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Form 8-K

sec.gov

8-K — Longeveron Inc.

Accession: 0001213900-26-088365

Filed: 2026-08-12

Period: 2026-08-12

CIK: 0001721484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0301757-8k_longeveron.htm (Primary)

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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 12, 2026

Longeveron Inc.

(Exact name of registrant as specified in its

charter)

Delaware

001-40060

47-2174146

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

1951 NW 7th Avenue, Suite 520

Miami, Florida

33136

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including

Area Code: (305) 909-0840

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:

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 Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Class A Common Stock, $0.001 par value per share

LGVN

The Nasdaq Capital Market

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 12, 2026, Longeveron Inc. (the “Company”)

issued a press release announcing its financial and operating results for the three and six months ended June 30, 2026, and certain other

business updates and information. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and

incorporated by reference herein.

The information provided under this Form 8-K (including

Exhibit 99.1) shall not be deemed “filed” for any purposes of Section 18 of the Securities Exchange Act of 1934 (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 a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

The exhibits listed in the following Exhibit Index

are being furnished as part of this Current Report on Form 8-K.

Exhibit No.

Description

99.1

Press Release issued by the Company on August 12, 2026

104

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

1

SIGNATURE

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.

LONGEVERON INC.

Date: August 12, 2026

/s/ Marie Washburn

Name:

Marie Washburn

Title:

Chief Financial Officer

2

EX-99.1 — PRESS RELEASE ISSUED BY THE COMPANY ON AUGUST 12, 2026

EX-99.1

Filename: ea030175701ex99-1.htm · Sequence: 2

Exhibit

99.1

Longeveron

Announces 2026 Second Quarter Financial Results and Provides Business Update

● On

track for September 2026 top-line results from Phase 2b clinical trial (ELPIS II) evaluating

laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome (HLHS),

a rare pediatric disease and orphan-designated indication

● Longeveron

selected as a Finalist and Milestone 2 Awardee for the XPRIZE Healthspan competition based on published clinical trial results which

indicated laromestrocel increased 6-minute walk distance in patients with aging frailty

● Three

new independent Directors join Longeveron’s Board of Directors

● Company

to host conference call and webcast today at 4:30 p.m. ET

MIAMI,

Fla., August 12, 2026 -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening,

rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended June 30, 2026 and provided

a business update.

“Longeveron

is approaching a series of potentially transformative milestones across our four stem cell therapy development programs that have the

potential to redefine the trajectory of our business,” said Stephen H. Willard, Chief Executive Officer of Longeveron. “Our

approach to stem cell therapy development has garnered external recognition and validation with positive clinical data having been published

in Nature Medicine and Cell Stem Cell and also serving as the foundation for our selection as a Finalist for the XPRIZE

Healthspan competition out of over 600 projects submitted worldwide. We are rapidly approaching the September top line data readout of

our ELPIS II Phase 2b clinical trial evaluating laromestrocel in HLHS and look forward to sharing those results.”

Development

Programs

Longeveron’s

investigational therapeutic candidate laromestrocel (Lomecel-B®) is a proprietary, scalable, allogeneic cellular therapy

being evaluated in multiple indications.

Hypoplastic

Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping

chambers of the heart) is either severely underdeveloped or missing.

● Topline

results from the Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated

in September 2026.

● In

May, the Company announced that the U.S. Food and Drug Administration (FDA) held a Type C meeting in late March 2026 focused on the ELPIS

II Phase 2b clinical trial and upcoming data readout.

● Also

in May, the Company announced that the independent Data Monitoring Committee (DMC) completed its final prespecified data review for ELPIS

II Phase 2b clinical trial (ELPIS II). The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study

to continue as designed to completion.

● ELPIS

II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes

of Health (NIH).

● The

FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment

of HLHS.

Pediatric

Dilated Cardiomyopathy (PDCM) – a rare pediatric cardiovascular disease in which the muscles in one or more of the heart chambers

become enlarged or stretched (dilated), with nearly 40% of children with PDCM requiring a heart transplant or dying within two years

of diagnosis.

● Longeveron’s

Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective

in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial.

● The

Company currently anticipates initiation of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026.

Alzheimer’s

disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited

therapeutic options.

● In

July, additional analysis of data from the Phase 2a clinical trial evaluating laromestrocel in mild AD was presented in a Poster Presentation

at the 2026 Alzheimer’s Association International Conference® (AAIC®). The data indicated

that laromestrocel reduced neuroinflammation in patients with mild Alzheimer’s disease.

● Results

from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s

disease and provided evidence-based support for further clinical development, were published in the peer-reviewed journal Nature Medicine

in March 2025.

● Positive

Type B meeting with FDA regarding pathway to potential BLA submission for laromestrocel in Alzheimer’s disease held in March 2025

with tentative alignment reached on proposed trial study design, population and endpoints for a single Phase 2/3 clinical trial that,

if positive, could be acceptable for BLA submission for Alzheimer’s disease.

.

● The

FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the

treatment of mild Alzheimer’s disease.

● The

Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD.

