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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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DELAWARE
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33-0969592
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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660 W. GERMANTOWN PIKE, SUITE 110
PLYMOUTH MEETING, PENNSYLVANIA
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19462
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(Address of principal executive offices)
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(Zip Code)
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COMMON STOCK, $0.001 PAR VALUE
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NASDAQ
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(Title of Class)
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(Name of Each Exchange on Which Registered)
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Large accelerated filer
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¨
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Accelerated filer
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x
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Non-accelerated filer
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¨
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(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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Development Status
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Product Area
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Product and
Indication(s)
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Pre-Clinical
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Phase 1
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Phase 2
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Phase 3
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Partner/Funding/Sponsor
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Cancer
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Cervical dysplasia (CIN 2/3)
(VGX-3100)
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X
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X
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X
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P
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Inovio
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HPV-related cancer (INO-3112)
(VGX-3100 + DNA-based IL-12 cytokine)
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X
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IP
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MedImmune
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Prostate cancer
(INO-5150 +/- DNA-based IL-12 cytokine)
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X
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IP
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Inovio
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hTERT expressing cancers (breast, lung, pancreatic)
INO-1400
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X
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IP
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Inovio
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New cancer target (INO-5400 (hTERT + 2 new antigens) +/- DNA-based IL-12 cytokine with checkpoint inhibitor
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X
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P
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Inovio
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Infectious Disease
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Hepatitis B Virus
INO-1800
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X
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IP
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Inovio
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Hepatitis C Virus
INO-1800 + DNA-based IL-28 cytokine)
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X
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IP
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GeneOne Life Sciences/NCI
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Zika
(GLS-5700)
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X
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IP
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GeneOne Life Sciences
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Ebola
(INO-4212)
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X
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IP
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GeneOne Life Sciences/DARPA
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MERS
(GLS-5300)
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X
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IP
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GeneOne Life Sciences/IVI
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HIV (preventive & therapeutic)
(PENNVAX®-GP)
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X
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IP
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NIH/NIAID
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Universal influenza (INO-3510)
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X
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X
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NIH
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Biodefense targets
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IP
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US AMRIID
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X
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= Completed
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IP
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= In Progress
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P
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= Planning
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•
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Target disease-specific antigens (i.e. proteins unique to a cancer or infectious disease)
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Do not depend on complex manufacturing processes such as removal of dendritic cells or T-cells from the patient that are then modified in the laboratory, amplified and then re-introduced in the patient as autologous or allogeneic cell based therapies.
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Activate functional
killer T cells with the necessary killing tools (e.g. granzyme and perforin)
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Generate robust T cell responses (e.g. a significant number of T cells) that are persistent and durable over time (memory response)
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Do not induce unwanted immune responses
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Do not induce toxic inflammatory responses
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Are capable of “breaking tolerance” of cancer cells grown in the body.
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Antigen-specific, dose-related T cell responses across the three dose groups;
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Strong antigen-specific antibody responses in all three dose groups;
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VGX-3100 delivered using Inovio’s proprietary CELLECTRA
®
intramuscular electroporation delivery device was generally safe and well tolerated at all dose levels; and
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•
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No immunotherapy-related serious adverse events (SAEs). Reported adverse events and injection site reactions were mild to moderate and required no treatment.
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•
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A therapeutic DNA-based monoclonal antibody product against the Ebola virus infection. This promising new technology has properties that best fit a response to the outbreak in that they could be designed and manufactured expediently on a large scale using common fermentation technology, are thermal-stable, and may provide more rapid therapeutic benefit.
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A highly potent conventional protein-based therapeutic monoclonal antibody (mAb) product against Ebola virus infection.
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A DNA-based vaccine against Ebola.
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Antigen-specific CD4 T cell responses were generated in 80.8% of evaluated immunotherapy recipients (21 of 26).
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Significant antigen-specific CD8 T cell responses were generated in 51.9% of evaluated immunotherapy recipients (14 of 27).
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Compared to a previously conducted HVTN 070 Phase 1 study, which assessed PENNVAX
®
-B with cytokine adjuvant IL-12 at double the dose, with four immunizations, but without electroporation delivery, response rates in HVTN 080 with electroporation were significantly higher than HVTN 070 CD4 responses (40.7%) and CD8 T cell responses (3.6%). Samples from eight placebo recipients and pre-vaccine samples were negative for both CD4 T cell responses and CD8 T cell responses.
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PENNVAX
®
-B delivered using the CELLECTRA
®
intramuscular electroporation delivery device with or without IL-12 was safe and generally well tolerated. There were no immunotherapy-related serious adverse events. Reported adverse events and injection site reactions were mild to moderate and required no treatment.
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•
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Eight of 17 (47%) immunized subjects had an HAI titer of 1:40 or higher against at least one of the tested H5N1 viruses.
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Twelve of 17 (71%) vaccinated subjects had an HAI titer of 1:20 or higher against at least one H5N1 strain.
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Seven of 17 (41%) had an HAI titer of 1:40 or higher against the Clade 2.2 A/Turkey/1/05 strain.
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•
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Five of 17 immunized subjects (29%) displayed an HAI titer of 1:20 or higher against at least three different H5N1 viruses tested.
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In an unprecedented result, two immunized subjects demonstrated an HAI titer of 1:20 or higher against all six strains tested.
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•
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A therapeutic DNA-based monoclonal antibody product dMAb
™
against the Ebola virus infection. This promising new technology has properties that best fit a response to the outbreak in that they could be designed and manufactured expediently on a large scale using common fermentation technology, are thermal-stable, and may provide more rapid therapeutic benefit.
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•
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A highly potent conventional protein-based therapeutic monoclonal antibody (mAb) product against Ebola virus infection.
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A DNA-based vaccine against Ebola.
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We have an extensive history and experience in developing the methods and devices that optimize the use of electroporation in conjunction with DNA-based agents. This experience has been validated with multiple sets of interim data from multiple clinical studies assessing DNA-based immunotherapies and vaccines against cancers and infectious disease. Together with our partners and collaborators, we have been the leader in establishing proof-of-principle of electroporation-delivered immunotherapies.
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We have a broad product line of electroporation instruments designed to enable DNA delivery in tumors, muscle, and skin.
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We have been very proactive in filing for patents, as well as acquiring and licensing additional patents, to expand our global patent estate.
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US Pat. No. 6,733,994, entitled, “Highly expressible genes” including claims directed to IgE signal leader
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•
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US Pat. No. 8,133,723, entitled, “Novel Vaccines Against Multiple Subtypes Of Influenza”
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•
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US Pat. No. 8,168,769, entitled, “Improved Vaccines and Methods for Using the Same,” with claims directed to HPV vaccine products.
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•
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US Pat. No. 8,178,660, entitled, "Vaccines And Immunotherapeutics Using Codon Optimized IL-15 And Methods For Using The Same"
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•
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US Pat. No. 8,535,687, entitled, "Smallpox DNA Vaccine And The Antigens Therein That Elicit An Immune Response"
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•
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US Pat. No. 8,697,084, and 9,376,471, entitled, "HIV Consensus Envelop Sequences And Methods For Using The Same"
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•
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US Pat. No. 8,835,620, “Novel Vaccines Against Multiple Subtypes Of Influenza Virus”
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•
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US Pat. No. 8,852,609, entitled, “Consensus Sequences of Chikungunya Viral Proteins, Nucleic Acid Molecules Encoding the Same and Compositions and Methods for Using the Same”
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•
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US Pat. No. 8,927,692, and 9,399,056, entitled, “Consensus Prostate Antigens, Nucleic Acid Molecule Encoding The Same And Vaccine And Uses Comprising The Same"
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•
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US Pat. No. 8,961,994, entitled, “DNA CONSTRUCTS ELICITING IMMUNE RESPONSE AGAINST FLAVIVIRUS AND EFFECTIVE ADJUVANTS”
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•
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US Pat. No. 9,034,313, entitled, “Nucleic Acid Molecules Encoding Rantes, and Compositions and Methods of Using The Same”
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•
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US Pat. Nos. 9,050,287 and 8,389,706, entitled, “Vaccines for Human Papilloma Virus and Methods for Using the Same”
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•
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US Pat. Nos. 9,156,891, 9,156,890, 8,921,536, and 8,829,174, "Improved HCV Vaccines And Methods For Using The Same"
|
•
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US Pat. No. 9,192,660 and 8,298,820, entitled, “Influenza Nucleic Acid Molecules and Vaccines Made Therefrom”
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•
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US Pat. No. 9,238,679, and 9,403,879, entitled, “Nucleic acid molecule encoding hepatitis B virus core protein and vaccine comprising the same”
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•
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US Pat. No. 9,243,041, entitled, “Nucleic acid molecule encoding novel herpes antigens, vaccine comprising the same, and methods of use thereof”
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•
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US Pat. No. 9,272,024 entitled, “Compositions, comprising improved IL-12 genetic constructs and vaccines, immunotherapeutics and methods of using the same”
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•
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US Pat. No. 9,290,546 entitled, “hTERT sequences and methods for using the same”
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•
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US Pat. No. 9,446,112 entitled, “Clostridium difficile DNA vaccine”
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•
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US Pat. No. 9,446,114 entitled, “Cross-protective arenavirus vaccines and their method of use.”
|
•
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US Pat. No. 6,110,161, entitled, “Method for introducing pharmaceutical drugs and nucleic acids into skeletal muscle”
|
•
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US Pat. No. 6,261,281, entitled, “Method for genetic immunization and introduction of molecules into skeletal muscle and immune cells”
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•
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US Pat. No. 6,752,780, entitled, “Intradermal injection system for injecting DNA-based injectables into humans”
|
•
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US Pat. No. 7,328,064, entitled, “Electroporation device and injection apparatus,” with claims directed to methods of delivering an agent plus electroporation.
|
•
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US Pat. No. 7,922,709, entitled, “Enhanced delivery of naked DNA to skin by non-invasive in vivo electroporation.”
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•
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US Pat. No. 9,452,285, entitled, “Electroporation devices and methods of using same for electroporation of cells in mammals.”
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•
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developing and securing United States and/or foreign regulatory approvals for our product candidates, including securing regulatory approval for conducting clinical trials with product candidates;
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developing our electroporation-based DNA delivery technology; and
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•
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commercializing any products for which we receive approval from the FDA and foreign regulatory authorities.
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•
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the progress of our current and new product development programs;
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•
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the progress, scope and results of our pre-clinical and clinical testing;
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•
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the time and cost involved in obtaining regulatory approvals;
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•
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the cost of manufacturing our products and product candidates;
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•
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the cost of prosecuting, enforcing and defending against patent infringement claims and other intellectual property rights;
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•
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competing technological and market developments; and
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•
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our ability and costs to establish and maintain collaborative and other arrangements with third parties to assist in potentially bringing our products to market.
|
•
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variations in the level of expenses related to our electroporation equipment, product candidates or future development programs;
|
•
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expenses related to corporate transactions, including ones not fully completed;
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•
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addition or termination of clinical trials or funding support;
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•
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any intellectual property infringement lawsuit in which we may become involved;
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•
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any legal claims that may be asserted against us or any of our officers;
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•
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regulatory developments affecting our electroporation equipment and product candidates or those of our competitors;
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•
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our execution of any collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements; and
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•
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if any of our products receives regulatory approval, the levels of underlying demand for our products.
