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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): February 8, 2024
REPLIMUNE GROUP, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-38596 |
|
82-2082553 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification Number) |
500 Unicorn Park Drive
Suite 303
Woburn, MA 01801
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including
area code: (781) 222-9600
Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
|
REPL |
|
The Nasdaq Stock Market LLC
(Nasdaq Global Select Market) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this
chapter). Emerging growth company x
If an
emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 2.02 | Results of Operations and Financial Condition. |
On February 8, 2024,
Replimune Group, Inc. (the “Company”) issued a news release announcing its financial results for the third quarter ended
December 31, 2023 and certain corporate updates. A copy of the news release is furnished as Exhibit 99.1 to this Current Report
on Form 8-K.
In accordance with General
Instruction B.2 of Form 8-K, the information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall
not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as expressly stated by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
|
REPLIMUNE GROUP, INC. |
|
|
|
Date: February 8, 2024 |
By: |
/s/ Philip Astley-Sparke |
|
|
Philip Astley-Sparke |
|
|
Chief Executive Officer |
Exhibit 99.1
Replimune Reports
Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update
| • | Positive
data update in December 2023 for all 140 patients in the IGNYTE clinical trial cohort
of RP1 in anti-PD1 failed melanoma demonstrating durability of response |
| • | Centrally
reviewed 12-month primary analysis data from IGNYTE trial of RP1 in anti-PD1 failed melanoma
and biologics license application (BLA) submission expected in 2H 2024 |
| • | Phase
3 confirmatory trial of RP1 in anti-PD1 failed melanoma skin cancers expected to initiate
2H 2024 |
| • | Cash
runway extended to fund operations into 2H 2026 |
Woburn, MA, February 8, 2024
– Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class
of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided
a business update.
“The collective data for RP1 shows
that it has the potential to be a safe and effective treatment option for patients with a range of different skin cancers in various
treatment settings. We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024. Subsequently, we
will explore the potential for additional submissions based on the evolving data from our multiple non-melanoma skin cancer studies,”
said Philip Astley-Sparke, CEO of Replimune. “We are excited about the data we have seen to-date with RP2 including as monotherapy
in very difficult to treat tumors. Planning is underway for a clinical trial in advanced uveal melanoma as a foundational study for establishing
a rare cancer franchise. Following the decision to reprioritize our pipeline, we have extended our cash runway to fund operations into
2H 2026, leaving us well positioned to bring our lead product to market.”
Program Highlights & Milestones
RP1
| • | RP1
combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma |
| o | The Company presented initial data from
the full population enrolled into the registration directed anti-PD1 failed melanoma cohort
from the IGNYTE clinical trial in December 2023. In the full data set of 156 patients
(140 patients from the registration-directed expansion cohort and 16 anti-PD1 failed cutaneous
melanoma patients from the prior phase 2 cohort), had an overall response rate (ORR) of 31.4%
with a complete response rate (CR) of 12% showing activity consistent with the prior snapshot
of 91 patients. RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade
1-2 “on target” side effects, observed. |
| o | Following a Type C meeting with the U.S.
Food and Drug Administration (FDA), a confirmatory study design concept consisting of a 2-arm
randomized trial with physician’s choice of treatment as a comparator arm in anti-PD1
failed melanoma patients was agreed. The FDA requested that the Phase 3 confirmatory trial
be underway at the time of a BLA submission under the accelerated approval pathway. The FDA
also indicated that all patients should be followed for at least 12 months and have undergone
central review by RECIST v1.1. A BLA submission for RP1 in combination with nivolumab in
anti-PD1 failed melanoma is planned for 2H 2024. |
| • | CERPASS
clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in CSCC |
| o | Following the initial report of the primary
analysis data from the CERPASS clinical trial in December 2023, it is intended that
a further analysis of the time-based endpoints of duration of response (DOR), progression
free survival (PFS) and overall survival (OS) will be conducted when the data set has further
matured. |
| • | RP1
in solid organ transplant recipients with skin cancers |
| o | Presented initial data from the ARTACUS
clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers
at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in November 2023.
The data included 23 evaluable patients with CSCC (n=20) and MCC (n=3). |
| o | The data demonstrated an ORR of 34.8%
and a CR of 21%. |
| o | RP1 monotherapy was well tolerated, and
the safety profile was similar to non-immunocompromised patients with advanced skin cancers
(i.e. from the IGNYTE study). No immune-mediated adverse events or evidence of allograft
rejection were observed. |
| • | RP1
combined with Opdivo in anti-PD1 failed non-melanoma skin cancers (NMSC) |
| o | Recruitment remains ongoing into the
cohort of patients with anti-PD1 failed NMSC. The Company provided a data from the first
30 patients with at least 6 months of follow up including patients with CSCC, Merkel cell
carcinoma (MCC), basal cell carcinoma, and angiosarcoma in December 2023. |
| o | The data showed that treatment with RP1
in combination with nivolumab led to an ORR of 30% which is consistent with data from the
anti-PD1 failed melanoma cohort with approximately a third of patients responding and 60%
demonstrating clinical benefit. The combination of RP1 and nivolumab was well tolerated in
this patient population with a safety profile consistent with the overall experience seen
with this treatment regimen to date. |
RP2
| • | RP2
in second-line (2L) uveal melanoma |
| o | The Company presented positive safety
and efficacy data from a cohort of metastatic uveal melanoma patients enrolled in the open-label,
multicenter Phase 1 study of RP2 as a single agent and in combination with nivolumab at the
20th Annual International Society for Melanoma Research Congress on November 8, 2023. |
| o | Based on the data in this population,
planning is underway for a potentially registrational clinical trial of RP2 in advanced uveal
melanoma as a foundational study for establishing a rare cancer franchise. |
Financial Highlights
| • | Cash
Position: As of December 31, 2023, cash, cash equivalents and short-term
investments were $466.4 million, as compared to $583.4 million as of March 31,
2023. The decrease was primarily related to cash utilized in operating activities in advancing
the Company’s clinical development plans. |
Based
on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31,
2023, will enable the Company to fund operations into the second half of 2026.
