HEB-2013.09.30-10Q



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 September 30, 2013
 
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.)
 
1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103
(Address of principal executive offices) (Zip Code)
 
(215) 988-0080
(Registrant's telephone number, including area code)
 
1617 JFK Boulevard, Suite 660, Philadelphia, PA 19103
 (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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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. (Check one):
¨ Large accelerated filer
¨     Accelerated filer
¨ Non-accelerated filer
x Smaller reporting company

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No
 
167,686,551 shares of common stock were outstanding as of November 1, 2013.
 




PART I - FINANCIAL INFORMATION

ITEM 1: Financial Statements
 
HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except for share and per share amounts) 
 
September 30,
2013
 
December 31,
2012
 
(Unaudited)
 
(Audited)
ASSETS
 

 
 

Current assets:
 

 
 

Cash and cash equivalents
$
1,598

 
$
2,212

Marketable securities – unrestricted
13,555

 
27,241

Marketable securities – restricted
14,068

 
14,500

Inventories
—

 
453

Prepaid expenses and other current assets
332

 
322

Total current assets
29,553

 
44,728

 
 
 
 
Property and equipment, net
5,145

 
5,292

Patent and trademark rights, net
1,074

 
1,034

Construction in progress
6,970

 
6,580

Other assets
136

 
65

Total assets
$
42,878

 
$
57,699

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

Accounts payable
$
1,723

 
$
2,157

Accrued expenses
1,822

 
3,395

Margin account loan
7,051

 
7,051

Current portion of capital lease
34

 
46

Total current liabilities
10,630

 
12,649

Long-term liabilities
 

 
 

Long-term portion of capital lease
31

 
55

Redeemable warrants
66

 
295

Total liabilities
10,727

 
12,999

 
 
 
 
Commitments and contingencies


 


 
 
 
 
Stockholders’ equity:
 

 
 

Preferred stock, par value $0.01 per share, authorized 5,000,000; issued and outstanding; none
—

 
—

Common stock, par value $0.001 per share, authorized 350,000,000 shares; issued and outstanding 167, 551,959 and 166,490,190, respectively
167

 
166

Additional paid-in capital
289,199

 
288,671

Accumulated other comprehensive loss
(91
)
 
(43
)
Accumulated deficit
(257,124
)
 
(244,094
)
 
 
 
 
Total stockholders’ equity
32,151

 
44,700

Total liabilities and stockholders’ equity
$
42,878

 
$
57,699


See accompanying notes to consolidated financial statements.
-2-


HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
 
 
Three months ended September 30,
 
Nine months ended September 30,
 
2013
 
2012
 
2013
 
2012
Revenues:
 
 
 
 
 

 
 

Clinical treatment programs
$
36

 
$
39

 
$
114

 
$
160

 
 
 
 
 
 
 
 
Total revenues
36

 
39

 
114

 
160

 
 
 
 
 
 
 
 
Costs and expenses:
 
 
 
 
 

 
 

Production/cost of goods sold
252

 
988

 
1,078

 
1,476

Research and development
2,173

 
2,357

 
6,827

 
5,758

General and administrative
2,070

 
1,659

 
5,964

 
5,271

 
 
 
 
 
 
 
 
Total costs and expenses
4,495

 
5,004

 
13,869

 
12,505

 
 
 
 
 
 
 
 
Operating loss
(4,459
)
 
(4,965
)
 
(13,755
)
 
(12,345
)
 
 
 
 
 
 
 
 
Interest expense
(4
)
 
(7
)
 
(14
)
 
(19
)
Interest and other income
89

 
353

 
624

 
873

Other than temporary impairment loss on marketable securities
(800
)
 
—

 
(800
)
 
—

Funds received from sale of income tax net operating losses
—

 
—

 
686

 
1,328

Redeemable warrants valuation adjustment
38

 
(1,968
)
 
229

 
(1,732
)
 
 
 
 
 
 
 
 
Net loss
(5,136
)
 
(6,587
)
 
(13,030
)
 
(11,895
)
 
 
 
 
 
 
 
 
Other Comprehensive Income (Loss):
 
 
 
 
 

 
 

Unrealized gain (loss) on marketable securities
867

 
306

 
(93
)
 
890

Realized gain (loss) on marketable securities
131

 
(168
)
 
44

 
(205
)
Less: Premium amortization
(1
)
 
24

 
1

 
132

Net comprehensive loss
$
(4,139
)
 
$
(6,425
)
 
$
(13,078
)
 
$
(11,078
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Basic and diluted loss per share
$
(0.03
)
 
$
(0.05
)
 
$
(0.08
)
 
$
(0.09
)
 
 
 
 
 
 
 
 
Weighted average shares outstanding, basic and diluted
167,389,685

 
137,012,240

 
167,135,111

 
136,260,727




See accompanying notes to consolidated financial statements.
-3-


HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Changes in Stockholders' Equity
(in thousands except share data)
(Unaudited)
 
 
Common
Stock
Shares
 
Common 
Stock
$0.001 
Par
Value
 
Additional
Paid-In
Capital
 
Accumulated 
Other 
Compre-
hensive 
Income 
(Loss)
 
Accumulated
Deficit
 
Total 
Stockholders’
Equity
Balance at December 31, 2012
166,490,190

 
$
166

 
$
288,671

 
$
(43
)
 
$
(244,094
)
 
$
44,700

Stock issued for settlement of accounts payable
1,061,769

 
1

 
236

 
—

 
—

 
237

Equity-based compensation
—

 
—

 
292

 
—

 
—

 
292

Net comprehensive loss
—

 
—

 
—

 
(48
)
 
(13,030
)
 
(13,078
)
 
 
 
 
 
 
 
 
 
 
 
 
Balance at September 30, 2013
167,551,959

 
$
167

 
$
289,199

 
$
(91
)
 
$
(257,124
)
 
$
32,151





See accompanying notes to consolidated financial statements.
-4-


HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
For the Nine Months Ended September 30, 2013 and 2012
(in thousands)
(Unaudited)
 
 
2013
 
2012
Cash flows from operating activities:
 
 
 
Net loss
$
(13,030
)
 
$
(11,895
)
 
 
 
 
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
Depreciation of property and equipment
504

 
469

Amortization of patent and trademark rights
144

 
29

Redeemable warrants valuation adjustment
(229
)
 
1,732

Equity-based compensation
292

 
195

 
 
 
 
Change in assets and liabilities:
 
 
 
Inventories
453

 
98

Prepaid expenses and other current assets
(10
)
 
274

Accounts payable
(197
)
 
925

Accrued expenses
(1,573
)
 
(8
)
Net cash used in operating activities
(13,646
)
 
(8,181
)
 
 
 
 
Cash flows from investing activities:
 
 
 
Purchase of property, equipment and construction in progress
(747
)
 
(4,821
)
Additions to patent and trademark rights
(184
)
 
(113
)
Deposits on capital leases refunded
3

 
6

Deposit paid on office lease
(74
)
 
—

Maturities of short-term and long-term marketable securities
14,070

 
13,380

Purchase of short-term and long-term marketable securities
—

 
(13,515
)
 
 
 
 
Net cash provided by (used in) investing activities
13,068

 
(5,063
)
 

See accompanying notes to consolidated financial statements.
-5-


HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows (Continued)
For the Nine Months Ended September 30, 2013 and 2012
(in thousands)
(Unaudited)
 
 
2013
 
2012
Cash flows from financing activities:
 
 
 
Payments on capital leases
$
(36
)
 
$
(35
)
Proceeds from margin account loan
—

 
4,066

Proceeds from sale of stock, net of issuance costs
—

 
9,268

Net cash provided by (used in) financing activities
(36
)
 
13,299

 
 
 
 
Net increase (decrease) in cash and cash equivalents
(614
)
 
55

 
 
 
 
Cash and cash equivalents at beginning of period
2,212

 
3,103

 
 
 
 
Cash and cash equivalents at end of period
$
1,598

 
$
3,158

 
 
 
 
Supplemental disclosures of non-cash investing and financing cash flow information:
 
 
 
Issuance of common stock for accounts payable and accrued expenses
$
237

 
$
262

Unrealized gain (loss) on marketable securities
$
(93
)
 
$
890

Redeemable warrants valuation adjustment
$
(229
)
 
$
1,732

Supplemental disclosure of cash flow information:
 
 
 
Cash paid for interest expense and capitalized construction interest
$
(144
)
 
$
(68
)

 

See accompanying notes to consolidated financial statements.
-6-


HEMISPHERX BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
Note 1: Basis Of Presentation
 
The consolidated financial statements include the financial statements of Hemispherx Biopharma, Inc. and its wholly-owned subsidiaries. The Company has three domestic subsidiaries: BioPro Corp., BioAegean Corp. and Core Biotech Corp., all of which are incorporated in Delaware and are dormant. The Company’s foreign subsidiary, Hemispherx Biopharma Europe N.V./S.A., established in Belgium in 1998, has minimal activity. All significant intercompany balances and transactions have been eliminated in consolidation.
 
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, 2012 and 2011, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.
 
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 stock options and warrants which amounted to 38,421,415 and 33,348,458 shares for the nine months ended September 30, 2013 and 2012, respectively, are excluded from the calculation of diluted net loss per share since their effect is anti-dilutive.
 
Note 3: Equity-Based Compensation

The fair value of each option award is estimated on the date of grant using a Black-Scholes-Merton option 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. The Company uses historical data to estimate expected dividend yield, expected life and forfeiture rates. Accordingly, the fair values of the options granted, were estimated based on the following weighted average assumptions:
 
Nine Months Ended September 30,
 
2013
 
2012
Risk-free interest rate
0.14% - 1.40%
 
0.68% - 0.86%
Expected dividend yield
—
 
—
Expected lives
1 year - 5 years
 
5.0 years
Expected volatility
89.727% - 118.222%
 
108.76% - 111.95%
Weighted average grant date fair value for options and warrants issued
$0.14 per option/warrant for 3,870,000 options / warrants
 
$0.23 per option for 1,499,000 options

Stock option for employees' activity during the nine months ended September 30, 2013 is as follows:
 

-7-


Stock option activity for employees:
 
Number of
Options
 
Weighted
Average
Exercise
Price
 
Weighted
Average
Remaining
Contractual
Term
(Years)
 
Aggregate
Intrinsic
Value
Outstanding January 1, 2013
9,441,480

 
$
1.90

 
5.35

 
$
—

Granted
1,170,000

 
0.36

 
9.74

 
—

Forfeited
—

 
—

 
—

 
—

Outstanding September 30, 2013
10,611,480

 
$
1.73

 
5.17

 
$
—

Vested and expected to vest September 30, 2013
10,611,480

 
$
1.73

 
5.17

 
$
—

Exercisable September 30, 2013
9,798,980

 
$
1.84

 
5.02

 
$
—

 
1,170,000 options to purchase shares were granted to employees during the nine months ended September 30, 2013.
 
Unvested stock option activity for employees:
 
Number of
Options
 
Weighted
Average
Exercise 
Price
 
Average 
Remaining
Contractual 
Term 
(Years)
 
Aggregate 
Intrinsic
Value
Outstanding January 1, 2013
516,373

 
$
0.45

 
9.43

 
$
—

Granted
882,500

 
0.27

 
9.40

 
—

Vested
(586,373
)
 
0.43

 
9.26

 
—

Forfeited
—

 
—

 
—

 
—

Outstanding September 30, 2013
812,500

 
$
0.27

 
8.87

 
$
—


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, 2013
3,428,432

 
$
1.73

 
4.71

 
$
—

Granted
600,000

 
0.69

 
9.69

 
—

Exercised
—

 
—

 
—

 
—

Forfeited
(150,000
)
 
2.00

 
—

 
—

Outstanding September 30, 2013
3,878,432

 
$
1.56

 
5.00

 
$
—

Vested and expected to vest September 30, 2013
3,878,432

 
$
1.56

 
5.00

 
$
—

Exercisable September 30, 2013
3,503,432

 
$
1.93

 
4.57

 
$
—


600,000 options to purchase shares were granted to non-employees during the nine months ended September 30, 2013.


-8-


Unvested stock option activity for non-employees during the year:
 
Number of
Options
 
Weighted
Average
Exercise 
Price
 
Weighted 
Average
Remaining 
Contractual
Term 
(Years)
 
Aggregate 
Intrinsic
Value
Outstanding January 1, 2013
210,422

 
$
0.40

 
9.68

 
$
—

Options granted
375,000

 
0.25

 
9.75

 
—

Options vested
(210,422
)
 
0.40

 
9.68

 
—

Options forfeited
—

 
—

 
—

 
—

Outstanding September 30, 2013
375,000

 
$
0.25

 
9.75

 
$
—

 
The impact on the Company’s results of operations of recording equity-based compensation for the nine months ended September 30, 2013 and 2012 was to increase general and administrative expenses by approximately $292,000 and $195,000, respectively. The impact on basic and fully diluted earnings per share for the nine months ended September 30, 2013 and 2012 was $0.00 and $0.00, respectively.
 
As of September 30, 2013 and 2012, respectively, there was $492,000 and $308,000 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 market method of accounting for inventory.
 
Inventories consist of the following:
(in thousands)
 
September 30,
 
December 31,
 
2013
 
2012
Inventory work-in-process, January 1
$
453

 
$
897

Production
5

 
579

Spoilage
(458
)
 
(1,023
)
Inventory work-in-process, end of period
$
—

 
$
453

 
As of December 31, 2012, all of our lots of Alferon® Work-In-Process Inventory had completed the fill, finish and packaging process. The inventory would not be classified as Finished Goods until stability and release testing were concluded and it is confirmed by the U.S. Food and Drug Administration ("FDA") that the product could be commercially sold as is.

In April 2012, FDA reviewers raised certain questions about the status of our existing lots of older Work-In-Process Alferon® materials and Alferon® Active Pharmaceutical Ingredient (“API”), which would need to be released by the FDA before those materials could be used in commercial product. After conducting all of the appropriate tests on samples of the inventory during 2013, the Company concluded that it could not alleviate certain questions the FDA had about the older Work-In-Process Alferon N Injection®. Accordingly, these lots will not be submitted to the FDA to request release for commercial sale and their remaining dollar value has been written-off in the quarter ended June 30, 2013.

Note 5: Marketable Securities - Unrestricted
 
Marketable securities consist of fixed income securities with remaining maturities of greater than three months at the date of purchase, debt securities and equity securities. As of September 30, 2013, it was determined that two of the marketable securities had other-than-temporary impairments and a loss of $300,000 was recognized. At September 30, 2013, all securities were classified as available for sale investments and were measured as Level 1 instruments of the fair value measurements standard (see "Note 11: Fair Value").
 

