Viskase Holdings, Inc 10-Q for FY2024 Q2
Viskase Holdings, Inc. (VISK)
About this 10-Q
Viskase Holdings, Inc filed this 10-Q on August 8, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $26K
- Net income
- $276K
- up 50.8% from net income of $183K a year earlier
- Diluted EPS
- $0.00
- compared with $0.00 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number
(Exact name of registrant as specified in its charter)
(State of incorporation) | (I.R.S. Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
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| N/A | | N/A |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
| 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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
Shares of Common Stock outstanding as of August 2, 2024:
ENZON PHARMACEUTICALS, INC.
Table of Contents
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 14 | |
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2
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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| June 30, |
| December 31, | ||
| | 2024 | | 2023 | ||
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| (Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents | | $ | | | $ | |
Other current assets | |
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Total current assets | | | | | | |
Deferred tax asset | | | | | | |
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Total assets | | $ | | | $ | |
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LIABILITIES AND STOCKHOLDERS’ EQUITY | |
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Current liabilities: | |
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Accounts payable | | $ | | | $ | |
Accrued expenses and other current liabilities | |
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Dividends payable on Series C preferred stock | | | — | | | |
Total current liabilities | | | | | | |
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Commitments and contingencies | |
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Mezzanine equity: | | | | | | |
Series C preferred stock - $ | | | | | ||
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Stockholders’ equity: | |
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Preferred stock - $ | |
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Common stock - $ | |
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Additional paid-in capital | |
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Accumulated deficit | |
| ( | | | ( |
Total stockholders’ equity | |
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Total liabilities, mezzanine equity and stockholders’ equity | | $ | | | $ | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
| | Three months ended | | Six months ended | ||||||||
| | June 30, | | June 30, | ||||||||
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| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||
Revenues: | | | | | | | | | | | | |
License fees | | $ | | | $ | — | | $ | | | $ | — |
Total revenues | |
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Operating expenses: | |
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General and administrative | |
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Total operating expenses | |
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Operating loss | |
| ( | | | ( | | | ( | | | ( |
Interest and dividend income | | | | | | | | | | | | |
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Income before income tax expense | | | | | | | | | | | | |
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Income tax expense | |
| ( | | | ( | | | ( | | | ( |
| | | | | | | | | | | | |
Net income | | | | | | | | | | | | |
Accretion of dividend on Series C preferred stock | | | ( | | | ( | | | ( | | | ( |
Net loss available to common shareholders | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
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Loss per common share | | | | | | | | | | | | |
Basic and diluted | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
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Weighted-average number of shares – basic | | | | | | | | | | | | |
Weighted-average number of shares – diluted | |
| | | | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY
(In thousands)
(Unaudited)
| | Mezzanine Equity – Series C | | | | | | | | | | | | | | | | |||
| | Preferred Stock | | | Common Stock | | Additional | | | | | Total | ||||||||
| | Number of | | Par | | | Number of | | Par | | Paid-in | | Accumulated | | Stockholders’ | |||||
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| Shares |
| Value |
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| Shares |
| Value |
| Capital |
| Deficit |
| Equity | |||||
Balance, December 31, 2022 | | | | $ | | | | | | $ | | | $ | | | $ | ( | | $ | |
Net income |
| — | |
| — | | | — | | | — | |
| — | |
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Preferred stock dividend accretion | | — | | | | | | — | | | — | | | ( | | | — | | | ( |
Balance, March 31, 2023 | | | | | | | | | | $ | | | | | | | ( | | | |
Net income | | — | | | — | | | — | | | — | | | — | | | | | | |
Preferred stock dividend accretion |
| — | | | | | | — | | | — | | | ( | | | — | | | ( |
Balance, June 30, 2023 | | | | $ | | | | | | $ | | | $ | | | $ | ( | | $ | |
| | Mezzanine Equity – Series C | | | | | | | | | | | | | | | ||||
| | Preferred Stock | | | Common Stock | | Additional | | | | | Total | ||||||||
| | Number of | | Par | | | Number of | | Par | | Paid-in | | Accumulated | | Stockholders’ | |||||
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| Shares |
| Value |
