| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-----------------------------------|-----------------------------|-------|----------------------------|------------------------------|-------|---------------------|-------|--------------------------------------|-------|------------------------------------------------|-------------------------------------|-------|--------------------------------------| | Balance, January 1, 2023 | Preferred Stock Shares \n61 | $ | Preferre ...

Clinical Trial Results - The Ph1b/2 trial showed an Overall Response Rate (ORR) of 29% (19 out of 66 patients) for all evaluable patients [12], with a median Duration of Response (mDoR) of 12 months [12] - In Bev Naive patients, the ORR was significantly higher at 73% (11 out of 15 patients) [12], with a mDoR of 13 months [12] - In Bev Exposed patients, the ORR was 16% (8 out of 51 patients) [12], with a mDoR of 89 months [12] - The median Progression-Free Survival (mPFS) for all patients was 93 months [1], while for Bev Naive patients it was 15 months [1] Safety and Tolerability - The trial reported various Treatment-Emergent Adverse Events (TEAEs), with Fatigue being the most common at 72% [2] - Other common TEAEs included Dyspepsia at 43%, Hypocalcemia at 37%, Dehydration and Hypokalemia each at 34% [2] Strategic Direction - The company is advancing its RAS-mutated mCRC program to the 1st line setting, based on FDA agreement [30, 82, 99] - A Phase 2 trial (CRDF-004) is underway for 1st line RAS-mutated mCRC with 90 patients randomized across different treatment arms [32, 87]

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 June 30, 2023 ☐ 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 | | --- | --- | | ...

Certain statements in this presentation are | --- | --- | --- | |----------------------------|---------------------------------|-----------------------------------------------------------------------------------------| | | | | | Our Drug: Onvansertib | WHAT Onvansertib has achieved | Robust clinical proof-of-concept results in Ph 1b/2 KRAS-mutated mCRC trial | | Highly selective and well- | | | | tolerated PLK1-inhibitor | WHERE Cardiff Oncology is going | Onvansertib has opportunity to become part of SOC i ...

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 March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 CARDIFF ONCOLOGY, INC. (Exact Name of registrant as specified in its charter) | Delaware | 27-2004382 | | --- | --- | | (State or other jurisdiction of incorporation or organization) | ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO 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 jurisdiction of ...

Summary of Cardiff Oncology Conference Call Company Overview - Cardiff Oncology is a clinical stage oncology company based in San Diego, California, focusing on developing onvansertib, a selective PLK1 inhibitor [3][4] Pipeline and Clinical Trials - The lead program targets KRAS mutated metastatic colorectal cancer, currently enrolling in a randomized trial [5] - Other programs include trials for pancreatic cancer, triple negative breast cancer, and small cell lung cancer [6] Mechanism of Action - PLK1 is a critical target in cancer therapy due to its role in the tumor cell cycle [7] - Onvansertib inhibits PLK1, preventing tumor cells from repairing DNA and promoting cell death [9] Clinical Data Highlights - In a single-arm trial for KRAS mutated metastatic colorectal cancer, response rates were significantly higher than historical data, with a 36% response rate from 14 evaluable patients and a 35% response rate from 48 evaluable patients [13] - A subset of bevacizumab-naive patients showed a 69% response rate and a median progression-free survival (PFS) of 13.5 months, compared to the typical 25% response rate and 6.9 months PFS [14] Randomized Trial Design - The randomized trial aims to demonstrate the efficacy of onvansertib in combination with standard care, with an 80% power to detect a meaningful difference in response rates [20] - The trial has started with six sites activated, aiming for a total of 40 sites [20] Pancreatic Cancer Program - A single-arm trial for pancreatic cancer is ongoing, targeting patients who have failed standard treatments [27] - Historical response rates for this patient population are low, with median PFS around three months [28] - Initial data showed one partial response and three stable diseases among five evaluable patients [28] Investigator Initiated Trials - Exciting trials are ongoing for triple negative breast cancer, combining onvansertib with paclitaxel, with data expected by the end of the year [31] Biomarker Data - The company plans to share biomarker data for pancreatic cancer and triple negative breast cancer trials, focusing on CA19-9 and KRAS mutations [34][35] Financial Overview - As of September 30, the company had approximately $114 million in cash, with a quarterly burn rate of $7 million, providing a runway into 2025 [37][38] Key Takeaways - Cardiff Oncology is advancing its clinical trials with promising data in colorectal cancer and ongoing efforts in pancreatic cancer and breast cancer - The company is strategically positioned for potential accelerated approval based on trial outcomes and has a solid financial foundation to support its initiatives [18][38]

The Onvansertib Opportunity Company Overview Forward-looking statements Certain statements in this presentation are FORWARD-LOOKING within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These forward-looking statements are based on our current expectations and actu ...

