Clinical Trial Results - Cardiff Oncology reported a 64% objective response rate (ORR) for patients on the 30mg onvansertib dose arm in the CRDF-004 trial, compared to a 33% ORR in the control arm[2] - Cardiff Oncology's clinical trial data indicated that the 30mg dose of onvansertib demonstrated deeper tumor regression compared to the 20mg dose[6] - Onvansertib showed promising results in combination with paclitaxel for HR+ breast cancer, with ongoing clinical trials evaluating its efficacy[12] - The company published clinical data demonstrating that onvansertib combined with FOLFIRI and bev exhibited clinical activity in second-line KRAS mutant mCRC[12] Financial Performance - The company raised $40 million in an oversubscribed underwritten registered direct offering, strengthening its balance sheet[7] - As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash and equivalents, projected to fund operations into Q1 2027[10][11] - Total operating expenses for the full year 2024 were approximately $49.3 million, an increase of $3.4 million from $45.9 million in 2023[13] - The net loss for the year ended December 31, 2024, was $45.4 million, compared to a net loss of $41.4 million in 2023[19] Intellectual Property - The company issued a new patent for the use of onvansertib in treating KRAS-mutated mCRC, with an expected expiration date of no earlier than 2043[5][8] Future Plans - The company plans to share additional clinical updates from the CRDF-004 trial in the first half of 2025[3]

Core Insights - Cardiff Oncology reported robust initial efficacy signals for onvansertib in combination with chemotherapy and bevacizumab for first-line RAS-mut metastatic colorectal cancer (mCRC) [1][2] - The company successfully raised $40 million through an oversubscribed underwritten registered direct offering, attracting both new and existing healthcare-focused investors [1][4] - A new patent was issued for onvansertib, specifically for its use in treating KRAS-mutated mCRC, with an expected expiration date no earlier than 2043 [1][4] - As of December 31, 2024, the company had cash and equivalents of $91.7 million, providing a projected runway into Q1 2027 [1][7] Clinical Trial Updates - The ongoing CRDF-004 trial showed that patients receiving the 30mg dose of onvansertib had a 64% objective response rate (ORR), compared to 33% in the control arm [2][4] - A dose-response relationship was observed, with the 30mg dose demonstrating deeper tumor regression compared to the 20mg dose, while both doses exhibited similar safety profiles [2][4] - The Phase 2 trial is currently enrolling patients with documented KRAS or NRAS mutations, randomizing them to receive either 20mg or 30mg of onvansertib alongside standard-of-care treatments [4] Financial Performance - For the full year 2024, the company reported total operating expenses of approximately $49.3 million, an increase from $45.9 million in 2023, primarily due to clinical program costs and increased staffing [8][16] - The net loss for 2024 was approximately $45.4 million, compared to a net loss of $41.4 million in 2023 [16][21] - Cash burn for operating activities was approximately $37.7 million for 2024, up from $30.9 million in 2023 [6][21] Upcoming Milestones - Additional clinical data from the CRDF-004 trial is expected in the first half of 2025 [3]

