On August 10, 2022 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 99.9 million in the second quarter of 2022 (Q1 2021: NOK 88.9 million), and a positive EBITDA of NOK 1.4 million (NOK 5.8 million) (Press release, PhotoCure, AUG 10, 2022, View Source [SID1234618074]). Karl Storz’s new high-definition blue light system is expected to become commercially available in the United States in late third quarter 2022, which is in turn expected to accelerate the placement of rigid towers.

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"We delivered 12% Hexvix/Cysview revenue growth and 9% unit growth in the second quarter of 2022, despite delays in the new Karl Storz blue light system launch and ongoing effects from Covid-19. The commitment of our commercial teams in both the U.S. and in Europe enabled the business to significantly recover from a difficult first quarter and achieve positive year over year growth with our base business, despite the staffing shortages that continue to plague healthcare systems around the world. While access to care has reopened, many hospital systems now have stricter rules for non-essential personnel within the facility, and limited staffing means less time for face-to-face customer engagement. Nevertheless, in the second quarter of 2022, our U.S. business achieved the highest unit sales volume in our history, and we continue to increase Cysview’s penetration into the bladder cancer treatment market," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 100.6 million in the second quarter of 2022 (NOK 90.4 million), and an EBITDA* of NOK 1.4 million (NOK 5.8 million). The Hexvix/Cysview revenues ended at NOK 99.9 million in the quarter (Q2 2021: NOK 88.9 million), on higher unit sales in both North American and Europe and a favorable net benefit from foreign exchange. The EBIT was NOK -4.6 million (NOK -0.2 million) and the cash balance at the end of the second quarter 2022 was NOK 273.1 million. The installed base of blue light cystoscopes in the U.S. was 329 at the end of the second quarter, an increase of 41 towers or 14% since the same period in 2021, including a total base of 58 flexible cystoscopes, which grew 38% year over year.

"I am pleased to reiterate that demand for blue light cystoscopy (BLC) continues to be very strong, and that new high-definition blue light equipment from Karl Storz is anticipated by our accounts in both the U.S. and European markets. Major capital equipment suppliers are highly aware of the need, and are preparing to launch new upgraded blue light systems in Europe. These technology upgrades are expected to improve the BLC experience for physicians, and we believe that the use of high-definition towers will further accelerate demand for Hexvix/Cysview. Our U.S. pipeline for new BLC towers remains robust, and we continue to work with Karl Storz in preparation of the launch of the new blue light system later this quarter," Schneider adds.

With the new Karl Storz system anticipated to launch in the U.S. in late third quarter of 2022, Photocure expects that the placements of new blue light rigid towers will accelerate in the fourth quarter of this 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 has increased.

"We believe that the second half of this year has potential for some exciting developments. With healthcare access now reopened and the new high-definition blue light system expected to launch in the coming weeks, we are looking forward to significantly expanding the base of blue light capital equipment and accelerating the growth of our Hexvix/Cysview franchise," 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 second quarter 2022 financial report on page 22.

Photocure will present its second quarter 2022 report on Wednesday 10 August 2022 at 14:00 CEST at Hotel Continental, Oslo, Norway. The investor presentation will also be streamed live and be hosted by Dan 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/20220810_2/

On August 10, 2022 Arbele, a clinical stage biopharmaceutical company, reported the successful dosing of the first patient in Australia in Phase I Study of ARB202, for the treatment of advanced gastrointestinal cancers patients (Press release, ARBELE, AUG 10, 2022, View Source [SID1234618073]). Globally, Arbele is the first company exploring the potential of CDH17xCD3 bispecific T-Cell engager antibody in cancer immunotherapy.

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"Dosing patients is a significant first step in targeting cadherin-17 on gastrointestinal cancers which globally affects so many lives, particularly in East Asia" said Dr. Dennis Wong, MD, Chief Medical Officer of Arbele.

The Phase I trial is a continuous multi-center, open-label, dose-escalation trial for both the ascending dose (Phase Ia) and dose ranging (Phase Ib/2a) phases (clinicaltrials.gov: NCT05411133), with aims to determine the tolerability and/or to be used dose of ARB202. The preliminary effects on biomarkers and clinical efficacy of ARB202 in GI cancer patients will be examined. Given tolerability potential expansion cohorts will further evaluate the safety and efficacy of ARB202 in specific indication(s) and in combination with other therapy. Arbele expects to report initial safety, tolerability, and PK/PD data in 2Q 2023.

