Full Press Release Details
Reports Second Quarter 2024 Financial Results and Provides a Business Update
Call Begins Today at 11:00 a.m. Eastern Time
N.J. (August 14, 2024) - IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company
in late-stage development with its DNA-mediated immuno-oncology therapy, today reported financial results for the three and six
months ended June 30, 2024. The Company also provided an update on its clinical development programs with IMNN-001, including positive
topline results from the Phase 2 OVATION 2 Study in patients with advanced ovarian cancer and an update on IMNN-101, its seasonal COVID-19
second quarter and recent weeks were exciting and highly rewarding," said Stacy Lindborg, Ph.D., president and chief executive
officer of IMUNON. "Positive topline results from our Phase 2 OVATION 2 Study with IMNN-001 in advanced ovarian cancer were
the culmination of years of dedication by the IMUNON team and set our company's strategic plan going forward. We reported overall
survival among patients treated with IMNN-001 of more than 11 months compared with patients treated with standard-of-care, and
believe these results provide hope to women suffering from a disease with such a poor prognosis. Our next steps include holding an End-of-Phase
2 meeting with the U.S. Food and Drug Administration (FDA) to clarify our path to a Phase 3 pivotal study."
Lindborg added, "The addition of approximately $9.3 million in net proceeds from a capital raise last month in a challenging market,
along with the steps we have taken to conserve capital allows the Company to report many important catalysts, including the initiation
of a planned Phase 3 study of IMNN-001."
Positive Topline Results From OVATION 2 Study in Advanced Ovarian Cancer - On June 24, 2024, the Company announced database
lock for the OVATION 2 Study. At that time, median overall survival (OS) and progression-free survival (PFS) had been reached, and all
patients in the open-label study had achieved treatment observation duration of 16 months, as required per protocol to evaluate efficacy.
On July 30, 2024, the Company announced positive topline results from the Phase 2 OVATION 2 Study. Highlights from patients treated with
IMNN-001 plus standard-of-care in a first-line treatment setting include:
| An 11.1 month increase in median OS compared with standard-of-care alone in the intent-to-treat (ITT) population. | ||
| A hazard ratio in the ITT population of 0.74, which indicates a 35% improvement in survival. | ||
| Among the approximately 90% of trial participants who received at least 20% of specified treatments per-protocol in both study arms, patients in the IMNN-001 arm had a 15.7 month increase in median OS, representing a further extension of life with a hazard ratio of 0.64, a 56% improvement in survival. | ||
| For the nearly 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased further to 0.41, with median OS in the IMNN-001 treatment arm not yet reached at the time of database lock, compared with median OS of 37.1 months in the standard-of-care treatment arm. |
PFS results, the trial's primary endpoint, support the OS results with:
| A three-month improvement in PFS compared with standard-of-care alone. | ||
| A hazard ratio in the ITT population of 0.79, indicating a 27% improvement in delaying progression for the IMNN-001 treatment arm. |
Company plans to hold an End-of-Phase 2 meeting with the FDA to discuss the protocol for a Phase 3 study, which is anticipated to begin
in the first quarter of 2025. The Company also plans to present full OVATION 2 Study results at an upcoming medical conference and to
submit the results for publication in a peer-reviewed medical journal.
Study Advancing: Phase 1/2 Study of IMNN-001 in Combination with Bevacizumab, titled "Targeting Ovarian Cancer Minimal
Residual Disease (MRD) Using Immune and DNA Repair Directed Therapies" - In February 2023, the Company and Break Through
Cancer, a public foundation dedicated to supporting translational research in the most difficult-to-treat cancers that partners with
top cancer research centers, announced the commencement of patient enrollment in a collaboration to evaluate IMNN-001 in combination
with bevacizumab in patients with advanced ovarian cancer in the frontline, neoadjuvant clinical setting. MD Anderson Cancer Center,
Dana-Farber Cancer Institute, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and Memorial Sloan Kettering Cancer Center
will be participating in the trial. In addition, The Koch Institute for Integrative Cancer Research at the Massachusetts Institute of
Technology (MIT) will provide artificial intelligence services including biomarker and genomic analysis.
study is expected to enroll 50 patients with Stage III/IV advanced ovarian cancer and is being led by principal investigator Amir
Jazaeri, M.D., Vice Chair for Clinical Research and Director of the Gynecologic Cancer Immunotherapy Program in the Department of
Gynecologic Oncology and Reproductive Medicine at MD Anderson. Patients are being randomized 1:1 in a two-arm trial. The trial's
primary endpoint is detection of minimal residual disease (MRD) by second look laparoscopy (SLL), with secondary endpoints
including overall survival (OS) and progression-free survival (PFS). SLL data are expected within one year following
the completion of enrollment and final data are expected approximately three years following the completion of
of June 30, 2024, seven patients were enrolled and had received treatment in the Phase 1 portion of this study at the University
of Texas MD Anderson Cancer Center. Memorial Sloan Kettering Cancer Center was added as a clinical site for this study in
the first quarter of 2024.
