Full Press Release Details
Replimune Reports Fiscal First Quarter
Financial Results and Provides Corporate Update
Clinical proof of principle established
with RP1 in combination with Opdivo for the treatment of immune-responsive tumors supporting registration directed development
in CSCC and anti-PD1 refractory melanoma
Pipeline progressing; initial single
agent data with RP2 for less immune-responsive tumors expected to be presented in the fourth calendar quarter with RP3 expected
to enter the clinic by the year end
Management team strengthened with the
appointment of Andrea Pirzkall, M.D. as Chief Medical Officer
Raised gross proceeds of $115 million
through a public offering; strengthened balance sheet allows for additional studies and extension of cash runway
Woburn, MA, August 7,
2020 - Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies
derived from its Immulytic platform, today announced financial results for the fiscal first quarter ended June 30,
2020 and provided a business update.
"In the past few months,
we have made important progress in demonstrating the power of our Immulytic platform to deliver meaningful new treatment options
for a range of cancers," said Philip Astley-Sparke, CEO of Replimune. "In June, we provided an interim update
from the Phase 2 portion of the Phase 1/2 clinical trial of RP1 in combination with Opdivo, establishing clinical proof of principle
for RP1 in immune-responsive tumor types, including in patients with anti-PD1 refractory disease. In particular, we believe the
data generated bode well for our registration directed programs already underway with RP1 in CSCC and anti-PD1 refractory melanoma.
Following a successful follow-on offering, Replimune is now well-financed to advance and expand our pipeline with many exciting
milestones ahead of us. We look forward to providing an initial data readout from RP2 later this year, as well as initiating clinical
development with RP3 as we seek to establish our products more broadly, beyond immune-responsive tumor types, as a cornerstone
of immuno-oncology."
Recent Events and Corporate Updates
Replimune is currently developing
three oncolytic immuno-gene therapies derived from its Immulytic platform. The Company's first clinical product candidate,
RP1, is a proprietary new strain of herpes simplex virus armed with a gene encoding a potent fusogenic protein (GALV-GP-R), intended
to enhance tumor killing potency, immunogenic cell death and the activation of systemic anti-tumor immune responses and a gene
encoding the cytokine GM-CSF. In addition to expressing GALV-GP-R and GM-CSF, the Company's second clinical candidate, RP2,
also expresses a genetically encoded anti-CTLA-4 antibody-like molecule intended to block the inhibition of the initiation of immune
response caused by CTLA-4. RP3 is a further armed oncolytic immuno-gene therapy which additionally expresses two immune co-stimulatory
activating ligands - CD40L and 4-1BBL - together with anti-CTLA-4 and GALV-GP-R. CD40L activates CD40, with the goal
of achieving broad activation of both innate and adaptive immunity, and 4-1BBL activates 4-1BB (CD137), intended to promote
the expansion of cellular and memory immune responses.
Financial Highlights
believes that the existing cash and cash equivalents and short-term investments, along with a limited use of debt, will enable
the Company to fund additional studies and the overall operating plan to mid-2023.
RP1 is Replimune's lead Immulytic product candidate
and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency, the immunogenicity
of tumor cell death and the activation of a systemic anti-tumor immune response.
RP2 and RP3 are derivatives of RP1 that express additional proteins.
RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses a pair of optimized immune co-stimulatory pathway
ligands. These therapeutics are intended to provide targeted and potent delivery to the sites of immune response initiation in
the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target
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. Replimune'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 across
a broad range of cancers. 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 cash runway, the advancement of our clinical trials,
our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, patient enrollments in
our existing and planned clinical trials and the timing thereof, the potential impact of COVID-19 on our operations and milestones,
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 operating our 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, political and global macro factors including the
impact of the coronavirus as a global pandemic and related public health issues, and other risks as may be detailed from time to
time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities
and Exchange Commission. 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.
Westwicke, an ICR Company
Verge Scientific Communications
Replimune Group, Inc.
Condensed Consolidated Statements of
(Amounts in thousands,
except share and per share amounts)
| Three Months Ended | ||||||||
| June 30, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 12,157 | $ | 7,457 | ||||
| General and administrative | 5,676 | 3,450 | ||||||
| Total operating expenses | 17,833 | 10,907 | ||||||
| Loss from operations | (17,833 | ) | (10,907 | ) | ||||
| Other income (expense): | ||||||||
| Research and development incentives | 686 | 621 | ||||||
| Investment income | 527 | 687 | ||||||
| Interest expense on finance lease liability | (561 | ) | - | |||||
| Interest expense on debt obligations | (284 | ) | - | |||||
| Other income (expense) | (28 | ) | 91 | |||||
| Total other income (expense), net | 340 | 1,399 | ||||||
| Net loss attributable to common stockholders | $ | (17,493 | ) | $ | (9,508 | ) | ||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (0.44 | ) | $ | (0.30 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 39,862,319 | 31,661,430 |
Replimune Group, Inc.
Condensed Consolidated
(Amounts In thousands,
except share and per share amounts)
| June 30, | March 31, | |||||||
| 2020 | 2020 | |||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 261,759 | $ | 168,555 | ||||
| Working capital | 255,863 | 162,377 | ||||||
| Total assets | 329,583 | 234,097 | ||||||
| Total stockholders' equity | 277,814 | 183,718 |