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•
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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our electroporation equipment and a product candidate are safe and effective for any indication;
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•
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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
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•
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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•
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we may not be successful in having the FDA remove the clinical hold on our proposed Phase 3 clinical program for VGX-3100;
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•
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we may not be successful in enrolling a sufficient number of participants in clinical trials;
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•
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we may be unable to demonstrate that our electroporation equipment and a product candidate's clinical and other benefits outweigh its safety risks;
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•
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we may be unable to demonstrate that our electroporation equipment and a product candidate presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;
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•
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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials;
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•
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the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a new drug application or other submission or to obtain regulatory approval in the United States or elsewhere;
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•
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the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of us or third-party manufacturers with which we or our collaborators contract for clinical and commercial supplies; and
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•
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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
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•
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obtaining regulatory approval to commence a clinical trial;
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•
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adverse results from third party clinical trials involving gene based therapies and the regulatory response thereto;
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•
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reaching agreement on acceptable terms with prospective CROs and trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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future bans or stricter standards imposed on gene based therapy clinical trials;
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•
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manufacturing sufficient quantities of our electroporation equipment and product candidates for use in clinical trials;
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obtaining institutional review board, or IRB, approval to conduct a clinical trial at a prospective site;
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slower than expected recruitment and enrollment of patients to participate in clinical trials for a variety of reasons, including competition from other clinical trial programs for similar indications;
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conducting clinical trials with sites internationally due to regulatory approvals and meeting international standards;
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retaining patients who have initiated a clinical trial but may be prone to withdraw due to side effects from the therapy, lack of efficacy or personal issues, or who are lost to further follow-up;
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collecting, reviewing and analyzing our clinical trial data; and
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global unrest, terrorist activities, and economic and other external factors.
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•
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues; and
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lack of adequate funding to continue the clinical trial.
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issue Warning Letters or untitled letters;
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impose civil or criminal penalties;
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suspend regulatory approval;
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suspend any ongoing clinical trials;
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refuse to approve pending applications or supplements to applications filed by us;
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impose restrictions on operations, including costly new manufacturing requirements; or
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seize or detain products or require us to initiate a product recall.
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decreased demand for our product candidates;
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impairment of our business reputation;
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withdrawal of clinical trial participants;
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costs of related litigation;
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distraction of management's attention from our primary business;
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substantial monetary awards to patients or other claimants;
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loss of revenues; and
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inability to commercialize our products.
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our ability to provide acceptable evidence of safety and efficacy;
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the relative convenience and ease of administration;
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the prevalence and severity of any actual or perceived adverse side effects;
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limitations or warnings contained in a product's FDA-approved labeling, including, for example, potential “black box” warnings
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availability of alternative treatments;
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pricing and cost effectiveness;
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the effectiveness of our or any future collaborators' sales and marketing strategies;
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our ability to obtain sufficient third-party coverage or reimbursement; and
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the willingness of patients to pay out of pocket in the absence of third-party coverage.
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our ability to set a price we believe is fair for our products;
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our ability to generate revenues and achieve or maintain profitability;
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the availability of capital; and
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our ability to obtain timely approval of our products.
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the federal healthcare program Anti-Kickback Statute, which prohibits, among other things, people from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
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federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;
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the ACA expands the government's investigative and enforcement authority and increases the penalties for fraud and abuse, including amendments to both the False Claims Act and the Anti-Kickback Statute to make it easier to bring suit under those statutes;
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•
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information;
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the Federal Food, Drug, and Cosmetic Act, which among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;
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the U.S. Foreign Corrupt Practices Act, which, among other things, prohibits companies issuing stock in the U.S. from bribing foreign officials for government contracts and other business; and
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state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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exposure to unknown liabilities;
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disruption of our business and diversion of our management's time and attention to develop acquired products or technologies;
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incurrence of substantial debt or dilutive issuances of securities to pay for acquisitions;
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higher than expected acquisition and integration costs;
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increased amortization expenses;
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difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
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impairment of relationships with key suppliers or customers of any acquired businesses due to changes in management and ownership; and
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•
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inability to retain key employees of any acquired businesses.
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•
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we, or the parties from whom we have acquired or licensed patent rights, may not have been the first to file the underlying patent applications or the first to make the inventions covered by such patents;
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•
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the named inventors or co-inventors of patents or patent applications that we have licensed or acquired may be incorrect, which may give rise to inventorship and ownership challenges;
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•
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others may develop similar or alternative technologies, or duplicate any of our products or technologies that may not be covered by our patents, including design-arounds;
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•
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pending patent applications may not result in issued patents;
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•
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the issued patents covering our products and technologies may not provide us with any competitive advantages or have any commercial value;
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•
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the issued patents may be challenged and invalidated, or rendered unenforceable;
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•
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the issued patents may be subject to reexamination, which could result in a narrowing of the scope of claims or cancellation of claims found unpatentable;
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•
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we may not develop or acquire additional proprietary technologies that are patentable;
|
•
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our trademarks may be invalid or subject to a third party's prior use; or
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•
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our ability to enforce our patent rights will depend on our ability to detect infringement, and litigation to enforce patent rights may not be pursued due to significant financial costs, diversion of resources, and unpredictability of a favorable result or ruling.
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•
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we may become involved in time-consuming and expensive litigation, even if the claim is without merit, the third party's patent is invalid or we have not infringed;
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•
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we may become liable for substantial damages for past infringement if a court decides that our technologies infringe upon a third party's patent;
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•
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we may be enjoined by a court to stop making, selling or licensing our products or technologies without a license from a patent holder, which may not be available on commercially acceptable terms, if at all, or which may require us to pay substantial royalties or grant cross-licenses to our patents; and
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•
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we may have to redesign our products so that they do not infringe upon others' patent rights, which may not be possible or could require substantial investment or time.
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•
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developments concerning any research and development, clinical trials, manufacturing, and marketing efforts or collaborations;
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•
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fluctuating public or scientific interest in the potential for influenza pandemic or other applications for our vaccine or other product candidates;
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•
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our announcement of significant acquisitions, strategic collaborations, joint ventures or capital commitments;
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•
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fluctuations in our operating results
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•
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announcements of technological innovations;
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•
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new products or services that we or our competitors offer;
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•
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the initiation, conduct and/or outcome of intellectual property and/or litigation matters;
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•
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changes in financial or other estimates by securities analysts or other reviewers or evaluators of our business;
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•
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conditions or trends in bio-pharmaceutical or other healthcare industries;
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•
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regulatory developments in the United States and other countries;
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•
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negative perception of gene based therapy;
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•
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changes in the economic performance and/or market valuations of other biotechnology and medical device companies;
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•
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additions or departures of key personnel;
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•
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sales or other transactions involving our common stock;
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•
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changes in our capital structure;
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•
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sales or other transactions by executive officers or directors involving our common stock;
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•
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changes in accounting principles;
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•
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global unrest, terrorist activities, and economic and other external factors; and
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•
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catastrophic weather and/or global disease pandemics.
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•
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the authority of our board of directors to issue shares of undesignated preferred stock and to determine the rights, preferences and privileges of these shares, without stockholder approval;
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•
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all stockholder actions must be effected at a duly called meeting of stockholders and not by written consent; and
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•
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the elimination of cumulative voting.
|
|
Year Ended December 31,
|
||||||||||||||
|
2016
|
|
2015
|
||||||||||||
Period:
|
High
|
|
Low
|
|
High
|
|
Low
|
||||||||
First Quarter
|
$
|
8.71
|
|
|
$
|
4.92
|
|
|
$
|
9.49
|
|
|
$
|
6.45
|
|
Second Quarter
|
$
|
11.39
|
|
|
$
|
8.29
|
|
|
$
|
10.60
|
|
|
$
|
7.86
|
|
Third Quarter
|
$
|
10.42
|
|
|
$
|
8.52
|
|
|
$
|
8.19
|
|
|
$
|
5.69
|
|
Fourth Quarter
|
$
|
9.52
|
|
|
$
|
5.98
|
|
|
$
|
7.41
|
|
|
$
|
5.65
|
|
|
Year Ended December 31,
2016 |
|
Year Ended December 31,
2015 |
|
Year Ended December 31,
2014 |
|
Year Ended December 31,
2013 |
|
Year Ended December 31,
2012 |
||||||||||
Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue under collaborative research and development arrangements, including from affiliated entity
|
$
|
7,891,341
|
|
|
$
|
27,655,700
|
|
|
$
|
7,896,032
|
|
|
$
|
9,664,547
|
|
|
$
|
660,003
|
|
Grants and miscellaneous revenue, including from affiliated entity
|
27,477,020
|
|
|
12,916,411
|
|
|
2,560,734
|
|
|
3,802,799
|
|
|
3,458,649
|
|
|||||
Total revenues
|
35,368,361
|
|
|
40,572,111
|
|
|
10,456,766
|
|
|
13,467,346
|
|
|
4,118,652
|
|
|||||
Loss from operations
|
(76,235,937
|
)
|
|
(34,283,702
|
)
|
|
(39,495,961
|
)
|
|
(19,544,332
|
)
|
|
(23,493,532
|
)
|
|||||
Interest and other income, net
|
1,257,257
|
|
|
305,071
|
|
|
331,461
|
|
|
132,214
|
|
|
166,113
|
|
|||||
Change in fair value of common stock warrants
|
127,554
|
|
|
177,561
|
|
|
348,143
|
|
|
(45,632,669
|
)
|
|
1,982,620
|
|
|||||
Gain (Loss) on investment in affiliated entity
|
1,110,787
|
|
|
2,600,467
|
|
|
2,676,224
|
|
|
(1,038,745
|
)
|
|
1,631,819
|
|
|||||
Income tax benefit
|
—
|
|
|
2,097,766
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
(73,740,339
|
)
|
|
(29,102,837
|
)
|
|
(36,140,133
|
)
|
|
(66,083,532
|
)
|
|
(19,712,980
|
)
|
|||||
Net (income) loss attributable to non-controlling interest
|
—
|
|
|
(84,769
|
)
|
|
18,420
|
|
|
55,084
|
|
|
44,025
|
|
|||||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(73,740,339
|
)
|
|
$
|
(29,187,606
|
)
|
|
$
|
(36,121,713
|
)
|
|
$
|
(66,028,448
|
)
|
|
$
|
(19,668,955
|
)
|
Net loss per common share attributable to common stockholders
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
$
|
(1.01
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.61
|
)
|
|
$
|
(1.43
|
)
|
|
$
|
(0.58
|
)
|
Diluted
|
$
|
(1.01
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.64
|
)
|
|
$
|
(1.43
|
)
|
|
$
|
(0.58
|
)
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
19,136,472
|
|
|
$
|
57,632,693
|
|
|
$
|
40,543,982
|
|
|
$
|
33,719,796
|
|
|
$
|
5,646,021
|
|
Short-term investments
|
85,629,412
|
|
|
105,357,277
|
|
|
53,075,974
|
|
|
18,905,608
|
|
|
8,034,001
|
|
|||||
Total assets
|
173,707,166
|
|
|
213,840,859
|
|
|
131,785,097
|
|
|
88,287,207
|
|
|
45,138,754
|
|
|||||
Current liabilities
|
43,823,027
|
|
|
31,466,406
|
|
|
14,085,294
|
|
|
28,966,456
|
|
|
8,376,577
|
|
|||||
Noncurrent liabilities
|
6,505,719
|
|
|
6,441,400
|
|
|
6,162,209
|
|
|
6,418,068
|
|
|
1,904,772
|
|
|||||
Accumulated deficit
|
(434,838,235
|
)
|
|
(361,097,896
|
)
|
|
(331,910,290
|
)
|
|
(295,788,577
|
)
|
|
(229,760,129
|
)
|
|||||
Total stockholders’ equity
|
123,378,420
|
|
|
175,933,053
|
|
|
111,537,594
|
|
|
52,902,683
|
|
|
34,857,405
|
|
1.
|
The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone,
|
2.
|
The consideration relates solely to past performance, and
|
3.