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| Shares |
| Value |
| Capital |
| Deficit |
| Equity | |||||
Balance, December 31, 2023 | | | | | | | | | | $ | | | $ | | | $ | ( | | $ | |
Net income | | — | | | — | | | — | | | — | | | — | | | | | | |
Preferred stock dividend accretion | | — | | | | | | — | | | — | | | ( | | | — | | | ( |
Balance, March 31, 2024 | | | | | | | | | | $ | | | $ | | | $ | ( | | $ | |
Net income |
| — | |
| — | | | — | | | — | |
| — | |
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Preferred stock dividend accretion | | — | | | | | | — | | | — | | | ( | | | — | | | ( |
Balance, June 30, 2024 |
| | | $ | | | | | | $ | | | $ | | | $ | ( | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| | Six months ended | ||||
| | June 30, | ||||
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| 2024 |
| 2023 | ||
Cash flows from operating activities: | | | | | | |
Net income | | $ | | | $ | |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |
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Deferred income taxes | |
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Changes in operating assets and liabilities | | | ( | | | |
Net cash provided by operating activities | |
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Cash flows from financing activities: | |
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Preferred stock dividend payments | | | ( | | | ( |
Net cash used in financing activities | |
| ( | | | ( |
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Net decrease in cash and cash equivalents | |
| ( | | | ( |
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Cash and cash equivalents, beginning of period | |
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Cash and cash equivalents, end of period | | $ | | | $ | |
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Non-cash financing activities: | | | | | | |
Accretion of dividend for Series C Preferred Stock | | $ | | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(1)Description of Business
Enzon Pharmaceuticals, Inc. (together with its subsidiaries, the “Company,” “Enzon,” “we” or “us”) is positioned as a public company acquisition vehicle, where it can become an acquisition platform and potentially utilize its net operating loss carryforwards (“NOLs”) in an effort to enhance stockholder value.
In September 2020, the Company initiated a rights offering for its common and preferred stock (see below and Note 12 to our Condensed Consolidated Financial Statements), which closed in October 2020, and it realized $
Historically, the Company had received royalty revenues from licensing arrangements with other companies primarily related to sales of certain drug products that utilized Enzon’s proprietary technology. In recent years, the Company has had no clinical operations and limited corporate operations. Enzon has a marketing agreement in the drug Vicineum, which, if approved, would, potentially, generate milestone and royalty payments to it in the future. Enzon cannot assure you that it will earn material future royalties or milestones.
The Board and the Company’s management are actively involved in pursuing, sourcing, reviewing and evaluating various potential acquisition transactions consistent with its strategy. The Company’s management and Board have made a number of contacts and engaged in discussions with principals of individual companies and financial advisors on behalf of various individual companies, while continuing to evaluate potential transactions. To date, no acquisition candidates have been identified that are in an actionable state.
The Company has a marketing agreement with Micromet AG, now part of Amgen, Inc. (the “Micromet Agreement”), pursuant to which it may be entitled to certain milestone and royalty payments if Vicineum, a drug that was being developed by Sesen, Inc., (Sesen”) is approved for the treatment of non-muscle invasive bladder cancer. Sesen announced that it had completed a merger with Carisma Therapeutics Inc. (“Carisma”), had paused further development of Vicineum in the United States, and had withdrawn its application to market Vicineum in Europe. Sesen also announced that the combined company will focus on the advancement of Carisma’s proprietary cell therapy for the treatment of cancer and other disorders, and it intends to seek a partner for any further development of Vicineum.
The Company receives an annual license maintenance fee of approximately $
In August 2020, the Board adopted a Section 382 rights plan and declared a dividend distribution of one right for each outstanding share of the Company’s common stock to stockholders of record at the close of business on August 24, 2020. (See Note 11 to the Consolidated Financial Statements.)
In September 2020, the Board approved a Rights Offering (the “Rights Offering”), by which the Company distributed, at no charge to all holders of its common stock on September 23, 2020 (the “Record Date”), transferable subscription rights to purchase units (“Units”) at a subscription price per Unit of $
As a result of the sale of all
7
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(1)Description of Business (continued)
On an annual basis, the Board may, at its sole discretion, cause a dividend with respect to the Series C Preferred Stock to be paid in cash to the holders in an amount equal to
As of June 30, 2024, the Board had not yet determined whether to declare a cash dividend at the end of 2024. Accordingly, the Company accrued an accretion at
The Company maintains its principal executive offices at 20 Commerce Drive, Suite 135, Cranford, New Jersey 07016 through a service agreement with Regus Management Group, LLC.
