Full Press Release Details
INOVIO Reports Fourth Quarter 2020
And Year-End Financial Results
Investor Call Today at 4:30 PM ET
MEETING, PA March 1, 2021 INOVIO (NASDAQ:INO), a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today reported financial results for the quarter ended December 31, 2020. INOVIO s management will host a live conference call and webcast at 4:30 p.m. Eastern Standard Time today
to discuss financial results and provide a general business update, including: top-line efficacy data from REVEAL 1; a Phase 3 clinical trial of VGX-3100; a progress
update for the company s INNOVATE Phase 2/3 COVID-19 vaccine clinical trial and its development strategy regarding the new COVID-19 vaccine addressing the current
and future COVID variants of concern (VOC); and a general update on its DNA medicines platform. The live webcast and a replay may be accessed by visiting INOVIO s website at
Quarter and Year-End 2020 Highlights
Dr. J. Joseph Kim, INOVIO s President and CEO, said, We have had a productive fourth
quarter across our DNA medicines platform, including significant developments within both our HPV and oncology programs. We presented encouraging clinical efficacy results in a landmark combination trial for
INO-5401 in GBM at the SNO 2020 Annual Meeting last November. Most importantly, we announced that our REVEAL 1 Phase 3 clinical trial for VGX-3100 met primary and
secondary endpoints among all evaluable subjects. We are truly proud to advance VGX-3100 as the first DNA medicine to reach this important milestone.
INOVIO recognizes and applauds the incredible work to address the global COVID-19 pandemic across the
industry, while also acknowledging the need for continued collaboration and coordination in vaccine development, manufacturing and distribution. I am also extremely proud of the dedication and efforts of our INOVIO team in contributing to this
global endeavor, grateful for the continued support of our partners, and thankful for all Phase 2 participants in our INNOVATE clinical trial for their help in the ongoing fight against the pandemic. We look forward to successfully completing our
Phase 2 segment in the second quarter and seeking to advance to the Phase 3 portion of the trial.
INOVIO Fourth Quarter 2020
DNA Immunotherapies: HPV-associated Diseases and Immuno-Oncology
HPV-related Diseases
VGX-3100: Cervical, Vulvar, and Anal HSIL
INOVIO announced today that it met primary and secondary endpoints
among all evaluable subjects for the REVEAL 1 trial. The trial protocol-defined modified intention to treat (mITT) population (N=193) includes all subjects with endpoint data. For the primary endpoint of histopathological regression of HSIL combined
with virologic clearance of HPV-16 and/or HPV-18 at week 36, the percentage of responders was 23.7% (31/131) in the treatment group, versus 11.3% (7/62) in the placebo
group (p=0.022; 12.4% difference in percentage, 95%CI: 0.4,22.5), thus achieving statistical significance. All secondary efficacy endpoints were achieved in the mITT population. These endpoints were: a) regression of cervical HSIL to normal tissue
combined with HPV16/18 viral clearance, b) regression of cervical HSIL alone, c) regression of cervical HSIL to normal tissue, and d) HPV 16/18 viral clearance alone.
The trial protocol-defined intention to treat (ITT) population (N=201) includes all randomized subjects regardless of availability of endpoint data and
defines those without endpoint data as non-responders. There were eight such subjects (seven in the treatment group, one in the placebo group). Including subjects with missing endpoint data, the percentage of
subjects meeting the primary endpoint was 22.5% (31/138) in the treatment group, versus 11.1% (7/63) in the placebo group (p=0.029; 11.4% difference in percentage, 95%CI: -0.4,21.2), which was not
statistically significant. All secondary endpoints were achieved in the ITT population except for regression of cervical HSIL alone (12.8% difference in percentage, 95%CI: -0.6,24.5). The reasons for missing
endpoint data were: one subject was randomized but was never dosed, one withdrawal due to pregnancy, one withdrawal due to administration error, one withdrawal due to post-administration pain, one loss of
follow-up due to COVID19-related travel restrictions, and three losses to follow-up due to undetermined reasons. A per-protocol
analysis will also be performed upon trial completion.
There were no treatment-related serious adverse events and most adverse events were self-resolving and
were considered to be mild to moderate, consistent with earlier clinical trials.
