What changed in AIM ImmunoTech Inc.'s 10-K — 2022 vs 2023
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Paragraph-level year-over-year comparison of AIM ImmunoTech Inc.'s 2022 and 2023 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 2023 report.
+92 added−62 removedSource: 10-K (2024-04-01) vs 10-K (2023-03-31)
Top changes in AIM ImmunoTech Inc.'s 2023 10-K
92 paragraphs added · 62 removed · 37 edited across 5 sections
- Item 3. Legal Proceedings+40 / −13 · 1 edited
- Item 7. Management's Discussion & Analysis+38 / −37 · 27 edited
- Item 5. Market for Registrant's Common Equity+9 / −5 · 5 edited
- Item 2. Properties+2 / −4 · 1 edited
- Item 6. [Reserved]+3 / −3 · 3 edited
Item 2. Properties
Properties — owned and leased real estate
1 edited+1 added−3 removed0 unchanged
Item 2. Properties
Properties — owned and leased real estate
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2022 filing
2023 filing
Biggest changeITEM 2. Properties. Our principal executive office and finance is located at 2117 SW Highway 484, Ocala FL 34473 and our human resource office is located at 604 Main Street, Riverton, NJ 08077. We currently lease our principal executive office for $2,700 per month and our accounting and human resource office for about $2,500 per month.
Biggest changeITEM 2. Properties. Our principal executive office and finance is located at 2117 SW Highway 484, Ocala FL 34473, human resource office is located at 604 Main Street, Riverton, NJ 08077 and manufacturing is located at 671A US-1 South, North Brunswick, NJ 08902.
Removed
In March 2018, we sold our property located at 783 Jersey Ave., New Brunswick, NJ. This property houses our development and production facilities. The purchase price was $4,080,000 gross and purchaser received 3,225,806 warrants to purchase common stock.
Added
We 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.
Removed
In May 2021, we exercised the option to re-purchase the New Brunswick manufacturing facility, pursuant to the terms of the March 2018 sale and lease-back agreement. We thereafter sold certain equipment and machinery that it determined to be obsolete and no longer needed for current or future manufacturing.
Removed
On March 3, 2022, we entered into an Agreement of Sale and Purchase with Acellories, Inc. to purchase the property for an estimated $3.9 million, and maintained some space specifically for its Alferon activity. The sale closed on November 1, 2022 for $3.7 million net of normal closing cost.
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+39 added−12 removed0 unchanged
Item 3. Legal Proceedings
Legal Proceedings — active lawsuits and investigations
1 edited+39 added−12 removed0 unchanged
2022 filing
2023 filing
Biggest changeThe court denied the motion several days later and scheduled a hearing on Jorgl’s motion for a preliminary injunction to be held on October 5, 2022.
Biggest changeOn 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.
Removed
ITEM 3. Legal Proceedings. We commenced an action against BioLife in December of 2017 for Breach of Contract. The amount of damages we are seeking in this matter have yet to be determined. Damages are not covered by insurance.
Added
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.
Removed
BioLife, the defendant, has filed its Answer, Affirmative Defenses and a Counterclaim in the amount of $96,676 representing the invoices withheld after BioLife indicated that they were not intending to fulfill the balance of the contract. We have denied the allegations of the counterclaim. We have conducted two mediation sessions, but have been unable to resolve the matter.
Added
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.
Removed
The parties are still currently engaged in discovery, which we believe will now lead to a trial date in the later part of 2023. The scheduled dates for these events to transpire were extended several times as they were dependent on the safe and full reopening of the Courts.
Added
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.
Removed
Although it cannot be reasonably determined at this time, we believe the likelihood of an unfavorable outcome on the defendant’s counterclaim is remote.
Added
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.
Removed
On July 8, 2022, we received a notice from Jonathan Jorgl (the “Jorgl Notice”), an AIM stockholder who first purchased 1,000 AIM shares on June 27, 2022, seeking to nominate a control slate of two individuals for election to the three-member AIM Board of Directors (the “Board”) at the 2022 Annual Meeting of Stockholders.
Added
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.
Removed
The Board unanimously determined the Jorgl Notice to be invalid due to numerous deficiencies, including failure to comply with the Company’s bylaws. The rejection of the Jorgl Notice was announced on July 18, 2022. Also on July 18, 2022, we filed a complaint in the U.S.
Added
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.
Removed
District Court for the Middle District of Florida, Ocala Division, against individuals we believe failed to register as a group pursuant to U.S. securities laws and committed other unlawful actions in the context of their attempt to effectuate a takeover of the Company’s Board. The court granted the defendants’ motion to dismiss, but allowed the filing of an amended complaint.
Added
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.
Removed
Defendants’ renewed motion to dismiss is pending, and AIM is in the process of obtaining discovery from the defendants.
Added
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.
