Q4 2021 Inovio Pharmaceuticals Inc Earnings Call
Operator: Good afternoon and welcome to the Inovio Pharmaceuticals fourth quarter 2021 financial results conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key, followed by zero. After today's presentation, there will be an opportunity to end, but- To ask a question, you may press star then 1 on your telephone, and to withdraw your question; please start them too. Please note, this event is being recorded. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead.
Good afternoon, and welcome to the <unk>.
Pharmaceuticals fourth quarter 2021 financial results conference call.
All participants will be in listen only mode.
Should you need assistance. Please signal conference specialist by pressing the star Keith I'll, let by zero.
After todays presentation, there will be an opportunity to ask questions.
To ask a question you May press Star then one on your telephone keypad.
To withdraw your question. Please press Star then two.
Please note this event is being recorded.
I would now like to turn the conference over to Dan motto Senior Director of Investor Relations. Please go ahead.
Thank you operator.
Ben Matone: Thank you. Thank you, operator. Good afternoon, and thank you for joining the Inovio fourth quarter 2021 financial results conference call. Joining me on today's call are Dr. Joseph Kim, President and CEO, Mr. Peter Kies, Chief Financial Officer, Dr. Jackie Shea, Chief Operating Officer, Dr. Lermont Hemot, Chief Scientific Officer, Mark Twyman, Chief Commercial Officer. Dr. Jeffrey Skolnick, Senior Vice President of Clinical Development, and Dr. Kate Broderick, Senior Vice President of Research and Development.
Good afternoon, and thank you for joining the <unk> fourth quarter 2021 financial results Conference call.
Joining me on today's call are Dr. Joseph Kim President and CEO .
Mr. Peter Keyes, Chief Financial Officer, Dr. Jackie Shea Chief operating Officer, Dr. Martin <unk>, Chief Scientific Officer.
Mark Twyman, Chief commercial officer.
Dr. Jeffrey Skolnik Senior Vice President clinical development and Dr. Kate Brodrick Senior Vice President of research and development.
Ben Matone: For today's call, we will review our corporate and financial information for the fourth quarter and full year ended December 31st, 2021, as well as provide an update on our efforts across our DNA medicines platform. We will address the status of Inovio's COVID-19 effort, as well as enrollment and dosing milestones achieved across our other infectious disease and HPV-associated programs.
For today's call, we will review, our corporate and financial information for the fourth quarter and full year ended December 31, 2021, as well as provide an update on our efforts across our DNA medicines platform.
I'll address the status of the <unk> COVID-19 efforts.
As well as enrollment and dosing milestones achieved across our other infectious disease and HPV associated programs.
Following prepared remarks, we will conduct a question and answer segment reserved for equity research analysts.
Ben Matone: During the call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's integrated platform DNA medicine, which include clinical and regulatory developments and timing of clinical data readout, along with Capital Resources and Strategic Matters. All of these statements are based on the beliefs and expectations of management as of today.
During the call, we will be making forward looking statements regarding future events and the future performance of the company.
These events relate to our business plans to develop <unk> integrated platform DNA medicine, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters.
All of these statements are based on the beliefs and expectations of management as of today.
Ben Matone: We refer you to the documents we file from time to time with the SEC, which, under the heading risk factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made during this afternoon's press conference. This call is being webcast live on our website, ir.inovio.com, and a replay will be made available shortly after this call. I will now turn the call over to Inovio's President and CEO, Dr. Joseph Kim. Thank you, Ben, and good afternoon. I appreciate everyone taking the time to join us today.
We refer you to the documents we file from time to time with the SEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release.
This call is being webcast live on our website IR dot <unk> dot com and a replay will be made available. Shortly after this call's concluded I will now turn the call over to <unk>, President and CEO Dr. Joseph Kim.
Thank you Ben and good afternoon.
I appreciate everyone, taking the time to join us today.
Dr. Joseph Kim: The impact of the highly transmissible Omicron variant of SARS-CoV-2 over the past few months highlights the enduring threat of COVID-19, particularly the unpredictability of current and future variants of concern. The ongoing impact of COVID-19 reaffirms and underscores the continued public health need and ongoing challenge to improve access to both primary vaccines and boosters across the global community. Testament to this challenge is the fact that while over 63% of the global population has received at least one vaccine dose and a growing number have received boosters, in certain countries First, those vaccination rates are still below 12%. There is clearly more work to be done. [inaudible] Since the emergence of Omicron as the predominant COVID-19 variant circulating in the globe in November, the expectation for vaccination has changed. The highly infectious nature of Omicron has meant that while vaccines currently available in the market may not directly prevent infection. They can significantly protect the vaccinated from severe disease, hospitalization, and ultimately death.
The impact of the highly transmissible omicron bearing end of Sars Cov two.
Over the past few months highlights enduring threat of COVID-19.
Particularly unpredictable.
Unpredictability of current and future variants of concern.
The ongoing impact of COVID-19, reaffirms and underscores the continued public health need and ongoing challenge to improve access to both primary vaccines and boosters across the global community.
Testament to this challenge is the fact that while over 63% of the global population has received at least one vaccine dose.
A growing number have received boosters.
In certain countries first dose vaccination rates are still below 12%.
There is clearly more work to be done.
Since the emergency.
Emergence of Omicron is the predominant COVID-19 Darien.
<unk> in the globe in November the expectation for vaccination has changed so.
So highly infectious nature of omicron has meant that while vaccines currently available in the market.
Not directly prevent infections.
Can significantly protect vaccinated from severe disease hospitalization and ultimately death.
Dr. Joseph Kim: In this regard, Many experts believe that virus targeting T cell responses are thought to play an important role in protection against severe disease and death and may be central to the durability of vaccine protection. Inovio observed full maintenance of T cell responses against the Omicron variant in clinical samples from INO4800 vaccinated individuals. The preservation of T cell responses continues to remain a consistent observation for INO4800 against the ancestral COVID-19 virus, and across all variants of concerns tested today, including Omicron, in response to the dominance of Omicron variant globally, and the persistence of cross-rective p-cell responses generated by INR 4800 across all VOCs to date, we plan to seek regulatory approval to amend the primary endpoint for our phase three, innovate trial, from prevention of all symptomatic disease, to prevention of severe disease.
In this regard.
Many experts believe that virus targeting T cell responses are thought to play an important role in protection against severe disease and death and may be central to the durability of that scene protection.
<unk> observed full maintenance of T cell responses against the Omicron Varian and clinical samples from INR 4800 vaccinated individuals.
The preservation of T cell responses continues to remain a consistent observation for INR 4800 against the ancestral COVID-19 virus and across all variants of concerns tested to date, including all Mccrumb.
In response to the dominance of OMA cranberry and globally.
The persistence of cross reactive T cell responses generated but I don't know 4800, okay.
All voc's today.
We plan to seek regulatory approval to amend the primary endpoint for our phase III innovate trial from prevention of all symptomatic disease too.
Prevention of severe disease.
Dr. Joseph Kim: We believe INO4800's ability to generate T-cell responses, could be critical in meeting the proposed amended primary endpoint. In addition, due to the emergence of Omicron, the Data Safety Monitoring Board of our Annual 4800 program recommended that we pause the enrollment of new participants today, to update the informed consent form and investigator brochure to reflect the potential impact of Omicron on the trial. The DSMB stated that safety issues were not a factor in this recommendation, and dosing may continue for those participants who have already received their first dose.
