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RP1: Initial Data from Phase 1 part of Phase 1/2 clinical trial alone and in combination with nivolumab expected to be presented in the fourth calendar quarter of 2019
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WOBURN, Mass., Aug. 14, 2019 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, today announced financial results for its first fiscal quarter, ended June 30, 2019, and provided an update on its business.
“All programs are on track and progressing as expected,” said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. “The second half of this year will be important for Replimune, with the release of the initial Phase 1 data from our ongoing Phase 1/2 clinical trial of RP1 alone and in combination with nivolumab in the fourth quarter, the initiation of a registration-directed randomized controlled Phase 2 clinical trial in cutaneous squamous carcinoma (CSCC), and the initiation of clinical development with our second product candidate, RP2. In particular, we look forward to sharing the initial Phase 1 results with RP1 in patients with advanced solid tumors later in the year.”
Recent Business Highlights and Upcoming Events
Replimune reported a net loss of $9.5 million for the quarter ended June 30, 2019 compared with $10.0 million for the same period in the prior year.
Research and development expenses for the quarter ended June 30, 2019 were $7.5 million compared with $3.9 million for the same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as an increase in employee headcount.
General and administrative expenses were $3.5 million for the quarter ended June 30, 2019 compared with $1.9 million for the same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in employee headcount and the impact of stock-based compensation in 2019.
Replimune ended the quarter with $120.8 million in cash and cash equivalents and short-term investments, compared with $134.8 million as of March 31, 2019.
Based on its current operating plan, Replimune expects that its current cash and cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of calendar 2021.
Replimune Group Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of “oncolytic immune-gene therapies” for the treatment of cancer. Replimune is developing novel, proprietary therapeutics intended to improve the direct cancer-killing effects of selective virus replication and the potency of the immune response to the tumor antigens released. The Company’s Immulytic™ platform is designed to maximize systemic immune activation, in particular to tumor neoantigens, through robust viral-mediated immunogenic tumor cell killing and the delivery of optimal combinations of immune-activating proteins to the tumor and draining lymph nodes. The approach is expected to be highly synergistic with immune checkpoint blockade and other approaches to cancer treatment. Replimune intends to progress these therapies rapidly through clinical development in combination with other immuno-oncology products with complementary mechanisms of action. For more information, please visit www.replimune.com.
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.
Pamela Esposito, Ph.D.
Replimune Group Inc.
Westwicke, an ICR Company
Verge Scientific Communications
|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|