|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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||
(Exact Name of Registrant as Specified in its Charter)
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|
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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|
|
||
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(
|
|
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
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Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company |
|
Emerging growth company |
Title of each class
|
Trading symbol
|
Name of each exchange on which
registered
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|||
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The
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TABLE OF CONENTS
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Page
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Part I. Financial Information
|
||
Item 1
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5
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5
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||
7
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||
8
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||
10
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||
11
|
||
Item 2
|
17
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Item 3
|
22
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Item 4
|
22
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Part II. Other Information
|
||
Item 1
|
23
|
|
Item 1A
|
23
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Item 2
|
23
|
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Item 3
|
24
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Item 4
|
24
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Item 5
|
24
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Item 6
|
24
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25
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• |
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;
|
• |
our ability to maintain compliance with Nasdaq’s continued listing requirements; and
|
• |
our expectations about market trends.
|
ITEM I. |
Financial Statements
|
Assets
|
June 30,
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 |
June 30,
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 June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2023
|
2022
|
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 JUNE 30, 2023
|
||||||||||||||||||||||||||||||||
Balance at March 31, 2023
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Issuance of common stock and warrants in connection with April 2023 Financing, net of issuance costs
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Issuance of common stock in connection with ESPP
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Exercise of pre-funded warrants
|
|
|
|
|
(
|
)
|
|
|
|
|||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||
Balance at June 30, 2023
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
|
||||||||||||||||||||||||||||||||
SIX MONTHS ENDED JUNE 30, 2023
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
|
||||||||||||||||||||||||||||||||
Issuance of common stock and warrants in connection with April 2023 Financing, net of issuance costs
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Issuance of common stock in connection with at-the-market offering, net of issuance costs
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Issuance of common stock in connection with ESPP
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Exercise of pre-funded warrants
|
|
|
|
|
(
|
)
|
|
|
|
|||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Balance at June 30, 2023
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Total | ||||||||||||||||||||||||||||||||
Common stock
|
Treasury stock
|
Additional | Accumulated | stockholders’ | ||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Warrants
|
paid-in capital
|
deficit
|
Equity
|
|||||||||||||||||||||||||
THREE MONTHS ENDED JUNE 30, 2022
|
||||||||||||||||||||||||||||||||
Balance at March 31, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Expiration of warrant
|
(
|
)
|
|
|
||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of options
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Balance at June 30, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
SIX MONTHS ENDED JUNE 30, 2022
|
||||||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||||||||
Expiration of warrant
|
(
|
)
|
|
|
||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of options
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Share-based compensation expense
|
—
|
|
—
|
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
—
|
|
—
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Balance at June 30, 2022
|
|
$
|
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Six Months Ended June 30,
|
||||||||
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
|
||||||||
Loss on disposal of assets
|
||||||||
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 the issuance of common stock, accompanying warrants and pre-funded warrants in April 2023 Financing
|
||||||||
Equity issuance costs
|
( |
) | ||||||
Proceeds from exercise of pre-funded warrants
|
||||||||
Proceeds from common stock issued through ESPP and exercised options
|
||||||||
Net proceeds from issuance of common stock in connection with at-the-market sales agreement
|
||||||||
Payments of deferred offering costs
|
( |
) | ||||||
Repayment of note payable
|
(
|
)
|
(
|
)
|
||||
Payments under lease obligations
|
(
|
)
|
(
|
)
|
||||
Net cash provided by (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: | ||||||||
Deferred offering costs included in accounts payable and accrued expenses
|
$ |
|||||||
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
|
June 30, | December 31, | |||||||
2023
|
2022 |
|||||||
Materials
|
$
|
|
|
|||||
Work in progress
|
|
|
||||||
Finished goods
|
|
|
||||||
Inventory, net
|
$
|
|
|
(4)
|
Accrued Expenses
|
June 30, | December 31, | |||||||
2023 |
2022 |
|||||||
Clinical trial costs
|
$
|
|
|
|||||
Compensation costs
|
|
|
||||||
Franchise taxes |
||||||||
Director fees |
||||||||
Other
|
|
|
||||||
Accrued expenses
|
$
|
|
|
(5)
|
Clinical Holdback
|
Balance at December 31, 2022
|
$
|
|
||
Clinical holdback retained
|
|
|||
Clinical holdback paid
|
(
|
)
|
||
Balance at June 30, 2023
|
$
|
|
||
Less: clinical holdback - current portion
|
(
|
)
|
||
Clinical holdback - long-term portion
|
$
|
|
(6)
|
Revenue Recognition
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
Primary geographical markets |
2023
|
2022
|
2023
|
2022
|
||||||||||||
U.S.
