On February 22, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported its results for the financial year ended 31 December 2023. All figures are in AUD$ unless otherwise stated (Press release, Telix Pharmaceuticals, FEB 22, 2024, View Source [SID1234640404]).

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2023 highlights

Total Group revenue of $502.5M, an increase of 214% from $160.1M in 2022 primarily driven by continued strong growth in sales of Illuccix in the second year since commercial launch (April 2022)
Delivered positive adjusted earnings before interest, tax, depreciation, and amortisation (adjusted EBITDA) of $58.4M an increase of $126.2M, compared to a loss of $67.8M in 2022
Inaugural full year profit of $5.2M after tax. A substantial improvement on the net loss after tax of $104.1M in 2022
Investment in research and development (R&D) and selling, general and administration (SG&A) reflects progress across the late-stage pipeline and scale-up of the commercial organisation
Overall operating costs as a percentage of revenue have reduced to 52% from 105% in 2022
Gross margin has improved to 63% (vs. 59% in 2022) reflecting distribution and manufacturing costs optimisation
Positive operating cash inflow in line with commercial sales growth, demonstrated through customer receipts of $463.7M (vs. $124.1M in 2022), and
Closing cash balance was $123.2M as at 31 December 2023.
Progress across the core pipeline includes:

First patients dosed in the ProstACT GLOBAL Phase III clinical trial of TLX591, a first-in-class investigational rADC[2] for prostate cancer therapy
Positive interim readout from the ProstACT SELECT Phase I clinical trial reinforcing the differentiation of TLX591, including favourable safety profile and clinical utility of the patient-friendly short dosing regimen
Submission of the Biologics License Application (BLA) for TLX250-CDx (Zircaix[3]) to the United States Food and Drug Administration (U.S. FDA) for kidney cancer imaging on a rolling review basis
Patients dosed in multiple clinical trials of Telix’s therapeutic candidate TLX250 for clear cell renal cell carcinoma (ccRCC) and other solid tumours expressing carbonic anhydrase IX (CAIX)
First cohort of patients dosed in the IPAX-2 trial investigating Telix’s glioblastoma therapy candidate, TLX101, in newly diagnosed patients
Commercialisation plans underway for glioma imaging agent, TLX101-CDx (Pixclara[3]), ahead of the planned submission of a New Drug Application (NDA) to the U.S. FDA in Q1 2024, and
Ethics approval granted to commence biodistribution and safety study of TLX300-CDx, first human study of radiolabelled olaratumab being developed as a therapeutic candidate for soft-tissue sarcoma.
Dr Christian Behrenbruch, Managing Director and Group CEO commented:

"This is an excellent result which demonstrates the strength of the Telix business model. We have achieved profitability while intensively investing in the development of our late-stage assets and the scale-up of our commercial infrastructure and marketing activity. This has resulted in Telix capturing a meaningful market share in the growing urology imaging market whilst laying the foundation for our next commercial products.

"We are highly focused on the development of our theranostic pipeline and vertical integration of supply and manufacturing. This activity is key to diversifying our revenue streams, creates additional value for our therapeutic assets and further differentiates Telix as a fully integrated global radiopharmaceutical company."

Further details on the Company’s results can be found in the Appendix 4E, the accompanying investor presentation, and 2023 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.

Revenue guidance is based on worldwide sales of Illuccix, with potential upside from Zircaix[3] (kidney cancer imaging) and Pixclara[3] (glioma imaging), subject to product regulatory approvals. Guidance will be updated throughout the year, as appropriate, to reflect product approvals.

Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.

2024 R&D investment activity is expected to include validation of commercial manufacturing and market launch activities in preparation for approval of Zircaix[3] and Pixclara[3] a fully operationalised ProstACT GLOBAL therapy trial in prostate cancer, and initiation of additional therapeutic clinical trials, including manufacturing activity, across the broader pipeline. 2024 R&D investment also includes indication expansion and life-cycle management of Illuccix.

Investor call

An investor webcast will be held at 9.00am AEDT on Friday 23 February 2024 (Thursday 22 February 2024, 5.00pm EST)

Participants can register for the webcast and find audio call details at the following link: View Source

On February 22, 2024 STORM Therapeutics Ltd. (STORM), the clinical stage biotechnology company discovering and developing novel small molecule therapies targeting RNA modifying enzymes (RMEs) for oncology and other diseases, reported that Alexandra Sapetschnig, Group Leader at STORM, will present results and conclusions on its METTL1 tRNA methyltransferase program at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2024 in Paris, France on 26 February (Press release, STORM Therapeutics, FEB 22, 2024, View Source [SID1234640403]).

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The presentation entitled "Targeting the tRNA methyltransferase METTL1 with small molecule inhibitors in cancer" illustrates STORM’s new data showing that pharmacological inhibition of a tRNA methyltransferase affects tumour growth in animal models.

