On November 7, 2024 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three and nine months ended September 30, 2024, and provided an operating forecast and business update (Press release, Ligand, NOV 7, 2024, View Source [SID1234647934]). Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss this announcement and answer questions.

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"We just had one of the best quarters of performance in the history of Ligand. This success is due to the ongoing strength of our growing portfolio of commercial-stage programs, and we are pleased to announce an increase in guidance for the second time this year," said Todd Davis, CEO of Ligand. "This quarter, we had several key portfolio events, including the successful commercial launches of Ohtuvayre and CAPVAXIVE as well as the full FDA approval of FILSPARI. We believe each of these products, along with our recently acquired QARZIBA, will be key drivers of revenue growth for Ligand in the coming years."

Third Quarter 2024 Financial Results

Total revenues and other income for the third quarter of 2024 were $51.8 million, compared with $32.9 million for the same period in 2023, with the 58% increase primarily due to an increase in royalty revenue and milestone payments earned upon the commercial launch of Verona Pharma plc’s (Nasdaq: VRNA) Ohtuvayre. Royalties for the third quarter of 2024 were $31.7 million, compared with $23.9 million for the same period in 2023, with the 33% increase primarily attributable to royalties earned on Ligand’s recently acquired product, QARZIBA, and an increase in sales of Travere Therapeutics’ (Nasdaq: TVTX) FILSPARI. Captisol sales were $6.3 million for the third quarter of 2024, compared with $8.6 million for the same period in 2023, with the change due to timing of customer orders. Contract revenue and other income was $13.8 million for the third quarter of 2024, compared with $0.4 million for the same period in 2023, with the increase driven by the $13.5 million milestone payment earned upon the commercial launch of Ohtuvayre.

Cost of Captisol was $2.4 million for the third quarter of 2024, compared with $3.5 million for the same period in 2023, with the change due to timing of customer orders of Captisol sales. Amortization of intangibles was $8.3 million for the third quarter of 2024, compared with $8.2 million for the same period in 2023. Research and development expenses were $5.7 million for the third quarter of 2024, compared with $5.5 million for the same period in 2023. General and administrative expenses were $24.5 million for the third quarter of 2024, compared with $14.7 million for the same period in 2023, with the increase primarily attributable to higher stock-based compensation driven primarily by a one-time non-cash stock award modification charge tied to the departure of Ligand’s former COO and operating costs associated with incubating the Pelthos Therapeutics business.
GAAP net loss from continuing operations was $7.2 million, or $0.39 net loss per share for the third quarter of 2024, compared with $10.3 million, or $0.59 net loss per share, for the same period in 2023. GAAP net loss from continuing operations for the third quarter of 2024 included $15.3 million loss from non-cash fair value adjustments on the company’s Agenus Inc. (Nasdaq: AGEN) derivative assets. Core adjusted net income from continuing operations for the third quarter of 2024 was $35.3 million, or $1.84 per diluted share, compared to $18.0 million, or $1.02 per diluted share, for the same period in 2023. We did not sell any shares of Viking Therapeutics (Nasdaq: VKTX) common stock in the third quarter of 2024 or 2023. The increase in core adjusted net income was driven primarily by the 58% increase in revenue. The definition of core adjusted net income (loss) is adjusted net income plus the after-tax impact from the realized gain from the sale of Viking Therapeutics common stock. See the table below for a reconciliation of net loss from continuing operations to core adjusted net income from continuing operations.
As of September 30, 2024, Ligand had cash, cash equivalents and short-term investments of $219.6 million which includes $63.3 million in Viking Therapeutics common stock. Ligand issued 334,325 shares under the company’s At-the-Market (ATM) equity offering program at a weighted average share price of $104.70 for gross proceeds of $35 million during the third quarter of 2024. Ligand may continue to issue shares of our common stock having an aggregate offering price of up to $65 million from time to time under terms of the ATM program.
Year-to-Date Financial Results
Total revenues and other income for the nine months ended September 30, 2024 were $124.3 million, compared with $103.2 million for the same period in 2023. Royalties for the nine months ended September 30, 2024 were $74.0 million, compared with $62.5 million for the same period in 2023, with the increase primarily attributable to royalties earned on QARZIBA and an increase in sales of Travere Therapeutics’ FILSPARI. Captisol sales were $23.0 million for the nine months ended September 30, 2024, compared with $24.5 million for the same period in 2023, with the change due to the timing of customer orders. Contract revenue and other income was $27.4 million for the nine months ended September 30, 2024, compared with $16.3 million for the same period in 2023, with the increase driven by milestone payments of $19.2 million earned from Verona Pharma upon the approval and commercial launch of Ohtuvayre.

Cost of Captisol was $8.2 million for the nine months ended September 30, 2024, compared with $8.9 million for the same period in 2023, with the change due to the timing of customer orders. Amortization of intangibles was $24.7 million for the nine months ended September 30, 2024, compared with $25.3 million for the same period in 2023. Research and development expenses were $17.0 million for the nine months ended September 30, 2024, compared with $19.0 million for the same period in 2023, with the decrease primarily attributable to lower employee related expenses and lab supplies resulting from the Pelican spin-off in September 2023. The decrease was partially offset by additional costs associated with incubating the Pelthos business. For the nine months ended September 30, 2024, general and administrative expenses were $53.0 million, compared to $36.8 million for the same period in 2023. This increase was primarily driven by higher stock-based compensation expenses related to new hire stock awards for business development and investment team members. Additionally, a one-time, non-cash stock award modification expense related to the departure of Ligand’s former COO and costs associated with incubating the Pelthos business contributed to the increase.

