Ocuphire Pharma(US:OCUP)2024-11-12 14:29Financial 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].