On February 27, 2025 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Altimmune, FEB 27, 2025, View Source [SID1234650726]).

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"2024 was a year of important progress for Altimmune as we continued to advance pemvidutide in multiple indications," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "As announced previously, we completed enrollment of the IMPACT Phase 2b trial of pemvidutide in MASH and are on track to report top-line data in the second quarter of 2025. IMPACT was one of the fastest enrolling biopsy-driven Phase 2b MASH trials, which we believe reflects the attractiveness of pemvidutide to patients and providers, specifically the compound’s potent reduction of both liver fat and body weight. Based on the totality of the data generated to date, including multiple non-invasive biomarkers of liver inflammation and fibrosis, we are confident that pemvidutide will achieve statistically significant improvements in biopsy endpoints, both MASH resolution and fibrosis improvement, at trial readout. We anticipate holding an end-of-Phase 2 meeting with FDA by the end of 2025 to gain alignment on the registrational Phase 3 program."

Dr. Garg continued, "In-line with our previously stated plan, we submitted INDs for two additional indications in Q4 2024, and I am excited to report that both have received FDA clearance, and we are on track to initiate Phase 2 efficacy studies mid-2025. We look forward to providing information on these additional indications and our development plans during the upcoming virtual R&D Day on March 13. We believe that these indications reinforce our vision for the broad therapeutic utility of pemvidutide."

Recent Highlights and Anticipated Milestones

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

IMPACT, the Company’s biopsy-driven Phase 2b trial of pemvidutide in MASH, is on track for top-line data readout in Q2 2025
IMPACT is evaluating the efficacy and safety of pemvidutide in approximately 190 subjects with biopsy-confirmed MASH.
With a successful readout from IMPACT, pemvidutide would be the first incretin to achieve statistical significance on MASH resolution and fibrosis improvement at only 24 weeks of treatment, and the first therapy in any class to achieve these endpoints along with meaningful weight loss at this timepoint.
Additional Indications for Pemvidutide

The Company submitted IND applications for pemvidutide in two additional indications at the end of 2024, both of which have been cleared by FDA
Phase 2 trials in additional indications are expected to initiate in mid-2025.
R&D Day March 13, 2025

Altimmune will hold a virtual R&D Day on Thursday, March 13, 2025 at 12:00pm Eastern Time
The program will feature presentations on pemvidutide development from Company management and key opinion leaders in obesity, MASH and the two additional indications which will be disclosed during the event.
Details of the R&D Day, including registration information, are available at View Source Additional information related to the event will be posted to this site.
Corporate Update

The Company strengthened its Board of Directors with the appointments of pharmaceutical industry veterans Teri Lawver and Jerry Durso
Ms. Lawver has nearly 30 years of experience spanning pharmaceuticals, medical devices and consumer health technology. She most recently served as Executive Vice President and Chief Commercial Officer of Dexcom. Previously she served for over 20 years at Johnson & Johnson in various leadership roles, including as Global Vice President for the Cardiovascular & Metabolism therapeutic area and Worldwide Vice President for the Immunology business at Janssen Pharmaceuticals.
Mr. Durso brings more than 30 years of leadership experience in the life sciences industry, most recently serving as Chief Executive Officer at Intercept Pharmaceuticals where he built a successful rare liver disease franchise and ultimately led the Company through its acquisition by Alfasigma. Prior to Intercept, he spent over two decades in a variety of leadership roles at Sanofi, including Chief Commercial Officer for its U.S. Pharmaceuticals business.
Financial Results for the Three Months Ended December 31, 2024

Altimmune reported cash, cash equivalents and short-term investments totaling $131.9 million on December 31, 2024.
Research and development expenses were $19.8 million for the three months ended December 31, 2024, compared to $16.9 million in the same period in 2023. The expenses for the quarter ended December 31, 2024, included $13.6 million in direct costs related to development activities for pemvidutide.
General and administrative expenses were $5.1 million for the three months ended December 31, 2024, compared to $4.3 million in the same period in 2023. The increase was primarily due to a $0.5 million increase in stock compensation.
Interest income was $1.6 million for the three months ended December 31, 2024, compared to $2.0 million for the same period in 2023.
Net loss for the three months ended December 31, 2024, was $23.2 million, or $0.33 net loss per share, compared to a net loss of $31.6 million, or $0.54 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.
Financial Results for the Year Ended December 31, 2024

