UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): August 10, 2023
 
Femasys Inc.
(Exact name of registrant as specified in its charter)

Delaware
001-40492
11-3713499
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100
Suwanee, Georgia
 
30024
(Address of principal executive offices)
 
(Zip Code)
 
(770) 500-3910
(Registrant’s telephone number, including area code)
 
n/a
(Former name or former address, if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
Common Stock, par value $0.001 per share
 
FEMY
 
The Nasdaq Stock Market LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
 
Emerging growth company
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.



Item 2.02
Results of Operations and Financial Condition.
 
On August 10, 2023, Femasys Inc. (the “Company”) announced its financial results for the second quarter ended June 30, 2023 and provided a corporate update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 5.02.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On August 10, 2023, the Company announced that it has designated Daniel Currie, the Company’s Senior Vice President, as its Chief Operating Officer. Mr. Currie, 59, has served as Senior Vice President, Operations since 2009, and Vice President, Operations since 2004. Mr. Currie has over 30 years of operational experience in the medical device industry, including assignments at early stage and large established companies. He worked closely with research and development teams, implemented and managed quality systems, spearheaded compliance and complaint handling systems at CIBA Vision Corporation. As head of Quality at Novoste Corporation, he oversaw and was directly involved in design and manufacturing controls, quality auditing (including FDA), evaluating and managing subcontractor operations, managing validation systems and performing product evaluations and testing. In addition, Mr. Currie was responsible for evaluating facilities outside the United States capable of manufacturing class III medical devices. Once the site was selected, Mr. Currie co-managed a team to establish full manufacturing operations. Mr. Currie is a graduate of Georgia Southern University with a BBA in Economics.

Mr. Currie has no family relationships with any of the Company’s directors or executive officers, and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K promulgated under the Securities Exchange Act of 1934, as amended.  As Chief Operating Officer, Mr. Currie  will receive an annual base salary of $389,000 (retroactive to January 1, 2023) and a target bonus percentage of 40% of his annual base salary upon the achievement of corporate goals.  Mr. Currie will also continue to participate in the Company’s equity incentive plan in accordance with the Company’s practices for senior executive generally.

Item 9.01
Financial Statements and Exhibits.
 
(d) Exhibits.

Exhibit
No.

Description
 


Press Release of Femasys Inc. dated August 10, 2023
104

Cover Page Interactive Data File (embedded within the Inline XBRL Document)


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Femasys Inc.




By:
/s/ Kathy Lee-Sepsick

Names: Kathy Lee-Sepsick

Title: Chief Executive Officer
 
Date: August 10, 2023
 



Exhibit 99.1

Femasys Inc. Announces Financial Results for the Second Quarter Ended
June 30, 2023 and Provides Corporate Update

- Patient enrollment has commenced in landmark pivotal trial for lead product candidate, FemBloc®
 
- Three product approvals achieved in Canada for FemaSeed®, FemCerv® and FemCath® products during the second quarter
 
- Raised $3.9 million in a registered direct offering
 
ATLANTA, August 10, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.
 
“The past quarter, we made significant, notable progress on all fronts to advance our synergistic programs in women’s health – from ushering forward the clinical development of our lead product candidates to broadening access to our complimentary diagnostic products by gaining additional commercial approvals,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We continue to successfully advance our lead product FemBloc for permanent birth control through the regulatory process with achievement of Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for the landmark pivotal trial. Thereafter, we were very pleased to announce the rapid initiation of enrollment in this trial, a very important milestone achieved for Femasys, brining us closer to making this much needed non-surgical alternative available to women.”
 
Ms. Lee-Sepsick, continued, “Of note this quarter, we received three new product approvals in Canada, including for FemaSeed, the first-ever, first-line approach designed to deliver sperm directly where conception occurs, broadening our commercial offerings, as we strive to bring safe, accessible novel options to women. We are exploring potential partnerships to maximize the value of our approved and available assets as we remain focused on prioritizing our use of capital on advancing our critical product candidates to ensure continued progress.”
 
Second Quarter 2023 and Recent Corporate Highlights:


In August, Femasys announced the initiation of enrollment in a prospective multi-center pivotal trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control (the “FINALE” trial), to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The robust trial is designed to address the high unmet need that exists for women seeking permanent birth control for whom elective surgery remains the only option. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants.



