anti-PD1 therapy anticipated to initiate in the third quarter of 2019.RP2 is a further armed oncolytic immuno-gene therapy that, in addition to expressing GALV-GP-R- and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the initiation of immune response caused by CTLA-4.RP2 is intended to be used primarily in combination with anti-PD1 or anti-PD-L1 therapy. Because of the need to address questions from regulatory authorities regarding certain Chemistry, Manufacturing, and Controls aspects ofRP2 , this clinical trial is expected to initiate one quarter later than originally anticipated. As with the clinical trial withRP1 in combination with nivolumab, this clinical trial will be conducted under a clinical trial supply agreement with BMS for the supply of nivolumab.RP3 – Phase 1 clinical trial ofRP3 as a single agent and in combination with anti-PD1 therapy to initiate in 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands in addition to the GALV-GP R- fusogenic protein and anti-CTLA-4. Following the assessment of a number of co-stimulatory pathways, which, like anti-CTLA-4, are expected to be primarily active at the site and time of anti-tumor immune response initiation, the selected immune co-stimulatory pathway activating proteins are CD40L and 4-1BBL. CD40L activates CD40, resulting in the broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137) to promote the expansion of cellular and memory immune responses.- Presented posters at
ASCO and AACR. At the 2019American Society of Clinical Oncology (ASCO ) Annual Meeting,Replimune presented a “trials in progress” poster on the Company’s Phase 1/2 clinical trial ofRP1 alone and in combination with nivolumab. A poster describing preclinical data relating to Replimune’s Immulytic platform and entitled “Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1” was presented at theAmerican Association of Cancer Research (AACR) annual meeting inMarch 2019 . Both posters are available on the Company’s website. - Build out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track and expected to be operational in the first half of 2020. In
July 2018 ,Replimune signed a lease for 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 capacity of this facility is expected to be sufficient to support full commercialization of the Company’s product candidates. The facility is expected to be operational in the first half of 2020.
Financial Highlights
Research and development expenses were
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, 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 set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended March 31, 2019. 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, an
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) | ||||||||||||||||||||
Year Ended March 31, | ||||||||||||||||||||
2019 | 2018 | 2017 | ||||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development | $ | 22,173 | $ | 13,516 | $ | 6,936 | ||||||||||||||
General and administrative | 8,773 | 5,713 | 2,711 | |||||||||||||||||
Total operating expenses | 30,946 | 19,229 | 9,647 | |||||||||||||||||
Loss from operations | (30,946 | ) | (19,229 | ) | (9,647 | ) | ||||||||||||||
Other income (expense): | ||||||||||||||||||||
Research and development incentives | 2,528 | 2,267 | 1,442 | |||||||||||||||||
Interest income | 2,585 | 288 | 25 | |||||||||||||||||
Change in fair value of warrant liability | (5,452 | ) | (972 | ) | (150 | ) | ||||||||||||||
Other income (expense), net | 451 | (2,056 | ) | 626 | ||||||||||||||||
Total other income (expense), net | 112 | (473 | ) | 1,943 | ||||||||||||||||
Net loss | (30,834 | ) | (19,702 | ) | (7,704 | ) | ||||||||||||||
Net loss attributable to common shareholders | $ | (30,834 | ) | $ | (19,702 | ) | $ | (7,704 | ) | |||||||||||
Net loss per share attributable to common shareholders, basic and diluted | $ | (1.33 | ) | $ | (3.96 | ) | $ | (1.55 | ) | |||||||||||
Weighted average common shares outstanding—basic and diluted | 23,198,400 | 4,978,539 | 4,973,439 | |||||||||||||||||
Replimune Group, Inc. | ||||||||||||||||||||
Condensed Consolidated Balance Sheets | ||||||||||||||||||||
(Amounts In thousands, except share and per share amounts) | ||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||
March 31, | ||||||||||||||||||||
2019 | 2018 | |||||||||||||||||||
Cash and cash equivalents | $ | 25,704 | $ | 17,583 | ||||||||||||||||
Short-term investments | 109,107 | 43,968 | ||||||||||||||||||
Research and development incentives receivable | 2,474 | 2,389 | ||||||||||||||||||
Prepaid expenses and other current assets | 3,696 | 763 | ||||||||||||||||||
Property, plant and equipment, net | 12,159 | 370 | ||||||||||||||||||
Restricted cash | 1,186 | 78 | ||||||||||||||||||
Total assets | $ | 154,326 | $ | 65,151 | ||||||||||||||||
Accounts payable | $ | 7,084 | $ | 1,993 | ||||||||||||||||
Accrued expenses and other current liabilities | 2,801 | 3,171 | ||||||||||||||||||
Deferred rent, net of current portion | 24 | 52 | ||||||||||||||||||
Warrant liability | - | 1,642 | ||||||||||||||||||
Lease liability | 6,561 | - | ||||||||||||||||||
Total liabilities | 16,470 | 6,858 | ||||||||||||||||||
Convertible preferred stock | - | 86,361 | ||||||||||||||||||
Total stockholders' equity (deficit) | 137,856 | (28,068 | ) | |||||||||||||||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 154,326 | $ | 65,151 | ||||||||||||||||
Source: Replimune Group Inc