|
The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
|
|
December 31,
2016
|
|
December 31,
2015
|
|
Increase/
(Decrease)
$
|
|
Increase/
(Decrease)
%
|
|||||||
Revenues:
|
|
|
|
|
|
|
|
|||||||
Revenue under collaborative research and development arrangements, including from affiliated entity
|
$
|
7,891,341
|
|
|
$
|
27,655,700
|
|
|
$
|
(19,764,359
|
)
|
|
(71
|
)%
|
Grants and miscellaneous revenue, including from affiliated entity
|
27,477,020
|
|
|
12,916,411
|
|
|
14,560,609
|
|
|
113
|
|
|||
Total revenues
|
35,368,361
|
|
|
40,572,111
|
|
|
(5,203,750
|
)
|
|
(13
|
)
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Research and development
|
88,712,035
|
|
|
57,791,923
|
|
|
30,920,112
|
|
|
54
|
|
|||
General and administrative
|
23,892,263
|
|
|
18,063,890
|
|
|
5,828,373
|
|
|
32
|
|
|||
Gain on sale of assets
|
(1,000,000
|
)
|
|
(1,000,000
|
)
|
|
—
|
|
|
—
|
|
|||
Total operating expenses
|
111,604,298
|
|
|
74,855,813
|
|
|
36,748,485
|
|
|
49
|
|
|||
Loss from operations
|
(76,235,937
|
)
|
|
(34,283,702
|
)
|
|
(41,952,235
|
)
|
|
(122
|
)
|
|||
Interest and other income, net
|
1,257,257
|
|
|
305,071
|
|
|
952,186
|
|
|
312
|
|
|||
Change in fair value of common stock warrants
|
127,554
|
|
|
177,561
|
|
|
(50,007
|
)
|
|
(28
|
)
|
|||
Gain on investment in affiliated entity
|
1,110,787
|
|
|
2,600,467
|
|
|
(1,489,680
|
)
|
|
(57
|
)
|
|||
Net loss before income tax benefit
|
(73,740,339
|
)
|
|
(31,200,603
|
)
|
|
(42,539,736
|
)
|
|
(136
|
)
|
|||
Income tax benefit
|
—
|
|
|
2,097,766
|
|
|
(2,097,766
|
)
|
|
(100
|
)
|
|||
Net loss
|
(73,740,339
|
)
|
|
(29,102,837
|
)
|
|
(44,637,502
|
)
|
|
(153
|
)
|
|||
Net income attributable to non-controlling interest
|
—
|
|
|
(84,769
|
)
|
|
84,769
|
|
|
(100
|
)
|
|||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(73,740,339
|
)
|
|
$
|
(29,187,606
|
)
|
|
$
|
(44,552,733
|
)
|
|
(153
|
)%
|
|
December 31,
2015 |
|
December 31,
2014 |
|
Increase/
(Decrease)
$
|
|
Increase/
(Decrease)
%
|
|||||||
Revenues:
|
|
|
|
|
|
|
|
|||||||
Revenue under collaborative research and development arrangements, including from affiliated entity
|
$
|
27,655,700
|
|
|
$
|
7,896,032
|
|
|
$
|
19,759,668
|
|
|
250
|
%
|
Grants and miscellaneous revenue
|
12,916,411
|
|
|
2,560,734
|
|
|
10,355,677
|
|
|
404
|
|
|||
Total revenues
|
40,572,111
|
|
|
10,456,766
|
|
|
30,115,345
|
|
|
288
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
|||||||
Research and development
|
57,791,923
|
|
|
34,095,039
|
|
|
23,696,884
|
|
|
70
|
|
|||
General and administrative
|
18,063,890
|
|
|
15,857,688
|
|
|
2,206,202
|
|
|
14
|
|
|||
Gain on sale of assets
|
(1,000,000
|
)
|
|
—
|
|
|
(1,000,000
|
)
|
|
100
|
|
|||
Total operating expenses
|
74,855,813
|
|
|
49,952,727
|
|
|
24,903,086
|
|
|
50
|
|
|||
Loss from operations
|
(34,283,702
|
)
|
|
(39,495,961
|
)
|
|
5,212,259
|
|
|
13
|
|
|||
Interest and other income, net
|
305,071
|
|
|
331,461
|
|
|
(26,390
|
)
|
|
(8
|
)
|
|||
Change in fair value of common stock warrants
|
177,561
|
|
|
348,143
|
|
|
(170,582
|
)
|
|
(49
|
)
|
|||
Gain on investment in affiliated entity
|
2,600,467
|
|
|
2,676,224
|
|
|
(75,757
|
)
|
|
(3
|
)
|
|||
Net loss before income tax benefit
|
(31,200,603
|
)
|
|
(36,140,133
|
)
|
|
4,939,530
|
|
|
14
|
|
|||
Income tax benefit
|
2,097,766
|
|
|
—
|
|
|
2,097,766
|
|
|
100
|
|
|||
Net loss
|
(29,102,837
|
)
|
|
(36,140,133
|
)
|
|
7,037,296
|
|
|
19
|
|
|||
Net (income) loss attributable to non-controlling interest
|
(84,769
|
)
|
|
18,420
|
|
|
(103,189
|
)
|
|
(560
|
)
|
|||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(29,187,606
|
)
|
|
$
|
(36,121,713
|
)
|
|
$
|
6,934,107
|
|
|
19
|
%
|
|
Total
|
|
Less than
1 year
|
|
1 – 3 years
|
|
3 – 5 years
|
|
More than
5 years
|
||||||||||
Operating lease obligations
|
$
|
26,133,000
|
|
|
$
|
1,818,000
|
|
|
$
|
4,948,000
|
|
|
$
|
5,819,000
|
|
|
$
|
13,548,000
|
|
|
/s/ Ernst & Young LLP
|
San Diego, California
|
|
March 15, 2017
|
|
1.
|
Financial Statements
|
2.
|
Financial Statement Schedules
|
3.
|
Exhibits
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
3.1(a)
|
|
|
Certificate of Incorporation with all amendments (incorporated by reference to Exhibit 3.1 of the registrant’s Form S-3 registration statement, filed on July 23, 2014).
|
|
|
|
|
3.2
|
|
|
Amended and Restated Bylaws of Inovio Pharmaceuticals, Inc. dated August 10, 2011 (incorporated by reference to Exhibit 3.2 to the registrant’s Form 8-K current report filed on August 12, 2011).
|
|
|
|
|
4.16+
|
|
|
Form of Restricted Stock Award Grants under the 2007 Omnibus Stock Incentive Plan (incorporated by reference to Exhibit 4.3 to the registrant’s Registration Statement on Form S-8 filed on May 14, 2007).
|
|
|
|
|
4.17+
|
|
|
Form of Incentive and Non-Qualified Stock Option Grants under the 2007 Omnibus Stock Incentive Plan (incorporated by reference to Exhibit 4.4 to the registrant’s Registration Statement on Form S-8 filed with on May 14, 2007).
|
|
|
|
|
4.20
|
|
|
Form of Warrant to Purchase Common Stock issued by Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 4.1 to the registrant’s Form 8-K current report filed March 7, 2013).
|
|
|
|
|
10.1
|
|
|
Lease Agreement by and between the registrant and 1787 Sentry Park West LLC dated December 10, 2009, as amended by First Amendment dated August 18, 2010, as amended by Second Amendment dated February 16, 2012, as amended by Third Amendment dated May 14, 2014, as amended by Fourth Amendment dated July 25, 2014 and as amended by Fifth Amendment dated January 30, 2015 (incorporated by reference to Exhibit 10.1 of the registrant’s Form 10-K annual report for the year ended December 31, 2009 filed on March 26, 2010).
|
|
|
|
|
10.2†
|
|
|
License Agreement dated June 30, 2013 by and between the registrant and the University of South Florida Research Foundation, Inc. (incorporated by reference to Exhibit 10.5 of the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2000 filed on November 9, 2000).
|
|
|
|
|
10.3
|
|
|
At-the-Market Equity Offering Sales Agreement dated June 17, 2016 between Inovio Pharmaceuticals, Inc. and Stifel, Nicolaus & Company, Incorporated (incorporated by reference to Exhibit 1.1 of the registrant's Form 8-K filed on June 17, 2016).
|
|
|
|
|
10.4
|
|
|
Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 4.2 of the registrant’s Form 8-K current report filed on August 6, 2007).
|
|
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
10.5+
|
|
|
Employment Agreement dated as of December 27, 2010 between Inovio Pharmaceuticals, Inc. and Peter Kies (incorporated by reference to Exhibit 10.5 to the registrant’s Form 10-K report for the year ended December 31, 2010 filed on March 16, 2011).
|
|
|
|
|
10.7+
|
|
|
Employment Agreement dated December 27, 2010 between Inovio Pharmaceuticals, Inc. and Niranjan Y. Sardesai (incorporated by reference to Exhibit 10.7 to the registrant’s Form 10-K report for the year ended December 31, 2011 filed on March 15, 2012).
|
|
|
|
|
10.8
|
|
|
Lease dated April 9, 2013 by and between BMR-Wateridge LP and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 to registrant's quarterly report for the quarter ended March 31, 2013, filed on May 10, 2013).
|
|
|
|
|
10.9
|
|
|
Form of Indemnification Agreement for Directors and Officers of Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 to the registrant’s Form 10-Q quarterly report for the quarterly period ended June 30, 2009, filed on August 19, 2009).
|
|
|
|
|
10.12+
|
|
|
Amended and Restated 2007 Omnibus Incentive Plan, as amended (incorporated by reference to Exhibit 10.12 to the registrant's Form 10-K report for the year ended December 31, 2015 filed on March 14, 2016).
|
|
|
|
|
10.15+
|
|
|
Inovio Pharmaceuticals, Inc. 2016 Omnibus Incentive Plan (incorporated by reference to the registrant's Form DEF-14A filed on March 25, 2016).
|
|
|
|
|
10.16†
|
|
|
R&D Alliance Agreement dated December 19, 2005 by and between Ganial Immunotherapeutics, Inc. and VGX Pharmaceuticals, Inc., as amended by Novation and Amendment Agreement by and between VGX Pharmaceuticals, Inc., Ganial Immunotherapeutics, Inc., and Onconox (incorporated by reference to Exhibit 10.31 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.17†
|
|
|
Asset Purchase Agreement dated February 21, 2007 by and among Ronald O. Bergan, Mary Alice Bergan, and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.32 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.18†
|
|
|
License Agreement dated May 9, 2007 by and between Baylor University and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.34 as filed with the registrant’s registration statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.23†
|
|
|
R&D Collaboration and License Agreement dated December 18, 2006 by and between VGX International, Inc. and VGX Pharmaceuticals, Inc., as amended by First Amendment dated October 31, 2007 and as amended by Second Amendment dated August 4, 2008 (incorporated by reference to Exhibit 10.39 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.24†
|
|
|
Sales and Marketing Agreement dated February 28, 2008 by and between VGX International and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.42 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.25+
|
|
|
Employment Agreement dated March 31, 2008 by and between J. Joseph Kim, Ph.D. and VGX Pharmaceuticals, Inc., as amended by First Amendment of Employment Agreement dated March 31, 2008 (incorporated by reference to Exhibit 10.43 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
10.26†
|
|
|
CELLECTRA
®
Device License Agreement dated April 16, 2008 by and between VGX International and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.44 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.27
|
|
|
Asset Purchase Agreement dated June 10, 2008 by and among VGXI, Inc. and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.48 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.29†
|
|
|
Patent License Agreement dated April 27, 2007 by and between The Trustees of the University of Pennsylvania and VGX Pharmaceuticals, Inc., as amended by First Amendment dated June 12, 2008 (incorporated by reference to Exhibit 10.50 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.30+
|
|
|
2001 Equity Compensation Plan for VGX Pharmaceuticals, Inc., as amended (incorporated by reference to Exhibit 10.62 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.31
|
|
|
Office Lease Agreement dated October 10, 2016 by and between 6759 Mesa Ridge Road Holdings, LLC and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 as filed with the registrant's Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.32
|
|
|
Memorandum of NIH Research Grant Agreement by and between National Institute of Allergy and Infectious Diseases and VGX Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.66 as filed with the registrant’s Registration Statement on Form S-4 (File No. 333-156035) on April 27, 2009).
|
|
|
|
|
10.33
|
|
|
Collaborative Research Agreement dated March 14, 2016 by and between The Wistar Institute of Anatomy and Biology, a Commonwealth of Pennsylvania nonprofit corporation, and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 as filed with the registrant's Form 10-Q quarterly report for the quarter ended March 31, 2016 filed on May 9, 2016).
|
|
|
|
|
10.34
|
|
|
Collaborative Research Agreement dated March 14, 2016 by and between The Wistar Institute of Anatomy and Biology, a Commonwealth of Pennsylvania nonprofit corporation, and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.2 as filed with the registrant's Form 10-Q quarterly report for the quarter ended March 31, 2016 filed on May 9, 2016).
