What changed in AIM ImmunoTech Inc.'s 10-K — 2023 vs 2024
vs
Paragraph-level year-over-year comparison of AIM ImmunoTech Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+83 added−97 removedSource: 10-K (2025-03-27) vs 10-K (2024-04-01)
Top changes in AIM ImmunoTech Inc.'s 2024 10-K
83 paragraphs added · 97 removed · 31 edited across 4 sections
- Item 7. Management's Discussion & Analysis+51 / −46 · 20 edited
- Item 3. Legal Proceedings+25 / −38 · 8 edited
- Item 5. Market for Registrant's Common Equity+6 / −12 · 2 edited
- Item 2. Properties+1 / −1 · 1 edited
Item 2. Properties
Properties — owned and leased real estate
1 edited+0 added−0 removed1 unchanged
Item 2. Properties
Properties — owned and leased real estate
1 edited+0 added−0 removed1 unchanged
2023 filing
2024 filing
Biggest changeWe currently lease our principal executive office and finance for $2,780 per month, our human resource office for $2,850 per month and our manufacturing office for $16,100 per month.
Biggest changeWe currently lease our principal executive office and finance for $3,672 per month, our human resource office for $3,000 per month and our manufacturing office for $16,700 per month. 36
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
8 edited+17 added−30 removed2 unchanged
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
8 edited+17 added−30 removed2 unchanged
2023 filing
2024 filing
Biggest changeNo estimate can be made of when the trial court and appellate court will address the pending matters. No estimate of the outcome can be made at this time pending determination of the Petition and the underlying issues presented in the appeal. AIM ImmunoTech, Inc. v.
Biggest changeNo estimate can be made at this time regarding the scheduling or ultimate determination of the matters set forth in the Petition and the underlying issues presented in the appeal. No judgement can be made at this time of the likelihood of the Company prevailing on its claims.
On November 1, 2022, Jorgl and the other participants in his nomination efforts and attempted proxy contest announced in a press release that they did not plan to proceed to trial or seek an appeal of the Court’s ruling denying the motion for preliminary injunction and that the proxies they solicited would not be voted at our annual meeting of stockholders.
On November 1, 2022, Jorgl and the other participants in his nomination efforts and attempted proxy contest announced in a press release that they did not plan to proceed to trial or seek an appeal of the Court’s ruling denying the motion for preliminary injunction and that the proxies they solicited would not be voted at the Company’s annual meeting of stockholders.
The complaint challenged the decision of our Board of Directors to reject Jorgl’s notice of intent to nominate two candidates for election to the our Board of Directors on the basis that the notice failed to comply with our bylaws.
The complaint challenged the decision of the Company’s Board of Directors to reject Jorgl’s notice of intent to nominate two candidates for election to the Company’s Board of Directors on the basis that the notice failed to comply with the Company’s bylaws.
We held our annual meeting of stockholders on November 3, 2022, and the stockholders re-elected Thomas Equels, William Mitchell, and Stewart Appelrouth as directors. On April 20, 2023, Jorgl filed a motion to dismiss the Jorgl Action. On June 20, 2023, the Court entered an order dismissing the Jorgl Action and retaining jurisdiction to adjudicate any related fee disputes.
AIM held its annual meeting of stockholders on November 3, 2022, and the stockholders re-elected Thomas Equels, William Mitchell, and Stewart Appelrouth as directors. On April 20, 2023, Jorgl filed a motion to dismiss the Jorgl Action. On June 20, 2023, the Court entered an order dismissing the Jorgl Action and retaining jurisdiction to adjudicate any related fee disputes.
The Complaint sought a declaration that Jorgl’s nomination was valid and effective and complied with our bylaws and that the we must list Jorgl’s candidates in our proxy materials, as well as a temporary restraining order, preliminary injunction, and permanent injunction enjoining defendants from taking any action to prevent Jorgl from exercising his alleged nomination rights and from making any statements that disparage Jorgl’s candidates prior to or during our annual meeting of stockholders.
The Complaint sought a declaration that Jorgl’s nomination was valid and effective and complied with the bylaws and that the Company must list Jorgl’s candidates in its proxy materials, as well as a temporary restraining order, preliminary injunction, and permanent injunction enjoining defendants from taking any action to prevent Jorgl from exercising his alleged nomination rights and from making any statements that disparage Jorgl’s candidates prior to or during the Company’s annual meeting of stockholders.
On August 15, 2022, the Court denied Jorgl’s motion for temporary restraining order, granted the motion to expedite, and scheduled a hearing on Jorgl’s preliminary injunction motion. After expedited discovery and briefing, the Court issued an opinion on October 28, 2022, denying Jorgl’s motion for preliminary injunction.
Potter Anderson was counsel to all the defendants in the Jorgl Action. On August 15, 2022, the Court denied Jorgl’s motion for temporary restraining order, granted the motion to expedite, and scheduled a hearing on Jorgl’s preliminary injunction motion. After expedited discovery and briefing, the Court issued an opinion on October 28, 2022, denying Jorgl’s motion for preliminary injunction.
The Delaware Court of Chancery ruled on certain discovery motions in October 2023 pertaining to the AIM Fee Motion, and on March 25, 2024, ordered the parties to provide a joint status report regarding the AIM Fee Motion and the Jorgl Fee Motion within 30 days.
The Delaware Court of Chancery ruled on certain discovery motions in October 2023 pertaining to the AIM Fee Motion. Subsequently, at the parties’ request, the Court directed the parties to file a joint status report within 21 days of the Delaware Supreme Court issuing a decision in the Kellner action (described below).
Ch.) On July 29, 2022, Jonathan Jorgl (“Jorgl”) filed a complaint against us and the then-members of our Board of Directors in the Delaware Court of Chancery (the “Jorgl Action”).
