Cardiff Oncology Appoints New CEO
Cardiff Oncology announced a leadership transition. Mani Mohindru, PhD, a member of Cardiff Oncology's Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles. As part of this transition, Brigitte Lindsay has been promoted to the role of Chief Accounting Officer. She has been with the Company for more than 14 years and was most recently the Senior Vice President of Finance.
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- Management Changes: Cardiff Oncology announced the resignation of CEO Mark Erlander and CFO James Levine, with board member Mani Mohindru appointed as interim CEO, reflecting a focus on execution and clinical advancement that may impact investor confidence negatively.
- Clinical Trial Data Update: In the CRDF-004 Phase 2 trial for RAS-mutated metastatic colorectal cancer, the 30 mg dose group achieved a confirmed objective response rate of 72.2%, significantly higher than the 43.2% in the standard care group, indicating the potential efficacy of the new drug and possibly driving future registrational trials.
- Registrational Trial Plans: Based on clinical data, Cardiff Oncology plans to initiate a registrational trial later this year comparing onvansertib with standard care for 1L patients, which, if successful, could help expand market share.
- Analyst Perspective: William Blair lowered the probability of success from 50% to 45%, suggesting that the abrupt management changes and narrow focus on onvansertib may limit market opportunities, leading to a 31.9% drop in stock price to $2, close to the 52-week low.
- Executive Departures: Cardiff Oncology's CEO Mark Erlander and CFO James Levine resigned, causing shares to plummet approximately 35% to a new 52-week low, indicating market concerns over leadership instability.
- Interim Leadership: The board appointed veteran biotech executive Mani Mohindru as interim CEO to replace Erlander, ensuring operational continuity during the executive transition period.
- Financial Stability: Brigitte Lindsay was promoted to Chief Accounting Officer to maintain the finance department's functionality, reflecting the company's commitment to financial management amid leadership changes.
- Clinical Trial Update: Cardiff announced plans to further test a 30 mg dose of its lead drug onvansertib in combination with FOLFIRI/bevacizumab, with a registrational trial expected to begin later this year pending FDA design confirmation, aiming to provide new treatment options for RAS-mutated metastatic colorectal cancer.

- Regulatory Milestone: Oncolytics Biotech has secured FDA approval for its pivotal Phase 3 trial design for pelareorep in pancreatic cancer, marking a significant step in a field lacking existing immunotherapy options, potentially providing new treatment avenues for patients.
- Clinical Trial Design: The trial will compare standard chemotherapy with pelareorep, with overall survival as the primary endpoint, and success could solidify Oncolytics' position in a competitive market, enhancing its market standing.
- Market Potential: Analysts project the global immuno-oncology market will grow at a CAGR of 15.7% to reach $416.28 billion by 2034, positioning Oncolytics favorably within this rapidly expanding sector.
- Strategic Development: Oncolytics has also established a Gastrointestinal Scientific Advisory Board to advance pelareorep beyond pancreatic cancer, further expanding its market potential and demonstrating the company's strategic focus on multiple tumor types.

Clinical Trial Results: Cardiff Oncology presented new data from a Phase 1 trial of onvansertib, a PLK1 inhibitor, for treating relapsed/refractory chronic myelomonocytic leukemia (CMML) at the ASH Annual Meeting, showing preliminary efficacy in about 40% of patients.
Drug Tolerability: Onvansertib was well-tolerated as a monotherapy, with manageable treatment-emergent adverse events reported among the nine enrolled patients.
Future Development Plans: Although Cardiff Oncology does not plan to further develop onvansertib for CMML, the results support its potential in treating various hematologic and solid tumors.
Stock Performance: Following the announcement, Cardiff Oncology's stock rose by 10.90% to $2.34, with a slight increase in after-hours trading, reflecting positive investor sentiment.

- Clinical Trial Results: In a Phase 1 dose escalation trial for chronic myelomonocytic leukemia (CMML), approximately 40% of the 9 patients showed preliminary efficacy with onvansertib as a monotherapy, indicating its potential despite the company's decision not to pursue further development for CMML.
- Tolerance Assessment: The trial results demonstrated that onvansertib was relatively well-tolerated, with one patient achieving an optimal marrow response at the 9 mg/m2 dose, highlighting its application prospects in both hematologic and solid tumors.
- Multiple Indication Development: Cardiff Oncology is evaluating onvansertib in combination with standard care for various cancers, including RAS-mutated metastatic colorectal cancer, aiming to overcome treatment resistance and deliver superior clinical benefits compared to standard therapies.
- Future Outlook: While there are no plans to develop onvansertib for CMML, its research results in other indications, such as small cell lung cancer, provide critical data support for the company's future clinical strategy.
- Clinical Trial Results: In a Phase 1 dose escalation trial for chronic myelomonocytic leukemia (CMML), approximately 40% of the 9 patients showed preliminary efficacy with onvansertib as a monotherapy, indicating its potential despite the company's decision not to pursue further development for CMML.
- Tolerance Assessment: The trial demonstrated that onvansertib was relatively well-tolerated, with one patient achieving an optimal marrow response at the 9 mg/m2 dose, highlighting its applicability in hematologic malignancies.
- Multiple Indication Development: Cardiff Oncology is evaluating onvansertib in combination with standard therapies for various cancers, including RAS-mutated metastatic colorectal cancer, aiming to overcome treatment resistance and deliver superior clinical benefits compared to standard care.
- Academic Presentation: The clinical data will be presented in a poster session at the ASH Annual Meeting on December 8, 2025, enhancing the company's academic influence in the oncology field.







