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S&P 500 Companies
Ticker symbol Security SEC filings GICS Sector GICS Sub Industry Location Date first added CIK Founded
MMM 3M Company reports Industrials Industrial Conglomerates St. Paul, Minnesota 66740 1902
ABT Abbott Laboratories reports Health Care Health Care Equipment North Chicago, Illinois 3/31/64 1800 1888
ABBV AbbVie Inc. reports Health Care Pharmaceuticals North Chicago, Illinois 12/31/12 1551152 2013 (1888)
ABMD ABIOMED Inc reports Health Care Health Care Equipment Danvers, Massachusetts 5/31/18 815094 1981
ACN Accenture plc reports Information Technology IT Consulting & Other Services Dublin, Ireland 7/6/11 1467373 1989
ATVI Activision Blizzard reports Information Technology Home Entertainment Software Santa Monica, California 8/31/15 718877 2008
ADBE Adobe Systems Inc reports Information Technology Application Software San Jose, California 5/5/97 796343 1982
AMD Advanced Micro Devices Inc reports Information Technology Semiconductors Sunnyvale, California 3/20/17 2488 1969
AAP Advance Auto Parts reports Consumer Discretionary Automotive Retail Roanoke, Virginia 7/9/15 1158449 1932
AES AES Corp reports Utilities Independent Power Producers & Energy Traders Arlington, Virginia 10/2/98 874761 1981
AET Aetna Inc reports Health Care Managed Health Care Hartford, Connecticut 6/30/76 1122304 1810
AMG Affiliated Managers Group Inc reports Financials Asset Management & Custody Banks Beverly, Massachusetts 7/1/14 1004434 1993
AFL AFLAC Inc reports Financials Life & Health Insurance Columbus, Georgia 5/28/99 4977 1955
A Agilent Technologies Inc reports Health Care Health Care Equipment Santa Clara, California 6/5/00 1090872 1999
APD Air Products & Chemicals Inc reports Materials Industrial Gases Allentown, Pennsylvania 4/30/85 2969 1940
AKAM Akamai Technologies Inc reports Information Technology Internet Software & Services Cambridge, Massachusetts 7/12/07 1086222 1998
ALK Alaska Air Group Inc reports Industrials Airlines Seattle, Washington 5/13/16 766421 1985
ALB Albemarle Corp reports Materials Specialty Chemicals Baton Rouge, Louisiana 7/1/16 915913 1994
ARE Alexandria Real Estate Equities Inc reports Real Estate Office REITs Pasadena, California 3/20/17 1035443 1994
ALXN Alexion Pharmaceuticals reports Health Care Biotechnology Cheshire, Connecticut 5/25/12 899866 1992
ALGN Align Technology reports Health Care Health Care Supplies San Jose, California 6/19/17 1097149 1997
ALLE Allegion reports Industrials Building Products Dublin, Ireland 12/2/13 1579241 1908
AGN Allergan, Plc reports Health Care Pharmaceuticals Dublin, Ireland 4/12/99 1578845 1983
ADS Alliance Data Systems reports Information Technology Data Processing & Outsourced Services Plano, Texas 12/23/13 1101215 1996
LNT Alliant Energy Corp reports Utilities Electric Utilities Madison, Wisconsin 7/1/16 352541 1917
ALL Allstate Corp reports Financials Property & Casualty Insurance Northfield Township, Illinois 7/13/95 899051 1931
GOOGL Alphabet Inc Class A reports Information Technology Internet Software & Services Mountain View, California 4/3/14 1652044 1998
GOOG Alphabet Inc Class C reports Information Technology Internet Software & Services Mountain View, California 4/3/06 1652044 1998
MO Altria Group Inc reports Consumer Staples Tobacco Richmond, Virginia 764180 1985
AMZN Amazon.com Inc. reports Consumer Discretionary Internet & Direct Marketing Retail Seattle, Washington 11/18/05 1018724 1994
AEE Ameren Corp reports Utilities Multi-Utilities St. Louis, Missouri 9/19/91 1002910 1902
AAL American Airlines Group reports Industrials Airlines Fort Worth, Texas 3/23/15 6201 1934
AEP American Electric Power reports Utilities Electric Utilities Columbus, Ohio 4904 1906
AXP American Express Co reports Financials Consumer Finance New York, New York 6/30/76 4962 1850
AIG American International Group, Inc. reports Financials Property & Casualty Insurance New York, New York 3/31/80 5272 1919
AMT American Tower Corp A reports Real Estate Specialized REITs Boston, Massachusetts 11/19/07 1053507
AWK American Water Works Company Inc reports Utilities Water Utilities Voorhees, New Jersey 3/4/16 1410636 1886
AMP Ameriprise Financial reports Financials Asset Management & Custody Banks Minneapolis, Minnesota 10/3/05 820027 1894
ABC AmerisourceBergen Corp reports Health Care Health Care Distributors Chesterbrook, Pennsylvania 8/30/01 1140859 1985
AME AMETEK Inc. reports Industrials Electrical Components & Equipment Berwyn, Pennsylvania 9/23/13 1037868 1930
AMGN Amgen Inc. reports Health Care Biotechnology Thousand Oaks, California 1/2/92 318154 1980
APH Amphenol Corp reports Information Technology Electronic Components Wallingford, Connecticut 9/30/08 820313 1932
APC Anadarko Petroleum Corp reports Energy Oil & Gas Exploration & Production The Woodlands, Texas 7/28/97 773910 1959
ADI Analog Devices, Inc. reports Information Technology Semiconductors Norwood, Massachusetts 10/12/99 6281 1965
ANDV Andeavor reports Energy Oil & Gas Refining & Marketing San Antonio, Texas 9/27/07 50104 1968
ANSS ANSYS reports Information Technology Application Software Canonsburg, Pennsylvania 6/19/17 1013462 1969
ANTM Anthem Inc. reports Health Care Managed Health Care Indianapolis, Indiana 7/25/02 1156039
AON Aon plc reports Financials Insurance Brokers London, United Kingdom 4/23/96 315293 1982 (1919)
AOS A.O. Smith Corp reports Industrials Building Products Milwaukee, Wisconsin 7/26/17 91142 1916
APA Apache Corporation reports Energy Oil & Gas Exploration & Production Houston, Texas 7/28/97 6769 1954
AIV Apartment Investment & Management reports Real Estate Residential REITs Denver, Colorado 3/14/03 922864
AAPL Apple Inc. reports Information Technology Technology Hardware, Storage & Peripherals Cupertino, California 11/30/82 320193
AMAT Applied Materials Inc. reports Information Technology Semiconductor Equipment Santa Clara, California 3/16/95 6951
APTV Aptiv Plc reports Consumer Discretionary Auto Parts & Equipment Gillingham, Kent, United Kingdom 12/24/12 1521332
ADM Archer-Daniels-Midland Co reports Consumer Staples Agricultural Products Decatur, Illinois 7/29/81 7084
ARNC Arconic Inc. reports Industrials Aerospace & Defense New York, New York 3/31/64 4281 2016
AJG Arthur J. Gallagher & Co. reports Financials Insurance Brokers Itasca, Illinois 5/31/16 354190
AIZ Assurant Inc. reports Financials Multi-line Insurance New York, New York 4/10/07 1267238
T AT&T Inc. reports Telecommunication Services Integrated Telecommunication Services Dallas, Texas 11/30/83 732717
ADSK Autodesk Inc. reports Information Technology Application Software San Rafael, California 12/1/89 769397
ADP Automatic Data Processing reports Information Technology Internet Software & Services Roseland, New Jersey 3/31/81 8670
AZO AutoZone Inc reports Consumer Discretionary Specialty Stores Memphis, Tennessee 1/2/97 866787
AVB AvalonBay Communities, Inc. reports Real Estate Residential REITs Arlington, Virginia[5] 1/10/07 915912
AVY Avery Dennison Corp reports Materials Paper Packaging Glendale, California 12/31/87 8818
BHGE Baker Hughes, a GE Company reports Energy Oil & Gas Equipment & Services Houston, Texas 1701605 2017
BLL Ball Corp reports Materials Metal & Glass Containers Broomfield, Colorado 10/31/84 9389
BAC Bank of America Corp reports Financials Diversified Banks Charlotte, North Carolina 6/30/76 70858
BK The Bank of New York Mellon Corp. reports Financials Asset Management & Custody Banks New York, New York 3/31/95 1390777
BAX Baxter International Inc. reports Health Care Health Care Equipment Deerfield, Illinois 9/30/72 10456 1931
BBT BB&T Corporation reports Financials Regional Banks Winston-Salem, North Carolina 12/4/97 92230
BDX Becton Dickinson reports Health Care Health Care Equipment Franklin Lakes, New Jersey 9/30/72 10795 1897
BRK.B Berkshire Hathaway reports Financials Multi-Sector Holdings Omaha, Nebraska 2/16/10 1067983
BBY Best Buy Co. Inc. reports Consumer Discretionary Computer & Electronics Retail Richfield, Minnesota 6/29/99 764478
BIIB Biogen Inc. reports Health Care Biotechnology Weston, Massachusetts 11/13/03 875045
BLK BlackRock reports Financials Asset Management & Custody Banks New York, New York 4/4/11 1364742
HRB Block H&R reports Financials Consumer Finance Kansas City, Missouri 11/30/86 12659
BA Boeing Company reports Industrials Aerospace & Defense Chicago, Illinois 12927 1916
BKNG Booking Holdings Inc reports Consumer Discretionary Internet & Direct Marketing Retail Norwalk, Connecticut 11/6/09 1075531
BWA BorgWarner reports Consumer Discretionary Auto Parts & Equipment Auburn Hills, Michigan 12/19/11 908255
BXP Boston Properties reports Real Estate Office REITs Boston, Massachusetts 4/3/06 1037540
BSX Boston Scientific reports Health Care Health Care Equipment Marlborough, Massachusetts[6] 2/24/95 885725
BHF Brighthouse Financial Inc reports Financials Life & Health Insurance Charlotte, North Carolina 8/8/17 1685040
BMY Bristol-Myers Squibb reports Health Care Health Care Distributors New York, New York 14272 1989
AVGO Broadcom reports Information Technology Semiconductors San Jose, California 5/8/14 1441634
BR Broadridge Financial Solutions reports Information Technology Data Processing & Outsourced Services Lake Success, New York 6/18/18 1383312 1962
BF.B Brown-Forman Corp. reports Consumer Staples Distillers & Vintners Louisville, Kentucky 10/31/82 14693
CHRW C. H. Robinson Worldwide reports Industrials Air Freight & Logistics Eden Prairie, Minnesota 3/2/07 1043277
CA CA, Inc. reports Information Technology Systems Software Islandia, New York 7/31/87 356028
COG Cabot Oil & Gas reports Energy Oil & Gas Exploration & Production Houston, Texas 6/23/08 858470
CDNS Cadence Design Systems reports Information Technology Application Software San Jose, California 9/18/17 813672
CPB Campbell Soup reports Consumer Staples Packaged Foods & Meats Camden, New Jersey 16732 1869
COF Capital One Financial reports Financials Consumer Finance Tysons Corner, Virginia 7/1/98 927628 1935
CAH Cardinal Health Inc. reports Health Care Health Care Distributors Dublin, Ohio 5/27/97 721371
KMX Carmax Inc reports Consumer Discretionary Specialty Stores Richmond, Virginia 6/28/10 1170010
CCL Carnival Corp. reports Consumer Discretionary Hotels, Resorts & Cruise Lines Miami, Florida 12/22/98 815097
CAT Caterpillar Inc. reports Industrials Construction Machinery & Heavy Trucks Peoria, Illinois 18230 1925
CBOE Cboe Global Markets reports Financials Financial Exchanges & Data Chicago, Illinois 3/1/17 1374310
CBRE CBRE Group reports Real Estate Real Estate Services Los Angeles, California 11/10/06 1138118
CBS CBS Corp. reports Consumer Discretionary Broadcasting New York, New York 9/1/94 813828
CELG Celgene Corp. reports Health Care Biotechnology Summit, New Jersey 11/6/06 816284
CNC Centene Corporation reports Health Care Managed Health Care St Louis, Missouri 3/30/16 1071739
CNP CenterPoint Energy reports Utilities Multi-Utilities Houston, Texas 7/31/85 1130310
CTL CenturyLink Inc reports Telecommunication Services Integrated Telecommunication Services Monroe, Louisiana 3/25/99 18926
CERN Cerner reports Health Care Health Care Technology North Kansas City, Missouri 4/30/10 804753
CF CF Industries Holdings Inc reports Materials Fertilizers & Agricultural Chemicals Deerfield, Illinois 8/27/08 1324404
SCHW Charles Schwab Corporation reports Financials Investment Banking & Brokerage San Francisco, California 6/2/97 316709
CHTR Charter Communications reports Consumer Discretionary Cable & Satellite Stamford, Connecticut 9/8/16 1091667
CVX Chevron Corp. reports Energy Integrated Oil & Gas San Ramon, California 93410 1879
CMG Chipotle Mexican Grill reports Consumer Discretionary Restaurants Denver, Colorado 4/28/11 1058090
CB Chubb Limited reports Financials Property & Casualty Insurance Zurich, Switzerland 7/15/10 896159
CHD Church & Dwight reports Consumer Staples Household Products Ewing, New Jersey 12/29/15 313927
CI CIGNA Corp. reports Health Care Managed Health Care Bloomfield, Connecticut 6/30/76 701221
XEC Cimarex Energy reports Energy Oil & Gas Exploration & Production Denver, Colorado 6/21/14 1168054
CINF Cincinnati Financial reports Financials Property & Casualty Insurance Fairfield, Ohio 12/18/97 20286
CTAS Cintas Corporation reports Industrials Diversified Support Services Mason, Ohio 3/1/01 723254
CSCO Cisco Systems reports Information Technology Communications Equipment San Jose, California 12/1/93 858877
C Citigroup Inc. reports Financials Diversified Banks New York, New York 5/31/88 831001
CFG Citizens Financial Group reports Financials Regional Banks Providence, Rhode Island 1/29/16 759944
CTXS Citrix Systems reports Information Technology Internet Software & Services Fort Lauderdale, Florida 12/1/99 877890
CLX The Clorox Company reports Consumer Staples Household Products Oakland, California 3/31/69 21076 1913
CME CME Group Inc. reports Financials Financial Exchanges & Data Chicago, Illinois 8/11/06 1156375
CMS CMS Energy reports Utilities Multi-Utilities Jackson, Michigan 5/3/99 811156
