UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
February 4, 2016 (January 26, 2016)
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0 - 27072 | 52-0845822 | ||
| (state or other juris- | (Commission | (I.R.S. Employer | ||
| diction of incorporation) | File Number) | (Identification No.) |
| 1617 JFK Boulevard, Suite 500, Philadelphia, PA | 19103 | ||||
| (Address of principal executive offices) | (Zip Code) | ||||
| Registrant's telephone number, including area code: (215) 988-0080 | |||||
| 1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103 | |||||
| (Former name or former address, if changed since last report) | |||||
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): | |||||
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||||
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||||
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||||
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||||
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Item 8.01. Other Events.
On January 26, 2016, the Board of Directors (the “Board”) of Hemispherx Biopharma, Inc. (the “Company”), based on the recommendation of the Compensation Committee of the Board (the “Compensation Committee”), established two programs - the 2016 Senior Executive Deferred Cash Performance Award Plan for Dr. William A. Carter and Thomas K. Equels, the Company’s two primary executive officers (the “Executive Plan”), and the 2016 Voluntary Incentive Stock Award Plan for Company employees and Board members other than Dr. Carter and Mr. Equels (the “Employee Plan”). Both Plans include a Base Pay Supplement provision.
The Executive Plan
The Executive Plan was established to both conserve cash and create appropriate incentives for senior executives to be rewarded based upon the performance of the Company. The two participants are Dr. William A. Carter, the Company’s Chairman of the Board, Chief Executive Officer and Chief Scientific Officer, and Thomas K. Equels, the Company’s President, Executive Vice Chairman of the Board, Secretary, General Counsel and Chief Financial Officer (the “Executives”).
The Executive Plan will be in effect for three months beginning with the commencement of the Employee Plan described below and may be extended for additional periods of three months thereafter subject to termination by the Company with the approval of the Board. The Executive Plan will be in effect during any period in which Employee Plan is in effect. The Executives will participate during each three-month period the Executive Plan is in effect (each such period, an “Executive Plan Period”). By participating in the Executive Plan, each Executive has authorized the Company to withhold 50% of the sum of his salary, consulting and director’s fees on each semi-monthly payroll date (each, a “Withholding Date”) occurring during the applicable Executive Plan Period. The Company will establish and maintain a record of the dollar amount withheld on each Withholding Date (each, a “Withheld Dollar Amount”) and the closing price of a share of the Company’s common stock (the “Stock”) on the NYSE MKT on the last trading day preceding the Withholding Date (each, a “Base Stock Price”).
On the 9-month anniversary of each Withholding Date (each, a “Payment Date”), if the Payment Condition, as defined below, in respect of the Withheld Dollar Amount on such Withholding Date is satisfied, the Company will pay the Executive an amount in cash (the “Performance Cash Payment”) equal to (a) the product of the applicable Withheld Dollar Amount multiplied by a fraction, the numerator of which will be the closing price of the Stock on the NYSE MKT for the last trading date preceding the Payment Date (a “Payment Stock Price”), and the denominator of which will be the applicable Base Stock Price, less (b) the minimum withholding taxes due in respect of such payment. The Payment Condition is that the closing price of the Stock for at least five (5) successive trading days in the period from withholding of compensation to the applicable Payment Date must have been at least $0.20 per share. If the Payment Condition is not fully satisfied with respect to a Withheld Dollar Amount then the Performance Cash Payment will be zero and the Senior Executives will loose the entire amount witheld.
The Company believes that this combination of a large compensation holdback coupled with the Executives’ ability to recoup this amount and possibly more aligns the Executives’ compensation to their performance and rewards them only if they are able to increase stockholder value and penalizes them if they fail to achieve the minimum floor stock price of $.20 per share for several successive days. This enhances the incentives related to improving the Company’s business and raising its stock price.
The Employee Plan is administered and interpreted by the Compensation Committee. The Compensation Committee has the authority to make appropriate adjustments to the Base Stock Price and the Payment Stock Price to reflect stock splits and stock combinations.
