Replimune Reports Financial Results for the First Fiscal Quarter, Ended June 30, and Provides Development and Corporate Updat...
August 30 2018 - 8:00AM
Completed initial public offering raising $111
million in total gross proceeds
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
- The investigational new drug (IND) application for RP1
submitted with the U.S. Food and Drug Administration (FDA) is
progressing on track. Replimune submitted an amendment to
the IND in early August to include the longer-term toxicology data
previously requested by the FDA and expects to receive acceptance
of the IND in the U.S. in the coming months. Replimune’s Phase 1/2
clinical trial with RP1 is currently ongoing in the United Kingdom,
and Replimune plans to open the clinical trial in the U.S. later in
the year. The first part of the clinical trial is testing RP1
initially alone and then in combination with nivolumab for safety
and biological activity in patients with advanced, heavily
pre-treated solid tumors, and the second part of the clinical trial
will test RP1 in combination with nivolumab in approximately 120
patients with metastatic melanoma, metastatic bladder cancer,
microsatelite instability high cancer, and non-melanoma skin
cancers, under Replimune’s collaboration agreement with
Bristol-Myers Squibb (BMS).
- Entered into a strategic collaboration with Regeneron
Pharmaceuticals. In May, Replimune entered into an
open-ended agreement with Regeneron that allows for clinical
development of Replimune’s Immulytic product candidates in
combination with Regeneron’s cemiplimab (REGN2810), an
investigational PD-1 antibody, on a 50/50 cost sharing basis. The
first clinical trial under this agreement is intended to be a
randomized, controlled Phase 2 clinical trial of RP1 combined with
cemiplimab compared to cemiplimab alone in cutaneous squamous cell
carcinoma (CSCC). CSCC is the highest mortality skin cancer after
melanoma, and while no drugs are currently FDA-approved for its
treatment, cemiplimab has been filed with the FDA for approval
based on encouraging data with cemiplimab in this disease.
- Entered into a collaboration with BMS. In
February, Replimune entered into a collaboration agreement with
Bristol-Myers Squibb under which BMS will provide to Replimune, at
no cost, nivolumab, its anti-PD-1 therapy, for use in combination
with RP1 in the ongoing Phase 1/2 clinical trial.
- Signed an agreement for the lease of a manufacturing
facility to support late-stage development and
commercialization. Replimune signed an agreement in June
for the lease of a 63,000-square-foot facility in Framingham, MA
where the Company intends to establish world-class, multi-product
manufacturing capabilities for its Immulytic product candidates.
The facility is expected to be operational in the first half of
2020.
- Continued to build a strong leadership
team. In June, Replimune appointed Dieter Weinand
and Hyam Levitsky to the Board of Directors. Mr. Weinand is the
current President of Bayer Pharmaceuticals and serves on the board
of Bayer AG. Dr. Levitsky is a pioneer in immuno-oncology
research with expertise in multiple areas including adoptive T cell
therapies, cancer vaccines, and immunomodulatory therapies for the
treatment of hematologic malignances and solid tumors, and most
recently served as Chief Scientific Officer of Juno Therapeutics
prior to its acquisition by Celgene Inc.
- Successfully completed an Initial Public Offering
(IPO). In July, the Company completed its IPO,
raising approximately $111 million in gross proceeds, before
underwriting discounts and commissions and other offering
expenses. Replimune intends to use the net proceeds to fund
the development of multiple product candidates derived from its
Immulytic platform into and through clinical trials, fund the
fit-out and commissioning of its manufacturing facility, and
general corporate expenses.
Guidance on Upcoming Events
- RP1 – In the second half of calendar 2018, define the dose of
RP1 intended for future use and initiate dosing of RP1 combined
with nivolumab in a cohort of 12 advanced cancer patients with a
range of solid tumors, in the second part of the Phase 1 stage of
the ongoing Phase 1/2 study.
- RP1 – In the first half of 2019, initiate dosing of
approximately 120 patients with RP1 in combination with nivolumab,
in four defined indications: metastatic melanoma, metastatic
bladder cancer, microsatelite instability high cancer, and
non-melanoma skin cancers.
- RP1 – In the first half of 2019, initiate a randomized,
controlled Phase 2 clinical trial of RP1 in combination with
cemiplimab, compared to cemiplimab alone, in approximately 240
patients with CSCC.
- RP2 – In the first half of 2019, file an IND with the FDA
and/or a CTA with the MHRA in the United Kingdom. RP2 is a version
of RP1 that, in addition to expressing a fusogenic protein and
GM-CSF, also expresses a genetically encoded anti-CTLA-4
antibody.
- In the second half of calendar 2018, finalize the RP3 product
candidate to be progressed into clinical trials. RP3 is intended to
additionally express immune co-stimulatory pathway activating
ligands, with the goal of activating immune co-stimulatory
pathways, in addition to blocking immune co-inhibition through
CTLA-4.
Financial Highlights
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.
About Replimune
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.
Replimune ContactPamela Esposito,
Ph.D.Replimune Group Inc.617.233.6988pamela@replimune.com
Investor Inquiries Chris BrinzeyWestwicke
Partners339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen Goldenberg Verge
Scientific
Communications917.548.1582agoldenberg@vergescientific.com
|
Replimune Group, Inc.Condensed
Consolidated Statements of
Operations (Amounts in thousands, except
share and per share
amounts) (Unaudited) |
|
|
|
Three Months Ended |
|
|
June 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
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)(Unaudited) |
|
|
|
June 30, |
|
March 31, |
|
|
|
2018 |
|
|
|
2018 |
|
|
|
|
|
|
Cash and cash
equivalents |
|
$12,910 |
|
|
$17,583 |
|
Short-term
investments |
|
|
39,119 |
|
|
|
43,968 |
|
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 |
|
|
|
- |
|
Restricted cash |
|
|
1,856 |
|
|
|
78 |
|
Total assets |
|
$59,293 |
|
|
$65,151 |
|
|
|
|
|
|
Accounts payable |
|
$2,854 |
|
|
$1,993 |
|
Accrued expenses and
other current liabilities |
|
|
1,642 |
|
|
|
3,171 |
|
Deferred rent, net of
current portion |
|
|
43 |
|
|
|
52 |
|
Warrant liability |
|
|
7,092 |
|
|
|
1,642 |
|
Total liabilities |
|
|
11,631 |
|
|
|
6,858 |
|
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 |
|
|
|
|
|
|
|
|
|
|
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