ITEM 3. Legal Proceedings. Jorgl v. AIM ImmunoTech, Inc. et al. , C.A. No. 2022-0669-LWW (Del. Ch.) On July 29, 2022, Jonathan Jorgl (“Jorgl”) filed a complaint against the Company and the then-members of its Board of Directors, Thomas Equels, William Mitchell, and Stewart Appelrouth, in the Delaware Court of Chancery (the “Jorgl Action”).
Removed
ITEM 3. Legal Proceedings. We are, and from time to time may become, subject to litigation and various legal proceedings that involve claims for substantial amounts of money or for other relief or that might necessitate changes to our business or operations. Please see Note 16 “Contingencies” to the consolidated financial statements included in Part II, “Item 8.
Added
On August 2, 2024, after the parties submitted the joint status report, the Court entered a stipulated scheduling order for the remaining briefing on the fee motions, which briefing was completed on September 24, 2024. On February 3, 2025, the Court entered a letter ruling denying the AIM Fee Motion and the Jorgl Fee Motion. The case is now concluded.
Removed
Financial Statements and Supplementary Data” of this Annual Report. Because litigation is inherently unpredictable, assessing contingencies related to litigation is a complex process involving highly subjective judgment about potential outcomes of future events.
Added
AIM ImmunoTech, Inc. v. Tudor, et al., in the United States District Court for the Middle District of Florida, Ocala Division, Case No. 5:2022cv00323. On April 22, 2024, the District Court issued an order granting-in-part Lautz and Jorgl’s Rule 59(e) and Rule 11 motions, respectively.
Removed
When evaluating litigation contingencies, we may be unable to provide a meaningful estimate due to a number of factors, including the procedural status of the matter in question, the availability of appellate remedies, insurance coverage related to the claim or claims in question, the presence of complex or novel legal theories, and the ongoing discovery and development of information important to the matter.
Added
The court entered an order finding Jorgl and Lautz were entitled to recover attorney’s fees and costs and entered judgment on behalf of Jorgl for $216,936, and on behalf of Lautz for $76,473.
Removed
In addition, damage amounts claimed in litigation against us may be unsupported, exaggerated, or unrelated to possible outcomes, and as such are not meaningful indicators of our potential liability or financial exposure.
Added
AIM has appealed these judgments to the United States Court of Appeals for the Eleventh Circuit, and secured a stay of the enforcement of the judgment spending the 11th Circuit Appeal. AIM’s appeal does not seek damages. AIM filed its initial brief on September 4, 2024. The parties attended mediation on November 5, 2024.
Removed
Accordingly, we review the adequacy of accruals and disclosures each quarter in consultation with legal counsel, and we assess the probability and range of possible losses associated with contingencies for potential accrual in the consolidated financial statements. However, the ultimate resolution of litigated claims may differ from our current estimates.
Added
The parties did not reach an agreement, and mediation impassed. After mediation, Appellees filed answer briefs and Jorgl and Lautz filed motions for sanctions seeking reimbursement of appellants Attorney’s fees. The appeal and Appellees ‘motions are fully briefed. The appellate court has not yet issued a ruling.
Removed
In the normal course of business, there are various claims in process, matters in litigation, and other contingencies, certain of which are covered by insurance policies.
Added
On June 18, 2024, The Carlyle Appellate Law firm was engaged for the above referenced appeal. The Carlyle Appellate Law firm has since filed a notice of appearance in that matter.
Removed
While it is not possible to predict the outcome of these suits, legal proceedings, and claims with certainty, management is of the opinion that adequate provision for potential losses associated with these matters has been made in the financial statements and that the ultimate resolution of any one of these matters will not have a material adverse effect on our financial position and results of operations.
Added
AIM is exposed in this matter for the amount of those Judgments (which have been bonded by AIM), interest on those judgements, as well as potentially paying attorney’s fees in the event the appeal is unsuccessful. Kellner v. AIM ImmunoTech Inc. et al., in the Supreme Court of the State of Delaware, Case No. 3, 2024.
Removed
A significant increase in the number of these claims, or one or more successful claims resulting in greater liabilities than the we currently anticipate, could materially and adversely affect our business, financial condition, results of operations, and cash flows.
Added
On January 16, 2024, the Delaware Supreme Court granted-in-part Kellner’s motion to expedite and scheduled oral argument before the en banc Delaware Supreme Court for April 10, 2024. On April 10, 2024, the en banc Delaware Supreme Court heard oral argument from AIM and Kellner in this matter and took the matter under consideration.
Removed
Hemispherx Biopharma, Inc (n/ka) AIM Immunotech vs BioLife Plasma Services, LP No 1711391858 ( Phila CCP) We commenced an action in the Philadelphia Court of Common Pleas in 2017 against Biolife Plasma Services, LP related to the defendants’ breach of a contract requiring the defendant to supply certain blood related products used by and necessary to us in the manufacture of our products, including the loss profits associated with the defendants’ breaches.
Added
On July 11, 2024, the Delaware Supreme Court issued a decision affirming in part and reversing in part the Court of Chancery’s December 28, 2023 opinion, and not remanding the matter to the Court of Chancery. The Supreme Court held that certain of the bylaws adopted by the board were legally invalid and inequitable.
Removed
The Defendant asserted defenses, including a counterclaim asserting our failure to have paid invoices billed for the product in the amount of $96,676 following the Defendant’s notification that it would not be fulfilling the terms of the contract. 34 The trial court issued a ruling in March 2023 on cross Motions for Summary Judgment in which it denied all of our motions and granted defendant’s Motion to exclude evidence of future loss of profit damages.
Added
The board has subsequently revised the bylaws to address and correct said deficiencies. The Delaware Supreme Court also held that No further action was required with respect to Kellner’s rejected nominations.
Removed
The ruling specified that we had properly pled, and the Court was specifically allowing our damages theory to proceed on reliance damages. We sought reconsideration of the ruling based on its internal inconsistency with the contemporaneously issued Order which allowed only the counterclaims to proceed. In July 2023, we sought appellate review of the inconsistent lower Court pretrial rulings.