The Employee Plan
Pursuant to the Employee Plan, all full-time employees and directors, other than Dr. Carter and Mr. Equels may participate in the plan. The Employee Plan will be in effect for three months commencing January 26, 2016 and may be extended for additional periods of three months thereafter subject to termination by the Company with the approval of the Board. Eligible employees and directors may elect to participate during any three-month period the Employee Plan is in effect (each, an “Employee Plan Period”) subject to election prior to the commencement of any such period. Employees and Directors who elect to participate in the Employee Plan (the “Participants”) may elect to cease their participation at the end of any Employee Plan Period.
By electing to participate in the Employee Plan, an employee will be authorizing the Company to withhold 20% of the employee’s salary on each semi-monthly payroll date and a director will be authorizing the Company to withhold 20% of the director’s fee on each semi-monthly payment date (each a “Withholding Date”) occurring during the applicable Employee Plan Period. On each Withholding Date, the Participant will be issued an Incentive Right for a number of shares of Stock, less applicable withholding taxes. The number of shares (the “Participant’s Amount”) will be computed by dividing the applicable salary/fee withheld for the period by the closing price of the Stock on the NYSE MKT on the trading day immediately preceding the Withholding Date. The Company will establish and maintain a record of the number of shares of Stock represented by each Incentive Right. Such number of shares of Stock represented by an Incentive Right will be subject to appropriate adjustment in the event of a stock split or stock consolidation.
Any employee earning salary at a rate of less than $75,000 per year may elect, in advance of a Employee Plan Period, to participate by authorizing the Company to withhold, at the employee’s option, 10% or 20% of the employee’s salary during such Employee Plan Period.
Prior to the beginning of each Employee Plan Period, each Participant may elect in writing to receive the Participant’s Amount, on the 6-month, 9-month or 12-month anniversary of each Withholding Date. In the absence of an election, the Participant will be paid on the 6-month anniversary of the applicable Withholding Date.
On the anniversary date on which the Participant is to be paid in accordance with his or her election (the “Payment Date”), the Company will determine, for tax withholding and basis purposes, the value of each Participant’s Amount for which payment is being made. The value on the Payment Date will be based on the closing price of a share of Stock on the NYSE MKT for the trading day preceding the Payment Date. On any date Stock is to be issued, the number of shares needed for sale to cover the related withholding taxes will be determined by the Company and communicated to the Participant. Unless the Participant elects prior to the commencement of the applicable Employee Plan Period to pay the withholding tax dollar amount directly to the Company on or before the Payment Date, the Company will withhold the required minimum withholding tax from any amounts due the Participant on such Payment Date by either, in its discretion, (a) reducing the number of shares of Stock to be issued to the Participant by the number of shares of Stock having a value equal to the applicable withholding taxes or (b) causing to be sold on the open market that number of shares of Stock issued to the Participant which is necessary to fund the payment of the withholding tax.
The Employee Plan is administered and interpreted by the Compensation Committee.
The Company will arrange, at its cost, for a registered brokerage firm to establish a trading account for each Participant. Shares of Stock being delivered under the Employee Plan will be transferred to that account. Delivery of shares of Stock under the Employee Plan will constitute taxable income to a Participant at the time the shares of Stock are delivered and will be subject to payroll taxes. The Company will bear all costs related to selling shares of Stock awarded under the Employee Plan in such amount as necessary to pay any withholding taxes. During the period a Participant remains an active employee or a Director, the Company will bear (i) the charges of the brokerage firm for the maintenance of the account, (ii) any transaction costs related to the transfer of shares by the Company into the account and (iii) transaction costs related to the sale of shares of Stock from the account.
All full-time employees have opted to participate in the Employee Plan.
The Employee Plan is an “Employee Wages or Hours Reduction Program” within the meaning of Article 2 of the Amended and Restated Hemispherx Biopharma, Inc. 2009 Equity Incentive Plan.
