Latest news with #LeapTherapeutics
Yahoo
23-06-2025
- Business
- Yahoo
Leap Therapeutics Reports Updated Clinical Data from Sirexatamab Colorectal Cancer Study and Announces Exploration of Strategic Alternatives
Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the DKK1-high, VEGF-naïve and liver metastasis subgroups Board of Directors has initiated process to explore strategic alternatives to maximize shareholder value CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported updated results from Part B of the DeFianCe study (NCT05480306), a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease. Due to the Company's financial position, Leap's Board of Directors is taking further steps to preserve capital and has initiated a process to explore strategic options to preserve and maximize shareholder value. "Sirexatamab demonstrated a statistically significant benefit in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis, with a positive trend on ORR and PFS in the full second-line CRC population. With the additional patient follow-up, we believe that the objectives of the DeFianCe study have been achieved. On behalf of everyone at Leap, I thank all the patients and physicians who have participated in our sirexatamab clinical trials," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "However, due to current market conditions, we have decided to wind-down the DeFianCe clinical trial and further reduce internal expenses. In parallel, we have initiated a review of the full range of strategic alternatives to maximize shareholder value." DeFianCe Study Update In the updated analysis as of May 22, 2025, sirexatamab demonstrated a positive trend on overall response rate (ORR), by investigator assessment (IA) and blinded independent central review (BICR), and progression-free survival (PFS) in the full second-line CRC population, driven by the statistically significant benefit in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis. Across the intent-to-treat population (n=188):Sirexatamab Arm (n=94) Control Arm (n=94)Median PFS 9.2 months 8.31 months HR 0.84 95% CI: 0.57, 1.22 p = 0.1749 ORR by IA 35.1 % 26.6 % p = 0.1009 ORR by BICR 33.0 % 20.2 % P = 0.0203 Remaining on study drug 21 15In patients with high DKK1 levels (upper quartile, n=44):Sirexatamab Arm (n=25) Control Arm (n=19)Median PFS 9.36 months 5.88 months HR 0.47 95% CI: 0.22, 1.01 p = 0.0237 ORR by IA 44.0 % 15.8 % p = 0.0149 ORR by BICR 40.0 % 15.8 % p = 0.0301 Median OS Not Yet Reached 9.66 months HR 0.19 95% CI: 0.05, 0.73 p = 0.0037 Remaining on study drug 7 1In patients with DKK1 levels above the median (upper median, n=88):Sirexatamab Arm (n=50) Control Arm (n=38)Median PFS 9.03 months 7.23 months HR 0.56 95% CI: 0.33, 0.94 p = 0.0146 ORR by IA 38.0 % 23.7 % p = 0.0706 ORR by BICR 40.0 % 15.8 % p = 0.0039 Median OS Not Yet Reached 14.39 months HR 0.48 95% CI: 0.2, 1.16 p = 0.0475 Remaining on study drug 12 3In patients who had not received prior anti-VEGF therapy (n=95):Sirexatamab Arm (n=49) Control Arm (n=46)Median PFS 11.2 months 8.34 months HR 0.61 95% CI: 0.35, 1.06 p = 0.0383 ORR by IA 55.1 % 32.6 % p = 0.0116 ORR by BICR 44.9 % 26.1 % p = 0.0252 Median OS Not Yet Reached Not Yet Reached HR 0.47 95% CI: 0.14, 1.6 p = 0.1069 Remaining on study drug 15 5In patients with liver metastases (n=138):Sirexatamab Arm (n=73) Control Arm (n=65)Median PFS 9.03 months 7.26 months HR 0.7 95% CI: 0.46, 1.06 p = 0.0443 ORR by IA 37.0 % 27.7 % p = 0.1203 ORR by BICR 30.1 % 24.6 % p = 0.233 Median OS Not Yet Reached 15.74 HR 0.69 95% CI: 0.33, 1.43 p = 0.1584 Remaining on study drug 14 6Corporate Update Leap is taking additional steps to reduce spending and preserve capital. Over the next two months as the DeFianCe study completes, the Company will implement a workforce reduction of approximately 75%. The total cash payments and costs related to this reduction in force, including severance payments, are estimated to be approximately $3.2 million. The majority of these costs will be recognized in the third quarter of 2025. The Company's cash and cash equivalents totaled $32.7 million as of March 31, 2025. Leap has initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Company's Board