-9-


Securities classified as available for sale consisted of:
 
September 30, 2013
(in thousands)
Securities
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair Value
 
Short-Term
Investments
 
Long Term
Investments
Mutual Funds
 
$
13,613

 
$
—

 
$
(58
)
 
$
13,555

 
$
13,555

 
$
—

 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
$
13,613

 
$
—

 
$
(58
)
 
$
13,555

 
$
13,555

 
$
—


December 31, 2012
(in thousands)
Securities
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair Value
 
Short-Term
Investments
 
Long Term
Investments
Mutual Funds
 
$
27,230

 
$
11

 
$
—

 
$
27,241

 
$
27,241

 
$
—

 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
$
27,230

 
$
11

 
$
—

 
$
27,241

 
$
27,241

 
$
—


Unrealized losses on investments

Investments with continuous unrealized losses for less than 12 months and 12 months or greater and their related fair values were as follows:
 
September 30, 2013
(in thousands)
 
 
 
 
Less Than 12 Months
 
12 Months or Greater
 
Totals
Securities
 
Total
number
in loss
position
 
Fair
Values
 
Unrealized 
Losses
 
Fair
Values
 
Unrealized
Losses
 
Total
Fair
Value
 
Total
Unrealized
Losses
Mutual Funds
 
2

 
$
13,555

 
$
(57
)
 
$
—

 
$
—

 
$
13,555

 
$
(57
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
2

 
$
13,555

 
$
(57
)
 
$
—

 
$
—

 
$
13,555

 
$
(57
)

No unrestricted investments were in a loss position as of December 31, 2012.

Note 6: Marketable Securities - Restricted
 
A Margin Account was established on July 26, 2011 for which the Company needs to pledge, restrict from sale and segregate marketable securities at an approximate ratio of approximately two-to-one, based on the diversity of securities pledged as collateral, for those funds withdrawn and outstanding (see “Note 9 Margin Account Loan”).

These restricted marketable securities consist of mutual funds. As of September 30, 2013, it was determined that two of the Marketable Securities had other-than-temporary impairments and a loss of $500,000 was recognized. At September 30, 2013, all restricted securities were measured as Level 1 instruments of the fair value measurements standard (see "Note 11: Fair Value").


-10-


Securities classified as restricted from sale consisted of:
 
September 30, 2013
(in thousands)
Securities
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair
 Value
 
Short-Term
Investments
 
Long Term
Investments
Mutual Funds
 
$
14,101

 
$
—

 
$
(33
)
 
$
14,068

 
$
14,068

 
$
—

 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
$
14,101

 
$
—

 
$
(33
)
 
$
14,068

 
$
14,068

 
$
—

 
December 31, 2012
(in thousands)
Securities
 
Amortized
Cost
 
Gross
Unrealized
Gains
 
Gross
Unrealized
Losses
 
Fair 
Value
 
Short-Term
Investments
 
Long Term
Investments
Mutual Funds
 
$
11,050

 
$
—

 
$
(54
)
 
$
10,996

 
$
10,996

 
$
—

Corporate Bonds
 
3,503

 
1

 
—

 
3,504

 
3,504

 
—

 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
$
14,553

 
$
1

 
$
(54
)
 
$
14,500

 
$
14,500

 
$
—

 
Unrealized losses on investments restricted from sale
 
Investments restricted from sale with continuous unrealized losses for less than 12 months and 12 months or greater and their related fair values were as follows:
 
September 30, 2013
(in thousands)
 
 
 
 
Less Than 12 Months
 
12 Months or Greater
 
Totals
Securities
 
Total
number
in loss
position
 
Fair
Values
 
Unrealized 
Losses
 
Fair
Values
 
Unrealized
Losses
 
Total
Fair
Value
 
Total
Unrealized
Losses
Mutual Funds
 
2

 
$
14,068

 
$
(33
)
 
$
—

 
$
—

 
$
14,068

 
$
(33
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
2

 
$
14,068

 
$
(33
)
 
$
—

 
$
—

 
$
14,068

 
$
(33
)
 
December 31, 2012
(in thousands)
 
 
 
 
Less Than 12 Months
 
12 Months or Greater
 
Totals
Securities
 
Total
number in
loss
position
 
Fair
Values
 
Unrealized 
Losses
 
Fair 
Values
 
Unrealized
Losses
 
Total
Fair
Value
 
Total
Unrealized
Losses
Mutual Funds
 
1

 
$
10,996

 
$
(54
)
 
$
—

 
$
—

 
$
10,996

 
$
(54
)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Totals
 
1

 
$
10,996

 
$
(54
)
 
$
—

 
$
—

 
$
10,996

 
$
(54
)
 
Management does not believe any remaining losses represent other-than-temporary impairment based on Management’s evaluation of available evidence as of September 30, 2013.
 

-11-


Note 7: Accrued Expenses
 
Accrued expenses consist of the following:
 
(in thousands)
 
September 30,
2013
 
December 31,
2012
Compensation
$
338

 
$
2,131

Professional fees
464

 
466

Other expenses
842

 
615

Accrued Alferon production costs
65

 
70

Due for returned product
113

 
113

 
$
1,822

 
$
3,395


Note 8: Property and Equipment

 
(in thousands)
 
September 30,
2013
 
December 31,
2012
Land, buildings and improvements
$
4,209

 
$
4,209

Furniture, fixtures, and equipment
5,019

 
4,662

Leasehold improvements
85

 
85

 
 
 
 
Total property and equipment
9,313

 
8,956

Less: accumulated depreciation and amortization
(4,168
)
 
(3,664
)
 
 
 
 
Property and equipment, net
$
5,145

 
$
5,292

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

Construction in progress consists of funds used for the construction and installation of property and equipment within the Company's New Brunswick, NJ facility. As of September 30, 2013, construction in progress is reported as $6,970,000 as compared to $6,580,000 as of December 31, 2012. The Company capitalized $130,000 through of September 30, 2013 as interest charges, as compared to $85,000 as of December 31, 2012, which will be expensed proportionately to each long-term asset class of the construction in progress over its respective life.

The Company owns and operates a 43,000 sq. ft. FDA approved facility in New Brunswick, NJ to produce Alferon® and Ampligen®. In December 2011, our Board of Directors reevaluated the facility enhancement project to focus on upgrading the facility to provide for a high volume, more cost effective manufacturing process for Alferon N Injection®, Alferon® LDO and Ampligen®. The facility enhancement project is currently in the validation phase of the Alferon® manufacturing project as we prepare to undertake the Installation and Operation Qualification phase of the enhancement project. Approximately $7,733,000 has been spent to date through September 30, 2013, as compared to $7,051,000 spent on the project through December 31, 2012, of which $7,051,000 has been financed through a Margin Account with an effective interest rate of approximately 2.50% (see "Note 9: Margin Account Loan"). While the facility is approved by the FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. We anticipate that it will take at least until the second half of 2014 before we will have newly produced Alferon® API ready for submission to the FDA for review and approval.
 

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Note 9: Margin Account Loan
 
A “Margin Account” loan was established with Wells Fargo Advisors for which the proceeds of this flexible form of indebtedness effectively serves the Company as a line of credit to finance the capital improvement project underway at the New Brunswick, New Jersey Manufacturing facility. In order to maintain this Margin Account, established on July 26, 2011, the Company needs to pledge, restrict from sale and segregate to a dedicated Margin Account its marketable securities at an approximate ratio of two to one of security collateral to debt undertaken. With the exception of collateral requirements, the Company maintains all the rights and benefits of ownership including receipt of interest, dividends or proceeds from the securities. While this Margin Account has no material establishment or maintenance fees, it currently carries an effective interest rate of approximately 2.5% per annum applied against the “Margin Debit Balance” (i.e., those funds withdrawn and outstanding), based on the prevailing “Wells Fargo Base Rate” less 2.75%. At September 30, 2013, the principal loan balance of the Margin Account was approximately $7,051,000, for which approximately $14,068,000 in Marketable Securities became restricted as dedicated collateral for the indebtedness. For the nine months ended September 30, 2013, the interest charge was approximately $130,000 which has been capitalized along with the other costs related to the capital improvement project (see “Note 6: Marketable Securities – Restricted”).

Note 10: Stockholders’ Equity
 
The Equity Incentive Plan of 2009, effective June 24, 2009, authorizes the grant of non-qualified and incentive stock options, stock appreciation rights, restricted stock and other stock awards. A maximum of 15,000,000 shares of common stock is reserved for potential issuance pursuant to awards under the Equity Incentive Plan of 2009. Unless sooner terminated, the Equity Incentive Plan of 2009 will continue in effect for a period of 10 years from its effective date. For the nine months ended September 30, 2013, the Company issued to consultants options and warrants to purchase 2,100,000 shares of common stock that had exercise prices ranging from $0.25 to $0.50 based on the NYSE MKT prices, containing milestone events to achieve vesting and having terms from one to five years. From the Equity Incentive Plan of 2009 through September 30, 2013, the Company issued 11,524,522 securities to Directors and consultants consisting of an aggregate 3,335,152 shares of common stock, and options and warrants to purchase 8,189,370 shares. The shares issued to consultants had prices ranging from $0.20 to $2.30 based on the NYSE MKT closing price.
 
The aggregate stock options had various exercise prices ranging from $0.23 to $2.81, had terms of ten years, issued at a premium value of 110% of the NYSE MKT stock closing price and vested over varying periods of time upon grant.
 
On July 23, 2012, the Company entered into a new Equity Distribution Agreement (the “New EDA”) with Maxim pursuant to which the Company may sell up to $75,000,000 worth of its shares of Common Stock from time to time through Maxim, as sales agent. Under the New EDA, Maxim is entitled to a fixed commission rate of 4.0% of the gross sales price of Shares sold under the EDA, up to aggregate gross proceeds of $10,000,000, and thereafter, at a fixed commission rate of 3.0% of the gross sales price of Shares sold under the EDA. Sales of the Shares, if any, may be made in transactions that are deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers' transactions, including on the NYSE MKT, at market prices or as otherwise agreed with Maxim. The Company has no obligation to sell any of the Shares and may at any time suspend offers under the New EDA or terminate the New EDA. The Shares are being sold pursuant to the Company's Universal Shelf Registration Statement on Form S-3, declared effective by the Securities and Exchange Commission on July 2, 2012. On September 14, 2012, the Company filed a Prospectus Supplement with the SEC increasing the number of shares covered by the Prospectus from 12,000,000 to 20,000,000 shares under the New ATM. On October 5, 2012, the Company filed an updated Prospectus Supplement increasing the number of shares covered by the Prospectus to 40,000,000 shares. For the nine months ended September 30, 2013, the Company did not sell any shares pursuant to the ATM. As of December 31, 2012, the Company had sold an aggregate of approximately 29,500,000 shares of the New EDA that resulted in net cash proceeds of approximately $23,003,000 after direct expenses along with commissions paid to Maxim for approximately $820,000.

The proceeds from this financing are intended to be used to fund infrastructure growth including manufacturing, regulatory compliance and market development.

Note 11: Fair Value
 
The Company is required under U.S. Generally Accepted Accounting Principles (“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 Sheet.
 
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.

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The Company also has certain warrants with a cash settlement feature in the unlikely occurrence of a Fundamental Transaction. The fair value recalculation of the Liability resulting from the issuance of the Warrants ("Call") and existence of the Fundamental Transaction ("Put") related to the May 2009 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 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.
 
Fair value at September30, 2013, was estimated using the following assumptions:
 
Underlying price per share
$0.19 - $0.24
Exercise price per share
$1.31 - $1.65
Risk-free interest rate
0.06% - 0.23%
Expected holding period
0.63 - 1.64 yrs.
Expected volatility
69.74% - 113.56%
Expected dividend yield
None
 
While the assumptions remain consistent from period to period (e.g., utilizing historical stock prices), the numbers input change from period to period (e.g., the actual historical prices input for the relevant period). The carrying amount and estimated fair value of the above warrants was approximately $66,000 at September 30, 2013. There were no other financial instruments at September 30, 2013.
 
On January 1, 2008, the Company adopted new accounting guidance (codified at FASB ASC 820 and formerly Statement No. 157 Fair Value Measurements) that defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, 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. As of September 30, 2013, the Company had no derivative assets or liabilities.

FASB ASC 820-10-35-37 (formerly SFAS No. 157) 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 September 30, 2013 and 2012, the Company has classified the Warrants with cash settlement features 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.


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The table below presents the balances of assets and liabilities measured at fair value on a recurring basis by level within the hierarchy as of September 30, 2013:
 
(in thousands)
 
Total
 
Level 1
 
Level 2
 
Level 3
Assets:
 
 
 
 
 
 
 
Marketable Securities-unrestricted
$
13,555

 
$
13,555

 
$
—

 
$
—

Marketable Securities-restricted
$
14,068

 
$
14,068

 
$
—

 
$
—

Liabilities:
 
 
 
 
 
 
 
Warrants
$
(66
)
 
$
—

 
$
—

 
$
(66
)
 
The changes in Level 3 Liabilities measured at fair value on a recurring basis are summarized as follows:
 
Fair Value of Redeemable
Warrants
 
(in thousands)
 
2013
 
2012
Balance at January 1
$
295

 
$
380

Fair value adjustment at March 31
(89
)
 
151

Balance at March 31
206

 
531

Fair value adjustment at June 30
(102
)
 
(387
)
Balance at June 30
104

 
144

Fair value adjustment at September 30
(38
)
 
1,968

Balance at September 30
$
66

 
$
2,112


Note 12: 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 13: Recent Accounting Pronouncements
 
In 2013, the FASB issued Accounting Standards Updates (“ASU”) 2013-01 through 2013-11. In February 2013, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") No. 2013-02, Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. ASU 2013-02 supersedes and replaces the presentation requirements for amounts reclassified out of Accumulated Other Comprehensive Income in ASU's 2011-05 and 2011-12. This ASU requires an entity to report the effect of significant reclassifications out of Accumulated Other Comprehensive Income on the respective line items in Net Income if the amount being reclassified is required under U.S. Generally Accepted Accounting Principles ("GAAP") to be reclassified in its entirety to Net Income. For other amounts that are not required under GAAP to be reclassified in their entirety to Net Income in the same reporting period, an entity is required to cross-reference other disclosures required under GAAP that provide additional detail about those amounts. Public companies are required to comply with the requirements of AUS 2013-02 for all reporting periods (interim and annual) beginning after December 15, 2012. The adoption of ASU 2013-02 did not have a significant impact on the financial statements.
 
Note 14: Funds Received From Sale Of Income Tax Net Operating Losses
 
As of December 31, 2012, the Company has approximately $119,000,000 of federal net operating loss carryforwards (expiring in the years 2013 through 2032) available to off-set future federal taxable income. The Company also had approximately $36,000,000 of Pennsylvania state net operating loss carryforwards (expiring in the years 2018 through 2032) and approximately $17,000,000 of New Jersey state net operating loss carryforwards (expiring in the years 2030 through 2032) available to off-set future state taxable income.
 

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In January 2013, the Company effectively sold $8,500,000 of its approximately $17,000,000 of New Jersey state net operating loss carryforwards (for the years 2010 and 2011) for approximately $685,000. The utilization of certain state net operating loss carry-forwards may be subject to annual limitations. With no tax due for the foreseeable future, the Company has determined that the accounting for interest or penalties related to the payment of tax is not necessary at this time.

