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Form 8-K

sec.gov

8-K — HCW Biologics Inc.

Accession: 0001493152-26-038258

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001828673

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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 14, 2026

HCW

Biologics Inc.

(Exact

name of Registrant as Specified in Its Charter)

Delaware

001-40591

82-5024477

(State

or Other Jurisdiction

of

Incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

2929 N. Commerce

Parkway

Miramar, Florida

33025

(Address of Principal

Executive Offices)

(Zip Code)

Registrant’s

Telephone Number, Including Area Code: 954 842-2024

Not

Applicable

(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:

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

Common Stock, par value

$0.0001 per share

HCWB

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 14, 2026, HCW Biologics Inc. issued a press release announcing its financial results for the quarter ended June 30, 2026. The

full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form

8-K.

The

information set forth in this Item 2.02 (including Exhibit 99.1) is being 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, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in

such a filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press release dated August 14, 2026.

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 thereunto duly authorized.

HCW BIOLOGICS INC.

Date: August 14, 2026

By:

/s/ Hing

C. Wong

Hing C. Wong

Founder and Chief Executive Officer

EX-99.1

EX-99.1

Filename: ex99-1.htm · Sequence: 2

EXHIBIT

99.1

HCW

Biologics Reports Second Quarter 2026

Business

and Clinical Development Highlights and Financial Results

Miramar,

FL – August 14, 2026 – HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage

biopharmaceutical company focused on developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer

and senescence-associated dysplasia, today reported financial results and recent business highlights for the three and six months ended

June 30, 2026.

On

June 16, 2026, the Company announced its preliminary human data readout for the first two cohorts in a dose-escalating Phase 1 clinical

study to evaluate HCW9302 as a monotherapy in patients with alopecia areata. HCW9302 is a fusion immunotherapeutic which is potentially

a best-in-class IL-2-based treatment for autoimmune diseases. These preliminary findings support the Company’s belief that HCW9302

has the potential to activate and expand regulatory T (Treg) cells in patients, reducing inflammation, while minimizing the

risk of broad immunosuppression or unwanted side effects caused by the activation of immune effector cells.

The

Company remains on track for a full Phase 1 clinical data readout in the fourth quarter of 2026. Treatment of patients in the third dose

cohort (i.e., eight (8) micrograms/kg body weight) is underway and evaluation of correlative study endpoints is ongoing. The Company

has not reported any dose-limiting toxicities.

In

the second dose cohort, comprised of patients who received a single subcutaneous dose of HCW9302 monotherapy of three (3) micrograms/kg

body weight, all three participants showed preliminary indications of improvement in Severity of Alopecia Tool (“SALT”) scores.

These three participants, all with mild alopecia, showed a ≥25% reduction in SALT scores compared to baseline at four and/or nine

weeks after dosing. In addition, there were no reported incidences of capillary leak or cytokine release syndromes associated with high

dose intravenous IL-2 therapy. HCW9302 treatment did not increase blood eosinophil count, another serious side effect commonly associated

with IL-2 therapy.

Dr.

Hing C. Wong, the Company’s Founder and Chief Executive Officer, stated, “HCW9302 was selected as our lead product candidate

for our autoimmune program because it has several unique features that differentiate it from other immunotherapeutic treatments for autoimmune

disorders. Because our clinical study was designed to administer HCW9302 as a monotherapy, we feel confident of our findings and clear

signals that indicate this drug has great potential. So far, our in-human clinical experience with HCW9302 is consistent with our

preclinical results showing HCW9302’s effectiveness in alopecia areata and atopic dermatitis in relevant animal models.”

Dr.

Wong continued, “HCW9302 targets CD25 directly, which we believe demonstrates activation and expansion of regulatory T cells. It

has preliminarily demonstrated it has an effect on alopecia areata, even when administered as monotherapy at a low dose. Our design does

not use pegylation, so we avoid anti-PEG immune responses, which account for efficacy loss and can possibly cause severe allergic symptoms.

