Bevacizumab

AUSTIN, Texas & VANCOUVER, Wash.--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, and CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn”), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, today announced a strategic collaboration to evaluate circulating tumor DNA (ctDNA) dynamics and generate real-world molecular insights to support CytoDyn’s metastatic colorectal cancer (mCRC) development program. Under the agreement, Natera will assess CytoDyn clinical trial samples from the CLOVER Phase 2 study (ClinicalTrials.gov Identifier: NCT06699836 ) in patients with mCRC. Signatera TM , Natera’s personalized assay for the detection of molecular residual disease (MRD), will be used to evaluate ctDNA dynamics and molecular response patterns associated with leronlimab treatment. Natera will also provide customized real-world data (RWD) analyses leveraging its proprietary oncology database, which is the largest multi-timepoint early- and late-stage oncology dataset with more than 2 million plasma timepoints and enriched clinical and imaging records. By integrating molecular response data from its MRD testing platform with curated electronic medical record (EMR) data, this multimodal dataset enables analyses of patient populations, treatment patterns, ctDNA response rates, and response dynamics across diverse clinical settings. Together, these capabilities are expected to generate insights into molecular response and disease progression that may help inform future clinical development of leronlimab, including clinical trial design, biomarker-driven patient selection strategies, and broader translational research efforts. The collaboration builds on CytoDyn’s growing oncology program and follows completion of enrollment in the CLOVER study, which is evaluating leronlimab in combination with trifluridine/tipiracil (TAS-102) and bevacizumab in patients with previously treated mCRC. The collaboration is also expected to complement ongoing translational and biomarker analyses from the study aimed at further characterizing treatment response and informing future development strategies. “Signatera has become an increasingly important tool in precision oncology and clinical development,” said Jacob Lalezari, M.D., chief executive officer, CytoDyn. “Through this collaboration, we expect to gain valuable insights into ctDNA response kinetics and disease progression that may help guide future development strategies for leronlimab in colorectal cancer and potentially other solid tumor indications.” “We are pleased to partner with CytoDyn and provide their team with insights derived from one of the largest and most comprehensive real-world molecular oncology data platforms,” said Matt Love, vice president, biopharma data & AI partnering, Natera. “Our platform enables biopharma partners to better understand disease biology, treatment response, and patient outcomes, helping inform key development decisions throughout the drug development lifecycle.” About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit . About CytoDyn CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide. For more information, please visit and follow us on LinkedIn . Forward-Looking Statements (for Natera) All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at and . Forward-Looking Statements (for CytoDyn) This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law. Contacts Contacts (for Natera) Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com Contacts (for CytoDyn) Corporate Contact: CytoDyn Inc., ir@cytodyn.com Media: David Schull or Ignacio Guerrero-Ros, Ph.D.; Russo Partners, LLC, CytoDyn@russopartnersllc.com

-​ The trial achieved its primary goal of selecting the efficacious and safe dose of onvansertib + standard-of-care (SoC) regimen for the registrational program -​ -​ 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a dose-dependent improvement in efficacy, including confirmed ORR of 72.2% compared to 42.1% for SoC -​ -​ Median PFS has not been reached in either 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arm, with nine of the 14 patients remaining on treatment in these arms -​ - Onvansertib continues to be safe and well-tolerated with no overlapping or new toxicities when added to SoC -​ - Registrational trial planned in first-line RAS-mutated mCRC following successful End-of-Phase 2 meeting with FDA -​ - Company to hold an investor webcast tomorrow, June 3, 2026 at 8:30 am ET/5:30 am PT to review the Phase 2 CRDF-004 data and registrational study plans for onvansertib - SAN DIEGO, June 02, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced positive results from CRDF-004, a randomized, controlled, dose-finding Phase 2 clinical trial evaluating onvansertib in combination with SoC regimens (FOLFIRI/bevacizumab (bev) or FOLFOX/bev) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results showed that the selected dose/regimen of the registrational program, onvansertib 30 mg + FOLFIRI/bev, demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) compared to SoC alone, with no additive adverse events. The data were presented today by Heinz-Josef