|
|
|
|
|
10.35†
|
|
|
License and Collaboration Agreement dated March 24, 2010 between Inovio Pharmaceuticals, inc. and VGX International, Inc. (incorporated by reference to Exhibit 10.2 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended March 31, 2010 filed on May 17, 2010).
|
|
|
|
|
10.36
|
|
|
Lease Agreement dated as of March 5, 2014 between Brandywine Operating Partnership L.P. and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.36 as filed with the registrant's Form 10-K annual report for the year ended December 31, 2014 filed on March 17, 2014).
|
|
|
|
|
10.37
|
|
|
Intentionally omitted.
|
|
|
|
|
10.38
|
|
|
Intentionally omitted.
|
|
|
|
|
10.39+
|
|
|
Employment Agreement dated December 10, 2009 between Inovio Pharmaceuticals, Inc. and Mark L. Bagarazzi (incorporated by reference to Exhibit 10.39 to the registrant’s Form 10-K report for the year ended December 31, 2011 filed on March 15, 2012).
|
|
|
|
|
10.40+
|
|
|
Collaborative Development and License Agreement dated October 7, 2011 between VGX International, Inc. and Inovio Pharmaceuticals, Inc., as amended by First Amendment dated August 21, 2013, and Second Amendment dated October 7, 2013 (incorporated by reference to Exhibit 10.1 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2011 filed on November 7, 2011).
|
|
|
|
Exhibit
Number
|
|
Description of Document
|
|
|
|
|
|
10.41+
|
|
|
First Amendment to Employment Agreement dated as of December 31, 2012 between Inovio Pharmaceuticals, Inc. and J. Joseph Kim, PhD. (incorporated by reference to Exhibit 10.41 of the registrant’s Form 10-K annual report for the year ended December 31, 2012 filed on March 18, 2013).
|
|
|
|
|
10.42+
|
|
|
First Amendment to Employment Agreement dated as of December 31, 2012 between Inovio Pharmaceuticals, Inc. and Peter Kies (incorporated by reference to Exhibit 10.42 of the registrant’s Form 10-K annual report for the year ended December 31, 2012 filed on March 18, 2013).
|
|
|
|
|
10.43+
|
|
|
First Amendment to Employment Agreement dated as of December 31, 2012 between Inovio Pharmaceuticals, Inc. and Mark L. Bagarazzi (incorporated by reference to Exhibit 10.43 of the registrant’s Form 10-K annual report for the year ended December 31, 2012 filed on March 18, 2013).
|
|
|
|
|
10.44+
|
|
|
First Amendment to Employment Agreement dated as of December 31, 2012 between Inovio Pharmaceuticals, Inc. and Niranjan Sardesai (incorporated by reference to Exhibit 10.44 of the registrant’s Form 10-K annual report for the year ended December 31, 2012 filed on March 18, 2013).
|
|
|
|
|
10.45+
|
|
|
Second Amendment to Employment Agreement dated November 7, 2014 by and between Inovio Pharmaceuticals, Inc. and Dr. Mark Bagarazzi (incorporated by reference to Exhibit 10.1 of the registrant's Form 10-Q quarterly report for the quarter ended September 30, 2014 filed on November 10 , 2014).
|
|
|
|
|
10.46+
|
|
|
Second Amendment to Employment Agreement dated November 7, 2014 by and between Inovio Pharmaceuticals, Inc. and Peter Kies (incorporated by reference to Exhibit 10.2 of the registrant's Form 10-Q quarterly report for the quarter ended September 30, 2014 filed on November 10 , 2014).
|
|
|
|
|
10.47+
|
|
|
Second Amendment to Employment Agreement dated November 7, 2014 by and between Inovio Pharmaceuticals, Inc. and Dr. Niranjan Sardesai (incorporated by reference to Exhibit 10.3 of the registrant's Form 10-Q quarterly report for the quarter ended September 30, 2014 filed on November 10 , 2014).
|
|
|
|
|
10.48†
|
|
|
DNA Cancer Vaccine Collaboration and License Agreement dated August 7, 2015 by and between MedImmune, Limited and Inovio Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 of the registrant's Form 10-Q quarterly report for the quarter ended September 30, 2015 filed on November 9, 2015).
|
|
|
|
|
10.49+
|
|
|
GENEOS Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.50+
|
|
|
Form of Incentive Stock Option Agreement under the GENEOS Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.51+
|
|
|
Form of Employee Non-Qualified Stock Option Agreement under the GENEOS Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.52+
|
|
|
Form of Outside Director Non-Qualified Stock Option Agreement under the GENEOS Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.5 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.53+
|
|
|
Form of Restricted Stock Agreement under the GENEOS Therapeutics, Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.6 as filed with the registrant’s Form 10-Q quarterly report for the quarter ended September 30, 2016 filed on November 9, 2016).
|
|
|
|
|
10.54+
|
|
|
Form of Restricted Stock Units Award Agreement under 2016 Omnibus Incentive Plan. (Filed herewith.)
|
|
|
|
|
10.55+
|
|
|
Form of Incentive Stock Option Agreement under 2016 Omnibus Incentive Plan. (Filed herewith.)
|
|
|
|
|
10.56+
|
|
|
Form of Nonqualified Stock Option Agreement under 2016 Omnibus Incentive Plan. (Filed herewith.)
|
|
|
|
Exhibit
Number
|
|
Description of Document
|
|
21.1
|
|
|
Subsidiaries of the registrant.
|
|
|
|
|
23.1
|
|
|
Consent of Independent Registered Public Accounting Firm.
|
|
|
|
|
24.1
|
|
|
Power of Attorney (included on signature page).
|
|
|
|
|
31.1
|
|
|
Certification of the Chief Executive Officer pursuant Securities Exchange Act Rule 13a-14(a).
|
|
|
|
|
31.2
|
|
|
Certification of the Chief Financial Officer pursuant Securities Exchange Act Rule 13a-14(a).
|
|
|
|
|
32.1
|
|
|
Certification pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
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.
|
+
|
Designates management contract, compensatory plan or arrangement.
|
†
|
Portions redacted pursuant to confidential treatment applications.
|
|
Inovio Pharmaceuticals, Inc.
|
|
|
|
|
|
By:
|
/s/ J. J
OSEPH
K
IM
|
|
|
J. Joseph Kim
President, Chief Executive Officer and Director
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ J. JOSEPH KIM
|
|
President, Chief Executive Officer and Director (Principal Executive Officer)
|
|
March 15, 2017
|
J. Joseph Kim
|
|
|
|
|
|
|
|
|
|
/s/ AVTAR DHILLON
|
|
Chairman of the Board of Directors
|
|
March 15, 2017
|
Avtar Dhillon
|
|
|
|
|
|
|
|
|
|
/s/ PETER KIES
|
|
Chief Financial Officer (Principal Accounting Officer and Principal Financial Officer)
|
|
March 15, 2017
|
Peter Kies
|
|
|
|
|
|
|
|
|
|
/s/ SIMON X. BENITO
|
|
Director
|
|
March 15, 2017
|
Simon X. Benito
|
|
|
|
|
|
|
|
|
|
/s/ ANGEL CABRERA
|
|
Director
|
|
March 15, 2017
|
Angel Cabrera
|
|
|
|
|
|
|
|
|
|
/s/ MORTON COLLINS
|
|
Director
|
|
March 15, 2017
|
Morton Collins
|
|
|
|
|
|
|
|
|
|
/s/ ADEL MAHMOUD
|
|
Director
|
|
March 15, 2017
|
Adel Mahmoud
|
|
|
|
|
|
|
|
|
|
/s/ DAVID WEINER
|
|
Director
|
|
March 15, 2017
|
David Weiner
|
|
|
|
|
|
|
|
|
|
/s/ NANCY J. WYSENSKI
|
|
Director
|
|
March 15, 2017
|
Nancy J. Wysenski
|
|
|
|
|
|
Page
|
|
/s/ ERNST & YOUNG LLP
|
|
|
San Diego, California
|
|
March 15, 2017
|
|
|
December 31,
|
||||||
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
19,136,472
|
|
|
$
|
57,632,693
|
|
Short-term investments
|
85,629,412
|
|
|
105,357,277
|
|
||
Accounts receivable
|
15,821,511
|
|
|
7,299,612
|
|
||
Accounts receivable from affiliated entity
|
748,355
|
|
|
33,447
|
|
||
Prepaid expenses and other current assets
|
1,749,059
|
|
|
917,257
|
|
||
Prepaid expenses and other current assets from affiliated entity
|
1,512,424
|
|
|
610,652
|
|
||
Total current assets
|
124,597,233
|
|
|
171,850,938
|
|
||
Fixed assets, net
|
9,025,446
|
|
|
7,306,695
|
|
||
Investment in affiliated entity - GeneOne
|
16,052,065
|
|
|
14,941,277
|
|
||
Investment in affiliated entity - PLS
|
3,777,510
|
|
|
5,045,915
|
|
||
Intangible assets, net
|
7,628,394
|
|
|
3,905,860
|
|
||
Goodwill
|
10,513,371
|
|
|
10,113,371
|
|
||
Common stock warrants
|
—
|
|
|
5,970
|
|
||
Other assets
|
2,113,147
|
|
|
670,833
|
|
||
Total assets
|
$
|
173,707,166
|
|
|
$
|
213,840,859
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
19,597,787
|
|
|
$
|
13,064,899
|
|
Accounts payable and accrued expenses due to affiliated entity
|
1,072,579
|
|
|
165,047
|
|
||
Accrued clinical trial expenses
|
6,368,389
|
|
|
2,600,483
|
|
||
Common stock warrants
|
1,167,614
|
|
|
1,301,138
|
|
||
Deferred revenue
|
14,762,720
|
|
|
13,449,768
|
|
||
Deferred revenue from affiliated entity
|
407,292
|
|
|
504,442
|
|
||
Deferred rent
|
446,646
|
|
|
380,629
|
|
||
Total current liabilities
|
43,823,027
|
|
|
31,466,406
|
|
||
Deferred revenue, net of current portion
|
317,808
|
|
|
103,074
|
|
||
Deferred revenue from affiliated entity, net of current portion
|
86,694
|
|
|
677,371
|
|
||
Deferred rent, net of current portion
|
5,926,424
|
|
|
5,485,313
|
|
||
Deferred tax liabilities
|
174,793
|
|
|
175,642
|
|
||
Total liabilities
|
50,328,746
|
|
|
37,907,806
|
|
||
Commitments and contingencies
|
|
|
|
||||
Inovio Pharmaceuticals, Inc. stockholders’ equity:
|
|
|
|
||||
Preferred stock—par value $0.001; Authorized shares: 10,000,000, issued and outstanding shares: 23 at December 31, 2016 and December 31, 2015
|
—
|
|
|
—
|
|
||
Common stock—par value $0.001; Authorized shares: 600,000,000 at December 31, 2016 and December 31, 2015, issued and outstanding: 74,062,370 at December 31, 2016 and 72,217,965 at December 31, 2015
|
74,062
|
|
|
72,218
|
|
||
Additional paid-in capital
|
556,718,356
|
|
|
534,004,564
|
|
||
Accumulated deficit
|
(434,838,235
|
)
|
|
(361,097,896
|
)
|
||
Accumulated other comprehensive income
|
1,327,968
|
|
|
2,708,339
|
|
||
Total Inovio Pharmaceuticals, Inc. stockholders’ equity
|
123,282,151
|
|
|
175,687,225
|
|
||
Non-controlling interest
|
96,269
|
|
|
245,828
|
|
||
Total stockholders’ equity
|
123,378,420
|
|
|
175,933,053
|
|
||
Total liabilities and stockholders’ equity
|
$
|
173,707,166
|
|
|
$
|
213,840,859
|
|
|
For the Year ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Revenue under collaborative research and development arrangements
|
$
|
6,490,747
|
|
|
$
|
26,876,533
|
|
|
$
|
7,416,568
|
|
Revenue under collaborative research and development arrangements with affiliated entity
|
1,400,594
|
|
|
779,167
|
|
|
479,464
|
|
|||
Grants and miscellaneous revenue
|
27,136,457
|
|
|
12,916,411
|
|
|
2,560,734
|
|
|||
Grants and miscellaneous revenue from affiliated entity
|
340,563
|
|
|
—
|
|
|
—
|
|
|||
Total revenues
|
35,368,361
|
|
|
40,572,111
|
|
|
10,456,766
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
88,712,035
|
|
|
57,791,923
|
|
|
34,095,039
|
|
|||
General and administrative
|
23,892,263
|
|
|
18,063,890
|
|
|
15,857,688
|
|
|||
Gain on sale of assets
|
(1,000,000
|
)
|
|
(1,000,000
|
)
|
|
—
|
|
|||
Total operating expenses
|
111,604,298
|
|
|
74,855,813
|
|
|
49,952,727
|
|
|||
Loss from operations
|
(76,235,937
|
)
|
|
(34,283,702
|
)
|
|
(39,495,961
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Interest and other income, net
|
1,257,257
|
|
|
305,071
|
|
|
331,461
|
|
|||
Change in fair value of common stock warrants
|
127,554
|
|
|
177,561
|
|
|
348,143
|
|
|||
Gain on investment in affiliated entity
|
1,110,787
|
|
|
2,600,467
|
|
|
2,676,224
|
|