of Directors has approved the engagement of Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process. About Leap TherapeuticLeap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates, including sirexatamab and FL-501; Leap's intention to implement a workforce reduction of approximately 75%, reduce clinical and operational activities, reduce spending and conserve cash, explore strategic alternatives to preserve and maximize shareholder value, including by leveraging its cash balance and potentially selling or partnering sirexatamab or FL-501; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully sell or enter into partnerships for sirexatamab or FL-501; (ii) the cost and timeline to complete the DeFianCe Study and wind-down clinical operations; (iii) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency or from site institutional review boards; (iv) the magnitude, timing and costs associated with the implementation of a workforce reduction; and (v) the availability of strategic alternatives would preserve or generate any shareholder value. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. OnsiPresident & Chief Executive OfficerLeap Therapeutics, Inc.617-714-0360donsi@ Matthew DeYoungInvestor RelationsArgot Partners212-600-1902leap@ View original content to download multimedia: SOURCE Leap Therapeutics, Inc.
Business Journals
14-05-2025
- Business
- Business Journals
Five things: Southie power plant, Fast 50 event, Harvard cuts and what caused Tatum's injury
Good morning, Boston. We had a blast at the Fast 50 event last night at Big Night Live — here are the winners, and stay tuned for photos later today. Now, here are the five things you need to know in local business news to start your busy Wednesday. 1. Southie project plans shift as market slows Grant Welker reports that the old Edison power plant in South Boston and its developers face a very different real estate market from when planning started in 2016. Now, the developer is considering changing the order in which it plans to build the six-building, 1.7-million-square-foot project. GET TO KNOW YOUR CITY Find Local Events Near You Connect with a community of local professionals. Explore All Events 2. Trump slashes another $450M in Harvard grants Welker also reports that the Trump administration yesterday said it is terminating roughly $450 million in grants to Harvard, on top of the $2.2 billion in funding already cut. 3. Mass. biotech leaders say drug pricing order 'not the solution' The executive order that President Donald Trump signed Monday — which he says will reduce prescription drug prices — was met with opposition from Massachusetts' life sciences trade group, Hannah Green reports. On the calendar: Join the Boston Business Journal for our 9th annual Business of Pride event, featuring our 2025 LGBT Corporate Ally Award and LGBT Trailblazer Award honorees. 4. Fastest-growing companies feted The No. 1 fastest-growing company in Massachusetts over the three-year period from 2021-2024 is mental health and wellness company Uwill of Natick. Uwill was among several awardees recognized last night at the BBJ's annual Fast 50 event, including an architecture firm that grew revenue 136% and a 30-year-old facilities-services business that grew 73% in just the past three years. 5. Cambridge cancer biotech halves workforce Green also reports that cash-strapped Leap Therapeutics is making significant job cuts as it navigates a 'difficult market environment.' What else you need to know By the numbers 600 — housing units that could start as soon as next year at the former Edison power plant in Southie (see above), instead of the 860,000 — square feet of office and R&D that had been planned initially could start as soon as next year 1,000 (approximately) — Aramark union workers at Fenway Park and MGM Music Hall who are planning a strike vote in June to advocate for higher wages. planning a strike vote 52 — employees at Leap Therapeutics, half of which are expected to be laid off What's going on? The Charles River Regional Chamber's annual Spring Business Breakfast: 2025 Economic Outlook is this morning at the Needham Sheraton Hotel, featuring Ashley Stolba, the interim state Secretary of