On May 10, 2022 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and treat people with cancer and HPV-associated diseases, reported financial results for the quarter ended March 31, 2022 and announced recent program and corporate developments (Press release, Inovio, MAY 10, 2022, View Source [SID1234614074]). 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. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source
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In a separate press release, the Company announced the appointment of Jacqueline Shea, Ph.D., as President and Chief Executive Officer (CEO). Dr. Shea, INOVIO’s former Chief Operating Officer, succeeds Dr. J. Joseph Kim in these roles.
"We believe in the potential of our DNA medicines and vaccines to combat infectious diseases, cancer and HPV-associated diseases," said Dr. Jacqueline Shea, President and CEO of INOVIO. "To achieve these goals, INOVIO must strategically prioritize our resources to capitalize on its demonstrated ability to generate functional T-cell and antibody immune responses, lack of anti-vector response, tolerability for re-administration and favorable temperature stability for transport, storage and distribution."
First Quarter Program Updates
COVID-19: INNOVATE
INOVIO has decided to prioritize its COVID-19 efforts to advance its heterologous booster strategy. In so doing, the company will discontinue its Phase 3 INNOVATE trial. This decision reflects emerging global data that indicate a lower incidence of severe COVID-19 cases1, which would necessitate an increase in trial size and costs for INNOVATE. In contrast, the heterologous booster market offers greater opportunities as the world prepares to enter the endemic phase of COVID-19.
COVID-19: Heterologous Booster – Preliminary Data
With its partner, Advaccine, INOVIO reported positive T cell immune response data with INO-4800 as a heterologous booster to an inactivated COVID-19 vaccine. This data came from a heterologous booster clinical trial conducted by Advaccine that assessed the immune responses following a primary series of two doses of an inactivated COVID-19 vaccine followed by a booster with INO-4800 after 3 or 6 months. Interim immunogenicity data showed that using INO-4800 as a booster after 6 months resulted in a 6.3-fold increase in T cell immune response. In a separate Advaccine study where a third dose of an inactivated COVID-19 vaccine was assessed, the cellular response increased by 1.7-fold. The highest booster effect of INO-4800 was observed with a 2 mg dose of INO-4800 delivered 6 months after a primary series with an inactivated vaccine.
Following INO-4800 vaccination, the preservation of cross-reactive T cell responses remains a consistent observation against multiple SARS-CoV-2 variants of concern, including Omicron, without a significant loss in response magnitude. T cells that can recognize SARS-CoV-2 may play a role in reducing disease severity. Therefore, INO-4800 has the potential to play an important role in reducing incidence of severe COVID-19 cases, which could reduce hospitalizations as the virus continues to mutate and new variants arise.
INOVIO is continuing discussions with regulators in select countries regarding potential regulatory pathways for licensure. The Company believes the increased global awareness about the importance of T cell immune responses and durability of protection for effective booster vaccines correspond well with INO-4800’s key strength – its ability to generate CD8+ T cell responses against SARS-CoV-2.
INOVIO is planning to expand its partnership with Advaccine beyond INO-4800 to include heterologous boosters and vaccine candidates covering future variants. The expanded partnership will allow both companies to share data, leverage Advaccine’s multiple manufacturing sites in China, and access opportunities globally.
VGX-3100: HPV-associated Cervical High-Grade Squamous Intraepithelial Lesions (HSIL)
Based on feedback from the U.S. Food and Drug Administration (FDA), INOVIO has changed its development plans for VGX-3100 for HPV-16/18-associated cervical HSIL to a biomarker-selected population. In a recent preliminary letter, the FDA advised INOVIO that the REVEAL2 Phase 3 study would not be sufficient to support approval of a potential marketing application for VGX-3100 in that population. The FDA recommended that using REVEAL2 as an exploratory study to evaluate a biomarker-selected population and then conducting one or two additional well-controlled trials in the biomarker-positive population would be more likely to provide sufficient evidence to support approval of a marketing application.
To better assess potential efficacy in a biomarker-selected population, the Company plans to amend the fully enrolled REVEAL2 trial to revise the primary analysis population from the all-comers population to the biomarker-positive population. Both the biomarker-positive population and the all-comers population will be analyzed.
INOVIO will continue its REVEAL2 trial to completion and assess the path forward for the VGX-3100 program following analysis of the REVEAL2 results. Given the likelihood for at least one additional trial, INOVIO no longer expects to submit a BLA in 2023 for VGX-3100.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)
INOVIO completed enrollment of 32 participants in the open-label, multicenter Phase 1/2 trial to evaluate the efficacy, safety, tolerability, and immunogenicity of INO-3107 in participants with HPV-6/11-associated RRP who have required at least two interventions in the past year for the removal of associated papilloma(s). For this study, adult participants will first undergo removal of their papilloma(s) and will subsequently receive four doses of INO-3107, one every three weeks. The efficacy endpoint will be a reduction in the frequency of therapeutic interventions following the first dose of INO-3107 relative to the frequency prior to study therapy.
INOVIO expects preliminary efficacy, safety and immunogenicity data from a portion of participants from this Phase 1/2 trial in the second half of this year. The Company will share additional clinical development plans after analysis of the data.
INO-5401: Newly Diagnosed Glioblastoma Multiforme (GBM)
INOVIO’s abstract providing follow-up Phase 1/2 overall survival, safety and immunogenicity data from the Company’s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed GBM has been selected for oral presentation as part of an Oral Abstract Session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting under the title "Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma".
The complete text of the abstract will be posted on the website, meetings.asco.org, on May 26, 2022 at 5:00 PM EDT. The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting will take place on June 3-7, 2022 at the McCormick Place Convention Center in Chicago, Illinois.
First Quarter 2022 Financial Results
INOVIO reported total revenue was $199,000 for the three months ended March 31, 2022, compared to $371,000 for the same period in 2021. Total operating expenses were $71.9 million compared to $52.9 million for the same period in 2021.
INOVIO’s net loss for the quarter ended March 31, 2022, was $79.1 million, or $0.36 per basic and diluted share, compared to net loss of $54.4 million, or $0.27 per basic and diluted share, for the quarter ended March 31, 2021.
Operating Expenses
Research and development (R&D) expenses for the three months ended March 31, 2022, were $56.0 million compared to $39.0 million for the same period in 2021. The increase in R&D expenses was primarily related to higher drug manufacturing and clinical trial expenses related to INO-4800 and higher employee compensation. The increase was also due to $6.3 million lower contra-research and development expense recorded from grant agreements. These increases were offset by lower engineering services and expensed equipment related to our CELLECTRA 3PSP device array automation project, among other variances.
General and administrative (G&A) expenses were $16.0 million for the three months ended March 31, 2022, versus $13.9 million for the same period in 2021. The increase in G&A expenses was primarily related to an increase in employee compensation and insurance expenses, among other variances.
Capital Resources
As of March 31, 2022, cash and cash equivalents and short-term investments were $360.4 million compared to $401.3 million as of December 31, 2021. As of March 31, 2022, the Company had 226.5 million common shares outstanding and 247.8 million 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.
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 March 31, 2022, which can be accessed at: View Source
Conference Call / Webcast Information
INOVIO’s management will host a live conference call and webcast at 4:30 p.m. Eastern Daylight Time today to discuss INOVIO’s financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO’s website at View Source