Added
On July 26, 2024, Kellner filed a Motion for Reargument, requesting the Supreme Court of the State of Delaware to reconsider certain aspects of its ruling and requesting clarification that the trial court retains jurisdiction for any fee applications.
Removed
In September 2023, the Court issued an Order in response to our Motion for Reconsideration granting the Motion, vacating its prior Order on summary judgment, and issued a new Order and Opinion. The new Order and Opinion again denied our motion for summary judgment, and granted defendants’ motion for summary judgment.
Added
By order dated July 29, 2024, the Supreme Court denied Kellner’s Motion for Reargument, directed that the case be closed, and specifically ruled that “The case is not remanded for an award of attorneys’ fees and costs” and deemed that the “this Case is Closed.” On August 27, 2024, counsel to Kellner delivered to us a demand for certain books and records under Section 220 of the DGCL, and a letter requesting that we reimburse him for his fees and expenses incurred in the Kellner litigation.
Removed
The effect of the Order was to again allow only the defendant’s counterclaim to proceed. The Order mooted the pending appellate review. On December 6, 2023, we petitioned the Superior (appellate) Court to allow immediate appeal. The Superior Court has not ruled on the Petition. The parties have twice mediated the matter with no resolution achieved.
Added
In the request for fee reimbursement letter, Kellner stated that he was prepared to file an action in the Delaware Court of Chancery to require AIM to pay his fees and expenses if the matter could not be resolved without court intervention.
Removed
Tudor., Case No. 2021-CA-393 (Marion County, FL) On August 13, 2021, the Marion County Circuit Court entered an Agreed Order Granting Joint Motion for Entry of Stipulated Injunction (“Injunction”), which precluded Tudor from contacting any of our business relations. We are currently pursuing enforcement of the Injunction against Tudor, who recently violated the Injunction.
Added
By letter dated, November 8, 2024, AIM, through its counsel, denied the request, noting, among other things, that the Delaware Supreme Court issued an order on July 29, 2024, denying Kellner’s Motion for Reargument of the appeal in the Kellner litigation, directing that the case be closed, and specifically ruling that “[t]he case is not remanded for an award of attorneys’ fees and costs.” BioLife On September 6, 2024, the parties filed a Stipulation with the Court dismissing the counterclaims, without prejudice, in order to allow the Superior Court (appellate) to consider the Appeal issues without the need for duplicate trials.
Removed
We are not seeking damages against Tudor. We intend on filing a motion to enforce the Injunction and will seek to recover its attorney’s fees and costs, along with any other sanction necessary to preclude Tudor from violating the injunction again. Jorgl v. AIM Immunotech, Inc. et al., C.A. No. 2022-0669-LWW (Del.
Added
The Stipulation was accepted by the Court on October 17, 2024 dismissing the counterclaims. On October 7 we perfected our Appeal in the Superior Court. On November 7, 2024, we served our Concise Statement of Matters Complained of on Appeal.
Removed
We anticipate that the parties will negotiate a schedule to complete briefing on the motions. 35 AIM ImmunoTech, Inc. v. Tudor, et al., Case 5:22-cv-00323 (M.D.
Added
The Superior Court issued a briefing schedule that required that our opening brief is due on January 21, 2025 and Appellee’s response is due 30 days thereafter. We filed our Answer. Appellee requested and was granted a 30 day extension. The Appellee sought and was granted an extension to file its Appellee’s Brief until March 24, 2025.
Removed
Florida 2022) On July 15, 2022, we filed suit against Franz Tudor, Todd Deutsch, Ted Kellner, Jonathan Jorgl, Walter Lautz, Robert Chioini, and Michael Rice (collectively, the “Tudor Group”) for injunctive relief arising from the Tudor Group’s alleged violations of the Securities Exchange Act for failing to register as a group and provide required disclosures.
Added
On March 24, 2025, Appellee filed its brief. Now our Reply Brief is due two weeks thereafter. Although we requested oral argument, the Superior Court has not yet indicated whether oral argument would be granted or issued an argument schedule on the matters to be considered on appeal.
Removed
On July 8, 2022, Jorgl served a notice of intent to nominate two director candidates from the Tudor Group for election at our 2022 annual meeting. We rejected the notice because we believed the notice did not comply with the bylaws, federal law, or Delaware law.
Removed
We allege the notice is missing critical information required by the bylaws and made material misrepresentations and omissions. We believe the Tudor Group was acting in concert to appoint the nominees and sued these individuals to enjoin them from violating our bylaws and federal law. On July 10, 2023, the court dismissed the complaint.
Removed
We filed a motion for reconsideration, which the trial court denied. We filed an appeal of the dismissal, which is pending and referenced below.
Removed
The defendants have filed motions for sanctions seeking to recover their legal costs from the inception of the case, which total hundreds of thousands of dollars, according to the defendants, and additional sums, also not quantified, to act as a deterrent. On December 19, 2023, the court heard oral argument on the motions.
Removed
The parties submitted post-hearing briefs, and the matter is pending before the Court. AIM ImmunoTech, Inc. v. Tudor, et al., Case No. 0:2023prici13576 (11th Cir. 2023) We filed a notice of appeal of the order of dismissal and the order denying its motion for reconsideration that were entered in AIM ImmunoTech, Inc. v. Tudor, et al., Case 5:22-cv-00323 (M.D.
Removed
Fla. 2022) (above). The appellate deadlines are stayed until the lower court rules on the pending motions. Kellner v. AIM Immunotech, Inc. et al. , C.A. No. 2023-0879-LWW (Del. Ch.) On August 25, 2023, Ted D.
Removed
Kellner (“Kellner”) filed a complaint against us and the four current members of our Board of Directors in the Delaware Court of Chancery (the “Kellner Action”).