Data demonstrated that:

Two distinct chemical series exhibit METTL1 inhibition in vitro at low nanomolar concentrations while displaying high selectivity over other RNA and protein methyltransferases.
Mechanistically, METTL1 inhibition leads to reduced tRNA methylation and stability of a subgroup of tRNAs.
In several cancer cell lines, METTL1 inhibition impairs cell proliferation and cell cycle progression accompanied by reduced expression of cell cycle regulators.
In vivo, METTL1 inhibitors induce tumour growth inhibition in both immune-deficient and immune-competent mouse strains.
Oliver Rausch, Chief Scientific Officer at STORM Therapeutics, said: "We are delighted to present this exciting new work which demonstrates that targeting specific tRNA pathways via inhibition of the novel RNA methyltransferase METTL1 results in cancer cell reprogramming and profound cancer growth inhibition in vivo. This follows hot on the heels of our groundbreaking work on METTL3 leading to the discovery of STC-15, currently in clinical testing for advanced malignancies, and highlights the immense potential of targeting RNA modifications for the development of new cancer treatments. As we continue to advance and develop our novel proprietary drug discovery pipeline, these new findings illustrate the advancements that STORM are making to transform the treatment landscape for cancer.

All accepted abstracts will be published online only in the ESMO (Free ESMO Whitepaper) TAT 2024 Abstract Book, a supplement to the ESMO (Free ESMO Whitepaper) journal, ESMO (Free ESMO Whitepaper) open.

Details of the conference and poster presentation are as follow:
Poster Title: Targeting the tRNA methyltransferase METTL1 with small molecule inhibitors in cancer
Presenter: Alexandra Sapetschnig1, Beth Thomas1, Eliza Yankova2, Harry Fischl1, Aleksandra Azevedo1, Sarah Bucknell1, Richard Fosbeary1, Sapphire Sawyer1, Sian Evans2, Carmen Livi1, Byron Andrews1, Jack Rogan1, Natalie Webster1, Matthew Fyfe1, Konstantinos Tzelepis2, Oliver Rausch1
Date and Time: 26 February 2024 at 17:15 – 18:15 CET
Session: Cocktail and Poster Display Session
Location: Hall Bordeaux
Presentation Number: 105P

On February 22, 2024 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that data will be highlighted in three separate poster presentations at the 2024 Miami Breast Cancer Conference (MBCC), held on March 7 – 10, 2024 at the Fontainebleau, Miami Beach, FL (Press release, PreludeDx, FEB 22, 2024, View Source [SID1234640402]).

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"We are excited to share data regarding our novel biosignature for invasive Stage I, II breast cancer test for radiation therapy, as well as clinical utility data on our DCISionRT test for DCIS at the prestigious MBCC conference," said Dan Forche, President and CEO of PreludeDx. "We look forward to connecting with colleagues and sharing our vision for future early-stage breast cancer products, as well as advancing collaboration opportunities."

PreludeDx MBCC Posters to Be Presented

Title: A Novel Biosignature for Early-Stage Invasive Breast Cancer to Predict Radiotherapy Benefit and Assess Recurrence Risk for Patients Treated with Breast-Conserving Surgery
Presenter: Troy Bremer, PhD, Chief Scientific Officer, PreludeDx
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

Title: Impact on Radiation Therapy Recommendation and Treatment Modality for Patients with Ductal Carcinoma in Situ Using the 7-Gene Biosignature: Analysis of the PREDICT Study
Presenter: Chirag S. Shah, MD, Co-Director of Breast Radiation Oncology, Department of Radiation Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

Title: Limitations in the Application of Clinicopathologic Factors Alone in Predicting Radiation Benefit for Women with Low-Risk DCIS after Breast Conserving Surgery: The Impact of a 7-Gene Biosignature Based on 10-year Ipsilateral Breast Recurrence (IBR) Rates
Presenter: Frank A. Vicini, MD, FASTRO, Radiation Oncologist at Michigan HealthCare Professionals, member of NRG Oncology
Date: Thursday, March 7, 5:30 – 6:30 p.m. and Friday, March 8, 4:45 – 6:00 p.m. ET

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On February 22, 2024 AbbVie Inc. (NYSE: ABBV) and Tentarix Biotherapeutics reported a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology (Press release, AbbVie, FEB 22, 2024, View Source [SID1234640401]). The collaboration will integrate AbbVie’s expertise in oncology and immunology with Tentarix’s proprietary Tentacles platform.

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Tentacles are multi-functional, conditionally-active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells.

"Oncology and immunology are two of our key strategic growth areas where we are pursuing novel technologies that aim to deliver transformative therapies, which address unmet patient needs," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "This strategic partnership complements our ongoing efforts in developing novel biologics, potentially to expand our oncology and immunology portfolios with conditionally-active multi-specific molecules."

"We are excited to join forces with AbbVie to help accelerate cutting-edge, conditionally-active therapeutic programs towards clinical applications for patients in need," said Don Santel, interim chief executive officer, Tentarix Biotherapeutics. "This collaboration adds to our portfolio of internal and external pipeline programs and is a strong validation of our approach in understanding and targeting complex immune interactions that drive cancers and inflammatory diseases."

Under the terms of the agreements, Tentarix will receive upfront option payments, totaling $64 million from AbbVie, for the two programs. AbbVie will receive an exclusive option to fully acquire the programs following candidate nomination, for an additional undisclosed payment for each program.

On February 22, 2024 Immunofoco, a company dedicated to developing cell therapy products for solid tumors, reported a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ) (Press release, Immunofoco, FEB 22, 2024, View Source [SID1234640400]).

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EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA.

The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) in 2022 and updated during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in 2023.

As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16.

Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco’s achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale.