Replimune Reports Financial Results for the Second Fiscal Quarter, Ended September 30, and Provides Development and Corporate...
November 14 2018 - 8:00AM
U.S. Clinical Sites for Phase 1/2 Trial of RP1 in
Patients with Solid Tumors on Track to Initiate by End of Year
Replimune Group Inc. (NASDAQ: REPL), a biotechnology company
developing oncolytic immunotherapies derived from its Immulytic™
platform, today announced financial results for its second fiscal
quarter ended September 30, 2018, and provided an update on its
business.
“All of our programs are progressing to track within the
timelines outlined to investors during our July 2018 initial public
offering” said Robert Coffin, Ph.D., co-founder and CEO of
Replimune. “We were pleased to receive FDA acceptance of our IND
for RP1 this past quarter which allows us to expand enrollment of
our Phase 1/2 trial beyond the U.K. and into the U.S. by year-end
2018. In addition, we continue to make progress developing both RP2
and RP3 which will expand the potential utility of our platform
beyond the current indications and into most solid tumors.”
Recent Business Highlights and Upcoming
Events
- Investigational New Drug (IND) application for RP1
accepted by the U.S. Food and Drug Administration
(FDA). RP1 is Replimune’s first Immulytic™ product
candidate to enter the clinic and is based on a proprietary new
strain of herpes simplex virus engineered to maximize tumor killing
potency intended to result in highly immunogenic cell death and
activation of a systemic anti-tumor immune response. The accepted
IND allows Replimune to start enrolling patients in the Company’s
ongoing Phase 1/2 clinical trial in the U.S., which is expected to
occur by year-end 2018.
- Continued progress with the Phase 1/2 study of RP1 in
multiple solid tumors. Replimune’s Phase 1/2
clinical trial with RP1 is currently ongoing in the U.K. In the
first part of the clinical trial Replimune is initially testing RP1
alone and then in combination with nivolumab for safety and
biological activity in patients with advanced, heavily pre-treated
solid tumors. The combination phase of the first part of the
clinical trial is expected to be underway in the U.S. and the U.K.
by the year end. The second part of the Phase 1/2 clinical trial is
on track to begin in the first half of 2019, and will study the
safety and efficacy of RP1 in combination with nivolumab in
approximately 120 patients with metastatic melanoma, metastatic
bladder cancer, microsatellite instability high cancer, and
non-melanoma skin cancers under Replimune’s collaboration agreement
with Bristol-Myers Squibb.
- Phase 2 clinical trial of RP1 in combination with
cemiplimab remains on track to initiate in the first half of
2019. This Phase 2 trial is intended to be a
randomized, controlled clinical trial of RP1 in combination with
the anti-PD-1 antibody cemiplimab compared to cemiplimab alone, in
approximately 240 patients with cutaneous squamous cell carcinoma
(CSCC). CSCC is the highest mortality skin cancer after melanoma
and accounts for 4,000 to 9,000 annual deaths in the U.S. The
primary objective of the Phase 2 clinical trial is intended to
assess the response rate of the combination therapy compared to
treatment with anti-PD-1 therapy alone, with key secondary
endpoints expected to include the rate of complete response and the
duration of response. This clinical trial is the first to be
conducted under our collaboration with Regeneron, and has been
designed as a potentially registration-directed clinical
trial.
- Build out of Replimune’s own manufacturing facility to
support late-stage development and commercialization is on track
and expected to be operational first half of 2020.
In July 2018, Replimune signed a lease for 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 currently being built
out and expected to be operational in the first half of 2020.
- IND filing for RP2 remains on track for the first half
of 2019. The Company expects to file an IND during
the first half of 2019 with the FDA in the U.S., and/or a Clinical
Trial Authorisation (CTA) with the Medicine and Healthcare Products
Regulatory Agency (MHRA) in the U.K., in order to initiate a Phase
1 trial of RP2 and RP2 in combination with anti-PD1 therapy in
mixed solid tumors. 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 intended to block the
inhibition of the immune response otherwise caused by CTLA-4.