KO Coca-Cola Company (The) reports Consumer Staples Soft Drinks Atlanta, Georgia 21344 1886
CTSH Cognizant Technology Solutions reports Information Technology IT Consulting & Other Services Teaneck, New Jersey 11/17/06 1058290
CL Colgate-Palmolive reports Consumer Staples Household Products New York, New York 21665 1806
CMCSA Comcast Corp. reports Consumer Discretionary Cable & Satellite Philadelphia, Pennsylvania 9/18/15 1166691
CMA Comerica Inc. reports Financials Diversified Banks Dallas, Texas 12/1/95 28412
CAG Conagra Brands reports Consumer Staples Packaged Foods & Meats Chicago, Illinois 8/31/83 23217
CXO Concho Resources reports Energy Oil & Gas Exploration & Production Midland, Texas 2/22/16 1358071
COP ConocoPhillips reports Energy Oil & Gas Exploration & Production Houston, Texas 1163165 2002
ED Consolidated Edison reports Utilities Electric Utilities New York, New York 1047862 1823
STZ Constellation Brands reports Consumer Staples Distillers & Vintners Victor, New York 7/5/05 16918
COO The Cooper Companies reports Health Care Health Care Supplies Pleasanton, California 9/23/16 711404
CPRT Copart Inc reports Industrials Diversified Support Services Dallas, Texas 7/2/18 900075
GLW Corning Inc. reports Information Technology Electronic Components Corning, New York 24741 1851
COST Costco Wholesale Corp. reports Consumer Staples Hypermarkets & Super Centers Issaquah, Washington 10/1/93 909832
COTY Coty, Inc reports Consumer Staples Personal Products New York, New York 10/3/16 1024305
CCI Crown Castle International Corp. reports Real Estate Specialized REITs Houston, Texas 3/14/12 1051470
CSX CSX Corp. reports Industrials Railroads Jacksonville, Florida 9/30/67 277948 1980
CMI Cummins Inc. reports Industrials Industrial Machinery Columbus, Indiana 3/31/65 26172 1919
CVS CVS Health reports Consumer Staples Drug Retail Woonsocket, Rhode Island 64803 1996
DHI D. R. Horton reports Consumer Discretionary Homebuilding Fort Worth, Texas 882184 1978
DHR Danaher Corp. reports Health Care Health Care Equipment Washington, D.C. 313616 1969
DRI Darden Restaurants reports Consumer Discretionary Restaurants Orlando, Florida 940944 1938
DVA DaVita Inc. reports Health Care Health Care Facilities Denver, Colorado 7/31/08 927066
DE Deere & Co. reports Industrials Agricultural & Farm Machinery Moline, Illinois 315189 1837
DAL Delta Air Lines Inc. reports Industrials Airlines Atlanta, Georgia 9/11/13 27904
XRAY Dentsply Sirona reports Health Care Health Care Supplies York, Pennsylvania 11/14/08 818479
DVN Devon EnergyCorp. reports Energy Oil & Gas Exploration & Production Oklahoma City, Oklahoma 8/30/00 1090012
DLR Digital Realty Trust Inc reports Real Estate Specialized REITs San Francisco, California 5/18/16 1297996
DFS Discover Financial Services reports Financials Consumer Finance Riverwoods, Illinois 7/2/07 1393612
DISCA Discovery Inc.Class A reports Consumer Discretionary Cable & Satellite Silver Spring, Maryland 3/1/10 1437107
DISCK Discovery Inc.Class C reports Consumer Discretionary Cable & Satellite Silver Spring, Maryland 8/7/14 1437107
DISH Dish Network reports Consumer Discretionary Cable & Satellite Meridian, Colorado 3/13/17 1001082
DG Dollar General reports Consumer Discretionary General Merchandise Stores Goodlettsville, Tennessee 12/3/12 29534
DLTR Dollar Tree reports Consumer Discretionary General Merchandise Stores Chesapeake, Virginia 12/19/11 935703
D Dominion Energy reports Utilities Electric Utilities Richmond, Virginia 715957 1983
DOV Dover Corp. reports Industrials Industrial Machinery Downers Grove, Illinois 10/31/85 29905
DWDP DowDuPont reports Materials Diversified Chemicals Midland, Michigan 1666700 2017
DTE DTE Energy Co. reports Utilities Multi-Utilities Detroit, Michigan 936340 1995
DRE Duke Realty Corp reports Real Estate Industrial REITs Indianapolis, Indiana 7/26/17 783280
DUK Duke Energy reports Utilities Electric Utilities Charlotte, North Carolina 6/30/76 1326160
DXC DXC Technology reports Information Technology IT Consulting & Other Services Tysons Corner, Virginia 4/4/17 1688568
ETFC E*Trade reports Financials Investment Banking & Brokerage New York, New York 3/31/04 1015780
EMN Eastman Chemical reports Materials Diversified Chemicals Kingsport, Tennessee 1/1/94 915389
ETN Eaton Corporation reports Industrials Electrical Components & Equipment Dublin, Ireland 1551182 1911
EBAY eBay Inc. reports Information Technology Internet Software & Services San Jose, California 1065088 1995
ECL Ecolab Inc. reports Materials Specialty Chemicals St. Paul, Minnesota 1/31/89 31462
EIX Edison Int'l reports Utilities Electric Utilities Rosemead, California 827052 1886
EW Edwards Lifesciences reports Health Care Health Care Equipment Irvine, California 4/1/11 1099800
EA Electronic Arts reports Information Technology Home Entertainment Software Redwood City, California 7/22/02 712515
EMR Emerson Electric Company reports Industrials Electrical Components & Equipment Ferguson, Missouri 3/31/65 32604 1890
ETR Entergy Corp. reports Utilities Electric Utilities New Orleans, Louisiana 65984 1913
EVHC Envision Healthcare reports Health Care Health Care Services Nashville, Tennessee 12/2/16 895930
EOG EOG Resources reports Energy Oil & Gas Exploration & Production Houston, Texas 11/2/00 821189
EQT EQT Corporation reports Energy Oil & Gas Exploration & Production Pittsburgh, Pennsylvania 12/19/08 33213
EFX Equifax Inc. reports Industrials Research & Consulting Services Atlanta, Georgia 6/19/97 33185
EQIX Equinix reports Real Estate Specialized REITs Redwood City, California 3/20/15 1101239
EQR Equity Residential reports Real Estate Residential REITs Chicago, Illinois 12/3/01 906107
ESS Essex Property Trust, Inc. reports Real Estate Residential REITs Palo Alto, California 4/2/14 920522
EL Estee Lauder Cos. reports Consumer Staples Personal Products New York, New York 1/5/06 1001250
EVRG Evergy reports Utilities Electric Utilities Kansas City, Missouri 6/5/18 1711269 1909
ES Eversource Energy reports Utilities Multi-Utilities Springfield, Massachusetts 72741 1966
RE Everest Re Group Ltd. reports Financials Reinsurance Hamilton, Bermuda 6/19/17 1095073
EXC Exelon Corp. reports Utilities Multi-Utilities Chicago, Illinois 1109357 2000
EXPE Expedia Inc. reports Consumer Discretionary Internet & Direct Marketing Retail Bellevue, Washington 10/2/07 1324424
EXPD Expeditors International reports Industrials Air Freight & Logistics Seattle, Washington 10/10/07 746515
ESRX Express Scripts reports Health Care Health Care Distributors Cool Valley, Missouri 9/25/03 1532063
EXR Extra Space Storage reports Real Estate Specialized REITs Salt Lake City, Utah 1/19/16 1289490
XOM Exxon Mobil Corp. reports Energy Integrated Oil & Gas Irving, Texas 34088 1999
FFIV F5 Networks reports Information Technology Communications Equipment Seattle, Washington 12/20/10 1048695 1996
FB Facebook, Inc. reports Information Technology Internet Software & Services Menlo Park, California 12/23/13 1326801
FAST Fastenal Co reports Industrials Building Products Winona, Minnesota 9/15/09 815556
FRT Federal Realty Investment Trust reports Real Estate Retail REITs Rockville, Maryland 2/1/16 34903
FDX FedEx Corporation reports Industrials Air Freight & Logistics Memphis, Tennessee 12/31/80 1048911
FIS Fidelity National Information Services reports Information Technology Internet Software & Services Jacksonville, Florida 11/10/06 1136893
FITB Fifth Third Bancorp reports Financials Regional Banks Cincinnati, Ohio 35527 1858
FE FirstEnergy Corp reports Utilities Electric Utilities Akron, Ohio 1031296 1997
FISV Fiserv Inc reports Information Technology Internet Software & Services Brookfield, Wisconsin 4/2/01 798354
FLT FleetCor Technologies Inc reports Information Technology Data Processing & Outsources Services Norcross, Georgia 6/20/18 1175454 2000
FLIR FLIR Systems reports Information Technology Electronic Equipment & Instruments Wilsonville, Oregon 1/2/09 354908
FLS Flowserve Corporation reports Industrials Industrial Machinery Irving, Texas 10/2/08 30625
FLR Fluor Corp. reports Industrials Construction & Engineering Irving, Texas 3/31/80 1124198
FMC FMC Corporation reports Materials Fertilizers & Agricultural Chemicals Philadelphia, Pennsylvania 8/19/09 37785
FL Foot Locker Inc reports Consumer Discretionary Apparel Retail New York, New York 4/4/16 850209
F Ford Motor reports Consumer Discretionary Automobile Manufacturers Dearborn, Michigan 37996 1903
FTV Fortive Corp reports Industrials Industrial Machinery Everett, Washington 7/1/16 1659166
FBHS Fortune Brands Home & Security reports Industrials Building Products Deerfield, Illinois 6/22/16 1519751
BEN Franklin Resources reports Financials Asset Management & Custody Banks San Mateo, California 38777 1947
FCX Freeport-McMoRan Inc. reports Materials Copper Phoenix, Arizona 831259 1912
GPS Gap Inc. reports Consumer Discretionary Apparel Retail San Francisco, California 8/31/86 39911
GRMN Garmin Ltd. reports Consumer Discretionary Consumer Electronics Schaffhausen, Switzerland 12/12/12 1121788
IT Gartner Inc reports Information Technology IT Consulting & Other Services Stamford, Connecticut 4/5/17 749251
GD General Dynamics reports Industrials Aerospace & Defense Falls Church, Virginia 40533 1899
GE General Electric reports Industrials Industrial Conglomerates Boston, Massachusetts 40545 1892
GGP General Growth Properties Inc. reports Real Estate Retail REITs Chicago, Illinois 12/10/13 1496048
GIS General Mills reports Consumer Staples Packaged Foods & Meats Golden Valley, Minnesota 3/31/69 40704 1856
GM General Motors reports Consumer Discretionary Automobile Manufacturers Detroit, Michigan 6/6/13 1467858
GPC Genuine Parts reports Consumer Discretionary Specialty Stores Atlanta, Georgia 12/31/73 40987 1925
GILD Gilead Sciences reports Health Care Biotechnology Foster City, California 7/1/04 882095
GPN Global Payments Inc. reports Information Technology Data Processing & Outsourced Services Atlanta, Georgia 4/25/16 1123360
GS Goldman Sachs Group reports Financials Investment Banking & Brokerage New York, New York 7/22/02 886982
GT Goodyear Tire & Rubber reports Consumer Discretionary Tires & Rubber Akron, Ohio 42582 1898
GWW Grainger (W.W.) Inc. reports Industrials Industrial Machinery Lake Forest, Illinois 6/30/81 277135
HAL Halliburton Co. reports Energy Oil & Gas Equipment & Services Houston, Texas 45012 1919
HBI Hanesbrands Inc reports Consumer Discretionary Apparel, Accessories & Luxury Goods Winston-Salem, North Carolina 3/20/15 1359841
HOG Harley-Davidson reports Consumer Discretionary Motorcycle Manufacturers Milwaukee, Wisconsin 793952 1903
HRS Harris Corporation reports Information Technology Communications Equipment Melbourne, Florida 9/22/08 202058
HIG Hartford Financial Svc.Gp. reports Financials Property & Casualty Insurance Hartford, Connecticut 874766
HAS Hasbro Inc. reports Consumer Discretionary Leisure Products Pawtucket, Rhode Island 9/30/84 46080
HCA HCA Holdings reports Health Care Health Care Facilities Nashville, Tennessee 1/27/15 860730
HCP HCP Inc. reports Real Estate Health Care REITs Long Beach, California 3/31/08 765880
HP Helmerich & Payne reports Energy Oil & Gas Drilling Tulsa, Oklahoma[7] 3/1/10 46765
HSIC Henry Schein reports Health Care Health Care Distributors Melville, New York 3/17/15 1000228
HSY The Hershey Company reports Consumer Staples Packaged Foods & Meats Hershey, Pennsylvania 47111 1894
HES Hess Corporation reports Energy Integrated Oil & Gas New York, New York 5/31/84 4447
HPE Hewlett Packard Enterprise reports Information Technology Technology Hardware, Storage & Peripherals Palo Alto, California 11/2/15 1645590
HLT Hilton WorldwideHoldings Inc reports Consumer Discretionary Hotels, Resorts & Cruise Lines Tysons Corner, Virginia 6/19/17 1585689
HFC HollyFrontier Corp reports Energy Oil & Gas Refining & Marketing Dallas, Texas 6/18/18 48039 1947
HOLX Hologic reports Health Care Health Care Equipment Marlborough, Massachusetts 3/30/16 859737
HD Home Depot reports Consumer Discretionary Home Improvement Retail Atlanta, Georgia 3/31/88 354950
HON Honeywell Int'l Inc. reports Industrials Industrial Conglomerates Morristown, New Jersey 3/31/64 773840 1906
HRL Hormel Foods Corp. reports Consumer Staples Packaged Foods & Meats Austin, Minnesota 3/4/09 48465
HST Host Hotels & Resorts reports Real Estate Hotel & Resort REITs Bethesda, Maryland 3/20/07 1070750
HPQ HP Inc. reports Information Technology Technology Hardware, Storage & Peripherals Palo Alto, California 12/31/74 47217 1939 (2015)
HUM Humana Inc. reports Health Care Managed Health Care Louisville, Kentucky 49071 1961
HBAN Huntington Bancshares reports Financials Regional Banks Columbus, Ohio 49196 1866
HII Huntington Ingalls Industries reports Industrials Aerospace & Defense Newport News, Virginia 1/3/18 1501585
IDXX IDEXX Laboratories reports Health Care Health Care Equipment Westbrook, Maine 1/5/17 874716
INFO IHS Markit Ltd. reports Industrials Research & Consulting Services London, United Kingdom 6/2/17 1598014
ITW Illinois Tool Works reports Industrials Industrial Machinery Glenview, Illinois 2/28/86 49826
