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Form 8-K

sec.gov

8-K — KORU Medical Systems, Inc.

Accession: 0001161697-26-000107

Filed: 2026-05-06

Period: 2026-05-06

CIK: 0000704440

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — form_8-k.htm (Primary)

EX-99 — PRESS RELEASE, DATED MAY 6, 2026 (ex_99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 6, 2026

KORU Medical Systems, Inc.

(Exact name of registrant as specified in its charter)

Delaware

0-12305

13-3044880

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

100 Corporate Drive, Mahwah, NJ

07430

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area

code   (845) 469-2042

______________________________________________

(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 Instruction

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 Act:

Title of each class

Trading symbol(s)

Name of each exchange on which registered

common stock, $0.01 par value

KRMD

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an

emerging growth company as defined in 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.

(a)   Public Announcement or Release.

On May 6, 2026, KORU Medical Systems, Inc. (the “Company”)

issued a press release announcing its financial results for the first fiscal quarter

ended March 31, 2026 and reiterating financial guidance for the fiscal year ended December 31, 2026. The Company’s press

release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A related conference call will be held on May 6, 2026 at 4:30pm

Eastern Time.

KORU Medical is making reference to

non-GAAP financial measures in both the press release and the conference call. Our management believes that investors’ understanding

of KORU Medical’s performance is enhanced by disclosing the non-GAAP financial measures of “adjusted EBITDA” and “adjusted

diluted EPS” (each as defined below) as a reasonable basis for comparison of our ongoing results of operations. KORU Medical strongly

encourages investors to review its consolidated financial statements and publicly filed reports in their entirety and cautions investors

that the non-GAAP measures used by KORU Medical may differ from similar measures used by other companies, even when similar terms are

used to identify such measures. Non-GAAP measures should not be considered replacements for, and should be read together with, the most

comparable GAAP financial measures. A reconciliation of GAAP to non-GAAP results is provided in the attached Exhibit 99.1 press release.

We define adjusted EBITDA as earnings

(net (loss)/income) before depreciation and amortization, interest (income), net, litigation expense and stock-based compensation expense.

We believe that adjusted EBITDA is used by investors and other users of our financial statements as a supplemental financial measure that,

when viewed with our GAAP results and the accompanying reconciliation, we believe provides additional information that is useful to gain

an understanding of the factors and trends affecting our business. We also believe the disclosure of adjusted EBITDA helps investors meaningfully

evaluate and compare our cash flow generating capacity from quarter to quarter and year to year. Adjusted EBITDA is used by management

as a supplemental internal measure for planning and forecasting overall expectations and for evaluating actual results against such expectations.

We present adjusted diluted earnings

per share (“adjusted diluted EPS”) after eliminating items that we believe are not part of our ordinary operations and affect

the comparability of the periods presented. Adjusted diluted EPS includes adjustments from reported diluted earnings per share for depreciation

and amortization, interest (income), net, litigation expense and stock-based compensation expense. We believe adjustments for these items

allow investors to better understand our underlying operating results and facilitate comparisons between the periods shown. Management

uses adjusted diluted EPS as a supplemental internal measure for planning and forecasting overall expectations and for evaluating actual

results against such expectations.

The information contained in this Item 2.02 of the

Form 8-K 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 to be incorporated by reference into any

filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as

expressly set forth by specific reference in such filing.

ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.

(d)   Exhibits.

Exhibit No.

Description

99.1

Press Release, dated May 6, 2026

104

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

- 2 -

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.

KORU Medical Systems, Inc.

(Registrant)

Date:  May 6, 2026

By:

/s/ Linda Tharby

Linda Tharby

Chief Executive Officer

- 3 -

EX-99 — PRESS RELEASE, DATED MAY 6, 2026

EX-99

Filename: ex_99-1.htm · Sequence: 2

EXHIBIT 99.1

KORU Medical Systems Announces First Quarter

2026 Results

MAHWAH, NJ – May 6, 2026 – KORU Medical

Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused

on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions,

today reported financial results for the first quarter ended March 31, 2026. The Company also reiterated guidance for the full year 2026.