Removed
On August 12, 2022, a hearing was held in the Delaware Court of Chancery concerning a motion for a temporary restraining order sought by Jorgl to require the AIM Board of Directors to accept his director nominations and include his nominees on a universal proxy card for the upcoming Annual Meeting of Stockholders.
Added
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.
Removed
Extensive discovery was conducted in advance of the hearing, which was then held as scheduled. 34 On October 5, 2022, the Delaware Court of Chancery held a hearing regarding a motion to require the AIM Board of Directors to accept the Jorgl Group’s director nominations and include the group’s nominees on a universal proxy card for the 2022 Annual Meeting of Stockholders.
Added
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.
Removed
On October 28, 2022, the court denied Jorgl’s motion, citing that he failed to meet the burden of proof in light of the evidence showing that he was part of efforts by convicted securities law felons working toward taking control of the AIM Board.
Added
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.
Removed
The Jorgl Group announced on November 2, 2022, that it did not intend to appeal the decision. ITEM 4. Mine Safety Disclosures. Not Applicable. PART II
Added
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
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
No 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.
Added
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
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
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”).
Added
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.
Added
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.
Added
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.
Added
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.
Added
On July 20, 2023, defendants filed a motion to shift all litigation fees they incurred in connection with the Jorgl Action to Jorgl on the basis that he brought the litigation in bad faith (the “AIM Fee Motion”).
Added
Also on July 20, 2023, Jorgl filed a motion to shift certain legal fees to defendants that he incurred in connection with contesting a subpoena defendants served on the legal counsel that advised Jorgl in his nomination efforts, Baker & Hostetler LLP (the “Jorgl Fee Motion”).
Added
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.
Added
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
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 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.
Added
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.
Added
We filed a motion for reconsideration, which the trial court denied. We filed an appeal of the dismissal, which is pending and referenced below.
Added
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.
Added
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.
Added
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.
Added
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”).
Added
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.
Added
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.
Added
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.
Added
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.
Added
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.
Added
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
5 edited+4 added−0 removed5 unchanged
Item 5. Market for Registrant's Common Equity
Market for Common Equity — stock, dividends, buybacks
5 edited+4 added−0 removed5 unchanged
2022 filing
2023 filing
Biggest changeRecent Sales of Unregistered Securities During the year ended December 31, 2022, we issued and sold the following unregistered securities 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: 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.
Biggest changeRecent 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.
Pursuant to NYSE American rules, this plan was effective for a sixty-day period commencing upon the date that the NYSE American approved the 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.
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.
The last plan approved by the board of directors for the fiscal year ending December 31, 2022, was on November 16, 2022. During the fiscal year ended December 31, 2020, we issued a total of 27,501 shares of our common stock at prices ranging from $1.72 to $2.03 for a total of $50,000.
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.
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. 35 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.
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]
During the fiscal year ended December 31, 2021, we issued a total of 132,238 shares of our common stock at prices ranging from $1.16 to $2.35 for a total of $205,000.
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.
Added
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
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
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.
Added
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.
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
3 edited+0 added−0 removed0 unchanged
Item 6. [Reserved]
Selected Financial Data — reserved (removed by SEC in 2021)
3 edited+0 added−0 removed0 unchanged
2022 filing
2023 filing
Biggest changePrincipal Accountant Fees and Services. 53 PART IV 54 ITEM 15. Exhibits and Financial Statement Schedules. 54 ITEM 16. Form 10-K Summary. 62 2 PART I
Biggest changePrincipal Accountant Fees and Services. 58 PART IV ITEM 15. Exhibits and Financial Statement Schedules. 59
ITEM 6. [Reserved] 36 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 36 ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk. 39 ITEM 8. Financial Statements and Supplementary Data. 3 9 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 39 ITEM 9A. Controls and Procedures. 40 ITEM 9B.
ITEM 6. [Reserved] 38 ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 38 ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk. 41 ITEM 8. Financial Statements and Supplementary Data. 41 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 42 ITEM 9A. Controls and Procedures. 42 ITEM 9B.
Other Information. 40 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 40 PART III 41 ITEM 10. Directors, Executive Officers and Corporate Governance. 41 ITEM 11. Executive Compensation. 45 ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 51 ITEM 13. Certain Relationships and Related Transactions and Director Independence. 53 ITEM 14.
Other Information. 42 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 42 PART III ITEM 10. Directors, Executive Officers and Corporate Governance. 43 ITEM 11. Executive Compensation. 48 ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 55 ITEM 13. Certain Relationships and Related Transactions and Director Independence. 58 ITEM 14.
