INO - Bull Thesis

(Updated 3/24/22 based on quarterly report)

BULL THESIS

• INO Corporate and summary

  • ~ $400M in cash (~2 years)

  • Extensive clinical pipeline of at least 11 DNA medicines (i.e. DNA vaccines)

  • Proprietary technology to optimize plasmid design and delivery technology

    • No anti-vector response

  • Off the shelf products that require no cold chain

    • Includes Covid vaccine candidate

  • Three Phase 3 trials, and seven Phase 2 trials, half that are externally funded

  • A number of govt. And private partnerships, including Advaccine global partnership for Covid-19

• INO-4800 - Covid

  • Uses electroporation for delivery of DNA plasmids

  • Phase 1 trial showed durable antibody response 6 months following second dose, well tolerated, no treatment-related serious adverse events

  • May offer advantages as a booster compared to other approaches

    • Showed broad-based immune responses

  • Two Phase 3 global trials and two ongoing boost studies

    • Testing to see its use as a homologous booster after two initial doses one month apart or heterologous booster (like in China trial) used after two doses of an inactivated COVID vaccine

    • Expect boost trial data in Q2 2022

  • One of two vaccine candidates included in the Solidarity Trial Vaccines

    • An international Phase 3 efficacy trial conducted by the WHO

    • Trial could uncover second gen vaccines with greater efficacy and greater protection against variants

  • Provided cross reactive immune response against multiple variants

    • INO-4800 maintained robust T cell level against the delta variant compared to responses from original strain

    • Observed full maintenance of T cell responses against the Omicron variant in clinical samples from INO-4800 vaccinated individuals

  • INNOVATE Phase ⅔ trial

    • Phase 2 portion all age groups showed immune responses and 2.0mg dose induced higher magnitude immune response than 1.0mg dose

    • Expecting to amend the primary endpoint?

  • Advanced into Phase 3 trials in Latin American and Asia, where vaccines aren’t as readily available

  • Regulatory authorization in India big milestone b/c of impact of pandemic on Indian population

    • INNOVATE Phase 3 portion recently had partial clinical hold lifted so US patients can now enroll in study

    • Enrollment paused due to Omicron variant and data no longer expected in H1 2022

    • EUA application planned afterwards

    • Non-binding memorandum of understanding w/ Colombia’s Ministry of Health

    • Partnered with Advaccine for a booster study in China

• INO-4802 - second generation COVID vaccine

  • Cross reactive immune responses against current and emerging viral variants

  • Showed consistency with platform wide safety and tolerability profile

• VGX-3100 - Precancerous cervical, vulvar, and anal dysplasia (HPV-associated)

  • Phase 3 study in precancerous cervical dysplasia demonstrated clinical efficacy

  • REVEAL 1 Phase 3 study

    • Met primary and secondary efficacy objectives for all evaluable subjects in modified ITT population

    • First DNA medicine to do so in a Phase 3 trial

    • Statistical significance of primary objective: regression of cervical HSIL combined w/ virologic clearance of HPV-16/18, 6 months after administration

    • QIAGEN companion Dx partnership

  • REVEAL 2 Phase 3 study

    • Fully enrolled in 2021 and data will be presented in Q4 2022

  • VGX-3100 could be first treatment for HPV infection of the cervix and first non-invasive treatment for cervical pre-cancer

• INO-4500

  • Lassa fever; full enrollment in Phase 1b trial at end of Q3 2021

  • First ever vaccine clinical trial for Lassa fever to be conducted on the African continent

    • Lassa fever is an endemic in Africa and no approved vaccine and currently impacts ~300,000 people annually

    • Funding for trial from CEPI

• INO-5401 (hTERT, WT-1, and PSMA vaccine) + INO-9012 (IL-12) - Glioblastoma multiforme (GBM)

  • Collab with Regeneron (to use PD-1 checkpoint inhibitor cemiplimab)

  • INO-5401 + INO-9012 + cemiplimab Phase ½ trial

  • Prior OS data presented, which the company reports is better than historical data

• INO-3107 - RRP

  • Rare, orphan disease that can lead to life threatening airway obstructions

  • Phase ½ data expected in second half of 2022

    • Immune responses and early clinical benefit data

• INO-4700 - MERS

  • Expect data around Q3 2022; about halfway through enrollment as of March 2022

FS/MV 3/18/22

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