GAAP net income from continuing operations was $27.1 million, or $1.46 per diluted share for the nine months ended September 30, 2024, compared with $35.6 million, or $2.00 per diluted share, for the same period in 2023. The decrease in GAAP net income from continuing operations from the prior year period is due primarily to the impairment of the financial royalty asset related to Takeda Pharmaceuticals’ (NYSE:TAK) soticlestat and the decrease in investments in Primrose Bio in connection with the equity funding received by Primrose Bio in June and July 2024. Adjusted net income from continuing operations for the nine months ended September 30, 2024 was $130.8 million, or $7.04 per diluted share, compared to $83.0 million, or $4.71 per diluted share, for the same period in 2023. Excluding the impact of gains from sales of Viking Therapeutics stock, core adjusted net income from continuing operations for the nine months ended September 30, 2024 was $83.0 million, or $4.46 per diluted share, compared with $53.0 million, or $3.01 per diluted share, for the same period in 2023. The increase in core adjusted net income is primarily driven by the increase in revenue. See the table below for a reconciliation of net income from continuing operations to core adjusted net income from continuing operations.

2024 Financial Guidance
Ligand is increasing its 2024 full year financial guidance previously outlined in July. The company now expects total revenue of $160 million to $165 million (previously $140 million to $157 million) and is raising core adjusted earnings per diluted share to $5.50 to $5.70 (previously $5.00 to $5.50).
Royalties are expected to be $105 million to $108 million (previously $100 million to $105 million), sales of Captisol of $27 million to $29 million (previously $25 million to $27 million) and contract revenue of $28 million (previously $15 million to $25 million). This guidance excludes the $60 million realized gain from short-term investments on the sale of Viking Therapeutics stock.Adjusted Financial Measures
Ligand reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, amortization of financial royalty assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, Pelthos operating loss, impairment of financial royalty assets, loss from equity method investment in Primrose Bio, income tax effect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. A reconciliation of forward-looking non-GAAP core adjusted earnings per diluted share to the most directly comparable GAAP measures is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculations of our core adjusted earnings per diluted share, which we expect to have a significant impact on our future GAAP financial results.

Third Quarter 2024 and Corporate Highlights
Portfolio Updates
FILSPARI
On September 5, Travere Therapeutics announced it received full FDA approval for FILSPARI for the treatment of IgA Nephropathy (IgAN) in adults. The FDA decision expands patient access to the first and only non-immunosuppressive therapy approved for the treatment of this rare progressive kidney disease.
On October 17, Travere Therapeutics and CSL Vifor announced that Swissmedic granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The Swissmedic approval was supported by results from the pivotal Phase 3 PROTECT Study of FILSPARI in IgA nephropathy (IgAN) and follows full marketing approval by the U.S. Food and Drug Administration in September 2024 and conditional marketing authorization by the European Medicines Agency in April 2024.
On October 26, Travere Therapeutics presented new data further demonstrating the clinical benefit of FILSPARI in IgAN and reinforcing its potential in focal segmental glomerulosclerosis (FSGS) at the American Society of Nephrology Kidney Week 2024. Presentations included new data from the SPARTAN Study which showed that nearly 60% of patients with IgAN achieved complete remission when using FILSPARI as a first-line treatment. In addition, presentations took place on the SPARTACUS Study, PROTECT open-label extension, and real-world evidence highlighting the initial safety and efficacy data of FILSPARI in IgAN in combination treatment with a SGLT2 inhibitor. A late-breaking presentation demonstrated sparsentan delivered rapid and sustained proteinuria reduction and long-term kidney health benefits in a subset of patients with genetic, often treatment resistant, FSGS.
Ohtuvayre
On November 4, Verona Pharma provided an update on the commercial launch of Ohtuvayre in the U.S. reporting net sales of $5.6 million and October net sales that exceeded total third quarter sales. Additionally, through October Verona Pharma reported more than 2,200 unique prescribers and more than 5,000 prescriptions were filled across a broad COPD population.

In September, Verona’s Pharma development partner in Greater China, Nuance Pharma (private), completed enrollment in its pivotal Phase 3 clinical trial evaluating Ohtuvayre for the maintenance treatment of COPD in China. Results from the trial are expected in 2025.
Other Programs
On October 23, Merck (NYSE: MRK) announced that the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and has recommended CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older. Additionally, ACIP shared clinical decision-making has also recommended a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 (pneumococcal 13-valent conjugate vaccine) and PPSV23 (pneumococcal 23-valent polysaccharide vaccine).
On October 9, Viking Therapeutics announced positive data from the company’s Phase 1b clinical trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta (TRβ), in patients with X-linked adrenoleukodystrophy. Results from this study showed VK0214 to be safe and well-tolerated following once-daily dosing over the 28-day study period. In addition, significant reductions were observed in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo. Ligand is entitled to a 3.5-7.5% royalty on future net sales of VK0214, as well as clinical, regulatory, and commercial milestones.
On July 1, Palvella Therapeutics (private) initiated SELVA, a 24-week, pivotal Phase 3, single-arm, baseline-controlled clinical trial of QTORIN rapamycin for the treatment of microcystic lymphatic malformations (MLM). The study’s primary and key secondary endpoints are clinician-reported outcomes and the study will enroll 40 subjects at leading vascular anomaly centers across the U.S.

Conference Call and Webcast
Ligand management will host a conference call today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement and answer questions. To participate via telephone, please dial (888) 596-4144 using the conference ID 8755336. Callers outside the U.S. may dial +1(646) 968-2525. To participate via live or replay webcast, a link is available at View Source

On November 7, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, reported operational highlights and financial results for the third quarter 2024, ending September 30, 2024 (Press release, Lantern Pharma, NOV 7, 2024, View Source [SID1234647933]).