Base Pay Supplement
All Participants in either plan will be awarded an amount (the “Approval Award”) equal to 30% of the pre-tax amount of their base annual salary as then in effect upon FDA Approval of Ampligen (the “Approval”). The Approval Award will be paid within three months following the Approval. In addition, all Participants in either plan will be awarded an amount (the “Pre-Approval Award”) equal to 30% of the pre-tax amount of their annual salary as then in effect upon the successful pre-approval inspection by the FDA of the Alferon facility (the “Pre-Approval”). The Pre-Approval Award will be paid within three months following the Pre-Approval. A Participant will not qualify for the Approval or Pre-Approval Award if the Participant’s employment is terminated prior to such Approval or Pre-Approval due to (i) termination by the Company for Cause or (ii) voluntary termination by the Participant.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
| 10.1 | 2016 Senior Executive Deferred Cash Performance Award Plan |
| 10.2 | 2016 Voluntary Incentive Stock Award Plan |
| 99.1 | Press release dated February 3, 2016 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| HEMISPHERX BIOPHARMA, INC. | ||
| February 4, 2016 | By: | /s/ Thomas K. Equels |
| Thomas K. Equels, President | ||
Exhibit 10.1
Hemispherx Biopharma, Inc.
2016 Senior Executive Deferred Cash Performance Award Plan
1. In order to conserve cash and create appropriate incentives for senior executives, Hemispherx Biopharma, Inc. (the “Company”), with the approval of the Board of Directors of the Company (the “Board”) based on the recommendation of the Compensation Committee of the Board (the “Committee”), has adopted the Hemispherx Biopharma, Inc. 2016 Senior Executive Deferred Cash Performance Award Plan (the “Plan”). The participants in the Plan (the “Participants”) will be Dr. William Carter and Mr. Thomas Equels.
2. The Plan will be in effect for three months beginning with the commencement of the 2016 Voluntary Incentive Stock Award Plan (the “Stock Award Plan”) and may be extended for additional periods of three months thereafter subject to termination by the Company with the approval of the Board. The Plan shall be in effect during any period in which the Stock Award Plan is in effect. The Participants will participate during each three-month period the Plan is in effect (each such period, a “Plan Period”).
3. By participating in the Plan, a Participant will be authorizing the Company to withhold 50% of the sum of his salary, consulting and director’s fees on each semi-monthly payroll date (each, a “Withholding Date”) occurring during the applicable Plan Period.
4. The Company will establish and maintain a record of the dollar amount withheld on each Withholding Date (each, a “Withheld Dollar Amount”) and the closing price of a share of the Company’s common stock (the “Stock”) on the NYSE MKT on the last trading day preceding the Withholding Date (each, a “Base Stock Price”).
5. On the 9-month anniversary of each Withholding Date (each, a “Payment Date”), if the Payment Condition, as defined below, in respect of the Withheld Dollar Amount on such Withholding Date is satisfied, the Company will pay the Participant an amount in cash (the “Performance Cash Payment”) equal to (a) the product of the applicable Withheld Dollar Amount multiplied by a fraction, the numerator of which will be the closing price of the Stock on the NYSE MKT for the last trading date preceding the Payment Date (a “Payment Stock Price”), and the denominator of which will be the applicable Base Stock Price, less (b) the minimum withholding taxes due in respect of such payment. The Payment Condition will be that the closing price of the Stock for five (5) successive trading days during the period beginning on the applicable Withholding Date and ending on the applicable Payment Date is at least $0.20 per share.
6. If the Payment Condition is not satisfied with respect to a Withheld Dollar Amount then the Performance Cash Payment will be zero.
Plan Administration.
Subject to the provisions of the Plan, the Committee is authorized to interpret the Plan and the grants made under the Plan, to establish, amend and rescind any rules, regulations or policies related to the Plan, to determine the terms and provisions of the agreements related to the Plan, and to make all other determinations necessary or advisable for the administration of the Plan. The Committee, in its sole discretion, may correct any defect, supply any omission and reconcile any inconsistency in the Plan. The Committee may adopt such rules, regulations and policies as it deems desirable for administering the Plan. The Committee will have the authority to make appropriate adjustments to the Base Stock Price and the Payment Stock Price to reflect stock splits and stock combinations. The determination of the Committee in the administration of the Plan, as described herein, shall be final and conclusive. For the sake of clarity, the authority and discretion of the Committee in respect of the Plan will include the Base Pay Supplement for Participants as provided below.
