Cardiff Oncology Contact: SAN DIEGO, May 13, 2024 (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 company management will present at two upcoming investor conferences in May 2024. Details of the presentations can be found below. H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ Location: The Nasdaq Headquarters, New York City Presenter: Mar ...

Cardiff Oncology, Inc. (NASDAQ:CRDF) Q1 2024 Results Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Kiki Patel - Investor Relations, Gilmartin Group Mark Erlander - Chief Executive Officer Jamie Levine - Chief Financial Officer Conference Call Participants Mark Frahm - TD Cowen Joseph Catanzaro - Piper Sandler Andy Hsieh - William Blair Operator Welcome to the Cardiff Oncology First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are i ...

[Business Update and Highlights](index=1&type=section&id=Cardiff%20Oncology%20Reports%20First%20Quarter%202024%20Results%20and%20Provides%20Business%20Update) Cardiff Oncology provided updates on its clinical programs, highlighting positive data for onvansertib in mCRC and other indications, with key trial readouts anticipated in 2H 2024 [CEO's Remarks and Strategic Overview](index=1&type=section&id=CEO's%20Remarks%20and%20Strategic%20Overview) The CEO emphasized new data supporting onvansertib's potential in RAS-mutated mCRC and other indications, anticipating a key value inflection point from upcoming trial results - Data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the positive signal for bev-naïve patients previously seen in the Phase 1b/2 KRAS-mutated mCRC trial[16](index=16&type=chunk) - Presentations at the AACR conference suggest potential new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer (SCLC), and ovarian cancer[16](index=16&type=chunk) - The upcoming data readout from the first-line trial in RAS-mutated mCRC is viewed as a key potential value inflection point for the company[16](index=16&type=chunk) [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) Clinical updates include the CRDF-004 trial readout expected in 2H 2024, a **50% ORR** in ONSEMBLE's bev-naïve cohort, and broad preclinical activity for onvansertib - The expected timing for the initial readout from the first-line RAS-mutated mCRC randomized trial (CRDF-004) has been updated to the second half of 2024[2](index=2&type=chunk) - In the second-line ONSEMBLE trial, bev-naïve patients receiving onvansertib plus standard of care (SoC) showed a **50% objective response rate (ORR)**, whereas no responses were seen in patients on SoC alone or those previously exposed to bevacizumab (bev)[3](index=3&type=chunk) - Preclinical data presented at AACR 2024 showed onvansertib, as a single agent, induced tumor stasis or regression in **70%** of RAS wild-type mCRC patient-derived xenograft (PDX) models. The combination with cetuximab was effective in **90%** of models[3](index=3&type=chunk) - Further preclinical data at AACR highlighted that onvansertib in combination with paclitaxel showed superior efficacy in SCLC models, and in combination with gemcitabine or carboplatin showed anti-tumor activity in platinum-resistant ovarian cancer models[3](index=3&type=chunk) [Upcoming Milestones](index=1&type=section&id=Upcoming%20expected%20milestones) Key upcoming milestones include interim topline results from the CRDF-004 trial in 2H 2024, potentially leading to a registrational Phase 3 trial - Interim topline results from the CRDF-004 trial for first-line RAS-mutated mCRC are expected in the second half of 2024[3](index=3&type=chunk) - Contingent on positive results from CRDF-004, the company plans to initiate a Phase 3 randomized trial, CRDF-005, with the intent for registration[3](index=3&type=chunk) [Financial Results](index=4&type=section&id=First%20Quarter%202024%20Financial%20Results) Cardiff Oncology reported a reduced net loss in Q1 2024, driven by lower operating expenses and increased royalty revenues, while maintaining sufficient liquidity [Financial Performance Summary](index=4&type=section&id=Financial%20Performance%20Summary) Q1 2024 saw a net loss of **$10.0 million**, an improvement from Q1 2023, driven by a **$1.0 million** decrease in operating expenses and higher royalty revenues Q1 2024 vs Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Royalty Revenues | $205 | $83 | | Research and Development | $8,008 | $9,052 | | Selling, General & Administrative | $3,130 | $3,083 | | **Total Operating Expenses** | **$11,138** | **$12,135** | | Loss from Operations | $(10,933) | $(12,052) | | **Net Loss** | **$(10,011)** | **$(11,223)** | | Net Loss Per Common Share | $(0.22) | $(0.25) | - Total operating expenses decreased by **$1.0 million** in Q1 2024 compared to Q1 2023, mainly due to a reduction in chemistry, manufacturing, and controls costs[18](index=18&type=chunk) [Liquidity and Cash Position](index=4&type=section&id=Liquidity%2C%20cash%20burn%2C%20and%20cash%20runway) As