10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

Quarterly Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

For the Quarterly Period Ended March 31, 2019

Commission File Number: 1-13441

HEMISPHERX BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware	52-0845822
(State or other jurisdiction of	(I.R.S. Employer
incorporation or organization)	Identification No.)

2117 SW Highway 484, Ocala FL 34473

(Address of principal executive offices) (Zip Code)

(407) 839-0095

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

[X] Yes [  ] No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

[X] Yes [  ] No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

[  ]	Large accelerated filer	[  ]	Accelerated filer
[  ]	Non-accelerated filer	[X]	Smaller reporting company
		[  ]	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 pursuant to Section 13(a) of the Exchange Act. [  ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). [  ] Yes [X] No

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.001 per share	HEB	NYSE American

86,621,318 shares of common stock were outstanding as of May 6, 2019.

PART I- FINANCIAL INFORMATION

ITEM 1: Financial Statements

HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(in thousands, except for share amounts)

(Unaudited)

	March 31, 2019			December 31, 2018
ASSETS
Current assets:
Cash and cash equivalents	$	2,394		$	299
Marketable securities		2,486			1,526
Funds receivable from sale of New Jersey net operating loss		—			859
Accounts receivable		101			235
Prepaid expenses and other current assets		874			880
Total current assets		5,855			3,799
Property and equipment, net		7,602			7,782
Right of use assets, net		137			—
Patent and trademark rights, net		1,019			912
Other assets		1,352			1,352
Total assets	$	15,965		$	13,845
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	768		$	680
Accrued expenses		1,082			1,005
Convertible note payable		—			3,408
Current portion of operating lease liabilities		36			—
Current portion of financing obligation		201			199
Total current liabilities		2,087			5,292
Long-term liabilities:
Operating lease obligation		104			—
Convertible note payable		3,682			—
Financing obligation arising from sale leaseback transaction (Note 13)		2,267			2,318
Redeemable warrants		3,895			1,061
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.01 per share, authorized 5,000,000		—			—
8,000 shares designated as Series B Convertible Preferred Stock, stated value $1,000 per share.		2,519			—
Common stock, par value $0.001 per share, authorized 350,000,000 shares; issued and outstanding 62,900,318 and 48,734,712, respectively		63			49
Additional paid-in capital		323,289			323,701
Accumulated other comprehensive loss		—			(3	)
Accumulated deficit		(321,941	)		(318,573	)
Total stockholders’ equity		3,930			5,174
Total liabilities and stockholders’ equity	$	15,965		$	13,845

See accompanying notes to consolidated financial statements.

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HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

	Three months ended March 31,
	2019			2018
Revenues:
Clinical treatment programs -United States	$	—		$	13
Clinical treatment programs - Europe		—			43
Total revenues		—			56
Costs and expenses:
Production costs		231			208
Research and development		928			855
General and administrative		1,767			1,563
Total costs and expenses		2,926			2,626
Operating loss		(2,926	)		(2,570	)
Interest and other income		12			4
Interest expense and other finance costs		(246	)		(139	)
Debt discount associated with extinguished debt		(250	)		—
Fair value of convertible note adjustment		90			—
Redeemable warrants valuation adjustment		(45	)		(231	)
Gain on sale of building		—			223
Loss on sale of marketable securities		(3	)		—
Net loss		(3,368	)		(2,713	)
Other comprehensive income (loss):
Reclassification adjustments for loss on sales of marketable securities		3			—
Unrealized loss on marketable securities		—			(12	)
Net comprehensive loss	$	(3,365	)	$	(2,725	)
Basic and diluted loss per share	$	(0.07	)	$	(0.07	)
Weighted average shares outstanding, basic and diluted		50,903,398			36,269,388

See accompanying notes to consolidated financial statements.

-3-

HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES

Consolidated Statement of Changes in Stockholders’ Equity

For the Three Months Ended March 31, 2019 and 2018

(in thousands except share data)

(Unaudited)

	Common Stock Shares		Common Stock $0.001 Par Value		Series B Preferred			Additional Paid-In Capital			Accumulated Other Compre- hensive  Loss			Accumulated Deficit			Total  Stockholders’ Equity
Balance at December 31, 2018		48,734,712	$	49	$	—		$	323,701		$	(3	)	$	(318,573	)	$	5,174
Equity-based compensation		—		—		—			175			—			—			175
Redeemable warrants		—		—		—			(2,787	)		—			—			(2,787	)
Common stock issuance, net of costs		14,165,606		14		—			2,200			—			—			2,214
Series B preferred shares issued, net of costs		—		—		5,312			—			—			—			5,312
Series B preferred shares converted to common shares		—		—		(2,793	)		—			—			—			(2,793	)
Net comprehensive loss		—		—		—			—			3			(3,368	)		(3,365	)
Balance at March 31, 2019		62,900,318	$	63	$	2,519		$	323,289		$	—		$	(321,941	)	$	3,930

	Common Stock Shares		Common Stock $0.001 Par Value		Series B Preferred		Additional Paid-In Capital		Accumulated Other Compre- hensive Income  (Loss)			Accumulated Deficit			Total Stockholders’ Equity
Balance at December 31, 2017		32,884,786	$	33	$	0	$	317,419	$	11		$	(308,760	)	$	8,703
Equity-based compensation		438,385		—		—				—			—			286
Warrants issued for building sale
leaseback		—		—		—		1,149		—			—			1,149
Redeemable warrants		—		—		—		221		—			—			221
Common stock issuance, net of costs		5,375,288		5		—		2,321		—			—			2,326
Common stock issued to settle accounts payable		520,909		1		—		239		—			—			240
Net comprehensive (loss)		—		—		—		—		(12	)		(2,713	)		(2,725	)
Balance at March 31, 2018		39,219,368	$	39	$	0	$	321,635	$	(1	)	$	(311,473	)	$	10,200

See accompanying notes to consolidated financial statements.

-4-

HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES

Consolidated Statements of Cash Flows

For the Three Months Ended March 31, 2019 and 2018

(in thousands)

(Unaudited)

	2019			2018
Cash flows from operating activities:
Net loss	$	(3,368	)	$	(2,713	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment		194			216
Redeemable warrants valuation adjustment		45			231
Fair value of convertible note adjustment		(90	)		15
Change in convertible debt – refinancing		20			—
Deferred debt write-off		344
Amortization of patent, trademark rights, and ROU assets		28			—
Equity-based compensation		175			286
Realized loss on sale of marketable securities		3			—
Gain on sale of building		—			(223	)
Amortization of finance and debt issuance costs		35			140
Change in assets and liabilities:
Accounts and other receivables		993			(6	)
Prepaid expenses and other current assets		7			(385	)
Lease liability payments		(8	)		—
Accounts payable		87			245
Accrued expenses		78			(348	)
Net cash used in operating activities		(1,457	)		(2,542	)
Cash flows from investing activities:
Sale and maturities of short term marketable securities		(960	)		—
Purchase of property and equipment		(14	)		—
Proceeds from sale of building		—			1,050
Purchase of patent and trademark rights		(124	)		(14	)
Net cash (used in) provided by investing activities		(1,098	)		1,036
Cash flows from financing activities:
Proceeds from lease financing obligation		—			4,080
Finance and debt issuance costs		—			(268	)
Financing obligation payment payments		(84	)		(19	)
Payoff of mortgage note payable		—			(1,957	)
Security deposits paid		—			(111	)
Proceeds from sale of stock, net of issuance costs		4,734			2,326
Net cash provided by financing activities		4,650			4,051
Net increase in cash and cash equivalents		2,095			2,545
Cash and cash equivalents at beginning of period		299			1,412
Cash and cash equivalents at end of period	$	2,394		$	3,957
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain on marketable securities	$	—		$	(12	)
Stock issued to settle accounts payable					240
ROU assets obtained in exchanged for operating lease liabilities	$	148		$

See accompanying notes to consolidated financial statements.

-5-

HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1: Business and Basis of Presentation

Hemispherx Biopharma, Inc. and its subsidiaries (collectively, “Hemispherx”, “Company”, “we” or “us”) are an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Hemispherx’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3). A first-in-class drug also known as a new chemical entity, is a drug that contains an active moiety that has not been approved by the FDA or marketed in the US.

Hemispherx received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe CFS in 2016. The product will be marketed by GP Pharm, our commercial partner in Latin America. Commercialization in Argentina will require, among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch.

Hemispherx is 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 drug, Ampligen, and our approved drug, Alferon N Injection. Lastly, the Company plans to access the public equity markets to raise further capital.

In the opinion of Management, all adjustments necessary for a fair presentation of such consolidated financial statements have been included. Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.

The interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”), and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes thereto.

These consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years ended December 31, 2018 and 2017, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on April 1, 2019.

Note 2: Net Loss Per Share

Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of 71,858,564 and 11,105,515 of stock options and warrants are excluded from the calculation of diluted net loss per share for the three months ended March 31, 2019 and 2018, respectively, since their effect is antidilutive due to the net loss.

Note 3: Equity-Based Compensation

The fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical data to estimate expected dividend yield, expected life and forfeiture rates. There were 1,727,756 and 1,336,505 options granted in the three months ended March 31, 2019 and 2018, respectively.

-6-

Stock option for employees’ activity during the three months ended March 31, 2019 is as follows:

Stock option activity for employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		5,110,589	$	0.75		9.01	$	—
Granted		1,213,070		0.22		—		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding March 31, 2019		6,323,659	$	0.65		8.99	$	—
Vested and expected to vest March 31, 2019		6,323,659	$	0.65		8.99	$	—
Exercisable March 31, 2019		2,518,172	$	0.82		7.48	$	—

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2019		3,305,659		$	0.32		9.31	$	—
Granted		1,213,070			0.22		—		—
Vested		(713,242	)		0.28		—		—
Unvested March 31, 2019		3,805,487		$	0.30		9.32	$	—

Stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual  Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		2,425,692		$	0.68		8.55	$	—
Granted		514,686			0.22		—		—
Forfeited		—			—		—		—
Expired		(1,666	)		8.64		—		—
Outstanding March 31, 2019		2,938,712		$	0.59		8.60	$	—
Vested and expected to vest March 31, 2019		2,938,712		$	0.59		8.60	$	—
Exercisable March 31, 2019		1,121,456		$	1.25		7.97	$	—

-7-

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic  Value
Unvested January 1, 2019		1,551,528		$	0.31		8.84	$	—
Granted		514,686			0.22				—
Vested		(248,958	)		0.31				—
Unvested March 31, 2019		1,817,256		$	0.28		8.86	$	—

Stock-based compensation expense was approximately $175,000 and $286,000 for the three months ended March 31, 2019 and 2018 resulting in an increase in general and administrative expenses, respectively.

As of March 31, 2019, and 2018, respectively, there was approximately $1,324,000 and $755,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

Note 4: Inventories

The Company uses the lower of first-in, first-out (“FIFO”) cost or net realizable value method of accounting for inventory.

Commercial sales of Alferon in the U.S. will not resume until new batches of commercial filled and finished product are produced and released by the Food and Drug Administration (“FDA”). While the facility is approved by the FDA under the Biologics License Application (“BLA”) for Alferon, this status will need to be reaffirmed by an FDA pre-approval inspection. The Company also will need the FDA’s approval to release commercial product once it has submitted satisfactory stability and quality release data. Currently, the manufacturing process is on hold and there is no definitive timetable to have the facility back online. The Company estimates it will need approximately $10,000,000 to commence the manufacturing process. Due to the Company extending the timeline of Alferon production to an excess of one year, the Company reclassified Alferon work in process inventory of $1,095,000 to other assets within our balance sheet as of December 31, 2018 and 2017 and due to the high cost estimates to bring the facility back online. The above estimated cost includes additional funds needed for the revalidation process in the Company’s facility to initiate commercial manufacturing, thereby readying itself for an FDA Pre-Approval Inspection. If the Company is unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon inventory, its operations most likely will be materially and/or adversely affected. In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

The Alferon work in process is currently compliant with our internal protocols, is stored in a controlled state, and the Company regularly monitors the stability of the product. All of these factors contribute to the potential sale of the Alferon work in process, after validation lots have been produced and including a successful pre-approval inspection.

Note 5: Marketable Securities

Marketable securities consist of mutual funds. For the three months ended March 31, 2019 and December 31, 2018, it was determined that none of the marketable securities had other-than-temporary impairments. At March 31, 2019 and December 31, 2018, all securities were classified as available for sale investments and were measured as Level 1 instruments of the fair value measurements standard (see Note 12: Fair Value).

-8-

Securities classified as available for sale consisted of:

March 31, 2019

(in thousands)

Securities	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value		Short-Term Investments
Mutual Funds	$	2,486	$	—	$	—	$	2,486	$	2,486
Totals	$	2,486	$	—	$	—	$	2,486	$	2,486

December 31, 2018

(in thousands)

Securities	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value		Short-Term Investments
Mutual Funds	$	1,529	$	—	$	(3	)	$	1,526	$	1,526
Totals	$	1,526	$	—	$	(3	)	$	1,526	$	1,526

Unrealized losses on investments

There were no investments with continuous unrealized losses for less than 12 months and 12 months or greater at March 31, 2019 and December 31, 2018.

Note 6: Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	March 31, 2019		December 31, 2018
Compensation	$	642	$	613
Professional fees		59		83
Clinical trial expenses		7		7
Other expenses		374		302
	$	1,082	$	1,005

Note 7: Property and Equipment

	(in thousands)
	March 31, 2019			December 31, 2018
Land, buildings and improvements	$	10,547		$	10,547
Furniture, fixtures, and equipment		5,059			5,045
Total property and equipment		15,606			15,592
Less: accumulated depreciation		(8,004	)		(7,810	)
Property and equipment, net	$	7,602		$	7,782

-9-

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, ranging from three to thirty-nine years.

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years. The lease payments are initially $408,000 per year for two years through March 31, 2020 and will escalate in subsequent years. (See Note 13 – Financing Obligation Arising from Sale Leaseback Transaction for more details on the sale leaseback of the property and equipment).

In February 2018, the Company sold the building located adjacent to its manufacturing facility located at 5 Jules Lane, New Brunswick, New Jersey to an unaffiliated party. The purchase price was $1,050,000 and the Company netted $963,000 in cash.

Note 8: Stockholders’ Equity

(a) Preferred Stock

The Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible Preferred Stock has a stated value $1,000 per share.

The Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $1,000 per share. As of March 31, 2019, the Company had 2,519 shares of Series B Convertible Preferred Stock outstanding. Each such Preferred Share is convertible into 5,000 shares of common stock.

Pursuant to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, Hemispherx distributed to its holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $0.20) and 5,000 warrants with an assumed exercise price of $0.20. The warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights offering were approximately $4.7 million.

(b) Common Stock

The Company is authorized to issue 350,000,000 shares of $0.001 par value common stock with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000 authorized shares.

In August 2016, the Company effected a 12 to 1 reverse stock split of the outstanding shares, in order to become compliant with the NYSE regulations. This did not affect the number of authorized shares.

On September 6, 2016, we entered into a Securities Purchase Agreement (the “September Purchase Agreement”) with certain investors for the sale by us of 3,333,334 shares of our common stock registered under our S-3 shelf registration statement on at a purchase price of $1.50 per share. Concurrently with the sale of the common stock, pursuant to the September Purchase Agreement, we also sold unregistered warrants to purchase 2,500,000 shares of common stock for aggregate gross proceeds of $5,000,000. Subject to certain ownership limitations, the warrants are initially exercisable six-month after issuance at an exercise price equal to $2.00 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. Pursuant to an engagement agreement, we paid our placement agent an aggregate fee equal to 7% of the gross proceeds received by us from the sale of the securities in the offering and granted to our placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 166,667 unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the placement agent warrants will expire on September 1, 2021 and have an exercise price equal to $1.875 per share of common stock.

-10-

On February 1, 2017, we entered into Securities Purchase Agreements (each, a “February Purchase Agreement”) with certain investors for the sale by us of 1,818,185 shares of our common stock at a purchase price of $0.55 per share. Concurrently with the sale of the common stock, pursuant to the February Purchase Agreement, we also sold unregistered warrants to purchase 1,363,639 shares of common stock for aggregate gross proceeds of approximately $1,000,000. The warrants have an exercise price of $0.75 per share, are exercisable six months after issuance, and will expire five years from the initial exercise date. Pursuant to an engagement agreement, we paid our placement agent an aggregate fee equal to 7% of the gross proceeds received by us from the sale of the securities in the offering and granted to our placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 90,910 unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the placement agent warrants will expire on February 1, 2022 and have an exercise price equal to $0.6875 per share of common stock. The Company subsequently registered the shares issuable upon exercise of the warrants on Form S-1.

The Board of Directors approved up to $500,000 for all directors, officers and employees to buy Company shares from the Company at the market price. As of the last issuance dated November 5, 2018, the Company had issued all the authorized shares for this program (980,392 shares) at prices between $0.20 and $0.69 per share directly to executives and employees, for $373,852 in a series of private transactions pursuant to stock purchase agreements.

On June 1, 2017, the exercise price of Warrants issued in September 2016 was changed to $0.50. As a result, the warrant holders exercised these Warrants and purchased 2,370,000 shares of Company common stock. The Company realized net proceeds of $1,055,000 from this exercise. In conjunction with the foregoing, the Company also issued 2,370,000 series A warrants with an exercise price of $0.60 per share, an initial exercise date of December 1, 2017 and expiring March 6, 2022 (the “Series A Warrants”) and 7,584,000 series B warrants with exercise price of $0.60, an initial exercise date December 1, 2017 per share and expiring March 1, 2018. The foregoing transactions are hereinafter referred to as the “Exchange Transaction”. In addition, on July 10, 2017, the warrant holders exercised the remaining 130,000 warrants issued in September 2016 and purchased 130,000 shares of common stock. The Company realized net proceeds of $65,000 from this exercise. In conjunction with the foregoing the Company issued 130,000 Series A Warrants and 416,000 Series B Warrants (with an exercise price of $0.60 and an initial exercise date January 10, 2018 on the three-month anniversary of the of the initial exercise date).

Pursuant to an engagement agreement, the Company paid its placement agent an aggregate fee equal to 7% and 10.5%, respectively, of the gross proceeds received by the Company from the sale of the securities in the offerings and granted to its placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 166,667 and 107,759, respectively, unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the 166,667 placement agent warrants issued in September 2017 will expire September 1, 2021 and have an exercise price equal to $1.875 per share of common stock and the 107,759 placement agent warrants issued in June 2017 will expire June 1, 2022 and have an exercise price of $0.625.

On August 23, 2017, the Holders of the Series A Warrants and Series B Warrants exchanged all of their Warrants for new warrants (respectively, the “Series A Exchange Warrants” and the “Series B Exchange Warrants” and, collectively, the “Exchange Warrants”) identical to the Warrants except as follows: The exercise price of both Exchange Warrants is $0.45 per share, subject to adjustment therein, and the number of Series B Exchange Warrants issued was proportionately reduced to an aggregate of 2,800,000 warrants so that all Exchange Warrants in the Exchange Transaction do not exceed 19.9% of the number of the Company’s issued and outstanding shares of Common Stock as of May 31, 2017, the date of the Exchange Transaction offer letters. The issuance of the Exchange Warrants by the Company and the shares of Common Stock issuable upon exercise of the Exchange Warrants is exempt from registration pursuant to Sections 3(a)(9) and 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The 2,800,000 warrants with an expiration date of March 1, 2018 and an exercise price on $0.45 were exercised in January and February 2018. The Company realized proceeds of $1,260,000 from these exercises.

On November 27, 2017, the Company reactivated equity distribution agreement with Maxim Group LLC (the “EDA”) pursuant to which it could sell shares of its common stock from time to time through Maxim, as sales agent. During the year ended December 31, 2018 and the three months ended March 31, 2019, the Company sold, respectively, an aggregate of 2,176,392 and 115,606 shares under the EDA for proceeds of $802,000 and $26,000 , respectively, net of $25,000 and $1,000, respectively, in commissions. Pursuant to a prospectus supplement dated February 7, 2018, the Company was able to sell up to 6,549,157 of its common stock (inclusive of shares already sold under the prospectus supplement) under the EDA. The actual number of shares, that the Company can sell, and the proceeds to be received there from are dependent upon the market price of its common stock.

