|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
||
(Exact Name of Registrant as Specified in its Charter)
|
|
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
|
|
||
|
(
|
|
(Address of principal executive offices, including zip code)
|
(Registrant’s telephone number, including area code)
|
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company |
|
Emerging growth company |
Title of each class
|
Trading symbol
|
Name of each exchange on which
registered
|
|||
|
|
The
|
|
TABLE OF CONENTS
|
|
Page
|
||
Part I. Financial Information
|
||
Item 1
|
5
|
|
5
|
||
7
|
||
8
|
||
9
|
||
10
|
||
Item 2
|
15
|
|
Item 3
|
19
|
|
Item 4
|
19
|
|
Part II. Other Information
|
||
Item 1
|
19
|
|
Item 1A
|
19
|
|
Item 2
|
19
|
|
Item 3
|
20
|
|
Item 4
|
20
|
|
Item 5
|
20
|
|
Item 6
|
20
|
|
21
|
•
|
our ability to develop and advance our current product candidates and programs into, and successfully initiate and complete, clinical trials;
|
•
|
the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results;
|
•
|
our ability to enroll subjects in the clinical trials for our product candidates in order to advance the development thereof on a timely basis;
|
•
|
our ability to obtain additional financing to fund the clinical development of our products and fund operations;
|
•
|
estimates regarding the total addressable market for our product candidates;
|
•
|
competitive companies and technologies in our industry;
|
•
|
our ability to obtain U.S. Food and Drug Administration (FDA) approval for our permanent birth control system, ability to gain FDA grant of a de novo
classification request for our intrauterine artificial insemination product, expand sales of our women-specific medical products and develop and commercialize additional products;
|
•
|
our ability to commercialize or obtain regulatory approvals, grants of de novo classification requests or 510(k) clearance for our product candidates, or the
effect of delays in commercializing or obtaining regulatory authorizations;
|
•
|
our business model and strategic plans for our products, technologies and business, including our implementation thereof;
|
•
|
commercial success and market acceptance of our product candidates;
|
•
|
our ability to achieve and maintain adequate levels of coverage or reimbursement for our FemBloc system or any future products we may seek to commercialize;
|
•
|
our ability to manufacture our products and product candidates in compliance with applicable laws, regulations and requirements and to oversee third-party
suppliers, service providers and vendors in the performance of any contracted activities in accordance with applicable laws, regulations and requirements;
|
•
|
adverse developments affecting the financial services industry;
|
•
|
the impact of the COVID-19 pandemic on our business, financial condition, results of operations, and prospects;
|
•
|
our ability to accurately forecast customer demand for our product candidates, and manage our inventory;
|
•
|
our ability to build, manage and maintain our direct sales and marketing organization, and to market and sell our permanent birth control system, artificial
insemination product and women-specific medical product solutions in markets in and outside of the United States;
|
•
|
our ability to hire and retain our senior management and other highly qualified personnel;
|
•
|
FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and
international markets;
|
•
|
the timing or likelihood of regulatory filings and approvals or clearances;
|
•
|
our ability to establish and maintain intellectual property protection for our product candidates and our ability to avoid claims of infringement;
|
•
|
the volatility of the trading price of our common stock; and
|
•
|
our expectations about market trends.
|
ITEM I. |
Financial Statements
|
Assets
|
March 31,
2023
|
December 31,
2022
|
||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
|
|||||
Accounts receivable, net
|
|
|
||||||
Inventory, net
|
|
|
||||||
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 |
March 31,
2023
|
December 31,
2022
|
||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
|
|||||
Accrued expenses
|
|
|
||||||
Note payable
|
||||||||
Clinical holdback - current portion
|
|
|
||||||
Lease liabilities – current portion
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Long-term liabilities:
|
||||||||
Clinical holdback - long-term portion
|
|
|
||||||
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 March 31,
|
||||||||
2023
|
2022
|
|||||||
Sales
|
$
|
|
|
|||||
Cost of sales