With an eye toward the future commercialization of HCW9302 for the treatment of alopecia areata and other autoimmune disorders, we developed

a manufacturing process for this drug that is a simple process capable of producing large quantities with consistent quality at a relatively

low cost.”

Business

and Clinical Development Highlights

Commercial-Ready

Molecules Used as Reagents

Since

the second quarter of 2025, the AlloTera Therapeutics License (formerly the Wugen License) was in a one-year suspension period, which

the Company agreed to at the request of AlloTera Therapeutics, Inc. (“AlloTera Therapeutics”). On May 21, 2026, the Company

re-acquired the ex vivo rights to two commercial-ready molecules that had previously been licensed to AlloTera Therapeutics by

exercising its right to terminate the AlloTera Therapeutics License Agreement according to the terms of the suspension letter agreement.

The

Company is actively pursuing a corporate partner to commercialize HCW9206 and like molecules as reagents to support the production

of cell-based immunotherapeutics, particularly CAR-T therapies. In collaboration with researchers at the Albert Einstein College

of Medicine, the Company demonstrated and published in a scientific paper in Science Advances that replacing standard activation

with HCW9206 during CAR-T cell manufacturing significantly increased the long-term persistence, functionality, and proportion of T memory

stem cells in immunotherapies for cancer and HIV and potentially significantly lowers the production costs.

The

market for reagents used in CAR-T therapy production is experiencing rapid expansion, driven by a projected increase in the global CAR-T

cell therapy market, which is expected to grow from $4.0 billion in 2025 to over $15.0 billion by 2032. One of the impediments to growth

is the manufacturing process, which is subject to delays and has difficult meeting target doses for commercial production.

Milestone

for Company’s T-Cell Engager Program

The

Company requested a Type B (pre-IND application) meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the

development and regulatory strategy for its investigational lead product candidate, HCW11-018b, a tetravalent T-cell engager (“TCE”)

constructed with the Company’s proprietary TRBC drug development platform. The Company would like to reach agreement with FDA on

requirements for a clinical study before we submit an IND application to evaluate HCW11-018b in cancer. This clinical trial is on track

to initiate in the first half of 2027, provided we secured FDA authorization.

HCW11-018b

is intended to treat solid tumors and is administered by subcutaneous injection. In preclinical studies, it has shown the ability to

target tissue factor-expressing cancer cells and activate CD3-positive effector T cells, while simultaneously reducing immunosuppression

in the tumor microenvironment. Immunosuppression in the tumor microenvironment can limit effector T-cell infiltration and antitumor activity

in solid tumors, particularly in gynecologic and pancreatic cancers.

The

Company believes that our robust, streamlined, and cost-efficient manufacturing process will produce high-quality cGMP material to support

clinical development. Our manufacturing process for HCW11-018b is based on high-producing recombinant CHO cell lines and a proprietary

monoclonal antibody needed for the affinity purification process. This monoclonal antibody will be manufactured under GMP standards using

a top-tier CDMO.

TCEs

have emerged as a potent therapeutic modality to treat cancer. First-generation TCEs represented a breakthrough in immunotherapy but

they continue to face significant challenges, including limited antigen selection, poor efficacy in solid tumors, tolerability and safety

concerns, and complex manufacturing processes. Extensive preclinical studies of HCW11-018b —including assessments of in vitro

and in vivo potency, antigen specificity, pharmacokinetics, toxicity in nonhuman primates, and its therapeutic window —

suggest that HCW11-018b may be able to overcome the limitations of earlier-generation TCEs.

$5.6

Million in Equity Financings

Pursuant

to a May 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 71,174 shares of Common

Stock, 403,322 Pre-Funded Warrants, and Common Warrants to purchase an aggregate of up to 474,496 shares of Common Stock for aggregate

gross proceeds of approximately $4.0 million at the closing, before deducting fees payable to the placement agent and other offering

expenses payable by the Company. The Investors included officers, directors and significant stockholders. Scott Garrett, Chairman of

the Company’s Board of Directors, purchased $250,000 of securities, Hing C. Wong, the Company’s Founder and Chief Executive

Officer, purchased $160,000 of securities, and Rebecca Byam, the Company’s Chief Financial Officer, purchased $20,000 of securities.