-11-

As part of the cash conservation program adopted on August 28, 2017, starting with the month of September 2017, the directors agreed to defer 100% of their fees until cash is available. In consideration of this deferral, 226,023 options were issued to each of the two independent directors in February 2018 with an exercise price of $0.37; 152,053 options were issued to each of the two independent directors in May 2018 with an exercise price of $0.30, and 98,098 options were issued in July 2018 with an exercise price of $0.31. All of the foregoing options and the options discussed below are exercisable for a period of 10 years with a vesting period of three years. This program was suspended as of July 15, 2018 and all remaining deferred fees were paid in July 2018. This Program was reactivated as of August 16, 2018 with the understanding that options would not be issued on the deferred amounts until the 2018 Equity Incentive Plan was approved by the stockholders and the securities issuable thereunder were registered with the SEC. The 2018 Equity Incentive Plan was approved by the stockholders and the securities issuable thereunder were registered with the SEC and, on October 17, 2018, 172,786 options were issued to each of the two independent directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year. On January 28, 2019, an aggregate of 514,686 options were issued to each of the directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year for the deferral of fees and for chairing various committees, respectively.

Also as part of the cash conservation program adopted on August 28, 2017, starting with the month of September 2017, certain officers agreed to defer 40% of their salaries until cash is available. In consideration of this deferral, 884,459 options were issued to these officers in February 2018 with an exercise price of $0.37; 599,168 options were issued to these officers in May 2018 with an exercise price of $0.30, and 389,249 options were issued to these officers in July 2018 with an exercise price of $0.31. This program was suspended as of July 15, 2018 and all remaining deferred salaries were paid on July 2018. This Program was reactivated as of August 16, 2018 for 50% of their salaries with the understanding that options would not be issued on the deferred amounts until the 2018 Equity Incentive Plan was approved by the shareholders and the plan registered with the SEC. The 2018 Equity Incentive Plan has been approved by the shareholders and registered with the SEC and on October 17, 2018, 808,712 options were issued to these officers with an exercise price on $0.22 for a period of ten years with a vesting period of one year. On January 28, 2019, 1,213,069 options were issued to each of these officers with an exercise price of $0.22 for a period of ten years with a vesting period of one year.

Also as part of the cash conservation program adopted on August 28, 2017, all employees agreed to be paid 50% of their salaries in the form of unrestricted common stock of the Company. Starting with the month of September 2017, the salaries of all the employees of the Company were paid 50% in the form of unrestricted common stock of the Company. The total number of shares issued as of June 30, 2018 to the employees under this program was 2,116,881 shares at stock prices ranging from $0.31 to $0.55 per share. This program was suspended by the Board of Directors on June 30, 2018.

On March 24, 2018, the Company sold 1,250,000 shares of common stock under its S-3 shelf registration. The Company realized net proceeds of $475,000 from this stock offering and paid $25,000 in placement agent fees.

On April 20, 2018, the Company entered into Securities Purchase Agreements (the “Purchase Agreements”) with certain investors (the “Investors”) for the sale by the Company of an aggregate of 6,600,000 shares (the “Common Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $0.39 per share. Concurrently with the sale of the Common Shares, pursuant to the Purchase Agreements the Company also sold 6,600,000 warrants, 50% of which are Class A Warrants and 50% of which are Class B Warrants (collectively, the “Warrants”). The Company received gross proceeds from the sale of the Warrants solely to the extent such Warrants are exercised for cash. Both classes of Warrants will not be exercisable until six months after issuance and will have an exercise price of $0.39 per share, subject to adjustments as provided under the terms of the Warrants. The Class A Warrants and Class B Warrants will expire, respectively, two and five years after the date on which they are first exercisable. The closing of the sales of these securities under the Purchase Agreements took place on April 24, 2018. The Company received net proceeds from the transactions of $2,343,820 after deducting certain fees due to the placement agent and the Company’s transaction expenses.

The 2009 Equity Incentive Plan, effective June 24, 2009, as amended, authorizes the grant of non-qualified and incentive stock options, stock appreciation rights, restricted stock and other stock awards. A maximum of 22,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the 2009 Equity Incentive Plan. Unless sooner terminated, the 2009 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. During 2018, there were 4,675,221 options granted by the Company under this Plan.

The 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. On October 17, 2018, the Board of Directors issued 1,154,284 options to the officers and directors at the exercise price of $0.22 expiring in 10 years, and on November 14, 2018, the Board of Directors issued 1,000 options to each employee, officer and director at the exercise price of $0.22 expiring in ten years. On January 28, 2019, 1,727,755 options were issued to the officers and directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year.

-12-

Note 9: Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.

Note 10: Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction and industry-specific revenue recognition guidance under current U.S. Generally Accepted Accounting Standards (“U.S.GAAP”) and replace it with a principal-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As of March 31, 2019, we have not identified any accounting changes that would materially impact the amount of reported revenues with respect to our product revenues. The Company applied the Full Retrospective Application to implement the new Accounting Standards Codification (“ASC”) 606. The Company, based on the nature of its Ampligen sales under its cost recovery programs, determined that there were no material differences between the new accounting standard and legacy GAAP and that difficulties will not arise for any “open” contract issues with its customers during the transition period. The Company also determined that the adoption of this standard had little or no impact to the Company’s opening balance of retained earnings.

In January 2016, the FASB has issued Accounting Standards Update (ASU) No. 2016-01, Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for public companies for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The new guidance permits early adoption of the own credit provision. The Company believes that the adoption of the guidance will have no material impact on the Company’s financial statement presentation or disclosures.

In August 2016, the FASB issued ASU 2016-15 - Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force). The new guidance is intended to address the diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The guidance addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. The amendments apply to all entities, including both business entities and not-for-profit entities that are required to present a statement of cash flows under Topic 230. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments in this Update should be applied using a retrospective transition method to each period presented. The Company believes that the adoption of the guidance will not have a material impact on the Company’s financial statement presentation or disclosures.

In 2019, the FASB also issued Accounting Standards Updates (“ASU”) 2019-01 through 2018-03. These updates did not have a significant impact on the financial statements.

Note 11: Convertible Note Payable

On September 28, 2018, the Company issued a Secured Convertible Promissory Note (the “Convertible Note”) to a Lender with an original principal amount of $3,170,000 that bears interest at a rate of 10% per annum and matures on September 28, 2019, unless earlier paid, redeemed or converted in accordance with its terms.

On March 13, 2019, the Company amended the Purchase Agreement pursuant to which it issued the Convertible Note (the “Amendment”). The Amendment extends the maturity of the Note to September 28, 2020. In addition, the redemption conversion rates were revised to a price to be determined by mutual agreement between the Company and the Holder. In the event that the Company and the Holder are unable to reach a mutually agreeable price, the Company will be required to pay the applicable redemption amount in cash. The maximum amount of the Convertible Note the Lender will be able to redeem in any given calendar month is $300,000.

-13-

The Company evaluated the Amendment in accordance with ASC 470, Debt (“ASC 470”) and determined the Amendment is considered an extinguishment of the existing debt and issuance of net debt. As a result, the Company derecognized the liability and recorded a loss on the extinguishment of debt of $272,812 which was equal to the difference between the reacquisition price of the debt and the net carrying amount (amount due at maturity, adjusted for unamortized discounts) of the extinguished debt. Subsequently, the amended note was recorded in accordance with ASC 480 at the fair value that the note was issued with changes in fair value recorded through earnings at each reporting period.

Interest expense associated with the amended note was $4,280 for the three months ended March 31, 2019, which included $2,543 associated with the amortization of applicable discounts.

Note 12: Fair Value

The Company is required under U.S. GAAP to disclose information about the fair value of all the Company’s financial instruments, whether or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

The Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to the short-term maturities of these items. The Company also has certain warrants with a cash settlement feature in the unlikely occurrence of a Fundamental Transaction, namely (1) a merger or consolidation with another person; (2) sale of substantially all of its assets; (3) holders of common stock sell 50% or more of outstanding shares; (4) the Company effects an exchange of all its securities for other securities, cash or property, and (5) the Company effects a stock purchase agreement or business combination for more than 50% of outstanding shares. The fair value of the redeemable warrants (“Warrants”) related to the Company’s August 2016, February 2017, June 2017, August 2017, April 2018 and March 2019 common stock warrant issuance, are calculated using a Monte Carlo Simulation. While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry accepted and fairly presented the fair value of the Warrants. As an additional factor to determine the fair value of the Put’s liability, the occurrence probability of a Fundamental Transaction event was factored into the valuation.

The Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. Such value computation includes subjective input assumptions that are consistently applied each period. If the Company were to alter its assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.

The Company utilized the following assumptions to estimate the fair value of the August 2016 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	1.88		$	1.88
Risk-free interest rate		2.24	%		2.47	%
Expected holding period		2.42			2.67
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.69-0.75		$	0.69-$0.75
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.34-3.35			3.59-3.60
Expected volatility		75	%		75	%
Expected dividend yield		-			-

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The Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.63		$	0.63
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.17			3.42
Expected volatility		75	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the August 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.45		$	0.45
Risk-free interest rate		2.21	%		2.46	%
Expected holding period		2.93			3.18
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.39		$	0.39
Risk-free interest rate		2.23%-2.33	%		2.51	%
Expected holding period		1.57-4.57			1.82-4.82
Expected volatility		65%-70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:

	March 31, 2019			March 8, 2019
Underlying price per share	$	0.16		$	0.15
Exercise price per share	$	0.20		$	0.20
Risk-free interest rate		2.23	%		2.42	%
Expected holding period		4.94			5.00
Expected volatility		65	%		65	%
Expected dividend yield		-			-

-15-

The significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:

(i)	Risk-Free Interest Rate. The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate with the remaining expected holding periods of the warrants.
(ii)	Expected Holding Period. The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period.
(iii)	Expected Volatility. Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate with the remaining expected holding period on the last day of the period for which the computation is made.
(iv)	Expected Dividend Yield. Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period. As the Company has never issued dividends, the expected dividend yield is $0.00 and this assumption will be continued in future calculations unless the Company changes its dividend policy.
(v)	Expected Probability of a Fundamental Transaction. The possibility of the occurrence of a Fundamental Transaction triggering a Put right is extremely remote. As discussed above, a Put right would only arise if a Fundamental Transaction (1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction involving a person or entity not traded on a national securities exchange. The Company believes such an occurrence is highly unlikely because:

a.	The Company only has one product that is FDA approved but which will not be available for commercial sales for 18 months at the earliest;
b.	The Company flagship product is approved only in Argentina for Severely Debilitated CFS patients;
c.	The Company may have to perform additional clinical trials for FDA approval of its flagship product;
d.	Industry and global market conditions continue to include uncertainty, adding risk to any transaction;
e.	Available capital for a potential buyer in a cash transaction continues to be limited;
f.	The nature of a life science company is heavily dependent on future funding and high costs, including research & development;
g.	The Company has minimal revenues streams which are insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and
h.	The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

The Monte Carlo Simulation has incorporated a 5.0% probability of a Fundamental Transaction to date for the life of the securities.

(vi)	Expected Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation of a Fundamental Transaction, for reasons stated above, the Company used a discrete uniform probability distribution over the Expected Holding Period to model the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.
(vii)	Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized as a proxy for the future volatility.
(viii)	Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation.
(ix)	Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers, and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

-16-

While the assumptions remain consistent from period to period (e.g., using historical stock prices), the numbers input change from period to period (e.g., the actual historical prices input for the relevant period).

The Company applies FASB ASC 820 that defines fair value, establishes a framework for measuring fair value in U.S. GAAP, and expands disclosures about fair value measurements. The guidance does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead applies to asset and liability balances required or permitted to be measured at fair value under existing accounting pronouncements. The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

FASB ASC 820-10-35-37 establishes a valuation hierarchy based on the transparency of inputs used in the valuation of an asset or liability. Classification is based on the lowest level of inputs that is significant to the fair value measurement. The valuation hierarchy contains three levels:

● Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes debt and equity securities that are traded in an active market.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market.

● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. As of March 31, 2019, the Company has classified the warrants with cash settlement features and convertible debt as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above, the Company utilized the Monte Carlo Simulation Model in valuing these warrants.

The table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy as:

	(in thousands) As of March 31, 2019
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	2,486	$	2,486	$	-	$	-
Liabilities:
Redeemable warrants	$	3,895	$	-	$	-	$	3,895
Convertible note payable	$	3,682	$	-	$	-	$	3,682

	(in thousands) As of December 31, 2018
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	1,526	$	1,526	$	-	$	-
Liabilities:
Redeemable warrants	$	1,061	$	-	$	-	$	1,061
Convertible note payable	$	3,408	$	-	$	-	$	3,408

-17-

The changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):

Redeemable warrants:

Balance at December 31, 2018	$	1,061
Warrants exercised and cancelled		(1	)
Warrants issued		2,790
Fair value adjustments		45
Balance at March 31, 2019	$	3,895

Convertible debt:

Balance at December 31, 2018	$	3,408
Deferred debt discount written off due to refinancing		344
Pay off of old note payable		(3,722	)
Amount of new note payable		3,742
Fair value adjustments		(90	)
Balance at March 31, 2019	$	3,682

Note 13: Financing Obligation Arising from Sale Leaseback Transaction

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments will increase 2.5% per year for the next three years through March 31, 2023 and the lease payments will increase 3% for the remaining five years through March 31, 2028. The sale of the property includes an option to repurchase the property at fair value which does not permanently transfer all the risks and rewards of ownership to the buyer. The option to repurchase the property also would be at a higher price than the sales price and is considered likely based upon the Company’s plans going forward. Because the sale of the property includes the option to repurchase the property and includes the above attributes, the transaction was accounted for as a financing transaction whereby the Company debited cash for the amount of cash received and credit financing obligation. The Company will continue to report the property as an asset and the property will continue to be depreciated. The fair value repurchase option is accounted for similar to a share appreciation mortgage. Accordingly, the guidance in ASC 470-30 related to participating mortgage loans would be applied to the liability. If the option expires unused, the sale is recognized at that time. The gain on the sale would be the excess of the liability (current fair value of the property) over its carrying amount. If the option is exercised, the cash payment by the seller-lessee is to pay off the financing obligation. As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 3,225,806 shares of Company common stock for a period of five years at an exercise price of $0.3875 per share, 125% of the closing price of the common stock on the NYSE American on the date of execution of the letter of intent for the purchase. The warrants cannot be exercised to the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

The Property and Equipment in Note 7 above are the property and equipment involved in this transaction. Depreciation on the building will continue until a sale has been recognized.

Future minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of March 31, 2019 are as follows:

During the year:

		(in thousands)
2019		306
2020		417
2021		427
2022		438
2023		450
Thereafter		2,025
Total of payments		4,063
Less deferred issuance costs		(239	)
Less discount on debt instrument		(1,025	)
Less imputed interest		(331	)
Total balance		2,468
Less current portion		201
Long term portion	$	2,267

Interest expense relating to this financing agreement was $18,000 for the three months ended March 31, 2019.

-18-

Note 14: Leases

In February 2016, the FASB established Topic 842, Leases, by issuing Accounting Standards Update (ASU) No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements; and ASU No. 2018-20, Narrow-Scope Improvements for Lessors. The new standard establishes a right-of-use model (ROU) that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement.

The new standard was effective for the Company on January 1, 2019, with early adoption permitted. The Company adopted the new standard on its effective date. A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. If an entity chooses the second option, the transition requirements for existing leases also apply to leases entered into between the date of initial application and the effective date. The entity must also recast its comparative period financial statements and provide the disclosures required by the new standard for the comparative periods. The Company adopted the new standard on January 1, 2019 and used the effective date as our date of initial application. Consequently, financial information will not be updated, and the disclosures required under the new standard will not be provided for dates and periods before January 1, 2019.

The new standard provides several optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits the Company not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. The Company elected all the new standard’s available transition practical expedients other than the use-of hindsight.

The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, The Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. The Company also currently elected the practical expedient to not separate lease and non-lease components for leases of office equipment.

On adoption, the Company recognized additional operating liabilities of approximately $148,000 with corresponding ROU assets of the same amount, based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases.

As of March 31, 2019, the balance of the right of use assets was $137,000 and the corresponding lease liability balance was $140,000. Total rent expense was $27,000 for the three months ended March 31, 2019.

Note 15: Subsequent Events

As of March 31, 2019, our stockholders’ equity was below $6 million, the minimum required for continued listing on the NYSE American. However, subsequent to March 31, 2019 and as of the date of filing of the Form 10-Q in which these financials have been included, the Company’s stockholders’ equity is above $6 million as a result of the following: (1) there were a series of debt conversions which partially converted $1,800,000 of the $3,170,000 convertible debt, as amended, in to stockholders’ equity, adding approximately $1,800,000 to shareholders’ equity; (2) on May 2, 2019, the Company entered into an agreement with the holders of 4,550,000 warrants (classified as debt) pursuant to which the warrant exercise price was reduced to $0.15 and all of the warrants were exercised, reducing the liability attributed to the warrants by approximately $404,000, and the Company realized about $682,000 in net proceeds, resulting in an addition to stockholders’ equity of approximately $1,086,000; and (3) on and after May 8, 2019, approximately 14 million of the warrants (also classified as debt) issued in the Company’s rights offering were exercised on a cashless basis for 70% of the number of shares issuable upon such exercise, resulting in approximately $1,500,000 added to stockholders’ equity.

The Company evaluated subsequent events through the date on which these financial statements were issued and determined that no subsequent event, other than the above, constituted a matter that required adjustment to the financial statements for the three months ended March 31, 2019.

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ITEM 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations

Special Note Regarding Forward-Looking Statements

Certain statements in this Report contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section; Item 1 “Legal Proceedings” in Part II; Item 1A. “Risk Factors” in Part II.

All statements, other than statements of historical fact, included or incorporated herein regarding our strategy, future operations, financial position, future revenues, projected costs, plans, prospects and objectives are forward-looking statements. Words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “estimate,” “think,” “may,” “could,” “will,” “would,” “should,” “continue,” “potential,” “likely,” “opportunity” and similar expressions or variations of such words are intended to identify forward-looking statements but are not the exclusive means of identifying forward-looking statements.

Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties inherent in our business including, without limitation: our ability to adequately fund our projects as we will need additional funding to proceed with our objectives, the potential therapeutic effect of our products, the possibility of obtaining regulatory approval, our ability to find senior co-development partners with the capital and expertise needed to commercialize our products and to enter into arrangements with them on commercially reasonable terms, our ability to manufacture and sell any products, our ability to enter into arrangements with third party vendors, market acceptance of our products, our ability to earn a profit from sales or licenses of any drugs, our ability to discover new drugs in the future, changing market conditions, changes in laws and regulations affecting our industry, and issues related to our New Brunswick, New Jersey facility. In February 2013, we received a Complete Response Letter from the Food and Drug Administration, or FDA, for our Ampligen New Drug Application, or NDA, for the treatment of CFS. The FDA communicated that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analysis. Accordingly, the remaining steps to potentially gain FDA approval of the Ampligen NDA, the final results of these and other ongoing activities could vary materially from our expectations and could adversely affect the chances for approval of the Ampligen NDA. These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may ask for additional data, information or studies to be completed or provided; and (ii) the FDA may require additional work related to the commercial manufacturing process to be completed or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved.

In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica, or ANMAT, for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. We believe, but cannot assure, that this approval provides a platform for potential sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, should add further validation for the product as the Early Access Program, or EAP, as discussed below and underway in Europe in pancreatic cancer. ANMAT approval is only an initial, but important, step in the overall successful commercialization of our product. There are a number of actions that must occur before we could be able to commence commercial sales in Argentina. Commercialization in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch. Approval of rintatolimod for severe CFS in the Argentine Republic does not in any way suggest that the Ampligen NDA in the United States or any comparable application filed in the European Union or elsewhere will obtain commercial approval.

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In May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey related to CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in this territory, is performing EAP activities. In January 2017, the EAP was extended to pancreatic cancer patients beginning in the Netherlands. In February 2018, we signed an amendment to extend the territory to cover Canada to treat pancreatic cancer patients, pending government approval. In March 2018, we signed an amendment to which myTomorrows will be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of CFS. No assurance can be given that we can sufficiently supply product should we experience an unexpected demand for Ampligen in our clinical studies, the commercial launch in Argentina or pursuant to the EAPs. No assurance can be given that Ampligen will prove effective in the treatment of pancreatic cancer.

