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Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update
Newsfilter· 2024-02-29 21:07
- First patient dosed in Phase 2 first-line trial in patients with RAS-mutated mCRC for new lead program with the support of FDA and clinical execution from Pfizer Ignite - - Interim topline data from first-line RAS-mutated mCRC trial is expected in mid-2024 - - New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in bev naïve RAS-mutated mCRC patients - - Cash and equivalents of $75 million as of December 31, ...
Cardiff Oncology(CRDF) - 2023 Q4 - Annual Results
2024-02-28 16:00
Cardiff Oncology Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update - First patient dosed in Phase 2 first-line trial in patients with RAS-mutated mCRC for new lead program with the support of FDA and clinical execution from Pfizer Ignite - - Interim topline data from first-line RAS-mutated mCRC trial is expected in mid-2024 - - New clinical data from second-line randomized ONSEMBLE trial provides further evidence of the efficacy of onvansertib in combination with FOLFIRI/bev in ...
Cardiff Oncology(CRDF) - 2023 Q4 - Annual Report
2024-02-28 16:00
Our business is subject to significant risks and uncertainties that make an investment in us speculative and risky. Below we summarize what we believe are the principal risk factors but these risks are not the only ones we face, and you should carefully review and consider the full discussion of our risk factors in the section titled "Risk Factors", together with the other information in this Annual Report on Form 10-K. If any of the following risks actually occurs (or if any of those listed elsewhere in th ...
Cardiff Oncology(CRDF) - 2023 Q3 - Earnings Call Transcript
2023-11-03 01:11
Financial Data and Key Metrics Changes - As of September 30, 2023, the company's cash and short-term investments totaled $81.4 million, with net cash used in operating activities for Q3 2023 approximately $8 million, indicating sufficient cash resources to fund operations into 2025 [26][66]. Business Line Data and Key Metrics Changes - The lead program in KRAS-mutated metastatic colorectal cancer showed a threefold increase in response rate and a doubling in median progression-free survival (PFS) in bevacizumab-naive patients compared to historical controls [36][37]. - In the CRDF-001 trial for pancreatic ductal adenocarcinoma (PDAC), four out of 21 patients achieved an objective partial response (PR), with one confirmed PR reported [19][29]. Market Data and Key Metrics Changes - The company reported a median PFS of five months for evaluable patients in the pancreatic cancer trials, approaching the benchmark of 5.5 months for first-line treatment [44]. Company Strategy and Development Direction - The primary focus is on the lead program in RAS-mutated metastatic colorectal cancer, with plans to execute the CRDF-004 clinical trial in collaboration with Pfizer Ignite [34][62]. - The company aims to explore new therapeutic indications for onvansertib, including combinations with FDA-approved treatments for various cancers [59]. Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging environment for publicly listed biotech companies but emphasized the strengths of Cardiff Oncology, including strong clinical data and financial resources [8][62]. - The company remains confident in generating interim data from the CRDF-004 trial by mid-2024, despite the trial not yet starting patient dosing [69]. Other Important Information - The company is conducting a preclinical program to investigate the underlying science of onvansertib and its combination with bevacizumab, which has shown promising results [14][15]. Q&A Session Summary Question: Can you discuss the expense trajectory as the first-line trial and colorectal starts to ramp up? - Management expects overall expenses to increase but not significantly, with current cash resources sufficient to extend operations into 2025 [55][66]. Question: Have any of the unconfirmed PDAC responses been confirmed recently? - Management confirmed that one additional patient has shown a deepening response, resulting in a second confirmed PR [29][63]. Question: What is the confidence level in generating interim data by mid-2024? - Management expressed confidence in being able to provide information by mid-next year, as the trial is open-label and progress can be monitored [69][71]. Question: Is there a strategy to minimize adverse events in the new trials? - The strategy to minimize adverse events from switching between bolus and infusional 5-FU will continue in the new trials [74][78].