Such purchases were made on the same terms and conditions as those offered to other investors. On June 18, 2026, the SEC declared effective

a resale registration statement on Form S-1 (File No. 333-296577) covering the resale of shares of Common Stock and warrants issued in

this private placement.

Pursuant

to a July 2026 securities purchase agreement, in a private placement, the Company issued and sold an aggregate of 218,862 shares of Common

Stock, 400,000 Pre-Funded Warrants and Common Warrants to purchase an aggregate of 618,682 shares of Common Stock for aggregate proceeds

of approximately $1.6 million at closing, before deducting offering fees. The Investors included officers and directors. Scott Garrett

purchased $20,000 of securities, Hing C. Wong purchased $60,000 of securities, and Lee Flowers, the Company’s SVP Business Development,

purchased $20,000 of securities. Under a Registration Rights Agreement, the Company is obligated to file a registration statement to

register the securities sold in this offering within 15 business days from closing.

Second

Quarter 2026 Financial Results

Revenues:

Revenues for the three months ended June 30, 2025 and 2026 were $6,550 and $135,568, respectively. Revenues in the six months ended

June 30, 2025 and 2026 were $11,615 and $6.7 million, respectively. In the three and six months ended June 30, 2026, the Company completed

the closing of the exclusive, worldwide licensing agreement with Beijing Trimmune Biotech Co., Ltd. (“Trimmune”) for the

in vivo rights for HCW11-006 (“Trimmune License”) and performed additional post-transfer services under the agreement.

Research

and development (R&D) expenses: R&D expenses for the three months ended June 30, 2025 and 2026 were $1.2 million and $1.2

million, respectively, a decrease of $23,472, or 2%. The decrease was primarily due to decreases in salaries, benefits and related taxes

and clinical trial expenses, partially offset by an increase in preclinical expenses with a focus on IND-enabling activities for the

Company’s lead product T-Cell Engager candidate, HCW11-018b. R&D expenses for the six months ended June 30, 2025 and 2026 were

$2.7 million and $2.5 million, respectively, a decrease of $244,236, or 9%. The decrease was primarily due to a decline in manufacturing

and materials expenses, partially offset by increases in taxes and salaries, benefits and related expenses.

General

and administrative (G&A) expenses: G&A expenses for the three months ended June 30, 2025 and 2026 were $2.1 million and $1.9

million, respectively, a decrease of $225,646, or 11%. The decrease was primarily attributable to decreases of $242,073 in salaries and

benefits related to a decline in stock-based compensation expense, $87,835 in accretion expense for the fixed bonus payable upon the

maturity date of outstanding Secured Notes and a $79,518 decrease in insurance premiums, partially offset by increases in taxes and expenses

related to financing activities. In May 2025, the Company restructured $7.4 million of debt related to the Secured Notes, and these Noteholders

converted to equity. G&A expenses for the six months ended June 30, 2025 and 2026 were $4.3 million and $3.7 million, respectively,

a decrease of $598,649, or 14%. The decrease was primarily attributable to decreases of $507,206 in salaries and benefits related to

a decline in stock-based compensation expense and $346,482 in accretion expense for the fixed bonus payable upon maturity date of outstanding

Secured Notes and a decrease of $175,343 in insurance premiums, partially offset by an increase in taxes and expenses related to financing

activities.

Legal

expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration,

net of insurance recoveries. In the six months ended June 30, 2025, the Company received a $2.0 million insurance recovery, partially

offset by $403,049 of legal expenses. The Company anticipates it will continue to incur some expenses for the costs of remaining in compliance

with the terms of the Settlement and Release Agreement from the Arbitration, primarily due to requirements for patents which are necessary

to protect the Company’s exclusive, worldwide intellectual property rights held in perpetuity.