ILMN Illumina Inc reports Health Care Life Sciences Tools & Services San Diego, California 11/19/15 1110803
IR Ingersoll-Rand PLC reports Industrials Industrial Machinery Dublin, Ireland 11/17/10 1466258
INTC Intel Corp. reports Information Technology Semiconductors Santa Clara, California 12/31/76 50863
ICE Intercontinental Exchange reports Financials Financial Exchanges & Data Atlanta, Georgia 9/26/07 1571949
IBM International Business Machines reports Information Technology IT Consulting & Other Services Armonk, New York 51143 1911
INCY Incyte reports Health Care Biotechnology Wilmington, Delaware 2/28/17 879169
IP International Paper reports Materials Paper Packaging Memphis, Tennessee 51434 1898
IPG Interpublic Group reports Consumer Discretionary Advertising New York, New York 10/1/92 51644
IFF Intl Flavors & Fragrances reports Materials Specialty Chemicals New York, New York 3/31/76 51253
INTU Intuit Inc. reports Information Technology Internet Software & Services Mountain View, California 12/5/00 896878
ISRG Intuitive Surgical Inc. reports Health Care Health Care Equipment Sunnyvale, California 6/2/08 1035267
IVZ Invesco Ltd. reports Financials Asset Management & Custody Banks Atlanta, Georgia 8/21/08 914208
IPGP IPG Photonics Corp. reports Information Technology Electronic Manufacturing Services Oxford, Massachusetts 3/7/18 1111928
IQV IQVIA Holdings Inc. reports Health Care Life Sciences Tools & Service Durham, North Carolina 8/29/17 1478242
IRM Iron Mountain Incorporated reports Real Estate Specialized REITs Boston, Massachusetts 1/6/09 1020569
JEC Jacobs Engineering Group reports Industrials Construction & Engineering Pasadena, California 10/26/07 52988
JBHT J. B. Hunt Transport Services reports Industrials Trucking Lowell, Arkansas 7/1/15 728535
JEF Jefferies Financial Group reports Financials Multi-Sector Holdings New York, New York 8/27/07 96223
SJM JM Smucker reports Consumer Staples Packaged Foods & Meats Orrville, Ohio 11/6/08 91419
JNJ Johnson & Johnson reports Health Care Health Care Equipment New Brunswick, New Jersey 6/30/73 200406 1886
JCI Johnson Controls International reports Industrials Building Products Cork, Ireland 8/27/10 833444
JPM JPMorgan Chase & Co. reports Financials Diversified Banks New York, New York 6/30/75 19617
JNPR Juniper Networks reports Information Technology Communications Equipment Sunnyvale, California 1043604 1996
KSU Kansas City Southern reports Industrials Railroads Kansas City, Missouri 5/24/13 54480
K Kellogg Co. reports Consumer Staples Packaged Foods & Meats Battle Creek, Michigan 55067 1906
KEY KeyCorp reports Financials Regional Banks Cleveland, Ohio 3/1/94 91576
KMB Kimberly-Clark reports Consumer Staples Household Products Irving, Texas 55785 1872
KIM Kimco Realty reports Real Estate Retail REITs New Hyde Park, New York 4/4/06 879101
KMI Kinder Morgan reports Energy Oil & Gas Storage & Transportation Houston, Texas 5/25/12 1506307
KLAC KLA-Tencor Corp. reports Information Technology Semiconductor Equipment Milpitas, California 319201 1975/1977 (1997)
KSS Kohl's Corp. reports Consumer Discretionary General Merchandise Stores Menomonee Falls, Wisconsin 885639 1962
KHC Kraft Heinz Co reports Consumer Staples Packaged Foods & Meats Pittsburgh, Pennsylvania 7/6/15 1637459
KR Kroger Co. reports Consumer Staples Food Retail Cincinnati, Ohio 56873 1883
LB L Brands Inc. reports Consumer Discretionary Apparel Retail Columbus, Ohio 9/30/83 701985
LLL L-3 Communications Holdings reports Industrials Aerospace & Defense New York, New York 1056239 1997
LH Laboratory Corp. of America Holding reports Health Care Health Care Services Burlington, North Carolina 11/1/04 920148
LRCX Lam Research reports Information Technology Semiconductor Equipment Fremont, California 6/29/12 707549
LEG Leggett & Platt reports Consumer Discretionary Home Furnishings Carthage, Missouri 58492 1883
LEN Lennar Corp. reports Consumer Discretionary Homebuilding Miami, Florida 10/4/05 920760
LLY Lilly (Eli) & Co. reports Health Care Pharmaceuticals Indianapolis, Indiana 12/31/70 59478 1876
LNC Lincoln National reports Financials Multi-line Insurance Radnor, Pennsylvania 6/30/76 59558
LKQ LKQ Corporation reports Consumer Discretionary Distributors Chicago, Illinois 5/23/16 1065696
LMT Lockheed Martin Corp. reports Industrials Aerospace & Defense Bethesda, Maryland 7/31/84 936468
L Loews Corp. reports Financials Multi-line Insurance New York, New York 60086
LOW Lowe's Cos. reports Consumer Discretionary Home Improvement Retail Mooresville, North Carolina 2/29/84 60667 1904/1946/1959
LYB LyondellBasell reports Materials Specialty Chemicals Rotterdam, Netherlands 9/5/12 1489393
MTB M&T Bank Corp. reports Financials Regional Banks Buffalo, New York 36270 1856
MAC Macerich reports Real Estate Retail REITs Santa Monica, California 5/9/13 912242
M Macy's Inc. reports Consumer Discretionary Department Stores Cincinnati, Ohio 794367 1929
MRO Marathon Oil Corp. reports Energy Oil & Gas Exploration & Production Houston, Texas 5/1/91 101778
MPC Marathon Petroleum reports Energy Oil & Gas Refining & Marketing Findlay, Ohio 7/1/11 1510295
MAR Marriott Int'l. reports Consumer Discretionary Hotels, Resorts & Cruise Lines Bethesda, Maryland 1048286 1927
MMC Marsh & McLennan reports Financials Insurance Brokers New York, New York 8/31/87 62709
MLM Martin Marietta Materials reports Materials Construction Materials Raleigh, North Carolina 7/2/14 916076
MAS Masco Corp. reports Industrials Building Products Taylor, Michigan 6/30/81 62996
MA Mastercard Inc. reports Information Technology Internet Software & Services Harrison, New York 7/18/08 1141391
MAT Mattel Inc. reports Consumer Discretionary Leisure Products El Segundo, California 3/31/82 63276
MKC McCormick & Co. reports Consumer Staples Packaged Foods & Meats Sparks, Maryland 63754 1889
MCD McDonald's Corp. reports Consumer Discretionary Restaurants Chicago, Illinois 6/30/70 63908 1940
MCK McKesson Corp. reports Health Care Health Care Distributors San Francisco, California 927653 1833
MDT Medtronic plc reports Health Care Health Care Equipment Dublin, Ireland 10/31/86 64670
MRK Merck & Co. reports Health Care Pharmaceuticals Whitehouse Station, New Jersey 310158 1891
MET MetLife Inc. reports Financials Life & Health Insurance New York, New York 1099219 1868
MTD Mettler Toledo reports Health Care Life Sciences Tools & Services Columbus, Ohio 9/6/16 1037646
MGM MGM Resorts International reports Consumer Discretionary Casinos & Gaming Paradise, Nevada 7/26/17 789570
KORS Michael Kors Holdings reports Consumer Discretionary Apparel, Accessories & Luxury Goods New York, New York 11/13/13 1530721
MCHP Microchip Technology reports Information Technology Semiconductors Chandler, Arizona 9/7/07 827054
MU Micron Technology reports Information Technology Semiconductors Boise, Idaho 9/27/94 723125
MSFT Microsoft Corp. reports Information Technology Systems Software Redmond, Washington 6/1/94 789019
MAA Mid-America Apartments reports Real Estate Residential REITs Memphis, Tennessee 12/2/16 912595
MHK Mohawk Industries reports Consumer Discretionary Home Furnishings Amsterdam, New York 12/23/13 851968
TAP Molson Coors Brewing Company reports Consumer Staples Brewers Denver, Colorado 6/30/76 24545
MDLZ Mondelez International reports Consumer Staples Packaged Foods & Meats Northfield, Illinois 10/2/12 1103982
MNST Monster Beverage reports Consumer Staples Soft Drinks Corona, California 6/28/12 865752
MCO Moody's Corp reports Financials Financial Exchanges & Data New York, New York 1059556 1909
MS Morgan Stanley reports Financials Investment Banking & Brokerage New York, New York 895421 1935
MOS The Mosaic Company reports Materials Fertilizers & Agricultural Chemicals Plymouth, Minnesota 9/26/11 1285785
MSI Motorola Solutions Inc. reports Information Technology Communications Equipment Schaumburg, Illinois 68505 1928 (2011)
MSCI MSCI Inc reports Financials Financial Exchanges & Data New York, New York 4/4/18 1408198
MYL Mylan N.V. reports Health Care Pharmaceuticals Amsterdam, Netherlands 4/23/04 69499
NDAQ Nasdaq, Inc. reports Financials Financial Exchanges & Data New York, New York 10/22/08 1120193
NOV National Oilwell Varco Inc. reports Energy Oil & Gas Equipment & Services Houston, Texas 3/14/05 1021860
NKTR Nektar Therapeutics reports Health Care Pharmaceuticals San Francisco, California 3/19/18 906709
NTAP NetApp reports Information Technology Internet Software & Services Sunnyvale, California 6/25/99 1002047
NFLX Netflix Inc. reports Information Technology Internet Software & Services Los Gatos, California 12/20/10 1065280
NWL Newell Brands reports Consumer Discretionary Housewares & Specialties Sandy Springs, Georgia 4/30/89 814453
NFX Newfield Exploration Co reports Energy Oil & Gas Exploration & Production Houston, Texas 12/20/10 912750
NEM Newmont Mining Corporation reports Materials Gold Denver, Colorado 6/30/69 1164727 1921
NWSA News Corp. Class A reports Consumer Discretionary Publishing New York, New York 8/1/13 1564708
NWS News Corp. Class B reports Consumer Discretionary Publishing New York, New York 9/18/15 1564708
NEE NextEra Energy reports Utilities Multi-Utilities Juno Beach, Florida 6/30/76 753308
NLSN Nielsen Holdings reports Industrials Research & Consulting Services New York, New York 7/9/13 1492633
NKE Nike reports Consumer Discretionary Apparel, Accessories & Luxury Goods Washington County, Oregon 11/30/88 320187
NI NiSource Inc. reports Utilities Multi-Utilities Merrillville, Indiana 1111711 1912
NBL Noble Energy Inc reports Energy Oil & Gas Exploration & Production Houston, Texas 10/8/07 72207
JWN Nordstrom reports Consumer Discretionary Department Stores Seattle, Washington 8/31/86 72333
NSC Norfolk Southern Corp. reports Industrials Railroads Norfolk, Virginia 702165 1881/1894 (1980)
NTRS Northern Trust Corp. reports Financials Asset Management & Custody Banks Chicago, Illinois 73124 1889
NOC Northrop Grumman Corp. reports Industrials Aerospace & Defense West Falls Church, Virginia 6/30/85 1133421
NCLH Norwegian Cruise Line reports Consumer Discretionary Hotels, Resorts & Cruise Lines Miami, Florida 10/13/17 1513761
NRG NRG Energy reports Utilities Independent Power Producers & Energy Traders Princeton, New Jersey 1/29/10 1013871
NUE Nucor Corp. reports Materials Steel Charlotte, North Carolina 4/30/85 73309
NVDA Nvidia Corporation reports Information Technology Semiconductors Santa Clara, California 11/30/01 1045810
ORLY O'Reilly Automotive reports Consumer Discretionary Specialty Stores Springfield, Missouri 3/27/09 898173
OXY Occidental Petroleum reports Energy Oil & Gas Exploration & Production Los Angeles, California 12/31/82 797468
OMC Omnicom Group reports Consumer Discretionary Advertising New York, New York 29989 1986
OKE ONEOK reports Energy Oil & Gas Storage & Transportation Tulsa, Oklahoma 3/15/10 1039684
ORCL Oracle Corp. reports Information Technology Application Software Redwood Shores, California 8/31/89 1341439
PCAR PACCAR Inc. reports Industrials Construction Machinery & Heavy Trucks Bellevue, Washington 12/31/80 75362
PKG Packaging Corporation of America reports Materials Paper Packaging Lake Forest, Illinois 7/26/17 75677
PH Parker-Hannifin reports Industrials Industrial Machinery Cleveland, Ohio 11/30/85 76334
PAYX Paychex Inc. reports Information Technology Internet Software & Services Penfield, New York 723531 1971
PYPL PayPal reports Information Technology Data Processing & Outsourced Services San Jose, California 7/20/15 1633917
PNR Pentair plc reports Industrials Industrial Machinery Worsley, UK 10/1/12 77360
PBCT People's United Financial reports Financials Thrifts & Mortgage Finance Bridgeport, Connecticut 11/13/08 1378946
PEP PepsiCo Inc. reports Consumer Staples Soft Drinks Purchase, New York 77476 1898
PKI PerkinElmer reports Health Care Health Care Equipment Waltham, Massachusetts 5/31/85 31791
PRGO Perrigo reports Health Care Pharmaceuticals Dublin, Ireland 12/19/11 1585364
PFE Pfizer Inc. reports Health Care Pharmaceuticals New York, New York 78003 1849
PCG PG&E Corp. reports Utilities Multi-Utilities San Francisco, California 1004980 1905
PM Philip Morris International reports Consumer Staples Tobacco New York, New York 3/31/08 1413329
PSX Phillips 66 reports Energy Oil & Gas Refining & Marketing Houston, Texas 5/1/12 1534701
PNW Pinnacle West Capital reports Utilities Multi-Utilities Phoenix, Arizona 764622 1985
PXD Pioneer Natural Resources reports Energy Oil & Gas Exploration & Production Irving, Texas 9/24/08 1038357
PNC PNC Financial Services reports Financials Regional Banks Pittsburgh, Pennsylvania 4/30/88 713676
RL Polo Ralph Lauren Corp. reports Consumer Discretionary Apparel, Accessories & Luxury Goods New York, New York 2/2/07 1037038
PPG PPG Industries reports Materials Specialty Chemicals Pittsburgh, Pennsylvania 79879 1883
PPL PPL Corp. reports Utilities Electric Utilities Allentown, Pennsylvania 922224
PX Praxair Inc. reports Materials Industrial Gases Danbury, Connecticut 7/1/92 884905
PFG Principal Financial Group reports Financials Life & Health Insurance Des Moines, Iowa 7/22/02 1126328