[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for the quarterly period ended September 30, 2022, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) The balance sheet as of September 30, 2022, shows a decrease in total assets to $123.6 million from $149.5 million at the end of 2021, primarily due to a reduction in short-term investments, with total liabilities increasing slightly and stockholders' equity decreasing Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,717 | $11,943 | | Short-term investments | $95,586 | $128,878 | | **Total Current Assets** | **$119,755** | **$146,127** | | **Total Assets** | **$123,631** | **$149,544** | | **Liabilities & Equity** | | | | Total current liabilities | $8,245 | $6,559 | | **Total Liabilities** | **$10,419** | **$9,127** | | **Total stockholders' equity** | **$113,212** | **$140,417** | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended September 30, 2022, the company reported an increased net loss of $8.6 million, driven by higher research and development expenses, with the nine-month net loss growing to $30.0 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Royalty revenues | $93 | $86 | $258 | $226 | | Research and development | $6,009 | $4,154 | $20,665 | $11,552 | | Selling, general and administrative | $3,077 | $2,930 | $10,103 | $8,003 | | **Loss from operations** | **($8,993)** | **($6,998)** | **($30,510)** | **($19,329)** | | **Net loss** | **($8,571)** | **($6,913)** | **($30,007)** | **($18,849)** | | Net loss per common share | ($0.20) | ($0.17) | ($0.69) | ($0.49) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operating activities increased to $24.4 million, while investing activities provided $31.1 million, primarily from short-term investments Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($24,430) | ($15,650) | | Net cash provided by (used in) investing activities | $31,129 | ($122,654) | | Net cash provided by financing activities | $75 | $20,488 | | **Net change in cash and cash equivalents** | **$6,774** | **($117,816)** | | Cash and cash equivalents—End of period | $18,717 | $13,165 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes provide context to the financial statements, detailing the company's business, accounting policies, liquidity, fair value measurements, lease obligations, and stockholders' equity - Cardiff Oncology is a clinical-stage biotechnology company focused on developing its lead asset, **onvansertib**, a PLK1 inhibitor, for various cancer indications[25](index=25&type=chunk) - As of September 30, 2022, the company had **$114.3 million** in cash, cash equivalents, and short-term investments and believes it has sufficient cash to meet funding requirements for at least the next **12 months**[27](index=27&type=chunk) - The company has a license agreement with Nerviano for the development and commercialization rights to onvansertib, which includes potential development milestones and royalty payments[64](index=64&type=chunk) - Subsequent to the quarter end, on October 11, 2022, **327,509 Series E Convertible Preferred Shares** were converted into **1,342,250 shares of common stock**[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management provides an overview of the company's business, focusing on the clinical development of its lead drug candidate, onvansertib, analyzing financial results and assessing liquidity and capital resources [Overview](index=18&type=section&id=Overview) The company is a clinical-stage biotech focused on developing onvansertib, an oral and highly selective PLK1 inhibitor, detailing progress of five clinical trials for onvansertib in various cancers - The company's lead drug candidate is **onvansertib**, an oral, highly selective PLK1 inhibitor with a **24-hour half-life**, being developed in combination with standard-of-care therapies[71](index=71&type=chunk)[72](index=72&type=chunk) - Updated data from the TROV-054 Phase 1b/2 trial in KRAS-mutated mCRC showed an Objective Response Rate (ORR) of **35%** and a median Progression-Free Survival (mPFS) of **9.3 months** across **48 evaluable patients**[79](index=79&type=chunk) - The company plans to activate the ONSEMBLE trial, a Phase 2 randomized clinical trial in KRAS-mutated mCRC, in **Q4 2022**, with topline data anticipated in the **second half of 2024**[82](index=82&type=chunk)[84](index=84&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the financial performance for the three and nine-month periods ending September 30, 2022, showing an increased net loss primarily due to a substantial rise in Research and Development (R&D) expenses R&D Expense Comparison (Three Months Ended Sep 30, in thousands) | Category | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Salaries and staff costs | $1,000 | $521 | $479 | | Clinical trials, outside services, and lab supplies | $4,279 | $3,104 | $1,175 | | **Total R&D** | **$6,009** | **$4,154** | **$1,855** | R&D Expense Comparison (Nine Months Ended Sep 30, in thousands) | Category | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Salaries and staff costs | $3,131 | $1,095 | $2,036 | | Clinical trials, outside services, and lab supplies | $15,699 | $9,510 | $6,189 | | **Total R&D** | **$20,665** | **$11,552** | **$9,113** | - The increase in net loss for the nine months ended September 30, 2022, was primarily driven by a **$9.1 million** increase in R&D expenses and a **$2.1 million** increase in SG&A expenses compared to the same period in 2021[98](index=98&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) As of September 30, 2022, the company had $114.3 million in cash, cash equivalents, and short-term investments, which management asserts are sufficient to fund operations into 2025, despite increased cash used in operating activities - The company had **$114.3 million** in cash, cash equivalents, and short-term investments as of September 30, 2022[106](index=106&type=chunk) - Based on current projections, the company expects its capital resources are sufficient to fund operations into **2025**[106](index=106&type=chunk) - Net cash used in operating activities for the nine months ended September 30, 2022, was **$24.4 million**, compared to **$15.7 million** for the same period in 2021, primarily due to a higher net loss[102](index=102&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable - Not applicable[109](index=109&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of September 30, 2022, with no material changes in internal control over financial reporting - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of **September 30, 2022**[110](index=110&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls[112](index=112&type=chunk) [PART II OTHER INFORMATION](index=25&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[116](index=116&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2021 - There have been no material changes from the risk factors disclosed in the Form 10-K for the year ended **December 31, 2021**[117](index=117&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents[122](index=122&type=chunk)

The Onvansertib Opportunity Company Overview Forward-Looking Statements Certain statements in this presentation are FORWARD-LOOKING within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern our expectations, strategy, plans or intentions. These forward-looking statements are based on our current expectations and actu ...