FEMY

EX-99.1

2 ef20080275_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended June 30, 2026 and Provides Corporate Update

-- $30 million financing enables execution of U.S. commercial strategy for the FemaSeed® fertility portfolio and advancement of the FemBloc® clinical and regulatory program toward U.S. approval --

ATLANTA, August 14, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator developing transformative fertility and non-surgical permanent birth control solutions designed to improve the standard of care, expand access, and reduce costs for women worldwide, announces its financial results for the quarter ended June 30, 2026 and provides a corporate update.

Corporate Highlights from 2Q 2026 to date

•

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.

“During the second quarter of 2026 and into the third quarter of 2026, we made meaningful progress strengthening our financial position, advancing our commercial strategy and expanding the reach of our innovative fertility solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “The completion of our $30 million private placement and restoration of Nasdaq compliance provide a stronger foundation to execute our growth strategy. We also achieved important commercial milestones, including the launch of FemaSeed Complete at ACOG 2026 and initial commercial use, advancing our strategy to expand access to first-line fertility treatment in the OB/GYN office and potentially enable earlier intervention. With this financing in place, we are well positioned to execute our commercial strategy, complete the U.S. FemBloc clinical program and advance our portfolio toward key value-creating milestones for patients and shareholders.”

Financial Results for Six Months Ended June 30, 2026

•

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.

Financial Results for Quarter Ended June 30, 2026

•

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.

For more information, please refer to the Company’s Form 10-Q filed August 14, 2026, which can be accessed on the SEC website.

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Assets

J

EX-99.1

2 ef20072749_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Femasys Announces Financial Results for Quarter Ended March 31, 2026 and Provides Corporate Update

-- With fertility rates at historic lows, Femasys advances access to early infertility care through FemaSeed® Complete, enabling OB/GYNs to treat patients within their own practices --

ATLANTA, May 8, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announces its financial results for the quarter ended March 31, 2026 and provides a corporate update.

Corporate Highlights from 1Q 2026 to date

•

Advanced initial commercial adoption of FemaSeed Complete, positioning Femasys to expand access to first-line fertility treatment through integrated, in-office care by OB/GYNs, supporting earlier intervention prior to referral to higher-cost specialty care.

•

Launched FemaSeed Complete at ACOG 2026, advancing commercialization and expanding provider awareness to support adoption of first-line fertility treatment in the OB/GYN office.

•

Established strategic partnership with AMI Technologies to introduce and commercialize its fertility portfolio in Israel, expanding international market opportunities.

•

Appointed John Canning as Chief Operating Officer, enhancing leadership to drive operational execution and support commercial growth.

•

Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, enhancing leadership and strategic oversight.

•

Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc®, advancing toward U.S. approval of a first-of-its kind, non-surgical permanent birth control.

•

FemBloc permanent birth control system achieved Medical Device Single Audit Program (MDSAP) certification, supporting global regulatory readiness and future market access.

•

Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed intratubal insemination (ITI), supporting future reimbursement and broader adoption in the U.S.

•

Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed, and other portfolio products in Switzerland, expanding European market access.

•

Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment and expanding access through community-based care.

“During the first quarter of 2026 and into the second quarter of 2026, we delivered meaningful clinical, regulatory and commercial progress across our FemBloc and FemaSeed platforms,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are accelerating commercialization of FemaSeed with the introduction of the FemSperm® product family, enabling OB/GYNs to deliver integrated, in-office fertility care. Concurrently, we advanced FemBloc with initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe our current cash resources are sufficient to fund operations into the third quarter of 2026. We remain focused on scaling a broad portfolio of innovative women’s health solutions globally, addressing critical unmet needs with safe, technologically advanced products.”

Financial Results for Quarter Ended March 31, 2026

•

Sales increased by $83,625, or 24.5%, to $424,889 in 2026 from $341,264 in 2025, primarily due to sales of FemBloc.

•

Research and development expenses decreased by $1,659,071, or 55.9%, to $1,309,401 in 2026 compared to $2,968,472 in 2025, primarily reflecting the transition of development products into inventory to support commercialization, along with lower development, clinical, compensation, and professional service costs.

•

Net income, including gains from changes in fair value of financial instruments, was $846,100, or $0.00 per basic and diluted share attributable to common stockholders for the quarter ended March 31, 2026, compared to a net loss of $5,896,839, or ($0.23) per basic and diluted share attributable to common stockholders, for the quarter ended March 31, 2025.

•

Cash and cash equivalents as of March 31, 2026, was approximately $5.4 million and the Company had an accumulated deficit of approximately $145.0 million. The Company expects, based on its current operating plan, its current cash and cash equivalents will be sufficient to fund its ongoing operations into the third quarter of 2026.

