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 ...

- Findings underscore that the combination of onvansertib with FOLFIRI and bevacizumab demonstrates clinical activity and is well tolerated in second-line KRAS-mutant mCRC - - Post hoc analysis resulted in a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77% compared to 10% in bev-exposed patients - - Results from this trial, along with translational studies, supported the transition of clinical development of onvansertib to first-line RAS-mutant mCRC - - Initial readout from first-l ...

howtogoto/iStock via Getty Images Cardiff Oncology, Inc. (NASDAQ:CRDF) is gearing up to report results from its phase 2 randomized CRDF-004 study, which is using its drug onvansertib + chemotherapy [Folfiri] + bevacizumab [Avastin] for the treatment of RAS-mutated metastatic colorectal cancer [mCRC] patients. This combination therapy of onvansertib is being compared to the current 1st-line standard of care [SOC] therapy chemotherapy + bevacizumab. The company is currently conducting this phase 2 randomized ...

Financial Data and Key Metrics Changes - As of June 30, 2024, cash and short-term investments totaled $60.3 million, with cash used in operating activities amounting to $9.2 million in Q2 2024 [13] - The company updated its cash runway guidance, now expecting to have sufficient resources through the end of Q3 2025, an extension from previous expectations [13] Business Line Data and Key Metrics Changes - The CRDF-004 trial is currently active in 33 sites, with plans to enroll 90 patients randomized to receive either a 20-milligram or a 30-milligram dose of onvansertib plus standard of care [6] - The pancreatic cancer program is shifting focus to an investigator-initiated trial combining onvansertib with NALIRIFOX, following the approval of NALIRIFOX for first-line metastatic PDAC [9] Market Data and Key Metrics Changes - The company is targeting a large patient population of nearly 50,000 new patients annually in the U.S. for RAS-mutated metastatic colorectal cancer [4] - There are currently no new therapies approved for RAS-mutated mCRC patients in the past 20 years, and no competing clinical trials exist for this patient population [4] Company Strategy and Development Direction - The company is focused on clinical execution of the CRDF-004 trial and is optimistic about the potential of onvansertib to change the treatment paradigm for RAS-mutated mCRC [14] - There is ongoing exploration of onvansertib's efficacy in other cancer indications, including ovarian cancer, where it has shown potential to overcome resistance to PARP inhibitors [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical development strategy for RAS-mutated mCRC and enthusiasm for the upcoming data readout of CRDF-004 later this year [14] - The company is encouraged by preclinical data demonstrating onvansertib's activity in various cancer indications with unmet clinical needs [10] Other Important Information - The company is leveraging Pfizer's resources to enhance patient enrollment in clinical trials [6] - Preclinical studies have shown onvansertib's potential in RAS wild-type mCRC, ER-positive breast cancer, triple-negative breast cancer, and platinum-resistant ovarian cancer [10] Q&A Session Summary Question: Enrollment trends in the CRDF-004 trial - Management confirmed that enrollment is tracking well and is on schedule for an initial data look later this year, aided by the partnership with Pfizer Ignite [15] Question: Adoption of NALIRIFOX in pancreatic cancer - Management explained that the combination of onvansertib with NALIRIFOX is based on previous positive data and good tolerability, making it a suitable choice for the first-line regimen [16][17] Question: Scientific validation of the change in pancreatic cancer trial - Management highlighted the synergy of onvansertib with irinotecan as a key reason for the new trial direction and noted the enthusiasm of the investigator involved [20] Question: Potential entry into ovarian cancer with ADCs - Management indicated that preclinical work is ongoing to explore combinations of onvansertib with ADCs across various cancer types, not limited to ovarian cancer [20]