We believe INR 48, hundred's ability to generate T cell responses could.
Could be critical in meeting the proposed amended primary endpoint.
In addition, due to the emergence emergence of OMA crime. The data safety monitoring board of Rino 4800 program recommended that we paused enrollment of new participants to date.
To update the informed consent form and investigator brochure.
Select the potential impact of OMA crime on the trial.
So the SMB stated that safety issues were not a factor in this recommendation.
And dosing May continue for those participants who have already received their first dose.
Dr. Joseph Kim: As a result of the DSMB recommendation, as well as our plan to seek approval to amend the trial's primary end point, we have paused enrollment of new participants for innovation. Interim efficacy data from Inovate will therefore not be available in the first half of 2022 as previously expected. In addition, we're also evaluating the feasibility of an additional XUS heterologous boost trial for INO 4800 as a booster in a non-interiority clinical trial compared to the previously approved viral vector and inactivated COVID-19 vaccine.
As a result of the DSM V recommendation as well as our plan to seek approval to amend the trial's primary endpoint, we have paused enrollment of new participants for innovate.
Interim efficacy data from innovate will therefore not be available in the first half of 2022 as previously expected.
In addition, we're also evaluating the feasibility of an additional ex U S. Heterologous spruce trial for INR 4800, as a booster in a non inferiority trial comparing compared to previously approved viral vector.
And then activate it COVID-19 vaccines.
Dr. Joseph Kim: This will complement the ongoing booster trials that are being conducted in China by our partner at Vaccine. Viral vector and inactivated COVID-19 vaccines have been the most widely administered vaccine types globally, particularly in low- to middle-income countries, accounting for more than half of all doses delivered worldwide.
This will complement the ongoing booster trials that are being conducted in China.
By our partner at vaccine.
Viral vector and inactivate COVID-19 vaccines have been the most widely administered.
<unk> types globally.
Securely in low to middle income countries accounting for more than half of all doses delivered worldwide.
Dr. Joseph Kim: Currently, approved and authorized vaccines may not meet the global demand for boosters to address their waning protection, a need which some regulatory agencies are considering with respect to evaluating a clinical pathway for heterologous boost candidates in clinical trials. In addition to early data from independent studies that suggest a mix and match booster strategy of heterologous boosting may confer advantages over the homologous boosting approach, INO4800's key advantages as a DNA vaccine correspond well with desired features of a heterologous boost vaccine. These advantages include:
Currently approved and authorized vaccines may not meet the global demand for boosters to address the waning protection.
Which some regulatory agencies are considering with respect to evaluating a clinical pathway for heterologous boost candidates and clinical trials.
In addition to early data from independent studies that suggest a mix and match booster strategy of heterologous boosting may confer advantages over the homologous approach.
Dr. Joseph Kim: It's observed T cell immunity for disease protection. Tolerability for re-administration, favorable thermal stability profile for global transport, storage, and distribution and ease of construct design, allowing for timely scaling and manufacturing. We are also pleased to share that a vaccine has completed enrollment of its 200 participant homologous and 267 participant heterologous boost phase 1 slash 2 clinical trial. The trials are designed to evaluate the safety, tolerability, and immunogenicity, of INO4800 as a homologous boost where INO4800 was administered as the primary vaccine and as heterologous boost where inactivated vaccines were administered as the primary vaccine.
Don't know 4800 key advantages.
DNA vaccine correspond well with desire features head of all of this boost vaccine.
These advantages include.
Observe T cell immunity for disease protection.
Tolerability for re administration.
Favorable thermal stability profile for global transport storage and distribution.
And ease of construct design, allowing for timely scaling in manufacturing.
We are also pleased to share that at vaccine has completed enrollment.
Obviously 200 participant homologous and 267 participants heterologous Booz face once last two clinical trials.
The trials are designed to evaluate the safety tolerability and Immunogenicity of <unk>.
I know 4800 SA homologous boost.
<unk> hundred 40, <unk> hundred was the minister as the primary vaccine.
S Heterologous booths, where inactivated vaccines, where administer as the primary vaccine.
Dr. Joseph Kim: We look forward to sharing additional updates as the vaccine progresses in the trial. And, as we shared last quarter, the World Health Organization, or WHO, selected INO4800 to be tested in a large international randomized control phase 3 clinical trial, the Solidarity Trial Vaccines, which is ongoing and being funded, sponsored, and conducted by WHO. We are truly proud that INO4800 is the only DNA vaccine selected for this trial. We believe Inovio can most effectively support the global community as COVID-19 shifts from the pandemic stage to the endemic stage while leveraging the strength of our DNA medicines platform and deep experience combating infectious diseases.
We look forward to sharing additional updates as a vaccine progresses with the trial.
And as we shared last quarter, the World Health organization or <unk> selected the INR 4800 to be tested in a large international randomized control phase III clinical trial, the solidarity trial vaccines, which is ongoing and <unk>.
Funded sponsored and conducted by the <unk>.
We are truly proud that INR 4800 is the only DNA vaccine select for this trial.
We believe I know.
We believe.
<unk> can most effectively support.
Our global community as COVID-19 shifts from pandemic stage to endemic stage, while leveraging the strength of our DNA medicines platform and deep experience combating infectious diseases.
Dr. Joseph Kim: With that, I'll turn it over to Dr. Kate Broderick, our Senior Vice President of R&D and co-program lead for COVID, who will provide further details regarding INO 4800 and the Omicron variant as well as our continued progress across our other infectious disease programs. Thank you, Joseph. And hello, everyone.
With that I'll turn it over to Dr. Kate Broderick, our senior Vice President of R&D.
And co program lead for Covid program.
Ill provide further details regarding iron ore 4800, and the <unk> as well as our continued progress across our other infectious disease programs.
Dr. Kate Broderick: It's very nice to be with you today. Inovio's in vitro assessment of the cross reactivity of INO4800 vaccine-induced immune responses against the Omicron variant of SARS-CoV-2 demonstrated full maintenance of T cell responses, including the all-important CD8 killer T responses. However, as was seen with the vaccines of other developers, it also showed significantly decreased levels of both neutralizing and binding antibodies against the Omicron variant. However, the maintenance and preservation of T cell responses remain a consistent observation for I-04800 against the ancestral COVID-19 virus, Omicron, and all the other variants of concern tested today.
Thank you Joseph and Hello, everyone, it's very nice to be with you today.
And it will be used in vitro assessment of the cross reactivity of INR 400 vaccine induced immune responses against <unk> Sars Covid two <unk>.
Demonstrated fuel maintenance of T cell responses, including the all important CD Keller Peter sponsors highway.
Hi.
<unk> seen with the vaccines of other developers also showed significantly decrease levels of both neutralized and binding antibodies against all mccrone variant.
The maintenance and the preservation of T cell responses remains a consistent observation for iron ore <unk> hundred against the ancestral COVID-19 virus on the <unk> and all the other variants of concern tested to date.
