On October 27, 2022 Novocure (NASDAQ: NVCR) reported that financial results for the quarter ended September 30, 2022. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields) (Press release, NovoCure, OCT 27, 2022, View Source [SID1234622522]).

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"In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer"

"In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer," said William Doyle, Novocure’s Executive Chairman. "We are diligently working to reach additional patients in our current markets, expand into new markets, enhance our products and treat patients in new indications throughout the body. We are investing aggressively to prepare Novocure for the future and are eager to treat many more patients in the coming years."

"Novocure is approaching a period that should be transformational for our company and patients," said Asaf Danziger, Novocure’s Chief Executive Officer. "January marks the beginning of a two-year period of multiple data releases from our pivotal studies exploring the use of TTFields in a variety of solid tumor cancers and combinations. These data catalysts could enable us to treat tens of thousands more patients in the future, and we look forward to sharing these results with physicians, patients, and the investor community in the coming quarters."

Financial updates for the third quarter ended September 30, 2022:

Total net revenues for the quarter were $131.0 million, a decrease of 2% compared to the same period in 2021.
The United States, EMEA and Japan contributed $102.7 million, $14.3 million, and $7.9 million in quarterly net revenues, respectively.
Net revenues were impacted by the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage updates and foreign exchange pressure.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $6.2 million.
Gross margin for the quarter was 77%.
Research, development and clinical studies expenses for the quarter were $52.0 million, an increase of 8% from the same period in 2021.
Sales and marketing expenses for the quarter were $41.4 million, an increase of 27% compared to the same period in 2021. This reflects increased investments in early commercial and market access capabilities.
General and administrative expenses for the quarter were $32.5 million, an increase of 4% compared to the same period in 2021.
Net loss for the quarter was $26.6 million with loss per share of $0.25.
Adjusted EBITDA* for the quarter was $4.4 million.
Cash, cash equivalents and short-term investments were $970.3 million as of September 30, 2022.
Operational updates for the third quarter ended September 30, 2022:

As of September 30, 2022, there were 3,420 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,181, 885 and 354 active patients, respectively.
1,389 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 978, 332 and 79 prescriptions, respectively.
Quarterly updates and achievements:

Today, we are announcing preliminary data from the phase 2 EF-33 pilot study evaluating the safety and efficacy of high density arrays in 25 patients with recurrent glioblastoma (GBM). Among those who used Optune as directed for at least one month, median progression-free survival was 4.5 months compared to 2.2 months in the historical control, Novocure’s pivotal EF-11 study. Further, notwithstanding the increased TTFields intensity, EF-33 patients reported no TTFields-related toxicity.
Our phase 3 pivotal METIS study for the treatment of brain metastases from non-small cell lung cancer (NSCLC) continues to enroll well, and we have visibility to final patient enrollment; however, we now expect to complete enrollment in the first quarter of 2023 versus the fourth quarter of 2022. This will begin the final patient’s 12-month follow-up period, and we anticipate top-line data in the first quarter of 2024.
In September 2022, we announced the creation of our U.S. CNS (central nervous system) Cancers Franchise, intended to strengthen focus on growth in our U.S. GBM business by streamlining decision-making and improving coordination.
Anticipated clinical milestones:

Top-line readout from phase 3 pivotal LUNAR study in NSCLC cancer (Q1 2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2024)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss third quarter 2022 financial results at 8 a.m. EDT today, Thursday, October 27, 2022. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On October 27, 2022 Ignyte Acquisition Corp. ("Ignyte") (NASDAQ: IGNY), a publicly traded special purpose acquisition company, reported that Ignyte’s stockholders have approved its proposed business combination (the "Business Combination") with Peak Bio Co., Ltd. ("Peak Bio") at a Special Meeting of its stockholders held on October 25, 2022 (the "Special Meeting") (Press release, Ignyte Acquisition, OCT 27, 2022, View Source [SID1234622521]). The Special Meeting to be held on October 31, 2022 has been canceled.