| • | Debt:
As of December 31, 2023, the debt (net of discount) balance was $44.4 million,
as compared to $28.6 million as of March 31, 2023. The increase was primarily
related to the draw down of $15M in December 2023, at the time of the closing of the
second amendment to the loan and security agreement with Hercules. |
| • | R&D
Expenses: Research and development expenses were $42.8 million for the
third quarter ended December 31, 2023, as compared to $30.3 million for
the third quarter ended December 31, 2022. This increase was primarily due to increased
clinical and manufacturing expenses driven by the Company’s lead programs and increased
personnel expenses. Research and development expenses included $3.8 million in
stock-based compensation expenses for the third quarter ended December 31, 2023. |
| • | S,G&A
Expenses: Selling, general and administrative expenses were $13.7 million for
the third quarter ended December 31, 2023, as compared to $11.4 million for
the third quarter ended December 31, 2022. The increase was primarily driven by
personnel related costs, including sales and marketing personnel associated with pre-launch
planning and build of the Company’s commercial infrastructure. Selling, general and
administrative expenses included $4.5 million in stock-based compensation expenses
for the third quarter ended December 31, 2023. |
| • | Net
Loss: Net loss was $51.1 million for the third quarter ended December 31,
2023, as compared to a net loss of $39.7 million for the third quarter ended December 31,
2022. |
About RP1
RP1 is Replimune’s lead product
candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein
(GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic
anti-tumor immune response.
About RP2
RP2 is a derivative of RP1, Replimune’s
lead product candidate that is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic
protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic
anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP-R- and GM-CSF. RP2 is
intended to provide targeted and potent delivery of these proteins 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.
About Replimune
Replimune Group, Inc., headquartered
in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio
of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic
cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic
activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering
of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic
with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with
a variety of other treatment options. 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 design and advancement of
our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates,
our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the
timing thereof, 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, the availability of combination therapies needed to conduct our clinical trials, 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 the Russian-Ukrainian
and Israel-Hamas political and military conflicts, 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.
Investor Inquiries
Chris Brinzey
ICR Westwicke
339.970.2843
chris.brinzey@westwicke.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
Replimune Group, Inc.
Condensed Consolidated
Statements of Operations
(Amounts in thousands,
except share and per share amounts)
(Unaudited)
| |
Three Months Ended December 31, | | |
Nine Months Ended December 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 42,847 | | |
$ | 30,261 | | |
$ | 132,384 | | |
$ | 88,573 | |
Selling, general and administrative | |
| 13,693 | | |
| 11,369 | | |
| 43,633 | | |
| 35,512 | |
Total operating expenses | |
| 56,540 | | |
| 41,630 | | |
| 176,017 | | |
| 124,085 | |
Loss from operations | |
| (56,540 | ) | |
| (41,630 | ) | |
| (176,017 | ) | |
| (124,085 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Research and development incentives | |
| 415 | | |
| 607 | | |
| 1,251 | | |
| 2,032 | |
Investment income | |
| 5,686 | | |
| 2,675 | | |
| 17,922 | | |
| 4,130 | |
Interest expense on finance lease liability | |
| (540 | ) | |
| (548 | ) | |
| (1,626 | ) | |
| (1,650 | ) |
Interest expense on debt obligations | |
| (1,012 | ) | |
| (941 | ) | |
| (3,083 | ) | |
| (941 | ) |
Other income (expense) | |
| 1,344 | | |
| 147 | | |
| 1,307 | | |
| (4,531 | ) |
Total other income (expense), net | |
| 5,893 | | |
| 1,940 | | |
| 15,771 | | |
| (960 | ) |
Loss before income taxes | |
$ | (50,647 | ) | |
$ | (39,690 | ) | |
$ | (160,246 | ) | |
$ | (125,045 | ) |
Income tax provision | |
| 473 | | |
| - | | |
| 473 | | |
| - | |
Net loss | |
$ | (51,120 | ) | |
$ | (39,690 | ) | |
$ | (160,719 | ) | |
$ | (125,045 | ) |
Net loss per common share, basic and diluted | |
$ | (0.77 | ) | |
$ | (0.69 | ) | |
$ | (2.42 | ) | |
$ | (2.25 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 66,645,691 | | |
| 57,857,132 | | |
| 66,532,488 | | |
| 55,618,052 | |
Replimune Group, Inc.
Condensed Consolidated
Balance Sheets
(Amounts In thousands,
except share and per share amounts)
(Unaudited)
| |
December 31, | | |
March 31, | |
| |
2023 | | |
2023 | |
Consolidated Balance Sheet Data: | |
| | | |
| | |
Cash, cash equivalents and short-term investments | |
$ | 466,351 | | |
$ | 583,386 | |
Working capital | |
| 440,514 | | |
| 558,778 | |
Total assets | |
| 532,930 | | |
| 646,591 | |
Total stockholders' equity | |
| 421,537 | | |
| 555,292 | |
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Replimune (NASDAQ:REPL)
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Replimune (NASDAQ:REPL)
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