Dr. Kate Broderick: We, along with many in the scientific community, believe that T cell responses play an important role in protecting against severe disease and death and may be central to the durability of vaccine protection. As Joseph noted, we've also advanced our other infectious disease programs. Progress that we're particularly proud of given the continued global pandemic and the hard work of our Inovio colleagues and our partners. I'm pleased to share that we have completed full enrolment of 192 participants for the post-finding stage of our Phase 2 trial to evaluate the safety, tolerability and immunogenicity of our DNA vaccine candidate INO4700 against MERS.
We along with many in the scientific community believes that T cell responses play an important role in protecting against severe diseases and.
And may be central to the durability of vaccine protection.
As Josef noted we've also advanced our other infectious disease programs.
We're particularly proud of given the continued global pandemic and the hard work and all of your colleagues and our partners.
I am pleased to share that we have completed full enrollment of 192 participants for the dose finding stage of our phase II trial to value the safety Tolerability and Immunogenicity of our DNA vaccine candidate iron ore 4700 against Mars.
Dr. Kate Broderick: The randomized double-blinded placebo-controlled trial will enroll approximately 500 healthy adults in total. Sponsored by Inovio and fully funded by CERI, the trial is being conducted at sites in Jordan, Lebanon, and Kenya. Inovio also completed full enrollment of our Phase 1b trial for INO4500, our DNA vaccine candidate for Lassa fever. Also funded by CEPI, this trial includes 220 participants and is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana.
The randomized double blinded placebo controlled trial.
Approximately 500 healthy adults.
And total sponsored by <unk> and fully funded by city.
<unk> is being conducted at sites in Jordan.
<unk> been on and Kenya.
Adobe will also completed full enrollment of our fees will be trial for iron ore 4500, our DNA vaccine candidate for Lassa fever.
Also funded by safety. This trial includes 220 participants and is ongoing.
Memorial Institute for Medical research in Accra, Ghana.
Dr. Kate Broderick: Notably, it is the first vaccine clinical trial for NASA fever conducted in West Africa, where the vital illness is endemic. There is currently no approved vaccine for Lassa fever, which impacts an estimated 300,000 people in the region annually.
Notably it is the first vaccine clinical trial for Lassa fever pitch in West Africa.
We had the vital illness is endemic.
There is currently no approved vaccine for Lassa fever, which in part for an estimated 300000 people in the region annually.
Dr. Kate Broderick: The WHO classifies this vital illness as one of the pathogens with epidemic potential, making the development of a safe and effective vaccine a global health priority. Finally, in another example of Inovio's experience leveraging our DNA medicines technology in a boosting capacity, we completed enrollment of 46 healthy participants as part of a randomized, placebo-controlled Phase 1b clinical trial evaluating the safety, tolerability, and immunogenicity of INO4201, The trial will have its first participant in November and will assess whether INO-4201 can be used as a booster in healthy participants previously vaccinated with our V-bowl. With that, I'll turn it back to you, Joseph.
The double you meet show classifies this vital illness I was one of the pathogen with epidemic potential making the development of a safe and effective vaccine a global health priority.
Finally, and another example of a new views expedient flavored aging, our DNA medicines technology and a boost in capacity.
We completed enrollment of 46 healthy participants.
Part of our randomized placebo controlled phase <unk> clinical trial evaluating the safety Tolerability and Immunogenicity of iron ore 42, or one or.
DNA vaccine candidate for Ebola.
The trial dosed its first participated to November .
And we will assess whether iron ore 42, one can be used as a booster and healthy participants previously vaccinated with our <unk>.
With that I'll turn it back to you Joseph Thank you.
Dr. Joseph Kim: Thank you. Thank you, Kay. Our efforts in infectious diseases underscore the differentiating attributes of our DNA Medicines platform. The tolerability of our DNA medicines and their ability to remain stable at room temperature for more than a year, at 37 degrees Celsius for more than a month, and have a five-year projected shelf life at normal refrigeration temperatures without needing to be frozen ever during transport or storage, allows us to support public health measures in tropical environments and all other areas where ultra-cold and cold And now, Dr. Jeffrey Skoneck, our SVP of clinical development, will provide an update on our other important clinical programs. Dr. Skoneck?
Thank you Kate.
Our efforts in infectious diseases underscore the differentiating attributes of our DNA medicines platform.
The tolerability of our DNA medicines, and the ability to remain stable at room temperature for more than a year.
At 37 degrees Celsius for more than a month.
And have a five year projected shelf life at normal refrigeration temperature without needing to be frozen ever during transport or storage.
Allows us to support public health measures and tropical environments, and all other areas, where ultra cool and cold storage may not be widely available.
And now Dr. Jeffrey Skolnik, our SVP of clinical development will provide an update on our other important clinical programs Jeffrey.
Dr. Jeffrey Skolnick: Thank you very much, Shiz. As it relates to our Inovio HPV-associated disease programs, we completed enrollment in REVEAL-2, our second global Phase III clinical trial of VGX3100 for Cervical High-Risk Squamous Intraepithelial Lesions, or H-CIL. And we expect to have top-line efficacy and safety data available in the fourth quarter. We've also completed the 52-week safety follow-up of Reveal One Participant, which showed that BGX 3100 remained well tolerated through week 88.
Thank you very much Joseph.
As it relates to our Nokia HPV associated disease programs, we completed enrollment in reveal two our second global phase III clinical trial of <unk> 3100.
Cervical high risk squamous.
Sealy Alicia.
H so.
And we expect to have top line efficacy and safety data available in the fourth quarter.
We've also completed the 52 week safety follow up of reveal one participants which showed that <unk> 3100 remained well tolerated through week 88.
Dr. Jeffrey Skolnick: Additionally, participants treated with VGX 3100 who met the primary endpoint at week 36 remained clear of HPV 16 and or HPV 18 at week 88. We continue to progress our efforts in the co-development of a liquid biopsy-based diagnostic, built on next-generation sequencing technology with QIAGEN. This diagnostic may serve to guide clinical decision making for the use of VGX 3100 in cervical H cells.
Additionally.
<unk> been treated with <unk> 3100, we met the primary endpoint at week 36.
And clear of HPV 16, <unk> HPV 18 at week eight again.
We continue to progress our efforts on the co development of a liquid biopsy based diagnostic built on next generation sequencing technology with Qiagen.
This diagnostic may serve to guide clinical decision, making for the use of <unk> 3100 in cervical <unk> and this biomarker if validated may have the potential to identify those women who are more likely to have a favorable treatment outcome with <unk>.
Dr. Jeffrey Skolnick: And this biomarker, if validated, may have the potential to identify those women who are more likely to have a favorable treatment outcome with VGX 3100, specifically the regression of cervical H-cells and clearance of the HPV virus. We expect to have additional information on our biomarker development process later this year. NETA update on INO 30107, our DNA immunotherapy candidate to treat HPV 6 and 11 associated recurrent respiratory papaloma toast. By year-end, Inovio had completed enrollment of 32 participants with HPV-6 and or HPV-11-associated RRP in our open-label, multi-center Phase I-II clinical trial. RRP is a rare disease characterized by the growth of tumors in the respiratory tract caused by HPV, which can lead to life-threatening airway obstruction.
31 countries, specifically, the regression of surgical <unk> and clearance of HPV virus.
We expect to have additional information on our biomarker development process later this year.
