Full Press Release Details
Reports Third Fiscal Quarter Financial Results and Provides
Initial data in new indications expected in 2021 in anti-PD1 failed NSCLC, anti-PD1 failed CSCC and CSCC solid organ transplant
recipient patients; further updates expected to be provided across all studies
data to be reported in 2021 in combination with Opdivo in Phase 1 all comers study
patient dosed; initial single agent data expected to be reported in 2021
facility operational; GMP manufacturing underway
Woburn, MA, February 4, 2021
- 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 third quarter ended December 31, 2020 and provided
"It has been a productive
start to 2021," said Philip Astley-Sparke, Chief Executive Officer of Replimune. "We started the current quarter with
the news that dosing has commenced with our third product candidate, RP3, which like RP2 is intended to treat tumor types that
are not traditionally thought of as immune-responsive'. The later stage clinical development pathway for these programs
is currently being defined. We continue to enroll into our two registration-directed clinical trials with RP1 in cutaneous squamous
cell carcinoma (CSCC), the "CERPASS" study, and anti-PD1 failed melanoma, the "IGNYTE" study, and commercial
planning activities are underway. We also expect to start dosing RP1 combined with Opdivo in anti-PD1 failed non-small cell
lung cancer (NSCLC) patients and anti-PD1 failed CSCC patients at approximately the quarter end and look forward to releasing
data on all our product candidates during the course of 2021."
Program Highlights and Upcoming
Financial Highlights
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 through the
expression of a GALV-GP R- fusogenic protein and GM-CSF.
RP2 and RP3 are derivatives of
RP1 that express additional proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune
co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 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 toxicity.
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 as well as in standalone indications. 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.
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Consolidated Statements of Operations
in thousands, except share and per share amounts)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 14,322 | $ | 11,948 | $ | 40,529 | $ | 27,573 | ||||||||
| General and administrative | 5,953 | 4,716 | 17,242 | 12,240 | ||||||||||||
| Total operating expenses | 20,275 | 16,664 | 57,771 | 39,813 | ||||||||||||
| Loss from operations | (20,275 | ) | (16,664 | ) | (57,771 | ) | (39,813 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Research and development incentives | 550 | 951 | 1,991 | 2,192 | ||||||||||||
| Investment income | 116 | 550 | 821 | 1,804 | ||||||||||||
| Interest expense on finance lease liability | (560 | ) | (834 | ) | (1,683 | ) | (1,029 | ) | ||||||||
| Interest expense on debt obligations | (247 | ) | - | (817 | ) | - | ||||||||||
| Loss on extinguishment of debt | (913 | ) | (913 | ) | - | |||||||||||
| Other income (expense) | (454 | ) | (192 | ) | (999 | ) | 10 | |||||||||
| Total other income (expense), net | (1,508 | ) | 475 | (1,600 | ) | 2,977 | ||||||||||
| Net loss attributable to common stockholders | $ | (21,783 | ) | $ | (16,189 | ) | $ | (59,371 | ) | $ | (36,836 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.44 | ) | $ | (0.46 | ) | $ | (1.34 | ) | $ | (1.13 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 49,382,213 | 34,877,944 | 44,436,680 | 32,742,148 |
Consolidated Balance Sheets
In thousands, except share and per share amounts)
| December 31, | March 31, | |||||||
| 2020 | 2020 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 493,272 | $ | 168,555 | ||||
| Working capital | 486,410 | 162,377 | ||||||
| Total assets | 559,198 | 234,097 | ||||||
| Total stockholders' equity | 516,195 | 183,718 |