Note 15: Subsequent Events
 
During the month of October 2013, we liquidated approximately one-half of the $14,068,000 in Marketable Securities - Restricted (see “Note 6: Marketable Securities – Restricted”) in order to pay-off in its entirety the approximately $7,051,000 of principal balance of the Margin Account Loan (see "Note 9: Margin Account Loan). As a result, the Margin Account Loan was eliminated and the remaining dollar value of the Marketable Securities - Restricted was reclassified to Unrestricted as of October 31, 2013. At September 30, 2013, we recognized $800,000 as other than temporary impairment loss for all of our fixed-income securities (bonds) that were primarily attributable to changes in interest rates and/or a reduction in their rating of credit worthiness as deemed by independent financial rating services and calculated by market price movements. The impact of the October 2013 sales of the Marketable Securities to pay-off the Margin Loan identified a realized loss of approximately $271,000, of which approximately $256,000 had already been recognized as other than temporary impairment loss in September 2013. Management believes that unrealized losses attributed to the Mutual Funds in 2012 and 2013 were limited to temporary impairment based on our evaluation of available evidence as of September 30, 2013 and December 31, 2012.

The Company evaluated subsequent events through the date on which these financial statements were issued, and with the exception of the above event, determined that no subsequent event constituted a matter that required disclosure or adjustment to the financial statements for the nine months ended September30, 2013.


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, including statements under “Item 1. Legal Proceedings” and “Item 1A. Risk Factors” in Part II, 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 involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements reflect our current views with respect to future events are based on assumptions and are subject to risks, uncertainties and other important factors. We discuss many of these risks, uncertainties and other important factors in greater detail under “Item 1A. Risk Factors” in Part II in this Report. Because the risk factors referred to above and in our Annual Report on Form 10-K for our most recent fiscal year filed with the Securities and Exchange Commission could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us, you should not place undue reliance on any such forward-looking statements.
 
Further, these forward-looking statements represent our estimates and assumptions only as of the date such forward-looking statements are made. You should carefully read this Report completely and with the understanding that our actual future results may be materially different from what we expect. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our business, results of operations and financial condition. Any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which will arise. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Any statements in this Report about our expectations, beliefs, plans, objectives, assumptions or future events or performance that are not historical facts are forward-looking statements. You can identify these forward-looking statements by the use of words or phrases such as “believe”, “may”, “could”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “seek”, “plan”, “expect”, “should”, or “would,” and similar expressions intended to identify 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: the possibility of obtaining regulatory approval, the potential therapeutic effect of our products, 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 commercially sell current drugs or discover new drugs in the future, changing market conditions, changes in laws and

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regulations affecting our industry, and issues related to the improvements of and construction at our New Brunswick, New Jersey facility. 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. With regard to our New Drug Application (“NDA”) for Ampligen® to treat Chronic Fatigue Syndrome (“CFS”), we note that there are additional steps which the FDA has advised Hemispherx to take in our seeking approval. The final results of these and other ongoing activities, and of the FDA review, could vary materially from Hemispherx' expectations and could adversely affect the chances for approval of the Ampligen® NDA. Any failure to satisfy the FDA’s requirements could significantly delay, or preclude outright, approval of our drugs for commercial sale.
 
We do not undertake and specifically decline any obligation to publicly release the results of any revisions which may be made to any forward-looking statement to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
 
Overview
 
General
 
We are a specialty pharmaceutical company headquartered in Philadelphia, Pennsylvania and engaged in the clinical development of new drug therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. We were founded in the early 1970s doing contract research for the National Institutes of Health. Since that time, we have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of natural interferon and nucleic acids to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain chronic diseases. We have three domestic subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp., all of which are incorporated in Delaware and are dormant. Our foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A. established in Belgium in 1998, which has minimal activity. All significant intercompany balances and transactions have been eliminated in consolidation.

Our current strategic focus is derived from four applications of our two core pharmaceutical technology platforms Ampligen® and Alferon N Injection®. The commercial focus for Ampligen® includes application as a treatment for CFS and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection® is an FDA approved product with an indication for refractory or recurring genital warts. Alferon® LDO (Low Dose Oral) is a formulation under development targeting influenza.

We own and operate a 43,000 sq. ft. FDA approved facility in New Brunswick, NJ to produce Alferon® and Ampligen®. The facility enhancement project is in its final stage. We are currently in the Installation and Operation Qualification phase for Alferon® production of the enhancement project. Approximately $7,733,000 has been spent to date through September 30, 2013, as compared to $7,051,000 spent on the project through December 31, 2012, of which $7,051,000 has been financed through a Margin Account with an effective interest rate of approximately 2.50% (see "Note 9: Margin Account Loan"). While facility upgrades are being undertaken to the Alferon® manufacturing process, this project has not impacted our capability to manufacture the Ampligen® drug substance intermediates needed for the final production steps of that product. The production of new Alferon® API inventory will not commence until the capital improvement and validation phases are complete. While the facility is approved by FDA under the Biological License Application (“BLA”) for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. We anticipate that it will take until at least the second half of 2014 before we will have newly produced Alferon® API ready for submission to the FDA for review and approval. We outsource certain components of our research and development, manufacturing, marketing and distribution while maintaining control over the entire process through our quality assurance group and our clinical monitoring group. We cannot provide any guarantee that the facility will necessarily pass a FDA pre-approval inspection for Ampligen® or Alferon® manufacture, which are conducted in separately dedicated areas within the overall New Brunswick manufacturing complex.

On February 1, 2013, we received a Complete Response Letter (“CRL”) from the FDA declining to approve our NDA for Ampligen® for CFS. Please see the discussion in "Ampligen®" below for more detail.

Ampligen®
 
Ampligen® is an experimental drug currently undergoing clinical development for the treatment of CFS. As noted above and discussed below, the FDA in its recent CRL declined to approve our NDA for the treatment of CFS with Ampligen®. Over

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its developmental history, Ampligen® has received various designations, including Orphan Drug Product Designation (FDA), Treatment IND (e.g., treatment investigational new drugs, or “Emergency” 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) RNA (nucleic acid) 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 as they are designed to act at the molecular level for treatment of human diseases. There are two forms of nucleic acids, DNA and 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. Our double-stranded RNA drug product, trademarked Ampligen®, is an experimental, unapproved drug, that would be 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).

Clinical trials of Ampligen® already conducted by us include studies of the potential treatment of CFS, Hepatitis B, HIV and cancer patients with renal cell carcinoma and malignant melanoma. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval.

In May 1997, the FDA approved an open-label treatment protocol, (“AMP 511”), allowing patient access to Ampligen® for treatment 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 a consortium group with active clinical sites in New York City, NY, Charlotte, NC, Miami, FL, Incline Village, NV and Salt Lake City, UT, provide safety information regarding the use of Ampligen® in patients with CFS. As of September 30, 2013, there were thirty-two patients participating in this open label treatment protocol with twenty-two taking treatment and ten on drug holiday. 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.

On December 20, 2012, the FDA held a meeting of its Arthritis Advisory Committee (“AAC”) to discuss the Ampligen® NDA. The AAC questions and the results of the members' voting thereon were as follows:
•
“Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?” The AAC voted 9 no, 4 yes and 1 AAC member did not vote;
•
“Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?” The AAC voted 9 no, 4 yes and 1 AAC member did not vote;
•
“Is the safety profile of Ampligen adequate for approval for the treatment of CFS?” The AAC voted 8 yes, 5 no and 1 non-vote; and
•
“Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of CFS?” The AAC voted 8 no, 5 yes and 1 non-vote.

The AAC based its voting on a review of data from the Ampligen® clinical development program included as part of our NDA submission. This submission included data on nine studies conducted in patients with CFS, including two randomized double-blind, placebo-controlled studies and seven open-label studies. The trials were designed to evaluate safety, tolerability and efficacy in the approximately 845 patients (589 unique subjects suffering from severely debilitating CFS) who received Ampligen®.

On February 1, 2013, we received a CRL from the FDA declining to approve Hemispherx' NDA for Ampligen® for CFS. In its CRL, the FDA communicated that Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. The additional clinical study should address, among other things, Ampligen®'s efficacy in treating CFS patients, be of sufficient size and duration to assess the safety of Ampligen® and be sufficient to determine appropriate dosing. The FDA set forth the reasons for this action and provided recommendations to address certain of the outstanding issues. The FDA stated that the submitted data do not provide substantial evidence of efficacy of Ampligen® for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use

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in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data. In addition to the safety and effectiveness issues recommended to be addressed in at least one additional clinical trial, the CRL states that Hemispherx should conduct complete rodent carcinogenicity studies in two species prior to approval and also conduct additional animal toxicology studies providing more comprehensive evaluation of Ampligen® fragments and degradation products. The CRL also requests evaluation of variation between lots of Ampligen® tested in the development process and recommends tighter control of the Ampligen® manufacturing process.

In response to the CRL, we continue to plan to avail ourselves of the opportunity for an “end-of-review” meeting with representatives of the Office of Drug Evaluation II which issued the CRL, in order to clarify and seek to narrow the outstanding issues regarding the further development of Ampligen® for the treatment of CFS.

FDA regulations provide a formal dispute resolution process to obtain review of any FDA decision, including a decision not to approve an NDA, by raising the matter with the supervisor of the FDA office that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific (including, medical) disputes and procedural (including, administrative) disputes that arise during the drug development, new drug review, and post-marketing oversight processes of the FDA. Depending on the results of a planned “end-of-review” meeting, we will determine whether or not to submit a formal appeal regarding the FDA's decision under applicable FDA regulations and guidance. Please see “Risks Associated With Our Business” in Item 1A. Risk Factors below.

Until we undertake the end-of-review conference(s) with the FDA, we are unable to reasonably estimate the nature, costs, necessary efforts to obtain FDA clearance or anticipated completion dates of any additional clinical study or studies. Utilizing the industry norms for undertaking a Phase III clinical study, we estimate upon acceptance of the study's design that it would take approximately 18 months to three years to complete a new well-controlled Ampligen® clinical study for resubmission to the FDA. Industry norms suggest that it will require three to six months to initiate the study, one to two years to accrue and test patients, three to six months to close-out the study and file the necessary documents with the FDA. The actual duration to complete the clinical study may be different based on the length of time it takes to design the study and obtain FDA's acceptance of the design, the final design of an acceptable Phase III clinical study 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. We anticipate that the time and cost to undertake clinical trial(s), studies and data analysis are beyond our current financial resources without gaining access to additional funding. Please see "Part II; Item 1A, Risk Factors: "We may require additional financing which may not be available. The limitation on the number of shares of common stock available for financing without prior stockholder approval eventually may hinder our ability to raise additional funding".
 
Alferon N Injection®
 
Alferon N Injection® is the registered trademark for our injectable formulation of natural alpha interferon, which is approved by the FDA in 1989 for the treatment of certain categories of genital warts. Alferon® is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. 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. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). The U.S. Centers for Disease Control and Prevention (“CDC”) estimates that “approximately twenty million Americans are currently infected with HPV with another six million becoming newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives.” Although they do not usually result in death, genital warts recurrence is common, cause 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

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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 antibodies observed against natural interferon 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, probably due to neutralizing antibody formation. Neutralizing antibody formation has not been reported with the use of Alferon N Injection®.

Commercial sales of Alferon N Injection® were halted in March 2008 when our finished goods inventory expired. The production of Alferon N Injection® from the Work-In-Process Inventory was restarted in May 2010, continued into January 2011 with its conversion into API and is completed for the related Final Lot Release Test. To formulate, fill, finish and package (“fill and finish”) Alferon N Injection® Drug Product, we require a FDA approved third party Contract Manufacturing Organization (“CMO”). In January 2012, we agreed to a Technology, Transfer, Validation and Commercial Supply Agreement with Althea Technologies, Inc. (“Althea”) of San Diego, CA, regarding the fill and finish process for Alferon N Injection®.

In April 2012, FDA reviewers raised certain questions about the status of our existing lots of older Work-In-Process Alferon® materials and Alferon® API, which would need to be released by the FDA before those materials could be used in commercial product. As of December 31, 2012, all of our existing lots of Alferon® Work-In-Process Inventory had completed the fill, finish and packaging process. After conducting all of the appropriate tests on samples of the inventory during 2013, we concluded that we could not alleviate certain questions the FDA had about the older Work-In-Process Alferon N Injection®. Accordingly, these lots will not be submitted to the FDA to request release for commercial sale and their remaining dollar value has been written-off (see "Note 4: Inventory" for greater details).

Commercial sales of Alferon® will not resume until new batches of API can be produced and released by the FDA. We are currently in the Installation and Operation Qualification phase for Alferon® production of the enhancement project. The production of new Alferon® API inventory will not commence until the capital improvement and validation phases are complete. While the facility is approved by FDA under the BLA for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. We anticipate that it will take until at least the second half of 2014 before we will have newly produced Alferon® API ready for submission to the FDA for review and approval. We outsource certain components of our research and development, manufacturing, marketing and distribution while maintaining control over the entire process through our quality assurance group and our clinical monitoring group. We cannot provide any guarantee that the facility will necessarily pass a FDA pre-approval inspection for Alferon® manufacture.

In January 2012, the ANMAT approved the sale and distribution of Alferon N Injection® (under the brand name “Naturaferon”) in Argentina. In June 2010, Hemispherx agreed to provide GP Pharm an option to market Alferon N Injection®, its FDA-approved natural interferon, in Argentina and other Latin American countries. The receipt of the ANMAT approval for HPV is the first step of a regulatory process towards the commercial sales of Naturaferon. On September 20, 2012, the Company filed with ANMAT an amended NDA for the use of Alferon N Injection® in patients with chronic hepatitis C who have become refractory to recombinant interferon as a result of the appearance of neutralizing antibodies against recombinant interferon. On February 6, 2013, we received the ANMAT approval for the treatment of refractory Hepatitis C with Naturaferon in Argentina.
 
Alferon® Low Dose Oral (LDO)
 
Alferon® LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection®, should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa. Oral interferon could be economically feasible for patients and logistically manageable in development programs in third-world countries primarily affected by influenza and other emerging viruses. Oral administration of Alferon® LDO, with its anticipated affordability, low toxicity, no production of antibodies, and broad range of potential bioactivity, could be a breakthrough treatment or prevention for viral diseases.
.

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In December 2010, the FDA authorized a protocol to conduct a Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO for the prophylaxis and treatment of seasonal and pandemic influenza of more than 200 subjects. Our Phase II study has continued to be delayed as we have redirected many of our resources to the Ampligen® NDA submission and New Brunswick manufacturing enhancement project.