PG Procter & Gamble reports Consumer Staples Personal Products Cincinnati, Ohio 80424 1837
PGR Progressive Corp. reports Financials Property & Casualty Insurance Mayfield Village, Ohio 8/4/97 80661
PLD Prologis reports Real Estate Industrial REITs San Francisco, California 7/17/03 1045609
PRU Prudential Financial reports Financials Life & Health Insurance Newark, New Jersey 7/22/02 1137774
PEG Public Serv. Enterprise Inc. reports Utilities Electric Utilities Newark, New Jersey 788784
PSA Public Storage reports Real Estate Specialized REITs Glendale, California 8/19/05 1393311
PHM Pulte Homes Inc. reports Consumer Discretionary Homebuilding Atlanta, Georgia 4/30/84 822416
PVH PVH Corp. reports Consumer Discretionary Apparel, Accessories & Luxury Goods New York, New York 2/15/13 78239
QRVO Qorvo reports Information Technology Semiconductors Greensboro, North Carolina 6/11/15 1604778
PWR Quanta Services Inc. reports Industrials Construction & Engineering Houston, Texas 7/1/09 1050915
QCOM QUALCOMM Inc. reports Information Technology Semiconductors San Diego, California 804328 1985
DGX Quest Diagnostics reports Health Care Health Care Services Madison, New Jersey 12/12/02 1022079
RJF Raymond James Financial Inc. reports Financials Investment Banking & Brokerage St. Petersburg, Florida 3/20/17 720005
RTN Raytheon Co. reports Industrials Aerospace & Defense Waltham, Massachusetts 1047122 1922
O Realty Income Corporation reports Real Estate Retail REITs San Diego, California 4/7/15 726728
RHT Red Hat Inc. reports Information Technology Systems Software Raleigh, North Carolina 7/27/09 1087423
REG Regency Centers Corporation reports Real Estate Retail REITs Jacksonville, Florida 3/2/17 910606
REGN Regeneron reports Health Care Biotechnology Tarrytown, New York 5/1/13 872589
RF Regions Financial Corp. reports Financials Regional Banks Birmingham, Alabama 8/28/98 1281761
RSG Republic Services Inc reports Industrials Environmental & Facilities Services Phoenix, Arizona 12/5/08 1060391
RMD ResMed reports Health Care Health Care Equipment San Diego, California 7/26/17 943819
RHI Robert Half International reports Industrials Human Resource & Employment Services Menlo Park, California 12/5/00 315213
ROK Rockwell Automation Inc. reports Industrials Electrical Components & Equipment Milwaukee, Wisconsin 1024478
COL Rockwell Collins reports Industrials Aerospace & Defense Cedar Rapids, Iowa 7/2/01 1137411
ROP Roper Technologies reports Industrials Industrial Conglomerates Sarasota, Florida 12/23/09 882835
ROST Ross Stores reports Consumer Discretionary Apparel Retail Pleasanton, California 12/21/09 745732
RCL Royal Caribbean Cruises Ltd reports Consumer Discretionary Hotels, Resorts & Cruise Lines Miami, Florida 12/5/14 884887
CRM Salesforce.com reports Information Technology Internet Software & Services San Francisco, California 9/15/08 1108524
SBAC SBA Communications reports Real Estate Specialized REITs Boca Raton, Florida 9/1/17 1034054
SCG SCANA Corp reports Utilities Multi-Utilities Cayce, South Carolina 1/2/09 754737
SLB Schlumberger Ltd. reports Energy Oil & Gas Equipment & Services Curaçao, Kingdom of the Netherlands 3/31/65 87347 1926
STX Seagate Technology reports Information Technology Technology Hardware, Storage & Peripherals Dublin, Ireland 7/2/12 1137789
SEE Sealed Air reports Materials Paper Packaging Elmwood Park, New Jersey 1012100
SRE Sempra Energy reports Utilities Multi-Utilities San Diego, California 1032208
SHW Sherwin-Williams reports Materials Specialty Chemicals Cleveland, Ohio 6/30/64 89800 1866
SPG Simon Property Group Inc reports Real Estate Retail REITs Indianapolis, Indiana 6/26/02 1063761
SWKS Skyworks Solutions reports Information Technology Semiconductors Woburn, Massachusetts 3/12/15 4127
SLG SL Green Realty reports Real Estate Office REITs New York, New York 3/20/15 1040971
SNA Snap-On Inc. reports Consumer Discretionary Household Appliances Kenosha, Wisconsin 9/30/82 91440
SO Southern Co. reports Utilities Electric Utilities Atlanta, Georgia 92122
LUV Southwest Airlines reports Industrials Airlines Dallas, Texas 7/1/94 92380
SPGI S&P Global, Inc. reports Financials Financial Exchanges & Data New York, New York 64040
SWK Stanley Black & Decker reports Consumer Discretionary Household Appliances New Britain, Connecticut 9/30/82 93556
SBUX Starbucks Corp. reports Consumer Discretionary Restaurants Seattle, Washington 829224 1971
STT State Street Corp. reports Financials Asset Management & Custody Banks Boston, Massachusetts 93751
SRCL Stericycle Inc reports Industrials Environmental & Facilities Services Lake Forest, Illinois 11/19/08 861878
SYK Stryker Corp. reports Health Care Health Care Equipment Kalamazoo, Michigan 12/12/00 310764
STI SunTrust Banks reports Financials Regional Banks Atlanta, Georgia 5/31/88 750556
SIVB SVB Financial reports Financials Regional Banks Santa Clara, California 3/19/18 719739
SYMC Symantec Corp. reports Information Technology Application Software Mountain View, California 3/25/03 849399
SYF Synchrony Financial reports Financials Consumer Finance Stamford, Connecticut 11/18/15 1601712
SNPS Synopsys Inc. reports Information Technology Application Software Mountain View, California 3/16/17 883241
SYY Sysco Corp. reports Consumer Staples Food Distributors Houston, Texas 12/31/86 96021
TROW T. Rowe Price Group reports Financials Asset Management & Custody Banks Baltimore, Maryland 1113169 1937
TTWO Take-Two Interactive reports Information Technology Home Entertainment Software New York, New York 3/19/18 946581
TPR Tapestry, Inc. reports Consumer Discretionary Apparel, Accessories & Luxury Goods New York, New York 1116132 2017
TGT Target Corp. reports Consumer Discretionary General Merchandise Stores Minneapolis, Minnesota 12/31/76 27419
TEL TE Connectivity Ltd. reports Information Technology Electronic Manufacturing Services Schaffhausen, Switzerland 10/17/11 1385157
FTI TechnipFMC reports Energy Oil & Gas Equipment & Services London, United Kingdom 6/5/09 1681459
TXN Texas Instruments reports Information Technology Semiconductors Dallas, Texas 97476 1930
TXT Textron Inc. reports Industrials Aerospace & Defense Providence, Rhode Island 12/31/78 217346
TMO Thermo Fisher Scientific reports Health Care Health Care Equipment Waltham, Massachusetts 97745 2006
TIF Tiffany & Co. reports Consumer Discretionary Apparel, Accessories & Luxury Goods New York, New York 6/21/00 98246
TWTR Twitter, Inc. reports Information Technology Internet Software & Services San Francisco, California 6/7/18 1418091 2006
TJX TJX Companies Inc. reports Consumer Discretionary Apparel Retail Framingham, Massachusetts 9/30/85 109198
TMK Torchmark Corp. reports Financials Life & Health Insurance McKinney, Texas 4/30/89 320335
TSS Total System Services reports Information Technology Internet Software & Services Columbus, Georgia 1/2/08 721683
TSCO Tractor Supply Company reports Consumer Discretionary Specialty Stores Brentwood, Tennessee 1/24/14 916365
TDG TransDigm Group reports Industrials Aerospace & Defense Cleveland, Ohio 6/3/16 1260221
TRV The Travelers Companies Inc. reports Financials Property & Casualty Insurance New York, New York 8/21/02 86312
TRIP TripAdvisor reports Consumer Discretionary Internet & Direct Marketing Retail Newton, Massachusetts 12/21/11 1526520
FOXA Twenty-First Century Fox Class A reports Consumer Discretionary Publishing New York, New York 7/1/13 1308161
FOX Twenty-First Century Fox Class B reports Consumer Discretionary Publishing New York, New York 9/18/15 1308161
TSN Tyson Foods reports Consumer Staples Packaged Foods & Meats Springdale, Arkansas 100493
UDR UDR Inc reports Real Estate Residential REITs Highlands Ranch, Colorado 3/7/16 74208
ULTA Ulta Beauty reports Consumer Discretionary Specialty Stores Bolingbrook, Illinois 4/18/16 1403568
USB U.S. Bancorp reports Financials Diversified Banks Minneapolis, Minnesota 36104 1968
UAA Under ArmourClass A reports Consumer Discretionary Apparel, Accessories & Luxury Goods Baltimore, Maryland 3/25/16 1336917
UA Under ArmourClass C reports Consumer Discretionary Apparel, Accessories & Luxury Goods Baltimore, Maryland 5/1/14 1336917
UNP Union Pacific reports Industrials Railroads Omaha, Nebraska 100885
UAL United Continental Holdings reports Industrials Airlines Chicago, Illinois 9/3/15 100517
UNH United Health Group Inc. reports Health Care Managed Health Care Minnetonka, Minnesota 7/1/94 731766
UPS United Parcel Service reports Industrials Air Freight & Logistics Atlanta, Georgia 7/22/02 1090727
URI United Rentals, Inc. reports Industrials Trading Companies & Distributors Stamford, Connecticut 9/20/14 1067701
UTX United Technologies reports Industrials Aerospace & Defense Hartford, Connecticut 101829
UHS Universal Health Services, Inc. reports Health Care Health Care Facilities King of Prussia, Pennsylvania 9/20/14 352915
UNM Unum Group reports Financials Life & Health Insurance Chattanooga, Tennessee 3/1/94 5513
VFC V.F. Corp. reports Consumer Discretionary Apparel, Accessories & Luxury Goods Greensboro, North Carolina 6/30/79 103379
VLO Valero Energy reports Energy Oil & Gas Refining & Marketing San Antonio, Texas 1035002 1980
VAR Varian Medical Systems reports Health Care Health Care Equipment Palo Alto, California 2/12/07 203527
VTR Ventas Inc reports Real Estate Health Care REITs Chicago, Illinois 3/4/09 740260
VRSN Verisign Inc. reports Information Technology Internet Software & Services Dulles, Virginia 2/1/06 1014473
VRSK Verisk Analytics reports Industrials Research & Consulting Services Jersey City, New Jersey 10/8/15 1442145
VZ Verizon Communications reports Telecommunication Services Integrated Telecommunication Services New York, New York 11/30/83 732712
VRTX Vertex Pharmaceuticals Inc reports Health Care Biotechnology Cambridge, Massachusetts 9/23/13 875320
VIAB Viacom Inc. reports Consumer Discretionary Cable & Satellite New York, New York 1339947
V Visa Inc. reports Information Technology Internet Software & Services San Francisco, California 12/21/09 1403161
VNO Vornado Realty Trust reports Real Estate Office REITs New York, New York 899689
VMC Vulcan Materials reports Materials Construction Materials Birmingham, Alabama 6/30/99 1396009
WMT Wal-Mart Stores reports Consumer Staples Hypermarkets & Super Centers Bentonville, Arkansas 8/31/82 104169
WBA Walgreens Boots Alliance reports Consumer Staples Drug Retail Deerfield, Illinois 12/31/79 1618921
DIS The Walt Disney Company reports Consumer Discretionary Cable & Satellite Burbank, California 6/30/76 1001039
WM Waste Management Inc. reports Industrials Environmental & Facilities Services Houston, Texas 823768 1968
WAT Waters Corporation reports Health Care Health Care Distributors Milford, Massachusetts 1000697 1958
WEC Wec Energy Group Inc reports Utilities Electric Utilities Milwaukee, Wisconsin 10/31/08 783325
WFC Wells Fargo reports Financials Diversified Banks San Francisco, California 6/30/76 72971
WELL Welltower Inc. reports Real Estate Health Care REITs Toledo, Ohio 1/30/09 766704
WDC Western Digital reports Information Technology Technology Hardware, Storage & Peripherals Irvine, California 7/1/09 106040
WU Western Union Co reports Information Technology Internet Software & Services Englewood, Colorado 1365135 1851
WRK WestRock Company reports Materials Paper Packaging Richmond, Virginia 1636023
WY Weyerhaeuser Corp. reports Real Estate Specialized REITs Federal Way, Washington 106535
WHR Whirlpool Corp. reports Consumer Discretionary Household Appliances Benton Harbor, Michigan 106640 1911
WMB Williams Cos. reports Energy Oil & Gas Storage & Transportation Tulsa, Oklahoma 3/31/75 107263
WLTW Willis Towers Watson reports Financials Insurance Brokers London, United Kingdom 1/5/16 1140536
WYNN Wynn Resorts Ltd reports Consumer Discretionary Casinos & Gaming Paradise, Nevada 11/14/08 1174922
XEL Xcel Energy Inc reports Utilities Multi-Utilities Minneapolis, Minnesota 72903 1909
XRX Xerox Corp. reports Information Technology Technology Hardware, Storage & Peripherals Norwalk, Connecticut 108772 1906
XLNX Xilinx Inc reports Information Technology Semiconductors San Jose, California 11/8/99 743988
XL XL Group reports Financials Property & Casualty Insurance Hamilton, Bermuda 875159 1998
XYL Xylem Inc. reports Industrials Industrial Machinery White Plains, New York 11/1/11 1524472
YUM Yum! Brands Inc reports Consumer Discretionary Restaurants Louisville, Kentucky 10/6/97 1041061
ZBH Zimmer Biomet Holdings reports Health Care Health Care Equipment Warsaw, Indiana 8/7/01 1136869
ZION Zions Bancorp reports Financials Regional Banks Salt Lake City, Utah 6/22/01 109380
ZTS Zoetis reports Health Care Pharmaceuticals Florham Park, New Jersey 6/21/13 1555280
$HGEN Humanigen Inc., SEC Form 10-Q Filing, Period Ending March 31, 2018, Full Text
10-Q 1 m5118010q.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| ☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended March 31, 2018
OR
| ☐ |
TRANSITION REPORT UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF 1934
|
From the transition period from to .
