On March 12, 2025 Faeth Therapeutics (Faeth), a clinical-stage biotechnology company focused on metabolism, and The GOG Foundation, Inc. (GOG-F), a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies, reported the first patient has been dosed in its Phase 2 combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel (Press release, Faeth Therapeutics, MAR 12, 2025, View Source [SID1234651106]). The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer.

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The PI3K/AKT/mTOR pathway is the most frequently mutated pathway in cancer and is essential for tumor metabolism. Endometrial cancer has the highest frequency of PI3K pathway mutations of any solid tumor, yet there are no approved therapies addressing this need. FTH-001, a PI3Kɑ inhibitor, and FTH-003, an mTORC 1/2 inhibitor, have both demonstrated potential in multiple previous cancer clinical trials and their combination represents a unique "multi-node" approach to targeting this pathway.

The current study, An Open-label, Multi-Center, Phase 2 Clinical Trial Evaluating Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, and a Substudy Evaluating PIKTOR With Paclitaxel Plus Diet, in Patients With Advanced or Recurrent Endometrial Cancer (FTH-PIK-201, GOG-3111)2 will expand on the strong Phase 1b data1 showing an 80% ORR in patients with endometrioid endometrial cancer with 11 months of progression-free survival. The Phase 2 study is based on Faeth’s metabolism-focused platform for developing novel therapeutic approaches. Endometrial cancer is one of the leading causes of cancer death in women and there is a high unmet need in patients with advanced and relapsed disease who have progressed after first line carboplatin-based therapy.

"Thanks to Faeth’s ability to uncover novel metabolism-targeting strategies, we are positioned to leverage the PIKTOR approach for endometrial cancer and other solid tumors," said Anand Parikh, J.D., Chief Executive Officer of Faeth Therapeutics. "Over its five decades, the GOG Foundation has established itself as a leading clinical partner against gynecologic cancers, and we are confident they will help us pave the way for the next generation of cancer treatments."

"This unique approach to target cancer metabolism has demonstrated impressive early results. We look forward to this trial to hopefully confirm these early findings and perhaps transform the way we treat patients with endometrial cancer," said David Starks, MD, Principal Investigator and Associate Professor, Avera Cancer Institute and University of South Dakota Sanford School of Medicine.

"Endometrial cancer is the leading cause of deaths among all gynecologic cancers. Finding better treatment options remains our highest priority. We are excited to partner with Faeth Therapeutics to further investigate this novel therapeutic approach," said Brian Slomovitz, MD, Director, Gynecologic Oncology, Mount Sinai Medical Center and Uterine Cancer Trial Lead, GOG Partners.

On March 12, 2025 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, reported that its phase 1 clinical trial has demonstrated the safety and early efficacy of targeted chemotherapy using PIPAC combined with systemic chemotherapy for patients with colorectal and appendiceal cancer that has spread to the peritoneum of the abdominal cavity (Press release, City of Hope, MAR 12, 2025, View Source [SID1234651107]). This data will be presented at a March 18 press briefing spotlighting some of the most consequential research to be shared at this year’s Society of Surgical Oncology Annual Meeting (SSO).

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Of all the possible sites that cancer can spread to, the abdomen’s peritoneum is the worst when it comes to survival rates because it is difficult for systemic chemotherapy to reach this region due to a low number of blood vessels. When surgery is not an option and peritoneal metastases are left untreated, these patients survive only a few months and few make it past one year with standard treatment.

"Up until recently, delivering a uniform dose of chemotherapy in the abdomen has not been possible. At City of Hope, we have been evaluating the use of pressurized intraperitoneal aerosolized chemotherapy, or PIPAC, which is the most optimized way to deliver chemotherapy in the abdominal cavity. It increases targeted medicinal exposure while limiting toxicity," said Mustafa Raoof, M.D., M.S., assistant professor in City of Hope’s Division of Surgical Oncology and first author of the SSO abstract entitled "Dose escalation Phase 1 trial of Mitomycin C Pressurized Intraperitoneal Aerosolized Chemotherapy in Combination with Systemic Chemotherapy for Unresectable Appendiceal and Colorectal Carcinomatosis," which will be featured in the SSO press briefing at 9 a.m. PST on March 18.

