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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Humanigen Inc (CE) | USOTC:HGEN | OTCMarkets | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0002 | 0.00 | 01:00:00 |
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐ |
TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934
|
Delaware
|
77-0557236
|
|
(State or other jurisdiction of
|
(IRS Employer
|
|
incorporation)
|
Identification No.)
|
Large accelerated filer
☐
|
Accelerated filer
☐
|
|
Non-accelerated filer
☐
(Do not check if a smaller reporting company) |
Smaller reporting company
☒
|
|
Emerging growth company
☒
|
Page
|
|||
3 | |||
Item 1.
|
3 | ||
3 | |||
4 | |||
5 | |||
6 | |||
Item 2.
|
17
|
||
Item 4.
|
24
|
||
25
|
|||
Item 1. | Legal Proceedings | 25 | |
Item 6.
|
26
|
||
28
|
March 31,
|
December 31,
|
|||||||
|
2018 |
2017
|
||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
1,560
|
$
|
737
|
||||
Prepaid expenses and other current assets
|
838
|
813
|
||||||
Total current assets
|
2,398
|
1,550
|
||||||
Property and equipment, net
|
10
|
19
|
||||||
Restricted cash
|
101
|
101
|
||||||
Total assets
|
$
|
2,509
|
$
|
1,670
|
||||
Liabilities and stockholders’ deficit
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
3,302
|
$
|
3,330
|
||||
Accrued expenses
|
3,239
|
3,307
|
||||||
Term loans payable
|
-
|
18,018
|
||||||
Total current liabilities
|
6,541
|
24,655
|
||||||
Notes payable to vendors
|
1,380
|
1,351
|
||||||
Total liabilities
|
7,921
|
26,006
|
||||||
Stockholders’ deficit:
|
||||||||
Common stock, $0.001 par value: 225,000,000 and 85,000,000 shares
|
||||||||
authorized at March 31, 2018 and December 31, 2017, respectively;
109,207,786 and 14,946,712 shares issued and outstanding at March 31,
2018 and December 31, 2017, respectively
|
109
|
15
|
||||||
Additional paid-in capital
|
262,163
|
238,246
|
||||||
Accumulated deficit
|
(267,684
|
)
|
(262,597
|
)
|
||||
Total stockholders’ deficit
|
(5,412
|
)
|
(24,336
|
)
|
||||
Total liabilities and stockholders’ deficit
|
$
|
2,509
|
$
|
1,670
|
Three Months Ended March 31,
|
||||||||
2018
|
2017
|
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
696
|
$
|
2,669
|
||||
General and administrative
|
3,957
|
2,449
|
||||||
Total operating expenses
|
4,653
|
5,118
|
||||||
Loss from operations
|
(4,653
|
)
|
(5,118
|
)
|
||||
Other expense:
|
||||||||
Interest expense
|
(394
|
)
|
(291
|
)
|
||||
Other expense, net
|
(3
|
)
|
(15
|
)
|
||||
Reorganization items, net
|
(37
|
)
|
(124
|
)
|
||||
Net loss
|
(5,087
|
)
|
(5,548
|
)
|
||||
Other comprehensive income
|
-
|
-
|
||||||
Comprehensive loss
|
$
|
(5,087
|
)
|
$
|
(5,548
|
)
|
||
Basic and diluted net loss per common share
|
$
|
(0.10
|
)
|
$
|
(0.37
|
)
|
||
Weighted average common shares outstanding used to
|
||||||||
calculate basic and diluted net loss per common share
|
49,155,859
|
14,977,397
|
Three Months Ended March 31,
|
||||||||
2018
|
2017
|
|||||||
Operating activities:
|
||||||||
Net loss
|
$
|
(5,087
|
)
|
$
|
(5,548
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
10
|
14
|
||||||
Noncash interest expense
|
393
|
288
|
||||||
Stock based compensation expense
|
2,675
|
1,086
|
||||||
Change in fair value of warrants issued in connection with acquisition of licenses
|
-
|
(28
|
)
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Prepaid expenses and other assets
|
(25
|
)
|
(191
|
)
|
||||
Accounts payable
|
(28
|
)
|
(507
|
)
|
||||
Accrued expenses
|
234
|
651
|
||||||
Liabilities subject to compromise
|
-
|
(130
|
)
|
|||||
Net cash used in operating activities
|
(1,828
|
)
|
(4,365
|
)
|
||||
Financing activities:
|
||||||||
Net proceeds from issuance of common stock
|
2,601
|
-
|
||||||
Net proceeds from term loan
|
