Nuvectis Pharma (NasdaqCM:NVCT) Update / Briefing December 02, 2025 08:00 AM ET Company ParticipantsAsier Unciti-Broceta - Professor of ChemistryRon Bentsur - Chairman, CEO and PresidentTara - Head of Investor RelationsAlexander Spira - Chief Scientific OfficerChristopher Liu - Managing DirectorConference Call ParticipantsAydin Huseynov - AnalystJoseph Pantginis - AnalystNaz Rahman - AnalystYale Jen - AnalystJonathan Aschoff - AnalystModeratorGreetings and welcome to the Nuvectis Pharma investor call to dis ...

Core Insights - Ascentage Pharma announced promising results from a Phase Ib study of olverembatinib for treating SDH-deficient GIST, published in a high-impact journal [2][4][3] - The study is the largest prospective clinical trial to date for this rare tumor subtype, demonstrating significant clinical benefits and a novel mechanism of action [4][7][8] Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on developing therapies for unmet medical needs in cancer [12] - The company has a diverse pipeline, including olverembatinib, which is a third-generation BCR::ABL1 inhibitor approved in China for specific indications [13][12] Clinical Study Details - The Phase Ib study involved 66 patients, including 26 with SDH-deficient GIST, showing an objective response rate (ORR) of 23.1% and a clinical benefit rate (CBR) of 84.6% [4][5] - The median progression-free survival (mPFS) for patients with SDH-deficient GIST was reported at 25.7 months [4][5] Mechanism of Action - Olverembatinib modulates lipid metabolism, inhibiting CD36 expression, which is linked to enhanced uptake of exogenous lipids in SDH-deficient tumors [6][7] - The study established a direct link between SDH deficiency and dysregulated lipid metabolism, providing a new therapeutic target for SDH-deficient GIST [7][6] Future Directions - Ascentage Pharma plans to continue clinical development of olverembatinib, with ongoing studies to validate its efficacy and safety in SDH-deficient GIST [9][10] - The drug has received Breakthrough Therapy Designation in China for this indication, indicating its potential as a new treatment option [10][11]

Core Insights - The FDA has granted full approval for KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation, marking it as the first once-daily oral menin inhibitor approved for this indication [1][11] - The approval is based on the KOMET-001 trial, which demonstrated a complete remission rate of 21.4% and a median duration of response of 5.0 months in patients with R/R NPM1-m AML [5][6] - KOMZIFTI is positioned to address a significant unmet need in a patient population with historically poor outcomes and limited treatment options [1][4] Company Overview - Kura Oncology, in collaboration with Kyowa Kirin, is committed to advancing the development of KOMZIFTI across the treatment continuum for AML, aiming to improve patient outcomes [2][8] - The companies have established a global strategic collaboration for the development and commercialization of KOMZIFTI, with Kura leading efforts in the U.S. [8] Clinical Data - In the pivotal KOMET-001 trial, 112 patients were evaluated, with 88% of those achieving complete remission or complete remission with partial hematologic recovery within 6 months of treatment initiation [5][6] - The trial also reported a median time to first response of 2.7 months, indicating a rapid onset of efficacy [5] Safety Profile - KOMZIFTI has a favorable safety profile, with no Boxed Warning related to QTc prolongation or Torsades de Pointes, which is significant for patients on multiple concurrent medications [6][7] - The most common adverse reactions included increased liver enzymes and infections, with serious adverse reactions reported in 79% of patients [21][23] Market Potential - The approval of KOMZIFTI represents a major advancement in targeted therapies for AML, particularly for patients who are older and unable to tolerate intensive chemotherapy [6][8] - The drug's once-daily oral administration and compatibility with other medications enhance its potential to become the preferred treatment option in its approved indication [2][6] Access and Support - Kura has established a support program, Kura RxKonnect, to facilitate access and reimbursement for patients prescribed KOMZIFTI [9]

Core Insights - Roivant Sciences Ltd and Priovant Therapeutics announced positive results from the Phase 3 VALOR study for brepocitinib in treating dermatomyositis, marking a significant advancement in targeted therapy for this chronic autoimmune disorder [1][4]. Group 1: Study Results - Brepocitinib 30 mg showed a statistically significant improvement on the primary endpoint with a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006) [2][3]. - The treatment demonstrated clinically meaningful improvements across all nine key secondary endpoints, including skin and muscle disease metrics, steroid-sparing effects, and rapidity of onset [2][4]. Group 2: Patient Background and Outcomes - Approximately 75% of patients in the VALOR study were on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib group and 11.3 mg/day in the placebo group [5]. - Among those on steroids, 62% of brepocitinib patients reduced their steroid dose to ≤2.5 mg/day by the end of the study, compared to 34% for placebo, and 42% of brepocitinib patients were able to discontinue steroids entirely, versus 23% for placebo [5]. Group 3: Safety and Future Plans - The safety profile of brepocitinib 30 mg was consistent with previous clinical trials, indicating a favorable safety outcome [6]. - Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026 [6].

