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Ascendis Pharma A/S to Participate in the Evercore ISI 4th Annual HealthCONx Conference

On November 17, 2021 Ascendis Pharma A/S (Nasdaq: ASND) reported that the Company is scheduled to participate in the Evercore ISI 4th Annual HealthCONx Conference (Press release, Ascendis Pharma, NOV 17, 2021, https://ascendispharma.gcs-web.com/news-releases/news-release-details/ascendis-pharma-participate-evercore-isi-4th-annual-healthconx [SID1234595757]). Company executives will participate in a virtual fireside chat hosted by Evercore ISI.

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Details

Event Evercore ISI 4th Annual HealthCONx Conference
Location Virtual
Date Wednesday, December 1, 2021
Time 3:55-4:15 p.m. Eastern Time
A live audio webcast of the presentation will be available on the Investors & News section of the Company’s website at View Source A webcast replay will be available on the Company’s website shortly after conclusion of the event for 30 days.

Entry into a Material Definitive Agreement

On November 17, 2021, Arcus Biosciences, Inc. ("Arcus") reported that entered into an amendment to its Option, License and Collaboration Agreement with Gilead Sciences, Inc. ("Gilead") dated May 27, 2020 (the "Collaboration Agreement") (Filing, 8-K, Arcus Biosciences, NOV 17, 2021, View Source [SID1234595756]). Pursuant to the amendment, Gilead exercised its options to three Arcus programs—its anti-TIGIT program (including domvanalimab and AB308), adenosine receptor antagonist program (including etrumadenant) and CD73 program (including quemliclustat). This transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act. Upon closing, Gilead will pay Arcus an aggregate of $725 million in option fees for its option exercise with respect to these three programs. Thereafter, in accordance with the terms of the Collaboration Agreement, as amended for these three programs, the companies will co-develop, equally share global development costs and equally share all profits and losses for the United States, subject to certain expense caps on Arcus’s spending and true-up adjustments. Gilead will obtain rights to exclusively commercialize these optioned programs outside of the U.S., subject to the rights of Arcus’s existing collaboration partners to any territories, and Gilead will pay to Arcus tiered royalties as a percentage of revenues ranging from the mid-teens to the low twenties.

In addition, the parties agreed to collaborate on discovery and early development of drug candidates against two novel research targets ("research programs") for which Arcus will lead performance of discovery and early development activities. With respect to these two research programs, Gilead has the right to exercise its option, on a program-by-program basis, upon Arcus’s completion of certain IND-enabling activities for an option payment of $60 million. If the option is exercised by Gilead at this stage, the collaboration terms for optioned programs will be applicable to each research program except, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from high single digits to low double digits. If Gilead declines to exercise its option at this stage, Gilead maintains an option, on a program-by-program basis, which must be exercised prior to the expiration of a prescribed period following the achievement of a development milestone in such program and Arcus’s delivery to Gilead of the requisite data package. If the option is exercised by Gilead at this later stage, the collaboration terms for optioned programs will be applicable to the joint development program including that, with respect to commercialization outside of the U.S., Gilead would pay to Arcus tiered royalties as a percentage of revenues ranging from the high-teens to the low twenties.

In connection with Gilead’s exercise of its options to three Arcus programs, the parties agreed to amend the $100 million option continuation payment due on the second anniversary of the Collaboration Agreement (the "2022 Continuation Payment"). Upon closing for all three programs, Gilead will no longer be obligated to make the 2022 Continuation Payment. In the event closing only occurs for one program, the 2022 Continuation Payment will be reduced to $67 million. In the event closing only occurs for two programs, the 2022 Continuation Payment will be reduced to $34 million.

The foregoing is only a brief description of the material terms of the amendment to the Collaboration Agreement and does not purport to be a complete description of its terms and is qualified in its entirety by reference to the amendment, which will be filed as an exhibit to Arcus’s Annual Report on Form 10-K for the year ending December 31, 2021.

