Initial clinical readout from Phase
Initial clinical readout from Phase
Company reducing its workforce by approximately 75%
Exploring partnerships across portfolio, including for Lunre+Camo
“Our recently implemented re-structuring and the re-prioritization of our clinical portfolio meaningfully extends our cash runway into late 2027. We are now focused on three ongoing Phase 1 clinical trials with readouts expected in 2025: the LIONS trial evaluating our
Fourth Quarter 2024 and Recent Portfolio Highlights:
-
RP-3467: Potential best-in-class, oral Polθ ATPase/helicase inhibitor
-
Repare initiated the Phase 1 clinical trial of
RP-3467 (POLAR) in the fourth quarter of 2024, dosing patients alone and in combination with the poly-ADP ribose polymerase (PARP) inhibitor, olaparib. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity ofRP-3647 alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. -
Upcoming expected milestones:
- Q3 2025: Topline safety, tolerability and early efficacy data from the POLAR trial in monotherapy and in combination with olaparib.
-
Repare initiated the Phase 1 clinical trial of
-
RP-1664: First-in-class, oral selective PLK4 inhibitor
-
Repare is currently evaluating
RP-1664 as a monotherapy in the Phase 1 LIONS clinical trial in adult and adolescent patients with TRIM37-high solid tumors. The LIONS clinical trial is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy ofRP-1664 . -
Upcoming expected milestones:
- Q3 2025: Initiation of a Phase 1/2 expansion trial in pediatric neuroblastoma
- Q4 2025: Initial topline safety, tolerability and early efficacy data from the LIONS trial
- Mid-2026: Trial completion and final trial readout of proof-of-concept from the LIONS trial
-
Repare is currently evaluating
-
Lunresertib (
RP-6306 ) in combination with Debio 0123-
Repare is evaluating lunresertib in combination with Debio 0123, a highly selective brain-penetrant, clinical WEE1 inhibitor, in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations as part of an ongoing 50/50, cost-sharing collaboration with
Debiopharm . -
Upcoming expected milestones:
- Q2 2025: Enrollment completion of MYTHIC trial evaluating lunresertib in combination with Debio 0123 (WEE1 inhibitor).
-
Repare is evaluating lunresertib in combination with Debio 0123, a highly selective brain-penetrant, clinical WEE1 inhibitor, in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations as part of an ongoing 50/50, cost-sharing collaboration with
-
Lunresertib (
RP-6306 ) and Camonsertib (RP-3500 )-
Repare reported positive efficacy and safety data from the Phase 1 MYTHIC gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer (EC) and platinum-resistant ovarian cancer (PROC) in
December 2024 . Nearly half of patients with gynecologic cancers in the trial maintained progression-free survival (PFS) at 24 weeks, comparing favorably to PFS for current standard of care. Repare intends to seek partnering opportunities for this program as a condition to further advancement of the program into pivotal development and will not continue to develop lunresertib or camonsertib in other studies.
-
Repare reported positive efficacy and safety data from the Phase 1 MYTHIC gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase 2 dose (RP2D) in patients with endometrial cancer (EC) and platinum-resistant ovarian cancer (PROC) in
-
Other Highlights
-
Repare announced a re-alignment of resources and a re-prioritization of its clinical portfolio to focus on the continued advancement of its Phase 1 clinical programs,
RP-1664 andRP-3467 . In connection with the re-alignment, the Company is reducing its workforce by approximately 75% to extend its cash runway into late-2027.
-
Repare announced a re-alignment of resources and a re-prioritization of its clinical portfolio to focus on the continued advancement of its Phase 1 clinical programs,
Fourth Quarter and Full Year 2024 Financial Results:
-
Cash, cash equivalents and marketable securities: Cash, cash equivalents and marketable securities as of
December 31, 2024 were$152.8 million , as compared to$223.6 million as ofDecember 31, 2023 . The Company believes that its cash, cash equivalents, and marketable securities, along with the expected cost-savings from the re-alignment, are sufficient to fund its current operational plans into late-2027. -
Revenue from collaboration agreements: Revenue from collaboration agreements was nil and
$53.5 million for the three- and twelve-month periods endedDecember 31, 2024 , respectively, as compared to$13.0 million and$51.1 million for the three- and twelve-month periods endedDecember 31, 2023 , respectively. -
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were
$24.5 million and$115.9 million for the three- and twelve-month periods endedDecember 31, 2024 , respectively, as compared to$35.3 million and$133.6 million for the three- and twelve-month periods endedDecember 31, 2023 , respectively. -
General and administrative (G&A) expenses: G&A expenses were
$6.3 million and$29.7 million for the three- and twelve-month periods endedDecember 31, 2024 , respectively, as compared to$8.6 million and$33.8 million for the three- and twelve-month periods endedDecember 31, 2023 , respectively. -
Net loss: Net loss was
$28.7 million , or$0.67 per share, and$84.7 million , or$2.00 per share, in the three- and twelve-month periods endedDecember 31, 2024 , respectively, and$28.0 million , or$0.67 per share, and$93.8 million , or$2.23 per share, in the three- and twelve-month periods endedDecember 31, 2023 , respectively.