Dr. Jeffrey Skolnick: RRP is impurable and often requires repeated surgeries due to its recurrence. INO 3107 received orphan drug designation from the FDA in July of 2020. And as you know, our phase one, two trials assessing safety, tolerability, immunogenicity, and efficacy of 30107 are ongoing, and we expect these preliminary efficacy data from a portion of participants in the second half of this year. Moving on next to Inovio's immuno-oncology efforts, Dr. David Reeves, a key opinion leader in grain..., and our coordinating PI for our GBM-001 trial presented updated data from our phase two trial for INO5401, our DNA medicine for patients with newly diagnosed glioblastoma or GBM at the CITSE pre-conference workshop last November. This trial showed that INO5401 combined with INO9012, simiclamab, and radiation and temozolomide chemotherapy has an acceptable safety profile, is immunogenic, and may improve survival in newly diagnosed GBM.
Now to update on iron ore 31 O R.
Our DNA immunotherapy candidate to treat HPV, six and 11 associated recurrent respiratory papillomatosis.
By year end <unk> completed enrollment of 32 participants with HBV six <unk> HPV 11th associated RP.
Open label Multicenter phase one two clinical trial.
RP is a rare disease characterized by the growth of tumors in the respiratory tract caused by HPV, which can lead to life threatening airway obstructions.
RP is incurable and often requires repeated surgeries due to its recurrence.
INR 37 received orphan drug designation from the FDA in.
In July of 2020.
And as you know our phase one two trials assessing safety.
Our ability immunogenicity and efficacy of $31 seven.
And we expect these preliminary efficacy data from our portion of participants in the second half of this year.
Moving on next to <unk> immuno oncology efforts, Dr. David <unk>, a key opinion leader in Green tubes, and are coordinating PR GBM <unk> one trial.
<unk> updated data from our phase II trial for Iron ore 50, 401, our DNA medicine for patients with newly diagnosed glioblastoma or GBM.
<unk> pre conference workshop last November .
This trial showed that INR 50, 401, combined with INR 912.
<unk> and radiation and team of dolomite chemotherapy.
Have an acceptable safety profile.
Our immunogenic and may improve survival in newly diagnosed GBM.
Dr. Jeffrey Skolnick: Overall survival at 24 months was 22%, or 7 out of 32, in the MGMT promoter unmethylated cohort, and 55%, or 11 out of 20, for the MGMT promoter methylated cohort. We continue to follow participants in the trial, and we plan to provide additional updates in the future. And now, I'll turn the call back over to Joseph. Thank you, Jeffrey, for a clear update. Before moving to our quarterly and full-year financials.
Overall survival at 24 months was 22% or seven out of 32 in.
In the MGMT promoter unmet the later cohorts and 55% or 11 out of 24, the MGMT promoter methylated cohort. We continue to follow a participants in the trial and we plan to provide additional updates in the future.
And now I'll turn the call back over to Joseph.
Thank you Jeffrey for clear updates.
Before moving to our quarterly and full year financials.
Dr. Joseph Kim: I want to briefly discuss our non-binding memorandum of understanding, find in October with Columbia's Ministry of Health and Social Protection. This MOU creates a framework for collaboration by which Inovio and the Colombian government can explore knowledge sharing, technology licensing, and capacity building that supports development and developing and producing vaccines and other biopharmaceuticals in Colombia. The potential results of these efforts include developing local manufacturing capabilities across Inovio's DNA medicines platform, as well as related products and technology. Now, I will turn the call over to Peter Kies, our CFO, for our fourth quarter and year-end financial summary. Peter?
I want to briefly discuss our non binding memorandum of understanding signed in October with Colombia's Ministry of health and social protection.
This Mou creates a framework for collaboration by which in OBO and the Colombian government can explore knowledge sharing.
Knowledge, you're licensing and capacity building.
Imports development and product developing and producing vaccines and other biopharmaceutical as in Colombia.
The potential results of these efforts include developing local manufacturing capabilities across <unk> DNA medicines platform.
<unk> related products and technologies.
Now I will turn the call over to Peter Keith our CFO for our fourth quarter and year end financial summary, Peter.
Peter Kies: Thanks, Joseph, and good afternoon, everyone. We ended the fourth quarter with $401.3 million in cash, cash equivalents, and short-term investments compared to $411.6 million as of December 31, 2020. As of December 31st, 2021, Inovio had 217.4 million common shares outstanding and 234 million common shares outstanding on a fully diluted basis.
Thanks, Joseph and good afternoon, everyone. We.
We ended the fourth quarter with $401 3 million in cash cash equivalents and short term investments compared to $411 6 million as of December 31, 2020.
As of December 31, two.
2021, and <unk> had $217 4 million common shares outstanding and.
234 million common shares outstanding on a fully diluted basis.
Peter Kies: Total revenue was $839,000 and $1.8 million for the quarter and year ended December 31, 2021, respectively, compared to $5.6 million and $7.4 million for the same periods in 2020. Total operating expenses were $106.3 million and $303 million for the quarter and year ended December 31, 2021, compared to $34.9 million and $131.5 million for the same periods in 2020. The increase in total operating expenses in 2021 was primarily due to scale-up and production costs related to plasmid and device manufacturing related to INO4800. Our net loss for the quarter and year ended December 31, 2021, was $106.9 million, or $0.50 per share, basic and dilutive, and $303.7 million, or $1.45 per share.
Total revenue was $839001 8 million for the quarter and year ended December 31 2021, respectively.
Compared to $5 6 million and $7 4 million for the same periods in 2020.
Total operating expenses were $106 3 million and $303 million for the quarter and year ended December 31, 2021, compared to $34 9 million and $131 5 million for the same period.
And 2020 the.
The increase in total operating expenses in 2021 was primarily due to scale up and production costs related to plasmid and device manufacturing related to iron ore 4800.
Our net loss for the quarter and year ended December 31, 2021 was $106 9 million or <unk> 50 per share basic and dilutive and $303 7 million or $1.45 per share.
Peter Kies: Basic and Dilutive, compared to a net loss of $24.3 million, or $0.14 per share of Basic and Dilutive, and $166.4 million, or $1.07 per share of Basic and Dilutive, for the same period in 2020. Inovio's research and development expenses for the quarter and year ended December 31, 2021, were $92.3 million and $249.2 million, compared to $26.3 million and $94.2 million for the same periods in 2020. The year-over-year increase in R&D expenses was primarily related to higher drug manufacturing, Outside Services and Clinical Trial Expenses related to INO 4800 expenses related to the acquisition and installation of manufacturing equipment related to INL 4800, higher engineering services, expensed equipment and inventory related to our Selectra 3PSP device array automation project, and higher employee and contractor compensation among other variances.
Basic and dilutive compared to a net loss of $24 3 million or <unk> 14 per share basic and dilutive and $166 4 million or $1 seven per share basic and dilutive for the same period in 2020.
<unk> research and development expenses for the quarter and year ended December 31, 2021 were $92 3 million and 249.2.
$2 million compared to $26 3 million and $94 2 million for the same periods in 2020.
The year over year increase in R&D expenses was primarily related to higher drug manufacturing.
Outside services and clinical trial expenses related to INR 4800 <unk>.
Expenses related to the acquisition and installation of manufacturing equipment related to INR, four 800 higher engineering services.