Cardiff Oncology(CRDF) - 2023 Q3 - Earnings Call Presentation
2023-11-02 22:21
Clinical Development & Efficacy - Onvansertib demonstrates a clinical signal of efficacy and tolerability [2, 18] - The company plans to generate data from the first-line RAS-mutated mCRC CRDF-004 trial in mid-2024 [3, 5, 11, 14, 32, 36] - In a mCRC study of 135 patients, data identified resistance mechanisms [7] - Onvansertib/paclitaxel combination achieved significant tumor regression [9] - In BC1117 mice models, complete response was observed in 6 out of 11 mice (54%) [10] - In BC1080 mice models, complete response was observed in 5 out of 8 mice (62%) [10] - Phase 1b/2 data from second-line KRAS-mutated mCRC showed a 73% ORR in bev naïve patients versus approximately 25% for historical controls, and a 15-month median PFS in bev naïve patients versus approximately 7-8 months for historical controls [31] Financial Position - The company's financial position is strong as of Q3 2023, with a cash runway extending into 2025 [11, 18, 33] - As of September 30, 2023, the company had $814 million in cash and investments [17] - Net cash used in Operating Activities for Q3 2023 was $8 million [17] Strategic Objectives - The company is focused on generating data from the first-line RAS-mutated mCRC [5, 14] - The company is developing earlier-stage programs in Pancreatic, SCLC, and TNBC through investigator-initiated trials [30, 37] - The company is expanding its pipeline through preclinical studies of new combinations and indications [35, 37]
Cardiff Oncology(CRDF) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
[Filing Information](index=1&type=section&id=Filing_Information) This section provides details on the Form 10-Q filing, registrant, and filer status for Cardiff Oncology, Inc [Form Type and Registrant Details](index=1&type=section&id=Form_Type_and_Registrant_Details) This document is a Quarterly Report on Form 10-Q for Cardiff Oncology, Inc., a Delaware-incorporated clinical-stage biotechnology company - The filing is a **Quarterly Report on Form 10-Q** for the period ended September 30, 2023[4](index=4&type=chunk) - Cardiff Oncology, Inc. is a Delaware corporation, headquartered in San Diego, California[3](index=3&type=chunk) - The company's common stock is listed on the Nasdaq Capital Market under the ticker symbol **'CRDF'**[183](index=183&type=chunk) Filer Status as of September 30, 2023 | Filer Status | Indication | | :---------------------- | :--------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | [PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART_I_FINANCIAL_INFORMATION) This part presents the unaudited condensed financial statements and management's discussion and analysis for the company [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed financial statements for Cardiff Oncology, Inc., highlighting continued net losses and negative operating cash flows [Condensed Balance Sheets](index=3&type=section&id=Condensed_Balance_Sheets) This section provides a snapshot of the company's financial position, showing a decrease in total assets and stockholders' equity Condensed Balance Sheet Highlights (in thousands) | Metric | September 30, 2023 | December 31, 2022 | | :-------------------------- | :----------------- | :---------------- | | Total Assets | $88,452 | $116,191 | | Total Current Assets | $83,905 | $111,284 | | Cash and cash equivalents | $15,233 | $16,347 | | Short-term investments | $66,130 | $88,920 | | Total Liabilities | $10,625 | $9,848 | | Total Stockholders' Equity | $77,827 | $106,343 | - Total assets decreased from **$116.2 million** at December 31, 2022, to **$88.5 million** at September 30, 2023, primarily due to a reduction in short-term investments[10](index=10&type=chunk) - Total stockholders' equity decreased from **$106.3 million** to **$77.8 million** over the same period, largely due to accumulated deficit from net losses[10](index=10&type=chunk) [Condensed Statements of Operations](index=4&type=section&id=Condensed_Statements_of_Operations) This section details the company's financial performance, showing increased net losses and higher research and development expenses Condensed Statements of Operations Highlights (in thousands, except per share) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Royalty revenues | $141 | $93 | $332 | $258 | | Research and development | $8,022 | $6,009 | $25,094 | $20,665 | | Selling, general and administrative | $2,939 | $3,077 | $10,318 | $10,103 | | Total operating expenses | $10,961 | $9,086 | $35,412 | $30,768 | | Loss from operations | $(10,820) | $(8,993) | $(35,080) | $(30,510) | | Interest income, net | $1,068 | $458 | $3,061 | $841 | | Net loss | $(9,731) | $(8,571) | $(32,104) | $(30,007) | | Net loss per common share — basic and diluted | $(0.22) | $(0.20) | $(0.72) | $(0.69) | - Net loss increased to **$(9.731) million** for the three months ended September 30, 2023, from **$(8.571) million** in the prior year, and to **$(32.104) million** for the nine months ended September 30, 2023, from **$(30.007) million** in the prior year[11](index=11&type=chunk) - Research and development expenses increased significantly, by **$2.0 million** for the three-month period and **$4.4 million** for the nine-month period, primarily due to clinical program costs and increased headcount[11](index=11&type=chunk)[115](index=115&type=chunk)[141](index=141&type=chunk) [Condensed Statements of Comprehensive Loss](index=5&type=section&id=Condensed_Statements_of_Comprehensive_Loss) This section presents the total comprehensive loss, reflecting net loss and unrealized gains or losses on available-for-sale securities Condensed Statements of Comprehensive Loss Highlights (in thousands) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Net loss | $(9,731) | $(8,571) | $(32,104) | $(30,007) | | Unrealized gain (loss) on securities available-for-sale | $24 | $203 | $(12) | $(637) | | Total comprehensive loss | $(9,707) | $(8,368) | $(32,116) | $(30,644) | | Comprehensive loss attributable to common stockholders | $(9,713) | $(8,374) | $(32,134) | $(30,662) | - Total comprehensive loss for the nine months ended September 30, 2023, was **$(32.116) million**, compared to **$(30.644) million** for the same period in 2022[24](index=24&type=chunk) [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed_Statements_of_Stockholders_Equity) This section outlines changes in stockholders' equity, primarily driven by net losses and stock-based compensation Condensed Statements of Stockholders' Equity Highlights (in thousands) | Metric | Balance, January 1, 2023 | Stock-based compensation | Other comprehensive gain (loss) | Net loss | Balance, September 30, 2023 | | :----------------------------------- | :----------------------- | :----------------------- | :------------------------------ | :---------- | :-------------------------- | | Preferred Stock Shares | 61 | — | — | — | 61 | | Common Stock Shares | 44,677 | — | — | — | 44,677 | | Additional Paid-In Capital | $404,834 | $1,064 | — | — | $408,434 | | Accumulated Other Comprehensive Loss | $(395) | — | $319 | — | $(407) | | Accumulated Deficit | $(298,100) | — | — | $(11,223) | $(330,204) | | Total Stockholders' Equity | $106,343 | $1,064 | $319 | $(11,223) | $77,827 | - Total stockholders' equity decreased from **$106.343 million** at January 1, 2023, to **$77.827 million** at September 30, 2023, primarily due to net losses[1](index=1&type=chunk) - Additional paid-in capital increased by **$3.6 million** during the nine months ended September 30, 2023, mainly due to stock-based compensation[1](index=1&type=chunk)[68](index=68&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed_Statements_of_Cash_Flows) This section details cash flow activities, showing continued cash usage in operations and changes in investing activities Condensed Statements of Cash Flows Highlights (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(23,748) | $(24,430) | | Net cash provided by investing activities | $22,634 | $31,129 | | Net cash provided by financing activities | $0 | $75 | | Net change in cash and cash equivalents | $(1,114) | $6,774 | | Cash and cash equivalents—End of period | $15,233 | $18,717 | - Net cash used in operating activities was **$(23.7) million** for the nine months ended September 30, 2023, a slight decrease from **$(24.4) million** in the prior year, primarily driven by net loss[12](index=12&type=chunk)[165](index=165&type=chunk) - Net cash provided by investing activities decreased to **$22.6 million** in 2023 from **$31.1 million** in 2022, mainly due to changes in sales and maturities of short-term investments[12](index=12&type=chunk)[144](index=144&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=Notes_to_Condensed_Financial_Statements) This section provides detailed explanations and disclosures supporting the condensed financial statements, covering accounting policies, fair value, and equity [1. Organization and Basis of Presentation](index=9&type=section&id=1_Organization_and_Basis_of_Presentation) Cardiff Oncology, Inc. is a clinical-stage biotechnology company focused on developing novel cancer therapies, with sufficient cash for the next 12 months - Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop cancer therapies, with **onvansertib** as its lead asset[37](index=37&type=chunk) - The company has incurred net losses and negative operating cash flows since inception[38](index=38&type=chunk) - As of September 30, 2023, the company had **$81.4 million** in cash, cash equivalents, and short-term investments, sufficient for at least the next 12 months[38](index=38&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2_Summary_of_Significant_Accounting_Policies) This note confirms GAAP and SEC compliance for interim financial statements, with no significant accounting policy changes, and ongoing evaluation of ASU 2020-06 - Unaudited interim condensed financial statements are prepared in accordance with **GAAP** and **SEC rules** for Form 10-Q[55](index=55&type=chunk) - No changes to significant accounting policies were made during the nine