Nonoperating

changes impacting net income (loss): The Company adopted the fair value method of accounting for its shares in AlloTera Therapeutics

in the second quarter of 2025. As a result, in the three and six months ended June 30, 2025, the Company recognized a $1.7 million gain

in both periods related to a change in the fair value for this investment. The Company recognized a warrant liability in connection with

warrants with a contingent settlement provision which was resolved on June 15, 2026. As a result, these warrants were reclassified

to permanent equity. In the three and six months ended June 30, 2026, the changes in the fair value of the warrant liability prior to

reclassification were a loss of $2.4 million and $1.8 million, respectively. In addition, during the three and six months ended June

30, 2026, the Company settled a $1.7 million liability for $1.2 million, and as a result recognized a gain on extinguishment of a liability

of $483,383 in both periods.

Net

loss: Net loss for the three months ended June 30,2025 and 2026 was $1.9 million and $5.2 million, respectively. Net loss for the

six months ended June 30, 2025 and 2026, was $4.1 million and $1.7 million, respectively.

Financial

Guidance

As

of June 30, 2026, the Company believes that substantial doubt exists regarding its ability to continue as a going concern for at least

12 months from the issuance date of the audited financial statements, without additional funding or financial support. We considered

future elements of our financing plan, especially business development programs. We have had early success in completing key elements

of our multi-step financing plan; however, we cannot be assured that we will continue to have success with remaining elements of our

plan.

On

June 26, 2025, the Company announced that it received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the

Company is in compliance with Listing Rule 5550(b)(1) (the “Equity Rule”). On June 29, 2026, HCW Biologics Inc. (the “Company”)

received written notice form the Listing Qualifications Staff (the “Staff”) of the Nasdaq Capital Market Nasdaq Stock Market

LLC (“Nasdaq”) that the Nasdaq Hearings Panel (the “Panel”) found that the Company regained compliance with Listing

Rule 5550(a)(2), the “Bid Price Rule,” per the terms set forth in the Panel’s decision letter dated May 29, 2026, as

amended. As indicated in the Panel’s decision letter, as amended, if the Company satisfies the remaining terms of the decision

through September 22, 2026, the Panel also intends to impose a Discretionary Panel Monitor on the Company pursuant to Listing Rule 5815(d)(4)(A)

for a one-year period from that date. On June 30, 2026, the Company effected a one-for-six reverse stock split.

About

HCW Biologics

HCW

Biologics Inc. (the “Company”) (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing transformative fusion

immunotherapeutics to treat diseases promoted by chronic inflammation, including autoimmune diseases, cancer, and senescence-associated

dysplasia. The Company’s immunotherapeutics represent a new class of drugs that it believes have the potential to fundamentally

change the treatment of proinflammatory and senescence-associated diseases and conditions that are promoted by chronic inflammation —and

in doing so, improve patients’ quality of life and possibly extend longevity. A key aspect of the Company’s clinical development

and financing strategy is to focus on its business development programs, including its commercial-ready reagents to be used in the production

of immunotherapeutics for cancer and infectious diseases. To date, the Company has entered into two licensing agreements in which it

has licensed exclusive, worldwide rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/

Forward

Looking Statements

Statements

in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These

statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking

statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,”

“believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,”

“forecast” or other similar words. Forward-looking statements are based on the Company’s current expectations and are

subject to inherent uncertainties, risks and assumptions that are difficult to predict, including timing and efficacy in human clinical

trial data for HCW9302, ability of HCW11-018b to treat solid tumors, ability to obtain U.S. Food and Drug Administration clearance to

advance Phase 2 clinical trials for HCW9302, success in obtaining FDA clearance to initiate clinical trials for HCW11-018b, and effectiveness

of commercial-ready reagents for production of immunotherapeutics; and the Company’s ability to license or sell reagents. 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, but are not limited to, the risks and uncertainties that are described in the section titled

“Risk Factors” in the annual report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”)

on June 30, 2026, the Form 10-Q filed with the SEC on August 14, 2026, and in other filings filed from time to time with the SEC. Forward-looking

statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except

as required under applicable law.