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
27 edited+11 added−10 removed17 unchanged
Item 7. Management's Discussion & Analysis
Management's Discussion & Analysis (MD&A) — revenue / margin commentary
27 edited+11 added−10 removed17 unchanged
2022 filing
2023 filing
Biggest changeThis increase in net loss for the year ended December 31, 2022, was primarily due to the following: ● an increase in general and administrative expenses of $4,402,000; ● an increase in loss on investments of $1,478,000; offset by ● an increase in interest/other income of $629,000; ● a decrease in interest expense and finance costs $2,768,000; and ● a decrease in impairment losses of $1,779,000; ● a decrease in research and development expenses of $682,000; ● a decrease in production costs of $850,000; ● a decrease in gain from sale of Income tax operating losses of $829,000; ● a decrease in gain of sale of fixed assets of $213,000 ● a decrease of the quarterly revaluation of certain redeemable warrants of $110,000; Net loss per share was $ (0.40) and $(0.40) for the years ended December 31, 2022, and 2021, respectively.
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.
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.
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.
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 two 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. Today, some three years after COVID-19 first appeared, the world has a number of vaccines and some promising therapeutics.
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, 2022 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, 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.
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(h) – Recent Accounting Standards and Pronouncements” under Notes to Consolidated Financial Statements.
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.
For the years ended December 31, 2022 and 2021, 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. 36 Production Costs Production costs were approximately $0 and $850,000, respectively, for the years ended December 31, 2022, and 2021, representing a decrease of $850,000 in production costs in the current period.
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.
Cash provided by investing activities for the year ended December 31, 2022, was approximately $10,988,000 compared to cash used in 2021 was approximately $631,000, representing a change of $11,619,000.
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.
Gain (loss) on Investments Gain (loss) on investments for the years ended December 31, 2022, and 2021 were approximately ($1,679,000) and ($201,000), respectively, reflecting an increase in the loss on investments of approximately ($1,478,000). The loss was due to the change in the fair value of equity investments.
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.
RESULTS OF OPERATIONS Year ended December 31, 2022 versus year ended December 31, 2021 Our net loss was approximately $19,445,000 and $19,127,000 for the years ended December 31, 2022 and 2021, respectively, representing an increase in net loss of approximately $318,000 when compared to the same period in 2021.
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.
General and Administrative Expenses General and Administrative (“G&A”) expenses for the years ended December 31, 2022, and 2021, were approximately $13,074,000 and $8,672,000, respectively, reflecting an increase of approximately $4,402,000.
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.
Liquidity and Capital Resources Cash used in operating activities for the year ended December 31, 2022, was approximately $16,108,000 compared to approximately $13,965,000 for the same period in 2021, an increase of $2,143,000.
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.
Revenues Revenues from our Ampligen® Cost Recovery Program were $141,000 and $135,000 for the years ended December 31, 2022, and 2021, representing an increase of $6,000 which is primarily related to the timing of orders.
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.
The primary reason for this decrease was our receipt of $13,042,000 in net proceeds from the sale of shares in 2021compared to $80,000 from the proceeds from sale of stock, net of issuance costs in 2022.
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.
At present we do not generate any material revenues from operations and we do not anticipate doing so in the near future. 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 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.
Gain from sale of income tax operating losses We effectively sold $20,500,000 New Jersey state operating losses from 2021 for approximately $1,676,000. Additionally, we recorded a deferred tax asset in the amount of $1,118,000 for the current year 2022 operating losses to be sold in 2023. (see Note 12 Income Taxes (FASB ASC 740 Income Taxes).
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).
We measure our long-lived assets, in accordance to ASC 360 impairment (patents, trademarks, intangibles, fixed assets) Long-lived assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized. Impairments are determined for groups of assets related to the lowest level of identifiable independent cash flows.
Long-lived assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized. Impairments are determined for groups of assets related to the lowest level of identifiable independent cash flows. The Company makes subjective judgments in determining the independent cash flows that can be related to specific asset groupings.
We measure the recoverability of assets that we will continue to use in our operations by comparing the carrying value of the asset grouping to our estimate of the related total future undiscounted net cash flows. If an asset grouping’s carrying value is not recoverable through the related undiscounted cash flows, the asset grouping is considered to be impaired.
When assessing for impairment, we measure the recoverability of assets that it will continue to use in its operations by comparing the carrying value of the asset grouping to our estimate of the related total future undiscounted net cash flows.
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 sixteen months. In February 2022, the SEC declared our universal shelf registration statement on Form S-3 effective.
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 primary reason for the decrease in research and development costs was due to decreases in Company sponsored clinical trials expenses of $1,728,000, offset by increases in salaries and outside consultant costs of $607,00, $66,000 in rent and $304,000 in patents & trademarks.
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.
Redeemable Warrants The quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted to a gain of $35,000 for the year ended December 31, 2022, compared to a gain of approximately $145,000 in December 31, 2021 (see “Financial Statements: Note 15: Fair Value” for the various factors considered in the valuation of redeemable warrants).
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).