Alpheus Medical Closes $16M In Series A Financing For Novel Glioma Brain Cancer Treatment

On November 17, 2021 Alpheus Medical, Inc, a privately held company developing a novel sonodynamic therapy (SDT) platform targeting solid body cancers, reported it has closed $16M in Series A financing (Press release, Alpheus Medical, NOV 17, 2021, View Source [SID1234595755]). Co-led by OrbiMed Advisors and Action Potential Venture Capital, the round included participation from the Medtech Convergence Fund, a SV Health Investors venture fund, the Brain Tumor Investment Fund, an affiliate of the National Brain Tumor Society, and BrightEdge, the American Cancer Society’s impact venture capital arm. The company’s investigational non-invasive sonodynamic therapy has the potential to offer whole hemisphere treatment that is designed to selectively target and kill cancer cells through an outpatient procedure that may be repeated, as needed, to treat the disease. The funds will support a FIH trial of the therapy for recurrent glioblastoma multiforme (rGBM), a fatal brain cancer with very limited treatment options.

The multi-site first-in-human trial will evaluate the safety, feasibility, and molecular and clinical effects of the proprietary sonodynamic therapy treatment in patients with recurrent high-grade gliomas. Enrollment is expected to begin in the coming months.

"Alpheus’ unique drug-device combination is poised to overcome the challenges of rGDM tumors"

"Glioblastomas are located within the blood-brain barrier and are very difficult to treat due to their heterogenous and invasive nature. Treatment of these devastating tumors is currently limited by procedures that are highly invasive, may not be repeated, often result in complications, and in many situations lead to undesirable quality of life trade-offs for the patient," commented Klaus Veitinger, MD, Venture Partner at OrbiMed Advisors and Executive Chairman of Alpheus Medical’s board of directors. "Our team has followed the brain cancer market closely. Alpheus’ unique drug-device combination is poised to overcome the challenges this tumor poses and deliver the hope of better outcomes for these critically ill patients."

Alpheus Medical’s drug-device combination uses a sonodynamic approach, where a drug, or sonosensitizer, selectively accumulates in cancer cells and is activated under low intensity ultrasound to kill the tumor cells. After the drug is administered, Alpheus’ proprietary ultrasound delivery device provides SDT treatment to activate cell death in only the cancer cells that have absorbed the drug. Alpheus’ therapy aims to address the heterogenous and diffuse nature of the disease with its large field treatment of cells both at the primary tumor site and those throughout the diseased hemisphere. The innovative therapy also eliminates the requirement for concomitant imaging, such as magnetic resonance imaging (MRI). It can be performed as a convenient outpatient procedure and may be repeated to maximize treatment effect.

"The ability to selectively target cancer cells with Alpheus’ treatment is very exciting and has the potential to deliver a much-needed option for this challenging disease, where drug therapies alone have struggled," stated Imran Eba, Partner with Action Potential Venture Capital and newly appointed board member of Alpheus Medical. "We are pleased to co-lead this round and look forward to supporting the team as it moves the platform into clinical trials."

INHIBITION OF FOCAL ADHESION KINASE (FAK) BY AMP945 IN PHASE 1 CLINICAL TRIAL

On November 17, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new drugs for the treatment of cancer and fibrosis, reported that it has received new data from its recent Phase 1 clinical trial that demonstrates the ability of AMP945 to inhibit the intended target, Focal Adhesion Kinase (FAK), in human volunteers when given as an orally administered capsule (Press release, Amplia Therapeutics, NOV 17, 2021, View Source;[email protected] [SID1234595754]). This supplementary data further strengthens the Company’s confidence in the planned Phase 2 clinical program as it shows that safe and well-tolerated oral doses of AMP945 can achieve sufficient drug levels in humans to inhibit FAK.

The primary focus of Amplia’s recent Phase 1 clinical trial was to establish the safety, tolerability and pharmacokinetics of AMP945. As part of the trial, skin biopsies were collected from participating healthy volunteers to evaluate the ability of AMP945 to inhibit FAK in human tissues. Analysis of these samples required Amplia to develop a sensitive assay that allowed the measurement of the active form of FAK (phospho-FAK or pFAK) in skin samples before and after AMP945 was administered. The data from these studies have now been analysed and demonstrate that oral administration of AMP945 results in a decrease in active pFAK and the extent of the inhibition of FAK activity correlates with drug levels of AMP945.

In addition to demonstrating the dose-dependent reduction in pFAK in healthy volunteers, these results verify the utility of the assay used to measure pFAK in human tissue samples, confirming the availability of a test method which can be used to guide dose selection in the Company’s planned Phase 2 clinical trials of AMP945.

