On February 23, 2022 Photocure ASA reported Hexvix/Cysview revenues of NOK 94.2 million in the fourth quarter of 2021 (Q4 2020: NOK 97.7 million) (Press release, , FEB 23, 2022, View Source,million%20(NOK%2015.2%20million). [SID1234611427]). Unit sales in the U.S. and Europe rose 11% and 12%, respectively, while the revenue comparison was impacted by a one-time reversal of an accrual in the prior-year period and foreign exchange. Photocure has a solid pipeline of anticipated Blue Light Cystoscopy (BLC) tower installations in the U.S. and expects placements to accelerate during the second half of 2022.

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"Photocure showed strong execution and resilience in 2021 as we continued to grow our U.S. business and successfully completed our first full year of operations in continental Europe despite several surges of Covid-19. While product revenue declined 4% in the fourth quarter of 2021 due to a one-time accrual reversal in Q4 2020 and the impact of foreign exchange, fourth quarter unit sales in the U.S. and Europe rose 11% and 12%, respectively year-over-year. We are particularly pleased with the progress that we made during the 2-year pandemic period, given the challenging conditions. Procedure volumes for bladder cancer resection surgeries in the U.S. declined 11%, while we grew Cysview unit volume by 24% from 2019 to 2021, resulting in an increase in our market penetration," says Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 94.5 million in the fourth quarter of 2021 (NOK 97.9 million), and an EBITDA* of NOK -5.5 million (NOK 15.2 million). Adjusted for the one-time reversal of an accrual in the fourth quarter of 2020, Hexvix/Cysview revenues increased 5% in the fourth quarter 2021 and were up 10% in constant currencies. The EBIT ended at NOK -11.5 million (-6.2) and the cash balance at the end of the fourth quarter 2021 was NOK 322.9 million. The installed base of rigid cystoscopes in the U.S. was 311 at the end of the fourth quarter, an increase of 43 units or 16% since the same period in 2020, including a total base of 48 flexible cystoscopes.

"Demand for BLC equipment remains very strong, and while some customers are awaiting the launch of the new Karl Storz system, we placed 9 towers in the fourth quarter. Our backlog for new capital equipment continues to grow, and we are extremely pleased that Karl Storz’s new blue light system was approved by the FDA earlier this month. As a result, both Photocure and Karl Storz are energized and preparing to launch this new system in the coming months," Schneider adds.

The Company’s pipeline of anticipated BLC tower installations in the U.S. remains robust given the demand by physicians and facilities to offer the benefits of BLC with Cysview in their practices. With the new Karl Storz blue light system anticipated to launch throughout the U.S. in the second quarter of 2022, Photocure expects that the placements of new blue light rigid towers will accelerate in the back half of the year. Meanwhile, the Company will continue to focus on increasing the use of Cysview in existing accounts as well as placing flexible BLC equipment, for which installation momentum is increasing.

"While the worldwide pandemic required us to take measures to manage through a period of great uncertainty, we used that time and deployed the necessary resources to position our global commercial organization to drive significant Hexvix/Cysview growth once healthcare access returns to normal. With our European operations fully integrated, a new high-definition BLC system launching in the U.S. market, and Covid-19 becoming better managed, we believe that 2022 will be an exciting year for Photocure as we help more bladder cancer patients realize the benefits of Hexvix/Cysview," Schneider concludes.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2021 financial report on page 24.

Photocure will present its fourth quarter 2021 report on Wednesday 23 February 2022 at 14:00 CET. The investor presentation will be streamed live and be hosted by Daniel Schneider, CEO and Erik Dahl, CFO.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20220223_10/

On February 23, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers, reported that it has completed patient enrollment in Part A of the Phase 2/3 RINGSIDE clinical trial evaluating AL102 in desmoid tumors (Press release, Ayala Pharmaceuticals, FEB 23, 2022, View Source [SID1234608871]). AL102 is a potent, selective, oral gamma-secretase inhibitor (GSI). The Company expects to report interim results from Part A by mid-2022.

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"Completion of enrollment in Part A of the RINGSIDE trial is an important milestone in our AL102 clinical program for desmoid tumors," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Part A will help us determine the optimal dose for the randomized portion of the study, we will be looking for safety and signs of anti-tumor activity based on MRI. We are extremely grateful to the patients who are participating and we look forward to sharing top line data around mid-year."

A total of 36 patients have been enrolled in Part A of the RINGSIDE study which is evaluating the safety, tolerability of AL102, as well as tumor volume by MRI at 16 weeks. Three dosing regimens of AL102 are being tested to determine the optimal dose regimen to advance forward.

In Part A, the effect of food on AL102 absorption was tested in a sub-study and PK results indicate that no food restrictions are required.

Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from Part A, enrolling up to 156 patients age 12 and up with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR,) and patient-reported Quality of Life (QOL) measures. Patients who participated in Part A are eligible to enroll into an open-label extension study at the selected dose, and long-term efficacy and safety will be monitored.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282.

