Praxis Precision Medicines Files 2023 Annual Report

TL;DR

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

AI Summary

Praxis Precision Medicines, Inc. (PRAX) filed a Annual Report (10-K) with the SEC on March 5, 2024. Praxis Precision Medicines, Inc. filed its 2023 10-K report on March 5, 2024. The company is incorporated in Delaware and headquartered in Boston, MA. The filing covers the fiscal year ending December 31, 2023. The SIC code for the company is 2834 (Pharmaceutical Preparations). The filing number is 001-39620.

Why It Matters

For investors and stakeholders tracking Praxis Precision Medicines, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of the company's financial health, operational activities, and strategic direction for investors and stakeholders. This annual report is crucial for understanding the company's progress, risks, and future outlook in the pharmaceutical sector.

Risk Assessment

Risk Level: — Praxis Precision Medicines, Inc. shows moderate risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant financial or operational disclosures that would alter the risk profile.

Analyst Insight

Review the full 10-K filing for detailed financial statements, risk factors, and management discussion to assess the company's performance and strategic initiatives.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed Period of Report)
• 2024-03-05 — Filing Date (Filed as of Date)
• 97 — Public Document Count (Number of documents in the filing)

Key Players & Entities

• Praxis Precision Medicines, Inc. (company) — Filer name
• 0001689548 (company) — Central Index Key
• 2834 (company) — Standard Industrial Classification
• DE (company) — State of Incorporation
• Boston (company) — Business Address City
• MA (company) — Business Address State
• 001-39620 (company) — SEC File Number
• 24718257 (company) — Film Number

FAQ

Industry Context

Praxis Precision Medicines operates within the pharmaceutical preparations industry, focusing on the development and commercialization of therapies.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports (10-K) detailing financial and operational information.

What Investors Should Do

1. Review the detailed financial statements within the 10-K for revenue, expenses, and cash flow.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Examine management's discussion and analysis (MD&A) for insights into business strategy and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-05: Filing Date — Date the 10-K report was officially submitted to the SEC.

Year-Over-Year Comparison

This is the 2023 10-K filing, representing the company's annual performance review for the most recent fiscal year.

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share PRAX The Nasdaq Global Select

Filing Documents

• prax-20231231.htm (10-K) — 2047KB
• exhibit1015_anemploymentag.htm (EX-10.15) — 91KB
• exhibit1017_directorcomppo.htm (EX-10.17) — 13KB
• exhibit231-eyconsent2023.htm (EX-23.1) — 5KB
• exhibit311-peo302certifica.htm (EX-31.1) — 21KB
• exhibit312-pfo302certifica.htm (EX-31.2) — 21KB
• exhibit321-peoandpfo906cer.htm (EX-32.1) — 14KB
• exhibit97_clawbackpolicy.htm (EX-97) — 33KB
• prax-20231231_g1.jpg (GRAPHIC) — 49KB
• prax-20231231_g2.jpg (GRAPHIC) — 42KB
• prax-20231231_g3.jpg (GRAPHIC) — 45KB
• prax-20231231_g4.jpg (GRAPHIC) — 78KB
• 0001689548-24-000034.txt (&nbsp;) — 8467KB
• prax-20231231.xsd (EX-101.SCH) — 47KB
• prax-20231231_cal.xml (EX-101.CAL) — 73KB
• prax-20231231_def.xml (EX-101.DEF) — 216KB
• prax-20231231_lab.xml (EX-101.LAB) — 661KB
• prax-20231231_pre.xml (EX-101.PRE) — 445KB
• prax-20231231_htm.xml (XML) — 781KB

Risk Factors

Item 1A. Risk Factors 28

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 84

Properties

Item 2. Properties 85

Legal Proceedings

Item 3. Legal Proceedings 85

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 85 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 86

[Reserved]

Item 6. [Reserved] 86

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

Item 7. Management's Discussion and Analysis of Financial Condition and results of Operations 87

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 99

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 100

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 131

Controls and Procedures

Item 9A. Controls and Procedures 131

Other Information

Item 9B. Other Information 131

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 131 Part III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 132

Executive Compensation

Item 11. Executive Compensation 136

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

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 147

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 150

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 152 Part IV

Exhibits, Financial Statement Schedules

Item 15. Exhibits, Financial Statement Schedules 153

Form 10-K Summary

Item 16. Form 10-K Summary 156

Signatures

Signatures Table of Contents SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS We are a clinical-stage biopharmaceutical company and we have incurred significant losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future. We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product discovery and development programs or commercialization efforts. The development and commercialization of drug products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration, or the FDA, and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis if at all, our business will be substantially harmed. Preclinical and clinical drug development involves a lengthy, complex and expensive process, with an uncertain outcome. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities. Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences following regulatory approval, if obtained. If we encounter difficulties enrolling patients in our future clinical trials, our clinical development activities could be delayed or otherwise adversely affected. We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, m

BUSINESS

BUSINESS COMPANY OVERVIEW We are a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and both rare and more prevalent neurological disorders. We are applying genetic insights to the discovery and development of therapies for neurological disorders through two proprietary platforms, using our understanding of shared biological targets and circuits in the brain. Each platform currently has multiple programs, with significant potential for additional program and indication expansion: Cerebrum , our small molecule platform, utilizes deep understanding of neuronal excitability and neuronal networks and applies a series of computational and experimental tools to develop orally available precision therapies Solidus , our antisense oligonucleotide, or ASO, platform, is an efficient, targeted precision medicine discovery and development engine anchored on a proprietary, computational methodology Our platforms utilize a deliberate, pragmatic and patient-guided approach, leveraging a suite of translational tools, including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients. Through this approach, we have established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy. Cerebrum (small molecule platform) We have built a platform, Cerebrum, which is enabled by innovative computational and experimental tools, to discover and develop first- and best-in-class CNS small molecule therapies. Our world-class ion channel discovery science team, along with external collaborators, accelera

View Full Filing

View this 10-K filing on SEC EDGAR