IMUNON, Inc. Third Quarter 2022 Conference Call Monday

Quarter 2022 Conference Call

stand by. Good morning. My name is Marlise and I will be your operator today. At this time, I would like to welcome you to IMUNON's

third quarter 2022 financial results conference call. All lines have been placed on mute to prevent any background noise. Following the

speakers' prepared remarks there will be a question-and-answer session. At that time, you may press star one on your phone to ask

a question. Please keep in mind, if you are using a speaker phone, you must release your mute function to allow the signal to reach our

equipment. Again, that's star one to ask a question during the Q&A session.

would now like to turn the call over to Kim Golodetz. Please go ahead.

you, and good morning everyone. This is Kim Golodetz with LHA.

to IMUNON's third quarter 2022 financial results and business update conference call. As has been IMUNON's practice and as

noted by the operator, prepared remarks will be followed by a question-and-answer session.

today's call management will be making forward-looking statements regarding IMUNON's expectations and projections about future

events. In general, forward-looking statements can be identified by terminologies such as expects, anticipates, believes or other similar

expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those

set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed,

and actual results may differ materially from such statements. In particular, there is significant uncertainty about the duration and

impact of the COVID-19 pandemic. This means results could change at any time, and the contemplated impact of COVID-19 on IMUNON's

operations, financial results and outlook is the best estimate based on the information for today's discussion.

also caution that the content of this conference call is accurate only as of the date of the live broadcast, November 14th,

2022. IMUNON undertakes no obligation to revise or update comments made during this call, except as required by law.

that said, I would like to turn the call over to Dr. Corinne Le Goff, President and Chief Executive Officer. Corinne?

you, Kim, and good morning, everyone.

me today is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Khursheed Anwer, our Chief Scientific Officer and Dr. Nicholas

Borys, our Chief Medical Officer, will be available during the Q&A session to answer your questions regarding our development programs

with PLACCINE, our prophylactic vaccine modality, and GEN-1, our IL-12 immunotherapy for the treatment of advanced Ovarian Cancer.

I am going to spend most of my time speaking about PLACCINE, as our recent progress in developing this modality has been extraordinarily

is one of IMUNON's DNA-based platform technologies that relies on DNA delivery with novel synthetic delivery systems that are independent

of viral vectors or devices. DNA vectors encompass molecular elements that are designed to improve the immune response by targeting multiple

antigens of a pathogen or multiple variants of the same antigen. IMUNON has produced a family of DNA vaccine vectors expressing one or

more SARS-CoV-2 surface antigens and we have demonstrated expression of the encoded genes. This promising vaccine approach has broad

applicability in infectious diseases and also in oncology.

have been conducting preclinical proof-of-concept studies on a DNA vaccine candidate targeting the SARS-CoV-2 virus in order to validate

our modality. To date, we are delighted with the results, which bode well for our ability to broaden applications to other pathogens.

before I dive into the data, I want to start by telling you why I am excited about the potential of our DNA-based vaccine modality.

the market opportunity is very large. Vaccines are the most powerful and cost-effective way to protect the health of billions of people

COVID, the global market for preventive vaccines was about $35B, roughly shared between four key players (Sanofi, Merck, GSK and Pfizer).

The market grew to $61B in 2021 and is expected to reach $125B in 2028. New viruses are being discovered all the time. In fact, over

the past 40 years, 80 new pathogenic viruses have been discovered, for an average of 2 new viruses per year. When it comes to the development

of vaccines, if you consider all the viruses known to mankind from 100 years ago, commercial vaccines have been approved for only 4%

clearly there is a large addressable market providing significant room for new technologies. And that brings me to my second point: I

believe that DNA has the potential to be an entirely new class of vaccines. In particular, our PLACCINE modality has the potential to

represent a viable alternative to current commercial vaccines.

vaccine technologies -- attenuated virus, protein sub-unit, mRNA and viral DNA vector vaccines have shortcomings that we want to address.

There are five important attributes that regulators and governments around the world want to see in the next generation of prophylactic

vaccines and we are addressing each with our technology:

data we've generated to date is extremely encouraging.

proof-of concept mouse immunogenicity studies we have demonstrated robust IgG, neutralizing antibody and T-cell responses with our PLACCINE

vaccines. The data also demonstrated the ability of our PLACCINE vaccines to protect a SARS-CoV-2 mouse model in a live viral challenge.

