On March 28, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, reported financial results for the year ended December 31, 2023 (Press release, IMUNON, MAR 28, 2024, View Source [SID1234641567]). The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.
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Highlights of 2023 and recent weeks include the following:
Reported interim progression-free survival (PFS) and overall survival (OS) data with IMNN-001 in the Phase 2 OVATION 2 Study in patients with advanced ovarian cancer. Interim data from the intent-to-treat (ITT) population showed an approximate 30% delay in disease progression or death in the treatment arm compared with the control arm, and preliminary OS data showed an approximate nine-month improvement in the treatment arm over the control arm.
Enrolled four patients in a Phase 1/2 clinical trial evaluating IMNN-001 in combination with bevacizumab in patients with advanced ovarian cancer at the University of Texas MD Anderson Cancer Center, and recently added Memorial Sloan Kettering Cancer Center as a clinical site for this study.
Announced results from a non-human primate study confirming PlaCCine as a viable modality for the development of the next generation of prophylactic vaccines.
Reported pre-clinical data demonstrating PlaCCine vaccines elicit robust and more durable T cell responses than commercial mRNA vaccines in animal models, signaling that PlaCCine vaccines may provide greater protection against reinfection, hospitalization or death.
Submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first quarter of 2024 for a Phase 1/2 proof-of-concept clinical trial with a seasonal COVID-19 booster vaccine.
Launched a new current Good Manufacturing Practices production facility to efficiently support R&D with significantly lower costs for infectious disease vaccines, and DNA-based immuno-oncology therapies.
"IMUNON has a dedicated management team to advance our two platform technologies and execute our strategic plan," said Mr. Michael Tardugno, IMUNON’S Executive Chairman. "We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer. If the interim data are confirmed in the final readout, the observed PFS benefit would represent a clinically meaningful outcome. We also remain on track to begin a Phase 1 proof-of-concept clinical study in the second quarter of 2024 with a seasonal COVID-19 booster vaccine, following FDA clearance of our IND application. Our objective is to confirm the safety and immunogenicity of our clinical vaccine in humans. Based on these results, we will advance discussions with potential partners to continue development of the platform."
"IMUNON made significant progress during 2023, in particular with advancing our clinical programs in immuno-oncology with IMNN-001, our gene-mediated IL-12 immunotherapy. In September we reported interim PFS and OS data in our OVATION 2 Study suggesting a delay in disease progression or death in the treatment arm of approximately 30% compared with the control arm, with the hazard ratio nearing the study objective. Preliminary OS data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. Subgroup analyses suggest patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with neoadjuvant chemotherapy (NACT) only," he added.
Our PlaCCine modality continues to advance with very encouraging data. We demonstrated the validity of this proprietary technology in prophylactic vaccines, with impressive preclinical proof-of-concept data not only in COVID-19, but also in a multiple of other pathogenic viruses. We also completed the evaluation of our vaccines in non-human primates. The final data from these studies show excellent immunological response and viral clearance. In a recent mouse study, we demonstrated that a single dose of our PlaCCine vaccine without a booster dose produced longer duration of IgG responses and higher T cell activation than an mRNA vaccine. We have also demonstrated continued drug stability at standard refrigerated temperature of 4C for more than 12 months, representing a significant commercial advantage over commercial mRNA-based vaccines.
Given the high costs and long lead times of third party CMOs, we have strategically invested in, and completed development of in-house pilot manufacturing capabilities for DNA plasmids and synthetic delivery systems. Our scientists can now select any protein from the human or pathogen proteomes to be engineered. Our labs also can conduct testing and run experiments in a variety of animal disease models independently supporting bench-to-bedside development of our novel therapies and vaccines. These capabilities are expected to allow us to realize our goal of attracting strategic partners while minimizing dependence on vendors so that we control both the costs and the development timelines.
"We are excited about the key value-creating milestones we face in 2024. The potential for advances in treating late-stage ovarian cancer may be within reach, while a better vaccine platform technology holds tremendous commercial promise. We look forward to continuing to create value for our stockholders and for patients," Mr. Tardugno concluded.
RECENT DEVELOPMENTS
IMNN-001 Immunotherapy
Reported Interim PFS and OS Data in OVATION 2 Study in Advanced Ovarian Cancer. In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study. This study is evaluating the dosing, safety, efficacy and biological activity of intraperitoneal IMNN-001 in combination with NACT in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.