Other Diseases
 
In July 2011, we received FDA authorization to proceed with the initiation of a new clinical trial of intranasal Ampligen® to be used in conjunction with commercially approved seasonal influenza vaccine. On April 16, 2012, a clinical trial was initiated in which Ampligen® is being nasally administered in conjunction with FluMist® to healthy human volunteers at the University of Alabama at Birmingham under the auspices of Dr. Paul Goepfert, Associate Professor of Medicine in the Division of Infectious Diseases and Director of the Alabama Vaccine Research Clinic. This study is a first use of Ampligen® with a seasonal vaccine in humans to assess the safety of Ampligen® when nasally delivered as a vaccine adjuvant. Another objective of this study is to determine the extent to which Ampligen® mobilizes potential protections against pandemic influenza by utilization of a seasonal flu vaccine. The study will evaluate the potential immunologic enhancement of Ampligen® by comparing immune parameters in the group receiving Ampligen® plus FluMist® with another group receiving FluMist® plus placebo. We intend to conduct a broad array of immune tests to compare the immune response for both its magnitude and breadth. It is our objective to qualify and enroll 72 patients for this clinical trial. As of September 30, 2013, twelve subjects have participated in this study. As required by the study's protocol, a Data Monitoring Committee has reviewed the safety data on all twelve subjects and approved the study to proceed at the next higher dosage level.

In August 2011, a study utilizing Ampligen® was initiated by investigators from the Tumor Vaccine Group (“TVG”) at the University of Washington in Seattle, WA. As of September 30, 2013, fifty patients have enrolled in this ninety-eight patient Phase I-II Study of HER2 vaccination with Ampligen® as an adjuvant in optimally treated breast cancer patients. The goal of this study is to see how well the combination works in treating patients with Stage II-IV human epidermal growth factor receptor 2 (“HER2”)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. The TVG has developed vaccines against several cancer proteins, and in this study, they are researching a new approach in an attempt to make the immune response to the vaccine even better. Compounds that specifically stimulate TLR receptors are promising immune stimulators, and Ampligen® has the potential to provide a profile of immune stimulation that could be clinically beneficial.

At the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado held in September 2013, our Director, William Mitchell, MD, Ph.D., Professor Pathology, Microbiology, and Immunology, Vanderbilt University, presented the results of a study of Alferon N Injection® against wild type and oseltamivir (Tamiflu)-resistant H7N9 influenza virus. The increasing prevalence of oseltamivir-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus makes it resistant to oseltamivir. Dr. Mitchell discussed new experiments on the inhibition of Tamiflu®-resistant H7N9 virus by Alferon N Injection®. These experiments were conducted at Kansas State University by Professor Juergen Richt, DVM, Ph.D., a scientific adviser to Hemispherx and Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Regents Distinguished Professor of Veterinary Medicine at Kansas State University and an Eminent Scholar of Kansas Bioscience Association (KBA) along with his staff. Dr. Mitchell described the results with Alferon®, including in-vitro experiments directed against inhibiting the Tamiflu®-resistant H7N9 highly pathogenic influenza strain. Tamiflu® (oseltamivir) and Alferon® were tested in A549 cells for antiviral activity in vitro against the wild-type (wt) human A(H7N9) isolate A/Anhui/1/2013 (wt Anhui 1) and a patient isolate (A/Shanghai/1/2013 (NA-292K; Shanghai 1-NA292K)) with resistance to oseltamivir. The wt Anhui 1 was sensitive to both Tamiflu® and Alferon®. The Shanghai 1-NA292K virus was resistant to Tamiflu® treatment but was sensitive to Alferon® when tested in A549 cells. These initial results showed that:
•
Tamiflu® and Alferon® have a significant inhibitory effect on the wild-type A(H7N9) virus. Alferon® but not Tamiflu® had a significant inhibitory effect on oseltamivir-resistant neuraminidase mutant Shanghai 1-NA292K;
•
Alferon® is similar to oseltamivir in reduction of titers from wt A(H7N9) isolates following 48 hours exposure to each drug;
•
Alferon® appears to be highly effective as an inhibitor the A(H7N9) strain which demonstrates marked resistance to oseltamivir (Tamiflu®); and
•
Tamiflu®-resistant H7N9 viruses are associated with poor clinical outcomes. The potential for pandemic spread is dependent on the acquisition of additional mutations in the viral hemagglutinin gene allowing efficient human to human spread. Based on the evidence discussed, Alferon® may prove, after additional study, to offer a new therapeutic strategy option to mitigate the health hazards associated with the potential pandemic spread of neuraminidase inhibitor-resistant human influenza viruses.


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Biosecurity / Biodefense

On September 9, 2013, we announced at the Rodman and Renshaw Conference in New York City a major new initiative in the BioSecurity field involving both Alferon N Injection® and Ampligen®. Our Chief Executive Officer, Dr. William Carter, MD, highlighted the broad anti-viral effect of both agents along with the Company’s strategy to undertake major programs in the biosecurity field, specifically with respect to the potential prevention or treatment of pandemic flu virus, H7N9, MERS (Middle East Respiratory Syndrome) and alpha viruses such as VEE (Venezuelan Equine Encephalomyelitis). With all three classes of viruses, researchers have now confirmed significant bioactivity with Ampligen® or Alferon N Injection®, or both, in either in vitro and/or in vivo non-human studies. Alferon N Injection® has been found to be highly active against SARS virus (a close relative of MERS) by the Singapore Genome Institute in laboratory studies. Dr. Carter highlighted that the results of the recent Kansas State University experiments, coupled with Dr. Richt’s work on influenza virus reassortment (mixing of genetic material) and other published studies, sets the stage for evaluating the possibility that mutational changes and reassortment could be prevented in animals by the use of type I interferon (α/ß) and/or a type I interferon inducer. Moreover, previous research suggested that Alferon® may be active against a range of viruses existing in animal populations even in the low dose oral (LDO) formulation referred to as Alferon® LDO.

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 as of March 15, 2008 and then was reinstated effective January 1, 2010. For the nine months ended September 30, 2013, the Company contributions towards the 401(k) Plan were $146,000.
 
New Accounting Pronouncements
 
See “Note 13: 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 I; Item 2: “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, 2012.
 
RESULTS OF OPERATIONS

Three months ended September 30, 2013 versus three months ended September 30, 2012
 
Net Loss
 
Our net loss was approximately $5,136,000 for the three months ended September 30, 2013, a decrease in loss of approximately $1,451,000 or 22% when compared to the same period in 2012. This decrease in loss for these three months was primarily due to the following:
1)
a decrease in Production Costs of approximately $736,000 or 74%;
2)
a decrease in Research and Development costs of approximately $184,000 or 8%;
3)
the revaluation of the Liability related to the Redeemable Warrants resulting in a non-cash gain of approximately $38,000 in 2013 as compared to non-cash loss of $1,968,000 for the same period in 2012, resulting in a decrease in loss of approximately $2,006,000; offset by
4)
an increase in General and Administrative expenses of approximately $411,000 or 25%;
5)
a decrease in interest and other income of approximately $264,000 from funds invested in Marketable Securities; and
6)
An estimated impairment loss of $800,000 against the public trading value of Marketable Securities deemed to be other than temporarily impaired.
 

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Net loss per share was $(0.03) and $(0.05) for the three months ended September 30, 2013 and 2012, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2013 was 167,389,685 as compared to 137,012,240 as of September 30, 2012.
 
Revenues
 
Revenues from our Ampligen® Cost Recovery Program decreased approximately $3,000, or 8%, for the third quarter of 2013 as compared to the same time period of 2013 due to the number of patients decreasing 4% in the three months ended September 30, 2013. As of September 30, 2013, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
 
Production/Cost of Goods Sold
 
Production/Cost of Goods Sold was approximately $252,000 and $988,000, respectively, for the three months ended September 30, 2013 and 2012. This decrease of approximately $736,000 or 74% was primarily due to a write-down of Alferon® work in process inventory of approximately $733,000 in the quarter ended September 30, 2012 which did not occur in 2013's current quarter (see “Overview; General; Alferon N Injection®” above).

Research and Development Costs

Overall Research and Development (“R&D”) costs for the three months ended September 30, 2013 were approximately $2,173,000 as compared to $2,357,000 for the same period a year ago, reflecting a decrease of approximately $184,000 or 8%. The decreased R&D costs during this three month period in 2013 were primarily due to decreased efforts regarding the Ampligen® NDA and related efforts. Specifically, Ampligen® expenses decreased during the three months ended September 30, 2013 for clinical studies by approximately $109,000, research costs by approximately $254,000 and polymer production by approximately$395,000. In addition, Alferon® related costs increased approximately $359,000 for cGMP compliance testing and approximately $177,000 for environmental studies at our New Brunswick manufacturing facility.
 
General and Administrative Expenses
 
General and Administrative (“G&A”) expenses for the three months ended September 30, 2013 and 2012, were approximately $2,070,000 and $1,659,000, respectively, reflecting an increase of approximately $411,000 or 25%. The higher G&A expenses in 2013 are due to higher legal fees of $289,000 (see "Part II - Other Information; Item 1: Legal Proceedings" for details) and public relations: expenses of $70,000 along with other minor increases which reflect normal period inflation.

Interest and Other Income
 
Interest and other income for the three months ended September 30, 2013 and 2012 were approximately $89,000 and $353,000, respectively, representing a decrease of approximately $264,000 or 75%. For the three month period ending September 30, 2012, the Company had sold an aggregate of 10,699,700 shares through the new EDA with Maxim that resulted in net cash proceeds of approximately $9,268,000, as compared to no sales for the same period in 2013. The cause for the decrease in investment income in 2013 was primarily due to greater value of funds available in 2012 for investment purposes.
 
Redeemable Warrants
 
The quarterly fiscal revaluation of certain redeemable warrants resulted in non-cash adjustments to the redeemable warrants liability for the three months ended September 30, 2013 and 2012 of gain of approximately $38,000 and loss of approximately ($1,968,000), respectively, representing a non-cash, increase in gain of $2,006,000 (see “Note 11: Fair Value” for the various factors considered in the valuation of redeemable warrants).

Impairment Loss from Marketable Securities

Our quarterly analysis of the trading value for marketable securities resulted in an observation that some of our investments had experienced a decrease in market value for a period of longer than the last six consecutive months. Accordingly, an estimated impairment loss of $800,000 was recognized in September 2013 for the sustained decrease in the respective market value.


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Nine months ended September 30, 2013 versus nine months ended September 30, 2012
 
Net Loss
 
Our net loss was approximately $13,030,000 for the nine months ended September 30, 2013, an increase in loss of approximately $1,135,000 or 10% when compared to the same period in 2012. This increase in loss for these nine months was primarily due to the following:
1)
an increase in Research and Development costs of approximately $1,069,000 or 19%;
2)
an increase in General and Administrative expenses of approximately $693,000 or 13%;
3)
sale in January 2013 of New Jersey state net operating loss carry-forwards (for the year 2011) for approximately $686,000 as compared to approximately $1,328,000 received in January 2012 (for the years 2009 and 2010), representing a decrease in cash gain of approximately $642,000 or 48%;
4)
a decrease in interest and other income of approximately $249,000 from funds invested in Marketable Securities; and
5)
an estimated impairment loss of $800,000 from Marketable Securities deemed to be other than temporarily impaired; offset by
6)
a decrease in Production Costs of approximately $398,000 or 27%; and
7)
the revaluation of the Liability related to the Redeemable Warrants resulting in a non-cash gain of approximately $229,000 in 2013 as compared to non-cash loss of ($1,732,000) for the same period in 2012, resulting in an increase in gain of approximately $1,961,000.
 
Net loss per share was $(0.08) and $(0.09) for the nine months ended September 30, 2013 and 2012, respectively. The weighted average number of shares of our common stock outstanding as of September 30, 2013 was 167,135,111, as compared to 136,260,727 as of September 30, 2012.
 
Revenues
 
Revenues from our Ampligen® Cost Recovery Program decreased approximately $46,000, or 29%, for the first nine months of 2013 as compared to the same time period of 2012 due to the number of patients decreasing 26% during the nine months ended September 30, 2013. As of September 30, 2013, we had no Alferon N Injection® Finished Good product to commercially sell and all revenue was generated from the FDA approved open-label treatment protocol, (“AMP 511”), that allows patient access to Ampligen® for treatment in an open-label safety study.
 
Production/Cost of Goods Sold
 
Production/Cost of Goods Sold was approximately $1,078,000 and $1,476,000, respectively, for the nine months ended September 30, 2013 and 2012. This decrease of approximately $398,000 or 27% was primarily due to the write-down of Alferon® work in process inventory of approximately $733,000 in 2012 versus $458,000 in 2013 (see “Overview; General; Alferon N Injection®” above) plus lower cost for the testing of finished goods inventory of approximately $123,000, which is being used for research purposes.

Research and Development Costs
 
Overall Research and Development (“R&D”) costs for the nine months ended September 30, 2013 were approximately $6,827,000 as compared to approximately $5,758,000 for the same period a year ago, reflecting an increase of approximately $1,069,000 or 19%. The increased R&D costs during this nine month period in 2013 were due to our efforts regarding the Ampligen® NDA and related activities. Specifically, Ampligen® expenses increased during the nine months ended September 30, 2013 for clinical studies by approximately $316,000 and polymer production costs of approximately $458,000 offset by lower research costs by $109,000. In addition, Alferon® related costs increased approximately $483,000 related to cGMP compliance testing at our New Brunswick manufacturing facility.


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General and Administrative Expenses
 
General and Administrative (“G&A”) expenses for the nine months ended September 30, 2013 and 2012, were approximately $5,964,000 and $5,271,000, respectively, reflecting an increase of $693,000 or 13%. The higher G&A expenses in 2013 are due to an increase in legal fees of approximately $543,000 and public relations expenses of approximately $238,000 along with other minor increases which reflect normal period inflation.

Interest and Other Income
 
Interest and other income for the nine months ended September 30, 2013 and 2012 were approximately $624,000 and $873,000, respectively, representing a decrease of $249,000 or 29%. For the nine month period ending September 30, 2012, the Company had sold an aggregate of 10,699,700 shares through the new EDA with Maxim that resulted in net cash proceeds of approximately $9,268,000, as compared to no sales for the same period in 2013 pursuant to the ATM. The cause for the decrease in investment income in 2013 was primarily due to greater value of funds available in 2012 for investment purposes during the third fiscal quarter of the respective years.

Redeemable Warrants
 
The quarterly fiscal revaluation of redeemable warrants resulted in non-cash adjustments to the redeemable warrants liability for the nine months ended September 30, 2013 and 2012 of gains of approximately $229,000 and loss of approximately ($1,732,000), respectively, representing a non-cash, increase in gain of $1,961,000 (see “Note 11: Fair Value” for the various factors considered in the valuation of redeemable warrants).
 
Sale of New Jersey Tax Net Operating Loss
 
In January 2013, the Company effectively sold of $8,500,000 of our approximately $17,000,000 of New Jersey State Net Operating Loss carryforwards (for the year 2011) for approximately $686,000 as compared to January 2012 sale of approximately $16,000,000 of our $25,000,000 of New Jersey state net operating loss carryforwards (for the years 2009 and 2010) for approximately $1,328,000, representing a decrease in cash gain of $642,000 or 48% (see “Note 14: Funds Received From Sale of Income Tax Net Operating Losses”) for the nine months ended September 30, 2013 as compared to the same period in 2012.

Impairment Loss from Marketable Securities

Our quarterly analysis of the trading value for marketable securities for the period ended September 30, 2013 resulted in an observation that some of our investments had experienced a decrease in market value for a period of longer than the last six consecutive months. Accordingly, an estimated impairment loss of $800,000 was recognized in September 2013 for the sustained decrease in the respective market value.

