UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2024 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Opus Genetics, Inc. (Exact name of registrant as specified in its charter) Delaware 11-3516358 (State or other jurisdiction of ...

Financial Performance - The company reported a net loss of approximately $56.8 million for the year ended December 31, 2024[6] - Net cash used in operating activities for the year ended December 31, 2024 was approximately $25.6 million[6] Cash Position - The cash and cash equivalents balance as of December 31, 2024 was approximately $30.3 million[6]

Financial Performance - The company reported a net loss of $7.5 million for Q3 2024, compared to a net income of $5.6 million in Q3 2023, and a net loss of $22.4 million for the nine months ended September 30, 2024, compared to a net loss of $5.2 million for the same period in 2023[179]. - The net loss for Q3 2024 was $7.5 million, compared to a net income of $5.6 million in Q3 2023, reflecting a significant year-over-year change of $13.1 million[192]. - For the nine months ended September 30, 2024, license and collaborations revenue was $6.7 million, down $10.7 million from $17.4 million in the same period of 2023[201]. - The loss from operations for the nine months ended September 30, 2024 was $24.0 million, compared to a loss of $5.1 million in the same period of 2023, indicating a deterioration of $18.9 million[201]. - Cash used in operating activities for the nine months ended September 30, 2024 was $18.1 million, attributed to a net loss of $22.4 million, partially offset by $2.6 million in non-cash operating expenses[229]. - The company reported a net decrease in cash and cash equivalents of $13.9 million for the nine months ended September 30, 2024, compared to a decrease of $284,000 in 2023[227]. - For the nine months ended September 30, 2023, the company reported a net loss of $5.2 million, with cash used in operating activities amounting to $5.7 million[230]. Revenue and Expenses - License and collaborations revenue for Q3 2024 was $3.9 million, a decrease of $8.1 million from $11.9 million in Q3 2023, primarily due to a one-time $10.0 million milestone payment in the prior year[192]. - Total operating expenses for Q3 2024 were $11.9 million, an increase of $6.3 million from $5.5 million in Q3 2023, driven by higher research and development costs[192]. - Research and development expenses for Q3 2024 were $9.0 million, up $5.5 million from $3.5 million in Q3 2023, mainly due to increased clinical costs and drug manufacturing expenses[197]. - General and administrative expenses for Q3 2024 were $2.9 million, an increase of $0.8 million from $2.1 million in Q3 2023, attributed to personnel-related costs and business development expenses[193]. - Total operating expenses for the nine months ended September 30, 2024 were $30.7 million, an increase of $8.2 million from $22.5 million in the same period of 2023[201]. - Research and development expenses for the nine months ended September 30, 2024 were $19.8 million, an increase of $6.0 million from $13.8 million in the same period of 2023[201]. - General and administrative expenses increased to $10.9 million for the nine months ended September 30, 2024, compared to $8.7 million in 2023, with a $2.2 million increase attributed mainly to legal support and business development activities[204]. Cash and Financing - As of September 30, 2024, cash and cash equivalents totaled $36.6 million, sufficient to fund operations for at least twelve months beyond the filing date[209]. - The company entered into a common stock purchase agreement with Lincoln Park for an equity line financing of up to $50 million over 30 months, with $5.2 million raised through September 30, 2024[211]. - The company has raised approximately $67.8 million through various equity offerings and $8.5 million through convertible notes to fund operations[210]. - The company expects to satisfy its cash requirements through cash on hand, future equity and debt financings, and reimbursement payments until it generates adequate revenue from commercial sales[248]. Clinical Development - The company’s most advanced gene therapy candidate, OPGx-LCA5, is in a Phase 1/2 clinical trial, with early data showing visual improvement in all three adult patients[166]. - Enrollment of the first pediatric patients in the LCA5 Phase 1/2 trial is expected in Q1 2025, with initial data anticipated in Q3 2025[167]. - The company plans to seek a strategic partner for the late-stage diabetic retinopathy program APX3330 due to capital requirements and developmental timelines[165]. - The company anticipates ongoing expenses related to clinical work for LCA5, BEST1, and other product candidates, as well as regulatory approvals and manufacturing contracts[179]. - The company expects research and development expenses to increase in the coming years due to higher costs associated with later-stage clinical trials[187]. Regulatory and Commercialization - The company received a $10 million milestone payment under the Viatris License Agreement following FDA approval of RYZUMVI for pharmacologically-induced mydriasis in September 2023[170]. - RYZUMVI was commercialized by Viatris in April 2024, following its approval[170]. - The company aims to establish a sales, marketing, and distribution infrastructure for future commercialization efforts[179]. - The company does not expect to generate significant revenue until RYZUMVI sales become material or regulatory approval is obtained for other product candidates[234]. - The company anticipates recognizing revenue from reimbursement for research and development services under the Viatris License Agreement, with a total of $35 million in one-time non-refundable payments and a $10 million milestone payment received to date[233]. Internal Controls and Legal Matters - As of September 30, 2024, the company's disclosure controls and procedures were evaluated as effective by its principal executive officer and principal financial officer[258]. - There were no changes in the company's internal control over financial reporting during the quarter ended September 30, 2024, that materially affected its internal control[259]. - The company is not currently involved in any legal proceedings that are likely to materially affect its business or financial results[260].

