| | | |
| | | |
| (State or other jurisdiction of incorporation or organization) | | (IRS Employer Identification No.) |
| | | |
| | | |
| (Address of principal executive offices) | | (Zip Code) |
| | | |
| ( | | |
| (Registrant’s telephone number, including area code) | | |
|
|
|
|
|
N/A
|
|
|
|
(Former name, former address and former fiscal year, if changed since last report)
|
|
|
| Title of each class | Trading symbol | Name of each exchange on which Registered | ||
| | | The |
| | |
| Large accelerated filer ☐ | Accelerated filer ☐ |
| | Smaller reporting company |
| Emerging growth company | |
|
TABLE OF CONTENTS
|
||
| Page | ||
| Part I. Financial Information | ||
|
Item 1
|
5 | |
| 5 | ||
| 7 | ||
| 8 | ||
| 9 | ||
| 10 | ||
|
Item 2
|
28 | |
|
Item 3
|
40 | |
|
Item 4
|
41 | |
| Part II. Other Information | ||
|
Item 1
|
41 | |
|
Item 1A
|
41 | |
|
Item 2
|
42 | |
|
Item 3
|
42 | |
|
Item 4
|
42 | |
|
Item 5
|
42 | |
|
Item 6
|
43 | |
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
June 30,
2026
|
|
|
|
December
31,
2025
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
|
|
|
|
|
|
|
Prepaid and other current assets
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
|
|
|
|
|
|
Property and equipment, at cost:
|
|
|
|
|
|
|
|
|
|
Leasehold improvements
|
|
|
|
|
|
|
|
|
|
Office equipment
|
|
|
|
|
|
|
|
|
|
Furniture and fixtures
|
|
|
|
|
|
|
|
|
|
Machinery and equipment
|
|
|
|
|
|
|
|
|
|
Construction in progress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less accumulated depreciation
|
|
|
( |
)
|
|
|
( |
)
|
|
Net property and equipment
|
|
|
|
|
|
|
|
|
|
Long-term assets:
|
|
|
|
|
|
|
|
|
|
Lease right-of-use assets, net
|
|
|
|
|
|
|
|
|
|
Intangible assets, net of accumulated amortization
|
|
|
|
|
|
|
|
|
|
Other long-term assets
|
|
|
|
|
|
|
|
|
|
Total long-term assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
June 30,
2026
|
|
|
|
December
31,
2025
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
|
|
|
|
|
|
|
Accrued expenses
|
|
|
|
|
|
|
|
|
|
Clinical holdback – current portion
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities – current portion
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
|
Clinical holdback – long-term portion
|
|
|
|
|
|
|
|
|
|
Convertible notes payable, net
|
|
|
|
|
|
|
|
|
|
Conversion option liability
|
|
|
|
|
|
|
|
|
|
Warrants liabilities
|
|
|
|
|
|
|
|
|
|
Operating lease liabilities – long-term portion
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
||
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
| Common stock, $ |
|
|
|
|
|
|
|
|
| Treasury stock, |
|
|
( |
) |
|
|
( |
) |
|
Warrants
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
( |
)
|
|
|
( |
)
|
|
Total stockholders’ equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
Six Months Ended June 30,
|
|
||||||||
|
|
|
|
2026
|
|
|
|
2025
|
|
|
|
2026
|
|
|
|
2025
|
|
|
Sales
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|||
|
Cost of sales (excluding depreciation expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of conversion option liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of warrants liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Other expense
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
Total other income (expense), net
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
Loss before income taxes
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Income tax expense (benefit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
)
|
|
Net loss
|
|
$
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
$
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Weighted-average common shares outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Common stock | Treasury common stock |
Warrants | Additional paid-in capital |
Accumulated deficit |
Total stockholders’ equity |
|||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||
|
THREE MONTHS ENDED JUNE 30, 2026
|
||||||||||||||||||||||||||||||||
|
Balance at March 31, 2026