Liquidity and Capital Resources
 
Cash used in operating activities for the nine months ended September 30, 2013 was approximately $13,646,000 compared to approximately $8,181,000 for the same period in 2012, an increase of $5,465,000 or 67%. Excluding the proceeds from the sale of New Jersey Net Operating Loss carry-forwards, cash used in operating activities for the nine months ended September 30, 2013 increased by approximately $6,107,000 or 89% over the comparable period in 2012. The primary reasons for this increase in 2013 were the January 2013 payout of 2012 employee and strategic consultant bonuses for approximately $2,196,000 and approximately $1,026,000 for payments of accounts payable and approximately $1,762,000 of 2013 accounts payable for increased research and development, and general and administrative expenses.

As of September 30, 2013, we had approximately $29,221,000 in cash, cash equivalents and marketable securities (restricted and unrestricted) inclusive of approximately $14,068,000 in Marketable Securities collateralizing certain debts, or a decrease of approximately $14,732,000 from December 31, 2012. However, if we are unable to commercialize and sell Ampligen® or Alferon® LDO and/or recommence material sales of Alferon N Injection®, our operations, financial position and liquidity may be adversely impacted, and additional financing may be required. However, there is no assurance that such financing will be available.

In October 2013, we liquidated approximately one-half of the $14,068,000 in Marketable Securities - Restricted (see “Note 6: Marketable Securities – Restricted”) in order to pay-off in its entirety the approximately $7,051,000 of principal balance of the Margin Account Loan (see "Note 9: Margin Account Loan). As a result, the Margin Account Loan was eliminated and the remaining dollar value of the Marketable Securities - Restricted was reclassified as Unrestricted as of October 31, 2013. Unrealized

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losses from fixed-income securities (bonds) are primarily attributable to changes in interest rates and/or a reduction in their rating of credit worthiness as deemed by independent financial rating services.

In its February 1, 2013 CRL, the FDA communicated that we should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. Until we undertake the end-of-review conference(s) with the FDA, we are unable to reasonably estimate the nature, costs, necessary efforts to obtain FDA clearance or anticipated completion dates of any additional clinical study or studies. Please see “Part II; Item 1A. Risk Factors; “We may require additional financing which may not be available. The limitation on the number of shares of common stock available for financing without prior stockholder approval eventually may hinder our ability to raise additional funding”. Utilizing the industry norms for undertaking a Phase III clinical study, we estimate upon acceptance of the study's design that it would take approximately 18 months to three years to complete a new well-controlled Ampligen® clinical study for resubmission to the FDA. We anticipate that the time and cost to undertake clinical trial(s), studies and data analysis are beyond our current financial resources without gaining access to additional funding. The actual duration to complete the clinical study may be different based on the length of time it takes to design the study and obtain FDA's acceptance of the study plan, the final design of an acceptable Phase III clinical study protocol, 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 which may require additional financing which may not be available. The limitation on the number of shares of common stock available for financing without prior stockholder approval eventually may hinder our ability to raise additional funding”.

On July 23, 2012, we entered into a new EDA with Maxim (the New EDA”) pursuant to which we may sell up to $75,000,000 worth of our shares of common stock from time to time through Maxim, as sales agent. Under the New EDA, Maxim is entitled to a fixed commission rate of 4.0% of the gross sales price of Shares sold under the New EDA, up to aggregate gross proceeds of $10,000,000, and thereafter, at a fixed commission rate of 3.0% of the gross sales price of Shares sold under the EDA. Sales of the Shares, if any, may be made in transactions that are deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers' transactions, including on the NYSE MKT, at market prices or as otherwise agreed with Maxim. We have no obligation to sell any of the Shares and may at any time suspend offers under the New EDA or terminate the New EDA. The Shares are being sold pursuant to our Universal Shelf Registration Statement on Form S-3, declared effective by the Securities and Exchange Commission on July 2, 2012. On September 14, 2012, we filed a Prospectus Supplement with the SEC increasing the number of shares covered by the Prospectus from 12,000,000 to 20,000,000 shares under the New ATM. On October 5, 2012, we filed an updated Prospectus Supplement increasing the number of shares covered by the Prospectus to 40,000,000 shares. As of September 30, 2012, we had sold an aggregate of 10,699,700 shares that resulted in net cash proceeds of approximately $9,268,000 and commissions paid to Maxim of approximately $393,000. As of December 31, 2012, we had sold an aggregate of approximately 29,500,000 shares of the New EDA that resulted in net cash proceeds of approximately $23,003,000 after direct expenses along with commissions paid to Maxim for approximately $820,000 (see “Note 10: Stockholders' Equity”). However, for the nine months ended September 30, 2013, we did not sell any shares pursuant to the ATM. The impact of 2012's fund raising effort through the New ATM, which did not occur in 2013, is reflected in the "Consolidated Statements of Cash Flow" Statement comparing the various financing activities for the nine months ended September 30, 2013 to the same period in 2012.

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. See Part II, ITEM 1A. Risk Factors; “We may require additional financing which may not be available. The limitation on the number of shares of common stock available for financing without prior stockholder approval eventually may hinder our ability to raise additional funding.”


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The proceeds from our financing have been used to fund infrastructure growth including manufacturing, regulatory compliance and market development along with our efforts regarding the 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 $29,221,000 in cash, cash equivalents and marketable securities (restricted and non-restricted inclusive of $14,068,000 in Marketable Securities collateralizing certain debts) at September 30, 2013 as compared to $43,953,000 at December 31, 2012 (inclusive of $14,500,000 in Marketable Securities collateralizing certain debts).

During October 2013, we liquidated approximately one-half of the $14,068,000 in Marketable Securities - Restricted (see “Note 6: Marketable Securities – Restricted”) in order to pay-off in its entirety the approximately $7,051,000 of principal balance of the Margin Account Loan (see "Note 9: Margin Account Loan). Please see Part I; Item 2: "Management's Discussion and Analysis of Financial Condition and Results of Operations; Liquidity and Capital Resources".

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 Chairman of the Board (serving as the principal executive officer) and the Chief Financial Officer 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 Chief Executive Officer and Chief Financial Officer concluded that the controls and procedures were effective as of September 30, 2013, to ensure that material information was accumulated and communicated to our Management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
 
During the nine months ended September 30, 2013, 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.
  
Part II – OTHER INFORMATION
 
ITEM 1:   Legal Proceedings
 
Except as set forth below, there have been no material developments in litigation from that disclosed in our Annual Report Form 10-K for the fiscal year ended December 31, 2012, Note 16 - Contingencies:

(a)
Stephanie A. Frater v. Hemispherx Biopharma, Inc., William A. Carter, David Strayer and Wayne Pambianchi, U.S. District Court for Eastern District of Pennsylvania, Case No. 2:12-cv-07152-WY.
(b)
Mark Zicherman v. Hemispherx Biopharma, Inc., William A. Carter, Thomas K. Equels, Iraj E. Kiani, William M. Mitchell, Richard C. Piani, David Strayer and Charles T. Bernhardt, U.S. District Court for Eastern District of Pennsylvania, Case No. 2:13-cv-00243-WY.
(c)
Michael Desclos v. Hemispherx Biopharma, Inc., William A. Carter, Charles T. Bernhardt, Thomas K. Equels, David R. Strayer, Richard C. Piani, William M. Mitchell, and Iraj E. Kiani, First Judicial District of Pennsylvania, Court of Common Pleas of Philadelphia, March 2013 Term, No. 110.
(d)
Richard J. Sussman and Douglas T. Lowe v. Hemispherx Biopharma, Inc., William A. Carter, Charles T. Bernhardt, Thomas K. Equels, David R. Strayer, Richard C. Piani, William M. Mitchell, and Iraj E. Kiani, First Judicial District of Pennsylvania, Court of Common Pleas of Philadelphia, April 2013 Term, No. 3458.
(e)
Rena A. Kastis and James E. Conroy v. Hemispherx Biopharma, Inc., William A. Carter, Thomas K. Equels, Richard C. Piani, William M. Mitchell, Iraj E. Kiani and Robert E Peterson, Chancery Court of the State of Delaware , June 18, 2013, Case No. 8657.

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On December 21, 2012, a putative Federal Securities Class Action Complaint was filed against the Company and three of its Officers in the United States District Court for the Eastern District of Pennsylvania. This action, Stephanie A. Frater v. Hemispherx Biopharma, Inc., et al., was purportedly brought on behalf of a putative class of Hemispherx investors who purchased the Company's publicly traded securities between March 14, 2012 and December 17, 2012. The Complaint generally asserted that Defendants made material misrepresentations and omissions regarding the status of the Company's New Drug Application for Ampligen®, which had been filed with the United States Food and Drug Administration, in alleged violation of Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”), Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act. On March 14, 2013, the Court appointed Hemispherx Investor Group as Lead Plaintiff pursuant to the Private Securities Litigation Reform Act of 1995 (“PSLRA”), 15 U.S.C. § 78u-4. Pursuant to the Court's March 29, 2013 scheduling order, Lead Plaintiff filed a Consolidated Amended Class Action Complaint (“Amended Complaint”) on May 20, 2013, and in its Amended Complaint, dropped Thomas K. Equels and Charles T. Bernhardt as Defendants and added David R. Strayer, M.D. and Wayne Pambianchi as Defendants. The Amended Complaint alleges an expanded Class Period of March 14, 2012 to December 20, 2012, which period encompasses statements made in the Company's 2011 Form 10-K filed on March 14, 2012, and at the FDA Advisory Committee Meeting on December 20, 2012. On July 19, 2013, Defendants filed a motion to dismiss the Amended Complaint. Lead Plaintiff filed its brief in opposition to Defendants' motion to dismiss is September 17, 2013, and Defendants filed their reply brief on October 17, 2013. Under the PSLRA, discovery is stayed pending the Court's decision on Defendants' motion to dismiss.

On January 15, 2013, a Shareholder Derivative Complaint was filed against the Company, as nominal defendant, and certain of its Officers and Directors in the United States District Court for the Eastern District of Pennsylvania. The Complaint in this action, Mark Zicherman v. Hemispherx Biopharma, Inc., et al., alleges violations of state law, including breaches of fiduciary duties, waste of corporate assets, and unjust enrichment, arising from the alleged federal securities violations asserted in the securities class action. On February 22, 2013, the Court entered an order staying this case pending the outcome of Defendants' motion to dismiss the securities class action. On July 3, 2013, Plaintiff filed an Amended Complaint, adding David R. Strayer, M.D., as a Defendant. On July 18, 2013, the Court entered an order staying the case as against Dr. Strayer pending the outcome of Defendants' motion to dismiss the securities class action.

On March 4, 2013, a Shareholder Derivative Complaint was filed against the Company, as nominal defendant, and certain of its Officers and Directors in the First Judicial District of Pennsylvania of the Court of Common Pleas of Philadelphia. The Complaint in this action, Michael Desclos v. Hemispherx Biopharma, Inc., et al., alleges violations of state law, including breaches of fiduciary duties, waste of corporate assets, and unjust enrichment. On April 10, 2013, the Court entered an order staying this case pending the outcome of Defendants' motion to dismiss the securities class action.

On April 23, 2013, a Shareholder Derivative Complaint was filed against the Company, as nominal defendant, and certain of its Officers and Directors in the First Judicial District of Pennsylvania of the Court of Common Pleas of Philadelphia. The Complaint in this action, Richard J. Sussman and Douglas T. Lowe v. Hemispherx Biopharma, Inc., et al., alleges violations of state law, including breaches of fiduciary duties, abuse of control, gross mismanagement, waste of corporate assets, and unjust enrichment. On May 10, 2013, the Court entered an order staying this case pending the outcome of the ruling on the Federal Securities Class Action Defendant's Motion to dismiss.

On June 18, 2013, a Shareholder Derivative Complaint was filed against the Company, as nominal defendant, and certain of its current and former Officers and Directors in the Court of Chancery of the State of Delaware. The Complaint in this action, Rena A. Kastis and James E. Conroy v. Hemispherx Biopharma, Inc., et al., alleges breaches of fiduciary duties, waste of corporate assets and unjust enrichment. The Company's Board of Directors has appointed a Special Litigation Committee (“SLC”) to review the allegations set forth in the Complaint. On September 10, 2013, the Court entered a Stipulation and Order staying all proceedings in this action pending the SLC’s review and recommendation concerning the allegations contained in the Complaint. This Order requires that the SLC issue its report and recommendation on or before December 20, 2013; and if the SLC seeks to dismiss or settle the claims asserted in the action, it must file an opening brief in support thereof on or before January 20, 2014. The plaintiffs will have until February 3, 2014 to accept, respond or otherwise take action with respect to the SLC’s report and recommendation.

The Company intends to vigorously defend these actions. The potential impact of these actions, which seek unspecified damages, equitable relief, attorneys' fees and expenses, is uncertain. There can be no assurance that an adverse result in these proceedings would not have a potentially material adverse effect on the Company's business, results of operations and financial condition.

(f)
Hemispherx Biopharma, Inc. v. Johannesburg Consolidated Investments, et al., U.S. District Court for the Southern District of Florida, Case No. 04-10129-CIV.


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Hemispherx and the other parties to the domestication action are seeking to convene an arbitral panel in South Africa to decide the domestication issue and, while no date has yet been agreed upon, it is estimated that it will be heard in the Spring of 2014.

(g)
MidSouth Capital, Inc. v. Hemispherx Biopharma, Inc., Civil Action No. 1:09-CV-03110-CAP.

After remand to the United States District Court, Northern District of Georgia, a Scheduling Order proposed by the parties was entered by the Court on October 17, 2012. The Company deposed representatives of two more of the investors to preserve their testimony for trial. Neither witness testified that MidSouth's activity significantly influenced the decision to invest. The parties have submitted a proposed pretrial Order. The Company has also filed a Motion to Reopen Discovery for a limited purpose, a Motion in Limine to exclude five categories of evidence and a Request for a Special Setting. The Court held a Pretrial Conference on October 3, 2013. The Court denied the Motion to Reopen Discovery, stated that the case will be number one on a published calendar for trial after the first of the year, and took all other matters under advisement. The Company will vigorously defend the remaining claims. No specific date has been set for trial.

As of November 1, 2013, no informed judgment can be made as to the likely outcome and Counsel is unable to provide a precise estimate of the merits or probability of success of the MidSouth claims. The maximum amount sought by MidSouth is $4,800,000, but Counsel believes the realistic exposure is substantially less than that.

(h)
Cato Capital, LLC v. Hemispherx Biopharma, Inc., U.S. District Court for the District of Delaware, Case No. 09-549-GMS.

The Parties had a Non-Jury trial on March 4, 5 and 6, 2013 before the United States District Court for the District of Delaware. On April 22, 2013 the Parties submitted Proposed Findings of Fact and Conclusions of Law, and on April 26, 2013, submitted hyperlinked copies to the Court pursuant to the Court's Order. There can be no estimate of when the Court may rule on the case.