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Approximately 75% of the votes cast at the Special Meeting, representing approximately 75% of Ignyte’s outstanding shares of common stock entitled to vote at the Special Meeting, were cast in favor of the proposal to approve the Business Combination with Peak Bio. The formal results of the Special Meeting will be included in a Current Report on Form 8-K to be filed by Ignyte with the Securities and Exchange Commission (the "SEC").

On October 27, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that updated findings from the Phase II SUMMIT basket trial of neratinib for EGFR exon 18-mutant non-small cell lung cancer (NSCLC) patients at the EORTC/NCI/AACR Molecular Targets and Cancer Therapeutics Symposium that is taking place in Barcelona, Spain (Press release, Puma Biotechnology, OCT 27, 2022, View Source [SID1234622520]). The poster, entitled, "Neratinib efficacy in patients with EGFR exon 18-mutant non-small cell lung cancer: findings from the SUMMIT basket trial," was presented by Alejandro Martínez Bueno, Head of Medical Oncology Service, Hospital Quirón Deuxes, Barcelona, Spain, on October 27 beginning at 10:00 a.m. CEST.

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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multi-national study evaluating the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, EGFR exon 18 or HER2 mutations. In the EGFR exon 18-mutant cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR tyrosine kinase inhibitor (TKI) naïve or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib monotherapy once daily. Anti-diarrheal prophylaxis with loperamide was required for the first 2 cycles.

This cohort of 29 patients had received 1-6 prior lines of therapy in the metastatic setting before entering the trial. Twenty-three patients (79%) had been previously treated with an EGFR-targeted TKI (e.g., afatinib, osimertinib).

The interim efficacy results showed that the objective response rate (ORR) was 35% overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs. Response or stable disease lasting for ≥ 48 weeks was observed in 7 patients (6 PR, 1 SD). Final data will be presented at a later date.

The safety profile observed in the cohort of patients with EGFR exon 18-mutant NSCLC showed that for the 31 patients who received at least one dose of neratinib, diarrhea, constipation, and nausea were the most commonly reported adverse events. There were no reports of grade 4 diarrhea, 3 patients (10%) reported grade 3 diarrhea, and 1 patient (3%) permanently discontinued neratinib due to diarrhea.

Dr. Martínez, an investigator of the study from Hospital Quirón Deuxes, said, "We are very excited about these interim study results in patients with EGFR exon 18-mutant lung cancer, for whom treatment options are limited. This study shows that neratinib has the potential to be an efficacious and safe option to treat their disease, even following treatment with other TKIs and chemotherapy."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased to observe that treatment with neratinib led to meaningful responses in patients with EGFR exon 18-mutated NSCLC. Improving the lives of our cancer patients is our foremost goal, and we are pleased to see the benefit that was provided to these patients in the SUMMIT trial."

On October 27, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the first half of fiscal year 2022 (period ended September 30, 2022), upgrading reported and core forecasts and free cash flow outlook for the fiscal year and reconfirming Management Guidance for core growth at constant exchange rate (CER) (Press release, Takeda, OCT 27, 2022, View Source [SID1234622519]).

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Takeda chief executive officer, Christophe Weber, commented:

"We succeeded in several major milestones in the first half of our fiscal year, including the first approval for Takeda’s dengue vaccine, QDENGA, in Indonesia and more recently the CHMP positive opinion for Europe and dengue-endemic countries. These milestones, together with our financial results, continue to demonstrate our ability to advance our robust pipeline and deliver new solutions for people and patients around the world."

Takeda chief financial officer, Costa Saroukos, commented:

"Our first half results are driven by strong momentum from our Growth and Launch Products, which grew at 19% year-on-year at constant exchange rate, and continued success in commercial execution, including new launches, contributing to core profit growth. Our core revenue and core operating profit grew 5.5% and 14.5% at constant exchange rate, respectively, enabling us to reconfirm our Management Guidance for FY2022.

"We have remained resilient amid rising inflation globally as a result of careful, long-term planning and strong execution and we continue to deleverage rapidly, finishing the first half with net debt to adjusted EBITDA at 2.6x, with 98% of our debt at fixed interest rates with a weighted average of 2%.

