First Wave BioPharma Files 2023 10-K, Details Financials and Strategic Events

TL;DR

<b>First Wave BioPharma filed its 2023 10-K detailing financial performance, strategic financing activities, and significant subsequent events.</b>

AI Summary

First Wave BioPharma, Inc. (GRDX) filed a Annual Report (10-K) with the SEC on March 29, 2024. First Wave BioPharma, Inc. (formerly AzurRx BioPharma, Inc.) filed its 2023 10-K on March 29, 2024. The company reported financial data for the fiscal year ending December 31, 2023. Key events include various preferred stock and warrant offerings throughout 2022 and 2023. A significant subsequent event on March 13, 2024, involved Tungsten Partners LLC and Immunogenx. The filing details business operations, risk factors, and executive compensation.

Why It Matters

For investors and stakeholders tracking First Wave BioPharma, Inc., this filing contains several important signals. The 10-K filing provides a comprehensive overview of the company's financial health and operational status for the fiscal year 2023, crucial for investors assessing its current standing and future prospects. The disclosure of recent financing activities and subsequent events, such as the March 2024 transaction with Tungsten Partners LLC, offers insights into potential strategic shifts or capital infusions impacting the company's trajectory.

Risk Assessment

Risk Level: medium — First Wave BioPharma, Inc. shows moderate risk based on this filing. The company has a history of financing activities including preferred stock and warrant issuances, indicating potential dilution and ongoing capital needs, which presents a medium-term risk to existing shareholders.

Analyst Insight

Investors should review the detailed risk factors and financial statements in the 10-K to understand the company's financial position and strategic direction.

Financial Highlights

revenue

1560998

net Income

49750

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-29 — Filing Date (Date of 10-K submission)
• 1560998 — Revenue (P9M) (Revenue for the nine months ending 2023-12-31)
• 49750 — Net Income (P9M) (Net income for the nine months ending 2023-12-31)

Key Players & Entities

• First Wave BioPharma, Inc. (company) — Filer name
• AzurRx BioPharma, Inc. (company) — Former company name
• Tungsten Partners LLC (company) — Entity involved in subsequent event
• Immunogenx (company) — Entity involved in subsequent event
• 2023-12-31 (date) — Fiscal year end
• 2024-03-29 (date) — Filing date
• 2024-03-13 (date) — Subsequent event date

FAQ

Risk Factors

• Going Concern [high — financial]: The company's ability to continue as a going concern is dependent on its ability to secure additional financing and achieve profitability.
• Financing Activities [medium — financial]: The company has engaged in multiple equity and warrant offerings, which may lead to dilution and impact the value of existing shares.
• Regulatory Compliance [medium — regulatory]: The company must comply with various FDA regulations and other healthcare laws applicable to its drug development and commercialization efforts.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-29: 10-K Filing Date — Official submission date of the annual report.

Key Financial Figures

• $0.0001 — ch registered Common stock, par value $0.0001 per share FWBI The Nasdaq Capital M

Filing Documents

• fwbi-20231231x10k.htm (10-K) — 2862KB
• fwbi-20231231xex4d31.htm (EX-4.31) — 44KB
• fwbi-20231231xex10d53.htm (EX-10.53) — 216KB
• fwbi-20231231xex14d1.htm (EX-14.1) — 28KB
• fwbi-20231231xex19d1.htm (EX-19.1) — 50KB
• fwbi-20231231xex21d1.htm (EX-21.1) — 1KB
• fwbi-20231231xex23d1.htm (EX-23.1) — 3KB
• fwbi-20231231xex31d1.htm (EX-31.1) — 10KB
• fwbi-20231231xex31d2.htm (EX-31.2) — 12KB
• fwbi-20231231xex32d1.htm (EX-32.1) — 11KB
• fwbi-20231231xex97d1.htm (EX-97.1) — 38KB
• fwbi-20231231xex14d1001.jpg (GRAPHIC) — 17KB
• fwbi-20231231xex19d1001.jpg (GRAPHIC) — 12KB
• fwbi-20231231xex97d1001.jpg (GRAPHIC) — 12KB
• 0001410578-24-000364.txt (&nbsp;) — 10959KB
• fwbi-20231231.xsd (EX-101.SCH) — 85KB
• fwbi-20231231_cal.xml (EX-101.CAL) — 55KB
• fwbi-20231231_def.xml (EX-101.DEF) — 322KB
• fwbi-20231231_lab.xml (EX-101.LAB) — 691KB
• fwbi-20231231_pre.xml (EX-101.PRE) — 511KB
• fwbi-20231231x10k_htm.xml (XML) — 1390KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 33 Item 1B. Unresolved Staff Comments 63 Item 1C. Cybersecurity 63 Item 2.

Properties

Properties 64 Item 3.

Legal Proceedings

Legal Proceedings 64 Item 4. Mine Safety Disclosures 64 PART II 65 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 65 Item 6. Reserved 65 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 66 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 77 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 77 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 77 Item 9A.

Controls and Procedures

Controls and Procedures 77 Item 9B. Other Information 78 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 78 PART III 79 Item 10. Directors, Executive Officers and Corporate Governance 79 Item 11.

Executive Compensation

Executive Compensation 85 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 89 Item 13. Certain Relationships and Related Transactions, and Director Independence 94 Item 14. Principal Accountant Fees and Services 95 PART IV 96 Item 15. Exhibits and Financial Statement Schedules 96 Item 16. Form 10-K Summary 101

Signatures

Signatures 102 Index to Consolidated Financial Statements F-1 -i- Table of Contents CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (" Annual Report" ) contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Annual Report other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words "anticipate", "believe", "estimate", "expect", "intend", "may", "plan", "predict", "project", "target", "potential", "will", "would", "could", "should", "continue" 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 ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market; our ability to satisfy our payment obligations related to the acquisition of First Wave Bio, Inc.; the availabili

BUSINESS

ITEM 1. BUSINESS Overview We are engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (" GI ") diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual's systemic circulation. We are currently focused on developing a therapeutic pipeline with multiple late-stage clinical programs built around four proprietary technologies: Latiglutenase, a targeted oral biotherapeutic for celiac disease designed to breakdown gluten into non-immunogenic peptides; the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency; Capeserod, a selective 5-HT4 receptor partial agonist which we are developing as a gastroparesis therapeutic; and Niclosamide, an oral small molecule with anti-inflammatory properties for patients with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. In March 2024, we announced the closing of an acquisition, referred to as a merger (the " IMGX Merger ") with ImmunogenX, Inc. (" IMGX "), a private, clinical-stage biopharmaceutical company founded in 2013, which is developing the biologic, Latiglutenase, for celiac disease. IMGX is also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (" GFDs "). In December 2023, we announced that we entered into a non-binding term (the " Niclosamide LOI ") sheet to sell our Niclosamide program (the " Niclosamide Sale "). The Niclosamide LOI includes a low seven-figure upfront payment to us for rights to Niclosamide, as well as economics related to future milestones and royalties. The Niclosamide LOI only represents a mutual indication of interest regarding the Niclosamide Sale and the t

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View this 10-K filing on SEC EDGAR