INO Inovio Pharmaceuticals Inc.

17
+1.33  (+8%)
Previous Close 15.67
Open 15.45
52 Week Low 1.915
52 Week High 33.79
Market Cap $2,847,847,395
Shares 167,520,435
Float 162,317,345
Enterprise Value $2,577,208,181
Volume 59,866,633
Av. Daily Volume 22,738,274
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Upcoming Catalysts

Drug Stage Catalyst Date
VGX-3100 - REVEAL-1
Cervical dysplasia
Phase 3
Phase 3
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INO-5401
Glioblastoma (GBM)
Phase 1/2
Phase 1/2
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MEDI0457
HPV-associated squamous cell carcinoma of the head & neck (SCCHN)
Phase 1/2
Phase 1/2
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INO-A002
Zika virus
Phase 1
Phase 1
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PENNVAX-GP
HIV
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
INO-4800
COVID-19 vaccine
Phase 1
Phase 1
Phase 1 interim data released June 30, 2020. 94% of Phase 1 trial participants demonstrated overall immune responses at Week 6 but no data on how many patients produced antibodies. Phase 2/3 trial to commence 2020.
INO-4700 / GLS-5300
MERS virus (Middle East Respiratory Syndrome)
Phase 1/2
Phase 1/2
Phase 2 trial planned.
INO-5401 and atezolizumab
Bladder cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial discontinued - noted July 16, 2019.
VGX-3100
Human papilloma virus (HPV)-related anal dysplasia
Phase 2
Phase 2
Phase 2 data noted 50% showed clearance of HPV lesions and 75% showed a decrease in the number of lesions 6 months after the start of treatment - March 26, 2020.
INO-3107
Recurrent respiratory papillomatosis
Phase 2
Phase 2
Phase 2 trial to be initiated 1H 2020.
INO-5151
Castration-resistant Prostate Cancer
Phase 1
Phase 1
Phase 1 trial announced July 29, 2019.
INO-5150
Prostate cancer
Phase 1b
Phase 1b
Phase 1b data at ESMO 2018 noted 86% of patients remained progression-free after 72 weeks.
MEDI0457
Human papilloma virus (HPV)
Phase 2
Phase 2
Phase 2 commencement of dosing announced December 4, 2018.
VGX-3100 - REVEAL-2
Cervical Dysplasia
Phase 3
Phase 3
Phase 3 initiation announced March 4, 2019.

Latest News

  1. PLYMOUTH MEETING, Pa., Sept. 8, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Thermo Fisher Scientific, the world leader in serving science, has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800.

    Thermo Fisher joins other contract development and manufacturing organizations in INOVIO's global manufacturing consortium, enabling INOVIO to potentially scale commercial production of INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 1001 million doses of INO-4800 manufactured in 2021, subject to FDA approval of…

    PLYMOUTH MEETING, Pa., Sept. 8, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Thermo Fisher Scientific, the world leader in serving science, has signed a letter of intent to manufacture INOVIO's DNA COVID-19 vaccine candidate INO-4800.

    Thermo Fisher joins other contract development and manufacturing organizations in INOVIO's global manufacturing consortium, enabling INOVIO to potentially scale commercial production of INO-4800. With its consortium of third-party manufacturers, INOVIO plans to have 1001 million doses of INO-4800 manufactured in 2021, subject to FDA approval of INO-4800 for use as a COVID-19 vaccine. Thermo Fisher plans to manufacture INO-4800 drug substance as well as perform fill and finish of INO-4800 drug product at its commercial facilities in the US. At peak capacity, Thermo Fisher projects that it could produce at least 100 million doses of INO-4800 annually.

    "INOVIO welcomes Thermo Fisher to our global consortium of commercial scale vaccine manufacturers and we look forward to partnering with them on this critically important endeavor," said Dr. J. Joseph Kim, INOVIO's President & Chief Executive Officer. "Thermo Fisher's global capabilities and scale will be central to our production progress – the organization's commitment to quality, reliable production will be key to our ability to meet the urgent, global demand for a safe and effective vaccine against COVID-19."

    Leon Wyszkowski, President, Commercial Operations for Thermo Fisher's Pharma Services business, said, "INOVIO has truly embraced the value of our end-to-end capabilities – starting with our initial work on clinical trials through supporting their commercial needs today. We remain extremely well-positioned to support INOVIO on its mission to manufacture 100 million doses of vaccine in 2021."

    "INOVIO is very excited to partner with Thermo Fisher for the manufacture of DNA plasmid drug substance and drug product," said Robert J. Juba Jr., INOVIO's Vice President of Biological Manufacturing and Clinical Supply Management. "Thermo Fisher provides an end-to-end solution for manufacturing, labeling, packaging and distribution that we believe will help us to provide hundreds of millions of doses of INO-4800 to the US and the rest of the world."