<unk> equipment and inventory related to our select draw three PSP device array automation project and higher employee and contractor compensation among other variances.
Peter Kies: General and administrative expenses were $14 million and $53.8 million, respectively, for the quarter-ended and year-ended December 31, 2021, versus $8.6 million and $37.2 million, respectively, for the same periods in 2020. The year-over-year increase in G&A expenses was primarily related to an increase in employee compensation, including non-cash, stock-based compensation, due to an increase in employee headcount, among other variances.
General and administrative expenses were $14 million and $53 8 million respectively for the quarter ended and year ended December 31, 2021 versus $8 6 million and $37 2 million respectively for the same P.
Areas in 2020, the year over year increase in G&A expenses was primarily related to increase in employee compensation.
Including noncash stock based compensation due to an increase in employee head count among other variances.
Dr. Joseph Kim: As a reminder, you can find our full financial statements in this afternoon's press release, as well as in the company's Form 10-K, filed with the SEC. And with that, I'll turn it back to you, Joseph. Thank you Peter. Before we take analyst questions, I want to express my true appreciation for the entire Inovio team, as well as our trial participants, collaborators, funders, and partners across all of our clinical programs. Without their contribution, we would not be able to advance our efforts to help address critical unmet global health needs. I am thankful for their continued support and proud of our collective efforts today. In closing,
As a reminder, you can find our full financial statements in this afternoon's press release as well as in the company's Form 10-K filed with the SEC.
And with that I'll turn it back to you Joseph.
Thank you Peter.
Before we take analyst questions.
I want to express my appreciation for the entire <unk> team.
As well as our trial participants collaborators Thunder and partners across all of our clinical programs.
Without their contributions.
It would not be able to advance our efforts to help address critical unmet global health needs.
I am thankful for their continued support and proud of our collective efforts to date.
In closing we.
Dr. Joseph Kim: We are committed to fulfilling the potential of our DNA medicines platform and are encouraged by our progress across our portfolio. This past quarter, we completed enrollment in four trials across four indications. We believe in the advantages of DNA medicine and the Vaccines Platform in combating infectious diseases, cancer, and HPV-associated diseases due to their ability to generate functional T-cell and antibody responses, tolerability, and strong thermostability profiles.
We're committed to fulfilling the potential of our DNA medicines platform and are encouraged by our progress across our portfolio.
This past quarter, we completed full enrollment in four trials across four indications.
We believe the advantages of DNA medicines.
In vaccines platform in combat in infectious diseases cancer, and HPV associated diseases due to their ability to generate functional T cell <unk>.
Antibody responses tolerability and strong thermal stability profile.
Operator: We look forward to sharing our continued progress as we advance these efforts. With that, let's open the call for questions. Operator, we will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.
We look forward to sharing our continued progress as we advance these efforts.
With that let's open the call for questions operator.
We will now begin the question and answer session.
To ask a question you May press Star then one on your telephone keypad.
Operator: If you are using a speakerphone, please pick up your handset before pressing... To withdraw your question, please press star then two (inaudible). At this time, we will pause momentarily to assemble our roster, and our first question will come from Jeff Meecham of Bank of America. Please go ahead. Hi, this is Alex Hammond on behalf of Jeff Meecham.
If you are using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
And our first question will come from Geoff Meacham of Bank of America. Please go ahead.
Hi, This is Alex tenant on for Geoff Meacham. Thank you for taking our question.
Alex Hammond: Thank you for taking our question. So on VGX 3100, will you utilize biomarker data generated in combo with chyogen to bucket patients for the C3 reveal 2 trial? And have you discussed the passport for submission with the FDA? Yeah, thank you, Alex, for the VGX 3100 question. I will turn it over to our program lead, Jeffrey, Dr. Jeffrey Skolnik. Jeffrey?
So on Bgs 3100 <unk>.
The biomarker data generated in combo with Qiagen to bucket patients for the phase III for Neil two trial.
And have you discuss the path forward for submission with the FDA.
Q.
Yes. Thank you Alex for <unk> 3100 question I'll turn it over to our program lead Jeffrey Dr. Jeffrey Skolnik Jeffrey.
Dr. Jeffrey Skolnick: Thanks, Joseph. And Alex, thanks for the question. So, you know, as we said, during the call, Inovio and QIAGEN are continuing to advance the biomarker development, essentially by identifying candidate biomarker signatures for VGX 3100, and to identify those signatures that ideally will be able to, as it were, prognosticate or predict those women that are most likely to respond to VGX 3100. That's the, That's the vision for the biomarker, and we are very encouraged by our progress so far.
Sure Thanks, Joseph and Alex Thanks for the question so.
As we said during the call an opioid and Qiagen are continuing to advance the biomarker development.
Essentially by identifying candidate biomarker signatures for VEGF 3100.
And to identify those signatures that ideally, we'll be able to visit.
Last the Cape or predict.
Those women that are most likely to respond to <unk> 31 country. That's the.
That's the vision for the biomarker and we are very encouraged by our progress so far.
Dr. Jeffrey Skolnick: The biomarker is validated, may have the potential to identify those women, and we are continuing to move that opportunity forward. As you know, both REVEAL-1 and REVEAL-2 are studies that were designed with the potential of the biomarker in mind.
The biomarker validated they have the potential to identify those women.
And we are continuing to move that opportunity forward.
As you know both reveal one and reveal two.
Studies that were designed.
With the potential for the biomarker in mind.
Dr. Jeffrey Skolnick: And so, we've always considered the biomarker to be an extremely important part of this program, to answer your second question. We are now looking to potentially engage with our regulatory colleagues to best understand the path forward for this biomarker. And as you know, Reveal 1 has shown us that, without the biomarker, we can show in the valuable population a statistically significant difference between VGX3100 women clearing and resolving cervical H-cell secondary 1618 in those treated with placebo. So we look forward very much to really understanding how best to utilize the biomarker and to have that conversation with our regulatory colleagues. Thank you for the color.
So we've always considered the biomarker to be an extremely important part of this program.
To answer your second question.
We are now looking to potentially engage with regulatory colleagues.
To best understand the path forward for this biomarker and as you know reveal one has shown us that we can without the biomarker.
So in the Evaluable population.
<unk> with significant difference between <unk> 3100, women clearing and resolving cervical HL secondary to 2018 and those treated with placebo. So we look forward very much to really understanding how best to utilize the biomarker.
To have that conversation with our regulatory colleagues.
Thank you for the color.
Okay. Thank you.
Hartaj Singh: Thank you. The next question comes from Hartaj Singh of Oppenheimer, please go ahead. Hey, everybody, thank you for the question and good and steady progress there. You know, on just your trial, the Innovate trial, Joseph and team, you know, Sanofi and GSK reported a vaccine efficacy of 58%, right? So, at the end of their trial before Omicron really hit, they're looking for approval. Their severe disease endpoint looked pretty good. Moderna's already talking about, you know, bivalent vaccines, Omicron.
The next question comes from hard times.
The timer. Please go ahead.
Hey, everybody. Thank you for the question.
<unk>.
Good and steady progress there.
On just two trial.
The <unk> trial, Joseph and team.
GSK reported a vaccine efficacy of 58% right. So at the end of their trial Colin really hit.
Theyre looking for approval there are severe disease endpoint look pretty good.