BASE PAY SUPPLEMENT FOR PARTICIPANTS.
Each of the Participants will be awarded an amount (the “Approval Award”) equal to 30% of the pre-tax amount of his base annual salary upon FDA Approval of Ampligen (the “Approval”). The Approval Award will be paid within three months following the Approval. A Participant will not qualify for the Approval Award if the Participant’s employment is terminated prior to the Approval due to (i) termination by the Company for Cause or (ii) voluntary termination by the Participant.
In addition, each of the Participants will be awarded an amount (the “Pre-Approval Award”) equal to 30% of the pre-tax amount of his base annual salary upon the successful pre-approval inspection by the FDA of the Alferon facility (the “Pre Approval”). The Pre-Approval Award will be paid within three months following the Pre Approval. A Participant will not qualify for the Pre-Approval Award if the Participant’s employment is terminated prior to the Pre Approval due to (i) termination by the Company for Cause or (ii) voluntary termination by the Participant.
Exhibit 10.2
Hemispherx Biopharma, Inc.
2016 Voluntary Incentive Stock Award Plan
1. In order to create appropriate employee incentives, Hemispherx Biopharma, Inc. (the “Company”), with the approval of the Board of Directors of the Company (the “Board”) based on the recommendation of the Compensation Committee of the Board (the “Committee”), has adopted the Hemispherx Biopharma, Inc. 2016 Voluntary Incentive Stock Award Plan (the “Plan”). The Plan will constitute an “Employee Wages or Hours Reduction Program” within the meaning of Article 2 of the Amended and Restated Hemispherx Biopharma, Inc. 2009 Equity Incentive Plan.
2. Participation in the Plan will be voluntary, meaning that participation will be at the election of individual employees and Directors, other than Dr. William Carter (“Dr. Carter”) and Mr. Thomas Equels (“Mr. Equels”) who instead will participate in a separate plan. For the sake of clarity, except as otherwise specifically provided, references to employees and Directors of the Company do not include references to Dr. Carter and Mr. Equels. The Plan will be in effect for three months commencing January 26, 2016 and may be extended for additional periods of three months thereafter subject to termination by the Company with the approval of the Board. All full-time employees of the Company and all members of the Board will be eligible to participate during any three-month period the Plan is in effect (each such period, a “Plan Period”) subject to election prior to the commencement of any such period. (An employee who also is a Director may participate as an employee as to salary and, in addition, at his or her election, as a Director in respect of his or her Director’s Fees.) Employees and Directors who elect to participate in the Plan (the “Participants”) may elect to cease their participation at the end of any Plan Period.
3. By electing to participate in the Plan, an employee will be authorizing the Company to withhold, except as noted below, 20% of the employee’s salary on each semi-monthly payroll date (each a “Withholding Date”) occurring during the applicable Plan Period. On each Withholding Date the Participant will be issued an Incentive Right. The Incentive Right will be for a number of shares of the Company’s common stock (the “Stock”) determined as provided in Paragraph 4 below. The Incentive Right will give the Participant the right to receive those shares of Stock, less applicable withholding taxes, as provided in Paragraph 6 below. Any employee earning salary at a rate of less than $75,000 per year may elect, in advance of a Plan Period, to participate by authorizing the Company to withhold, at the employee’s option, 10% or 20% of the employee’s salary during such Plan Period.
4. On each Withholding Date, the Company will determine the number of shares of Stock represented by the applicable Incentive Right (the “Participant’s Amount”) attributable to the payroll withholding by dividing the applicable salary withholding amount for the payroll period by the closing price of the Stock on the NYSE MKT on the trading day immediately preceding the Withholding Date. The Company will establish and maintain a record of the number of shares of Stock represented by each Incentive Right issued by the Company to a Participant in consideration for the Participant’s agreement to withhold salary. Such number of shares of Stock represented by an Incentive Right will be subject to appropriate adjustment in the event of a stock split or stock consolidation.
