Replimune Reports Financial Results for the Second Fiscal Quarter, Ended September 30, and Provides Development and Corporate Update
U.S. Clinical Sites for Phase 1/2 Trial of
Additional Product Candidates
“All of our programs are progressing to track within the timelines outlined to investors during our
Recent Business Highlights and Upcoming Events
- Investigational New Drug (IND) application for
RP1accepted by the U.S. Food and Drug Administration( FDA). RP1is Replimune’s first Immulytic™ product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency intended to result in highly immunogenic cell death and activation of a systemic anti-tumor immune response. The accepted IND allows Replimuneto start enrolling patients in the Company’s ongoing Phase 1/2 clinical trial in the U.S., which is expected to occur by year-end 2018.
- Continued progress with the Phase 1/2 study of
RP1in multiple solid tumors. Replimune’s Phase 1/2 clinical trial with RP1is currently ongoing in the U.K.In the first part of the clinical trial Replimuneis initially testing RP1alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors. The combination phase of the first part of the clinical trial is expected to be underway in the U.S. and the U.K.by the year end. The second part of the Phase 1/2 clinical trial is on track to begin in the first half of 2019, and will study the safety and efficacy of RP1in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatellite instability high cancer, and non-melanoma skin cancers under Replimune’s collaboration agreement with Bristol-Myers Squibb.
- Phase 2 clinical trial of
RP1in combination with cemiplimab remains on track to initiate in the first half of 2019. This Phase 2 trial is intended to be a randomized, controlled clinical trial of RP1in combination with the anti-PD-1 antibody cemiplimab compared to cemiplimab alone, in approximately 240 patients with cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma and accounts for 4,000 to 9,000 annual deaths in the U.S. The primary objective of the Phase 2 clinical trial is intended to assess the response rate of the combination therapy compared to treatment with anti-PD-1 therapy alone, with key secondary endpoints expected to include the rate of complete response and the duration of response. This clinical trial is the first to be conducted under our collaboration with Regeneron, and has been designed as a potentially registration-directed clinical trial.
- Build out of Replimune’s own manufacturing facility to support late-stage development and commercialization is on track and expected to be operational first half of 2020. In
July 2018, Replimunesigned a lease for a 63,000-square-foot facility in Framingham, MAwhere the Company intends to establish world-class multi-product manufacturing capabilities for its Immulytic product candidates. The facility is currently being built out and expected to be operational in the first half of 2020.
- IND filing for
RP2remains on track for the first half of 2019. The Company expects to file an IND during the first half of 2019 with the FDAin the U.S., and/or a Clinical Trial Authorisation (CTA) with the Medicine and Healthcare Products Regulatory Agency(MHRA) in the U.K., in order to initiate a Phase 1 trial of RP2and RP2in combination with anti-PD1 therapy in mixed solid tumors. RP2is a version of RP1that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody intended to block the inhibition of the immune response otherwise caused by CTLA-4. RP3product candidate to be finalized by year-end 2018. RP3is the Company’s third oncolytic immunotherapy and includes the properties of both RP1and RP2while also expressing ligands for the various immune co-stimulatory pathways responsible for T-cell proliferation and/or activation. The precise payload of immune-activating ligands for RP3is expected to be finalized by the end of 2018, and initiation of the Phase 1 clinical trial with RP3remains on track for the first half of 2020.
Research and development expenses for the quarter ended
General and administrative expenses were
Based on its current operating plan,
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 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 second quarter ended September 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.
Verge Scientific Communications
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share amounts)
|Three Months Ended||Six Months Ended|
|September 30,||September 30,|
|Research and development||$||4,962||$||3,149||$||8,898||$||5,440|
|General and administrative||2,142||1,107||4,085||1,992|
|Total operating expenses||7,104||4,256||12,983||7,432|
|Loss from operations||(7,104||)||(4,256||)||(12,983||)||(7,432||)|
|Total other income (expense), net||643||(404||)||(3,522||)||(780||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.26||)||$||(0.94||)||$||(1.11||)||$||(1.65||)|
|Weighted average common shares outstanding, basic and diluted||24,574,239||4,978,264||14,831,266||4,975,865|
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|September 30,||March 31,|
|Cash and cash equivalents||$||23,282||$||17,583|
|Research and development incentives receivable||2,221||2,389|
|Prepaid expenses and other current assets||1,752||763|
|Property, plant and equipment, net||420||370|
|Research and development incentives receivable - long term||343||-|
|Accrued expenses and other current liabilities||1,672||3,171|
|Deferred rent, net of current portion||36||52|
|Convertible preferred stock||-||86,361|
|Total stockholders' equity (deficit)||150,036||(28,068||)|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||153,816||$||65,151|
Source: Replimune Group Inc