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"Lantern is achieving remarkable momentum, balancing meticulous execution with innovation. While progressing on the initial positive results from our Harmonic trial in both the US and Asia, we are also advancing our RADR AI platform to strategically guide our therapeutic pipeline. The emerging combination therapy opportunities we are identifying for both LP-184 and LP-284 underscore the strength of our AI-guided approach. Seeing our drug candidates advance in clinical trials, with the potential to meaningfully impact cancer patients’ lives, reinforces our mission. Additionally, as Starlight Therapeutics enters its next chapter of growth in CNS cancers, we look ahead to our plans for a Phase1b/2 clinical trial for STAR-001. We remain focused on the objective of developing therapies—at a fraction of the cost and time of traditional drug development by using our AI platform and data-driven methodologies. Our goal is ultimately to address critical and often unmet patient needs in oncology," said Panna Sharma, President and CEO of Lantern Pharma.

Highlights of AI-Powered Pipeline:

● LP-300: The Harmonic Phase 2 Clinical Trial – The Phase 2 Harmonic trial is aimed at making a significant advancement in addressing an urgent unmet need for never-smoker patients with non-small cell lung cancer (NSCLC). In the initial safety lead-in cohort of 7 patients, LP-300 demonstrated encouraging preliminary results when combined with standard-of-care chemotherapy (pemetrexed and carboplatin), achieving an 86% clinical benefit rate and a 43% objective response rate. Of particular note, 3 patients achieved partial responses with an average tumor size reduction of 51%, while 3 additional patients achieved stable disease with an average tumor reduction of 13%. Importantly, these preliminary results were observed regardless of prior tyrosine kinase inhibitor (TKI) treatments, patient demographics, or metastatic disease sites, suggesting broad potential applicability across the never-smoker NSCLC population.

The trial’s safety profile has been especially promising, with no dose-limiting toxicities observed and no discontinuations due to LP-300 treatment-related toxicity. The most common adverse events were manageable decreases in white blood cell count and thrombocytopenia.

The Harmonic trial has now progressed to its randomization and expansion phase, which is designed to enroll up to an additional 84 patients in a 2:1 ratio comparing LP-300 plus standard-of-care chemotherapy versus chemotherapy alone. With regulatory approval to expand into multiple Asian countries, the trial is positioned to accelerate enrollment in the targeted patient population of never-smokers with NSCLC, which we believe represents a potential global market estimated at over $4 billion annually. Leading our Harmonic trial efforts in Japan is Dr. Yasushi Goto, a renowned physician and researcher at the National Cancer Center Japan, where the incidence of never-smoker NSCLC is more than double that of the United States. The company has also initiated five trial sites in Taiwan, where over 40% of the new lung cancer diagnoses are among never-smokers, strategically positioning the Harmonic trial in regions with the highest prevalence of the target patient population. Lantern believes that this improves the potential for drug-candidate LP-300 to develop collaboration and co-development partnerships with global biopharma companies with a primary focus in serving the Asian markets. The study’s co-primary endpoints are progression-free survival (PFS) and overall survival (OS), with planned interim analysis after 31 patients have experienced disease progression which is expected by mid 2025.

● LP-184 – LP-184 continues to advance through its Phase 1a first-in-human basket trial (NCT05933265) across multiple solid tumor indications. Nine patient cohorts have been successfully dosed at escalating dose levels, and no dose-limiting toxicities observed to date. The trial is actively enrolling patients with relapsed/refractory advanced solid tumors, including pancreatic cancer, glioblastoma (GBM), triple-negative breast cancer, and other solid tumor types with DNA damage response deficiencies. Based on pharmacokinetic analyses, the upcoming cohorts are expected to reach dosage levels where therapeutic concentrations should be attainable, with enrollment projected to complete this year and initial safety and molecular correlation data expected by year-end 2024 or early 2025.

The LP-184 development program received a significant boost with the FDA granting Fast Track Designation in glioblastoma, recognizing both the serious nature of GBM and the significant unmet medical need in this indication which affects more than 13,000 U.S. adults annually. Through Lantern’s wholly-owned subsidiary Starlight Therapeutics, LP-184 (designated as STAR-001 for CNS indications) is being positioned for a Phase 1b/2a clinical trial in recurrent GBM that is targeted to begin in early 2025. Lantern has also made important progress towards developing a quantitative PCR-based molecular diagnostic test that could help identify patients most likely to respond to LP-184 treatment. Lantern is in the process of validating the PCR assay with patient samples from the initial seven cohorts from the LP-184 Phase 1a trial and we plan on using the molecular correlations to power future development and trial design.

Additional ongoing preclinical studies continue to demonstrate LP-184’s potential, particularly in combination therapy settings with some of the most widely used FDA approved drugs. One of these combinations using an FDA approved agent, spironolactone, is directed at the treatment of GBM and will be part of the planned Phase 1b study. Recent data presented at scientific conferences has highlighted promising synergy when LP-184 is combined with various FDA-approved treatments, including PARP inhibitors and immune checkpoint inhibitors. LP-184 has also shown promise in cancers with DNA damage response deficiencies beyond deficiencies in homologous recombination repair, demonstrating synthetic lethality in indications beyond those traditionally considered for PARP inhibitors. With an estimated aggregate annual market potential of approximately $12+ billion across its target indications ($4.5+ billion for CNS cancers and $7.5+ billion for solid tumors), we believe LP-184 represents a significant commercial opportunity while potentially addressing critical unmet patient needs across multiple cancer types.

● LP-284 – The fourth cohort of patients are being dosed, and no dose-limiting toxicities have been observed in the LP-284 Phase 1a clinical trial. We are in the process of opening additional hematology-focused sites later this year, with the potential to advance to Phase 1b or 2 by early to mid 2025. LP-284 has shown nanomolar potency across multiple published in vitro and in vivo studies, including mantle cell lymphoma (MCL), double hit lymphoma (DHL), and other advanced NHL cancer subtypes with DNA damage response deficiencies, notably those with compromised functioning of the ataxia-telangiectasia mutated (ATM) gene due to mutations or deletions. Nearly all MCL, DHL, and HGBL patients relapse from the current standard-of-care agents and there is an urgent and unmet need for novel improved therapeutic options for these patients. In the US and Europe, MCL, DHL, and HGBLs are diagnosed in 16,000-20,000 patients each year and these indications represent an estimated annual market potential of over $3+ billion.

