INO - Bull Thesis
(Published 2/9/22; Please note that because of our bearish view on INO currently, we likely will not update this bull/bear thesis in the near future.0
*Slightly updated on 3/18/22 based on Q4 '21 financial report)
BULL THESIS SUMMARY
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
FS/MV 3/18/22
(See full bull/bear analysis below)
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
(Historical analysis from 2/9/22)
BULL THESIS
INO Corporate and summary
Almost $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
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
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
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
Currently the trial advancing in seven countries and data expected in first half of 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 H2 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 first half of 2022
Immune responses and early clinical benefit data
FS/MV 2/9/22
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