What changed in this filing

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Item 1. Financial Statements

2025-07-31 compared with 2025-04-30 · 123 added, 103 removed, 125 unchanged (64% of the section changed)

1 unchanged sentence

MEDICAL CORPORATION

CONSOLIDATED BALANCE SHEETS

March 31, 2025

December 31, 2024

(In thousands except par values, unless otherwise indicated)

BALANCE SHEETS

thousands except par values, unless otherwise indicated)

Current assets:

13 unchanged sentences

Total liabilities

Commitments and Contingencies (Note 8)

Commitments and Contingencies

Stockholders’ Equity:

Preferred stock, par value $ 0.00001 , 10,000 shares authorized:

no shares issued or outstanding

Common stock, par value $ 0.00001 , 250,000 shares authorized, 17,536 shares issued and outstanding as of March 31, 2025 and December 31, 2024

Preferred stock, par value $ 0.00001 , 10,000 shares authorized, no shares issued or outstanding

Common stock, par value $ 0.00001 , 250,000 shares authorized, 19,247 and 17,536 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

2 unchanged sentences

Total liabilities and stockholders’ equity

Notes to these Unaudited Condensed Consolidated Financial Statements

Notes to these Unaudited Condensed Financial Statements

MEDICAL CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

STATEMENTS OF OPERATIONS

thousands, except per share data)

For the Three Months Ended

(In thousands, except per share data)

the Six Months Ended

Operating expenses:

3 unchanged sentences

Other income:

Realized gain from sales of trading securities

Unrealized gain (loss) from trading securities

Realized gains from sales of trading securities

Unrealized gain (loss) from

trading securities

Interest income, net

Total other income

Net Loss Per Basic and Diluted Common Share:

Weighted Average Number of Common Shares Outstanding:

Net loss per basic and diluted

common share:

Weighted average number of

common shares outstanding:

Basic and Diluted

Notes to these Unaudited Condensed Consolidated Financial Statements

Notes to these Unaudited Condensed Financial Statements

MEDICAL CORPORATION

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

thousands, unless otherwise indicated)

Three Months Ended June 30, 2025

Stockholders’

Balance at January 1, 2025

Balance, April 1, 2025

$ ( 156,358 )

Common stock issued for exercise of pre-funded warrants

Stock-based compensation

Balance at March 31, 2025

Balance, June 30, 2025

$ ( 163,052 )

Three Months Ended June 30, 2024

Stockholders’

Balance at January 1, 2024

Balance, April 1, 2024

$ ( 135,028 )

Stock-based compensation

Balance, June 30, 2024

$ ( 139,984 )

Six Months Ended June 30, 2025

Stockholders’

Balance, January 1, 2025

$ ( 151,855 )

Stock-based compensation

Common stock issued for exercise of pre-funded warrants

Balance, June 30, 2025

$ ( 163,052 )

Six Months Ended June 30, 2024

Stockholders’

Balance, January 1, 2024

$ ( 130,036 )

Stock-based compensation

Options exercised

Balance at March 31, 2024

Balance, June 30, 2024

$ ( 139,984 )

Notes to these Unaudited Condensed Consolidated Financial Statements

Notes to these Unaudited Condensed Financial Statements

MEDICAL CORPORATION

CONSOLIDATED STATEMENTS OF CASH FLOWS

STATEMENTS OF CASH FLOWS

thousands, unless otherwise indicated)

For the Three Months Ended

For the Six Months Ended June 30,

Cash Flows from Operating Activities

11 unchanged sentences

Maturities of investments

Purchase of investments

Purchase of property and equipment

Purchases of investments

Net cash provided by investing activities

2 unchanged sentences

Net cash provided by financing activities

Net Increase (Decrease) in Cash

Cash, cash equivalents - Beginning of period

Cash, cash equivalents - End of period

Notes to these Unaudited Condensed Consolidated Financial Statements

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents - Beginning of period

Cash and cash equivalents - End of period

Notes to these Unaudited Condensed Financial Statements

MEDICAL CORPORATION

TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

TO CONDENSED FINANCIAL STATEMENTS

1 – Business Organization and Nature of Operations

Medical Corporation (the “Company”) is a late clinical-stage medical device company focused on the advancement of

innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.

Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous

Insufficiency (“CVI”) of the deep venous system of the leg.

Company’s lead product is the VenoValve®, a potential first of its kind

surgical replacement venous valve currently in post-enrollment follow-up of its U.S.

Medical Corporation (the “Company”) is a late clinical-stage medical device company focused on the advancement of innovative

bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease.

The Company is developing

surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”)

of the deep venous system of the leg.

Company’s lead product is the VenoValve®, a potential first of its kind surgical replacement venous valve currently in post-enrollment

follow-up of its U.S.

pivotal study.

The Company is also developing a second

product called enVVe®, a next-generation, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe

valve, the enVVe delivery system, and the delivery system accessories.

The Company is also developing a second product called enVVe®, a next-generation, non-surgical,

transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system

The Company is currently conducting pre-clinical testing on enVVe.

Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back

to the heart and lungs.

Both the VenoValve and enVVe are designed to act as one-way

valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

VenoValve and enVVe are being developed first for approval by the U.S.

Food and Drug Administration (“FDA”).

We expect the VenoValve to

be eligible for FDA approval first, followed two to three years later by enVVe.

If approved, we expect the VenoValve and enVVe to co-exist,

with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option.

We expect the

VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe.

If approved, we expect the VenoValve and

enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve

2 – Management’s Liquidity Plan

of March 31, 2025, the Company had a cash and investment balance of $ 38.9 million and working capital of $ 37.8 million.

Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations,

pursue its product development initiatives and penetrate markets for the sale of its products.

Management believes the Company’s capital resources

are sufficient to meet its obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.

of June 30, 2025, the Company had a cash and investment balance of $ 35.1

million and working capital of $ 32.6

Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional

capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products,

management believes that the Company’s capital resources are sufficient to meet its obligations as they become due within one

year after the date of this Quarterly Report, and sustain operations.

3 – Significant Accounting Policies

4 unchanged sentences

of America for complete financial statements.

In the opinion of management, such statements include all adjustments (consisting only

of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of

the Company as of March 31, 2025 and December 31, 2024, and for the three months ended March 31, 2025 and 2024.

results of operations for the three months ended March 31, 2025 are not necessarily indicative of the operating results for the full

These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for

the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February 28, 2025.

In the opinion of management, such statements include all adjustments (consisting of normal

recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company

as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024.

results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the operating results for the

These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto

for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February 28,

The accompanying condensed balance sheet as of December 31, 2024 has been derived from the Company’s audited financial statements.

MEDICAL CORPORATION

TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

4 – Investments

components of investments were as follows at March 31, 2025 and December 31, 2024:

components of investments at June 30, 2025 and December 31, 2024 were as follows:

of Components of Investments

March 31, 2025

June 30, 2025

December 31, 2024

(In thousands)

Fair Value Level 1

3 unchanged sentences

to changes in interest rates.

Management does not believe any remaining unrealized losses represent impairments based on our evaluation

Management does not believe any remaining unrealized losses represent impairments based on its evaluation

of available evidence.

4 unchanged sentences

There were aggregate uninsured cash balances of

$ 1.5 million and $ 0.9 million as of March 31, 2025 and December 31, 2024, respectively.

6 – Property and Equipment

of March 31, 2025 and December 31, 2024, property and equipment consist of the following:

of Property and Equipment

(In thousands)

March 31, 2025

December 31, 2024

Laboratory equipment

Computer equipment and software

Leasehold improvements, furniture and fixtures

Total property and equipment

accumulated depreciation

Property and equipment, net

expense amounted to $ 0.1 million for the three months ended March 31, 2025 and 2024.

Depreciation expense is reflected in general and

administrative expenses in the accompanying statements of operations.

MEDICAL CORPORATION

TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

$ 0.7 million and $ 0.9 million as of June 30, 2025 and December 31, 2024, respectively.