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
November 2025 conversion option liability and warrants liabilities reclassification
|
— | — | |
|
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Share-based compensation expense
|
— | — | |
|
||||||||||||||||||||||||||||
|
Net loss
|
— | — | ( |
)
|
( |
)
|
||||||||||||||||||||||||||
|
Balance at June 30, 2026
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
SIX MONTHS ENDED JUNE 30, 2026
|
||||||||||||||||||||||||||||||||
|
Balance at December 31, 2025
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
November 2025 conversion option liability and warrants liabilities reclassification
|
— | — | — | |
|
|
||||||||||||||||||||||||||
|
Issuance of common shares in payment of 2023 convertible note interest, including related parties
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Conversion of 2025 convertible notes into common stock
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Share-based compensation expense
|
— | — | |
|
||||||||||||||||||||||||||||
|
Net loss
|
— | — | ( |
)
|
( |
)
|
||||||||||||||||||||||||||
|
Balance at June 30, 2026
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
| Common stock | Treasury common stock |
Warrants | Additional paid-in capital |
Accumulated deficit |
Total stockholders’ equity |
|||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||
|
THREE MONTHS ENDED JUNE 30, 2025
|
||||||||||||||||||||||||||||||||
|
Balance at March 31, 2025
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with June 2025 financing, net of issuance costs
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Issuance of warrants in connection with June 2025 financing
|
— | — | |
( |
)
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Share-based compensation expense
|
— | — | |
|
||||||||||||||||||||||||||||
|
Expiration of warrant
|
— | — | ( |
)
|
|
|||||||||||||||||||||||||||
|
Conversion of convertible notes into common stock
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Net loss
|
— | — | ( |
)
|
( |
)
|
||||||||||||||||||||||||||
|
Balance at June 30, 2025
|
|
$
|
|
|
$
|
( |
)
|
|
$
|
|
$
|
( |
)
|
$
|
|
|||||||||||||||||
|
SIX MONTHS ENDED JUNE 30, 2025
|
||||||||||||||||||||||||||||||||
|
Balance at December 31, 2024
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with June 2025 financing, net of issuance costs
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Issuance of warrants in connection with June 2025 financing
|
— | — | |
( |
)
|
|||||||||||||||||||||||||||
|
Issuance of common stock in connection with ESPP
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Share-based compensation expense
|
— | — | |
|
||||||||||||||||||||||||||||
|
Expiration of warrant
|
— | — | ( |
)
|
|
|||||||||||||||||||||||||||
|
Conversion of convertible notes into common stock
|
|
|
— | |
|
|||||||||||||||||||||||||||
|
Net loss
|
— | — | ( |
)
|
( |
)
|
||||||||||||||||||||||||||
|
Balance at June 30, 2025
|
|
$
|
|
|
$
|
( |
)
|
$
|
|
$
|
|
$
|
( |
)
|
$
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30
|
|
|||||
|
|
|
2026
|
|
|
2025
|
|
||
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
( |
)
|
|
|
( |
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
|
|
|
|
|
|
|
Amortization
|
|
|
|
|
|
|
|
|
|
Change in fair value of conversion option liability
|
|
|
( |
)
|
|
|
|
|
|
Change in fair value of warrants liabilities
|
|
|
( |
)
|
|
|
|
|
|
Amortization of right-of-use assets
|
|
|
|
|
|
|
|
|
|
Loss on fixed asset dispositions
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs and discount
|
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
( |
)
|
|
|
( |
)
|
|
Prepaid and other assets
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
|
|
|
|
|
Accrued expenses
|
|
|
( |
)
|
|
|
( |
)
|
|
Lease liabilities
|
|
|
( |
)
|
|
|
( |
)
|
|
Other liabilities
|
|
|
( |
)
|
|
|
( |
)
|
|
Net cash used in operating activities
|
|
|
( |
)
|
|
|
( |
)
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
Acquisition of patents
|
|