The Society of Surgical Oncology is an international community of cancer surgeons and care professionals who are shaping advances in the delivery of the highest quality surgical care for cancer patients. City of Hope was the first U.S. institution to offer PIPAC in a clinical trial, and has hosted the first and second U.S. PIPAC training workshops.

The City of Hope-led multicenter phase 1 trial, in collaboration with Northwell Health and Mayo Clinic in Florida, included 19 patients with a median age of 60 who had colorectal or appendiceal cancer that had spread to the peritoneum and was inoperable even after four months of first- or second-line systemic chemotherapy. These patients received treatments that included Mitomycin C chemotherapy targeted to the abdomen via PIPAC and standard-of-care FOLFIRI systemic chemotherapy. This combination treatment is necessary to maximize the medicinal delivery via systemic and regional exposure.

"While we were able to demonstrate safety in this study, what we are really excited about is the early efficacy results seen as measured by several response criteria — histologic, laparoscopic, radiographic and tumor marker CEA," Dr. Raoof said. "This trial provides strong rationale for a multicenter randomized trial, which City of Hope will open soon. The new trial will determine if the addition of PIPAC to standard therapy could both improve survival and preserve quality of life. At this time, we caution against off-label use of PIPAC until the definitive efficacy of PIPAC in this population is proven."

In addition to Dr. Raoof’s oral abstract to be presented March 28 at 8:26 p.m. ET in TCC Ballroom BC, City of Hope also will have five poster abstracts at SSO 2025 happening March 27 to 29 in Tampa, Florida:

P64: Genetic Pathogenic Variants in Asian American/Pacific Islander Women with Breast Cancer: Implications for Surgical and Oncologic Care
Presenter: Jennifer Tseng, M.D.
P167: Impact of Systematic Discontinuation of Mitomycin C HIPEC for Colorectal Peritoneal Metastasis on Oncologic Outcomes at an NCI Cancer Center
Presenter: Muhammad Talha Waheed, M.D.
P187: Upfront Colectomy vs. Initial Appendectomy followed by Completion Colectomy for Appendiceal Cancer: Comparison of Outcomes
Presenter: Muhammad Talha Waheed, M.D.
P453: Percutaneous Transesophageal Gastrostomy as an Alternative Approach for Palliative Decompression of Malignant Bowel Obstruction
Presenter: Kristofor Olson, M.D., Ph.D.
P114: Reduced hepatotoxicity and equivalent survival with a lower hepatic arterial floxuridine starting dose in the adjuvant treatment of colorectal cancer liver metastases
Presenter: Kevin Labadie, M.D.

On March 12, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported it will participate at the 37th Annual Roth Conference on March 16th to 18th (Press release, Actinium Pharmaceuticals, MAR 12, 2025, View Source [SID1234651092]).

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Actinium management will be in attendance during the conference and will be available for 1-on-1 meetings on March 17th and 18th. Interested investors should contact their ROTH representative or submit a registration request at Roth2025Registration.

On March 12, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported full year 2024 financial results and provided a corporate update (Press release, Alpha Tau Medical, MAR 12, 2025, View Source [SID1234651093]).

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"Alpha Tau has been incredibly busy and very successful throughout 2024. With fantastic clinical results observed across a number of difficult cancers, we are now able to demonstrate the broader Alpha Tau vision of expanding our focus on treating internal organ tumors of high unmet need, as well as helping metastatic patients by harnessing the potential systemic immune benefits of Alpha DaRT", said Alpha Tau Chief Executive Officer Uzi Sofer. "FDA approval of our forthcoming U.S. trials in patients with newly diagnosed pancreatic cancer and our investigator-initiated trial in immunocompromised patients with recurrent cSCC, not only aligns with our broader vision but also reflects continued progress in our regulatory pathway to approval for Alpha DaRT. In parallel, we remain focused on expanding our operational capabilities, with our Hudson, NH facility expected to complete its first phase of construction in the coming months and come online for production of Alpha DaRT later in 2025."

