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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): November 7, 2023
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 November 7, 2023, Replimune
Group, Inc. (the “Company”) issued a news release announcing its financial results for the second quarter ended September 30,
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 (the “Securities Act”), 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: November 7, 2023 |
By: |
/s/ Philip Astley-Sparke |
|
|
Philip Astley-Sparke |
|
|
Chief Executive Officer |
Exhibit
99.1
Replimune
Reports Fiscal Second Quarter 2024 Financial Results and Provides Corporate Update
The
Company plans to hold a conference call in early December to provide a comprehensive RP1 skin cancer program update including:
| · | Topline
data from the CERPASS clinical trial of RP1 combined with Libtayo in cutaneous squamous cell
carcinoma |
| · | An
initial data snapshot for all 140 patients in the IGNYTE clinical trial cohort of RP1 in
anti-PD1 failed melanoma |
| · | Initial
data from the IGNYTE cohort of RP1 in anti-PD1 failed non-melanoma skin cancers |
| · | A
recap of interim data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant
recipients with skin cancer recently presented at SITC 2023 |
Woburn,
MA, November 7, 2023 – Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the
development of a novel portfolio of oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended
September 30, 2023 and provided a business update.
“We
look forward to presenting the topline data from our registration-directed CERPASS clinical trial of RP1 in combination with Libtayo
in cutaneous squamous cell carcinoma (CSCC) as well as sharing an initial snapshot from the full patient population in the IGNYTE clinical
trial cohort of RP1 combined with Opdivo in anti-PD1 failed melanoma at an investor call in a few weeks time,” said Philip Astley-Sparke,
CEO of Replimune. “We are also excited to present the design of a confirmatory study agreed with the FDA to support a potential
approval of RP1 in anti-PD1 failed melanoma via the accelerated approval pathway. For RP2 and RP3, we are continuing to see anti-tumor
activity in our Phase 1 program and look forward to providing a full update in early 2024.”
Program
Highlights & Milestones
RP1
| · | CERPASS
clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in CSCC |
| o | The
trigger for the primary analysis from the registration-directed CERPASS clinical trial occurred
in late June and data collection activities are now complete. The independent review
process is expected to complete shortly, triggering a defined process timeline to disclosure
in early December. |
| o | Assuming
positive data demonstrating overall clinical benefit, the Company plans to submit a Biologics
License Application (BLA) for RP1 in Q2 2024. |
| · | RP1
combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma |
The
Company will present initial snapshot data for all patients on its conference call in early December by which point all patients
will have had at least 6 months follow up. The Company also plans to provide a regulatory update including the design of the intended
confirmatory clinical trial to support a potential approval under the accelerated pathway. Planning for the confirmatory study is underway
to ensure it has commenced ahead of any BLA submission. The per protocol primary analysis will take place 12 months post the last patient
enrolled. Accordingly, the Company plans to submit the BLA in Q3 2024.
| · | 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, including CSCC. The
Company plans to provide a data update of the first 30 patients with at least 6 months follow
up on its conference call in early December. |
| · | 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 Merkel cell carcinoma (n=3). |
| o | The
data demonstrated an overall response rate (ORR) of 34.5% and a confirmed complete response
(CR) rate 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. |
RP2
and RP3
| · | RP2
and RP3 Phase 1 program |
| o | Accrual
in the Phase 1 program is now substantially complete. Any additional Phase 2 development
programs not already announced which are driven by data from the full Phase 1 data and other
opportunistic considerations are expected to be announced in early 2024. |
| o | The
Company will present updated 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 during a Plenary Session at the 20th Annual International Society for Melanoma
Research Congress on November 8, 2023. |
| · | RP2
and RP3 Phase 2 program |
| o | RP2
and RP3 in combination with atezolizumab and bevacizumab in third-line colorectal cancer
(CRC) |
| ■ | Two
signal finding cohorts of 30 patients each are being enrolled in collaboration with Roche.
Patients in the first cohort will be treated with atezolizumab combined with bevacizumab
and RP2 and the second cohort with atezolizumab and bevacizumab and RP3. This clinical trial
is ongoing. |
| o | RP2
and RP3 in combination with atezolizumab and bevacizumab in second-line (2L) hepatocellular
carcinoma (HCC) |
| ■ | Two
signal finding cohorts of 15 patients each will be enrolled in collaboration with Roche.
The first cohort will enroll 2L patients treated with standard of care atezolizumab combined
with bevacizumab and RP3, and the second cohort will enroll 2L patients treated with atezolizumab
combined with bevacizumab and RP2. This clinical trial has recently initiated. |
| o | RP3
in combination with standard of care therapy in squamous cell carcinoma of the head and neck
(SCCHN) |
| ■ | Initiation
has been delayed due to the global shortage of cisplatin and carboplatin. |
Corporate
Update
| · | Announced
the appointment of Emily Hill as Chief Financial Officer (CFO). Ms. Hill was most recently
CFO of the commercial stage biotech company PTC Therapeutics and has more than 15 years of
experience in the biotechnology and life sciences industry having held senior financial management
and investor relations roles at several leading public biotechnology and pharmaceutical companies. |
| · | Due
to the timing of expected data, the company will commence a quiet period on November 13,
2023 that will remain in effect until the planned conference call in early December. |
Financial
Highlights
| · | Cash
Position: As of September 30, 2023, cash, cash equivalents and short-term
investments were $496.8 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 expended clinical development plans. |
Based
on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of September 30,
2023, will enable the Company to fund operations into the second half of calendar year 2025.