Clinical Trials and Drug Development - Onvansertib, a highly selective PLK1 inhibitor, demonstrated an overall response rate (ORR) of 64% in the 30mg dose group combined with standard-of-care (SoC) in the CRDF-004 trial for RAS-mutated metastatic colorectal cancer (mCRC) [23] - The CRDF-004 trial is expected to enroll approximately 90 evaluable patients, with primary endpoints focusing on ORR and secondary endpoints including progression-free survival and duration of response [20] - In the ONSEMBLE trial, the overall response rate across all evaluable patients was 29%, with a median duration of response of 12.0 months and median progression-free survival of 9.3 months [29] - The FDA approved NALIRIFOX as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC), leading to a new investigator-initiated trial of onvansertib in combination with NALIRIFOX [30] - A biomarker discovery trial showed one patient with mPDAC had an 86% decrease in Ki67 and a 28% decrease in CA 19-9, indicating potential anti-tumor activity of onvansertib [36] - The Phase 2 trial of onvansertib in combination with nanoliposomal irinotecan for second-line mPDAC completed enrollment in October 2023 [32] - The CRDF-005 trial, a Phase 3 randomized trial with registrational intent, is planned contingent upon the results of CRDF-004 [21] - Onvansertib has shown a favorable safety profile with no major or unexpected toxicities reported in combination with SoC therapies [24] - The ongoing Phase 2 trial for small cell lung cancer (SCLC) aims to enroll 15 patients in Stage 1, with a disease control rate of 57% observed in preliminary data [38] - The company is utilizing correlative biomarker analyses to optimize drug development and identify patient populations more likely to respond to onvansertib therapy [41] - The company is conducting a clinical trial for CRDF-004 in RAS-mutated metastatic colorectal cancer (mCRC), assessing changes in RAS mutational burden using ctDNA blood tests [42] - In the TROV-054 trial, decreases in KRAS Mutant Allelic Frequency (MAF) after the first treatment cycle were highly predictive of tumor shrinkage [42] Financial Condition and Capital Needs - As of December 31, 2024, the company has an accumulated total deficit of approximately $384.2 million, with net losses attributable to common stockholders of approximately $45.5 million and $41.5 million for the fiscal years ended December 31, 2024 and 2023, respectively [108] - The company's cash, cash equivalents, and short-term investments balance was approximately $91.7 million, with working capital of approximately $81.6 million as of December 31, 2024 [111] - The company is a clinical stage entity and has not yet generated significant revenue from operations, expecting to incur substantial net losses for the foreseeable future [109] - The company may need to raise substantial additional capital to continue the development and commercialization of onvansertib, which could be challenging under current market conditions [111] - The company has historically relied on private and public sales of equity and debt financings to fund operations, which may not be available on favorable terms in the future [111] Regulatory Environment - The FDA review process for marketing applications typically takes ten months, with potential extensions for additional information [72] - The FDA requires compliance with CGMPs for drug product manufacturing before approving NDAs or BLAs [73] - An approval letter from the FDA allows for commercial marketing but may impose post-approval testing and surveillance requirements [75] - The FDA may issue complete response letters outlining deficiencies that require additional testing before reconsideration of applications [74] - Manufacturers must continue to comply with CGMPs post-approval, or risk withdrawal of product approvals [79] - The regulatory approval process for the company's product candidate is lengthy and unpredictable, potentially taking many years and requiring substantial resources [132] - The company must provide extensive preclinical and clinical data to demonstrate the safety and efficacy of its product candidate before it can be approved for marketing [122] - The company plans to seek regulatory approval and commercialize its product candidate worldwide, including in the U.S. and the European Union, but must comply with varying regulatory requirements in different countries [137] Market and Competitive Landscape - The company faces significant competition from established pharmaceutical and biotechnology companies, which may have greater financial resources and expertise [147] - If the product candidate is approved, it will compete with existing prescription therapies in the targeted therapeutic area, potentially limiting demand [148] - The ability to manufacture the product candidate in commercial quantities is uncertain, which could hinder its market launch [157] - Market acceptance of the product candidate will depend on its demonstrated safety and efficacy, as well as pricing and reimbursement factors [161] - Recommendations from government agencies and professional organizations could impact the usage of the product, potentially leading to decreased demand [162] Intellectual Property and Legal Risks - The company faces risks related to intellectual property protection, as challenges to patents could impair competitive advantage and lead to costly litigation [192] - The U.S. patent system changes may increase uncertainties and costs surrounding patent applications and enforcement, impacting the company's ability to protect its technology [194] - The company may incur substantial costs from litigation related to intellectual property rights, which could divert management attention and resources [198] - The company may face significant costs related to patent litigation, which could adversely affect its financial condition [200] Operational Challenges - The company relies on third-party manufacturers and distributors for the supply and distribution of onvansertib used in clinical studies [58] - The company relies on third-party manufacturers for production, and any failure to meet regulatory compliance could delay product development and commercialization [151] - The company must ensure compliance with Good Manufacturing Practices (GMP) requirements, and any failure could result in significant penalties and delays [156] - The company relies on third-party contract manufacturers for product candidate formulation and manufacturing, exposing it to risks that could delay clinical trials or increase costs [163] - The company has limited resources for conducting preclinical studies and clinical trials, relying on third-party vendors, which may lead to delays or additional expenses if these vendors fail to perform satisfactorily [119] - The company faces challenges in recruiting and managing clinical trials, which could impair the timing of obtaining FDA approval and materially harm the business [120] Employee and Management Considerations - The company has a total of 33 employees, with 32 being full-time, and considers its relations with employees to be good [105] - The company is highly dependent on its management team and key personnel for the successful development of its product candidate, and losing key staff could delay clinical trials [126] - The company has identified material weaknesses in internal controls, which could harm financial reporting reliability and investor confidence [215] Economic and Market Conditions - General economic conditions, including healthcare reform and geopolitical issues, may negatively impact the company's business and financial condition [180] - The failures of Silicon Valley Bank, Signature Bank, and First Republic Bank in the first half of 2023 caused significant disruptions in the financial services industry, potentially affecting cash access [188] - Geopolitical risks from Russia's invasion of Ukraine have led to increased market volatility, which could adversely impact the company's financial condition and results of operations [189] Stock and Financial Reporting - The closing price of the company's common stock ranged from a low of $1.46 to a high of $5.91 during the year ended December 31, 2024 [205] - The company has never paid cash dividends on its common stock and does not expect to do so in the foreseeable future [207] - The market price of the company's common stock may be volatile due to various factors, including technological innovations and clinical trial results [206] - The company may face stockholder litigation, which could divert resources and adversely affect profitability [213] - The company is at risk of delisting from Nasdaq if it fails to meet continued listing requirements, which could reduce liquidity and investor confidence [214]

