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RP1: Initiated Phase 2 part of Phase 1/2 clinical trial of RP1 in combination with nivolumab in the U.S. and the U.K.
RP1: Initial Data from Phase 1 part of Phase 1/2 clinical trial expected to be presented in the fourth quarter of 2019
RP1: Randomized controlled Phase 2 clinical trial in combination with cemiplimab expected to initiate in the near term
RP2: Phase 1 clinical trial of RP2 as single agent and in combination with anti-PD1 expected to initiate in the third quarter of 2019
WOBURN, Mass., June 28, 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 fourth fiscal quarter and year ended March 31, 2019, and provided an update on its business.
“This past fiscal year has been incredibly productive for Replimune, with the advancement of several important clinical programs and a successful IPO that provides us with a solid financial foundation to continue to develop our portfolio of therapies,” said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. “We are continuing to make significant strides as we work towards delivering on the promise of our oncolytic immuno-gene therapies. Importantly, we expect to initiate our randomized controlled registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) in the near term, and to advance our second product candidate into the clinic with the initiation of a Phase 1 trial of RP2 later this year. The Phase 2 part of our clinical trial of RP1 in combination with nivolumab in four solid tumor types has also initiated, and we expect to be sharing the first set of clinical data from the Phase 1 part of the clinical trial in the fourth quarter of 2019.”
Recent Business Highlights and Upcoming Events
Replimune reported a net loss of $6.6 million for the fiscal fourth quarter, ended March 31, 2019, and a net loss of $30.8 million for the fiscal year ended March 31, 2019, as compared to a net loss of $7.1 million and net loss of $19.7 million for the comparable periods in the prior fiscal year, respectively. The increase in net losses for both periods were primarily due to an increase in research and development expenses and administrative costs associated with our operations.
Research and development expenses were $5.4 million for the fiscal fourth quarter of 2019, and $22.2 million for the year ended March 31, 2019, as compared to $4.5 million and $13.5 million for the comparable periods in the prior fiscal year, respectively. 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 increased salary and related benefits costs due to the increase in employee headcount from 44 on March 31, 2018 to 67 on March 31, 2019.
General and administrative expenses were $2.4 million for the fiscal fourth quarter of 2019, and $8.8 million for the year ended March 31, 2019, as compared to $2.5 million and $5.7 million for the comparable periods in the prior fiscal year, respectively. The increase in general and administrative expenses was primarily due to the increase in employee headcount and the impact of stock-based compensation in 2019.
Replimune ended the fiscal year with $134.8 million in cash and cash equivalents and short-term investments, compared with $141.8 million as of December 31, 2018 and $61.6 million as of March 31, 2018. The year-on-year increase reflects net proceeds received of $103.3 million (net of deferred offering costs of $9.9 million) in connection with the Company’s IPO in July 2018.
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)|
|Year Ended March 31,|
|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|
|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 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)|
|Cash and cash equivalents||$||25,704||$||17,583|
|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|
|Accrued expenses and other current liabilities||2,801||3,171|
|Deferred rent, net of current portion||24||52|
|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|