Commission File Number 001-35798
Humanigen, Inc.
(Exact name of registrant as specified in its charter)
Delaware
|
77-0557236
| |
(State or other jurisdiction of
|
(IRS Employer
| |
incorporation)
|
Identification No.)
|
533 Airport Boulevard, Suite 200, Burlingame, CA 94010
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (650) 243-3100
1000 Marina Blvd., Suite 250, Brisbane, CA 94005
(Former address)
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. 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 for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer ☐
|
Accelerated filer ☐
| |
Non-accelerated filer ☐
(Do not check if a smaller reporting company) |
Smaller reporting company ☒
| |
Emerging growth company ☒
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☒ No ☐
As of May 7, 2018, there were 109,207,786 shares of common stock of the issuer outstanding.
HUMANIGEN, INC.
FORM 10-Q
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
| |||
Humanigen, Inc.
(in thousands, except share data)
(Unaudited)
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
| ||||
See accompanying notes.
Humanigen, Inc.
(in thousands, except share and per share data)
(Unaudited)
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
| ||||||
See accompanying notes.
Humanigen, Inc.
(in thousands)
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
|
$
|
-
| ||||
See accompanying notes.
Humanigen, Inc.
(Unaudited)
1. Nature of Operations
Description of the Business
Humanigen, Inc. (the “Company”) was incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. The Company completed its initial public offering in January 2013. Effective August 7, 2017, the Company changed its legal name to Humanigen, Inc.
As disclosed in the Company’s 2017 Form 10-K, since August 29, 2017 the Company has shifted its primary focus toward developing its proprietary monoclonal antibody portfolio, which comprises lenzilumab, ifabotuzumab and HGEN005, for use in addressing significant, serious and potentially life-threatening unmet needs in oncology and immunology. These product candidates are at various stages of development and will require substantial time, expenses, clinical development, testing, and regulatory approval from the United States Food and Drug Administration (“FDA”) prior to commercialization, if they are approved at all. Furthermore, none of these product candidates has advanced into a pivotal registration study and it may be years before any such studies are initiated, if at all.
Lenzilumab is a recombinant monoclonal antibody, or mAb, that neutralizes soluble granulocyte-macrophage colony-stimulating factor, or GM-CSF, a critical cytokine in the inflammatory cascade associated with serious and potentially life-threatening CAR-T-related side effects and in the growth of certain hematologic malignancies, solid tumors and other serious conditions. The Company expects to study lenzilumab’s potential in reducing the side effects associated with CAR-T therapy and potentially also improving efficacy. The Company has begun to explore lenzilumab’s effectiveness in preventing or ameliorating neurotoxicity and potentially cytokine release syndrome (“CRS”) associated with CAR-T therapy. Pre-clinical animal data suggests there may be an increase in CAR-T cell expansion when combined with lenzilumab, which potentially could translate into improved CAR-T efficacy and this is likely to be an area of further study. In addition, the Company has completed enrollment of patients in a Phase 1 clinical trial for chronic myelomonocytic leukemia (“CMML”), to identify the maximum tolerated dose, (“MTD”), or recommended Phase 2 dose (“RPTD”) of lenzilumab and to assess lenzilumab’s safety, pharmacokinetics, and clinical activity. Twelve patients in the 200, 400 and 600 mg dose cohorts of the CMML trial have been enrolled, and the Company is evaluating subjects in the highest dose cohort of 600 mg for continuing accrual of up to 18 patients. The Company also plans to review preliminary safety and potential efficacy results and anticipates completion of the ad hoc interim analysis in the first half of 2018. The Company may also use the interim data from the lenzilumab CMML Phase 1 study to determine the feasibility of rapidly commencing a Phase 1 study in juvenile myelomonocytic leukemia (“JMML”) patients, or to explore progressing a Phase 2 CMML study. JMML is a rare pediatric cancer, is associated with poor outcomes and a very high unmet medical need, for which there are no FDA-approved therapies.
Ifabotuzumab is an anti-Ephrin Type-A receptor 3, or EphA3, mAb that has the potential to offer a novel approach to treating solid tumors and hematologic malignancies, serious pulmonary conditions and as a CAR construct. EphA3 is aberrantly expressed on the surface of tumor cells and stroma cells in certain cancers. The Company completed the Phase 1 dose escalation portion of a Phase 1/2 clinical trial for ifabotuzumab in multiple hematologic malignancies for which the preliminary results were published in the journal Leukemia Research in 2016. An investigator-sponsored Phase 0/1 radio-labeled imaging trial of ifabotuzumab in glioblastoma multiforme, a particularly aggressive and deadly form of brain cancer, has begun at the Olivia-Newton John Cancer Institute in Melbourne, Australia. The Company is also in discussions with a leading center in the U.S. to develop a series of CAR constructs based on ifabotuzumab and may take these constructs, if developed, into pre-clinical testing for a range of cancer types. The Company will also continue to explore partnering opportunities to enable further development of ifabotuzumab.
HGEN005 is a pre-clinical stage anti-human epidermal growth factor-like module containing mucin-like hormone receptor 1, or EMR1, mAb. EMR1 is a therapeutic target for eosinophilic disorders. Eosinophils are a type of white blood cell. If too many are produced in the body, chronic inflammation and tissue and organ damage may result. Analysis of blood and bone marrow shows that surface expression of EMR1 is restricted to mature eosinophils and correlated with eosinophilia. Tissue eosinophils also express EMR1. In pre-clinical work, the Company has demonstrated that eosinophil killing is enhanced in the presence of HGEN005 and immune effector cells. A major limitation of current eosinophil targeted therapies is incomplete depletion of tissue eosinophils and/or lack of cell selectivity, which may mean that HGEN005 could offer promise in a range of eosinophil-driven diseases, such as eosinophilic asthma, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis. The Company is in discussion with a leading center in the U.S. to develop a series of CAR constructs based on HGEN005 and may take these constructs, if developed, into pre-clinical testing for eosinophilic leukemia, an orphan condition with significant unmet need.
The Company’s monoclonal antibody portfolio was developed with its proprietary, patent-protected Humaneered®technology, which consists of methods for converting antibodies (typically murine) into engineered, high-affinity antibodies designed for human therapeutic use.
Liquidity and Going Concern
The Company has incurred significant losses since its inception in March 2000 and had an accumulated deficit of $267.7 million as of March 31, 2018. At March 31, 2018, the Company had a working capital deficit of $4.1 million. On February 27, 2018, the Company issued 91,815,517 shares of common stock in exchange for the extinguishment of all term loans, related fees and accrued interest and received $1.5 million in cash proceeds. See Note 9 for a more detailed discussion of these restructuring transactions. On March 12, 2018 the Company issued 2,445,557 shares of common stock for proceeds of $1.1 million to accredited investors. The Company will require additional financing in order to meet its anticipated cash flow needs during the next twelve months. The Company has financed its operations primarily through the sale of equity securities, debt financings, interest income earned on cash and cash equivalents, grants and the payments received under its agreements with Novartis Pharma AG (“Novartis”) and Sanofi Pasteur S.A. (“Sanofi”). To date, none of the Company’s product candidates has been approved for sale and therefore the Company has not generated any revenue from product sales. Management expects operating losses to continue for the foreseeable future. As a result, the Company will continue to require additional capital through equity offerings, debt financing and/or payments under new or existing licensing or collaboration agreements. If sufficient funds are not available on acceptable terms when needed, the Company could be required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and results of operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.
The Condensed Consolidated Financial Statements for the three months ended March 31, 2018 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The ability of the Company to meet its total liabilities of $7.9 million at March 31, 2018 and to continue as a going concern is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
Basis of Presentation
The accompanying interim unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements and include all adjustments necessary for the presentation of the Company’s condensed consolidated financial position, results of operations and cash flows for the periods presented. The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiaries. These financial statements have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The December 31, 2017 Condensed Consolidated Balance Sheet was derived from the audited financial statements but does not include all disclosures required by U.S. GAAP. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2018, or for any other future annual or interim period. The accompanying unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s 2017 Form 10-K.
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the Condensed Consolidated Financial Statements and accompanying notes. Actual results could differ materially from those estimates. The Company believes judgment is involved in determining the valuation of the fair value-based measurement of stock-based compensation, accruals and warrant valuations. The Company evaluates its estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements.
2. Chapter 11 Filing
On December 29, 2015, the Company filed a voluntary petition for bankruptcy protection under Chapter 11 of the U.S. Bankruptcy Code. The filing was made in the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) (Case No. 15-12628 (LSS) (the “Bankruptcy Case”).
Plan of Reorganization
On May 9, 2016, the Company filed with the Bankruptcy Court a Plan of Reorganization and related amended disclosure statement (the “Plan”) pursuant to Chapter 11 of the Bankruptcy Code. On June 16, 2016, the Bankruptcy Court entered an order confirming the Plan.
The Plan became effective on June 30, 2016 (the “Effective Date”) and the Company emerged from its Chapter 11 bankruptcy proceedings.
Bankruptcy Claims Administration
The reconciliation of certain proofs of claim filed against the Company in the Bankruptcy Case, including certain General Unsecured Claims, Convenience Class Claims and Other Subordinated Claims, is ongoing. As a result of its examination of the claims, the Company may ask the Bankruptcy Court to disallow, reduce, reclassify or otherwise adjudicate certain claims the Company believes are subject to objection or otherwise improper. Under the terms of the Plan, the Company had until December 27, 2016 to file additional objections to disputed claims, subject to the Company’s right to seek an extension of this deadline from the Bankruptcy Court. By Order dated April 24, 2018, the Bankruptcy Court extended the claims objection deadline to June 25, 2018. The Company may compromise certain claims with or without specific prior approval of the Bankruptcy Court as set forth in the Plan and may identify additional liabilities that will need to be recorded or reclassified to liabilities subject to compromise. The resolution of such claims could result in material adjustments to the Company’s financial statements.