Core Insights - Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel therapies through PLK1 inhibition for various cancers [4] - The company will present at two upcoming investor conferences, highlighting its commitment to engaging with the investment community [1] Conference Details - At the B. Riley Securities Precision Oncology & Radiopharma Conference, CEO Mark Erlander will participate in a panel discussion on improving responses in colorectal cancer on February 28, 2025, in New York City [2] - The TD Cowen 45th Annual Health Care Conference will feature a company presentation by CEO Mark Erlander on March 5, 2025, at 11:50 AM ET in Boston, MA, with a live webcast available [3] Company Overview - Cardiff Oncology's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care therapies for RAS-mutated metastatic colorectal cancer and other cancers [4] - The company's development strategy aims to target tumor vulnerabilities to overcome treatment resistance and provide superior clinical benefits compared to standard therapies [4]

- Management will hold a conference call on Thursday, February 27 at 4:30 p.m. ET/1:30 p.m. PT -SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that it will hold a conference call on Thursday, February 27 after the close of trading to review financial results for the fourth quarter ended December 31, 2024. Conference Call and Webcast Card ...

Cardiff Oncology (NASDAQ: CRDF ) has been a biotech of growing interest over the past few years, racing up and down as the fortunes of their PLK1 inhibitor onvansertib have risen and fallen. In particular, thereI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of in ...

Core Viewpoint - Cardiff Oncology announced promising efficacy data from a mid-stage study of onvansertib in combination with standard-of-care chemotherapy for treating first-line RAS-mutated metastatic colorectal cancer, leading to a significant stock price increase of 54.9% [1][5]. Group 1: Study Results - The phase II CRDF-004 study showed that the 30 mg dose of onvansertib achieved an objective response rate (ORR) of 64%, nearly double the 33% ORR of the control arm [2]. - The 20 mg dose arm had an ORR of 50%, indicating that the 30 mg dose was more effective [2]. - Overall, patients treated with onvansertib had an ORR of 57% [2]. Group 2: Treatment Efficacy - Spider plots indicated that patients receiving the 30 mg dose experienced greater tumor size reduction over time compared to those in the control and 20 mg dose arms, with similar safety profiles for both doses [3]. - The combination therapy was well tolerated, with no major or unexpected toxicities reported [3]. Group 3: Future Plans - Management believes onvansertib could transform treatment for first-line RAS-mutated mCRC, with approximately 50,000 new diagnoses annually in the U.S. [4]. - Cardiff Oncology plans to share additional clinical updates in the first half of 2025 and may initiate a phase III registrational study based on positive results from the CRDF-004 study [6]. - The FDA has agreed that an interim analysis of ORR in the planned registrational study could support an accelerated approval pathway for the onvansertib/SOC combination [7]. Group 4: Financial Activities - Cardiff Oncology announced an underwritten offering of 15,384,619 shares at $2.60 per share, aiming to raise approximately $40 million for clinical costs and general corporate purposes [10][11]. - The transaction is expected to close on December 11, 2024, subject to customary conditions [12].

Group 1 - Cardiff Oncology reported a quarterly loss of $0.25 per share, better than the Zacks Consensus Estimate of a loss of $0.27, representing an earnings surprise of 7.41% [1] - The company posted revenues of $0.17 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 32%, compared to revenues of $0.14 million a year ago [2] - Cardiff Oncology shares have increased approximately 157.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 24.3% [3] Group 2 - The earnings outlook for Cardiff Oncology is mixed, with the current consensus EPS estimate for the coming quarter at -$0.27 on revenues of $0.14 million, and -$1.01 on revenues of $0.55 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which Cardiff Oncology belongs, is currently ranked in the top 36% of over 250 Zacks industries, indicating a favorable outlook [8] Group 3 - Cardiff Oncology has surpassed consensus EPS estimates three times over the last four quarters and has topped consensus revenue estimates four times in the same period [2] - The estimate revisions trend for Cardiff Oncology is currently mixed, resulting in a Zacks Rank 3 (Hold) for the stock, suggesting it is expected to perform in line with the market in the near future [6]