|
( |
)
|
|
|
( |
)
|
|
Purchases of property and equipment
|
|
|
( |
)
|
|
|
( |
)
|
|
Net cash used in investing activities
|
|
|
( |
)
|
|
|
( |
)
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock in June 2025 financing
|
|
|
|
|
|
|
|
|
|
Issuance costs for June 2025 financing
|
|
|
|
|
|
|
( |
)
|
|
Proceeds from at-the-market sales of common stock
|
|
|
|
|
|
|
|
|
|
Issuance costs for at-the-market sales of common stock
|
|
|
( |
)
|
|
|
( |
)
|
|
Proceeds from common stock issued through ESPP
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents
|
|
|
( |
)
|
|
|
( |
)
|
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
|
Beginning of period
|
|
|
|
|
|
|
|
|
|
End of period
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information
|
|
|
|
|
|
|
|
|
|
Cash paid for:
|
|
|
|
|
|
|
|
|
|
Income taxes
|
|
$
|
|
|
|
|
|
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
Property and equipment costs included in accounts payable
|
|
|
|
|
|
|
|
|
|
Acquisition of patents included in accounts payable
|
|
|
|
|
|
|
|
|
|
Issuance of warrants for underwriter commission
|
|
|
|
|
|
|
|
|
|
Conversion of November 2025 convertible notes into common stock
|
|
|
|
|
|
|
|
|
|
Conversion of November 2023 convertible notes into common stock
|
|
|
|
|
|
|
|
|
|
Payment of November 2023 convertible note interest in common stock
|
|
|
|
|
|
|
|
|
|
Deferred offering costs reclassified to additional paid-in capital
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value of
Conversion Option Liability
|
|
|
Fair Value
of
Warrants
Liabilities
|
|
||
|
Balance at December 31, 2025
|
|
$
|
|
|
|
$
|
|
|
|
Change in fair value other than modification
|
|
|
( |
)
|
|
|
( |
)
|
|
Change in fair value related to March 19, 2026 modification
|
|
|
( |
)
|
|
|
( |
)
|
|
Issuance of Series D-1 Warrants
|
|
|
|
|
|
|
|
|
|
Conversion of convertible note
|
|
|
( |
)
|
|
|
|
|
|
Change in fair value other than modification
|
|
|
( |
)
|
|
|
( |
)
|
|
Reclassification to equity upon April 29, 2026 shareholder approval
|
|
|
( |
)
|
|
|
( |
)
|
|
Balance at April 29, 2026 reclassification
|
|
$
|
|
|
|
$
|
|
|
| | | Conversion Option Liability | | | Warrants Liabilities | | ||
| Expected term (in years) | | | | | | | | |
| Risk‑free interest rate | | | | % | | | | % |
| Dividend yield | | | | % | | | | % |
| Expected volatility | | | | % | | | | % |
| Exercise price | | $ | | | | | $ | |
| Stock price | | $ | | | | $ | | |
| | | | | | | | | |
| Black-Scholes value | | $ | | | | | $ | |
|
|
|
|
June 30,
2026
|
|
|
|
December 31,
2025
|
|
|
Materials
|
$
|
|
|
|
|
|
||
|
Work in progress
|
|
|
|
|
|
|
|
|
|
Finished goods
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
$
|
|
|
|
|
|
|
|
|
|
|
June 30,
2026
|
|
|
|
December 31,
2025
|
|
|
Incentive and other compensation costs
|
$
|
|
|
|
|
|
||
|
Clinical trial costs
|
|
|
|
|
|
|
|
|
|
Director fees
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
Accrued expenses
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
||||||||||
|
Primary geographical markets
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
U.S.
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stated
Interest
Rate
|
|
|
June 30,
2026
|
|
|
December 31,
2025
|
|
|||
|
Face value of November 2025 Notes
|
|
|
|
%
|
|
|
|
|
|
|
|
|
|
PIK interest on November 2025 Notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less unamortized discount and debt issuance costs
|
|
|
|
|
|
|
( |
)
|
|
|
( |
)
|
|
Convertible Notes Payable
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
| | | | | | | | | | | | | |
| | | Pre- funded warrants | | | Common warrants | | | Underwriter warrants | | |||
| Expected term (in years) | | | | | | | | | | |||
| Risk‑free interest rate | | | | % | | | | % | | | | % |
| Dividend yield | | | | % | | | | % | | | | % |
| Expected volatility | | | | % | | | | % | | | | % |
| Exercise price | | $ | | | | | $ | | | $ | | |
| Stock price | | $ | | | | | $ | | | $ | | |
| Black-Scholes value | | $ | | | | | $ | | | $ | | |