    Thermo Fisher Scientific will join existing partners Richter-Helm BioLogics and Ology Biosciences in INOVIO's global manufacturing consortium. INOVIO is in active discussions with additional manufacturers to join the consortium as INOVIO seeks to complement its existing members with additional manufacturing partnerships to meet global supply needs. Having multiple manufacturers involved in the production of INO-4800 is intended to support timely, cost-effective and scalable production of this DNA-based vaccine. INOVIO's third-party manufacturers will produce the patent-protected formulation for INO-4800, developed to enhance stability of the vaccine with a favorable tolerability profile. Importantly, INO-4800 has shown an excellent thermo-stability profile. INOVIO's other platform DNA vaccine candidates have demonstrated a shelf life of greater than 5 years when refrigerated and stability for more than 30 days at 37 degrees Celsius, and more than one year at room temperature. INOVIO's candidates also do not need to be frozen during transport or storage, a vital factor when implementing immunizations on a global scale. INO-4800 is administered via INOVIO's proprietary CELLECTRA® smart delivery device, which delivers the vaccine locally into the patient's skin, a process that takes only a few seconds.

    INOVIO is conducting a Phase 1 clinical trial of INO-4800 in the United States and has submitted the full trial results for the first 40 subjects for publication in a peer-reviewed journal. The company plans to initiate its Phase 2/3 COVID-19 vaccine trials in September, subject to FDA clearance to proceed.

    Earlier this summer, INOVIO received $71 million in funding from the U.S. Department of Defense (DoD) to support the large-scale manufacture of the company's proprietary CELLECTRA® 3PSP and the procurement of CELLECTRA® 2000 devices. The DoD contract builds upon two separate prior $5 million grants from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI), to accelerate the testing of CELLECTRA® 3PSP. Initial development of this next generation CELLECTRA® 3PSP smart device began in 2019 with $8.1 million in funding from the medical arm of the U.S. Defense Threat Reduction Agency's Medical CBRN Defense Consortium.

    About INOVIO's Global Coalition Advancing INO-4800

    INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University. INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is working with a team of contract manufacturers including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Biosciences to manufacture INO-4800 on a commercial scale and is seeking additional external funding and partnerships to further scale up manufacturing capacities to satisfy the urgent global demand for safe and effective vaccines. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.

    About INO-4800

    INO-4800 is INOVIO's DNA vaccine candidate intended to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INOVIO has extensive experience working with coronaviruses and was the first company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The simple-to-use CELLECTRA device provides a brief electrical pulse to reversibly open small pores in the local skin area cells resulting in more than a hundred-fold increase in product delivery providing dose sparing and consistency. Once inside the cell, the DNA plasmids instruct the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers a specific T cell and antibody-mediated immune responses. Administration with the CELLECTRA device, which takes only a few seconds, is designed to ensure that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines are transient, and do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the consistent immune response, safety profile, and tolerability that have been observed in clinical trials with multiple products.

    With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, Thermo Fisher Scientific, University of Pennsylvania, VGXI, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and manufacture DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

    1 1 mg dose equivalent 

     

    Cision View original content:http://www.prnewswire.com/news-releases/inovio-adds-thermo-fisher-scientific-to-global-manufacturing-consortium-301125241.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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  2. PLYMOUTH MEETING, Pa., Sept. 1, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Dr. J. Joseph Kim, President and CEO, along with other members of INOVIO management, will present at the following investor conferences in September:

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Time: 9:30 a.m. ET
    Presentation Format: Corporate Presentation

    Cantor Global Healthcare Conference
    Date: Thursday, September 17, 2020
    Time: 10:40 a.m. ET
    Presentation Format: Fireside Chat

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: Wednesday, September

    PLYMOUTH MEETING, Pa., Sept. 1, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that Dr. J. Joseph Kim, President and CEO, along with other members of INOVIO management, will present at the following investor conferences in September:

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Time: 9:30 a.m. ET

    Presentation Format: Corporate Presentation

    Cantor Global Healthcare Conference

    Date: Thursday, September 17, 2020

    Time: 10:40 a.m. ET

    Presentation Format: Fireside Chat

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Wednesday, September 23, 2020

    Time: 10:50 a.m. ET

    Presentation Format: Fireside Chat

    Live and archived versions of the virtual presentations will be available through the INOVIO Investor Relations Events page and may be accessed by visiting INOVIO's website at http://ir.inovio.com/investors/events/default.aspx. All presentation times are subject to change.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The simple-to-use CELLECTRA device provides a brief electrical pulse to reversibly open small pores in the local skin area cells resulting in more than a hundred-fold increase in product delivery providing dose sparing and consistency. Once inside the cell, the DNA plasmids instruct the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers a specific T cell and antibody-mediated immune responses. Administration with the CELLECTRA device, which takes only a few seconds, is designed to ensure that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines are transient, and do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the consistent immune response, safety profile, and tolerability that have been observed in clinical trials with multiple products.

    With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,  

    Investors: Ben Matone, 484-362-0076,

    * * * *

    This press release contains certain forward-looking statements relating to our business, including our plans to develop and manufacture DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

    Cision View original content:http://www.prnewswire.com/news-releases/inovio-to-present-at-upcoming-investor-conferences-in-september-301121579.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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  3. Investment advisory giants, SB Capital Management Inc., has continued to expand its investment portfolio and relief endeavors in light of the Coronavirus in a bid to achieve long-term growth, development, and strong returns.