- RP3 product candidate to be finalized by year-end
2018. RP3 is the Company’s third oncolytic
immunotherapy and includes the properties of both RP1 and RP2 while
also expressing ligands for the various immune co-stimulatory
pathways responsible for T-cell proliferation and/or activation.
The precise payload of immune-activating ligands for RP3 is
expected to be finalized by the end of 2018, and initiation of the
Phase 1 clinical trial with RP3 remains on track for the first half
of 2020.
Financial Highlights
Replimune reported a net loss of $6.5 million for the quarter
ended September 30, 2018 compared with $4.7 million for same period
in the prior year. The increase in net loss for the year was due to
increased research and development expenses as well as expenses
related to Replimune’s initial public offering (IPO).
Research and development expenses for the quarter ended
September 30, 2018 were $5.0 million compared with $3.1 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 September 30, 2017 to 43 on September 30, 2018.
General and administrative expenses were $2.1 million for the
quarter ended September 30, 2018 compared with $1.1 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 $147.9 million in cash, cash
equivalents and short-term investments, compared with $61.6 million
as of March 31, 2018. The increase reflects net proceeds received
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 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 second quarter ended September 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 InquiriesChris BrinzeyWestwicke
Partners339.970.2843chris.brinzey@westwicke.com
Media InquiriesArleen GoldenbergVerge
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 |
|
Six Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
4,962 |
|
|
$ |
3,149 |
|
|
$ |
8,898 |
|
|
$ |
5,440 |
|
General and
administrative |
|
|
2,142 |
|
|
|
1,107 |
|
|
|
4,085 |
|
|
|
1,992 |
|
Total operating
expenses |
|
|
7,104 |
|
|
|
4,256 |
|
|
|
12,983 |
|
|
|
7,432 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(7,104 |
) |
|
|
(4,256 |
) |
|
|
(12,983 |
) |
|
|
(7,432 |
) |
Total other income
(expense), net |
|
|
643 |
|
|
|
(404 |
) |
|
|
(3,522 |
) |
|
|
(780 |
) |
Net loss |
|
$ |
(6,461 |
) |
|
$ |
(4,660 |
) |
|
$ |
(16,505 |
) |
|
$ |
(8,212 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.11 |
) |
|
$ |
(1.65 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic and diluted |
|
|
24,574,239 |
|
|
|
4,978,264 |
|
|
|
14,831,266 |
|
|
|
4,975,865 |
|
|
|
|
|
|
|
|
|
|
Replimune Group,
Inc.Condensed Consolidated Balance
Sheets(Amounts In thousands, except share and per
share amounts)(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
March 31, |
|
|
|
|
|
|
|
|
2018 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
23,282 |
|
$ |
17,583 |
|
Short-term
investments |
|
|
124,612 |
|
|
43,968 |
|
Research
and development incentives receivable |
|
|
2,221 |
|
|
2,389 |
|
Prepaid
expenses and other current assets |
|
|
1,752 |
|
|
763 |
|
Property,
plant and equipment, net |
|
|
420 |
|
|
370 |
|
Research
and development incentives receivable - long term |
|
|
343 |
|
|
- |
|
Restricted
cash |
|
|
1,186 |
|
|
78 |
|
Total
assets |
|
|
$ |
153,816 |
|
$ |
65,151 |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
2,072 |
|
$ |
1,993 |
|
Accrued
expenses and other current liabilities |
|
|
1,672 |
|
|
3,171 |
|
Deferred
rent, net of current portion |
|
|
36 |
|
|
52 |
|
Warrant
liability |
|
|
- |
|
|
1,642 |
|
Total
liabilities |
|
|
3,780 |
|
|
6,858 |
|
Convertible
preferred stock |
|
|
- |
|
|
86,361 |
|
Total
stockholders' equity (deficit) |
|
|
150,036 |
|
|
(28,068 |
) |
Total
liabilities, convertible preferred stock and stockholders’ equity
(deficit) |
|
$ |
153,816 |
|
$ |
65,151 |
|
|
|
|
|
|
|
|
|
|
|
|
Replimune (NASDAQ:REPL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Replimune (NASDAQ:REPL)
Historical Stock Chart
From Apr 2023 to Apr 2024