Currently, four Ampligen clinical trials are underway. Two of the trials have a number of subjects enrolled at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint blockade. One is at Roswell Park Comprehensive Cancer Center and the other is at the University of Pittsburgh Medical Center. The other two trials have been approved for enrollment and subjects are being screened for enrollment at Roswell Park Comprehensive Cancer Center and the University of Pittsburgh Medical Center using Ampligen in conjunction with pembrolizumab. No assurance can be given as to the results of these underway trials. Five additional cancer trials in collaboration with University Medical/Cancer Research Centers are in various pre-enrollment stages. Four of these trials are using Ampligen plus checkpoint blockade and one trial is using Ampligen as pre-treatment/neoadjuvant conditioning. No assurance can be given as to whether some or all of the planned additional oncology clinical trials will occur and they are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the sponsoring Universities or Cancer Centers. Even if these additional clinical trials are initiated, we cannot assure that these clinical studies or the four studies underway will be successful or yield any useful data.

Our overall objectives include plans to continue seeking approval for commercialization of Ampligen in the United States and abroad as well as seeking to broaden commercial therapeutic indications for Alferon N Injection presently approved in the United States and Argentina. We continue to pursue senior co-development partners with the capital and expertise needed to commercialize our products and to enter into arrangements with them on commercially reasonable terms. Our ability to commercialize our products, widen commercial therapeutic indications of Alferon N Injection and/or capitalize on our collaborations with research laboratories to examine our products are subject to a number of significant risks and uncertainties including, but not limited to our ability to enter into more definitive agreements with some of the research laboratories and others that we are collaborating with, to fund and conduct additional testing and studies, whether or not such testing is successful or requires additional testing and meets the requirements of the FDA and comparable foreign regulatory agencies. We do not know when, if ever, our products will be generally available for commercial sale for any indication.

We outsource certain components of our manufacturing, quality control, marketing and distribution while maintaining control over the entire process through our quality assurance and regulatory groups. We cannot provide any guarantee that the facility or our contract manufacturer will necessarily pass an FDA pre-approval inspection for Alferon manufacture.

The production of new Alferon Active Pharmaceutical Ingredient, or API, inventory will begin once the validation phase is complete. While the facility has already been approved by the FDA under the Biological License Application, or BLA, for Alferon, this status will need to be reaffirmed by a successful Pre-Approval Inspection by the FDA prior to commercial sale of newly produced inventory product. If and when the Company obtains a reaffirmation of FDA BLA status and has begun production of new Alferon API, it will need FDA approval as to the quality and stability of the final product before commercial sales can resume. We will need additional funds to finance the revalidation process in our facility to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection. If we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon inventory, our operations most likely will be materially and/or adversely affected. In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels. In addition, we are currently readying the New Brunswick facility to start manufacturing polymers used for the production of Ampligen to satisfy our future needs. While we anticipate that we will be able to commence manufacturing polymers at the New Brunswick facility, we may need additional funding to continue manufacturing. There cannot be any guarantee that we will obtain adequate funds to sustain manufacturing at the New Brunswick facility or that the facility will be able to manufacture sufficient lots for the commercial launch of Ampligen.

We believe, and are investigating, Ampligen’s potential role in enhancing the activity of influenza vaccines. While certain studies involving rodents, non-human primates (monkeys) and healthy human subjects indicate that Ampligen may enhance the activity of influenza vaccines by conferring increased cross-reactivity or cross-protection, further studies will be required and no assurance can be given that Ampligen will assist in the development of a universal vaccine for influenza or other viruses.

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Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained or incorporated herein, whether as a result of any new information, future events, changed circumstances or otherwise.

This Report also refers to estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

Overview

General

Hemispherx Biopharma, Inc. and its subsidiaries (collectively, “Hemispherx”, “Company”, “we” or “us”) are an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Hemispherx’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3). A first-in-class drug also known as a new chemical entity, is a drug that contains an active moiety that has not been approved by the FDA or marketed in the US.

Ampligen® represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen® has in the clinic demonstrated the potential for standalone efficacy in a number of solid tumors. We have also seen success in increasing survival rates and efficacy in the treatment of animal tumors when Ampligen® is used in combination with checkpoint blockade therapies. This success in the field of immuno-oncology has guided our focus toward the potential use of Ampligen® as a combinational therapy for the treatment of a variety of solid tumor types. There are currently multiple Ampligen® clinical trials — both underway and planned — at major cancer research centers around the country. Ampligen ® is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.

Ampligen® is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Hemispherx is currently sponsoring an expanded access program (EAP) for ME/CFS patients in the U.S. In August 2016, we received approval of our NDA from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of Ampligen® in the Argentine Republic for the treatment of severe CFS. With regulatory approval in Argentina, Ampligen® is the world’s only approved therapeutic for ME/CFS. We continue to pursue our Ampligen New Drug Application, or NDA, for the treatment of CFS with the Food and Drug Administration, or FDA. Please see “Research And Development (“R&D”); Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)” below.

Alferon N Injection® is approved for a category of STD infection and patients that are intolerant to recombinant interferon in Argentina. Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional treatment of refractory (resistant to other treatment) or recurring external Condylomata Acuminata/genital warts (GW) in patients 18 years of age or older. Certain types of human papilloma viruses cause GW. Hemispherx also has approval from ANMAT for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon in Argentina. We have developed and, with proper funding, will be seeking FDA Pre-Approval Inspection of a high-volume, high-efficiency, upgraded manufacturing process to allow for the commercial viability of Alferon®.

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We operate a 30,000 sq. ft. facility in New Brunswick, NJ with the objective of producing Ampligen® and Alferon®. 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 Ampligen® and our FDA-approved drug Alferon® N.

OUR PRODUCTS

Our primary pharmaceutical product platform consists of Ampligen®, first-in-class drug of large macromolecular double-stranded (ds) RNA (ribonucleic acid) molecules and our FDA approved natural alpha-interferon product, Alferon N Injection®.

Ampligen®

Ampligen® is approved for sale in Argentina for severe Chronic Fatigue Syndrome (CFS) and is an experimental drug in the United States currently undergoing clinical development for the treatment of certain cancers and ME/CFS. Over its developmental history, Ampligen® has received various designations, including Orphan Drug Product Designation (FDA and European Medicines Agency (“EMA”)), Treatment protocol (e.g., “Expanded Access” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality). Ampligen® represents the first drug in the class of large (macromolecular) dsRNA molecules to apply for NDA review. Based on the results of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties.

We believe that nucleic acid compounds represent a potential new class of pharmaceutical products designed to act at the molecular level for treatment of many human diseases. There are two forms of nucleic acids, deoxyribonucleic acid (“DNA”) and ribonucleic acid (“RNA”). DNA is a group of naturally occurring molecules found in chromosomes, the cell’s genetic machinery. RNA is a group of naturally occurring informational molecules which orchestrate a cell’s behavior which, in turn, regulates the action of groups of cells, including the cells which compromise the body’s immune system. RNA directs the production of proteins and regulates certain cell activities including the activation of an otherwise dormant cellular defense against viruses and tumors. Our drug technology utilizes specifically-configured RNA and is a selective TLR3 agonist that is administered intravenously. Ampligen® has been assigned the generic name rintatolimod by the United States Adopted Names Council (USANC) and has the chemical designation poly(I):poly(C₁₂U).

EAP/clinical trials of Ampligen® that have been conducted or that are ongoing include studies of the potential treatment of patients with renal cell carcinoma, malignant melanoma, non-small cell lung, ovarian, breast, colorectal, urothelial, prostate and pancreatic cancer, CFS, Hepatitis B and HIV.

We have received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe CFS. The product will be marketed by GP Pharm, our commercial partner in Latin America. Commercialization in Argentina will require, among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch.

The FDA has authorized an open-label expanded access treatment protocol, (“AMP-511”), allowing patient access to Ampligen® in an open-label safety study under which severely debilitated CFS patients have the opportunity to be on Ampligen® to treat this very serious and chronic condition. The data collected from the AMP-511 protocol through clinical sites provide safety information regarding the use of Ampligen® in patients with CFS. We are establishing an enlarged data base of clinical safety information which we believe will provide further documentation regarding the absence of autoimmune disease associated with Ampligen® treatment. We believe that continued efforts to understand existing data, and to advance the development of new data and information, will ultimately support our future filings for Ampligen® and/or the design of future clinical studies that the FDA requested in a complete response letter. The FDA recently approved the increase reimbursement level from $200 to $345 per 200mg vial of Ampligen, due to increased production costs. At this time, we do not plan on passing this adjustment along the patients in this program. As of March 31, 2019, there are 13 patients being treated in this open-label expanded access treatment protocol.

In May 2016, we entered into a five-year agreement with myTomorrows, a Netherlands based company, for the commencement and management of an Early Access Program (“EAP”) in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, as amended, myTomorrows also will manage all Early Access Programs and Special Access Programs in Europe, Canada and Turkey to treat pancreatic cancer and ME/CFS patients.

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In April 2018, we completed data analysis of an intranasal human safety study of Ampligen® plus FluMist® known as AMP-600. The study was previously closed after the US Centers for Disease Control and Prevention (“CDC”) recommended against the use of FluMist®. Intranasal Ampligen® in combination with FluMist® was generally well-tolerated in the study.

In June 2018, Ampligen® was cited as outperforming two other TLR3 agonists, poly IC and natural double stranded RNA, in creating an enhanced tumor microenvironment for checkpoint blockage therapy in the journal of Cancer Research (http://cancerres.aacrjournals.org/content/early/2018/05/31/0008-5472.CAN-17-3985). In a head-to-head study in explant culture models, Ampligen® activated the TLR3 pathway and promoted an accumulation of killer T cells but, unlike the other two TLR3 agonists, it did so without causing regulatory T cell (Treg) attraction. These findings were considered important because they indicate that Ampligen® selectively reprograms the tumor microenvironment by inducing the beneficial aspects of tumor inflammation (attracting killer T cells), without amplifying immune suppressive elements such as regulatory T cells. The study was conducted at the University of Pittsburgh and Roswell Park Comprehensive Cancer Center, as a part of the NIH-funded P01 CA132714 and Ovarian Cancer Specialized Program of Research Excellence (SPORE). Based upon these findings Hemispherx and Roswell Park Comprehensive Cancer Center expanded their existing scientific collaboration to advance the clinical development of Ampligen® which has shown promise in preclinical studies when combined with checkpoint inhibitors (CPIs). The parties executed a Memorandum of Understanding (“MOU”) designed to further assess the clinical potential of Ampligen® in treating certain cancers. This phase I/II study will evaluate the potential of Ampligen® to enhance the immune mediated effects of CPIs in patients with advanced solid tumors including bladder, melanoma and renal cell carcinoma.

Current Ampligen inventory is being used for multiple programs including the product launch in Argentina, for the treatment of ME/CFS, the pancreatic cancer EAP in the Netherlands, ongoing and future clinical studies in oncology, and our ME/CFS EAP in the U.S. and Europe.

Alferon N Injection®

Alferon N Injection® is the registered trademark for our injectable formulation of natural alpha interferon. Alferon® is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. and Argentina for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Alferon® is also approved in Argentina for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferons. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). According to the CDC, HPV is the most common sexually transmitted infection, with approximately 79 million Americans — most in their late teens and early 20s — infected with HPV. In fact, the CDC states that “HPV is so common that nearly all sexually active men and women get the virus at some point in their lives.” Although they do not usually result in death, genital warts commonly recur, causing significant morbidity and entail substantial health care costs.

Interferons are a group of proteins produced and secreted by cells to combat diseases. Researchers have identified four major classes of human interferon: alpha, beta, gamma and omega. Alferon N Injection® contains a multi-species form of alpha interferon. The world-wide market for injectable alpha interferon-based products has experienced rapid growth and various alpha interferon injectable products are approved for many major medical uses worldwide. Alpha interferons are manufactured commercially in three ways: by genetic engineering, by cell culture, and from human white blood cells. All three of these types of alpha interferon are or were approved for commercial sale in the U.S. Our natural alpha interferon is produced from human white blood cells.

The potential advantages of natural alpha interferon over recombinant (synthetic) interferon produced and marketed by other pharmaceutical firms may be based upon their respective molecular compositions. Natural alpha interferon is composed of a family of proteins containing many molecular species of interferon. In contrast, commercial recombinant alpha interferon products each contain only a single species. Researchers have reported that the various species of interferons may have differing antiviral activity depending upon the type of virus. Natural alpha interferon presents a broad complement of species, which we believe may account for its higher activity in laboratory studies. Natural alpha interferon is also glycosylated (partially covered with sugar molecules). Such glycosylation is not present on the currently U.S. marketed recombinant alpha interferons. We believe that the absence of glycosylation may be, in part, responsible for the production of interferon-neutralizing antibodies seen in patients treated with recombinant alpha interferon. Although cell culture-derived interferon is also composed of multiple glycosylated alpha interferon species, the types and relative quantity of these species are different from our natural alpha interferon.

Alferon N Injection® [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product. There are essentially no neutralizing antibodies observed against Alferon N Injection® to date and the product has a relatively low side-effect profile. The recombinant DNA derived alpha interferon formulations have been reported to have decreased effectiveness after one year of treatment, probably due to neutralizing antibody formation.

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See “Manufacturing” and “Marketing/Distribution” sections below for more details on the manufacture and marketing/distribution of Alferon N Injection®.

Cancer

We have been working with the University of Pittsburgh’s chemokine modulation research initiative which includes the use of Ampligen® as a potential adjuvant to modify the tumor microenvironment (TME) with the goal of increasing anti-tumor responses to check point inhibitors (CPI). As part of this collaboration, Hemispherx has supplied Ampligen® (rintatolimod) to the University. The study, under the leadership of Robert P. Edwards, MD, chair of gynecologic services at Magee-Women’s Hospital of the University of Pittsburgh School of Medicine, and Professor of Surgery Pawel Kalinski, M.D., Ph.D., at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., involved the chemokine modulatory regimen developed by Dr. Kalinski’s group and successfully completed the Phase 1 dose escalation in patients with resectable colorectal cancer. In the 1st quarter of 2017, Dr. Kalinski relocated to Roswell Park Comprehensive Cancer Center (“RPCCC”) in Buffalo, NY and has established a cancer program which will continue to require a supply of Ampligen®.

In October 2018, we signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center to evaluate Ampligen® in combination with checkpoint inhibitors (CPIs). The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs in patients with primary resistance to CPI therapy. The protocol will seek to evaluate the combination of Ampligen® and CPIs in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma. Ampligen® is our investigational immune-enhancing TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs. This new agreement expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do not respond or progress following treatment with standard CPI-based therapy.

Currently, four Ampligen® clinical trials are underway at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including checkpoint inhibitors:

Recurrent Ovarian Cancer - Phase 1 / 2 study of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer at University of Pittsburgh Medical Center. Dr. R. Edwards, PI. Study underway. An interim report from Dr. Edwards’ team is expected within thirty days and a summary of same will be disclosed upon receipt. See: https://www.clinicaltrials.gov/ct2/show/NCT02432378

Colorectal Cancer - Phase 2a study of Ampligen as component of chemokine modulatory regimen on colorectal cancer metastatic to liver at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. This study is underway. See: https://www.clinicaltrials.gov/ct2/show/NCT03403634

Metastatic Triple Negative Breast Cancer - Open label study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab, at Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI. This study is underway. See: https://www.clinicaltrials.gov/ct2/show/NCT03599453

Recurrent Ovarian Cancer – This is a Phase 2 investigator-sponsored trial being conducted in advanced recurrent ovarian cancer at the University of Pittsburgh Medical Center that will evaluate Ampligen in combination with pembrolizumab and cisplatin. Patient enrollment has been initiated in this study designed for 45 subjects. Dr. Robert Edwards, world renowned expert in ovarian cancer is the lead investigator. See: https://www.clinicaltrials.gov/ct2/show/NCT03734692

In addition, five Ampligen clinical trials are planned for initiation in 2019, subject to funding:

● Phase 2 study that will evaluate Ampligen in combination with pembrolizumab in refractory metastatic colorectal carcinoma at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Study design and budget being developed.

● Phase 2 study of advanced urothelial (bladder), melanoma and renal cell carcinoma, resistant to checkpoint blockade that will evaluate Ampligen in combination with a checkpoint blockade therapy at Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI. Protocol design currently being finalized. Hemispherx Biopharma signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center to study Ampligen in combination with checkpoint inhibitors in a phase 2a study in urothelial carcinoma, renal cell carcinoma and melanoma. This Phase 2a study will be led by Mateusz Opyrchal, MD, PhD, Assistant Professor of Medicine and Associate Director of the Early Phase Clinical Trial Program at Roswell Park, in collaboration with Dr. Kalinski.

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● First-line therapy for non-small cell lung cancer with SOC chemotherapy that will evaluate Ampligen in combination with pembrolizumab at University of Nebraska Medical Center. Dr. V. Ernani, PI. Study design and budget being developed.

● Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University of Nebraska Medical Center. Dr. K. Klute, PI. Protocol and budget being developed. Based upon success in the initial animal studies, an additional round of more extensive and comprehensive pre-clinical animal pancreatic cancer studies are being conducted at University of Nebraska to reconfirm results, test additional PC tumor types, examine anti-PD-1 in addition to the prior anti-PD-L1 analysis, then fine tune the focus of the proposed future pancreatic cancer clinical trial and reduce the chances of error in clinical trial design. This information will also be used to formulate proposed future combination therapy clinical activity in the Kingdom of the Netherlands.

● Phase 2 study of neoadjuvant conditioning of prostate cancer tumor microenvironment using Ampligen at Roswell Park Comprehensive Cancer Center. Dr. G. Chatta, PI. This protocol is now authorized by the FDA. See: https://clinicaltrials.gov/ct2/show/NCT03899987.

● In January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen® to ME/CFS patients had been extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in Europe and Turkey and will manage all EAP activities relating to the pancreatic cancer extension of the program. In February 2018, the agreement with myTomorrows was extended to cover Canada to treat pancreatic cancer patients, pending government approval.

As of March 31, 2019, 42 pancreatic cancer patients have received treatment with Ampligen® immuno-oncology therapy under the EAP program at Erasmus University in the Netherlands.

Supervised by Prof. Casper van Eijck, MD, a world-renowned specialist in this dread malignancy, and Diba Latifi, MD, the team at Erasmus is making progress. As disclosed recently, the Dutch government has approved and extended the therapeutic program for an additional year. Early progress was reported in a published abstract from Erasmus, and a copy of the abstract can be found at https://hemispherx.net/stockholder-meeting/. The abstract was part of a larger original report covering a variety of medical topics, which can be found at https://www.pancreasclub.com/wp-content/uploads/2018/06/Poster-Abstracts.pdf.

As of March 2019, we reported that four out of 24 patients with either locally advanced or metastatic disease have survived for more than one year on the Ampligen protocol without additional therapy. Another four patients had survived for more than one year since the start of the Ampligen protocol with palliative chemotherapy. However, in this group of patients 15 died within seven months since start of Ampligen. Of the five resected patients two died on Ampligen, 24 and 27 months after resection. The other three patients are still alive with a mean survival of 26 months after resection and adjuvant Ampligen treatment.

All patients reported improvement in quality of life during treatment. We expect within 60 days a more comprehensive update from the Erasmus team on the immunological response in relation to survival. Hemispherx hopes to work with Dr. Van Eijck, Dr. Latifi, and Erasmus M.C. to initiate a combination therapy program to extend the results seen thus far in the Netherlands by combining Ampligen with checkpoint blockade therapy.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”)

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), also known as Chronic Fatigue Immune Dysfunction Syndrome (“CFIDS”) and Chronic Fatigue Syndrome (“CFS”), is a serious and debilitating chronic illness and a major public health problem. ME/CFS is recognized by both the government and private sector as a significant unmet medical need, including the U.S. National Institutes of Health (“NIH”), FDA and the CDC. The CDC states on its website at https://www.cdc.gov/me-cfs/ that “Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious, long-term illness that affects many body systems. People with ME/CFS are often not able to do their usual activities. At times, ME/CFS may confine them to bed. People with ME/CFS have severe fatigue and sleep problems. ME/CFS may get worse after people with the illness try to do as much as they want or need to do. This symptom is known as post-exertional malaise (PEM). Other symptoms can include problems with thinking and concentrating, pain, and dizziness.”