As of March 31, 2018, approximately $0.5 million in claims remain subject to review and reconciliation by the Company. The Company may file objections to these claims after it completes the reconciliation process. As of March 31, 2018, the Company has recorded $0.06 million related to these claims in Accounts payable and Notes payable to vendors, which represents management’s best estimate of claims to be allowed by the Bankruptcy Court.
Although the Bankruptcy Case remains open, other than with respect to certain matters relating to the implementation of the Plan, the administration of certain claims, or over which the Bankruptcy Court may have otherwise retained jurisdiction, the Company is no longer operating under the direct supervision of the Bankruptcy Court. The Company anticipates that the Bankruptcy Case will be closed following the completion of the claims reconciliation process and will seek to close the Bankruptcy as soon as possible.
Financial Reporting in Reorganization
The Company applied Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 852, Reorganizations, which is applicable to companies under bankruptcy protection, and requires amendments to the presentation of key financial statement line items. It requires that the financial statements for periods subsequent to the Chapter 11 filing distinguish transactions and events that are directly associated with the reorganization from the ongoing operations of the business. Revenues, expenses, realized gains and losses, and provisions for losses that can be directly associated with the reorganization and restructuring of the business must be reported separately as reorganization items in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The balance sheet must distinguish pre-petition liabilities subject to compromise from both those pre-petition liabilities that are not subject to compromise and from post-petition liabilities. Liabilities that may be subject to a plan of reorganization must be reported at the amounts expected to be allowed in the Company’s Chapter 11 case, even if they may be settled for lesser amounts as a result of the plan of reorganization or negotiations with creditors.
As of March 31, 2018, approximately $0.06 million of pre-petition liabilities remain in Accounts payable and Notes payable to vendors. For the three months ended March 31, 2017, the Company wrote off approximately $0.2 million in claims that had been reduced or for which a settlement had been reached at a lower amount than had been previously accrued. Remaining amounts will be paid based on terms of the Plan.
For the three months ended March 31, 2018 and 2017, Reorganization items, net consisted of the following charges:
Three months ended March 31,
| ||||||||
2018
|
2017
| |||||||
Legal fees
|
$
|
30
|
$
|
112
| ||||
Professional fees
|
7
|
12
| ||||||
Total reorganization items, net
|
$
|
37
|
$
|
124
| ||||
Cash payments for reorganization items totaled $0.1 million and $0.4 million for the three months ended March 31, 2018 and 2017, respectively.
3. Summary of Significant Accounting Policies
There have been no material changes in the Company’s significant accounting policies since those previously disclosed in the 2017 Annual Report.
4. Potentially Dilutive Securities
The Company’s potentially dilutive securities, which include stock options, restricted stock units and warrants, have been excluded from the computation of diluted net loss per common share as the effect of including those securities would be to reduce the net loss per common share and be antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in each period presented.
The following outstanding potentially dilutive securities have been excluded from the computations of diluted net loss per common share:
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
| |||||||
5. Investments
At March 31, 2018, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows:
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
| ||||||||||||||
At December 31, 2017, the amortized cost and fair value of investments, with gross unrealized gains and losses, were as follows:
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
| ||||||||||||||
6. Fair Value of Financial Instruments
Cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value given their short-term nature. Marketable securities and cash equivalents are carried at fair value.
The fair value of financial instruments reflects the amounts that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The fair value hierarchy is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable, and the third is considered unobservable, as follows:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs other than those included in Level 1 that are directly or indirectly observable, such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities 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.
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.
The Company measures the fair value of financial assets and liabilities using the highest level of inputs that are reasonably available as of the measurement date. The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy:
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
| ||||||||
7. Debt
Notes Payable to Vendors
On June 30, 2016, the Company issued promissory notes in an aggregate principal amount of approximately $1.2 million to certain claimants in accordance with the Plan. The notes are unsecured, bear interest at 10% per annum and are due and payable in full, including principal and accrued interest on June 30, 2019. As of March 31, 2018 and 2017, the Company has accrued $0.2 million and $0.1 million in interest related to these promissory notes, respectively.
Term Loans
Term Loans consisted of the following at December 31, 2017:
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 | ||||||||||
On December 21, 2016, the Company entered into a Credit and Security Agreement, as amended on March 21, 2017 and on July 8, 2017 (as amended, the “Term Loan Credit Agreement”), with Black Horse Capital Master Fund (“BHCMF”) as administrative agent and lender, and lenders Black Horse Capital (“BHC”), Cheval Holdings, Ltd. (“Cheval” and collectively with BHCMF and BHC, the “Black Horse Entities”) and Nomis Bay LTD (“Nomis Bay”) (collectively the “Lenders”). The Term Loan Credit Agreement provided for the December 2016 Loan, the March 2017 Loan and the July 2017 Loan (the “Term Loans”).
In accordance with the terms of the Term Loan Credit Agreement, the Company used the proceeds of the Term Loans for general working capital, the payment of certain fees and expenses owed to BHCMF and the Lenders and other costs incurred in the ordinary course of business. Dr. Dale Chappell, one of the Company’s former directors, is an affiliate of each of BHCMF, BHC and Cheval.
The Term Loans bore interest at 9.00% and were subject to certain customary representations, warranties and covenants, as set forth in the Term Loan Credit Agreement.
On December 1, 2017 the Term Loans matured and began bearing interest at the default rate of 14.00%. The Company’s obligations under the Term Loan Credit Agreement were secured by a first priority interest in all of the Company’s real and personal property, subject only to certain carve outs and permitted liens, as set forth in the agreement.
On December 21, 2017, the Company entered into a Forbearance and Loan Modification Agreement, where among other things, it obtained a $1.5 million bridge loan (the "Bridge Loan") from Cheval and a credit facility with Nomis Bay (the “Claims Advances Loan”). Both loans bear interest at 14.00% and are treated as secured loans under the Term Loan Credit Agreement.
On February 27, 2018 the Term Loans, the Bridge Loan and the Claims Advances Loan along with all related fees and accrued interest, were extinguished in connection with the Restructuring Transactions described in Note 9.
8. Commitments and Contingencies
Contractual Obligations and Commitments
As of March 31, 2018, there were no material changes to the Company’s contractual obligations from those set forth in the 2017 Annual Report.
Guarantees and Indemnifications
The Company has certain agreements with service providers with which it does business that contain indemnification provisions pursuant to which the Company typically agrees to indemnify the party against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. The Company would also accrue for estimated incurred but unidentified indemnification issues based on historical activity. As the Company has not incurred any indemnification losses to date, there were no accruals for or expenses related to indemnification issues for any period presented.
9. Stockholders’ Equity
This summarizes the activity in Stockholders’ Equity discussed below:
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
|
)
| |||||||||
Restructuring Transactions
On December 21, 2017, the Company entered into a Securities Purchase and Loan Satisfaction Agreement (the “Purchase Agreement”) and a Forbearance and Loan Modification Agreement (the “Forbearance Agreement” and, together with the Purchase Agreement, the “Agreements”), each with the Lenders. The Agreements provided for a series of transactions (the “Restructuring Transactions”) pursuant to which, at the closing of the Restructuring Transactions (the “Transaction Closing”), which occurred on February 27, 2018, the Company would: (i) in exchange for the satisfaction and extinguishment of the entire balance of the Term Loans, (a) issue to the Lenders an aggregate of 59,786,848 shares of Common Stock (the “New Lender Shares”), and (b) transfer and assign to Madison Joint Venture LLC (“Madison”), an affiliate of Nomis Bay, all of the assets of the Company related to benznidazole (the “Benz Assets”), the Company’s former drug candidate; and (ii) issue to Cheval an aggregate of 32,028,669 shares of Common Stock (the “New Black Horse Shares” and, collectively with the New Lender Shares, the “New Common Shares”) for total consideration of $3.0 million.
Issuance of the New Lender Shares
Under the Purchase Agreement, at the Transaction Closing, the Company issued to the Lenders the New Lender Shares, of which 29,893,424 shares of Common Stock were issued to the Black Horse Entities and 29,893,424 shares of Common Stock were issued to Nomis Bay. The issuance of the New Lender Shares to the Lenders and the assignment of the Benz Assets to Madison resulted in the satisfaction and extinguishment of the Company’s outstanding obligations under the Credit Agreement and the cancellation of the Term Loans, including the Bridge Loan and the Claims Advances Loan, described below and all security interests of the Lenders in the Company’s assets were released. The conversion of the Term Loans, Bridge Loan and Claims Advances Loan was accounted for as a decrease to Long-term debt and an increase to Common stock and Additional paid-in capital in the amount of the liabilities outstanding at the time of conversion.
Transfer of the Benz Assets; Claims Advances
Under the Purchase Agreement, at the Transaction Closing, the Company transferred and assigned the Benz Assets to Madison. The Company also agreed to retain, but provide Madison the benefits of, any Benz Assets which are not permitted to be assigned absent receipt of third-party consents. Madison (at the election of Nomis Bay, which controls Madison) has 180 days from the Transaction Closing to decide, in its sole discretion, whether to elect to keep the Benz Assets (a “Positive Election”). The Benz Assets will revert back to the Company in the event that Madison (at the election of Nomis Bay) elects not to make a Positive Election.
In connection with the transfer of the Benz Assets to Madison, Nomis Bay paid certain amounts incurred by the Company and Madison after December 21, 2017 and prior to the Transaction Closing in investigating certain causes of action and claims related to or in connection with the Benz Assets (the “Claims Advances Loan”), including the right to pursue causes of action and claims related to potential misappropriation of the Company’s trade secrets by a competitor in connection with such competitor’s submissions to the U.S. Food and Drug Administration (the “Claims”). In addition, if Madison (at the election of Nomis Bay) makes a Positive Election: (i) Nomis Bay will assume certain legal fees and expenses owed by the Company to its litigation counsel, and (ii) the Company will be entitled to receive 30% of any amounts realized from the successful prosecution of the Claims or otherwise from the Benz Assets, after Nomis Bay is reimbursed for certain expenses in connection with funding the Claims Advances Loan and after giving effect to any payments that Madison may be required to make to any third parties.
Nomis Bay will have full control, in its sole discretion, over the management of Madison, any development of or realization on the Benz Assets and the prosecution of the Claims. Since the Benz Assets had no carrying value on the Company’s Condensed Consolidated Balance Sheet, the initial investment in Madison was recorded at $0.
Issuance of the New Black Horse Shares; Bridge Loan
Under the Purchase Agreement, at the Transaction Closing, the Company issued to Cheval the New Black Horse Shares for total consideration of $3.0 million, including extinguishment of the Bridge Loan. The Company used the proceeds from the issuance of the New Black Horse Shares for working capital and other costs incurred in the ordinary course of business. At the Transaction Closing, the entire amount of the Bridge Loan was credited to Cheval’s $3.0 million payment obligation and was converted into New Black Horse Shares and all security interests of Cheval in the non-benznidazole assets was released.
Equity Financing
On March 12, 2018, the Company issued 2,445,557 shares of its common stock for total proceeds of $1.1 million to accredited investors.
Amendments to Articles of Incorporation
Effective February 26, 2018, the Company amended its Amended and Restated Certificate of Incorporation, as amended (the “Charter”), to amend Article IV of the Charter to (i) increase the number of authorized shares of Common Stock from 85,000,000 to 225,000,000, and (ii) authorize the issuance of 25,000,000 shares of preferred stock of the Company, par value $0.001 (the “Preferred Stock”), with such powers, rights, terms and conditions as may be designated by the Company’s board of directors upon the issuance of shares of Preferred Stock at one or more times in the future (the “Charter Amendment”). The Charter Amendment was approved and adopted by the written consent of a majority of the stockholders of the Company in accordance with the applicable provisions of the Delaware General Corporation Law, the Charter, and the Company’s Second Amended and Restated Bylaws.
Termination of Equity Financing Facility
On August 24, 2017, the Company entered into a Common Stock Purchase Agreement, dated as of August 23, 2017 (the “ELOC Purchase Agreement”), with Aperture Healthcare Ventures Ltd. (“Aperture”) pursuant to which the Company may, subject to certain conditions and limitations set forth in the ELOC Purchase Agreement, require Aperture to purchase up to $15 million worth of newly issued shares (the “Put Shares”) of the Company’s common stock, over the 36-month term.
The Company terminated the ELOC Purchase Agreement on March 12, 2018. No Put Shares were issued pursuant to the ELOC Purchase Agreement prior to such termination.
2012 Equity Incentive Plan
Under the Company’s 2012 Equity Incentive Plan, the Company may grant shares, stock units, stock appreciation rights, performance cash awards and/or options to employees, directors, consultants, and other service providers. For options, the per share exercise price may not be less than the fair market value of a Company common share on the date of grant. Awards generally vest and become exercisable over three to four years and expire 10 years from the date of grant. Options generally become exercisable as they vest following the date of grant.
On March 9, 2018, the Board of Directors of the Company approved an amendment to the Company’s 2012 Equity Incentive Plan (the “Equity Plan”) to increase the number of shares of the Company’s common stock authorized for issuance under the Equity Plan by 16,050,000 shares, and to increase the annual maximum aggregate number of shares subject to stock option awards that may be granted to any one person under the Equity Plan during a calendar year to 7,500,000.
A summary of stock option activity for the three months ended March 31, 2018 under all of the Company’s options plans is as follows:
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
| |||||
The weighted average fair value of options granted during the three months ended March 31, 2018 was $0.51 per share.