Economic Development, and Mary Burke, a principal economist at the Federal Reserve Bank of Boston. See you there? En español The number of people in Massachusetts identifying as lesbian, gay, bisexual or transgender is growing — and a new study shows significant differences across age groups. This article is also available in Spanish in partnership with El Planeta Media. Este informe está disponible en español, traducido por El Planeta Media. Today in history On this day in 1984, lawyer Jan Schlichtmann filed the first motion in the Woburn case made famous by the book and film "A Civil Action." (Read more at What's good on WERS-FM Most Wanted Man, by Lucy Dacus What I'm listening to Carrigan & Co. podcast What I'm watching Celtics City, on HBO/Max Who's at fault for Tatum's injury? The news Monday night about Celtics star Jayson Tatum's ruptured his achilles tendon came as a shock to everyone. As a 'non-contact' injury, every Celtics fan is looking around helplessly and wondering, 'how did this happen?' I have the answer. I discovered that a member of the Business Journal newsroom who hails from Los Angeles and is an avowed Lakers fan — along with four friends — cursed the Celtics at the start of the playoff series against the Knicks. It wasn't an ordinary curse. No run-of-the-mill hex. They pooled their money and purchased a bad luck spell from a witch who sells such curses on Etsy. This is not a joke. They really did this. I have no proof that their purchased curse — which could also be to blame for the Celtics choking so badly in Games 1 and 2 — was powerful enough to do the damage done to Tatum. I'm told they spent $3 each. But it was a bad-luck spell they purchased, and there's no worse luck than what happened to Tatum on the court Monday night. I'm not revealing the name of this particular employee, to protect him from any ill-intentioned Celtics fans who may read this. But I have suggested he start wearing an Italian horn necklace and carrying a Mexican milagro or a rabbit's foot if he knows what's good for him. PARTING SHOT Speaking of basketball, how many times have you passed by public courts in rough shape, full of cracks, weeds and divots? This New York artist resurfaces public courts and turns them into pieces of art: Subscribe to the Morning Edition or Afternoon Edition for the business news you need to know, all free.
Yahoo
25-04-2025
- Business
- Yahoo
Leap Therapeutics to Present Preclinical Data of FL-501, a Novel GDF-15 Neutralizing Antibody, at the AACR 2025 Annual Meeting
FL-501 fully restored body composition and reversed key indicators of cachexia in preclinical models Findings confirm GDF-15's role in cachexia and support advancing FL-501 into the clinic CAMBRIDGE, Mass., April 25, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced it will present preclinical data of FL-501 in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting taking place April 25-30 in Chicago, Illinois. FL-501 is a potential best-in-class monoclonal antibody targeting growth differentiation factor 15 (GDF-15), a cytokine that is implicated in multiple diseases and therapeutic areas, including cancer cachexia. "Cancer cachexia is a devasting and potentially life-threatening condition characterized by significant weight loss, muscle wasting, fatigue, and severely reduced quality of life. It is a major contributor to cancer-related mortality, and unfortunately there are no effective treatment options available to patients," said Jason Baum, PhD, Chief Scientific Officer of Leap. "These data not only demonstrate that FL-501 is a novel and potential best-in-class anti-GDF-15 antibody, but also capable of fully restoring body composition in preclinical models that is comparable or better than other, clinical-stage antibodies. We look forward to progressing the development of FL-501 and bringing the asset into the clinic in 2026." Key Findings: In humanized FcRn mouse studies, FL-501 demonstrated a 2-3-fold longer half-life and 50% reduced clearance compared to its wild-type precursor and ponsegromab In mouse cachexia models using GDF-15-overexpressing colorectal cancer cells, FL-501 fully restored body composition, comparably or better than clinical-stage