Recent Highlights

First quarter 2026 net revenues of $11.8 million grew 22% over the prior year period

First quarter 2026 gross profit grew 20% over the prior year period to $7.2 million, with gross margin of 61.5%

First quarter 2026 net loss improved 31% to ($0.8) million

Ending cash balance of $8.8 million reflects cash usage of approximately $0.1 million in the first quarter of 2026

Submitted 510(k) application for use of the Freedom Infusion System with deferoxamine

Two existing non-Ig pharma collaborations advanced to Phase III clinical trials

“We are proud to deliver a record start to 2026,

with $11.8 million in revenue, representing 22% growth,” said Linda Tharby, CEO of KORU Medical. “Our Core business continues

to outperform the underlying SCIg market, driven increased share gains in current and new accounts. Internationally, momentum remains

robust as we expand into prefilled syringe markets with our patient-preferred Freedom Infusion System. With a growing recurring patient

base and scalable commercial model, Koru is well positioned for further success.”

Adam Kalbermatten, President and Chief Commercial

Officer, added, "Equally exciting to our strength in core markets is the momentum we are building in new drug categories with our

support of late-stage molecules through their regulatory pathways, including compelling oncology opportunities ahead. A strong team, a

clear strategic roadmap, and an expanding platform to access new therapies and new geographies, makes me confident in our long-term strategy

and the strong foundation we have built to execute."

2026 First Quarter Financial Results

Three Months Ending March 31,

Change from Prior Year

% of Net Revenues

2026

2025

$

%

2026

2025

Net Revenues

Domestic Core

$

7,739,872

$

6,927,964

$

811,908

11.7%

65.8%

71.9%

International Core

3,284,041

2,428,662

855,379

35.2%

27.9%

25.2%

Total Core

11,023,913

9,356,626

1,667,287

17.8%

93.7%

97.1%

Pharma Services and Clinical Trials

740,711

278,449

462,262

166.0%

6.3%

2.9%

Total

$

11,764,624

$

9,635,075

$

2,129,549

22.1%

100%

100%

Total net revenues increased $2.1 million, or 22.1%,

to $11.8 million for the three months ending March 31, 2026, as compared to $9.6 million in the prior year period. Domestic core revenues

were $7.7 million, an increase of 11.7% over the prior year period, primarily due to higher consumable volumes, driven by new patient

starts and market share gains within new and existing accounts, supported by a strong underlying SCIg market. International core revenues

were $3.3 million, an increase of 35.2% over the prior year period, primarily due to higher pump and consumable volumes, driven by distributor

purchases supporting pre-filled syringe (PFS) conversions for a key EU market. Pharma services and clinical trials net revenues were $0.7

million, an increase of 166.0% over the prior year period, primarily due to higher clinical trial product revenues for advancing existing

collaborations.

Gross profit increased $1.2 million, or 19.6%,

to $7.2 million in the three months ending March 31, 2026, as compared to $6.0 million in the prior year period. Gross margin

decreased to 61.5% in the three months ending March 31, 2026, as compared to 62.8% in the prior year period. The decrease in gross

margin was primarily driven by higher production costs based on timing of production runs in the prior quarter that were amortized

in the three months ended March 31, 2026, and tariff-related charges that did not occur in the prior year period, partially offset

by a favorable geographic sales mix.

Total operating expenses increased $0.8 million, or

11.0%, to $8.1 million for the first quarter of 2026 primarily driven by an increase of $0.6 million in selling, general, and administrative

expenses, and an increase of $0.2 million in research and development expenses. The increase in selling, general and administrative expenses

was primarily driven by increases in legal fees and compensation expenses related to salary and stock compensation, partially offset by

lower temporary labor expenses.

Net loss decreased $0.4 million to $0.8 million or

($0.02) per diluted share for the first quarter of 2026, compared to a net loss of $1.2 million, or ($0.03) per diluted share, for the

prior year period. Adjusted EBITDA for the quarter was ($0.01) million, or $0.00 per diluted share versus ($0.2) million or ($0.00) per

diluted share in the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS to the most directly comparable GAAP

measures is provided at the end of this press release.

Cash and cash equivalents were $8.8 million as of

March 31, 2026, reflecting cash usage of $0.1 million in the first quarter of 2026.

Reiterating 2026 Guidance

KORU Medical expects:

Reiterating full year 2026 net revenues between $47.5 - $50.0 million representing growth of 15% - 22%

Reiterating full year 2026 gross margin between 61 - 63%

Reiterating positive adjusted EBITDA and positive cash flow for the full year 2026

Conference Call and Webcast Details

The Company will host a live conference call and webcast

to discuss these results and provide a corporate update on Wednesday, May 6, 2026, at 4:30 PM ET.