The Company valued the options granted using the Black-Scholes options pricing model and the following weighted-average assumption terms for the three months ended March 31, 2018:
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
|
-
| |||
Stock-Based Compensation
The Company recorded stock-based compensation expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss as follows:
Three months ended March 31,
| ||||||||
2018
|
2017
| |||||||
| General and administrative | $ | 2,474 | $ | 923 | ||||
| Research and development | 201 | 163 | ||||||
| $ | 2,675 | $ | 1,086 | |||||
At March 31, 2018, the Company had $5.4 million of total unrecognized stock-based compensation expense, net of estimated forfeitures, related to outstanding stock options that will be recognized over a weighted-average period of 1.8 years.
10. Savant Arrangements
On February 29, 2016, the Company entered into a binding letter of intent (the “LOI”) with Savant Neglected Diseases, LLC (“Savant”). The LOI provided that the Company would acquire certain worldwide rights relating to benznidazole (the “Compound”) from Savant.
On the Effective Date, as authorized by the Plan and the Confirmation Order, the Company and Savant entered into an Agreement for the Manufacture, Development and Commercialization of Benznidazole for Human Use (the “MDC Agreement”), pursuant to which the Company acquired certain worldwide rights relating to the Compound. The MDC Agreement consummates the transactions contemplated by the LOI.
In addition, on the Effective Date the Company and Savant also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company granted Savant a continuing senior security interest in the assets and rights acquired by the Company pursuant to the MDC Agreement and certain future assets developed from those acquired assets.
On the Effective Date, the Company issued to Savant a five year warrant (the “Warrant”) to purchase 200,000 shares of the Company’s Common Stock, at an exercise price of $2.25 per share, subject to adjustment. The Warrant is exercisable for 25% of the shares immediately and exercisable for the remaining shares upon reaching certain regulatory related milestones. As of March 31, 2018 the number of shares for which the Warrant is currently exercisable totals 100,000 shares at an exercise price of $2.25 per share.
The Company reevaluated the performance conditions and expected vesting of the Warrant as of March 31, 2017 and recorded a reduction in expense of approximately $0.03 million during the three months ended March 31, 2017 due to a decline in the fair value, which reduction is included in Research and development expense in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss. As a result of the FDA granting accelerated and conditional approval of a benznidazole therapy manufactured by a competitor for the treatment of Chagas disease and awarding such competitor a neglected tropical disease PRV in August 2017, the Company re-evaluated the final two vesting milestones and concluded that the probability of achievement of these milestones had decreased to 0%.
Before a compound receives regulatory approval, the Company records upfront and milestone payments made to third parties under licensing arrangements as expense. Upfront payments are recorded when incurred and milestone payments are recorded when the specific milestone has been achieved.
On May 26, 2017, the Company submitted its benznidazole IND to FDA which became effective on June 26, 2017. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with the IND being declared effective.
On July 10, 2017 FDA notified the Company that it granted Orphan Drug Designation to benznidazole for the treatment of Chagas disease. The Company recorded expense of $1.0 million during the year ended December 31, 2017 as Research and development expense related to the milestone achievement associated with Orphan Drug Designation.
In July 2017, the Company commenced litigation against Savant alleging that Savant breached the MDC Agreement and seeking a declaratory judgement. Savant has asserted counterclaims for breaches of contract under the MDC Agreement and the Security Agreement. The dispute primarily concerns the Company’s right under the MDC Agreement to offset certain costs incurred by the Company in excess of the agreed upon budget against payments due Savant. See Note 11, below, for more information regarding the Savant litigation. The aggregate cost overages as of June 30, 2017 that the Company asserts are Savant’s responsibility total approximately $3.4 million, net of a $0.5 million deductible. The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such that as of June 30, 2017, Savant owed the Company approximately $1.4 million. As of March 31, 2018, the cost overages totaled $4.1 million such that Savant owed the Company approximately $2.1 million in cost overages. Such cost overages have been charged to Research and development expense as incurred. Recovery of such cost overages, if any, will be recorded as a reduction of Research and development expense in the period received.
The $2.0 million in milestone payments due Savant are included in Accrued expenses in the accompanying Condensed Consolidated Balance Sheet as of March 31, 2018 and December 31, 2017.
11. Litigation
Bankruptcy Proceeding
The Company filed for protection under Chapter 11 of Title 11 of the United States Bankruptcy Code on December 29, 2015. See Note 2 for additional information related to the bankruptcy.
Savant Litigation
On July 10, 2017, the Company filed a complaint against Savant Neglected Diseases, LLC (“Savant”) in the Superior Court for the State of Delaware, New Castle County (the “Delaware Court”). KaloBios Pharmaceuticals, Inc. v. Savant Neglected Diseases, LLC, No. N17C-07-068 PRW-CCLD. The Company asserted breach of contract and declaratory judgment claims against Savant arising under the MDC Agreement. See Note 10 - “Savant Arrangements” for more information about the MDC Agreement. The Company alleges that Savant has breached its MDC Agreement obligations to pay cost overages that exceed a budgetary threshold as well as other related MDC Agreement representations and obligations. In the litigation, the Company has alleged that as of June 30, 2017, Savant was responsible for aggregate cost overages of approximately $3.4 million, net of a $0.5 million deductible under the MDC. The Company asserts that it is entitled to offset $2.0 million in milestone payments due Savant against the cost overages, such that as of June 30, 2017 Savant owed the Company approximately $1.4 million.
On July 12, 2017, Savant removed the case to the Bankruptcy Court, claiming that the action is related to or arises under the Bankruptcy Case from which we emerged in July 2016. On July 27, 2017, Savant filed an Answer and Counterclaims. Savant’s filing alleges breaches of contracts under the MDC Agreement and the Security Agreement, claiming that the Company breached its obligations to pay the milestone payments and other related representations and obligations.
On August 1, 2017, the Company moved to remand the case back to the Delaware Court (the “Motion to Remand”).
On August 2, 2017, Savant sent a foreclosure notice to the Company, demanding that it provide the Collateral as defined in the Security Agreement for inspection and possession on August 9, 2017, with a public sale to be held on September 1, 2017. The Company moved for a Temporary Restraining Order (the “TRO”) and Preliminary Injunction in the Bankruptcy Court on August 4, 2017. Savant responded on August 7, 2017. On August 7, 2017, the Bankruptcy Court granted the Company’s motion for a TRO, entering an order prohibiting Savant from collecting on or selling the Collateral, entering our premises, issuing any default notices to us, or attempting to exercise any other remedies under the MDC Agreement or the Security Agreement. The parties have stipulated to continue the provisions of the TRO in full force and effect until further order of the appropriate court.
On January 22, 2018, Savant wrote to the Bankruptcy Court requesting dissolution of the TRO. On January 29, 2018, the Bankruptcy Court granted the Motion to Remand and denied Savant’s request to dissolve the TRO, ordering that any request to dissolve the TRO be made to the Delaware Court.
On February 13, 2018 Savant made a letter request to the Delaware Superior Court to dissolve the TRO. Also on February 13, 2018, Humanigen filed its Answer and Affirmative defenses to Savant’s Counterclaims. On February 15, 2018 Humanigen filed a letter opposition to Savant’s request to dissolve the TRO and requesting a status conference. A hearing on Savant’s request to dissolve the TRO was held before the Delaware Superior Court on March 19, 2018. The Delaware Superior Court denied Savant’s request to dissolve the TRO and the TRO remains in effect.
On April 11, 2018, Humanigen advised the Delaware Superior Court that it would meet and confer with Savant regarding a proposed case management order and date for trial, and that it anticipated submitting a proposed case management order by April 23, 2018.
There have been no further proceedings in this matter to date.
You should read the following discussion and analysis together with our financial statements and the notes to those statements included elsewhere in this Quarterly Report on Form 10‑Q and our Annual Report on Form 10-K for the fiscal year ended December 31, 2017. This Quarterly Report on Form 10-Q contains statements that discuss future events or expectations, projections of results of operations or financial condition, trends in our business, business prospects and strategies and other “forward-looking” information. In some cases, you can identify “forward-looking statements” by words like “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “intends,” “potential” or “continue” or the negative of those words and other comparable words. These statements may relate to, among other things, our expectations regarding the scope, progress, expansion, and costs of researching, developing and commercializing our product candidates; our opportunity to benefit from various regulatory incentives; expectations for our financial results, revenue, operating expenses and other financial measures in future periods; and the adequacy of our sources of liquidity to satisfy our working capital needs, capital expenditures, and other liquidity requirements. Actual events or results may differ materially due to known and unknown risks, uncertainties and other factors such as:
| · |
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.
|
These are only some of the factors that may affect the forward-looking statements contained in this Form 10-Q. For a discussion identifying additional important factors that could cause actual results to vary materially from those anticipated in the forward-looking statements, see “Risk Factors” in Item 1A of Part I of our 2017 Form 10-K. You should review these risk factors for a more complete understanding of the risks associated with an investment in our securities. However, we operate in a competitive and rapidly changing environment and new risks and uncertainties emerge, are identified or become apparent from time to time. It is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Form 10-Q. You should be aware that the forward-looking statements contained in this Form 10-Q are based on our current views and assumptions. We undertake no obligation to revise or update any forward-looking statements made in this Form 10-Q to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law. The forward-looking statements in this Form 10-Q are intended to be subject to protection afforded by the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Overview
We were incorporated on March 15, 2000 in California and reincorporated as a Delaware corporation in September 2001 under the name KaloBios Pharmaceuticals, Inc. We completed our initial public offering in January 2013. Effective August 7, 2017, we changed our legal name to Humanigen, Inc.
As disclosed in our 2017 Form 10-K, since August 29, 2017, we have shifted our primary focus toward developing our proprietary monoclonal antibody portfolio, which comprises lenzilumab, ifabotuzumab and HGEN005, for use in addressing significant unmet needs in oncology and immunology. These product candidates are at various stages of development and will require substantial time, expenses, clinical development, testing, and regulatory approval from the FDA prior to commercialization, if they are approved at all. Furthermore, none of these product candidates has advanced into pivotal registration studies and it may be years before any such studies are initiated, if at all.
Lenzilumab is a recombinant mAb that neutralizes soluble GM-CSF, a critical cytokine in the inflammatory cascade associated with serious and potentially life-threatening CAR-T-related side effects and in the growth of certain hematologic malignancies, solid tumors and other serious conditions. We expect to study lenzilumab’s potential in reducing the side effects associated with CAR-T therapy and potentially also improving efficacy. We have begun to explore lenzilumab’s effectiveness in preventing or ameliorating neurotoxicity and potentially CRS associated with CAR-T therapy. Pre-clinical animal data suggests there may be an increase in CAR-T cell expansion when combined with lenzilumab, which potentially could translate into improved CAR-T efficacy and this is likely to be an area of further study. In addition, we have completed enrollment of patients in a Phase 1 clinical trial for CMML to identify the MTD, or RPTD of lenzilumab and to assess lenzilumab’s safety, pharmacokinetics, and clinical activity. Twelve patients in the 200, 400 and 600 mg dose cohorts of the CMML trial have been enrolled, and we are evaluating subjects in the highest dose cohort of 600 mg for continuing accrual of up to 18 patients. We also plan to review preliminary safety and potential efficacy results and anticipate completion of the ad hoc interim analysis in the first half of 2018. We may also use the interim data from the lenzilumab CMML Phase 1 study to determine the feasibility of rapidly commencing a Phase 1 study in JMML patients, or to explore progressing a Phase 2 CMML study. JMML is a rare pediatric cancer, is associated with a very high unmet medical need and there are no FDA-approved therapies.
Ifabotuzumab is an EphA3 mAb that has the potential to offer a novel approach to treating solid tumors and hematologic malignancies, serious pulmonary conditions and as a CAR construct. EphA3 is aberrantly expressed on the surface of tumor cells and stroma cells in certain cancers. We completed the Phase 1 dose escalation portion of a Phase 1/2 clinical trial for ifabotuzumab in multiple hematologic malignancies for which the preliminary results were published in the journal Leukemia Research in 2016. An investigator-sponsored Phase 0/1 radio-labeled imaging trial of ifabotuzumab in glioblastoma multiforme, a particularly aggressive and deadly form of brain cancer, has begun at the Olivia-Newton John Cancer Institute in Melbourne, Australia. We are also in discussions with a leading center in the U.S. to develop a series of CAR constructs based on ifabotuzumab and may take these constructs, if developed, into pre-clinical testing for a range of cancer types. We will also continue to explore partnering opportunities to enable further development of ifabotuzumab.
HGEN005 is a pre-clinical stage anti-EMR1 mAb. EMR1 is a therapeutic target for eosinophilic disorders. Eosinophils are a type of white blood cell. If too many are produced in the body, chronic inflammation and tissue and organ damage may result. Analysis of blood and bone marrow shows that surface expression of EMR1 is restricted to mature eosinophils and correlated with eosinophilia. Tissue eosinophils also express EMR1. In pre-clinical work, we demonstrated that eosinophil killing is enhanced in the presence of HGEN005 and immune effector cells. A major limitation of current eosinophil targeted therapies is incomplete depletion of tissue eosinophils and/or lack of cell selectivity, which may mean that HGEN005 could offer promise in a range of eosinophil-driven diseases, such as eosinophilic asthma, eosinophilic esophagitis and eosinophilic granulomatosis with polyangiitis. We are in discussion with a leading center in the U.S. to develop a series of CAR constructs based on HGEN005 and may take these constructs, if developed, into pre-clinical testing for eosinophilic leukemia, an orphan condition with significant unmet need.