"We are very encouraged by the way all the data is lining up as we prepare to start our first Phase 2 clinical trial of AMP945," said Dr Mark Devlin, Chief Scientific Officer at Amplia. "Being able to observe inhibition of FAK in human volunteersis an important piece of the jigsaw. We have observed inhibition of FAK by AMP945 in animal models and this has been associated with anti-tumour and anti-fibrotic activity. Getting such clear and compelling FAK inhibition data in our Phase 1 trial is very pleasing and provides additional comfort as we start trialling AMP945 in patients. Furthermore, we now have an assay for monitoring the effects of AMP945 that can be used to guide dosing in our upcoming Phase 2 trials in pancreatic cancers and other fibrotic diseases."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

Photocure ASA: Results for the third quarter of 2021

On November 17, 2021 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 86.7 million in the third quarter of 2021 (Q3 2020: NOK 49.6), and EBITDA of NOK -0.2 million (-5.4), following the continued successful launch in markets previously operated by Ipsen Pharma SAS (Press release, PhotoCure, NOV 17, 2021, View Source [SID1234595753]). The Company plans to increase its investment in commercial activities to further penetrate the large potential market opportunity for its bladder cancer treatment.

"Photocure continued to grow its business during the third quarter of 2021, despite the challenges that arose from the surge of Covid-19 Delta which impacted medical procedures around the world. We delivered Hexvix/Cysview revenue of NOK 86.7 million, up 75% compared to the third quarter of 2020. These results were primarily driven by our reacquisition of the Hexvix business in continental Europe and our focus on territories where healthcare access improved in the third quarter. Importantly, demand for blue light cystoscopy (BLC) equipment remains strong with 14 towers placed in the U.S. in Q3. We remain conservative on the number of towers that we expect to place over the next couple of quarters, given Karl Storz’s planned transition to a new high-definition system in 2022. We believe that launch of the upgraded BLC system is an exciting opportunity with the potential to significantly increase the installed base of BLC towers in the U.S. next year and beyond," said Daniel Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 87.4 million in the third quarter of 2021 (NOK 49.9 million), and EBITDA* of NOK -0.2 million (NOK -5.4 million). Hexvix/Cysview revenues were NOK 86.7 million (NOK 49.6 million) following the successful transition of the Ipsen territories and unit sales growth of 6% in the U.S. EBIT ended at NOK -6.3 million (-16.4) and the cash balance at the end of third quarter 2021 was NOK 330.1 million, compared to NOK 321.8 million reported in the third quarter of 2020.

The installed base of blue light cystoscopes in the U.S. was 302 at the end of the third quarter, an increase of 49 units or 19% since the same period in 2020. BLC with Cysview in the surveillance setting is a priority for Photocure in the U.S. market. By the end of the third quarter, a total base of 45 flexible cystoscopes had been installed giving more patients access to the procedure with less constraints.

"We continue to maintain a strong financial position with NOK 330 million in cash and minimal debt. We reported break-even EBITDA in the third quarter, as we continue to manage through what appears to be the tail end of the pandemic and have begun to invest more aggressively in initiatives to regain growth in our direct markets. We also reacquired the commercial rights to Cysview in Canada and are preparing to begin growing that business in January," Schneider added.

After regaining sales and marketing rights to the European markets that were previously out-licensed, the Company has established a strong commercial presence in the largest markets of the world and believes that it is well-positioned to accelerate revenues in a post Covid-19 environment. Assuming that the effects of Covid-19 and its variants can be appropriately managed, Photocure plans to increase spending back to normalized business levels in the fourth quarter of 2021, increasing investment primarily in commercial activities to grow Hexvix/Cysview unit sales.

"We are optimistic that the challenging conditions of the pandemic that have persisted for nearly two years will improve going forward. Our teams are energized to deliver patient value and revenue growth in 2022, with the expectation of new enhanced BLC equipment and focus from Karl Storz, expansion of our business into Canada, the ability of our strengthened European commercial team to have broader access to our new customers and territories, the potential to execute on enriching our portfolio through partnerships or M&A opportunities, and anticipated progress on the ongoing Phase 3 trial for Cevira. With the impact of Covid-19 expected to abate in H1 2022, Photocure remains in a strong position to get back to the growth rates that we were delivering pre-pandemic, and to capitalize on other opportunities that can enhance our growth and path toward sustainable profitability," Schneider concluded.

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 third quarter 2021 financial report on page 25.

Photocure will present its third quarter 2021 report on Wednesday 17 November 2021 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/20211117_5/