    The company, headquartered in New York City, has added four premier investment companies to its portfolio, which includes firms such as The vanguard group, Geode capital management, I Shares Russell 2000 ETF, and SSGA Funds Management Inc.

    This is in addition to the company’s significant holdings in up-and-comers Moderna, Inc. (NASDAQ:MRNA) and Inovio (NASDAQ:INO), as well as premier blue-chip stocks like Johnson and Johnson (NYSE:JNJ), all of whose current focus is the creation and mass-production of a COVID-19 vaccine…

    Investment advisory giants, SB Capital Management Inc., has continued to expand its investment portfolio and relief endeavors in light of the Coronavirus in a bid to achieve long-term growth, development, and strong returns.

    The company, headquartered in New York City, has added four premier investment companies to its portfolio, which includes firms such as The vanguard group, Geode capital management, I Shares Russell 2000 ETF, and SSGA Funds Management Inc.

    This is in addition to the company’s significant holdings in up-and-comers Moderna, Inc. (NASDAQ:MRNA) and Inovio (NASDAQ:INO), as well as premier blue-chip stocks like Johnson and Johnson (NYSE:JNJ), all of whose current focus is the creation and mass-production of a COVID-19 vaccine.

    In the global race to cure this deadly virus, SB Capital has modified its investment strategy to include these top three pharmaceutical candidates and top 4 investment firms who each have shares in many pharmaceutical companies.

    According to Levi Russel, Co-Founder and President of SB Capital Management Inc.  “There are more than a dozen leading companies striving to accomplish the same goal, But these are among the most attractive based on our internal analytics and gut feeling.”

    Under the visionary leadership of Mr. Levi Russell and CEO, Mr. Nguyen Van Anh, the company recently acquired and opened the SBVINA Company, a large-scale manufacturing operation for the Asian market, specializing in high demand products. SBVINA’s offerings will include both standard and N95 face masks, plastic gloves, and alcohol-based hand sanitizer for hospitals.

    Speaking about the new company, Mr. Nguyen said: “Many of these specific items are unavailable anywhere else right now. We are in a position where our business and humanitarian instincts can intersect. This is positive for all concerned.”

    On the charity front, SB Capital Management Inc. has also been actively seeking to alleviate the COVID-induced hardship of many people worldwide. With the primary purpose of giving back to the people, the company recently held a charity event in Vietnam, which yielded significant results with contributions of food, basic supplies and over 10,000 protective face masks.

    Despite present circumstances, SB Capital Management Inc. continues to have a positive outlook for the post-COVID world, and will keep up with its customer-specific financial strategy to ensure long term opportunity for its investors.

    Media Contact
    Company Name: SB Capital Management Inc.
    Contact Person: Levi Russell
    Email: Send Email
    Phone: (332)255-5599
    Country: United States
    Website: www.sbcapitalmanagementinc.com

     

    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: SB Capital Management Inc. continues its expansion with the inclusion of 4 investment firms to its portfolio

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  4. PLYMOUTH MEETING, Pa., Aug. 10, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today reported financial results for the quarter ended June 30, 2020. INOVIO's management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update, including near-term expectations for its COVID-19 DNA vaccine development program and a mid-year clinical program update for its DNA medicines portfolio.

    Dr. J. Joseph Kim, INOVIO's President and Chief Executive Officer, said, "The second quarter further demonstrated the versatility…

    PLYMOUTH MEETING, Pa., Aug. 10, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today reported financial results for the quarter ended June 30, 2020. INOVIO's management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update, including near-term expectations for its COVID-19 DNA vaccine development program and a mid-year clinical program update for its DNA medicines portfolio.

    Dr. J. Joseph Kim, INOVIO's President and Chief Executive Officer, said, "The second quarter further demonstrated the versatility and potential of INOVIO's DNA medicines platform to meet urgent global health needs. In addition to advancing our DNA vaccine INO-4800 to combat the ongoing COVID-19 pandemic, INOVIO presented encouraging results for one of the most devastating and difficult-to-treat cancers, GBM. We believe our DNA medicines are ideally suited to safely drive robust immune responses across infectious diseases and cancer, and we look forward to publishing our latest INO-4800 data, starting our Phase 2/3 COVID-19 clinical study in the U.S. in September, and expanding the manufacturing capacity to produce at least 100 million doses of INO-4800 in 2021 via our growing global coalition of partners and funders."