Many severe ME/CFS patients become completely disabled or totally bedridden and are afflicted with severe pain and mental confusion even at rest. ME/CFS is characterized by incapacitating fatigue with profound exhaustion and extremely poor stamina, sleep difficulties and problems with concentration and short-term memory. It is also accompanied by flu-like symptoms, pain in the joints and muscles, tender lymph nodes, sore throat and new headaches. A distinctive characteristic of the illness is a worsening of symptoms following physical or mental exertion, which do not subside with rest.

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In October 2016, an analysis of a subset of CFS patients from the AMP-516 Phase 3 study was performed and presented at the IACFS/ME annual meeting in Fort Lauderdale, FL. The ITT Population (n=208) was separated into two subsets based primarily on baseline CFS symptom duration (2-8 years (n=75) and <2 years plus >8 years (n=133)). Responder analyses of the ITT Population and both subsets were performed. Responder analyses of rintatolimod vs. placebo patients improving ET duration from baseline by ≥25% shows over twice the % of patients with clinical enhancement in ET effect in the rintatolimod cohort compared to placebo for the 2-8 year subset vs. the ITT population. This subset may assist in the design of future clinical studies of Ampligen® in the treatment for ME/CFS patients.

Other Diseases

In Europe, the EMA has approved the Orphan Medicinal Products Designation for rintatolimod (Ampligen®) as a potential treatment of Ebola virus disease and for Alferon® N Injection, also known as interferon alfa-n3, as a potential treatment of MERS.

We concluded our series of collaborations designed to determine the potential effectiveness of Ampligen® and Alferon® N as potential preventative and/or therapeutic treatments for Ebola related disorders. Although we believe that the threat of both MERS and Ebola globally may reemerge in the future, it appears that the spread of these disorders has somewhat diminished. As a result, we have elected to focus our research and development efforts on other areas at this time.

Manufacturing

In January 2017, Hemispherx and Jubilant Hollister-Stier LLC (“Jubilant”) entered into a commitment pursuant to which Jubilant has manufactured commercial size batches of Ampligen®. Two commercial size batches consisting of over 16,000 vials were produced in 2018 for use in our clinical studies and EAP.

Jubilant was approved by the FDA as a manufacturer of Ampligen by the successful completion of a previous preapproval inspection by the agency. The National Administration of Drugs, Food and Medical Devices (A.N.M.A.T) in Argentina has approved Ampligen for commercial distribution for the treatment of Chronic Fatigue Syndrome (CFS). The release testing of the drug, which is needed by A.N.M.A.T., has been initiated in Argentina. We are currently working with the FDA to allow us to export Ampligen to Argentina.

The production of the polymers (Ampligen intermediates) at our New Brunswick facility is required for the production of additional lots of Ampligen. The manufacture of polymer is currently being worked on to provide the intermediates needed for the production of Ampligen. Once polymer is available we will schedule the manufacture of additional lots at Jubilant.

Alferon® is approved by the FDA for commercial sales in the US for the treatment of genital warts. It is also approved by A.N.M.A.T in Argentina for commercial sales for the treatment of genital warts and in patients refractory to treatment with recombinant interferons. While the Hemispherx facility in New Brunswick is approved by the FDA under the Biologic License Application (BLA) for Alferon®, this status will need to be reaffirmed by an FDA pre-approval inspection which will not occur until new batches of commercial filled and finished product are produced and released by the FDA. Currently, the manufacturing process is on hold and there is no definitive timetable to have the facility back online until additional funding is obtained.

Marketing/Distribution

In May 2016, we entered into a five-year exclusive Renewed Sales, Marketing, Distribution and Supply Agreement (the “Agreement”) with GP Pharm. Under this Agreement, GP Pharm was responsible for gaining regulatory approval in Argentina for Ampligen® to treat severe CFS in Argentina and for commercializing Ampligen® for this indication in Argentina. We granted GP Pharm the right to expand rights to sell this experimental therapeutic into other Latin America countries based upon GP Pharm achieving certain performance milestones. We also granted GP Pharm an option to market Alferon N Injection® in Argentina and other Latin America countries.

In January 2017, the ANMAT granted a five-year extension to a previous approval to sell and distribute Alferon N Injection® (under the brand name “Naturaferon”) in Argentina. This extends the approval until 2022. In February 2013, we received the ANMAT approval for the treatment of refractory patients that failed or were intolerant to treatment with recombinant interferon, with Naturaferon® in Argentina.

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In May 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”), a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing EAP activities. These activities will be directed to (a) the education of physicians and patients regarding the possibility of early access to innovative medical treatments not yet the subject of a Marketing Authorization (regulatory approval) through named-patient use, compassionate use, expanded access and hospital exemption, (b) patient and physician outreach related to a patient-physician platform, (c) the securing of Early Access Approvals (exemptions and/or waivers required by regulatory authorities for medical treatments prior to Marketing Authorization) for the use of such treatments, (d) the distribution and sale of such treatments pursuant to such Early Access Approvals, (e) pharmacovigilance (drug safety) activities and/or (f) the collection of data such as patient-reported outcomes, doctor-reported experiences and registry data. We are supporting these efforts and supplying Ampligen® to myTomorrows at a predetermined transfer price. In the event that we receive Marketing Authorization in any country in the Territory, we will pay myTomorrows a royalty on products sold. Pursuant to the Impatients Agreement, the royalty would be a percentage of Net Sales (as defined in the Impatients Agreement) of Ampligen® sold in the Territory where Marketing Authorization was obtained, and the maximum royalty would be a percentage of Net Sales. The formula to determine the percentage of Net Sales will be based on the number of patients that are entered into the EAP. The Company believes that disclosure of the exact maximum royalty rate and royalty termination date could cause competitive harm. However, to assist the public in gauging these terms, the actual maximum royalty rate is somewhere between 2% and 10% and the royalty termination date is somewhere between five and fifteen years from the First Commercial Sale of a product within a specific country. The parties established a Joint Steering Committee comprised of representatives of both parties to oversee the EAP. No assurance can be given that activities under the EAP will result in Marketing Authorization or the sale of substantial amounts of Ampligen® in the Territory.

In January 2017, the EAP through our agreement with myTomorrows designed to enable access of Ampligen® to ME/CFS patients has been extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in the Territory and will manage all EAP activities relating to the pancreatic cancer extension of the program.

In February 2018, we signed an amendment to the EAP with myTomorrows. This amendment extended the territory to cover Canada to treat pancreatic cancer patients, pending government approval.

In March 2018, we signed an amendment to the EAP with myTomorrows, pursuant to which myTomorrows will be our exclusive service provider for special access activities in Canada for the supply of Ampligen® for the treatment of ME/CFS.

In August 2017, we extended our agreement with Asembia, formerly Armada Healthcare, LLC, to undertake the marketing, education and sales of Alferon N Injection® throughout the United States.

401(k) Plan

Each participant immediately vests in his or her deferred salary contributions, while Company contributions will vest over one year. The 6% Company matching contribution was terminated effective January 1, 2016. For the three months ended March 31, 2019, the Company did not make any contributions towards the 401(k) Plan.

New Accounting Pronouncements

See “Note 10: Recent Accounting Pronouncements”.

Disclosure About Off-Balance Sheet Arrangements

None.

Critical Accounting Policies

There have been no material changes in our critical accounting policies and estimates from those disclosed in Part II; Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations; Critical Accounting Policies” contained in our Annual Report on Form 10-K for the year ended December 31, 2018.

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RESULTS OF OPERATIONS

Three months ended March 31, 2019 versus three months ended March 31, 2018

Net Loss

Our net loss was approximately $3,368,000 and $2,713,000 for the three months ended March 31, 2019 and 2018, respectively, representing an increase in loss of approximately $655,000 or 24% when compared to the same period in 2018. This increase in loss for these three months was primarily due to the following:

1)	an increase in general and administrative expense of $204,000 or 13%;
2)	a gain from the sale of the underutilized building in New Brunswick of $223,000 in 2018 which did not occur in 2019; and
3)	a write off of the balance of debt discounts associated with extinguished debt of $250,000.

Net loss per share was $(0.07) and $(0.07) for the three months ended March 31, 2019 and 2018, respectively. The weighted average number of shares of our common stock outstanding as of March 31, 2019 was 50,903,398 as compared to 36,269,388 as of March 31, 2018.

Revenues

Revenues from our Ampligen Cost Recovery Program were $0 and $56,000 for the three months ended March 31, 2019 and 2018, respectively. There were no sales in the current quarter, because the clinical sites purchased inventory in 2018 to make sure they have drug supply for the patients currently enrolled in the expanded access program.

Production Costs

Production costs were approximately $231,000 and $208,000, respectively, for the three months ended March 31, 2019 and 2018, representing an increase of $23,000 in production costs in the current period. These costs primarily represent stability testing and pre-production expenses related to Alferon. The increase in costs was primarily due to an overall increase in costs.

Research and Development Costs

Overall Research and Development (“R&D”) costs for the three months ended March 31, 2019 were approximately $928,000 as compared to $855,000 for the same period a year ago, reflecting an increase of approximately $73,000 or 8%. Costs increased mainly due to Ampligen stability costs, which increased $51,000, along with general maintenance costs increased $22,000.

General and Administrative Expenses

General and Administrative (“G&A”) expenses for the three months ended March 31, 2019 and 2018, were approximately $1,767,000 and $1,563,000, respectively, reflecting an increase of approximately $204,000 or 13%. The increase in G&A expenses during the current period was mainly due to an increase in stock compensation of $84,000, an increase in stock market fees of $20,000 and an increase in salaries of $64,000.

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Other Income-Expenses

There was a gain from the sale of the underutilized building in New Brunswick of $223,000 in 2018 which did not occur in 2019.

There was a write off of the balance of debt discounts associated with extinguished debt of $250,000 in 2019 which did not occur in 2018.

Convertible Debt

Interest and finance costs increased $107,000 in the three months ended March 31, 2019 mostly due to costs associated with the convertible debt which was not in effect in the three months ended March 31, 2018.

The convertible debt is valued using the Monte Carlo method and for the three months ended March 31, 2019 there was a gain of $90,000 as a result of the Monte Carlo method, which was not in effect in 2018.

Redeemable Warrants

The quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability for the three months ended March 31, 2019 which amounted to a loss of approximately $45,000, compared to a loss of $231,000 for March 31, 2018 (see Note 12: Fair Value - for the various factors considered in the valuation of redeemable warrants).

Liquidity and Capital Resources

As of March 31, 2019, we had approximately $4,880,000 in cash, cash equivalents and marketable securities inclusive of approximately $2,486,000 in Marketable Securities, representing an increase of approximately $3,055,000 from December 31, 2018. Cash used in operating activities for the three months ended March 31, 2019 was approximately $1,457,000 compared to approximately $2,542,000 for the same period in 2018, a decrease of 1,085,000 or 43%. The primary reason for this decrease was collection of other receivables in 2019.

Cash used in investing activities for the three months ended March 31, 2019 was approximately $1,098,000 compared to cash provided by investing activities of approximately $1,036,000 for the same period in 2018, representing an increase of $2,134,000. The primary reasons for the increase during the current period is the receipt of $963,000 from the sale of the underutilized second building in New Brunswick, New Jersey in 2018 and use of marketable securities of $960,000 for operation, purchase of equipment of $14,000 and payments of patent and trademark fees of $124,000.

Cash provided by financing activities for the three months ended March 31, 2019 was approximately $4,650,000 compared to approximately $4,051,000 for the same period in 2018, an increase of $599,000. The primary reasons for the increase in the three months ended March 31, 2019 can be attributable to our receipt of net proceeds of approximately $4,734,000 from the sale common stock pursuant to our EDA with Maxim Group, the exercise of warrants and the sale of shares through a stock offering as compared to $2,326,000 in 2018 (see “Note 8: Stockholders’ Equity”). Also we received $1,678,000 from the sale leaseback of the main building located in New Brunswick, New Jersey in 2018.

If we are unable to commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and liquidity may be adversely impacted, and additional financing will be required. In this regard, due to the high cost estimates to bring the facility back online, we most likely will need additional funds to finance the revalidation process in our facility and to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection and to commercialize our products. However, there is no assurance that such financing will be available.

As of September 1, 2017, the directors agreed to defer 100% of their fees until cash is available. In consideration of this deferral, 226,023 options were issued to each of the two independent directors in February 2018 with an exercise price of $0.37 for a period of 10 years with a vesting period of 3 years. As of September 1, 2017, certain officers agreed to defer 40% of their salaries until cash is available and all employees agreed to be paid 50% of their salaries in the form of unrestricted common stock of the Company. In April 2018, the Board of Directors approved a payment of 50% of the deferred Board fees and the deferred officer salaries. However, 100% of the current Board fees and 40% of the current officer salaries continue to be deferred.

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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.

We reactivated our Equity Distribution Agreement with Maxim under our universal shelf registration statement in December 2017. Since December 5, 2017, we have sold an aggregate of 2,970,273 shares under the EDA for proceeds of $1,098,020 net of $32,940 in commissions. The actual number of shares that we can sell Pursuant to the EDA and the proceeds to be received therefrom are dependent upon the market price of our common stock.

In January and February 2018, we realized net proceeds of approximately $1,260,000 from the exercise of 2,800,000 warrants with an exercise price on $0.45.

On March 16, 2018, we sold our property located at 783 Jersey Ave, New Brunswick, NJ for $4,080,000 and the purchasers received 3,225,806 warrants to purchase common stock. Simultaneously therewith, we leased the facility back.

On March 24, 2018, we sold 1,250,000 shares of common stock for net proceeds of approximately $475,000 from this stock offering.

In February 2018, we sold our unencumbered, unutilized, and wholly owned property located at 5 Jules Lane, New Brunswick, New Jersey to Acellories, NJ LLC, a New Jersey limited liability company, pursuant to a sale agreement dated September, 11, 2017. The sale price was $1,050,000.

There can be no assurances that, if needed, we will be able to raise adequate funds from these or other sources or enter into licensing, partnering or other arrangements to advance our business goals. Our inability to raise such funds or enter into such arrangements, if needed, could have a material adverse effect on our ability to develop our products. Also, we have the ability to curtail discretionary spending, including some research and development activities, if required to conserve cash. Because of our long-term capital requirements, we may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. We are unable to estimate the amount, timing or nature of future sales of outstanding common stock or instruments convertible into or exercisable for our common stock. Any additional funding may result in significant dilution and could involve the issuance of securities with rights, which are senior to those of existing stockholders. We may also need additional funding earlier than anticipated, and our cash requirements, in general, may vary materially from those now planned, for reasons including, but not limited to, changes in our research and development programs, clinical trials, acquisitions of intellectual property or assets, enhancements to the manufacturing process, competitive and technological advances, the regulatory processes including the commercializing of Ampligen products or new utilization of Alferon products.

The proceeds from our financings have been used to fund infrastructure growth including manufacturing, regulatory compliance and market development along with our efforts regarding the Ampligen manufacturing, Ampligen NDA and preparedness for the FDA pre-approval inspections of the New Brunswick manufacturing facility. There can be no assurances that, if needed, we will raise adequate funds from these or other sources, which may have a material adverse effect on our ability to develop our products. Also, we have the ability to curtail discretionary spending, including some research and development activities, if required to conserve cash

ITEM 3: Quantitative and Qualitative Disclosures About Market Risk

We had approximately $4,880,000 in cash, cash equivalents and marketable securities at March 31, 2019 as compared to $1,825,000 at December 31, 2018.

To the extent that our cash and cash equivalents exceed our near term funding needs, we intend to invest the excess cash in money market accounts, high-grade corporate bonds or fixed-income type bond funds. We employ established conservative policies and procedures to manage any risks with respect to investment exposure.

ITEM 4: Controls and Procedures

Our Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) performed an evaluation of the effectiveness of our disclosure controls and procedures, which have been designed to permit us to effectively identify and timely disclose important information. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on that evaluation, our CEO and CFO concluded that the controls and procedures were effective as of March 31, 2019, to ensure that material information was accumulated and communicated to our management, including our CEO and CFO, is appropriate to allow timely decisions regarding required disclosure.

During the three months ended March 31, 2019, we have made no change in our internal controls over financial reporting that has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

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Part II – OTHER INFORMATION

ITEM 1: Legal Proceedings

Hemispherx commenced an action against Baxter in December of 2017 for Breach of Contract. The amount of damages we are seeking in this matter are yet to be determined. Damages are not covered by insurance. BioLife, the defendant, has filed its Answer, Affirmative Defenses and a Counterclaim in the amount of $96,676.39 representing the Invoices withheld after BioLife indicated that they were not intending to fulfill the balance of the contract. Hemispherx has denied the allegations of the counterclaim. We recently attempted mediation and were, to date, unable to resolve the matter. A discovery schedule has been issued by the Court and we are now in the initial stages of discovery. Although it cannot be determined, we believe there is little chance for an unfavorable outcome in this case.

Hemispherx filed and served a Complaint in Philadelphia Court of Common Pleas against Travelers Property Casualty Company of America at the end of March 2019 seeking compensation for business interruption loss and other damages following a flood loss to its New Brunswick manufacturing facility which occurred in January 2016. The Complaint also seeks bad faith and additional damages. On or about April 17, 2019, Travelers removed the case to the United States District Court for Eastern District of Pennsylvania. On or about May 2, 2019, Travelers filed an Answer with Affirmative Defenses to the Complaint. The Court has scheduled an initial scheduling conference for May 30, 2019. The parties are proceeding with the initial stages of discovery.

ITEM 1A: Risk Factors

The following cautionary statements identify important factors that could cause our actual results to differ materially from those projected in the forward-looking statements made in this Form 10-Q. Among the key factors that have a direct bearing on our results of operations are

Risks Associated with Our Business:

We may continue to incur substantial losses and our future profitability is uncertain.

As of March 31, 2019, our accumulated deficit was approximately $321,941,000. We have not yet generated significant revenues from our products and may incur substantial and increased losses in the future. We cannot assure that we will ever achieve significant revenues from product sales or become profitable. We require, and will continue to require, the commitment of substantial resources to develop our products. We cannot assure that our product development efforts will be successfully completed or that required regulatory approvals will be obtained or that any products will be manufactured and marketed successfully, or be profitable.

We will require additional financing which may not be available.

The development of our products requires the commitment of substantial resources to conduct the time consuming research, preclinical development, and clinical trials that are necessary to bring pharmaceutical products to market. As of March 31, 2019, we had approximately $4,880,000 in cash, cash equivalents and marketable securities (inclusive of approximately $2,486,000 in Marketable Securities). However, if we are unable to commercialize and sell Ampligen, recommence material sales of Alferon N Injection and/or continue to obtain funding, our operations, financial position and liquidity most likely will be adversely impacted.

Our current primary focus is research and development of the potential use of Ampligen® as a combinational therapy for the treatment of a variety of solid tumor types. There are currently multiple Ampligen® clinical trials — both underway and planned. In addition, we continue to pursue our NDA at the FDA for use of Ampligen for the treatment of CFS. In this regard, we will need to conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. The time and cost to undertake the studies and data analysis are beyond our current financial resources without gaining access to additional funding. The actual duration to complete the studies may be different based on the length of time it takes to design the study and obtain acceptance of the design, availability of suitable participants and clinical sites along with other factors that could impact the implementation of the study, analysis of results or requirements of the FDA and/or other governmental organizations.

Given the challenging economic conditions, we continue to review every aspect of our operations for cost and spending reductions to assure our long-term financial stability while maintaining the resources necessary to achieve our primary objectives discussed above along with the manufacturing, marketing and distribution of our products, including Alferon N Injection. We also will need additional funds to finance the revalidation process in our facility to initiate commercial manufacturing, thereby readying ourselves for an FDA Pre-Approval Inspection. We may also need additional capital to eventually commercialize and sell Ampligen and/or recommence and increase sales of Alferon N Injection or our other products. We anticipate considering multiple options in an attempt to secure funding, including but not limited to such methods as the sales of additional equity, licensing agreements, partnering with other organizations, debt financing or other sources of capital.