About
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in
Consolidated Balance Sheets (Unaudited)
(Amounts in thousands of |
||||||||
|
|
As of |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
84,717 |
|
|
$ |
111,268 |
|
Marketable securities |
|
|
68,074 |
|
|
|
112,359 |
|
Income tax receivable |
|
|
10,600 |
|
|
|
10,813 |
|
Other current receivables |
|
|
1,746 |
|
|
|
4,499 |
|
Prepaid expenses |
|
|
6,012 |
|
|
|
4,749 |
|
Total current assets |
|
|
171,149 |
|
|
|
243,688 |
|
Property and equipment, net |
|
|
2,294 |
|
|
|
4,215 |
|
Operating lease right-of-use assets |
|
|
1,924 |
|
|
|
3,326 |
|
Income tax receivable |
|
|
960 |
|
|
|
2,276 |
|
Other assets |
|
|
179 |
|
|
|
396 |
|
TOTAL ASSETS |
|
$ |
176,506 |
|
|
$ |
253,901 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
3,623 |
|
|
$ |
2,400 |
|
Accrued expenses and other current liabilities |
|
|
19,819 |
|
|
|
24,057 |
|
Operating lease liabilities, current portion |
|
|
1,845 |
|
|
|
2,400 |
|
Deferred revenue, current portion |
|
|
— |
|
|
|
10,222 |
|
Total current liabilities |
|
|
25,287 |
|
|
|
39,079 |
|
Operating lease liabilities, net of current portion |
|
|
88 |
|
|
|
1,010 |
|
Deferred revenue, net of current portion |
|
|
— |
|
|
|
1,730 |
|
TOTAL LIABILITIES |
|
|
25,375 |
|
|
|
41,819 |
|
Commitments and Contingencies |
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
|
||
Preferred shares, no par value per share; unlimited shares authorized as of |
|
|
— |
|
|
|
— |
|
Common shares, no par value per share; unlimited shares authorized as of |
|
|
486,674 |
|
|
|
483,350 |
|
Warrants |
|
|
10 |
|
|
|
— |
|
Additional paid-in capital |
|
|
82,191 |
|
|
|
61,813 |
|
Accumulated other comprehensive income |
|
|
54 |
|
|
|
28 |
|
Accumulated deficit |
|
|
(417,798 |
) |
|
|
(333,109 |
) |
TOTAL SHAREHOLDERS’ EQUITY |
|
|
151,131 |
|
|
|
212,082 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
176,506 |
|
|
$ |
253,901 |
|
Consolidated Statements of Operations (Unaudited)
(Amounts in thousands of |
||||||||
|
|
Year Ended
|
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Revenue: |
|
|
|
|
|
|
||
Collaboration agreements |
|
$ |
53,477 |
|
|
$ |
51,133 |
|
Operating expenses: |
|
|
|
|
|
|
||
Research and development, net of tax credits |
|
|
115,941 |
|
|
|
133,593 |
|
General and administrative |
|
|
29,680 |
|
|
|
33,764 |
|
Restructuring |
|
|
1,379 |
|
|
|
— |
|
Total operating expenses |
|
|
147,000 |
|
|
|
167,357 |
|
Loss from operations |
|
|
(93,523 |
) |
|
|
(116,224 |
) |
Other income (expense), net |
|
|
|
|
|
|
||
Realized and unrealized loss on foreign exchange |
|
|
(2 |
) |
|
|
(170 |
) |
Interest income |
|
|
10,391 |
|
|
|
13,334 |
|
Other expense, net |
|
|
(115 |
) |
|
|
(119 |
) |
Total other income, net |
|
|
10,274 |
|
|
|
13,045 |
|
Loss before income taxes |
|
|
(83,249 |
) |
|
|
(103,179 |
) |
Income tax (expense) benefit |
|
|
(1,440 |
) |
|
|
9,383 |
|
Net loss |
|
$ |
(84,689 |
) |
|
$ |
(93,796 |
) |
Other comprehensive income: |
|
|
|
|
|
|
||
Unrealized gain on available-for-sale marketable securities |
|
|
26 |
|
|
|
456 |
|
Total other comprehensive income |
|
$ |
26 |
|
|
$ |
456 |
|
Comprehensive loss |
|
$ |
(84,663 |
) |
|
$ |
(93,340 |
) |
Net loss per share attributable to common shareholders—basic and diluted |
|
$ |
(2.00 |
) |
|
$ |
(2.23 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
|
42,411,085 |
|
|
|
42,093,293 |
|
|
|
Three Months Ended
|
|
|||||
|
|
2024 |
|
|
2023 |
|
||
Key financial highlights: |
|
|
|
|
|
|
||
Revenues from collaboration agreements |
|
$ |
— |
|
|
$ |
13,047 |
|
Research and development, net of tax credits |
|
$ |
24,495 |
|
|
$ |
35,266 |
|
General and administrative |
|
$ |
6,301 |
|
|
$ |
8,648 |
|
Restructuring |
|
$ |
(148 |
) |
|
$ |
— |
|
Net loss |
|
$ |
(28,671 |
) |
|
$ |
(28,030 |
) |
Net loss per share attributable to common shareholders—basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.67 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
|
42,510,708 |
|
|
|
42,139,096 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20250303910838/en/
Executive Vice President and Chief Financial Officer
[email protected]
Source: