Latest news with #clinicaldata
Yahoo
4 days ago
- Business
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MRO Recognized on the 2025 Inc. 5000 Annual List for Tenth Year
MRO continues its impressive track record of rapid growth while maintaining award-winning client satisfaction and product portfolio expansion NORRISTOWN, Pa., Aug. 15, 2025 /PRNewswire/ -- MRO, the leading clinical data exchange company in healthcare, announced today it made the Inc. 5000 annual list of fastest-growing private companies in America for the 10th year. The list provides a data-driven snapshot of the most successful companies within the economy's most dynamic segment—its independent, entrepreneurial businesses. This year's Inc. 5000 honorees have demonstrated exceptional growth while navigating economic uncertainty, inflationary pressure, and a fluctuating labor market. "Making the Inc. 5000 is always a remarkable achievement, but earning a spot this year speaks volumes about a company's tenacity and clarity of vision," says Mike Hofman, editor-in-chief of Inc. "These businesses have thrived amid rising costs, shifting global dynamics, and constant change. They didn't just weather the storm—they grew through it, and their stories are a powerful reminder that the entrepreneurial spirit is the engine of the U.S. economy." "Earning a place on the Inc. 5000 list for the tenth time is a true honor for MRO," said Jason Brown, CEO of MRO. "This recognition reflects our continued growth, the expansion of our portfolio, and the exceptional value we provide to clients and partners. We're grateful for our team's dedication and achievements, which fuel our commitment to accelerating clinical data and driving the healthcare industry forward." For the full list, company profiles, and a searchable database by industry and location, visit: About Inc. Inc. is the leading media brand and playbook for the entrepreneurs and business leaders shaping our future. Through its journalism, Inc. aims to inform, educate, and elevate the profile of its community: the risk-takers, the innovators, and the ultra-driven go-getters who are creating the future of business. Inc. is published by Mansueto Ventures LLC, along with fellow leading business publication Fast Company. For more information, visit About MROMRO is accelerating the exchange of clinical data throughout the healthcare ecosystem on behalf of providers, payers and users of clinical data. By utilizing industry-leading solutions and incorporating the latest technology, MRO facilitates the efficient management and exchange of clinical data for all stakeholders. With a 23-year legacy, MRO brings a technology-driven mindset built upon a client-first service foundation and a relentless focus on client excellence. For more information on how MRO is empowering healthcare organizations of every type and scale with proven, enterprise-wide clinical data solutions, visit Media Contacts:Stephanie KindlickVice President, MarketingMROskindlick@ View original content to download multimedia: SOURCE MRO Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 days ago
- Business
- Yahoo
Inovio Pharmaceuticals Inc (INO) Q2 2025 Earnings Call Highlights: Strategic Advances and ...
Release Date: August 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points Inovio Pharmaceuticals Inc (NASDAQ:INO) is on track to submit its BLA for INO 3,107 in the second half of 2025, with the goal of file acceptance by year-end. The company has completed the design verification testing of its Selecttra 5 PSP device, a key milestone for regulatory progress. INO 3,107 has been granted breakthrough therapy designation by the FDA, allowing for a rolling submission of the BLA. Clinical data from INO 3,107 has been published in reputable journals, supporting its potential as a preferred treatment for RRP. Inovio Pharmaceuticals Inc (NASDAQ:INO) has significantly reduced its operating expenses by 31% year-over-year, demonstrating fiscal responsibility. Negative Points Inovio Pharmaceuticals Inc (NASDAQ:INO) experienced a decrease in cash equivalents and short-term investments, from $94.1 million at the end of 2024 to $47.5 million by mid-2025. The company anticipates an operational net cash burn of approximately $22 million for the third quarter of 2025. There is uncertainty regarding the potential need for an advisory committee meeting for the BLA submission, which could impact timelines. The company faces competition from other treatments in the RRP space, which could affect market share and enrollment in confirmatory trials. Inovio Pharmaceuticals Inc (NASDAQ:INO) has not provided specific guidance on the size of its commercial organization, which may impact its ability to effectively launch INO 3,107. Q & A Highlights Warning! GuruFocus has detected 5 Warning Signs with INO. Q: Are you anticipating having an advisory committee meeting for the BLA submission of INO 3,107? A: Dr. Mike Sumner, Chief Medical Officer, stated that based on interactions with the FDA, there has been no indication that an advisory committee meeting will be necessary. The overall risk-benefit data presented does not suggest a requirement for such a meeting, although the final decision rests with the agency. Q: How does the upcoming regulatory decision for a competitor affect Inovio's launch plans for INO 3,107? A: Dr. Jackie Shea, President and CEO, highlighted significant differences between Inovio's program and the competitor's, including trial design and technology. Inovio's focus is on a placebo-controlled confirmatory trial, and the differences in technology and trial design suggest distinct paths for each product. Q: Was there any delay in the DV testing for the Selecttra 5 PSP device, and how does it impact the BLA submission timeline? A: Dr. Jackie Shea confirmed that while the DV testing involved multiple external vendors and was complex, the overall timeline for the BLA submission remains on track for the second half of the year, with file acceptance expected by year-end. Q: What is the strategy for a redosing approach for INO 3,107 based on recent data? A: Dr. Mike Sumner explained that Inovio plans to implement a redosing strategy, likely involving annual dosing, to enhance the clinical effect and maintain the reduction in surgeries for RRP patients. This approach leverages the strengths of their DNA medicine platform. Q: How does Inovio plan to address potential enrollment challenges for the confirmatory trial if a competitor's product is approved? A: Dr. Mike Sumner noted that the trial is designed to recruit 100 patients across 20 sites in the U.S., and despite potential market competition, there remains a sizable population of patients who may not have immediate access to the competitor's product due to insurance coverage and other factors. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
08-08-2025
- Business
- Yahoo
Oncolytics Biotech® Reports Second Quarter Financial Results and Details Clinical Program Plans for Pelareorep
Key opinion leader event and pancreatic cancer clinical data validate decision to engage with regulators on plans for a registration-enabling study New members of the management team bring expertise in progressing clinical programs and executing successful biotech transactions Translational data further elucidate pelareorep's mechanism of action and ability to prime the tumor microenvironment for treatment Commitment to limiting dilution evidenced by termination of At-the-Market and Equity Line of Credit facilities SAN DIEGO, Aug. 8, 2025 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today reported financial results and recent highlights for the second quarter of 2025. All dollar amounts are expressed in Canadian currency unless otherwise noted. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, Chief Executive Officer of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." Second Quarter and Subsequent Highlights Poster presentation at the American Society of Clinical Oncology Annual Meeting features translational data further demonstrating pelareorep's mechanism of action. Additional analyses of the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line ("1L") metastatic pancreatic ductal adenocarcinoma ("mPDAC") patients enhance the understanding of pelareorep's ability to stimulate the immune system and enable treatment regimens to be effective in a traditionally hostile tumor microenvironment (click here for the PR, click here for the poster). Pelareorep expands reovirus-specific T cells, increases cytokines and chemokines, and increases tumor-infiltrating lymphocytes ("TILs") in the blood. New Chief Executive Officer Jared Kelly and Chief Business Officer Andrew Aromando hired to optimize pelareorep's development path. Both are experienced biotech executives with decades of experience advising companies, advancing clinical programs, and navigating successful transactions. They were both instrumental in guiding the sale of Ambrx Biopharma to Johnson & Johnson. Analyses of clinical data show pelareorep's ability to improve survival, and translational data confirming how the intended benefits are achieved. Recently highlighted survival data in mPDAC and breast cancer point to meaningful survival benefits for patients treated with pelareorep-based regimens compared to either control arms or historical data (click here for the PR). In 1L mPDAC, a review of landmark studies shows a historical benchmark of 9.2% two-year survival for chemotherapy regimens, in contrast to the 21.9% two-year survival rate recorded for 100 patients receiving pelareorep and chemotherapy. Translational data from multiple studies and tumor types provide evidence as to how these impressive results have been achieved (click here for the PR). In the GOBLET and AWARE-1 studies, pelareorep converted immunologically "cold" tumors to "hot" ones as a result of the upregulation of interferons, CXCL9/10/11, and