50
|
5,500
|
||||||
Net cash provided by financing activities
|
2,651
|
5,500
|
||||||
Net increase in cash and cash equivalents
|
823
|
1,135
|
||||||
Cash and cash equivalents, beginning of period
|
737
|
2,906
|
||||||
Cash and cash equivalents, end of period
|
$
|
1,560
|
$
|
4,041
|
||||
Supplemental cash flow disclosure:
|
||||||||
Cash paid for interest
|
$
|
1
|
$
|
2
|
||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Conversion of notes payable and related accrued interest and fees to common stock
|
$
|
18,432
|
$
|
-
|
||||
Change in fair value of warrants issued in connection with acquisition of licenses
|
$
|
-
|
$
|
(28
|
)
|
|||
Issuance in stock options in lieu of cash compensation
|
$
|
303
|
$
|
-
|
Three months ended March 31,
|
||||||||
2018
|
2017
|
|||||||
Legal fees
|
$
|
30
|
$
|
112
|
||||
Professional fees
|
7
|
12
|
||||||
Total reorganization items, net
|
$
|
37
|
$
|
124
|
As of March 31,
|
||||||||
2018
|
2017
|
|||||||
Options to purchase common stock
|
15,527,069
|
2,432,843
|
||||||
Warrants to purchase common stock
|
331,193
|
356,193
|
||||||
15,858,262
|
2,789,036
|
Amortized
|
Gross
Unrealized
|
Gross
Unrealized
|
||||||||||||||
(in thousands)
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||
Money market funds
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Total investments
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Reported as:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
—
|
||||||||||||||
Restricted cash, long-term
|
101
|
|||||||||||||||
Total investments
|
$
|
101
|
Amortized
|
Gross
Unrealized
|
Gross
Unrealized
|
||||||||||||||
(in thousands)
|
Cost
|
Gains
|
Losses
|
Fair Value
|
||||||||||||
Money market funds
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Total investments
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Reported as:
|
||||||||||||||||
Cash and cash equivalents
|
$
|
—
|
||||||||||||||
Restricted cash, long-term
|
101
|
|||||||||||||||
Total investments
|
$
|
101
|
Fair Value Measurements as of
March 31, 2018
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Investments:
|
||||||||||||||||
Money market funds
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Total assets measured at fair value
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
Fair Value Measurements as of
December 31, 2017
|
||||||||||||||||
(in thousands)
|
Level 1
|
Level 2
|
Level 3
|
Total
|
||||||||||||
Investments:
|
||||||||||||||||
Money market funds
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
||||||||
Total assets measured at fair value
|
$
|
101
|
$
|
—
|
$
|
—
|
$
|
101
|
As of December 31, 2017
|
||||||||||||||||||||
Original
Principal
Amount
|
Accrued
Interest
|
Loan
Balance
|
Fees
|
Balance
Due
|
||||||||||||||||
December 2016 Loan
|
$
|
3,315
|
$
|
324
|
$
|
3,639
|
$
|
153
|
$
|
3,792
|
||||||||||
March 2017 Loan
|
5,978
|
452
|
6,430
|
275
|
6,705
|
|||||||||||||||
July 2017 Loan
|
5,435
|
249
|
5,684
|
250
|
5,934
|
|||||||||||||||
Bridge Loan
|
1,500
|
6
|
1,506
|
-
|
1,506
|
|||||||||||||||
Claims Advances Loan
|
80
|
1
|
81
|
-
|
81
|
|||||||||||||||
Totals
|
$
|
16,308
|
$
|
1,032
|
$
|
17,340
|
$
|
678
|
$
|
18,018
|
Additional
|
Total
|
|||||||||||||||||||
Common Stock
|
Paid-In
|
Accumulated
|
Stockholders’
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Deficit
|
||||||||||||||||
Balances at December 31, 2017
|
14,946,712
|
$
|
15
|
$
|
238,246
|
$
|
(262,597
|
)
|
$
|
(24,336
|
)
|
|||||||||
Conversion of notes payable and related accrued interest
|
||||||||||||||||||||
and fees to common stock
|
76,007,754
|
76
|
18,356
|
18,432
|
||||||||||||||||
Issuance of common stock
|
18,253,320
|
18
|
2,583
|
2,601
|
||||||||||||||||
Issuance of stock options in lieu of cash compensation
|
