On August 14, 2024 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported financial results for the second quarter of 2024 and provided a business update (Press release, Viracta Therapeutics, AUG 14, 2024, View Source [SID1234645932]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter, we took several important steps to drive forward our clinical development program for Nana-val, our first-in-class, all-oral combination treatment regimen for Epstein-Barr virus (EBV) associated cancers," said Mark Rothera, President and Chief Executive Officer of Viracta. "We received productive feedback from our meeting with the FDA and are encouraged by additional positive data from the ongoing NAVAL-1 trial, particularly in the second-line EBV-positive PTCL subgroup. To optimize the clinical benefit of Nana-val, we plan to focus on the second-line EBV-positive PTCL subpopulation in the NAVAL-1 trial’s expansion phase and initiate a randomized controlled trial in 2025 to potentially support registration. We believe our sharpened focus on the EBV-positive lymphoma program will propel us forward to key milestones and support our speed to market strategy. We look forward to providing more updates on our progress."

Clinical Trial Updates and Anticipated Milestones

Phase 2 NAVAL-1 trial of Nana-val (nanatinostat in combination with valganciclovir) in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma

Clinical Trial Updates:

Announced positive combined Stage 1 and Stage 2 data (n=21) in the R/R EBV+ PTCL cohort of patients treated with nanatinostat (20 mg orally once daily, 4 days/week) in combination with valganciclovir (900 mg orally once daily, 7 days/week) across the first two stages of the study.
As of the June 28, 2024 data cutoff, combined Stages 1 and 2 data demonstrated Nana-val’s substantial antitumor activity and generally well-tolerated safety profile with a median duration of response (DOR) that has not yet been reached.
In the R/R EBV+ PTCL population, the overall response rate (ORR) was 33% and the complete response rate (CRR) was 19% in the intent-to-treat (ITT) population (N=21); the ORR was 41% and the CRR was 24% in the efficacy-evaluable (EE) population (N=17).
Notably, there was a particularly robust clinical response observed in the second-line EBV+ PTCL subpopulation, as the ORR was 60% and the CRR was 30% in the intent-to-treat population (n=10), and the ORR was 67% and the CRR was 33% in the efficacy-evaluable population (n=9).
Held a productive FDA meeting to align on a potential regulatory path forward for Nana-val in patients with R/R EBV+ PTCL. Based on feedback from the FDA and the particularly robust response rates observed in the second-line treatment setting, Viracta will focus the primary analysis on the second-line EBV+ PTCL subpopulation in the ongoing NAVAL-1 trial’s expansion phase. The Company plans to begin a randomized controlled trial (RCT) of Nana-val in the second-line treatment of EBV+ PTCL patients in 2025.
Viracta believes this strategy will best position Nana-val for a potential NDA filing in 2026 for accelerated approval based on an interim analysis of second-line EBV+ PTCL patient data from the NAVAL-1 trial, provided that the ORR and DOR are compelling and the RCT is well underway; for accelerated approval based on final analysis of NAVAL-1 trial data; or for accelerated or full approval based on the outcomes of the RCT at interim or final analysis, respectively.
Anticipated Milestones

Viracta plans to deliver on the following milestones:

The recommended Phase 2 dose in patients with advanced EBV+ solid tumors is expected to be determined in the second half of 2024.
Report additional data from the expansion phase of the NAVAL-1 trial in second-line EBV+ PTCL patients in the fourth quarter of 2024.
Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) in the first half of 2025.
Meet with the FDA to finalize the proposed RCT design in the second-line treatment of patients with EBV+ PTCL in the first half of 2025.
Initiate the RCT in the second half of 2025.
Present interim analysis outcomes from the NAVAL-1 trial in second-line EBV+ PTCL patients in 2026.
File NDA for accelerated approval in 2026 based on interim analysis of the NAVAL-1 trial’s expansion cohort.
Business Updates

Appointed Michael Faerm as Chief Financial Officer. Mr. Faerm is a seasoned biotech executive with more than 25 years of experience in life sciences companies, equity research and investment banking.
Viracta has aligned resources to prioritize its more advanced EBV+ lymphoma and will pause its EBV+ solid tumor program. Along with this pipeline reprioritization, a reduction in force has been implemented that impacts approximately 23% of the company’s employees.
Second Quarter 2024 Financial Results