(2)Basis of Presentation
Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements have been prepared from the books and records of the Company in accordance with United States accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and Rule 10-01 of Regulation S-X promulgated by the Securities and Exchange Commission (“SEC”). Accordingly, these financial statements do not include all of the information and footnotes required for complete annual financial statements. Interim results are not necessarily indicative of the results that may be expected for the full year. Interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated as part of the consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. These estimates include legal and contractual contingencies and income taxes. Although management bases its estimates on historical experience, relevant current information and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
8
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(2)Basis of Presentation (continued)
Revenue Recognition
Royalty revenues from the Company’s agreements with third parties and pursuant to the sale of the Company’s former specialty pharmaceutical business are recognized when the Company can reasonably determine the amounts earned. In most cases, this will be upon notification from the third-party licensee, which is typically during the quarter following the quarter in which the sales occurred. The Company does not participate in the selling or marketing of products for which it receives royalties. Because the Company records revenue only when collection is assured,
Contingent payments with third parties and pursuant to the sale of the Company’s former specialty pharmaceutical business are recognized as income when the milestone has been achieved and collection is assured, such payments are non-refundable and no further effort is required on the part of the Company or the other party to complete the earning process.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be realized. The effect of a change in tax rates or laws on deferred tax assets and liabilities is recognized in operations in the period that includes the enactment date of the rate change. A valuation allowance is established to reduce the deferred tax assets to the amounts that are more likely than not to be realized from operations.
Tax benefits of uncertain tax positions are recognized only if it is more likely than not that the Company will be able to sustain a position taken on an income tax return. The Company has
(3)Recent Accounting Pronouncements
Recent Accounting Standards Updates issued by the Financial Accounting Standards Board (the “FASB”) and guidance issued by the SEC did not, or are not believed by management to, have a material effect on the Company’s present or future consolidated financial statements.
(4)Financial Instruments and Fair Value
The carrying values of cash and cash equivalents, other current assets, accounts payable, accrued expenses and other current liabilities in the Company’s consolidated balance sheets approximated their fair values at June 30, 2024 and December 31, 2023 due to their short-term nature. As of each of June 30, 2024 and December 31, 2023, the Company held cash equivalents aggregating approximately $
(5)Supplemental Cash Flow Information
The Company made
(6)Cash Dividend
On December 28, 2023, the Board declared a cash dividend of
9
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(6)Cash Dividend (continued)
On December 29, 2022, the Board declared a cash dividend of
(7)Loss Per Common Share
Basic earnings (loss) per common share (EPS) is calculated by dividing net income (loss), less any dividends, accretion or reduction or redemption on the Company’s Series C Preferred Stock, by the weighted average number of common shares outstanding during the reported period. Restricted stock awards and restricted stock units (collectively, “nonvested shares”) are not considered to be outstanding shares until the service or performance vesting period has been completed.
The diluted earnings per common share calculation would normally involve adjusting both the denominator and numerator as described here if the effect is dilutive.
For purposes of calculating diluted earnings per common share, the denominator normally includes both the weighted-average number of shares of common stock outstanding and the number of common stock equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock equivalents potentially include stock options and nonvested shares using the treasury stock method and shares issuable under the employee stock purchase plan. During each of the quarters ended June 30, 2024 and 2023, there were no common stock equivalents. There were no stock options or other equity-based incentives outstanding in either such period.
| | Three months ended | | Six months ended | ||||||||
| | June 30, | | June 30, | ||||||||
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| 2024 |
| 2023 |
| 2024 |
| 2023 | ||||
Loss Per Common Share – Basic and Diluted: | | | | | | | | | | | | |
Net income | | $ | | | $ | | | $ | | | $ | |
Accretion of dividend on Series C preferred stock | | | ( | | | ( | | | ( | | | ( |
Net loss available to common shareholders | | $ | ( | | $ | ( | | | ( | | $ | ( |
| | | | | | | | | | | | |
Weighted-average number of common shares outstanding | |
| | | | | | | | | | |
| | | | | | | | | | | | |
Basic and diluted loss per common share | | $ | ( | | $ | ( | | $ | ( | | $ | ( |
10
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(8)Income Taxes
During the six-month period ended June 30, 2024 the Company recorded approximately $
ASC 740 requires the reduction of deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Because of the inherent uncertainties, including future interest rates, whether or when an acquisition of a profitable entity will come to fruition and other factors, projecting long-term future performance of the Company is problematical. Accordingly, the Company is only projecting pre-tax book income through June 30, 2025 due to interest rates on its short-term cash investments and the absence of any potentially actionable acquisitions at this time. Upon review of positive and negative evidence in determining a partial reversal of the valuation allowance, the Company has concluded that a partial reversal of the valuation allowance is necessary. Interest rates may fluctuate throughout the period through June 30, 2025. However, the Company does not expect them to return to low rates of the past creating a projected taxable income position. Accordingly, a deferred tax expense of approximately $
Management of the Company will continue to assess the need for this valuation allowance and will make adjustments when or if appropriate.