Company

Contact:

Rebecca

Byam

CFO

HCW

Biologics Inc.

rebeccabyam@hcwbiologics.com

HCW

Biologics Inc.

Condensed

Statements of Operations

(Unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2025

2026

2025

2026

Revenues:

Revenues

$ 6,550

$ 135,568

$ 11,615

$ 6,678,569

Cost of revenues

(5,240 )

(229,455 )

(9,292 )

(240,526 )

Net revenues

1,310

(93,887 )

2,323

6,438,043

Operating expenses:

Research and development

1,226,824

1,203,352

2,705,536

2,461,300

General and administrative

2,096,021

1,870,375

4,302,301

3,703,652

Legal expenses (recoveries), net

142,542

(1,325 )

(1,596,951 )

5,525

Indirect tax expense

-

-

-

198,146

Total operating expenses

3,465,387

3,072,402

5,410,886

6,368,623

Operating income (loss)

(3,464,077 )

(3,166,289 )

(5,408,563 )

69,420

Interest expense

(228,714 )

(100,541 )

(505,853 )

(209,815 )

Change in fair value of warrant liability

-

(2,443,335 )

-

(1,775,992 )

Change in fair value of investment, net

1,748,688

-

1,748,688

-

Gain on extinguishment of liability

-

483,383

-

483,383

Other income, net

16,373

7,551

41,122

16,439

Net loss before income taxes

$ (1,927,730 )

$ (5,219,231 )

$ (4,124,606 )

$ (1,416,565 )

Income tax expense

-

-

-

(330,186 )

Net loss

$ (1,927,730 )

$ (5,219,231 )

$ (4,124,606 )

$ (1,746,751 )

Equity dividend to investor

(10,153,799 )

(10,154,642 )

(10,153,799 )

(11,643,114 )

Net loss attributable to Common Stockholders

$ (12,081,529 )

$ (15,373,873 )

$ (14,278,405 )

$ (13,389,865 )

Net loss per share, basic and diluted

$ (40.72 )

$ (11.58 )

$ (59.14 )

$ (11.98 )

Weighted average shares outstanding, basic and diluted

296,686

1,327,966

241,417

1,117,350

HCW

Biologics Inc.

Condensed

Balance Sheets

December 31,

June 30,

2025

2026

Unaudited

ASSETS

Current assets:

Cash and cash equivalents

$ 1,952,464

$ 741,324

Accounts receivable, net

32,175

18,451

Prepaid expenses

222,156

282,533

Other current assets

77,564

97,702

Total current assets

2,284,359

1,140,010

Investments

1,326,329

4,854,028

Property, plant and equipment, net

20,880,849

20,745,804

Other assets

28,476

28,476

Total assets

$ 24,520,013

$ 26,768,318

LIABILITIES AND STOCKHOLDERS’ EQUITY

Liabilities

Current liabilities:

Accounts payable

$ 13,143,394

$ 10,609,950

Accrued liabilities and other current liabilities

1,110,104

1,128,592

Short-term debt, net

6,809,215

6,561,361

Deferred revenue

348,270

Total current liabilities

21,062,713

18,648,173

Contingent liability - related party

692,531

692,531

Total liabilities

21,755,244

19,340,704

Commitments and contingencies (Note 12)

Stockholders’ equity:

Common stock:

Common, $0.0001 par value; 250,000,000 shares authorized

and 546,635 shares issued at December 31, 2025; 250,000,000 shares

authorized and 1,617,642 shares issued at June 30, 2026

55

161

Additional paid-in capital

111,280,560

117,690,050

Accumulated deficit

(108,515,846 )

(110,262,597 )

Total stockholders’ equity

2,764,769

7,427,614

Total liabilities and stockholders’ equity

$ 24,520,013

$ 26,768,318

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Name of the state or province.

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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

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Indicate if registrant meets the emerging growth company criteria.

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

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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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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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Local phone number for entity.

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

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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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Name of the Exchange on which a security is registered.

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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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