About Us | ScientistRPTX Repare Therapeutics Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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RP-3500
Solid tumors
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
RP-6306
Solid tumors
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Phase 1
Phase 1
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Phase 1 initiation of dosing announced May 3, 2021.
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Latest News
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Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today announced that members of its senior management team will participate in a fireside chat at the 42nd Annual Goldman Sachs Virtual Global Healthcare Conference on Wednesday, June 9 at 3:50 p.m. Eastern Time.
A live webcast of the fireside chat can be accessed in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 30 days.
About Repare Therapeutics Inc.
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company's pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor currently in Phase 1/2 clinical development, its second clinical candidate, RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development, a Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210602005095/en/
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Introduced PKMYT1 as synthetic-lethal target for tumors with CCNE1 amplification or FBXW7 loss and highlighted program progress at RP-6306 Virtual Investor Day Event
Announced enrollment of first patient in RP-6306 Phase 1 clinical trial
Activated 10 clinical trial sites across North America and Europe for the PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial
Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today reported financial results for the first quarter ended March 31, 2021.
"We have advanced the Phase 1/2 clinical development of our ATR inhibitor RP-3500, with initial results expected from the monotherapy arm of the trial in the second half of 2021. The PARP inhibitor and RP-3500 combination arm is now recruiting," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We are pleased that the first patient has been dosed in our Phase 1 clinical trial of RP-6306, materially ahead of the timeline we disclosed at the time of our IPO last June."
First Quarter 2021 Review and Operational Updates:
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Highlighted program progress and introduced PKMYT1 as synthetic-lethal target to CCNE1 and FBXW7 at RP-6306 Virtual Investor Day Event.
- In April 2021, the Company highlighted pre-clinical anti-tumor activity of RP-6306, a potential first-in-class small molecule product candidate targeting PKMYT1, which is synthetic lethal with CCNE1 amplification, FBXW7 loss, and potentially other genomic alterations.
-
Announced enrollment of first patient in RP-6306 Phase 1 clinical trial.
- In April 2021, the Company dosed the first patient in its Phase 1 clinical trial of RP-6306.
- The trial (NCT04855656) is expected to enroll approximately 60 patients with recurrent tumors characterized by genomic alterations predicted by the Company's SNIPRx® CRISPR-based platform to be sensitive to RP-6306.
- The trial objectives include assessment of safety, tolerability, dose and schedule (including the establishment of a recommended Phase 2 dose).
- Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022 targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other undisclosed alterations identified through its proprietary STEP2 screen.
- Prospective enrichment of patient trial populations will be guided by the Company's ongoing efforts to develop patient selection, target engagement and functional biomarkers.
-
Initiated patient recruitment of PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial.
- Repare has activated 10 clinical trial sites across North America and Europe, and is actively recruiting patients to evaluate RP-3500 in a combination arm with Pfizer's PARP inhibitor, talazoparib, in addition to a monotherapy arm.
- Initial results are expected to be reported from the monotherapy arm of the trial in the second half of 2021.
First Quarter 2021 Financial Results:
- Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of March 31, 2021 were $319.1 million.
- Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $16.5 million and $8.6 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in R&D expenses year-over-year was primarily due to increases in development costs related to the Company's RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including stock-based compensation, and certain other R&D expenses.
- General and administrative (G&A) expenses: G&A expenses were $5.2 million and $2.2 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in G&A expenses year-over-year was due to increases in personnel related costs, including stock-based compensation, and D&O insurance which increased as a result of the Company's transition to a public company.
- Net loss: Net loss was $21.4 million, or $0.58 per share in the quarter ended March 31, 2021 and $12.6 million, or $7.71 per share, in the quarter ended March 31, 2020.