Research and development expenses were $82.2 million for the year ended December 31, 2024, compared to $65.8 million in the same period in 2023. The expenses for the year ended December 31, 2024, included $53.3 million in direct costs related to development activities for pemvidutide and $1.3 million in initial costs for additional research and discovery projects.
General and administrative expenses were $21.0 million for the year ended December 31, 2024, compared to $18.1 million in the same period in 2023. The increase was primarily due to a $2.7 million increase in stock compensation and other labor-related expenses, including the $1.0 million increase in stock compensation expense caused by modifications of stock awards.
Interest income was $8.1 million for the year ended December 31, 2024, compared to $7.4 million for the same period in 2023.
Net loss for the year ended December 31, 2024, was $95.1 million, or $1.34 net loss per share, compared to a net loss of $88.4 million, or $1.66 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.
Conference Call Information:
Date: February 27, 2025
Time: 8:30 a.m. Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.

On February 27, 2025 BioInvent reported year-end report January 1 to December 31, 2024 (Presentation, BioInvent, FEB 27, 2025, https://www.bioinvent.com/sites/bioinvent/files/pr/20250227-92fc1f95-a930-49cc-a48b-32c70e35f4c8-1.pdf?ts=1740639699 [SID1234652093]).

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On February 27, 2025 Akeso, Inc. (9926.HK) reported the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies in Australia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate), is Akeso’s first ADC drug to enter clinical studies (Press release, Akeso Biopharma, FEB 27, 2025, View Source [SID1234655612]).

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Akeso is dedicated to transforming the global oncology treatment landscape by establishing new standards of care for cancer patients worldwide. A key element of this mission is the company’s "IO 2.0 + ADC" strategy. Akeso’s self-developed, first-in-class bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), have both received regulatory approval and are now available to patients in China. Akeso is the only global biopharmaceutical company with two approved bispecific checkpoint antibodies for cancer immunotherapy.

The continued development of differentiated ADC therapies, such as AK138D1, further extend Akeso’s ability to explore the full clinical potential of its innovative in-house pipeline and to create synergistic new combination treatment options includes that multiple checkpoints and tumor targets.

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso said,

"The initiation of the clinical study for AK138D1 in Australia marks a pivotal moment in Akeso’s strategic advancement into next-generation ADC therapies. Building on our global prominence in bispecific antibodies and a robust pipeline of high-potential drug candidates, the development of AK138D1 and subsequent ADCs/bispecific ADCs will significantly bolster our product offering. This is part of Akeso’s continued effort to redefine standard of care in cancer treatment.

Following our achievements in bispecific antibody development, ADC therapies have emerged as a strategic priority for Akeso. Based on our extensive experience in bispecific antibody development, we are excited by the potential of our proprietary ADCs and bispecific ADCs. Our goal is to enhance drug efficacy while minimizing ADC toxicity, offering transformative treatment alternatives for patients worldwide.

Moreover, Akeso has established cutting-edge ADC research, pilot production, and manufacturing facilities. These investments position us for high-quality clinical development and for global market expansion of our ADC portfolio."

HER3 has emerged as an active target in cancer drug development and is the focus of ongoing research. Although experimental drugs targeting HER3 have not shown satisfactory antitumor effects over the past 30 years, studies indicate that HER3 is expressed or overexpressed in various malignancies, including breast cancer, ovarian cancer, lung cancer, colorectal cancer, melanoma, head and neck cancers, cervical cancer, and prostate cancer. Additionally, upregulation of HER3 and its synergistic interactions with other receptors contribute to tumor initiation, metastasis, and resistance to certain anticancer treatments, such as resistance to EGFR-targeted therapies, endocrine therapy in breast cancer, HER2-targeted therapies, and chemotherapy.

About AK138D1

Injectable AK138D1 is a HER3-targeted antibody-drug conjugate (ADC), with a fully humanized anti-HER3 IgG1 antibody, patritumab. It is conjugated to the topoisomerase I inhibitor DXd through a cleavable linker, MC-AAA (maleimide-alanine-alanine-alanine). After binding to HER3 on tumor cells, the ADC is internalized into the tumor cells, where the linker is cleaved, releasing the membrane-permeable DXd. This leads to DNA damage and subsequent cell apoptosis. Currently, Akeso has initiated patient enrollment for a Phase I dose-escalation and expansion clinical study in Australia. This study will investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AK138D1 for the treatment of advanced malignancies.