303
|
303
|
||||||||||||||||||
Stock-based compensation expense
|
2,675
|
2,675
|
||||||||||||||||||
Comprehensive loss
|
(5,087
|
)
|
(5,087
|
)
|
||||||||||||||||
Balances at March 31, 2018
|
109,207,786
|
$
|
109
|
$
|
262,163
|
$
|
(267,684
|
)
|
$
|
(5,412
|
)
|
Options
|
Weighted
Average
Exercise
Price
|
|||||||
Outstanding at December 31, 2017
|
2,448,383
|
$
|
3.67
|
|||||
Granted
|
13,363,274
|
0.67
|
||||||
Cancelled (forfeited)
|
(243,459
|
)
|
1.27
|
|||||
Cancelled (expired)
|
(41,129
|
)
|
37.82
|
|||||
Outstanding at March 31, 2018
|
15,527,069
|
$
|
1.00
|
Three months ended
March 31, 2018
|
||||
Exercise price
|
$
|
0.67
|
||
Market value
|
$
|
0.67
|
||
Risk-free rate
|
2.74%
|
|
||
Expected term
|
6 years
|
|||
Expected volatility
|
92.6%
|
|||
Dividend yield
|
-
|
Three months ended March 31,
|
||||||||
2018
|
2017
|
|||||||
General and administrative
|
$
|
2,474
|
$
|
923
|
||||
Research and development
|
201
|
163
|
||||||
$
|
2,675
|
$
|
1,086
|
· |
our lack of revenues, history of operating losses, bankruptcy, limited cash reserves and ability to obtain additional capital to develop and commercialize our product candidates, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate, and continue as a going concern;
|
· |
the effect on our stock price and the significant dilution to the share ownership of our existing stockholders that resulted from conversion of the term loans into equity of the company or that may result in the future upon additional issuances of our equity securities;
|
· |
our ability to execute our new strategy and business plan focused on developing our proprietary monoclonal antibody portfolio;
|
· |
our ability to preserve our stock quotation on the OTCQB Venture Market or, in the future, to list our common stock on a national securities exchange, whether through a new listing or by completing a reverse merger or other strategic transaction;
|
· |
the success, progress, timing and costs of our efforts to evaluate or consummate various strategic alternatives if in the best interests of our stockholders;
|
· |
the potential timing and outcomes of pre-clinical and clinical studies of lenzilumab, ifabotuzumab, HGEN005 or any other product candidates and the uncertainties inherent in pre-clinical and clinical testing;
|
· |
our ability to timely source adequate supply of our development products from third-party manufacturers on which we depend;
|
· |
the potential, if any, for future development of any of our present or future products;
|
· |
our ability to successfully progress, partner or complete further development of our programs;
|
· |
our ability to identify and develop additional products;
|
· |
our ability to attain market exclusivity or to protect our intellectual property;
|
· |
our ability to reach agreement with a partner to effect a successful commercialization of any of our product candidates;
|
· |
the outcome of pending or future litigation;
|
· |
the ability of the Black Horse Entities (as defined below) to exert control over all matters of the Company, including their ability to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction;
|
· |
competition; and
|
· |
changes in the regulatory landscape that may prevent us from pursuing or realizing any of the expected benefits from the various regulatory incentives, or the imposition of regulations that affect our products.
|
· |
expenses incurred under agreements with contract research organizations, investigative sites, and consultants that conduct our clinical trials and a substantial portion of our preclinical activities;
|
· |
the cost of acquiring and manufacturing clinical trial and other materials; and
|
· |
other costs associated with development activities, including additional studies.