About ARB202

ARB202 is a first-in-class bispecific antibody based on Abele’s patented CDH17 biomarker. The unique differential binding affinities of ARB202 toward CDH17 and CD3 allows it to have high specificity and cytotoxicity, while avoiding the "off-target" overactivation of T cells. Preclinical data showed that ARB202 can effectively increase interactions between T cells and target cancer cells that expresses CDH17. The trial is being led by Professor Paul de Souza of Western Sydney University Medical School and conjoint Professor, UNSW in Sydney, and Prof. Roland Leung of University of Hong Kong at Queen Mary Hospital. We also plan to expand the studies in the US and China, Japan, and Singapore.

On August 10, 2022 Peel Therapeutics, an evolutionary-inspired, clinical-stage biotech company developing medicines for cancer and inflammatory diseases reported that it has initiated a first-in-human clinical study of PEEL-224 in patients with advanced solid tumors (Press release, PEEL Therapeutics, AUG 10, 2022, View Source [SID1234618072]). This follows recent acceptance of the company’s Investigational New Drug (IND) Application by the U.S. Food and Drug Administration (FDA). PEEL-224 was developed from a medicine that originates from the leaves and stem of an ancient tree used for thousands of years in traditional Chinese medicine.

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The company is evaluating PEEL-224, a novel topoisomerase I inhibitor, in a Phase 1 dose escalation, repeat-dose, multi-center, open-label study in patients with advanced solid tumors. The trial will evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of PEEL-224.

"Building on millions of years of evolution, Peel Therapeutics’ scientists and collaborators have modified this plant compound to overcome chemotherapy cancer resistance," said Joshua Schiffman, M.D., CEO and Co-Founder of Peel Therapeutics. "We are very encouraged by the preclinical data seen in multiple solid tumor types. Our company looks forward to further evaluation of PEEL-224 in patients, bringing us closer to our goal of delivering safer and more effective cancer therapy."

Peel Therapeutics’ first clinical study comes on the heels of closing an $18M convertible note financing last year. The company has raised $30M overall since its start in oversubscribed note rounds and small business grants.

"At Peel Therapeutics, evolution is our platform and patients are our purpose. Our Peel scientists unlock evolutionary biology to treat cancer and inflammation," continued Dr. Schiffman. "With our additional programs also quickly advancing towards the clinic, we are optimistic about our progress. We are pleased to forge ahead with the support of our investors to introduce safer and more effective medicines for patients."

About PEEL-224
PEEL-224 is a small molecule nanoparticle for the treatment of cancer. The active molecule of PEEL-224 derives from camptothecin, a naturally occurring compound found in the Chinese Happy Tree (Camptotheca acuminata) thought to have evolved as a plant defense mechanism. Camptothecin and its derivatives inhibit topoisomerase 1 DNA repair, effectively killing dividing cells with mutations. By engineering the natural molecule and conjugating it with a synthetic polymer, Peel Therapeutics has designed PEEL-224 to improve efficacy while limiting toxicity.

On August 10, 2022 Medtronic plc (NYSE:MDT), a global leader in healthcare technology, reported that it will report financial results for its first quarter of fiscal year 2023 on Tuesday, August 23, 2022 (Press release, Medtronic, AUG 10, 2022, View Source [SID1234618071]). A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at View Source The news release will include summary financial information for the company’s first quarter of fiscal year 2023, which ended on Friday, July 29, 2022.

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Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 23, 2022, to discuss results for its first quarter of fiscal year 2023. The webcast can be accessed at View Source

Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at View Source

Looking ahead, Medtronic plans to report its fiscal year 2023 second, third, and fourth quarter results on Tuesday, November 22, 2022, Tuesday, February 21, 2023, and Thursday, May 25, 2023, respectively. For these events, confirmation and additional details will be provided closer to the specific event.

On August 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) (Press release, Everest Medicines, AUG 10, 2022, View Source [SID1234618070]).

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In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin).

"The acceptance of our New Drug Application for Xerava and our agreement with TTY are key steps towards bringing this important and novel therapy to Taiwan," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "With a robust organization that includes expert functions in regulatory, medical, marketing and sales, and a successful record of commercializing other important anti-infective products in the region, TTY was a clear partner of choice as we continue our work to expand the regional reach and access of this critical therapy for patients with complicated intra-abdominal infections and other potentially life-threatening infections."

"TTY Biopharm has been dedicated in the fields of cancer and critical care for many years. It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing. Through this partnership, TTY may provide more options and better solutions to both patients and medical professionals in the near future," said Sara Hou, Chief Executive Officer of TTY Biopharm.

Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.

Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region.

About Xerava (eravacycline)

Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore and the medicine is currently under review for cIAI in Greater China. Everest is also developing Xerava for the treatment of community-acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit View Source

About Complicated Intra-Abdominal Infections

Complicated intra-abdominal infections (cIAI) is a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.