PD-L1 in addition to the expansion and mobilization of TILs in the blood, which is correlated with a reduction in tumor size. Key Opinion Leader ("KOL") webinar discussion solidifies pelareorep's opportunity in mPDAC and other gastrointestinal cancers. Presentations from KOLs and a roundtable discussion of pelareorep's clinical data in mPDAC and gastrointestinal cancers point to a potentially significant opportunity for an immunotherapeutic drug candidate that already has shown the ability to extend survival for patients (click here for the PR). Specifically, 1L mPDAC would be ideal for pelareorep as there are no immunotherapies approved for that line of treatment, multiple 1L studies have already demonstrated pelareorep's ability to improve survival in that patient population, and it is backed up by translational data showing the ability to activate the immune system and alter the tumor microenvironment so it is more amenable to therapeutic intervention. Strategic decision to pursue registration-enabling pivotal study for pelareorep in 1L mPDAC. Discussions with regulators are underway to finalize the approval pathway for pelareorep in 1L mPDAC (click here for the PR). This includes decisions on which treatment regimens will be involved, whether to collaborate with a third party on the study, and formalizing overall survival as the primary endpoint. The prioritization of the pancreatic cancer program is based on the compelling survival and translational data from previous studies involving over 100 patients, and the particularly high unmet medical need in this indication. Pelareorep has already received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration (the "FDA") for mPDAC. If discussions with regulators proceed as expected and the feedback is positive, start-up activities for the study are expected to commence as early as Q4 2025. Commitment to limiting dilutive financing and maximizing shareholder value. Oncolytics intends to terminate its At-the-Market financing facility with Cantor Fitzgerald and Equity Line of Credit with Alumni Capital. The Company believes it has sufficient capital to reach critical regulatory and clinical milestones this fall and pursue strategic opportunities that demonstrate pelareorep's potential without the need for near-term dilutive financings at this time. Additionally, as separately announced, the Company has given formal notice to delist from the Toronto Stock Exchange (the "TSX"). Once delisted from the TSX, the Company's common shares will continue to trade under the symbol "ONCY" on the Nasdaq. Financial Highlights As of June 30, 2025, the Company reported $14.6 million in cash and cash equivalents, projecting a cash runway through key milestones and into the first quarter of 2026. The net loss for the second quarter of 2025 was $6.2 million, compared to a net loss of $7.3 million for the second quarter of 2024. The basic and diluted loss per share was $0.07 in the second quarter of 2025, compared to a basic and diluted loss per share of $0.10 in the second quarter of 2024. Research and development ("R&D") expenses for the second quarter of 2025 were $2.8 million, compared to $4.6 million for the second quarter of 2024. The decrease was primarily attributable to lower clinical trial expenses as the Company focused its R&D efforts on Cohort 5 of the GOBLET study, which is supported by the Pancreatic Cancer Action Network ("PanCAN") Therapeutic Accelerator Award. General and administrative expenses for the second quarter of 2025 were $2.9 million, compared to $3.4 million for the second quarter of 2024. The decrease was primarily due to lower public company-related expenses, and partially offset by higher personnel-related expenses associated with changes to the management team. Net cash used in operating activities for the six months ended June 30, 2025, was $12.0 million, compared to $14.3 million for the six months ended June 30, 2024. The decrease reflected lower operating activities in 2025, partially offset by higher non-cash working capital changes. Anticipated Milestones Q3 2025: Provide an updated clinical timeline for the registration-enabling pivotal study for pelareorep in 1L mPDAC. As early as Q4 2025: Initiate start-up activities for the registration-enabling study for pelareorep in 1L mPDAC. End of 2025: Updated clinical data regarding safety and efficacy in Cohort 4 of the GOBLET study investigating pelareorep combined with atezolizumab in anal carcinoma. Q4 2025: Initial responses from the U.S. Patent and Trademark Office ("PTO") regarding the company's application to extend patent protection for pelareorep. Annual General Meeting and Conference Call Change Management is hosting the Annual General Meeting later today at 10:00 a.m. ET, August 8, 2025. Oncolytics' Chief Executive Officer, Jared Kelly, will provide a brief update after the formal portion of the meeting. To access the meeting as a guest (i.e., a non-voting shareholder): Visit the webcast site: Click the button "I am a Guest" and complete the form If necessary, provide the case-sensitive password: onc2025 Information on how to vote your shares by proxy and attend the meeting as a shareholder is available in the Company's most recent Management Information Circular (the "Circular") dated June 18, 2025. The Circular is available on the Reports page of the investor relations section of the Company's website at and in Canadian and American securities filings. Going forward, Oncolytics will continue to announce quarterly financial results via press releases and in securities filings, but will no longer host quarterly conference calls with the management team. ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) (in thousands of Canadian dollars, except share amounts) As at June 30,2025December 31,2024 AssetsCurrent assetsCash and cash equivalents $ 14,626$ 15,942 Other receivables 7268 Prepaid expenses 3,1741,885 Warrant derivative 1,024980 Total current assets 18,89618,875 Property and equipment 351411 Right-of-use assets 727901 Total assets $ 19,974$ 20,187 Liabilities and Shareholders' EquityCurrent liabilitiesAccounts payable and accrued liabilities $ 5,285$ 4,792 Other liabilities 9821,618 Lease liabilities 291277 Total current liabilities 6,5586,687 Contract liability 6,7306,730 Lease liabilities 597787 Total liabilities 13,88514,204 Commitments Shareholders' equity Share capital Authorized: unlimited Issued: June 30, 2025 – 97,407,903 December 31, 2024 – 80,020,131 451,142438,193 Contributed surplus 44,79244,542 Accumulated other comprehensive income 720961 Accumulated deficit (490,565)(477,713) Total shareholders' equity 6,0895,983 Total liabilities and shareholders' equity $ 19,974$ 20,187 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) (in thousands of Canadian dollars, except share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025202420252024 Expenses Research and development $ 2,809$ 4,558$ 6,892$ 10,301 General and administrative 2,8973,3625,8136,345 Loss before the following (5,706)(7,920)(12,705)(16,646) Change in fair value of warrant derivative (196)235441,104 Foreign exchange (loss) gain (282)184(333)701 Interest income, net 104340227786 Loss before income taxes (6,080)(7,161)(12,767)(14,055) Income tax expense (85)(95)(85)(95) Net loss (6,165)(7,256)(12,852)(14,150) Other comprehensive (loss) income items that may be reclassified to net loss Translation adjustment (238)52(241)178 Comprehensive loss $ (6,403)$ (7,204)$ (13,093)$ (13,972) Basic and diluted loss per common share $ (0.07)$ (0.10)$ (0.15)$ (0.19) Weighted average number of shares (basic and diluted) 90,999,58676,090,40687,833,10775,667,521 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) (in thousands of Canadian dollars) Share CapitalContributed SurplusAccumulated Other ComprehensiveIncomeAccumulated DeficitTotal As at December 31, 2023 $ 430,906$ 42,116$ 544$ (446,003)$ 27,563 Net loss and other comprehensive income ——178(14,150)(13,972) Issued pursuant to incentive share award plan 3(3)——— Issued pursuant to "At the Market" Agreement 3,840———3,840 Share issue costs (202)———(202) Share-based compensation expense —1,082——1,082 As at June 30, 2024 $ 434,547$ 43,195$ 722$ (460,153)$ 18,311 As at December 31, 2024 $ 438,193$ 44,542$ 961$ (477,713)$ 5,983 Net loss and other comprehensive loss ——(241)(12,852)(13,093) Issued pursuant to incentive share award plan 1,481(1,481)——— Issued pursuant to "At the Market" Agreement 8,714———8,714 Issued pursuant to share purchase agreement 3,841———3,841 Share issue costs (1,087)———(1,087) Share-based compensation expense —1,731——1,731 As at June 30, 2025 $ 451,142$ 44,792$ 720$ (490,565)$ 6,089 ONCOLYTICS BIOTECH INC. CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) (in thousands of Canadian dollars) Six Months Ended June 30, 20252024 Operating Activities Net loss for the period$ (12,852)$ (14,150) Depreciation - property and equipment 5156 Depreciation - right-of-use-assets 140165 Share-based compensation expense 1,7311,082 Interest expense on lease liabilities7457 Unrealized foreign exchange loss (gain)1(576) Change in fair value of warrant derivative (44)(1,104) Net change in non-cash working capital (1,070)182 Cash used in operating activities(11,969)(14,288) Investing Activities Acquisition of property and equipment—(201) Cash used in investing activities—(201) Financing Activities Proceeds from "At the Market" equity distribution agreement, net 8,3863,638 Proceeds from share purchase agreement, net 3,082— Payment of lease liabilities(205)(168) Cash provided by financing activities11,2633,470 Decrease in cash and cash equivalents(706)(11,019) Cash and cash equivalents, beginning of period15,94234,912 Impact of foreign exchange on cash and cash equivalents(610)957 Cash and cash equivalents, end of period$ 14,626$ 24,850 About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer and early-phase studies in anal