Mcdonald's already talking about bivalent vaccines on the crown so it seems youre getting.
Dr. Joseph Kim: So, it seems you're getting, you know, proactive in trying to get ahead of what Omicron can do to current vaccines in development or approvals. You know, how are you thinking if you were to get that protocol amendment, you know, would you essentially market the vaccine, you know, on that disease severity endpoint, hospitalization endpoint, plus the risk-benefit profile, the actual product profile of the vaccine? Is that how you're thinking about it, assuming you get the product profile and a success in phase 3? And I just got a quick follow-up. Yeah, I hire Taj.
Proactive and trying to get ahead of what <unk> can do to current vaccines in development of approvals.
Are you thinking if you were to get that full protocol amendment.
Would you essentially market the vaccine.
On that disease severity endpoint hospitalization endpoint plus the risk benefit profile of the actual product profile of Kodak is that how youre thinking about it assuming you get the product profile and our success in phase III and I just got a quick follow up.
Yeah, Hi touch absolutely.
Dr. Joseph Kim: Absolutely. That's the view that we have. Obviously, Omicron has thrown a curve ball to all vaccine developers with reduction in antibody responses from the original ancestral strain targeted vaccine, which is seen in all of the approved vaccines and some of the ones in testing, including INO4800. What's great about our Omicron data, as described by Kate and myself earlier, is that our T-cell responses, including CD8 killer T-cells, were fully maintained against Omicron. So that really leads us to believe that whether we're targeting the original variants, alpha, beta, gamma, delta, or even Omicron, or even what's next, right?
That's the view that we have.
Obviously, the omicron has thrown a curve ball to all vaccine developers.
With reduction in antibody responses from.
From the original ancestral strained target a vaccine, which all of the approved vaccines and some of the ones in testing, including INR 4800.
Yes.
Great about the <unk> data as described by by Cade and myself earlier is that our T cell responses, including CVA killer T cells were fully maintain again some across so that really leads us to believe that whether we're targeting.
The original variance.
Beta Gamma Delta, where you have the normal crime or even.
What's next right.
Dr. Joseph Kim: The Delta Omicron or the next variant, we have full faith that our CD8 T-cell responses and our overall T-cell responses generated from INO4800 are going to persist and be maintained. So with that in mind, we are taking a proactive step, knowing that our probability of success in demonstrating prevention of severe disease with our vaccine against COVID-19 virus is high. And that's the label that we would look for, and all of the other attributes and target profile that we had mentioned earlier. We believe our INO4800 has a strong position once we get the phase three data and once we get the emergency and full license to demonstrate this benefits as a vaccine against SARS-CoV-2. Yeah, great, great, Joe. I mean, your in vitro data, you know, matches up pretty well against, you know, some of the commercial and vaccines and approval. Just a quick question on the WHO trial.
Soma kron ore or the next varian.
Have full faith that our Cta T cell responses in our overall T cell responses.
Generated from INR 48, Andre this is going to persist.
And be maintained so with that in mind, we are taking a proactive step.
Knowing that our.
Our probability of success.
Demonstrating.
Prevention of severe disease with our vaccine.
Against COVID-19 virus.
Hi.
And that's the <unk>.
Labor that we would look for and all of the other attributes and target profile that we have mentioned earlier.
We believe our INR 4800 has a strong <unk>.
<unk> once we get the <unk>.
Phase III data and once we get the emergency and for licensure to demonstrate.
This.
Benefits.
As a vaccine against.
Sorry <unk>.
Hartaj Singh: Are they planning on doing any protocol amendments there, you know, to also kind of support the Omicron or maybe future variants, just any updates there? In fact, Yeah, you know, as a process, you know, WHO only speaks for WHO. So we're not privy to speaking for them.
Yes, great Great Joe I mean, you're in vitro data matches up pretty well against some of the commercial vaccine can approval just quick question on <unk>.
Trial.
Are they planning on doing any protocol amendments there too.
Also kind of.
For the on the corner, maybe future bearings, just any updates there. Thanks for the question.
Dr. Joseph Kim: But what I can tell you is Omicron has equally impacted all vaccines being developed and trials in, in, in currently undergoing. So, as you know, solidarity trial vaccines are run and sponsored by the WHO, and they have full control, and we have full confidence that they will be able to execute the trial as they see most appropriately. So far, everything is moving as they had stated in the fall. Great. Thank you, Joe.
Yes.
That's a process.
WH show me speaks for that we chose.
We're not privy to speaking for them, but what I can tell you is omicron has equally impacted all vaccines being developed.
And trials.
And.
Currently undergoing so ashwin the solidarity trial vaccines as.
Ron and sponsored by the <unk> show and they they have the full control and.
Sure.
We have full confidence that they will be able to execute.
The trial.
The C. Most appropriately so so.
So far everything is moving as they had.
Stated in the fall.
Great. Thank you Joe.
Yes, thanks attached.
Gregory Renzo: Yep, thanks for time, and next question comes from Gregory Renzo of RBC Capital Market. Please go ahead. Hi, this is Ying Wong from Gregg.
Our next question comes from Gregory Zhao of RBC capital markets. Please go ahead.
Hi, this thinking long term Greg. Thank you for taking our question maybe.
Ying Wong: Thank you for taking our question. Maybe first, a question on 4800. I was just wondering if you could, you know, provide some more color on your expectations around steps to seek regulatory approval to amend the primary endpoint and the timeline for that. And also, do you expect a change in trial size due to the change in primary endpoint? Yeah, thanks for that great question. So, the steps to getting the primary endpoint amended are modifying and amending the protocol and, and, and getting them approved through various regulators who are overseeing innovative trials in their respective countries.
Maybe first a question on 4800 I was just wondering if you could provide some more color on your expectation.
Around the stats to seek regulatory approval and met the primary endpoint and the timeline for that.
And also do you expect a change in trial size due to the change at primary endpoint.
Yes.
Yes, thanks for that great question. So.
The steps to getting the.
Primary endpoint amended is.
Modifying and amending the protocol.
And getting them approved through various regulators who are overseeing.
And of the trial.
In their respective countries.
Dr. Joseph Kim: So we expect that to occur in the next, you know, as expediently as possible across these regulatory bodies and their local ethics committees. We think we have a strong position in because of our T cell maintenance against Omicron, as well as other variants of concern. I think we have a very strong case in that regard. In terms of the sizing, you know, that is based on severe case rates, including hospitalization, death, and mortality, and such across various territories where Innovate is being tested.
So we expect that to occur in the next.
As expediently as possible across these regulatory bodies.
And their local ethics committees.
We think we have a strong position and because of our T cell maintenance against all Mccann.
As well as other variants of concern.
I think we have a very strong case in that regard.
In terms of the sizing.
That is based on the severe.
Severe case rates, including hospitalization.
<unk>.
And such.
Cross various territories that innovate as being.
Tested.
Dr. Joseph Kim: And we don't expect to significantly change the sample size at this time. But, of course, we are evaluating all of this real-time information that is fed into our Innovate trial execution. Thank you.
And we don't expect to significantly change the sample size at this time, but of course, we are evaluating all of those.
Real time information that gets fed into our innovate trial execution.
Great. Thank you I appreciate that and maybe another question on 3100, yes.
