femasys(US:FEMY)2025-11-14 21:13Financial Performance - Sales for the three months ended September 30, 2025, were $729,394, up 31.4% from $554,908 in the same period of 2024[21] - Net loss for the nine months ended September 30, 2025, was $14.68 million, compared to a net loss of $13.69 million for the same period in 2024, indicating a 7.2% increase in losses[21] - The company reported a net loss per share of $0.10 for the three months ended September 30, 2025, compared to $0.24 for the same period in 2024[21] - For the nine months ended September 30, 2025, total revenue reached $1,479,926, up 41.2% from $1,047,532 in the prior year[54] - U.S. sales for the nine months ended September 30, 2025, were $1,015,168, up from $755,082 in 2024, representing a 34.4% increase[54] - International sales for the nine months ended September 30, 2025, were $464,758, compared to $292,450 in 2024, marking a 58.8% increase[54] - Total sales for the nine months ended September 30, 2025, were $1,479,926, an increase from $1,047,532 in the same period of 2024, reflecting a 41.2% year-over-year growth[100] Assets and Liabilities - Total assets increased to $16.29 million as of September 30, 2025, from $12.45 million as of December 31, 2024, representing a 30.5% growth[16] - Total current liabilities rose to $10.54 million as of September 30, 2025, compared to $8.58 million as of December 31, 2024, reflecting a 22.8% increase[19] - Total stockholders' equity increased to $4.56 million as of September 30, 2025, from $2.30 million as of December 31, 2024, a growth of 97.8%[19] - The accumulated deficit as of September 30, 2025, was $141,875,839, with expectations of continued losses and negative operating cash flows for at least the next twelve months[39] Cash Flow and Financing - Cash and cash equivalents increased to $4.57 million as of September 30, 2025, from $3.45 million as of December 31, 2024, a growth of 32.4%[16] - The company reported a net cash used in operating activities of $14,505,325 for the nine months ended September 30, 2025, compared to $14,369,440 for the same period in 2024, indicating a slight increase in cash outflow of about 0.9%[30] - The company raised $7,998,826 from the issuance of common stock, accompanying warrants, and pre-funded warrants in August 2025 financing[30] - The company generated proceeds of $4,510,001 from the issuance of common stock in June 2025 financing[30] - The company executed a promissory note with AFCO for $367,450 in July 2025, with a monthly installment of $31,672 at an interest rate of 7.44%[58] - The company entered into a definitive agreement for the issuance of senior secured convertible notes in November 2025, with an aggregate principal amount of $12,000,000, convertible into 16,378,563 common shares at a conversion price of $0.73 per share[102] Expenses - Research and development expenses decreased to $5.76 million for the nine months ended September 30, 2025, from $6.05 million in 2024, a reduction of 4.5%[21] - Interest expense for the nine months ended September 30, 2025, was $1.48 million, up from $1.16 million in the same period of 2024, an increase of 27.5%[21] - Share-based compensation expense for the nine months ended September 30, 2025, was $723,722, compared to $310,004 for the same period in 2024, representing an increase of approximately 133.3%[30] - The company reported total operating expenses of $13,876,592 for the nine months ended September 30, 2025, compared to $13,758,269 in 2024, indicating a slight increase of 0.9%[100] Stock and Shareholder Information - The company issued 10,434,586 shares of common stock in connection with August 2025 financing, net of issuance costs, raising approximately $7,068,694[24] - The weighted average number of shares used in computing net loss per share increased to 41,015,196 in 2025 from 22,232,799 in 2024, indicating a significant increase in share dilution[94] - The company granted 1,599,915 stock options during the nine months ended September 30, 2025, with an average exercise price of $1.08[82] - The company issued 49,247 shares under its Employee Stock Purchase Plan (ESPP) for a fair value of $40,875 during the nine months ended September 30, 2025, compared to 12,081 shares for $10,390 in the same period of 2024[88] Regulatory and Market Developments - The company aims to obtain FDA approval for its FemBloc product candidate, which is critical for future commercialization efforts[10] - The company has received regulatory approvals for its products in multiple regions, including the U.S., EU, UK, Canada, and Australia, enhancing its market presence[1] - The company announced strategic distribution partnerships for FemBloc in Spain and the France/Benelux region in March and September 2025, respectively[32] - The company received FDA approval in November 2025 for its investigational device exemption supplement to proceed with the final phase of the pivotal clinical trial for FemBloc[32]