To participate in the call, please dial (877) 407-0784

(domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors

section of KORU Medical’s website.

Non-GAAP Measures

This press release includes the non-GAAP financial

measures “adjusted diluted EPS” and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally

accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based

on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or

superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges

that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures

to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction

with GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release.

About KORU Medical Systems

KORU Medical Systems develops, manufactures, and commercializes

innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world.

The Freedom Syringe Infusion System (the “Freedom System”) currently includes the Freedom60® and FreedomEDGE®

Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which

received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory

infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products

for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of

customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.

- 2 -

Forward-looking Statements

This press release contains forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are

not historical fact are forward-looking statements, including, but not limited to, financial guidance and expected operating performance

for fiscal 2026. Forward-looking statements discuss the Company’s current expectations and projections relating to its financial

position, results of operations, plans, objectives, future performance, and business. Forward-looking statements can be identified by

words such as “guidance”, “expect” and “will”. Actual results may differ materially from the results

predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties

that could cause actual results to differ from the results predicted include, among others, uncertainties associated with inflation, tariffs,

war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to

recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration

and foreign authority regulations and the outcome of regulatory audits, introduction and adoption of competitive products, acceptance

of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement

related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market

of the Freedom System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the

impact of recent accounting pronouncements, and those risks and uncertainties included under the captions “Risk Factors” in

our Annual Report on Form 10-K for the year ended December 31, 2025, which is on file with the SEC and available on our website at www.korumedical.com/investors

and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of May 6, 2026. Undue reliance

should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date

hereof. We undertake no duty to update this information unless required by law.

Investor Contact:

Louisa Smith

investor@korumedical.com

- 3 -

KORU MEDICAL SYSTEMS, INC.

BALANCE SHEETS

March 31,

December 31,

2026

2025

(UNAUDITED)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

8,767,774

$

8,872,212

Accounts receivable

5,982,536

6,209,950

Inventory, net

4,476,304

3,678,131

Other receivables

335,206

319,955

Prepaid expenses

1,026,614

908,542

TOTAL CURRENT ASSETS

20,588,434

19,988,790

Property and equipment, net

4,335,882

4,471,386

Intangible assets, net of accumulated amortization of $545,302 and $527,949 as of March 31, 2026 and December 31, 2025, respectively

711,211

684,841

Operating lease right-of-use assets

2,857,341

2,956,192

Other assets

98,970

98,970

TOTAL ASSETS

$

28,591,838

$

28,200,179

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES

Accounts payable

$

2,635,701

$

2,267,473

Accrued expenses

5,271,100

4,828,830

Other liabilities

11,068

27,722

Accrued payroll and related taxes

385,890

531,972

Financing lease liability

126,323

124,913

Operating lease liability

421,727

413,448

TOTAL CURRENT LIABILITIES

8,851,809

8,194,358

Financing lease liability, net of current portion

46,560

78,675

Operating lease liability, net of current portion

2,771,115

2,879,224

TOTAL LIABILITIES

11,669,484

11,152,257

STOCKHOLDERS’ EQUITY

Common stock, $0.01 par value, 75,000,000 shares authorized, 49,933,502 and 49,790,934 shares issued 46,133,000 and 46,370,432 shares outstanding as of March 31, 2026, and December 31, 2025, respectively

499,335

497,909

Additional paid-in capital

54,795,722

52,449,339

Treasury stock, 3,818,526 and 3,438,526 shares as of March 31, 2026 and December 31, 2025, respectively, at cost

(5,548,793

)

(3,882,494

)

Accumulated deficit

(32,823,910

)

(32,016,832

)

TOTAL STOCKHOLDERS’ EQUITY

16,922,354

17,047,922

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

28,591,838

$

28,200,179

- 4 -

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF OPERATIONS

(UNAUDITED)

Three Months Ended

March 31,

2026

2025

NET REVENUES

$

11,764,624

$

9,635,075

Cost of goods sold

4,533,235

3,588,740

Gross Profit

7,231,389

6,046,335

OPERATING EXPENSES

Selling, general and administrative

6,582,178

5,959,374

Research and development

1,316,603

1,114,609

Depreciation and amortization

197,531

217,357

Total Operating Expenses

8,096,312

7,291,340

Net Operating Loss

(864,923

)

