Oncorus to Present at the Jefferies London Healthcare Conference

On November 17, 2021 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the Jefferies London Healthcare Conference (Press release, Oncorus, NOV 17, 2021, View Source [SID1234595737]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will be available for on-demand viewing beginning Thursday, November 18, 2021 at 3:00 a.m. ET under the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 30 days following the event.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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/

Financial Results for the Second Quarter
of the Fiscal Year Ending March 31, 2022
(FY2022 1H)

ON November 17, 2021 Nippon Kayaku reported that Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2022 (FY2022 1H) FY2022 : 1H (Press release, Nippon Kayaku, NOV 17, 2021, View Source [SID1234595723])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Topics (1) Net sales and income increase year-on-year; revised full-year business forecasts Net sales of 97%, operating income by industry segment of 107%, operating income of 111%, and profit attributable to owners of parent of 115% compared with forecasts for the first half of FY 2022 (announced on July 30, 2021)

・ Gross profit increased due to robust sales of Functional Chemicals business and others and cost reductions stemming from an increased capacity utilization rate
・ Although a 2Q impact was observed in the Safety Systems business and other areas due to a slowdown in automobile production affected by a semiconductor shortage, performance as a whole was solid in the first half
・ Profits increased due to controlled selling, general and administrative expenses. Acquisition of Treasury Stock (May to September)
・ 2.63 million shares (approx. 3.0bn yen)
・ 1.54% of the total number of issued shares excluding treasury stock Summary of Nippon Kayaku Group 5 FY2022 : 1H Topics

(2) Functional Chemicals Business Functional Materials
• Continued strong sales of semiconductor-related epoxy resins, such as for circuit boards and encapsulations
• In UV-curable resins, strong sales of materials for resists and display products
• Strong sales of cleaners for LCDs, semiconductors and electronic components Color Materials
• Continued strong demand for consumer inkjet printer colorants
• Good performance of industrial inkjet inks due to recoveries in printing demand and capital investment. Favorable sales of textile inkjet dyes due to market recovery

• Developers for thermal paper and dyes improved in the first half, but are still mid-recovery Catalyst
• Sales higher than expected due to orders received ahead of schedule Polatechno
• Optical Films business showed signs of recovery, particularly for automotive applications, but declined in 2Q under the impact of a decrease in production caused by a shortage of ICs
• Precision Components business is solid based on recovery in projector demand; X-ray analyzer components are strong 6 FY2022 : 1H Topics

(3) Pharmaceuticals Business
• Introduced ALAGLIOⓇ, a photodynamic diagnostics agent, acquired marketing rights, and commenced promotional activities
• PORTRAZZAⓇ, a new biomedicine for lung cancer treatment, achieved market penetration
• Biosimilars: INFLIXIMAB BS and TRASTUZUMAB BS grew
• Launched generic anti-cancer drug: PEMETREXED, metabolic malignancies
• Approved FOSAPREPITANT, antiemetic agent Safety Systems Business
• Decrease in sales stemming from a slowdown in automobile production in response to the worldwide semiconductor shortage
• Customer orders of local subsidiaries ceasing operations under lockdown in Malaysia have been covered within the Group Agrochemicals and Other Businesses
• In the agrochemicals business, domestic sales of the soil fumigants, TERONTM and ASAHI D-D were firm
• Sluggish overseas due to difficulties in procuring raw materials

Quest Diagnostics Declares Quarterly Cash Dividend

On November 17, 2021 Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that its Board of Directors declared a quarterly cash dividend of $0.62 per share, payable on February 2, 2022 to shareholders of record of Quest Diagnostics common stock on January 19, 2022 (Press release, Quest Diagnostics, NOV 17, 2021, View Source [SID1234595738]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.