|
|
|
||||||
Gross margin
|
|
|
||||||
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
|
|
|
||||||
Interest expense
|
( |
) | ( |
) | ||||
Other income (expense), net
|
( |
) | ||||||
|
||||||||
Net loss
|
$
|
(
|
)
|
(
|
)
|
|||
Net loss attributable to common stockholders, basic and diluted
|
$
|
(
|
)
|
(
|
)
|
|||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(
|
)
|
(
|
)
|
|||
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
|
|
Total
|
||||||||||||||||||||||||||||||||
Common stock
|
Treasury stock
|
Additional
|
Accumulated
|
stockholders’
|
||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Warrants
|
paid-in capital
|
deficit
|
Equity
|
|||||||||||||||||||||||||
THREE MONTHS ENDED MARCH 31, 2023
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Issuance of common stock in connection with At-The-Market offering,
net of issuance costs
|
||||||||||||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Balance at March 31, 2023
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
THREE MONTHS ENDED MARCH 31, 2022
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Balance at March 31, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
(
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
|
|
||||||
Amortization
|
|
|
||||||
Amortization of right-of-use assets
|
|
|
||||||
Inventory reserve
|
||||||||
Share-based compensation expense
|
|
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(
|
)
|
(
|
)
|
||||
Inventory
|
(
|
)
|
(
|
)
|
||||
Other assets
|
|
|
||||||
Accounts payable
|
|
|
||||||
Accrued expenses
|
|
(
|
)
|
|||||
Lease liabilites
|
(
|
)
|
(
|
)
|
||||
Other liabilities
|
|
(
|
)
|
|||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of common stock
|
||||||||
Repayment of note payable
|
(
|
)
|
(
|
)
|
||||
Payments under lease obligations
|
(
|
)
|
(
|
)
|
||||
Net cash used in 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: | ||||||||
Interest
|
$ | |||||||
Income taxes
|
$ | |||||||
Non-cash investing and financing activities: | ||||||||
Property and equipment costs included in accounts payable
|
$ | |||||||
Commissions and deferred offering costs relating to proceeds from issuance of common stock
|
$ | |||||||
Prepaid insurance financed with promissory notes
|
$ |
(1)
|
Organization, Nature of Business, and Liquidity
|
(2)
|
Cash and Cash Equivalents
|
(3)
|
Inventories
|
March 31, | December 31, | |||||||
2023
|
2022 |
|||||||
Materials
|
$
|
|
|
|||||
Work in progress
|
|
|
||||||
Finished goods
|
|
|
||||||
Inventory, net
|
$
|
|
|
(4)
|
Accrued Expenses
|
March 31, | December 31, | |||||||
2023 |
2022 |
|||||||
Clinical trial costs
|
$
|
|
|
|||||
Compensation costs
|
|
|
||||||
Franchise taxes |
||||||||
Other
|
|
|
||||||
Accrued expenses
|
$
|
|
|
(5)
|
Clinical Holdback
|
Balance at December 31, 2022
|
$
|
|
||
Clinical holdback retained
|
|
|||
Clinical holdback paid
|
(
|
)
|
||
Balance at March 31, 2023
|
$
|
|
||
Less: clinical holdback - current portion
|
(
|
)
|
||
Clinical holdback - long-term portion
|
$
|
|
(6)
|
Revenue Recognition
|
Three Months Ended March 31,
|
||||||||
Primary geographical markets |
2023
|
2022
|
||||||
U.S.
|
$
|
|
|
|||||
International
|
|
|
||||||
Total
|
$
|
|
|
|
(7)
|
Commitments and Contingencies
|
(8)
|
Notes Payable
|
(9)
|
Stockholders’ Equity
|
(10)
|
Equity Incentive Plans
|
(a) |
Stock Option Plans
|
Number of | Weighted Average |
|||||||
Options | Exercise Price | |||||||
Outstanding at December 31, 2022 | $ | |||||||
Granted | ||||||||
Forfeited | ( |
) | ||||||
Outstanding at March 31, 2023 | $ | |||||||
Vested and exercisable at March 31, 2023 | $ |
Fair Value of Awards |
$ | |||
Grant Price |
$ | |||
Expected term (in years)
|
|
|||
Risk‑free interest rate
|
|
%
|
||
Dividend yield
|
|
%
|
||
Expected volatility
|
|
%
|
(b) |
Inducement Grants
|
(c) | Share-Based Compensation Expense |
Three Months Ended March 31, |
||||||||
2023
|
2022
|
|||||||
Research and development
|
$
|
|
|
|||||
Sales and marketing
|
(
|
)
|
|
|||||
General and administrative
|
|
|
||||||
Total share-based compensation expense
|
$
|
|
|
(d) |
Employee Stock Purchase Plan (ESPP)
|
(11)
|
Net Loss per Share Attributable to Common Stockholders
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
Net loss attributable to common stockholders, basic & diluted
|
$
|
(
|
)
|
(
|
)
|
|||
|
||||||||
Weighted average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted
|
|
|
||||||
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(
|
)
|
(
|
)
|
March 31,
2023
|
March 31,
2022
|
|||||||
