Replimune Reports First Fiscal Quarter Financial Results and Provides Corporate Update
“All programs are on track and progressing as expected,” said
Recent Business Highlights and Upcoming Events
RP1– Data from the Phase 1 part of the Phase 1/2 clinical trial of RP1alone and in combination with nivolumab expected to be reported at a medical conference in the fourth quarter of 2019. The Phase 1 part of the clinical trial enrolled patients with advanced heavily pre-treated cancers, who have failed available therapy. Initially, single-agent RP1was administered into a single tumor up to five times at a range of dose levels by direct injection into superficial tumors or by imaging-guided injection into deeper, including visceral, tumors. Following determination of the recommended Phase 2 dose, an expansion group of advanced cancer patients then received RP1in combination with nivolumab. The main goals of the Phase 1 part of the clinical trial were to assess safety, to determine the optimal dose to administer in combination with nivolumab in the Phase 2 portion of the study, and to gather evidence of clinical activity in line with the expected profile of RP1. This clinical trial is being conducted under a clinical trial collaboration and supply agreement with Bristol Myers Squibb(BMS) for the supply of nivolumab.
RP1– Enrollment is ongoing in the Phase 2 part of the Phase 1/2 trial of RP1in combination with nivolumab. The Phase 2 part of the clinical trial is currently enrolling 30-patient cohorts of patients with melanoma, non-melanoma skin cancers and metastatic bladder cancer. Enrollment in a fourth, microsatellite instability high (MSI-H) tumor cohort, is expected to open once a protocol-required MSI-H patient is evaluable for safety from Phase 1 (expected in September). The patients enrolled into the melanoma cohort will either be treatment naïve or have received 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– Phase 2 clinical trial of RP1in combination with cemiplimab remains on track to open in August 2019. This registration-directed randomized controlled Phase 2 clinical trial is planned to enroll approximately 240 patients with CSCC, comparing treatment with cemiplimab alone to treatment with cemiplimab in combination with RP1, under the Company’s collaboration with Regeneron. Cemiplimab is Regeneron’s anti-PD1 therapy which was approved by the U.S. Food and Drug Administration( FDA) for the treatment of locally recurrent or metastatic CSCC in 2018.
RP2– Phase 1 clinical trial of RP2as a single agent and in combination with nivolumab remains on track to initiate in the current quarter. RP2is 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. As with the clinical trial with RP1in combination with nivolumab, this clinical trial will be conducted under a clinical trial collaboration and supply agreement with BMS for the supply of nivolumab.
RP3– Phase 1 clinical trial of RP3as a single agent and in combination with anti-PD1 therapy to initiate in 2020. RP3is 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. The Phase 1 trial of RP3as a single agent and in combination with anti-PD1 therapy remains on track to be initiated in 2020.
- Paper describing the development of Replimune’s Imylytic platform published in the
Journal for Immunotherapy of Cancer(JITC). A paper describing the design, underlying characteristics and pre-clinical data for the Company’s enhanced potency oncolytic immuno-gene therapy product platform and entitled “Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1” was recently published in JITC.
- Build-out of Replimune’s manufacturing facility to support late-stage development and commercialization is on track. The 63,000-square-foot facility in
Framingham, MAis 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 and is expected to be operational in 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, 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 Group, Inc.|
|Condensed Consolidated Statements of Operations|
|(Amounts in thousands, except share and per share amounts)|
|Three Months Ended|
|Research and development||$||7,457||$||3,936|
|General and administrative||3,450||1,943|
|Total operating expenses||10,907||5,879|
|Loss from operations||(10,907||)||(5,879||)|
|Total other income (expense), net||1,399||(4,165||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.30||)||$||(2.02||)|
|Weighted average common shares outstanding, basic and diluted||31,661,430||4,981,227|
|Replimune Group, Inc.|
|Condensed Consolidated Balance Sheets|
|(Amounts In thousands, except share and per share amounts)|
|June 30,||March 31,|
|Cash and cash equivalents||$||38,364||$||25,704|
|Research and development incentives receivable||2,410||2,474|
|Prepaid expenses and other current assets||4,529||3,696|
|Property, plant and equipment, net||963||12,159|
|Research and development incentives receivable - long term||613||-|
|Long-term prepaid rent||11,901||-|
|Accrued expenses and other current liabilities||1,829||2,801|
|Lease liabilities, current||394||-|
|Total current liabilities||13,053||9,885|
|Deferred rent, net of current portion||-||24|
|Lease liabilities, non-current||336||-|
|Total stockholders' equity (deficit)||130,152||137,856|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||143,541||$||154,326|
Source: Replimune Group Inc