Removed
The complaint challenged (1) our adoption of amendments to the advance notice provision of our bylaws; and (2) the decision of our Board of Directors to reject Kellner’s notice of intent to nominate himself and two other candidates’ election to our Board of Directors at our 2023 annual meeting of stockholders on the basis that the nomination notice failed to comply with our amended bylaws.
Removed
The complaint seeks, among other things, a declaration that (1) the amendments to our Bylaws were unlawful; and/or (2) the Board’s application of the amended bylaws to reject Kellner’s nomination notice was unlawful or inequitable. On September 11, 2023, defendants in the Kellner Action filed an answer responding to Kellner’s complaint and we filed a counterclaim.
Removed
Our counterclaim seeks a declaration that (1) our bylaw amendments are lawful and valid; and (2) Kellner’s nomination notice did not comply with our bylaws. Upon completion of expedited discovery and briefing, the Court held trial in the Kellner Action from October 30, 2023, to November 1, 2023.
Removed
The Court of Chancery issued an opinion on December 28, 2023, that declared (1) the Board’s rejection of Kellner’s nomination notice was lawful and equitable, (2) certain of our bylaw amendments were valid, and (3) certain of the our bylaw amendments were invalid.
Removed
Kellner has appealed the court’s ruling concerning the Board’s rejection of his nomination notice, and the bylaw amendments the court ruled were valid. The Defendants have appealed the court’s ruling as to the bylaw amendments the court ruled were invalid. The parties agreed to, and the Delaware Supreme Court ordered, expedited briefing, which is now complete.
Removed
Oral argument is scheduled for April 10, 2024. Although Kellner is not presently seeking monetary relief from us in the Kellner Action, he has reserved the right to seek reimbursement of certain legal fees and expenses from us if the Delaware Supreme Court upholds the invalidation of certain bylaws.
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
2 edited+4 added−10 removed2 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
2 edited+4 added−10 removed2 unchanged
2023 filing
2024 filing
Biggest changeIt is management’s intention not to declare or pay dividends on our Common Stock, but to retain earnings, if any, for the operation and expansion of our business.
Biggest changeIt is management’s intention not to declare or pay dividends on our Common Stock, but to retain earnings, if any, for the operation and expansion of our business. Recent Sales of Unregistered Securities On March 15, 2024, Mr. Equels purchased 75,758 shares of our common stock at a purchase price of $0.33 per share; Mr.
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed and traded on the NYSE American under the symbol AIM. Holders of Common Stock As of March 25, 2023, there were approximately 150 holders of record of our Common Stock.
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed and traded on the NYSE American under the symbol AIM. Holders of Common Stock As of March 24, 2025, there were approximately 146 holders of record of our Common Stock.
Removed
Recent Sales of Unregistered Securities 2018 Equity Incentive Plan During the year ended December 31, 2022, we issued a total of 850,000 options under the 2018 Equity Incentive Plan, effective September 12, 2018, which will continue in effect for a period of 10 years from its effective date.
Added
Rodino purchased 37,879 shares of our common stock at a purchase price of $0.33 per share; and Mr. Appelrouth purchased 90,910 shares of our common stock at a purchase price of $0.33 per share. On March 21, 2024, Ms. Bryan purchased 38,462 shares of our common stock at a purchase price of $0.39. On May 6, 2024, Mr.
Removed
During the year ended December 31, 2023, we issued a total of 400,000 options under the 2018 Equity Incentive Plan, effective September 12, 2018, which will continue in effect for a period of 10 years from its effective date.
Added
Equels purchased 61,729 shares of our common stock at a purchase price of $0.405. On May 6, 2024, Mr. Rodino purchased 30,865 shares of our common stock at a purchase price of $0.405. One November 20, 2024, Mr. Equels purchased 60,110 shares of our common stock at a purchase price of $0,183.
Removed
Employees and Directors Purchase Plan On July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from us up to an aggregate of $500,000 worth of shares at the market price.
Added
Subsequent to December 31, 2024, on March 4, 2025, Mr. Equels purchased 83,334 shares of our common stock at a purchase price of $0.12 price per share. All purchases were under the Employee Stock Purchase Plan. No commissions were paid with regard to these sales.
Removed
Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved our Supplemental Listing Application. We issued 10,730 shares of our common stock at a price of $2.33 for a total of $25,000 under this plan.
Added
The sales were made pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended.
Removed
When this plan expired, the board of directors approved subsequent similar $500,000 plans for all directors, officers and employees to buy shares from us at the market price. Subsequent plans were approved by the board of directors upon the expiration of prior plans.
Removed
The last plan approved by the Board of Directors for the fiscal year ended December 31, 2023, was on October 26, 2023. During the fiscal year ended December 31, 2022, we issued a total of 86,817 shares of our common stock at prices ranging from $0.76 to $1.02 for a total of $80,000 under the plan.
Removed
During the fiscal year ended December 31, 2023, we issued a total of 419,285 shares of our common stock at prices ranging from $0.31 to $0.67 for a total of $150,500 under the plan. In March 2024, we sold 204,547 and 38,462 shares of our common stock at prices of $0.33 and $0.39 per share, respectively, under the plan.
Removed
Azenova On December 6, 2023, the Company issued to Azenova, LLC, an option to purchase up to three hundred and sixty thousand (360,000) shares of our “Common Stock” at a price equal to $0.46 per share. This Option was awarded pursuant to the Consulting Agreement dated October 16, 2023 between the Company and Azenova, LLC.
Removed
On December 6, 2023, 180,000 options were transferred to Jeffrey Southerton and 180,000 options were transferred to Stacy J. Evans; both transfers with an exercise price of $0.46.