Third Quarter 2024 Financial Highlights

● Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $28.1 million as of September 30, 2024, compared to approximately $41.3 million as of December 31, 2023. The quarterly cash burn rate continues to reflect our capital-efficient, collaborator-centered business model.

● R&D Expenses: Research and development expenses were approximately $3.7 million for the quarter ended September 30, 2024, compared to approximately $2.2 million for the quarter ended September 30, 2023.

● G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended September 30, 2024, compared to approximately $1.3 million for the quarter ended September 30, 2023.

● Net Loss: Net loss was approximately $4.5 million (or $0.42 per share) for the quarter ended September 30, 2024, compared to a net loss of approximately $3.2 million (or $0.29 per share) for the quarter ended September 30, 2023.

● Total Share and Warrant Count: During the three months ended September 30, 2024, the Company issued 2,088 shares of common stock relating to the cashless exercise of warrants to purchase 7,664 shares, which warrants were expiring. Also during the three months ended September 30, 2024, the Company issued 3,832 shares of common stock for aggregate proceeds of $11,994 relating to the exercise of warrants that were expiring. As of the date of this press release, the Company has 10,784,725 shares of common stock outstanding, and outstanding warrants to purchase 70,000 shares of common stock.

Additional Operational Highlights:

● Lantern is building an efficient internal clinical operations team that it is leveraging across a range of clinical activities, from project management to site startup through data and quality management, and as a result is expected to rely less on external CRO providers with the aim of further managing ongoing clinical trial costs.

● Lantern published new research in PLOS ONE highlighting its data-driven approach to ADC design and development. The publication, titled ‘Expanding the repertoire of Antibody Drug Conjugate (ADC) targets with improved tumor selectivity and range of potent payloads through in-silico analysis,’ demonstrates a multi-step filtering approach to identify optimal ADC targets and payloads. Starting with over 20,000 protein-coding genes, they systematically narrowed candidates using membrane protein status, expression levels in critical tissues, and surface protein validation. The study uniquely analyzed how 416 different mutations across 22 tumor types affect target expression, revealing how specific mutations like KRAS in pancreatic cancer and EGFR in gliomas influence target levels. The analysis identified 82 promising ADC targets and 729 potential payloads, including novel candidates and repurposing opportunities for existing compounds with picomolar to nanomolar potency. We believe this comprehensive approach provides a framework for developing more precise and effective ADC therapeutics and assessing the utility and viability of an ADC design earlier in the development process.

● New data and scientific findings conducted in conjunction with Drs. Yong Du and Shiaw-Yih (Phoebus) Lin at MD Anderson were presented at The Immuno-Oncology Summit 2024. The findings showcased what Lantern believes to be the role of LP-184 to be combined with checkpoint inhibitors to provide greater response in TNBC due to synergy and to potentially transform TNBC tumors that are unresponsive (cold) to checkpoint inhibitors to responsive (hot). The poster was titled: LP-184, a Novel Acylfulvene, Sensitizes Immuno-Refractory Triple Negative Breast Cancers (TNBCs) To Anti-PD1 Therapy by Affecting the Tumor Microenvironment.

● Lantern will host its final Webinar Wednesday of 2024 on December 11, 2024, focusing on the company’s unique ability to predict blood-brain barrier penetration of drug compounds. The webinar will also discuss future development plans and potential commercial availability of this RADR platform module, which leverages extensive molecular feature analysis enriched with proprietary insights and data. According to the Therapeutic Data Commons, a coordinated initiative to access and evaluate artificial intelligence capability across therapeutic modalities and stages of discovery, Lantern’s BBB algorithms are 5 of the top 10 performing algorithms on the "Leaderboard".

Earnings Call and Webinar Details:

Lantern will host its 3rd quarter 2024 earnings call and webinar today, November 7th, 2024, at 4:30 p.m. ET. A link to register can be accessed at: (LTRN: 3rd Quarter Earnings Call & Zoom link)

On November 7, 2024 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported third quarter 2024 financial results and provided a corporate update (Press release, Kura Oncology, NOV 7, 2024, View Source [SID1234647932]).

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"We approach the end of 2024 in a strong position, with a series of important catalysts ahead," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "First, we look forward to sharing a robust dataset from more than 100 patients in our Phase 1a dose-escalation study of ziftomenib in combination with standards of care in acute myeloid leukemia (AML) at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, followed by topline results from our registration-directed trial of ziftomenib in relapsed/refractory (R/R) NPM1-mutant (NPM1-m) AML early next year. In the meantime, we continue to enroll rapidly across all our ziftomenib studies, further supporting the broad development of our menin inhibitor programs."