Ying Wong: And maybe another question on 3100, just wondering when we should expect to learn more granularity on the timeline for review to trial readout? Just wanted to clarify if there were any design adjustments in the trial.
Wondering when should we expect to learn more granularity on the timeline for reveal two trial readout.
Just wanted to clarify if there were any design adjustments of the trial. Thank you.
Yes.
Dr. Joseph Kim: I'm going to take it, and if there's a follow-up question, I will let our expert, Dr. Skolnik, address it. But we fully enrolled about 200 participants in Reveal-2 in the fourth quarter. It's the last patient in 40 weeks of trial follow-up. So our projection is we will have preliminary data on safety, immunogenicity, and efficacy in the fourth quarter of 2022. And, no, we haven't had any changes to the Reveal-2 protocol. It's identical to Reveal-1, except the follow-up, safety follow-up, is one month instead of one year. Great. Thank you very much. Yeah, thank you, and then his question comes from Stephen Miley of Cephal. Please go ahead. Yeah, good afternoon. Thanks for taking the questions. Hey, I'm Leo Joseph.
I'm going to take it and if there is a follow up question that will.
Our expert Dr <unk> addressed it but.
We fully enrolled.
About 200.
Suspense in reveal two.
In the fourth quarter.
It's the last patients in 40 weeks.
Trial follow up sorry projection as we would have.
Preliminary.
Data safety and Immunogenicity and efficacy in.
In the fourth quarter of 2022.
And no we haven't had any changes to reveal two protocol.
It's identical to reveal one except for follow up safety follow up is one months instead of one one year.
Great. Thank you very much.
Thank you.
The next question comes from Stephen Willey of Stifel. Please go ahead.
Yes, good afternoon, thanks for taking the questions.
I see.
Stephen Miley: Are you able to say how many patients were enrolled and innovated at the time of the past? Yeah, no, it's our policy not to provide up-to-date information. But we were, we have a significant number of volunteers who have been dosed, and they will continue to receive the second dose and continue to follow during the pause period. It's just the new enrollment that's paused.
Okay.
Are you able to say how many patients were enrolled in the innovator.
Kind of on pause.
Yes no.
It's our policy not to provide.
The up to date information.
But we were we have significant number of.
Volunteers, who had been dosed.
And they will continue to receive the second dose and Belo during the.
The policy period. This just the new enrollment Thats Pos.
Yes.
Dr. Joseph Kim: Okay, and then maybe just to follow up on the last question, right, so, when you look across stage three, [inaudible] Joe Johnson, M.D. : Vaccine trials, I guess, whether it's know that certain Pfizer and Moderna. You know, the incidence rate of severe disease that has been seen across those studies is anywhere between more than 1000 participants and 1 to 4 to 5,000. So I guess in the context of having- 7,000 to 8,000 patients studied, in a setting where Omicron is presumably generating lower rates of severe disease. I mean, is there a chance that you see, you know, a low single-digit number of severe events?
Okay, and then maybe just a follow up on.
On the last question right. So.
When you look across the phase three.
Vaccine trials, I guess, whether it's <unk> or visor Mcdonough.
At its rate of severe disease that is seen across those studies is anywhere between like 101000 participants.
1% to 4% to 5000 participants so I guess in the context.
<unk>.
Seven to 8000 patient study.
In a setting where omicron is presumably.
Generating lower rates of severe disease, I mean is there.
There a chance that you see.
Low single digit number of severe events.
How do you.
Stephen Miley: And I guess, how do you, How do you contemplate... from a statistical power perspective when you think about not meaningfully changing the size of the study? Yeah, that's, that's a great question. We're still powering our sample size to 90% power. So, Um...
How do you contemplate that.
Typical power perspective, when you think about not meaningfully changing the size of the study.
Yes, that's a great question risk of powering.
Size to 90% power so.
Dr. Joseph Kim: While it is true that the severity of Omicron infection has been reduced by, I believe, 50 to 75% of Delta, we believe the higher instances of infections will equalize out. But so, your point about severe disease incidences being a major driver of us hitting the end point is a fair one. We are, and we have evaluated those impacts, and we expect the sample size to be around 7 to 10,000 as we had projected initially with our innovative trial.
While it is true that.
The severity of mcbrien infection.
Has been reduced by I believe.
52% to 75% of Delta.
We believe the higher instances of infections will equalize out.
But so your point about the.
The severe disease incidence as being a major driver of that.
Yes.
Hitting the endpoint I think Thats a fair one.
We have we are and we have evaluated those impacts and we expect the sample size to be around seven to 10000.
We had projected initially with our innovate trial.
Dr. Joseph Kim: And as I mentioned, we will be continually monitoring those severe disease rates across these territories, but I think we feel fairly good that we should be able to achieve our objectives going forward. Okay, and then maybe just a question for Peter. You know, how should we think about just kind of wearing off that trend during the first half of the year?
And.
As I mentioned, we will be continually monitoring those.
So severe disease rates across these territories.
I think.
We feel fairly good that.
We should be able to achieve our objectives going forward.
Yes.
Okay, and then maybe just a question for Peter.
<unk>.
How should we think about just kind of where opex trends two year during the first half of the year, but there is some uncertainty obviously with any pause but.
Stephen Miley: I know that there's some uncertainty, obviously, with innovate being paused, but should we anticipate a fairly significant step down in the pace of R&D spend in conjunction with the positive? And if there's any... No, we have ongoing efforts in a lot of areas going on with this. So I think you're going to see it remain fairly consistent with the other quarters, running in the $65 million burn range about per quarter.
Should we anticipate.
Fairly significant step down in the pace of R&D spend in conjunction with the Basel.
If there's no.
We have ongoing efforts and a lot of areas going on with this so I think youre going to see it remained fairly consistent.
With the other quarters.
Running in the $65 million.
Burn range about.
Per quarter.
Okay.
Peter Kies: Thank you for taking the question. Thank you, Steve. The next question comes from Roger Song of Jefferies. Please go ahead. Great, thank you for taking our question. So one question is related to the booster. So Joseph, can you just comment, what is the timing will look like for those phase one two data for the booster, heterologers or the homologers, and also what will be the next step for the booster? Yeah, so thank you, Roger.
Thank you for taking the questions.
Thank you Steve.
Sure.
Our next question comes from Roger song of Jefferies. Please go ahead.
Great. Thank you for taking our question. So one question is related to the booster dose.
Joseph can you just comment what is the timing will look like for those phase <unk> data for the.
Sure Heather.
First of all the logos and also what will be the next step for them for the booster regimen.
Peter Kies: The vaccine homologous and heterologous boost trials that's fully enrolled, they expect to have the data in the second quarter of this year. So it's, of course, being run and executed by our partner in China, a vaccine. So we expect the data from that trial sometime in the next quarter. In terms of additional heterologous boosts, you know, we're, We're deeply investigating the feasibility and execution ability of a head-of-all-this boost trial, again, outside the U.S., where we can compare with two of the most prolifically utilized primary vaccines for COVID in viral vector and inactivated vaccines. So we're in the planning and feasibility stage. But if this is a go, we think we can execute this all through 2022. Got it. That's very helpful.
Yes, so thank.
Thank you Roger.
The vaccine homologous end heterologous boost trials.
Fully enroll.
