| • | Completed $30 million private placement with potential proceeds of up to $90 million upon full cash exercise of warrants. |
| • | Regained compliance with Nasdaq Listing Requirements. |
| • | Issuance of patents in the U.S. and key international markets that expand intellectual property protection for the blended polymer component of FemBloc. |
| • | Received CE Mark approval for FemHSGTM Catheter, to complement FemVue and support streamlined in-office fertility evaluation. |
| • | Advanced initial commercial use of FemaSeed Complete, expanding access to first-line fertility treatment in the OB/GYN office. |
| • | Launched FemaSeed Complete at ACOG 2026, increasing provider awareness and initiating commercial efforts with OB/GYNs. |
| • | Established strategic partnership with AMI Technologies to commercialize its fertility portfolio in Israel, demonstrating international market interest. |
| • | Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth. |
| • | Sales increased by $6,184, or 0.8%, to $756,716 in 2026 from $750,532 in 2025, primarily due to sales of FemaSeed. |
| • | Research and development expenses decreased by $1,126,622, or 25.7%, to $3,256,279 in 2026 compared to $4,382,901 in 2025, primarily reflecting lower compensation costs, regulatory and professional service fees. |
| • | Net loss was $3,622,995, or ($1.08) per basic and diluted share attributable to common stockholders, for the six months ended June 30, 2026, compared to a net loss of $10,482,761, or ($7.76) per basic and diluted share attributable to common stockholders, for the six months ended June 30, 2025. |
| • | Cash and cash equivalents as of June 30, 2026, was approximately $1.4 million and the Company had an accumulated deficit of approximately $149.4 million. Subsequent to June 30, 2026, the Company completed a private placement transaction that generated approximately $30.0 million of gross proceeds. Management believes the additional capital provides the financial resources necessary to support the Company's strategic priorities, including the execution of its commercial initiatives, advancement of its clinical programs, and pursuit of key operational objectives. |
| • | Sales decreased by $77,441, or 18.9%, to $331,827 in 2026 from $409,268 in 2025, primarily attributable to lower sales of FemVue. |
| • | Research and development expenses increased by $532,449, or 37.6%, to $1,946,878 in 2026 compared to $1,414,429 in 2025, primarily reflecting the transition of development products into inventory to support commercialization during 2025, and increased clinical costs, partially offset by reduced compensation costs. |
| • | Net loss was $4,469,095, or ($1.33) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2026, compared to a net loss of $4,585,922, or ($3.18) per basic and diluted share attributable to common stockholders, for the quarter ended June 30, 2025. |
| Assets | June 30, 2026 | December 31, 2025 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,443,502 | 9,266,353 | |||||
| Accounts receivable, net | 151,049 | 616,600 | ||||||
| Inventory | 6,191,277 | 5,740,249 | ||||||
| Prepaid and other current assets | 546,085 | 833,133 | ||||||
| Total current assets | 8,331,913 | 16,456,335 | ||||||
| Property and equipment, at cost: | ||||||||
| Leasehold improvements | 1,238,886 | 1,238,886 | ||||||
| Office equipment | 87,515 | 78,155 | ||||||
| Furniture and fixtures | 424,586 | 417,876 | ||||||
| Machinery and equipment | 3,121,131 | 3,065,713 | ||||||
| Construction in progress | 919,412 | 897,885 | ||||||
| 5,791,530 | 5,698,515 | |||||||
| Less accumulated depreciation | (3,932,324 | ) | (3,802,940 | ) | ||||
| Net property and equipment | 1,859,206 | 1,895,575 | ||||||
| Long-term assets: | ||||||||