|||
Net loss before income tax benefit
|
(73,740,339
|
)
|
|
(31,200,603
|
)
|
|
(36,140,133
|
)
|
|||
Income tax benefit
|
—
|
|
|
2,097,766
|
|
|
—
|
|
|||
Net loss
|
(73,740,339
|
)
|
|
(29,102,837
|
)
|
|
(36,140,133
|
)
|
|||
Net (income) loss attributable to non-controlling interest
|
—
|
|
|
(84,769
|
)
|
|
18,420
|
|
|||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(73,740,339
|
)
|
|
$
|
(29,187,606
|
)
|
|
$
|
(36,121,713
|
)
|
Net loss per common share attributable to Inovio Pharmaceuticals, Inc. stockholders
|
|
|
|
|
|
||||||
Basic
|
$
|
(1.01
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.61
|
)
|
Diluted
|
$
|
(1.01
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.64
|
)
|
Weighted average number of common shares outstanding used in per share calculations:
|
|
|
|
|
|
||||||
Basic
|
73,214,766
|
|
|
68,198,142
|
|
|
59,127,349
|
|
|||
Diluted
|
73,214,766
|
|
|
68,365,265
|
|
|
59,408,252
|
|
|
For the Year ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Net loss
|
(73,740,339
|
)
|
|
$
|
(29,102,837
|
)
|
|
$
|
(36,140,133
|
)
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
||||||
Unrealized gain (loss) on investment in affiliated entity, net of tax
|
(1,268,404
|
)
|
|
2,952,201
|
|
|
—
|
|
|||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
(1,689
|
)
|
|||
Unrealized gain (loss) on short-term investments, net of tax
|
(111,967
|
)
|
|
7,528
|
|
|
(173,336
|
)
|
|||
Comprehensive loss
|
$
|
(75,120,710
|
)
|
|
$
|
(26,143,108
|
)
|
|
$
|
(36,315,158
|
)
|
Comprehensive (income) loss attributable to non-controlling interest
|
—
|
|
|
(84,769
|
)
|
|
18,420
|
|
|||
Comprehensive loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(75,120,710
|
)
|
|
$
|
(26,227,877
|
)
|
|
$
|
(36,296,738
|
)
|
|
Preferred stock
|
|
Common stock
|
|
Additional
paid-in
capital
|
|
Accumulated
deficit
|
|
Accumulated
other
comprehensive
income (loss)
|
|
Non-
controlling
interest
|
|
Total
stockholders’
equity
|
|||||||||||||||||||
|
Number
of shares
|
|
Amount
|
|
Number
of shares
|
|
Amount
|
|
||||||||||||||||||||||||
Balance at December 31, 2013
|
26
|
|
|
—
|
|
|
52,576,390
|
|
|
$
|
52,577
|
|
|
$
|
348,267,389
|
|
|
$
|
(295,788,577
|
)
|
|
$
|
(76,365
|
)
|
|
$
|
447,659
|
|
|
$
|
52,902,683
|
|
Issuance of shares related to reverse stock split
|
—
|
|
|
—
|
|
|
6,378
|
|
|
6
|
|
|
57,181
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
57,187
|
|
||||||
Issuance of common stock for cash, net of financing costs of $5.5 million
|
—
|
|
|
—
|
|
|
5,452,725
|
|
|
5,453
|
|
|
59,203,729
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
59,209,182
|
|
||||||
Conversions of preferred stock to common stock
|
(3
|
)
|
|
—
|
|
|
1,103
|
|
|
1
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Acquisition of non-controlling interest
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
118,621
|
|
|
—
|
|
|
—
|
|
|
(118,621
|
)
|
|
—
|
|
||||||
Exercise of stock options and warrants for cash
|
—
|
|
|
—
|
|
|
2,689,868
|
|
|
2,689
|
|
|
13,249,854
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,252,543
|
|
||||||
Cashless exercise of warrants
|
—
|
|
|
—
|
|
|
14,618
|
|
|
15
|
|
|
(15
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Change in classification of warrants from liability to equity due to exercise
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,002,211
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
17,002,211
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,428,946
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5,428,946
|
|
||||||
Net loss attributable to common stockholders
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36,121,713
|
)
|
|
—
|
|
|
(18,420
|
)
|
|
(36,140,133
|
)
|
||||||
Unrealized loss on short-term investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(173,336
|
)
|
|
—
|
|
|
(173,336
|
)
|
||||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,689
|
)
|
|
—
|
|
|
(1,689
|
)
|
||||||
Balance at December 31, 2014
|
23
|
|
|
—
|
|
|
60,741,082
|
|
|
$
|
60,741
|
|
|
$
|
443,327,915
|
|
|
$
|
(331,910,290
|
)
|
|
$
|
(251,390
|
)
|
|
$
|
310,618
|
|
|
$
|
111,537,594
|
|
Issuance of common stock for cash, net of financing costs of $4.0 million
|
—
|
|
|
—
|
|
|
10,925,000
|
|
|
10,925
|
|
|
81,891,438
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
81,902,363
|
|
||||||
Payment to minority stockholders
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(149,559
|
)
|
|
(149,559
|
)
|
||||||
Exercise of stock options and warrants for cash
|
—
|
|
|
—
|
|
|
551,883
|
|
|
552
|
|
|
2,598,363
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,598,915
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,186,848
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,186,848
|
|
||||||
Net loss attributable to common stockholders
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(29,187,606
|
)
|
|
—
|
|
|
84,769
|
|
|
(29,102,837
|
)
|
||||||
Unrealized gain on short-term investments, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,528
|
|
|
—
|
|
|
7,528
|
|
||||||
Unrealized gain on investment in affiliated entity, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,952,201
|
|
|
—
|
|
|
2,952,201
|
|
||||||
Balance at December 31, 2015
|
23
|
|
|
—
|
|
|
72,217,965
|
|
|
$
|
72,218
|
|
|
$
|
534,004,564
|
|
|
$
|
(361,097,896
|
)
|
|
$
|
2,708,339
|
|
|
$
|
245,828
|
|
|
$
|
175,933,053
|
|
Issuance of common stock for cash, net of financing costs of $128,000
|
—
|
|
|
—
|
|
|
658,748
|
|
|
659
|
|
|
6,295,102
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,295,761
|
|
||||||
Issuance of common stock for Bioject acquisition
|
—
|
|
|
—
|
|
|
440,122
|
|
|
440
|
|
|
4,299,560
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,300,000
|
|
||||||
Payment to minority stockholders
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(149,559
|
)
|
|
(149,559
|
)
|
||||||
Exercise of stock options and warrants for cash, net of tax payments
|
—
|
|
|
—
|
|
|
450,045
|
|
|
449
|
|
|
1,640,291
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,640,740
|
|
||||||
Cashless exercise of stock options and warrants
|
—
|
|
|
—
|
|
|
295,490
|
|
|
296
|
|
|
(296
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,479,135
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,479,135
|
|
||||||
Net loss attributable to common stockholders
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(73,740,339
|
)
|
|
—
|
|
|
—
|
|
|
(73,740,339
|
)
|
||||||
Unrealized loss on short-term investments, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(111,967
|
)
|
|
—
|
|
|
(111,967
|
)
|
||||||
Unrealized loss on investment in affiliated entity, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,268,404
|
)
|
|
—
|
|
|
(1,268,404
|
)
|
||||||
Balance at December 31, 2016
|
23
|
|
|
—
|
|
|
74,062,370
|
|
|
$
|
74,062
|
|
|
$
|
556,718,356
|
|
|
$
|
(434,838,235
|
)
|
|
$
|
1,327,968
|
|
|
$
|
96,269
|
|
|
$
|
123,378,420
|
|
|
For the Year ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Cash flows from operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(73,740,339
|
)
|
|
$
|
(29,102,837
|
)
|
|
$
|
(36,140,133
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation
|
1,708,498
|
|
|
1,048,431
|
|
|
626,554
|
|
|||
Amortization of intangible assets
|
1,377,466
|
|
|
870,199
|
|
|
942,719
|
|
|||
Change in value of common stock warrants
|
(127,554
|
)
|
|
(177,561
|
)
|
|
(348,143
|
)
|
|||
Stock-based compensation
|
10,479,135
|
|
|
6,186,848
|
|
|
5,428,946
|
|
|||
Issuance of shares in connection with reverse stock split
|
—
|
|
|
—
|
|
|
57,187
|
|
|||
Amortization of premiums on investments
|
266,290
|
|
|
348,566
|
|
|
54,534
|
|
|||
Deferred taxes
|
(849
|
)
|
|
14,166
|
|
|
27,537
|
|
|||
Deferred rent
|
(16,728
|
)
|
|
383,584
|
|
|
762,616
|
|
|||
Loss on short-term investments
|
139,249
|
|
|
432,174
|
|
|
36,949
|
|
|||
Gain on investment in affiliated entity
|
(1,110,787
|
)
|
|
(2,600,467
|
)
|
|
(2,676,224
|
)
|
|||
Gain on sale of intangible assets
|
(1,000,000
|
)
|
|
(1,000,000
|
)
|
|
—
|
|
|||
Income tax benefit from other unrealized gains on securities
|
—
|
|
|
(2,097,766
|
)
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
(8,521,899
|
)
|
|
(4,497,225
|
)
|
|
499,176
|
|
|||
Accounts receivable from affiliated entity
|
(714,908
|
)
|
|
(31,627
|
)
|
|
(1,820
|
)
|
|||
Prepaid expenses and other current assets
|
(831,802
|
)
|
|
(119,284
|
)
|
|
(160,540
|
)
|
|||
Prepaid expenses and other current assets from affiliated entity
|
(901,772
|
)
|
|
771,723
|
|
|
674,975
|
|
|||
Restricted cash
|
—
|
|
|
—
|
|
|
100,762
|
|
|||
Other assets
|
(1,442,314
|
)
|
|
(196,265
|
)
|
|
(72,493
|
)
|
|||
Accounts payable and accrued expenses
|
6,367,965
|
|
|
6,456,581
|
|
|
925,820
|
|
|||
Accrued clinical trial expenses
|
3,767,906
|
|
|
593,051
|
|
|
561,252
|
|
|||
Accounts payable and accrued expenses due to affiliated entity
|
907,532
|
|
|
136,640
|
|
|
(493,848
|
)
|
|||
Deferred revenue
|
1,527,686
|
|
|
10,191,840
|
|
|
(260,719
|
)
|
|||
Deferred revenue from affiliated entity
|
(687,827
|
)
|
|
(49,672
|
)
|
|
(368,751
|
)
|
|||
Net cash used in operating activities
|
(62,555,052
|
)
|
|
(12,438,901
|
)
|
|
(29,823,644
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
||||||
Purchases of investments
|
(57,317,671
|
)
|
|
(63,526,830
|
)
|
|
(47,185,945
|
)
|
|||
Maturities of investments
|
76,528,030
|
|
|
10,484,267
|
|
|
12,753,719
|
|
|||
Purchases of capital assets
|
(2,738,470
|
)
|
|
(2,781,544
|
)
|
|
(1,379,980
|
)
|
|||
Proceeds from sale of intangible assets
|
1,000,000
|
|
|
1,000,000
|
|
|
—
|
|
|||
Purchase of intangible and other assets
|
(1,200,000
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash provided by (used in) investing activities
|
16,271,889
|
|
|
(54,824,107
|
)
|
|
(35,812,206
|
)
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock and warrants, net of issuance costs
|
6,295,761
|
|
|
81,902,363
|
|
|
59,209,182
|
|
|||
Proceeds from stock option and warrant exercises, net of tax payments
|
1,640,740
|
|
|
2,598,915
|
|
|
13,252,543
|
|
|||
Other financing activities
|
(149,559
|
)
|
|
(149,559
|
)
|
|
—
|
|
|||
Net cash provided by financing activities
|
7,786,942
|
|
|
84,351,719
|
|
|
72,461,725
|
|
|||
Effect of exchange rate changes on cash and cash equivalents
|
—
|
|
|
—
|
|
|
(1,689
|
)
|
|||
Increase (Decrease) in cash and cash equivalents
|
(38,496,221
|
)
|
|
17,088,711
|
|
|
6,824,186
|
|
|||
Cash and cash equivalents, beginning of period
|
57,632,693
|
|
|
40,543,982
|
|
|
33,719,796
|
|
|||
Cash and cash equivalents, end of period
|
$
|
19,136,472
|
|
|
$
|
57,632,693
|
|
|
$
|
40,543,982
|
|
|
|
|
|
|
|
||||||
Supplemental disclosure of non-cash activities
|
|
|
|
|
|
||||||
Common stock issued for purchase of Bioject
|
$
|
4,300,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Change in amounts accrued for purchases of property and equipment
|
$
|
164,923
|
|
|
$
|
225,148
|
|
|
$
|
12,842
|
|
Lease incentive recorded as fixed assets and deferred rent
|
$
|
523,856
|
|
|
$
|
773,000
|
|
|
$
|
933,000
|
|
1.
