What changed in this filing

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Item 1. Financial Statements

2025-04-30 compared with 2024-10-31 · 101 added, 97 removed, 127 unchanged (61% of the section changed)

1 unchanged sentence

MEDICAL CORPORATION

BALANCE SHEETS

September 30, 2024

CONSOLIDATED BALANCE SHEETS

March 31, 2025

December 31, 2024

15 unchanged sentences

Total Liabilities

Commitments and Contingencies

Commitments and Contingencies (Note 8)

Stockholders’ Equity:

1 unchanged sentence

no shares issued or outstanding

Common stock, par value $ 0.00001 , 250,000 shares authorized, 17,536 and 13,317 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

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

Additional paid-in capital

2 unchanged sentences

Total Liabilities and Stockholders’ Equity

Notes to these Unaudited Condensed Financial Statements

Notes to these Unaudited Condensed Consolidated Financial Statements

MEDICAL CORPORATION

STATEMENTS OF OPERATIONS

CONSOLIDATED STATEMENTS OF OPERATIONS

For the Three Months Ended

For the Nine Months Ended

September 30,

(In thousands, except per share data)

5 unchanged sentences

Realized gain from sales of trading securities

Unrealized gain from trading securities

Unrealized gain (loss) from trading securities

Interest income, net

3 unchanged sentences

Basic and Diluted

Notes to these Unaudited Condensed Financial Statements

Notes to these Unaudited Condensed Consolidated Financial Statements

MEDICAL CORPORATION

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

thousands, unless otherwise indicated)

Three Months Ended September 30, 2024

Stockholders’

Balance at July 1, 2024

$ ( 139,984 )

Common Stock and Warrants Issued in Public Offering

Share-Based Compensation

Balance at September 30, 2024

$ ( 145,626 )

Three Months Ended September 30, 2023

Stockholders’

Balance at July 1, 2023

$ ( 119,386 )

Share-Based Compensation

Balance at September 30, 2023

$ ( 124,387 )

Nine Months Ended September 30, 2024

Stockholders’

Balance at January 1, 2025

$ ( 151,855 )

Common Stock and Warrants Issued in Public Offering

Share-Based Compensation

Options exercised

Balance at September 30, 2024

Stock-based compensation

Balance at March 31, 2025

$ ( 156,358 )

Nine Months Ended September 30, 2023

Stockholders’

2 unchanged sentences

$ ( 130,036 )

Share-Based Compensation

Balance at September 30, 2023

Stock-based compensation

Options exercised

Balance at March 31, 2024

$ ( 135,028 )

Notes to these Unaudited Condensed Financial Statements

Notes to these Unaudited Condensed Consolidated Financial Statements

MEDICAL CORPORATION

STATEMENTS OF CASH FLOWS

CONSOLIDATED STATEMENTS OF CASH FLOWS

thousands, unless otherwise indicated)

For the Nine Months Ended

September 30,

For the Three Months Ended

Cash Flows from Operating Activities

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

Share-based compensation

Stock-based compensation

Depreciation and amortization

Amortization of right of use assets

Unrealized gain from investments, net

Unrealized gain (loss) from investments

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

Security deposit and other assets

Accounts payable, accrued expenses and other current liabilities

2 unchanged sentences

Cash Flows from Investing Activities

Purchase of property and equipment

Purchases of investments

Maturities of investments

Purchase of investments

Purchase of property and equipment

Net Cash Provided by Investing Activities

Cash Flows from Financing Activities

Proceeds from public offering

Proceeds from Stock Option Exercises

Net Cash Provided by Financing Activities

Net Increase in Cash, Cash Equivalents

Net Increase (Decrease) in Cash

Cash, cash equivalents - Beginning of period

Cash, cash equivalents - End of period

Notes to these Unaudited Condensed Financial Statements

Notes to these Unaudited Condensed Consolidated Financial Statements

MEDICAL CORPORATION

TO CONDENSED FINANCIAL STATEMENTS

TO CONDENSED CONSOLIDATED 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 venous disease.

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®, which is a potential first-in-class surgical replacement venous valve that is currently

being evaluated in a U.S.

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.

pivotal study.

The Company is also developing a second product called enVVe®, which is a potential first-in-class,

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 accessories.

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.

5 unchanged sentences

2 – Management’s Liquidity Plan

of September 30, 2024, the Company had a cash and investment balance of $ 48.4 million and working capital of $ 47.3 million.

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

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.

MEDICAL CORPORATION

TO CONDENSED FINANCIAL STATEMENTS

3 – Significant Accounting Policies

6 unchanged sentences

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

the Company as of September 30, 2024 and December 31, 2023, and for the three and nine months ended September 30, 2024 and 2023.

results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the operating results

for the full year.

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

thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February

The accompanying condensed balance sheet as of December 31, 2023 has been derived from the Company’s audited financial

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.

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 September 30, 2024 and December 31, 2024:

Schedule of Components of Investments

September 30, 2024

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

of Components of Investments

March 31, 2025

December 31, 2024

6 unchanged sentences

of available evidence.

MEDICAL CORPORATION

TO CONDENSED FINANCIAL STATEMENTS

5 – Concentrations

3 unchanged sentences

There were aggregate uninsured cash balances of

$ 14.9 million and $ 3.4 million as of September 30, 2024 and December 31, 2023, respectively.

$ 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

7 – Accounts Payable Accrued Expenses and Other Current Liabilities

of September 30, 2024, and December 31, 2023, accounts payable, accrued expenses and other current liabilities consist of the following:

of March 31, 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)

September 30, 2024

March 31, 2025

December 31, 2024

8 unchanged sentences

MEDICAL CORPORATION

TO CONDENSED FINANCIAL STATEMENTS

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

9 – Stockholders’ Equity

Company consummated a public offering on September 30, 2024 whereby it raised net proceeds of $ 13.3 million and issued 4.2 million

shares of common stock, 0.1 million prefunded warrants and 0.3 million warrants to the underwriter.

The weighted average exercise price

of the warrants is $ 3.18 .

fees in connection with the capital raise were $ 1.4 million.

warrants have a fair value of $ 1.0 million based on the Black Scholes method and the following weighted average input assumptions:

of Estimated Fair values and Assumptions

Contractual term in years

Risk free interest rate

Dividend yield

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

was $ 1.0 million and $ 1.1 million during the three months ended September 30, 2024 and 2023, respectively, and $ 3.1 million and $ 4.1

million during the nine months ended September 30, 2024 and 2023.

As of September 30, 2024, there was $ 4.3 million of unrecognized stock-based

compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period

of 1.9 years.

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.

10 – 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 September 30, 2024 and 2023:

Schedule of Dilutive Net Loss Per Common Share

(In thousands)

September 30,

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

of Dilutive Net Loss Per Common Share

(In thousands)

2 unchanged sentences

Potentially dilutive common stock equivalents excluded from diluted net loss per share

11 – 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.

The following table sets forth segment expenses.

of Segment Expenses

(In thousands)

Research and Development:

Employee expense

Total research and development

Selling, general and administrative expense

Employee expense

Professional fees

Total selling, general and administrative expense

Loss from Operations

Adjustments and reconciling Items

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.

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