Full Press Release Details
Reports Fiscal Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
Woburn, MA, June 3, 2020
- Replimune Group, Inc. (NASDAQ: REPL), a biotechnology company developing a series of oncolytic immuno-gene therapies derived
from its Immulytic platform, today announced financial results for the fiscal fourth quarter and year ended March 31, 2020
and provided a business update.
"I am very pleased with
our continued progress developing our pipeline of oncolytic immuno-gene therapies. Today we released additional data with RP1
in our lead indications of cutaneous squamous cell carcinoma (CSCC) and anti-PD1 refractory cutaneous melanoma that we believe
point to a high probability of success in our registration-directed clinical trial in CSCC and our potentially registrational
cohort of patients currently being enrolled with anti-PD1 refractory melanoma. We also today announced plans to initiate
clinical development of RP1 in anti-PD1 refractory patients with non-small cell lung cancer (NSCLC)," said Philip Astley-Sparke,
CEO of Replimune. "We look forward to presenting further clinical updates from our skin cancer programs later
in the year, together with single agent safety and efficacy data and initial data in combination with Opdivo from
our ongoing Phase 1 clinical trial with our second product candidate, RP2. We believe we have established clinical proof
of principle with RP1 in immune-responsive tumor types and that we now have a solid foundation to further establish our product
candidates more universally as the second cornerstone of immune-oncology."
Recent Events and Corporate
Replimune is currently developing
three oncolytic immuno-gene therapies derived from its Immulytic platform. RP1 is Replimune's first clinical product candidate
and is based on 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 with a gene encoding the cytokine GM-CSF. RP2 is a version of RP1 that in addition to expressing GALV-GP-R and GM-CSF 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
on our current operating plan, we believe that our existing cash and cash equivalents and short-term investments along with our
debt commitments will enable us to fund our operating expenses and capital expenditure requirements through 2022.
is the second most common form of skin cancer and is estimated to be responsible for at least 7,000 deaths each year in the U.S.
It currently accounts for approximately 20% of all skin cancers in the U.S., with the number of newly diagnosed cases expected
to rise annually. When CSCC invades deeper layers of the skin or adjacent tissues, it is categorized as locally advanced. Once
it spreads to other distant parts of the body, it is considered metastatic. Libtayo
is the only approved therapy in the United
States and Brazil, and conditionally approved therapy in the European Union and Canada, for the treatment of locally advanced
Melanoma is a form of skin cancer
characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. Metastatic melanoma is
the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs. The incidence
of melanoma has been increasing steadily for the last 30 years. In the United States, 91,270 new diagnoses of melanoma and more
than 9,320 related deaths are estimated for 2018. Globally, the World Health Organization estimates that by 2035, melanoma incidence
will reach 424,102, with 94,308 related deaths. Melanoma is mostly curable when treated in its very early stages; however, survival
rates are roughly halved if regional lymph nodes are involved.
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.
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. 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, advancement of our clinical
trials, our plans to initiate new clinical trials, our goals to develop and commercialize our product candidates, our expectations
regarding commercialization of our product candidates, our expectations regarding the size of the patient populations for our
product candidates if approved for commercial use, patient enrollments in our existing and planned clinical trials and the timing
thereof, our expectations with respect to 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 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
Consolidated Statements of Operations
in thousands, except share and per share amounts)
| Year Ended March 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 38,761 | $ | 22,173 | $ | 13,516 | ||||||
| General and administrative | 17,437 | 8,773 | 5,713 | |||||||||
| Total operating expenses | 56,198 | 30,946 | 19,229 | |||||||||
| Loss from operations | (56,198 | ) | (30,946 | ) | (19,229 | ) | ||||||
| Other income: | ||||||||||||
| Research and development incentives | 3,084 | 2,528 | 2,267 | |||||||||
| Investment income | 2,424 | 2,585 | 288 | |||||||||
| Interest expense on finance lease liability | (1,185 | ) | - | - | ||||||||
| Interest expense on debt obligations | (734 | ) | - | - | ||||||||
| Change in fair value of warrant liability | - | (5,452 | ) | (972 | ) | |||||||
| Other income (expense), net | (16 | ) | 451 | (2,056 | ) | |||||||
| Total other income (expense), net | 3,573 | 112 | (473 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (52,625 | ) | $ | (30,834 | ) | $ | (19,702 | ) | |||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (1.54 | ) | $ | (1.33 | ) | $ | (3.96 | ) | |||
| Weighted average common shares outstanding- basic and diluted | 34,261,548 | 23,198,400 | 4,978,539 |
Consolidated Balance Sheets
In thousands, except share and per share amounts)
| March 31, | ||||||||
| 2020 | 2019 | |||||||
| (in thousands) | ||||||||
| Consolidated Balance Sheet Data: | ||||||||
| Cash, cash equivalents and short-term investments | $ | 168,555 | $ | 134,811 | ||||
| Working capital | 162,377 | 131,096 | ||||||
| Total assets | 234,097 | 154,326 | ||||||
| Total stockholders' equity | 183,718 | 137,856 |