antibodies visugromab and ponsegromab In a non-small cell lung cancer patient-derived xenograft model, FL-501 effectively countered cisplatin-induced weight loss, restoring body weight, composition, and condition scores These findings confirm GDF-15's role in cachexia and support FL-501's advancement in development Poster Details: Title: FL-501 is a potential best in class GDF-15 inhibitor with extended half-life and potent anti-cachexia activity in preclinical modelsPresenter: Roma Kaul, PhD, Leap TherapeuticsSession Category: Experimental and Molecular TherapeuticsSession Title: New and Emerging Cancer Drug TargetsDate and Time: Tuesday, April 29, 2025, 9:00 a.m. – 12:00 p.m. CTPoster Board Number: 15Published Abstract Number: 4258 About FL-501FL-501 is a potential best-in-class monoclonal antibody in preclinical development that targets growth differentiation factor-15 (GDF-15), a cytokine that is produced at elevated levels in response to various stresses, including chronic inflammation, obesity, cardiovascular diseases, cancers, and chemotherapy treatment. High GDF-15 expression is associated with cancer cachexia including loss of appetite, nausea and weight loss. FL-501 was engineered for higher affinity to GDF-15 and longer plasma half-life compared to competing therapies. In addition to cachexia, FL-501 may be able to reverse immunosuppression in cancers where elevated GDF-15 is correlated with poor survival, as well as play a role in treating other GDF-15-related diseases. FL-501 is being developed through a collaboration agreement with Adimab. About LeapLeap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) the results of Leap's clinical trials and pre-clinical studies, including the final data from Part B of the DeFianCe study and additional preclinical data for FL-501, (ii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or FL-501; (iii) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the sirexatamab or FL-501; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. OnsiPresident & Chief Executive OfficerLeap Therapeutics, Inc.617-714-0360donsi@ Matthew DeYoungInvestor RelationsArgot Partners212-600-1902leap@ View original content to download multimedia: SOURCE Leap Therapeutics, Inc. Sign in to access your portfolio
Yahoo
26-03-2025
- Business
- Yahoo
Leap Therapeutics Reports Positive Updated Data from Sirexatamab Colorectal Cancer Study
Updated data confirms statistically significant 32% higher ORR and 3.5 month longer PFS in second-line CRC patients with high DKK1 levels treated with sirexatamab plus bevacizumab and chemotherapy Statistically significant 22% higher ORR and 2.6 month longer PFSin patients who had not had prior anti-VEGF therapy Leap to host a conference call to present clinical data today, March 26, 2025, at 8:00 a.m. ET CAMBRIDGE, Mass., March 26, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today presented updated preliminary data from Part B of the DeFianCe study (NCT05480306), a Phase 2, open-label, global study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease. The updated analysis includes overall response rate (ORR), by both investigator-assessment (IA) and blinded independent central review (BICR), an additional two months of patient follow-up for progression-free survival (PFS) that demonstrates a favorable maturation of the data, and initial overall survival (OS) data. As of March 12, 2025, 34 patients remain on study drug in the sirexatamab Experimental Arm compared to 24 patients in the Control Arm. "The updated data from Part B of the DeFianCe study presented today confirms that sirexatamab can generate significantly higher ORR and longer PFS in CRC patients who have high levels of DKK1 or who have not had prior anti-VEGF therapy, two exploratory populations with strong scientific rationale. In the full intent-to-treat population, sirexatamab demonstrated a higher ORR and a tail population with longer PFS that continues to mature. With more sirexatamab-treated patients currently continuing on study drug than control arm patients, there is potential for the dataset to continue to strengthen over the coming months," said Cynthia Sirard, MD, Chief Medical Officer of Leap. "We believe