Aging-related

Frailty (AF) – a chronic condition driven by systemic physiologic decline, characterized by reduced reserve and resilience

across multiple organ systems with common features including weakness, fatigue, weight loss, slowness and reduced activity. No FDA-approved

therapies currently exist.

● Laromestrocel

data from its Phase 2b clinical trial in Aging-related Frailty were published in Cell Stem Cell in February 2026.

● The

Phase 2b results indicated that intravenous laromestrocel improved the physical condition of patients with age-related clinical frailty

after nine months, compared to placebo.

Corporate

Updates

● In

April, the Company announced that the China National Intellectual Property Administration granted a patent covering potency assay methods

for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic

fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs).

● In

May, the Company issued a CEO Letter to Shareholders highlighting corporate strategy, strategic partnering approach and 2026 key priorities.

● In

June, the Company participated in the BIO International Convention. Members of the senior management team hosted meetings to explore

potential partnership and strategic opportunities for the Company’s four stem cell development programs.

2

● In

June, the Company announced that it has been granted Small or Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA).

The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products

in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information

and training from dedicated EMA personnel during the clinical development process. Companies with this designation can engage in early

dialogue with the EMA multidisciplinary team and discuss regulatory strategy with the goal of mitigating delay and accelerating patient

access to lifesaving treatments.

● On

August 11, 2026, the Company announced that it has been selected as a Finalist Team in the

XPRIZE Healthspan global competition, a seven-year, $101 million global competition to identify

therapeutic approaches to increase human healthspan. As a result, the Company will receive

a $1.0 million Milestone 2 Award to be used towards the future clinical trial required in

accordance with the XPRIZE competition rules, with the opportunity to compete for the XPRIZE

Grand Prize of up to $81 million, subject to the successful completion of the required clinical

trial and financing thereof.

2026

Second Quarter Summary Financial Results

● Revenues,

Cost of Revenues and Gross Profit: Revenues for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3

million. 2026 revenues decreased by $29,000, or 10%, when compared to 2025, primarily due to the absence of contract manufacturing revenue.

Clinical

trial revenue, which is derived from The Bahamas Registry Trial, for each of the three-month periods ended June 30, 2026 and June 30,

2025 was $0.3 million. Contract manufacturing revenues for the three months ended June 30, 2026 and 2025, were $0 and $18,000, respectively.

This decrease of $18,000, or 100%, when compared to the same period in 2025, was driven by the absence of any additional contract manufacturing

services from our third-party client.

Related

cost of revenues were $0.1 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. This resulted in

a gross profit of approximately $0.2 million for the three months ended June 30, 2026, an increase of $36,000, or 25%, when compared

to 2025.

● General

and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2026 were $3.2 million, compared

to $2.6 million for the same period in 2025. The increase of $0.6 million, or 23%, was primarily due to a $0.4 million increase in legal

spend and a $0.2 million increase in personnel-related costs.

● Research

and Development Expenses: Research and development expenses were $3.2 million for the three months ended June 30, 2026, compared

to $3.0 million for the same period in 2025. The increase of $0.2 million, or 7%, was due to higher clinical trial expenses to support

the ELPIS II top-line results expected in September 2026.

● Other

Income: Other income for the three months ended June 30, 2026 was $0.1 million, primarily consisting of interest earned on money

market funds. Other income for the three months ended June 30, 2025, was $0.4 million, primarily consisting of $250,000 received as a

recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.1 million of interest earned on money market funds.

● Net

Loss: Net loss was $6.1 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended

June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above.

● Cash

and cash equivalents: As of June 30, 2026, the Company had cash and cash equivalents of $10.1 million. We currently anticipate our

existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth

quarter of 2026, based on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for

the foreseeable future in connection with our ongoing activities. We intend to seek additional financing opportunities, capital raises,

as well as non-dilutive funding options to support our operating plans.

Conference

Call and Webcast Details:

Conference Call Number:

1.877.407.0789

Conference ID:

13761959

Call meTM Feature:

Click Here

Webcast:

Click Here

An

archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website

following the conference.

3

About

Longeveron Inc.

Longeveron

is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead

investigational product is laromestrocel (Lomecel-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated

from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular,

pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease

areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric

Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important

U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation;

and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information,

visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.

Forward-Looking

Statements

Certain

statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions

of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates

of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors

that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the

statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,”

“believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,”

“intend,” “looks to,” “may,” “on condition,” “plan,” “potential,”

“predict,” “preliminary,” “project,” “see,” “should,” “target,”

“will,” “would,” or the negative thereof or comparable terminology, although not all forward-looking statements

contain these words, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause

actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are

not limited to, the ability of our clinical trials to demonstrate safety and efficacy of our investigational products, and

other positive results; our ability to successfully transition toward a more capital-efficient, asset-light operating model; our ability

to secure one or more strategic licensing partnerships for our stem cell therapy laromestrocel in our development programs; our ability

to reach alignment with the FDA and other regulatory authorities on a potential path toward regulatory approval of our investigational

products; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the

readout of top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials,

and the reporting of data from those studies and trials; market and other conditions, our cash position and need to raise additional

capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial

performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will

be sufficient to fund our future operating expenses and capital expenditure requirements; the size of the market opportunity for certain

of our investigational products, including our estimates of the number of patients who suffer from the diseases we are targeting;

our ability to scale production and commercialize the investigational products for certain indications; the success of competing

therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational

products; our ability to obtain and maintain regulatory approval of our investigational products in the U.S. and

other jurisdictions; our plans relating to the further development of our investigational products, including additional disease

states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of

existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire

additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital

requirements and needs for additional financing.