At June 30, 2024, the Company had federal NOLs of approximately $
At June 30, 2024, the Company has federal research and development (“R&D”) credit carryforwards of approximately $
The Company’s ability to use the NOLs and R&D tax credit carryforwards may be limited, as they are subject to certain limitations due to ownership changes as defined by rules pursuant to Section 382 of the Internal Revenue Code of 1986, as amended. However, management of the Company believes that the Company’s NOLs will not be limited by any changes in the Company’s ownership as a result of the successful completion of the Rights Offering. (See Note 12 to the Consolidated Financial Statements.) Additionally, in an effort to protect stockholder value by attempting to protect against a possible limitation on the Company’s ability to use its NOLs, the Board adopted a Section 382 rights plan. (See Note 11 to the Consolidated Financial Statements.)
The Company has not recorded a liability for unrecognized income tax benefits.
(9)Commitments and Contingent Liabilities
On January 17, 2024, the Company was notified by the OTCQX Markets Group (the “OTCQX”), the marketplace for the over-the-counter trading of its stock, that it no longer met the standards for continued qualification for the OTCQX, in that its stock bid price had fallen below $
The Company has been involved in various claims and legal actions arising in the ordinary course of business. In the opinion of management, the ultimate disposition of these matters will not have a material effect on the Company’s consolidated financial position, results of operations, or liquidity.
11
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(10)Accounts Payable and Accrued Expenses
Prior to 2017, the Company’s primary source of royalty revenues was derived from sales of PegIntron, which is marketed by Merck & Co., Inc. (“Merck”). At December 31, 2023, the Company recorded a liability to Merck of approximately $
Accrued expenses and other current liabilities consisted of the following as of June 30, 2024 and 2023 (in thousands):
|
| June 30, |
| December 31, | ||
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| 2024 |
| 2023 | ||
Professional and consulting fees | | $ | | | $ | |
Other | | | | | | |
| | $ | | | $ | |
(11)Section 382 Rights Plan
On August 14, 2020, in an effort to protect stockholder value by attempting to protect against a possible limitation on the Company’s ability to use its NOLs, the Board adopted a Section 382 rights plan and declared a dividend distribution of
(12)Rights Offering
On September 1, 2020, the Board approved a Rights Offering. For every
12
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(12)Rights Offering (continued)
On an annual basis, the Board may, at its sole discretion, cause a dividend with respect to the Series C Preferred Stock to be paid in cash to the holders in an amount equal to
Since November 1, 2022, the Company is able to redeem the Series C Preferred Stock at any time, in whole or in part, for an amount based on the liquidation preference per share as in effect at such time. Holders of Series C Preferred Stock have the right to demand that the Company redeem their shares in the event that the Company undergoes a change of control as defined in the Certificate of Designation of the Series C Preferred Stock.
(13)Series C Preferred Stock
In October 2020, the Company issued
As of December 31, 2021, the Board had not declared a cash dividend on the Series C Preferred Stock. Accordingly, during the year ended December 31, 2021, the Company recorded a
As of June 30, 2024, the Board had not yet determined whether to declare a cash dividend at the end of 2024. Accordingly, the Company accrued an accretion at
There is no prohibition on the repurchase or redemption of Series C Preferred Shares while there is any arrearage in the payment of dividends.
Since the redemption of the Series C Preferred Stock is contingently or optionally redeemable, unless and until the Company undertakes a change of control, the Series C Preferred Stock has been classified in mezzanine equity on the Consolidated Balance Sheets.
(14)Cash and Cash Equivalents
The Company defines cash equivalents as highly liquid, short-term investments with original maturities of three months or less. These financial instruments potentially subject the Company to concentrations of credit risk. The Company maintains deposit accounts with several financial institutions. These balances are partially insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 per depositor, per FDIC-insured bank, per ownership category. Such deposits may exceed FDIC insurance limits. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the six-month periods ended June 30, 2024 and 2023 and the year ended December 31, 2023.
13
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Enzon,” the “Company,” “we,” “us,” or “our” and similar terms mean Enzon Pharmaceuticals, Inc. and its subsidiaries. The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our 2023 Annual Report on Form 10-K.