Options to purchase common stock
|
|
|
||||||
Warrants to purchase to common stock
|
|
|
||||||
Total potential shares
|
|
|
|
(12)
|
Subsequent Events
|
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
Three Months Ended March 31,
|
||||||||||||||||
2023
|
2022
|
Change
|
% Change
|
|||||||||||||
Sales
|
$
|
293,984
|
321,405
|
(27,421
|
)
|
-8.5
|
%
|
|||||||||
Cost of sales
|
105,120
|
122,675
|
(17,555
|
)
|
-14.3
|
%
|
||||||||||
Gross margin
|
188,864
|
198,730
|
(9,866
|
)
|
-5.0
|
%
|
||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
1,537,439
|
1,421,063
|
116,376
|
8.2
|
%
|
|||||||||||
Sales and marketing
|
244,896
|
68,863
|
176,033
|
255.6
|
%
|
|||||||||||
General and administrative
|
1,315,137
|
1,447,355
|
(132,218
|
)
|
-9.1
|
%
|
||||||||||
Depreciation and amortization
|
133,066
|
144,199
|
(11,133
|
)
|
-7.7
|
%
|
||||||||||
Total operating expenses
|
3,230,538
|
3,081,480
|
149,058
|
4.8
|
%
|
|||||||||||
Loss from operations
|
(3,041,674
|
)
|
(2,882,750
|
)
|
(158,924
|
)
|
5.5
|
%
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
97,089
|
2,454
|
94,635
|
3856.4
|
%
|
|||||||||||
Interest expense
|
(1,672
|
)
|
(2,734
|
)
|
1,062
|
-38.8
|
%
|
|||||||||
Other income (expense), net
|
95,417
|
(280
|
)
|
95,697
|
-34177.5
|
%
|
||||||||||
Net loss
|
$
|
(2,946,257
|
)
|
(2,883,030
|
)
|
(63,227
|
)
|
2.2
|
%
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
Compensation and related personnel costs
|
$
|
900,288
|
764,792
|
|||||
Clinical-related costs
|
366,360
|
443,970
|
||||||
Material and development costs
|
167,161
|
131,450
|
||||||
Professional and outside consultant costs
|
91,935
|
68,664
|
||||||
Other costs
|
11,695
|
12,187
|
||||||
Total research and development expenses
|
$
|
1,537,439
|
1,421,063
|
Three Months Ended March 31,
|
||||||||
2023
|
2022
|
|||||||
Net cash used in operating activities
|
$
|
(2,647,637
|
)
|
(2,754,021
|
)
|
|||
Net cash used in investing activities
|
(8,901
|
)
|
(120,368
|
)
|
||||
Net cash used in financing activities
|
(144,060
|
)
|
(141,006
|
)
|
||||
Net change in cash and cash equivalents
|
$
|
(2,800,598
|
)
|
(3,015,395
|
)
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk
|
Item 4. |
Controls and Procedures
|
Item 1. |
Legal Proceedings
|
Item 1A. |
Risk Factors
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3. |
Defaults Upon Senior Securities
|
Item 4. |
Mine Safety Disclosures
|
Item 5. |
Other Information
|
Incorporated by Reference
|
|||||
Exhibit
|
File
|
||||
Number Description of Document
|
Schedule/Form
|
Number
|
Exhibit
|
Filing Date
|
|
First Amendment to the Amended and Restated Bylaws of Femasys Inc.
|
Form 8-K
|
001-40492
|
3.1
|
March 30, 2023
|
|
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)
|
||||
*Filed herewith
|
Dated: May 11, 2023
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By: /s/ Kathy Lee-Sepsick
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Kathy Lee-Sepsick
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||
Chief Executive Officer and President
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||
By: /s/ Dov Elefant
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Dov Elefant
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Chief Financial Officer
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(principal financial and accounting officer)
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FEMASYS INC.
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Date: May 11, 2023
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By:
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/s/ Kathy Lee-Sepsick
|
Kathy Lee-Sepsick
|
||
Chief Executive Officer and President
|
||
(principal executive officer)
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FEMASYS INC.
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||
Date: May 11, 2023
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By:
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/s/ Dov Elefant
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Dov Elefant
|
||
Chief Financial Officer
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||
(principal financial and accounting officer)
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FEMASYS INC.
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||
Date: May 11, 2023
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By:
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/s/ Kathy Lee-Sepsick
|
Kathy Lee-Sepsick
|
||
Chief Executive Officer and President
|
||
(principal executive officer)
|
FEMASYS INC.