|
Three months ended March 31,
|
||||||||
(in thousands)
|
2018
|
2017
|
||||||
External Costs
|
||||||||
Lenzilumab
|
$
|
461
|
$
|
69
|
||||
Ifabotuzumab
|
25
|
64
|
||||||
Benznidazole
|
-
|
1,880
|
||||||
Internal costs
|
210
|
656
|
||||||
Total research and development
|
$
|
696
|
$
|
2,669
|
Three Months Ended March 31,
|
Increase/(Decrease)
|
|||||||||||||||
(in thousands)
|
2018
|
2017
|
$'s
|
%
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
696
|
$
|
2,669
|
$
|
(1,973
|
)
|
(74
|
)
|
|||||||
General and administrative
|
3,957
|
2,449
|
1,508
|
62
|
||||||||||||
Loss from operations
|
(4,653
|
)
|
(5,118
|
)
|
(465
|
)
|
(9
|
)
|
||||||||
Interest expense
|
(394
|
)
|
(291
|
)
|
103
|
35
|
||||||||||
Other expense, net
|
(3
|
)
|
(15
|
)
|
(12
|
)
|
(80
|
)
|
||||||||
Reorganization items, net
|
(37
|
)
|
(124
|
)
|
(87
|
)
|
(70
|
)
|
||||||||
Net loss
|
$
|
(5,087
|
)
|
$
|
(5,548
|
)
|
$
|
(461
|
)
|
(8
|
)
|
Three Months Ended March 31,
|
||||||||
(In thousands)
|
2018
|
2017
|
||||||
Net cash (used in) provided by:
|
||||||||
Operating activities
|
$
|
(1,828
|
)
|
$
|
(4,365
|
)
|
||
Financing activities
|
2,651
|
5,500
|
||||||
Net increase in cash and cash equivalents
|
$
|
823
|
$
|
1,135
|
· |
the type, number, timing, progress, costs, and results of the product candidate development programs that we are pursuing or may choose to pursue in the future;
|
· |
the scope, progress, expansion, costs, and results of our pre-clinical and clinical trials;
|
· |
the timing of and costs involved in obtaining regulatory approvals;
|
· |
the success, progress, timing and costs of our efforts to evaluate or consummate various strategic alternatives if in the best interests of our stockholders;
|
· |
our ability to preserve our stock quotation on the OTCQB Venture Market or, in the future, to list our common stock on a national securities exchange, whether through a new listing or by completing a strategic transaction;
|
· |
our ability to establish and maintain development partnering arrangements and any associated funding;
|
· |
the emergence of competing products or technologies and other adverse market developments;
|
· |
the costs of maintaining, expanding, and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
|
· |
the resources we devote to marketing, and, if approved, commercializing our product candidates;
|
· |
the scope, progress, expansion and costs of manufacturing our product candidates; and
|
· |
the costs associated with being a public company.
|
|
|
|
|
|
|
|
|
|
|
Filed or
|
|
|
|
|
Incorporated by Reference
|
|
Furnished
|
||||
Exhibit No.
|
|
Exhibit Description
|
|
Form
|
|
Date
|
|
Number
|
|
Herewith
|
2.1
|
|
|
8-K
|
|
June 22, 2016
|
|
2.1
|
|
|
|
3.1
|
|
|
8-K
|
|
July 6, 2016
|
|
3.1
|
|
|
|
3.2
|
|
|
8-K
|
|
August 7, 2017
|
|
3.1
|
|
|
|
3.3
|
|
|
8-K
|
|
February 28, 2018
|
|
3.1
|
|
|
|
3.4
|
|
|
8-K
|
|
August 7, 2017
|
|
3.2
|
|
|
|
4.1
|
|
|
S-1
|
|
January 15, 2013
|
|
4.1
|
|
|
|
4.2
|
|
|
8-K
|
|
June 24, 2013
|
|
10.2
|
|
|
|
4.3
|
|
|
8-K
|
|
December 9, 2015
|
|
4.1
|
|
|
|
4.4
|
|
|
8-K
|
|
December 9, 2015
|
|
4.2
|
|
|
|
4.5†
|
|
|
10-Q
|
|
September 23, 2016
|
|
4.1
|
|
|
|
4.6
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
|
10.1
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
10.2*
|
|
|
S-8
|
|
April 18, 2018
|
|
10.3
|
|
|
|
10.3*
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
|
31.1
|
|
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|
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|
|
|
|
Furnished
herewith
|
|
31.2
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
|
32.1**
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
|
32.2**
|
|
|
|
|
|
|
|
|
Furnished
herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
†
|
Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.
|
|
*
|
Denotes management or director compensation plan or arrangement.
|
|
**
|
The Certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Humanigen, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
HUMANIGEN, INC.
|
|||
Date: May 7, 2018
|
By:
|
/s/ Cameron Durrant
|
|
Cameron Durrant
|
|||
Chief Executive Officer
|
|||
(Principal Executive Officer)
|
|||
Date: May 7, 2018
|
By:
|
/s/ Greg Jester
|
|
Greg Jester
|
|||
Chief Financial Officer
|
|||
(Principal Financial and Accounting Officer)
|
1 Year Humanigen (CE) Chart |
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