On November 4, 2022 Kyowa Hakko Kirin reported of Consolidated Financial Results Fiscal 2022 Third Quarter (Press release, Kyowa Hakko Kirin, NOV 4, 2022, View Source [SID1234623159])

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1. Consolidated Financial Results for the Nine Months Ended September 30, 2022

(1) Consolidated operating results

2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022)

* Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.

* Notice regarding the appropriate use of the earnings forecasts and other special comments The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.

1. Operating Results and Financial Statements

(1) Summary of Consolidated Financial Position Assets as of September 30, 2022, were ¥940.4 billion, an increase of ¥18.5 billion compared to the end of the previous fiscal year.

 Non-current assets increased by ¥14.3 billion compared to the end of the previous fiscal year, to ¥418.0 billion, due mainly to increases in deferred tax assets and property, plant and equipment.  Current assets increased by ¥4.1 billion compared to the end of the previous fiscal year, to ¥522.4 billion, due mainly to an increase in inventories.  Liabilities as of September 30, 2022, were ¥177.5 billion, a decrease of ¥7.2 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and contract liabilities.

 Equity as of September 30, 2022, was ¥762.8 billion, an increase of ¥25.7 billion compared to the end of the previous fiscal year, due mainly to the recording of profit attributable to owners of parent, despite a decrease due to the payment of dividends, etc. As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the third quarter was 81.1%, an increase of 1.1 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance

1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amount. For the nine months ended September 30, 2022 (January 1, 2022 to September 30, 2022), revenue was ¥283.8 billion (up 11.7% compared to the same period of the previous fiscal year), and core operating profit was ¥60.9 billion (up 30.0%). Profit attributable to owners of parent was ¥49.2 billion (up 49.5%).

 The increase in revenue was the result of growth of global strategic products in North America and EMEA and a rise in revenue from technology out-licensing, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥18.7 billion.  Core operating profit rose, despite increases in selling, general and administrative expenses and research and development expenses, due to higher gross profit resulting from an increase in overseas revenue and a rise in revenue from technology out-licensing. The positive effect on core operating profit from foreign exchange was ¥6.7 billion.

 Profit attributable to owners of parent increased as a result of an increase in finance income in addition to an increase in core operating profit, despite an increase in income taxes.

1. Revenue by regional control function is classified based on consolidated revenue from products of regional control functions in the One Kyowa Kirin structure (a global management structure with axes combining four regions – Japan, North America, EMEA, and Asia/Oceania – and the functions needed by a global specialty pharmaceutical company).

2. EMEA consists of Europe, the Middle East, Africa, etc.

3. Others consists of revenue from technology out-licensing, original equipment manufacturing, etc. Revenue in North America increased year on year due to the growth of global strategic products.  Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been growing since its launch in 2018.  Revenue from POTELIGEO, an anticancer agent, has been growing.  Revenue from NOURIANZ (product name in Japan: NOURIAST), an antiparkinsonian agent, has been growing since its launch in October 2019.  Revenue in EMEA increased year on year due to the growth of global strategic products.

 Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been growing as the number of countries where it has been released has been increasing since its launch in 2018. Approval for the extended indication for tumor induced osteomalacia (TIO) was acquired from the European Commission (EC) in August 2022, and sales were launched in Germany and other countries.  Revenue from POTELIGEO, an anticancer agent, has been growing as the number of countries where it has been released has been increasing since its launch in June 2020.  Revenue from Abstral, a treatment for cancer pain, decreased due to the impact of the market penetration of generics.  Revenue in Asia/Oceania increased year on year.