On February 27, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported business highlights and financial results for the fourth quarter and year ended December 31, 2024 (Press release, Arcellx, FEB 27, 2025, View Source [SID1234650687]).

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"2024 was a transformational year for Arcellx as our ASH (Free ASH Whitepaper) data presentations for anito-cel, in partnership with Kite, continued to demonstrate anito-cel’s differentiated clinical profile for the potential treatment of patients with relapsed or refractory multiple myeloma," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "In our Phase 1 and iMMagine-1 studies, data demonstrate that anito-cel has the potential to provide a meaningful benefit to a broad population of patients. Our Phase 1 study demonstrated that the deep responses observed with anito-cel also translated to durable benefit for patients with a 30.2 month median progression-free survival in a challenging patient cohort and the preliminary data from our pivotal iMMagine-1 study demonstrated anito-cel also delivered deep responses for late line myeloma patients with a 97% overall response rate and 62% complete response rate at a median follow-up of 9.5 months. Most notably, as presented during ASH (Free ASH Whitepaper), the safety profile for anito-cel continues to be manageable with no delayed neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in the155 patients dosed across the Phase 1 and iMMagine-1 studies. Physician engagement and enthusiasm for anito-cel continues to build following these data presentations and as more sites gain experience with anito-cel through iMMagine-3, our earlier-line study. Kite is manufacturing for iMMagine-3, and turnaround times are consistent with Kite commercial products. This year, we look forward to presenting updated data from our iMMagine-1 study mid-year, preparing for the commercial launch of anito-cel in multiple myeloma in 2026, enrolling our program in generalized myasthenia gravis, and expanding our ARC-SparX program in acute myeloid leukemia to include an additional SparX antigen target. Thank you to our Arcellx team who are willing to embrace challenges and think creatively to make an impact for the patients we serve."

Recent Business Progress

Presented positive preliminary data for the Phase 2 pivotal iMMagine-1 study of anito-cel in patients with relapsed or refractory multiple myeloma (RRMM) at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The data presented on December 9, 2024 demonstrated deep and durable responses with a predictable and manageable safety profile in a high-risk fourth-line or higher (4L+) RRMM population, including triple- and penta-class refractory disease. The data were from an October 31, 2024 data cutoff date, with a median follow-up of 9.5 months for the 86 patients who were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel.

Overall response rate was 97% (83/86) with a complete response/stringent complete response rate of 62% (53/86) and a very good partial response or higher rate of 81% (70/86), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing, 93.1% (54/58) achieved MRD negativity at a minimum of 10 -5 sensitivity. Median progression-free survival (mPFS) and overall survival (OS) were not reached; 6-month PFS and OS rates were 93.3% and 96.5%, respectively, and 12-month PFS and OS rates were 78.5% and 96.5%, respectively. No delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, were observed in the 155 patients dosed with anito-cel.

Fourth Quarter and Full Year 2024 Financial Highlights

Cash, cash equivalents, and marketable securities:

As of December 31, 2024, Arcellx had cash, cash equivalents, and marketable securities of $625.7 million. Arcellx anticipates that its cash, cash equivalents, and marketable securities will fund its operations into 2027.

Collaboration revenue:

Collaboration revenue were $15.3 million and $63.1 million for the quarters ended December 31, 2024 and 2023, respectively, a decrease of $47.8 million. This decrease was primarily driven by the December 2023 expansion to the license and collaboration agreement with Kite Pharma, Inc. Collaboration revenue were $107.9 million and $110.3 million for the twelve months ended December 31, 2024 and 2023, respectively, a decrease of $2.4 million.

R&D expenses:

Research and development expenses were $44.6 million and $28.8 million for the quarters ended December 31, 2024 and 2023, respectively, an increase of $15.8 million. Research and development expenses were $157.1 million and $133.8 million for the twelve months ended December 31, 2024 and 2023, respectively, an increase of $23.3 million. The increases were primarily driven by increased personnel costs, which include non-cash stock-based compensation expense, and increased costs relating to anito-cel and other pipeline programs.

G&A expenses:

General and administrative expenses were $23.8 million and $19.4 million for the quarters ended December 31, 2024 and 2023, respectively, an increase of $4.4 million. General and administrative expenses were $88.4 million and $66.4 million for the twelve months ended December 31, 2024 and 2023, respectively, an increase of $22.0 million. The increases were primarily driven by increased personnel costs, which include non-cash stock-based compensation expense, increased costs relating to commercial readiness, and increased depreciation expense.