| Lease right-of-use assets, net | 1,064,346 | 1,297,121 | ||||||
| Intangible assets, net of accumulated amortization | 115,499 | 134,914 | ||||||
| Other long-term assets | 918,618 | 940,232 | ||||||
| Total long-term assets | 2,098,463 | 2,372,267 | ||||||
| Total assets | $ | 12,289,582 | 20,724,177 | |||||
| Liabilities and Stockholders’ Equity | June 30, 2026 | December 31, 2025 | ||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,337,354 | 1,830,124 | |||||
| Accrued expenses | 1,033,712 | 1,265,773 | ||||||
| Clinical holdback – current portion | 42,726 | 52,644 | ||||||
| Operating lease liabilities – current portion | 473,034 | 487,624 | ||||||
| Total current liabilities | 3,886,826 | 3,636,165 | ||||||
| Long-term liabilities: | ||||||||
| Clinical holdback – long-term portion | 54,598 | 52,370 | ||||||
| Convertible notes payable, net | 3,521,226 | 3,178,864 | ||||||
| Conversion option liability | — | 2,014,000 | ||||||
| Warrants liabilities | — | 4,943,000 | ||||||
| Operating lease liabilities – long-term portion | 795,985 | 1,030,476 | ||||||
| Total long-term liabilities | 4,371,809 | 11,218,710 | ||||||
| Total liabilities | 8,258,635 | 14,854,875 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par, 200,000,000 authorized, 3,029,829 shares issued and 3,023,967 outstanding as of June 30, 2026; and 2,986,116 shares issued and 2,980,254 outstanding as of December 31, 2025 | 3,030 | 2,986 | ||||||
| Treasury stock, 5,862 common shares | (60,000 | ) | (60,000 | ) | ||||
| Warrants | 5,961,150 | 5,246,150 | ||||||
| Additional paid-in capital | 147,575,906 | 146,506,310 | ||||||
| Accumulated deficit | (149,449,139 | ) | (145,826,144 | ) | ||||
| Total stockholders’ equity | 4,030,947 | 5,869,302 | ||||||
| Total liabilities and stockholders' equity | $ | 12,289,582 | 20,724,177 | |||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Sales | $ | 331,827 | 409,268 | 756,716 | 750,532 | |||||||||||
| Cost of sales (excluding depreciation expense) | 142,436 | 158,171 | 301,042 | 275,437 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,946,878 | 1,414,429 | 3,256,279 | 4,382,901 | ||||||||||||
| Sales and marketing | 1,293,998 | 984,977 | 2,609,753 | 1,893,544 | ||||||||||||
| General and administrative | 1,931,578 | 1,616,972 | 3,713,968 | 3,339,685 | ||||||||||||
| Depreciation and amortization | 82,811 | 86,285 | 165,081 | 171,138 | ||||||||||||
| Total operating expenses | 5,255,265 | 4,102,663 | 9,745,081 | 9,787,268 | ||||||||||||
| Loss from operations | (5,065,874 | ) | (3,851,566 | ) | (9,289,407 | ) | (9,312,173 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 19,694 | 17,144 | 69,521 | 36,173 | ||||||||||||
| Change in fair value of conversion option liability | 219,000 | — | 1,732,413 | — | ||||||||||||
| Change in fair value of warrants liabilities | 545,000 | — | 4,228,000 | — | ||||||||||||
| Interest expense | (186,050 | ) | (491,500 | ) | (362,657 | ) | (950,949 | ) | ||||||||
| Other expense | — | (260,000 | ) | — | (260,000 | ) | ||||||||||
| Total other income (expense), net | 597,644 | (734,356 | ) | 5,667,277 | (1,174,776 | ) | ||||||||||
| Loss before income taxes | (4,468,230 | ) | (4,585,922 | ) | (3,622,130 | ) | (10,486,949 | ) | ||||||||
| Income tax expense (benefit) | 865 | — | 865 | (4,188 | ) | |||||||||||
| Net loss | $ | (4,469,095 | ) | (4,585,922 | ) | (3,622,995 | ) | (10,482,761 | ) | |||||||
| Net loss attributable to common stockholders | $ | (4,469,095 | ) | (4,585,922 | ) | (3,622,995 | ) | (10,482,761 | ) | |||||||
| Basic and diluted loss per share | $ | (1.33 | ) | (3.18 | ) | (1.08 | ) | (7.76 | ) | |||||||
| Weighted-average common shares outstanding, basic and diluted | 3,357,117 | 1,444,036 | 3,344,767 | 1,351,264 | ||||||||||||