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||
Date: May 11, 2023
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By:
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/s/ Dov Elefant
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Dov Elefant
|
||
Chief Financial Officer
|
||
(principal financial and accounting officer)
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Balance Sheets (Parenthetical) - $ / shares |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Stockholders' equity: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, issued (in shares) | 11,989,796 | 11,986,927 |
Common stock, outstanding (in shares) | 11,872,573 | 11,869,704 |
Treasury stock, shares (in shares) | 117,223 | 117,223 |
Statements of Stockholders' Equity - USD ($) |
Common Stock [Member] |
Treasury Stock [Member] |
Warrants [Member] |
Additional Paid-in Capital [Member] |
Accumulated Deficit [Member] |
Total |
---|---|---|---|---|---|---|
Balance at Dec. 31, 2021 | $ 11,921 | $ (60,000) | $ 702,492 | $ 108,418,304 | $ (82,740,335) | $ 26,332,382 |
Balance (in shares) at Dec. 31, 2021 | 11,921,388 | 117,223 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 44,359 | 0 | 44,359 |
Net loss | 0 | 0 | 0 | 0 | (2,883,030) | (2,883,030) |
Balance at Mar. 31, 2022 | $ 11,921 | $ (60,000) | 702,492 | 108,462,663 | (85,623,365) | 23,493,711 |
Balance (in shares) at Mar. 31, 2022 | 11,921,388 | 117,223 | ||||
Balance at Dec. 31, 2022 | $ 11,987 | $ (60,000) | 567,972 | 108,857,065 | (94,134,505) | 15,242,519 |
Balance (in shares) at Dec. 31, 2022 | 11,986,927 | 117,223 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock in connection with At-The-Market offering, net of issuance costs | $ 3 | $ 0 | 0 | 3,365 | 0 | 3,368 |
Issuance of common stock in connection with At-The-Market offering, net of issuance costs (in shares) | 2,869 | 0 | ||||
Share-based compensation expense | $ 0 | $ 0 | 0 | 56,954 | 0 | 56,954 |
Net loss | 0 | 0 | 0 | 0 | (2,946,257) | (2,946,257) |
Balance at Mar. 31, 2023 | $ 11,990 | $ (60,000) | $ 567,972 | $ 108,917,384 | $ (97,080,762) | $ 12,356,584 |
Balance (in shares) at Mar. 31, 2023 | 11,989,796 | 117,223 |
Organization, Nature of Business, and Liquidity |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Organization, Nature of Business, and Liquidity [Abstract] | |||
Organization, Nature of Business, and Liquidity |
Organization and Nature of Business
Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19,
2004 and is headquartered in Suwanee, Georgia. The Company is a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely
underserved areas. The Company’s mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics. The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility
issues.
Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product
initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemBloc® (FemBloc), the Company’s solution for
permanent birth control, is based on the Company’s non-surgical platform technology and we recently completed a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and plan to
use the study data to support which of the two confirmation tests (ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc. Results of the small study along with the trial
design for the pivotal clinical trial was submitted to the FDA in the first quarter of 2023. FemaSeed® (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provides a
lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical study was initiated in July 2021. An updated study design received approval in October 2022 from the FDA. FemaSeed is
approved for sale in Canada. FemVue® (FemVue), a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S.,
Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the
endocervical canal as an alternative to the single biopsy method, and is approved for sale in the U.S. FemCath™ (FemCath), allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter
that is undirected, is approved for sale in the U.S.
Basis of Presentation
The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain
information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to
these rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2022 included in our Annual Report on Form 10K filed
with the SEC on March 30, 2023 (the Annual Report). ,There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report.
In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly
the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year.
Use of Estimates
The preparation of financial statements in
conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment and intangible assets.. Estimates
for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates.
Liquidity
As of March 31, 2023, the Company had cash and cash equivalents of $10,161,338. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt
financing arrangements, and revenue primarily from the sale of FemVue to support the Company’s research and development activities, largely in connection with FemBloc and FemaSeed. There can be no assurance that the Company will be able to obtain
additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could
be materially adversely impacted.
For the three months ended March 31, 2023, the Company generated a net loss of $2,946,257. The Company expects such losses to increase over the next few years as the Company advances FemBloc and FemaSeed through clinical development
until FDA approval is received and the products are available to be marketed.
The financial statements have been prepared on a going-concern
basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of March 31,
2023 of $97,080,762 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The
Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions (see Note 12). Although management expects the Company will continue as a going concern,
there is no assurance that management’s plans will be successful since the availability and amount of such funding is not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one
year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that
may result from the possible inability of the Company to continue as a going concern.
Recently Issued Accounting Pronouncements – Recently Adopted
On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the
Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, that are not measured
at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur
over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions.
The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this
new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited).
Recently Issued Accounting Pronouncements – Not Yet Adopted
No other new accounting pronouncement issued or effective has had, or is expected to have, a material
impact on the Company’s financial statements.
|
Cash and Cash Equivalents |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Cash and Cash Equivalents [Abstract] | |||
Cash and Cash Equivalents |
As of March 31, 2023 and December 31, 2022,
money market funds included in cash and cash equivalents on the balance sheets were $60,805 and $12,553,557, respectively, which represent level 1 within the fair value hierarchy where there are quoted prices in active markets for identical assets.
|
Inventories |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories |
Inventory stated at cost,
net of reserve, consisted of the following:
The FemVue reserve for slow moving, obsolete, or unusable inventories was $2,380 and $2,103 as of March 31, 2023 and December 31, 2022, respectively.