|
$
|
|
|
|
|
|||||||||||
International
|
|
|
|
|
||||||||||||
Total
|
$
|
|
|
|
|
(7)
|
Commitments and Contingencies
|
(8)
|
Notes Payable
|
(9)
|
Stockholders’ Equity
|
(10)
|
Equity Incentive Plans and Warrants
|
(a) |
Stock Option Plans
|
Number of
options
|
Weighted
average
exercise
price
|
|||||||
Outstanding at December 31, 2022 | $ | |||||||
Granted | ||||||||
Forfeited | ( |
) | ||||||
Outstanding at March 31, 2023 | $ | |||||||
Granted
|
||||||||
Forfeited
|
( |
) | ||||||
Outstanding at June 30, 2023
|
$ |
|||||||
Vested and exercisable at June 30, 2023 | $ |
Employee |
Nonemployee | |||||||
Expected term (in years)
|
|
|||||||
Risk‑free interest rate
|
|
%
|
% | |||||
Dividend yield
|
|
%
|
% |
|||||
Expected volatility
|
|
%
|
% |
(b) |
Inducement Grants
|
(c) | Share-Based Compensation Expense |
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2023
|
2022
|
2023 | 2022 | |||||||||||||
Research and development
|
$
|
|
|
|||||||||||||
Sales and marketing
|
|
|
( |
) | ||||||||||||
General and administrative
|
|
|
||||||||||||||
Total share-based compensation expense
|
$
|
|
|
(d) |
Employee Stock Purchase Plan (ESPP)
|
(e) |
April 2023 Financing
|
Pre-funded
warrants
|
Common
warrants
|
|||||||
Expected term (in years)
|
|
|
||||||
Risk‑free interest rate
|
|
%
|
|
%
|
||||
Dividend yield
|
|
% |
|
% | ||||
Expected volatility
|
|
%
|
|
%
|
||||
Exercise price
|
$
|
|
$
|
|
||||
Stock price
|
$
|
|
$
|
|
||||
Black-Scholes value |
$ | $ |
(11)
|
Net Loss per Share Attributable to Common Stockholders
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2023
|
2022
|
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
|
$
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Options to purchase common stock
|
|
|
|
|
||||||||||||
Warrants to purchase common stock, in connection with April 2023 financing |
||||||||||||||||
Warrants to purchase 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 June 30,
|
Change
|
% Change
|
||||||||||||||
2023
|
2022
|
|||||||||||||||
Sales
|
$
|
320,514
|
303,113
|
17,401
|
5.7
|
%
|
||||||||||
Cost of sales
|
110,469
|
102,353
|
8,116
|
7.9
|
%
|
|||||||||||
Gross margin
|
210,045
|
200,760
|
9,285
|
4.6
|
%
|
|||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
1,527,172
|
1,472,924
|
54,248
|
3.7
|
%
|
|||||||||||
Sales and marketing
|
128,899
|
63,177
|
65,722
|
104.0
|
%
|
|||||||||||
General and administrative
|
1,356,637
|
1,181,938
|
174,699
|
14.8
|
%
|
|||||||||||
Depreciation and amortization
|
133,299
|
142,684
|
(9,385
|
)
|
-6.6
|
%
|
||||||||||
Total operating expenses
|
3,146,007
|
2,860,723
|
285,284
|
10.0
|
%
|
|||||||||||
Loss from operations
|
(2,935,962
|
)
|
(2,659,963
|
)
|
(275,999
|
)
|
10.4
|
%
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
42,652
|
26,745
|
15,907
|
59.5
|
%
|
|||||||||||
Interest expense
|
(198
|
)
|
(883
|
)
|
685
|
-77.6
|
%
|
|||||||||
Other income (expense), net
|
42,454
|
25,862
|
16,592
|
64.2
|
%
|
|||||||||||
Net loss
|
$
|
(2,893,508
|
)
|
(2,634,101
|
)
|
(259,407
|
)
|
9.8
|
%
|
Three Months Ended June 30,
|
||||||||
2023
|
2022
|
|||||||
Compensation and related personnel costs
|
$
|
840,506
|
790,292
|
|||||
Clinical-related costs
|
361,578
|
377,058
|
||||||
Material and development costs
|
205,095
|
175,527
|
||||||
Professional and outside consultant costs
|
120,527
|
116,692
|
||||||
Other costs
|
(534