Forward-Looking Information and Factors That May Affect Future Results
The following discussion contains forward-looking statements within the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in the following discussion, other than statements that are purely historical, are forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “potential,” “anticipates,” “plans,” or “intends” or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy. Forward-looking statements are based upon management’s present expectations, objectives, anticipations, plans, hopes, beliefs, intentions or strategies regarding the future and are subject to known and unknown risks and uncertainties that could cause actual results, events or developments to be materially different from those indicated in such forward-looking statements, including the risks and uncertainties set forth in Item 1A. Risk Factors in our 2023 Annual Report on Form 10-K. These risks and uncertainties should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. As such, no assurance can be given that the future results covered by the forward-looking statements will be achieved.
The percentage changes throughout the following discussion are based on amounts stated in thousands of dollars and not the rounded millions of dollars reflected in this section.
Overview
During 2020, the Company adopted a Section 382 rights plan and completed a Rights Offering, each as further described below. As a result of the successful completion of the Rights Offering, we are positioned as a public company acquisition vehicle, where we can become an acquisition platform and potentially utilize our NOLs and enhance stockholder value. We may acquire businesses, entities or revenue streams that could generate sufficient income so that we can utilize our approximately $101.9 million of federal NOLs. To date, no acquisition candidates have been identified that are in an actionable state and, while we may be successful in realizing the value of our NOLs, we cannot assure you that we will be able to do so.
Prior to 2017, the primary source of our royalty revenues was derived from sales of PegIntron, which is marketed by Merck. We currently have no clinical operations and limited corporate operations. We have no intention of resuming any clinical development activities. We had no revenues from sales of PegIntron for the year ended December 31, 2023 and the six - month periods ended June 30, 2024 and 2023.
We have a marketing agreement with Micromet AG, now part of Amgen, Inc. (the “Micromet Agreement”), pursuant to which we may be entitled to certain milestone and royalty payments if Vicineum, a drug that was being developed by Sesen, Inc., (Sesen”) is approved for the treatment of non-muscle invasive bladder cancer. Sesen announced that it had completed a merger with Carisma Therapeutics Inc. (“Carisma”), had paused further development of Vicineum in the United States, had withdrawn its application to market Vicineum in Europe and that the combined company will focus on the advancement of Carisma’s proprietary cell therapy for the treatment of cancer and other disorders and that it intends to seek a partner for any further development of Vicineum.
Due to the challenges associated with developing and obtaining approval for drug products, and the lack of our involvement in the development and approval process, there is substantial uncertainty as to whether we will receive any milestone or royalty payments under the Micromet Agreement. We will not recognize revenue until all revenue recognition requirements are met.
We may be entitled to certain potential future milestone payments contingent upon the achievement of certain regulatory approval-related milestones by third-party licensees. We cannot assure you that we will receive any milestone payments resulting from our agreements with any of our third-party licensees or that any sales of related products will be made. We will not recognize revenue from any of our third-party licensees until all revenue recognition requirements are met.
14
Acquisition Activities
Our Board of Directors and our management are actively involved in pursuing, sourcing, reviewing and evaluating various potential acquisition transactions consistent with our long-term strategy. Our management and Board of Directors have made a number of contacts and engaged in discussions with principals of individual companies and financial advisors on behalf of various individual companies, while continuing to evaluate potential transactions. To date, we have not developed any actionable transactions. We will continue to update our stockholders as material developments arise.
Throughout this Management’s Discussion and Analysis, the primary focus is on our results of operations, cash flows and financial condition. The percentage changes throughout the following discussion are based on amounts stated in thousands of dollars.
Results of Operations
Revenues:
License Fees
In the six and three-months periods ended June 30, 2024, we earned approximately $26,000 in license fees. In the three and six-month periods ended June 30, 2023, we had no revenue from license fees.
Interest and Dividend Income (in thousands of dollars):
| | Three Months Ended June 30, | | Six Months Ended June 30, | ||||||||||||
| | | | | % | | | | | | | | % | | | |
|
| 2024 |
| Change |
| 2023 |
| 2024 |
| Change |
| 2023 | ||||
Interest and dividend income | | $ | 605 | | 9 | % | $ | 553 | | $ | 1,252 | | 25 | % | $ | 1,000 |
Interest and dividend income is attributable to the interest and dividends received on the invested cash and cash equivalents we received from the $46.2 million of proceeds from our rights offering (See Note 13 to our Consolidated Financial Statements). Interest and dividend income increased by approximately $52,000, or 9%, to $605,000 for the three months ended June 30, 2024 from $553,000 for the comparable period in 2023. The increase in interest and dividend income is attributable to the higher rates of interest in the 2024 period compared to the same period in 2023.
