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)
August 15, 2017 (August 14, 2017)
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-27072 | 52-0845822 | ||
| (state or other jurisdiction | (Commission | (I.R.S. Employer | ||
| 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)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 2.02 Results of Operations and Financial Condition
On August 14, 2017, Hemispherx Biopharma, Inc. (the “Company”) filed its quarterly report on Form 10-Q for the quarter ended June 30, 2017 and, thereafter, issued a press release announcing its financial results for that quarter. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
As noted in the press release, the Company will host a conference call at 1:00 PM Eastern Daylight Time (EDT) on Tuesday, August 15, 2017 to provide a general business update. Hemispherx will respond to various stockholder questions submitted prior to the call.
Conference Call Information
| Date: | Tuesday, August 15, 2017 |
| Time: | 1:00 PM EDT |
| Dial-in numbers: | 800-346-7359 (domestic) |
| 973-528-0008 (international) | |
| Conference number: | 27781 |
| Questions: | ir@hemispherx.net by 5:00 p.m. EDT on Monday, August 14, 2017 |
| http://ir.hemispherx.net/Events_Presentations |
Item 7.01 Regulation FD Disclosure.
The information disclosed in Item 2.02 above is incorporated into this Item 7.01. The information included in this Current Report on Form 8-K (including the exhibit hereto) is being furnished under Item 2.02, “Results of Operations and Financial Condition,” Item 7.01, “Regulation FD Disclosure” and Item 9.01 “Financial Statements and Exhibits” of Form 8-K. As such, the information (including the exhibit) herein shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such a filing. This Current Report (including the exhibit hereto) will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
| 99.1 | Press Release dated August 15, 2017 |
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.
| Dated: August 15, 2017 | HEMISPHERX BIOPHARMA, INC. | |
| By: | /s/ Thomas K. Equels | |
| Thomas K. Equels, President & CEO | ||
Exhibit 99.1
Company/Investor Contact:
Charles Jones
CJones & Associates Public Relations
888-557-6480
305-987-7418
cjones@cjonespr.com
Hemispherx
Biopharma Announces Corporate Progress and Financial Results for the
Six Months Ended June 30, 2017
The Company has Generated Revenues and Advanced in R&D for Intranasal Ampligen and in Immuno-Oncology
Conference Call Scheduled for Tuesday, August 15th at 1:00 PM EDT
PHILADELPHIA – August 15, 2017 – Hemispherx Biopharma (NYSE MKT: HEB): This quarter we see Ampligen® potentially repurposed beyond the single indication of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), to maximize the potential of this proven immunotherapeutic in indications in which a healthier and more stimulated immune system can play an important role in successful outcomes. We have made Ampligen® available in an Early Access Program for pancreatic cancer patients, looking at quality of life measures and collecting immunological data which we hope will help direct research into combinational therapies for this and other lethal solid tumors. We also see future opportunities for Ampligen® as a potential immune-enhancing vaccine adjuvant. As we recently announced, we believe that the intranasal human safety study of Ampligen® plus FluMist® known as AMP-600 indicates that intranasal Ampligen® is generally well-tolerated. Finally, this quarter we have made significant steps toward a potential New Drug Application in Canada for ME/CFS by working with patient advocacy groups and doctors, led by Millions Missing Canada.
Hemispherx announced its financial results for the six months ended June 30, 2017. The net loss was approximately $5,014,000 or ($0.19) per share as compared to a net loss of $3,467,000 or ($0.16) per share for the same six month period in 2016. Cash, cash equivalents and marketable securities were approximately $3,211,000 at June 30, 2017 as compared to $5,868,000 as of December 31, 2016.
Revenues from our Ampligen® Cost Recovery Program were $213,000 and $15,000 for the three months ended June 30, 2017 and 2016, respectively, primarily due to our Early Access Program, through our agreement with MyTomorrows, designed to enable access of Ampligen® to pancreatic cancer patients in the Netherlands. The increase in revenues of $198,000 is an increase of 1,320%. Revenues from our Ampligen® Cost Recovery Program were $297,000 and $54,000 for the six months ended June 30, 2017 and 2016, respectively. The increase in revenues of $243,000 is an increase of 450%.
We intend to continue our pursuit of profitable self-sufficiency while seeking FDA approval of Ampligen® in the United States and rapid expansion of our European operations.
Conference Call Information
| Date: | Tuesday, August 15, 2017 |
| Time: | 1:00 PM EDT |
| Dial-in numbers: | 800-346-7359 (domestic) |
| 973-528-0008 (international) | |
| Conference number: | 27781 |
| Audio Replay: | http://ir.hemispherx.net/Events_Presentations |
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, no assurance can be given that Ampligen® will prove effective in the treatment of pancreatic cancer or any other additional indications or that additional testing will confirm that it is effective when administered intranasally. Moreover, conducting such studies will require Hemispherx to obtain additional financing and no assurance can be given that such funding will be available. While Hemispherx had begun to generate revenues from Ampligen®, no assurance can be given that revenues will continue or grow. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.