|
The consideration is commensurate with either the entity's performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone,
|
2.
|
The consideration relates solely to past performance, and
|
3.
|
The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Numerator
|
|
|
|
|
|
||||||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(73,740,339
|
)
|
|
$
|
(29,187,606
|
)
|
|
$
|
(36,121,713
|
)
|
Reflect adjustment for decrease in fair value of warrant liability
|
—
|
|
|
(721,591
|
)
|
|
(2,181,203
|
)
|
|||
Numerator for use in diluted loss per share
|
$
|
(73,740,339
|
)
|
|
$
|
(29,909,197
|
)
|
|
$
|
(38,302,916
|
)
|
|
|
|
|
|
|
||||||
Denominator
|
|
|
|
|
|
||||||
Weighted average number of common shares outstanding
|
73,214,766
|
|
|
68,198,142
|
|
|
59,127,349
|
|
|||
Effect of dilutive potential common shares from warrants
|
—
|
|
|
167,123
|
|
|
280,903
|
|
|||
Denominator for use in diluted loss per share
|
73,214,766
|
|
|
68,365,265
|
|
|
59,408,252
|
|
|||
|
|
|
|
|
|
||||||
Net loss per share, diluted
|
$
|
(1.01
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.64
|
)
|
|
Year Ended December 31,
|
|||||||
|
2016
|
|
2015
|
|
2014
|
|||
Options to purchase common stock
|
6,806,183
|
|
|
5,862,364
|
|
|
4,840,514
|
|
Warrants to purchase common stock
|
284,091
|
|
|
276,813
|
|
|
727,969
|
|
Restricted stock units
|
798,834
|
|
|
230,000
|
|
|
—
|
|
Convertible preferred stock
|
8,456
|
|
|
8,456
|
|
|
8,456
|
|
Total
|
7,897,564
|
|
|
6,377,633
|
|
|
5,576,939
|
|
|
Year Ended December 31,
|
||||
|
2016
|
|
2015
|
|
2014
|
Risk-free interest rate
|
0.91%
|
|
0.99%
|
|
1.47%
|
Expected volatility
|
76%
|
|
74%
|
|
109%
|
Expected life in years
|
5
|
|
5
|
|
5
|
Dividend yield
|
—
|
|
—
|
|
—
|
Forfeiture rate
|
7%
|
|
7%
|
|
8%
|
|
|
|
As of December 31, 2016
|
||||||||||||||
|
Contractual
Maturity (in years)
|
Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Market Value
|
|||||||||
Mutual funds
|
---
|
|
$
|
60,883,065
|
|
|
$
|
94,374
|
|
|
$
|
(387,693
|
)
|
|
$
|
60,589,746
|
|
US corporate debt securities
|
Less than 2
|
|
25,098,122
|
|
|
6,853
|
|
|
(65,309
|
)
|
|
25,039,666
|
|
||||
Investment in affiliated entity (PLS)
|
---
|
|
—
|
|
|
3,777,510
|
|
|
—
|
|
|
3,777,510
|
|
||||
Total investments
|
|
|
$
|
85,981,187
|
|
|
$
|
3,878,737
|
|
|
$
|
(453,002
|
)
|
|
$
|
89,406,922
|
|
|
|
|
As of December 31, 2015
|
||||||||||||||
|
Contractual
Maturity (in years)
|
Cost
|
|
Gross Unrealized
Gains
|
|
Gross Unrealized
Losses
|
|
Fair Market Value
|
|||||||||
Mutual funds
|
---
|
|
$
|
78,571,294
|
|
|
$
|
435
|
|
|
$
|
(185,737
|
)
|
|
$
|
78,385,992
|
|
US corporate debt securities
|
Less than 2
|
|
26,923,855
|
|
|
—
|
|
|
(54,452
|
)
|
|
26,869,403
|
|
||||
Municipal bonds
|
Less than 1
|
|
101,936
|
|
|
—
|
|
|
(54
|
)
|
|
101,882
|
|
||||
Investment in affiliated entity (PLS)
|
---
|
|
—
|
|
|
5,045,915
|
|
|
—
|
|
|
5,045,915
|
|
||||
Total investments
|
|
|
$
|
105,597,085
|
|
|
$
|
5,046,350
|
|
|
$
|
(240,243
|
)
|
|
$
|
110,403,192
|
|
|
Fair Value Measurements at
|
||||||||||||||
|
December 31, 2016
|
||||||||||||||
|
Total
|
|
Quoted Prices
in Active Markets
(Level 1)
|
|
Significant
Other Unobservable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
10,300,813
|
|
|
$
|
10,300,813
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Mutual funds
|
60,589,746
|
|
|
—
|
|
|
60,589,746
|
|
|
—
|
|
||||
US corporate debt securities
|
25,039,666
|
|
|
—
|
|
|
25,039,666
|
|
|
—
|
|
||||
Investments in affiliated entities
|
19,829,575
|
|
|
19,829,575
|
|
|
—
|
|
|
—
|
|
||||
Total Assets
|
$
|
115,759,800
|
|
|
$
|
30,130,388
|
|
|
$
|
85,629,412
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
1,167,614
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,167,614
|
|
Total Liabilities
|
$
|
1,167,614
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,167,614
|
|
|
Fair Value Measurements at
|
||||||||||||||
|
December 31, 2015
|
||||||||||||||
|
Total
|
|
Quoted Prices
in Active Markets
(Level 1)
|
|
Significant
Other Unobservable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money market funds
|
$
|
54,474,609
|
|
|
$
|
54,474,609
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Mutual funds
|
78,385,992
|
|
|
—
|
|
|
78,385,992
|
|
|
—
|
|
||||
US corporate debt securities
|
26,869,403
|
|
|
—
|
|
|
26,869,403
|
|
|
—
|
|
||||
Municipal bonds
|
101,882
|
|
|
—
|
|
|
101,882
|
|
|
—
|
|
||||
Investments in affiliated entities
|
19,987,192
|
|
|
19,987,192
|
|
|
—
|
|
|
—
|
|
||||
Common stock warrants
|
5,970
|
|
|
—
|
|
|
—
|
|
|
5,970
|
|
||||
Total Assets
|
$
|
179,825,048
|
|
|
$
|
74,461,801
|
|
|
$
|
105,357,277
|
|
|
$
|
5,970
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Common stock warrants
|
$
|
1,301,138
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,301,138
|
|
Total Liabilities
|
$
|
1,301,138
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,301,138
|
|
|
Year Ended December 31,
|
||
|
2016
|
|
2015
|
Risk-free interest rate
|
0.51%
|
|
0.64%
|
Expected volatility
|
88%
|
|
90%
|
Expected life in years
|
0.25
|
|
0.75-1.25
|
Dividend yield
|
—
|
|
—
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Balance at beginning of year
|
$
|
5,970
|
|
|
$
|
550,000
|
|
Decrease in fair value included in change in fair value of common stock warrants
|
(5,970
|
)
|
|
(544,030
|
)
|
||
Balance at end of year
|
$
|
—
|
|
|
$
|
5,970
|
|
|
Year Ended December 31,
|
||
|
2016
|
|
2015
|
Risk-free interest rate
|
1.1%
|
|
1.36%
|
Expected volatility
|
61%
|
|
81%
|
Expected life in years
|
1.70
|
|
2.70
|
Dividend yield
|
—
|
|
—
|
|
Year Ended December 31,
|
||||||
|
2016
|
|
2015
|
||||
Balance at beginning of year
|
$
|
1,301,138
|
|
|
$
|
2,022,729
|
|
Decrease in fair value included in change in fair value of common stock warrants
|
(133,524
|
)
|
|
(721,591
|
)
|
||
Balance at end of year
|
$
|
1,167,614
|
|
|
$
|
1,301,138
|
|
Customer
|
2016
|
|
% of Total
Revenue
|
|
2015
|
|
% of Total
Revenue
|
|
2014
|
|
% of Total
Revenue
|
|||||||||
MedImmune
|
$
|
1,518,639
|
|
|
4
|
%
|
|
$
|
16,037,731
|
|
|
40
|
%
|
|
$
|
—
|
|
|
—
|
%
|
DARPA
|
26,602,183
|
|
|
75
|
|
|
11,582,623
|
|
|
28
|
|
|
123,605
|
|
|
1
|
|
|||
Roche
|
4,917,929
|
|
|
14
|
|
|
10,778,688
|
|
|
27
|
|
|
7,357,346
|
|
|
70
|
|
|||
NIAID
|
118,171
|
|
|
—
|
|
|
901,475
|
|
|
2
|
|
|
1,229,084
|
|
|
12
|
|
|||
GeneOne (affiliated entity)
|
1,188,432
|
|
|
4
|
|
|
450,000
|
|
|
1
|
|
|
479,464
|
|
|
5
|
|
|||
All other
|
1,023,007
|
|
|
3
|
|
|
821,594
|
|
|
2
|
|
|
1,267,267
|
|
|
12
|
|
|||
Total Revenue
|
$
|
35,368,361
|
|
|
100
|
%
|
|
$
|
40,572,111
|
|
|
100
|
%
|
|
$
|
10,456,766
|
|
|
100
|
%
|
|
Cost
|
|
Accumulated
Depreciation
and
Amortization
|
|
Net Book
Value
|
||||||
As of December 31, 2016
|
|
|
|
|
|
||||||
Leasehold improvements
|
$
|
5,248,311
|
|
|
$
|
(1,199,415
|
)
|
|
$
|
4,048,896
|
|
Laboratory equipment
|
3,534,302
|
|
|
(1,072,188
|
)
|
|
2,462,114
|
|
|||
Office furniture and fixtures
|
1,814,493
|
|
|
(1,108,187
|
)
|
|
706,306
|
|
|||
Computer equipment and other
|
3,684,521
|
|
|
(1,876,391
|
)
|
|
1,808,130
|
|
|||
|
$
|
14,281,627
|
|
|
$
|
(5,256,181
|
)
|
|
$
|
9,025,446
|
|
As of December 31, 2015
|
|
|
|
|
|
||||||
Leasehold improvements
|
$
|
3,571,619
|
|
|
$
|
(721,280
|
)
|
|
$
|
2,850,339
|
|
Laboratory equipment
|
1,875,561
|
|
|
(540,555
|
)
|
|
1,335,006
|
|
|||
Office furniture and fixtures
|
987,436
|
|
|
(399,524
|
)
|
|
587,912
|
|
|||
Computer equipment and other
|
4,419,761
|
|
|
(1,886,323
|
)
|
|
2,533,438
|
|
|||
|
$
|
10,854,377
|
|
|
$
|
(3,547,682
|
)
|
|
$
|
7,306,695
|
|
|
|
|
December 31, 2016
|
|
December 31, 2015
|
||||||||||||||||||||
|
Useful
Life
(Yrs)
|
Gross
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Gross
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|||||||||||||
Indefinite lived:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Goodwill(a)
|
|
|
$
|
10,513,371
|
|
|
$
|
—
|
|
|
$
|
10,513,371
|
|
|
$
|
10,113,371
|
|
|
$
|
—
|
|
|
$
|
10,113,371
|
|
Definite lived:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Patents
|
8 – 17
|
|
5,802,528
|
|
|
(5,618,854
|
)
|
|
183,674
|
|
|
5,802,528
|
|
|
(5,516,122
|
)
|
|
286,406
|
|
||||||
Licenses
|
8 – 17
|
|
1,323,761
|
|
|
(1,161,861
|
)
|
|
161,900
|
|
|
1,323,761
|
|
|
(1,133,113
|
)
|
|
190,648
|
|
||||||
CELLECTRA
®
(b)
|
5 – 11
|
|
8,106,270
|
|
|
(6,825,028
|
)
|
|
1,281,242
|
|
|
8,106,270
|
|
|
(6,397,947
|
)
|
|
1,708,323
|
|
||||||
GHRH(b)
|
11
|
|
335,314
|
|
|
(240,264
|
)
|
|
95,050
|
|
|
335,314
|
|
|
(208,581
|
)
|
|
126,733
|
|
||||||
Bioject (c)
|
2 – 15
|
|
5,100,000
|
|
|
(562,222
|
)
|
|
4,537,778
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Other(d)
|
18
|
|
4,050,000
|
|
|
(2,681,250
|
)
|
|
1,368,750
|
|
|
4,050,000
|
|
|
(2,456,250
|
)
|
|
1,593,750
|
|
||||||
Total intangible assets
|
|
|
24,717,873
|
|
|
(17,089,479
|
)
|
|
7,628,394
|
|
|
19,617,873
|
|
|
(15,712,013
|
)
|
|
3,905,860
|
|
||||||
Total goodwill and intangible assets
|
|
|
$
|
35,231,244
|
|
|
$
|
(17,089,479
|
)
|
|
$
|
18,141,765
|
|
|
$
|
29,731,244
|
|
|
$
|
(15,712,013
|
)
|
|
$
|
14,019,231
|
|
(a)
|
Goodwill was recorded from the Inovio AS acquisition in January 2005, the acquisition of VGX in June 2009 and the acquisition of Bioject in April 2016 for
$3.9 million
,
$6.2 million
and
$400,000
, respectively.