Next Generation Prophylactic Vaccine Proof of Concept
Participants Vaccinated in IMUNON's IMNN-101 Phase 1 Clinical Trial - On April 18, 2024, the Company announced that it
received clearance from the FDA to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine. The primary objectives of
this proof-of-concept study of the PlaCCine DNA Vaccine technology platform are to evaluate safety, tolerability, neutralizing
antibody response and the vaccine's durability in healthy adults. Secondary objectives include evaluating the ability of the IMNN-101
vaccine to elicit binding antibodies and cellular responses and their associated durability. As currently planned, the Phase 1 study
will enroll 24 subjects evaluating three escalating doses of IMNN-101. For this study, IMMN-101 has been designed to protect against
the SARS-CoV-2 Omicron XBB1.5 variant. Assuming positive results, IMUNON will advance discussions with potential partners to continue
development of the platform.
the second quarter of 2024, the Company announced that DM Clinical Research in Philadelphia was the first clinical site activated and
ready for patient recruitment for this Phase 1 study. DM Clinical Research is an integrated national network of clinical trial sites
focused on delivering advanced, preventive medicine to underserved communities. Topline data are anticipated by year-end 2024.
Gross Proceeds of $10 Million in Registered Direct Financing - On July 30, 2024, the Company entered into a Securities Purchase
Agreement with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell in a registered
direct offering an aggregate of 5,000,000 shares of the Company's common stock at an offering price of $2.00 per share for gross
proceeds of $10.0 million. In a concurrent private placement (together with the registered direct offering) and also pursuant
to the Securities Purchase Agreement, the Company agreed to issue to the Purchasers unregistered warrants to purchase shares of common
stock. The warrants have an exercise price of $2.00 per share and will be exercisable immediately for a term of five and one-half
years following the date of issuance. The closing of the registered direct offering occurred on August 1, 2024.
QUARTER FINANCIAL RESULTS
reported a net loss for the second quarter of 2024 of $4.8 million, or $0.51 per share, compared with a net loss of $5.6 million, or
$0.61 per share, for the second quarter of 2023. Operating expenses were $5.0 million for the second quarter of 2024, a decrease of $0.5
million or 8% from $5.5 million for the second quarter of 2023.
and development ("R&D") expenses were $2.8 million in the second quarter of 2024, compared with $3.1 million in the same
period of 2023. Costs associated with the OVATION 2 Study were $0.4 million in the second quarter of 2024, compared with $0.3 million
in the same period of 2023. Costs associated with the PlaCCine vaccine trial were $0.3 million in the second quarter of 2024. Other clinical
and regulatory costs were $0.6 million in the second quarter of 2024, compared with $0.4 million in the same period of 2023.
costs associated with the development of IMNN-001 to support the OVATION 2 Study were $0.2 million in the second quarter of 2024, compared
with $0.4 million in the same period of 2023. The development costs of the PlaCCine DNA vaccine technology platform decreased
to $0.7 million in the second quarter of 2024, compared with $1.3 million in the same period of 2023. CMC costs decreased to $0.5 million
in the second quarter of 2024, compared with $0.7 million in the same period of 2023. The lower CMC costs were primarily due to the Company's
establishment of internal capability to produce plasmid DNA.
and administrative expenses were $2.2 million in the second quarter of 2024, compared with $2.3 million in the same period of 2023. The
decrease was primarily attributable to lower non-cash stock compensation expenses of $0.1 million and employee-related expenses of $0.1
million, offset by an increase in legal fees of $0.1 million.
non-operating income was $0.2 million in the second quarter of 2024, compared with other non-operating expenses of $0.1 million in the
same period of 2023. The Company incurred a loss on extinguishment of debt expense of $0.3 million on its loan facility with Silicon
Valley Bank in the second quarter of 2023 upon the repayment in full of this loan facility. Investment income from the Company's
short-term investments decreased by $0.1 million for the second quarter of 2024, compared with the same period in 2023.
Company had $5.3 million in cash, investments and accrued interest receivable as of June 30, 2024. Combined with net proceeds
of approximately $9.0 million from the registered direct offering announced in July 2024, the Company believes it has sufficient capital
resources to fund its operations into the third quarter of 2025.
HALF FINANCIAL RESULTS
the six months ended June 30, 2024, the Company reported a net loss was $9.7 million, or $1.03 per share, compared with a net loss of
$11.2 million, or $1.28 per share, for the same six-month period of 2023.
cash used for operating activities was $10.4 million for the first six months of 2024, compared with $10.8 million for the same period
in 2023. Cash used in financing activities for the first six months of 2023 resulted from the early repayments of the Company's
loan facility with Silicon Valley Bank of $6.4 million, partially offset by sales of equity under the Company's At-the-Market Equity
Facility of $2.7 million.
expenses were $6.1 million in the first half of 2024, compared with $5.8 million in the same period of 2023. Costs associated with the
OVATION 2 Study were $0.7 million in the first half of 2024, compared with $0.6 million in the same period of 2023. Costs associated
with the PlaCCine vaccine trial were $0.9 million in the first half of 2024. Other clinical and regulatory costs were $1.1 million in
the first half of 2024, compared with $0.7 million in the same period of 2023.
costs associated with the development of IMNN-001 to support the OVATION 2 Study were $0.7 million in the first half of 2024, compared
with $0.8 million in the same period in 2023. The development of the PlaCCine DNA vaccine technology platform decreased to $2.0
million in the first half of 2024 from $2.3 million in the same period of 2023. CMC costs decreased to $0.8 million in the first half
of 2024 from $1.4 million in the same period of 2023.