What changed in this filing

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Item 1. Financial Statements

2025-10-30 compared with 2025-07-31 · 103 added, 65 removed, 183 unchanged (48% of the section changed)

3 unchanged sentences

thousands except par values, unless otherwise indicated)

September 30,

Current assets:

16 unchanged sentences

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

Common stock, par value $ 0.00001 , 250,000 shares authorized, 20,216 and 17,536 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

7 unchanged sentences

For the Three Months Ended

the Six Months Ended

September 30,

For the Nine Months Ended

September 30,

Operating expenses:

4 unchanged sentences

Realized gains from sales of trading securities

Unrealized gain (loss) from

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:

loss per basic and diluted common share:

average number of common shares outstanding:

Basic and Diluted

3 unchanged sentences

thousands, unless otherwise indicated)

Three Months Ended June 30, 2025

Three Months Ended September 30, 2025

Stockholders’

Balance, April 1, 2025

Balance, July 1, 2025

$ ( 163,052 )

Common stock issued for exercise of pre-funded warrants

Common stock issued for exercise of warrants

Stock-based compensation

Balance, June 30, 2025

$ ( 163,052 )

Three Months Ended June 30, 2024

Balance, September 30, 2025

Three Months Ended September 30, 2024

Stockholders’

Balance, April 1, 2024

Balance, July 1, 2024

$ ( 139,984 )

Common Stock and Warrants Issued in Public Offering

Stock-based compensation

Balance, June 30, 2024

Balance, September 30, 2024

$ ( 145,626 )

Six Months Ended June 30, 2025

Nine Months Ended September 30, 2025

Stockholders’

1 unchanged sentence

$ ( 151,855 )

Common stock issued for exercise of warrants

Stock-based compensation

Common stock issued for exercise of pre-funded warrants

Balance, June 30, 2025

Balance, September 30, 2025

$ ( 167,591 )

Six Months Ended June 30, 2024

Nine Months Ended September 30, 2024

Stockholders’

2 unchanged sentences

$ ( 130,036 )

Common Stock and Warrants Issued in Public Offering

Stock-based compensation

Options exercised

Balance, June 30, 2024

Balance, September 30, 2024

$ ( 145,626 )

4 unchanged sentences

thousands, unless otherwise indicated)

For the Six Months Ended June 30,

For the Nine Months Ended September 30,

Cash Flows from Operating Activities

15 unchanged sentences

Cash Flows from Financing Activities

Proceeds from private placement offering

Proceeds from warrant exercises

Proceeds from stock option exercises

27 unchanged sentences

2 – Management’s Liquidity Plan

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.

of September 30, 2025, the Company had a cash and investment balance of $ 31.0 million and working capital of $ 29.1 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 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

6 unchanged sentences

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.

as of September 30, 2025 and December 31, 2024, and for the three and nine months ended September 30, 2025 and 2024.

results of operations for the three and nine months ended September 30, 2025 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, 2024 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February

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

4 – Investments

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

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

of Components of Investments

June 30, 2025

September 30, 2025

December 31, 2024

12 unchanged sentences

There were aggregate uninsured cash balances of

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

$ 1.0 million and $ 0.9 million as of September 30, 2025 and December 31, 2024, respectively.

6 – Accounts Payable Accrued Expenses and Other Current Liabilities

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

payable, accrued expenses and other current liabilities consist of the following:

of Accounts Payable, Accrued Expenses and Other Current Liabilities

(In thousands)

September 30,

Accounts payable

11 unchanged sentences

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.

and was $ 0.7 million and $ 1.0 million during the three months ended September 30, 2025 and 2024, respectively, and $ 2.8 million and $ 3.1

million during the nine months ended September 30, 2025 and 2024.

As of September 30, 2025, there was $ 3.7 million of unrecognized stock-based

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

of 1.83 years.

were no options granted during the three months ended September 30, 2025 and 2024.

There were 600,000 and 423,000 options granted during

the nine months ended September 30, 2025 and 2024, respectively, in connection with entering into certain employment and consulting agreements.

were no option grants forfeited during the three months ended September 30, 2025.

There were approximately 529,000 option grants forfeited

during the nine months ended September 30, 2025.

There were approximately 2,000 and 44,000 option grants forfeited during the three and

nine months ended September 30, 2024, respectively.

were no option grants exercised during the three and nine months ended September 30, 2025.

There were no option grants exercised during

the three months ended September 30, 2024 and there were approximately 13,000 option grants exercised during the nine months ended September

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.

During the three and nine months ended

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

No expense has been

recorded as of September 30, 2025.

warrants issued in 2021 totaling approximately 909,000 units were exercised during the three months ended September 30, 2025, at an exercise

price of $ 0.0001 per share.

Pre-funded warrants issued in 2023 and 2021 totaling approximately 861,000 and 1,759,000 units, respectively,

were exercised during the nine months ended September 30, 2025, at an exercise price of $ 0.0001 per share.

issued in 2024 totaling 60,000 units were exercised during the three months ended September 30, 2025, at an exercise price of $ 4.025

warrant issued in 2021 was exercised during the three months ended September 30, 2025, at an exercise price of $ 7.00 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 June 30, 2025 and 2024:

per common share:

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

1 unchanged sentence

(In thousands)

September 30,

Shares of common stock issuable upon exercise of warrants

2 unchanged sentences

10 – Segment Reporting

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 has determined that it currently operates in a single 1

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.

5 unchanged sentences

For the Three Months Ended

For the Six Months Ended

September 30,

For the Nine Months Ended

September 30,

(In thousands)

5 unchanged sentences

Professional fees

Reserve for uncollectible prepaid clinical costs

Reserve for (recovery of) uncollectible prepaid clinical costs

Total selling, general and administrative expense

3 unchanged sentences

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

11 – Subsequent Events

October 7, 2025, the Company received notification from Nasdaq notifying the Company that, because the closing bid price for the Company’s

common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price

requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2) of Nasdaq Listing Rules.

notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until

April 6, 2026, to regain compliance with the minimum bid price requirement.

To regain compliance, the closing bid price of the Company’s

common stock must close at or above $1.00 per share for a minimum of 10 consecutive trading days (which period may be extended to greater

than 10 consecutive trading days at the sole discretion of Nasdaq) prior to April 6, 2026.

the event the Company does not regain compliance by April 6, 2026, the Company may be eligible for an additional 180 calendar day compliance

period to demonstrate compliance with the bid price requirement.

To qualify for the additional 180-day period, the Company will be required

to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq

Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to

cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.

If the Nasdaq staff determines

that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance

period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting.

The Company would have the right

to appeal a determination to delist its common stock, and the common stock would remain listed on the Nasdaq Capital Market until the

completion of the appeal process.

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