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Risks Associated with an Investment in Our Common Stock:

The trading price of our common stock has decreased significantly and, as a result, the NYSE American has informed us that we are not in compliance with the standards for continued listing on the NYSE American. In addition, while our stockholders’ equity as of the date of this report is above the required amount for continued listing, it was below the amount as of December 31, 2018 and March 31, 2019. If we are unable to raise the trading price or to continue to meet the minimum stockholders’ equity requirements, our common stock could be delisted from the NYSE American and the market for our common stock most likely would be adversely affected.

The price per share of our common stock has closed at or below $0.20 since February 26, 2019 and most recently closed on March 26, 2019 at $0.16, with a 30 day average of $0.19. On March 26, 2016, we received written notice from the NYSE American LLC (the “Exchange”) that we are not in compliance with the continued listing standards set forth in Section 1003(f)(v) of the Exchange’s Company Guide because our common stock has been selling for a low price per share for a substantial period of time. The Exchange has determined that the continued listing of our common stock is predicated on us effecting a reverse stock split of our common stock or otherwise demonstrating sustained price improvement within a reasonable period of time. We have until September 26, 2019 to demonstrate compliance. To rectify this issue, we are holding a special stockholders meeting on May 29, 2019 seeking approval of a reverse split of our outstanding shares of common stock. In addition, while as of the date of this Report our stockholders’ equity was above $6 million, the minimum stockholders’ equity required for continued listing pursuant to Section 1003(a)(iii) of the Exchange’s Company Guide, it was below $6 million as of December 31, 2019 and March 31, 2019.

If we are unable to sufficiently raise the trading price of our common stock or continue to meet the minimum stockholders’ equity requirement, we risk delisting on the Exchange. Should our stock be so delisted, stockholders’ ability to sell their shares in the open market most likely will be adversely affected even if the shares are then quoted for trading on an interdealer quotation system such as the OTCBB or OTC Markets.

In addition to the other information set forth in this Report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the SEC on April 1, 2019, which could materially affect our business, financial condition, or future results. The risks described in our Annual Report on Form 10-K are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and operating results.

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds

None

ITEM 3: Defaults upon Senior Securities

None.

ITEM 4: Mine Safety Disclosures

Not Applicable.

ITEM 5: Other Information

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ITEM 6: Exhibits

(a) Exhibits

31.1	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.
31.2	Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.
32.1	Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Executive Officer.
32.2	Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 from the Company’s Chief Financial Officer.

101.INS	XBRL Instance Document *
101.SCH	XBRL Taxonomy Extension Schema Document *
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document *
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document *
101.LAB	XBRL Taxonomy Extension Label Linkbase Document *
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document *

* Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities and Exchange Act of 1934, as amended and otherwise are not subject to liability under those sections.

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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 thereunto duly authorized.

	HEMISPHERX BIOPHARMA, INC.
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer & President
	/s/ Adam Pascale
	Adam Pascale
	Chief Financial Officer
Date: May 15, 2019

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EX-31.1

EXHIBIT 31.1

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Thomas K. Equels, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Hemispherx Biopharma, Inc. (the “Registrant”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.	The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.	Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.	Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5. The Registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.	Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: May 15, 2019
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer

EX-31.2

EXHIBIT 31.2

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

I, Adam Pascale, certify that:

1.	I have reviewed this quarterly report on Form 10-Q of Hemispherx Biopharma, Inc. (the “Registrant”);
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;
4.	The Registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

a.	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.	Evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.	Disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

5. The Registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

a.	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
b.	Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

Date: May 15, 2019
	/s/ Adam Pascale
	Adam Pascale
	Chief Financial Officer

EX-32.1

EXHIBIT 32.1

CERTIFICATION PURSUANT TO

SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Hemispherx Biopharma, Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Thomas K. Equels, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: May 15, 2019
	/s/ Thomas K. Equels
	Thomas K. Equels, Esq.
	Chief Executive Officer

EX-32.2

EXHIBIT 32.2

CERTIFICATION PURSUANT TO

SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Hemispherx Biopharma, Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Adam Pascale, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:

(1)	The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)	The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: May 15, 2019
	/s/ Adam Pascale
	Adam Pascale
	Chief Financial Officer

XML

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2019	May 06, 2019
Document And Entity Information
Entity Registrant Name	HEMISPHERX BIOPHARMA INC
Entity Central Index Key	0000946644
Document Type	10-Q
Document Period End Date	Mar. 31, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business Flag	true
Entity Emerging Growth Company	false
Entity Ex Transition Period	false
Entity Common Stock, Shares Outstanding		86,621,318
Trading Symbol	HEB
Document Fiscal Period Focus	Q1
Document Fiscal Year Focus	2019

XML

Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 2,394	$ 299
Marketable securities	2,486	1,526
Funds receivable from sale of New Jersey net operating loss		859
Accounts receivable	101	235
Prepaid expenses and other current assets	874	880
Total current assets	5,855	3,799
Property and equipment, net	7,602	7,782
Right of use assets, net	137
Patent and trademark rights, net	1,019	912
Other assets	1,352	1,352
Total assets	15,965	13,845
Current liabilities:
Accounts payable	768	680
Accrued expenses	1,082	1,005
Convertible note payable		3,408
Current portion of operating lease liabilities	36
Current portion of financing obligation	201	199
Total current liabilities	2,087	5,292
Long-term liabilities:
Operating lease obligation	104
Convertible note payable	3,682
Financing obligation arising from sale leaseback transaction (Note 13)	2,267	2,318
Redeemable warrants	3,895	1,061
Commitments and contingencies
Stockholders' equity:
Preferred stock, value
Common stock, par value $0.001 per share, authorized 350,000,000 shares; issued and outstanding 62,900,318 and 48,734,712, respectively	63	49
Additional paid-in capital	323,289	323,701
Accumulated other comprehensive loss		(3)
Accumulated deficit	(321,941)	(318,573)
Total stockholders' equity	3,930	5,174
Total liabilities and stockholders' equity	15,965	13,845
Series B Convertible Preferred Stock [Member]
Stockholders' equity:
Preferred stock, value	$ 2,519

XML

Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2019	Dec. 31, 2018
Preferred stock, par or stated value	$ 0.01	$ 0.01
Preferred stock, shares authorized	5,000,000	5,000,000
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	350,000,000	350,000,000
Common stock, shares issued	62,900,318	48,734,712
Common stock, shares outstanding	62,900,318	48,734,712
Series B Convertible Preferred Stock [Member]
Preferred stock, par or stated value	$ 1,000	$ 1,000
Preferred stock, shares designated	8,000

XML

Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Revenues:
Total revenues		$ 56
Costs and expenses:
Production costs	231	208
Research and development	928	855
General and administrative	1,767	1,563
Total costs and expenses	2,926	2,626
Operating loss	(2,926)	(2,570)
Interest and other income	12	4
Interest expense and other finance costs	(246)	(139)
Debt discounts associated with extinguished debt	(250)
Fair value of convertible note adjustment	90
Redeemable warrants valuation adjustment	(45)	(231)
Gain on sale of building		223
Loss on sale of marketable securities	(3)
Net loss	(3,368)	(2,713)
Other comprehensive income (loss):
Reclassification adjustments for loss on sales of marketable securities	3
Unrealized loss on marketable securities		(12)
Net comprehensive loss	$ (3,365)	$ (2,725)
Basic and diluted loss per share	$ (0.07)	$ (0.07)
Weighted average shares outstanding, basic and diluted	50,903,398	36,269,388
United States [Member]
Revenues:
Clinical treatment programs		$ 13
Europe [Member]
Revenues:
Clinical treatment programs		$ 43

XML

Consolidated Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-In Capital [Member]	Accumulated Other Comprehensive (Loss) [Member]	Accumulated Deficit [Member]	Series B Preferred [Member]	Total
Balance at Dec. 31, 2017	$ 33	$ 317,419	$ 11	$ (308,760)		$ 8,703
Balance, shares at Dec. 31, 2017	32,884,786
Equity-based compensation		286				286
Equity-based compensation, shares	438,385
Warrants issued for building sale leaseback		1,149				1,149
Redeemable warrants		(221)				(221)
Common stock issuance, net of costs	$ 5	2,321				2,326
Common stock issuance, net of costs, shares	5,375,288
Common stock issued to settle accounts payable	$ 1	239				240
Common stock issued to settle accounts payable, shares	520,909
Net comprehensive loss			(21)	(2,713)		(2,725)
Balance at Mar. 31, 2018	$ 39	321,635	(1)	(311,473)		10,200
Balance, shares at Mar. 31, 2018	39,219,368
Balance at Dec. 31, 2018	$ 49	323,701	(3)	(318,573)		5,174
Balance, shares at Dec. 31, 2018	48,734,712
Equity-based compensation		175				175
Equity-based compensation, shares
Redeemable warrants		(2,787)				(2,787)
Common stock issuance, net of costs	$ 14	2,200				2,214
Common stock issuance, net of costs, shares	14,165,606
Series B preferred shares issued, net of costs					5,312	5,312
Series B preferred shares converted to common shares					(2,793)	(2,793)
Net comprehensive loss			3	(3,368)		(3,365)
Balance at Mar. 31, 2019	$ 63	$ 323,289		$ (321,941)	$ 2,519	$ 3,930
Balance, shares at Mar. 31, 2019	62,900,318

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Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Cash flows from operating activities:
Net loss	$ (3,368)	$ (2,713)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment	194	216
Redeemable warrants valuation adjustment	45	231
Fair value of convertible note adjustment	(90)
Change in convertible debt - refinancing	20
Deferred debt write-off	344
Amortization of patent, trademark rights, and ROU assets	28
Equity-based compensation	175	286
Realized loss on sale of marketable securities	3
Gain on sale of building		(223)
Amortization of finance and debt issuance costs	35	140
Change in assets and liabilities:
Accounts and other receivables	993	(6)
Prepaid expenses and other current assets	7	(385)
Lease liability payments	(8)
Accounts payable	87	245
Accrued expenses	78	(348)
Net cash used in operating activities	(1,457)	(2,542)
Cash flows from investing activities:
Sale and maturities of short term marketable securities	(960)
Purchase of property and equipment	(14)
Proceeds from sale of building		1,050
Purchase of patent and trademark rights	(124)	(14)
Net cash provided by (used in) investing activities	(1,098)	1,036
Cash flows from financing activities:
Proceeds from lease financing obligation		4,080
Finance and debt issuance costs		(268)
Financing obligation payment payments	(84)	(19)
Payoff of mortgage note payable		(1,957)
Security deposits paid		(111)
Proceeds from sale of stock, net of issuance costs	4,734	2,326
Net cash provided by financing activities	4,650	4,051
Net increase in cash and cash equivalents	2,095	2,545
Cash and cash equivalents at beginning of period	299	1,412
Cash and cash equivalents at end of period	2,394	3,957
Supplemental disclosures of non-cash investing and financing cash flow information:
Unrealized gain on marketable securities		(12)
Stock issued to settle accounts payable		240
ROU assets obtained in exchanged for operating lease liabilities	$ 148

XML

Business and Basis of Presentation

3 Months Ended

Mar. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Business and Basis of Presentation

Note 1: Business and Basis of Presentation

Hemispherx Biopharma, Inc. and its subsidiaries (collectively, “Hemispherx”, “Company”, “we” or “us”) are an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Hemispherx’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3). A first-in-class drug also known as a new chemical entity, is a drug that contains an active moiety that has not been approved by the FDA or marketed in the US.

Hemispherx received approval of our NDA from ANMAT for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe CFS in 2016. The product will be marketed by GP Pharm, our commercial partner in Latin America. Commercialization in Argentina will require, among other things, GP Pharm to establish disease awareness, medical education, creation of an appropriate reimbursement level, design of marketing strategies and completion of manufacturing preparations for launch.

Hemispherx is 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 drug, Ampligen, and our approved drug, Alferon N Injection. Lastly, the Company plans to access the public equity markets to raise further capital.

In the opinion of Management, all adjustments necessary for a fair presentation of such consolidated financial statements have been included. Such adjustments consist of normal recurring items. Interim results are not necessarily indicative of results for a full year.

The interim consolidated financial statements and notes thereto are presented as permitted by the Securities and Exchange Commission (“SEC”), and do not contain certain information which will be included in the Company’s annual consolidated financial statements and notes thereto.

These consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements for the years ended December 31, 2018 and 2017, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on April 1, 2019.

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Net Loss Per Share

3 Months Ended

Mar. 31, 2019

Earnings Per Share [Abstract]

Net Loss Per Share

Note 2: Net Loss Per Share

Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Equivalent common shares, consisting of 71,858,564 and 11,105,515 of stock options and warrants are excluded from the calculation of diluted net loss per share for the three months ended March 31, 2019 and 2018, respectively, since their effect is antidilutive due to the net loss.

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Equity-Based Compensation

3 Months Ended

Mar. 31, 2019

Share-based Payment Arrangement [Abstract]

Equity-Based Compensation

Note 3: Equity-Based Compensation

The fair value of each option and equity warrant award is estimated on the date of grant using a Black-Scholes-Merton option pricing valuation model. Expected volatility is based on the historical volatility of the price of the Company’s stock. The risk-free interest rate is based on U.S. Treasury issues with a term equal to the expected life of the option and equity warrant. The Company uses historical data to estimate expected dividend yield, expected life and forfeiture rates. There were 1,727,756 and 1,336,505 options granted in the three months ended March 31, 2019 and 2018, respectively.

Stock option for employees’ activity during the three months ended March 31, 2019 is as follows:

Stock option activity for employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		5,110,589	$	0.75		9.01	$	—
Granted		1,213,070		0.22		—		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding March 31, 2019		6,323,659	$	0.65		8.99	$	—
Vested and expected to vest March 31, 2019		6,323,659	$	0.65		8.99	$	—
Exercisable March 31, 2019		2,518,172	$	0.82		7.48	$	—

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2019		3,305,659		$	0.32		9.31	$	—
Granted		1,213,070			0.22		—		—
Vested		(713,242	)		0.28		—		—
Unvested March 31, 2019		3,805,487		$	0.30		9.32	$	—

Stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual  Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		2,425,692		$	0.68		8.55	$	—
Granted		514,686			0.22		—		—
Forfeited		—			—		—		—
Expired		(1,666	)		8.64		—		—
Outstanding March 31, 2019		2,938,712		$	0.59		8.60	$	—
Vested and expected to vest March 31, 2019		2,938,712		$	0.59		8.60	$	—
Exercisable March 31, 2019		1,121,456		$	1.25		7.97	$	—

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic  Value
Unvested January 1, 2019		1,551,528		$	0.31		8.84	$	—
Granted		514,686			0.22				—
Vested		(248,958	)		0.31				—
Unvested March 31, 2019		1,817,256		$	0.28		8.86	$	—

Stock-based compensation expense was approximately $175,000 and $286,000 for the three months ended March 31, 2019 and 2018 resulting in an increase in general and administrative expenses, respectively.

As of March 31, 2019, and 2018, respectively, there was approximately $1,324,000 and $755,000 of unrecognized equity-based compensation cost related to options granted under the Equity Incentive Plan.

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Inventories

3 Months Ended

Mar. 31, 2019

Inventory Disclosure [Abstract]

Inventories

Note 4: Inventories

The Company uses the lower of first-in, first-out (“FIFO”) cost or net realizable value method of accounting for inventory.

Commercial sales of Alferon in the U.S. will not resume until new batches of commercial filled and finished product are produced and released by the Food and Drug Administration (“FDA”). While the facility is approved by the FDA under the Biologics License Application (“BLA”) for Alferon, this status will need to be reaffirmed by an FDA pre-approval inspection. The Company also will need the FDA’s approval to release commercial product once it has submitted satisfactory stability and quality release data. Currently, the manufacturing process is on hold and there is no definitive timetable to have the facility back online. The Company estimates it will need approximately $10,000,000 to commence the manufacturing process. Due to the Company extending the timeline of Alferon production to an excess of one year, the Company reclassified Alferon work in process inventory of $1,095,000 to other assets within our balance sheet as of December 31, 2018 and 2017 and due to the high cost estimates to bring the facility back online. The above estimated cost includes additional funds needed for the revalidation process in the Company’s facility to initiate commercial manufacturing, thereby readying itself for an FDA Pre-Approval Inspection. If the Company is unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon inventory, its operations most likely will be materially and/or adversely affected. In light of these contingencies, there can be no assurances that the approved Alferon N Injection product will be returned to production on a timely basis, if at all, or that if and when it is again made commercially available, it will return to prior sales levels.

The Alferon work in process is currently compliant with our internal protocols, is stored in a controlled state, and the Company regularly monitors the stability of the product. All of these factors contribute to the potential sale of the Alferon work in process, after validation lots have been produced and including a successful pre-approval inspection.

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Marketable Securities

3 Months Ended

Mar. 31, 2019

Marketable Securities [Abstract]

Marketable Securities

Note 5: Marketable Securities

Marketable securities consist of mutual funds. For the three months ended March 31, 2019 and December 31, 2018, it was determined that none of the marketable securities had other-than-temporary impairments. At March 31, 2019 and December 31, 2018, all securities were classified as available for sale investments and were measured as Level 1 instruments of the fair value measurements standard (see Note 12: Fair Value).

Securities classified as available for sale consisted of:

March 31, 2019

(in thousands)

Securities	Amortized Cost		Gross Unrealized  Gains		Gross  Unrealized Losses		Fair  Value		Short-Term  Investments
Mutual Funds	$	2,486	$	—	$	—	$	2,486	$	2,486
Totals	$	2,486	$	—	$	—	$	2,486	$	2,486

December 31, 2018

(in thousands)

Securities	Amortized  Cost		Gross  Unrealized  Gains		Gross  Unrealized  Losses			Fair  Value		Short-Term  Investments
Mutual Funds	$	1,529	$	—	$	(3	)	$	1,526	$	1,526
Totals	$	1,526	$	—	$	(3	)	$	1,526	$	1,526

Unrealized losses on investments

There were no investments with continuous unrealized losses for less than 12 months and 12 months or greater at March 31, 2019 and December 31, 2018.

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Accrued Expenses

3 Months Ended

Mar. 31, 2019

Payables and Accruals [Abstract]

Accrued Expenses

Note 6: Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	March 31, 2019		December 31, 2018
Compensation	$	642	$	613
Professional fees		59		83
Clinical trial expenses		7		7
Other expenses		374		302
	$	1,082	$	1,005

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Property and Equipment

3 Months Ended

Mar. 31, 2019

Property, Plant and Equipment [Abstract]

Property and Equipment

Note 7: Property and Equipment

	(in thousands)
	March 31, 2019			December 31, 2018
Land, buildings and improvements	$	10,547		$	10,547
Furniture, fixtures, and equipment		5,059			5,045
Total property and equipment		15,606			15,592
Less: accumulated depreciation		(8,004	)		(7,810	)
Property and equipment, net	$	7,602		$	7,782

Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets, ranging from three to thirty-nine years.

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years. The lease payments are initially $408,000 per year for two years through March 31, 2020 and will escalate in subsequent years. (See Note 13 – Financing Obligation Arising from Sale Leaseback Transaction for more details on the sale leaseback of the property and equipment).

In February 2018, the Company sold the building located adjacent to its manufacturing facility located at 5 Jules Lane, New Brunswick, New Jersey to an unaffiliated party. The purchase price was $1,050,000 and the Company netted $963,000 in cash.

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Stockholders' Equity

3 Months Ended

Mar. 31, 2019

Equity [Abstract]

Stockholders' Equity

Note 8: Stockholders’ Equity

(a) Preferred Stock

The Company is authorized to issue 5,000,000 shares of $0.01 par value preferred stock with such designations, rights and preferences as may be determined by the Board of Directors. Of our authorized preferred stock, 250,000 shares have been designated as Series A Junior Participating Preferred Stock and 8,000 shares have been designated as Series B Convertible Preferred Stock. The Series B Convertible Preferred Stock has a stated value $1,000 per share.

The Company is authorized to issue 8,000 Series B Convertible Preferred Stock, no par value, stated value $1,000 per share. As of March 31, 2019, the Company had 2,519 shares of Series B Convertible Preferred Stock outstanding. Each such Preferred Share is convertible into 5,000 shares of common stock.

