Form 8-K
8-K — FEMASYS INC
Accession: 0001140361-26-021081
Filed: 2026-05-13
Period: 2026-05-13
CIK: 0001339005
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — ef20073379_8k.htm (Primary)
EX-99.1 — EXHIBIT 99.1 (ef20073379_ex99-1.htm)
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8-K
8-K (Primary)
Filename: ef20073379_8k.htm · Sequence: 1
false0001339005NASDAQ00013390052026-05-132026-05-13
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): May 13, 2026
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 7.01
Regulation FD Disclosure Other Events
On May 13, 2026, Femasys Inc. (the “Company”) posted on its website an updated slide presentation, which is attached as Exhibit 99.1 to this Current Report on Form 8-K
and incorporated by reference herein. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time.
The information furnished in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as may be expressly set
forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the corporate presentation.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No.
Description
99.1
Press Release of Femasys Inc. dated May 13, 2026
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: May 13, 2026
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: ef20073379_ex99-1.htm · Sequence: 2
Exhibit 99.1
CONFIDENTAIL | NASDAQ: FEMY 1 CORPORATE PRESENTATION May 2026 ©️ 2026
Femasys Inc. Redefining Women’s Reproductive Health at Global Scale NASDAQ: FEMY
Forward Looking Statements NASDAQ: FEMY 2 This Presentation contains
"forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to current beliefs, expectations and assumptions
regarding the future of our business, future plans and strategies, results of clinical trials and other future conditions. Words such as, but not limited to, "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan",
"potential", "predict", "project", "should", "will", "would" or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, identify forward-looking statements. These forward-looking statements
reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties. Moreover, the Company operates in a very
competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor,
or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
The Company qualifies all of the forward-looking statements in this Presentation by these cautionary statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise. Statements contained herein are made as of the date of this Presentation unless stated otherwise, and neither this Presentation, nor any sale of securities, shall under any circumstances
create an implication that the information contained herein is correct as of any time after such date or that the information will be updated or revisited to reflect information that subsequently becomes available or changes occurring after
that date hereof. Certain information contained in this Presentation relates to or is based on statistical and other industry and market data obtained from independent industry publications and research, surveys and studies conducted by
independent third parties as well as the Company's own estimates. The market data used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications
and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The Company's
estimates of the total addressable market of the patient population with the potential to benefit from treatment with any products and product candidates the Company may develop, our ability to commercialize our products and product
candidates, or the effect of delays in commercializing include several key assumptions based on its industry knowledge, industry publications and third-party research, which may be based on a small sample size and may fail to accurately
reflect the addressable patient population. While the Company believes that its internal assumptions are reasonable, no independent source has verified such assumptions. This Presentation contains trademarks, trade names, or service marks
belonging to other entities. The Company does not intend the use or display of other parties' trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of, or by these other parties. This
Presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Femasys Inc., nor shall there be any
sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall
be made except by means of a prospectus, meeting the requirements of the Securities Act of 1933, as amended.
Femasys Overview NASDAQ: FEMY 3 STRONG INFRASTRUCTURE Experienced leadership
team U.S. and global regulatory approvals In-house, scalable U.S. manufacturing Efficiency over years of optimization INNOVATIVE PRODUCTS Near-term revenue inflection with meaningful growth acceleration Limited competition enabling
market creation Expanding access patient-driven in-office procedures Compelling economics for physicians and practices COMMERCIALIZATION & GROWTH A woman-founded, U.S. based biomedical device company unlocking one of healthcare’s
largest untapped markets Market-first solutions Purpose-built for safe, in-office delivery Clinically validated with extensive data 200+ issued patents
Key Leadership NASDAQ: FEMY 4 Chief Financial Officer 30+ years of
experience Cellectar Biosciences, Akari Therapeutics, Lev Pharmaceuticals, EpiCept DovElefant Chief Executive Officer & Founder 30+ years of experience Terumo Medical, Novoste, Salumedica Kathy Lee-Sepsick Sr. Vice
President Global Marketing 20+ years of experience Neurolief, Bolton Medical, Medtronic, Intuitive Surgical Megan Eckerman Chief Medical Officer 40+ years of experience Chair, Dept OB/ GYN Univ Heath System, Chair Dept Reproductive
Biology at Case Western, and Division Head Univ of Cincinnati James Liu, MD Chief Operating Officer 25+ years of experience Terumo Aortic, Bolton Medical, Medtronic Vascular John Canning Chief Technology Officer 20+ years of
experience Theragenics Jeremy Sipos Extensive industry expertise with a proven track record of execution
NASDAQ: FEMY 5 Commercializing Multi-Asset Women’s Health Portfolio Unlocking
large market opportunities through office-based innovation FERTILITY PRODUCT FAMILY PERMANENT BIRTH CONTROL First-line fertility treatment Non-Surgical permanent birth control Companion Diagnostic: FemCerv® for cervical cancer
diagnosis Additional OB/GYN product: (enabled by FemSperm® for in-office sperm handling) FemBloc is approved in Europe and select countries outside the U.S. and is currently in a U.S. trial for FDA approval. All other products have
regulatory approval across the U.S., Europe, and select global markets.