As of November 1, 2013, no informed judgment can be made as to the likely outcome and Counsel is unable to provide an estimate of the merits or probability of success of the Cato claims or a range of potential recovery or loss.

(i)
Summation.

In reference to Contingencies identified, there can be no assurance that an adverse result in these proceedings would not have a potentially material adverse effect on our business, results of operations, and financial condition. The Company believes it has meritorious defenses and is vigorously defending against the claims identified. There is currently no projection as to the likely outcome of the cases and the Company has not recorded any gain or loss contingencies as a result of the above matters for the nine months ended September 30, 2013 or year ended December 31, 2012. Also with regards to Contingency (a), (b), (c), (d) and (e), the Company maintains insurance coverage which is expected to respond to certain claims and expenses.
 
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
 
No assurance of successful product development.
 
Ampligen® and related products. The development of Ampligen® and our other related products is subject to a number of significant risks. Ampligen® may be found to be ineffective or to have adverse side effects, fail to receive necessary regulatory clearances, be difficult to manufacture on a commercial scale, be uneconomical to market or be precluded from commercialization by proprietary right of third parties. Our investigational products are in various stages of clinical and pre-clinical development and require further clinical studies and appropriate regulatory approval processes before any such products can be marketed. We do not know when, if ever, Ampligen® or our other products will be generally available for commercial sale for any indication. Generally, only a small percentage of potential therapeutic products are eventually approved by the FDA for commercial sale. (Please see the next Risk Factor and Part 1, Item I Business, “Our Products” “Ampligen®” above for more information).


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Alferon N Injection®. Although Alferon N Injection® is approved for marketing in the United States for the intra-lesional treatment of refractory or recurring external genital warts in patients 18 years of age or older, to date it has not been approved for other indications. We face many of the risks discussed above, with regard to developing this product for use to treat other ailments. (Please see the next Risk Factor and Part 1, Item I Business, “Our Products” “Alferon N Injection®” above for more information).

Our drug and related technologies are investigational and subject to regulatory approval. If we are unable to obtain regulatory approval in a timely manner, or at all, our operations will be materially harmed and our stock adversely affected.

All of our drugs and associated technologies, other than Alferon N Injection®, are investigational and must receive prior regulatory approval by appropriate regulatory authorities for commercial distribution and sale and are currently legally available only through clinical trials with specified disorders. At present, Alferon N Injection® is only approved for the intra-lesional treatment of refractory or recurring external genital warts in patients 18 years of age or older. Use of Alferon N Injection® for other indications will require regulatory approval.

Our products, including Ampligen®, are subject to extensive regulation by numerous governmental authorities in the United States (“U.S.”) and other countries, including, but not limited to, the FDA in the U.S., the Health Protection Branch (“HPB”) of Canada, the Agency for the European Medicines Agency (“EMA”) in Europe and the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) in Argentina. Obtaining regulatory approvals is a rigorous and lengthy process and requires the expenditure of substantial resources. In order to obtain final regulatory approval of a new drug, we must demonstrate to the satisfaction of the regulatory agency that the product is safe and effective for its intended uses and that we are capable of manufacturing the product to the applicable regulatory standards. We require regulatory approval in order to market Ampligen® or any other proposed product and receive product revenues or royalties. We cannot assure you that Ampligen® will ultimately be demonstrated to be safe and efficacious. While Ampligen® is authorized for use in clinical trials in the U.S., we cannot assure you that additional clinical trial approvals will be authorized in the United States or in other countries, in a timely fashion or at all, or that we will complete these clinical trials. In addition, although Ampligen® has been authorized by the FDA for treatment use under certain conditions, including provision for cost recovery, there can be no assurance that such authorization will continue in effect.
 
On February 1, 2013, we received a CRL from the FDA declining to approve our Ampligen® 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. For more detailed information about the current status of our Ampligen® NDA please see “Our Products; Ampligen®” in Part 1, Item 1. Business above.

The FDA's regulatory review and approval process is extensive, lengthy, expensive and inherently uncertain. To receive approval for a product candidate, we must, among other things, demonstrate to the FDA's satisfaction with substantial evidence from well-controlled pre-clinical and clinical trials that the product candidate is both safe and effective for each indication for which approval is sought. Before we can sell Ampligen® for any use, or Alferon® for any use other than as Alferon N Injection® for treatment of refractory or recurring genital warts, we will need to file the appropriate NDA with the FDA in the U.S. and the appropriate regulatory agency outside of the U.S. where we intend to market and sell such products. At present the only NDA we have filed with the FDA is the NDA for the use of Ampligen® to treat CFS. As discussed in the prior paragraph, the FDA declined to approve this NDA and indicated that we needed to conduct additional work. Therefore, ultimate FDA approval, if any, may be delayed by several years and may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to make our applications approvable. If any of these outcomes occur, we may be forced to abandon one or more of our future applications for approval, which might significantly harm our business and prospects. As a result, we cannot predict if or when we might receive regulatory approval for the use of Ampligen® to treat CFS or for the use of any other products. Even if regulatory approval from the FDA is received for the use of Ampligen® to treat CFS or eventually, for the use of any other product, any approvals that we obtain could contain significant limitations in the form of narrow indications, patient populations, warnings, precautions or contra-indications or other conditions of use, or the requirement that we implement a risk evaluation and mitigation strategy. In such an event, our ability to generate revenues from such products could be greatly reduced and our business could be harmed.

Even if we believe that data collected from our preclinical studies and clinical trials of our product candidate are promising, these data have not been, and may not be in the future, sufficient to support marketing approval by the FDA, and regulatory interpretation of these data and procedures may continue to be unfavorable.

To the extent that we are required by the FDA pursuant to the Ampligen® NDA to conduct additional studies and take additional actions, approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have available. It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for approval or even to make our applications approvable. If any of these outcomes occur,

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we may be forced to abandon one or more of our future applications for approval, which might significantly harm our business and prospects. As a result, we cannot predict when or whether regulatory approval will be obtained for any product candidate we develop.

Obtaining approval of a NDA by the FDA, or a comparable foreign regulatory authority, is inherently uncertain. Even after completing clinical trials and other studies, a product candidate could fail to receive regulatory approval for many reasons, including the following:
•
not be able to demonstrate to the satisfaction of the FDA that our product candidate is safe and effective for any indication;
•
the FDA may disagree with the design or implementation of our clinical trials or other studies;
•
the results of the clinical trials or other studies may not demonstrate that a product candidate's clinical and other benefits outweigh its safety risks;
•
the FDA may disagree with our interpretation of data from clinical trials or other studies;
•
the data collected from clinical trials and other studies of a product candidate may not be sufficient to support the submission of a NDA;
•
the approval policies or regulations of the FDA may significantly change in a manner rendering our clinical and other study data insufficient for approval; and
•
the FDA may not approve the proposed manufacturing processes and facilities for a product candidate.

In April 2012, FDA reviewers raised certain questions about the status of our existing lots of older Work-In-Process Alferon® materials and Alferon® API, which would need to be released by the FDA before those materials could be used in commercial product. After conducting all of the appropriate tests on samples of the inventory during 2013, we concluded that we could not alleviate certain questions the FDA had about the older Work-In-Process Alferon N Injection®. Accordingly, these lots will not be submitted to the FDA to request release for commercial sale and their remaining dollar value has been written-off. In the absence of FDA approvals for product manufactured from existing inventory, commercial sales of Alferon® will not resume until new batches of Alferon® inventory and API can be produced, filled and finished, and released by the FDA for commercial sale. (Please see Part 1, Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations; “Overview; General; Alferon N Injection®” above for more information).

Alferon® LDO has been approved for pre-clinical testing for possible use as prophylaxis against influenza. While the studies to date have been encouraging, preliminary testing in the laboratory and in animal models is not necessarily predictive of successful results in clinical testing or human treatment. No assurance can be given that similar results will be observed in clinical trials. Use of Alferon® as a possible treatment of influenza requires prior regulatory approval. In October 2009, we originally submitted a protocol to the FDA proposing to conduct a Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO for the prophylaxis and treatment of seasonal and pandemic influenza of more than 200 subjects. In December 2010, the FDA authorized this Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon® LDO for the prophylaxis and treatment of seasonal and pandemic influenza of more than 200 subjects. Our Phase II study has been delayed. The outcome of this confirmatory study, if and when resumed, will allow us to better evaluate the potential effectiveness of this product and to proceed with this study of seasonal and pandemic influenza. We are unable to provide any assurances that the Phase II Alferon® LDO study for the prophylaxis and treatment of seasonal and pandemic influenza will be undertaken.

If we are unable to gain necessary FDA approvals related to Ampligen® and Alferon® on a timely basis, our operations most likely will be materially and/or adversely affected. Additionally, if we are unable to generate the additional data, successfully complete inspections or obtain approvals as required by the FDA on a timely manner, or at all, or determine that any of our clinical studies are not cost/justified to undertake or if, for that or any other reason, Ampligen®, Alferon® or one of our other products or production processes do not receive necessary regulatory approval in the U.S. or elsewhere:
•
our ability to generate revenues to sustain our operations will be substantially impaired, which would increase the likelihood that we would need to obtain additional financing for our other development efforts;
•
our reputation among investors might be harmed, which might make it more difficult for us to obtain equity capital on attractive terms or at all; and
•
our profitability would be delayed, our business will be materially harmed and our stock price may be adversely affected.

Biotechnology stock prices, including our stock price, have declined significantly in certain instances where companies have failed to meet expectations with respect to FDA approval or the timing for FDA approval.
 

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We may continue to incur substantial losses and our future profitability is uncertain.
 
We began operations in 1966 and last reported net profit from 1985 through 1987. Since 1987, with a major emphasis on new drug diagnostic and development, we have incurred substantial operating losses, as we pursued our clinical trial effort to get our experimental drug, Ampligen®, approved. As of September 30, 2013, our accumulated deficit was approximately $(257,124,000). 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 most likely will require additional financing which may not be available. The limitation on the number of shares of common stock available for financing without prior stockholder approval eventually may hinder our ability to raise additional funding.
 
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 September 30, 2013, we had approximately $29,221,000 in cash, cash equivalents and marketable securities (inclusive of approximately $14,068,000 in Marketable Securities collateralizing approximately $7,051,000 of principal balance of the Margin Account Loan). However, if we are unable to commercialize and sell Ampligen® or Alferon® LDO and/or recommence material sales of Alferon N Injection®, our operations, financial position and liquidity may be adversely impacted.

In its CRL, the FDA communicated that Hemispherx should conduct at least one additional clinical trial, complete various nonclinical studies and perform a number of data analyses. Until we undertake the end-of-review conference(s) with the FDA, we are unable to reasonably estimate the nature, costs, necessary efforts to obtain FDA clearance or anticipated completion dates of any additional clinical study or studies. Utilizing the industry norms for undertaking a Phase III clinical study, we estimate upon acceptance of the study's design that it would take approximately 18 months to three years to complete a new well-controlled Ampligen® clinical study for resubmission to the FDA. It can be reasonably anticipated that the time and cost to undertake clinical trial(s), studies and data analysis are beyond our current financial resources without gaining access to additional funding. The actual duration to complete the clinical study may be different based on the length of time it takes to design the study and obtain FDA's acceptance of the design, the final design of an acceptable Phase III clinical study 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 of obtaining NDA approval of Ampligen® along with the manufacturing, marketing and distribution of our products, including Alferon N Injection®. We may also need additional capital to eventually commercialize and sell Ampligen® or Alferon® LDO 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.

In this regard, on July 23, 2012, we entered into a New Equity Distribution Agreement with Maxim (the “New EDA”) pursuant to which we may sell up to $75,000,000 worth of our shares of Common Stock from time to time through Maxim, as sales agent (See Part I; Item 2: “Management's Discussion and Analysis of Financial Condition and Results of Operations; Liquidity and Capital Resources” above). We cannot assure how much funding will be obtained from the New EDA or whether it will be sufficient in conjunction with current financial resources to permit us to take all actions needed to obtain FDA approval for Ampligen® and manufacturing, commercialization, marketing and distribution of our products.

Our ability to raise additional funds from the sale of equity securities may be limited due to limitations on our ability to sell stock for funding purposes. Pursuant to our Amended and Restated Certificate of Incorporation, the purpose for which 75,000,000 of 150,000,000 of our authorized shares (the “Restricted Shares”) may be utilized is limited. Specifically, without stockholder approval, the Restricted Shares can only be issued where such issuance would be primarily in connection with strategic transactions or other non-fundraising purpose that met certain significant criteria. In this regard, approximately 65,362,000 shares are authorized but unissued and unreserved at September 30, 2013 with an additional 75,000,000 of the Restricted Shares approved by Stockholders for certain generally defined business purposes.


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There can be no assurances that we can obtain the requisite stockholder approval to use any additional Restricted Shares for funding purposes or raise adequate funds from other sources. If we are unable to obtain additional funding, through the New Maxim EDA or otherwise, our ability to develop our products, commercially produce inventory or continue our operations may be materially adversely affected.

Our Alferon N Injection® Commercial Sales were halted due to lack of finished goods inventory. If we are unable to gain the necessary FDA approvals related to Alferon®, our operations most likely will be materially and/or adversely affected.
 
Commercial sales of Alferon N Injection® were halted in March 2008 when our finished goods inventory expired. The production of Alferon N Injection® from the Work-In-Process Inventory was restarted in May 2010, continued into January 2011 with its conversion into API.

In April 2012, FDA reviewers raised certain questions about the status of our existing lots of older Work-In-Process Alferon® materials and Alferon® API, which would need to be released by the FDA before those materials could be used in commercial product. After conducting all of the appropriate tests on samples of the inventory during 2013, we concluded that we could not alleviate certain questions the FDA had about the older Work-In-Process Alferon N Injection® and their remaining dollar value has been written-off. As we no longer have any existing inventory, commercial sales of Alferon® will not resume until new batches of Alferon® inventory and API can be produced, filled and finished, and released by the FDA for commercial sale.

While our facility is FDA approved under the BLA by the FDA for Alferon®, this status will need to be reaffirmed upon the completion of the facility's upgrades for Alferon®. We cannot provide any guarantee that the facility will necessarily pass a FDA pre-approval inspection for Ampligen® or Alferon® manufacture, which are conducted in separately dedicated areas within the overall New Brunswick manufacturing complex. Please see “There is no assurance that our manufacturing facility will again be granted a BLA certification by the FDA upon completion of the manufacturing enhancements or return to commercial, large-scale production” below for more information.

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. For more information on Alferon N Injection® regarding potential commercial sales, please see “Alferon N Injection®” in Item 2: “Management's Discussion and Analysis of Financial Condition and Results of Operations; Overview; General”.

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.
 
We may not be profitable unless we can protect our patents and/or receive approval for additional pending patents.
 