Net losses:

Net losses were $47.1 million and $19.8 million for the quarters ended December 31, 2024 and 2023, respectively. Net losses were $107.3 million and $70.7 million for the twelve months ended December 31, 2024 and 2023, respectively.

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About anitocabtagene autoleucel (anito-cel)

Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

On February 27, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported financial results for the year ended December 31, 2024 and highlighted recent business updates including progress in advancing the IMNN-001 development program toward initiation of a Phase 3 clinical trial in advanced ovarian cancer (Press release, IMUNON, FEB 27, 2025, View Source [SID1234650706]).

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"2024 was a pivotal year for IMUNON. We reported robust and unprecedented data from our Phase 2 OVATION 2 Study, demonstrating that IMNN-001 is the first immunotherapy to consistently show clinical benefits in both progression-free and overall survival in ovarian cancer when combined with chemotherapy," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "Treated patients achieved an overall survival of 13 months, compared to the current standard of care. Even more remarkable, the survival extension was greater among patients treated with IMNN-001 plus PARP inhibitors."

"We stand at the threshold of a historic advance in the frontline treatment of women with advanced ovarian cancer, a group with limited options and a desperate need for safe, effective treatments," Dr. Lindborg continued. "The most recent advances in ovarian cancer treatment have focused on maintenance treatment for those who have already responded to chemotherapy. However, our results in newly diagnosed patients with advanced disease are unprecedented and highly encouraging. The rapid clinical progress we have made reflects our compelling data and the strong support from trial investigators, patients, regulators, and global scientific leaders. We have engaged with the U.S. Food and Drug Administration through an End-of-Phase 2 meeting to finalize the design of our planned registrational study. As we look forward to an exciting year ahead, we are preparing to initiate a Phase 3 pivotal study of IMNN-001 in the first quarter of 2025."

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Translational Data from OVATION 2 Study reinforce dose-dependent mechanism with IMNN-001 100mg/m2 dose and continue to validate TheraPlas technology, demonstrating DNA-mediated production of key anti-cancer immune cytokines following treatment – On February 19, 2025, IMUNON announced new translational data from ongoing analyses of results from the Company’s Phase 2 OVATION 2 Study of IMNN-001 for the treatment of newly diagnosed advanced ovarian cancer. Results demonstrated a 20% increase in IL-12 levels in women treated with IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) compared to IL-12 levels in women treated with IMNN-001 (79 mg/m2). In this analysis increases in IL-12 levels were sampled in the peritoneal fluid cavity, which is the primary tumor microenvironment. Little to no changes were observed in the systemic blood stream of treated patients. In addition, the rise in IL-12 levels was accompanied by local increases in interferon-gamma (IFN-γ) and tumor necrosis factor-alpha (TNF-α), key downstream anti-cancer immune cytokines. Results showed no reports of serious immune-related adverse events including cytokine release syndrome.

Positive CMC Meeting with FDA for IMNN-001 – On December 19, 2024, IMUNON announced the positive outcome of a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA) regarding production of IMNN-001 for the treatment of women with newly diagnosed advanced ovarian cancer. The goal of the meeting was to seek alignment and agreement with the FDA on key CMC topics to support IMNN-001 production for the planned Phase 3 pivotal trial and a potential future new biologics license application (BLA) submission. The meeting with the FDA included a review of IMUNON’s current good manufacturing practice (cGMP) clinical-scale and commercial manufacturing processes for IMNN-001, conducted at the Company’s manufacturing facility based in Huntsville, Alabama. The FDA agreed that IMUNON’s potency assay, which measures interferon-gamma (IFN-γ), is acceptable for the Phase 3 trial and for use in a commercial setting for release of drug product. The agency also agreed with the Company’s strategy to establish comparability of the core components of IMNN-001 produced by IMUNON with product previously produced through an external contract development and manufacturing organization.