Cash position – Cash, cash equivalents, and short-term investments totaled approximately $30.0 million as of June 30, 2024, which Viracta expects will be sufficient to fund operations late into the first quarter of 2025.
Research and development expenses – Research and development expenses were approximately $6.5 million and $16.5 million for the three and six months ended June 30, 2024, respectively, compared to approximately $8.2 million and $15.8 million for the same periods in 2023. The decrease in research and development expenses for the three months ended June 30, 2024 compared to the same period in 2023, was driven by decreases in costs incurred to support the advancement and expansion of our clinical development programs, including incremental costs to support NAVAL-1, our Phase 2 trial of Nana-val in patients with R/R EBV+ lymphomas and personnel-related costs. The increase in research and development expenses for the six months ended June 30, 2024 compared to the same period in 2023, was largely due to a non-cash adjustment for insurance costs related to the February 2021 reverse merger with Sunesis Pharmaceuticals of $1.8 million, partially offset by decrease in costs incurred related to our clinical development programs and personnel-related costs.
General and administrative expenses – General and administrative expenses were approximately $3.0 million and $7.0 million for the three and six months ended June 30, 2024, respectively, compared to $4.3 million and $8.9 million for the same periods in 2023. The decrease in general and administrative expenses was largely due to decreases in personnel-related costs, corporate liability insurance premiums and legal costs.
Net loss – Net loss was approximately $9.8 million, or $0.25 per share (basic and diluted), for the quarter ended June 30, 2024, compared to a net loss of $12.5 million, or $0.32 per share (basic and diluted), for the same period in 2023. This change was primarily the result of decreases in research and development expenses and personnel-related costs. Net loss was approximately $19.0 million, or $0.48 per share, (basic and diluted) for the six months ended June 30, 2024, compared to a net loss of $24.7 million, or $0.64 per share, (basic and diluted) for the same period in 2023. This change was primarily the result of $5.0 million of other income received related to the monetization of a pre-commercialization, event-based milestone from Day One Biopharmaceuticals, Inc. in March 2024, partially offset by the non-cash adjustment for insurance costs related to the February 2021 merger of $1.8 million.
About the NAVAL-1 Trial
NAVAL-1 (NCT05011058) is a global, multicenter, clinical trial of Nana-val in patients with relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma. This trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into one of three indication cohorts based on EBV+ lymphoma subtype. If two objective responses are achieved within a lymphoma subtype in Stage 1 (n=10), then additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV+ lymphoma subtypes demonstrating promising antitumor activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)
Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a potentially registrational, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory (R/R) EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 clinical trial in patients with recurrent or metastatic (R/M) EBV+ NPC and other advanced EBV+ solid tumors.

About Peripheral T-Cell Lymphoma
T-cell lymphomas comprise a heterogeneous group of rare and aggressive malignancies, including peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). There are approximately 5,600 newly diagnosed T-cell lymphoma patients and approximately 2,600 newly diagnosed PTCL-NOS and AITL patients in the U.S. annually. Approximately 70% of these patients are either refractory to first-line therapy, or eventually experience relapse of their disease. Clinical trials are currently recommended for all lines of PTCL therapy, and most patients with R/R PTCL have poor outcomes, with median progression-free survival and median overall survival times reported to be 3.7 and 6.5 months, respectively. Approximately 40% to 65% of PTCL is associated with EBV, the incidence of EBV+ PTCL varies by geography, and reported outcomes for patients with EBV+ PTCL are inferior to those whose disease is EBV-negative. There is no approved targeted treatment specific for EBV+ PTCL, and therefore this represents a high unmet medical need.

About EBV-Associated Cancers
Approximately 90% of the world’s adult population is infected with EBV. Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV-positive (EBV+) lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma (NPC), and gastric cancer.