The open-label study is directional and designed with an 80% confidence interval to show an approximate 33% improvement in PFS, when comparing the treatment arm (NACT + IMNN-001) with the control arm (NACT only). The secondary endpoints include OS, objective response rate, pathological response, surgical response and serologic response. The final readout of this study is expected in mid-2024. A positive readout would inform next development steps.
Interim data from the ITT population showed efficacy trends in PFS, demonstrating a delay in disease progression in the treatment arm of approximately three months compared with the control arm, with the hazard ratio nearing the study objective. Preliminary OS data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm.
Non-prespecified subgroup analyses suggest that patients treated with a PARPi as maintenance therapy had longer PFS and OS if they were also treated with IMNN-001, compared with patients treated with NACT only.
The median PFS in the PARPi + NACT group and the PARPi + NACT + IMNN-001 group was 15.7 months and 23.7 months, respectively.
The median OS in the PARPi + NACT group was 45.6 months and has not yet been reached in the PARPi + NACT + IMNN-001 group.
Continued benefits were seen in other secondary endpoints including an approximately 25% higher R0 tumor resection score and a doubling of the CRS 3 chemotherapy response score to approximately 30% in the treatment arm, versus 14% in the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. Safety analyses continue to show good tolerability of IMNN-001 in this setting.
Began Treatment in a Phase 1/2 Clinical Trial Evaluating IMNN-001 in Combination with Bevacizumab (Avastin) in Advanced Ovarian Cancer. In October 2023, the first patient was enrolled in this trial at the University of Texas MD Anderson Cancer Center. This trial is expected to enroll 50 patients with Stage III/IV ovarian cancer. Patients undergoing frontline neoadjuvant therapy will be randomized 1:1 to receive standard chemotherapy plus bevacizumab, or standard chemotherapy plus bevacizumab and IMNN-001. The trial’s primary endpoint is detection of minimal residual disease (MRD) by second-look laparoscopy and the secondary endpoint is PFS. This trial will also include a wealth of translational endpoints aimed at understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers.
In February 2024, the Company announced that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in this clinical trial. A total of four patients have been enrolled in the study to date.
PlaCCine: Developing the Prophylactic Vaccines of the Future
Preclinical Data for IMUNON’s PlaCCine DNA-Based Vaccine in SARS-CoV-2 Published in Peer-Reviewed Journal Vaccine. In February 2024, the Company announced that an article titled "Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functionalized polymer" was published in the peer-reviewed journal Vaccine, by Elsevier.
The article is available at View Source(24)00077-X.
The study described in the article used IMUNON’s proprietary formulation against the spike proteins from two SARS-CoV-2 variants, both alone and in combination. Data from the study show:
IMUNON’s proprietary formulation of functionalized polymer protected DNA from degradation and enhanced protein expression, while the combination with an adjuvant led to an increase in immunogenicity.
PlaCCine vaccines are stable for up to one year at 4°C and at least one month at 37°C.
Vaccination with PlaCCine resulted in the induction of spike-specific neutralizing antibodies and cytotoxic T cells.
In the in vivo challenge model, the vaccine-induced immune response was capable of suppressing viral replication.
Multiple inserts can be cloned into the PlaCCine backbone (a plug-and-play strategy), therefore allowing for an immune response with broader protection.
IMUNON’s Vice President of R&D Presented at the Vaccines Summit-2023. In November 2023, Jean Boyer, Ph.D. delivered a presentation titled "Robust Immunogenicity and Protection with PlaCCine: A Novel DNA Vaccine Delivered with a Functionalized Polymeric Delivery System" during the "New Vaccine Development" session at the Vaccines Summit-2023 in Boston. The presentation included updated data related to IMUNON’s PlaCCine SARS-CoV-2 DNA vaccine, including studies showing PlaCCine expresses spike proteins in mice and primates demonstrating induction of spike-specific neutralizing antibody responses and CD8 and CD4 spike-specific cellular responses. The induced immune responses in vaccinated mice were maintained for up to 14 months after vaccination. The presentation also showed that in both primates and mice, the induced immune responses reduced lung viral loads by more than 90%. In mouse studies, robust immune responses were observed following a single intramuscular injection of either PlaCCine SARS-CoV-2 DNA vaccine or a novel PlaCCine Lassa Virus DNA vaccine.