 Revenue from REGPARA, a treatment for secondary hyperparathyroidism, declined after it became subject to China’s centralized governmental purchasing system* in October 2021. * Volume-Based Procurement (VBP) program that was introduced in 2018 for reducing healthcare cost in China. Even though only 2 to 5 companies are selected as suppliers through a tender, drug prices dramatically dropped down.  Revenue from Gran, a neutropenia treatment drug, has been growing particularly in South Korea. < Revenue from Others >

 Revenue from Others increased year on year.  Technology out-licensing increased due to the recognition of revenue of upfront payment of USD400 million over a certain period in conjunction with the conclusion of an agreement in 2021 with Amgen Inc. to jointly develop and commercialize KHK4083, anti-OX40 fully human monoclonal antibody for the treatment of atopic dermatitis, in addition to an increase in royalties revenue from AstraZeneca in relation to benralizumab.

Core operating profit increased compared to the same period of the previous fiscal year due mainly to an increase in gross profit due to increases in revenue from U.S. and Europe, mainly from global strategic products, and in revenue from technology out-licensing, despite increases in research and development expenses mainly regarding progress in development of next-generation strategic products, in addition to increases in selling, general and administrative expenses related to investments in human resources and in IT/digital platform aimed at maximizing the value of global strategic products and rapidly establishing competitive global business bases. The positive effect on core operating profit from foreign exchange was ¥6.7 billion

On November 4, 2022 NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, reported it will present first data from the combination of its main asset, NT-I7 (efineptakin alfa), with the chimeric antigen receptor T-cell (CAR-T) tisagenlecleucel, at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held in New Orleans, Louisiana, December 10-13, 2022 (Press release, NeoImmuneTech, NOV 4, 2022, View Source [SID1234623144]).

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The NIT-112 phase 1b study is the first and only clinical trial that aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of a long-acting human IL-7, NT-I7 (efineptakin alfa), after treatment with tisagenlecleucel (Kymriah) in patients with relapsed/refractory large B-cell Lymphoma (r/r LBCL).

Tisagenlecleucel (Kymriah), a CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, has become standard of care for patients with r/r LBCL. The successful expansion and persistence of CAR-T cells strongly predicts response to this therapy. The scientific hypothesis is that the combination may increase expansion and persistence of CAR-T, increasing tumor response rate and improving clinical outcomes without safety concerns.

As of 30 May, 2022, only the first three dose escalation groups out of seven dose levels (DL1-7: 60, 120, 240, 360, 480, 600, and 720 μg/kg of NT-I7) had completed recruitment. No serious adverse events were observed. All patients experienced treatment-emergent adverse events, most of which were mild. Despite the limited number of patients currently enrolled in the lowest NT-I7 dose levels (DL1-3), and CAR-T levels being near the limit of assay detection, a single dose of NT-I7 at the CAR-T contraction phase (day 21) was able to increase both the absolute lymphocyte count (ALC) and the CAR-T absolute numbers.

Dr Se Hwan Yang, Ph.D., President and Chief Executive Officer of NeoImmuneTech, Inc. said: "The early results of the Phase 1b study NIT-112 are promising and may have strong clinical implications. We feel encouraged to further investigate NT-I7 in combination with tisagenlecleucel as a potential efficacious addition to CAR-T standard of care in relapsed/refractory large B-cell lymphoma".

About NT-I7 (efineptakin alfa) (rhIL-7-hyFc)
NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7 and is being developed in oncologic and immunologic indications, where T cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On November 4, 2022 Flatiron Health reported their attendance and presence at the ISPOR, The Professional Society for Health Economics and Outcomes Research Europe 2022 Conference, held in Vienna, Austria this year (Press release, Flatiron Health, NOV 4, 2022, View Source [SID1234623143]). A total of 7 presentations will be presented by Flatiron, including one oral podium presentation and one in-person poster being recognized as top 5% finalists for 2022 Research Presentation Awards. Research presented at this year’s ISPOR Europe represents an important milestone in Flatiron Health’s growth and leadership within real-world evidence and clinical research, as learnings from the experiences of every person with cancer in the US begin to inform and improve the lives of people living with cancer in many other parts of the world.

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"The quality of our research being presented at this year’s ISPOR Europe demonstrates our commitment to use data for good," said Javier Jimenez, Flatiron Chief Medical Officer. "Flatiron is dedicated to thoughtful and rigorous generation of EHR-derived real-world evidence, and innovating machine learning technologies to learn from every person with cancer."