In the study, mice were vaccinated with a PLACCINE vaccine expressing the SARS-CoV-2 spike antigen from the D614G variant, the Delta

variant or a combination vaccine expressing both variants. All three vaccines were found to be safe and elicited IgG responses and inhibited

viral load by 90-95%. The key exciting finding is that our bivalent vaccine was equally effective against both variants of the SARS CoV-2

virus we tested. The murine model data also suggest that our approach provides not only flexibility, but also the potential for efficacy

that is at least comparable to benchmark mRNA commercial vaccines with durability of protection expected to exceed six months.

encouraging results from the mouse study formed the basis of a non-human primate challenge study. The partial results from this ongoing

study were reported last month. In the study, we are examining a single plasmid DNA vector containing the SARS-CoV-2 spike antigen from

the D614G variant that is formulated with a synthetic DNA delivery system and administered by intramuscular injection.

vaccinated Cynomolgus monkeys with either the PLACCINE vaccine or a commercial mRNA vaccine three times over 84 days. Analyses of blood

samples for IgG and neutralizing antibodies showed evidence of immunogenicity both in PLACCINE and mRNA vaccinated subjects. In a head-to-head

comparison, the protection efficiency as measured by viral clearance following challenge with the SARS-CoV-2 virus was equivalent between

PLACCINE and the commercial mRNA vaccine. We look forward to the completion of this study and the final report by the end of this year.

Also of importance, in an ongoing stability study the physio-chemical properties and immunogenicity of the PLACCINE vaccine did not change

during storage at 4 Celsius for up to six months. It is a clear advantage over mRNA vaccines with respect to transport and flexibility.

what is next for PLACCINE?

the highly encouraging data to date, and the potential for key commercial advantages over existing vaccines, we have moved to broaden

and strengthen the platform and we entered into an agreement with Acuitas Therapeutics to evaluate our PLACCINE nucleic acid constructs

formulated with their proprietary lipid nanoparticle delivery system, or LNP. Acuitas is known for its LNP systems for mRNA vaccines,

having worked with Pfizer/BioNTech on their commercial vaccine. Our work with Acuitas will focus on various LNP formulations for gene

expression and immunogenicity in murine models. The combinations of our technologies will expand our delivery portfolio, thereby enabling

us to pursue a broad spectrum of formulation capabilities and delivery modalities with greater potential to improve currently available

vaccines against a multitude of pathogens and also to develop novel cancer vaccines.

that our proof-of concept studies using SARS-CoV-2 have yielded highly promising results, we are considering an option to developing

a multivalent PLACCINE DNA vaccine as a SARS-CoV-2 booster vaccine and expanding PLACCINE vaccine to other pathogens.

respect to developing a SARS-CoV-2 booster vaccine and selecting the next pathogens for development, last week we held a "tech

watch" with The Biomedical Advanced Research and Development Authority, the division of HHS responsible for strategic preparedness

and response. Our discussion with BARDA focused on the characteristics of PLACCINE for developing the vaccines of the future.

presentation was very well received. There was a clear reaction that IMUNON has made real progress making plasmid vaccines more effective.

They were impressed with our ability to make DNA technology a potential strong contender in further vaccine development.

our near-term plan is to request a pre-IND meeting for a Covid booster based on the next variants of interest, we also plan to file a

second IND for another pathogen. We are looking for BARDA's input on the vaccines of the future and hope to receive some non-dilutive

funding from them to apply to our development programs.

used the term "vaccines of the future," and that is exactly what our vision is - to be the provider of safe and

effective vaccines of the future that are superior to current vaccines in durability and breadth of protection, stability at workable

temperatures, speed in manufacturing process that allows for quick response to changing pathogens, and have better compliance for mass

immunization by not requiring a device or virus.

let's turn to our clinical oncology program, which utilizes GEN-1 developed from our TheraPlas modality. GEN-1 is a DNA plasmid

that is administered into the abdomen of patients to induce cells to manufacture the potent natural immuno-modulating agent interleukin-12

(or "IL-12"). Our clinical studies have established that GEN-1 produces IL-12 and is favorably impacting the tumor microenvironment.

These data were published in the Journal of Cancer Clinical Research in 2021 and are the basis of the OVATION 2 Study.

OVATION 2 Study is designed to determine how safe and active GEN-1 is in patients with advanced ovarian cancer who will be undergoing

neoadjuvant chemotherapy (or NACT). NACT is designed to shrink tumors as much as possible for optimal surgical removal. Following surgery,

another three cycles are administered to address any remaining tumor. In the OVATION 2 Study GEN-1 is added to standard-of-care NACT

to boost the natural immune response to the cancer. OVATION 2 is a randomized Phase II study that compares patients treated with standard

NACT against patients who get standard NACT plus GEN-1. The results of this study will help us determine the course of registration for

GEN-1 in ovarian cancer. As previously announced, 110 patients from more than 20 centers in the U.S. and Canada have been enrolled in

important to note that since the OVATION 2 Study was initiated several years ago, a new class of drugs called PARP inhibitors have been

approved that benefit ovarian cancer patients who have a specific gene mutation called BRCA positive or HRD. In our study, when we focus

on the BRCA negative patients, who have not received a PARPi we can see that GEN-1 is providing a progression-free survival benefit.

Please note this data is interim and is not statistically significant, but it serves as a basis for our interest in continuing evaluating

BRCA negative population and initiating combination studies with other therapies such as Avastin or checkpoint inhibitors.

interim data has been reviewed by our independent data and safety monitoring board and experts in the field of ovarian cancer. They agree