Loading, Please Wait...
Completed initial public offering raising $111 million in total gross proceeds
Entered into strategic collaboration with Regeneron Pharmaceuticals
Signed lease for 63,000 sq. ft. manufacturing facility
WOBURN, Mass., Aug. 30, 2018 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ:REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic™ platform, today announced financial results for its first fiscal quarter ended June 30, 2018, and provided an update on its business.
“With the completion of our successful initial public offering, Replimune is well funded to advance our new generation of oncolytic immunotherapy product candidates derived from our Immulytic platform through clinical trials in multiple tumor types and to establish in-house manufacturing capabilities,” said Robert Coffin, Ph.D., co-founder and CEO of Replimune. “We are pleased with the preparations underway to initiate clinical studies under our collaboration agreements with Bristol-Myers Squibb, entered in February, for the development of RPI in combination with the anti-PD-1 antibody nivolumab, and with Regeneron, entered in May, for the development of RP1 in combination with the anti-PD1 antibody cemiplimab. We were also pleased to enter an agreement for the lease of a manufacturing site in Framingham, MA where we intend to produce supplies for later-stage clinical development and ultimate commercialization of our product candidates.”
Recent Business Highlights
Guidance on Upcoming Events
Replimune reported a net loss of $10.0 million for the quarter ended June 30, 2018 compared with $3.6 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses, change in fair value of warrant liability, as well as expenses related to Replimune’s IPO.
Research and development expenses for the quarter ended June 30, 2018 were $3.9 million compared with $2.3 million for 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 increased salary and related benefits costs due to the increase in employee headcount from 28 on June 30, 2017 to 36 on June 30, 2018.
General and administrative expenses were $1.9 million for the quarter ended June 30, 2018 compared with $0.9 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.
Replimune ended the quarter with $52.0 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The decrease reflected continuing expenses in the ordinary course, along with a transfer of $1.8 million to restricted cash in connection with the signing of a lease for our manufacturing facility in Framingham, MA. Following the end of the first quarter, the Company received net proceeds of $103.3 million in connection with its IPO.
Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.
Replimune Group Inc., headquartered in Woburn, MA, was founded in 2015 to develop the next generation of “oncolytic immunotherapies” 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, 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 obtain necessary funding, 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 first quarter ended June 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.
Pamela Esposito, Ph.D.
Replimune Group Inc.
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||$3,936||$2,291|
|General and administrative||1,943||885|
|Total operating expenses||5,879||3,176|
|Loss from operations||(5,879)||(3,176)|
|Total other income (expense), net||(4,165)||(376)|
|Net loss||$ (10,044)||$ (3,552)|
|Net loss per share attributable to common stockholders, basic and diluted||$ (2.02)||$ (0.71)|
|Weighted average common shares outstanding, basic and diluted||4,981,227||4,973,439|
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share amounts)
|June 30,||March 31,|
|Cash and cash equivalents||$12,910||$17,583|
|Research and development incentives receivable||2,251||2,389|
|Prepaid expenses and other current assets||944||763|
|Property, plant and equipment, net||443||370|
|Deferred offering costs||1,344||-|
|Research and development incentives receivable - long term||426||-|
|Accrued expenses and other current liabilities||1,642||3,171|
|Deferred rent, net of current portion||43||52|
|Convertible preferred stock||86,361||86,361|
|Total stockholders' deficit||(38,699)||(28,068)|
|Total liabilities, convertible preferred stock and stockholders’ deficit||$59,293||$65,151|