| · | R&D
Expenses: Research and development expenses were $49.1 million for the
second quarter ended September 30, 2023, as compared to $28.8 million for
the second quarter ended September 30, 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 $4.4 million in
stock-based compensation expenses for the second quarter ended September 30, 2023. |
| · | S,G&A
Expenses: Selling, general and administrative expenses were $14.7 million for
the second quarter ended September 30, 2023, as compared to $12.7 million for
the second quarter ended September 30, 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 $4.7 million in stock-based compensation expenses
for the second quarter ended September 30, 2023. |
| · | Net
Loss: Net loss was $60.0 million for the second quarter ended September 30,
2023, as compared to a net loss of $43.1 million for the second quarter ended September 30,
2022. |
About
CERPASS
CERPASS
is Replimune’s registration-directed randomized, global Phase 2 clinical trial to compare the effects of Libtayo®
(cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical
trial enrolled 211 patients with locally advanced or metastatic cutaneous squamous cell carcinoma who are naïve to anti-PD-1 therapy.
The clinical trial will evaluate complete response rate and overall response rate as its two independent primary efficacy endpoints as
assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival, and overall
survival. The clinical trial is being conducted under a clinical trial collaboration agreement with Regeneron and full commercial rights
retained by Replimune. Libtayo is a registered trademark of Regeneron.
About
IGNYTE
IGNYTE
is Replimune’s multi-cohort Phase 1/2 clinical trial of RP1 in combination with Opdivo® (nivolumab). There are 3
tumor specific cohorts in this clinical trial including a cohort in anti-PD1 failed melanoma with registrational intent that has completed
enrollment with 140 patients enrolled. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical
trial of approximately 30 patients with melanoma. The additional cohorts currently enrolling and are in non-melanoma skin cancers which
includes both naïve and anti-PD1 failed CSCC, and in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors. This
trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb. Opdivo is a registered trademark of Bristol-Myers
Squibb.
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 & RP3
RP2
and RP3 are derivatives of RP1 that express additional immune-activating 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, but does not express GM-CSF. RP2
and RP3 are 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 mechanism of action (MOA) 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.
This MOA is 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 September 30, | | |
Six
Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Operating
expenses: | |
| | | |
| | | |
| | | |
| | |
Research
and development | |
$ | 49,101 | | |
$ | 28,834 | | |
$ | 89,538 | | |
$ | 58,312 | |
Selling,
general and administrative | |
| 14,730 | | |
| 12,745 | | |
| 29,941 | | |
| 24,143 | |
Total
operating expenses | |
| 63,831 | | |
| 41,579 | | |
| 119,479 | | |
| 82,455 | |
Loss
from operations | |
| (63,831 | ) | |
| (41,579 | ) | |
| (119,479 | ) | |
| (82,455 | ) |
Other
income (expense): | |
| | | |
| | | |
| | | |
| | |
Research
and development incentives | |
| 443 | | |
| 574 | | |
| 836 | | |
| 1,425 | |
Investment
income | |
| 6,049 | | |
| 1,112 | | |
| 12,235 | | |
| 1,455 | |
Interest
expense on finance lease liability | |
| (542 | ) | |
| (550 | ) | |
| (1,086 | ) | |
| (1,102 | ) |
Interest
expense on debt obligations | |
| (955 | ) | |
| - | | |
| (2,070 | ) | |
| - | |
Other
(expense) income | |
| (1,409 | ) | |
| (2,659 | ) | |
| (35 | ) | |
| (4,678 | ) |
Total
other income (expense), net | |
| 3,586 | | |
| (1,523 | ) | |
| 9,880 | | |
| (2,900 | ) |
Loss
before income taxes | |
$ | (60,245 | ) | |
$ | (43,102 | ) | |
$ | (109,599 | ) | |
$ | (85,355 | ) |
Income
tax (benefit) | |
| (201 | ) | |
| - | | |
| - | | |
| - | |
Net
loss | |
$ | (60,044 | ) | |
$ | (43,102 | ) | |
$ | (109,599 | ) | |
$ | (85,355 | ) |
Net
loss per common share, basic and diluted | |
$ | (0.90 | ) | |
$ | (0.79 | ) | |
$ | (1.65 | ) | |
$ | (1.57 | ) |
Weighted
average common shares outstanding, basic and diluted | |
| 66,582,280 | | |
| 54,770,291 | | |
| 66,475,577 | | |
| 54,492,395 | |
Replimune
Group, Inc.
Condensed
Consolidated Balance Sheets
(Amounts
In thousands, except share and per share amounts)
(Unaudited)
| |
September 30, | | |
March 31, | |
| |
2023 | | |
2023 | |
Consolidated
Balance Sheet Data: | |
| | | |
| | |
Cash,
cash equivalents and short-term investments | |
$ | 496,761 | | |
$ | 583,386 | |
Working
capital | |
| 468,343 | | |
| 558,778 | |
Total
assets | |
| 562,398 | | |
| 646,591 | |
Total
stockholders' equity | |
| 465,172 | | |
| 555,292 | |
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