|
|
|
Number
of
options
|
|
|
Weighted
average
exercise
price
|
|
|
Aggregate
Intrinsic
Value
|
|
|||
|
Outstanding at December 31, 2025
|
|
|
|
$
|
|
|
|
|
|
|||
|
Granted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2026
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at June 30, 2026
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
| | | | | | | | | | | | | |
| | | Number of options | | | Weighted average exercise price | | | Weighted average remaining life years | | |||
| Outstanding at December 31, 2025 | | | | | | $ | | | | | | |
| Granted | | | | | | | | | | | | |
| Forfeited | | | ( | ) | | | | | | | — | |
| Outstanding at June 30, 2026 | | | | | | $ | | | | | | |
| | | | | | | | | | | | | |
| Vested and exercisable at June 30, 2026 | | | | | | $ | | | | | | |
| | | | | | | | | | | | | |
| | | Six Months Ended June 30, 2026 | | |||||||||
| | | Employees | | | Nonemployees | | ||||||
| | | 2021 Plan | | | Inducement Grants | | | 2021 Plan | | |||
| Options Granted | | | | | | | | | | | | |
| Fair Value of Awards | | $ | | | | | | | | $ | | |
| Exercise Price | | $ | | | | | | | | $ | | |
| | | | | | | | | | | | | |
| Expected term (in years) | | | | | | | | | | | | |
| Risk‑free interest rate | | | | % | | | | % | | | | % |
| Dividend yield | | | | % | | | | % | | | | % |
| Expected volatility | | | | % | | | | % | | | | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
of
RSUs
|
|
|
Weighted
average
grant
date
fair value
|
|
||
|
Outstanding at December 31, 2025
|
|
|
|
|
|
$
|
|
|
|
Granted
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
( |
)
|
|
|
|
|
|
Outstanding at June 30, 2026
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
Research and development
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
Stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ESPP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders, basic and diluted
|
|
$
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Weighted average common shares outstanding, basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic and diluted
|
|
$
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
Options to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted stock units to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock, in connection with April 2023 financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock, in connection with November 2023 financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock, in connection with June 2025 financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock, in connection with August 2025 financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
November 2025 convertible notes and PIK interest, if converted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock, in connection with November 2025 financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase common stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total potential shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
Sales
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales (excluding depreciation expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other research and development expense1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
Loss before income taxes
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Income tax expense (benefit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
)
|
|
Net loss
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
||||||||||
|
|
|
2026
|
|
|
2025
|
|
|
2026
|
|
|
2025
|
|
||||
|
Interest income
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs and discount for 2025 and 2023 notes
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
|
( |
)
|
|
Interest expense
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
Change in fair value of Conversion Option Liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of Warrants liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt issuance costs for AMPA
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