Removed
The offers, sales and issuances of securities described above was deemed to be exempt from registration under the Securities Act in reliance on either Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering, or Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701. 37 ITEM 6. [Reserved]
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
20 edited+31 added−26 removed9 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
20 edited+31 added−26 removed9 unchanged
2023 filing
2024 filing
Biggest changeThis increase in net loss for the year ended December 31, 2023, was primarily due to the following: ● an increase in general and administrative expenses of $8,063,000; ● an increase in research and development expenses of $3,949,000; ● an increase in production costs of $42,000; offset by ● an increase in revenue of $61,000; ● an increase on income from investments of $1,879,000; ● an increase in interest/other income of $440,000; ● an increase in gain from sale of Income tax operating losses of $177,000; ● an increase on the gain from sale of fixed assets of $15,000; ● a decrease of the quarterly revaluation of certain redeemable warrants of $35,000.
Biggest changeThis decrease in net loss for the year ended December 31, 2024, was primarily due to the following: ● a decrease in general and administrative expenses of $7,423,000; ● a decrease in research and development expenses of $4,742,000; ● an increase in interest/other income of $4,123,000; ● a decrease in production costs of $11,000; net with ● a decrease in gain from sale of income tax operating losses of $3,271,000; ● an increase on loss from investments of $293,000; ● an increase in interest expense of $585,000; ● an increase in warrant valuation of $458,000; ● a decrease on the gain from sale of fixed assets of $18,000; and a ● a decrease in revenue of $32,000. 38 Net loss per share was $ (0.31) and $ (0.60) for the years ended December 31, 2024 and 2023, respectively.
The significant accounting estimates that we believe are most critical to aid in fully understanding our reported financial results are the following: 40 Long-Lived Assets We assess long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets or the asset grouping may not be recoverable.
The significant accounting estimates that we believe are most critical to aid in fully understanding our reported financial results are the following: Long-Lived Assets We assess long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets or the asset grouping may not be recoverable.
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis is related to our financial condition and results of operations for the two years ended December 31, 2023 This information should be read in conjunction with our consolidated financial statements and related notes thereto beginning on F-1 of this Form 10-K.
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. The following discussion and analysis is related to our financial condition and results of operations for the two years ended December 31, 2024. This information should be read in conjunction with our consolidated financial statements and related notes thereto beginning on F-1 of this Form 10-K.
See Part I, Item 1A - “Risk Factors; We may require additional financing which may not be available ”. Certain Relationships and Related Transactions Refer to PART III, ITEM 13 - “Certain Relationships and Related Transactions, and Director Independence. New Accounting Pronouncements Refer to “Note 2(g) – Recent Accounting Standards and Pronouncements” under Notes to Consolidated Financial Statements.
See Part I, Item 1A - “Risk Factors; We will require additional financing which may not be available ”. Certain Relationships and Related Transactions Refer to PART III, ITEM 13 - “Certain Relationships and Related Transactions, and Director Independence. New Accounting Pronouncements Refer to “Note 2(h) – Recent Accounting Standards and Pronouncements” under Notes to Consolidated Financial Statements.
We may need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.
We will need to obtain additional funding in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.
Our quest to prove the antiviral activities of Ampligen continues. If Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics which attack the virus, Ampligen works differently.
If Ampligen has the broad-spectrum antiviral properties that we believe that it has, it could be a very valuable tool in treating variants of existing viral diseases, including COVID-19, or novel ones that arise in the future. Unlike most developing therapeutics which attack the virus, Ampligen works differently.
In addition, as the Company reviews its manufacturing process and other manufacturing planning decisions, if the useful lives of assets are shorter than the Company had originally estimated, it accelerates the rate of depreciation over the assets’ new, shorter useful lives.
In addition, as the Company reviews its manufacturing process and other manufacturing planning decisions, if the useful lives of assets are shorter than the Company had originally estimated, it accelerates the rate of depreciation over the assets’ new, shorter useful lives. Research & Development (R&D) Expenses We expense R&D costs as incurred.
Revenues Revenues from our Ampligen® Cost Recovery Program were $202,000 and $141,000 for the years ended December 31, 2023 and 2022, representing an increase of $61,000 which is primarily related to the fluctuation of patient participation.
Revenues Revenues from our Ampligen® Cost Recovery Program were $170,000 and $202,000 for the years ended December 31, 2024 and 2023, representing a decrease of $32,000 which is primarily related to the fluctuation of patient participation.
For the years ended December 31, 2023 and 2022, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study. 38 Production Costs Production costs were approximately $42,000 and $0, respectively, for the years ended December 31, 2023 and 2022, representing an increase of $42,000 in production costs in the current period.
For the years ended December 31, 2024 and 2023, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection. Today, some three years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.
We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon N Injection.
RESULTS OF OPERATIONS Year ended December 31, 2023 versus year ended December 31, 2022 Our net loss was approximately $28,962,000 and $19,445,000 for the years ended December 31, 2023 and 2022, respectively, representing an increase in net loss of approximately $9,517,000 or (49%) when compared to the same period in 2022.
RESULTS OF OPERATIONS Year ended December 31, 2024 versus year ended December 31, 2023 Our net loss was approximately $17,320,000 and $28,962,000 for the years ended December 31, 2024 and 2023, respectively, representing a decrease in net loss of approximately $11,642,000 or 40% when compared to the same period in 2023.
General and Administrative Expenses General and Administrative (“G&A”) expenses for the years ended December 31, 2023 and 2022, were approximately $21,137,000 and $13,074,000, respectively, reflecting an increase of approximately $8,063,000.
General and Administrative Expenses For the years ended December 31, 2024 and 2023, general and administrative (“G&A”) expenses were approximately $13,714,000 and $21,137,000, respectively, reflecting a decrease of approximately $7,423,000.
Gain (loss) on Investments Gain (loss) on investments for the years ended December 31, 2023 and 2022 was approximately $200,000 and ($1,679,000), respectively, reflecting an increased gain on investments of approximately $1,879,000. The gain was due to the change in the fair value of equity investments.