Interest and dividend income increased by approximately $252,000, or 25%, to $1,252,000 for the six months ended June 30, 2024 from $1,000,000 for the six months ended June 30, 2023. The increase in interest and dividend income is attributable to the higher rates of interest in 2024.
Operating Expenses:
General and Administrative (in thousands of dollars):
|
| Three Months Ended June 30, |
| Six Months Ended June 30, | ||||||||||||
|
| | |
| % |
| | |
| | |
| % |
| | |
| | 2024 | | Change | | 2023 | | 2024 | | Change | | 2023 | ||||
General and administrative | | $ | 351 | | 10 | % | $ | 318 | | $ | 677 | | 12 | % | $ | 603 |
General and administrative expenses increased by approximately $33,000, or 10%, to $351,000 for the three months ended June 30, 2024 from $318,000 for the three months ended June 30, 2023. The increase in general and administrative expense is substantially attributable to an increase in professional fees and insurance.
General and administrative expenses increased by approximately $74,000, or 12%, to $677,000 for the six months ended June 30, 2024 from $603,000 for the first six months of 2023. The increase in general and administrative expense is substantially attributable to an increase in professional fees and insurance.
15
Tax Expense:
Assuming no acquisition is completed or material changes in results through June 2025, the Company has partially reversed the valuation allowances as of June 30, 2024. Deferred tax expenses of $3,000 and $15,000, respectively were recorded during the six-month periods ended June 30, 2024 and 2023. (See Note 8 to the Condensed Consolidated Financial Statements.)
Liquidity and Capital Resources
Our current source of liquidity is our existing cash on hand, which includes the approximately $43.6 million of gross proceeds from our Rights Offering and the interest earned on that amount. (See Note 12 to the Condensed Consolidated Financial Statements.) While we no longer have any research and development activities, we continue to retain rights to receive fees, royalties and milestone payments from existing licensing arrangements with other companies and, accordingly, we may be entitled to a share of milestone and royalty payments from our few remaining licensed patents. We believe that our existing cash on hand will be sufficient to fund our operations, at least, through August 2025. Our future royalty revenues are expected to be de minimis over the forseeable future and we cannot assure you that we will receive any royalty, milestone or other revenues.
While we are positioned as a public company acquisition vehicle, where we can become an acquisition platform and more fully utilize our NOLs and enhance stockholder value, we cannot assure you that we will succeed in making acquisitions that are profitable and that will enable us to utilize our NOLs.
Cash provided by operating activities, as adjusted for certain non-cash items including the effect of changes in operating assets and liabilities, during the six months ended June 30, 2024 was approximately $492,000, as compared to cash provided by operating activities of approximately $424,000 during the comparable period in 2023. The increase of approximately $68,000 was primarily attributable to the increase in interest and dividend income of approximately $252,000, increasing to approximately $1,252,000 during the six months ended June 30, 2024, from approximately $1,000,000 during the comparable period in 2023.
Cash used in financing activities represents cash dividends of approximately $1,275,000 paid to holders of the Company’s Series C Preferred Stock in each of the periods.
The net effect of the foregoing was a decrease of cash and cash equivalents of approximately $800,000 from $47.0 million at December 31, 2023 to $46.2 million at June 30, 2024.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (SPEs), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of June 30, 2024, we were not involved in any SPE transactions.
Critical Accounting Policies and Estimates
A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Our consolidated financial statements are presented in accordance with accounting principles that are generally accepted in the U.S. (“U.S. GAAP”). All applicable U.S. GAAP accounting standards effective as of June 30, 2024 have been taken into consideration in preparing the consolidated financial statements. The preparation of the consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. The following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements.
We base our estimates, to the extent possible, on historical experience. Historical information is modified as appropriate based on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when necessary. Actual results could differ from our estimates.
16
Income Taxes
Under the asset and liability method of accounting for income taxes, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance on net deferred tax assets is provided for when it is more likely than not that some portion or all of the deferred tax assets will not be realized. As of June 30, 2024, we believe, based on our projections, that a partial reversal of the valuation allowance is necessary. Interest rates may fluctuate throughout 2024 and during the first half of 2025, however, they are not expected to return to low rates of the past creating a projected taxable income position. Therefore, the Company will partially reverse the valuation allowances. We are positioned as a public company acquisition vehicle, where we can become an acquisition platform and potentially utilize our NOLs. We may acquire businesses, entities or revenue streams that could generate sufficient income so that we can utilize our approximately $101.9 million of federal NOLs. At this time, however, we cannot assure you that we will be successful in doing so. Accordingly, our management will continue to assess the need for this valuation allowance and will make adjustments when appropriate. Additionally, our management believes that our NOLs will not be limited by any changes in our ownership as a result of the successful completion of the Rights Offering (See Note 12 to the Consolidated Financial Statements).