"We are upgrading our peak sales estimate for our biggest selling product, ENTYVIO, based on potential for further biologic market growth and share expansion, and our updated assumption for biosimilar entry timing. We are also raising our reported and core forecasts and free cash flow outlook for the full year, primarily reflecting favorable foreign exchange rates.

"We look forward to building on our first half business momentum throughout FY2022."

FINANCIAL HIGHLIGHTS

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.
(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, non-recurring items, purchase accounting effects and transaction related costs, as well as amortization and impairment of intangible assets and other operating income and expenses.
(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

Growth in our key business areas in the first half of FY2022 was driven largely by Growth & Launch Products1, which delivered revenue of 759.8 billion yen, marking a 19% increase on a CER basis.

Gastroenterology (GI), with 546.4 billion yen in reported revenue, grew +12% on a CER basis driven by 17% global sales growth for ENTYVIO on a CER basis in the first half. Due to this strong performance and other factors, we are raising the peak sales outlook range for ENTYVIO to $7.5-9.0 billion, from a previous estimate of $5.5-6.5 billion.
Rare Diseases, with 362.2 billion yen in reported revenue, grew +8% on a CER basis driven by strong sales of hereditary angioedema treatment TAKHZYRO, which grew 31% year-over-year on a CER basis due to the expansion of the prophylactic market, continued geographic expansion and strong patient uptake. LIVTENCITY, which launched in the U.S. in December 2021, continues to generate high interest and strong uptake with 75% of U.S. transplant centers having initiated therapy with at least one patient.
Plasma-Derived Therapies (PDT) Immunology, with 314.0 billion yen in reported revenue, delivered strong growth of +14% on a CER basis driven by strong demand for Immunoglobulin (+17% growth at CER), particularly in the U.S. amid increasing supply, as well as solid growth for Albumin (+8% at CER) tempered by the impact of lockdowns in China. The PDT business continues to innovate and deliver for patients with life-threatening conditions.
Oncology, with 225.3 billion yen in reported revenue, declined -12% on a CER basis as a result of expected entry of multiple VELCADE generic entrants that began in the U.S. in May 2022. Besides VELCADE, all other revenue totaled 204.5 billion JPY, a year-over-year increase of 6% at CER, led by strong demand for ALUNBRIG in Japan, Europe and Growth & Emerging Markets, and ADCETRIS, which continues to gain from increased access and uptake in frontline indications, and ICLUSIG in the U.S.
Neuroscience, with 302.3 billion yen in reported revenue, grew +11% on a CER basis, driven by an expanding ADHD adult market in the U.S. for VYVANSE/ELVANSE. Sales of TRINTELLIX were 49.8 billion yen (+5% growth at CER), due to continued recovery of the Major Depressive Disorder (MDD) market in the U.S. and strong market share gains in Japan.
PIPELINE UPDATE

Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on momentum within its innovative pipeline. Updates since the FY2022 Q1 announcement include:

TAK-003, Takeda’s dengue vaccine candidate, was recommended for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in individuals four years of age and older in the European Union (EU) and dengue-endemic countries. This was the CHMP’s first-ever parallel assessment of a medicinal product for use in the EU and non-EU dengue-endemic countries participating in the EU-M4all procedure. Marketing authorization in Europe is expected in the coming months and regulatory reviews are in progress in dengue-endemic countries in Latin America and Asia.
Additional information related to this announcement is available here.
The Indonesia National Agency for Drug and Food Control approved QDENGA for use in individuals six to 45 years of age regardless of prior dengue exposure. This approval is the first for Takeda’s dengue vaccine candidate and marks the company’s first marketed vaccine outside of Japan. The decision was based on the ongoing Phase 3 TIDES trial that enrolled more than 20,000 children and adolescents living in dengue-endemic countries across Asia and Latin America.
Additional information related to this announcement is available here.
Takeda entered a collaboration and licensing agreement to develop a potential first-in-class therapy for the treatment of celiac disease. TAK-227 is designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease. There are currently no approved therapies for the treatment of celiac disease and Takeda now has three celiac disease programs in Phase 2 development.
Additional information related to this announcement is available here.
The U.S. FDA accepted Takeda’s supplemental biologics license application for TAKHZYRO to prevent hereditary angioedema (HAE) attacks in children from age 2 to <12. If approved, this would be the first and only prophylaxis treatment for HAE patients younger than six years of age.
Additional information related to this announcement is available here.
The EMA’s CHMP recommended the approval of maribavir for adults with post-transplant cytomegalovirus (CMV) refractory (with or without resistance) to prior therapies. If approved, maribavir would be the first and only inhibitor of CMV-specific UL97 protein kinase in the EU for this patient population.
Additional information related to this announcement is available here.
In October, Takeda submitted a new drug application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for its immune globulin subcutaneous (human) 20% solution for use in patients with primary immunodeficiency (PI) or secondary immunodeficiency (SID). Approved as CUVITRU in more than 30 countries, approval in Japan would offer a new treatment option to patients with agammaglobulinemia or hypogammaglobulinemia.
FY2022 OUTLOOK