Exhibit 2.1 AGREEMENT AND PLAN OF MERGER among: OCUPHIRE PHARMA, INC. a Delaware corporation; ORANGE MERGER SUB I, INC., a Delaware corporation; ORANGE MERGER SUB II, LLC, a Delaware limited liability company; and OPUS GENETICS INC. a Delaware corporation Dated as of October 22, 2024 THIS MERGER AGREEMENT IS SUBJECT TO REVISION BY THE PARTIES AT ANY TIME AND MUST BE KEPT CONFIDENTIAL IN ACCORDANCE WITH THE TERMS OF THE CONFIDENTIALITY AGREEMENT ENTERED INTO BETWEEN THE PARTIES. THIS DOCUMENT HAS BEEN PREPAR ...

The resulting company will operate under the name Opus Genetics and the Nasdaq ticker symbol (IRD) RALEIGH, N.C., Oct. 25, 2024 /PRNewswire/ -- The RD Fund (Retinal Degeneration Fund) – the venture arm of the Foundation Fighting Blindness – announces the all-stock acquisition of Opus Genetics, Inc. "Opus" (private) by Ocuphire Pharma, Inc., (Nasdaq: OCUP) a clinical-stage ophthalmic biopharmaceutical company. The companies have combined under the name of Opus Genetics to create a transformative biotech comp ...

On Wednesday, Ocuphire Pharma, Inc. OCUP announced the all-stock acquisition of Opus Genetics, Inc., a clinical-stage gene therapy company for inherited retinal diseases (IRDs).The merger creates a biotech company focused on developing gene therapies for IRDs.The combined company will be renamed Opus Genetics, effective October 23, 2024, and trade on the Nasdaq under the “IRD” ticker, effective October 24, 2024.The combined company now has an expanded pipeline that includes multiple assets from its adeno-as ...

Core Insights - The acquisition of Opus Genetics by Ocuphire Pharma creates a leading clinical-stage company focused on gene therapy treatments for rare inherited retinal degenerations [1][2] - The combined company will be renamed Opus Genetics, Inc. and will trade under the ticker symbol "IRD" on Nasdaq starting October 24, 2024 [1][2] - The merger is expected to accelerate the development of a promising pipeline of gene therapies, with significant clinical milestones anticipated in 2025 [2][6] Company Overview - Ocuphire Pharma is a clinical-stage ophthalmic biopharmaceutical company developing therapies for retinal and refractive disorders, including adeno-associated virus (AAV)-based gene therapies [9] - The most advanced gene therapy candidate, OPGx-LCA5, is in a Phase 1/2 trial and has shown visual improvement in all three adult patients with late-stage disease [3][4] - The combined company will focus on multiple assets, including Phentolamine Ophthalmic Solution 0.75% for presbyopia and dim light disturbances [2][9] Clinical Development - The OPGx-LCA5 Phase 1/2 trial is ongoing, with pediatric patient enrollment expected in Q1 2025 and initial data anticipated in Q3 2025 [4][6] - The LYNX-2 Phase 3 trial for dim light disturbances and the VEGA-3 Phase 3 trial for presbyopia are on track for top-line data in Q1 and H1 2025, respectively [1][6] - The company plans to seek a strategic partner for the development of APX3330, an oral small-molecule inhibitor for non-proliferative diabetic retinopathy [1][2] Financial Aspects - The acquisition involved the issuance of 5.2 million shares of common stock and 14.1 thousand shares of convertible preferred stock to Opus Genetics' stockholders [7] - Following the acquisition, pre-acquisition stockholders of Ocuphire will own approximately 58% and those of Opus Genetics will own about 42% of the combined company's fully diluted capitalization [7] - The expected cash runway for the combined company has been extended into 2026, allowing for continued clinical development [6]

FARMINGTON HILLS, Mich., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small molecule therapies for the treatment of patients with retinal and refractive eye disorders, today announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) that evaluated the safety and efficacy of RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) for the treatment o ...

Top-line data from VEGA-3 Phase 3 trial expected in first half of 2025 Top-line data from LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery expected in first quarter of 2025 FARMINGTON HILLS, Mich., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of patients with retinal an ...