of March 31, 2024, the company held **$67.2 million** in cash, projecting sufficient liquidity to fund operations into Q3 2025, with reduced cash burn - The company held approximately **$67.2 million** in cash, cash equivalents, and short-term investments as of March 31, 2024[4](index=4&type=chunk) - Current cash resources are projected to be sufficient to fund operations into Q3 2025[9](index=9&type=chunk) - Net cash used in operating activities was approximately **$7.7 million** for Q1 2024, down from **$8.7 million** in Q1 2023[17](index=17&type=chunk) [Condensed Financial Statements (Unaudited)](index=7&type=section&id=Condensed%20Financial%20Statements%20(unaudited)) The unaudited condensed financial statements provide detailed figures for the company's operations, balance sheet, and cash flows for the first quarter of 2024 [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) The condensed statements of operations show a net loss of **$10.0 million** for Q1 2024, an improvement from **$11.2 million** in Q1 2023, with increased royalty revenues Condensed Statements of Operations (in thousands, except per share amounts) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2024** | **2023** | | Royalty revenues | $205 | $83 | | Research and development | $8,008 | $9,052 | | Selling, general and administrative | $3,130 | $3,083 | | **Total operating expenses** | **$11,138** | **$12,135** | | Loss from operations | $(10,933) | $(12,052) | | Interest income, net | $926 | $940 | | **Net loss** | **$(10,011)** | **$(11,223)** | | Net loss per common share — basic and diluted | $(0.22) | $(0.25) | [Condensed Balance Sheets](index=8&type=section&id=Condensed%20Balance%20Sheets) The balance sheet shows total assets of **$74.0 million** and total liabilities of **$13.1 million** as of March 31, 2024, reflecting a decrease in cash and investments Condensed Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $18,658 | $21,655 | | Short-term investments | $48,529 | $53,168 | | Total current assets | $69,990 | $77,412 | | **Total Assets** | **$74,038** | **$81,637** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $11,843 | $10,440 | | **Total Liabilities** | **$13,144** | **$11,898** | | Stockholders' equity | $60,894 | $69,739 | | **Total liabilities and stockholders' equity** | **$74,038** | **$81,637** | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$7.7 million** in Q1 2024, with investing activities providing **$4.6 million**, resulting in a **$3.0 million** net decrease in cash Condensed Statements of Cash Flows (in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2024** | **2023** | | Net cash used in operating activities | $(7,740) | $(8,659) | | Net cash provided by investing activities | $4,636 | $7,329 | | Net cash provided by financing activities | $107 | $— | | **Net change in cash and cash equivalents** | **$(2,997)** | **$(1,330)** | | Cash and cash equivalents—Beginning of period | $21,655 | $16,347 | [About Cardiff Oncology, Inc.](index=4&type=section&id=About%20Cardiff%20Oncology%2C%20Inc.) Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel cancer therapies by inhibiting PLK1, with onvansertib as its lead asset [Company Description](index=4&type=section&id=Company%20Description) Cardiff Oncology is a clinical-stage biotech company developing novel cancer therapies through PLK1 inhibition, with onvansertib as its lead asset in multiple clinical programs - Cardiff Oncology is a clinical-stage biotechnology company developing novel therapies by inhibiting PLK1, a validated oncology drug target[10](index=10&type=chunk) - The company's lead asset is onvansertib, which is being evaluated in combination with standard-of-care (SoC) therapies to overcome treatment resistance[10](index=10&type=chunk) - Key indications for onvansertib clinical programs include RAS-mutated metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), and triple negative breast cancer (TNBC)[10](index=10&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements, emphasizing that actual results may differ materially from projections [Risk Disclosure](index=4&type=section&id=Risk%20Disclosure) Forward-looking statements are subject to significant risks, including uncertain clinical trial outcomes, financing needs, and regulatory challenges, with no guarantee of commercial success - The press release contains forward-looking statements based on current expectations, but actual results could differ materially[20](index=20&type=chunk) - Significant risks include the uncertain outcomes of clinical trials, potential for trial suspension due to safety risks, the need for additional financing, and regulatory approval challenges[20](index=20&type=chunk)[11](index=11&type=chunk) - Investors are advised to read the risk factors detailed in the company's Form 10-K and other SEC filings for a complete understanding of potential risks[11](index=11&type=chunk)