On August 14, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported second quarter 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, AUG 14, 2024, View Source [SID1234645902]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"While we continue to advance our ReSTART U.S. multicenter pivotal trial in recurrent cutaneous squamous cell carcinoma, the overwhelming interest from clinicians and the broader community in our ongoing internal organ trials has been fantastic," stated Alpha Tau CEO Uzi Sofer. "We are fortunate to see such strong clinician demand for participation in clinical trials, at a time when we expect meaningful data generation, in particular with continued progress in our clinical trials in pancreatic cancer outside the U.S. as well as regulatory progress on similar trials in the U.S. We also continue to prepare for potential future product launches by advancing our commercial planning activities and solidifying our supply chain, as we have secured approvals for our new manufacturing plant in Hudson, New Hampshire and commenced renovation of the facility for our needs. Alpha Tau expects to remain adequately capitalized to support all of these programs over the coming years," he concluded.

Recent Corporate Highlights:

● In June, Alpha Tau announced the publication of "Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers" in the journal Cancers. The pooled analysis included data from 4 international clinical trials spanning an array of hard-to-treat indications including skin, head & neck, and oral cavity. Initial response data demonstrated an overall response rate of almost 100% in treated lesions and a complete response rate of 89%. With follow-up as long as 51 months (median follow-up of 14 months), no moderate or severe long-term toxicities were noted, and 2-year local recurrence-free survival was estimated at 77%. For more information, please refer to View Source

● In May, the first patient with liver cancer metastases was treated in a feasibility and safety study of Alpha DaRT at McGill University Health Center in Montreal, Canada. The trial aims to recruit up to 10 patients who are eligible for a two-staged hepatectomy to resect liver metastases of colorectal cancer. For more information, please refer to View Source

Upcoming Milestones

● Planning treatment of the first patient in the Israeli recurrent lung cancer safety and feasibility trial in H2 2024. The trial is currently open for recruitment; for more information please see here: View Source

● Targeting first brain cancer treatment in H2 2024.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma by around year-end 2024. For more information please see here: View Source

● Anticipating response from PMDA in Japan by year-end 2024 for pre-market approval for Alpha DaRT in patients with recurrent head and neck cancer.

● Targeting announcement of safety, feasibility and efficacy data from advanced inoperable pancreatic cancer studies in Montreal and in Jerusalem by the end of Q1 2025. For more information please see here: View Source and View Source

Financial results for quarter ended June 30, 2024

R&D expenses for the six months ended June 30, 2024 were $13.3 million, compared to $12.3 million for the same period in 2023, due to increased employee compensation and benefits, increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the six months ended June 30, 2024 were $1.1 million, compared to $0.9 million for the same period in 2023, due to increased employee compensation and benefits and increased marketing expenses.

G&A expenses for the six months ended June 30, 2024 were $3.0 million, compared to $3.6 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.

Financial income, net, for the six months ended June 30, 2024 was $2.1 million, compared to $0.02 million financial expense, net, for the same period in 2023, due to a decrease in revaluation of warrants, an increase in interest from bank deposits, and changes in foreign exchange rates, offset by interest on long-term loan.

For the six months ended June 30, 2024, the Company had a net loss of $15.4 million, or $0.22 per share, compared to a net loss of $16.9 million, or $0.24 per share, in the first half of 2023.

Balance Sheet Highlights

As of June 30, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $74.1 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On August 14, 2024 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, reported its financial results for the fiscal quarter ended June 30, 2024 and provided an update on recent developments (Press release, IGM Biosciences, AUG 14, 2024, View Source [SID1234645903]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make significant progress in the clinical development of our two lead product candidates," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We are pleased to have completed enrollment of 127 patients in our randomized study of 3mg/kg of aplitabart plus FOLFIRI and bevacizumab in second line colorectal cancer. We are also pleased to have successfully cleared the first two cohorts of our clinical trial of imvotamab in severe rheumatoid arthritis as well as the first cohort of our clinical trial of imvotamab in severe systemic lupus erythematosus."

Pipeline Updates

Aplitabart (death receptor 5 agonist)

Clinical development of aplitabart advances.
Enrollment completed in randomized colorectal cancer clinical trial. The Company announced that it has completed enrollment in its randomized clinical trial of 3 mg/kg of aplitabart plus FOLFIRI and bevacizumab in second-line metastatic colorectal cancer. A total of 127 patients, exceeding the trial design target of 110 patients, were enrolled across multiple clinical trial sites in the United States, Asia and Europe. This randomized trial is designed to assess the benefit of 3 mg/kg of aplitabart when administered in combination with FOLFIRI and bevacizumab compared to the current standard of care treatment of FOLFIRI and bevacizumab, with a primary endpoint of progression-free survival (PFS). The release of data from this randomized clinical trial will depend on the timing of PFS events in both the control and the experimental arms of this study. Based on its assumptions as to the timing of PFS events, the Company expects to be able to release top-line PFS results from this study by the end of the first quarter of 2025.
Imvotamab (CD20 x CD3 T cell engager)