[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) Cardiff Oncology reported significant clinical progress, highlighted by positive Phase 2 trial results for onvansertib and promising preclinical data - Published positive Phase 2 trial results of onvansertib in combination with FOLFIRI and bevacizumab (bev) for second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology[1](index=1&type=chunk)[3](index=3&type=chunk) - A post hoc analysis revealed significantly greater clinical benefit in bev naïve patients, who showed an **Objective Response Rate (ORR) of 77%** and **median Progression-Free Survival (mPFS) of 14.9 months**, compared to an ORR of 10% and mPFS of 6.6 months in patients previously exposed to bev[2](index=2&type=chunk)[3](index=3&type=chunk) - The company expects to provide an initial data readout from its first-line RAS-mutated mCRC randomized trial (CRDF-004) by the end of 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - Published promising preclinical data showing the combination of onvansertib and alpelisib synergistically inhibited cell viability and demonstrated superior anti-tumor activity in PIK3CA-mutated HR-positive breast cancer models[4](index=4&type=chunk)[5](index=5&type=chunk) [Third Quarter 2024 Financial Results](index=2&type=section&id=Third%20Quarter%202024%20Financial%20Results) Cardiff Oncology reported increased Q3 2024 operating expenses due to clinical advancements, with cash runway into Q1 2026 [Liquidity, Cash Burn, and Cash Runway](index=2&type=section&id=Liquidity%2C%20Cash%20Burn%2C%20and%20Cash%20Runway) The company's cash position and burn rate indicate a projected cash runway extending into Q1 2026 Cash Position and Runway | Metric | Value | | :------------------------------------------------------------------------ | :-------------- | | Cash, cash equivalents, and short-term investments (as of Sep 30, 2024) | $57.7 million | | Net cash used in operating activities (Q3 2024) | $10.5 million | | Projected cash runway | Into Q1 2026 | - Net cash used in operating activities increased by **$2.5 million** in Q3 2024 compared to the same period in 2023 (**$10.5 million** vs **$8.0 million**)[7](index=7&type=chunk) [Operating Results](index=2&type=section&id=Operating%20results) Total operating expenses increased in Q3 2024, primarily driven by higher costs for clinical program advancements Operating Expenses Comparison (Q3) | Period | Total Operating Expenses | | :------ | :----------------------- | | Q3 2024 | $12.8 million | | Q3 2023 | $11.0 million | - The increase in operating expenses was primarily driven by costs related to clinical programs and outside services for the development of the lead drug candidate, onvansertib[8](index=8&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) This section presents the unaudited condensed financial statements, including Statements of Operations, Balance Sheets, and Cash Flows [Condensed Statements of Operations](index=3&type=section&id=Condensed%20Statements%20of%20Operations) The Condensed Statements of Operations detail the company's financial performance, showing an increased net loss for Q3 2024 Q3 2024 vs Q3 2023 Statement of Operations (in thousands, except per share data) | Metric | Q3 2024 | Q3 2023 | | :------------------------------------------ | :---------- | :---------- | | Research and development | $9,640 | $8,022 | | Total operating expenses | $12,766 | $10,961 | | Loss from operations | $(12,601) | $(10,820) | | Net loss | $(11,855) | $(9,731) | | Net loss per common share — basic and diluted | $(0.25) | $(0.22) | [Condensed Balance Sheets](index=6&type=section&id=Condensed%20Balance%20Sheets) The Condensed Balance Sheets provide a snapshot of the company's financial position, detailing changes in assets, liabilities, and equity Balance Sheet Summary (in thousands) | Metric | Sep 30, 2024 | Dec 31, 2023 | | :----------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $13,038 | $21,655 | | Short-term investments | $44,629 | $53,168 | | Total current assets | $59,332 | $77,412 | | Total Assets | $62,896 | $81,637 | | Total Liabilities | $13,504 | $11,898 | | Total Stockholders' equity | $49,392 | $69,739 | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) The Condensed Statements of Cash Flows summarize cash inflows and outflows from operating, investing, and financing activities Cash Flow Summary for Nine Months Ended Sep 30 (in thousands) | Activity | 2024 | 2023 | | :---------------------------------------- | :---------- | :---------- | | Net cash used in operating activities | $(27,426) | $(23,748) | | Net cash provided by investing activities | $9,217 | $22,634 | | Net cash provided by financing activities | $9,592 | $0 | | Net change in cash and cash equivalents | $(8,617) | $(1,114) |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER 001-35558 CARDIFF ONCOLOGY, INC. (Exact Name of registrant as specified in its charter) Delaware 27-2004382 (State or other j ...