Pursuant to a registration statement relating to a rights offering declared effective by the SEC on February 14, 2019, Hemispherx distributed to its holders of common stock and to holders of certain options and warrants as of February 14, 2019, at no charge, one non-transferable subscription right for each share of common stock held or deemed held on the record date. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series B Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into common stock at an assumed conversion price of $0.20) and 5,000 warrants with an assumed exercise price of $0.20. The warrants are exercisable for five years after the date of issuance. The net proceeds realized from the rights offering were approximately $4.7 million.

(b) Common Stock

The Company is authorized to issue 350,000,000 shares of $0.001 par value common stock with specific limitations and restrictions on the usage of 8,000,000 of the 350,000,000 authorized shares.

In August 2016, the Company effected a 12 to 1 reverse stock split of the outstanding shares, in order to become compliant with the NYSE regulations. This did not affect the number of authorized shares.

On September 6, 2016, we entered into a Securities Purchase Agreement (the “September Purchase Agreement”) with certain investors for the sale by us of 3,333,334 shares of our common stock registered under our S-3 shelf registration statement on at a purchase price of $1.50 per share. Concurrently with the sale of the common stock, pursuant to the September Purchase Agreement, we also sold unregistered warrants to purchase 2,500,000 shares of common stock for aggregate gross proceeds of $5,000,000. Subject to certain ownership limitations, the warrants are initially exercisable six-month after issuance at an exercise price equal to $2.00 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. Pursuant to an engagement agreement, we paid our placement agent an aggregate fee equal to 7% of the gross proceeds received by us from the sale of the securities in the offering and granted to our placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 166,667 unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the placement agent warrants will expire on September 1, 2021 and have an exercise price equal to $1.875 per share of common stock.

On February 1, 2017, we entered into Securities Purchase Agreements (each, a “February Purchase Agreement”) with certain investors for the sale by us of 1,818,185 shares of our common stock at a purchase price of $0.55 per share. Concurrently with the sale of the common stock, pursuant to the February Purchase Agreement, we also sold unregistered warrants to purchase 1,363,639 shares of common stock for aggregate gross proceeds of approximately $1,000,000. The warrants have an exercise price of $0.75 per share, are exercisable six months after issuance, and will expire five years from the initial exercise date. Pursuant to an engagement agreement, we paid our placement agent an aggregate fee equal to 7% of the gross proceeds received by us from the sale of the securities in the offering and granted to our placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 90,910 unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the placement agent warrants will expire on February 1, 2022 and have an exercise price equal to $0.6875 per share of common stock. The Company subsequently registered the shares issuable upon exercise of the warrants on Form S-1.

The Board of Directors approved up to $500,000 for all directors, officers and employees to buy Company shares from the Company at the market price. As of the last issuance dated November 5, 2018, the Company had issued all the authorized shares for this program (980,392 shares) at prices between $0.20 and $0.69 per share directly to executives and employees, for $373,852 in a series of private transactions pursuant to stock purchase agreements.

On June 1, 2017, the exercise price of Warrants issued in September 2016 was changed to $0.50. As a result, the warrant holders exercised these Warrants and purchased 2,370,000 shares of Company common stock. The Company realized net proceeds of $1,055,000 from this exercise. In conjunction with the foregoing, the Company also issued 2,370,000 series A warrants with an exercise price of $0.60 per share, an initial exercise date of December 1, 2017 and expiring March 6, 2022 (the “Series A Warrants”) and 7,584,000 series B warrants with exercise price of $0.60, an initial exercise date December 1, 2017 per share and expiring March 1, 2018. The foregoing transactions are hereinafter referred to as the “Exchange Transaction”. In addition, on July 10, 2017, the warrant holders exercised the remaining 130,000 warrants issued in September 2016 and purchased 130,000 shares of common stock. The Company realized net proceeds of $65,000 from this exercise. In conjunction with the foregoing the Company issued 130,000 Series A Warrants and 416,000 Series B Warrants (with an exercise price of $0.60 and an initial exercise date January 10, 2018 on the three-month anniversary of the of the initial exercise date).

Pursuant to an engagement agreement, the Company paid its placement agent an aggregate fee equal to 7% and 10.5%, respectively, of the gross proceeds received by the Company from the sale of the securities in the offerings and granted to its placement agent or its designees warrants to purchase up to 5% of the aggregate number of shares sold in the transactions amounting to 166,667 and 107,759, respectively, unregistered warrants. The placement agent warrants have substantially the same terms as the investor warrants, except that the 166,667 placement agent warrants issued in September 2017 will expire September 1, 2021 and have an exercise price equal to $1.875 per share of common stock and the 107,759 placement agent warrants issued in June 2017 will expire June 1, 2022 and have an exercise price of $0.625.

On August 23, 2017, the Holders of the Series A Warrants and Series B Warrants exchanged all of their Warrants for new warrants (respectively, the “Series A Exchange Warrants” and the “Series B Exchange Warrants” and, collectively, the “Exchange Warrants”) identical to the Warrants except as follows: The exercise price of both Exchange Warrants is $0.45 per share, subject to adjustment therein, and the number of Series B Exchange Warrants issued was proportionately reduced to an aggregate of 2,800,000 warrants so that all Exchange Warrants in the Exchange Transaction do not exceed 19.9% of the number of the Company’s issued and outstanding shares of Common Stock as of May 31, 2017, the date of the Exchange Transaction offer letters. The issuance of the Exchange Warrants by the Company and the shares of Common Stock issuable upon exercise of the Exchange Warrants is exempt from registration pursuant to Sections 3(a)(9) and 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The 2,800,000 warrants with an expiration date of March 1, 2018 and an exercise price on $0.45 were exercised in January and February 2018. The Company realized proceeds of $1,260,000 from these exercises.

On November 27, 2017, the Company reactivated equity distribution agreement with Maxim Group LLC (the “EDA”) pursuant to which it could sell shares of its common stock from time to time through Maxim, as sales agent. During the year ended December 31, 2018 and the three months ended March 31, 2019, the Company sold, respectively, an aggregate of 2,176,392 and 115,606 shares under the EDA for proceeds of $802,000 and $26,000 , respectively, net of $25,000 and $1,000, respectively, in commissions. Pursuant to a prospectus supplement dated February 7, 2018, the Company was able to sell up to 6,549,157 of its common stock (inclusive of shares already sold under the prospectus supplement) under the EDA. The actual number of shares, that the Company can sell, and the proceeds to be received there from are dependent upon the market price of its common stock.

As part of the cash conservation program adopted on August 28, 2017, starting with the month of September 2017, the directors agreed to defer 100% of their fees until cash is available. In consideration of this deferral, 226,023 options were issued to each of the two independent directors in February 2018 with an exercise price of $0.37; 152,053 options were issued to each of the two independent directors in May 2018 with an exercise price of $0.30, and 98,098 options were issued in July 2018 with an exercise price of $0.31. All of the foregoing options and the options discussed below are exercisable for a period of 10 years with a vesting period of three years. This program was suspended as of July 15, 2018 and all remaining deferred fees were paid in July 2018. This Program was reactivated as of August 16, 2018 with the understanding that options would not be issued on the deferred amounts until the 2018 Equity Incentive Plan was approved by the stockholders and the securities issuable thereunder were registered with the SEC. The 2018 Equity Incentive Plan was approved by the stockholders and the securities issuable thereunder were registered with the SEC and, on October 17, 2018, 172,786 options were issued to each of the two independent directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year. On January 28, 2019, an aggregate of 514,686 options were issued to each of the directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year for the deferral of fees and for chairing various committees, respectively.

Also as part of the cash conservation program adopted on August 28, 2017, starting with the month of September 2017, certain officers agreed to defer 40% of their salaries until cash is available. In consideration of this deferral, 884,459 options were issued to these officers in February 2018 with an exercise price of $0.37; 599,168 options were issued to these officers in May 2018 with an exercise price of $0.30, and 389,249 options were issued to these officers in July 2018 with an exercise price of $0.31. This program was suspended as of July 15, 2018 and all remaining deferred salaries were paid on July 2018. This Program was reactivated as of August 16, 2018 for 50% of their salaries with the understanding that options would not be issued on the deferred amounts until the 2018 Equity Incentive Plan was approved by the shareholders and the plan registered with the SEC. The 2018 Equity Incentive Plan has been approved by the shareholders and registered with the SEC and on October 17, 2018, 808,712 options were issued to these officers with an exercise price on $0.22 for a period of ten years with a vesting period of one year. On January 28, 2019, 1,213,069 options were issued to each of these officers with an exercise price of $0.22 for a period of ten years with a vesting period of one year.

Also as part of the cash conservation program adopted on August 28, 2017, all employees agreed to be paid 50% of their salaries in the form of unrestricted common stock of the Company. Starting with the month of September 2017, the salaries of all the employees of the Company were paid 50% in the form of unrestricted common stock of the Company. The total number of shares issued as of June 30, 2018 to the employees under this program was 2,116,881 shares at stock prices ranging from $0.31 to $0.55 per share. This program was suspended by the Board of Directors on June 30, 2018.

On March 24, 2018, the Company sold 1,250,000 shares of common stock under its S-3 shelf registration. The Company realized net proceeds of $475,000 from this stock offering and paid $25,000 in placement agent fees.

On April 20, 2018, the Company entered into Securities Purchase Agreements (the “Purchase Agreements”) with certain investors (the “Investors”) for the sale by the Company of an aggregate of 6,600,000 shares (the “Common Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a purchase price of $0.39 per share. Concurrently with the sale of the Common Shares, pursuant to the Purchase Agreements the Company also sold 6,600,000 warrants, 50% of which are Class A Warrants and 50% of which are Class B Warrants (collectively, the “Warrants”). The Company received gross proceeds from the sale of the Warrants solely to the extent such Warrants are exercised for cash. Both classes of Warrants will not be exercisable until six months after issuance and will have an exercise price of $0.39 per share, subject to adjustments as provided under the terms of the Warrants. The Class A Warrants and Class B Warrants will expire, respectively, two and five years after the date on which they are first exercisable. The closing of the sales of these securities under the Purchase Agreements took place on April 24, 2018. The Company received net proceeds from the transactions of $2,343,820 after deducting certain fees due to the placement agent and the Company’s transaction expenses.

The 2009 Equity Incentive Plan, effective June 24, 2009, as amended, authorizes the grant of non-qualified and incentive stock options, stock appreciation rights, restricted stock and other stock awards. A maximum of 22,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the 2009 Equity Incentive Plan. Unless sooner terminated, the 2009 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. During 2018, there were 4,675,221 options granted by the Company under this Plan.

The 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards. Initially, a maximum of 7,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan. Unless sooner terminated, the 2018 Equity Incentive Plan will continue in effect for a period of 10 years from its effective date. On October 17, 2018, the Board of Directors issued 1,154,284 options to the officers and directors at the exercise price of $0.22 expiring in 10 years, and on November 14, 2018, the Board of Directors issued 1,000 options to each employee, officer and director at the exercise price of $0.22 expiring in ten years. On January 28, 2019, 1,727,755 options were issued to the officers and directors with an exercise price of $0.22 for a period of ten years with a vesting period of one year.

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Cash and Cash Equivalents

3 Months Ended

Mar. 31, 2019

Cash and Cash Equivalents [Abstract]

Cash and Cash Equivalents

Note 9: Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.

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Recent Accounting Pronouncements

3 Months Ended

Mar. 31, 2019

Accounting Changes and Error Corrections [Abstract]

Recent Accounting Pronouncements

Note 10: Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction and industry-specific revenue recognition guidance under current U.S. Generally Accepted Accounting Standards (“U.S.GAAP”) and replace it with a principal-based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 is effective for reporting periods beginning after December 15, 2017, and early adoption is not permitted. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. As of March 31, 2019, we have not identified any accounting changes that would materially impact the amount of reported revenues with respect to our product revenues. The Company applied the Full Retrospective Application to implement the new Accounting Standards Codification (“ASC”) 606. The Company, based on the nature of its Ampligen sales under its cost recovery programs, determined that there were no material differences between the new accounting standard and legacy GAAP and that difficulties will not arise for any “open” contract issues with its customers during the transition period. The Company also determined that the adoption of this standard had little or no impact to the Company’s opening balance of retained earnings.

In January 2016, the FASB has issued Accounting Standards Update (ASU) No. 2016-01, Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new guidance is intended to improve the recognition and measurement of financial instruments. The new guidance is effective for public companies for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The new guidance permits early adoption of the own credit provision. The Company believes that the adoption of the guidance will have no material impact on the Company’s financial statement presentation or disclosures.

In August 2016, the FASB issued ASU 2016-15 - Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force). The new guidance is intended to address the diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows under Topic 230, Statement of Cash Flows, and other Topics. The guidance addresses eight specific cash flow issues with the objective of reducing the existing diversity in practice. The amendments apply to all entities, including both business entities and not-for-profit entities that are required to present a statement of cash flows under Topic 230. The amendments are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts the amendments in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes that interim period. An entity that elects early adoption must adopt all of the amendments in the same period. The amendments in this Update should be applied using a retrospective transition method to each period presented. The Company believes that the adoption of the guidance will not have a material impact on the Company’s financial statement presentation or disclosures.

In 2019, the FASB also issued Accounting Standards Updates (“ASU”) 2019-01 through 2018-03. These updates did not have a significant impact on the financial statements.

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Convertible Note Payable

3 Months Ended

Mar. 31, 2019

Debt Disclosure [Abstract]

Convertible Note Payable

Note 11: Convertible Note Payable

On September 28, 2018, the Company issued a Secured Convertible Promissory Note (the “Convertible Note”) to a Lender with an original principal amount of $3,170,000 that bears interest at a rate of 10% per annum and matures on September 28, 2019, unless earlier paid, redeemed or converted in accordance with its terms.

On March 13, 2019, the Company amended the Purchase Agreement pursuant to which it issued the Convertible Note (the “Amendment”). The Amendment extends the maturity of the Note to September 28, 2020. In addition, the redemption conversion rates were revised to a price to be determined by mutual agreement between the Company and the Holder. In the event that the Company and the Holder are unable to reach a mutually agreeable price, the Company will be required to pay the applicable redemption amount in cash. The maximum amount of the Convertible Note the Lender will be able to redeem in any given calendar month is $300,000.

The Company evaluated the Amendment in accordance with ASC 470, Debt (“ASC 470”) and determined the Amendment is considered an extinguishment of the existing debt and issuance of net debt. As a result, the Company derecognized the liability and recorded a loss on the extinguishment of debt of $272,812 which was equal to the difference between the reacquisition price of the debt and the net carrying amount (amount due at maturity, adjusted for unamortized discounts) of the extinguished debt. Subsequently, the amended note was recorded in accordance with ASC 480 at the fair value that the note was issued with changes in fair value recorded through earnings at each reporting period.

Interest expense associated with the amended note was $4,280 for the three months ended March 31, 2019, which included $2,543 associated with the amortization of applicable discounts.

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Fair Value

3 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

Fair Value

Note 12: Fair Value

The Company is required under U.S. GAAP to disclose information about the fair value of all the Company’s financial instruments, whether or not these instruments are measured at fair value on the Company’s consolidated balance sheets.

The Company estimates that the fair values of cash and cash equivalents, other assets, accounts payable and accrued expenses approximate their carrying values due to the short-term maturities of these items. The Company also has certain warrants with a cash settlement feature in the unlikely occurrence of a Fundamental Transaction, namely (1) a merger or consolidation with another person; (2) sale of substantially all of its assets; (3) holders of common stock sell 50% or more of outstanding shares; (4) the Company effects an exchange of all its securities for other securities, cash or property, and (5) the Company effects a stock purchase agreement or business combination for more than 50% of outstanding shares. The fair value of the redeemable warrants (“Warrants”) related to the Company’s August 2016, February 2017, June 2017, August 2017, April 2018 and March 2019 common stock warrant issuance, are calculated using a Monte Carlo Simulation. While the Monte Carlo Simulation is one of a number of possible pricing models, the Company has determined it to be industry accepted and fairly presented the fair value of the Warrants. As an additional factor to determine the fair value of the Put’s liability, the occurrence probability of a Fundamental Transaction event was factored into the valuation.

The Company recomputes the fair value of the Warrants at the issuance date and the end of each quarterly reporting period. Such value computation includes subjective input assumptions that are consistently applied each period. If the Company were to alter its assumptions or the numbers input based on such assumptions, the resulting fair value could be materially different.

The Company utilized the following assumptions to estimate the fair value of the August 2016 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	1.88		$	1.88
Risk-free interest rate		2.24	%		2.47	%
Expected holding period		2.42			2.67
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.69-0.75		$	0.69-$0.75
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.34-3.35			3.59-3.60
Expected volatility		75	%		75	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.63		$	0.63
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.17			3.42
Expected volatility		75	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the August 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.45		$	0.45
Risk-free interest rate		2.21	%		2.46	%
Expected holding period		2.93			3.18
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.39		$	0.39
Risk-free interest rate		2.23%-2.33	%		2.51	%
Expected holding period		1.57-4.57			1.82-4.82
Expected volatility		65%-70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:

	March 31, 2019			March 8, 2019
Underlying price per share	$	0.16		$	0.15
Exercise price per share	$	0.20		$	0.20
Risk-free interest rate		2.23	%		2.42	%
Expected holding period		4.94			5.00
Expected volatility		65	%		65	%
Expected dividend yield		-			-

The significant assumptions using the Monte Carlo Simulation approach for valuation of the Warrants are:

(i)	Risk-Free Interest Rate. The risk-free interest rates for the Warrants are based on U.S. Treasury constant maturities for periods commensurate with the remaining expected holding periods of the warrants.
(ii)	Expected Holding Period. The expected holding period represents the period of time that the Warrants are expected to be outstanding until they are exercised. The Company utilizes the remaining contractual term of the Warrants at each valuation date as the expected holding period.
(iii)	Expected Volatility. Expected stock volatility is based on daily observations of the Company’s historical stock values for a period commensurate with the remaining expected holding period on the last day of the period for which the computation is made.
(iv)	Expected Dividend Yield. Expected dividend yield is based on the Company’s anticipated dividend payments over the remaining expected holding period. As the Company has never issued dividends, the expected dividend yield is $0.00 and this assumption will be continued in future calculations unless the Company changes its dividend policy.
(v)	Expected Probability of a Fundamental Transaction. The possibility of the occurrence of a Fundamental Transaction triggering a Put right is extremely remote. As discussed above, a Put right would only arise if a Fundamental Transaction (1) is an all cash transaction; (2) results in the Company going private; or (3) is a transaction involving a person or entity not traded on a national securities exchange. The Company believes such an occurrence is highly unlikely because:

a.	The Company only has one product that is FDA approved but which will not be available for commercial sales for 18 months at the earliest;
b.	The Company flagship product is approved only in Argentina for Severely Debilitated CFS patients;
c.	The Company may have to perform additional clinical trials for FDA approval of its flagship product;
d.	Industry and global market conditions continue to include uncertainty, adding risk to any transaction;
e.	Available capital for a potential buyer in a cash transaction continues to be limited;
f.	The nature of a life science company is heavily dependent on future funding and high costs, including research & development;
g.	The Company has minimal revenues streams which are insufficient to meet the funding needs for the cost of operations or construction at their manufacturing facility; and
h.	The Company’s Rights Agreement and Executive Agreements make it less attractive to a potential buyer.

With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

The Monte Carlo Simulation has incorporated a 5.0% probability of a Fundamental Transaction to date for the life of the securities.

(vi)	Expected Timing of Announcement of a Fundamental Transaction. As the Company has no specific expectation of a Fundamental Transaction, for reasons stated above, the Company used a discrete uniform probability distribution over the Expected Holding Period to model the potential announcement of a Fundamental Transaction occurring during the Expected Holding Period.
(vii)	Expected 100 Day Volatility at Announcement of a Fundamental Transaction. An estimate of future volatility is necessary as there is no mechanism for directly measuring future stock price movements. Daily observations of the Company’s historical stock values for the 100 days immediately prior to the Warrants’ grant dates, with a floor of 100%, were utilized as a proxy for the future volatility.
(viii)	Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction. The Company utilized a risk-free interest rate corresponding to the forward U.S. Treasury rate for the period equal to the time between the date forecast for the public announcement of a Fundamental Transaction and the Warrant expiration date for each simulation.
(ix)	Expected Time Between Announcement and Consummation of a Fundamental Transaction. The expected time between the announcement and the consummation of a Fundamental Transaction is based on the Company’s experience with the due diligence process performed by acquirers, and is estimated to be six months. The Monte Carlo Simulation approach incorporates this additional period to reflect the delay Warrant Holders would experience in receiving the proceeds of the Put.