Clinical development of imvotamab in autoimmune diseases advances.
First and second dose cohorts in rheumatoid arthritis successfully completed. The Company announced that it has cleared both the first and second dose cohorts of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis and is currently enrolling the third cohort. This study is designed to evaluate three cohorts of progressively higher dose regimens of imvotamab, with each cohort designed to recruit eight patients, six of whom receive imvotamab and two of whom receive placebo.
First dose cohort in systemic lupus erythematosus successfully completed. The Company announced that it has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE), with each dose cohort designed to recruit six patients, all of whom are to be treated with imvotamab. The Company is currently enrolling patients in a second dose cohort and plans to enroll a third dose cohort, with each cohort at progressively higher dose regimens of imvotamab.
Enrollment initiated in myositis. The Company has initiated recruitment of patients in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis).
IGM-2644 (CD38 x CD3 T cell engager)

Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company has made significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. The Company currently expects to begin enrolling patients in a single arm, open-label clinical study testing IGM-2644 in generalized myasthenia gravis (gMG) by the end of 2024.
Second Quarter 2024 Financial Results

Cash and Investments: Cash and investments as of June 30, 2024 were $256.4 million, compared to $337.7 million as of December 31, 2023.
Collaboration Revenue: For the second quarter of 2024, collaboration revenues were $1.3 million compared to $0.4 million for the second quarter of 2023.
Research and Development (R&D) Expenses: For the second quarter of 2024, R&D expenses were $42.0 million, compared to $55.7 million for the second quarter of 2023.
General and Administrative (G&A) Expenses: For the second quarter of 2024, G&A expenses were $10.6 million, compared to $13.0 million for the second quarter of 2023.
Net Loss: For the second quarter of 2024, net loss was $47.9 million, or a loss of $0.79 per share, compared to a net loss of $64.4 million, or a loss of $1.43 per share, for the second quarter of 2023.
2024 Financial Guidance
The Company expects full year 2024 GAAP operating expenses of $210 million to $220 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2026.

On August 14, 2024 OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, reported that three of its research abstracts have been selected for presentation at the upcoming World Conference on Lung Cancer (WCLC 2024) (Press release, OncoHost, AUG 14, 2024, View Source [SID1234645934]). The abstracts highlight OncoHost’s significant work in developing predictive models for immunotherapy-related toxicities and clinical outcomes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The research to be presented includes one oral presentation and two poster presentations, each showcasing the potential of plasma proteomics in advancing personalized treatment strategies for lung cancer patients.

Oral Presentation

Title: Plasma Proteomics-Based Models for Predicting Immunotherapy- and Chemotherapy-Related Toxicity in NSCLC Patients
Presenter: Prof. Jarushka Naidoo

This study addresses a critical need in the management of metastatic non-small cell lung cancer (NSCLC) patients who are treated with PD-1/PD-L1-based immune checkpoint inhibitors (ICIs). Prof. Naidoo will present innovative plasma proteomics-based models designed to predict the likelihood of severe immune-related adverse events (irAEs) and chemotherapy-related adverse events (chemo-AEs) before treatment begins. These models offer a promising approach to improving patient care by identifying those at higher risk of experiencing significant toxicities, thereby allowing for more informed treatment decisions.

"The field of immunotherapy for lung cancer has a well-developed focus on identifying biomarkers of response and resistance to treatment. However, biomarkers of toxicity from immunotherapy and chemotherapy are also of clinical relevance, with the potential to refine treatment selection and monitoring," said Jarushka Naidoo, MD, consultant medical oncologist at Beaumont Hospital Dublin, professor at the Royal College of Surgeons in Ireland, and corresponding author of the study. "These data explore the use of proteomics for this purpose and are an important area for continued study."