Further

information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the

Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the

year ended December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, its Quarterly Reports on Form

10-Q, and its Current Reports on Form 8-K. The Company operates in a highly competitive and rapidly changing environment; therefore,

new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor

assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ

materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release

are made as of the date of this press release based on information available as of the date of this press release, are inherently

uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking

statements, whether as a result of new information, future events, or otherwise.

Investor

and Media Contact:

Derek

Cole

Investor Relations Advisory Solutions

derek.cole@iradvisory.com

---tables

follow---

4

Longeveron

Inc.

Condensed

Balance Sheets

(In

thousands, except share and per share data)

June 30,

2026

December 31,

2025

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$ 10,077

$ 4,661

Prepaid expenses and other current assets

1,181

686

Accounts receivable

65

104

Total current assets

11,323

5,451

Property and equipment, net

1,602

1,836

Intangible assets, net

2,202

2,285

Operating lease asset, net

348

513

Other assets

12

176

Total assets

$ 15,487

$ 10,261

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 633

$ 423

Accrued expenses

2,653

2,969

Current portion of lease liability

581

655

Deferred revenue

40

40

Other current liabilities

400

Total current liabilities

4,307

4,087

Long-term liabilities:

Long-term portion of operating lease liability

169

Liability related to the sale of future PRV proceeds

778

Other liabilities

330

Total long-term liabilities

778

499

Total liabilities

5,085

4,586

Commitments and contingencies (Note 9)

Stockholders’ equity:

Preferred stock, $0.001 par value per share, 4,973,025 shares authorized, no shares issued and outstanding at June 30, 2026, and December 31, 2025

Series A non-voting convertible preferred stock, $0.001 par value per share, 26,975 shares authorized, 11,542.28 issued and outstanding at June 30, 2026, no shares issued and outstanding at December 31, 2025

Class A common stock, $0.001 par value per share, 175,000,000 shares authorized, 30,269,636 shares issued and outstanding at June 30, 2026; 21,445,336 issued and outstanding at December 31, 2025

30

21

Class B common stock, $0.001 par value per share, 15,705,000 shares authorized, 1,449,005 shares issued and outstanding at June 30, 2026; 1,484,005 shares issued and outstanding at December 31, 2025

1

1

Additional paid-in capital

153,491

137,964

Accumulated deficit

(143,120 )

(132,311 )

Total stockholders’ equity

10,402

5,675

Total liabilities and stockholders’ equity

$ 15,487

$ 10,261

See

accompanying notes to financial statements.

5

Longeveron

Inc.

Condensed

Statements of Operations

(In

thousands, except per share data)

(Unaudited)

Three months ended

June 30,

Six months ended

June 30,

2026

2025

2026

2025

Revenues

Clinical trial revenue

$ 287

$ 298

$ 665

$ 557

Contract manufacturing lease revenue

6

12

Contract manufacturing revenue

12

20

128

Total revenues

287

316

685

697

Cost of revenues

105

170

239

276

Gross profit

182

146

446

421

Operating expenses

General and administrative

3,159

2,589

5,879

5,530

Research and development

3,194

2,954

5,513

5,469

Total operating expenses

6,353

5,543

11,392

10,999

Loss from operations

(6,171 )

(5,397 )

(10,946 )

(10,578 )

Other income

Other income, net

98

369

137

539

Total other income, net

98

369

137

539

Net loss

$ (6,073 )

$ (5,028 )

$ (10,809 )

$ (10,039 )

Basic and diluted net loss per share

$ (0.19 )

$ (0.33 )

$ (0.38 )

$ (0.67 )

Basic and diluted

weighted average common shares  outstanding

31,377,630

15,013,072

28,100,164

14,982,075

See

accompanying notes to financial statements.

6

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- Definition

Indicate if registrant meets the emerging growth company criteria.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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-Section 12

-Subsection b-2

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Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

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-Section B

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- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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No definition available.

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- Definition

Two-character EDGAR code representing the state or country of incorporation.

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No definition available.

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- Definition

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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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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-Publisher SEC

-Name Exchange Act

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Local phone number for entity.

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- Definition

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 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

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-Number 240

-Section 13e

-Subsection 4c

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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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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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- Definition

Title of a 12(b) registered security.

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-Publisher SEC

-Name Exchange Act

-Number 240

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-Subsection b

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Name of the Exchange on which a security is registered.

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-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

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.

+ References

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-Publisher SEC

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-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

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No definition available.

+ Details

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Period Type:

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- Definition

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.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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