|
(b)
|
CELLECTRA
®
and GHRH are developed technologies which were recorded from the acquisition of VGX.
|
(c)
|
Bioject intangible assets represent the fair value of developed technology and intellectual property which were recorded from the acquisition of Bioject.
|
(d)
|
Other intangible assets represent the fair value of acquired intellectual property from the Inovio AS acquisition.
|
2017
|
$
|
1,618,664
|
|
2018
|
1,249,584
|
|
|
2019
|
1,066,251
|
|
|
2020
|
547,081
|
|
|
2021
|
520,414
|
|
|
Thereafter
|
2,626,400
|
|
|
|
$
|
7,628,394
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Trade accounts payable, including from affiliated entity
|
$
|
5,920,642
|
|
|
$
|
4,292,374
|
|
Accrued compensation
|
6,531,983
|
|
|
4,157,440
|
|
||
Accrued subcontract costs
|
5,475,359
|
|
|
946,597
|
|
||
Accrued license fees
|
—
|
|
|
2,300,000
|
|
||
Other accrued expenses
|
1,669,803
|
|
|
1,368,488
|
|
||
|
$
|
19,597,787
|
|
|
$
|
13,064,899
|
|
|
|
|
|
|
Outstanding as of
December 31,
|
||||||
|
Authorized
|
|
Issued
|
|
2016
|
|
2015
|
||||
Series C Preferred Stock, par $0.001
|
1,091
|
|
|
1,091
|
|
|
23
|
|
|
23
|
|
|
|
|
|
|
|
As of December 31, 2016
|
|
As of December 31, 2015
|
||||||||||||
Issued in Connection With:
|
|
Exercise
Price
|
|
Expiration
Date
|
|
Number of
Warrants
|
|
Common Stock
Warrant Liability
|
|
Number of
Warrants
|
|
Common Stock
Warrant Liability
|
||||||||
March 2013 financing
|
|
$
|
3.17
|
|
|
September 12, 2018
|
|
284,091
|
|
|
$
|
1,167,614
|
|
|
284,091
|
|
|
$
|
1,301,138
|
|
Warrants assumed in June 2009 Merger
|
|
$ 4.08 - 5.12
|
|
|
April 28, 2016
|
|
—
|
|
|
—
|
|
|
276,813
|
|
|
—
|
|
|||
Total
|
|
|
|
|
|
284,091
|
|
|
$
|
1,167,614
|
|
|
560,904
|
|
|
$
|
1,301,138
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Exercise Price
|
|
Options
Outstanding
|
|
Weighted-Average
Remaining
Contractual Life
(in Years)
|
|
Weighted
Average
Exercise Price
|
|
Options
Exercisable
|
|
Weighted-Average
Exercise Price
|
||||||
$0.00-$3.00
|
|
1,184,058
|
|
|
5.6
|
|
$
|
2.25
|
|
|
1,184,058
|
|
|
$
|
2.25
|
|
$3.01-$6.00
|
|
1,063,941
|
|
|
2.1
|
|
$
|
4.76
|
|
|
1,055,351
|
|
|
$
|
4.75
|
|
$6.01-$9.00
|
|
3,337,860
|
|
|
7.7
|
|
$
|
7.25
|
|
|
1,668,725
|
|
|
$
|
7.23
|
|
$9.01-$12.00
|
|
418,612
|
|
|
8.6
|
|
$
|
9.75
|
|
|
155,420
|
|
|
$
|
9.92
|
|
$12.01-$15.00
|
|
801,712
|
|
|
6.4
|
|
$
|
12.94
|
|
|
626,277
|
|
|
$
|
12.93
|
|
|
|
6,806,183
|
|
|
6.3
|
|
$
|
6.81
|
|
|
4,689,831
|
|
|
$
|
6.26
|
|
|
Number of
Shares
|
|
Weighted-Average
Exercise Price
|
|||
Balance, December 31, 2015
|
230,000
|
|
|
$
|
—
|
|
Granted
|
671,500
|
|
|
—
|
|
|
Vested
|
(96,666
|
)
|
|
—
|
|
|
Cancelled
|
(6,000
|
)
|
|
—
|
|
|
Balance, December 31, 2016
|
798,834
|
|
|
$
|
—
|
|
2017
|
$
|
1,818,000
|
|
2018
|
2,266,000
|
|
|
2019
|
2,682,000
|
|
|
2020
|
2,869,000
|
|
|
2021
|
2,950,000
|
|
|
Thereafter
|
13,548,000
|
|
|
Total
|
$
|
26,133,000
|
|
Developed technology
|
$
|
3,800,000
|
|
Customer-related intangible
|
1,000,000
|
|
|
Trademarks
|
200,000
|
|
|
Covenants not-to-compete
|
100,000
|
|
|
Goodwill
|
400,000
|
|
|
Total purchase consideration
|
$
|
5,500,000
|
|
|
Year Ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Income (benefit) taxes at statutory rates
|
$
|
(25,809,000
|
)
|
|
$
|
(10,920,000
|
)
|
|
$
|
(12,639,000
|
)
|
State income tax, net of federal benefit
|
(4,000
|
)
|
|
(2,640,000
|
)
|
|
(2,362,000
|
)
|
|||
Change in valuation allowance
|
29,678,000
|
|
|
7,882,000
|
|
|
14,235,000
|
|
|||
Research and development tax credits
|
(3,117,000
|
)
|
|
(1,537,000
|
)
|
|
(849,000
|
)
|
|||
Fair value warrant
|
(47,000
|
)
|
|
(253,000
|
)
|
|
(180,000
|
)
|
|||
Stock compensation
|
113,000
|
|
|
2,288,000
|
|
|
1,573,000
|
|
|||
Uncertain tax positions
|
1,367,000
|
|
|
1,968,000
|
|
|
340,000
|
|
|||
Expired NOL's and credits
|
4,269,000
|
|
|
339,000
|
|
|
728,000
|
|
|||
Limited NOL's and credits
|
(6,456,000
|
)
|
|
(297,000
|
)
|
|
(749,000
|
)
|
|||
Change in state tax rate
|
(495,000
|
)
|
|
676,000
|
|
|
(60,000
|
)
|
|||
Other
|
501,000
|
|
|
396,000
|
|
|
(8,000
|
)
|
|||
|
$
|
—
|
|
|
$
|
(2,098,000
|
)
|
|
$
|
29,000
|
|
|
As of December 31,
|
||||||
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
||||
Capitalized research expense
|
$
|
567,000
|
|
|
$
|
1,201,000
|
|
Net operating loss carryforwards
|
95,500,000
|
|
|
71,848,000
|
|
||
Research and development and other tax credits
|
5,300,000
|
|
|
3,339,000
|
|
||
Deferred revenue
|
5,452,000
|
|
|
5,213,000
|
|
||
Deferred rent
|
2,231,000
|
|
|
2,171,000
|
|
||
Stock-based compensation
|
4,511,000
|
|
|
2,135,000
|
|
||
Acquired intangibles
|
269,000
|
|
|
—
|
|
||
Other
|
4,328,000
|
|
|
3,457,000
|
|
||
|
118,158,000
|
|
|
89,364,000
|
|
||
Valuation allowance
|
(113,407,000
|
)
|
|
(83,245,000
|
)
|
||
Total deferred tax assets
|
4,751,000
|
|
|
6,119,000
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Acquired intangibles
|
—
|
|
|
(596,000
|
)
|
||
Investment in affiliated entity
|
(3,624,000
|
)
|
|
(4,399,000
|
)
|
||
Fixed assets
|
(1,302,000
|
)
|
|
(1,299,000
|
)
|
||
Net deferred tax liabilities
|
$
|
(175,000
|
)
|
|
$
|
(175,000
|
)
|
|
Amount (in millions)
|
||
2017
|
$
|
5.8
|
|
2028 and beyond
|
67.8
|
|
|
Total
|
$
|
73.6
|
|
|
Year ended December 31,
|
||||||||||
|
2016
|
|
2015
|
|
2014
|
||||||
Balance at beginning of the year
|
$
|
5,455,000
|
|
|
$
|
2,759,000
|
|
|
$
|
2,416,000
|
|
Increases related to current year tax positions
|
1,183,000
|
|
|
615,000
|
|
|
331,000
|
|
|||
Increases related to prior year tax positions
|
217,000
|
|
|
2,081,000
|
|
|
12,000
|
|
|||
Balance at end of the year
|
$
|
6,855,000
|
|
|
$
|
5,455,000
|
|
|
$
|
2,759,000
|
|
|
Quarter Ended
|
|
Quarter Ended
|
|
Quarter Ended
|
|
Quarter Ended
|
||||||||
|
December 31,
2016 |
|
September 30,
2016 |
|
June 30,
2016 |
|
March 31,
2016 |
||||||||
Consolidated Statements of Operations:
|
|
|
|
|
|
|
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Revenue under collaborative research and development arrangements
|
$
|
476,586
|
|
|
$
|
2,327,316
|
|
|
$
|
1,889,988
|
|
|
$
|
1,796,857
|
|
Revenue under collaborative research and development arrangements with affiliated entity
|
189,278
|
|
|
574,596
|
|
|
499,720
|
|
|
137,000
|
|
||||
Grants and miscellaneous revenue
|
7,735,428
|
|
|
9,410,648
|
|
|
3,814,083
|
|
|
6,176,298
|
|
||||
Grants and miscellaneous revenue from affiliated entity
|
112,660
|
|
|
227,903
|
|
|
—
|
|
|
—
|
|
||||
Total revenues
|
8,513,952
|
|
|
12,540,463
|
|
|
6,203,791
|
|
|
8,110,155
|
|
||||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
23,911,731
|
|
|
26,980,343
|
|
|
19,630,801
|
|
|
18,189,160
|
|
||||
General and administrative
|
6,965,517
|
|
|
5,755,603
|
|
|
5,799,530
|
|
|
5,371,613
|
|
||||
Gain on sale of assets
|
—
|
|
|
—
|
|
|
(1,000,000
|
)
|
|
—
|
|
||||
Total operating expenses
|
30,877,248
|
|
|
32,735,946
|
|
|
24,430,331
|
|
|
23,560,773
|
|
||||
Loss from operations
|
(22,363,296
|
)
|
|
(20,195,483
|
)
|
|
(18,226,540
|
)
|
|
(15,450,618
|
)
|
||||
Interest and other income, net
|
191,460
|
|
|
391,596
|
|
|
341,131
|
|
|
333,070
|
|
||||
Change in fair value of common stock warrants
|
644,888
|
|
|
2,690
|
|
|
(113,775
|
)
|
|
(406,249
|
)
|
||||
Gain (Loss) from investment in affiliated entity
|
(4,706,522
|
)
|
|
(958,141
|
)
|
|
(705,527
|
)
|
|
7,480,977
|
|
||||
Net loss attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(26,233,470
|
)
|
|
$
|
(20,759,338
|
)
|
|
$
|
(18,704,711
|
)
|
|
$
|
(8,042,820
|
)
|
Net loss per common share attributable to Inovio Pharmaceuticals, Inc. stockholders
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.35
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.11
|
)
|
Diluted
|
$
|
(0.36
|
)
|
|
$
|
(0.28
|
)
|
|
$
|
(0.26
|
)
|
|
$
|
(0.11
|
)
|
|
Quarter Ended
|
|
Quarter Ended
|
|
Quarter Ended
|
|
Quarter Ended
|
||||||||
|
December 31,
2015 |
|
September 30,
2015 |
|
June 30,
2015 |
|
March 31,
2015 |
||||||||
Consolidated Statements of Operations:
|
|
|
|
|
|
|
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Revenue under collaborative research and development arrangements
|
$
|
1,820,643
|
|
|
$
|
16,475,083
|
|
|
$
|
4,335,236
|
|
|
$
|
4,245,571
|
|
Revenue under collaborative research and development arrangements with affiliated entity
|
375,000
|
|
|
125,000
|
|
|
166,667
|
|
|
112,500
|
|
||||
Grants and miscellaneous revenue
|
3,739,919
|
|
|
7,583,151
|
|
|
784,775
|
|
|
808,566
|
|
||||