In July, Femasys announced that the United States Patent and Trademark Office (“USPTO”) issued a Notice of Allowance for U.S. Patent Application 16/402,193 further strengthening Femasys’ intellectual property position and coverage for the Company’s therapeutic product candidate, FemBloc permanent birth control. Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2039 at the earliest.


In June, Femasys announced the approval of an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in the FINALE pivotal clinical trial. This prospective, multi-center, open-label, single-arm study design includes pregnancy rate as the primary endpoint. FemBloc has the potential to offer women a convenient and reliable option for permanent birth control.


In June, Femasys announced the appointment of Mr. Keith J. Kendall, former CEO of drug delivery company Aquestive Therapeutics and Mr. Alistair Milnes, COO of biopharmeutical company Bicycle Therapeutics, to its board of directors. Messrs. Kendall and Milnes replaced Mr. John Dyett and Mr. John Adams, both of whom have served as members of Femasys’ board of directors for over eight years. Mr. Kendall also replaced Mr. Dyett as Audit Committee Chair.


In April, May and June, respectively, Femasys received three product approvals for FemaSeed®, FemCerv® and FemCath® from Health Canada, the Public Health Agency of Canada.


In April, Femasys raised $3.9 million in a registered direct offering priced at-the-market under Nasdaq rules. The offering closed on April 20, 2023. The proceeds from this offering will be used for working capital and general corporate purposes and is expected to extend Femasys’ cash runway into the second quarter of 2024.

Second Quarter 2023 Financial Results

Research & Development expenses increased by $54,248 to $1,527,172 for the three months ended June 30, 2023 compared to $1,472,924 for the same period in 2022. The increase relates primarily to increased compensation and related personnel, professional and outside consultant costs, mostly offset by reduced clinical-related costs.

General and administrative expenses increased by $174,699 to $1,356,637 for the three months ended June 30, 2023 compared to $1,181,938 for the same period in 2022. The increase was largely due to increased professional costs, compensation and related personnel costs, partially offset by decreased facility and overhead costs.


Sales increased by $17,401 to $320,514 for the three months ended June 30, 2023 compared to $303,113 for the same period in 2022. The $17,401 net increase was largely attributable to international sales of $58,045 for the three months ended June 30, 2023 as compared to no international sales for the same period last year. U.S. sales decreased by $40,644, or 13.4%, for the three months ended June 30, 2023 as compared to the same period last year. U.S. units sold decreased by 13.0% for the three months ended June 30, 2023 as compared to the same period last year.

Sales and marketing expenses increased by $65,722 to $128,899 for the three months ended June 30, 2023 compared to $63,177 for the same period in 2022. The increase is largely due to increased marketing costs to promote our commercial efforts.

Cost of sales increased by $8,116 to $110,469 for the three months ended June 30, 2023 compared to $102,353 for the same period in 2022 mainly due to the increase in international sales which have lower gross margin. Gross margin percentage was 65.5% for the three months ended June 30, 2023 as compared to 66.2% for the three months ended June 30, 2022.

Net loss was $2,893,508 or $0.22 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the three months ended June 30, 2023, compared to $2,634,101, or $0.22 per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2022.

Cash and cash equivalents as of June 30, 2023 and December 31, 2022, were $10,705,017 and $12,961,936, respectively. Based on our current operating plan, our existing cash and cash equivalents are expected to be sufficient to fund our ongoing operations into the second quarter of 2024.

Year to Date 2023 (Six-Month) Financial Results

Research & Development expenses increased by $170,624 to $3,064,611 for the six months ended June 30, 2023 from $2,893,987 for the same period in 2022. The increase of $170,624 relates primarily to increased compensation and related personnel, professional and outside consultant costs, partially offset by reduced clinical-related costs.
 
General and administrative expenses increased by $42,481 to $2,671,774 for the six months ended June 30, 2023 compared to $2,629,293 for the same period in 2022. The increase was largely due to increased professional costs, partially offset by a decrease in facility and other overhead and insurance costs.


Sales decreased by $10,020 to $614,498 for the six months ended June 30, 2023 compared to $624,518 for the six months for the same period in 2022. The $10,020 decrease is entirely attributable to U.S. sales for the six months ended June 30, 2023 as compared to the same period last year; international sales remained consistent with $58,045 for both the six month periods ended June 30, 2023 and 2022. U.S. units sold decreased by 3.6% for the six month periods ended June 30, 2023 as compared to the same period last year.