months ended September 30, 2023[56](index=56&type=chunk) - The company is evaluating **ASU 2020-06** regarding convertible instruments and diluted EPS, with adoption planned for January 1, 2024[80](index=80&type=chunk) Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share (as of September 30, 2023 and December 31, 2022) | Security Type | September 30, 2023 | December 31, 2022 | | :----------------------------------- | :----------------- | :---------------- | | Options to purchase Common Stock | 6,652,427 | 5,101,572 | | Warrants to purchase Common Stock | 2,807,948 | 4,490,159 | | Series A Convertible Preferred Stock | 877 | 877 | | Series E Convertible Preferred Stock | — | 1,342,250 | | Total Potentially Dilutive Securities| 9,461,252 | 10,934,858 | [3. Fair Value Measurements](index=10&type=section&id=3_Fair_Value_Measurements) This note details fair value measurements of assets, primarily cash equivalents and available-for-sale investments, mostly classified as Level 2 Fair Value Measurements at September 30, 2023 (in thousands) | Asset Category | Level 1 (Quoted Prices) | Level 2 (Observable Inputs) | Level 3 (Unobservable Inputs) | Total | | :---------------------------------- | :---------------------- | :-------------------------- | :---------------------------- | :------- | | Money market fund | $14,928 | — | — | $14,928 | | Total included in cash and cash equivalents | $14,928 | — | — | $14,928 | | Available for sale investments: | | | | | | Certificate of deposit | — | $9,181 | — | $9,181 | | Corporate debt securities | — | $22,368 | — | $22,368 | | Commercial paper | — | $7,613 | — | $7,613 | | U.S. government agencies | — | $6,821 | — | $6,821 | | U.S. treasury securities | $20,147 | — | — | $20,147 | | Total available for sale investments| $20,147 | $45,983 | — | $66,130 | | Total assets measured at fair value on a recurring basis | $35,075 | $45,983 | — | $81,058 | - No transfers into or out of Level 3 of the fair value hierarchy occurred during the nine months ended September 30, 2023[83](index=83&type=chunk) [4. Supplementary Balance Sheet Information](index=12&type=section&id=4_Supplementary_Balance_Sheet_Information) This note provides detailed breakdowns of investments, property, and accrued liabilities, noting unrealized losses due to interest rates Investments Available for Sale at September 30, 2023 (in thousands) | Investment Type | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Market Value | | :-------------------------- | :------------- | :--------------------- | :---------------------- | :---------------- | | Maturity less than 1 year: | | | | | | Certificate of deposit | $9,181 | $3 | $(3) | $9,181 | | Corporate debt securities | $12,194 | $3 | $(28) | $12,169 | | Commercial paper | $7,616 | — | $(3) | $7,613 | | U.S. government agencies | $6,852 | — | $(31) | $6,821 | | U.S. treasury securities | $1,935 | — | $(13) | $1,922 | | Total maturity less than 1 year | $37,778 | $6 | $(78) | $37,706 | | Maturity 1 to 2 years: | | | | | | Corporate debt securities | $10,281 | $3 | $(85) | $10,199 | | U.S. treasury securities | $18,478 | — | $(253) | $18,225 | | Total maturity 1 to 2 years | $28,759 | $3 | $(338) | $28,424 | | Total short-term investments| $66,537 | $9 | $(416) | $66,130 | - Unrealized losses on available-for-sale debt securities at September 30, 2023, were primarily due to **increases in interest rates**, not credit risks[85](index=85&type=chunk) Accrued Liabilities (in thousands) | Accrued Liability | September 30, 2023 | December 31, 2022 | | :-------------------------- | :----------------- | :---------------- | | Accrued compensation | $2,455 | $1,849 | | Clinical trials | $2,878 | $2,333 | | Research agreements and services | $591 | $509 | | Director fees | $125 | $125 | | Patent, license and other fees | $33 | $24 | | Other accrued liabilities | $69 | $337 | | Total accrued liabilities | $6,151 | $5,177 | [5. Stockholders' Equity](index=13&type=section&id=5_Stockholders_Equity) This note details stock-based compensation, option and warrant activity, and preferred stock changes, including a modification for a departing employee Stock-based Compensation Expense (in thousands) | Expense Category | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :---------------------------------------------- | :------------------------------ | :------------------------------ | :----------------------------- | :----------------------------- | | Included in research and development expense | $294 | $286 | $985 | $746 | | Included in selling, general and administrative expense | $661 | $751 | $2,615 | $2,498 | | Total stock-based compensation expense | $955 | $1,037 | $3,600 | $3,244 | - Unrecognized compensation cost for non-vested stock options was **$7.5 million** as of September 30, 2023, to be recognized over a weighted-average remaining vesting period of **2.3 years**[88](index=88&type=chunk) Stock Option Activity (as of September 30, 2023) | Metric | Total Options | Weighted-Average Exercise Price Per Share | | :-------------------------------------- | :------------ | :---------------------------------------- | | Balance outstanding, December 31, 2022 | 5,069,458 | $5.92 | | Granted | 2,138,624 | $1.70 | | Forfeited and expired | (555,655) | $8.40 | | Balance outstanding, September 30, 2023 | 6,652,427 | $4.36 | - The company modified stock options for a departing employee in June 2023, resulting in an incremental stock-based compensation expense of **$0.6 million**[93](index=93&type=chunk) - On August 8, 2023, the company filed a Certificate of Elimination for Series B, C, D, and E Convertible Preferred Stock, returning previously designated but unissued shares to authorized but undesignated status[73](index=73&type=chunk) [6. Commitments and Contingencies](index=15&type=section&id=6_Commitments_and_Contingencies) This note outlines commitments under research and development agreements, including onvansertib licensing, and confirms no material legal liabilities - The company has a license agreement for **onvansertib** with Nerviano, involving potential development and commercial milestones, and sales-based royalties[96](index=96&type=chunk) - No milestone or royalty payments were made under the onvansertib license agreement during the nine months ended September 30, 2023 and 2022[96](index=96&type=chunk) - Management believes there are no legal liabilities that are probable or reasonably possible requiring accrual or disclosure, nor any claims that would result in a material adverse effect[97](index=97&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, operations, business strategy, clinical trials, and liquidity [Forward-Looking Statements](index=16&type=section&id=Forward-Looking_Statements) This section highlights that the report contains forward-looking statements subject to risks and uncertainties, and actual results may differ - The report contains forward-looking statements regarding future financial position, business strategy, and operational plans, identified by words like 'believe,' 'may,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'should,' 'plan,' and 'expect'[77](index=77&type=chunk) - These statements are based on current expectations and projections but are subject to risks, uncertainties, and assumptions, and actual results may differ materially[77](index=77&type=chunk)[99](index=99&type=chunk) [Overview](index=16&type=section&id=Overview) Cardiff Oncology is a clinical-stage biotechnology company developing novel cancer therapies by inhibiting PLK1, with onvansertib as its lead asset - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies for various cancers by inhibiting **PLK1**, a validated oncology drug target[122](index=122&type=chunk) - The company's strategy involves combining **onvansertib**, an oral and highly selective PLK1 inhibitor, with standard-of-care therapeutics to target tumor vulnerabilities[122](index=122&type=chunk) - Clinical programs are focused on **RAS-mutated metastatic colorectal cancer (mCRC)**, **metastatic pancreatic ductal adenocarcinoma (mPDAC)**, **small cell lung cancer (SCLC)**, and **triple negative breast cancer (TNBC)**[122](index=122&type=chunk) [Our Lead Drug Candidate, Onvansertib](index=16&type=section&id=Our_Lead_Drug_Candidate,_Onvansertib) Onvansertib is an oral, highly specific PLK1 inhibitor with high potency and selectivity, showing synergistic effects in studies - Onvansertib is an oral, small molecule drug candidate that is highly specific for **PLK1 inhibition** with a **24-hour half-life**[123](index=123&type=chunk) - It demonstrates high potency and selectivity against the PLK1 enzyme (**IC50 = 2nM**), with low or no activity on other PLK members or a panel of 63 other kinases[124](index=124&type=chunk) - In vitro and in vivo studies show **synergistic effects** when onvansertib is combined with various cytotoxic agents and standard-of-care cancer agents[103](index=103&type=chunk)[125](index=125&type=chunk) [RAS-mutated mCRC Program](index=17&type=section&id=RAS-mutated_mCRC_Program) The CRDF-004 Phase 2 trial evaluates onvansertib in first-line RAS-mutated mCRC, with enrollment starting in Q4 2023 and interim data in mid-2024 - **CRDF-004** is a Phase 2 open-label, randomized multi-center clinical trial evaluating onvansertib in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab for first-line treatment of **RAS-mutated mCRC**[126](index=126&type=chunk) - Primary objectives include evaluating safety, efficacy, and two doses (**20mg and 30mg**) of onvansertib against standard-of-care alone, with **objective response rate (ORR)** as the primary endpoint[126](index=126&type=chunk) - Enrollment is expected to begin in **Q4 2023**, with interim data anticipated in **mid-2024**, and Pfizer Ignite is responsible for clinical execution[126](index=126&type=chunk) [Phase 1b/2 Clinical Trial in KRAS-mutated mCRC](index=17&type=section&id=Phase_1b/2_Clinical_Trial_in_KRAS-mutated_mCRC) The TROV-054 trial for KRAS-mutated mCRC showed a 29% ORR and 9.3 months mPFS, with bevacizumab-naïve patients achieving 73% ORR and 15 months mPFS - **TROV-054** is