Recent Corporate Highlights:

● In January, Alpha Tau hosted a virtual R&D Update Day to present interim results from multiple trials as well as more information regarding the expected regulatory path forward in internal organs. Principal investigators presented data showing high disease control rate and strong interim safety results observed across three trials exploring the use of Alpha DaRT in pancreatic cancer patients. Principal investigators also reported strong interim results in median survival of patients treated with Alpha DaRT after prior therapy as compared to previously published studies of alternative monotherapies, across all analyzed subgroups.

● At the R&D Update Day, positive interim results were also reported for the first eight patients recruited in a combination trial of Alpha DaRT with pembrolizumab (Keytruda), a checkpoint inhibitor, in treating patients with recurrent unresectable or metastatic head and neck squamous cell carcinoma (HNSCC). A reported systemic objective response rate of 75% and complete response rate of 37.5% were observed, compared to historical benchmarks of 19% and 5%, respectively, for pembrolizumab on its own in the KEYNOTE-048 trial.

● Approvals for two forthcoming clinical trials exploring the use of Alpha DaRT in treating pancreatic cancer were also announced during the R&D Update Day:

o Investigational Device Exemption (IDE) received from the FDA to conduct a U.S. pilot study of Alpha DaRT together with first-line chemotherapy in patients with newly diagnosed pancreatic cancer, the first step toward regulatory approval in the U.S. The trial was initially approved for 12 patients with metastatic cancer, but was then expanded to 30 patients in two cohorts of 15 patients each, one cohort of patients with newly diagnosed locally advanced cancer and the other of patients with newly diagnosed metastatic cancer.

o Approval from France’s Ministry of Health to commence a French multicenter clinical trial of Alpha DaRT alongside capecitabine for patients with locally advanced pancreatic cancer, as well as a second study at a single center in France examining the use of Alpha DaRT delivered via Fine Needle System, or FNS, in the treatment of locally advanced pancreatic cancer.

● In January, researchers from Hadassah Medical Center presented a poster entitled "Interim analysis of feasibility, safety, and tumor control in two first-in-human trials of a novel alpha-emitting radionuclide for pancreatic adenocarcinoma" at the prestigious 2025 ASCO (Free ASCO Whitepaper) GI Symposium, with interim data demonstrating 100% disease control rate and a strong safety profile. They also reported on a patient with pancreatic adenocarcinoma with metastases in the liver, who was seeing inadequate response from second-line chemotherapy but then saw full resolution of all tumors on PET scan after adding in Alpha DaRT treatment.

● In December, Alpha Tau announced the appointment of Maya Netser to its Board of Directors, bringing a wealth of experience and a keen understanding of the industry from her many years of corporate leadership and advisory, following the completion of Meir Jakobsohn’s term as a director.

Upcoming Milestones:

● Targeting first patient treated in Israel for brain cancer in H1 2025.

● Anticipating response from Japan’s PMDA in Q3 2025 to application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Targeting first patient enrolled in pancreatic cancer pilot study in the U.S. in Q2 2025.

● Seeking FDA IDE approval in Q2 2025 to conduct early feasibility study in recurrent glioblastoma multiforme (GBM) patients.

● Targeting completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q3 2025. For more information, please see here: View Source

Financial results for year ended December 31, 2024

R&D expenses for the year ended December 31, 2024 were $27.0 million, compared to $26.4 million for the same period in 2023, due to increased employee compensation and benefits, including share-based compensation, increased costs of raw materials, reduced government grants, and increased travel expenses related to our U.S. multi-center pivotal trial, offset by lower third-party contractor expenses.

Marketing expenses for the year ended December 31, 2024 were $2.3 million, compared to $1.9 million for the same period in 2023, due to increased marketing activities and travel abroad.

G&A expenses for the year ended December 31, 2024 were $6.7 million, compared to $7.3 million for the same period in 2023, primarily due to decreased professional fees (including D&O insurance and legal expenses), offset by increased travel expenses and increased employee compensation and benefits, including share-based compensation.

Financial income, net, for the year ended December 31, 2024 was $4.3 million, compared to $6.5 million for the same period in 2023, due to a decrease in income from revaluation of warrants and in interest from bank deposits and an increase in interest on long-term loan, offset by changes in foreign exchange rates .

For the year ended December 31, 2024, the Company had a net loss of $31.8 million, or $0.45 per share, compared to a net loss of $29.2 million, or $0.42 per share, in the year ending December 31, 2023.

Balance Sheet Highlights

As of December 31, 2024, the Company had cash and cash equivalents, short-term deposits and restricted deposits in the amount of $62.9 million, compared to $84.9 million at December 31, 2023. The Company expects that this cash balance will be sufficient to fund anticipated operations for at least two years.

About Alpha DaRT

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

On March 12, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter ended December 31, 2024 (Press release, Nektar Therapeutics, MAR 12, 2025, View Source [SID1234651096]).

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Cash and investments in marketable securities on December 31, 2024 were $269.1 million as compared to $329.4 million at December 31, 2023. Nektar’s cash and marketable securities are expected to support strategic development activities and operations into the fourth quarter of 2026.

"The significant progress we made last year in advancing our immunology pipeline positions us for two value-creating data milestones in 2025," said Howard W. Robin, President and CEO of Nektar. "With enrollment now complete for the atopic dermatitis and alopecia areata Phase 2b trials, we are on track to report topline data for rezpegaldesleukin in the second quarter and in the fourth quarter of this year, respectively. This program is poised to emerge as the first T regulatory cell treatment option to help the millions of patients battling these chronic autoimmune disorders."

"We also made progress on our preclinical immunology programs," continued Robin. "We reported the first data for NKTR-0165, our novel antibody targeting TNFR2, and unveiled a new bispecific antibody, NKTR-0166. We plan to submit the IND for NKTR-0165 in the second half of this year."

Summary of Financial Results

Revenue in the fourth quarter of 2024 was $29.2 million as compared to $23.9 million in the fourth quarter of 2023. Revenue for the year ended December 31, 2024 was $98.4 million as compared to $90.1 million in 2023.

Total operating costs and expenses in the fourth quarter of 2024 were $14.8 million as compared to $57.4 million in the fourth quarter of 2023. Total operating costs and expenses for the full year 2024 were $203.6 million as compared to $353.8 million in 2023. Operating costs and expenses for both the fourth quarter and the full year 2024 decreased as compared to 2023 primarily due to a $40.4 million gain from sale of the Huntsville manufacturing facility in 2024, as well as decreases in restructuring and impairment costs. Operating expenses for the full year 2024 also decreased as compared to 2023 due to a one-time $76.5 million non-cash goodwill impairment recognized in the first quarter of 2023.

R&D expense in the fourth quarter of 2024 was $28.7 million as compared to $29.9 million for the fourth quarter of 2023. R&D expense for the year ended December 31, 2024 was $120.9 million as compared to $114.2 million in 2023. R&D expense increased for full year 2024 primarily due to increases in development expenses for rezpegaldesleukin partially offset by decreases in employee and related facilities costs, as well as development expenses for NKTR-255.

G&A expense was $17.1 million in the fourth quarter of 2024 and $17.3 million in the fourth quarter of 2023. G&A expense for the full year 2024 was $76.8 million as compared to $77.4 million in 2023. G&A expense remained consistent for the full year 2024 as compared to the full year 2023. Decreases in employee costs were offset by a reduction of facilities costs allocated to research and development expense as well as an increase in commercial litigation expense.

Restructuring and impairment costs were $1.4 million in the fourth quarter of 2024 and $15.7 million in the full year 2024, as compared to $2.9 million in the fourth quarter of 2023 and $52.0 million in the full year 2023. The full year 2024 amount includes $8.3 million in non-cash lease impairment charges, and $7.4 million in other restructuring costs. The full year 2023 amount includes $7.9 million in severance expense, $35.3 million in non-cash lease impairment charges, and $8.8 million in other restructuring costs.

