Onvansertib

Onvansertib in combination with trastuzumab deruxtecan demonstrated enhanced antitumor activity, including tumor regression and apoptosis in HER2-low breast cancer models, supporting its potential for patients with limited treatment options SAN DIEGO, Calif., April 17, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, will present new preclinical data in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17–22 in San Diego, California. These data highlight the potential of Cardiff’s highly specific oral PLK1 inhibitor, onvansertib, in combination with the HER2-targeted antibody-drug conjugate (ADC), trastuzumab deruxtecan (T-DXd), demonstrating robust antitumor activity and the ability to overcome resistance in HER2-low breast cancer models. “These preclinical findings highlight a potential new opportunity for onvansertib, demonstrating its ability to enhance the activity of ADCs, which are becoming mainstays in oncology across multiple indications,” said Tod Smeal, Ph.D., Chief Scientific Officer of Cardiff Oncology. “By enhancing and prolonging DNA damage, this combination appears to drive greater apoptosis than either agent alone, offering a promising new approach for patients whose cancers have become resistant to standard-of-care treatments.” Poster Presentation Highlights: Onvansertib + T-DXd synergistically inhibited the viability of HER2-low breast cancer cell lines, including fulvestrant- and CDK4/6i-resistant cells In the resistant triple-negative breast cancer model and two hormone receptor-positive models, the combination drove tumor regression in nearly all mice, with complete response rates up to 62% Increased tumor regression, improved tumor growth inhibition, and extended event-free survival across models Combination showed favorable tolerability in vivo Following the presentation on April 19, 2026 from 2:00–5:00 PM PT, the poster titled “PLK1 inhibitor onvansertib potentiates the antitumor efficacy of trastuzumab deruxtecan (T-DXd) and reverses its resistance in therapy-resistant HER2-low breast cancer models” will be available on the Scientific Publications page of the Company's website. About Onvansertib Onvansertib is a highly specific, oral PLK1 inhibitor currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer. It 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; 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

→ Anthropic keeps deepening its ties to the biopharma industry, appointing Novartis CEO Vas Narasimhan to its board. The AI giant recently acquired Coefficient Bio , a New York-based stealth AI biotech. Narasimhan, who has led Novartis since 2018 and previously served as PhRMA’s chair, will bring a healthcare industry perspective to a board that also includes former Microsoft and General Motors CFO Chris Liddell , and Netflix co-founder Reed Hastings . → Obesity pill developer Structure Therapeutics has hired Matthew Lang as COO and general counsel. Lang was most recently chief legal officer at obesity player Metsera , where he helped choreograph the biotech’s acquisition by Pfizer for $7.6 billion upfront last year. Perhaps Structure is contemplating a similar deal, or perhaps it felt it needed a new lawyer on board after Novo Nordisk ’s recent legal travails. Novo was forced to sue Hims & Hers alleging patent infringement after the compounder launched a copycat of its oral Wegovy pill in February. The two companies eventually reached a truce, but Structure might want to guard against a similar situation emerging if its GLP-1 pill, called aleniglipron , gains approval too. The asset recently generated highly promising Phase 2 data. Lang spent more than six years with Myovant and helped guide the development, approval and sale of endometriosis drug Myfembree and prostate cancer therapy Orgovyx . He was also chief business and legal officer at Lyell Immunopharma . → ADC specialist Kivu Bioscience had been operating without a CEO since it spun out of Synaffix in 2024 . But president and COO Mohit Trikha has been the voice of the company from the beginning, and his appointment as CEO this week was billed as a “natural next step” by chairman Daniel O’Connell . Trikha has pharma experience from AbbVie as its head of oncology early development from 2017-22, and he was also a venture partner at Apple Tree Partners , which has since filed for bankruptcy. He used to sit on the board at Replicate Bioscience and Galvanize Therapeutics , two biotechs from the ATP portfolio. → Cardiff Oncology has officially tapped Mani Mohindru as permanent CEO, and it has recruited Josh Muntner as CFO. When Cardiff released mixed Phase 2 data for its colorectal cancer drug onvansertib , Mohindru replaced Mark Erlander on an interim basis that same day and finance chief James Levine stepped down. Mohindru will keep her spot on the board of directors. Muntner held the CFO post at Imvax and Mesoblast before coming to Cardiff last week. He won’t be the new guy for much longer, because