Financial Performance - Ocuphire Pharma reported a net loss of $7.8 million and $14.9 million for the three and six months ended June 30, 2024, respectively, compared to a net loss of $5.0 million and $10.8 million for the same periods in 2023[136]. - The company has an accumulated deficit of $96.3 million as of June 30, 2024[136]. - License and collaborations revenue decreased to $1.1 million for the three months ended June 30, 2024, down from $3.7 million in the same period of 2023, primarily due to reduced PS research and development services[150]. - License and collaborations revenue for the six months ended June 30, 2024 was $2.8 million, down from $5.4 million in the same period of 2023, reflecting a decrease in PS research and development services[157]. - General and administrative expenses for the three months ended June 30, 2024 were $3.4 million, a decrease of $1.0 million compared to $4.3 million in the prior year, mainly due to reduced payroll-related costs[151]. - General and administrative expenses for the six months ended June 30, 2024 were $8.0 million, an increase of $1.4 million compared to $6.6 million in the prior year[159]. - Research and development expenses increased to $6.1 million for the three months ended June 30, 2024, compared to $4.7 million in the same period of 2023, driven by higher manufacturing and toxicology costs for APX3330[154]. - Research and development expenses for the six months ended June 30, 2024 were $10.8 million, slightly up from $10.3 million in the same period of 2023, primarily due to increased manufacturing costs for APX3330[160]. - Total operating expenses for the three months ended June 30, 2024 were $9.4 million, slightly higher than $9.1 million in the same period of 2023[150]. - Other income, net for the three months ended June 30, 2024 was $0.6 million, compared to $0.4 million in the same period of 2023, mainly from interest income[155]. - Other income, net for the six months ended June 30, 2024 was $1.2 million, up from $0.8 million in the same period of 2023, primarily due to interest income[161]. - For the six months ended June 30, 2024, the company reported a net cash used in operating activities of $13.0 million, attributed to a net loss of $14.9 million[176]. Product Development - Ocuphire's lead product candidate, APX3330, is in development for diabetic retinopathy, which affects approximately 10 million diabetics and is projected to impact over 14 million Americans by 2050[127]. - The FDA approved Phentolamine Ophthalmic Solution 0.75% (RYZUMVI) in September 2023, triggering a $10 million milestone payment under the Viatris License Agreement[131]. - RYZUMVI was commercialized by Viatris in April 2024, following a comprehensive clinical trial program involving over 600 subjects[131]. - The VEGA-2 Phase 3 study for presbyopia achieved its primary endpoint, and the VEGA-3 Phase 3 clinical trial has begun recruiting[134]. - Ocuphire has in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330, targeting other retinal diseases[129]. - The company anticipates recognizing revenue from the Viatris License Agreement and potential future milestone and royalty payments, but significant revenue generation is uncertain until product sales materialize[179]. - The development of APX3330 is subject to uncertainties, and the company cannot assure future profitability or positive cash flow from operating activities[183]. Funding and Capital Structure - Ocuphire has funded operations primarily through equity financings totaling $67.3 million, including $21.15 million from a merger with Rexahn Pharmaceuticals[136]. - The company expects to finance its cash needs through a combination of equity and debt financings, as well as collaborations and licensing arrangements[135]. - The company raised approximately $67.3 million from various equity offerings and $8.5 million from convertible notes, including a one-time non-refundable payment of $35 million and a $10 million milestone payment related to the Viatris License Agreement[163]. - The company entered into a Purchase Agreement with Lincoln Park Capital Fund, allowing for the purchase of up to $50 million of common stock over a 30-month term[164]. - The company has a shelf registration effective for an aggregate offering price of up to $175 million, with $26 million raised through an At-The-Market program since inception[165]. - The company may face dilution of stockholder ownership if additional capital is raised through equity or convertible debt securities[182]. - The company expects to satisfy short-term and long-term obligations through cash on hand, future equity and debt financings, and reimbursement payments[191]. Legal and Regulatory Matters - The company is not currently a party to any legal proceedings that are likely to materially affect its business or financial results[204]. - The company has a full valuation allowance on net deferred tax assets due to uncertainty of future taxable income[196]. - The company has not triggered any milestone or royalty payments as of the date of the report[187]. Miscellaneous - As of June 30, 2024, the company had cash and cash equivalents of $41.4 million, sufficient to fund operations for at least twelve months[162]. - As of June 30, 2024, the company had 5,665,838 Series A Warrants outstanding, with an initial exercise price of $4.4795 per share[172]. - The company has no significant cash flows from investing activities during the reported periods[178]. - Research and development expenses related to the development of PS are fully reimbursed by Viatris[183]. - The company has potential milestone payments totaling up to $11 million and sales milestone payments of up to $20 million under the Apexian Sublicense Agreement[186]. - The company has a non-cancellable operating lease with a base rent of $3,000 per month expiring on December 31, 2024[185]. - The company recognizes license and collaborations revenue based on the stand-alone price of each performance obligation[194].