About AL102

AL102 is a potent, selective, oral gamma secretase inhibitor (GSI). AL102 is currently being developed for the treatment of desmoid tumors, as well as in combination with Novartis’ B-cell maturation antigen (BCMA)-targeting agents for the treatment of multiple myeloma (MM).

About Desmoid Tumors

Desmoid tumors, also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.

On February 23, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Mark Enyedy, President and CEO, will participate in the ovarian cancer panel discussion at the upcoming Cowen 42nd Annual Health Care Conference (Press release, ImmunoGen, FEB 23, 2022, View Source [SID1234608891]). The panel is scheduled for March 9, 2022 from 12:50 – 1:50pm ET.

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A webcast of the panel will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On February 23, 2022 American Oncology Network, LLC (AON) , a high-growth medical oncology provider with a focus on supporting the long-term viability of oncology treatment in community-based settings, reported a strategic collaboration with VieCure, a national leader in the deployment of Artificial Intelligence (AI), codified clinical content and point-of-care clinical decision support in oncology (Press release, American Oncology Network, FEB 23, 2022, View Source [SID1234608910]). The collaboration is designed to facilitate the delivery of precision oncology and personalized care and treatment for patients across the ever-expanding AON network.

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Foundational to the future of oncology treatment is the execution of a vision for personalized medicine. Realizing this vision requires access to patients, oncologists and robust molecular information and patient outcomes data. This strategic collaboration will serve as a key vehicle to do just that. AON oncologists and staff will improve clinical decision-making at the individual patient level, while standardizing care plans and associated care delivery across the patient population to better outcomes. Longitudinal information which tracks the same type of information on the same patient at multiple times will be generated in real time as patients move throughout their complex cancer care journey. This information will be used to evaluate treatment approaches, create new value-based care funding options, improve overall treatment outcomes and provide insights into next generation prevention, screening, diagnostic and therapuetic opportunities. Given the value of the data and associated insights, AON and VieCure will work jointly with industry on transformational initiatives.

The parties have strategically aligned to accelerate the adoption of three critically important paradigm shifts that are currently underway in oncology, including: (1) the compliant use of next generation tumor sequencing, targeted therapy, immunotherapy and emerging therapies such as radio-ligands; (2) the transition to value-based care, and (3) increasing patient participation in the management of their care given more and more patients are living longer with their disease and being treated at home. While these transformational changes are improving overall survival and quality of life for patients, they are also driving the need for change at the point of care given oncologists are having to evaluate an ever growing amount of patient data and clinical evidence.

"Clinicians want to do what’s best for their patients, for their staff and for practices," said Dr. Stephen "Fred" Divers, Chairman of the AON Advisory Board and a practicing Medical Oncologist. "They want to make the right decisions at the right time, but they’re often overwhelmed by data which is poorly accessible and manageable, leading to clinical workflow burdens which get in the way of achieving the best outcomes for their patients. They need a technology solution that helps simplify cancer’s complexities and empowers them to do their best. At AON, we partner with physicians and their practices to help them navigate the complex oncologic landscape, improve quality of care and elevate oncology in community settings. VieCure aligns perfectly with that mission."

AON leadership recognized the need for 21st century clinical decision making tools and turned to VieCure to be their partner. The two entities will work together to codify AON’s unique clinical content including but not limited to therapeutic and drug contracts, commercial payer rules and clinical trials.

"We understand that knowledge is the secret to beating cancer," said Dr. Fred Ashbury, Chief Scientific Officer at VieCure. "That’s why we’re embracing the power of clinical inferencing to do what the human brain cannot, which is to enable clinicians to easily sift through the overwhelming amount of information to find the right answers for every patient, every time. At VieCure we’re about creating simplexity in cancer care, which means we use AI technology to cut through the dense fog of information that holds clinicians back; we help to superpower them to do their best work. By codifying the latest in clinical evidence and financial rules, we can envelop our clinicians with a halo of knowledge in real time which can be easily and quickly interpreted and actioned right at the point of care."

The multi-year strategic collaboration will not only serve to meet the clinical needs of the AON community today but will ensure the VieCure platform evolves over time. Together the parties have committed to:

Joint research and development, creating and deploying new features and technology innovations as the oncology landscape changes.
Advancing access to, and administration of, the latest codified content including national and international evidence, therapy (eg. drug/bio-similar) agreements, and phase I, II, and III clinical trials.
Centralization of precision oncology infrastructure including one-click order entry for next generation tumor sequencing and the return of relevant discrete data to facilitate real-time clinical inferencing of results to help guide treatment selection and management decisions.
Facilitation of joint/new partnerships with industry collaborators – clinical research, radiation therapy, radioligand, pharma and molecular diagnostic partners.
Facilitating clinical paradigm shifts and appropriate adoption of radioligand therapy, proteomics, biology guided radiotherapy, digital transformation at the patient/family level, and more.
Advancing value-based care in a personalized cancer care and precision oncology environment.

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