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.

On November 7, 2024 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the third quarter of 2024 and recent business highlights (Press release, Geron, NOV 7, 2024, View Source [SID1234647928]).

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"This has been a transformative year for Geron, following our first FDA approval and commercial launch of RYTELO in June. The initial full quarter of product revenue from our U.S. launch exceeded our expectations and demonstrates strong execution as a commercial company. These results also reflect the high unmet need in lower-risk MDS and the compelling value proposition of RYTELO for hematologists and patients, giving us confidence in future continued demand and momentum for RYTELO," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "We were also pleased to announce this morning the completion of important synthetic royalty and debt financing transactions with Royalty Pharma and Pharmakon Advisors. We believe that the favorable terms in these transactions reflect the significant commercial potential of RYTELO and provide us with critical flexibility to fuel continued growth and invest in our future."

Recent Business Highlights

Strong execution in the first full quarter of U.S. launch, with net product revenue for RYTELO (imetelstat) of $28.2 million in the third quarter of 2024.
In November 2024, completed synthetic royalty and debt financing transactions to strengthen our cash position and further solidify our balance sheet while providing strategic flexibility to invest in our future. We entered into a synthetic royalty agreement with Royalty Pharma providing $125 million of capital in exchange for tiered royalty payments. We also entered into a 5-year, senior term loan agreement with Pharmakon for up to $250 million, from which we have drawn a first tranche of $125 million, a portion of which was used to fully repay amounts owed under our existing loan with Hercules Capital, Inc. and Silicon Valley Bank ($86.5 million), which has now been terminated, with the ability to borrow another $125 million prior to the end of 2025, subject to specified conditions.
Jim Ziegler appointed as Executive Vice President, Chief Commercial Officer in September 2024, to spearhead Geron’s global commercial strategy and operations, lead the commercial organization and be responsible for driving growth of RYTELO. Mr. Ziegler brings more than 25 years of commercial experience in the biopharmaceutical industry, spanning leadership, strategic and operational roles in both large and smaller organizations.
New data to be presented at upcoming American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlights the potential of imetelstat in myeloid hematologic malignancies (please view ASH (Free ASH Whitepaper) press release for more details).
Upcoming Milestones

We expect review of the Marketing Authorization Application (MAA) for RYTELO in lower-risk MDS by the Committee for Medicinal Products for Human Use (CHMP) could be completed in late 2024 or early 2025, with potential approval by the European Commission in the first half of 2025. We are continuing to prepare for the potential launch of RYTELO in the EU, and subject to regulatory approval, are planning to commercialize RYTELO in select EU markets commencing in 2026.
We expect an interim analysis from the Phase 3 IMpactMF trial in patients with relapsed/refractory MF may occur in early 2026 (when approximately 35% of planned enrolled patients have died) and the final analysis may occur in early 2027 (when approximately 50% of planned enrolled patients have died), based on our most recent planning assumptions for enrollment and death rates in the trial.
Third Quarter 2024 Financial Results

As of September 30, 2024, we had approximately $378.9 million in cash, cash equivalents, restricted cash and marketable securities. On a pro forma basis, including gross proceeds from the upfront payment under the Royalty Pharma Agreement and the first tranche of the Pharmakon loan and after repayment of our existing debt, we had approximately $542.4 million in cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2024.

Net Loss

For the three and nine months ended September 30, 2024, the Company reported a net loss of $26.4 million, or $0.04 per share, and $149.2 million, or $0.23 per share, respectively, compared to $44.8 million, or $0.08 per share and $132.2 million, or $0.23 per share, respectively, for the three and nine months ended September 30, 2023.

Revenues

Total product revenue, net for the three and nine months ended September 30, 2024, was $28.2 million and $29.0 million, respectively.

Total net revenue for the three and nine months ended September 30, 2024, was $28.3 million and $29.5 million, respectively, compared to $164,000 and $214,000 for the same periods in 2023. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was available for prescribers to order from specialty distributors as of June 27, 2024.

Operating Expenses

Total operating expenses for the three and nine months ended September 30, 2024, were $56.5 million and $183.1 million, respectively, compared to $47.8 million and $139.9 million for the same periods in 2023.

Cost of goods sold was approximately $456,000 and $473,000 for the three and nine months ended September 30, 2024, respectively, which consisted of costs to manufacture and distribute RYTELO.

Research and development expenses for the three months and nine months ended September 30, 2024, were $20.2 million and $80.3 million, respectively, and $29.4 million and $92.1 million, for the same periods in 2023. The decrease is primarily due to manufacturing and quality costs that were capitalized in the current period due to FDA approval of RYTELO, compared to being expensed in the prior period.

Selling, general and administrative expenses for the three and nine months ended September 30, 2024, were $35.9 million, and $102.4 million, respectively, and $18.4 million and $47.7 million for the same periods in 2023. The increase in selling, general and administrative expenses primarily reflects higher commercial launch expenses, and increases in headcount and related expenses in connection with the U.S. launch of RYTELO.

Interest income was $4.9 million and $14.4 million for the three and nine months ended September 30, 2024, respectively, compared to $5.0 million and $13.6 million for the same periods in 2023. The decrease in interest income for the three months ended September 30, 2024, compared to the same period in 2023 was due to a decrease in interest rates. The increase in interest income for the nine months ended September 30, 2024, compared to the same period in 2023 primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from recent marketable securities purchases.