Total other income (expense), net
|
|
$
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
( |
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
|
|
|
|
|
|||||||
|
|
|
2026
|
|
|
2025
|
|
|
Change
|
|
|
%
Change
|
|
||||
|
Sales
|
|
$
|
331,827
|
|
|
|
409,268
|
|
|
|
(77,441
|
)
|
|
|
(18.9
|
)%
|
|
Cost of sales (excluding depreciation expense)
|
|
|
142,436
|
|
|
|
158,171
|
|
|
|
(15,735
|
)
|
|
|
(9.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,946,878
|
|
|
|
1,414,429
|
|
|
|
532,449
|
|
|
|
37.6
|
%
|
|
Sales and marketing
|
|
|
1,293,998
|
|
|
|
984,977
|
|
|
|
309,021
|
|
|
|
31.4
|
%
|
|
General and administrative
|
|
|
1,931,578
|
|
|
|
1,616,972
|
|
|
|
314,606
|
|
|
|
19.5
|
%
|
|
Depreciation and amortization
|
|
|
82,811
|
|
|
|
86,285
|
|
|
|
(3,474
|
)
|
|
|
(4.0
|
)%
|
|
Total operating expenses
|
|
|
5,255,265
|
|
|
|
4,102,663
|
|
|
|
1,152,602
|
|
|
|
28.1
|
%
|
|
Loss from operations
|
|
|
(5,065,874
|
)
|
|
|
(3,851,566
|
)
|
|
|
(1,214,308
|
)
|
|
|
31.5
|
%
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
19,694
|
|
|
|
17,144
|
|
|
|
2,550
|
|
|
|
14.9
|
%
|
|
Change in fair value of conversion option liability
|
|
|
219,000
|
|
|
|
—
|
|
|
|
219,000
|
|
|
|
100.0
|
%
|
|
Change in fair value of warrants liabilities
|
|
|
545,000
|
|
|
|
—
|
|
|
|
545,000
|
|
|
|
100.0
|
%
|
|
Interest expense
|
|
|
(186,050
|
)
|
|
|
(491,500
|
)
|
|
|
305,450
|
|
|
|
(62.1
|
)%
|
|
Other expense
|
|
|
—
|
|
|
|
(260,000
|
)
|
|
|
260,000
|
|
|
|
(100.0
|
)%
|
|
Total other income (expense), net
|
|
|
597,644
|
|
|
|
(734,356
|
)
|
|
|
1,332,000
|
|
|
|
(181.4
|
)%
|
|
Loss before income taxes
|
|
|
(4,468,230
|
)
|
|
|
(4,585,922
|
)
|
|
|
117,692
|
|
|
|
2.6
|
%
|
|
Income tax expense
|
|
|
865
|
|
|
|
—
|
|
|
|
865
|
|
|
|
100.0
|
%
|
|
Net loss
|
|
$
|
(4,469,095
|
)
|
|
|
(4,585,922
|
)
|
|
|
116,827
|
|
|
|
(2.5
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|||||
|
|
|
2026
|
|
|
2025
|
|
||
|
Compensation and related personnel costs
|
|
$
|
1,085,653
|
|
|
|
1,249,096
|
|
|
Clinical-related costs
|
|
|
464,449
|
|
|
|
262,389
|
|
|
Material and development costs
|
|
|
198,087
|
|
|
|
(216,134
|
)
|
|
Professional and outside consultant costs
|
|
|
153,909
|
|
|
|
111,749
|
|
|
Other costs
|
|
|
44,780
|
|
|
|
7,329
|
|
|
Total research and development expenses
|
|
$
|
1,946,878
|
|
|
|
1,414,429
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|||||
|
|
|
|
2026
|
|
|
|
2025
|
|
|
Interest income
|
|
$
|
19,694
|
|
|
|
17,144
|
|
|
Amortization of debt issuance costs and discount for 2025 Notes
|
|
|
(186,050
|
)
|
|
|
—
|
|
|
Amortization of debt issuance costs and discount for 2023 Notes
|
|
|
—
|
|
|
|
(389,913
|
)
|
|
Interest expense
|
|
|
—
|
|
|
|
(101,587
|
)
|
|
Change in fair value of Conversion Option liability
|
|
|
219,000
|
|
|
|
—
|
|
|
Change in fair value of Warrants liabilities
|
|
|
545,000
|
|
|
|
—
|
|
|
Debt issuance costs for AMPA
|
|
|
—
|
|
|
|
(260,000
|
)
|
|
Total other income (expense), net
|
|
$
|
597,644
|
|
|
|
(734,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
|
|
|
|||||||
|
|
|
2026
|
|
|
2025
|
|
|
Change
|
|
|
% Change
|
|
||||
|
Sales
|
|
$
|
756,716
|
|
|
|
750,532
|
|
|
|
6,184
|
|
|
|
0.8
|
%
|
|
Cost of sales (excluding depreciation expense)
|
|
|
301,042
|
|
|
|
275,437
|
|
|
|
25,605
|
|
|
|
9.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
3,256,279
|
|
|
|
4,382,901
|
|
|
|
(1,126,622
|
)
|
|
|
(25.7
|
)%
|
|
Sales and marketing
|
|
|
2,609,753
|
|
|
|
1,893,544
|
|
|
|
716,209
|
|
|
|
37.8
|
%
|
|
General and administrative
|
|
|
3,713,968
|
|
|
|
3,339,685
|
|
|
|
374,283
|
|
|
|
11.2
|
%
|
|
Depreciation and amortization
|
|
|
165,081
|
|
|
|
171,138
|
|
|
|
(6,057
|
)
|
|
|
(3.5
|
)%
|
|
Total operating expenses
|
|
|
9,745,081
|
|
|
|
9,787,268
|
|
|
|
(42,187
|
)
|
|
|
(0.4
|
)%
|
|
Loss from operations
|
|
|
(9,289,407
|
)
|
|
|
(9,312,173
|
)
|
|
|
22,766
|
|
|
|
(0.2
|
)%
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
69,521