Clinical Trials and Efficacy - Onvansertib, a highly selective PLK1 inhibitor, has shown a 29% objective response rate (ORR) in the ongoing TROV-054 trial for KRAS-mutated metastatic colorectal cancer (mCRC) with a median duration of response of 12.0 months[67]. - The CRDF-004 trial for first-line treatment in RAS-mutated mCRC is expected to enroll approximately 90 evaluable patients, with initial data anticipated in the second half of 2024[63]. - In the ONSEMBLE trial, patients who were bevacizumab naïve had an ORR of 73% and a median progression-free survival of 15 months, significantly higher than historical controls[71]. - The Phase 2 trial in first-line mPDAC will assess the combination of onvansertib with Gemzar and Abraxane, with the primary endpoint being ORR[75]. - The objective response rate (ORR) in the Phase 2 trial for mPDAC was 19%, significantly higher than the historical control of 7.7%[79]. - Median progression-free survival (mPFS) in the same trial was 5.0 months, compared to 3.1 months with standard care[79]. - The disease control rate (DCR) in the Phase 2 trial for SCLC was 57%, with 4 out of 7 patients showing either confirmed partial response or stable disease[82]. Safety and Tolerability - Onvansertib has demonstrated favorable safety and tolerability, with no Grade 4 treatment-emergent adverse events (TEAEs) observed in the combination arms of the trials[71]. - Onvansertib has shown synergistic effects in combination with various cytotoxic agents, enhancing its potential efficacy across multiple cancer therapies[60]. Financial Performance - Total revenues for Q1 2024 were $205,000, up from $83,000 in Q1 2023, reflecting a significant increase in sales-based royalties[86]. - Research and development expenses decreased by $1.0 million to $8.0 million in Q1 2024 compared to $9.1 million in Q1 2023, primarily due to reduced clinical trial costs[88]. - As of March 31, 2024, the company had working capital of $58.1 million, down from $67.0 million at the end of 2023[91]. - Net cash used in operating activities for Q1 2024 was $7.7 million, a slight improvement from $8.7 million in Q1 2023[96]. - The company reported a net loss of $10.0 million for Q1 2024, compared to a net loss of $11.2 million in Q1 2023[97]. - Cash and cash equivalents totaled $67.2 million as of March 31, 2024, sufficient to meet funding requirements for at least the next 12 months[92]. - Net cash provided by investing activities for Q1 2024 was $4.6 million, down from $7.3 million in Q1 2023[99]. Future Plans and Regulatory Aspects - The company plans to initiate CRDF-005, a Phase 3 trial with registrational intent, contingent upon the results of CRDF-004, focusing on objective response rate as an interim endpoint[64]. - The ongoing clinical programs include five trials targeting various cancers, including mCRC and metastatic pancreatic ductal adenocarcinoma (mPDAC)[61]. - The FDA has agreed that a seamless trial design with ORR as an interim endpoint is acceptable for pursuing accelerated approval for onvansertib[64]. - The company emphasizes the importance of tumor genomics and biomarker assays in refining patient response assessments in its clinical development programs[57].

- Management will hold a conference call on Thursday, May 2 at 4:30 p.m. ET/1:30 p.m. PT - SAN DIEGO, April 25, 2024 (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 plans to release financial results for the first quarter ended March 31, 2024 on Thursday, May 2 after the close of trading. Conference Call and Webcast Cardiff Oncology will host a conference ...

RAS-mutated mCRC – In RAS-mutated mCRC, novel preclinical finding demonstrates onvansertib inhibits the tumor's ability to adapt to hypoxia resulting in a significant decrease in both tumor vascularization and growth – – Enhanced clinical efficacy signal in bev naïve patients in Phase 1b/2 trial is consistent with results of randomized ONSEMBLE trial providing two independent data sets in second-line mCRC validating our strategy to evaluate onvansertib in combination with chemo/bev in RAS-mutated first-line ...

While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock aliv ...

Cardiff Oncology, Inc. (CRDF) is developing novel therapeutic candidates to treat various types of cancer, with an initial focus on RAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC) indications.Cardiff’s pipeline only comprises its lead investigational candidate, onvansertib, which is currently being evaluated in combination with standard-of-care (SOC) therapeutics in separate early to mid-stage studies to treat mCRC and mPDAC.Onvansertib is an oral and ...

While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, ...

Cardiff Oncology (CRDF) shares soared 20.5% in the last trading session to close at $5.40. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 169.9% gain over the past four weeks.The sudden rise in the stock price can be attributed to the positive investor mindset regarding the company's pipeline, which comprises only its lead candidate, onvansertib. Cardiff Oncology oncology is currently developing onvansertib in separate early to ...