Full Press Release Details
Replimune Reports Fiscal Second Quarter
Financial Results and Provides Corporate Update
RP1: Updated deep and durable response
data with Opdivo in CSCC and anti-PD1 failed melanoma continue to support ongoing registration-directed development
RP2: Single agent deep and durable responses
in heavily pre-treated patients with immune insensitive tumor-types demonstrates the potential of the platform to become the second
cornerstone of immune-based cancer treatments
RP3: Regulatory clearance to initiate
Phase 1 clinical development obtained
Raised gross proceeds of approximately
$287 million through October upsized public offering; strengthened balance sheet allows for additional clinical
trials, initial build of commercial infrastructure
Woburn, MA, November 5, 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 second quarter ended September 30, 2020 and provided a business update.
"In October, we released clinical data with our second
product candidate, RP2, demonstrating durable single agent responses in heavily pre-treated patients with immune insensitive tumor
types that provides validation of our platform," said Philip Astley-Sparke, CEO of Replimune. "We also presented updated
data for RP1 in combination with Opdivo in melanoma and non-melanoma skin cancers that continues to improve upon our recent June update
in terms of depth and durability of response, and supports our two registration-directed clinical programs in both cutaneous squamous
cell carcinoma and anti-PD1 failed melanoma. Following a successful follow-on offering in October, we are well-financed to advance
and expand our pipeline of product candidates and to fund the initial build of our commercial infrastructure with many exciting
milestones ahead. In particular, we look forward to initiating clinical development with RP3 as we seek to establish our products
more broadly beyond immune-responsive tumor types, as a cornerstone of immune-based cancer treatments."
Recent Events and Corporate Updates
The Company has been selected to participate in the SITC 2020
Virtual Press Conference being held on Monday, November 9, 2020 at 7:45 AM ET where the principal investigator will discuss the
Company's poster titled "An Open-label, multicenter, Phase 1/2 clinical trial of RP1, an enhanced potency oncolytic
HSV, combined with nivolumab: Updated results from the skin cancer cohorts".
Financial Highlights
company closed on an offering of common stock and pre-funded warrants raising approximately $287 million in gross proceeds and
received aggregate net proceeds of approximately $270 million after deducting underwriting discounts, commissions, and other offering
expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock.
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
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
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 our expectations about the appointment of a new director, our expectation about the timing of the release of product from our
manufacturing facility 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 SEC. 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 | Six Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 14,050 | $ | 8,168 | $ | 26,207 | $ | 15,625 | ||||||||
| General and administrative | 5,613 | 4,074 | 11,289 | 7,524 | ||||||||||||
| Total operating expenses | 19,663 | 12,242 | 37,496 | 23,149 | ||||||||||||
| Loss from operations | (19,663 | ) | (12,242 | ) | (37,496 | ) | (23,149 | ) | ||||||||
| Other income: | ||||||||||||||||
| Research and development incentives | 755 | 620 | 1,441 | 1,241 | ||||||||||||
| Investment income | 178 | 567 | 705 | 1,254 | ||||||||||||
| Interest expense on finance lease liability | (562 | ) | (195 | ) | (1,123 | ) | (195 | ) | ||||||||
| Interest expense on debt obligations | (286 | ) | - | (570 | ) | - | ||||||||||
| Other income | (517 | ) | 111 | (545 | ) | 202 | ||||||||||
| Total other income, net | (432 | ) | 1,103 | (92 | ) | 2,502 | ||||||||||
| Net loss attributable to common stockholders | $ | (20,095 | ) | $ | (11,139 | ) | $ | (37,588 | ) | $ | (20,647 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.35 | ) | $ | (0.90 | ) | $ | (0.65 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 44,015,786 | 31,675,323 | 41,950,401 | 31,668,414 |
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share
and per share amounts)
| September 30, | March 31, | |||||||
| 2020 | 2020 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 244,646 | $ | 168,555 | ||||
| Working capital | 239,449 | 162,377 | ||||||
| Total assets | 314,244 | 234,097 | ||||||
| Total stockholders' equity | 261,390 | 183,718 |