Poster Presentations

Title: A Plasma Proteomics-Based Model for Clinical Benefit Prediction in Small Cell Lung Cancer Patients Receiving Immunotherapy
Presenter: Prof. David R. Gandara

This research focuses on small cell lung cancer (SCLC), a particularly aggressive form of lung cancer with limited treatment options. Prof. Gandara will present a novel computational model that utilizes pretreatment plasma proteomic profiles to predict clinical outcomes for SCLC patients receiving immunotherapy (ICIs) combined with chemotherapy. The study highlights the potential of this model to refine treatment strategies by identifying patients most likely to benefit from ICIs, paving the way for more personalized and effective therapies.

"Although checkpoint immunotherapy combined with chemotherapy has extended survival in patients with extensive stage SCLC, many patients do not benefit, and most patients develop recurrence. Identifying those patients most likely to have meaningful benefit is a critical unmet need," said David R. Gandara, MD, Division of Hematology and Oncology, University of California Davis Comprehensive Cancer Center, and corresponding author of the study. "This study describes the development of a blood-based proteomic test to distinguish these patients at the time of diagnosis, prior to therapy. Given the rapid progression and aggressive nature of this malignancy, this assay has the potential to truly personalize initial treatment plans."

Title: Deciphering Immunotherapy Resistance Mechanisms in Metastatic NSCLC: Insights from Plasma Proteomics Analysis
Presenter: Dr. Itamar Sela, VP R&D, OncoHost

This study delves into the mechanisms of immunotherapy resistance in metastatic NSCLC. Dr. Sela will present findings from the PROphetNSCLC test, a plasma proteomics and machine learning-based tool designed to assist in first-line treatment management. The research identifies six distinct groups of resistance-associated proteins (RAPs) linked to the immune system, tumor, and other tissues, offering valuable insights into the biological processes underlying resistance to immunotherapy.

"Our research showcases the groundbreaking potential of plasma proteomics in oncology," said Yehuda Brody, PhD, Senior Computational Biologist Researcher at OncoHost. "By leveraging non-invasive liquid biopsy samples, we’ve identified specific resistance mechanisms and biomarkers within the plasma proteome. This approach provides a multisystem overview, bringing us closer to truly personalized treatment strategies for lung cancer patients. Our study marks a significant advancement in decoding the complex, multifaceted nature of immunotherapy resistance, ultimately aiming to improve personalized patient treatment decisions."

OncoHost’s participation in WCLC 2024 underscores its commitment to advancing the field of oncology through innovative research and technology. The company looks forward to sharing these important findings with the global oncology community.

On August 14, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immuno-oncology therapy, reported financial results for the three and six months ended June 30, 2024 (Press release, IMUNON, AUG 14, 2024, View Source [SID1234645904]). 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 booster candidate.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The 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."

Dr. 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."

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Reported 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.
The 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.
The 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.

MRD 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.

The 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 enrollment.

As 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.

PlaCCine: Next Generation Prophylactic Vaccine Proof of Concept

First 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.

During 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.

Corporate Developments

Received 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.

SECOND QUARTER FINANCIAL RESULTS

IMUNON 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.

Research 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.

R&D 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.

General 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.

Other 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.

The 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.

FIRST HALF FINANCIAL RESULTS

For 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.

Net 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.

R&D 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.

R&D 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.

General and administrative expenses were $3.9 million in the first half of 2024, compared with $5.4 million in the same period of 2023. The decrease was primarily attributable to lower non-cash stock compensation expenses of $0.4 million, legal expenses of $0.4 million, employee-related expenses of $0.3 million and insurance expenses of $0.1 million.

Other non-operating income was $0.3 million in the first half of 2024, compared with $8,505 in the same period of 2023. The Company incurred interest expense of $0.2 million on its loan facility with Silicon Valley Bank in the first half of 2023. The Company incurred debt extinguishment expense on its loan facility with Silicon Valley Bank in the first half of 2023 of $0.3 million, which was repaid in full in the second quarter of 2023. Investment income from the Company’s short-term investments decreased by $0.2 million for the first half of 2024 from the same period in 2023 due to lower investment balances.

Conference Call and Webcast

The Company is hosting a conference call at 11:00 a.m. Eastern time today to provide a business update, discuss second quarter 2024 financial results and answer questions. 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 Second Quarter 2024 Earnings Call. A live webcast of the call will be available here.

The call will be archived for replay until August 28, 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 1829664. A webcast of the call will be available here for 90 days.