    INOVIO Second Quarter Program Updates

    DNA Vaccines for COVID-19 and MERS

    INO-4800: COVID-19

    INOVIO reported positive interim clinical data from the first two cohorts in its Phase 1 clinical trial in the U.S. Specifically:

    • The trial enrolled 40 healthy adult volunteers 18 to 50 years of age at two U.S. sites.
    • The participants were enrolled into 1.0 mg and 2.0 mg dose cohorts; each participant received two doses of INO-4800 four weeks apart, administered by intradermal injection using INOVIO's CELLECTRA® 2000 device.
    • INOVIO has submitted the full clinical data to a peer-reviewed medical journal.
    • INO-4800 was generally safe and well-tolerated in all participants in both cohorts through week 8: there were no reported serious adverse events (SAEs) and 6 reported mild (all Grade 1 in severity), transient adverse events related to vaccine dose.
    • 100% (38 out of 38) of trial participants demonstrated overall immunological responses based on binding and neutralizing antibody responses and T cell immune responses.
    • 95% of vaccinated participants had overall seroconversion (defined as those participants who respond with neutralization and/or binding antibodies) after 2 vaccine doses.
    • Nearly 90% of vaccinated participants generated strong T cell responses, including CD8+ killer T cell responses. T cell responses were higher in magnitude than convalescent samples tested and were similar or greater responses to those previously reported for other vaccine candidates.
    • The Phase 1 trial was also recently expanded with 80 additional participants age 18 and up, with no upper age limit, and with the inclusion of a low-dose arm. The study extension was fully enrolled by mid-July.

    INOVIO has received significant funding from government and private sources in 1H 2020 to support vaccine development and manufacturing scale-up. Funders include:

    • The Department of Defense (DoD), which awarded INOVIO $71 million to support the large-scale manufacture of the company's proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA 2000 devices that are used to deliver INO-4800 intradermally. The DoD also awarded Ology Bioservices $11.9 million to work with INOVIO to manufacture INO-4800 DNA plasmids.
    • The Coalition for Epidemic Preparedness Innovations (CEPI), which awarded INOVIO a total of $17.2 million in funding to date to support the Phase 1 clinical trial of INO-4800 in the U.S. and a Phase 1/2 clinical trial in South Korea as well as a $5 million grant to support CELLECTRA 3PSP smart device development.
    • The Bill & Melinda Gates Foundation, which provided INOVIO a $5 million grant to accelerate testing and production scale-up of CELLECTRA 3PSP.

    INOVIO and the International Vaccine Institute in partnership with Seoul National University Hospital has initiated a Phase 1/2 clinical trial of INO-4800 in South Korea. This is the first COVID-19 vaccine clinical study approved in South Korea and is funded by CEPI through INOVIO and supported by the Korea Center for Disease Control and Prevention (KCDC)/Korea National Institute of Health (KNIH). The two-stage trial will assess the safety, tolerability, and immunogenicity of INO-4800 in 40 healthy adults aged 19-50 years in the Phase 1 portion, and will further expand to enroll an additional 120 people aged 19-64 years in the Phase 2 portion.

    In addition, INOVIO is collaborating with Advaccine to advance the development of INO-4800 in China. INOVIO will leverage Advaccine's expertise and has initiated a Phase 1 trial in China in parallel with INOVIO's clinical development efforts in the U.S. and South Korea. In July, regulatory authorities in China approved the clinical testing of INO-4800 by Advaccine in China.

    Preclinical study data of INO-4800 was published May 20 in the peer-reviewed journal Nature Communications in a manuscript titled, "Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibody as well as T cell responses in mice and guinea pigs.

    Animal challenge data submitted to a peer-reviewed journal support and expand upon these preclinical findings. Specifically, INO-4800 reduced viral load in both the nasal passages and lower lungs in five macaques that received two doses of INO-4800 four weeks apart and then were challenged with live virus at week 17. Compared to five macaques that received placebo, the INO-4800-treated subjects had protective neutralizing antibodies and T cells in blood samples more than four months after inoculation. The antibody levels in primates were similar to and in some instances greater than those seen in human patients who have recovered from COVID-19. All other previously reported NHP vaccine protection studies actually challenged the animals at the time near their peak immune responses (1-4 weeks from their last vaccination). INOVIO's study demonstrates that INO-4800 could provide protection in a more real-world setting, where vaccine-generated memory immune responses protected NHPs for more than 3 months (13 weeks) from the last vaccination. This is the first time vaccine protection in non-human primates was reported from memory immune responses. INO-4800 vaccination in the NHPs also generated antibodies that neutralized both the earlier strain of virus as well as the mutant variant (D614G) that has emerged with greater infectivity, and now accounts for >80% of newly circulating virus.

    No adverse events or antibody dependent enhancement (ADEs) were reported. Safety is paramount when assessing the viability of a vaccine for mass immunizations. These findings bolster the safety profile INOVIO has seen in over 7,000 administrations of its DNA medicines with its CELLECTRA delivery devices. These results support the robust immune ability of INO-4800 to induce both antibody and T cell responses, which are believed to be important for providing durable protection against COVID-19 disease.

    INO-4700: MERS

    Positive interim data were presented at the American Society of Gene & Cell Therapy (ASGCT) Conference (May 12-15, 2020) from a Phase 1/2a trial of DNA vaccine INO-4700 (GLS-5300) for the coronavirus MERS-CoV that causes MERS (Middle East Respiratory Syndrome). Vaccine recipients demonstrated strong antibody and T cell immune responses, showing 100% binding and 92% neutralizing antibody responses, after two or three doses with 0.6 mg of INO-4700, which was delivered intradermally via the CELLECTRA smart device. The vaccination regimen was well-tolerated with no vaccine-associated SAEs reported. With previously announced CEPI funding of $56 million, INOVIO is preparing for a Phase 2 clinical trial to begin in the Middle East later this year.

    DNA Immunotherapies: Immuno-oncology and HPV-related Diseases

    Immuno-oncology

    INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)

    In a Phase 1/2 clinical trial, 85% (44 out of 52) of patients newly diagnosed with the deadly brain cancer glioblastoma multiforme (GBM) who received INO-5401 in combination with INO-9012 (IL-12) and PD-1 inhibitor Libtayo® (cemiplimab) were alive for at least 12 months (overall survival at 12 months) following treatment. These data were featured at an oral poster presentation at the ASCO 2020 Virtual Scientific Program.

    GBM is the most common and aggressive type of brain cancer. Currently, the median overall survival with standard of care therapy, which includes radiation and chemotherapy (temozolomide: TMZ), is approximately 15 to 22 months.

    The trial demonstrated that 84.4% percent (27 of 32) of patients with MGMT promoter unmethylated tumors, and 85% (17 of 20) of patients with MGMT promoter methylated tumors were alive at 12 months. This promising clinical result is coupled with a robust immunological response to all three tumor associated antigens in INO-5401, including human telomerase (hTERT), Wilms Tumor-1 (WT-1) and prostate specific membrane antigen (PSMA). Activated, cytotoxic T cells directed towards these cancer antigens commonly expressed on GBM tumors were detected in all patients tested to date, supporting the immunogenic potential of INOVIO's DNA medicines. Importantly, INO-5401 + INO-9012 was safe and well-tolerated when given not only with radiation and TMZ, but also with PD-1 inhibitor Libtayo®, which is being jointly developed by Regeneron and Sanofi.

    INOVIO plans to report 18-month overall survival data in Q4 this year.

    HPV-related Diseases

    VGX-3100: Cervical, vulvar, and anal Precancerous Dysplasia or HSIL

    The REVEAL 2 Phase 3 clinical trial evaluating DNA medicine VGX-3100 for treatment of HPV-related precancerous cervical dysplasia or high-grade squamous intraepithelial lesions (HSIL) has maintained a total of 43 recruiting sites worldwide. Top-line efficacy data guidance from the REVEAL 1 Phase 3 clinical trial remains unchanged and is expected to readout in 4Q 2020.

    INOVIO presented positive interim safety and efficacy data from two separate open-label Phase 2 studies of its lead DNA medicine candidate VGX-3100 in both HPV-related anal and vulvar HSIL patients at the annual American Society for Colposcopy and Cervical Pathology meeting. Full data from the Phase 2 clinical trials for anal and vulvar dysplasia are expected to readout in 4Q 2020.

    INO-3107: Recurrent Respiratory Papillomatosis (RRP)

    In July, INO-3107 received Orphan Disease designation by the FDA. Enrollment recently began in the Phase 1/2 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of DNA medicine INO-3107 in 63 participants with HPV-6 and/or HPV-11 associated recurrent respiratory papillomatosis (RRP), a rare, debilitating and potentially life-threatening disease currently treated by invasive and recurrent surgeries. The trial population is divided into two cohorts: Cohort A: Participants with diagnoses of juvenile-onset RRP as defined by age at first diagnosis of RRP < 12 years. Cohort B: Participants with adult-onset RRP as defined by age at first diagnosis of RRP ≥ 12 years. A safety run-in will be performed with up to six participants across cohorts A and B with a one-week waiting period between each enrolled participant. For more information on the clinical trial please visit clinicaltrials.gov (Identifier: NCT04398433). 

    Second Quarter 2020 Financial Results

    Total revenue was $267,000 for the three months ended June 30, 2020, compared to $136,000 for the same period in 2019. Total operating expenses were $33.4 million compared to $28.3 million for the same period in 2019.

    INOVIO's net loss for the quarter ended June 30, 2020 was $128.7 million, or $0.83 per basic and diluted share, compared to $29.4 million, or $0.30 per basic and diluted share, for the quarter ended June 30, 2019. The increase in net loss for the quarter was primarily due to the change in fair value of the derivative liability related to the embedded conversion feature in our August 2019 Convertible Bonds, which is revalued at each reporting period. Without this non-cash derivative liability expense, the Company's net loss for the quarter would be consistent with the 2nd quarter 2019 and our net loss per share would be $0.20 per share rather than $0.83 per share, which is $0.10 per share less than the loss per share for the same period in 2019. Subsequent to June 30, 2020, these bonds were converted voluntarily by the bond holders, into common stock.

    Operating Expenses

    Research and development (R&D) expenses for the three months ended June 30, 2020 were $22.4 million compared to $22.5 million for the same period in 2019. The decrease in R&D expenses was primarily related to an increase in contra-research and development expense recorded from grant agreements, offset by an increase in drug manufacturing expenses related to our COVID-19 and VGX-3100 clinical trials and an increase in device inventory and engineering equipment.

    General and administrative (G&A) expenses were $11.1 million for the three months ended June 30, 2020 versus $5.9 million for the same period in 2019. The increase in G&A expenses was primarily related to an increase in legal expenses, work performed related to corporate marketing and communications and higher employee-stock-based compensation expense.

    Capital Resources

    As of June 30, 2020, cash and cash equivalents and short-term investments were $371.7 million compared to $89.5 million as of December 31, 2019. As of June 30, 2020, the Company had 158,756,411 common shares outstanding and 191,378,948 common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

    The end of quarter cash position included net proceeds of $121.7 million the Company received by selling 12,041,178 shares of common stock during the three months ended June 30, 2020 under an at-the-market (ATM) sales agreement.

    INOVIO's balance sheet and statement of operations are provided below. Additional information is included in INOVIO's quarterly report on Form 10-Q for the quarter ended June 30, 2020, which can be accessed at: http://ir.inovio.com/investors/financial-reports/default.aspx.

    Conference Call / Webcast Information

    INOVIO's management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss INOVIO's financial results and provide a general business update.

    The live webcast and a replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/investors/events/default.aspx. Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10146894.

    About INOVIO's Global Coalition Advancing INO-4800

    INOVIO has assembled a global coalition of collaborators, partners and funders to rapidly advance the development of INO-4800. R&D collaborators to date include the Wistar Institute, the University of Pennsylvania, the University of Texas, Fudan University and the Laval University. INOVIO has partnered with Advaccine and the International Vaccine Institute to conduct clinical trials of INO-4800 in China and South Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800 in several animal challenge models with Public Health England (PHE) and Commonwealth Scientific and Industrial Research Organization (CSIRO) in Australia. INOVIO is also working with a team of contract manufacturers including VGXI, Inc., Richter-Helm BioLogics, and Ology Biosciences to produce INO-4800 and seeking additional external funding and partnerships to scale up the manufacturing capacities to satisfy the urgent global demand for a safe and effective vaccine. To date, the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed significant funding to the advancement and manufacturing of INO-4800.

    About INO-4800

    INO-4800 is INOVIO's DNA vaccine candidate intended to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INOVIO has extensive experience working with coronaviruses and is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

    INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen in transport of storage, which are important factors when implementing mass immunizations.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been observed in clinical trials.

    With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials and the availability and timing of data from those studies and trials, and our ability to successfully manufacture and produce large quantities of our product candidates if they receive regulatory approval. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, our ability to secure sufficient manufacturing capacity to mass produce our product candidates, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

    INOVIO Pharmaceuticals, Inc.

    CONDENSED CONSOLIDATED BALANCE SHEETS





    June 30,

     2020



    December 31,

     2019



    (Unaudited)





    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    215,432,713





    $

    22,196,097



    Short-term investments

    156,231,102





    67,338,017



    Accounts receivable

    3,513,159





    700,073



    Accounts receivable from affiliated entities

    482,373





    1,332,044



    Prepaid expenses and other current assets

    4,591,966





    1,584,598



    Prepaid expenses and other current assets from affiliated entities

    1,811,140





    1,050,140



    Total current assets

    382,062,453





    94,200,969



    Fixed assets, net

    11,323,531





    12,773,017



    Investment in affiliated entities

    17,327,569





    6,315,356



    Investment in Geneos

    2,717,241







    Intangible assets, net

    3,420,311





    3,693,851



    Goodwill

    10,513,371





    10,513,371



    Operating lease right-of-use assets

    13,265,144





    13,783,009



    Other assets

    2,555,782





    2,672,024



    Total assets

    $

    443,185,402





    $

    143,951,597



    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable and accrued expenses

    $

    17,216,875





    $

    18,237,258



    Accounts payable and accrued expenses due to affiliated entities

    511,953





    729,729



    Accrued clinical trial expenses

    6,870,450





    4,049,727



    Deferred revenue

    14,853





    92,353



    Deferred revenue from affiliated entities

    94,275





    31,775



    Operating lease liability

    2,200,459





    2,074,842



    Grant funding liability

    10,330,235





    6,065,212



    Grant funding liability from affiliated entities

    742,875





    708,425



    Total current liabilities

    37,981,975





    31,989,321



    Deferred revenue, net of current portion

    86,641





    101,567



    Convertible senior notes

    65,844,260





    64,180,325



    Convertible bonds

    13,718,528





    12,842,592



    Derivative liability

    119,796,000





    8,819,023



    Operating lease liability, net of current portion

    19,261,354





    20,409,922



    Deferred tax liabilities

    32,046





    32,046



    Grant funding liability from affiliated entity, net of current portion

    37,500





    135,000



    Other liabilities

    66,629





    36,943



    Total liabilities

    256,824,933





    138,546,739



    Stockholders' equity:







    Preferred stock







    Common stock

    158,756





    101,361



    Additional paid-in capital

    1,087,745,242





    742,646,785



    Accumulated deficit

    (901,029,768)





    (739,785,655)



    Accumulated other comprehensive income (loss)

    (610,030)





    472,608



    Total Inovio Pharmaceuticals, Inc. stockholders' equity

    186,264,200





    3,435,099



    Non-controlling interest

    96,269





    1,969,759



    Total stockholders' equity

    186,360,469





    5,404,858



    Total liabilities and stockholders' equity

    $

    443,185,402





    $

    143,951,597



     

    INOVIO Pharmaceuticals, Inc.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited)