REVEAL 1 and REVEAL 2 are designed to assess and confirm the
safety, tolerability, immunogenicity, and efficacy of VGX-3100. INOVIO will continue to follow subjects in REVEAL 1 for safety and durability of response for 18 months following the last administration and
REVEAL 2 is currently enrolling subjects. INOVIO expects to present REVEAL 1 findings at a scientific meeting this year.
In December 2020, the
company reported positive Phase 2 efficacy results demonstrating that VGX-3100 showed resolution of HPV-16/18-associated
precancerous anal HSIL in 50% (11 of 22) of subjects six months following the start of treatment. The open-label, single-arm trial also showed VGX-3100 to be
well-tolerated in treating men and women with HPV-16-/18-associated anal HSIL.
In January 2021, the company also reported positive efficacy results from an open-label Phase 2 trial of
VGX-3100 to treat HPV-16 and HPV-18-associated vulvar HSIL. A 25% or more reduction in HPV-16/18-associated vulvar HSIL was observed for 63% of trial participants (12 of 19) treated with VGX-3100 at six months
post-treatment. Three out of the 20 participants with histology data (15%) resolved their vulvar HSIL and had no HPV-16/18 virus detectable in the healed area. By comparison, the spontaneous resolution of
vulvar HSIL caused by HPV-16/18 is estimated to be 2%. The trial also showed VGX-3100 to be well-tolerated.
INOVIO will continue to evaluate expansion of indications for vulvar and anal dysplasia.
INO-3107: Recurrent Respiratory Papillomatosis (RRP)
In November, INOVIO dosed its first subject with DNA medicine INO-3107 in a Phase 1/2 clinical trial for the
treatment of RRP. The trial, called RRP-001, is a clinical trial investigating the efficacy, safety, tolerability and immunogenicity of INOVIO s novel HPV-6/HPV-11 therapy in subjects with RRP, designed to eradicate both the cause, and sequelae, of infection of the airway with HPV in subjects who have required at least two surgical interventions per year
for the past three years for the removal of associated papilloma(s). For this study, adult subjects will first undergo surgical removal of their papilloma(s) and then receive four doses of INO-3107, once every
three weeks. The primary efficacy endpoint is a doubling or more in the time between surgical interventions following the first dose of INO-3107 relative to the frequency prior to study therapy. The study is
currently open in the United States and is listed on ClinicalTrials.Gov (NCT04398433).
INO-5401: Newly Diagnosed GBM
At the SNO 2020 Annual Meeting last November, INOVIO presented data from the company s novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo (cemiplimab)
in the treatment of newly diagnosed GBM. In the MGMT promoter unmethylated cohort, which is the more difficult to treat group, 19/22 (86%) subjects had an IFN-gamma T cell response that increased over baseline
to one or more of the antigens encoded by INO-5401. In the MGMT promoter methylated cohort, 16/17 (94%) subjects had an IFN-gamma response that increased over baseline
to one or more of the antigens encoded by INO-5401. The novel combination of INO-5401 + INO-9012 continues to demonstrate a
well-tolerated safety profile when given not only with radiation and chemotherapy, but also with PD-1 blockade by Libtayo , which is being jointly
developed by Regeneron and Sanofi. Additional data will be provided in the coming months, including correlative immunology and tissue data, as well as additional patient survival data.
INO-4800: COVID-19 DNA Vaccine
Phase 1 Update and Publication
December 2020, Phase 1 clinical data from the first cohort of 40 participants for INO-4800 was published in The Lancet s EClinicalMedicine in a paper, titled Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: a preliminary report of an open-label, Phase 1 clinical trial. The trial found that INO-4800 was immunogenic in all vaccinated subjects, effectively generating an immune response of humoral (including neutralizing antibodies) and/or cellular responses (both CD4 and CD8 T cells). Key findings from
After the quarter, INOVIO completed enrollment of 400 subjects in the Phase 2 segment of the INNOVATE clinical trial. The U.S.
Department of Defense (DoD) has committed to provide funding for both the Phase 2 and Phase 3 segments of the INNOVATE clinical trial, in addition to the $71.1 million of funding previously announced in June 2020 for the large-scale manufacture
of the company s proprietary smart device CELLECTRA 3PSP, production of doses and the procurement of CELLECTRA 2000 devices.