|
Accrued Expenses |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses |
Accrued expenses consisted of the following:
|
Clinical Holdback |
3 Months Ended | ||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||||
Clinical Holdback [Abstract] | |||||||||||||||||||||||||||||||||
Clinical Holdback |
The following table shows the activity
within the clinical holdback liability accounts for the three months ended March 31, 2023:
|
Revenue Recognition |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition |
Revenue is recognized upon shipment of
our goods based upon contractually stated pricing at standard payment terms ranging from 30 to 60 days. All revenue is recognized point in time and no revenue is recognized over time. For the three months ended March 31, 2023 and 2022, there
was no revenue recognized from performance obligations satisfied or partially satisfied in prior periods, nor were there any
unsatisfied performance obligations as of March 31, 2023 or 2022.
The majority of products sold directly
to U.S customers are shipped via common carrier, and the customer pays for shipping and handling and assumes control Free on Board (FOB) shipping point. Products shipped to our international distributors are in accordance with their respective
agreements; however, the shipping terms are generally EX-Works, reflecting that control is assumed by the distributor at the shipping point. Returns are only accepted with prior authorization from the Company. Items to be returned must be in
original unopened cartons and are subject to a 30% restocking fee. Throughout the periods presented, the Company has not had a
history of significant returns.
The following table summarizes our
sales, primarily from FemVue, by geographic region as follows:
|
Commitments and Contingencies |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Commitments and Contingencies [Abstract] | |||
Commitments and Contingencies |
Legal Claims
Occasionally, the Company may be a party to legal claims or
proceedings of which the outcomes are subject to significant uncertainty. In accordance with Accounting Standards Codification (ASC) 450, Contingencies, the Company will assess the
likelihood of an adverse judgment for any outstanding claim as well as ranges of probable losses. When it has been determined that a loss is probable and the amount can be reasonably estimated, the Company will record a liability. For both periods
presented, there were no material legal contingencies requiring accrual or disclosure.
The Company, as permitted under Delaware law and in accordance
with its bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The Company entered into employment
agreements with its officers, which provides for indemnification protection in the executive’s capacity as an officer for actions taken within the scope of employment. The maximum amount of potential future indemnification is unlimited; however, the
Company has obtained director and officer insurance that limits its exposure. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these
obligations as of March 31, 2023 and December 31, 2022.
|
Notes Payable |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Notes Payable [Abstract] | |||
Notes Payable |
AFCO
Credit Corporation (AFCO)
As of March 31, 2023 and December 31, 2022, the principal balance
on the remaining AFCO promissory note was $0 and $141,298, respectively and is included in Notes payable in the accompanying balance sheets. Interest expense in connection with the AFCO promissory notes was $1,319 and $1,796 for the three months ended March 31, 2023 and
2022, respectively.
|
Stockholders' Equity |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Stockholders' Equity [Abstract] | |||
Stockholders' Equity |
In July 2022, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Piper Sandler & Co. (“Piper Sandler”
or the “Sales Agent”) and filed a related Prospectus establishing an “at-the-market” facility, pursuant to which the Company may offer and sell shares of common stock having an aggregate offering price of up to $8,800,000 from time to time through the Sales Agent pursuant to the Prospectus. For the three months ended March 31, 2023, 2,869 shares of common stock were sold under the Equity Distribution Agreement.
As of March 31, 2023, the Company had 11,872,573 shares of common stock outstanding, and no
dividends have been declared or paid.
|
Equity Incentive Plans |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans |
Stock-Based Awards
Activity under the Company’s stock option plans for the three
months ended March 31, 2023 was as follows:
The 5,000 options granted under our 2021 Stock Option Plan for the three months ended March 31, 2023 was to a nonemployee with a fair value of $0.62
using the Black-Scholes assumptions as follows:
No options were
exercised for the three months ended March 31, 2023 under our stock option plans.
As of March 31, 2023, the total number of shares of common stock reserved for future awards under the 2021 Stock Option Plan was 1,754,980.
For the three months ended March 31, 2023, no inducement awards were granted. As of March 31, 2023, 150,000
shares were outstanding with a weighted average exercise price of $2.42, and 25,000 shares were vested and exercisable with a weighted average exercise price of $2.97.
The following table shows the share-based compensation expense related to vested
stock option grants to employees and nonemployees by financial statement line item on the accompanying statement of comprehensive loss:
As March 31, 2023, the remaining share-based compensation expense that is expected to be recognized in future periods for employees and nonemployees is
$926,280, which includes $463,311
of compensation expense to be recognized upon achieving certain performance conditions. For service-based awards, the $462,969 of
unrecognized expense is expected to be recognized over a weighted average period of 2.7 years.