Ajay Aggarwal will become COO on April 27. Aggarwal has spent the last four and a half years with Aclaris Therapeutics as head of clinical development. → Prime Medicine is finally getting a new CFO in Svetlana Makhni , who is joining the gene editing company from Marengo Therapeutics . The move comes after Prime’s former finance chief Allan Reine became CEO last May as part of a broader revamp . Prime earlier this year reversed course and said it would continue to develop a previously shelved therapy for a rare condition called chronic granulomatous disease. The company also expects to enter the clinic soon for two liver disease programs. → Parabilis Medicines has introduced Helen Ho as chief business and strategy officer, and promoted Tom Kotarakos to CFO. Ho is the latest Blueprint Medicines exec to find a new home, serving as CBO until it was sold to Sanofi . “After taking some time off to reflect on what I wanted my next chapter to look like, I knew I wasn’t just looking for a role,” Ho wrote in a LinkedIn post . “For me, it’s identifying the right problem to solve, the very best people to solve it with, and the opportunity to be part of something truly extraordinary. This is what led me to Parabilis Medicines.” Kotarakos joined Mathai Mammen ’s crew as SVP of finance in 2021, when it was named FogPharma and led by Greg Verdine . Kotarakos’ LinkedIn page says he was elevated to CFO in February, a month after Parabilis announced a $305 million Series F. → Jack O’Meara ’s brain drug company Aerska has appointed co-founder Stuart Milstein as chief platform officer, and added Sonoma Biotherapeutics COO Lisa Taylor Ash to its board. Milstein brings RNA experience from Alnylam , Korro Bio and Sail Biomedicines . Aerska is developing targeted RNA treatments for brain diseases like Alzheimer’s and Parkinson’s, and debuted in October with $21 million in seed funding. → Corbus Pharmaceuticals medical chief Dominic Smethurst will resign on June 30, according to an SEC filing . Smethurst took this job in early 2024 after three years as CMO of Bicycle Therapeutics . Corbus reported Phase 1a data in December for its CB1 inverse agonist CRB-913 in obesity, and it’s also developing a Nectin-4 ADC called CRB-701 . → ALX Oncology ’s CD47 aspirations have run into some potholes , while other biotechs have similarly been foiled in the space. But the South San Francisco biotech keeps plugging away with evorpacept , and it’ll do so with Jeff Knight as chief development and operating officer. On April 10, Knight resigned from the same position at Crinetics Pharmaceuticals , which now sells the acromegaly treatment Palsonify . The Amgen vet was SVP, portfolio management, alliance management and corporate operations at the end of a three-year run with Poseida Therapeutics . → Zealand Pharma has signed up Eric Rojas as its new head of investor relations. Rojas joins the company at a tricky time: Its share price slid more than 30% after its Roche -partnered amylin analog posted weaker-than-expected mid-stage data last month. He has held senior investor relations positions at companies including Stoke Therapeutics , Vertex and Shire . Zealand has another shot on goal with its obesity and fatty liver disease drug survodutide , though that is being developed by Boehringer Ingelheim under the partners’ licensing deal. Phase 3 obesity data on survodutide, a GLP-1 and glucagon agonist, are due in the summer. → Harbour BioMed — Chinese biotech partner to the stars — has lined up Bristol Myers Squibb and Merck alum Adam Zong as president. Zong was the founding CEO of Hengrui Therapeutics in the US and then president and COO of Seven & Eight Biopharmaceuticals from 2017-21. Harbour BioMed has teamed up with Bristol Myers, AstraZeneca , Otsuka and others, with an R&D engine that’s humming along in I&I diseases and immuno-oncology. → As Idorsia searches for a CEO, Amer Joseph will go to the Swiss biotech on May 1 as CMO and head of global clinical development. Alberto Gimona , who worked with Jean-Paul Clozel at Actelion in the 2010s, is retiring after four years of leading global clinical development and seven years overall at Idorsia. Joseph handled global clinical development duties for Chiesi and had two separate stints at Bayer (with a brief stop at GSK in between). Clozel has filled in as interim CEO since Srishti Gupta ’s departure . → Evotec has made its second major hire this month, naming Ingrid Müller as COO. Müller was VP of portfolio strategy & execution at fellow German company CureVac until rival BioNTech bought the vaccine maker for $1.25 billion. She also spent eight years with Sanofi, culminating in her role as SVP, global procurement outsourcing & external manufacturing. While Müller starts her new job at Evotec on May 1, ex- Iktos CBO Ashiq Khan is settling in as chief commercial officer. → Matthew Gall is replacing Daniella Beckman as CFO of targeted cancer drug developer Tango Therapeutics . Gall is joining Tango