Sales and marketing expenses increased by $241,755 to $373,795 for the six months ended June 30, 2023 compared to $132,040 for the same period in 2022 largely due to increased compensation and related personnel costs and marketing costs to promote our commercial efforts.

Cost of sales decreased by $9,439 to $215,589 for the six months ended June 30, 2023 compared to $225,028 for the same period in 2022. The decrease is largely due to prior investment in equipment and tooling, resulting in reduced labor in certain manufacturing processes, and reduced material costs. Gross margin percentage was 64.9% for the six months ended June 30, 2023 as compared to 64.0% for the same period in 2022. Gross margins improved mainly due to manufacturing efficiencies.

Net loss was $5,839,765 or $0.47 per basic and diluted share attributable to common stockholders, primarily reflecting the factors noted above, for the six month period ended June 30, 2023, compared to $5,517,131, or $0.47 per basic and diluted share attributable to common stockholders, for the same period ended June 30, 2022.


FEMASYS INC.
Balance Sheets
(unaudited)

Assets
 
June 30,
2023
   
December 31,
2022
 
Current assets:
           
Cash and cash equivalents
 
$
10,705,017
     
12,961,936
 
Accounts receivable, net
   
155,746
     
77,470
 
Inventory, net
   
581,474
     
436,723
 
Other current assets
   
587,828
     
655,362
 
Total current assets
   
12,030,065
     
14,131,491
 
Property and equipment, at cost:
               
Leasehold improvements
   
1,195,637
     
1,195,637
 
Office equipment
   
99,344
     
99,344
 
Furniture and fixtures
   
419,303
     
419,303
 
Machinery and equipment
   
2,628,509
     
2,572,243
 
Construction in progress
   
384,888
     
413,843
 
 
   
4,727,681
     
4,700,370
 
Less accumulated depreciation
   
(3,472,349
)
   
(3,217,319
)
Net property and equipment
   
1,255,332
     
1,483,051
 
Long-term assets:
               
Lease right-of-use assets, net
   
162,006
     
319,557
 
Intangible assets, net of accumulated amortization
   
970
     
3,294
 
Other long-term assets
   
865,588
     
958,177
 
Total long-term assets
   
1,028,564
     
1,281,028
 
Total assets
 
$
14,313,961
     
16,895,570
 

(continued)


FEMASYS INC.
Balance Sheets
(unaudited)

Liabilities and Stockholders’ Equity
 
June 30,
2023
   
December 31,
2022
 
Current liabilities:
           
Accounts payable
 
$
546,877
     
510,758
 
Accrued expenses
   
536,830
     
456,714
 
Note payable
   
     
141,298
 
Clinical holdback - current portion
   
88,738
     
45,206
 
Lease liabilities – current portion
   
209,098
     
373,833
 
Total current liabilities
   
1,381,543
     
1,527,809
 
Long-term liabilities:
               
Clinical holdback - long-term portion
   
56,245
     
96,658
 
Lease liabilities – long-term portion
   
     
28,584
 
Total long-term liabilities
   
56,245
     
125,242
 
Total liabilities
   
1,437,788
     
1,653,051
 
Commitments and contingencies Stockholders’ equity:
               
Common stock, $.001 par, 200,000,000 authorized, 15,190,376 shares issued and 15,073,153 outstanding as of June 30, 2023; and 11,986,927 shares issued and 11,869,704 outstanding as of December 31, 2022
   
15,190
     
11,987
 
Treasury stock, 117,223 shares
   
(60,000
)
   
(60,000
)
Warrants
   
1,918,103
     
567,972
 
Additional paid-in-capital
   
110,977,150
     
108,857,065
 
Accumulated deficit
   
(99,974,270
)
   
(94,134,505
)
Total stockholders’ equity
   
12,876,173
     
15,242,519
 
Total liabilities and stockholders' equity
 
$
14,313,961
     
16,895,570
 


FEMASYS INC.
Statements of Comprehensive Loss
(unaudited)

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2023
   
2022
   
2023
   
2022
 
   
$
320,514
     
303,113
     
614,498
     
624,518
 
Sales
   
110,469
     
102,353
     
215,589
     
225,028
 
Cost of sales
   
210,045
     
200,760
     
398,909
     
399,490
 
Gross margin
                               
Operating expenses:
   