5. Prior to the beginning of each Plan Period, each Participant may elect in writing to receive the Participant’s Amount in Stock as provided in Paragraph 6, on the 6-month, 9-month or 12-month anniversary of each Withholding Date. In the absence of an election, the Participant will be paid on the 6-month anniversary of the applicable Withholding Date.
6. On the anniversary date on which the Participant is to be paid in accordance with Paragraph 5 above (the “Payment Date”) the Company shall determine the value of the shares of Stock allocated to the Incentive Right for which payment is being made. The value on the Payment Date will be based on the closing price of a share of Stock on the NYSE MKT for the trading day preceding the Payment Date and payment of such value will be made in shares of Stock. Withholding taxes due on each payment will be deducted from the payment, or otherwise satisfied, as provided below.
7. Directors who elect to participate in the Plan will authorize the Company to withhold 20% of the Director’s fee on each semi-monthly payroll date occurring during each Plan Period in which he or she is a Participant. Determination of the Participant’s Amount, election by a Participant as to payout on the 6-month, 9-month or 12-month anniversary of each Withholding Date, and payments in respect of the Participant’s Amount and tax withholdings will be made on the same basis as described in Paragraph 6 above in respect of an employee Participant.
8. All shares of Stock deliverable under the Plan will be registered with the SEC on Form S-8, as provided in Paragraph 2. All Participants who are not “Affiliates” of the Company, as defined in the Securities Act of 1933, upon their receipt of such shares will receive shares free of transfer restrictions.
Plan Administration.
| A. | The Company will arrange, at its cost, for a registered brokerage firm to establish a trading account for each Participant. Shares of Stock being delivered under the Plan will be transferred to that account. |
| B. | Delivery of shares of Stock under the Plan will constitute taxable income to a Participant at the time the shares of Stock are delivered and will be subject to payroll taxes. The Company will bear all costs related to selling shares of Stock awarded under the Plan in such amount as necessary to pay any withholding taxes. These costs include any brokerage fees, commissions and other transaction costs. |
| C. | During the period a Participant remains an active employee or a Director, the Company will bear (i) the charges of the brokerage firm for the maintenance of the account, (ii) any transaction costs related to the transfer of shares by the Company into the account and (iii) transaction costs related to the sale of shares of Stock from the account (including those noted in Paragraph B above). |
| D. | In the case of individuals who cease to be Participants, the Company will cease to bear the costs of the brokerage firm for the maintenance of the account or any expenses related to selling Stock held in the account except for the costs associated with selling Stock for withholding tax purposes. |
| E. | The Company makes no representations as to the ultimate value of the Stock issued to a Participant under the Plan. |
| F. | Subject to the provisions of the Plan, the Committee is authorized to interpret the Plan and the grants made under the Plan, to establish, amend and rescind any rules, regulations or policies related to the Plan, to determine the terms and provisions of the agreements related to the Plan, and to make all other determinations necessary or advisable for the administration of the Plan. The Committee, in its sole discretion, may correct any defect, supply any omission and reconcile any inconsistency in the Plan. The Committee may adopt such rules, regulations and policies as it deems desirable for administering the Plan. The determination of the Committee in the administration of the Plan, as described herein, shall be final and conclusive. For the sake of clarity, the authority and discretion of the Committee in respect of the Plan shall include the Base Pay Supplement for Employee Participants as provided below. |
Withholding Taxes.
On any date Stock is to be issued, the number of shares needed for sale to cover the related withholding taxes will be determined by the Company and communicated to the Participant. Unless the Participant elects in writing prior to the commencement of the applicable Plan Period to pay the withholding tax dollar amount directly to the Company on or before the Payment Date, the Company will withhold the required minimum withholding tax from any amounts due the Participant on such Payment Date by either, in its discretion, (a) reducing the number of shares of Stock to be issued to the Participant by the number of shares of Stock having a value equal to the applicable withholding taxes or (b) causing to be sold on the open market that number of shares of Stock issued to the Participant which is necessary to fund the payment of the withholding tax.
