Opus Genetics Files Q3 2024 10-Q

Ticker: IRD · Form: 10-Q · Filed: Nov 12, 2024 · CIK: 1228627

Sentiment: neutral

Topics: 10-Q, pharmaceutical, financials

TL;DR

Opus Genetics filed its Q3 2024 10-Q. Financials and operations updated.

AI Summary

Opus Genetics, Inc. filed its 10-Q for the period ending September 30, 2024. The company, formerly known as Ocuphire Pharma, Inc., reported financial results and operational updates. Key financial data and strategic developments for the third quarter of 2024 are detailed in this filing.

Why It Matters

This filing provides investors with the latest financial performance and operational status of Opus Genetics, crucial for understanding the company's trajectory in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Opus Genetics faces inherent risks related to drug development, regulatory approvals, and market competition.

Key Players & Entities

FAQ

What is the reporting period for this 10-Q filing?

The reporting period for this 10-Q filing is the period ending September 30, 2024.

What was Opus Genetics, Inc. formerly known as?

Opus Genetics, Inc. was formerly known as Ocuphire Pharma, Inc.

When was this 10-Q filed with the SEC?

This 10-Q was filed on November 12, 2024.

What is the Standard Industrial Classification code for Opus Genetics, Inc.?

The Standard Industrial Classification code for Opus Genetics, Inc. is 2834, which corresponds to Pharmaceutical Preparations.

What is the fiscal year end for Opus Genetics, Inc.?

The fiscal year end for Opus Genetics, Inc. is December 31.

Filing Stats: 4,425 words · 18 min read · ~15 pages · Grade level 16.4 · Accepted 2024-11-12 09:29:25

Key Financial Figures

Filing Documents

Financial Statements

Financial Statements 3 Condensed Balance Sheets as of September 30, 2024 (unaudited) and December 31, 2023 3 Condensed Statements of Comprehensive (Loss) Income for the three and nine months ended September 30, 2024 and 2023 (unaudited) 4 Condensed Statements of Changes in Stockholders' Equity for the three and nine months ended September 30, 2024 and 2023 (unaudited) 5 Condensed Statements of Cash Flows for the nine months ended September 30, 2024 and 2023 (unaudited) 6 Notes to Condensed Financial Statements (unaudited) 7 Item 2.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 29 Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 44 Item 4.

Controls and Procedures

Controls and Procedures 45

– OTHER INFORMATION

PART II – OTHER INFORMATION Item 1.

Legal Proceedings

Legal Proceedings 45 Item 1A.

Risk Factors

Risk Factors 45 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 84 Item 3. Defaults Upon Senior Securities 84 Item 4. Mine Safety Disclosures 84 Item 5. Other Information 85 Item 6. Exhibits 85

SIGNATURES

SIGNATURES 86 2 Index PART I – FINANCIAL INFORMATION Item 1.

Financial Statements

Financial Statements Ocuphire Pharma, Inc. Condensed Balance Sheets (in thousands, except share amounts and par value) As of September 30 , December 31, 2024 2023 Assets (unaudited) Current assets: Cash and cash equivalents $ 36,632 $ 50,501 Accounts receivable 1,857 926 Contract assets and unbilled receivables 1,468 1,407 Prepaids and other assets 429 1,099 Short-term investments 3 15 Total current assets 40,389 53,948 Property and equipment, net — — Total assets $ 40,389 $ 53,948 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 844 $ 2,153 Accrued expenses 5,171 1,815 Derivative liability 74 74 Total current liabilities 6,089 4,042 Total liabilities 6,089 4,042 Commitments and contingencies (Note 3 and Note 8) Stockholders' equity: Preferred stock, par value $ 0.0001 ; 10,000,000 shares authorized as of September 30, 2024 and December 31, 2023 ; no shares issued and outstanding at September 30, 2024 and December 31, 2023 . — — Common stock, par value $ 0.0001 ; 125,000,000 and 75,000,000 shares authorized as of September 30, 2024 and December 31, 2023 , respectively; 26,198,444 and 23,977,491 shares issued and outstanding at September 30, 2024 and December 31, 2023 , respectively. 3 2 Additional paid-in capital 138,160 131,370 Accumulated deficit ( 103,863 ) ( 81,466 ) Total stockholders' equity 34,300 49,906 Total liabilities and stockholders' equity $ 40,389 $ 53,948 See accompanying notes. 3 Index Ocuphire Pharma, Inc. Condensed Statements of Comprehensive (Loss) Income (in thousands, except share and per share amounts) (Unaudited) For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 License and collaborations revenue $ 3,867 $ 11,935 $ 6,690 $ 17,358 Operating expenses: General and administrative 2,894 2,055 10,918

Financial Statements

Financial Statements 1. Company Description and Summary of Significant Accounting Policies Nature of Business On October 22, 2024, Opus Genetics, Inc., a Delaware corporation formerly known as Ocuphire Pharma, Inc. (the "Company" or "Opus"), acquired a private corporation then operating under the name of "Opus Genetics, Inc." ("Former Opus") pursuant to the terms of an Agreement and Plan of Merger, dated as of October 22, 2024 (such agreement, the "Merger Agreement" and the transaction consummated via the Merger Agreement, the "Opus Acquisition"), by and among the Company, Former Opus, and certain merger subsidiaries party thereto. The accompanying unaudited condensed financial statements do not give effect to the Opus Acquisition. The historical financial statements have been labeled under the name "Ocuphire Pharma, Inc." solely for purposes of this filing, as this was the name of the Company for the entirety of the historical periods presented . Following the Opus Acquisition, the Company is a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmologic disorders. The pipeline includes adeno-associated virus (AAV)-based gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. The Company's most advanced gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for presbyopia and dim (mesopi

View Full Filing

View this 10-Q filing on SEC EDGAR

View on Read The Filing