and colorectal cancer. It induces anti-cancer immune responses by converting immunologically "cold" tumors "hot" through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, both of which have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include statements regarding Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; its upcoming milestones; its belief that we will establish our position as the only platform immunotherapy in gastrointestinal tumors; its plans for a potential registration-enabling pivotal study in 1L mPDAC; the anticipated potential timing of commencement of start-up activities and enrollment in a study; the focus of its discussions with the FDA in respect of the study; the anticipated trial design; its plan to delist from the Toronto Stock Exchange; its plans with respect to shareholder communications; and its plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; its belief in the clinical promise of pelareorep in mPDAC and other gastrointestinal cancers; financial projections and the sufficiency of capital to reach critical milestones and pursue strategic opportunities and its need for near-term dilutive financing. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics' public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law. Company Contact Jon PattonDirector of IR & Communicationjpatton@ Investor Relations for OncolyticsMike MoyerLifeSci Advisors+1-617-308-4306mmoyer@ Media Contact for OncolyticsOwen BlaschakLifeSci Communicationsoblaschak@ Logo: View original content: SOURCE Oncolytics Biotech® Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
08-08-2025
- Business
- Yahoo
CytomX Therapeutics Inc (CTMX) Q2 2025 Earnings Call Highlights: Strategic Advances Amid ...
Cash and Investments: $158.1 million as of June 30, 2025. Revenue: $18.7 million for Q2 2025, compared to $25.1 million in Q2 2024. Operating Expenses: $19.9 million for Q2 2025, down from $33.6 million in Q2 2024. R&D Expenses: $13.3 million for Q2 2025, a decrease of $11.9 million from Q2 2024. General and Administrative Expenses: $6.6 million for Q2 2025, down from $8.4 million in Q2 2024. Cash Runway: Projected to last until Q2 2027. Warning! GuruFocus has detected 5 Warning Signs with CTMX. Release Date: August 07, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive Points CytomX Therapeutics Inc (NASDAQ:CTMX) announced promising clinical data for CX-2051, showing a 28% confirmed overall response rate and 94% disease control in colorectal cancer patients. The company completed a $100 million follow-on offering, strengthening its financial position with a cash runway projected to the second quarter of 2027. CX-2051's probody masking technology successfully avoids EpCAM toxicities, such as pancreatitis, which have hindered previous drug developments. CytomX Therapeutics Inc (NASDAQ:CTMX) is making progress with CX-801, a masked interferon alpha 2b program, in combination with Keytruda, targeting metastatic melanoma. The company is exploring potential expansion of CX-2051 into earlier lines of colorectal cancer therapy and other solid tumors, indicating a broad scope for future development. Negative Points CytomX Therapeutics Inc (NASDAQ:CTMX) reported a decrease in total revenue to $18.7 million from $25.1 million in the second quarter of 2024, attributed to the completion of performance obligations in collaborations. Operating expenses remain high, with $19.9 million reported for the second quarter, although this is a decrease from the previous year. The company faces challenges in managing adverse events such as diarrhea, nausea, vomiting, and anemia in the CX-2051 trial. There is uncertainty regarding regulatory pathways for accelerated approval in colorectal cancer, as there is no precedent for approval based on overall response rate in this setting. CytomX Therapeutics Inc (NASDAQ:CTMX) is heavily reliant on the success of its key programs, CX-2051 and CX-801, which are still in early stages of clinical development. Q & A Highlights Q: What factors are influencing the decision to move CX-2051 into earlier lines of colorectal cancer therapy, and how will these trials be announced? A: Sean McCarthy, CEO, explained that while the focus is currently on late-line opportunities, moving into earlier lines will require combination studies to assess doses selected for Phase 2 monotherapy. The company is considering combinations with drugs like bevacizumab to enter third and second lines of treatment, aiming to replace irinotecan. The strategy will be announced after completing the Phase 1 study and dose selection. Q: What is the strategy for expanding CX-2051 beyond colorectal cancer, and are partnerships being considered? A: Sean McCarthy, CEO, noted that while the current focus is on colorectal cancer, EpCAM is expressed in many solid tumors, presenting a broad opportunity. The company is open to partnerships for expanding CX-2051's development beyond colorectal cancer when the time