(1,245,005

)

Non-Operating Income/(Expense)

Gain/(Loss) on currency exchange

(23,150

)

5,588

Interest income, net

80,995

73,180

TOTAL OTHER INCOME

57,845

78,768

LOSS BEFORE INCOME TAXES

(807,078

)

(1,166,237

)

Income Tax Refund (Expense)

NET LOSS

$

(807,078

)

$

(1,166,237

)

NET LOSS PER SHARE

Basic & Diluted

$

(0.02

)

$

(0.03

)

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING

Basic & Diluted

46,364,905

45,981,826

- 5 -

KORU MEDICAL SYSTEMS, INC.

STATEMENTS OF CASH FLOWS

(UNAUDITED)

For the

Three Months Ended

March 31,

2026

2025

CASH FLOWS FROM OPERATING ACTIVITIES

Net Loss

$

(807,078

)

$

(1,166,237

)

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense and warrant expense

681,510

697,590

Depreciation and amortization

197,531

217,357

Non-cash leasing charges

(979

)

Changes in operating assets and liabilities:

Accounts receivable

227,414

(228,661

)

Inventory

(798,173

)

(474,977

)

Prepaid expenses and other assets

(133,323

)

(8,094

)

Other liabilities

(16,655

)

80,828

Accounts payable

368,228

363,608

Accrued payroll and related taxes

(146,081

)

227,316

Accrued expenses

442,269

53,803

NET CASH FROM/(USED IN) OPERATING ACTIVITIES

14,663

(237,467

)

CASH FLOWS FROM INVESTING ACTIVITIES

Purchases of property and equipment

(46,163

)

(443,438

)

Purchases of intangible assets

(43,722

)

(3,400

)

NET CASH USED IN INVESTING ACTIVITIES

(89,885

)

(446,838

)

CASH FLOWS FROM FINANCING ACTIVITIES

Payments on insurance finance indebtedness

(133,973

)

Payments on finance lease liability, net of asset

(29,216

)

(26,835

)

NET CASH USED IN FINANCING ACTIVITIES

(29,216

)

(160,808

)

NET DECREASE IN CASH AND CASH EQUIVALENTS

(104,438

)

(845,113

)

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

8,872,212

9,580,947

CASH AND CASH EQUIVALENTS, END OF PERIOD

$

8,767,774

$

8,735,834

Supplemental Information

Cash paid during the periods for:

Interest

$

2,155

$

5,385

- 6 -

KORU MEDICAL SYSTEMS, INC.

SUPPLEMENTAL INFORMATION

(UNAUDITED)

A reconciliation of our non-GAAP measures is below:

Three Months Ended

Reconciliation of GAAP Net Loss

March 31,

to Non-GAAP Adjusted EBITDA:

2026

2025

GAAP Net Loss

$

(807,078

)

$

(1,166,237

)

Depreciation and Amortization*

197,531

217,357

Interest (Income), Net

(80,996

)

(73,180

)

Litigation Expense

133,411

Stock-based Compensation Expense*

681,510

697,590

Adjusted EBITDA

$

(9,032

)

$

(191,059

)

Weighted average number of common shares

46,364,905

45,981,826

Three Months Ended

Reconciliation of Reported Diluted EPS

March 31,

to Non-GAAP Adjusted Diluted EPS:

2026

2025

Reported Diluted Earnings Per Share

$

(0.02

)

$

(0.03

)

Depreciation and Amortization*

0.00

0.00

Interest (Income), Net

(0.00

)

(0.00

)

Litigation Expense

0.00

Stock-based Compensation Expense*

0.01

0.02

Adjusted Diluted Earnings Per Share

$

(0.00

)

$

(0.00

)

*Numbers presented are rounded to the nearest whole

cent and percentage

Stock-based Compensation Expense. We have excluded

the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expenses related

to grants of options and restricted shares for executives, employees and consultants, and grants of shares to our board of directors.

Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in

future periods.

Litigation Expense. We have excluded the effect

of start-up litigation expense in calculating our non-GAAP measures. In the first quarter 2025 we incurred legal fees with respect to

a claim filed by the Company alleging patent infringement, which we would not have otherwise incurred in the period presented as part

of continuing operations.

- 7 -

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Code for the postal or zip code

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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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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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-Subsection d1-1

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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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