Plus Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Plus Therapeutics, Inc. filed its 2023 annual report (10-K) detailing financial performance, business operations, and risk factors.</b>

AI Summary

PLUS THERAPEUTICS, INC. (PSTV) filed a Annual Report (10-K) with the SEC on March 5, 2024. Plus Therapeutics, Inc. filed its 2023 Form 10-K on March 5, 2024. The company was formerly known as Cytori Therapeutics, Inc. and Macropore Inc. Key agreements mentioned include the Biocept Agreement and the Piramal Pharma Solutions Inc. agreement. Financing activities include common stock transactions with Lincoln Park Capital Fund, LLC and Series F Convertible Preferred Stock subscription agreements. The filing covers the fiscal year ending December 31, 2023.

Why It Matters

For investors and stakeholders tracking PLUS THERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Plus Therapeutics' financial health and strategic direction for the fiscal year 2023, crucial for investors to assess the company's current standing and future prospects. Understanding the company's historical name changes and various financing agreements, such as those with Lincoln Park Capital Fund, LLC, is important for evaluating its capital structure and past funding strategies.

Risk Assessment

Risk Level: medium — PLUS THERAPEUTICS, INC. shows moderate risk based on this filing. The company's financial performance and ability to secure future funding are critical, as indicated by various financing agreements and the nature of the biotechnology industry.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the company's operational performance and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-05 — Filing Date (Date of submission)
• 737.255.7194 — Business Phone (Contact number)
• DE — State of Incorporation (Legal domicile)

Key Players & Entities

• PLUS THERAPEUTICS, INC. (company) — Filer name
• PSTV (company) — Ticker symbol
• CYTORI THERAPEUTICS, INC. (company) — Former company name
• MACROPORE INC (company) — Former company name
• Lincoln Park Capital Fund, LLC (company) — Financing counterparty
• Piramal Pharma Solutions Inc (company) — Business partner
• Biocept (company) — Business partner
• Cancer Prevention and Research Institute of Texas (company) — Contracting party

FAQ

Risk Factors

• Financial Condition and Liquidity [high — financial]: The company's ability to continue as a going concern is dependent on its ability to secure additional financing and achieve profitability.
• Regulatory Approval Process [high — regulatory]: The development and commercialization of pharmaceutical products are subject to extensive regulatory review and approval processes by agencies like the FDA.
• Market Acceptance and Competition [medium — market]: The success of the company's products depends on market acceptance and its ability to compete with existing and emerging therapies.
• Reliance on Third-Party Manufacturers [medium — operational]: The company relies on third-party manufacturers for the production of its products, which could lead to supply chain disruptions.

Key Dates

• 2023-12-31: Fiscal Year End — Defines the period covered by the annual report.
• 2024-03-05: Filing Date — Indicates when the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share PSTV Nasdaq Capital Marke
• $2.02 — ported on the Nasdaq Capital Market, of $2.02 per share. As of February 26, 2024, t
• $3.0 million — al cancer targets and we have an active $3.0 million award from U.S. National Institutes of

Filing Documents

• pstv-20231231.htm (10-K) — 2646KB
• pstv-ex10_16.htm (EX-10.16) — 60KB
• pstv-ex23_1.htm (EX-23.1) — 5KB
• pstv-ex31_1.htm (EX-31.1) — 13KB
• pstv-ex31_2.htm (EX-31.2) — 13KB
• pstv-ex32_1.htm (EX-32.1) — 13KB
• pstv-ex97_1.htm (EX-97.1) — 61KB
• 0000950170-24-025851.txt (&nbsp;) — 8958KB
• pstv-20231231.xsd (EX-101.SCH) — 1313KB
• pstv-20231231_htm.xml (XML) — 1075KB

Business

Business 8 Item 1A.

Risk Factors

Risk Factors 26 Item 1B. Unresolved Staff Comments 50 Item IC. Cybersecurity 50 Item 2.

Properties

Properties 51 Item 3.

Legal Proceedings

Legal Proceedings 51 Item 4. Mine Safety Disclosures 51 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 52 Item 6. [Reserved] 52 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 53 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 63 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 64 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 87 Item 9A.

Controls and Procedures

Controls and Procedures 87 Item 9B. Other Information 88 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 88 PART III Item 10. Directors, Executive Officers and Corporate Governance 88 Item 11.

Executive Compensation

Executive Compensation 94 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 99 Item 13. Certain Relationships and Related Transactions, and Director Independence 101 Item 14. Principal Accounting Fees and Services 102 PART IV Item 15. Exhibits, Financial Statement Schedules 104 Item 16. Form 10-K Summary 104 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This report contains certain statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about our anticipated expenditures, including research and development, and general and administrative expenses; our strategic collaborations and license agreements, intellectual property, U.S. Food and Drug Administration and European Medicines Agency approvals and interactions and government regulation; the potential size of the market for our product candidates; our research and development efforts; results from our pre-clinical and clinical studies and the implications of such results regarding the efficacy or safety of our product candidates; the safety profile, pathways, and efficacy of our product candidates and formulations; anticipated advantages of our product candidates over other products available in the market and being developed; the populations that will most benefit from our product candidates

B usiness

Item 1. B usiness References to "Plus Therapeutics," the "Company," "we," "us" and "our" refer to Plus Therapeutics, Inc. References to "Notes" refer to the Notes to Financial Statements included herein (refer to Item 8). General Plus Therapeutics, Inc. is a U.S. pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system ("CNS") cancers. Our novel radioactive drug formulations and therapeutic candidates are designed to deliver safe and effective doses of radiation to tumors. To achieve this, we have developed innovative approaches to drug formulation, including encapsulating radionuclides such as rhenium isotopes with nanoliposomes and microspheres. Our formulations are intended to achieve elevated patient absorbed radiation doses and extend retention times such that the clearance of the isotope occurs after significant and essentially complete radiation decay, which will contribute and provide less normal tissue/organ exposure and improved safety margins. Traditional approaches to radiation therapy for cancer, such as external beam radiation, have many disadvantages including continuous treatment for four to six weeks (which is onerous for patients), that the radiation damages healthy cells and tissue, and that the amount of radiation delivered is very limited and, therefore, is frequently inadequate to fully destroy the cancer. Our targeted radiotherapeutic platform and unique investigational drugs have the potential to overcome these disadvantages by directing higher, more powerful radiation doses at the tumor—and only the tumor—potentially in a single treatment. By minimizing radiation exposure to healthy tissues while simultaneously maximizing locoregional delivery and, thereby, efficacy, we hope to reduce the radiation toxicity for patients, improving their quality of life and life expectancy. Our radiotherapeutic platform, combined with advances in surgery, nuclear medicine, interventi

View Full Filing

View this 10-K filing on SEC EDGAR