If the guidance of ASC 480 is deemed inconclusive, we continue our analysis utilizing ASC 815 Derivatives and Hedging.
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.
The weighted average number of shares of our common stock outstanding as of December 31, 2022, was 48,047,288 as compared to 47,339,975 as of December 31, 2021.
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 decrease was due primarily to the sale of the facility and no production for 2022 compared to 2021. Research and Development Costs Overall Research and Development (“R&D”) costs for the year ended December 31, 2022, were approximately $6,990,000 as compared to $7,672,000 for the same period a year ago, reflecting a decrease of approximately $682,000.
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.
The primary reason for the change during the current period is the net purchase and sale of marketable securities activity of $7,359,000 compared to the $243,000 for the same period in 2021, and by the proceeds from the sale of the asset held for sale of $3,900,000 in 2022. 37 Cash provided by financing activities for the year ended December 31, 2022, was approximately $80,000 compared to approximately $8,188,000 for the same period in 2021, a decrease of $8,108,000.
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.
Pursuant to that registration statement, we can sell up to $100 million of our securities and raise additional capital as needed in the future. No assurance can be given as to the amount of funds that could be raised pursuant to this registration statement or the potential dilution to current stockholders.
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.
The primary reasons for this increase in cash used in operations in 2022 was related to the loss on marketable securities of $1,679,000, as well as in increase in the prepaid expenses of $151,000 and an increase in accounts payable of $179,000.
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.
As of December 31, 2022, we had approximately $34,190,000 in cash, cash equivalents and marketable securities, inclusive of approximately $7,137,000 in Marketable Securities, representing a decrease of approximately $14,078,000 from December 31, 2021.
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.
Removed
The increase in G&A expenses during the current period was mainly due to increases in legal fees of $4,582,000, public relations expenses of $348,000, insurance expenses of $439,000 and general expense of $51,000 net of decreases in stock compensation of $613,000, salary expenses of $243,000 and depreciation of $12,000.
Added
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.
Removed
Impairment of plant property and equipment and other assets During the year ended December 31, 2022, there was a loss of $0 related to the impairment of plant property and equipment (see Note 2 Summary of Significant Accounting Policies).
Added
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.
Removed
During the year ended December 31, 2021, there was a loss of $1,779,000 related to the impairment of plant property and equipment (see Note 2 Summary of Significant Accounting Policies).
Added
Redeemable Warrants The revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability.
Removed
Interest expense and finance costs for the year ended December 31, 2022, was $0 compared to $2,768,000 in the prior year, a decrease of $2,768,000 primarily due to the extinguishment of debt of $2,768,000 in 2021.
Added
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.
Removed
Factors that we consider in deciding when to perform an impairment review include significant under-performance of a business or product line in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of the assets.
Added
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.
Removed
In the event if the carrying value exceeds the future undiscounted net cash flows, we would estimate the fair values using a combination of market and income approaches. Under the market approach, fair values would be estimated using published market multiples for comparable companies.
Added
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.
Removed
Under the income approach, a discounted cash flow methodology would be used, considering: (i) management estimates, such as projections of revenue, operating costs and cash flows, taking into consideration historical and anticipated financial results; (ii) general economic and market conditions; and (iii) the impact of planned business and operational strategies. 38 We measure the impairment by comparing the difference between the asset grouping’s carrying value and its fair value.
Added
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.
Removed
We make subjective judgments in determining the independent cash flows that can be related to specific asset groupings. In addition, as we review our manufacturing process and other manufacturing planning decisions, we must make subjective judgments regarding the remaining useful lives of assets.
Added
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).
Removed
When we determine that the useful lives of assets are shorter than originally estimated, we accelerate the rate of depreciation over the assets’ new, shorter useful lives. At the end of fiscal year December 31, 2022, we engaged an outside third party to provide a valuation for the impairment of our patents and trademarks.
Added
Factors that the Company considers in deciding when to perform an impairment review include significant decreases in the market price of a long-lived asset or group, a significant adverse change in the extent or manner in which a long-lived asset (asset group) is being used or its physical condition, a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group, including an adverse action or assessment by a regulator, an accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of a long-lived asset (asset group), a current period operating or cash flow loss combined with a history of operating or cash flow losses or projection or forecast that demonstrates continuing losses associated with the use of a long-lived asset (asset group) or a current expectation that, more likely than not, a long-lived asset (asset group) will be sold or otherwise disposed of significantly before the end of its previously estimated useful life.
Removed
The determination was, from a qualitative standpoint, it would appear highly unlikely that there would be any impairment to the patnets. (see Note 2 Summary of Significant Accounting Policies) 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.
Added
If an asset grouping’s carrying value is not recoverable through the related undiscounted cash flows, the asset grouping is considered to be impaired. We measure the impairment by comparing the difference between the asset grouping’s carrying value and its fair value.
Added
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.