Interest expense was $3.0 million and $9.8 million for the three and nine months ended September 30, 2024, respectively, compared to $2.1 million and $6.0 million for the same periods in 2023. The increase in interest expense primarily reflects rising interest rates.

2024 Financial Guidance

For fiscal year 2024, we expect total operating expenses to be in the range of approximately $260 million to $270 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities (including the $250 million gross proceeds received under the Pharmakon loan and Royalty Pharma agreements), together with anticipated revenues from U.S. sales of RYTELO, will be sufficient to fund our projected operating requirements for at least the next 12 months from the date of this press release. We believe that our projected financial resources will be sufficient to support commercial launch of RYTELO in the U.S. and potential launch in the EU, complete the Phase 3 IMpactMF trial in relapsed/refractory MF, invest in supply chain redundancy for RYTELO, and fund our general working capital requirements.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Thursday, November 7, 2024, to discuss business updates and third quarter financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link, View Source

About RYTELO (imetelstat)

RYTELO (imetelstat) is an FDA-approved oligonucleotide telomerase inhibitor for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration.

On November 7, 2024 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported third quarter 2024 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 7, 2024, View Source [SID1234647927]).

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"We are encouraged by the progress during Q3 across our clinical pipeline including the ongoing Phase 1a evaluation of CX-904 and robust early enrollment for the CX-2051 Phase 1 study in colorectal cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. "We continue to explore the optimal dose and schedule for CX-904 to enable potential initiation of tumor-specific Phase 1b cohorts in 2025. Regarding CX-2051, our successful continued escalation to higher dose levels reflects the favorable tolerability profile observed to date for this first in class antibody drug conjugate directed against EpCAM, a very high potential but previously undruggable target expressed in many cancer types. We are also thrilled to have treated the first patient in the Phase 1 study of CX-801, reinforcing the multi-modality breadth of the PROBODY therapeutic platform and our ongoing commitment to addressing as many areas of unmet need as we can with our technology," continued Dr. McCarthy.

Third Quarter Business Highlights and Recent Developments

Pipeline

CX-904, PROBODY T-cell-engager (TCE) targeted to EGFRxCD3; Phase 1a dose escalation and optimization continue.

Preliminary data from 35 patients were presented on May 8, 2024, based on a data cutoff of April 16, 2024, including non-step and step dosing cohorts up to a target dose of 10 mg.
CX-904 has now cleared the 15 mg target dose level, utilizing a step-dose schedule. Dose escalation and optimization continue in pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma, and non-small cell lung cancer. A maximum tolerated dose for step-dosing has not yet been reached.
Potential Phase 1b initiation in one or more tumor types is anticipated in 2025 pending the selection of an optimized dose and schedule and alignment with our global development partner, Amgen.
CX-2051, a first in class EpCAM-directed PROBODY antibody drug conjugate; Phase 1a dose escalation continues.

The Phase 1 study of CX-2051 was initiated in Q2 2024 and is currently focused in metastatic colorectal cancer, one of many tumor types in which high expression of EpCAM has been documented. EpCAM expression levels in the Phase 1 study are being assessed retrospectively and are anticipated to be high in the majority of CRC patients.
The CX-2051 payload, a next generation topoisomerase-1 inhibitor licensed from AbbVie (formerly Immunogen), is tailored to specific EpCAM-expressing indications, including colorectal cancer, and includes a payload-antibody linker designed to drive bystander effect, contributing to anti-tumor activity.
The study is currently enrolling the fifth dose escalation cohort with favorable safety and tolerability having been observed to date.
Initial Phase 1a data are expected in the first half 2025.
CX-801, PROBODY interferon-alpha 2b; Phase 1a dose escalation study initiated.

In Q3 2024, the first patient was dosed in the CX-801 Phase 1 study.
Phase 1 dose escalation is ongoing with a primary focus in melanoma. The study will evaluate safety and initial clinical activity for CX-801 monotherapy and for CX-801 in combination with KEYTRUDA.
Initial Phase 1a data are expected in the second half of 2025.
Q3 2024 Financial Results

Cash, cash equivalents and investments totaled $117.6 million as of September 30, 2024, compared to $137.2 million as of June 30, 2024. Based our current operating plan, we expect our existing capital resources will be sufficient to fund operations to the end of 2025, not including the impact of potential milestones that may be earned in our existing collaborations.

Total revenue was $33.4 million for the three months ended September 30, 2024 compared to $26.4 million for the corresponding period in 2023. The increase in revenue was driven primarily by a higher percentage of completion of research activities related to the collaboration with Bristol Myers Squibb.

Research and development expenses increased by $4.9 million for the three months ended September 30, 2024 to $21.4 million, compared to $16.5 million for the corresponding period of 2023 primarily due to increased clinical and manufacturing activities for CX-2051 and clinical-related expenses for CX-904.

General and administrative expenses increased by $1.1 million for the three months ended September 30, 2024 to 8.0 million, compared to the corresponding period of 2023, primarily due to higher professional services expenses supporting intellectual property related activities and internal controls.

Conference Call & Webcast
CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EST (2 p.m. PST) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website.