Lenz, MD, associate director for clinical research and co-leader of the GI cancers program at the University of Southern California (USC) Norris Comprehensive Cancer Center, in a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Following the completion of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the Company has aligned on the design of the registrational trial with onvansertib in mCRC. The randomized, controlled Phase 3 trial will evaluate the safety and efficacy of onvansertib 30 mg + FOLFIRI/bev as first-line therapy versus standard-of-care FOLFIRI/bev in patients with RAS-mutated mCRC. “RAS-mutated metastatic colorectal cancer remains a significant clinical challenge, with limited therapeutic progress over the past two decades. Patients with RAS-mutated mCRC continue to face poor outcomes, and there are currently no treatment options specifically approved for patients with RAS-mutated mCRC—except for KRAS G12C mutations, which account for less than 4% of all colorectal cancers,” said Dr. Lenz. “With its novel mechanism of action, onvansertib, when combined with FOLFIRI/bev, demonstrated deep and durable tumor shrinkage over time. A positive confirmatory Phase 3 study that builds on the Phase 2 data presented today could potentially establish onvansertib + FOLFIRI/bev as a new standard-of-care for these patients.” Data Highlights from the ongoing Phase 2 trial (Data cut: March 18, 2026): In the intent-to-treat (ITT) population, the dose selected for the registrational program, 30 mg onvansertib arm in combination with FOLFIRI/ bev achieved: Primary endpoint of confirmed objective response rate of 72.2% (13/18), compared with 42.1% (8/19) for FOLFIRI/bev alone, a 30% improvement over standard-of-care (SoC). The responses were deeper and more durable in the onvansertib arm. Secondary endpoint of progression free survival (PFS) hazard ratio (HR) of 0.55 (95% CI: 0.15–2.09) and 0.57 (95% CI: 0.20–1.65) vs. FOLFIRI/bev by Blinded Independent Central Review (BICR) and investigator assessment (IA), respectively. Median PFS not reached in 30 mg onvansertib + FOLFIRI/bev arm, but has been reached in both SoC arms. Four patients remain on onvansertib treatment beyond 15 months, including 2 beyond 20 months. Notably, fourteen patients remain on trial, with nine patients in the onvansertib (20 or 30 mg) plus FOLFIRI/bev arms and one patient remaining on SoC. No meaningful differences in efficacy were observed between the onvansertib + FOLFOX/bev arms and FOLFOX/bev alone. Safety/Tolerability: Onvansertib in combination with both chemotherapy (FOLFIRI or FOLFOX)/bev regimens was well-tolerated. There were no major or unexpected toxicities observed and no additive adverse events reported. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event across both the onvansertib combination and SoC arms. “We are excited to share these updated results and are highly encouraged by the consistent efficacy seen with onvansertib in combination with FOLFIRI/bev across two clinical trials in patients with RAS-mutated mCRC,” said Mani Mohindru, PhD, President and Chief Executive Officer. “The data generated to date continue to support the potential of onvansertib in combination with standard-of-care FOLFIRI/bev in RAS-mutated mCRC and reinforce our plans to advance the program into a global registrational study. We look forward to providing additional updates on those plans in the coming months.” The ASCO presentation will be made available on the Scientific Publications page of the Company’s website following the rapid oral presentation. Conference Call and Webcast The investor webcast will take place on June 3, 2026 at 8:30 am ET/5:30 am PT. To register for and access the live webcast, please visit the “Events” page of the Cardiff Oncology website. The slides from the conference call will be posted after the call has concluded. CRDF-004 Trial Design The CRDF-004 Phase 2 trial was designed to evaluate the safety, efficacy, and pharmacokinetics of two different doses of onvansertib in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab in first-line patients with KRAS- or NRAS-mutated metastatic colorectal cancer (mCRC). The randomized, controlled trial was designed to enroll 110 patients across 6 different arms, and the trial’s endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response, and safety. For additional information about the trial, please visit (Trial ID: NCT06106308). About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab for advancement into a registrational trial in first-line patients with RAS-mutated mCRC. Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML). About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients. For more information, please visit . Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; ; uncertainty as to the outcome of pending litigation against Nerviano Medical Sciences S.r.l. with respect to our license agreement with Nerviano; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Investor Contact: Candice Masse astr partners candice.masse@astrpartners.com Media Contact: Amy Bonanno Lyra Strategic Advisory abonanno@lyraadvisory.com