About Repare Therapeutics' SNIPRx® Platform
Repare's SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company's therapies based on the genetic profile of their tumors. Repare's platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company's pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor currently in Phase 1/2 clinical development, its second clinical candidate, RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development, a Polθ inhibitor program, as well as eight other early-stage, pre-clinical programs. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are "forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the clinical development of the Company's pipeline and its research and development programs, including the anticipated timing, anticipated patient enrollment, trial outcomes or associated costs of its clinical trials of RP-3500 and RP-6306; and the Company's ability to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 4, 2021. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Repare Therapeutics Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(Amounts in thousands of U.S. dollars, except share data)
As of
March 31,As of
December 31,2021
2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
311,399
$
326,184
Marketable securities
7,497
7,526
Research and development tax credits receivable
2,263
2,011
Other receivables
3,169
4,153
Prepaid expenses
3,882
6,678
Total current assets
328,210
346,552
Property and equipment, net
4,466
3,948
Restricted cash
215
212
Operating lease right-of-use assets
4,303
4,674
Other assets
288
288
Deferred tax assets
1,586
1,412
TOTAL ASSETS
$
339,068
$
357,086
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable
$
3,352
$
2,251
Accrued expenses and other current liabilities
6,389
5,975
Operating lease liability, current portion
568
697
Deferred revenue, current portion
2,081
2,073
Income tax payable
30
18
Total current liabilities
12,420
11,014
Operating lease liability, net of current portion
3,235
3,308
Deferred revenue, net of current portion
55,760
55,934
TOTAL LIABILITIES
71,415
70,256
SHAREHOLDERS' EQUITY
Preferred shares, no par value per share; unlimited shares authorized
as of March 31, 2021 and December 31, 2020, respectively; 0 shares issued
and outstanding as of March 31, 2021 and December 31, 2020, respectively
—
—
Common shares, no par value per share; unlimited shares authorized as of
March 31, 2021 and December 31, 2020; 36,990,710 and 36,902,924 shares
issued and outstanding as of March 31, 2021, and December 31, 2020,
respectively
384,610
384,313
Additional paid-in capital
7,818
5,875
Accumulated deficit
(124,775
)
(103,358
)
Total shareholders' equity
267,653
286,830
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
$
339,068
$
357,086
Repare Therapeutics Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(Amounts in thousands of U.S. dollars, except share and per share data)
Three Months Ended
March 31,2021
2020
Revenue:
Collaboration agreements
$
166
$
—
Operating expenses:
Research and development, net of tax credits
16,509
8,632
General and administrative
5,237
2,183
Total operating expenses
21,746
10,815
Loss from operations
(21,580
)
(10,815
)
Other income (expense), net
Realized and unrealized loss on foreign exchange
(31
)
(1,731
)
Interest income
64
—
Other expense
(7
)
(2
)
Total other income (expense), net
26
(1,733
)
Loss before income taxes
(21,554
)
(12,548
)
Income tax recovery (expense)
137
(53
)
Net loss and comprehensive loss
$
(21,417
)
$
(12,601
)
Net loss attributable to common shareholders—basic and diluted
$
(21,417
)
$
(12,601
)
Net loss per share attributable to common shareholders— basic and diluted
$
(0.58
)
$
(7.71
)
Weighted-average common shares outstanding—basic and diluted
36,916,734
1,634,056
View source version on businesswire.com: https://www.businesswire.com/news/home/20210513006011/en/
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Highlighted program progress and introduced PKMYT1 as synthetic-lethal target to CCNE1 and FBXW7 at RP-6306 Virtual Investor Day Event.
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Closed IPO and Raised $144 Million in Gross Proceeds to Fund Targeted Oncology Therapies
IND Submissions for Lead Targeted Oncology Program, IK-930, and BMS-partnered program, IK-412, Remain on Track for Second Half of 2021
Ikena Oncology, Inc. (NASDAQ:IKNA), a targeted oncology company focused on developing therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced financial results for the quarter ended March 31, 2021.
"This first quarter marked important milestones for Ikena, both with our entrance into the public markets and the advances we have made across our pipeline. We continued to progress our clinical development programs and our lead targeted oncology program is on track for an IND submission in the second half of the year," said Mark Manfredi, PhD, President & Chief Executive Officer of Ikena. "We are thrilled that through our IPO, we brought in new long-term partners and deepened our relationships with our current investors. The funding, along with a dedicated and passionate team, are propelling us towards our mission of bringing novel targeted cancer therapies to patients."
Recent Business Highlights and Corporate Update
Financial and Corporate
- In March 2021, Ikena completed a successful initial public offering (IPO), raising $143.8 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, and listed on The Nasdaq Global Market. The IPO followed the closing of a Series B crossover financing of $120 million in gross proceeds in December 2020.
- In April 2021, Maria Koehler, MD, PhD, current Chief Medical Officer of Repare Therapeutics, Inc. (NASDAQ:RPTX), was appointed to the Ikena Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she contributed to the strategic direction of the oncology portfolio.
Development Pipeline
- IK-930: IND-enabling studies are ongoing for Ikena's lead targeted oncology program, IK-930, a potent, selective and well tolerated oral small molecule TEAD inhibitor in the Hippo signaling pathway. In preclinical studies, IK-930 demonstrated anti-tumor activity in Hippo pathway-driven cancer models and synergy with EGFR inhibition and MEK inhibition.
