On January 31, 2024 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the third quarter of fiscal year 2023 (period ended December 31, 2023) (Press release, Takeda, JAN 31, 2024, View Source [SID1234639760]). With year-to-date strong momentum in its Growth & Launch Products (+12.7% at CER) offsetting the significant revenue impact of generic entrants, Takeda remains on track towards its full-year Management Guidance.

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Takeda chief financial officer, Costa Saroukos, commented:
"In FY2023 Q3 we made further progress in our vision to discover and deliver life-transforming treatments, receiving two new U.S. FDA approvals and broadening the reach of our existing portfolio with multiple life-cycle management approvals for our Growth & Launch Products.

"We remain on track towards our full-year Management Guidance at CER, reflecting significant generic impact, lower coronavirus vaccines revenue and investment in R&D and data, digital and technology to secure our long-term competitiveness, as well as continued strong momentum in our Growth & Launch Products.

"We continue to improve our debt profile with 100% of our debt now at fixed interest rates averaging 1.6%, and our financial foundation remains strong as we enter the fourth quarter of FY2023."

FINANCIAL HIGHLIGHTS

Results for FY2023 Q3 YTD Ended December 31, 2023

(Billion yen,
except
percentages and
per share
amounts)

REPORTED

CORE(c)

(Non-IFRS)(a)

FY2023 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

FY2023 Q3 YTD

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change(d))

Revenue

3,212.9

+4.6%

3,212.9

+4.6%

+0.0%

Operating Profit

224.1

-44.2%

865.6

-9.3%

-12.7%

Margin

7.0%

-6.1pp

26.9%

-4.1pp

Net Profit

147.1

-48.6%

643.6

-9.0%

-12.2%

EPS (yen)

94

-48.9%

412

-9.7%

-12.9%

Operating Cash Flow

437.8

-36.0%

Free Cash Flow
(Non-IFRS)(a)(b)

36.3

-93.8%

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source." target="_blank" title="View Source." rel="nofollow">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.

FY2023 OUTLOOK

On track towards full-year FY2023 Management Guidance

(Billion yen except per share amounts)

FY2023

FORECAST
(Unchanged from

October 2023)

FY2023

MANAGEMENT GUIDANCE

Core Change at CER (Non-IFRS)
(Unchanged from May 2023)

Revenue

3,980.0

Core Revenue

3,980.0

Low-single-digit % decline

Reported Operating Profit

225.0

Core Operating Profit

1,015.0

Low-10s % decline

Reported Net Profit

93.0

Reported EPS (yen)

59

Core EPS (yen)

447

Low-20s % decline

Free Cash Flow*

400.0-500.0

Annual Dividend per Share (yen)

188

*Free Cash Flow forecast reflects expenditures related to the acquisition of TAK-279 from Nimbus and in-licensing of FRUZAQLA (fruquintinib) from HUTCHMED.

Additional Information About Takeda’s FY2023 Q3 Earnings Results
For more details on Takeda’s FY2023 Q3 results and other financial information, including key assumptions in FY2023 forecast and management guidance, please visit: View Source

For more information on Takeda’s commercial progress across the five key business areas and pipeline updates, please visit: View Source

On January 31, 2024 Anbogen Therapeutics, a clinical-stage biotechnology company specializing in groundbreaking cancer drug development, reported the successful completion of its Series A funding round (Press release, Anbogen Therapeutics, JAN 31, 2024, View Source [SID1234639759]). The lead investor is China Development Industrial Bank (CDIB), with significant contributions from Taian Venture Capital, Maxpro and the National Development Fund (Business Angel Investment Program, and Implementation Project for Strengthening Investment in SMEs), with a total investment of approximately 12.5 million. The raised capital will be directed towards the ongoing development of Anbogen’s two main drug candidates, ABT-101 and ABT-301. It is worth mentioning that both of these candidate drugs were supported by the National Research Program for Biopharmaceuticals (NRPB) before Anbogen took over. With the continued endeavor from Anbogen, these candidate drugs are steadily advancing in clinical trials for evaluation of their efficacy.