Gain (loss) on Investments For the years ended December 31, 2024, and 2023, gain (loss) on investments was approximately ($93,000) and $200,000, respectively, reflecting an increase in investment losses of approximately $293,000. This loss was primarily driven by changes in the fair value of equity investments.
Net loss per share was $ (0.60) and $(0.40) for the years ended December 31, 2023 and 2022, respectively. The weighted average number of shares of our common stock outstanding as of December 31, 2023, was 48,585,404 as compared to 48,047,288 as of December 31, 2022.
The weighted average number of shares of our common stock outstanding as of December 31, 2024, was 56,016,870 as compared to 48,585,404 as of December 31, 2023.
Liquidity and Capital Resources Cash used in operating activities for the year ended December 31, 2023, was approximately $21,267,000 compared to approximately $16,108,000 for the same period in 2022, an increase of $5,159,000.
This decline was primarily due to our company reaching the program’s lifetime cap of $20,000,000 in cumulative NOL sales. Liquidity and Capital Resources Cash used in operating activities for the year ended December 31, 2024, was approximately $14,888,000 compared to approximately $21,267,000 for the same period in 2023, a decrease of $6,379,000.
We believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials over approximately the next twenty-four months.
The development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. We believe, based on our current financial condition, that we do not have adequate funds to meet our anticipated operational cash needs and fund current clinical trials.
No assurance can be given as to the amount of funds that could be raised or the potential dilution to current stockholders. At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future.
At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future. We will need to obtain additional funding in the future to continue operations and for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional studies.
We believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well. The development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market.
We believe that it activates antiviral immune system pathways that fight not just a particular virus or viral variant, but other similar viruses as well. 41 At present we do not generate any material revenues from operations, and we do not anticipate doing so in the near future.
The increase was due to the cost incurred for production of Ampligen that occurred in the last quarter of 2023. Research and Development Costs Overall Research and Development (“R&D”) costs for the year ended December 31, 2023, were approximately $10,939,000 as compared to $6,990,000 a year ago, reflecting an increase of approximately $3,949,000.
Production Costs For the years ended December 31,2024 and 2023, production costs were approximately $31,000 and $42,000, respectively, reflecting a decrease of $11,000 in the current period. This reduction was primarily due to production costs incurred for of the manufacturing of Ampligen in the last quarter of 2023, which did not recur in 2024.
Gain from sale of income tax operating losses In December 2023, we effectively sold $14,156,000 of our New Jersey state net operating loss carryforward and $38,600 in R&D credits for the year 2022 for approximately $1,313,000.
Gain (loss) from sale of income tax operating losses In 2024, we recognized a ($1,604,000) impact related to the sale of our net operating losses (NOLs) under the New Jersey Technology Business Tax Certificate Transfer Program, compared to a $1,667,000 benefit in 2023.
Removed
Fair Value We have issued warrants (the “Warrants”) in February 2017, June 2017, August 2017, April 2018, and March 2019 that are single compound derivatives containing both an embedded right to obtain stock upon exercise (a “Call”) and a series of embedded rights to settle the Warrants for cash upon the occurrence of certain events (each, a “Put”).
Added
Research and Development Costs For the year ended December 31, 2024, research and development (“R&D”) expenses totaled approximately $6,197,000, compared to $10,939,000 in the prior year, representing a decrease of approximately $4,742,000. This reduction was primarily driven by a $3,216,000 decrease in company sponsored clinical trial expenses and a $1,622,000 reduction in outside consultant costs.
Removed
Generally, the Put provisions allow the Warrant Holders liquidity protection; the right to receive cash in certain situations where the Holders would not have a means of readily selling the shares issuable upon exercise of the Warrants (e.g., where there would no longer be a significant public market for our common stock).
Added
This reduction was primarily driven by a $7,211,000 decrease in legal, financial and consulting fees, which were higher in the prior year due to expenses incurred in response to stockholder nomination litigation issues in 2023.
Removed
However, because the contractual formula used to determine the cash settlement value of the embedded Put requires use of certain assumptions, the cash settlement value of the embedded Put can differ from the fair value of the unexercised embedded Call option at the time the embedded Put option is exercised.
Added
Net cash used in operating activities for the year ended December 31, 2024 was impacted by a net loss of approximately $17,320,000, an improvement from approximately $28,962,000 in 2023. However, since net loss includes significant non-cash expenses, actual cash from operations was influenced by several adjustments.
Removed
We recompute the fair value of the Warrants at the end of each quarterly reporting period. Such value computation includes subjective input assumptions that are consistently applied each period. If we were to alter our assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.
Added
Non-cash adjustments comparing 2024 to 2023 included a decrease of $2,000 in depreciation of property, plant, and equipment, an increase of $10,000 in amortization of patents and trademarks, an increase of $301,000 in amortization of financial obligations. Other significant non-cash expenses included $17,000 in non-cash lease expenses and $443,000 in equity-based compensation.
Removed
The primary reason for the increase in research and development costs was due to the increases in Company sponsored clinical trials expenses of approximately $2,162,000 and an increase in outside consultant costs of approximately $1,787,000.
Added
Additionally, we recognized a $293,000 loss on the sale of marketable securities, a $458,000 loss related to the valuation of warrants, a $34,000 loss from patent abandonments. Proceeds from the sale of fixed assets were $0 in 2024, compared to $18,000 in 2023, reflecting a decrease in asset sales and related cash inflows year-over-year.
Removed
The increase in G&A expenses during the current period was largely due to increases in legal fees of approximately $6,500,000 primarily related to responding to an attempt by a group of shareholders to bypass our bylaws and nominating procedures, and financial consultant fees of $2,407,000 offset by a decrease in stock compensation of $711,000.