Upgrading Full-Year FY2022 Reported and Core Forecasts and Free Cash Flow Outlook, and Reconfirming Management Guidance

Based on Takeda’s first half results, and primarily reflecting expected favorable foreign exchange rates during the remaining second half of FY2022, Takeda’s reported and core forecasts and free cash flow outlook have been revised from the original forecast.

For more details on Takeda’s first half FY2022 results and other financial information including key assumptions in FY2022 forecast and management guidance, please visit: View Source

On October 27, 2022 Prestige Biopharma group comprised of Prestige Biopharma Limited (950210: KRX) and Prestige Biologics Co., Ltd. (334970: KOSDAQ) reported that it will be appearing at CPhI Frankfurt 2022 on 1-3 November at Messe Frankfurt, Germany (Press release, Prestige BioPharma, OCT 27, 2022, View Source [SID1234622518]).

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The Prestige group will showcase its latest antibody drug pipeline and innovative CDMO service at a large-scale independent booth, which will be located in BioProduction Zone, #91G10. At the booth, clients and visitors are invited to take part in the experience zones and a transparent OLED display will be exhibited to highlight the EU-GMP certified facility and 154,000 liters of global-scale production capacity of Prestige Biologics in South Korea.

"We are excited to provide an inside look into Prestige Biopharma group at CPhI 2022 and are looking forward to having meaningful partner discussions. We will be introducing our capabilities for development and manufacturing of antibody and vaccine therapeutics, to support our partners to bring life-saving medicines to the patient," said Dr. Michael Ruppert, head of global business development of Prestige Biopharma.

At CPhI Frankfurt 2022, Prestige Biopharma introduces its first-in-class mAb, PBP1510 (INN: ulenistamab) anti-PAUF for pancreatic cancer that recently obtained FDA approval for Phase 1/2a IND and orphan designation from FDA, EMA and Korea MFDS. The company’s rich portfolio of biosimilars in various stages including HD201 trastuzumab under marketing authorization review, HD204 bevacizumab in Phase 3 and PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. Prestige’s business also includes alliance vaccine development and production, starting with the partnered commercial production of COVID-19 vaccines.

Together with Prestige Biologics, the Prestige group has full value chain technological capability, from discovery and development to manufacturing. Prestige Biologics is a leading Korean biopharmaceutical CDMO with 154,000 liters of top-notch production facility that provides efficient and high-quality complete solutions to development and manufacturing requirements throughout drug development continuum from the early-stage concept of clinical biopharmaceuticals through to full, global commercialization of products. Prestige Biologics also provides a customized engineering solution called ‘CDEMO’ service and it includes process optimization engineering, productivity enhancement engineering and cost reduction engineering.

Prestige Biopharma group will continue to pursue ‘innovation for life’ in every area which is the group’s business purpose, while ensuring corporate DNA, innovation, efficiency and agility, to ultimately create a difference for humanity.

The Prestige group looks forward to the on-site collaboration with biopharmaceutical partners at CPhI Frankfurt 2022. For more information, please visit www.prestigebio.com.