6 – Accounts Payable Accrued Expenses and Other Current Liabilities

of March 31, 2025, and December 31, 2024, accounts payable, accrued expenses and other current liabilities consist of the following:

of June 30, 2025, and December 31, 2024, accounts payable, accrued expenses and other current liabilities consist of the following:

of Accounts Payable, Accrued Expenses and Other Current Liabilities

(In thousands)

March 31, 2025

December 31, 2024

Accounts payable

Accrued compensation costs

Accrued clinical costs

Accrued severance

Other accrued expenses

Total accrued expenses and other current liabilities

Total accounts payable, accrued expenses and other current liabilities

7 – Commitments and Contingencies

2 unchanged sentences

The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable

MEDICAL CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

8 – Stockholders’ Equity

compensation is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and

was $ 0.7 million and $ 1.1 million during the three months ended March 31, 2025 and 2024, respectively.

As of March 31, 2025, there was

$ 4.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted

average remaining vesting period of 1.95 years.

Incentive Plan

compensation expense is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations

and was $ 1.4 million and $ 1.0 million during the three months ended June 30, 2025 and 2024, respectively, and $ 2.1 million during the

six months ended June 30, 2025 and 2024.

As of June 30, 2025, there was $ 4.4 million of unrecognized stock-based compensation expense

related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 2.02 years.

were 600,000 and 423,000 options granted during the three and six months ended June 30, 2025 and 2024, respectively, in connection with

entering into certain employment and consulting agreements.

were approximately 529,000 option grants forfeited during the three and six months ended June 30, 2025.

There were 19,000 and 42,000

option grants forfeited during the three and six months ended June 30, 2024.

were no option grants exercised during the three and six months ended June 30, 2025.

There were no option grants exercised during the

three months ended June 30, 2024 and there were 13,000 option grants exercised during the six months ended June 30, 2024.

stock unit vesting is conditioned on achieving the Pre-Market Approval of the VenoValve milestone.

During the three and six months ended

June 30, 2025, there were 50,000 restricted stock units forfeited in connection with employment termination.

No expense has been recorded

as of June 30, 2025.

warrants issued in 2023 and 2021 totaling approximately 861,000 and 850,000 units, respectively, were exercised during the three and

six months ended June 30, 2025, at an exercise price of $ 0.0001 per share.

9 – Net Loss per Share

following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss

per common share as of March 31, 2025 and 2024:

of Dilutive Net Loss Per Common Share

per common share as of June 30, 2025 and 2024:

of Potentially Dilutive Common Stock Equivalents Excluded From Calculation of Diluted Net Loss

Per Common Share

(In thousands)

3 unchanged sentences

10 – Segment Reporting

The Company has determined

that it currently operates in a single segment, Medical Device development, located in a single geographic location, the United

The accounting policies of the segment are the same as those described in the summary of significant accounting policies set forth in our Form 10-K/A, filed with the SEC on February 28, 2025.

Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that

reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations,

respectively.

The Company’s chief operating

decision maker (“CODM”) is the chief executive officer.

The CODM uses operating expenses to measure performance against progress

in its clinical trials and its product development.

Company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location,

the United States.

The accounting policies of the segment are the same as those described in the summary of significant accounting policies

set forth in the Company’s Form 10-K/A, filed with the SEC on February 28, 2025.

Since the Company operates in a single segment, the measure of

segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the

accompanying statement of operations as loss from operations, respectively.

Company’s chief operating decision maker (“CODM”) is the chief executive officer.

The CODM uses operating expenses

to measure performance against progress in its clinical trials and its product development.

The following table sets forth segment expenses.

1 unchanged sentence

(In thousands)

For the Three Months Ended

For the Six Months Ended

(In thousands)

5 unchanged sentences

Professional fees

Reserve for uncollectible prepaid clinical costs

Total selling, general and administrative expense

2 unchanged sentences

and reconciling items between loss from operations and net loss consist of interest income and realized and unrealized gains and losses

related to our investments in US Treasury securities.

related to the Company’s investments in US Treasury securities.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements