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INO Inovio Pharmaceuticals

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. INOVIO's lead immunotherapy candidate, VGX-3100, currently in Phase 3 trials for precancerous cervical dysplasia, cleared high-risk HPV-16 and/or HPV-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 infectious disease DNA vaccine development programs in coronaviruses associated with COVID-19 diseases and MERS, Lassa fever, Ebola, and HIV. 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), Kaneka Eurogentec, 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, Thermo Fisher Scientific, 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.

Company profile

Ticker
INO, 0A43
Exchange
Website
CEO
Jong Kim
Employees
Incorporated
Location
Fiscal year end
Former names
GENETRONICS BIOMEDICAL CORP, GENETRONICS BIOMEDICAL LTD, INOVIO BIOMEDICAL CORP
SEC CIK
Subsidiaries
Inovio Asia, LLC ...
IRS number
330024450

INO stock data

(
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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

9 Aug 21
26 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 58.93M 58.93M 58.93M 58.93M 58.93M 58.93M
Cash burn (monthly) 8.24M 13.04M 27.73M 16.79M 26.15M 21.39M
Cash used (since last report) 31.9M 50.52M 107.42M 65.01M 101.3M 82.86M
Cash remaining 27.02M 8.41M -48.5M -6.09M -42.37M -23.93M
Runway (months of cash) 3.3 0.6 -1.7 -0.4 -1.6 -1.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
9 Aug 21 Laurent Humeau Common Stock Sell Dispose S No Yes 9.15 10,317 94.4K 68,587
9 Jun 21 Peter Kies Common Stock Sell Dispose S No Yes 10.01 33,750 337.84K 130,788
9 Jun 21 Peter Kies Common Stock Option exercise Acquire M No No 2.16 13,750 29.7K 164,538
9 Jun 21 Peter Kies Common Stock Option Common Stock Option exercise Dispose M No No 2.16 13,750 29.7K 20,000
9 Jun 21 Laurent Humeau Common Stock Sell Dispose S No Yes 9.07 10,318 93.58K 78,904
9 Jun 21 Jacqueline Elizabeth Shea Common Stock Sell Dispose S No Yes 10.01 38,535 385.74K 21,592
3 Jun 21 Peter Kies Common Stock Sell Dispose S No Yes 8.03 10,000 80.3K 150,788

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

34.4% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 211 215 -1.9%
Opened positions 42 35 +20.0%
Closed positions 46 51 -9.8%
Increased positions 67 87 -23.0%
Reduced positions 46 52 -11.5%
13F shares
Current Prev Q Change
Total value 768.38M 894.53M -14.1%
Total shares 72.43M 73.48M -1.4%
Total puts 3.43M 4.09M -16.0%
Total calls 2.55M 3.06M -16.8%
Total put/call ratio 1.3 1.3 +0.9%
Largest owners
Shares Value Change
BLK Blackrock 18.17M $168.45M +3.7%
Vanguard 10.95M $101.49M -4.7%
STT State Street 8.91M $82.57M +7.9%
Geode Capital Management 3.62M $33.59M +9.1%
Wasatch Advisors 3.58M $33.16M +12.1%
JPM JPMorgan Chase & Co. 3.44M $31.86M +117.6%
Nuveen Asset Management 2.16M $20.05M +22.5%
D. E. Shaw & Co. 2.09M $19.37M +129.1%
NTRS Northern Trust 2.07M $19.18M -2.3%
Susquehanna International 1.47M $13.63M +58.7%
Largest transactions
Shares Bought/sold Change
Avidity Partners Management 0 -4M EXIT
Coatue Management 0 -3.13M EXIT
JPM JPMorgan Chase & Co. 3.44M +1.86M +117.6%
D. E. Shaw & Co. 2.09M +1.18M +129.1%
GS Goldman Sachs 1.3M +1.05M +410.5%
Marshall Wace 0 -784.81K EXIT
BLK Blackrock 18.17M +656.65K +3.7%
STT State Street 8.91M +651.62K +7.9%
Susquehanna International 1.47M +543.81K +58.7%
Vanguard 10.95M -540.98K -4.7%

Financial report summary

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Risks
  • We have incurred losses since inception, expect to incur significant net losses in the foreseeable future and may never become profitable.
  • We have limited sources of revenue and our success is dependent on our ability to develop our DNA vaccines, DNA immunotherapies, dMAbs and electroporation equipment.
  • We will need substantial additional capital to develop our DNA vaccines, DNA immunotherapies and dMAb programs and electroporation delivery technology.
  • If we are unable to obtain FDA approval of our products, we will not be able to commercialize them in the United States.
  • Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
  • Delays in the commencement or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.
  • None of our human vaccine candidates, including INO-4800, or our immunotherapy and DNA encoded monoclonal antibody product candidates have been approved for sale, and we may never develop commercially successful vaccine, immunotherapy or DNA encoded monoclonal antibody products.
  • Our planned Phase 3 clinical trial of INO-4800 in the United States as a potential COVID-19 vaccine has been placed on partial clinical hold by the U.S. FDA, which may cause delays in our ability to conduct clinical trials in the United States.
  • Newly emerging SARS-CoV-2 variants could reduce the immunogenicity and effectiveness of INO-4800 as a potential COVID-19 vaccine.
  • There can be no assurance that the product we are developing for COVID-19 would be granted an Emergency Use Authorization by the FDA or similar authorization by regulatory authorities outside of the United States if we were to decide to apply for such an authorization. The option of seeking an Emergency Use Authorization may no longer exist if the public health emergency has expired or if a sufficient supply of COVID-19 vaccines have obtained full Biologics License Approval, or foreign equivalent, by the time we are ready to submit an application. If we do not timely apply for such an emergency use authorization or, if we do apply and no authorization is granted or, once granted, it is terminated, we will be unable to sell our product in the near future and instead, will be required to pursue the biologic licensure process in order to sell our product, which is lengthy and expensive.
  • If we and the contract manufacturers upon whom we rely fail to produce our electroporation devices and product candidates in the volumes that we require on a timely basis, or at all, or fail to comply with their obligations to us or with stringent regulations, we may face delays in the development and commercialization of our electroporation equipment and product candidates.
  • Even if our products receive regulatory approval, they may still face future development and regulatory difficulties.
  • Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States.
  • We have obtained Orphan Drug Designation for one of our product candidates. As part of our business strategy, we may continue to seek Orphan Drug Designation for additional product candidates, and we may be unsuccessful in obtaining new designations or may be unable to obtain or maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.
  • If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.
  • A small number of licensing partners and government contracts account for a substantial portion of our revenue.
  • We have agreements with government agencies, which are subject to termination and uncertain future funding.
  • We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our product candidates.
  • We currently have no marketing and sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenues.
  • If products for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
  • We are subject to uncertainty relating to coverage and reimbursement policies which, if not favorable to our product candidates, could hinder or prevent our products' commercial success.
  • We are currently subject to litigation and may become subject to additional litigation, which could harm our business, financial condition and reputation.
  • Our business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic.
  • We face intense and increasing competition and many of our competitors have significantly greater resources and experience.
  • Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow.
  • We depend upon key personnel who may terminate their employment with us at any time and we may need to hire additional qualified personnel in order to obtain financing, pursue collaborations or develop or market our product candidates.
  • Changes in funding for the FDA and other government agencies could hinder our ability to hire and retain key leadership and other personnel, or otherwise prevent new products from being developed or commercialized in a timely manner, which could negatively impact our business.
  • We are dependent on information technology and our systems and infrastructure face certain risks, including from cybersecurity breaches and data leakage.
  • We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability.
  • Healthcare reform measures could hinder or prevent our products' commercial success.
  • If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • We have entered into collaborations with Chinese companies and conduct certain research and development activities in China. Uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, a trade war or political unrest in China could materially adversely affect our business, financial condition and results of operations.
  • It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
  • If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • An active trading market for our common stock may not be sustained.
  • The price of our common stock has been and may continue to be volatile, and an investment in our common stock could decline substantially in value.
  • Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock.
  • We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.
  • Our quarterly operating results may fluctuate significantly.
  • Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
  • We incur significant costs and demands upon management as a result of being a public company.
Management Discussion
  • Revenue. Total revenue was $273,000 and $644,000, respectively, for the three and six months ended June 30, 2021, as compared to $267,000 and $1.6 million, respectively, for the three and six months ended June 30, 2020. Revenue primarily consisted of revenues under collaborative research and development arrangements, including arrangements with affiliated entities, for the three and six months ended June 30, 2021 and 2020. The decrease in revenue for the six-month period year over year was primarily due to less milestone revenue earned from our affiliated entity PLS.
  • Research and development expenses. Research and development expenses for the three and six months ended June 30, 2021 were $70.8 million and $109.9 million, respectively, as compared to $22.4 million and $41.5 million, respectively, for the three and six months ended June 30, 2020. In each case, the significant increase was primarily attributable to manufacturing scale-up activities for INO-4800 in 2021. These INO-4800 activities included:
  • •expenses related to the acquisition and installation of manufacturing equipment, which increased by $21.9 million for each of the three-month and six-month periods; and
Content analysis
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Readability
H.S. sophomore Avg
New words: argued, expressed, faith, installation, jointly, Maryland, MFN, minimal, open, reevaluated, Register, reinstitute, sixty, stemming
Removed: Judge, ruled