Our monoclonal antibody portfolio was developed with our proprietary, patent-protected Humaneered® technology, which consists of methods for converting antibodies (typically murine) into engineered, high-affinity antibodies designed for human therapeutic use.
We have incurred significant losses and had an accumulated deficit of $267.7 million as of March 31, 2018. We expect to continue to incur net losses for the foreseeable future as we develop our drug candidates, expand pre-clinical and clinical trials for our drug candidates currently in development, expand our development activities and seek regulatory approvals. Significant capital is required to continue to develop and to launch a product and many expenses are incurred before revenue is received, if any. We are unable to predict the extent of any future losses or when we will receive revenue or become profitable, if at all.
Despite completing the Restructuring Transactions and the common stock financing (as discussed below), we will require substantial additional capital to continue as a going concern and to support our business efforts, including obtaining regulatory approvals for our product candidates, clinical trials and other studies, and, if approved, the commercialization of our product candidates. We anticipate that we will seek additional financing from a number of sources, including, but not limited to, the sale of equity or debt securities, strategic collaborations, and licensing of our product candidates. Additional funding may not be available to us on a timely basis or at acceptable terms, if at all. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would materially harm our business, financial condition and results of operations. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our development programs. We may also be required to sell or license to others our technologies, product candidates, or development programs that we would have preferred to develop and commercialize ourselves and on less than favorable terms, if at all. If in the best interests of our stockholders, we may also find it appropriate to enter into a strategic transaction that could result in, among other things, a sale, merger, consolidation or business combination.
If management is unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital is not expected to be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern.
The consolidated financial statements for the three months ended March 31, 2018 were prepared on the basis of a going concern, which contemplates that we will be able to realize our assets and discharge liabilities in the normal course of business. Our ability to meet our liabilities and to continue as a going concern is dependent upon the availability of future funding. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Critical Accounting Policies and Use of Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our Condensed Consolidated Financial Statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of our financial statements in conformity with GAAP requires our management to make estimates and assumptions that affect the amounts and disclosures reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Our management believes judgment is involved in determining revenue recognition, valuation of financing derivative, the fair value-based measurement of stock-based compensation, accruals and warrant valuations. Our management evaluates estimates and assumptions as facts and circumstances dictate. As future events and their effects cannot be determined with precision, actual results could differ from these estimates and assumptions, and those differences could be material to the Condensed Consolidated Financial Statements. If our assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material adverse effect on our statements of operations, liquidity and financial condition.
We are an emerging growth company under the JOBS Act. Emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, we may not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.
There were no significant and material changes in our critical accounting policies and use of estimates during the three months ended March 31, 2018, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Use of Estimates” in our 2017 Form 10-K, filed with the SEC on March 27, 2018.
Results of Operations
General
We have not generated net income from operations, except for the year ended December 31, 2007 during which we recognized a one-time license payment from Novartis. At March 31, 2018, we had an accumulated deficit of $267.7 million primarily as a result of research and development and general and administrative expenses. While we may in the future generate revenue from a variety of sources, including license fees, milestone payments, and research and development payments in connection with strategic partnerships, our product candidates may never be successfully developed or commercialized and we may therefore never realize revenue from any product sales, particularly because most of our product candidates are at an early stage of development. Accordingly, we expect to continue to incur substantial losses from operations for the foreseeable future, and there can be no assurance that we will ever generate significant revenue or profits.
Research and Development Expenses
Conducting research and development is central to our business model. We expense both internal and external research and development costs as incurred. We track external research and development costs incurred by project for each of our clinical programs. Our external research and development costs consist primarily of:
| · |
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.
|
Other research and development costs consist primarily of internal research and development costs such as salaries and related fringe benefit costs for our employees (such as workers compensation and health insurance premiums), stock‑based compensation charges, travel costs, lab supplies, overhead expenses such as rent and utilities, and external costs not allocated to one of our clinical programs. Internal research and development costs generally benefit multiple projects and are not separately tracked per project.
The following table shows our total research and development expenses for the three months ended March 31, 2018 and 2017:
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
| ||||
General and Administrative Expenses
General and administrative expenses consist principally of personnel-related costs, professional fees for legal, consulting, audit and tax services, rent and other general operating expenses not otherwise included in research and development.
Comparison of Three Months Ended March 31, 2018 and 2017
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
|
)
| |||||
Research and development expenses decreased by $2.0 million, from $2.7 million for the three months ended March 31, 2017 to $0.7 million for the three months ended March 31, 2018. The decrease is primarily due to the discontinuation of the development of benznidazole in August 2017 and lower internal costs, partially offset by an increase in spending on the development of lenzilumab, primarily in connection with the CMML trial.
General and administrative expenses increased $1.5 million from $2.5 million for the three months ended March 31, 2017 to $4.0 million for the three months ended March 31, 2018. The increase is primarily due to a $1.5 million increase in stock-based compensation expense related to the issuance of options to management, consultants and board members subsequent to the completion of the Restructuring Transactions.
Reorganization items, net, decreased $0.1 million for the three months ended March 31, 2018 versus the three months ended March 31, 2017. The decrease is primarily related to the decrease in legal fees in the current three-month period.
Interest expense increased $0.1 million from $0.3 million recognized for the three months ended March 31, 2017 to $0.4 million for the three months ended March 31, 2018. The increase in interest expense was related to higher average Term Loans balances for the three months ended March 31, 2018 compared to the three months ended March 31, 2017.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily through proceeds from the public offerings of our common stock, private placements of our preferred stock, debt financings, interest income earned on cash, and cash equivalents, and marketable securities, borrowings against lines of credit, and receipts from agreements with Sanofi and Novartis. At March 31, 2018, we had cash and cash equivalents of $1.6 million. As of May 7, 2018, we had cash and cash equivalents of $0.7 million.
The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below:
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
| ||||
Net cash used in operating activities was $1.8 million and $4.4 million for the three months ended March 31, 2018 and 2017, respectively. Cash used in operating activities of $1.8 million for the three months ended March 31, 2018 primarily related to our net loss of $5.1 million, adjusted for non-cash items, such as $2.7 million in stock-based compensation, $0.4 million in noncash interest expense, and net increases in working capital items of $0.2 million, primarily related to an increase of $0.2 million in Accrued expenses.
Cash used in operating activities of $4.4 million for the three months ended March 31, 2017 primarily related to our net loss of $5.5 million, adjusted for non-cash items, such as $1.1 million in stock-based compensation, $0.3 million in noncash interest expense, and net cash outflows of $0.3 million related to changes in operating assets and liabilities, primarily Prepaid expenses and other assets, Liabilities subject to compromise, Accounts payable and Accrued expenses.
Net cash provided by financing activities was $2.7 million for the three months ended March 31, 2018. This amount consists primarily of $1.5 million received from Cheval related to the Restructuring Transactions (see “Restructuring Transactions” below) and $1.1 million from the issuance of 2,445,557 shares of our common stock to accredited investors on March 12, 2018. Net cash provided by financing activities was $5.5 million for the three months ended March 31, 2017 related to the March 2017 Term Loan.
Restructuring Transactions
On December 1, 2017, our obligations matured under the Term Loan Credit Agreement with the Term Loan Lenders. On December 21, 2017, we entered into the Restructuring Agreements, each with the Term Loan Lenders, in connection with a series of transactions providing for, among other things, the satisfaction and extinguishment of our outstanding obligations under the Term Loan Credit Agreement and the infusion of $3.0 million of new capital. As of February 27, 2018, the date the Restructuring Transactions were completed, the aggregate amount of our obligations under the Term Loan Credit Agreement, including the Bridge Loan, the Claims Advances Loan (each as discussed below) and all accrued interest and fees, approximated $18.4 million.
On February 27, 2018 (the “Restructuring Effective Date”), the Restructuring Transactions were completed in accordance with the Restructuring Agreements. As a result, on the Restructuring Effective Date, we: (i) in exchange for the satisfaction and extinguishment of the entire $18.4 million balance of the Term Loans, including the Bridge Loan, the Claims Advances Loan and all accrued interest and fees, (a) issued to the Term Loan Lenders an aggregate of 59,786,848 shares of our common stock (the “New Lender Shares”), and (b) transferred and assigned to Madison, an entity owned 70% by Nomis Bay and 30% by us, the Benz Assets, our former drug candidate, capable of being so assigned; and (ii) issued to Cheval an aggregate of 32,028,669 shares of our common stock (the “New Black Horse Shares” and, collectively with the New Lender Shares, the “New Common Shares”) for total consideration of $3.0 million (collectively, the “Restructuring Transactions”), $1.5 million of which we received on December 22, 2017 in the form of a bridge loan (the “Bridge Loan”).
On the Restructuring Effective Date, the aggregate amount of the Term Loans that were deemed to be satisfied and extinguished (i) previously owed to the Black Horse Entities, including the Bridge Loan and all accrued interest and fees, totaled $9.9 million, and (ii) previously owed to Nomis Bay, including the Claims Advances Loan totaling $0.1 million and all accrued interest and fees, totaled $8.5 million. In addition, on the Restructuring Effective Date, (i) each of the Term Loan Credit Agreement, all promissory notes issued thereunder and the Intellectual Property Security Agreement, dated as of December 21, 2016, by and between us and the Term Loan Lenders, were terminated and are of no further force or effect, and (ii) all security interests of the Black Horse Entities and Nomis Bay in our assets were released. Although the Term Loans were satisfied and extinguished, if Madison (at the election of Nomis Bay) elects to keep the Benz Assets after the Restructuring Effective Date, Nomis Bay will be obligated to pay or cause Madison to pay $0.3 million in legal fees and expenses owed by us to our litigation counsel, which remain unpaid in our Accounts payable as of March 31, 2018.
Upon completion of the Restructuring Transactions, the Black Horse Entities collectively held 66,870,851 shares of our common stock, or approximately 62.6% of our outstanding common stock. Accordingly, the completion of the Restructuring Transactions on the Restructuring Effective Date resulted in a change in control of our company, as the Black Horse Entities and their affiliates owning more than a majority of our outstanding common stock. Dr. Dale Chappell, a member of our board of directors from June 30, 2016 until November 10, 2017, controls the Black Horse Entities and accordingly, will be able to exert control over matters of our company and will be able to determine all matters of our company requiring stockholder approval.
Despite completing the Restructuring Transactions and the March 12, 2018 common stock issuance, we will require substantial additional capital to continue as a going concern and to support our business efforts, including obtaining regulatory approvals for our product candidates, clinical trials and other studies, and, if approved, the commercialization of our product candidates. The amount of capital we will require and the timing of our need for additional capital will depend on many factors, including:
| · |
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.
|
We are pursuing efforts to raise additional capital from a number of sources, including, but not limited to, the sale of equity or debt securities and strategic collaborations. Additional funding may not be available to us on a timely basis or at acceptable terms, if at all. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would materially harm our business, financial condition and results of operations. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our development programs. We may also be required to sell or license to others our technologies, product candidates, or development programs that we would have preferred to develop and commercialize ourselves and on less than favorable terms, if at all. If in the best interests of our stockholders, we may also find it appropriate to enter into a strategic transaction that could result in, among other things, a sale, merger, consolidation or business combination.
If management is unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital will not be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern.
Our common stock currently trades on the OTCQB Venture Market under the ticker symbol “HGEN”. Although our common stock is listed for quotation on the OTCQB Venture Market, trading is limited and an active market for our common stock may never develop in the future, which could harm our ability to raise capital to continue to fund operations.
Termination of Equity Financing Facility
On March 12, 2018, we notified Aperture of our decision to terminate the ELOC Purchase Agreement, pursuant to which Aperture had agreed to provide us with an equity line of credit. We did not sell any shares pursuant to the equity line of credit prior to its termination.
Off-Balance Sheet Arrangements
We currently have no off-balance sheet arrangements, such as structured finance, special purpose entities or variable interest entities.
Management’s Evaluation of our Disclosure Controls and Procedures
“Disclosure controls and procedures,” as defined in Rules 13a‑15(e) and 15d‑15(e) promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
Disclosure controls and procedures include, without limitation, those designed to ensure that this information is accumulated and communicated to our management to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based upon the evaluation our Chief Executive Officer and Chief Financial Officer concluded that the disclosure controls and procedures were not effective as of March 31, 2018 to ensure that information required to be disclosed in the reports we file and submit under the Exchange Act is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosure.
Changes in Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a‑15(f) and 15d‑15(f) under the Exchange Act). Our Chief Executive Officer and Chief Financial Officer assessed the effectiveness of our internal control over financial reporting as of March 31, 2018. In making this assessment, our Chief Executive Officer and Chief Financial Officer used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control—Integrated Framework. Based on that assessment and using the COSO criteria, our Chief Executive Officer and Chief Financial Officer have concluded that, as of March 31, 2018, our internal control over financial reporting was not effective because of the material weaknesses described below.
A material weakness is defined as “a deficiency, or a combination of deficiencies in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.”
The ineffectiveness of our internal control over financial reporting at March 31, 2018, was due to an insufficient degree of segregation of duties among our accounting and financial reporting personnel.
During 2018, we intend to work to remediate the material weaknesses identified above, which could include the addition of accounting and financial reporting personnel and/or the engagement of accounting and personnel consultants on a limited-time basis until we add a sufficient number of personnel. However, our current financial position could make it difficult for us to add the necessary resources.
Inherent Limitations of Controls
Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost‑benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision‑making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost‑effective control system, misstatements due to error or fraud may occur and not be detected.
Please see Note 11 to the Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for a summary of legal proceedings and developments during the quarter ended March 31, 2018.
EXHIBIT INDEX
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
|
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.
|
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.
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)
| |||
28
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