a Phase 1b/2 open-label multi-center clinical trial of onvansertib with FOLFIRI and bevacizumab for second-line treatment of **KRAS-mutated mCRC**, which completed enrollment in October 2022[46](index=46&type=chunk) - Data presented on August 7, 2023, showed an **Objective Response Rate (ORR) of 29%** and median **Progression-Free Survival (mPFS) of 9.3 months** across all evaluable patients[107](index=107&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - A subgroup analysis revealed that bevacizumab-naïve patients (n=15) had a **73% ORR** and **15 months mPFS**, significantly higher than historical controls and patients previously treated with bevacizumab[108](index=108&type=chunk) [mDPAC Program](index=18&type=section&id=mDPAC_Program) The CRDF-001 Phase 2 trial for mPDAC showed a 19% ORR and 5.0 months mPFS, with an ongoing biomarker discovery trial - **CRDF-001** is a Phase 2 open-label multi-center clinical trial of onvansertib in combination with nanoliposomal irinotecan, leucovorin, and fluorouracil for second-line treatment of **mPDAC**, with enrollment closing in October 2023[47](index=47&type=chunk)[131](index=131&type=chunk) - Preliminary data from September 26, 2023, showed a **19% Objective Response Rate (ORR)** compared to a historical control of 7.7% in the second-line setting, and a median **Progression-Free Survival (mPFS) of 5.0 months** compared to 3.1 months for standard of care[109](index=109&type=chunk)[132](index=132&type=chunk) - A biomarker discovery trial for onvansertib monotherapy in mPDAC patients is ongoing, with preliminary data showing an **86% decrease in Ki67** and a **28% decrease in CA 19-9** in one patient[109](index=109&type=chunk)[156](index=156&type=chunk) [Other Clinical Programs](index=19&type=section&id=Other_Clinical_Programs) Ongoing Phase 2 trials include onvansertib monotherapy for SCLC, showing a 57% disease control rate, and combination therapy for TNBC - A single-arm, two-stage, Phase 2 investigator-initiated trial of onvansertib monotherapy in patients with relapsed **Small Cell Lung Cancer (SCLC)** is open for enrollment, with a primary endpoint of **Objective Response Rate (ORR)**[48](index=48&type=chunk)[134](index=134&type=chunk) - Preliminary efficacy data for seven SCLC patients showed **1 confirmed partial response**, **3 stable disease**, and **3 progressive disease**, resulting in a **57% disease control rate**[111](index=111&type=chunk) - A Phase 1b/2 investigator-initiated trial of onvansertib in combination with paclitaxel for unresectable locally advanced or metastatic **Triple Negative Breast Cancer (TNBC)** is open for enrollment[135](index=135&type=chunk)[158](index=158&type=chunk) [Critical Accounting Policies](index=19&type=section&id=Critical_Accounting_Policies) This section confirms no changes to the company's critical accounting policies since December 31, 2022 - There have been no changes to the company's critical accounting policies since December 31, 2022, as described in its Annual Report on Form 10-K[136](index=136&type=chunk) [Results of Operations - Three Months Ended September 30, 2023 and 2022](index=19&type=section&id=Results_of_Operations_-_Three_Months_Ended_September_30,_2023_and_2022) This section analyzes the company's financial performance for the three-month period, detailing changes in revenues and expenses [Revenues](index=19&type=section&id=Revenues_3M) Royalty revenues for the three months ended September 30, 2023, increased to $141,000 from $93,000 in the prior year Royalty Revenues (in thousands) | Period | 2023 | 2022 | Change | | :------------------------------------ | :--- | :--- | :----- | | Three Months Ended September 30, 2023 | $141 | $93 | +$48 | - Revenue recognition depends on the timing and overall sales activities of the licensees[113](index=113&type=chunk) [Research and Development Expenses](index=19&type=section&id=Research_and_Development_Expenses_3M) Research and development expenses increased by $2.0 million for the three months ended September 30, 2023, due to clinical program costs and headcount growth Research and Development Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :----- | :----- | :------------------ | | Salaries and staff costs | $1,615 | $1,000 | $615 | | Stock-based compensation | $294 | $286 | $8 | | Clinical trials, outside services, and lab supplies | $5,603 | $4,279 | $1,324 | | Facilities and other | $510 | $444 | $66 | | Total research and development | $8,022 | $6,009 | $2,013 | - Average headcount in research and development grew by **50%** over the comparative period[115](index=115&type=chunk) [Selling, General and Administrative Expenses](index=20&type=section&id=Selling,_General_and_Administrative_Expenses_3M) Selling, general and administrative expenses decreased by $0.1 million for the three months, mainly due to lower headcount and reduced stock-based compensation Selling, General and Administrative Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :----- | :----- | :------------------ | | Salaries and staff costs | $731 | $808 | $(77) | | Stock-based compensation | $661 | $751 | $(90) | | Outside services and professional fees | $1,011 | $840 | $171 | | Facilities and other | $536 | $678 | $(142) | | Total selling, general and administrative | $2,939 | $3,077 | $(138) | - The decrease was primarily due to lower headcount, reduced stock-based compensation, and lower insurance costs[138](index=138&type=chunk) - Outside services and professional fees increased due to additional legal fees for contract reviews[138](index=138&type=chunk) [Interest Income, Net](index=20&type=section&id=Interest_Income,_Net_3M) Net interest income increased to $1.1 million for the three months ended September 30, 2023, driven by higher interest rates Interest Income, Net (in thousands) | Period | 2023 | 2022 | Change | | :------------------------------------ | :----- | :----- | :----- | | Three Months Ended September 30, 2023 | $1,068 | $458 | +$610 | - The increase was primarily due to **higher interest rates** on the short-term investments portfolio[139](index=139&type=chunk) [Results of Operations - Nine Months Ended September 30, 2023 and 2022](index=20&type=section&id=Results_of_Operations_-_Nine_Months_Ended_September_30,_2023_and_2022) This section analyzes the company's financial performance for the nine-month period, detailing changes in revenues and expenses [Revenues](index=20&type=section&id=Revenues_9M) Total royalty revenues for the nine months ended September 30, 2023, increased to $332,000 from $258,000 in the prior year Royalty Revenues (in thousands) | Period | 2023 | 2022 | Change | | :----------------------------------- | :--- | :--- | :----- | | Nine Months Ended September 30, 2023 | $332 | $258 | +$74 | - Revenues are from sales-based or usage-based royalties on other intellectual property licenses, unrelated to onvansertib[161](index=161&type=chunk) [Research and Development Expenses](index=20&type=section&id=Research_and_Development_Expenses_9M) Research and development expenses increased by $4.4 million for the nine months ended September 30, 2023, due to clinical program costs and headcount growth Research and Development Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :------ | :------ | :------------------ | | Salaries and staff costs | $4,475 | $3,131 | $1,344 | | Stock-based compensation | $985 | $746 | $239 | | Clinical trials, outside services, and lab supplies | $18,118 | $15,699 | $2,419 | | Facilities and other | $1,516 | $1,089 | $427 | | Total research and development | $25,094 | $20,665 | $4,429 | - Average headcount in research and development grew by **37%** over the comparative period[141](index=141&type=chunk) [Selling, General and Administrative Expenses](index=21&type=section&id=Selling,_General_and_Administrative_Expenses_9M) Selling, general and administrative expenses increased by $0.2 million for the nine months, mainly due to higher salaries and staff costs Selling, General and Administrative Expenses (in thousands) | Expense Category | 2023 | 2022 | Increase (Decrease) | | :------------------------------------ | :------ | :------ | :------------------ | | Salaries and staff costs | $2,888 | $2,460 | $428 | | Stock-based compensation | $2,615 | $2,498 | $117 | | Outside services and professional fees | $3,102 | $3,119 | $(17) | | Facilities and other | $1,713 | $2,026 | $(313) | | Total selling, general and administrative | $10,318 | $10,103 | $215 | - Salaries and staff costs increased due to an employee severance agreement[142](index=142&type=chunk) [Interest Income, Net](index=21&type=section&id=Interest_Income,_Net_9M) Net interest income significantly increased to $3.1 million for the nine months ended September 30, 2023, due to higher interest rates Interest Income, Net (in thousands) | Period | 2023 | 2022 | Change | | :----------------------------------- | :----- | :--- | :----- | | Nine Months Ended September 30, 2023 | $3,061 | $841 | +$2,220 | - The increase was primarily due to **higher interest rates** on the short-term investments portfolio[143](index=143&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity_and_Capital_Resources) The company has $81.4 million in cash and investments, sufficient for at least 12 months, but expects continued losses and need for additional capital - As of September 30, 2023, the company had working capital of **$74.9 million** and **$81.4 million** in cash, cash equivalents, and short-term investments[145](index=145&type=chunk) - The company believes it has sufficient cash to meet its funding requirements for at least the next 12 months and expects capital resources to fund operations into **2025**[145](index=145&type=chunk) - The company expects to continue incurring losses and negative operating cash flows, requiring additional capital to advance clinical trial programs[147](index=147&type=chunk)[165](index=165&type=chunk) - There is uncertainty regarding the availability of additional funding on acceptable terms, and future equity issuances could dilute stockholders[147](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the