Highlights include:

an oral podium presentation using machine learning to accelerate outcomes research, replicating and comparing results to health outcomes studies using a traditional abstraction approach.
a poster on real-world radiology imaging data with an assessment of the representativeness of scan-derived cohorts relative to a broader population of patients living with advanced non-small cell lung cancer and DLBCL.
a poster presentation replicating comparative-effectiveness findings with machine learning extracted variables as an alternative to expert-abstracted data in patients with metastatic non-small cell lung cancer.
a workshop featuring Flatiron Health researcher, Corey Benedum, discussing the use of real-world data at scale, specifically focusing on how machine learning extraction of information from unstructured documents can enable learnings from all patients.

On November 4, 2022 Peak Bio, Inc. ("Peak Bio" or the "Company") (NASDAQ: PKBO), a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory diseases, reported that it has entered into a Common Stock Purchase Agreement (the "Agreement") with White Lion Capital, LLC ("White Lion Capital") (Press release, Peak Bio, NOV 4, 2022, View Source [SID1234623142]). The Agreement governs a committed equity facility that provides the Company with the right, without the obligation, to sell White Lion Capital up to $100 million of its common stock over a 36-month period, subject to certain limitations and conditions. The Company intends to use the net proceeds from the transaction for working capital to support its clinical and preclinical programs.

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Stephen LaMond, PharmD, MBA, Peak Bio, Inc. COO, commented, "We are pleased to announce the closing of the Agreement with White Lion Capital as it demonstrates the strong vote of confidence we are receiving from investors. This equity line will help bolster our investments in our programs and allow for opportunistic portfolio expansion. "

On November 4, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the following presentations will be presented at the 64th ASH (Free ASH Whitepaper) (American Society Hematology) Annual Meeting taking place from December 10-13, 2022, in New Orleans, Louisiana (Press release, Innate Pharma, NOV 4, 2022, View Source [SID1234623141]).

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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

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Lacutamab in patients with advanced Sezary syndrome: results from an interim analysis of the TELLOMAK phase 2 trial
Abstract Number: 1631
Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I
Session Date and Time: Saturday, December 10, 2022, 5:30 PM – 7:30 PM
Location: Ernest N. Morial Convention Center, Hall D
Presenter: Dr Pierluigi Porcu, Director, Division of Medical Oncology and Hematopoietic Stem Cell Transplantation, Thomas Jefferson University Hospitals, Philadelphia
Scientific Symposia: Antibody-Based NK Cell Engager Therapeutics
Session Title: Biology and Translation of NK Cells
Session date and Time: Saturday December 10th, 2022, 2:00 PM – 3:15 PM
Location: Ernest N. Morial Convention Center, 293-294
Presenter: Eric Vivier, DVM, PhD, Chief Scientific Officer of Innate Pharma
An open-label, first-in-human, dose-escalation study of SAR443579 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high-risk myelodysplasia (HR-MDS) (Sanofi)
Abstract Number: 3329
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster II
Session Date and Time: Sunday, December 11, 2022, 6:00 PM – 8:00 PM
Location: Ernest N. Morial Convention Center, Hall D
Presenter: Anthony Stein, MD
The Novel Trifunctional Anti-BCMA NK Cell Engager SAR’514 Has Potent in-Vitro and in-Vivo Anti-Myeloma Effect through Dual NK Cell Engagement (Sanofi)
Abstract Number: 4486
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Poster III
Session Date and Time: Monday, December 12, 2022, 6:00 PM – 8:00 PM
Location: Ernest N. Morial Convention Center, Hall D
Presenter: Alexandre Tang, Ph.D
The posters and presentation will be available on the Publications section of innate-pharma.com following the meeting.

About Lacutamab:

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes has a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors (NKp46 and CD16), a tumor antigen and an interleukin-2 receptor (via an IL-2 variant, IL-2v) via a single molecule.