Press Release
Replimune Reports Financial Results for the Third Fiscal Quarter, Ended December 31, and Provides Development and Corporate Update
Part 1 Enrollment Opened for Combination with Nivolumab in Patients with Solid Tumors in the US
Versus Cemiplimab Alone On Track to Initiate in First Half 2019
Therapy On Track to Initiate in First Half 2019
“Replimune continues to make significant progress with all of our development programs,” said
Recent Business Highlights and Upcoming Events
RP1 - Completed enrollment ofRP1 as single agent and opened enrollment of patients to be treated withRP1 in combination with nivolumab in the Phase 1 portion of the Phase 1/2 clinical trial.RP1 is Replimune’s first product candidate to enter the clinic and is based on a proprietary strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein, intended to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses, and with a gene encoding the cytokine GM-CSF. Replimune is currently testingRP1 in a two-part Phase 1/2 clinical trial ofRP1 alone and in combination with nivolumab in approximately 150 patients. In the Phase 1 portion of the Phase 1/2 clinical trial,Replimune is assessing the safety and tolerability ofRP1 administered alone in patients with advanced solid tumors followed by dosing in combination with nivolumab anti-PD1 therapy. In part 2 of the Phase 1/2 clinical trial,Replimune intends to study the safety and efficacy ofRP1 in combination with nivolumab in four cohorts of patients with melanoma, bladder cancer, microsatellite instability high cancers, and non-melanoma skin cancers. The Phase 2 portion of the clinical trial is on track to initiate in the first half of 2019. Data from the Phase 1 portion of the clinical trial (RP1 alone andRP1 combined with nivolumab) is expected to be presented at a medical conference in the second half of 2019.
RP1 - Phase 2 clinical trial ofRP1 in combination with cemiplimab remains on-track to initiate in the first half of 2019. The registration directed randomized controlled Phase 2 clinical trial is intended to enroll approximately 240 patients with cutaneous squamous cell carcinoma (CSCC) comparing treatment with cemiplimab alone to treatment in combination withRP1 , under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 drug which was approved by theU.S. Food and Drug Administration (FDA ) for the treatment of locally recurrent and metastatic CSCC in 2018.
RP 2 - Phase 1 clinical trial ofRP2 as a single agent and in combination with anti-PD1 therapy remains on-track to initiate in first half of 2019.RP2 is a version ofRP1 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.
RP3 - Phase 1 clinical trial ofRP3 as a single agent and in combination with anti-PD1 therapy remains on-track to initiate in the first half of 2020.RP3 is a further armed oncolytic immuno-gene therapy which expresses two immune co-stimulatory activating ligands. 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 selectedRP3 product candidate expresses CD40L and 4-1BBL together with anti-CTLA-4 and GALV-GP-R-. 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.
- Poster to be presented at AACR. A poster describing pre-clinical data relating to Replimune’s Immulytic™ platform and entitled “Development & characterization of a new oncolytic immunotherapy platform based on herpes simplex virus type 1” is to be presented at the
American Association of Cancer Research (AACR) annual meeting inAtlanta, Georgia ,March 29 th-April 1 st, 2019 (Abstract # 3136). The poster will be made available on the Company’s website at the time of presentation.
- 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 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, 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 Quarterly Report on Form 10-Q for the third quarter ended December 31, 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
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||||||||
December 31, | December 31, | |||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||||
Research and development | $ | 7,857 | $ | 3,573 | $ | 16,760 | $ | 9,013 | ||||||||||||||
General and administrative | 2,280 | 1,159 | 6,360 | 3,151 | ||||||||||||||||||
Total operating expenses | 10,137 | 4,732 | 23,120 | 12,164 | ||||||||||||||||||
Loss from operations | (10,137 | ) | (4,732 | ) | (23,120 | ) | (12,164 | ) | ||||||||||||||
Total other income (expense), net | 2,464 | 378 | (1,058 | ) | (690 | ) | ||||||||||||||||
Net loss | $ | (7,673 | ) | $ | (4,354 | ) | $ | (24,178 | ) | $ | (12,854 | ) | ||||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.24 | ) | $ | (0.87 | ) | $ | (1.18 | ) | $ | (2.58 | ) | ||||||||||
Weighted average common shares outstanding, basic and diluted | 31,577,313 | 4,981,227 | 20,433,580 | 4,977,659 | ||||||||||||||||||
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
(Unaudited)
December 31, | March 31, | ||||||||||||
2018 | 2018 | ||||||||||||
Cash and cash equivalents | $ | 21,052 | $ | 17,583 | |||||||||
Short-term investments | 120,751 | 43,968 | |||||||||||
Research and development incentives receivable | 1,843 | 2,389 | |||||||||||
Prepaid expenses and other current assets | 1,300 | 763 | |||||||||||
Property, plant and equipment, net | 6,055 | 370 | |||||||||||
Deferred offering costs | - | - | |||||||||||
Restricted cash | 1,186 | 78 | |||||||||||
Total assets | $ | 152,187 | $ | 65,151 | |||||||||
Accounts payable | $ | 1,501 | $ | 1,993 | |||||||||
Accrued expenses and other current liabilities | 2,307 | 3,171 | |||||||||||
Deferred rent, net of current portion | 168 | 52 | |||||||||||
Warrant liability | - | 1,642 | |||||||||||
Lease liability | 4,972 | - | |||||||||||
Total liabilities | 8,948 | 6,858 | |||||||||||
Convertible preferred stock | - | 86,361 | |||||||||||
Total stockholders' equity (deficit) | 143,239 | (28,068 | ) | ||||||||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 152,187 | $ | 65,151 | |||||||||
Source: Replimune Group Inc