For the three months ended March 31, 2023, no shares have been issued under the Company’s ESPP Plan. As of March 31, 2023, the total number of shares of common stock reserved for future awards
under the ESPP Plan was 398,561.
|
Net Loss per Share Attributable to Common Stockholders |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss per Share Attributable to Common Stockholders |
The following table sets forth the
computation of the basic and diluted net loss per share:
The following potentially dilutive securities have been excluded from the computations of diluted weighted
average shares outstanding because they would be anti-dilutive:
|
Subsequent Events |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 | |||
Subsequent Events [Abstract] | |||
Subsequent Events |
Effective April 18, 2023, the Company
suspended its “at-the-market” facility with the Sales Agent pursuant to that certain prospectus supplement dated July 12, 2022 and Equity Distribution Agreement, dated July 1, 2022 and terminated the continuous offering under such prospectus. The
Company will not make any sales of its Common Stock pursuant to the Equity Distribution Agreement unless and until a new prospectus supplement is filed with the Securities and Exchange Commission; however, the Equity Distribution Agreement
remains in full force and effect.
On April 18, 2023, the Company entered into a definitive agreement for the issuance and sale of an aggregate of 3,196,722 of its shares of common stock (or common stock equivalents) at a purchase price of $1.22 per share (or common stock equivalent) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 3,196,722 shares of common stock. The gross proceeds from this offering was $3,900,000. The net proceeds to the Company from this offering was approximately $3,400,000, after deducing placement agent fees expenses and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The offering closed on April 20, 2023. |
Organization, Nature of Business, and Liquidity (Policies) |
3 Months Ended |
---|---|
Mar. 31, 2023 | |
Organization, Nature of Business, and Liquidity [Abstract] | |
Organization and Nature of Business |
Organization and Nature of Business
Femasys Inc. (the Company or Femasys) was incorporated in Delaware on February 19,
2004 and is headquartered in Suwanee, Georgia. The Company is a biomedical company focused on transforming women’s healthcare by developing novel solutions and next-generation advancements providing significant clinical impact to address severely
underserved areas. The Company’s mission is to provide women with superior minimally-invasive, non-surgical product technologies, accessible in the office, improving patient care and overall health economics. The Company currently operates as one segment with an initial focus on servicing the reproductive health needs for those seeking permanent birth control or solutions for infertility
issues.
Femasys has an expansive intellectual property portfolio which covers both design and utility patents in the U.S. and significant ex-U.S. markets for each product
initiative. Femasys has taken concepts internally conceived and protected through development, including domestic and foreign regulatory approvals, and production, through in-house manufacturing. FemBloc® (FemBloc), the Company’s solution for
permanent birth control, is based on the Company’s non-surgical platform technology and we recently completed a validation study under an approved Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) and plan to
use the study data to support which of the two confirmation tests (ultrasound or radiology) should be studied in a new pivotal trial to support a potential future application for PMA for FemBloc. Results of the small study along with the trial
design for the pivotal clinical trial was submitted to the FDA in the first quarter of 2023. FemaSeed® (FemaSeed), a solution which enables directed intrauterine insemination to improve on traditional intrauterine insemination (IUI) and provides a
lower cost option to in vitro fertilization methods, received approval in April 2021 from the FDA on its IDE and the clinical study was initiated in July 2021. An updated study design received approval in October 2022 from the FDA. FemaSeed is
approved for sale in Canada. FemVue® (FemVue), a solution that enables fallopian tube assessment with ultrasound as an alternative to the radiologic approach (hysterosalpingogram) for the diagnosis of infertility, is approved for sale in the U.S.,
Japan, and Canada. FemChec® (FemChec), allows for fallopian tube evaluation after a FemBloc procedure to confirm occlusion (or procedure success). FemCerv® (FemCerv) is a solution for complete tissue sampling with minimal contamination of the
endocervical canal as an alternative to the single biopsy method, and is approved for sale in the U.S. FemCath™ (FemCath), allows for selective evaluation of an individual fallopian tube as an alternative to the traditional intrauterine catheter
that is undirected, is approved for sale in the U.S.
|
Basis of Presentation |
Basis of Presentation
The Company has prepared the accompanying financial statements pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC). Certain
information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) have been condensed or omitted pursuant to
these rules and regulations. These financial statements should be read in conjunction with the Company’s audited financial statements and footnotes related thereto for the year ended December 31, 2022 included in our Annual Report on Form 10K filed
with the SEC on March 30, 2023 (the Annual Report). ,There have been no material changes to the Company’s significant accounting policies described in Note 2 to the financial statements included in the Annual Report.
