Soligenix(US:SNGX)2025-11-07 21:06Financial Performance - For the three months ended September 30, 2025, the net loss was $2.53 million, compared to a net loss of $1.72 million for the same period in 2024, indicating an increase in loss of approximately 47.1%[10] - For the nine months ended September 30, 2025, the net loss was $8.18 million, up from $5.28 million in 2024, reflecting an increase of about 55.5%[10] - Basic and diluted net loss per share for the nine months ended September 30, 2025, was $2.30, compared to $3.84 in 2024, showing an improvement of approximately 40.0%[8] - The net loss applicable to common stockholders for the nine months ended September 30, 2025, was $8,184,191, compared to $5,279,210 in 2024, representing a 55% increase[10] - The adjusted loss from operations for the Company was $(2,580,483) for the three months ended September 30, 2025, reflecting significant expenses in both segments[71] - For the nine months ended September 30, 2025, the total research and development expenses were $4,844,593, with general and administrative expenses amounting to $3,168,297[73] - The total loss from operations for the nine months ended September 30, 2025, was $4,926,589, compared to $2,144,124 in 2024, reflecting a 129.5% increase[74] Assets and Liabilities - Total assets increased to $11.29 million as of September 30, 2025, compared to $8.97 million as of December 31, 2024, reflecting a growth of approximately 26.5%[7] - Total current assets rose to $10.88 million, up from $8.83 million, marking an increase of about 23.3%[7] - Total liabilities decreased to $3.70 million from $4.85 million, a reduction of approximately 23.7%[7] - Total current liabilities decreased from $4,848,412 as of September 30, 2024, to $3,422,021 as of September 30, 2025, reflecting a reduction of approximately 29.4%[7] - The accumulated deficit as of September 30, 2025, was $242,154,943, compared to $230,983,386 as of September 30, 2024, reflecting an increase in the deficit of approximately 4.9%[12] Shareholder Equity - Shareholders' equity improved to $7.60 million, compared to $4.12 million, representing a growth of about 84.5%[7] - As of September 30, 2025, total shareholders' equity increased to $7,597,976 from $5,935,188 as of September 30, 2024, representing a growth of approximately 28.1%[12] - Total common stock shares outstanding increased from 2,295,304 as of September 30, 2024, to 9,861,130 as of September 30, 2025, reflecting a significant increase of 330%[12] Expenses - Research and development expenses for the three months ended September 30, 2025, were $1.58 million, compared to $0.97 million in 2024, an increase of approximately 63.1%[8] - General and administrative expenses for the nine months ended September 30, 2025, totaled $3.17 million, slightly up from $3.16 million in 2024, indicating a marginal increase of about 0.3%[8] - The total operating expenses for the nine months ended September 30, 2025, reached $8,370,870, compared to $5,727,002 in 2024, which is an increase of 46%[8] Funding and Grants - The company reported no grant revenue for the three and nine months ended September 30, 2025, compared to $119,371 in the same periods of 2024[8] - The company has received approximately $1.1 million from a U.S. FDA Orphan Products Development grant for an expanded study of HyBryte™[19] - The company plans to submit additional contract and grant applications for further support of its programs, although there is no assurance of obtaining additional funding[22] Public Offering and Financing - The company issued 4,064,080 shares of common stock in connection with the September 2025 public offering, raising $7,498,522 after issuance costs[13] - Issuance costs associated with the September 2025 public offering totaled $742,549, impacting the net proceeds from the offering[13] - The Company completed a public offering on September 29, 2025, raising approximately $7.5 million by issuing 4,064,080 shares of common stock and pre-funded warrants[53] Clinical Development - The company is developing HyBryte™ for the treatment of cutaneous T-cell lymphoma, with patient enrollment for the second Phase 3 study, FLASH2, beginning in December 2024, and top-line results expected in the second half of 2026[16] - The company plans to expand the development of synthetic hypericin into psoriasis (SGX302) and dusquetide (SGX945) into Behçet's Disease, with ongoing clinical trials[27] Strategic Initiatives - The company is exploring merger and acquisition strategies and evaluating additional financing opportunities[22] - The company’s focus remains on advancing its product development pipeline in the Specialized BioTherapeutics segment, which is its primary strategic priority[68] Risks and Compliance - The company is subject to risks common in the biotechnology industry, including regulatory compliance and dependence on key personnel[20] - The Company’s ability to secure government grants and contracts is crucial for the sustainability of the Public Health Solutions segment, which covers employee salaries and overhead costs[69]