BASE PAY SUPPLEMENT FOR EMPLOYEE PARTICIPANTS.
All employee Participants will be awarded an amount (the “Approval Award”) equal to 30% of the pre-tax amount of their annual salary as then in effect upon FDA Approval of Ampligen (the “Approval”). The Approval Award will be paid within three months following the Approval. A Participant will not qualify for the Approval Award if the Participant’s employment is terminated prior to the Approval due to (i) termination by the Company for Cause or (ii) voluntary termination by the Participant.
In addition, all employee Participants will be awarded an amount (the “Pre-Approval Award”) equal to 30% of the pre-tax amount of their annual salary as then in effect upon the successful pre-approval inspection by the FDA of the Alferon facility (the “Pre-Approval”). The Pre-Approval Award will be paid within three months following the Pre-Approval. A Participant will not qualify for the Pre-Approval Award if the Participant’s employment is terminated prior to the Pre-Approval due to (i) termination by the Company for Cause or (ii) voluntary termination by the Participant.
| Print Name | Date | |
| Signature |
Company/Investor Contact:
Charles Jones
CJones & Associates Public Relations
Office: 888-557-6480
Cell: 305-987-7418
Email: cjones@cjonespr.com
Hemispherx Biopharma Introduces a Voluntary Stock Purchase Plan to Create Shareholder Value
… Senior Management, Entire Board of Directors, and 100% of All Employees Participate
PHILADELPHIA, Feb. 03, 2016 - Hemispherx Biopharma, Inc. (NYSE MKT:HEB) announced today, February 3, 2016, a Voluntary Pay for Stock Plan (the “Plan”). Hemispherx Biopharma is seeking to create ownership incentives as well as to provide additional cash for various operational activities. All members of Senior Management, all members of the Board of Directors, and all employees volunteered to participate. Senior Management believes that this Plan creates significant shareholder value as the participants will voluntarily use up to 20% of their salaries to purchase stock from the Company, creating long term incentives for them to reach corporate goals. In addition, the CEO/Chairman and President/CFO, will both voluntarily reduce their salaries further to a cumulative reduction of 50%. The plan goes in effect immediately. “ We are all excited for the opportunity to invest in Hemispherx’s future ,” said Hemispherx’s Chairman and CEO, Dr. William A. Carter, “ Our efforts will be redoubled in 2016 to make progress on all of our major goals .”
Foremost, in the major goal categories are: a) accelerating success in the recently initiated Expanded Access programs globally for both Ampligen (an experimental therapeutic) and Alferon N; b) achieving further regulatory progress with Ampligen as a potential biotherapeutic for Chronic Fatigue Syndrome (CFS) treatment; c) advancing new clinical tests in cancer immunotherapy, including potential treatment of metastatic colon cancer wherein all “standard of care” therapies have faltered; and expanding research on the use of our experimental drug Ampligen and Alferon N as an early onset broad spectrum antivirals for diseases such as MERS, Ebola virus, Equine Encephalitis and, given the new pandemic threat, the Zika virus. Previous studies (preclinical) have shown that both Ampligen and interferon are active against the flavivirus family of viruses which includes the West Nile virus and Zika virus.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development
of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N
Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic
acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue
Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and
life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated
safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx
has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved
for sale in the U.S. and Argentina. The Company’s Alferon® N approval in Argentina includes the use of Alferon N Injection®
(under the brand name “Naturaferon”) for use in any patients who fail, or become intolerant to recombinant interferon,
including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified
manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net
Disclosure Notice
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties including, but not limited to, general industry conditions and competition; general economic factors; the Company’s ability to adequately fund its projects; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Company’s ability to accurately predict the future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of the Company’s patents and other protections for products; and the exposure to litigation, including patent litigation, and/or regulatory actions; and numerous other factors discussed in this release and in the Company’s filings with the Securities and Exchange Commission. The final results of these efforts and/or any other activities could vary materially from Hemispherx’s expectations. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of Ampligen® in the United States and other countries.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “potential,” “potentially,” “possible,” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx’s filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.