Financial Data and Key Metrics Changes - For the second quarter of 2025, the company reported revenues of approximately $422,000 from commercial sales of the RenovaCATH device, driven by new customer purchase orders and early repeat orders [17] - Research and development expenses were $1.4 million, reflecting a $100,000 decrease from the same quarter year over year [17] - The company ended the quarter with $12.3 million in cash and cash equivalents [17] Business Line Data and Key Metrics Changes - The RenovaCATH device achieved over $400,000 in sales in the second quarter, marking a significant accomplishment shortly after its launch [7][11] - The company has randomized 95 patients in the Phase three TIGER PACT trial, with 61 events occurring, keeping it on track to complete enrollment later this year or early next year [10][13] Market Data and Key Metrics Changes - The initial U.S. total addressable market for the RenovaCATH device is estimated at $400 million in peak annual sales opportunity [12] - The company believes there is potential for a several billion dollar total addressable market as it expands into additional cancer applications [12] Company Strategy and Development Direction - The company aims to transform patient outcomes through safer, more effective targeted therapy, particularly for difficult-to-treat cancers like locally advanced pancreatic cancer [10] - The company is focused on building commercialization momentum while maintaining a lean operational structure [11] - The company plans to explore international markets after establishing a strong presence in the U.S. [41] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive recommendation from the independent data monitoring committee (DMC) to continue the TIGER PACT trial, indicating confidence in the trial's potential outcomes [9][13] - The company anticipates a ramp-up in enrollment pace due to the addition of larger cancer centers [29] Other Important Information - The company launched a multicenter post-marketing registry study called PANTHER to evaluate the safety and effectiveness of the RenovaCATH device in real-world clinical settings [14] - The company is exploring the use of the RenovaCATH device for various solid tumors beyond pancreatic cancer, including cholangiocarcinoma and non-small cell lung cancer [52][53] Q&A Session Summary Question: Clarification on trial patient numbers - Management confirmed that the DMC's feedback was positive, and the trial will maintain the same sample size without adding patients [22] Question: Timing for data from the PANTHER trial - Management indicated that data from the PANTHER study will be published as interesting findings arise, without a specific timeline [31] Question: Update on partnerships with top cancer centers - Management reported that they are currently in 13 hospitals with approvals to purchase the device, with four centers already treating patients [39] Question: Revenue from clinical studies vs. commercial sales - Management clarified that the reported revenue of $422,000 is from new customers outside of the clinical trial, with no revenue recognized from the TIGER PACT trial [46] Question: Plans for international market expansion - Management stated that while the focus is currently on the U.S. market, there are plans to explore international opportunities in the future [41] Question: Gross margins sustainability - Management expressed confidence that gross margins could increase towards the 70% to 90% range as the company scales [72] Question: Future revenue expectations - Management anticipates growth throughout the year, with a significant ramp-up expected in 2026 as the sales team is fully established [76]

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced positive results from the REZILIENT1 trial for zipalertinib in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations [1][4] - The trial results will be presented at the 2025 ASCO Annual Meeting [1] Company Overview - Taiho Oncology specializes in developing and commercializing orally administered anti-cancer agents, focusing on solid tumors and hematological malignancies [9] - Cullinan Therapeutics is dedicated to creating new standards of care in cancer and autoimmune diseases, with a diversified portfolio of clinical-stage assets [11] Clinical Trial Details - REZILIENT1 is a Phase 1/2 global study evaluating the efficacy and safety of zipalertinib in patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations [5] - The primary endpoints of the trial were overall response rate (ORR) and duration of response (DOR) [5] Efficacy Results - Zipalertinib demonstrated a confirmed ORR of 35.2% overall, with a median DOR of 8.8 months and progression-free survival of 9.4 months [8] - In patients who received prior platinum-based chemotherapy, the ORR was 40% with a median DOR of 8.8 months [8] - Subgroup analyses showed a confirmed ORR of 30% and median DOR of 14.7 months in patients who had prior amivantamab [8] Safety Profile - The safety profile of zipalertinib was manageable and consistent with previously reported data [8]

Company Overview - Lisata Therapeutics is a clinical-stage therapeutics company developing a novel solid tumor targeting and penetration technology with tumor microenvironment (TME) modifying properties[7] - The company's mission is to enhance the treatment benefits of existing and emerging therapies for solid tumors without additional side effects[9] - Lisata has a cash runway extending into 3Q2026 with no debt, funding current clinical programs[11] Certepetide Technology and Partnerships - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing TME immunosuppression, inhibiting metastasis, and working with any modality of anti-cancer therapeutics[23] - Lisata has existing partnerships with Qilu Pharmaceutical, Kuva Labs, and Valo Therapeutics, with potential for additional partnerships[25] - Qilu granted exclusive rights in China, Taiwan, Hong Kong and Macau, Lisata collected $15 million in milestones to date, with potential for additional $221 million in milestones plus royalties[27] Clinical Development and Regulatory Designations - Certepetide has FDA Fast Track Designation for pancreatic cancer, potentially eligible for Accelerated Approval, Priority Review and Rolling Review[93] - Certepetide has FDA Rare Pediatric Disease Designation for Osteosarcoma, eligible for Priority Review Voucher upon approval, vouchers have sold recently for $75-$100 million[94] - Lisata is pursuing rapid global registration in mPDAC, initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC)[67] Clinical Trial Data - Two Phase 1 clinical trials (CEND1-001 in Australia and CEND1-201 in China) demonstrate that certepetide plus SoC chemotherapy improves overall survival in metastatic PDAC[90] - ASCEND Phase 2 trial Cohort A data demonstrate positive trend in overall survival, including 4 complete responses observed in certepetide treatment group compared to none in placebo group[90] - In ASCEND Phase 2 trial Cohort A, the median overall survival was 1268 months for the Certepetide arm compared to 972 months for the Placebo arm[86]