NASDAQ: FEMY 6 From Historical Headwinds to Future Opportunity Driven by a
strong pipeline, expanding patient access and favorable provider economics MULTI-ASSET WOMEN’S HEALTH PORTFOLIO BIPARTISAN POLITICS STRATEGIC TARGET Diversified portfolio across indications and stages delivers scale and
resilience. Support for women’s health and access drives policy tailwinds. Aim to create future optionality for large healthcare players with large underserved markets, limited competition. MACRO TRENDS Record-low fertility rates and
rising post-Roe contraception demand1. CAPITAL ENVIRONMENT More focus may equate to favorable conditions for innovation in women’s health and medtech. Martinez GM. (2024) DOI: https://dx.doi.org/10.15620/cdc/169629
Fertility in Crisis – Massive Unmet Need NASDAQ: FEMY 7 Centuries of limited
innovation in first-line treatment have limited access for millions U.S. women with infertility1 (~50% male factor contribution2) ~10M Take first step and undergo infertility testing3 ~100K Receive IVF transfer
cycle4 https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm Kumar N, et al. (2015). doi: 10.4103/0974-1208.170370. Nugent CN, Chandra A. Use of fertility services in women ages 20–49 in the United States: 2022–2023. NCHS Data Brief.
2025 Dec;(542):1–10. DOI: https://dx.doi.org/10.15620/cdc/174628. Centers for Disease Control and Prevention. 2022 Assisted Reproductive Technology (ART) Fertility Clinic and National Summary Report. US Dept of Health and Human Services;
2024. Hamilton BE, Osterman MJK, Gregory ECW. Births: Provisional data for 2025. Vital Statistics Rapid Release. 2026 Apr;(43):1–7. DOI: https://dx.doi. org/10.15620/cdc/252434. 2025: U.S. fertility rate dropped to another record
low5 ~5M
Fertility Portfolio with Strong Revenue Potential NASDAQ: FEMY 8 Scalable
growth driven by expanding access and adoption Estimate <10% Early REI Launch Established foundation, KOL advocacy and REI alignment Initial OB/GYN Launch Growth OB/GYN Expansion Existing patient base, validate seamless integration
Drive growth through broader patient engagement and market expansion $1B of infertile women Choose FemaSeed first-line treatment ~1,500 REIs, ~500 centers1 ~20k OB/GYNs, ~13k offices2 Sunderam S, et al. Assisted Reproductive
Technology Surveillance - United States, 2018. MMWR Surveill Summ. 2022 Feb 18;71(4):1-19. https://www.bls.gov/oes/2023/may/oes291218.htm
Femasys Fertility FastTrack™ NASDAQ: FEMY 9 Connecting diagnosis to treatment
in a streamlined pathway in OB/GYN office FemaSeed® OB/GYN qualifies patients in-office Leverages existing workflows (no lab required) First-line fertility treatment in OB/GYN office Intratubal
Insemination DIAGNOSE PREPARE TREAT Enhances Natural Fertilization FemSperm® Sperm Handling FemVue® Diagnosis - HER SpermVue™ Diagnosis - HIM
FemaSeed Offers Favorable Competitive Advantages NASDAQ: FEMY 10 Artificial
Insemination Assisted Reproductive FemaSeed IUI IVF ICSI No surgery (risks/cost) ✓ ✓ — — No egg retrieval or storage ✓ ✓ — — No required injections ✓ — — — Delivery to fallopian tube(s) (site of
conception) ✓ — N/A N/A Cost-effective ✓ ✓ $15-30k on avg1 More than IVF Minimal safety risks ✓ ✓ — — Low male sperm count efficacy ✓ Rec for IVF/ICSI ✓ ✓ Single fallopian tube solution ✓ — N/A N/A Widespread
accessibility ✓ ✓ Varies Varies https://bettercare.com/costs/ivf-cost#average-ivf-cost (does not include genetic testing, embryo freezing and storage)
FemaSeed Transforming the IUI Standard of Care NASDAQ: FEMY 11 Reducing time
lost in repeated, low-efficiency IUI cycles Artificial insemination has remained largely unchanged since first being performed in 1790. Why Historic IUI Falls Short… Sperm Counts worldwide have declined by >50%.1 Levine H. et al.
(2023). doi: 10.1093/humupd/dmac035. Brannigan RE, et al. Updates to male infertility: AUA/ASRM guideline (2024). J Urol. Published online August 15, 2024. doi:10.1097/JU.0000000000004180. Low sperm count reduces IUI effectiveness and may
necessitate IVF/ICSI.2
Commercial Readiness to Unlock the Fertility Market NASDAQ: FEMY 12 Proven
clinical performance, strong revenue potential and high-intent patients drive adoption Prospective clinical trial demonstrated superior results against historic IUI1 CLINICAL VALIDATTION COMPELLING ECONOMICS ENGAGED PATIENTS Robust
clinical data supported 510(k) pathway conversion from de novo Cash-pay procedures are established at OB/GYN practices Seamless integrationinto existing workflows without adding headcount Elective procedureswith high patient intent and
urgency to act In-office solution providing cost-effective access before infertility referral No additional data required New services create meaningful revenue Patients prefer accessible OB/GYN-led care Liu et al. (2024). doi:
10.33140/JGRM.08.02.08
FemaSeed Delivering Clinically Superior Care NASDAQ: FEMY 13 Liu et al.
(2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08. Duran et al.
(2002). Intrauterine insemination: a systematic review on determinants of success. Human Reproduction, vol.8, no.4, pp.373-384. A first-line fertility solution designed to expand access and improve outcomes 2X Pregnancy rate with
FemaSeed vs IUI1 Key Results 1:4 women became pregnant 26.3% of women became pregnant with FemaSeed for low male sperm count1 Most pregnancies occurred in 1 or 2 cycles (IUI attempts 3–6+) No safety concerns Performed in-office in few
minutes FemaSeed1 IUI2 Pregnancy Rate per Cycle (%)
Compelling Economics for OB/GYN Practices NASDAQ: FEMY 14 ~70% States have
Limited to NO fertility coverage1 Femasys fertility portfolio enables a new, high-value in-office revenue stream Resolve.org/learn/financial-resources/insurance-coverage/insurance-coverage-by-state Cash Pay Opportunity In covered
states CAT III approved for reimbursement (effective Jan 2027) Diagnosis for HER for tubal evaluation FemVue® FemSperm® Sperm collection and preparation Potential >$1,000 net revenue contribution Treatment for HIM for
Sperm analysis SpermVue™ FemaSeed® Intratubal Insemination With prepared sperm
Fertility Portfolio Enables Accelerated FemBloc Adoption NASDAQ:
FEMY 15 Commercial Synergies Same OB/GYN call point as fertility portfoliowith pre-trained physicians at FemBloc launch Leverages delivery platform with FemaSeed for FemBloc treatment Shares device & procedure with FemVue for
FemBloc confirmation testing Leveraging shared commercial infrastructure Then… First… Expanding access to in-office fertility care Advancing in-office permanent birth control
U.S. women no longer intend to have children1,2 ~13M Remain on form
oftemporary birth control2,3 Elect surgical sterilization every year2,4 ~1.2M Permanent Contraception – Critical Gap NASDAQ: FEMY 16 Centuries of limited innovation have created massive unmet need for millions of women Jones et. al,
Current contraceptive use in the United States, 2006–2010, and changes in patterns of use since 1995. National health statistics reports; no 60. Hyattsville, MD: National Center for Health Statistics. 2012. Daniels et. al, Current
contraceptive status among women aged 15–49: United States, 2017–2019. NCHS Data Brief, no 388. Hyattsville, MD: National Center for Health Statistics. 2020. National health statistics reports; no 60. Hyattsville, MD: National Center for
Health Statistics. 2012. Martinez GM. Receipt of family planning services in the United States: 2022–2023. NCHS Data Brief, no 520. Hyattsville, MD: National Center for Health Statistics. 2024. DOI: https://dx.doi.org/10.15620/cdc/169629
~12M Today: Only surgery remains an option
FemBloc Potential for Exponential Revenue Expansion NASDAQ:
FEMY 17 Leveraging existing fertility portfolio and physician base to drive outside growth Estimate ~30% Europe Launch Gather real-world evidence Initial OB/GYN Launch Growth OB/GYN Expansion Broaden access, drive adoption Scale
reach, expand market and accelerate growth $3B every year + electing surgery ~5% on temp birth control but done having children Choose non-surgical FemBloc
Natural with No Implant and No Hormones FemBloc: Non-Surgical Permanent Birth
Control NASDAQ: FEMY 18 Patient-Centered Market Drivers High demand for natural & safe optionsthat empower women with choice Growing concern with hormone-based birth control options Patients seek non-implant solutions due to fear
of safety risks Blended Polymer delivered as liquid through catheters Balloons positioned at each fallopian tube opening Blended Polymer solidifies; delivery system removed Blended Polymer degrades leaving patient’s scar tissue to block
tubes 1 2 3 4