Recent Highlights

Topline results from registration-directed trial of ziftomenib in early 2025 – In May 2024, Kura completed enrollment of 85 patients in the Phase 2 portion of KOMET-001, a registration-directed clinical trial of its menin inhibitor, ziftomenib, in patients with R/R NPM1-m AML. Ziftomenib is the first and only investigational therapy to be granted Breakthrough Therapy Designation (BTD) for the treatment of R/R NPM1-m AML, which accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists. Results from the Phase 1 portion of KOMET-001 were recently published in the leading clinical oncology journal, The Lancet Oncology.
Data from Phase 1a dose-escalation study of ziftomenib at ASH (Free ASH Whitepaper) – Two abstracts reporting preliminary data from the Phase 1a dose-escalation study of ziftomenib in combination with standards of care in patients with NPM1-m and KMT2A-rearranged (KMT2A-r) AML have been accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting in December. As of the June 21, 2024 data cutoff, the abstracts continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care, including venetoclax plus azacitidine (ven/aza) as well as cytarabine plus daunorubicin (7+3). Kura expects to present a more mature dataset from more than 100 patients in the Phase 1a dose-escalation study in the presentations at ASH (Free ASH Whitepaper).
Phase 1b expansion study of ziftomenib now enrolling in all cohorts – All four cohorts in the Phase 1a dose-escalation study have cleared the highest dose and advanced into the Phase 1b expansion study at 600 mg. The Phase 1b expansion study includes multiple combination cohorts, including ziftomenib plus ven/aza in newly diagnosed NPM1-m or KMT2A-r AML and ziftomenib plus 7+3 in newly diagnosed NPM1-m or KMT2A-r AML without qualification for high-risk disease. Each of the seven combination cohorts is expected to enroll at least 20 patients. A total of 45 patients have already enrolled in the study since the first dose-expansion cohort opened in August 2024. The Company anticipates sharing preliminary data from the Phase 1b expansion study at a medical meeting in 2025.
Preclinical data support opportunity for ziftomenib in GIST – Last month, at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Kura reported preclinical data supporting the combination of ziftomenib and imatinib for the treatment of advanced gastrointestinal stromal tumors (GIST). The combination showed unexpectedly robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST patient-derived xenograft models, and in all cases was significantly superior to imatinib monotherapy. The Company received FDA clearance of its Investigational New Drug application for ziftomenib for the treatment of advanced GIST in August and expects to initiate a proof-of-concept study in the first half of 2025 evaluating ziftomenib and imatinib in patients with advanced GIST who have failed imatinib.
First patient dosed in study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC – In August 2024, Kura began dosing patients in its study of KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in combination with adagrasib in KRASG12C-mutated non-small cell lung cancer (NSCLC). The Company’s findings suggest that combining KO-2806 with adagrasib may drive tumor regressions and enhance both duration and depth of antitumor response in preclinical models of KRASG12C-mutated NSCLC. The study of KO-2806 and adagrasib is supported by a clinical collaboration and supply agreement with Mirati, now a Bristol Myers Squibb company.
Preclinical data support potential for menin inhibitor in diabetes – In June 2024, Kura reported data showing that ziftomenib induces insulin production, improves insulin sensitivity and reduces insulin resistance in a preclinical in vivo model of type 2 diabetes. Ziftomenib demonstrated meaningful levels of glycemic control, including reduced fasting blood glucose levels and %HbA1C within 27 days, as well as consistent improvement in both insulin sensitivity and insulin production. The data were presented at the American Diabetes Association Scientific Sessions in Orlando. The Company expects to nominate a next generation menin inhibitor candidate targeting diabetes in the first half of 2025.
Financial Results

Research and development expenses for the third quarter of 2024 were $41.7 million, compared to $29.3 million for the third quarter of 2023.
General and administrative expenses for the third quarter of 2024 were $18.2 million, compared to $13.1 million for the third quarter of 2023.
Net loss for the third quarter of 2024 was $54.4 million, compared to a net loss of $38.6 million for the third quarter of 2023. This included non-cash share-based compensation expense of $8.3 million, compared to $7.1 million for the same period in 2023.
As of September 30, 2024, Kura had cash, cash equivalents and short-term investments of $455.3 million, compared to $424.0 million as of December 31, 2023.
Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations into 2027.
Forecasted Milestones

Present updated data from the KOMET-007 trial of ziftomenib in combination with ven/aza and 7+3 at ASH (Free ASH Whitepaper) in December 2024.
Report topline results from the KOMET-001 registration-directed trial of ziftomenib in NPM1-mutant R/R AML in early 2025.
Present preliminary data from the Phase 1b expansion portion of KOMET-007 at a medical meeting in 2025.
Initiate proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST in the first half of 2025.
Nominate a next generation menin inhibitor development candidate targeting diabetes in the first half of 2025.
Identify the maximum tolerated dose for KO-2806 as a monotherapy in the second half of 2024.
Initiate one or more expansion cohorts for the combination of KO-2806 and cabozantinib in renal cell carcinoma in the first half of 2025.
Present data from the KURRENT-HN trial of tipifarnib in combination with alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) in the first half of 2025.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, November 7, 2024, to discuss the financial results for the third quarter 2024 and to provide a corporate update. The live call may be accessed by dialing (800) 225-9448 for domestic callers and (203) 518-9708 for international callers and entering the conference ID: KURAQ3. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On November 7, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported third quarter and year to date 2024 financial results and corporate updates (Press release, Iovance Biotherapeutics, NOV 7, 2024, View Source [SID1234647931]).

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance is executing a successful U.S. commercial launch of Amtagvi for patients with previously treated advanced melanoma. Robust demand for Amtagvi and Proleukin continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As such, we are actively pursuing additional regulatory approvals to expand our commercial footprint, driving growth beyond the U.S. into new markets with a high prevalence of advanced melanoma. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer."

Third Quarter and Year to Date 2024 Financial Results, Corporate Guidance, and Updates