Continued Improvement in Overall Survival Data from OVATION 2 Study of IMNN-001 – On December 10, 2024, the Company announced additional clinical data based on ongoing analyses of results from the Phase 2 OVATION 2 Study of IMNN-001 in the treatment of advanced ovarian cancer. The updated results, which were based on an additional seven months of patient monitoring, showed the hazard ratio (HR) decreased from 0.74 to 0.69, with an increase in median overall survival (OS) from 11.1 to 13 months following treatment with IMNN-001 plus standard-of-care (SoC) neoadjuvant and adjuvant chemotherapy (NACT) versus SoC alone. More than one-third of patients in the trial survived more than 36 months from the point of study enrollment, with 62% of those surviving patients from the IMNN-001 treatment arm and 38% from the SoC arm. More than 10% of trial participants reached 48 months or beyond at the time of this data assessment. Results also continued to demonstrate a favorable safety and tolerability profile, with no reports of cytokine release syndrome or any other serious immune-related adverse events. Initial results from the OVATION 2 Study were reported in July 2024 and results were presented in a late-breaking session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting.

End-of-Phase 2 Meeting with the FDA for IMNN-001 Clinical Program – On November 25, 2024, IMUNON announced a positive outcome of its End-of-Phase 2 in-person meeting with the FDA, supporting the advancement of IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study. IMUNON remains on track to initiate the Phase 3 trial in the first quarter of 2025. The interaction with the FDA included an extensive review of data generated to date, including the positive results from the Phase 2 OVATION 2 Study.

IMUNON Ovarian Cancer R&D Day – On September 18, 2024, the Company held an Ovarian Cancer R&D Day in New York City that included presentations from executive management and a panel of renowned leaders in oncology research and patient care including:

Sid Kerkar, M.D., T cell biology review editor, Frontiers in Immunology. Dr. Kerkar discussed the important role of interleukin-12 (IL-12) in treating cancer.

William Bradley, M.D., Professor, Obstetrics and Gynecology, Gynecologic Oncology, Medical College of Wisconsin. Dr. Bradley discussed the safety and efficacy of IMNN-001.

L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health. Dr. Wei discussed the opportunity to combine progression-free survival (PFS) and overall survival (OS) to provide a clinically interpretable evaluation of the IMNN-001 treatment effect.

Amir Jazaeri, M.D., Vice Chair for Clinical Research, Director, Gynecologic Cancer Immunotherapy Program, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Jazaeri discussed the ongoing Phase 1/2 study of IMNN-001 in combination with bevacizumab in advanced ovarian cancer, for which he serves as principal investigator, including the importance of minimal residual disease and early translational insights.

Premal Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research, Washington University School of Medicine, and the OVATION 2 Study Chair. Dr. Thaker discussed the OVATION 2 top-line results and their clinical significance.

A webcast of the Ovarian Cancer R&D Day is available here.

PlaCCine: Next Generation Vaccine Proof of Concept

Data from PlaCCine DNA Vaccine Phase 1 Proof-of-Concept Clinical Study Demonstrate Persistent Immunogenicity in Trial Participants, Show an Acceptable Safety Profile and Further Validate PlaCCine Technology – On February 26, 2025, the Company announced safety and immunogenicity data from the Company’s first Phase 1 proof-of-concept clinical trial of IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform. The Phase 1 study was conducted in 24 healthy volunteers as a seasonal COVID-19 vaccine, targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Results demonstrated that IMNN-101 is safe and well-tolerated with no serious adverse effects. IMNN-101 induced a persistent 2- to 4-fold increase in serum neutralizing antibody (NAb) titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine’s cross-reactivity. The participants in the Phase 1 trial had high baseline immune characteristics presumably from prior infection and multiple previous vaccinations against COVID-19 and ongoing infection as evidenced by the rise in viral nucleocapsid antigen during the study period. Modest increases in T cell responses were observed in this setting of trial participants having received multiple immunizations prior to the study.

The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing that protection exceeded 95% in non-human primates, which is comparable to mRNA vaccines. The robust immunogenicity profile, expected durability of protection, comparative ease of manufacturing, and stability at workable temperatures (up to one year at 4°C and one month at 37°C) suggest that a vaccine based on the PlaCCine technology platform may be a potential viable alternative to available messenger RNA (mRNA) vaccines. The Company plans to seek potential partners for further development.

Corporate Development

Addition to Leadership Team to Support Future Clinical Programs – On February 10, 2025, Douglas V. Faller, M.D., Ph.D. was appointed Chief Medical Officer effective February 18, 2025. Dr. Faller joins IMUNON with more than 30 years of industry, academic and laboratory experience, with specialized expertise in oncology and immunology. Dr. Faller will lead the Company’s clinical strategy including advancing the IMNN-001 program for the treatment of newly diagnosed advanced ovarian cancer.