Added
These were partially offset by a $692,000 gain from funds received under the New Jersey NOL program and a $50,000 reduction in prepaid expenses. Changes in working capital also impacted operating cash flows, with a $6,126,000 decrease in accounts payable, a $2,378,000 decrease in accrued expenses, a $1,062,000 increase in other assets, and a $35,000 decrease in lease liabilities.
Removed
We are in the process of submitting an insurance claim and hopes to recover a portion of the legal expenses related to the shareholder action, but recovery, if any, at this time cannot be determined.
Added
Collectively, these factors contributed to the overall cash flow from operating activities during the period. 39 Cash provided by investing activities was $4,706,000 in 2024, a significant improvement from $(832,000) in 2023, reflecting a $5,538,000 year-over-year increase. The primary driver of this improvement was $5,623,000 in proceeds from the sale of marketable securities in 2024, compared to $1,299,000 in 2023.
Removed
Redeemable Warrants The revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability.
Added
Additionally, purchases of marketable securities declined to $361,000 in 2024 from $1,593,000 in the prior year, further contributing to the positive cash flow impact. The Company continued investing in intellectual property, with $538,000 spent on patents and trademarks in 2024, compared to $585,000 in 2023.
Removed
There was no change for the twelve months ended December 31, 2023, compared with a gain of $35,000 for the twelve months ended December 31, 2022 (see “Financial Statements: Note 15: Fair Value” for the various factors considered in the valuation of redeemable warrants).
Added
Capital expenditures included $18,000 in purchases of property, plant, and equipment (PP&E) in 2024, whereas 2023 included $47,000 in proceeds from the sale of PP&E. The overall increase in net investing cash flow was primarily attributable to higher proceeds from marketable securities and lower investment purchases, improving the company’s liquidity position.
Removed
Additionally, we recorded a deferred tax asset in the amount of approximately $1,604,000 for the current year 2023 operating losses to be sold in 2024. (see Note 12 Income Taxes (FASB ASC 740 Income Taxes).
Added
Cash provided by financing activities totaled $6,444,000 in 2024, a significant increase compared to $485,000 in 2023, reflecting a $5,959,000 year-over-year improvement. This increase was primarily driven by $892,000 in net proceeds from the sale of stock in 2024, up from $485,000 in 2023.
Removed
The primary reasons for this increase in cash used in operations in 2023 was an increased net loss during the year of $9,517,000 and a gain on investments of $1,879,000, a decrease in stock compensation of $711,000 which was partially offset by an increase in accounts payable of $5,887,000 an increase in accrued expenses of $812,000.
Added
Additionally, the company secured $2,500,000 in proceeds from the issuance of notes payable, compared to zero in the prior year. Another key factor was a $3,303,000 non-cash warrant valuation adjustment in 2024, which had no comparable entry in 2023. In 2024, we repaid $251,000 in debt, whereas no debt repayments were made in 2023.
Removed
Cash used in investing activities for the year ended December 31, 2023, was approximately ($832,000) compared to cash provided by investing activities in 2022 of approximately $10,988,000, representing a change of $11,820,000.
Added
These financing activities strengthened the company’s liquidity position and provided additional capital to support ongoing operations and strategic initiatives. Our principal source of liquidity is our cash and cash equivalents, marketable securities, and proceeds from financing activities to provide the necessary funding to meet our obligations as they become due.
Removed
The primary reason for the change during the current period is the net purchase and sale of marketable investments activity of ($294,000) compared to the $7,359,000 for the same period in 2022, and by the proceeds from the sale of property and equipment of $47,000 in 2023, compared with $3,900,000 in 2022.
Added
As noted above, as of December 31, 2024, we had approximately $3,977,000 in cash, cash equivalents and marketable securities, inclusive of approximately $2,276,000 in marketable securities, representing a decrease of approximately $9,093,000 from December 31, 2023. In addition, we have suffered losses from operations as of December 31, 2024, and have a working capital deficit.
Removed
Cash provided by financing activities for the year ended December 31, 2023, was approximately $485,000 compared to approximately $80,000 for the same period in 2022, an increase of $405,000.
Added
These conditions raise substantial doubt regarding our ability to continue as a going concern for a period of at least one year from the date of the issuance of these consolidated financial statements. See Note 1 to our audited Consolidated Financial Statements.
Removed
The primary reason for this increase was the receipt of $485,000 in net proceeds from the sale of shares in 2023 compared to $80,000 from the proceeds from sale of stock, net of issuance costs in 2022.
Added
Please see “Risk Factors - We have a history of losses, expect to continue to incur losses in the near term and may not achieve or sustain profitability in the future, and as a result, there is a substantial doubt about our ability to continue as a going concern.” The accompanying audited consolidated financial statements have been prepared assuming that we will continue as a going concern.
Removed
As discussed below, in April 2023 we entered into an Equity Distribution Agreement, which was the primary source of additional equity proceeds in 2023 compared with 2022. 39 As of December 31, 2023, we had approximately $13,070,000 in cash, cash equivalents and marketable investments, inclusive of approximately $7,631,000 in marketable investments, representing a decrease of approximately $21,120,000 from December 31, 2022.
Added
On December 31, 2024, our current liabilities exceeded our current assets by $5,359,000 which raised doubt about our ability to continue as a going concern. Additionally, at December 31, 2024, our stockholders’ equity was below the minimum requirements for continued listing on the NYSE American.
Removed
In this regard, in April, 2023, we entered into an Equity Distribution Agreement (the “EDA”), with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of our common stock having an aggregate offering price of up to $8.5 million through Maxim, as agent.
Added
Management evaluated the conditions, and their significance of those conditions related to our ability to meet our obligations and determined that the primary cause of the working capital deficit was related to an accounts payable balance of approximately $6,400,000. This balance includes approximately $4,900,000 of legal fees related to litigation.
Removed
During the year ended December 31, 2023, we sold 598,114 shares under the EDA for total gross proceeds of approximately $344,000, which includes a 3.0% fee to Maxim of $10,326. In February 2022, the SEC declared our universal shelf registration statement on Form S-3 effective.