Product Revenue and Guidance

3Q24 Total Product Revenue: Iovance recognized total revenue of $58.6 million from sales of Amtagvi and Proleukin during the third quarter ended September 30, 2024.
Amtagvi Revenue: Product revenue was $42.1 million from U.S. Amtagvi sales in the third quarter of 2024, reflecting increasing strong demand and adoption. The Amtagvi launch, with revenue recognized upon patient infusion, began during the second quarter of 2024.
Proleukin Revenue: Product revenue also included $16.5 million of Proleukin sales in the third quarter of 2024. Proleukin is used in the Amtagvi treatment regimen and other commercial and clinical settings. Proleukin revenue is recognized upon delivery to distributors and ATCs and purchased several months in advance of anticipated infusions and Amtagvi revenue recognition.
Year to Date Total Product Revenue and Infusions: Through the end of the third quarter of 2024, $90.4 million in total product revenue has been recognized following the U.S. launch of Amtagvi on February 20, 2024.
Amtagvi Infusions: A total of 146 patients have been infused with Amtagvi since the first commercial infusion in April 2024, including 25 patients infused in the second quarter, 82 patients infused in the third quarter, and 39 patients infused since the start of the fourth quarter.
Amtagvi and Proleukin Revenue: Amtagvi and Proleukin revenue is $54.9 million and $35.5 million year to date, respectively.
FY24 and FY25 Total Product Revenue Guidance: Amtagvi adoption is on track to continue accelerating, driven by broader utilization, higher demand from our expanding ATC network, and growth in community referrals. Iovance is reaffirming its guidance for FY24 and FY25 and expects quarter-over-quarter product revenue growth for the fourth quarter of 2024, full year 2025, and beyond.
Revenue Guidance in FY24: Total product revenue for the full year 2024 continues to be within the range of $160 to $165 million, reflecting three quarters of Amtagvi sales following U.S. Food and Drug Administration (FDA) approval in mid-February.
Revenue Guidance in FY25: Total product revenue remains on track to be within the range of $450 to $475 million in 2025, the first full calendar year of Amtagvi sales. Gross margins are increasing as the launch advances and are expected to surpass 70% over the next several years. In line with anticipated growth in Amtagvi demand, Proleukin revenue is also expected to increase significantly in 2025 and beyond.
Cash Position: As of September 30, 2024, Iovance had cash, cash equivalents, investments, and restricted cash of $403.8 million. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations, including manufacturing expansion, into early 2026.
Amtagvi (Lifileucel) U.S. Launch Highlights in Advanced Melanoma

The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication.
Onboarding is complete at 56 U.S. ATCs across 29 states and more than 90% of addressable patients are now located within 200 miles of an ATC. Approximately 70 ATCs remain on track to be onboarded by the end of 2024.
Manufacturing turnaround time has been on target, with launch expectations of approximately 34 days from inbound to return shipment to ATCs. With efforts underway, turnaround time is expected to be reduced in the near term. The commercial manufacturing experience is consistent with prior clinical experience.
Amtagvi is a preferred second-line or subsequent therapy in the National Comprehensive Cancer Network guidelines for treatment of cutaneous melanoma.
Reimbursement remains successful, with an average financial clearance time of about three weeks.
Approximately 75% of enrolled Amtagvi patients are covered by private payers. To date, payers or plans covering more than 250 million lives have added Amtagvi to policies since its launch.
Lifileucel Launch Expansion into New Markets

Amtagvi has the potential to address more than 20,000 patients annually with previously treated advanced melanoma across the U.S. and multiple global markets where regulatory submissions have been submitted or are planned for 2024 and 2025.1
Regulatory dossiers are under review, submitted, or planned across multiple international markets for lifileucel for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all markets.
A marketing authorization application (MAA) for all EU member states was validated and accepted for review by the European Medicines Agency for potential approval in the second half of 2025.
An MAA was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for potential approval in the first half of 2025.
A near-term new drug submission (NDS) was deemed eligible for Notice of Compliance with Conditions (NOC/c) by Health Canada. The NOC/c policy includes a prioritized 200-day review process for potential NDS approval in mid-2025.
Additional regulatory dossiers remain on track for submission in 2025 and 2026 in markets with significant populations of previously treated advanced melanoma patients, including Australia in the first half of 2025 and Switzerland in the second half of 2025.
Iovance TIL Cell Therapy Pipeline Highlights

Lifileucel in Frontline Advanced Melanoma
Updated clinical data from Cohort 1A of the IOV-COM-202 trial was presented at ASCO (Free ASCO Whitepaper) 2024 and demonstrated an unprecedented rate, depth and durability of responses, including a 30% confirmed complete response rate, and a differentiated safety profile in advanced melanoma patients who were naive to immune checkpoint inhibitors.
Cohort 1D in the IOV-COM-202 trial is exploring lifileucel in combination with nivolumab and relatlimab in patients with frontline advanced melanoma, representing another potential best-in-class frontline alternative for physicians and patients in the U.S.
Strong momentum continues with global site activation and patient enrollment in the TILVANCE-301 trial, with nearly 50 active sites across 11 countries, including the U.S., Europe, Australia, and Canada, and more than 50 additional sites across 15 countries committed to join the trial. TILVANCE-301 is intended to support accelerated and full U.S. approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, as well as full approval of Amtagvi in post-anti-PD-1 melanoma.
Lifileucel in Non-Small Cell Lung Cancer (NSCLC)
Enrollment is accelerating in the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC with high demand at clinical sites in the U.S., Canada, and Europe. Iovance is also activating sites in additional regions with strong track records for enrollment in NSCLC studies. Iovance expects to present updated data from the IOV-LUN-202 trial at a medical conference in 2025.
The FDA previously provided positive regulatory feedback on the proposed potency matrix for lifileucel in NSCLC, as well as the single-arm IOV-LUN-202 trial design to support accelerated approval of lifileucel in post-anti-PD-1 NSCLC.
Iovance expects data from the IOV-LUN-202 trial to support a potential accelerated U.S. approval for lifileucel in NSCLC in 2027.
Updated preliminary results from Cohort 3A in the IOV-COM-202 trial continue to demonstrate robust response rates and durability for lifileucel in combination with pembrolizumab in NSCLC patients who were not previously treated with immune checkpoint inhibitor therapy.
A confirmed objective response was observed in 9 of 14 EGFR wild type patients (64.3%), including 6 of 11 (54.5%) patients who also had difficult-to-treat PD-L1 negative disease.
Median duration of response (DOR) was not reached at a median study follow up of 26.5 months.
This data supports the opening of a new cohort, 3D, in the IOV-COM-202 trial to investigate lifileucel plus pembrolizumab following chemotherapy as part of frontline therapy for patients with EGFR wild type NSCLC, representing the majority of patients with an unmet medical need in this setting.
Additional Cohort 3A results are available in a late-breaking poster that will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (SITC) (Free SITC Whitepaper) on November 9, 2024
Lifileucel in Endometrial Cancer
Patient enrollment commenced in the IOV-END-201 Phase 2 trial to investigate lifileucel for advanced endometrial cancer patients who have progressed after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status. IOV-END-201 is supported by preclinical and manufacturing success data presented at the International Gynecologic Cancer Society (IGCS) 2024 annual global meeting in October 2024, as well as positive feedback from gynecological oncology experts.
Endometrial cancer represents a significant opportunity for TIL cell therapy to address an additional unmet medical need in the post-anti-PD-1 treatment setting and may address both mismatch repair deficient and proficient tumors. There are no currently approved therapies in the second-line setting after frontline post-anti-PD-1 therapy and chemotherapy.