    Three Months Ended June 30,



    Six Months Ended June 30,



    2020



    2019



    2020



    2019

    Revenues:















    Revenue under collaborative research and development arrangements

    $

    74,102





    $

    64,283





    $

    145,602





    $

    2,834,995



    Revenue under collaborative research and development arrangements with affiliated entities

    95,146





    71,390





    1,267,272





    126,970



    Miscellaneous revenue

    97,939









    181,587





    3,614



    Total revenues

    267,187





    135,673





    1,594,461





    2,965,579



    Operating expenses:















    Research and development

    22,376,575





    22,486,266





    41,487,763





    46,876,155



    General and administrative

    11,071,510





    5,850,101





    18,519,864





    12,825,129



    Total operating expenses

    33,448,085





    28,336,367





    60,007,627





    59,701,284



    Loss from operations

    (33,180,898)





    (28,200,694)





    (58,413,166)





    (56,735,705)



    Other income (expense):















    Interest income

    1,067,399





    755,330





    1,483,968





    1,380,864



    Interest expense

    (2,846,641)





    (2,194,783)





    (5,650,396)





    (2,851,031)



    Change in fair value of derivative liability

    (97,755,000)









    (110,976,977)







    Gain (loss) on investment in affiliated entities

    (3,883,176)





    (173,212)





    9,298,443





    (923,315)



    Net unrealized gain (loss) on available-for-sale equity securities

    4,358,634









    (691,458)







    Other income (expense), net

    (152,102)





    127,512





    (577,602)





    91,673



    Gain on deconsolidation of Geneos

    4,121,075









    4,121,075







    Net loss before income tax benefit and share in net loss of Geneos

    (128,270,709)





    (29,685,847)





    (161,406,113)





    (59,037,514)



    Income tax benefit





    106,771









    169,571



    Share in net loss of Geneos

    (901,757)









    (901,757)







    Net loss

    (129,172,466)





    (29,579,076)





    (162,307,870)





    (58,867,943)



    Net loss attributable to non-controlling interest

    469,407





    191,850





    1,063,757





    261,455



    Net loss attributable to Inovio Pharmaceuticals, Inc.

    $

    (128,703,059)





    $

    (29,387,226)





    $

    (161,244,113)





    $

    (58,606,488)



    Net loss per share attributable to Inovio Pharmaceuticals, Inc. stockholders















              Basic and diluted

    $

    (0.83)





    $

    (0.30)





    $

    (1.15)





    $

    (0.60)



    Weighted average number of common shares outstanding















              Basic and diluted

    155,807,054





    98,083,896





    140,215,158





    97,795,910



     

    Cision View original content:http://www.prnewswire.com/news-releases/inovio-reports-second-quarter-2020-financial-results-provides-dna-medicines-clinical-program-mid-year-update-301109361.html

    SOURCE INOVIO Pharmaceuticals, Inc.

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  5. PLYMOUTH MEETING, Pa., July 30, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination.

    These results, submitted to a peer-reviewed journal and also published today on the non-peer reviewed online preprint site bioRxiv, demonstrate that INO-4800 reduced viral load in both the…

    PLYMOUTH MEETING, Pa., July 30, 2020 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, today announced that its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting non-human primates (NHPs; specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. These protective results were mediated by memory T and B cell immune responses from INO-4800 vaccination.

    These results, submitted to a peer-reviewed journal and also published today on the non-peer reviewed online preprint site bioRxiv, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in macaques that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17). The reduced viral loads following exposure to SARS-CoV-2 infection at this timeframe demonstrate an important durable impact mediated by INO-4800.  This is the first time a vaccine protection in non-human primates was reported from memory immune responses as previously reported monkey vaccine challenge studies were conducted at the time near their peak immune responses (1-4 weeks from their last vaccination).

    INO-4800-treated animals demonstrated seroconversion after a single vaccination, with protective neutralizing antibodies and T cells lasting in their blood more than four months after the initial dose. The antibody levels were similar to or greater than those seen in patients who have recovered from COVID-19, the infection caused by SARS-CoV-2, and the T cell responses were significantly higher than those from convalescent patients.

    Dr. J. Joseph Kim, President and Chief Executive Officer of INOVIO, said, "All other previously reported NHP vaccine protection studies actually challenged the animals at the peak of their immune response.  Our study demonstrates that INO-4800 could provide protection in a more real-world setting, where vaccine-generated memory immune responses protected NHPs for more than 3 months (13 weeks) from the last vaccination. Given the importance of protective antibody and T cell responses, this study gives us more confidence as we continue to advance INO-4800 in the clinic. We believe INO-4800 holds significant potential to help address this global public health crisis."

    B cells are responsible for producing the antibodies that recognize SARS-CoV-2, while T cells play a role in killing the virally infected cells as well as supporting the B cell response. The published data support that immunization with INO-4800 limits active viral replication and has the potential to reduce severity of disease, as well as reduced viral shedding in the nasal cavity. In the study, researchers assessed the ability of INO-4800 to induce acute and memory T cell and B cell immune responses, including neutralizing antibody responses against both early virus as well as now-dominant G614 mutant variants. To INOVIO's knowledge, this is the first report of vaccine-induced responses driving immunity against G614 variants. A strong anamnestic or memory T and B cell responses were demonstrated following challenge with the live virus.