While the assumptions remain consistent from period to period (e.g., using historical stock prices), the numbers input change from period to period (e.g., the actual historical prices input for the relevant period).

The Company applies FASB ASC 820 that defines fair value, establishes a framework for measuring fair value in U.S. GAAP, and expands disclosures about fair value measurements. The guidance does not impose any new requirements around which assets and liabilities are to be measured at fair value, and instead applies to asset and liability balances required or permitted to be measured at fair value under existing accounting pronouncements. The Company measures its warrant liability for those warrants with a cash settlement feature at fair value.

FASB ASC 820-10-35-37 establishes a valuation hierarchy based on the transparency of inputs used in the valuation of an asset or liability. Classification is based on the lowest level of inputs that is significant to the fair value measurement. The valuation hierarchy contains three levels:

● Level 1 – Quoted prices are available in active markets for identical assets or liabilities at the reporting date. Generally, this includes debt and equity securities that are traded in an active market.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Generally, this includes debt and equity securities that are not traded in an active market.

● Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include financial instruments whose value is determined using pricing models, discounted cash flow methodologies, or other valuation techniques, as well as instruments for which the determination of fair value requires significant management judgment or estimation. As of March 31, 2019, the Company has classified the warrants with cash settlement features and convertible debt as Level 3. Management evaluates a variety of inputs and then estimates fair value based on those inputs. As discussed above, the Company utilized the Monte Carlo Simulation Model in valuing these warrants.

The table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy as:

	(in thousands) As of March 31, 2019
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	2,486	$	2,486	$	-	$	-
Liabilities:
Redeemable warrants	$	3,895	$	-	$	-	$	3,895
Convertible note payable	$	3,682	$	-	$	-	$	3,682

	(in thousands) As of December 31, 2018
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	1,526	$	1,526	$	-	$	-
Liabilities:
Redeemable warrants	$	1,061	$	-	$	-	$	1,061
Convertible note payable	$	3,408	$	-	$	-	$	3,408

The changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):

Redeemable warrants:

Balance at December 31, 2018	$	1,061
Warrants exercised and cancelled		(1	)
Warrants issued		2,790
Fair value adjustments		45
Balance at March 31, 2019	$	3,895

Convertible debt:

Balance at December 31, 2018	$	3,408
Deferred debt discount written off due to refinancing		344
Pay off of old note payable		(3,722	)
Amount of new note payable		3,742
Fair value adjustments		(90	)
Balance at March 31, 2019	$	3,682

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Financing Obligation Arising from Sale Leaseback Transaction

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Financing Obligation Arising from Sale Leaseback Transaction

Note 13: Financing Obligation Arising from Sale Leaseback Transaction

On March 16, 2018, the Company sold land and a building for $4,080,000 and concurrently entered into an agreement to lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments will increase 2.5% per year for the next three years through March 31, 2023 and the lease payments will increase 3% for the remaining five years through March 31, 2028. The sale of the property includes an option to repurchase the property at fair value which does not permanently transfer all the risks and rewards of ownership to the buyer. The option to repurchase the property also would be at a higher price than the sales price and is considered likely based upon the Company’s plans going forward. Because the sale of the property includes the option to repurchase the property and includes the above attributes, the transaction was accounted for as a financing transaction whereby the Company debited cash for the amount of cash received and credit financing obligation. The Company will continue to report the property as an asset and the property will continue to be depreciated. The fair value repurchase option is accounted for similar to a share appreciation mortgage. Accordingly, the guidance in ASC 470-30 related to participating mortgage loans would be applied to the liability. If the option expires unused, the sale is recognized at that time. The gain on the sale would be the excess of the liability (current fair value of the property) over its carrying amount. If the option is exercised, the cash payment by the seller-lessee is to pay off the financing obligation. As part of the sale of this building, warrants were provided to the buyer for the purchase of up to 3,225,806 shares of Company common stock for a period of five years at an exercise price of $0.3875 per share, 125% of the closing price of the common stock on the NYSE American on the date of execution of the letter of intent for the purchase. The warrants cannot be exercised to the extent that any exercise would result in the purchaser owning in excess of 4.99% of our issued and outstanding shares of common stock.

The Property and Equipment in Note 7 above are the property and equipment involved in this transaction. Depreciation on the building will continue until a sale has been recognized.

Future minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of March 31, 2019 are as follows:

During the year:

		(in thousands)
2019		306
2020		417
2021		427
2022		438
2023		450
Thereafter		2,025
Total of payments		4,063
Less deferred issuance costs		(239	)
Less discount on debt instrument		(1,025	)
Less imputed interest		(331	)
Total balance		2,468
Less current portion		201
Long term portion	$	2,267

Interest expense relating to this financing agreement was $18,000 for the three months ended March 31, 2019.

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Leases

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Leases

Note 14: Leases

In February 2016, the FASB established Topic 842, Leases, by issuing Accounting Standards Update (ASU) No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; ASU No. 2018-11, Targeted Improvements; and ASU No. 2018-20, Narrow-Scope Improvements for Lessors. The new standard establishes a right-of-use model (ROU) that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement.

The new standard was effective for the Company on January 1, 2019, with early adoption permitted. The Company adopted the new standard on its effective date. A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application. An entity may choose to use either (1) its effective date or (2) the beginning of the earliest comparative period presented in the financial statements as its date of initial application. If an entity chooses the second option, the transition requirements for existing leases also apply to leases entered into between the date of initial application and the effective date. The entity must also recast its comparative period financial statements and provide the disclosures required by the new standard for the comparative periods. The Company adopted the new standard on January 1, 2019 and used the effective date as our date of initial application. Consequently, financial information will not be updated, and the disclosures required under the new standard will not be provided for dates and periods before January 1, 2019.

The new standard provides several optional practical expedients in transition. The Company elected the ‘package of practical expedients’, which permits the Company not to reassess under the new standard our prior conclusions about lease identification, lease classification and initial direct costs. The Company elected all the new standard’s available transition practical expedients other than the use-of hindsight.

The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, The Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. The Company also currently elected the practical expedient to not separate lease and non-lease components for leases of office equipment.

On adoption, the Company recognized additional operating liabilities of approximately $148,000 with corresponding ROU assets of the same amount, based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases.

As of March 31, 2019, the balance of the right of use assets was $137,000 and the corresponding lease liability balance was $140,000. Total rent expense was $27,000 for the three months ended March 31, 2019.

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Subsequent Events

3 Months Ended

Mar. 31, 2019

Subsequent Events [Abstract]

Subsequent Events

Note 15: Subsequent Events

As of March 31, 2019, our stockholders’ equity was below $6 million, the minimum required for continued listing on the NYSE American. However, subsequent to March 31, 2019 and as of the date of filing of the Form 10-Q in which these financials have been included, the Company’s stockholders’ equity is above $6 million as a result of the following: (1) there were a series of debt conversions which partially converted $1,800,000 of the $3,170,000 convertible debt, as amended, in to stockholders’ equity, adding approximately $1,800,000 to shareholders’ equity; (2) on May 2, 2019, the Company entered into an agreement with the holders of 4,550,000 warrants (classified as debt) pursuant to which the warrant exercise price was reduced to $0.15 and all of the warrants were exercised, reducing the liability attributed to the warrants by approximately $404,000, and the Company realized about $682,000 in net proceeds, resulting in an addition to stockholders’ equity of approximately $1,086,000; and (3) on and after May 8, 2019, approximately 14 million of the warrants (also classified as debt) issued in the Company’s rights offering were exercised on a cashless basis for 70% of the number of shares issuable upon such exercise, resulting in approximately $1,500,000 added to stockholders’ equity.

The Company evaluated subsequent events through the date on which these financial statements were issued and determined that no subsequent event, other than the above, constituted a matter that required adjustment to the financial statements for the three months ended March 31, 2019.

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Equity-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2019

Employee [Member]

Schedule of Stock Option Activity

Stock option activity for employees:

	Number of Options		Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		5,110,589	$	0.75		9.01	$	—
Granted		1,213,070		0.22		—		—
Forfeited		—		—		—		—
Expired		—		—		—		—
Outstanding March 31, 2019		6,323,659	$	0.65		8.99	$	—
Vested and expected to vest March 31, 2019		6,323,659	$	0.65		8.99	$	—
Exercisable March 31, 2019		2,518,172	$	0.82		7.48	$	—

Schedule of Unvested Stock Option Activity

Unvested stock option activity for employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value
Unvested January 1, 2019		3,305,659		$	0.32		9.31	$	—
Granted		1,213,070			0.22		—		—
Vested		(713,242	)		0.28		—		—
Unvested March 31, 2019		3,805,487		$	0.30		9.32	$	—

Non-Employees [Member]

Schedule of Stock Option Activity

Stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual  Term (Years)		Aggregate Intrinsic Value
Outstanding January 1, 2019		2,425,692		$	0.68		8.55	$	—
Granted		514,686			0.22		—		—
Forfeited		—			—		—		—
Expired		(1,666	)		8.64		—		—
Outstanding March 31, 2019		2,938,712		$	0.59		8.60	$	—
Vested and expected to vest March 31, 2019		2,938,712		$	0.59		8.60	$	—
Exercisable March 31, 2019		1,121,456		$	1.25		7.97	$	—

Schedule of Unvested Stock Option Activity

Unvested stock option activity for non-employees:

	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic  Value
Unvested January 1, 2019		1,551,528		$	0.31		8.84	$	—
Granted		514,686			0.22				—
Vested		(248,958	)		0.31				—
Unvested March 31, 2019		1,817,256		$	0.28		8.86	$	—

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Marketable Securities (Tables)

3 Months Ended

Mar. 31, 2019

Marketable Securities [Abstract]

Schedule of Available for Sale

Securities classified as available for sale consisted of:

March 31, 2019

(in thousands)

Securities	Amortized Cost		Gross Unrealized  Gains		Gross  Unrealized Losses		Fair  Value		Short-Term  Investments
Mutual Funds	$	2,486	$	—	$	—	$	2,486	$	2,486
Totals	$	2,486	$	—	$	—	$	2,486	$	2,486

December 31, 2018

(in thousands)

Securities	Amortized  Cost		Gross  Unrealized  Gains		Gross  Unrealized  Losses			Fair  Value		Short-Term  Investments
Mutual Funds	$	1,529	$	—	$	(3	)	$	1,526	$	1,526
Totals	$	1,526	$	—	$	(3	)	$	1,526	$	1,526

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Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2019

Payables and Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses consist of the following:

	(in thousands)
	March 31, 2019		December 31, 2018
Compensation	$	642	$	613
Professional fees		59		83
Clinical trial expenses		7		7
Other expenses		374		302
	$	1,082	$	1,005

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Property and Equipment (Tables)

3 Months Ended

Mar. 31, 2019

Property, Plant and Equipment [Abstract]

Schedule of Property and Equipment

	(in thousands)
	March 31, 2019			December 31, 2018
Land, buildings and improvements	$	10,547		$	10,547
Furniture, fixtures, and equipment		5,059			5,045
Total property and equipment		15,606			15,592
Less: accumulated depreciation		(8,004	)		(7,810	)
Property and equipment, net	$	7,602		$	7,782

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Fair Value (Tables)

3 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

Schedule of Assumptions to Estimate Fair Value of Warrants

The Company utilized the following assumptions to estimate the fair value of the August 2016 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	1.88		$	1.88
Risk-free interest rate		2.24	%		2.47	%
Expected holding period		2.42			2.67
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the February 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.69-0.75		$	0.69-$0.75
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.34-3.35			3.59-3.60
Expected volatility		75	%		75	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the June 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.63		$	0.63
Risk-free interest rate		2.21	%		2.47	%
Expected holding period		3.17			3.42
Expected volatility		75	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the August 2017 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.45		$	0.45
Risk-free interest rate		2.21	%		2.46	%
Expected holding period		2.93			3.18
Expected volatility		70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the April 2018 Warrants:

	March 31, 2019			December 31, 2018
Underlying price per share	$	0.16		$	0.18
Exercise price per share	$	0.39		$	0.39
Risk-free interest rate		2.23%-2.33	%		2.51	%
Expected holding period		1.57-4.57			1.82-4.82
Expected volatility		65%-70	%		70	%
Expected dividend yield		-			-

The Company utilized the following assumptions to estimate the fair value of the March 2019 Warrants:

	March 31, 2019			March 8, 2019
Underlying price per share	$	0.16		$	0.15
Exercise price per share	$	0.20		$	0.20
Risk-free interest rate		2.23	%		2.42	%
Expected holding period		4.94			5.00
Expected volatility		65	%		65	%
Expected dividend yield		-			-

Schedule of Range of Probabilities

With the above factors utilized in analysis of the likelihood of the Put’s potential Liability, the Company estimated the range of probabilities related to a Put right being triggered as:

Range of Probability	Probability
Low		0.5	%
Medium		1.0	%
High		5.0	%

Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis

The table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy as:

	(in thousands) As of March 31, 2019
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	2,486	$	2,486	$	-	$	-
Liabilities:
Redeemable warrants	$	3,895	$	-	$	-	$	3,895
Convertible note payable	$	3,682	$	-	$	-	$	3,682

	(in thousands) As of December 31, 2018
	Total		Level 1		Level 2		Level 3
Assets:
Marketable securities	$	1,526	$	1,526	$	-	$	-
Liabilities:
Redeemable warrants	$	1,061	$	-	$	-	$	1,061
Convertible note payable	$	3,408	$	-	$	-	$	3,408

Schedule of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis

The changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows (in thousands):

Redeemable warrants:

Balance at December 31, 2018	$	1,061
Warrants exercised and cancelled		(1	)
Warrants issued		2,790
Fair value adjustments		45
Balance at March 31, 2019	$	3,895

Convertible debt:

Balance at December 31, 2018	$	3,408
Deferred debt discount written off due to refinancing		344
Pay off of old note payable		(3,722	)
Amount of new note payable		3,742
Fair value adjustments		(90	)
Balance at March 31, 2019	$	3,682

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Financing Obligation Arising from Sale Leaseback Transaction (Tables)

3 Months Ended

Mar. 31, 2019

Leases [Abstract]

Schedule of Future Minimum Payments Under Financing Obligation

Future minimum payments required under the Financing Obligation and the balance of the Finance Obligation as of March 31, 2019 are as follows:

During the year:

		(in thousands)
2019		306
2020		417
2021		427
2022		438
2023		450
Thereafter		2,025
Total of payments		4,063
Less deferred issuance costs		(239	)
Less discount on debt instrument		(1,025	)
Less imputed interest		(331	)
Total balance		2,468
Less current portion		201
Long term portion	$	2,267

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Net Loss Per Share (Details Narrative) - shares	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Earnings Per Share [Abstract]
Equivalent common shares, consisting of stock options and warrants	71,858,564	11,105,515

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Equity-Based Compensation (Details Narrative) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended
	Jul. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Share-based Payment Arrangement [Abstract]
Number of options granted	98,098	1,727,756	1,336,505
Stock-based compensation expense		$ 175	$ 286
Unrecognized equity-based compensation cost		$ 1,324	$ 755

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Equity-Based Compensation - Schedule of Stock Option Activity (Details) - USD ($)	1 Months Ended	3 Months Ended
	Jul. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Number of options, granted	98,098	1,727,756	1,336,505
Weighted average exercise price, granted	$ 0.31
Employees [Member]
Number of options outstanding, beginning of period		5,110,589
Number of options, granted		1,213,070
Number of options, forfeited
Number of options, expired
Number of options outstanding, end of period		6,323,659
Number of options, vested and expected to vest		6,323,659
Number of options exercisable, end of period		2,518,172
Weighted average exercise price outstanding, beginning of period		$ 0.75
Weighted average exercise price, granted		0.22
Weighted average exercise price, forfeited
Weighted average exercise price, expired
Weighted average exercise price outstanding, end of period		0.65
Weighted average exercise price, vested and expected to vest		0.65
Weighted average exercise price outstanding, end of period		$ 0.82
Weighted average remaining contracted term (years) outstanding, beginning of period		9 years 4 days
Weighted average remaining contracted term (years), granted		0 years
Weighted average remaining contracted term (years), forfeited		0 years
Weighted average remaining contracted term (years), expired		0 years
Weighted average remaining contracted term (years) outstanding, end of period		8 years 11 months 26 days
Weighted average remaining contracted term (years), vested and expected to vest		8 years 11 months 26 days
Weighted average remaining contracted term (years), exercisable at end of period		7 years 5 months 23 days
Aggregate intrinsic value outstanding, beginning of period
Aggregate intrinsic value, granted
Aggregate intrinsic value, forfeited
Aggregate intrinsic value, expired
Aggregate intrinsic value outstanding, end of period
Aggregate intrinsic value, vested and expected to vest
Aggregate intrinsic value, exercisable at end of period
Non-Employees [Member]
Number of options outstanding, beginning of period		2,425,692
Number of options, granted		514,686
Number of options, forfeited
Number of options, expired		(1,666)
Number of options outstanding, end of period		2,938,712
Number of options, vested and expected to vest		2,938,712
Number of options exercisable, end of period		1,121,456
Weighted average exercise price outstanding, beginning of period		$ 0.68
Weighted average exercise price, granted		0.22
Weighted average exercise price, forfeited
Weighted average exercise price, expired		8.64
Weighted average exercise price outstanding, end of period		0.59
Weighted average exercise price, vested and expected to vest		0.59
Weighted average exercise price outstanding, end of period		$ 1.25
Weighted average remaining contracted term (years) outstanding, beginning of period		8 years 6 months 18 days
Weighted average remaining contracted term (years), granted		0 years
Weighted average remaining contracted term (years), forfeited		0 years
Weighted average remaining contracted term (years), expired		0 years
Weighted average remaining contracted term (years) outstanding, end of period		8 years 7 months 6 days
Weighted average remaining contracted term (years), vested and expected to vest		8 years 7 months 6 days
Weighted average remaining contracted term (years), exercisable at end of period		7 years 11 months 19 days
Aggregate intrinsic value outstanding, beginning of period
Aggregate intrinsic value, granted
Aggregate intrinsic value, forfeited
Aggregate intrinsic value, expired
Aggregate intrinsic value outstanding, end of period
Aggregate intrinsic value, vested and expected to vest
Aggregate intrinsic value, exercisable at end of period

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Equity-Based Compensation - Schedule of Unvested Stock Option Activity (Details) - USD ($)	1 Months Ended	3 Months Ended
	Jul. 31, 2018	Mar. 31, 2019	Mar. 31, 2018
Number of options, granted	98,098	1,727,756	1,336,505
Employees [Member]
Number of options unvested, beginning of period		3,305,659
Number of options, granted		1,213,070
Number of options, vested		(713,242)
Number of options unvested, end of period		3,805,487
Weighted average exercise price unvested, beginning of period		$ 0.32
Weighted average exercise price, granted		0.22
Weighted average exercise price, vested		0.28
Weighted average exercise price unvested, end of period		$ 0.30
Average remaining contractual term (years) unvested, beginning of period		9 years 3 months 22 days
Average remaining contractual term (years), granted		0 years
Average remaining contractual term (years), vested		0 years
Average remaining contractual term (years) unvested, end of period		9 years 3 months 26 days
Aggregate intrinsic value unvested, beginning of period
Aggregate intrinsic value, granted
Aggregate intrinsic value, vested
Aggregate intrinsic value unvested, end of period
Non-Employees [Member]
Number of options unvested, beginning of period		1,551,528
Number of options, granted		514,686
Number of options, vested		(248,958)
Number of options unvested, end of period		1,817,256
Weighted average exercise price unvested, beginning of period		$ 0.31
Weighted average exercise price, granted		0.22
Weighted average exercise price, vested		0.31
Weighted average exercise price unvested, end of period		$ 0.28
Average remaining contractual term (years) unvested, beginning of period		8 years 10 months 3 days
Average remaining contractual term (years), granted		0 years
Average remaining contractual term (years), vested		0 years
Average remaining contractual term (years) unvested, end of period		8 years 10 months 10 days
Aggregate intrinsic value unvested, beginning of period
Aggregate intrinsic value, granted
Aggregate intrinsic value, vested
Aggregate intrinsic value unvested, end of period