We need to preserve and acquire enforceable patents covering the use of Ampligen® for a particular disease in order to obtain exclusive rights for the commercial sale of Ampligen® for such disease. We obtained all rights to Alferon N Injection®, and we plan to preserve and acquire enforceable patents covering its use for existing and potentially new diseases. Our success depends, in large part, on our ability to preserve and obtain patent protection for our products and to obtain and preserve our trade secrets and expertise. Certain of our know-how and technology is not patentable, particularly the procedures for the manufacture of our experimental drug, Ampligen®. We also have been issued patents on the use of Ampligen® in combination with certain other drugs for the treatment of chronic Hepatitis B virus, chronic Hepatitis C virus, and a patent which affords protection on the use of Ampligen® in patients with Chronic Fatigue Syndrome. We have not yet been issued any patents in the United States for the use of Ampligen® as a sole treatment for any of the cancers which we have sought to target.

One of our Alferon® composition patents (#5,676,942) expired in April 2013. This patent related to the manufacturing process for Alferon® API, a complex mixture of natural interferon species that is manufactured from human leukocytes obtained from human blood donors. In addition, while it is the current standard by the FDA to treat biological drug products like interferon as “Well Characterized” biologics, a process for which chemical entities can have their identity, purity, impurities, potency, and quality controlled by chemical testing, Alferon®, as a natural interferon, does not lend itself well to such testing. Moreover, FDA continues to require that each lot or Alferon we produce be tested and released by the FDA before it can distributed for commercial sales. Because of the complexity of the Alferon manufacturing process and these additional regulatory requirements, we believe that potential manufacturers of generic, or so-called “bio-similar,” drug products are focused on developing recombinant interferon products, rather than natural interferon products. For these reasons we believe, but cannot assure, that the expiration of this Alferon® composition patent in April 2013 should have no or little impact on the Company. Alferon® composition patent #5,676,942, relates to a methodology by which we no longer produce the product. However, in the event that a potential manufacturer does produce an interferon ingredient similar to Alferon® API, and generates sufficient data to demonstrate the

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effectiveness of its product for one or more clinical uses, that manufacturer could obtain an approval to sell its product and to compete with and/or supplant Alferon N Injection® in the market for natural alpha interferon products. The requirements for FDA approval of so-called “biosimilar” biological products are still evolving, with few such products having been approved for any use, and the likely requirements that may apply to a new alpha interferon product cannot be predicted at this time.

We cannot assure that our competitors will not seek and obtain patents regarding the use of similar products in combination with various other agents, for a particular target indication prior to our doing so. If we cannot protect our patents covering the use of our products for a particular disease, or obtain additional patents, we may not be able to successfully market our products.

The patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions.
 
To date, no consistent policy has emerged regarding the breadth of protection afforded by pharmaceutical and biotechnology patents. There can be no assurance that new patent applications relating to our products, process or technology will result in patents being issued or that, if issued, such patents will afford meaningful protection against competitors with similar technology. It is generally anticipated that there may be significant litigation in the industry regarding patent and intellectual property rights. Such litigation could require substantial resources from us and we may not have the financial resources necessary to enforce the patent rights that we hold. No assurance can be made that our patents will provide competitive advantages for our products, process and technology or will not be successfully challenged by competitors. No assurance can be given that patents do not exist or could not be filed which would have a materially adverse effect on our ability to develop or market our products or to obtain or maintain any competitive position that we may achieve with respect to our products. Our patents also may not prevent others from developing competitive products or process using related technology.

There can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent rights we may hold. In addition, the failure of third parties from whom we currently license certain proprietary information or from whom we may be required to obtain such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect the value of such licenses to us.
 
If we cannot enforce the patent rights we currently hold we may be required to obtain licenses from others to develop, manufacture or market our products. There can be no assurance that we would be able to obtain any such licenses on commercially reasonable terms, if at all. We currently license certain proprietary information from third parties, some of which may have been developed with government grants under circumstances where the government maintained certain rights with respect to the proprietary information developed. No assurances can be given that such third parties will adequately enforce any rights they may have or that the rights, if any, retained by the government will not adversely affect the value of our license.
 
There is no guarantee that our trade secrets will not be disclosed or known by our competitors.
 
To protect our rights, we require all employees and certain consultants to enter into confidentiality agreements with us. There can be no assurance that these agreements will not be breached, that we would have adequate and enforceable remedies for any breach, or that any trade secrets of ours will not otherwise become known or be independently developed by competitors.
 
We have limited marketing and sales capability. If we are unable to obtain additional distributors and our current and future distributors do not market our products successfully, we may not generate significant revenues or become profitable.
 
We have limited marketing and sales capability. We are dependent upon existing and, possibly future, marketing agreements and third party distribution agreements for our products in order to generate significant revenues and become profitable. As a result, any revenues received by us will be dependent in large part on the efforts of third parties, and there is no assurance that these efforts will be successful.

Our commercialization strategy for Ampligen® for CFS, if and when it is approved for marketing and sale by the FDA, may include licensing/co-marketing agreements utilizing the resources and capacities of a strategic partner(s). We continue to seek world-wide marketing partner(s), with the goal of having a relationship in place before approval is obtained. In parallel to partnering discussions, appropriate premarketing activities will be undertaken. It is our current intention to control manufacturing of Ampligen® on a world-wide basis.

Our commercialization strategy for Alferon N Injection® may include the utilization of internal functions and/or licensing/co-marketing agreements that would utilize the resources and capacities of one or more strategic partners. Accordingly, we have engaged Armada Healthcare to undertake the marketing, education and sales of Alferon N Injection® throughout the United States along with GP Pharm for both Ampligen® and Alferon® in Argentina along with other South and Latin American countries.

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We cannot assure that our U.S. or foreign marketing strategy will be successful or that we will be able to establish future marketing or third party distribution agreements on terms acceptable to us, or that the cost of establishing these arrangements will not exceed any product revenues. Our inability to establish viable marketing and sales capabilities would most likely have a materially adverse effect on us. There can be no assurances that the approved Alferon N Injection® product will be returned to prior sales levels.
 
There are no long-term agreements with suppliers of required materials and services for Ampligen® and there are a limited number of raw material suppliers. If we are unable to obtain the required raw materials and/or services, we may not be able to manufacture Ampligen®.
 
A number of essential raw materials are used in the production of Ampligen® as well as packaging materials utilized in the fill and finish process. We do not have, but continue to work towards having long-term agreements for the supply of such materials, when possible. There can be no assurance we can enter into long-term supply agreements covering essential materials on commercially reasonable terms, if at all.

There are a limited number of suppliers in the United States available to provide the raw and packaging materials for use in manufacturing Ampligen®. At present, we do not have any agreements with third parties for the supply of any of these materials. We have established relevant manufacturing operations within our New Brunswick, New Jersey facility for the production of Ampligen® polymers from raw materials in order to obtain a more consistent manufacturing basis in the quantities necessary for clinical testing. In September 2011 and similar to our prior agreements, Hollister-Stier has agreed to undertake the manufacturing sets to formulate, fill, finish and package Ampligen® from the key polymers that we would supply. Hollister-Stier would have the right of first refusal to manufacture certain Ampligen® related products. For more information on Ampligen®, please see the “Ampligen®” in Item 2: "Management's Discussion and Analysis of Financial Condition and Results of Operations; Overview; General".

If we are unable to obtain or manufacture the required materials, and/or procure services needed in the final steps in the manufacturing process, we may be unable to manufacture Ampligen®. The costs and availability of products and materials we need for the production of Ampligen® are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology, ownership of intellectual property, FDA and other governmental regulations. There can be no assurance that we will be able to obtain such products and materials on terms acceptable to us or at all.
 
There are a limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill, finish and packing sets for Alferon N Injection® and Ampligen®.
 
There are a limited number of organizations in the United States available to provide the final steps in the manufacturing for Alferon N Injection® and Ampligen®. To formulate, fill, finish and package our products (“fill and finish”), we require a FDA approved third party CMO.

In January 2012, we agreed to a Technology, Transfer, Validation and Commercial Supply Agreement with Althea Technologies, Inc. regarding the fill and finish process for Alferon N Injection® (see Part 1, Item 2; Management's Discussion and Analysis of Financial Condition and Results of Operations; “Overview; General; Alferon N Injection®”). As we no longer have any existing inventory, commercial sales of Alferon® will not resume until new batches of Alferon® inventory and API can be produced, filled and finished, and released by the FDA for commercial sale.

Pursuant our Supply Agreement with Hollister-Stier, they will formulate, fill, finish and package Ampligen® from the key raw materials that we would supply. We are unable to provide any assurances that the FDA will approve the inventory manufactured by us or produced by Hollister-Stier. If this finish goods inventory is not granted approval by the FDA, our operations may be materially adversely affected. This Supply Agreement, as amended extends through March 11, 2014.

If we are unable to procure services needed in the final steps in the manufacturing process, we may be unable to manufacture Alferon N Injection® and/or Ampligen®. The costs and availability of products and materials we need for the production of Ampligen® and the commercial production of Alferon N Injection® and other products which we may commercially produce are subject to fluctuation depending on a variety of factors beyond our control, including competitive factors, changes in technology, and FDA and other governmental regulations and there can be no assurance that we will be able to obtain such products and materials on terms acceptable to us or at all. For more information on Ampligen® and Alferon N Injection®, please see “Ampligen®”, “Alferon N Injection®” in Item 2: “Management's Discussion and Analysis of Financial Condition and Results of Operations; Overview; General”.
 

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There is no assurance that our manufacturing facility will again be granted a BLA certification by the FDA upon completion of the manufacturing enhancements or return to commercial, large-scale production.

We are currently in the Installation and Operation Qualification phase for Alferon® production of the enhancement project. The production of new Alferon® API inventory will not commence until the validation phase is completed. While the facility is approved by FDA under the BLA for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. We anticipate that it will take until at least the second half of 2014 before we will have newly produced Alferon® API ready for submission to the FDA for review and approval. For more information, please see ITEM 2: “Management's Discussion and Analysis of Financial Condition and Results of Operations; Overview; General; Alferon N Injection®” above. There can be no assurance the BLA status will be recertified by the FDA upon the completion of the enhancement process or that the manufacturing facility will return to commercial, large-scale production for Alferon®. Additionally, there can be no assurance that any given product will be determined to be safe and effective, or capable of being manufactured under applicable quality standards.

Only if and when our BLA status is recertified by the FDA to produce new lots of Alferon® at our enhanced manufacturing facility can batches of Alferon® API be produced, formulated, filled, finished, packaged and then approved for release by the FDA. We are unable to provide any assurances that the FDA will approve our enhanced manufacturing process and/or newly created finish product lots. Without FDA approval, our Alferon N Injection® will not be considered suitable for commercial sales.

In light of these contingencies, there can be no assurances that the approved Alferon N Injection® product will be returned to commercial production or sale 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.

There is no assurance that upon successful manufacture of a drug on a limited scale basis for investigational use will lead to a successful transition to commercial, large-scale production.

Changes in methods of manufacturing, including commercial scale-up, may affect the chemical structure of Ampligen® and other RNA drugs, as well as their safety and efficacy. The transition from limited production of pre-clinical and clinical research quantities to production of commercial quantities of our products will involve distinct management and technical challenges and may require additional management, technical personnel and capital to the extent such manufacturing is not handled by third parties. While we believe that the Company could successfully upgrade our production capability at our New Brunswick, NJ facility in a commercial scale-up of Ampligen®, there can be no assurance that our manufacturing will be successful or that any given product will be determined to be safe and effective, or capable of being manufactured under applicable quality standards, economically, and in commercial quantities, or successfully marketed.
 
We have limited manufacturing experience for Ampligen® and Alferon®. We may not be profitable unless we can produce Ampligen®, Alferon® or other products in commercial quantities at costs acceptable to us.
 
Satisfactory inspection by the FDA of both our Ampligen® and Alferon® manufacturing process is required before commercial sale of project would be allowed. The CRL from the FDA on February 1, 2013, requests evaluation of variation between lots of Ampligen® tested in the development process and recommends tighter control of the Ampligen® manufacturing process. We cannot provide any guarantee that the facility will pass a FDA pre-approval inspection for Ampligen® or Alferon® manufacture, which are conducted in separately dedicated areas within the overall New Brunswick manufacturing complex. The failure to obtain FDA approval for either of our manufacturing process areas would most likely have a materially adverse impact upon us.

Ampligen® has been produced to date in limited quantities for use in our clinical trials, and we are dependent upon a qualified third party supplier for the manufacturing, filling, finish and packaging process. The failure to continue these arrangements or to achieve other such arrangements on satisfactory terms could have a material adverse effect on us.

In furtherance of the capital improvement program at our New Brunswick, NJ facility to upgrade our manufacturing capability to produce bulk quantities of Alferon N Injection® API, the validation phase of the Alferon® manufacturing project is currently underway as we undertake the Installation and Operation Qualification phase of the enhancement project. While the facility is approved by FDA under the BLA for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. We anticipate that it will take until at least the second half of 2014 before we will

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have newly produced Alferon® API ready for submission to the FDA for review and approval. 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. The failure to obtain FDA approval of any of our manufacturing process would most likely have a materially adverse impact upon us.

Also to be successful, our products must be manufactured in commercial quantities in compliance with regulatory requirements and at acceptable costs. We believe, but cannot assure, that our enhancements to our manufacturing facilities will be adequate for our future needs for the production of our proposed products for large-scale commercialization. We intend to ramp up our existing facility and/or utilize third party facilities if and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities. We will need to comply with regulatory requirements for such facilities, including those of the FDA pertaining to cGMP requirements or maintaining our BLA status. There can be no assurance that such facilities can be used, built, or acquired on commercially acceptable terms, or that such facilities, if used, built, or acquired, will be adequate for the production of our proposed products for large-scale commercialization or our long-term needs.

We have never produced Ampligen®, Alferon® or any other products in large commercial quantities. We must manufacture our products in compliance with regulatory requirements in large commercial quantities and at acceptable costs in order for us to be profitable. We intend to utilize third party manufacturers and/or facilities if and when the need arises or, if we are unable to do so, to build or acquire commercial-scale manufacturing facilities. If we cannot manufacture commercial quantities of Ampligen® and/or Alferon®, or continue to maintain third party agreements for its manufacture at costs acceptable to us, our operations will be significantly affected. If and when the Ampligen® NDA is approved, we may need to find an additional vendor to manufacture the product for commercial sales. Also, each production lot of Alferon N Injection® is subject to FDA review and approval prior to releasing the lots to be sold. This review and approval process could take considerable time, which would delay our having product in inventory to sell, nor can we provide any assurance as to the receipt of FDA approval of our finished inventory product. There can be no assurances that the Ampligen® and/or Alferon® can be commercially produced at costs acceptable to us.
 
Rapid technological change may render our products obsolete or non-competitive.
 
The pharmaceutical and biotechnology industries are subject to rapid and substantial technological change. Technological competition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase. Most of these entities have significantly greater research and development capabilities than us, as well as substantial marketing, financial and managerial resources, and represent significant competition for us. There can be no assurance that developments by others will not render our products or technologies obsolete or noncompetitive or that we will be able to keep pace with technological developments.
 
Our products may be subject to substantial competition.
 