1,527,172
     
1,472,924
     
3,064,611
     
2,893,987
 
Research and development
   
128,899
     
63,177
     
373,795
     
132,040
 
Sales and marketing
   
1,356,637
     
1,181,938
     
2,671,774
     
2,629,293
 
General and administrative
   
133,299
     
142,684
     
266,365
     
286,883
 
Depreciation and amortization
   
3,146,007
     
2,860,723
     
6,376,545
     
5,942,203
 
Total operating expenses
   
(2,935,962
)
   
(2,659,963
)
   
(5,977,636
)
   
(5,542,713
)
Loss from operations
                               
Other income (expense):
                               
Interest income
   
42,652
     
26,745
     
139,741
     
29,199
 
Interest expense
   
(198
)
   
(883
)
   
(1,870
)
   
(3,617
)
Other income (expense), net
   
42,454
     
25,862
     
137,871
     
25,582
 
Net loss
 
$
(2,893,508
)
   
(2,634,101
)
   
(5,839,765
)
   
(5,517,131
)
                                 
Net loss attributable to common stockholders, basic and diluted
 
$
(2,893,508
)
   
(2,634,101
)
   
(5,839,765
)
   
(5,517,131
)
Net loss per share attributable to common stockholders, basic and diluted
 
$
(0.22
)
   
(0.22
)
   
(0.47
)
   
(0.47
)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted
   
13,107,590
     
11,812,988
     
12,493,334
     
11,808,601
 

About FemaSeed®
 
FemaSeed is a first-of-its-kind infertility solution in development for directional intrauterine insemination that delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization and provide a first-line treatment option for infertility. FemaSeed is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

About FemBloc®
 
FemBloc® is a first-of-its-kind, non-surgical, non-implant, in-office solution in late-stage clinical development for permanent birth control. It is intended to be a safer option for women and its cost is estimated to be substantially less than the long-standing surgical alternative by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer a convenient, accessible, and reliable option to women seeking permanent birth control. For over 100 years, there has been stagnant innovation in the area of permanent birth control; this could lead to a $20 billion market expansion opportunity for FemBloc in the U.S. alone. For more information, visit www.FemBloc.com.

About FemVue® FemVue is the first FDA-cleared product that creates natural saline and air contrast and enables safe, reliable, and real time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN’s office.
 

About FemCath®
 
FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with the FemVue device. The ultrasound-based diagnostic test is part of an infertility evaluation, which is essential prior to any infertility treatment, including with our other biomedical solution in development, FemaSeed.

About FemCerv®
 
FemCerv is the first FDA-cleared product that allows for the capture and protection of a comprehensive 360-degree endocervical tissue sample in a relatively pain-free office visit. FemCerv features an expandable collection chamber that is exposed during sampling and closed during removal for containment of cervical cells and tissue for diagnosis of cervical cancer.
 
About Femasys
 
Femasys Inc. is a biomedical company focused on meeting women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates in late-stage clinical development are FemBloc® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company has developed diagnostic products that complement these two lead product candidates for which it has achieved regulatory approvals to market in the U.S., Canada and other countries outside the U.S and are commercial ready with in-house manufacturing capabilities. The Company’s diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. FemaSeed, FemCerv, and FemCath have also received product approval in Canada. Learn more at www.femasys.com, or follow us on Twitter, Facebook and LinkedIn.
 

Forward-Looking Statements
 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts:
 
Investors
Chuck Padala
LifeSci Advisors, LLC
917-741-7792
chuck@lifesciadvisors.com

Femasys Inc.
Investor Contact:
IR@femasys.com

Media Contact:
Media@femasys.com



v3.23.2
Document and Entity Information
Aug. 10, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 10, 2023
Entity File Number 001-40492
Entity Registrant Name Femasys Inc.
Entity Central Index Key 0001339005
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 11-3713499
Entity Address, Address Line One 3950 Johns Creek Court
Entity Address, Address Line Two Suite 100
Entity Address, City or Town Suwanee
Entity Address, State or Province GA
Entity Address, Postal Zip Code 30024
City Area Code 770
Local Phone Number 500-3910
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol FEMY
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period true
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false

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