In the opinion of management, the unaudited financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly
the Company’s financial position and the results of its operations and cash flows at the dates for periods presented. The results of operations for such interim periods are not necessarily indicative of the results to be expected for the full year.
|
Use of Estimates |
Use of Estimates
The preparation of financial statements in
conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used in these financial statements include the valuation of stock options, warrants, useful lives of property and equipment and intangible assets.. Estimates
for these and other items are subject to change and are reassessed by management in accordance with U.S. GAAP. Actual results could differ from those estimates.
|
Liquidity |
Liquidity
As of March 31, 2023, the Company had cash and cash equivalents of $10,161,338. The Company plans to finance its operations and development needs with its existing cash and cash equivalents, additional equity and/or debt
financing arrangements, and revenue primarily from the sale of FemVue to support the Company’s research and development activities, largely in connection with FemBloc and FemaSeed. There can be no assurance that the Company will be able to obtain
additional financing on terms acceptable to the Company, on a timely basis, or at all. If the Company is not able to obtain sufficient funds on acceptable terms when needed, the Company’s business, results of operations, and financial condition could
be materially adversely impacted.
For the three months ended March 31, 2023, the Company generated a net loss of $2,946,257. The Company expects such losses to increase over the next few years as the Company advances FemBloc and FemaSeed through clinical development
until FDA approval is received and the products are available to be marketed.
The financial statements have been prepared on a going-concern
basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of March 31,
2023 of $97,080,762 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The
Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions (see Note 12). Although management expects the Company will continue as a going concern,
there is no assurance that management’s plans will be successful since the availability and amount of such funding is not certain. Accordingly, substantial doubt exists about the Company’s ability to continue as a going concern for at least one
year from the issuance of these financial statements. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability of assets or the amounts and classifications of liabilities that
may result from the possible inability of the Company to continue as a going concern.
|
Recently Issued Accounting Pronouncements Adopted and Not Yet Adopted |
Recently Issued Accounting Pronouncements – Recently Adopted
On January 1, 2023, the Company adopted Accounting Standards Update (ASU) 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the
Financial Accounting Standards Board (FASB) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets, that are not measured
at fair value through net income. Under legacy standards, we recognize an impairment of receivables when it was probable that a loss had been incurred. Under the new standard, we are required to recognize estimated credit losses expected to occur
over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions.
The guidance is effective for smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this
new guidance did not have a material impact on the Company’s financial statements and footnote disclosures (unaudited).
Recently Issued Accounting Pronouncements – Not Yet Adopted
No other new accounting pronouncement issued or effective has had, or is expected to have, a material
impact on the Company’s financial statements.
|
Inventories (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Stated at Cost, Net of Reserve |
Inventory stated at cost,
net of reserve, consisted of the following:
|
Accrued Expenses (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Expenses |
Accrued expenses consisted of the following:
|
Clinical Holdback (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||
Clinical Holdback [Abstract] | |||||||||||||||||||||||||||||||
Clinical Holdback Liability |
The following table shows the activity
within the clinical holdback liability accounts for the three months ended March 31, 2023:
|
Revenue Recognition (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||
Revenue Recognition [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Sales by Geographic Region |
The following table summarizes our
sales, primarily from FemVue, by geographic region as follows:
|
Equity Incentive Plans (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity Incentive Plans [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Option Plan Activity |
Activity under the Company’s stock option plans for the three
months ended March 31, 2023 was as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Using Assumptions |
The 5,000 options granted under our 2021 Stock Option Plan for the three months ended March 31, 2023 was to a nonemployee with a fair value of $0.62
using the Black-Scholes assumptions as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Compensation Expense |
The following table shows the share-based compensation expense related to vested
stock option grants to employees and nonemployees by financial statement line item on the accompanying statement of comprehensive loss:
|
Net Loss per Share Attributable to Common Stockholders (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss per Share Attributable to Common Stockholders [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computation of Basic and Diluted Net Loss Per Share |