Dr. Faller joins IMUNON with more than 30 years of experience at biotechnology and pharmaceutical companies leading strategies across discovery, preclinical, clinical and regulatory stages of small molecule development in several therapeutic areas including oncology, immunology and hematology. He also brings more than 25 years of experience in academic clinical and laboratory research settings with a focus on drug discovery and development, oncology and hematology, and cell and molecular biology. Dr. Faller most recently served as chief medical officer at Skyhawk Therapeutics, where he was responsible for global clinical and regulatory development of novel small molecule RNA-splicing modifiers for the treatment of hematological and solid tumors and rare neurological diseases. Before that, he served as chief medical officer at Oryzon Genomics, Inc. Previously, he worked at Takeda for more than five years in roles of increasing responsibility, most recently serving as executive medical director where he led the development of multiple late-stage therapies including a CAR-T program for leukemias and lymphomas and solid tumor programs including in gynecologic oncology.

Dr. Faller received an M.D. from Harvard Medical School and a Ph.D. and B.S. from the Massachusetts Institute of Technology. He was professor of medicine at Harvard Medical School, and subsequently he founded and served as first director of Boston University Comprehensive Cancer Center where he was also Grunebaum Professor for Cancer Research and professor of medicine, biochemistry, pediatrics, microbiology, pathology and laboratory medicine. Dr. Faller is the scientific founder of multiple biotechnology and pharmaceutical companies.

Financial Results for the Year Ended December 31, 2024

IMUNON reported a net loss for 2024 of $18.6 million, or $1.62 per share compared with a net loss for 2023 of $19.5 million, or $2.16 per share. Operating expenses were $19.1 million for 2024, a decrease of $1.9 million or 9% from $21.0 million for 2023. The Company recognized tax benefits from the sale of its New Jersey net operating losses of $1.3 million in 2023.

Research and development (R&D) expenses were $11.6 million for 2024, a decrease of $0.3 million from $11.3 million for 2023. Costs associated with the OVATION 2 Study were $1.4 million and $1.2 million for 2024 and 2023, respectively. Costs associated with our PlaCCine vaccine initiative were $1.4 million in 2024. Other clinical and regulatory costs, which include start up costs for OVATION 3, were $2.4 million for 2024 compared with $1.8 million for 2023. R&D costs associated with the development of IMNN-001 to support the OVATION 2 Study were $1.8 million for 2024 compared with $1.5 million for 2023. The development of the PlaCCine DNA vaccine technology platform decreased to $2.6 million in 2024 compared to $4.5 million in 2023. CMC costs were $2.0 million for 2024 compared with $2.3 million for 2023 due to the development of in-house cGMP manufacturing capabilities for DNA plasmids and nanoparticle delivery systems and product development costs for OVATION 3.

General and administrative expenses were $7.5 million for 2024 compared with $9.7 million for 2023. This 23% decrease was primarily attributable to lower legal costs ($1.4 million), lower employee-related costs ($0.4 million), lower non-cash stock compensation expense ($0.3 million), lower public company franchise expenses ($0.2 million) and lower insurance costs ($0.1 million), offset by higher consulting fees ($0.2 million).

Other non-operating income was $0.5 million for 2024 compared with $0.2 million for 2023. This increase was primarily attributable to the following:

Investment income from the Company’s short-term investments was $0.5 million for 2024 compared with $1.2 million for 2023.

In June 2021, the Company entered into a $10.0 million loan facility with Silicon Valley Bank (SVB). IMUNON 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 the first half of 2023. 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.

Net cash used for operating activities was $18.9 million for 2024 compared with $19.0 million for 2023. Cash provided by financing activities of $9.1 million for 2024 resulted from an at-the-market equity offering in July 2024 and sales under the Company’s At-the-Market Equity Facility compared with cash used in financing activities of $3.6 million for 2023 resulting 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).

The Company ended 2024 with $5.9 million in cash and cash equivalents. The Company believes it has sufficient capital resources to fund its operations into late second quarter of 2025.

Conference Call and Webcast

The Company is hosting a conference call to review 2024 financial results and provide business updates today at 11:00 a.m. ET. To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON 2024 Earnings Call. A live webcast of the call will also be available here.

The call will be archived for replay until March 12, 2025. 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 7147564. An audio replay of the call will also be available here for 90 days.