FemBloc Offers Favorable Competitive Advantages NASDAQ: FEMY 19 Permanent
Birth Control Temporary FemBloc(non-surgical) SurgicalSterilization Essure®(off-market) IUD Permanent ✓ ✓ ✓ — Office procedure ✓ — Some ✓ No special capital equipment ✓ — — ✓ No anesthesia ✓ N/A N/A ✓ No implant
(coil/clip) ✓ — — — No surgery (risks/cost) ✓ — — ✓ No hormones ✓ ✓ ✓ — Reimbursement in-place / expected ✓ ✓ ✓ ✓ Widespread accessibility ✓ Varies N/A ✓
FemBloc Extensive Clinical Data Redefining Birth Control NASDAQ: FEMY 20 Over
20 years of comprehensive research and successful regulatory review and approvals Liu et al. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi:
10.33140/JGRM.09.01.05. Gariepy et al. (2022). Comparative Effectiveness of Hysteroscopic and Laparoscopic Sterilization for Women: A Retrospective Cohort Study. Fertility and Sterility, 117(6):1322-1331. doi:
10.1016/j.fertnstert.2022.03.001. LOW RISK In-office FemBloc1 Sterilization2(control) Pregnancy Rate (%) 0% Safety (Risk) HIGH RISKSurgery with general anesthesia Adoption Advantages 0% pregnancy rate statistically lower than
historical control; expected to evolve with larger sample size (pivotal trial on-going) Earlier FemBloc clinical studies (n=228 subjects)1Prospective, multi-center, unblinded Safe with only Mild AEs reported (spotting/bleeding, cramping);
NO Serious AEs Immediate return to normal activities
Limited options and strong interest support efficient enrollment FemBloc
Advancing Toward U.S. Approval NASDAQ: FEMY 21 De-risked through international regulatory approvals and clinical use Study design: U.S. FINALE pivotal trial for FDA approval1Prospective, multi-center, open-label, single-arm with
historical control Part A for safety (n=50) – completed Part B (n=523) – currently enrolling, initiated Mar 2026 Primary endpoint: Pregnancy rate, 1-year relying on FemBloc (n=401) Safety analysis: 2-5 years post-market Additional
analyses: Interim for sample re-estimation (n=300) Clinicaltrials.gov: NCT05977751 European Post-Market Real-World StudyProspective, multi-center, with oversight from Spanish Contraception Society (n=200) – initiated Q4 2025
U.S. Cost Breakdown Compared to Surgical Sterilization Expansion of In-Office
Revenue Opportunities NASDAQ: FEMY 22 Potential to reduce healthcare system costs while enhancing practice profitability Changing Economic Paradigm In-Office Proceduresmaximize physician time and efficiency Reimbursement
Expected increase patient access through ACA coverage >10X Profit Potential for physician/ practice Planned parenthood (2019). https://www.plannedparenthood.org/learn/birth-control; Doximity 2019; U.S. Bureau of Labor
Statistics. 0 1000 2000 3000 4000 5000 6000 Amount in $ Pre-Op Facility Anesthesia Post-Op FemBloc Cost Anesthe Physician / Practice FemBloc estimate < ½ cost of surgery Physician Surgical Sterilization1 FemBloc
Major Value Inflection Points NASDAQ: FEMY 23 FEMASEED Additional
partnership Cat III reimbursement Q1 2026 FEMBLOC MDSAP approval Initiate U.S. trial (FINALE) enrollment ACHIEVED ACHIEVED FEMASEED Launch FemSperm U.S. OB/GYN partnerships Q2 2026 FEMBLOC Additional U.S. trial sites Expand
post-market study ACHIEVED IN-PROGRESS FEMASEED Expand OB/GYN partnerships Patient advocacy Q3 2026 (anticipated) FEMBLOC Additional U.S. trial sites Support post-market study FEMASEED Post-market study data U.S. Billing
partnership(s) Q4 2026 (anticipated) FEMBLOC Advance FINALE enrollment Post-market study data OUS Strategic execution across the portfolio expected to drive value creation
Contact Details Investor RelationsIR@femasys.com Public Relations
Media@femasys.com NASDAQ: FEMY
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v3.26.1
Document and Entity Information
May 13, 2026
Cover [Abstract]
Document Type
8-K
Amendment Flag
false
Document Period End Date
May 13, 2026
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
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Written Communications
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Soliciting Material
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Pre-commencement Issuer Tender Offer
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The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
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Address Line 1 such as Attn, Building Name, Street Name
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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
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Title of a 12(b) registered security.
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
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Trading symbol of an instrument as listed on an exchange.
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
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