We recognize the benefit of an uncertain tax position that we have taken or expect to take on the income tax returns we file if it is more likely than not that we will be able to sustain our position.
Forward-Looking Information and Factors That May Affect Future Results
This Quarterly Report on Form 10-Q contains forward-looking statements within the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in the Quarterly Report on Form 10-Q, other than statements that are purely historical, are forward-looking statements. Forward-looking statements can be identified by the use of forward-looking terminology such as the words “believes,” “expects,” “may,” “will,” “should,” “potential,” “anticipates,” “plans” or “intends” or the negative thereof, or other variations thereof, or comparable terminology, or by discussions of strategy. Forward-looking statements are based upon management’s present expectations, objectives, anticipations, plans, hopes, beliefs, intentions or strategies regarding the future and are subject to known and unknown risks and uncertainties that could cause actual results, events or developments to be materially different from those indicated in such forward-looking statements, including, but not limited to, the following risks and uncertainties:
We may be unsuccessful in our strategy to fully utilize our NOLs and other tax assets (which may expire unutilized) and enhance stockholder value as a public company acquisition vehicle.
| ● | Our sources of revenue are limited and, as a result of our cash reserves, we expect only limited revenue and profitability for the foreseeable future. |
| ● | In recent years, we derived most of our royalty revenues from continued sales of PegIntron, which have been in sharp decline. In addition, our right to receive royalties on U.S. and European sales of PegIntron expired in 2016 and 2018, respectively, which has negatively impacted our royalty revenues. |
| ● | Our rights to receive royalties on sales of PegIntron and sales of other drug products have expired. Our only remaining right to receive royalties relates to Vicineum for which our licensee has stopped development. We currently do not anticipate any significant royalties from other sources, but we may acquire new sources of royalty revenues. |
| ● | The unprecedented actions taken globally to control the spread of COVID 19 and its related variants, as well as the uncertainty surrounding the success of global vaccination efforts, may materially and adversely affect our future right to receive licensing fees, milestone payments and royalties on product candidates that are being developed by third parties. |
| ● | We have reallocated all employment responsibilities and outsourced all corporate functions, which makes us more dependent on third parties to perform these corporate functions. |
| ● | We may be subject to a variety of types of product liability or other claims based on allegations that the use of our product candidates by participants in our previously conducted clinical trials has resulted in adverse effects, and our insurance may not cover all product liability or other claims. |
17
| ● | Our revenues largely depend on proprietary rights, which may offer only limited protection against the development of competing products. |
| ● | We are party to license agreements whereby we may receive royalties and or milestone payments from products subject to regulatory approval. |
| ● | The price of our common stock has been, and may continue to be, volatile. |
| ● | Our common stock is quoted on the OTCQX market of the OTC Markets Group, Inc., which has a very limited trading market and, therefore, market liquidity for our common stock is low and our stockholders’ ability to sell their shares of our common stock may be limited. |
| ● | The declaration of dividends is within the discretion of our Board of Directors, subject to any applicable limitations under Delaware corporate law, as well as the requirements of the Series C Preferred Stock. Our ability to pay dividends in the future depends on, among other things, our fulfillment of the conditions of the Series C Preferred Stock, fluctuating royalty revenues, our ability to acquire other revenue sources and our ability to manage expenses, including costs relating to our ongoing operations. |
| ● | We have adopted a Section 382 rights plan, which may discourage a corporate takeover. |
| ● | Anti-takeover provisions in our charter documents and under Delaware corporate law may make it more difficult to acquire us, even though such acquisitions may be beneficial to our stockholders. |
| ● | The terms of our outstanding Series C Preferred Stock and the issuance of additional series of preferred stock may adversely affect rights of our common stockholders. |
| ● | The interests of our significant stockholders may conflict with the interests of other stockholders. |
| ● | If we experience an “ownership change,” as defined in Section 382 of the Internal Revenue Code of 1986, as amended, our ability to fully utilize our NOLs on an annual basis will be substantially limited, and the timing of the usage of the NOLs could be substantially delayed, which could therefore significantly impair the value of those benefits. |
| ● | If we experience a “Change of Control,” as defined in Certificate of Designation of the Series C Preferred Stock, the holders of the Series C Preferred Stock shall have the right, at such holder’s option, to require the Company to redeem at the Liquidation Preference then in effect all or a portion of such holder’s shares of Series C Preferred Stock, which would negatively impact our available cash. |
A more detailed discussion of these risks and uncertainties and other factors that could affect results is contained in our filings with the SEC, including in Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023. These risks and uncertainties and other factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. As such, no assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this Quarterly Report on Form 10-Q is as of the date of this report, unless otherwise indicated, and we undertake no duty to update this information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide information required by this item.