|
|
|
|
36,173
|
|
|
|
33,348
|
|
|
|
92.2
|
%
|
|
Change in fair value of conversion option liability
|
|
|
1,732,413
|
|
|
|
—
|
|
|
|
1,732,413
|
|
|
|
100.0
|
%
|
|
Change in fair value of warrants liabilities
|
|
|
4,228,000
|
|
|
|
—
|
|
|
|
4,228,000
|
|
|
|
100.0
|
%
|
|
Interest expense
|
|
|
(362,657
|
)
|
|
|
(950,949
|
)
|
|
|
588,292
|
|
|
|
(61.9
|
)%
|
|
Other expense
|
|
|
—
|
|
|
|
(260,000
|
)
|
|
|
260,000
|
|
|
|
(100.0
|
)%
|
|
Total other income (expense), net
|
|
|
5,667,277
|
|
|
|
(1,174,776
|
)
|
|
|
6,842,053
|
|
|
|
(582.4
|
)%
|
|
Loss before income taxes
|
|
|
(3,622,130
|
)
|
|
|
(10,486,949
|
)
|
|
|
6,864,819
|
|
|
|
(65.5
|
)%
|
|
Income tax expense (benefit)
|
|
|
865
|
|
|
|
(4,188
|
)
|
|
|
5,053
|
|
|
|
(120.7
|
)%
|
|
Net loss
|
|
$
|
(3,622,995
|
)
|
|
|
(10,482,761
|
)
|
|
|
6,859,766
|
|
|
|
(65.4
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30,
|
|
|||||
|
|
|
2026
|
|
|
2025
|
|
||
|
Compensation and related personnel costs
|
|
$
|
1,975,979
|
|
|
|
2,554,755
|
|
|
Clinical-related costs
|
|
|
719,161
|
|
|
|
656,364
|
|
|
Material and development costs
|
|
|
292,696
|
|
|
|
325,365
|
|
|
Professional and outside consultant costs
|
|
|
210,033
|
|
|
|
303,944
|
|
|
Regulatory and other costs
|
|
|
58,410
|
|
|
|
542,473
|
|
|
Total research and development expenses
|
|
$
|
3,256,279
|
|
|
|
4,382,901
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
June 30,
|
|
|||||
|
|
|
2026
|
|
|
2025
|
|
||
|
Interest income
|
|
$
|
69,521
|
|
|
|
36,173
|
|
|
Amortization of debt issuance costs and discount for 2025 Notes
|
|
|
(362,657
|
)
|
|
|
—
|
|
|
Amortization of debt issuance costs and discount for 2023 Notes
|
|
|
—
|
|
|
|
(746,612
|
)
|
|
Interest expense
|
|
|
—
|
|
|
|
(204,337
|
)
|
|
Change in fair value of Conversion Option liability
|
|
|
1,732,413
|
|
|
|
—
|
|
|
Change in fair value of Warrants liabilities
|
|
|
4,228,000
|
|
|
|
—
|
|
|
Debt issuance costs for AMPA
|
|
|
—
|
|
|
|
(260,000
|
)
|
|
Total other income (expense), net
|
|
$
|
5,667,277
|
|
|
|
(1,174,776
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|||||
|
|
|
2026
|
|
|
2025
|
|
||
|
Net cash used in operating activities
|
|
$
|
(8,079,197
|
)
|
|
|
(9,117,950
|
)
|
|
Net cash used in investing activities
|
|
|
(101,317
|
)
|
|
|
(193,567
|
)
|
|
Net cash provided by financing activities
|
|
|
357,663
|
|
|
|
9,077,823
|
|
|
Net change in cash and cash equivalents
|
|
$
|
(7,822,851
|
)
|
|
|
(233,694
|
)
|
| Incorporated by Reference | |||||
|
Exhibit
|
|||||
|
Number
|
Description of Document
|
Schedule/Form | File Number | Exhibit | Filing Date |
|
Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc.
|
Form 8-K | 001-40492 | 3.1 | June 22, 2021 | |
| 3.2 | Certificate of Amendment to the Eleventh Amended and Restated Certificate of Incorporation of Femasys Inc. | Form 8-K | 001-40492 | 3.1 | June 5, 2026 |
|
Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K | 001-40492 | 3.2 | June 22, 2021 | |
|
First Amendment to the Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K | 001-40492 | 3.1 | March 30, 2023 | |
|
Employment
Agreement between Femasys Inc. and John Canning
|
Form 8-K | 001-40492 | 10.1 | April 1, 2026 | |
|
|
|
|
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
101.INS*
|
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
|
|
|
|
|
101.SCH*
|
Inline XBRL Taxonomy Extension Schema Document
|
|
|
|
|
101.CAL*
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
101.DEF*
|
Inline XBRL Taxonomy Definition Linkbase Document
|
|
|
|
|
101.LAB*
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
101.PRE*
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
104*
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
|
|
|
|
|
|
|
FEMASYS INC
|
|
|
|
|
|
|
Dated: August 14, 2026
|
By: /s/ Kathy Lee-Sepsick
|
|
|
|
Kathy Lee-Sepsick
|
|
|
|
Chief Executive Officer and President
|
|
|
|
|
|
|
Dated: August 14, 2026
|
|
|
|
|
By: /s/ Dov Elefant
|
|
|
|
Dov Elefant
|
|
|
|
Chief Financial Officer
|
|