    "As we eagerly anticipate initiating a Phase 2/3 efficacy trials this summer, an animal challenge is currently the closest thing we have to testing a vaccine's efficacy when confronting a live virus. We are very encouraged with the duration of protection that INO-4800 demonstrated in this NHP study and look forward to reassessing its impact on durability of response at 12 months out from our other ongoing non-human primate and animal challenge studies," said Dr. Kate Broderick, Ph.D., INOVIO's Senior Vice President, Research & Development.

    "In addition to safety and efficacy, it is essential that any vaccine targeting SARS-CoV-2 generates a relevant durability of response," Dr. Broderick added. "A vaccine that only provides protection for a very short period of time is not going to realistically solve the problem of this pandemic."

    A separate NHP study evaluating the durability of INO-4800 at 12 months after vaccination is currently under way. INO-4800 also has been selected by U.S. Operation Warp Speed for its COVID-19 non-human primate challenge study.

    In May, the peer-reviewed journal Nature Communications published an INOVIO study ("Immunogenicity of a DNA vaccine candidate for COVID-19") showing that vaccination with INO-4800 generated robust binding and neutralizing antibody and T cell responses in mice and guinea pigs. The study was funded by a grant from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About INO-4800

    INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 is currently in Phase 1 trials in the U.S. and a Phase 2/3 trial is planned for the summer. Interim Phase 1 results showed a favorable safety profile and strong immunogenicity, including antibody and T cell responses. The Phase 1 study recently expanded to include adults over the age of 65 with no age limit given the propensity for COVID-19 to severely impact the health of older people. INO-4800 also is in Phase 1/2 trials for COVID-19 in South Korea and China.

    In animal studies, INO-4800 has demonstrated robust and durable T cell and B cell acute and memory responses in a non-human primate challenge study showing protective immune responses in both nasal passages and lungs. INO-4800 also was selected by U.S. Operation Warp Speed for its COVID-19 non-human primate challenge study.

    INO-4800 was designed using INOVIO's proprietary DNA medicine platform rapidly after the publication of the genetic sequence of SARS-CoV-2. INOVIO has extensive experience working with coronaviruses and is the only company with a Phase 2 vaccine for a related coronavirus that causes Middle East Respiratory Syndrome (MERS).

    INO-4800 is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not need to be frozen in transport of storage, which are important factors when implementing mass immunizations.

    About INOVIO's DNA Medicines Platform

    INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S. Department of Defense. DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA that are synthesized or reorganized by a computer sequencing technology and designed to produce a specific immune response in the body.

    INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. The CELLECTRA device uses a brief electrical pulse to reversibly open small pores in the cell to allow the plasmids to enter, overcoming a key limitation of other DNA and other nucleic acid approaches, such as mRNA. Once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses. Administration with the CELLECTRA device ensures that the DNA medicine is efficiently delivered directly into the body's cells, where it can go to work to drive an immune response. INOVIO's DNA medicines do not interfere with or change in any way an individual's own DNA. The advantages of INOVIO's DNA medicine platform are how fast DNA medicines can be designed and manufactured; the stability of the products, which do not require freezing in storage and transport; and the robust immune response, safety profile, and tolerability that have been demonstrated in clinical trials.

    With more than 2,000 patients receiving INOVIO investigational DNA medicines in more than 7,000 applications across a range of clinical trials, INOVIO has a strong track record of rapidly generating DNA medicine candidates with potential to meet urgent global health needs.

    About INOVIO

    INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response. Specifically, INOVIO's lead candidate VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18 in a Phase 2b clinical trial. High-risk HPV is responsible for 70% of cervical cancer, 91% of anal cancer, and 69% of vulvar cancer. Also in development are programs targeting HPV-related cancers and a rare HPV-related disease, recurrent respiratory papillomatosis (RRP); non-HPV-related cancers glioblastoma multiforme (GBM) and prostate cancer; as well as externally funded infectious disease DNA vaccine development programs in Zika, Lassa fever, Ebola, HIV, and coronaviruses associated with MERS and COVID-19 diseases. Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI), Defense Advanced Research Projects Agency (DARPA)/Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)/Department of Defense (DOD), GeneOne Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute (IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Ology Bioservices, the Parker Institute for Cancer Immunotherapy, Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, Roche/Genentech, University of Pennsylvania, Walter Reed Army Institute of Research, and The Wistar Institute. INOVIO also is a proud recipient of 2020 Women on Boards "W" designation recognizing companies with more than 20% women on their board of directors. For more information, visit www.inovio.com.

    CONTACTS:

    Media: Jeff Richardson, 267-440-4211,

    Investors: Ben Matone, 484-362-0076,

    This press release contains certain forward-looking statements relating to our business, including our plans to develop DNA medicines, our expectations regarding our research and development programs, including the planned initiation and conduct of preclinical studies and clinical trials, and the availability and timing of data from those studies and trials. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured or commercialized, that final results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

     

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    SOURCE INOVIO Pharmaceuticals, Inc.

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