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ABT-101, a HER2-targeting tyrosine kinase inhibitor (TKI), has exhibited substantial potency and safety during its pre-clinical and phase 1b clinical trial. During the pre-clinical study, ABT-101 demonstrated superior selectivity against HER2 exon20 insertion mutation. In the Phase 1b trial, Dr. Tsu-An Hsu, CEO of Anbogen, stated, "Signs of safety and clinical benefits have been observed in non-small cell lung cancer patients, including sustained tumor suppression in patients who previously developed resistance to Enhertu treatment." ABT-101 has completed the DLT evaluation of 3 dosage groups (100 mg, 150 mg, and 200 mg), and is now advancing to the 250 mg cohort in the phase 1b trial to continue evaluation of safety, tolerability, pharmacokinetics and efficacy. Phase 2 is scheduled to commence upon the completion of phase 1 trial in 2024.

Joe Hsueh, Anbogen’s General Manager, stated, "With bioventure investors support, we aim to expedite ABT-101 development and broaden its use across various solid tumor types (including colorectal, biliary tract, breast, urothelial, and other gastrointestinal cancers) through our basket trial. Furthermore, the integration of Next-Generation Sequencing (NGS) will facilitate our efforts in developing precision medicine for cancers with unmet clinical need, making a substantial contribution to the advancement of the field."

Additionally, Anbogen is actively progressing ABT-301, a novel small molecule drug that potentiates efficacy of immune checkpoint inhibitors (ICIs). Having completed its phase 1 trial, ABT-301 exhibited superior safety and pharmacokinetic profiles compared to other marketed drugs with similar mechanism of action. Repeated animal studies reveal a surprising synergistic effect when ABT-301 is used in combination with immune ICIs (anti-PD1/anti-PD-L1) in animal models including colorectal cancer of microsatellite stable (MSS). ABT-301 can modulate the tumor microenvironment, increase the number of killer T cells in peripheral blood and infiltrating the tumor, enabling ICIs to overcome the limitations of "cold" tumors and produce immunotherapeutic effects. Additionally, remarkable efficacy of such combination was observed in head and neck cancer, triple-negative breast cancer (TNBC) and liver cancer animal models. Based on these results, Anbogen has initiated preparations for the Phase 2 clinical trial of ABT-301, combining it with ICIs for the treatment of cancer patients.

Furthermore, leveraging years of experience in developing small molecule cancer drugs, Anbogen’s R&D team independently developed the ABT-200 series of small molecule inhibitors targeting pan-KRAS gene mutations. The ABT-200 series is an exciting development in the field of cancer treatment, showing promising advancements in its early stages. This series holds tremendous potential for addressing cancers that currently lack approved KRAS-targeted drugs, including pancreatic cancer and colorectal cancer.

The Series A funding not only reflects the value of Anbogen’s innovative pipeline, but also underscores the company’s commitment to advancing cancer treatment to fulfill the unmet medical needs.

On January 31, 2024 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that the first patient has been dosed with the study drugs in a Phase II clinical trial investigating RVU120 in combination with venetoclax for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) – the RIVER-81 study (NCT06191263) (Press release, Ryvu Therapeutics, JAN 31, 2024, View Source [SID1234639758]).

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The primary goal of the RIVER-81 study will be to evaluate safety and efficacy of RVU120 in combination with venetoclax in r/r AML patients who have failed prior venetoclax treatment.
The RIVER-81 study is initially launching at clinical sites in Poland and Italy. Ultimately, the study will expand to other EU and non-EU countries, covering up to 50 clinical sites globally. The planned overall enrollment for the study is up to approx. 98 patients.
The study is part of the RVU120 Development Plan presented in October 2023 and aligns with the company’s cash runway to Q1 2026. Execution of the RIVER-81 study is supported with a PLN 62.3 mln grant from the Polish Medical Research Agency (ABM).
In H1 2024, Ryvu plans to launch four Phase II RVU120 clinical studies and enroll over 100 patients across the studies by the end of the year. Ryvu aims to prioritize further development options in Q1 2025 based on the study outcomes. Clinical trials conducted in various hematological indications and treatment regimens (monotherapy and combination therapy) will contribute to the global RVU120 safety database, which would support potential future regulatory approvals.
RVU120 is a selective, first-in-class dual CDK8/19 kinase inhibitor developed by Ryvu Therapeutics. RVU120 monotherapy has demonstrated positive clinical activity in a Phase Ib study, where 50% of evaluable patients with r/r AML or HR-MDS achieved clinical benefit, including a complete response, a morphologic leukemia-free state, multiple clinically significant blast reductions, hematologic improvements, and reduction of bone marrow fibrosis.

Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said:

– Considering the encouraging results from the Phase Ib study of RVU120 as monotherapy for patients with r/r AML and HR-MDS, along with compelling translational evidence of synergistic activity with venetoclax, we have launched the Phase II RIVER-81 study with optimism. AML patients who fail the current standard of care, consisting of venetoclax and a hypomethylating agent, have very few alternative treatment options and a poor prognosis. We are delighted to commence the new Phase II RVU120 study in Poland and Italy, with plans to expand to up to 50 clinical sites globally. Our goal is to bring meaningful clinical benefits to AML patients.

Kamil Sitarz, Ph.D., Chief Operating Officer of Ryvu Therapeutics, said:

– We have successfully confirmed the safety profile of RVU120, and our focus is now on substantiating its efficacy signals. With the activation of dozens of clinical sites globally, we aim to dose over 100 patients across four RVU120 Phase II studies by the end of 2024. Subsequently, and based on treatment outcomes, we will strategically prioritize further development paths. This progress aligns with the RVU120 development plan unveiled in October 2023, supported by secured financing until Q1 2026.

RIVER-81 is a multicenter, open-label clinical trial that aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with AML who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent.

The study is divided into two parts. Part 1 aims to identify safe and tolerated doses of RVU120 and venetoclax when used in combination, through dose escalation of both study drugs. In Part 2, the selected doses will be evaluated for both safety and efficacy in a larger group of patients.

The study has received approval from the Competent Authorities in Poland and Italy following a clinical trial application in accordance with the European Union Clinical Trial Regulation (EU-CTR) 536/2014, as well as positive opinions from the respective Ethics Committees, enabling patient enrollment in both countries. Start-up activities in other EU and non-EU countries are currently in progress.

RIVER-81 marks the commencement of the first of four planned RVU120 Phase II clinical studies, scheduled to launch in H1 2024. Following RIVER-81, Ryvu intends to initiate the RIVER-52 study (evaluating RVU120 as a monotherapy in patients with genetically defined subtypes of AML and in patients with HR-MDS). Upcoming plans also include the initiation of the REMARK study (conducted as an investigator-initiated trial, exploring RVU120 as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes; LR-MDS) and the POTAMI-61 study (evaluating both monotherapy and combination therapy for the treatment of patients with myelofibrosis; MF).

On January 31, 2024 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the following investor conferences (Press release, Merus, JAN 31, 2024, View Source [SID1234639757]):

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Guggenheim 6th Annual Biotechnology Conference: Wednesday, February 7, 2024 at 2:30 p.m. ET
Citi’s 2024 Oncology Leadership Summit: Thursday, February 22, 2024 at 9:00 a.m. ET

The webcasts of the presentations will be contemporaneously available on the Investors page of the Company’s website. Archived presentations will also be available there for a limited time after the event.

On January 31, 2024 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported that new preclinical data demonstrating the potential of INTASYL self-delivering siRNA targeting Cbl-b improves natural killer (NK) cell activity for adoptive cell therapy and may result in a more effective cell therapy for hematological malignancies will be presented at the 10th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC10), which will be held in Munich, Germany from March 21-23, 2024 (Press release, Phio Pharmaceuticals, JAN 31, 2024, View Source [SID1234639756]).

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Presentation Details are as follows:

Title: Enhancing NK cell cytotoxicity against tumor cells with a novel self-delivering RNAi compound targeting Cbl-b
Poster Number: P01.03
Topic: 01.Emerging concepts / New Agents
Presenting Author: Melissa Maxwell
Date and Time: 18:00 hrs Thursday, March 21, 2024
18:00-19:00 hrs Friday, March 22, 2024
Location: Ludwig Maximilian University Campus Großhadern,
Lecture Room 3, Marchioninistrasse 15
81377 Munich, Germany
The poster presentation will be accessible in person and will also be available on March 21st, on Phio’s website.