that there is a compelling opportunity to move forward with a registrational study for sirexatamab to confirm these results and bring a new therapy to patients with CRC." DeFianCe Study Update In patients with high DKK1 levels (upper quartile, n=44), the sirexatamab Experimental Arm has a statistically significant 32% higher ORR, 3.5 month longer PFS, and OS compared to the Control Arm:Sirexatamab Experimental Arm (n=25) Control Arm (n=19)ORR by IA 48.0 % 15.8 % p = 0.0067 ORR by BICR 40.0 % 5.3 % p < 0.001 Median PFS 9.36 months 5.88 months HR 0.46 95% CI: 0.21, 1.02 p = 0.0248 Median OS Not Yet Reached 9.49 months HR 0.09 95% CI: 0.01, 0.69 p = 0.0018 Patients on study drug 10 1In patients who had not received prior anti-VEGF therapy (n=95), the sirexatamab Experimental Arm has a statisticially significant 22% higher ORR and 2.6 month longer PFS compared to the Control Arm, with OS not mature but favoring the sirexatamab Experimental Arm:Sirexatamab Experimental Arm (n=49) Control Arm (n=46)ORR by IA 55.1 % 32.6 % p = 0.0116 ORR by BICR 44.9 % 21.7 % p = 0.0066 Median PFS 10.94 months 8.34 months HR 0.59 95% CI: 0.32, 1.07 p = 0.0386 Median OS Not Yet Reached Not Yet Reached HR 0.22 95% CI: 0.03, 2.01 p = 0.0719 Patients on study drug 23 8Across the intent-to-treat population (n=188), the sirexatamab Experimental Arm has improved ORR compared to the Control Arm, with the primary endpoint of PFS still to mature due to the higher number of patients remaining on sirexatamab driving separation after the median:SirexatamabExperimental Arm (n=94) Control Arm (n=94)ORR by IA 36.2 % 25.5 % p = 0.0536 ORR by BICR 33.0 % 16.0 % p = 0.0023 Median PFS 7.82 months 8.31 months HR 0.83 95% CI: 0.56, 1.24 p = 0.1809 Patients on study drug 34 24The combination of sirexatamab plus bevacizumab and chemotherapy is well tolerated with a safety profile that is consistent with previous studies. The strong signal from the DeFianCe study supports a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high DKK1 levels or in patients who have not received prior anti-VEGF therapy. With approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next 7 largest markets, sirexatamab has a large market opportunity in the 25-50% of patients who have high DKK1 levels or in the approximately 50% of patients who did not receive prior anti-VEGF therapy. In addition, the outcomes in patients with no prior anti-VEGF therapy provides an opportunity to move into treating first-line CRC patients, where there are an estimated 45,000 patients in the US and 265,000 in the next 7 largest markets who receive therapy for their advanced disease. Leap has engaged a leading financial advisor to explore business development opportunities to further the development of sirexatamab. Conference Call Leap's management team will host a conference call today, March 26, 2025 at 8:00 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the webcast URL: A replay of the event will be available for a limited time on the Investors page of the Company's website at About Leap TherapeuticsLeap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) the results of Leap's clinical trials and pre-clinical studies, including whether the final data from Part B of the DeFianCe study or Part C of the DisTinGuish study are the same as the initial data reported, (ii) the actual size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy, may be smaller than estimated, (iii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or any of its other programs; (iv) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the registrational Phase III clinical trials that Leap proposes to conduct using sirexatamab for the treatment of patients with second-line CRC or with respect to any other pre-clinical or clinical development activities that Leap will be required to conduct in order to obtain regulatory approval of sirexatamab for the treatment of second-line CRC; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. OnsiPresident & Chief Executive Officer Leap Therapeutics, Inc. 617-714-0360 donsi@ Matthew DeYoung Investor RelationsArgot Partners212-600-1902 leap@ View original content to download multimedia: SOURCE Leap Therapeutics, Inc.