18
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, consisting of Richard L. Feinstein who serves as our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of June 30, 2024. Disclosure controls and procedures are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2024, the Company’s disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect our internal control over financial reporting.
Part II – OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any lawsuit or proceeding which, in the opinion of management, is likely to have a material adverse effect on us or our business.
Item 1A. Risk Factors.
Other than as set forth below, there are no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 20, 2024.
Our common stock is quoted on the OTCQX market of the OTC Markets Group, Inc., which has a very limited trading market and, therefore, market liquidity for our common stock is low and our stockholders’ ability to sell their shares of our common stock may be limited.
Our common stock is quoted on the OTCQX market of the OTC Markets Group, Inc. and the quotation of our common stock on the OTCQX market does not assure that a liquid trading market exists or will develop. Stocks traded on the OTCQX market generally have very limited trading volume and exhibit a wider spread between the bid/ask quotations than stocks traded on national exchanges. Moreover, a significant number of institutional investors have investment policies that prohibit them from trading in stocks on the OTCQX marketplace. As a result, investors may find it difficult to dispose of, or to obtain accurate quotations of the price of, our common stock. This significantly limits the liquidity of our common stock and may adversely affect the market price of our common stock.
In January 2024, we received a compliance deficiency notice from the OTCQX indicating that our stock’s bid price had closed below $0.10 for more than 30 consecutive calendar days and therefore no longer met the continued listing qualifications of the OTCQX. We were granted until July 15, 2024, to regain compliance with the minimum bid price requirement. As a result of our stock price trading at, or in excess of $0.10 for the period of time that was required to regain compliance, on June 10, 2024, we were notified by the OTCQX that we had regained compliance with the OTCQX’s standards for continued qualification. Although we are currently compliant with the OTCQX continued listing qualifications, there can be no assurance that we will be able to remain compliant.
We do not currently, and are not expected in the future to, meet the listing standards of any national exchange. We presently anticipate that our common stock will continue to be quoted on the OTCQX market. As a result, investors must bear the economic risk of holding their shares of our common stock for an indefinite period of time. In the future, our common stock could become subject to “penny stock” rules which impose additional disclosure requirements on broker-dealers and could further negatively impact market liquidity for our common stock and our stockholders’ ability to sell their shares of our common stock.
19
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Item 6. Exhibits
(a) Exhibits required by Item 601 of Regulation S-K.
Exhibit |
| Description |
| Reference |
31.1 |
|
| + | |
32.1 |
|
| + | |
101.INS |
| Inline XBRL Instance Document |
| + |
101.SCH | | Inline XBRL Taxonomy Extension Schema Document | | + |
101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | + |
101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document | | + |
101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document | | + |
101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | + |
104 | | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101) | | + |
+Filed herewith.
20
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.
| ENZON PHARMACEUTICALS, INC. |
| (Registrant) |
|
|
|
|
Dated: August 8, 2024 | /s/ Richard L. Feinstein |
| Richard L. Feinstein |
| Chief Executive Officer, Chief Financial Officer and Secretary |
| (Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) |
21
Exhibit 31.1
CERTIFICATION PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Richard L. Feinstein, certify that:
1. | I have reviewed this Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 of Enzon Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | As the registrant’s sole certifying officer, I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to me by others within those entities, particularly during the period in which this report is being prepared; |
(b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
August 8, 2024 | /s/ Richard L. Feinstein |
| Richard L. Feinstein |
| Chief Executive Officer, Chief Financial Officer and Secretary |
| (Principal Executive Officer and Principal Financial Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. §1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Enzon Pharmaceuticals, Inc. (the Company) on Form 10-Q for the quarterly period ended June 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Richard L. Feinstein, Chief Executive Officer, Chief Financial Officer and Secretary of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
August 8, 2024 | /s/ Richard L. Feinstein |
| Richard L. Feinstein |
| Chief Executive Officer, Chief Financial Officer and Secretary |
| (Principal Executive Officer and Principal Financial Officer) |
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Enzon Pharmaceuticals, Inc. and will be furnished to the Securities Exchange Commission or its staff upon request.