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)
May 2, 2018 (May 2, 2018)
HEMISPHERX BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0 - 27072 | 52-0845822 | ||
| (state or other jurisdiction | (Commission | (I.R.S. Employer | ||
| of incorporation) | File Number) | Identification No.) |
| 860 N. Orange Avenue, Suite B Orlando, FL | 32801 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (215) 988-0080
(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 7.01. Regulation FD Disclosure.
On May 1, 2018, we issued a stockholder letter, a copy of which is attached hereto as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information set forth herein is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Hemispherx Letter to Stockholders dated May 2, 2018. |
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. | ||
| May 2, 2018 | By: | /s/ Thomas K. Equels |
| Thomas K. Equels, CEO |
Exhibit 99.1
Dear Fellow Stockholders:
As you probably know, we recently announced the completion of fill and finish operations for our first commercial-size lot of Ampligen at our Contract Manufacturing Organization (“CMO”). More than 8,500 vials now await routine release testing before heading to the shipping dock in the next few weeks. An additional similar size lot is scheduled for fill and finish at our CMO this month for release in July.
This is an important milestone for Hemispherx. We can now not only fill pending orders, but also proceed with important new clinical studies designed to take Ampligen — a potent TLR-3 agonist amplifying the immune response — forward as a next generation candidate in the fast-growing field of immuno-oncology.
Roughly one-fourth of the recently completed Ampligen production (2,100 vials) will be shipped for its Early Access Programs. A portion is also allocated to initiate our commercial launch in Argentina. Part is earmarked for compassionate use in ME/CFS patients in the United States. Finally, the balance is allocated for what we expect to be a significant increase in U.S. clinical trial activity, testing Ampligen’s performance as a single agent and in combination immunotherapy for a variety of cancers.
In case you missed the news release we issued on April 2, 2018 about our 2017 full year results, let me summarize the highlights:
Operationally, it was a banner year. We supplied Ampligen for the European Early Access Program in pancreatic cancer; the FDA approved a price increase for cost-recovery in the United States; we commenced the safety analysis of Ampligen in combination with FluMist; we completed the flood-damage renovations to our cGMP manufacturing facility; we collaborated with Millions Missing Canada to potentially make Ampligen available to Canadians with ME/CFS; we continued to work with the FDA to identify a path toward approval for Ampligen for ME/CFS; and we initiated plans for advanced clinical trials of Ampligen as a single agent and combination cancer therapy.
Since the beginning of January 2018 we have added to cash by booking $10 million from Ampligen sales, the sale/leaseback of our manufacturing facility, the sale of non-strategic real estate, the exercise of warrants and the sale of common stock. Monies recently raised are important to enhance our increased Ampligen production capacity and to fulfill our ever increasing commercial and clinical needs.
Evidence is increasing about the role of checkpoint drugs in transforming the standard of care in many cancers beyond chemotherapy alone. In the April 16, 2018 edition of The New York Times , Dr. Roy Herbst, chief of Medical Oncology at the Yale Cancer Center, is quoted saying, “If you want to see long-term survival, you’ve got to give immunotherapy as soon as possible. Chemotherapy has limitations. Immunotherapy has the ability to cure.”
Now attention is turning to ways of enhancing the performance of current immunotherapeutic drugs, especially with TLR agonists, which are potent stimulators of the immune system. Evidence continues to build about their performance in cancer settings, particularly in combination with checkpoint drugs. Ampligen’s safety profile may provide an important advantage over other TLR agonists, especially with the more than 93,000 systemic doses administered intravenously showing that Ampligen is generally well-tolerated.
Our Goals For 2018
We expect to advance Ampligen through the clinic as a differentiated immuno-oncology agent, building on a strong safety profile and encouraging outcomes in Phase 1/2 studies. We anticipate publications and presentations on the findings of independent studies of Ampligen as a single agent and combination therapy in a variety of difficult cancers. Top-line results from non-clinical combination studies have supported Ampligen’s potential role in strengthening the cancer-killing capabilities of checkpoint inhibitors like Keytruda and Opdivo, two of the leading checkpoint drugs. Advanced studies combining Ampligen with checkpoint drugs are being planned. We believe Ampligen will be an important player in this immuno-oncology revolution.
Conclusion
We are proud of all that we have accomplished in 2017 and 2018 to date to move Ampligen toward commercialization. Importantly, with growing evidence about the potential role of checkpoint drugs in transforming the standard of care in many cancers beyond chemotherapy alone, we believe Ampligen can become an important asset to improve the prognosis and treatment of multitudes of patients in a variety of ways across the globe. The goals that we have set for ourselves in 2018 will help us to facilitate this aspiration for Ampligen.
Sincerely,
/s/ Thomas K. Equels
Chief Executive Officer