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Inventories (Details Narrative) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Dec. 31, 2018	Dec. 31, 2017
Inventory Disclosure [Abstract]
Amount required to commence manufacturing process	$ 10,000
Work-in-process inventory		$ 1,095	$ 1,095

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Marketable Securities (Details Narrative) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
Marketable Securities [Abstract]
Unrealized losses on investments

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Marketable Securities - Schedule of Available for Sale (Details) - USD ($) $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
Amortized Cost	$ 2,486	$ 1,526
Gross Unrealized Gains
Gross Unrealized Losses		(3)
Fair Value	2,486	1,526
Short-Term Investments	2,486	1,526
Mutual Funds [Member]
Amortized Cost	2,486	1,529
Gross Unrealized Gains
Gross Unrealized Losses		(3)
Fair Value	2,486	1,526
Short-Term Investments	$ 2,486	$ 1,526

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Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Compensation	$ 642	$ 613
Professional fees	59	83
Clinical trial expenses	7	7
Other expenses	374	302
Accrued expenses	$ 1,082	$ 1,005

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Property and Equipment (Details Narrative) - USD ($) $ in Thousands		1 Months Ended	3 Months Ended
	Mar. 16, 2018	Feb. 28, 2018	Mar. 31, 2019
Property, Plant and Equipment [Abstract]
Proceeds from sale of property	$ 4,080	$ 1,050
Lease description	Concurrently entered into an agreement to lease the property back for ten years. The lease payments are initially $408,000 per year for two years through March 31, 2020 and will escalate in subsequent years.
Lease of rent expenses	$ 408		$ 27
Sale of property amount netted		$ 963

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Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Total property and equipment	$ 15,606	$ 15,592
Less: accumulated depreciation	(8,004)	(7,810)
Property and equipment, net	7,602	7,782
Land, Buildings and Improvements [Member]
Total property and equipment	10,547	10,547
Furniture, Fixtures and Equipment [Member]
Total property and equipment	$ 5,059	$ 5,045

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Stockholders' Equity (Details Narrative) - USD ($)																	1 Months Ended							3 Months Ended		12 Months Ended
	Jan. 28, 2019	Nov. 14, 2018	Nov. 05, 2018	Oct. 17, 2018	Oct. 17, 2018	Aug. 16, 2018	Jun. 30, 2018	Mar. 24, 2018	Feb. 07, 2018	Sep. 30, 2017	Aug. 28, 2017	Aug. 23, 2017	Jul. 10, 2017	Jun. 02, 2017	Feb. 01, 2017	Sep. 06, 2016	Jul. 31, 2018	May 31, 2018	Apr. 20, 2018	Feb. 28, 2018	Sep. 30, 2017	Jun. 30, 2017	Aug. 31, 2016	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018	Sep. 12, 2018	Mar. 16, 2018
Preferred stock, shares authorized																								5,000,000		5,000,000
Preferred stock par/face value																								$ 0.01		$ 0.01
Subsription/exercise price																												$ 0.3875
Preferred stock value
Proceeds from issuance of rights																								$ 4,734,000	$ 2,326,000
Common stock, shares authorized																								350,000,000		350,000,000
Common stock, par value																								$ 0.001		$ 0.001
Common stock, restrictions usage																								8,000,000		8,000,000
Reverse stock split description																							12 to 1 reverse stock split on the outstanding shares
Number of warrant to purchase shares of common stock													130,000
Proceeds from sale of common stock, net of issuance costs								$ 475,000					$ 65,000
Number of shares issued in transaction, value								1,250,000
Common stock shares issued, value																								$ 2,214,000	$ 2,326,000
Commissions paid								$ 25,000
Option exercise price per share																	$ 0.31
Options holding period																	10 years
Option vested years																	3 years
Number of options, granted																	98,098							1,727,756	1,336,505
Number of warrants sold																												3,225,806
2009 Equity Incentive Plan [Member]
Number of options, granted																										4,675,221
2018 Equity Incentive Plan [Member]
Number of common stock reserved for potential issuance																											7,000,000
Executive and Employees [Member]
Number of shares issued upon transaction			980,392
Common stock shares issued, value			$ 373,852
Independent Director One [Member]
Percentage of fees paid																				100.00%
Option exercise price per share	$ 0.22			$ 0.22														$ 0.30		$ 0.37
Options holding period	10 years			10 years
Option vested years	1 year			1 year
Number of options, granted	514,686			172,786														152,053		226,023
Independent Director Two [Member]
Percentage of fees paid																				100.00%
Option exercise price per share	$ 0.22			$ 0.22														$ 0.30		$ 0.37
Options holding period	10 years			10 years
Option vested years	1 year			1 year
Number of options, granted				172,786														152,053		226,023
Officers [Member]
Option exercise price per share	$ 0.22			$ 0.22													$ 0.31	$ 0.30		$ 0.37
Options holding period	10 years			10 years
Option vested years	1 year			1 year
Percentage of salary paid										40.00%
Number of options, granted	1,213,069			808,712													389,249	599,168		884,459
Employees [Member]
Number of shares issued upon transaction							2,116,881
Percentage of salary paid						50.00%					50.00%										50.00%
Officers and Directors [Member]
Option exercise price per share	$ 0.22				$ 0.22
Options holding period	10 years				10 years
Option vested years	1 year
Number of options, granted	1,727,755				1,154,284
Employee, Officers and Directors [Member]
Option exercise price per share		$ 0.22
Options holding period		10 years
Number of options, granted		1,000
Maximum [Member]
Maximum exchange warrants percentage												19.90%
Maximum [Member] | Executive and Employees [Member]
Shares issued price per share			$ 0.69
Maximum [Member] | Employees [Member]
Shares issued price per share							$ 0.55
Minimum [Member] | Executive and Employees [Member]
Shares issued price per share			$ 0.20
Minimum [Member] | Employees [Member]
Shares issued price per share							$ 0.31
Series A and B Exchange Warrant [Member]
Subsription/exercise price												$ 0.45
Directors, Officers and Employees [Member] | Maximum [Member]
Payments approved for company shares, value																								$ 500,000
Securities Purchase Agreement [Member] | Investors [Member]
Subsription/exercise price															$ 0.75	$ 2.00
Number of shares issued upon transaction															1,818,185	3,333,334
Shares issued price per share															$ 0.55	$ 1.50
Percentage of fees paid															7.00%	7.00%
Number of shares issued in transaction																			6,600,000
Securities Purchase Agreement [Member] | Investors [Member] | Warrant [Member]
Subsription/exercise price														$ 0.50	$ 0.6875	$ 1.875			$ 0.39
Warrants exercisable term																5 years
Number of warrant to purchase shares of common stock														2,370,000	1,363,639	2,500,000
Proceeds from sale of common stock, net of issuance costs															$ 1,000,000	$ 5,000,000
Warrant initially exercisable term															6 months	6 months
Warrant exercisable term															5 years
Warrants to purchase shares, percentage															5.00%	5.00%
Number of shares issued in transaction															90,910	166,667
Warrant expiry date															Feb. 01, 2022	Sep. 01, 2021
Proceeds from warrants exercised														$ 1,055,000
Number of warrants sold																			6,600,000
Warrant description																			Company also sold 6,600,000 warrants, 50% of which are Class A Warrants and 50% of which are Class B Warrants (collectively, the "Warrants").
Proceeds from issuance of warrants																			$ 2,343,820
Securities Purchase Agreement [Member] | Investors [Member] | Series A Warrant [Member] | December 1, 2017 [Member]
Subsription/exercise price														$ 0.60
Number of warrant to purchase shares of common stock														2,370,000
Warrant expiry date														Mar. 06, 2022
Securities Purchase Agreement [Member] | Investors [Member] | Series A Warrant [Member] | January 10, 2018 [Member]
Subsription/exercise price													$ 0.60
Number of warrant to purchase shares of common stock													130,000
Securities Purchase Agreement [Member] | Investors [Member] | Series B Warrant [Member] | December 1, 2017 [Member]
Subsription/exercise price														$ 0.60
Number of warrant to purchase shares of common stock														7,584,000
Warrant expiry date														Mar. 01, 2018
Securities Purchase Agreement [Member] | Investors [Member] | Series B Warrant [Member] | January 10, 2018 [Member]
Subsription/exercise price													$ 0.60
Number of warrant to purchase shares of common stock													416,000
Engagement Agreement [Member] | Placement Agent [Member]
Percentage of fixed commissions aggregate gross proceeds																								7.00%		10.50%
Engagement Agreement [Member] | Placement Agent [Member] | Warrant [Member]
Warrants issued																								166,667		107,759
Shares issued price per share										$ 1.875											$ 1.875	$ 0.625
Number of shares issued in transaction																					166,667
Warrant expiry date										Sep. 01, 2021											Sep. 01, 2021	Jun. 01, 2022
Percentage of fixed commissions aggregate gross proceeds																								5.00%		5.00%
Engagement Agreement [Member] | Placement Agent [Member] | Placement Agent Warrant [Member]
Number of shares issued in transaction																						107,759
Equity Distribution Agreement [Member]
Number of shares issued in transaction																								115,606		2,176,392
Number of shares issued in transaction, value																								$ 26,000		$ 802,000
Commissions paid																								$ 1,000		$ 25,000
Equity Distribution Agreement [Member] | Maximum [Member]
Number of shares issued upon transaction									6,549,157
Rights [Member]
Subsription/exercise price																								$ 1,000
Common stock conversion price																								$ 0.20
Proceeds from issuance of rights																								$ 4,700,000
Warrant [Member]
Subsription/exercise price																								$ 0.20
Warrants issued																								5,000
Warrants exercisable term																								5 years
January and February 2018 [Member]
Subsription/exercise price																								$ 0.45
Number of warrant to purchase shares of common stock																								2,800,000
Warrant expiry date																								Mar. 01, 2018
Proceeds from warrants exercised																								$ 1,260,000
Series A Junior Participating Preferred Stock [Member]
Preferred stock, shares designated																								250,000
Series B Convertible Preferred Stock [Member]
Preferred stock par/face value																								$ 1,000		$ 1,000
Preferred stock, shares outstanding																								2,519
Preferred stock, shares designated																								8,000
Number of shares to be issued on conversion																								5,000
Preferred stock value																								$ 2,519,000
Series B Convertible Preferred Stock [Member] | Rights [Member]
Preferred stock value																								$ 1,000

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Convertible Note Payable (Details Narrative) - USD ($)			3 Months Ended
	Mar. 13, 2019	Sep. 28, 2018	Mar. 31, 2019
Convertible promissory note		$ 3,170,000
Convertible promissory note, interest percentage		10.00%
Debt instrument maturity date		Sep. 28, 2019
Maximum amount of redemption	$ 300,000
Loss on extinguishment of debt			$ 272,812
Interest expense			4,280
Amortization of Note discount			$ 2,543
Extended Maturity [Member]
Debt instrument maturity date	Sep. 28, 2020

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Fair Value (Details Narrative)	3 Months Ended
	Mar. 31, 2019
Sale of stock, description	The Company also has certain warrants with a cash settlement feature in the unlikely occurrence of a Fundamental Transaction, namely (1) a merger or consolidation with another person; (2) sale of substantially all of its assets; (3) holders of common stock sell 50% or more of outstanding shares; (4) the Company effects an exchange of all its securities for other securities, cash or property, and (5) the Company effects a stock purchase agreement or business combination for more than 50% of outstanding shares.
Probability of fundamental transaction	5.00%
Floor rate used as proxy for future volatility percentage	100.00%
Expected Dividend Rate [Member]
Fair value measurement, input Percentage	0.00%

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Fair Value - Schedule of Assumptions to Estimate Fair Value of Warrants (Details) - $ / shares	2 Months Ended	3 Months Ended	12 Months Ended
	Mar. 08, 2019	Mar. 31, 2019	Dec. 31, 2018
Expected Dividend Rate [Member]
Fair value measurement, input Percentage		0.00%
August 2016 Warrants [Member]
Underlying price per share		$ 0.16	$ 0.18
August 2016 Warrants [Member] | Exercise Price Per Share [Member]
Fair value measurement, input per share		$ 1.88	$ 1.88
August 2016 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage		2.24%	2.47%
August 2016 Warrants [Member] | Expected Holding Period [Member]
Fair value measurement, input term		2 years 5 months 1 day	2 years 8 months 2 days
August 2016 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage		70.00%	70.00%
August 2016 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage		0.00%	0.00%
February 2017 Warrants [Member]
Underlying price per share		$ 0.16	$ .18
February 2017 Warrants [Member] | Exercise Price Per Share [Member] | Minimum [Member]
Fair value measurement, input per share		0.69	.69
February 2017 Warrants [Member] | Exercise Price Per Share [Member] | Maximum [Member]
Fair value measurement, input per share		$ 0.75	$ .75
February 2017 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage		2.21%	2.47%
February 2017 Warrants [Member] | Expected Holding Period [Member] | Minimum [Member]
Fair value measurement, input term		3 years 4 months 2 days	3 years 7 months 2 days
February 2017 Warrants [Member] | Expected Holding Period [Member] | Maximum [Member]
Fair value measurement, input term		3 years 4 months 6 days	3 years 7 months 6 days
February 2017 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage		75.00%	70.00%
February 2017 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage		0.00%	0.00%
June 2017 Warrants [Member]
Underlying price per share		$ 0.16	$ 0.18
June 2017 Warrants [Member] | Exercise Price Per Share [Member]
Fair value measurement, input per share		$ 0.63	$ 0.63
June 2017 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage		2.21%	2.47%
June 2017 Warrants [Member] | Expected Holding Period [Member]
Fair value measurement, input term		3 years 2 months 1 day	3 years 5 months 1 day
June 2017 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage		0.00%	70.00%
June 2017 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage		75.00%	0.00%
August 2017 Warrants [Member]
Underlying price per share		$ 0.16	$ 0.18
August 2017 Warrants [Member] | Exercise Price Per Share [Member]
Fair value measurement, input per share		$ 0.45	$ 0.45
August 2017 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage		2.21%	2.46%
August 2017 Warrants [Member] | Expected Holding Period [Member]
Fair value measurement, input term			3 years 2 months 5 days
August 2017 Warrants [Member] | Expected Holding Period [Member] | Minimum [Member]
Fair value measurement, input term		2 years 11 months 4 days
August 2017 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage		70.00%	70.00%
August 2017 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage		0.00%	0.00%
April 2018 Warrants [Member]
Underlying price per share		$ 0.16	$ 0.18
April 2018 Warrants [Member] | Exercise Price Per Share [Member]
Fair value measurement, input per share		$ 0.39	$ 0.39
April 2018 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage			2.51%
April 2018 Warrants [Member] | Risk Free Interest Rate [Member] | Minimum [Member]
Fair value measurement, input Percentage		2.23%
April 2018 Warrants [Member] | Risk Free Interest Rate [Member] | Maximum [Member]
Fair value measurement, input Percentage		2.33%
April 2018 Warrants [Member] | Expected Holding Period [Member] | Minimum [Member]
Fair value measurement, input term		1 year 6 months 25 days	1 year 9 months 25 days
April 2018 Warrants [Member] | Expected Holding Period [Member] | Maximum [Member]
Fair value measurement, input term		4 years 6 months 25 days	4 years 9 months 25 days
April 2018 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage			70.00%
April 2018 Warrants [Member] | Expected Volatility [Member] | Minimum [Member]
Fair value measurement, input Percentage		65.00%
April 2018 Warrants [Member] | Expected Volatility [Member] | Maximum [Member]
Fair value measurement, input Percentage		70.00%
April 2018 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage		0.00%	0.00%
March 2019 Warrants [Member]
Underlying price per share	$ 0.15	$ 0.16
March 2019 Warrants [Member] | Exercise Price Per Share [Member]
Fair value measurement, input per share	$ 0.20	$ 0.20
March 2019 Warrants [Member] | Risk Free Interest Rate [Member]
Fair value measurement, input Percentage	2.42%	2.23%
March 2019 Warrants [Member] | Expected Holding Period [Member]
Fair value measurement, input term	5 years	4 years 11 months 8 days
March 2019 Warrants [Member] | Expected Volatility [Member]
Fair value measurement, input Percentage	65.00%	65.00%
March 2019 Warrants [Member] | Expected Dividend Rate [Member]
Fair value measurement, input Percentage	0.00%	0.00%

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Fair Value - Schedule of Range of Probabilities (Details)	3 Months Ended
	Mar. 31, 2019
Minimum [Member]
Percentage of probability	0.50%
Weighted Average [Member]
Percentage of probability	1.00%
Maximum [Member]
Percentage of probability	5.00%

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Fair Value - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Marketable securities	$ 2,486	$ 1,526
Redeemable warrants	3,895	1,061
Convertible note payable		3,408
Level 1 [Member]
Marketable securities	2,486	1,526
Redeemable warrants
Convertible note payable
Level 2 [Member]
Marketable securities
Redeemable warrants
Convertible note payable
Level 3 [Member]
Marketable securities
Redeemable warrants	3,895	1,061
Convertible note payable	$ 3,682	$ 3,408

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Fair Value - Schedule of Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2019 USD ($)
Redeemable Warrants [Member]
Balance at beginning	$ 1,061
Warrants exercised and cancelled	(1)
Warrants issued	2,790
Fair value adjustments	45
Balance at ending	3,895
Convertible Notes [Member]
Balance at beginning	3,408
Deferred debt discount written off due to refinancing	344
Pay off of old note payable	(3,722)
Amount of new note payable	3,742
Fair value adjustments	(90)
Balance at ending	$ 3,682

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Financing Obligation Arising from Sale Leaseback Transaction (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended	3 Months Ended
	Mar. 16, 2018	Feb. 28, 2018	Mar. 31, 2019
Proceeds from sale of property	$ 4,080	$ 1,050
Lease of rent expenses	$ 408		$ 27
Lease and property agreement description	Lease the property back for ten years at $408,000 per year for two years through March 31, 2020. The lease payments will increase 2.5% per year for the next three years through March 31, 2023 and the lease payments will increase 3% for the remaining five years through March 31, 2028.
Warrant term	5 years
Warrant to purchase of common stock	3,225,806
Warrant exercise price per share	$ 0.3875
Warrant closing price, percentage	125.00%
Warrant owning excess percentage	4.99%
Financing Agreement [Member]
Interest expenses			$ 18

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Financing Obligation Arising from Sale Leaseback Transaction - Schedule of Future Minimum Payments Under Financing Obligation (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Leases [Abstract]
2019	$ 306
2020	417
2021	427
2022	438
2023	450
Thereafter	2,025
Total of payments	4,063
Less deferred issuance costs	(239)
Less discount on debt instrument	(1,025)
Less imputed interest	(331)
Total balance	2,468
Less current portion	201	$ 199
Long term portion	$ 2,267	$ 2,318

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Leases (Details Narrative) - USD ($) $ in Thousands		3 Months Ended
	Mar. 16, 2018	Mar. 31, 2019	Dec. 31, 2018
Leases [Abstract]
Operating lease liability		$ 148
Operating lease right of use assets		137
Operating lease liability current and noncurrent		140
Operating lease rent expense	$ 408	$ 27

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Subsequent Events (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands			1 Months Ended
	May 02, 2019	Mar. 08, 2019	May 15, 2019	May 08, 2019	Mar. 31, 2019	Dec. 31, 2018	Mar. 31, 2018	Mar. 16, 2018	Dec. 31, 2017
Stockholders equity					$ 3,930	$ 5,174	$ 10,200		$ 8,703
Warrant exercise price								$ 0.3875
Warrant [Member]
Amount of impact to net equity		$ 1,500
Warrants outstanding					5,000
Warrant exercise price					$ 0.20
Subsequent Event [Member]
Stockholders equity			$ 6,000
Warrants issued				14,000,000
Exercised percentage of warrants				70.00%
Subsequent Event [Member] | Warrant [Member]
Amount of impact to net equity	$ 1,086
Warrants outstanding	4,550,000
Warrant exercise price	$ 0.15
Reduction of liability	$ 404
Proceeds from warrant	$ 682
Subsequent Event [Member] | Convertible Notes [Member]
Conversion of debt, amount			1,800
Convertible debt			3,170
Amount of impact to net equity			$ 1,800
Maximum [Member]
Stockholders equity					$ 6,000