- ERK5 Inhibitor: Lead optimization is ongoing for Ikena's ERK5 inhibitor program which is being developed for the treatment of KRAS mutant tumors. Ikena's ERK5 tool molecule inhibitor has shown single agent and synergistic anti-tumor activity with MEK inhibition in preclinical models of KRAS mutant pancreatic cancer and lung adenocarcinoma.
- IK-175: The ongoing Phase 1b clinical trial with IK-175, Ikena's AHR antagonist, continues to enroll patients in the monotherapy dose expansion arm. In addition, the first patient was recently dosed in the dose escalation combination arm which consists of IK-175 with nivolumab in patients with bladder cancer, including patients with AHR-activated tumors.
- IK-412: IND-enabling studies are currently ongoing for IK-412, a novel enzymatic therapeutic designed to lower levels of kynurenine, an immunosuppressive metabolite in the tumor microenvironment. IK-412 has demonstrated profound and durable kynurenine depletion in preclinical models.
- IK-007: The ongoing Phase 1b clinical trial continues to enroll patients with advanced or progressive microsatellite stable colorectal cancer (MSS-CRC) with IK-007 in combination with pembrolizumab. The clinical trial is enriching for patients that have high urinary prostaglandin E metabolite (PGEM) biomarker.
Milestones and Key Priorities for 2021
- Complete IND-enabling studies for TEAD inhibitor, IK-930, and submit IND application to FDA during the second half of 2021.
- Nominate ERK5 inhibitor development candidate and initiate IND-enabling studies in the second half of 2021.
- Complete IND-enabling studies for kynurenine degrading enzyme, IK-412, and submit IND to FDA during the second half of 2021.
- Complete enrollment into the Phase 1b study of EP4 antagonist IK-007 in combination with pembrolizumab in patients with advanced or progressive MSS-CRC.
First Quarter 2021 Financial Results
As of March 31, 2021, the Company had cash and cash equivalents totaling $281.0 million, which will fund operations through 2023. Net cash used in operations was $13.2 million for the first quarter of 2021 compared to $9.9 million for the first quarter of 2020.
Research and development expenses for the first quarter 2021 were $10.0 million, compared to $7.9 million for the first quarter 2020. The increase in R&D expense was primarily related to on-going IND-enabling studies and manufacturing development costs for IK-930, on-going IND-enabling studies and manufacturing development costs for IK-142, increased research activities of other discovery stage programs and increased personnel expenses due to increase in headcount.
General and administrative expenses for the first quarter were $3.2 million, compared to $2.5 million for the first quarter 2020. The increase in G&A expense were primarily related to compensation expense due to an increase in headcount, as well as general increases in audit, legal and consulting expenses to support our transition to becoming a public company.
Net loss for the first quarter 2021 was $9.7 million, compared to $6.9 million for the first quarter 2020, driven predominantly by increase in research and development expenses.
About Ikena Oncology
Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
Condensed Consolidated Balance Sheet Data
(Unaudited)
(in thousands)
March 31,
2021December 31,
2020Cash and cash equivalents
$
281,010
$
162,491
Total assets
293,662
168,404
Total liabilities
66,018
63,473
Redeemable convertible preferred stock
-
205,979
Additional paid-in-capital
348,663
10,288
Accumulated deficit
(121,055)
(111,339)
Total stockholders' equity (deficit)
227,644
(101,048)
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
Three Months Ended March 31,
2021
2020
Research and development revenue under collaboration agreement
$
3,474
$
3,227
Operating expenses:
Research and development
10,021
7,893
General and administrative
3,173
2,510
Total operating expenses
13,194
10,403
Loss from operations
(9,720)
(7,176)
Other income
4
231
Net loss and comprehensive loss
$
(9,716)
$
(6,945)
Net loss per share attributable to common stockholders basic and diluted
$
(2.52)
$
(2.62)
Weighted-average common stocks outstanding, basic and diluted
3,850,264
2,655,767
View source version on businesswire.com: https://www.businesswire.com/news/home/20210513005116/en/
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Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality (SL) approach to the discovery and development of novel therapeutics, today announced the first patient has been dosed in the Company's Phase 1 clinical trial of RP-6306, a first-in-class small molecule product candidate targeting PKMYT1, which is a novel target that Repare discovered to be synthetic lethal with CCNE1 amplification and other genomic mutations to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers.
