aTYR PHARMA INC Files 2023 Annual Report on Form 10-K

TL;DR

<b>aTYR PHARMA 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

aTYR PHARMA INC (ATYR) filed a Annual Report (10-K) with the SEC on March 14, 2024. aTYR PHARMA INC filed its 2023 Form 10-K on March 14, 2024. The company's fiscal year ends on December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. Key entities mentioned include Kyorin Pharmaceutical Co Ltd and Pangu Bio Pharma Limited. The company is incorporated in Delaware and headquartered in San Diego, CA.

Why It Matters

For investors and stakeholders tracking aTYR PHARMA INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of aTYR PHARMA INC's financial health, operational status, and strategic direction for the past fiscal year, crucial for investors and stakeholders to assess the company's performance and future prospects. The detailed financial statements and risk factors within the report offer insights into the company's revenue streams, expenses, assets, liabilities, and potential challenges, enabling informed investment decisions.

Risk Assessment

Risk Level: medium — aTYR PHARMA INC shows moderate risk based on this filing. The company operates in the biotechnology sector, which is inherently risky due to long development cycles, high R&D costs, and regulatory hurdles, as evidenced by the nature of its business (Biological Products).

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand aTYR PHARMA INC's current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period for the 10-K.)
• 2024-03-14 — Filing Date (The date the 10-K was filed with the SEC.)
• 2023-01-01 — Reporting Period Start (The start date of the reporting period for the 10-K.)

Key Players & Entities

• aTYR PHARMA INC (company) — Filer of the 10-K report.
• Kyorin Pharmaceutical Co Ltd (company) — Mentioned in relation to financial data for 2023.
• Pangu Bio Pharma Limited (company) — Mentioned in relation to financial data for 2023.
• Jefferies LLC (company) — Associated with ATM Offering Program in 2021 and 2023.
• Jones Trading Institutional Services LLC (company) — Associated with ATM Offering Program in 2021.
• DE (jurisdiction) — State of incorporation for aTYR PHARMA INC.
• San Diego, CA (location) — Business and mailing address for aTYR PHARMA INC.

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The company is subject to extensive government regulation, including the FDA, which can impact product development, approval, and marketing.
• Funding and Liquidity [high — financial]: The company may require additional financing to fund its operations and development activities, and there is no assurance it will be able to secure such financing on favorable terms.
• Research and Development Risks [high — operational]: The success of the company's product candidates depends on successful research and development, which is inherently uncertain and may not result in approved products.
• Competition [medium — market]: The company faces intense competition from other biotechnology and pharmaceutical companies, which could affect its ability to achieve market penetration.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-14: 10-K Filing Date — The date the annual report was officially submitted to the SEC.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 per share LIFE The Nasdaq Capital M
• $2.16 — n stock on the Nasdaq Capital Market of $2.16 per share on June 30, 2023, the last bu
• $10.0 million — in the EFZO-FIT study which triggered a $10.0 million milestone payment to us. To date, the K
• $20.0 million — ate, the Kyorin Agreement has generated $20.0 million in upfront and milestone payments to us
• $155.0 million — eligible to receive up to an additional $155.0 million in the aggregate upon achievement of ce

Filing Documents

• life-20231231.htm (10-K) — 2398KB
• life-ex4_6.htm (EX-4.6) — 36KB
• life-ex10_19.htm (EX-10.19) — 13KB
• life-ex23_1.htm (EX-23.1) — 10KB
• life-ex31_1.htm (EX-31.1) — 11KB
• life-ex31_2.htm (EX-31.2) — 11KB
• life-ex32_1.htm (EX-32.1) — 7KB
• life-ex32_2.htm (EX-32.2) — 7KB
• life-ex97_1.htm (EX-97.1) — 53KB
• img144823663_0.jpg (GRAPHIC) — 501KB
• 0000950170-24-031584.txt (&nbsp;) — 10931KB
• life-20231231.xsd (EX-101.SCH) — 1393KB
• life-20231231_htm.xml (XML) — 1720KB

Forward-Looking Statements

Forward-Looking Statements 3 Summary of Risks Associated with Our Business 3 PART I Item 1

Business

Business 4 Item 1A

Risk Factors

Risk Factors 24 Item 1B Unresolved Staff Comments 59 Item 1C Cybersecurity 59 Item 2

Properties

Properties 60 Item 3

Legal Proceedings

Legal Proceedings 60 Item 4 Mine Safety Disclosures 60 PART II Item 5 Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 61 Item 6 [Reserved] 61 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 61 Item 7A

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 68 Item 8

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 Item 9 Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 90 Item 9A

Controls and Procedures

Controls and Procedures 91 Item 9B Other Information 91 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 91 PART III Item 10 Directors, Executive Officers and Corporate Governance 92 Item 11

Executive Compensation

Executive Compensation 92 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 92 Item 13 Certain Relationships and Related Transactions, and Director Independence 92 Item 14 Principal Accountant Fees and Services 92 PART IV Item 15 Exhibit and Financial Statement Schedules 92 Item 16 Form 10-K Summary 94

Signatures

Signatures 95 2 In this Annual Report on Form 10-K (Annual Report), unless the context requires otherwise, "aTyr Pharma," "aTyr," "Company," "we," "our," and "us" means aTyr Pharma, Inc. and our subsidiary, Pangu BioPharma Limited. The market data and certain other statistical information used in this Annual Report are based on independent industry publications, governmental publications, reports by market research firms or other independent sources. Some data are also based on our good faith estimates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. We own various U.S. federal trademark applications and unregistered trademarks, including our company name. All other trademarks or trade names referred to in this Annual Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Annual Report are referred to without the symbols and , but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. Forward-Look ing Statements In addition to historical information, this Annual Report and the information incorporated herein by reference contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act) including statements regarding our business, our financial position, the research and development of biopharmaceutical products, the timing of clinical trial activities and other statements describing our goals, expectations, intentions or beliefs. These statements include but are not limited to statements under the captions "Business" and "Managem

Bu siness

Item 1. Bu siness. We are a clinical stage biotechnology company leveraging evolutionary intelligence to translate tRNA synthetase biology into new therapies for fibrosis and inflammation. tRNA synthetases are ancient, essential proteins that have evolved novel domains that regulate diverse pathways extracellularly in humans. Our discovery platform is focused on unlocking hidden therapeutic intervention points by uncovering signaling pathways driven by our proprietary library of domains derived from all 20 tRNA synthetases. Efzofitimod Our lead therapeutic candidate is efzofitimod, a first-in-class biologic immunomodulator in clinical development for the treatment of interstitial lung disease (ILD), a group of immune-mediated disorders that can cause inflammation and fibrosis, or scarring, of the lungs. Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 (NRP2) to resolve aberrant inflammation without immune suppression and potentially prevent the progression of fibrosis. ILDs are predominantly immune-mediated disorders that are characterized by chronic inflammation, which can lead to progressive fibrosis of the lung. There are limited treatment options for ILD and there remains a high unmet medical need. Sarcoidosis and systemic sclerosis (SSc, also known as scleroderma)-associated ILD (SSc-ILD) are two major forms of ILD. The U.S. Food and Drug Administration (FDA) has granted efzofitimod orphan drug designations for the treatment of sarcoidosis and for the treatment of SSc, and Fast Track designations for the treatment of pulmonary sarcoidosis and for the treatment of SSc-ILD. The European Commission (EC) has granted efzofitimod orphan drug designations for the treatment of sarcoidosis and for the treatment of SSc, based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). In September 2021, we announced positive results and clinical proof

View Full Filing

View this 10-K filing on SEC EDGAR