Ampligen®. Competitors may be developing technologies that are, or in the future may be, the basis for competitive products. Some of these potential products may have an entirely different approach or means of accomplishing similar therapeutic effects to products being developed by us. These competing products may be more effective and less costly than our products. In addition, conventional drug therapy, surgery and other more familiar treatments may offer competition to our products. Furthermore, many of our competitors have significantly greater experience than we do in preclinical testing and human clinical trials of pharmaceutical products and in obtaining FDA, HPB and other regulatory approvals of products. Accordingly, our competitors may succeed in obtaining FDA, HPB or other regulatory product approvals more rapidly than us. There are no drugs approved for commercial sale with respect to treating CFS in the United States. The dominant competitors with drugs to treat disease indications in which we plan to address include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca. Biotech competitors include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta. These potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we have. Although we believe our principal advantage is the unique mechanism of action of Ampligen® on the immune system, we cannot assure that we will be able to compete.

Alferon N Injection®. Our competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities than we have. Alferon N Injection® currently competes with Merck's injectable recombinant alpha interferon product (INTRON® A) for the treatment of genital warts. In addition, other pharmaceutical firms offer self-administered topical cream, for the treatment of external genital and perianal warts such as Graceway Pharmaceuticals (Aldara®), Watson Pharma (Condylox®) and MediGene (Veregen®). Alferon N Injection® also competes with surgical, chemical, and other methods of treating genital warts. We cannot assess the impact products developed by our competitors, or advances in

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other methods of the treatment of genital warts, will have on the commercial viability of Alferon N Injection®. If and when we obtain additional approvals of uses of this product, we expect to compete primarily on the basis of product performance. Our competitors have developed or may develop products (containing either alpha or beta interferon or other therapeutic compounds) or other treatment modalities for those uses. There can be no assurance that, if we are able to obtain regulatory approval of Alferon N Injection® for the treatment of new indications, we will be able to achieve any significant penetration into those markets. In addition, because certain competitive products are not dependent on a source of human blood cells, such products may be able to be produced in greater volume and at a lower cost than Alferon N Injection®. Currently, our wholesale price on a per unit basis of Alferon N Injection® is higher than that of the competitive recombinant alpha and beta interferon products. Please see “We may not be profitable unless we can protect our patents and/or receive approval for additional pending patents" above for additional information.

General. Other companies may succeed in developing products earlier than we do, obtaining approvals for such products from the FDA more rapidly than we do, or developing products that are more effective than those we may develop. While we will attempt to expand our technological capabilities in order to remain competitive, there can be no assurance that research and development by others or other medical advances will not render our technology or products obsolete or non-competitive or result in treatments or cures superior to any therapy we develop.
 
Possible side effects from the use of Ampligen® or Alferon N Injection® could adversely affect potential revenues and physician/patient acceptability of our product.
 
Ampligen®. We believe that Ampligen® has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating or life threatening diseases that have been treated. A mild flushing reaction has been observed in approximately 15-20% of patients treated in our various studies. This reaction is occasionally accompanied by a rapid heartbeat, a tightness of the chest, urticaria (swelling of the skin), anxiety, shortness of breath, subjective reports of “feeling hot”, sweating and nausea. The reaction is usually infusion-rate related and can generally be controlled by reducing the rate of infusion. Other adverse side effects include liver enzyme level elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash, visual disturbances, slow or irregular heart rate, decreases in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting. These flu-like side effects typically subside within several months.

The FDA in its February 1, 2013 CRL, set forth the reasons for not approving Ampligen® at this time and provided recommendations to address certain of the outstanding issues. The Agency stated that the submitted data do not provide substantial evidence of efficacy of Ampligen® for the treatment of CFS and that the data do not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data.

If approved, one or more of the potential side effects of the drug might deter usage of Ampligen® in certain clinical situations and therefore, could adversely affect potential revenues and physician/patient acceptability of our product.

Alferon N Injection®. At present, Alferon N Injection® is only approved for the intra-lesional (within the lesion) treatment of refractory or recurring external genital warts in adults. In clinical trials conducted for the treatment of genital warts with Alferon N Injection®, patients did not experience serious side effects; however, there can be no assurance that unexpected or unacceptable side effects will not be found in the future for this use or other potential uses of Alferon N Injection® which could threaten or limit such product's usefulness.

We may be subject to product liability claims from the use of Ampligen®, Alferon N Injection®, or other of our products which could negatively affect our future operations. We have limited product liability insurance.
 
We maintain Products Liability and Clinical Trial insurance coverage world-wide for Ampligen® and Alferon®. However even with retaining Products Liability and Clinical Trial insurance coverage for Ampligen®, Alferon N Injection® and Alferon® LDO, a claim against the products could have a materially adverse effect on our business and financial condition.
 
We face an inherent business risk of exposure to product liability claims in the event that the use of Ampligen®, Alferon N Injection® or other of our products results in adverse effects. This liability might result from claims made directly by patients, hospitals, clinics or other consumers, or by pharmaceutical companies or others manufacturing these products on our behalf. Our future operations may be negatively affected from the litigation costs, settlement expenses and lost product sales inherent to these claims. While we will continue to attempt to take appropriate precautions, we cannot assure that we will avoid significant product liability exposure.
 

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The loss of services of key personnel including Dr. William A. Carter could hurt our chances for success.
 
Our success is dependent on the continued efforts of our staff, especially certain doctors and researchers along with the continued efforts of Dr. William A. Carter because of his position as a pioneer in the field of nucleic acid drugs, his being the co-inventor of Ampligen®, and his knowledge of our overall activities, including patents and clinical trials. The loss of the services of Dr. Carter or other personnel key to our operations, could have a material adverse effect on our operations and chances for success. As a cash conservation measure, we have elected to discontinue the Key Man life insurance on the life of Dr. Carter. An employment agreement continues to exist with Dr. Carter that, as amended, runs until December 31, 2016. However, Dr. Carter has the right to terminate his employment upon not less than 30 days prior written notice. The loss of Dr. Carter or other key personnel or the failure to recruit additional personnel as needed could have a materially adverse effect on our ability to achieve our objectives.
 
Uncertainty of health care reimbursement for our products.
 
Our ability to successfully commercialize our products will depend, in part, on the extent to which reimbursement for the cost of such products and related treatment will be available from government health administration authorities, private health coverage insurers and other organizations. Significant uncertainty exists as to the reimbursement status of newly approved health care products, and from time to time legislation is proposed, which, if adopted, could further restrict the prices charged by and/or amounts reimbursable to manufacturers of pharmaceutical products. We cannot predict what, if any, legislation will ultimately be adopted or the impact of such legislation on us. There can be no assurance that third party insurance companies will allow us to charge and receive payments for products sufficient to realize an appropriate return on our investment in product development.
 
There are risks of liabilities associated with handling and disposing of hazardous materials.
 
Our business involves the controlled use of hazardous materials, carcinogenic chemicals, flammable solvents and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply in all material respects with the standards prescribed by applicable regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of such an accident or the failure to comply with applicable regulations, we could be held liable for any damages that result, and any such liability could be significant. We do not maintain insurance coverage against such liabilities.
 
A Securities Federal Class Action and Four Shareholder Derivative Actions Have Been Filed Against Us and We May Be Subject to Civil Liabilities.
 
As described below in Item 3. Legal Proceedings, paragraphs (a), (b), (c), (d) and (e), five actions have been filed against Hemispherx and certain of its Officers and Directors: a putative class action alleging violations of the federal securities laws and seeking monetary damages, costs, and attorneys' fees; and four shareholder derivative actions alleging various state law breach of fiduciary duty, waste of corporate assets and unjust enrichment claims along with seeking monetary damages, costs, attorneys' fees, and equitable and injunctive relief. Defending against these suits, even if meritless, can result in substantial costs to us and could divert the attention of our management.

The existence of these proceedings could have a material adverse effect on our ability to access the capital markets to raise additional funds. While Management believes that the lawsuits are without merit, we cannot predict or determine the timing or final outcomes of the lawsuits and are unable to estimate the amount or range of loss that could result from unfavorable outcomes. Adverse results in some or all of these legal proceedings could be material to our results of operations, financial condition or cash flows.

Risks Associated With an Investment in Our Common Stock:
 
The market price of our stock may be adversely affected by market volatility.
 
The market price of our common stock has been and is likely to be volatile. This is especially true given the current significant instability in the financial markets. In addition to general economic, political and market conditions, the price and trading volume of our stock could fluctuate widely in response to many factors, including:

•
announcements of the results of clinical trials by us or our competitors;
•
announcements of availability or projections of our products for commercial sale;
•
announcements of legal actions against us and/or settlements or verdicts adverse to us;
•
adverse reactions to products;

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•
governmental approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory agency comments regarding the safety or effectiveness of our products, or the adequacy of the procedures, facilities or controls employed in the manufacture of our products;
•
changes in U.S. or foreign regulatory policy during the period of product development;
•
developments in patent or other proprietary rights, including any third party challenges of our intellectual property rights;
•
announcements of technological innovations by us or our competitors;
•
announcements of new products or new contracts by us or our competitors;
•
actual or anticipated variations in our operating results due to the level of development expenses and other factors;
•
changes in financial estimates by securities analysts and whether our earnings meet or exceed the estimates;
•
conditions and trends in the pharmaceutical and other industries;
•
new accounting standards;
•
overall investment market fluctuation;
•
restatement of prior financial results;
•
notice of NYSE MKT non-compliance with requirements; and
•
occurrence of any of the risks described in these "Risk Factors".

Our common stock is listed for quotation on the NYSE MKT. For the nine month period ended September 30, 2013, the trading price of our common stock has ranged from $0.18 to $0.36 per share. We expect the price of our common stock to remain volatile. The average daily trading volume of our common stock varies significantly.
 
In the past, following periods of volatility in the market price of the securities of companies in our industry, securities class action litigation has often been instituted against companies in our industry. In this regard, please see “A Securities Federal Class Action and Four Shareholder Derivative Actions Have Been Filed Against Us and We May Be Subject to Civil Liabilities" above.
 
Our stock price may be adversely affected if a significant amount of shares are sold in the public market.
 
In May 2009, we issued an aggregate of 25,543,339 shares and warrants to purchase an additional 14,708,687 shares under a Universal Shelf Registration Statement. 4,895,000 of these warrants have been exercised as of both September 30, 2013 and December 31, 2012. Depending upon market conditions, we anticipate selling 9,813,687 shares pursuant to the conversion of remaining warrants.
 
Additionally, we registered with the SEC on September 29, 2009, 1,038,527 shares issuable upon exercise of certain other warrants. To the extent the exercise price of our outstanding warrants is less than the market price of the common stock, the holders of the warrants are likely to exercise them and sell the underlying shares of common stock and to the extent that the exercise price of certain of these warrants are adjusted pursuant to anti-dilution protection, the warrants could be exercisable or convertible for even more shares of common stock. We also may issue shares to be used to meet our capital requirements or use shares to compensate employees, consultants and/or Directors. In this regard, we have registered $150,000,000 of securities for public sale pursuant to a universal shelf registration statement and we have been selling shares under this shelf registration statement and the New EDA with Maxim. Through September 30, 2013, we had sold an aggregate of approximately 29,500,000 shares under the New EDA.
 
Pursuant to the New Maxim EDA, we may sell up to $75,000,000 worth of our shares of Common Stock from time to time through Maxim, as sales agent. While we have no obligation to sell any of the Shares and may at any time suspend offers under the New Maxim EDA or terminate the EDA, the sale of substantial numbers of Shares under the EDA may have an adverse impact on the trading value of the stock.
 
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. Sales of substantial amounts of our common stock in the public market, including additional sale of securities pursuant to the New EDA with Maxim or otherwise under the universal shelf registration statement or upon exercise of outstanding options, could cause the market price for our common stock to decrease. Furthermore, a decline in the price of our common stock would likely impede our ability to raise capital through the issuance of additional shares of common stock or other equity securities.
 

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Provisions of our Certificate of Incorporation and Delaware law could defer a change of our Management which could discourage or delay offers to acquire us.
 
Provisions of our Certificate of Incorporation and Delaware law may make it more difficult for someone to acquire control of us or for our stockholders to remove existing management, and might discourage a third party from offering to acquire us, even if a change in control or in Management would be beneficial to our stockholders. For example, our Certificate of Incorporation allows us to issue shares of preferred stock without any vote or further action by our stockholders. Our Board of Directors has the authority to fix and determine the relative rights and preferences of preferred stock. Our Board of Directors also has the authority to issue preferred stock without further stockholder approval. As a result, our Board of Directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock. In this regard, on November 2, 2012, we amended and restated our Stockholder Rights Plan (“Rights Plan”) and, under the Rights Plan, our Board of Directors declared a dividend distribution of one Right for each outstanding share of Common Stock to stockholders of record at the close of business on November 29, 2002. Each Right initially entitles holders to buy one-hundredth unit of preferred stock for $30.00 and may be redeemed prior to November 19, 2017, the expiration date, at $0.001 per Right under certain circumstances. The Rights generally are not transferable apart from the common stock and will not be exercisable unless and until a person or group acquires or commences a tender or exchange offer to acquire, beneficial ownership of 15% or more of our common stock. At September 30, 2013, for Dr. Carter, our Chief Executive Officer and President, who already beneficially owns approximately 5.58% of our common stock, the Rights Plan’s threshold will be 20%, instead of 15%.
 
Special Note Regarding Forward Looking Statements
 
Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us, you should not place undue reliance on any such forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made and we undertake no obligation to update any forward-looking statement or statements to reflect events or circumstances after the date on which such statement is made or reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Our research in clinical efforts may continue for the next several years and we may continue to incur losses due to clinical costs incurred in the development of Ampligen® for commercial application. Possible losses may fluctuate from quarter to quarter as a result of differences in the timing of significant expenses incurred and receipt of licensing fees and/or cost recovery treatment revenue.

ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds
 
We did not have any unregistered sales nor repurchase any of our securities during the nine months ended September 30, 2013.
 
ITEM 3: Defaults upon Senior Securities
 
None.
 
ITEM 4: Mine Safety Disclosures

Not Applicable.
 
ITEM 5: Other Information

The Company entered into a new agreement with The Sage Group, with substantially the same terms as the prior agreement, retroactive to June 15, 2013, the expiration date of the prior agreement.
 

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ITEM 6: Exhibits
 
(a)Exhibits
10.1

The Sage Group Advisors Agreement, effective October 22, 2013.
 
 
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

The following materials from Hemispherx’ Quarterly Report on Form 10-Q for the period ended September 30, 2013, formatted in eXtensible Business Reporting Language (“XBRL”): (i) Condensed Balance Sheets ; (ii) Condensed Consolidated Statements of Comprehensive Loss; (iii) Condensed Consolidated Statements of Cash Flows; and (iv) Notes to Condensed Consolidated Financial Statements.


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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/ William A. Carter
 
William A. Carter, M.D.
 
Chief Executive Officer & President
 
 
 
/s/ Charles T. Bernhardt
 
Charles T. Bernhardt, CPA
 
Chief Financial Officer
 
 
Date: November 8, 2013
 


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