"The dosing of the first patient in this RP-6306 trial marks a key milestone in Repare's development of targeted cancer therapeutics. We are pleased to have initiated this trial six months ahead of what we projected at our IPO launch last June," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Patients with tumors carrying CCNE1, FBXW7 and certain other genetic alterations we have identified as sensitive to PKMYT1 inhibition have few treatment options available, and the incidence of these cancers is rising. This Phase 1 trial will assess the safety and tolerability of RP-6306, as well as dosing schedule, to inform Repare's planned Phase 2 program."
The Phase 1 multi-center clinical trial is expected to enroll approximately 70 patients with recurrent tumors characterized by specific genomic alterations predicted by Repare's SNIPRx platform to render sensitivity to RP-6306. The primary goal of the Phase 1 clinical trial is to assess preliminary safety and tolerability in patients and to establish the recommended Phase 2 dose and dosing schedule for RP-6306 for evaluation in further trials. Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other treatment modalities, into proof-of-concept studies in 2022, targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare's proprietary STEP2 screens.
About RP-6306
RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare's SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company's pipeline includes its lead product candidate RP-3500, a potential best-in-class ATR inhibitor currently in Phase 1/2 clinical development, as well as RP-6306, a first-in-class, selective, oral inhibitor of PKMYT1 to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers, and a Polθ inhibitor program. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are "forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, the clinical development of RP-6306 including the initiation, timing, design and results of the Phase 1 clinical trial of RP-6306 and the determination of a recommended Phase 2 dose; the efficacy of RP-6306 as a monotherapy or in combination with other therapies; and the ability of RP-6306 to target patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare's proprietary STEP2 screens. These forward-looking statements are based on the Company's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause the Company's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission ("SEC") on March 4, 2021. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210503005361/en/
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Ikena Oncology, Inc. (NASDAQ:IKNA) ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, today announced the appointment of Maria Koehler, M.D., Ph.D. to its Board of Directors. Dr. Koehler is a board-certified hematologist and oncologist with more than 20 years of pharmaceutical and biotech oncology experience in clinical development, including senior roles at Pfizer where she led the development of Ibrance® (palbociclib) and contributed to the strategic direction of the oncology portfolio.
"We are extremely pleased to welcome Maria to our Board of Directors at this important next stage of Ikena's evolution," said Mark Manfredi, President & Chief Executive Officer of Ikena. "Maria is a highly accomplished biopharmaceutical veteran. During her distinguished career, she has led the development of numerous oncology drugs from early- to late-stage clinical investigation, through to commercialization. Her leadership and strategic expertise will be invaluable as we advance IK-930, our lead targeted oncology candidate, into clinical development, followed thereafter by our other pipeline programs targeting cancers with high unmet need."
"It is a privilege to join Ikena's Board of Directors during such an exciting period of growth following the Company's recent IPO, and as Ikena advances IK-930 towards clinical development during the second half of 2021," said Dr. Koehler. "I look forward to working alongside Ikena's current Board members and executive management to advance Ikena's innovative drug candidates through clinical development and toward commercialization where they can truly benefit patients."
Dr. Koehler brings deep experience in both early drug development and bringing new drugs to global markets, having developed strategies for product candidates at all stages of development. Dr. Koehler currently serves as the Chief Medical Officer at Repare Therapeutics (NASDAQ:RPTX), where she leads clinical strategy and oversees all operations. Dr. Koehler joined Repare from Bicycle Therapeutics (NASDAQ:BCYC) where she was Chief Medical Officer. Prior to Bicycle, she was Vice President of Strategy, Innovation and Collaborations for the Oncology Business Unit at Pfizer. Prior to Pfizer, she served in leadership roles at GlaxoSmithKline and at AstraZeneca. She is board certified in hematology and oncology. She began her career as a practicing physician and served as the clinical director of Bone Marrow Transplantation at University Hospital in Pittsburgh as well as the director of the Bone Marrow Transplant Program and associate professor at St. Christopher's Hospital in Philadelphia. Dr. Koehler received her M.D. and Ph.D. from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters, and patents.
About Ikena Oncology
Ikena Oncology is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies: IK-930, a TEAD inhibitor targeting the Hippo signaling pathway; an ERK5 inhibitor program targeting the KRAS signaling pathway; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme; and IK-007, an EP4 receptor antagonist. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb Company for its IK-175 and IK-412 programs. To learn more visit www.ikenaoncology.com or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new director; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other risks identified in our SEC filings, including our Registration Statement on Form S-1, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
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