The following table sets forth the
computation of the basic and diluted net loss per share:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computations of Diluted Weighted Average Shares Outstanding |
The following potentially dilutive securities have been excluded from the computations of diluted weighted
average shares outstanding because they would be anti-dilutive:
|
Organization, Nature of Business, and Liquidity (Details) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023
USD ($)
Segment
|
Mar. 31, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
|
Organization and Nature of Business [Abstract] | |||
Number of operating segments | Segment | 1 | ||
Liquidity [Abstract] | |||
Cash and cash equivalents | $ 10,161,338 | $ 12,961,936 | |
Net loss | (2,946,257) | $ (2,883,030) | |
Accumulated deficit | $ (97,080,762) | $ (94,134,505) |
Cash and Cash Equivalents (Details) - USD ($) |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Level 1 [Member] | Money Market Funds [Member] | ||
Assets, Fair Value Disclosure [Abstract] | ||
Cash and cash equivalent | $ 60,805 | $ 12,553,557 |
Inventories (Details) - USD ($) |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Inventories [Abstract] | ||
Materials | $ 283,655 | $ 244,498 |
Work in progress | 98,775 | 100,453 |
Finished goods | 118,311 | 91,772 |
Inventory, net | 500,741 | 436,723 |
Reserve for expired inventory | $ 2,380 | $ 2,103 |
Accrued Expenses (Details) - USD ($) |
Mar. 31, 2023 |
Dec. 31, 2022 |
---|---|---|
Accrued Expenses [Abstract] | ||
Clinical trail costs | $ 315,428 | $ 333,440 |
Compensation costs | 111,457 | 85,191 |
Franchise taxes | 7,100 | 26,886 |
Other | 101,432 | 11,197 |
Accrued expenses | $ 535,417 | $ 456,714 |
Clinical Holdback (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
|
Clinical Holdback Liability [Roll Forward] | ||
Balance | $ 141,864 | |
Clinical holdback retained | 2,634 | |
Clinical holdback paid | (328) | |
Balance | 144,170 | |
Less: clinical holdback - current portion | (45,352) | $ (45,206) |
Clinical holdback - long-term portion | $ 98,818 | $ 96,658 |
Revenue Recognition (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Revenue Recognition [Abstract] | ||
Revenue recognized from performance obligations in prior periods | $ 0 | $ 0 |
Percentage of restocking fee | 30.00% | |
Primary Geographical Markets [Abstract] | ||
Sales | $ 293,984 | 321,405 |
FemVue [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 293,984 | 321,405 |
FemVue [Member] | U.S. [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | 293,984 | 263,360 |
FemVue [Member] | International [Member] | ||
Primary Geographical Markets [Abstract] | ||
Sales | $ 0 | $ 58,045 |
Minimum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 30 days | |
Maximum [Member] | ||
Revenue Recognition [Abstract] | ||
Revenue recognition payment period term | 60 days |
Notes Payable (Details) - USD ($) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2022 |
|
Notes Payable [Abstract] | |||
Note payable | $ 0 | $ 141,298 | |
Promissory Notes [Member] | AFCO Credit Corporation [Member] | |||
Notes Payable [Abstract] | |||
Note payable | 0 | $ 141,298 | |
Interest expense on loan | $ 1,319 | $ 1,796 |
Stockholders' Equity (Details) - USD ($) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2023 |
Dec. 31, 2022 |
Jul. 12, 2022 |
|
Stockholders Equity [Abstract] | |||
Common stock, outstanding (in shares) | 11,872,573 | 11,869,704 | |
Dividends declared or paid | $ 0 | ||
Common Stock [Member] | |||
Stockholders Equity [Abstract] | |||
Authorized offering amount of securities | $ 8,800,000 | ||
Common stock sold (in shares) | 2,869 |
Equity Incentive Plans, Inducement Grant (Details) - Inducement Grant [Member] |
3 Months Ended |
---|---|
Mar. 31, 2023
$ / shares
shares
| |
Inducement Grant [Abstract] | |
Granted (in shares) | 0 |
Shares outstanding (in shares) | 150,000 |
Weighted average exercise price (in dollars per share) | $ / shares | $ 2.42 |
Options vested and exercisable, Number of option vested (in shares) | 25,000 |
Options vested and exercisable, Weighted average exercise price (in dollars per shares) | $ / shares | $ 2.97 |
Equity Incentive Plans, Share-Based Compensation Expense (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 56,954 | $ 44,359 |
Share-based compensation expense expected to be recognized for employees and nonemployees | 926,280 | |
Compensation expense to be recognized upon achieving certain performance condition | 463,311 | |
Unrecognized expenses | $ 462,969 | |
Weighted-average period over which unrecognized compensation is expected to be recognized | 2 years 8 months 12 days | |
Research and Development [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 25,059 | 29,139 |
Sales and Marketing [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | (2,544) | 1,126 |
General and Administrative [Member] | ||
Share-based Compensation Expense [Abstract] | ||
Share-based compensation expense | $ 34,439 | $ 14,094 |
Equity Incentive Plans, Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan [Member] |
3 Months Ended |
---|---|
Mar. 31, 2023
shares
| |
Employee Stock Purchase Plan [Abstract] | |
Stock issued (in shares) | 0 |
Common stock reserved for issuance (in shares) | 398,561 |
Subsequent Events (Details) - Subsequent Event [Member] |
Apr. 18, 2023
USD ($)
$ / shares
shares
|
---|---|
Issuance Sale of Common Stock [Abstract] | |
Issuance and sale of common stock (in shares) | shares | 3,196,722 |
Purchase price (in dollars per share) | $ / shares | $ 1.22 |
Warrants issued to purchase common stock (in shares) | shares | 3,196,722 |
Gross proceeds from offering | $ | $ 3,900,000 |
Net proceeds from offering | $ | $ 3,400,000 |
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