|
)
|
13,355
|
|||||
Total research and development expenses
|
$
|
1,527,172
|
1,472,924
|
Six Months Ended June 30,
|
Change
|
% Change
|
||||||||||||||
2023
|
2022
|
|||||||||||||||
Sales
|
$
|
614,498
|
624,518
|
(10,020
|
)
|
-1.6
|
%
|
|||||||||
Cost of sales
|
215,589
|
225,028
|
(9,439
|
)
|
-4.2
|
%
|
||||||||||
Gross margin
|
398,909
|
399,490
|
(581
|
)
|
-0.1
|
%
|
||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
3,064,611
|
2,893,987
|
170,624
|
5.9
|
%
|
|||||||||||
Sales and marketing
|
373,795
|
132,040
|
241,755
|
183.1
|
%
|
|||||||||||
General and administrative
|
2,671,774
|
2,629,293
|
42,481
|
1.6
|
%
|
|||||||||||
Depreciation and amortization
|
266,365
|
286,883
|
(20,518
|
)
|
-7.2
|
%
|
||||||||||
Total operating expenses
|
6,376,545
|
5,942,203
|
434,342
|
7.3
|
%
|
|||||||||||
Loss from operations
|
(5,977,636
|
)
|
(5,542,713
|
)
|
(434,923
|
)
|
7.8
|
%
|
||||||||
Other income (expense):
|
||||||||||||||||
Interest income
|
139,741
|
29,199
|
110,542
|
378.6
|
%
|
|||||||||||
Interest expense
|
(1,870
|
)
|
(3,617
|
)
|
1,747
|
-48.3
|
%
|
|||||||||
Other income (expense), net
|
137,871
|
25,582
|
112,289
|
438.9
|
%
|
|||||||||||
Net loss
|
$
|
(5,839,765
|
)
|
(5,517,131
|
)
|
(322,634
|
)
|
5.8
|
%
|
Six Months Ended June 30,
|
||||||||
2023
|
2022
|
|||||||
Compensation and related personnel costs
|
$
|
1,740,794
|
1,555,084
|
|||||
Clinical-related costs
|
727,938
|
821,028
|
||||||
Material and development costs
|
372,256
|
306,977
|
||||||
Professional and outside consultant costs
|
212,462
|
185,356
|
||||||
Other costs
|
11,161
|
25,542
|
||||||
Total research and development expenses
|
$
|
3,064,611
|
2,893,987
|
Six Months Ended June 30,
|
||||||||
2023
|
2022
|
|||||||
Net cash used in operating activities
|
$
|
(5,388,824
|
)
|
(5,133,896
|
)
|
|||
Net cash used in investing activities
|
(71,849
|
)
|
(295,058
|
)
|
||||
Net cash provided by (used in) financing activities
|
3,203,754
|
(237,656
|
)
|
|||||
Net change in cash and cash equivalents
|
$
|
(2,256,919
|
)
|
(5,666,610
|
)
|
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, Use of Proceeds, and Issuer Purchases of Equity Securities
|
Item 3. |
Defaults Upon Senior Securities
|
Item 4. |
Mine Safety Disclosures
|
Item 5. |
Other Information
|
Item 6. |
Exhibits
|
Exhibit |
|
Incorporated by Reference
|
||||
File
|
||||||
Number |
Description of Document
|
Schedule/Form
|
Number
|
Exhibit
|
Filing Date
|
|
4.1 |
Pre-Funded Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.1
|
April 20, 2023
|
|
4.2 |
Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.2
|
April 20, 2023
|
|
4.3 |
Placement Agent Common Stock Purchase Warrant
|
Form 8-K
|
001-40492
|
4.3
|
April 20, 2023
|
|
10.1 |
Securities Purchase Agreement dated April 18, 2023, between Femasys Inc. and the Purchaser
|
Form 8-K
|
001-40492
|
10.1
|
April 20, 2023
|
|
31.1* |
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
|
|||||
31.2* |
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
|
|||||
32.1* |
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
|
|||||
32.2* |
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: August 10, 2023
|
By:
|
/s/ Kathy Lee-Sepsick
|
|
Kathy Lee-Sepsick
|
|||
Chief Executive Officer and President
|
|||
By:
|
/s/ Dov Elefant
|
||
Dov Elefant
Chief Financial Officer
(principal financial and accounting officer)
|