They expect to have the data in the second quarter of this year. So.
Yes of course being run and executed by our partner in China a vaccine.
So we expect that.
Data from that trial some time.
In the next quarter.
In terms of.
Additional hurdle or the boost.
We are.
Deeply investigating the feasibility.
And execution ability of a head of all of the spruce trial again outside the U S, where we can compare with two of the most prolifically utilized primary vaccine for COVID-19 in viral vector and inactivated vaccine. So.
We're in the planning and feasibility stage.
But.
If this is a go.
We think we can execute this.
All through 2022.
Roger Song: Thank you. And also, we know you have your own pan-coronavirus vaccine, 4802. Just any kind of update regarding the program? Yeah, absolutely. Maybe I'll turn to Dr. Broderick to address that.
Got it that's very helpful. Thank you and also we know you have there.
Have your own.
Coronavirus vaccine 48, Oh shoot.
Just any kind of update regarding the progress.
Yes, absolutely.
Ill turn to Dr. Broderick.
Yes.
Okay.
Dr. Kate Broderick: Okay. Yes, thanks very much. A great question.
Yes, thanks, very much great question.
Dr. Kate Broderick: Really, you know, pan-COVID vaccines are very pertinent in the discussion at the moment. And that's something that the whole field is very interested in. We certainly are very excited about what our pan-coronavirus vaccine, INO4802, has shown preclinically. And we continue to develop it. But really what's particularly striking about our COVID vaccines across the board, including INO4800, is this pan-COVID T-cell response that we're able to generate thus far.
Really you don't Pan Covid vaccines are very part in the discussion at the movement not something that.
The whole field is very interested and we certainly are very excited about for am.
Our Pan Coronavirus vaccine INR 42, two has shown pre clinically and we continue to develop it and.
And really whats.
What's particularly striking about our COVID-19 vaccines across the board, including Iron ore <unk> hundred is this pan Covid T cell response that we're able to January thus far so even in the face of the.
Dr. Kate Broderick: So even in the face of the, you know, the wrench in the works that was Omicron, we're still maintaining those all-important T-cell responses. So we're very excited and very encouraged about what our vaccines are able to do.
A wrench in the works that was all mccrone, we're still maintaining booz all important T cell responses. So so we're very excited I'm very encouraged by our vaccines are able to generate.
Roger Song: Okay. Thanks for taking all the questions. Yeah, thank you. The next question comes from Yi Chen of H.C. Wainwright. Please go ahead.
Got it okay. Thanks for taking my question.
Thank you.
Our next question comes from <unk> Chen of H C. Wainwright. Please go ahead.
Yi Chen: Thank you for taking my question. My first question is, do you think it is possible that once you have the, The biomarker fully developed for the VGX 3100. You will need to conduct an additional clinical trial using the biomarker. Hi, that's a very good question for VGX 3100.
Thank you for taking my question. My first question is do you think.
It is possible that.
Once you have the.
The biomarker fully developed for the VJ sorry 100.
You will need to conduct an additional clinical trial using a biomarker.
Alright.
That's a very good question for Bgs 3100, again, I'll turn it over to Dr. <unk>.
Dr. Joseph Kim: Again, I'll turn over to Dr. Skolnik with this question. Yeah, thanks. That's a great question. And, you know, as we mentioned before, remember that both reveal one and reveal to always anticipated, examining, looking at this potentially predictive biomarker. So it has always been our intention to ask a biomarker question on both reveal one and reveal two. And ultimately, those opportunities are, in truth, already in the protocols.
With this question.
Yes, Thanks, Greg.
Great question.
As we mentioned before.
Remember that both reveal one and reveal two.
As anticipated.
Examining looking at this potentially predictive biomarker.
So it has always been our intention to ask a biomarker question, both reveal one and reveal two and.
And ultimately those opportunities are in truth already in the protocols. So ultimately to answer your question clearly we're going to explore all of the opportunities that we have with respect to these two studies with our regulatory colleagues.
Dr. Jeffrey Skolnick: So ultimately, to answer your question clearly, we're going to explore all of the opportunities that we have with respect to these two studies with our regulatory colleagues, and certainly moving forward will continue to have that conversation with them. But again, it's always been our intention to examine and potentially to utilize this biomarker. And the next question is, with respect to 5401 in GBM, what is the next step and what are the expected catalysts for this program?
And certainly moving forward.
Continue to have that conversation with them.
But again, it's always been our intention to examine potentially to utilize this biomarker.
Got it.
And the next question is with respect to <unk>.
<unk> 401.
Yeah.
What is the next step and what are the expected catalysts for this program this year.
Dr. Jeffrey Skolnick: While we're continually following. We're continually following. These patients, you know, Jeffrey Skolnick shared with you our OS24 data, which is very encouraging compared to the standard of care in this very hard-to-treat cancer types in GVM. So, we'll continue to follow them.
While we are continually following.
We're continually following.
These patients.
Jeffrey Skolnik shared with you our OS 24 data, which is very encouraging compared to.
The standard of care.
In this very.
Hard to treat cancer.
Cancer types in GBM.
So we will continue to follow them.
Dr. Joseph Kim: We're evaluating our next steps with our collaborator, Regeneron. So, you know, I think the overall survival as well as the follow-up of these surviving participants will give us additional insight into the path forward for this program. And my last question is, when do you expect to report results from a Phase II trial of 4700? The Merch, Yeah, so I'm going to turn that over to Kate.
Evaluating our next steps with our collaborator Regeneron.
So.
I think the overall survival as well as the.
The following of the.
This surviving participants.
<unk> gave us additional insights.
Into the past.
Forward for this program.
Got it and my last question is when do you expect to report results from the Phase III trial 47 hundreds.
The mers.
Yes so.
I'm going to turn that over to Kate.
Okay.
Kate: I'm so sorry. Could you repeat the question for me? The line went bad for a minute.
I'm sorry could you repeat the question for me the line.
Operator: When do you expect to report results from the phase 2 trial of the MERS vaccine? Great question. So we're currently still enrolling patients at the moment. We're about halfway through now, so probably by Q3 of this year. Okay, thank you. Absolutely.
For a minute.
When do you expect to report results from the Phase III trial.
Merce messaging.
Yeah. Great question. So we are currently still enrolling and the movement.
We through now so probably by Q3 of this year.
Okay. Thank you.
Yes, absolutely.
Kate: Inclusive question and answer session. I would like to turn the conference back over to Joseph Kim for any closing remarks. Thank you very much for listening to our fourth quarter and full year 2021 conference call. We have an exciting year ahead of us in 22 with all of these programs, and we look forward to sharing them with you in the coming months. Thank you very much.
This concludes our question and answer session I would like to turn the conference back over to Joseph Kim for any closing remarks.
Thank you very much for listening to our fourth quarter and full year 2021.
Since call.
We have an exciting year ahead of us in 'twenty two with all of these programs.
And we look forward to sharing them with you in the coming months. Thank you very much.
Dr. Joseph Kim: Researchers in the field. Our conferences help to provide a more comprehensive understanding of the challenges and opportunities that exist. We are committed to providing the best information and resources available to all participants, Thank you for attending today's presentation, and you may now disconnect Thank you for attending today's presentation, and you may now disconnect, © The Bulletproof Executive 2013
The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.
[music].