IMUNON’s Chief Science Officer Presented at the 3rd International Vaccines Congress. In October 2023, Khursheed Anwer, Ph.D. delivered a presentation titled "A DNA-based Vaccine Technology Independent of Virus or Device" at the 3rd International Vaccines Congress in Boston. The presentation described the multiple advantages of the PlaCCine modality over current commercial vaccine platforms. The presentation also described the versatility of the PlaCCine modality, demonstrating activity against Marburg and influenza viruses in collaboration with the Wistar Institute, and activity against Lassa virus being evaluated at the NIH/NIAID.
Corporate Developments
Received $1.3 Million in Non-Dilutive Funding from the Sale of New Jersey Net Operating Losses. In March 2024, the Company received $1.3 million in net cash proceeds from the sale of approximately $1.4 million of its unused New Jersey net operating losses (NOLs). The NOL sales cover the tax year 2022 and are administered through the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer (NOL) program. This non-dilutive funding further strengthened the Company’s balance sheet.
Financial Results for the Year Ended December 31, 2023
IMUNON reported a net loss for 2023 of $19.5 million, or $2.16 per share, compared with a net loss for 2022 of $35.9 million, or $5.03 per share. Operating expenses were $21.0 million for 2023, a decrease of $4.4 million or 17% from $25.4 million for 2022. The Company recognized tax benefits from the sale of its New Jersey NOLs of $1.3 million and $1.6 million in 2023 and 2022, respectively.
Research and development (R&D) expenses were $11.3 million for 2023, a decrease of $0.4 million from $11.7 million for 2022. Costs associated with the OVATION 2 Study were $1.2 million and $1.5 million for 2023 and 2022, respectively. Costs associated with the Phase 3 OPTIMA Study were de minimis for 2023 compared with $1.0 million for 2022. Other clinical and regulatory costs were $1.8 million for 2023 compared with $1.9 million for 2022. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study, as well as development of the PlaCCine DNA vaccine technology platform, were $6.0 million for 2023 compared with $6.1 million for 2022. CMC costs increased to $2.3 million for 2023 compared with $1.2 million for 2022 due to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems in 2023.
General and administrative expenses were $9.7 million for 2023 compared with $13.7 million for 2022. This decrease was primarily attributable to lower non-cash stock compensation expense ($1.3 million), lower employee-related costs ($0.8 million), lower legal costs ($1.0 million), lower insurance costs ($0.6 million) and lower public company expenses ($0.2 million), offset by higher consulting fees ($0.2 million).
Other non-operating income was $0.2 million for 2023 compared with other non-operating expenses of $12.5 million for 2022. This increase was attributable to the following:
Investment income from the Company’s short-term investments was $1.2 million for 2023 and $0.5 million for 2022.
In June 2021, the Company entered into a $10.0 million loan facility with Silicon Valley Bank (SVB). The Company immediately used $6.0 million from this facility to retire all outstanding indebtedness with Horizon Technology Finance Corporation. In connection with the loan facility, the Company incurred $0.2 million in interest expense in 2023 compared with $0.5 million in 2022. In the second quarter of 2023, the Company terminated the SVB Loan Facility, paid early termination and end-of-term charges and recognized $0.3 million as a loss on debt extinguishment.
In 2022, the Company recognized (i) an impairment charge of $13.4 million due to the write off of In-Process Research & Development (IPR&D) assets and (ii) a non-cash gain of $5.4 million due to the write-off of the earnout milestone liability because of the requirements not being achieved.
In 2022, the Company incurred additional interest expense attributable to the one-time payment of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $28.5 million of Series A & B convertible redeemable preferred stock.
Net cash used for operating activities was $19.0 million for 2023 compared with $23.1 million for 2022. This decrease was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $28.5 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022. Cash used in financing activities was $3.6 million for 2023 from the pay-off of the SVB loan ($6.4 million), offset by sales under the Company’s At-the-Market Equity Facility ($2.8 million). This compares with cash provided by financing activities of $6.7 million for 2022 resulting from an at-the-market equity offering ($6.2 million) and sales under the Company’s At-the-Market Equity Facility ($0.5 million).
The Company ended 2023 with $15.7 million in cash, investments and accrued interest receivable. Along with future planned sales of the Company’s remaining $1.3 million of New Jersey NOLs, the Company believes it has sufficient capital resources to fund its operations into the fourth quarter of 2024.
Conference Call and Webcast
The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today. To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call. A live webcast of the call will be available here.
The call will be archived for replay until April 11, 2024. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 8601697. A webcast of the call will be available here for 90 days.