information regarding quantitative and qualitative disclosures about market risk is not applicable to the company - This item is not applicable to Cardiff Oncology, Inc[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures, confirming their effectiveness and no material changes to internal control [Evaluation of Disclosure Controls and Procedures](index=22&type=section&id=Evaluation_of_Disclosure_Controls_and_Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, providing reasonable assurance for information reporting - Management, including the CEO and CFO, concluded that disclosure controls and procedures were **effective** as of September 30, 2023[149](index=149&type=chunk) - Disclosure controls are designed to provide reasonable assurance that information required to be disclosed is recorded, processed, summarized, and reported within specified time periods[149](index=149&type=chunk)[169](index=169&type=chunk) [Changes in Internal Control over Financial Reporting](index=22&type=section&id=Changes_in_Internal_Control_over_Financial_Reporting) There were no material changes in internal control over financial reporting during the three months ended September 30, 2023 - There was **no change** in internal control over financial reporting during the three months ended September 30, 2023, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[170](index=170&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART_II_OTHER_INFORMATION) This part covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) This section states no material changes from the legal proceedings disclosed in the company's prior Form 10-K - No material changes from the legal proceedings disclosed in the Form 10-K for the year ended December 31, 2022[177](index=177&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) This section indicates no material changes from the risk factors disclosed in the company's prior Form 10-K - No material changes from the risk factors disclosed in the Form 10-K for the year ended December 31, 2022[177](index=177&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there is no information to report regarding unregistered sales of equity securities and use of proceeds - None to report for unregistered sales of equity securities and use of proceeds[36](index=36&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there is no information to report regarding defaults upon senior securities - Not applicable for defaults upon senior securities[152](index=152&type=chunk) [Item 4. Mine Safety Disclosures](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there is no information to report regarding mine safety disclosures - None to report for mine safety disclosures[178](index=178&type=chunk) [Item 5. Other Information](index=23&type=section&id=Item%205.%20Other%20Information) This section states that there is no other information to report - None to report for other information[172](index=172&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL documents List of Exhibits | Exhibit Number | Description of Exhibit | | :------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | 31.1 | Certification of Principal Executive Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. | | 31.2 | Certification of Principal Financial Officer required by Rule 13a-14(a)/15d-14(a) under the Exchange Act. | | 32.1 | Certification of Principal Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 32.2 | Certification of Principal Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 101.INS | Inline XBRL Instance Document | | 101.SCH | Inline XBRL Taxonomy Extension Schema | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase | | 101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase | | 104 | Cover Page Interactive Data File - the cover page from the Registrant's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, is formatted in Inline XBRL | [SIGNATURES](index=24&type=section&id=SIGNATURES) This section confirms the official signing of the Quarterly Report on Form 10-Q by the company's executive officers [Signatories](index=24&type=section&id=Signatories) The Quarterly Report on Form 10-Q was duly signed on November 2, 2023, by the Chief Financial Officer and Chief Executive Officer - The report was signed on **November 2, 2023**[176](index=176&type=chunk)[181](index=181&type=chunk) - Signed by **James Levine**, Chief Financial Officer[176](index=176&type=chunk) - Signed by **Mark Erlander**, Chief Executive Officer[181](index=181&type=chunk)
Cardiff Oncology (CRDF) Investor Presentation - Slideshow
2023-08-15 17:46
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]
Cardiff Oncology(CRDF) - 2023 Q2 - Quarterly Report
2023-08-08 16:00
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 | | --- | --- | | ...
Cardiff Oncology (CRDF) Investor Presentation - Slideshow
2023-05-05 20:40
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 ...
Cardiff Oncology(CRDF) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
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) | ( ...