after a brief stop at eye therapy developer Kalaris Therapeutics in the same role. Tango has also hired MorphoSys vets Yen-Ching Chua as chief development operations officer, and Janice Kapty as SVP of corporate strategy and project leadership. Tango’s shares $TNGX jumped 20% this week following a highly promising Phase 3 readout from Revolution Medicines ’ pancreatic cancer drug. Tango is studying its PRMT5 inhibitor vopimetostat in combination with Revolution Medicines’ treatments in both pancreatic and lung cancers, and expects to have initial data from that combination trial this year. → Charles Morris has replaced Jane Huang as CMO of Prelude Therapeutics , which shelved its SMARCA2 degrader program in favor of a KAT6A degrader to treat ER+ breast cancer. Morris took on the same responsibilities at Lava Therapeutics , Celyad Oncology and Radius Health . No word on what’s next for Huang, who joined Prelude in 2022 after six years at BeOne Medicines (then known as BeiGene ). → Former Acorda medical chief Burkhard Blan k has reunited with Ron Cohen at Oryon Cell Therapies . Blank will serve as Oryon’s CMO, leaving his post at MannKind Corporation . Oryon is one of a handful of biotech companies developing Parkinson’s cell therapies derived from stem cells. Blank brings experience developing Parkinson’s drugs from his time at Acorda, where he oversaw the Phase 3 program and approval for Inbrija , as well as from Boehringer Ingelheim. His new role comes after longtime Acorda leader Cohen joined Oryon as CEO earlier this year as the company raised $21 million. → Harmony Biosciences has followed up its appointment of COO Peter Anastasiou by hiring Glenn Reicin as finance chief. This is Reicin’s fourth CFO job this decade, following stops at Sigilon Therapeutics , now-defunct Alladapt Immunotherapeutics and AstraZeneca’s oral GLP-1 partner Eccogene . Reicin succeeds Sandip Kapadia , who had held this position for the past five years. → With the demise of iTeos Therapeutics behind her, Yvonne McGrath has moved on to French protein degradation biotech Enodia Therapeutics as CSO. McGrath was promoted to CSO at iTeos in 2022, but it had to shut down last year as the TIGIT field continues to take on water. Enodia kicked off 2026 with a €20.7 million seed round. → Wolfram Brugger has been named CMO at Swedish gene therapy maker Asgard Therapeutics . Brugger led clinical development at CAR-T cell therapy shop Autolus and helped develop the lymphoma drug tafasitamab at MorphoSys. Incyte shelled out $25 million for the full global rights to tafasitamab, now marketed as Monjuvi . Johnson & Johnson Innovation – JJDC and Novo Holdings contributed to Asgard’s €30 million Series A in March 2024. Is another round of financing on the horizon? → On the heels of Inhwan Kim ’s promotion, Boulder, CO biotech Enveda has installed Christopher Porter as SVP, clinical operations. Porter just completed a stint at Theravance Biopharma as VP of development strategy and innovation, and he arrives at a critical juncture after Enveda released the first clinical data for its atopic dermatitis hopeful ENV-294 . → Prothena has promoted Annie Kingston to chief strategy officer and Michael Isaacs to general counsel. Kingston celebrates her third anniversary with the company this month and she’s been VP, corporate strategy and chief of staff since March 2025. Isaacs was elevated to deputy general counsel in 2023 and he’ll get started in his new role when current legal chief Michael Malecek leaves in June. → Rytelo maker Geron has selected Tim Williams as chief legal officer. Williams had been busy with legal work as general counsel at Vanda Pharmaceuticals since 2018. Vanda’s motion sickness drug Nereus was approved as 2025 drew to a close, after the company dropped a lawsuit against the FDA over a partial clinical hold of the drug. → Adagene has welcomed ex- J&J oncology exec Peter Lebowitz to its scientific and strategic advisory board. Lebowitz runs Endpoints 11 winner Third Arc Bio , which raised a $165 million Series A in July 2024 and is partnering with Adagene on “masked” T cell engagers. → Ottimo Pharma CEO David Epstein has joined the board of directors at Frontier Medicines , which hasn’t pulled the trigger on an IPO yet and raised a Series C round in 2024. Epstein chairs the board at newly public biotech Agomab and ran Seagen when it was purchased by Pfizer. → In other boardrooms, Aktis Oncology is bringing in Daiichi Sankyo veteran Glenn Gormley , while Helen Kim and Oleg Nodelman will depart on May 26; Orum Therapeutics has added ex-Bicycle and Repare Therapeutics CMO Maria Koehler and Locust Walk ’s Geoff Meyerson ; Anika Therapeutics chair Cheryl Blanchard has clinched a spot at Xilio Therapeutics ; and Edwin Moses will be chairman of Oxford, UK-based Greywolf Therapeutics after chairing the board at Amgen’s M&A prize Dark Blue Therapeutics . Andrew Dunn contributed to this edition. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.