Net income for the fourth quarter of 2024 was $7.3 million or $0.03 basic and diluted earnings per share as compared to a net loss of $42.1 million or $0.22 basic and diluted loss per share in the fourth quarter of 2023. Net loss for the year ended December 31, 2024 was $119.0 million or $0.58 basic and diluted loss per share as compared to a net loss of $276.1 million or $1.45 basic and diluted loss per share in 2023. Excluding the $40.4 million gain from sale of the Huntsville manufacturing facility, and the $1.4 million in non-cash restructuring charges, net loss, on a non-GAAP basis, for the fourth quarter of 2024 was $31.8 million or $0.15 basic and diluted loss per share. Excluding the $40.4 million gain from sale of the Huntsville manufacturing facility, and the $15.7 million in non-cash restructuring and real estate impairment charges, net loss, on a non-GAAP basis, for the full year 2024 was $143.7 million or $0.70 basic and diluted loss per share.

2024 and Recent Business Highlights

● In February 2025, Nektar announced completion of target enrollment in the REZOLVE-AA 84-patient Phase 2b clinical trial of rezpegaldesleukin in severe-to-very severe alopecia areata.

● In February 2025, Nektar announced a new clinical trial agreement with TrialNet, an international clinical trial network at the forefront of diabetes research, to evaluate rezpegaldesleukin in a 66-patient Phase 2 study with new onset type 1 diabetes mellitus.

● In February 2025, the FDA granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

● In January 2025, Nektar announced completion of target enrollment in the REZOLVE-AD 396-patient Phase 2b clinical trial of rezpegaldesleukin in moderate-to-severe atopic dermatitis.

● At the 66th Annual ASH (Free ASH Whitepaper) Meeting in December 2024, Nektar presented proof-of-concept clinical data showing that NKTR-255 following CD19-directed CAR-T therapy enhanced complete response rates in patients with relapsed or refractory large B-cell lymphoma, with 73% of the NKTR-255 treatment group, compared to 50% of the placebo group, achieving a complete response at 6 months.

● At the 2024 American College of Rheumatology (ACR) Convergence meeting in November 2024, Nektar presented first preclinical data from its novel CSF-1 Program, NKTR-422. The program demonstrated inflammation resolution and tissue repair in multiple preclinical models of chronic inflammatory conditions.

● At the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2024, Nektar and collaborators presented results from a planned interim analysis in the Phase 2 trial of NKTR-255 for the treatment of patients with radiation induced lymphopenia in locally advanced non-small cell lung cancer. These results suggest that NKTR-255 effectively reversed radiation induced lymphopenia in patients with locally advanced NSCLC receiving consolidation therapy with durvalumab. The Phase 2 single-arm study is being conducted by MD Anderson.

● In November 2024, Nektar announced a definitive agreement with Ampersand Capital Partners to sell its commercial PEGylation manufacturing business in Huntsville, Alabama for $90 million in enterprise value, which is comprised of $70 million in cash and $20 million in equity ownership in the new portfolio company. Nektar and the new Ampersand portfolio company have also entered into manufacturing supply agreements to meet Nektar’s PEG reagent needs for rezpegaldesleukin and certain pipeline programs.

● In October 2024, Nature Communications published results from Phase 1b studies of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis or chronic plaque psoriasis. Data from both trials demonstrate durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes. In the atopic dermatitis study, EASI improvement of ≥75% and vIGA-AD responses were maintained for 36 weeks after treatment discontinuation in 71% and 80% of week 12 responders. Biomarker analyses demonstrate plurality of Treg-mediated pathways with potential effect on tissue resident memory T cell populations resulting in sustained efficacy seen in the antigen challenged mouse model and in clinical trials.

● In October 2024, Nektar announced publication in Blood of Phase 1 data showing that NKTR-255 in Combination with Autologous CD19-22 CAR-T cell therapy in patients with B-cell acute lymphoblastic leukemia exhibited relapse-free/progression-free survival for 67% of patients at 12 months, double that of historical controls. Eight of nine patients achieved complete remission, all without detectable measurable residual disease.

● At the European Alliance of Associations for Rheumatology (EULAR) in June 2024, Nektar presented preclinical data on NKTR-0165, a TNFR2 agonist antibody, demonstrating selective enhancement of Treg cell function through novel agonistic mechanism. IND-enabling studies are underway for NKTR-0165 with first-in-human studies planned in first half of 2025.

Conference Call to Discuss Fourth Quarter 2024 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on March 12, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through April 12, 2025.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.