For more information, please refer to the Company’s Form 10-Q filed May 8, 2026, which can be accessed on the SEC website.

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Assets

March 31,

2026

December 31,

2025

Current assets:

Cash and cash equivalents

$

5,386,041

9,266,353

Accounts receivable, net

172,264

616,600

Inventory

6,105,267

5,740,249

Prepaid and other current assets

679,917

833,133

Total current assets

12,343,489

16,456,335

Prope

EX-99.1

2 ef20069346_ex99-1.htm

EXHIBIT 99.1

Exhibit 99.1

Femasys Announces Financial Results for Year Ended December 31, 2025 and Provides Corporate Update

-- Enrollment underway in FDA-authorized FINALE pivotal trial demonstrating execution toward FemBloc® U.S. approval --

ATLANTA, March 31, 2026 – Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the year ended December 31, 2025 and provides a corporate update.

Corporate Highlights from 4Q 2025 to date

•

Initiated patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc, advancing toward U.S. approval.

•

Appointed Kenneth D. Eichenbaum, M.D., M.S.E., to the Board of Directors, strengthening leadership and strategic oversight.

•

FemBloc permanent birth control system achieved certification under the Medical Device Single Audit Program (MDSAP), supporting global regulatory readiness.

•

Received AMA CPT Editorial Panel approval of a new Category III CPT code for FemaSeed® intratubal insemination (ITI), supporting future reimbursement pathway.

•

Entered a strategic distribution partnership with OR Consulting to support commercial launch of FemBloc, FemaSeed and other products within the portfolio in Switzerland.

•

Established partnership with Refuah Health Center, advancing adoption of FemaSeed as a first-line infertility treatment in community-based care.

•

Secured FDA 510(k) clearance for the FemVue® Controlled device, supporting commercialization of an innovative solution for evaluating fallopian tube status.

•

Completed $12 million financing, strengthening balance sheet to support ongoing clinical and commercial execution.

•

Initiated European post-market surveillance study for FemBloc, advancing real-world evidence generation and commercialization efforts.

“During the fourth quarter of 2025 and into the first quarter of 2026 we achieved significant clinical, regulatory and commercial milestones for our FemBloc non-surgical permanent birth control and our FemaSeed first-line intratubal insemination product solutions,” said Kathy Lee-Sepsick, Founder and Chief Executive Officer of Femasys. “We are actively expanding FemaSeed commercialization in the U.S. with the introduction of the FemSperm® product family, which enables gynecologists to perform in-office sperm preparation and analysis for use with our first-step infertility treatment. Concurrently, we are advancing FemBloc with the initiation of patient enrollment in the FINALE pivotal clinical trial, a key step toward U.S. FDA approval. We believe we have sufficient cash to fund operations into the third quarter of 2026. We continue to strive to redefine women’s reproductive health by addressing critical gaps with innovative, safe, and technologically advanced solutions.”

Financial Results for Year Ended December 31, 2025

•

Sales increased by $664,205, or 40.8%, to $2,293,313 in 2025 from $1,629,108 in 2024, primarily due to sales of FemBloc.

•

Research and development expenses decreased by $638,839, or 7.8%, to $7,577,704 in 2025 compared to $8,216,543 in 2024, primarily due to commercialization of development products into inventory, reduced professional fees and compensation costs, partially offset by increased regulatory costs.

•

Net loss was $18,627,887, or ($0.47) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2025, compared to a net loss of $18,816,628, or ($0.85) per basic and diluted share attributable to common stockholders, for the year ended December 31, 2024.

•

Cash and cash equivalents as of December 31, 2025, was approximately $9.3 million and the Company had an accumulated deficit of approximately $145.8 million. The Company expects, based on its current operating plan, its current cash and cash equivalents, will be sufficient to fund its ongoing operations into the third quarter of 2026.

For more information, please refer to the Company’s Form 10-K filed March 31, 2026, which can be accessed on the SEC website.

FEMASYS INC.

Condensed Balance Sheets

(unaudited)

Assets

December 31,

2025

December 31,

2024

Current assets:

Cash and cash equivalents

$

9,266,353

3,451,761

Accounts receivable, net

616,600

488,373

Inventory

5,740,249

3,046,323

Prepaid and other current assets

833,133

1,035,993

Total current assets

16,456,335

8,022,450

Property and equipment, at cost:

Leasehold improvements

1,238,886

1,238,886

Office equipment

78,155

60,921

Furniture and fixtures

417,876

417,876

Machinery and equipment

3,065,713

2,856,740

Construction in progress

897,885

762,445

5,698,515

5,336,868

Less accumulated depreciation

(3,802,940

)

(3,740,769

)

Net property and equipment

1,895,575

1,596,099

Long-term assets:

Lease right-of-use assets, net

1,297,121

1,805,543

Intangible assets, net of accumula