Next Generation TIL Pipeline
IOV-4001 (PD-1 Inactivated TIL Cell Therapy): The first in human IOV-GM1-201 trial to investigate PD-1 inactivated TIL cell therapy (IOV-4001) in previously treated advanced melanoma and NSCLC is in the multi-center Phase 2 efficacy stage. Iovance continues to utilize the TALEN technology licensed from Cellectis to develop other investigational gene-edited TIL cell therapies with multiple knockout targets to potentially improve efficacy.
Next Generation IL-2 for TIL Treatment Regimen: An Investigational New Drug application (IND) was submitted and allowed to proceed for a Phase 1/2 clinical trial of IOV-3001, a second-generation, modified interleukin-2 (IL-2) analog, for use in the TIL therapy treatment regimen. Non-human primate and IND-enabling studies of IOV-3001 demonstrated the potential for improved safety with strong effector T cell expansion.
Next Generation, Cytokine-Tethered TIL Therapy: IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy. A clinical trial of a prior generation IL-12 TIL therapy at the National Cancer Institute showed improved efficacy with low cell doses and provides the rationale for modifying IOV-5001 to enhance TIL efficacy while optimizing safety. In preclinical studies, IOV-5001 drove superior antitumor activity in a simulated tumor microenvironment. These results will be featured in a poster at SITC (Free SITC Whitepaper) on November 9, 2024. Iovance plans to submit a pre-IND meeting request to FDA in 2024 and commence clinical development for multiple indications in 2025.
Manufacturing Capacity Expansion

The Iovance Cell Therapy Center (iCTC), and an FDA-approved contract manufacturer, currently have capacity to treat several thousands of patients annually. Expansion is currently underway for the iCTC campus to supply TIL cell therapies to more than 5,000 patients annually in the next few years. Iovance is also developing a manufacturing network to address more than 10,000 patients annually.
Corporate Updates

Iovance currently owns more than 230 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide Amtagvi with exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.
Third Quarter and Year to Date 2024 Financial Results

As of September 30, 2024, Iovance’s cash position is approximately $403.8 million, which includes net proceeds of approximately $200.0 million raised from an at-the market (ATM) equity financing facility during the second and early third quarter of 2024. The current cash position and anticipated product revenue are expected to be sufficient to fund current and planned operations into early 2026.

Net loss for the third quarter of 2024 was $83.5 million, or $0.28 per share, compared to a net loss of $113.8 million, or $0.46 per share, for the third quarter ended September 30, 2023. Net loss for the first nine months of 2024 was $293.6 million, or $1.03 per share, compared to a net loss of $327.7 million, or $1.44 per share, for the nine-month period ended September 30, 2023.

Revenue was $58.6 million for the third quarter of 2024 and consisted of product revenue from Amtagvi sales as well as recurring revenue from Proleukin. Iovance recognized $42.1 million in revenue from Amtagvi infusions that were completed during the third quarter of 2024 and $16.5 million in global revenue for Proleukin.

Revenue for the first nine months of 2024 was $90.4 million and reflected product revenue from Proleukin and Amtagvi. Revenue for the first nine months of 2023 was $0.7 million for global sales of Proleukin, which Iovance began to recognize during the three-month period ended June 30, 2023.

The increases in revenue in the third quarter and first nine months of 2024 over the prior year periods were primarily attributable to the U.S. launch of Amtagvi, including revenue recognized for Amtagvi, as well as significant growth in U.S. Proleukin revenue for use in the Amtagvi treatment regimen, beginning in the second quarter of 2024.

Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi. Cost of sales for the three months ended September 30, 2024 was $39.8 million, primarily attributed to $8.3 million in period costs associated with patient drop off and manufacturing success rates, $5.5 million for non-cash amortization expense for intangible assets, and $3.9 million in royalties payable on product sales. Cost of sales for the three months ended September 30, 2023 was $4.3 million, primarily related to non-cash amortization for intangible assets.

Cost of sales for the nine months ended September 30, 2024 was $78.5 million, primarily related to $17.2 million in certain costs associated with patient drop off and manufacturing success rates, $15.5 million in non-cash amortization expense for intangible assets, and $8.2 million royalties payable on product sales. Cost of sales for the nine months ended September 30, 2023 was $6.4 million, primarily related to non-cash amortization for intangible assets.

The increases in cost of sales in the third quarter and year to date 2024 over the prior year periods were primarily attributable to the initiation of product sales, commercial manufacturing and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024.

Research and development expenses were $68.2 million for the third quarter of 2024, a decrease of $19.3 million compared to $87.5 million for the same period ended September 30, 2023. Research and development expenses were $210.1 million for the first nine months of 2024, a decrease of $46.5 million compared to $256.6 million for the same period ended September 30, 2023.

The decreases in research and development expenses in the third quarter and year to date 2024 over the prior year periods were primarily attributable to the transition of Amtagvi to commercial manufacturing, decreased costs associated with certain clinical activities, and the completion of pre-commercial qualification activities in 2023. These decreases in research and development were partially offset by increases in headcount and related costs, including stock-based compensation resulting from growth in headcount.