is right, but the immediate focus remains on maximizing value in colorectal cancer. Q: What is the bar for accelerated approval in colorectal cancer for CX-2051, and is ORR the most relevant outcome? A: Sean McCarthy, CEO, acknowledged the lack of precedent for accelerated approval in colorectal cancer based on ORR. While PFS and OS are typical endpoints, the unmet need and encouraging activity of CX-2051 suggest potential for accelerated approval discussions with the FDA. The regulatory landscape remains uncertain, but the goal is to expedite patient access. Q: What are the expectations for the preliminary CX-801 monotherapy data in Q4, and how will it inform the combination potential with Keytruda? A: Sean McCarthy, CEO, stated that the preliminary data will focus on translational insights from tumor biopsies, assessing how CX-801 modulates the tumor microenvironment and upregulates interferon-stimulated genes like PDL1. This data will support the rationale for combining CX-801 with Keytruda, with combination safety and efficacy data expected in 2026. Q: What should be expected from the Phase 1 update for CX-2051 in Q1 2026, and will it include biomarker data? A: Sean McCarthy, CEO, indicated that the update will include data from approximately 70 patients across three dose levels, with a focus on clinical activity and safety. The update will also outline the strategy for Phase 2 development. While biomarker data may be included, the primary focus will be on clinical outcomes and dose selection. Q: What are the criteria for advancing CX-2051 to Phase 2 as a monotherapy in fourth-line colorectal cancer? A: Sean McCarthy, CEO, highlighted that the initial 28% confirmed ORR in Phase 1 is promising for advancing to Phase 2. While a specific ORR threshold isn't set, the data provides flexibility for decision-making. The focus is on maintaining a strong efficacy profile as data matures. Q: Are multiple combinations being considered for CX-2051 in earlier lines of colorectal cancer, and have there been discussions with the FDA? A: Sean McCarthy, CEO, confirmed that multiple combinations are possible, with bevacizumab being a likely starting point. Significant FDA discussions on combination strategies will occur as Phase 1 data matures. Q: How is CytomX addressing grade 3 diarrhea in CX-2051 trials, and what follow-up is expected for the Q1 update? A: Sean McCarthy, CEO, stated that prophylactic measures like loperamide are being used to manage diarrhea, with ongoing evaluation of its effectiveness. By Q1 2026, the company expects substantial follow-up data from the expansion cohorts, although specific follow-up duration wasn't provided. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
23-07-2025
- Business
- Yahoo
IDEAYA Biosciences Announces 10-Year Anniversary R&D Day on September 8, 2025 to Present Multiple Clinical Data Updates and Outline Future Growth Strategy
SOUTH SAN FRANCISCO, Calif., July 23, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced it will host an in-person and virtual R&D Day on September 8, 2025 from 8:00am to 10:00am ET in New York City to present multiple clinical data updates across the pipeline and highlight the next key drivers of growth and upcoming milestones. "This year marks IDEAYA's ten-year anniversary since our founding, and we look forward to providing multiple clinical data updates across our potential first-in-class pipeline, and highlight our strategic vision, priority areas of scientific focus, and emerging clinical pipeline that will drive the next phase of our growth as a global leader in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Speakers will include members of IDEAYA's senior leadership team and key opinion leader(s). Registration for this event can be accessed here or at the investors section of the IDEAYA website at About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies to address unmet medical needs in cancer. The company integrates small molecule drug discovery, structural biology and bioinformatics with extensive capabilities in identifying and validating translational biomarkers to develop potentially first-in-class targeted therapies for selected patient populations. IDEAYA has built a robust pipeline of targeted therapies focused on synthetic lethality and antibody-drug conjugates, or ADCs, including bispecifics, with the goal of improving clinical outcomes for patients with cancer. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to participation in and/or presentation at a certain investor relation event. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's current and future filings with the U.S. Securities and exchange Commission, including its Annual Report on Form 10-K filed on February 18, 2025. Investor and Media Contact IDEAYA BiosciencesJoshua Bleharski, Financial Officer investor@ View original content to download multimedia: SOURCE IDEAYA Biosciences, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