License Agreement for Greater China with Advaccine
INOVIO also entered into a collaboration and license agreement for INO-4800 with Advaccine, who will have the
exclusive right to develop, manufacture and commercialize INO-4800 within Greater China, which includes Mainland China, Hong Kong, Macao, and Taiwan. Advaccine will license its plasmid manufacturing process
for use with INO-4800 and other INOVIO pipeline product candidates to INOVIO with the right to sublicense to INOVIO s manufacturing partners. INOVIO received an upfront payment of $3.0 million and is
eligible to receive up to an aggregate of $108.0 million upon the achievement of specified development and sales-based milestones for INO-4800 in Greater China. INOVIO is entitled to receive a royalty
equal to a high single-digit percentage of annual net sales in each region within Greater China.
INOVIO s Strategy to Address New Variants of Concern (VOC)
INOVIO has been closely monitoring the development and evolution of
SARS-CoV-2 (which causes COVID-19) mutations, with a particular focus on the UK, South African and Brazilian variants. With
instances of these variants on the rise globally and the UK variant expected to be the dominant strain in the United States by March, the emergence and the spread of the variants have been an area of high priority for INOVIO.
INOVIO is addressing the VOC through a two-pronged approach:
INOVIO s DNA vaccines are designed to mitigate the risk of the new viral variants through three main mechanisms:
DNA-encoded monoclonal antibody
(dMAb ) for COVID-19- Innovative monoclonal antibody platform
In December 2020, INOVIO announced that the company and a team of scientists from The Wistar Institute, AstraZeneca, the University of Pennsylvania, and
Indiana University received a $37.6 million grant from DARPA, a research and development agency of the DoD and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), to use INOVIO s
innovative dMAb technology to develop anti-SARS-CoV-2-specific dMAbs which could offer versatile capabilities to function as both a therapeutic and preventive treatment for COVID-19. Using our core DNA platform technology,
dMAbs are constructed by encoding the DNA sequence for a specific monoclonal antibody in a DNA plasmid. The plasmids are then directly delivered into cells of the body using CELLECTRA delivery devices, enabling these cells to manufacture the mAbs in vivo, unlike conventional mAb technology that requires manufacturing outside of the body. INOVIO s dMAbs also offer a cost-effective treatment option, are fast to administer to subjects, can be quickly manufactured and scaled up compared to traditional recombinant monoclonal antibody-based
therapies, and do not require cold chain transport or storage. Notably, the overall approach can be applied beyond COVID-19 for any preventive and therapeutic treatment modalities, including infectious
disease, cancer, or any other disease that can be treated by recombinant monoclonal antibody-based therapies.
Fourth Quarter and Full Year 2020 Financial Results
Total revenue was $5.6 million and $7.4 million for the quarter and year ended December 31, 2020, respectively, compared to $279,000 and
$4.1 million for the same periods in 2019, respectively. Total operating expenses were $34.9 million and $131.5 million for the quarter and year ended December 31, 2020, respectively, compared to $30.7 million and
$115.2 million for the same periods in 2019.
INOVIO s net loss for the quarter and year ended December 31, 2020 was
$24.3 million, or $0.14 per basic and diluted share, and $166.4 million, or $1.07 per basic and diluted share, respectively, compared to net loss of $37.7 million, or $0.38 per basic and diluted share, and $119.4 million, or
$1.21 per basic and diluted share, for the quarter and year ended December 31, 2019, respectively.
Research and development (R&D) expenses for the quarter and year ended December 31, 2020 were $26.3 million and $94.2 million,
respectively, compared to $22.0 million and $88.0 million, respectively, for the same periods in 2019. The year-over-year increase in R&D expenses was primarily related to an increase in drug manufacturing expenses and outside services
related to INO-4800 and other clinical trials, an increase in engineering services related to our CELLECTRA 3PSP device, higher device inventory
expense, an increase in consulting services related to COVID-19, higher employee stock-based compensation expense due to increased staff numbers and an increase in patent maintenance and milestone fees to
Wistar. These increases were offset by an increase in contra-research and development expense recorded from grant agreements of $33.5 million, among other variances.
General and administrative (G&A) expenses were $8.6 million and $37.2 million, respectively, for the quarter and year ended
December 31, 2020, versus $8.7 million and $27.2 million, respectively, for the same periods in 2019. The year-over-year increase in G&A expenses was primarily related to an increase in legal expenses and employee and consultant non-cash stock-based compensation, partially offset by a gain on foreign exchange among other variances.