Selling, general and administrative expenses were $39.6 million for the third quarter of 2024, an increase of $12.6 million compared to $27.0 million for the same period ended September 30, 2023. Selling, general and administrative expenses were $110.5 million for the first nine months of 2024, an increase of $33.5 million compared to $77.0 million for the prior year’s nine-month period.

The increase in selling, general and administrative expenses in the third quarter and year to date 2024 compared to the prior year periods was primarily attributable to increases in headcount and related costs, including stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as legal costs and costs incurred to support the commercialization of Amtagvi and Proleukin.

For additional information, please see the Company’s Selected Condensed Consolidated Balance Sheets and Statements of Operations below.

Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 4:30 p.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

On November 7, 2024 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported financial results for the three and nine months ended September 30, 2024 (Press release, IMUNON, NOV 7, 2024, View Source [SID1234647930]). The Company also provided an update on its clinical development of IMNN-001 including progress toward commencing a Phase 3 study in advanced ovarian cancer, and an update on IMNN-101, its seasonal COVID-19 booster candidate.

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"The third quarter was a period of important milestones and outstanding progress for IMUNON, driven largely by presentation of highly compelling topline results from our OVATION 2 Study with IMNN-001 in advanced ovarian cancer," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "In this study, treatment with IMNN-001 was associated with an overall survival improvement of 11.1 months compared to treatment with standard of care, and results were even stronger in the subset of patients who were also treated with PARP inhibitors. Building on this momentum, we have been highly encouraged by the interest in these results among global leaders from the medical and scientific communities. We have also engaged with the U.S. Food and Drug Administration to craft the design of our planned registrational study and are preparing for an in-person End-of-Phase 2 meeting with the agency later this month. We remain on track to begin our planned 500-patient pivotal Phase 3 study during the first quarter of 2025."

"Tomorrow afternoon we will be presenting new OVATION 2 data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting. Our abstract is being highlighted as a late-breaking acceptance, so compelling that it was accepted after the deadline. Given the strength of the data, we are unsurprised with SITC (Free SITC Whitepaper)’s decision to include our data for presentation. This is an exceptional opportunity to gain further awareness for IMNN-001 and our trial results."

"In summary, IMUNON is extraordinarily well-positioned to address the unmet need in a deadly cancer while also playing an important role in public health. We are justifiably excited about our prospects for patients and shareholders alike," Dr. Lindborg concluded.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Presenting Additional Phase 2 data for IMNN-001 at SITC (Free SITC Whitepaper) – On October 30, 2024 the Company announced the acceptance of a late-breaking presentation featuring new clinical data from the Phase 2 OVATION 2 Study of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting, being held in Houston, TX. The presentation, titled "Phase I/II study of Safety and Efficacy of Intraperitoneal IMNN-001 with Neoadjuvant Chemotherapy of Paclitaxel and Carboplatin in Patients Newly Diagnosed with Advanced Epithelial Ovarian Cancer," will be made on Friday, November 8, 2024 from 12:15-1:45 p.m. and 5:30-7:30 p.m. CST by Jennifer Scalici, M.D., Professor, Division of Gynecological Oncology, Emory University School of Medicine and a principal investigator in the trial.

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 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 topline results and their clinical significance.

Positive topline results from the OVATION 2 Study in advanced ovarian cancer – On July 30, 2024, the Company announced topline results from the study that provide strong further validation of the potential safety and efficacy of IMNN-001 in the treatment of advanced ovarian cancer. Highlights from patients treated with IMNN-001 plus standard of care in a first-line treatment setting included:

● 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 represents 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.

CORPORATE DEVELOPMENTS

Raised gross proceeds of $10 million in a 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 issued, 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 issued to the Purchasers unregistered warrants to purchase shares of common stock. The warrants have an exercise price of $2.00 per share and became exercisable immediately after the issuance 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.

Additions to leadership team to ensure operational excellence and support future plans – On October 7, 2024, Susan Eylward was named General Counsel and Corporate Secretary. She was most recently Senior Counsel at Science 37, Inc., a solutions organization focused on decentralized clinical trials, where she was responsible for a variety of complex legal matters, including corporate governance, securities compliance, executive compensation and acquisitions.

Kristin Longobardi was named Senior Vice President of Operations, bringing more than two decades of experience in enhancing business processes and operations across the biotech and pharmaceutical sectors. Previously, she served as Vice President of R&D Quality, Operations and Performance at Biogen. Her expertise in portfolio management, financial planning and operational excellence will be pivotal in driving IMUNON’s operational frameworks toward supporting ambitious company growth.

THIRD QUARTER FINANCIAL RESULTS

The Company had $10.3 million in cash, investments and accrued interest receivable as of September 30, 2024. The Company believes it has sufficient capital resources to fund its operations into the third quarter of 2025.

Research and development expenses were $3.3 million for the third quarter of 2024, compared with $2.0 million for the third quarter of 2023. General and administrative expenses were $1.7 million for the third quarter of 2024, compared with $1.9 million for the third quarter of 2023.

Net loss was $4.9 million, or $0.34 per share, for the third quarter of 2024, compared with a net loss of $3.5 million, or $0.37 per share, for the third quarter of 2023.

YEAR-TO-DATE FINANCIAL RESULTS

Research and development expenses were $9.4 million for the nine months ended September 30, 2024, compared with $7.7 million for the nine months ended September 30, 2023. General and administrative expenses were $5.6 million for the nine months ended September 30, 2024, compared with $7.3 million for nine months ended September 30, 2023.

Year-to-date net loss was $14.6 million, or $1.39 per share, compared with a net loss of $14.6 million, or $1.64 per share, for the same period of 2023.

Conference Call and Webcast

The Company is hosting a conference call at 11:00 a.m. ET today to provide a business update, discuss third 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 third quarter 2024 earnings call. A live webcast of the call will be available here.

The call will be archived for replay until November 21, 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 10193110. A webcast of the call will be available here for 90 days.