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

TL;DR

<b>Aileron Therapeutics, Inc. has filed its annual report detailing its 2023 fiscal year performance and business operations.</b>

AI Summary

Aileron Therapeutics, Inc. (RNTX) filed a Annual Report (10-K) with the SEC on April 15, 2024. Aileron Therapeutics, Inc. filed its 2023 Form 10-K on April 15, 2024. The filing covers the fiscal year ending December 31, 2023. Key agreements mentioned include those with Harvard and Dana-Farber, Umicore, and the University of Texas Health Science Center at Tyler. The company's business address is located in Austin, TX. The filing references various stock incentive plans and employee stock purchase plans.

Why It Matters

For investors and stakeholders tracking Aileron Therapeutics, 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 agreements for the fiscal year 2023. Investors and stakeholders can use this filing to assess the company's progress, identify potential risks, and understand its future outlook based on disclosed information.

Risk Assessment

Risk Level: low — Aileron Therapeutics, Inc. shows low risk based on this filing. The company's financial performance and future prospects are not detailed in the provided filing snippet, making a definitive risk assessment difficult.

Analyst Insight

Review the full 10-K filing to understand Aileron Therapeutics' financial performance, strategic initiatives, and any disclosed risks for the 2023 fiscal year.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed Period of Report)
• 2024-04-15 — Filing Date (Filed As Of Date)
• 97 — Public Document Count (Document Count)

Key Players & Entities

• Aileron Therapeutics, Inc. (company) — Filer
• Harvard and Dana-Farber (company) — Agreement Member
• Umicore (company) — Agreement Member
• University of Texas Health Science Center at Tyler (company) — Agreement Member
• Austin, TX (location) — Business Address
• Lung Therapeutics, Inc. (company) — Subsidiary
• Vivarta Therapeutics LLC (company) — Acquisition Target

FAQ

Industry Context

Aileron Therapeutics operates in the pharmaceutical preparations industry.

Regulatory Implications

The filing is a standard SEC Form 10-K, adhering to regulations for public companies.

What Investors Should Do

1. Review the full 10-K for detailed financial statements and management discussion.
2. Analyze the company's agreements and their impact on operations.
3. Assess any disclosed risks and their potential effect on the company.

Key Dates

• 2024-04-15: 10-K Filing — Annual report submission
• 2023-12-31: Fiscal Year End — Reporting period end date

Year-Over-Year Comparison

This is the 2023 annual report filing, following previous filings for prior fiscal years.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value ALRN The Nasdaq Capital M
• $18.4 m — gregate purchase price of approximately $18.4 million, which included the conversion of
• $1.6 million — egate principal amount of approximately $1.6 million issued by Lung to Bios Partners prior t

Filing Documents

• alrn-20231231.htm (10-K) — 2932KB
• alrn-ex3_3.htm (EX-3.3) — 13KB
• alrn-ex4_2.htm (EX-4.2) — 28KB
• alrn-ex10_11.htm (EX-10.11) — 119KB
• alrn-ex10_42.htm (EX-10.42) — 178KB
• alrn-ex21_1.htm (EX-21.1) — 13KB
• alrn-ex23_1.htm (EX-23.1) — 3KB
• alrn-ex23_2.htm (EX-23.2) — 6KB
• alrn-ex31_1.htm (EX-31.1) — 11KB
• alrn-ex31_2.htm (EX-31.2) — 13KB
• alrn-ex32_1.htm (EX-32.1) — 7KB
• alrn-ex32_2.htm (EX-32.2) — 8KB
• alrn-ex97_1.htm (EX-97.1) — 24KB
• 0000950170-24-044508.txt (&nbsp;) — 11085KB
• alrn-20231231.xsd (EX-101.SCH) — 1640KB
• alrn-20231231_htm.xml (XML) — 1470KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 93 Item 1C. Cybersecurity 93 Item 2.

Properties

Properties 94 Item 3.

Legal Proceedings

Legal Proceedings 94 Item 4. Mine Safety Disclosures 94 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 95 Item 6. [Reserved] 95 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 96 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 106 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 106 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 106 Item 9A.

Controls and Procedures

Controls and Procedures 106 Item 9B. Other Information 108 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 108 PART III Item 10. Directors, Executive Officers and Corporate Governance 109 Item 11.

Executive Compensation

Executive Compensation 109 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 109 Item 13. Certain Relationships and Related Transactions, and Director Independence 109 Item 14. Principal Accounting Fees and Services 109 PART IV Item 15. Exhibits, Financial Statement Schedules 110 Item 16. Form 10-K Summary 110 Aileron and the other trademarks or service marks of Aileron appearing in this Annual Report on Form 10-K are the property of Aileron. All other trademarks, service marks or other trade names appearing in this Annual Report on Form 10-K are the property of their respective owners. i SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA This Annual Report on Form 10-K of Aileron Therapeutics Inc. ("Aileron," "we," "us," "our," or the "Company") contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this proxy statement, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among other things, statements about: our plans to develop and commercialize LTI-03 and LTI-01, including the potential benefits thereof; the timing and expectation of the results of the Phase 1b study of LTI-03; our unproven approach to drug research and development in the area of fibrotic diseases, with a focus on Caveolin-1, or Cav1, -related peptides, and our ability to develop marketab

Business

Item 1. Business Overview and Recent Developments Aileron Therapeutics, Inc. ("Aileron," "we," "us," "our," or the "Company") is a clinical stage biopharmaceutical company focused on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications with no approved or limited effective treatments. We currently have two product candidates in clinical development, LTI-03 and LTI-01, and multiple candidates in preclinical development focused on fibrosis indications. Our pipeline includes: LTI-03, a peptide, for which we are currently recruiting patients for a Phase 1b dose-ranging, placebo-controlled safety, tolerability, and pharmacodynamic biomarker activity trial in development for the treatment of idiopathic pulmonary fibrosis, or IPF, that has demonstrated the ability to protect healthy lung epithelial cells and reduce pro-fibrotic signaling; LTI-01, a proenzyme that completed a Phase 2a dose-ranging, placebo-controlled trial and a Phase 1b safety, tolerability and proof of mechanism trial in loculated pleural effusion, or LPE, patients, an indication that has no approved drug treatment; and preclinical programs targeting cystic fibrosis and a peptide program focused on the Cav1 protein for systemic fibrosis indications. Prior to the termination of development of our main product candidate in February 2023 and the acquisition of Lung Therapeutics, Inc. (as described below), our focus was the development of our main product candidate, ALRN-6924, a MDM2/MDMX dual inhibitor that leveraged our proprietary peptide drug technology. Since our inception, we have devoted a substantial portion of our resources to developing our product candidates, including ALRN-6924, developing our proprietary stabilized cell-permeating peptide platform, building our intellectual property portfolio, business planning, raising capital and providing general and administrative support for these operations. Announcement of Exploration of Strategic Alternat

View Full Filing

View this 10-K filing on SEC EDGAR