Yahoo
26-03-2025
- Business
- Yahoo
Leap Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results
Leap to host a conference call to present updated CRC clinical data today, March 26, 2025, at 8:00 a.m. ET CAMBRIDGE, Mass., March 26, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2024. Leap Highlights: Reported positive updated data from Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) in second-line patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) confirming: Statistically significant 32% higher overall response rate (ORR), 3.5 month longer progression-free survival (PFS), and longer overall survival (OS) in patients with high DKK1 levels Statistically significant 22% higher ORR and 2.6 month longer PFS in patients who had not had prior anti-VEGF therapy FL-501 abstract accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting. "In 2024, we continued to advance sirexatamab, our anti-DKK1 antibody, through Phase 2 randomized controlled clinical trials as part of our mission to bring personalized medicines to patients fighting against cancer. In particular, the updated data from Part B of the DeFianCe study that we announced today demonstrated significantly higher ORR and longer PFS for sirexatamab in patients who have high levels of DKK1 or who have not had prior anti-VEGF therapy, two exploratory populations with strong scientific rationale that each represent 25-50% of the second-line CRC market," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We believe that there is a compelling opportunity to move forward with a registrational study for sirexatamab in patients with CRC and to advance FL-501 towards clinical trials." DKN-01 Development Update Reported updated clinical data from Part B of the DeFianCe Study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. Today, the Company announced updated preliminary data from Part B of the DeFianCe study (NCT05480306), a Phase 2, open-label, global study of sirexatamab in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with MSS CRC who have received one prior systemic therapy for advanced disease. In the updated data announced today, Patients with high DKK1 levels, either at the upper quartile or above the median, treated in the sirexatamab Experimental Arm had significantly improved ORR, PFS, and OS compared to the Control Arm. In patients who had not received prior anti-VEGF therapy, the sirexatamab Experimental Arm had significantly improved ORR and PFS compared to the Control Arm, with an early advantage in OS. Across the intent-to-treat population, the sirexatamab Experimental Arm had improved ORR compared to the Control Arm, with PFS and OS maturing with a higher number of patients continuing to benefit on the sirexatamab Experimental Arm. The strong signal from the DeFianCe study supports a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high DKK1 levels or in patients who have not received prior anti-VEGF therapy. With approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next 7 largest markets, sirexatamab has a large market opportunity in the 25-50% of patients who have high DKK1 levels or in the approximately 50% of patients who did not receive prior anti-VEGF therapy. In addition, the outcomes in patients with no prior anti-VEGF therapy provides an opportunity to move into treating first-line CRC patients, where there are an estimated 45,000 patients in the US and 265,000 in the next 7 largest markets who receive therapy for their advanced disease. Leap has engaged a leading financial advisor to explore business development opportunities to further the development of sirexatamab. Pipeline Update Presenting preclinical FL-501 data at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Preclinical data from FL-501, a potential best-in-class monoclonal antibody designed to neutralize GDF-15 to treat patients with cachexia and other GDF-15-driven diseases, will be featured during a poster session at the 2025 AACR Annual Meeting taking place April 25-30 in Chicago. In addition, manufacturing and non-clinical development continues with the goal of beginning a clinical trial in 2026. Conference Call Leap's management team will host a conference call today, March 26, 2025 at 8:00 a.m. Eastern Time to further discuss the data. The conference call will be broadcast live in listen-only mode and can be accessed via the webcast URL: A replay of the event will be available for a limited time on the Investors page of the Company's website at Selected Year-End and Fourth Quarter 2024 Financial Results Net Loss was $67.6 million for the year ended December 31, 2024, compared to $81.4 million for the year ended December 31, 2023. The decrease was primarily due to a decrease in research and development expenses. Research and development expenses were $57.2 million for the full year 2024, compared to $73.2 million for the same period in 2023. Research and development expenses were $13.1 million for the fourth quarter ended 2024, compared to $11.7 million for the same period in 2023. The decreases for the full year 2024 were primarily due to in-process research and development acquired in the Flame merger which were expensed in the year ended December 31, 2023. General and administrative expenses were $12.8 million for the full year 2024, compared to $13.8 million for the same period in 2023. General and administrative expenses were $3.0 million for the fourth quarter ended 2024, compared to $3.1 million for the same period in 2023. The decreases for the full year 2024 were primarily due to a decrease in professional fees due to lower finance and legal costs. Cash and cash equivalents totaled $47.2 million at December 31, 2024. About Leap TherapeuticsLeap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. Sirexatamab is being studied in patients with colorectal cancer. Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, in preclinical development. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy; the anticipated timing for initiation or completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) the results of Leap's clinical trials and pre-clinical studies, including whether the final data from Part B of the DeFianCe study or Part C of the DisTinGuish study are the same as the initial data reported, (ii) the actual size of the potential addressable market for sirexatamab, including the number or percentage of patients with advanced CRC that have or are likely to have high levels of DKK1 or that have not had or are likely not to have prior anti-VEGF therapy, may be smaller than estimated, (iii) Leap's ability to successfully finance or enter into new strategic partnerships for sirexatamab or any of its other programs; (iv) any regulatory feedback that Leap may receive from U.S. Food and Drug Administration (FDA) or equivalent foreign regulatory agency with respect to the registrational Phase III clinical trials that Leap proposes to conduct using sirexatamab for the treatment of patients with second-line CRC or with respect to any other pre-clinical or clinical development activities that Leap will be required to conduct in order to obtain regulatory approval of sirexatamab for the treatment of second-line CRC; (v) whether any Leap products will receive approval from the FDA or equivalent foreign regulatory agencies; and (vi) exposure to inflation and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. OnsiPresident & Chief Executive OfficerLeap Therapeutics, Inc.617-714-0360donsi@ Matthew DeYoungInvestor RelationsArgot Partners212-600-1902leap@ Leap Therapeutics, Inc. Consolidated Statements of Operations (in thousands, except share and per share amounts) (Unaudited)(Unaudited) Year Ended December 31Three Months Ended December 31 2024202320242023Operating expenses:Research and development$ 57,211$ 73,234$ 13,112$ 11,685General and administrative 12,84613,8073,0133,135 Total operating expenses70,05787,04116,12514,820 Loss from operations(70,057)(87,041)(16,125)(14,820) Interest income 3,1294,027595938 Australian research and development incentives-1,101-(23) Other income -500-500 Foreign currency gain (loss)(42)(13)(24)940 Change in fair value of Series X preferred stock warrant liability-12-- Loss before income taxes (66,970)(81,414)(15,554)(12,465) Provision for (benefit from) income taxes(585)-123- Net loss (67,555)(81,414)(15,431)(12,465) Dividend attributable to common stockholders(234)--- Net loss attributable to common stockholders$ (67,789)$ (81,414)$ (15,431)$ (12,465)Net loss per share Basic and Diluted$ (1.81)$ (3.98)$ (0.37)$ (0.46)Weighted average common shares outstanding Basic and diluted37,550,67720,445,10941,252,02226,987,182 Leap Therapeutics, Inc. Consolidated Balance Sheets (in thousands, except share and per share amounts)December 31, 20242023 Cash and cash equivalents$ 47,249$ 70,643 Research and development incentive receivable704771 Prepaid expenses and other current assets86183 Total current assets48,03971,597 Property and equipment, net-5 Right of use assets, net262257 Deposits 823966 Total assets$ 49,124$ 72,825 Accounts payable$ 4,743$ 6,465 Accrued expenses8,5365,957 Income tax payable531- Lease liability - current portion266262 Total current liabilities14,07612,684 Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding -- Common stock, $0.001 par value; 240,000,000 shares authorized; 38,329,894 and 25,565,414 shares issued and outstanding as of December 31, 2024 and 2023, respectively3826 Additional paid-in capital502,501459,591 Accumulated other comprehensive (loss) income (120)106 Accumulated deficit (467,371)(399,582) Total stockholders' equity 35,04860,141 Total liabilities and stockholders' equity $ 49,124$ 72,825 Leap Therapeutics, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (Unaudited) (Unaudited) Year Ended December 31, Three Months Ended December 31, 2024202320242023 Cash used in operating activities $ (60,299)$ (43,753)$ (15,512)$ (10,380) Cash provided by investing activities -48,969-- Cash provided by (used in) financing activities 37,184(30)104- Effect of exchange rate changes on cash and cash equivalents (279)(43)(166)280 Net increase (decrease) in cash and cash equivalents $ (23,394)$ 5,143(15,574)(10,100) Cash and cash equivalents at beginning of period 70,64365,50062,82380,743 Cash and cash equivalents at end of period $ 47,249$ 70,643$ 47,249$ 70,643 View original content to download multimedia: SOURCE Leap Therapeutics, Inc.