Added
We are currently negotiating with the law firm to reduce prior billings. These negotiations are ongoing and could, if resolved favorably to us, partially alleviate the working capital deficit. On September 6, 2024, an amendment to an agreement dated April 7, 2022, was executed by us and Amarex clarifying and changing the nature of the remaining execution fee of $725,437.
Removed
Pursuant to that registration statement, we can sell up to $100 million of our securities and raise additional capital as needed in the future. Subsequent to the end of 2023, we raised $2,500,000 in net proceeds from the sale of an unsecured Note and entered into an equity line of credit (see exhibits 10.104 and 10.105).
Added
The amendment allowed that the remainder would not be exclusive to the agreement dated on April 7, 2022, that the nature of the payment changed from an execution fee to a fully refundable deposit, and that it could be applied to any invoice upon mutual agreement of the parties, removed the threshold contingencies, and if such invoices were not sufficient to exhaust the balance, that the refund would be refunded in cash.
Removed
Redeemable Warrants We utilize the guidance contained in ASC 480 Distinguishing Liabilities from Equity in the determination of whether to record warrants and options as Equity and/or Liability. If the guidance of ASC 480 is deemed inconclusive, we continue our analysis utilizing ASC 815 Derivatives and Hedging.
Added
Due to the changes brought about by the amendment, the nature of the payment changed to deposit status. At December 31, 2024, we had an outstanding deposit of $653,000 which may be used to offset future clinical research expenditures.
Removed
Our method of recording the related value is consistent with the standards as defined by the Financial Accounting Standards Board utilizing the concept of “Fair Value” from ASC 820-10-55-1 that states that any fair value measurement requires that the reporting entity, to determine the valuation technique(s) appropriate for the measurement, consider the availability of data with which to develop inputs that represent the assumptions that market participants would use in pricing the asset or liability and the level in the fair value hierarchy within which the inputs fall.
Added
This deposit is listed as a non-current asset on the balance sheet but could provide working capital if the timing of expenditures are realized within the next 12 months. As a research and development company, we are conducting research necessary to bring our product, Ampligen, to market.
Removed
We recomputed the value of the redeemable warrants at the end of each quarterly period. We use the Monte Carlo Simulation approach which includes subjective input assumptions that are consistently applied each quarter. If we were to alter our assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.
Added
As such, we primarily rely on financing activities to provide the necessary funding to meet our obligations as they become due. AIM has a long and demonstrated history of success in these efforts, however, there is no assurance that we will be successful in attaining the necessary funding in the future. 40 Potential Delisting from the NYSE American .
Removed
As discussed in greater detail in “Fair Value” at the beginning of this ITEM 7, the significant assumptions using this model are: (i) Risk-Free Interest Rate; (ii) Expected Holding Period; (iii) Expected Volatility; (iv) Expected Dividend Yield; (v) Expected Probability of a Fundamental Transaction; (vi) Expected Timing of Announcement of a Fundamental Transaction; (vii) Expected 100 Day Volatility at Announcement of a Fundamental Transaction; (viii) Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction; and (ix) Expected Time Between Announcement and Consummation of a Fundamental Transaction.
Added
The closing price of our common stock on the NYSE American on March 24, 2025 was $0.14 per share. On December 11, 2024, we received an official notice of noncompliance with the NYSE American’s continued listing requirements. This includes the need for us to have stockholders’ equity of $6.0 million or more.
Removed
The derivative is values using Level 3 inputs which are highly subjective and require a high degree of judgment.
Added
The NYSE American’s review showed that we were not in compliance with that requirement. As required, we submitted a plan (the “Plan”) to the NYSE American illustrating how we can regain compliance by June 11, 2026. The Plan includes a number of ways to raise capital. The NYSE American accepted our Plan on February 26, 2025.
Removed
Concentration of Credit Risk Our policy is to limit the amount of credit exposure to any one financial institution and place investments with financial institutions evaluated as being credit worthy, or in short-term money markets, which are exposed to minimal interest rate and credit risks. We have bank deposits and overnight repurchase agreements that exceed federally insured limits.
Added
If we are not able to regain compliance by June 11, 2026, our common stock may be delisted from the NYSE American. As of December 31, 2024, our stockholders’ deficit was ($1.3) million. We must increase our stockholders’ equity to be at least $6 million to regain compliance with this rule.
Removed
Concentration of credit risk, with respect to receivables, is limited through our credit evaluation process. We do not require collateral on our receivables. Our receivables historically consisted principally of amounts due from wholesale drug companies.
Added
If we are not able to raise sufficient capital as set forth in the Plan or by other means, we may be unable to regain compliance with the NYSE American’s listing standards and our securities could be subject to delisting.
Added
In the event that the price of our Common Stock drops to $0.10 per share, our Common Stock will automatically be delisted from the NYSE American. As part of the Plan, we will be holding a special meeting of stockholders solely for the purpose of authorizing a reverse split of our outstanding shares.
Added
The proxy statement for that meeting has been filed with the SEC and is available on the SEC’s website. We believe that effecting a reverse split will assist us with raising capital we need to continue our business and avoiding an automatic delisting if the stock price drops to $0.10 per share.
Added
Today, some four years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics. Our quest to prove the antiviral activities of Ampligen continues.
Added
However, we estimate and accrue costs related to clinical trials, third-party contract research organizations (CRO’s), manufacturing development, and preclinical studies based on services performed. Material changes in assumptions could significantly impact R&D expenses in any given period. 42 Stock-Based Compensation We grant stock options, the valuation of which requires significant judgement.
Added
To estimate their fair value, we use the Black-Scholes model, which involves assumptions about stock volatility, expected option life, and risk-free interest rates. Changes in estimated volatility or expected option life could have a material impact stock-based compensation expenses.