Total revenues
|
5,935,562
|
|
|
24,183,234
|
|
|
5,286,678
|
|
|
5,166,637
|
|
||||
Operating Expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
15,601,891
|
|
|
16,075,201
|
|
|
16,688,511
|
|
|
9,426,320
|
|
||||
General and administrative
|
4,860,086
|
|
|
4,377,616
|
|
|
4,718,260
|
|
|
4,107,928
|
|
||||
Gain on sale of assets
|
—
|
|
|
—
|
|
|
(1,000,000
|
)
|
|
—
|
|
||||
Total operating expenses
|
20,461,977
|
|
|
20,452,817
|
|
|
20,406,771
|
|
|
13,534,248
|
|
||||
Income (Loss) from operations
|
(14,526,415
|
)
|
|
3,730,417
|
|
|
(15,120,093
|
)
|
|
(8,367,611
|
)
|
||||
Interest and other income, net
|
(194,519
|
)
|
|
214,982
|
|
|
146,332
|
|
|
138,276
|
|
||||
Change in fair value of common stock warrants
|
(290,316
|
)
|
|
518,877
|
|
|
(49,773
|
)
|
|
(1,227
|
)
|
||||
Gain (Loss) from investment in affiliated entity
|
(3,249,315
|
)
|
|
(659,054
|
)
|
|
8,861,145
|
|
|
(2,352,309
|
)
|
||||
Net income (loss) before income tax benefit
|
(18,260,565
|
)
|
|
3,805,222
|
|
|
(6,162,389
|
)
|
|
(10,582,871
|
)
|
||||
Income tax benefit
|
308,520
|
|
|
1,789,246
|
|
|
—
|
|
|
—
|
|
||||
Net income (loss)
|
(17,952,045
|
)
|
|
5,594,468
|
|
|
(6,162,389
|
)
|
|
(10,582,871
|
)
|
||||
Net (income) loss attributable to non-controlling interest
|
—
|
|
|
—
|
|
|
(85,861
|
)
|
|
1,092
|
|
||||
Net income (loss) attributable to Inovio Pharmaceuticals, Inc.
|
$
|
(17,952,045
|
)
|
|
$
|
5,594,468
|
|
|
$
|
(6,248,250
|
)
|
|
$
|
(10,581,779
|
)
|
Net income (loss) per common share attributable to Inovio Pharmaceuticals, Inc. stockholders
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.25
|
)
|
|
$
|
0.08
|
|
|
$
|
(0.09
|
)
|
|
$
|
(0.17
|
)
|
Diluted
|
$
|
(0.25
|
)
|
|
$
|
0.07
|
|
|
$
|
(0.09
|
)
|
|
$
|
(0.18
|
)
|
Participant:
|
|
Restricted Stock Units:
|
|
Grant Date:
|
|
Vesting Commencement Date:
|
|
Vesting Schedule:
|
[Three substantially equal consecutive annual installments on _____________, ______________ and _____________, each a “
Vesting Date
” respectively.]
|
PARTICIPANT
|
INOVIO PHARMACEUTICALS, INC.
|
Date of Grant
:
|
Type of Option
: Incentive Stock Option
|
Exercise Price per Share
: $
______, which represents the fair market value on the date of grant
|
Expiration Date
:
|
Total Number of
Shares Granted : |
Total Exercise Price
:
$
|
Vesting Schedule
:
(i)
immediately as to
______
of the Shares subject to the Option, or any portion thereof, and ending on the Expiration Date;
(ii)
as to
______
of the Shares subject to the Option, or any portion thereof, during the period commencing
, and ending on the Expiration Date;
(iii)
as to
______
of the Shares subject to the Option, or any portion thereof, during the period commencing
, and ending on the Expiration Date; and
(iv)
as to
_______
of the Shares subject to the Option, or any portion thereof, during the period commencing
, and ending on the Expiration Date.
Vesting is accelerated in full upon a Change in Control under Section 2(c)
of the attached Terms and Conditions of Stock Option Award.
After vesting, all or any portion of the Option may be exercised until the Expiration Date, unless the Option is earlier terminated as provided below under “Exercise After Termination of Service” or in the Agreement or the Plan.
|
Exercise After Termination of Employment
:
Termination of Employment for any reason
: any non-vested portion of the Option expires immediately;
Termination of Employment due to death or Disability
: vested portion of the Option is exercisable by the Optionee (or, in the event of the Optionee’s death, the Optionee’s Beneficiary) for one (1) year after the Optionee’s Termination;
Termination of Employment for any reason other than death or Disability
: vested portion of the Option is exercisable for a period of three (3) months following the Optionee’s Termination.
In no event may this Option be exercised after the Expiration Date as provided above
.
|
I.
|
AGREEMENT
|
Date of Grant: -
|
Type of Option: Non-Qualified Stock
Option
|
Exercise Price per Share: $______,
which represents the fair market value on the date of grant
|
Expiration Date:
|
Total Number of
Shares Granted: |
Total Exercise Price: $
|
Vesting Schedule
: (i) immediately as to ______ of the Shares subject to the Option, or any portion thereof, and ending on the Expiration Date;
(ii) as to ______ of the Shares subject to the Option, or any portion thereof, during the period commencing ______, and ending on the Expiration Date;
(iii) as to ______ of the Shares subject to the Option, or any portion thereof, during the period commencing ______, and ending on the Expiration Date; and
(iv) as to _______ of the Shares subject to the Option, or any portion thereof, during the period commencing _____, and ending on the Expiration Date.
Vesting is accelerated in full upon a Change in Control under Section 2(c) of the attached Terms and Conditions of Stock Option Award.
After vesting, all or any portion of the Option may be exercised until the Expiration Date, unless the Option is earlier terminated as provided below under “Exercise After Termination of Service” or in the Agreement or the Plan.
Upon Termination of Service for any reason, any non-vested portion of the Option shall expire immediately.
|
|
Exercise After Termination of Service
:
Upon Termination of Service, the vested portion of the Option shall be exercisable by the Optionee (or, in the event of the Optionee’s death, by the Optionee’s Beneficiary) for a period of one (1) year after the effective date of the Termination of Service; provided that, if the Optionee has served as a Director of the Company continuously for at least five (5) years prior to the effective date of the Termination of Service, the vested portion of the Option may be exercised until the Expiration Date, except as otherwise provided in the Agreement or the Plan.
In no event may the Option be exercised after the Expiration Date stated above
.
|
I.
|
AGREEMENT
|
|
|
|
|
|
Subsidiary Name(1)
|
|
Jurisdiction of Organization
|
|
|
Genetronics, Inc.
|
|
|
California
|
|
VGX Pharmaceuticals, LLC
|
|
|
Delaware
|
|
VGX Animal Health, Inc.
|
|
|
Delaware
|
|
|
|
|
|
|
(1)
|
In accordance with Instructions (ii) to Exhibit (21) to the Exhibit Table in Item 601 of Regulation S-K, Registrant has omitted from the above table one of its subsidiaries because such omitted subsidiary does not constitute a significant subsidiary of registrant as of the end of the year covered by this report.
|
1.
|
Registration Statement (Form S-3 No. 333-176670) of Inovio Pharmaceuticals, Inc.,
|
2.
|
Registration Statement (Form S-3 No. 333- 204420) of Inovio Pharmaceuticals, Inc.,
|
3.
|
Registration Statement (Form S-8 No. 333-120061) pertaining to Genetronics Biomedical Corporation Amended 2000 Stock Option Plan,
|
4.
|
Registration Statement (Form S-8 No. 333-136126) pertaining to Inovio Biomedical Corporation Amended 2000 Stock Option Plan,
|
5.
|
Registration Statement (Form S-8 Nos. 333-142938, 333-150769, and 333-161559) pertaining to Inovio Biomedical Corporation 2007 Omnibus Incentive Plan,
|
6.
|
Registration Statement (Form S-8 No. 333-156035) pertaining to Inovio Biomedical Corporation Viral Genomics, Inc. Equity Compensation Plan,
|
7.
|
Registration Statement (Form S-8 Nos. 333-166906, 333-174353, 333-181532, 333-192318, 333-196325, 333-209155, and 333-216061) pertaining to Inovio Pharmaceuticals, Inc’s 2007 Omnibus Incentive Plan,
|
8.
|
Registration Statement (Form S-8 No. 333-216059) of Inovio Pharmaceutical, Inc.’s 2016 Omnibus Incentive Plan,
|
1.
|
I have reviewed this annual report on Form 10-K of Inovio Pharmaceuticals, Inc.
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
Date:
|
March 15, 2017
|
/s/ J. J
OSEPH
K
IM
|
|
|
J. Joseph Kim
President, Chief Executive Officer and Director
|
1.
|
I have reviewed this annual report on Form 10-K of Inovio Pharmaceuticals, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
(a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
(a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
(b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control
|
Date:
|
March 15, 2017
|
/s/ P
ETER
K
IES
|
|
|
Peter Kies
Chief Financial Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date:
|
March 15, 2017
|
/s/ J. J
OSEPH
K
IM
|
|
|
J. Joseph Kim
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
|
|
|
Date:
|
March 15, 2017
|
/s/ P
ETER
K
IES
|
|
|
Peter Kies
Chief Financial Officer
(Principal Financial and Accounting Officer)
|