Cardiff Oncology, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Cardiff Oncology, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

Cardiff Oncology, Inc. (CRDF) filed a Annual Report (10-K) with the SEC on February 29, 2024. Cardiff Oncology, Inc. filed its 2023 Form 10-K on February 29, 2024. The filing covers the fiscal year ending December 31, 2023. The company was formerly known as Trovagene, Inc. and Xenomics Inc. Cardiff Oncology is in the Biological Products industry. The company's principal business address is in San Diego, California.

Why It Matters

For investors and stakeholders tracking Cardiff Oncology, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Cardiff Oncology's financial health, operational activities, and strategic direction for the past fiscal year, which is crucial for investors to assess the company's performance and future prospects. As a publicly traded company, Cardiff Oncology is required to disclose detailed financial information and business risks, offering transparency to shareholders and the market regarding its operations in the biotechnology sector.

Risk Assessment

Risk Level: medium — Cardiff Oncology, Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated biotechnology sector, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products, as indicated by its industry classification and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Cardiff Oncology's current financial position and potential challenges in bringing its products to market.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-29 — Filing Date (Date of submission)
• 2836 — SIC Code (Standard Industrial Classification)
• DE — State of Incorporation (Legal domicile)

Key Players & Entities

• Cardiff Oncology, Inc. (company) — Filer name
• CRDF (company) — Ticker symbol
• 10-K (document) — Filing type
• 2023-12-31 (date) — Fiscal year end
• 2024-02-29 (date) — Filing date
• Trovagene, Inc. (company) — Former company name
• Xenomics Inc (company) — Former company name
• San Diego, CA (location) — Business address

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including FDA requirements, which can impact product development, approval, and marketing.
• Market Competition [high — market]: The biotechnology market is highly competitive, with numerous companies developing similar therapies, posing a risk to market share and pricing.
• Need for Additional Financing [medium — financial]: The company may require additional capital to fund its operations and clinical development, which may not be available on favorable terms or at all.
• Clinical Trial Risks [high — operational]: The success of the company's drug candidates depends on the outcome of clinical trials, which are inherently uncertain and can fail at various stages.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-29: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.0001 — nge on which registered: Common Stock, $0.0001 par value CRDF The Nasdaq Stock Market
• $1.47 — liates based on a closing sale price of $1.47 per share, which was the last sale pric

Filing Documents

• crdf-20231231.htm (10-K) — 1380KB
• a231exq42023.htm (EX-23.1) — 3KB
• a311exq42023.htm (EX-31.1) — 12KB
• a312exq42023.htm (EX-31.2) — 12KB
• a321exq42023.htm (EX-32.1) — 6KB
• a322exq42023.htm (EX-32.2) — 6KB
• a97exq42023.htm (EX-97) — 43KB
• 0001628280-24-007948.txt (&nbsp;) — 6811KB
• crdf-20231231.xsd (EX-101.SCH) — 43KB
• crdf-20231231_cal.xml (EX-101.CAL) — 84KB
• crdf-20231231_def.xml (EX-101.DEF) — 167KB
• crdf-20231231_lab.xml (EX-101.LAB) — 571KB
• crdf-20231231_pre.xml (EX-101.PRE) — 358KB
• crdf-20231231_htm.xml (XML) — 1033KB

Business

Business 6 Item 1A

Risk Factors

Risk Factors 18 Item 1B Unresolved Staff Comments 40 Item 1 C Cybersecurity 40 Item 2

Properties

Properties 41 Item 3

Legal Proceedings

Legal Proceedings 41 Item 4 Mine Safety Disclosures 41 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 42 Item 6 [Reserved] 42 Item 7

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 42 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 45 Item 9 Changes In and Disagreements with Accountants on Accounting and Financial Disclosure 45 Item 9A

Controls and Procedures

Controls and Procedures 45 Item 9B Other Information 46 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 46 PART III Item 10 Directors, Executive Officers, and Corporate Governance 46 Item 11

Executive Compensation

Executive Compensation 46 Item 12

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 46 Item 13 Certain Relationship and Related Transactions, and Director Independence 46 Item 14 Principal Accountant Fees and Services 46 PART IV 47 Item 15 Exhibits 47 Item 16 Form 10-K Summary 49

SIGNATURES

SIGNATURES 50 2 Table of Contents

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties. You should not place undue reliance on these forward-looking statements. Our actual results could differ materially from those anticipated in the forward-looking statements for many reasons, including the reasons described in our "Business," "Risk Factors," and "Management Discussion and Analysis of Financial Condition and Result of Operations," sections. In some cases, you can identify these forward-looking statements by terms such as "anticipate," "believe," "continue," "could," "depends," "estimate," "expects," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms or other similar expressions, although not all forward-looking statements contain those words. Our operations and business prospects are always subject to risks and uncertainties including, among others: the timing of regulatory submissions; our ability to obtain and maintain regulatory approval of our existing product candidate and any other product candidates we may develop, and the labeling under any approval we may obtain; approvals for clinical trials may be delayed or withheld by regulatory agencies; pre-clinical and clinical studies will not be successful or confirm earlier results or meet expectations or meet regulatory requirements or meet performance thresholds for commercial success; risks relating to the timing and costs of clinical trials, the timing and costs of other expenses; risks associated with obtaining funding from third parties; management and employee operations and execution risks; loss of key personnel; competition; risks related to market acceptance of products; intellectual property risks; assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; risks associated with the unce

BUSINESS

ITEM 1. BUSINESS We are a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers with the greatest unmet medical need. Our goal is to target tumor vulnerabilities with treatment combinations of onvansertib, our oral and highly selective PLK1 inhibitor, and standard-of-care therapeutics. We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC"). Our clinical development programs incorporate tumor genomics and biomarker assays to refine assessment of patient response to treatment. Our Lead Drug Candidate, Onvansertib Onvansertib is an oral, small molecule drug candidate that is highly specific for PLK1 inhibition with a 24-hour half-life. We believe the attributes of onvansertib described below, as well as early clinical evidence of favorable safety and efficacy, with expected on-target, manageable and transient side effects, may prove beneficial in addressing clinical therapeutic needs across a variety of cancers: Onvansertib is highly potent and highly selective against the PLK1 enzyme (IC 50 = 2nM; IC 50 is the concentration for 50% inhibition), compared to prior PLK1 inhibitors that were pan-inhibitors of several PLK targets. Low or no activity of onvansertib was observed on a panel of 63 kinases (IC50>500 nM), including the PLK members PLK2 and PLK3 (IC 50 >10,000 nM); Onvansertib is orally bioavailable, allowing for relative ease and flexibility of dosing; Onvansertib has a relatively short drug half-life of 24 hours, allowing for flexible dosing and scheduling which has shown favorable safety and tolerability across multiple clinical trials; In vitro studies have shown synergistic effects when onvansertib was administe

View Full Filing

View this 10-K filing on SEC EDGAR