Isofol Medical AB (publ) publishes interim report, January–September 2023

On November 9, 2023 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–September 2023 is now available, in Swedish, on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, NOV 10, 2023, View Source [SID1234637439]).

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The information in the press release is intended for investors.

Third quarter, July – September 2023

Net revenue amounted to TSEK 0 (2,907) and other revenue to TSEK 0 (0)
The result for the period amounted to TSEK -6,260 (-32,513)
Earnings per share amounted to SEK -0.04 (-0.20)
Cash and cash equivalents as of September 30 amounted to TSEK 144,226 (234,983)

January – September 2023
Net revenue amounted to TSEK 721 (10,940) and other revenue to TSEK 23 (1)
The result for the period amounted to TSEK -28,162 (-134,420)
Earnings per share amounted to SEK -0.17 (-0.38)

Significant events during the third quarter 2023

On July 4, presented the conclusions from the in-depth analysis of data from the Phase III study AGENT. The results from the analysis support the hypothesis that a different dose and administration regimen has the potential to improve the efficacy of the company’s drug candidate arfolitixorin.
Significant events after the event of the period

On October 5, the company announced that the company has taken notice of the results from the investigator-initiated study Modelle 001. Isofol will quality review the material when a study report is available.
On November 9, the company obtained a request to call an extraordinary general meeting from shareholders representing a minority of at least 10 percent in order to take a decision on the election of additional board members. The notice to the extraordinary general meeting will be announced as soon as is practically possible.

CEO´s comment:

"In addition to our ongoing collaboration with a Norwegian laboratory, we recently engaged a US-based company in order to generate more data to gain a strong basis for decisions on a potential minor clinical study in a time-efficient way. During the fourth quarter, we have planned a first meeting with the Swedish Medical Products Agency to discuss the conditions for such a clinical study. At the same time, I would like to emphasize that no decision on continued clinical development of arfolitixorin has yet been made", says acting CEO Roger Tell.

TheraPPI Bioscience announces an exclusive license agreement with PULSALYS to develop novel drugs in oncology and rare diseases

On November 9, 2023 TheraPPI Bioscience SAS, a preclinical biotechnology company developing small molecules that modify protein interactions in oncology, rare diseases and inflammation, reported the company and PULSALYS SAS ("PULSALYS"), Deeptech innovations incubator and accelerator in Lyon and Saint-Etienne, entered into a license agreement for the development of drugs targeting a novel protein interaction in the Ras-MAPK pathway (Press release, TheraPPI, NOV 9, 2023, View Source [SID1234657178]).

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Under the license agreement, TheraPPI obtains exclusive and global rights for the development of novel drugs from compounds discovered within Dr Toufic Renno’s team at the Lyon Cancer Research Centre (CRCL: University Claude Bernard Lyon 1, Inserm, Centre Léon Bérard and CNRS) in collaboration with the C3D technology platform of Lyon (Centre for Drug Discovery and Development) and with the support of Hospices Civils de Lyon. The Renno team has discovered a new therapeutic target, a protein-protein interaction (PPI) in the Ras-MAPK pathway, which is critical to cancer development and certain rare diseases. TheraPPI will develop two drug programs targeting this Ras-MAPK protein interaction in oncology and in rare diseases.

"PULSALYS is proud to support this ambitious project, led by TheraPPI Bioscience, which will enable to meet major healthcare challenges through new solutions developed for patients experiencing therapeutic failure. Furthermore, this project illustrates the cohesion and complementarity of the key players in the local oncology ecosystem, bringing together all stakeholders to boost TheraPPI Bioscience’s development," emphasizes Sophie Jullian, President of PULSALYS. Luc Otten, CEO of TheraPPI added: "The exclusive rights on these novel compounds enable TheraPPI to continue building a portfolio of small molecules that target protein interactions against cancer resistance and provide a cure to rare diseases."

Pursuant to the agreement, PULSALYS is entitled to receive milestone and royalty payments, based on the development of drugs targeting a novel Ras-MAPK protein interaction.

Carcell and OBiO enter into a strategic agreement for lipid nanoparticle services

On November 9, 2023 Carcell Biopharma ("Carcell") and OBiO Technology ("OBiO") reported their collaboration to provide lipid nanoparticle (LNP) services worldwide (Press release, Carcell Biopharma, NOV 9, 2023, View Source [SID1234637815]).

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This collaboration aims to deliver contract research and manufacturing services globally for clients developing LNP-based drugs. These services will utilize Carcell’s proprietary cationic lipids and unique high throughput in vivo lipid screening platform, coupled with OBiO’s advanced capabilities for large-scale manufacturing of LNP-based drugs. Under the terms of the agreement, OBiO will have non-exclusive rights to utilize Carcell’s LNP technology for servicing its clients.

Lanlin Wu, CEO of Carcell, said, "Carcell is thrilled to be collaborating with OBiO to deliver a comprehensive suite of contract research and manufacturing services for clients requiring bespoke LNP solutions. Together, we will harness our combined strengths to drive the development and accessibility of LNP-based therapeutics worldwide."

To learn more, visit OBiO’s WeChat page to view the Chinese press release at: View Source

Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2024

On November 9, 2023 Kureha Corporation reported its Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2024 (From April 1, 2023 to September 30, 2023) (Press release, Kureha Corporation, NOV 9, 2023, View Source [SID1234637728]).

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(1) Overview of Operating Results for the Period under Review
During the first six months of the fiscal year ending March 31, 2024, as the impact of the COVID-19 pandemic wanes, the Japanese and global economies continued to show signs of normalization of socioeconomic activity and are expected to continue their gradual recovery. Nevertheless, the outlook remains uncertain due to concerns over the effects of global monetary tightening, a slowdown of the Chinese economy, and the protracted conflict in Ukraine.

Under these circumstances, the Kureha Group, to fulfill our dual goals of "improving medium- to long-term corporate value" and "contributing toward a sustainable society," and to achieve further growth of the Kureha Group by promoting sustainability-focused management, has newly established the Kureha Group Corporate Philosophy and the Kureha Vision. At the same time, looking toward FY2030, we formulated our Management Policy and the Mid- to Long-term Management Plan "Toward Creating a New Future."

In the first six months of the fiscal year, the Group’s revenue and profits decreased year on year as sales of polyvinylidene fluoride (PVDF), used as a binder material for lithium-ion secondary batteries, declined in the Advanced Materials segment.

Revenue was 88,490 million yen (down 13.0% year on year), operating profit was 9,148 million yen (down 45.3% year on year), profit before income taxes was 9,859 million yen (down 43.3% year on year), net profit was 6,828 million yen (down 44.4% year on year), and profit attributable to owners of the Company was 6,797 million yen (down 44.2% year on year).

Celyad Oncology reports third quarter 2023 financial results and recent business highlights

On November 9, 2023 Celyad Oncology, a biotechnology company focused on innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported its financial results for the third quarter of 2023 and provides an update on recent business developments (Press release, Celyad, NOV 9, 2023, View Source [SID1234637727]).

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"Celyad Oncology team is resolutely dedicated to harnessing our expertise, extensive know-how, and valuable intellectual property portfolio to address the existing challenges within CAR T-cell therapies. We are excited to report compelling data from our short hairpin RNA (shRNA)-based multiplexing platform, underscoring the remarkable versatility and adaptability of this technology. In addition, we are making significant progress with our multispecific CAR program, and we look forward to sharing an update at international conferences in the coming months. These achievements mark our commitment to advancing the frontiers of cellular immunotherapy and bringing innovative solutions to patients in need " commented Georges Rawadi, Chief Executive Officer of the Company

Third quarter 2023 and recent corporate highlights:
On August 24, 2023, the Company announced that it has obtained commitments from Fortress, Tolefi and other longstanding existing shareholders to subscribe to a capital increase of up to €9.8 million in 2 tranches:
-A first tranche of 2.0 million was disbursed in the context of authorized capital as of September 4, 2023; and
-A second tranche to be subscribed by Fortress is subject to the approval by the extraordinary shareholders’ meeting. Following this private placement, the Company believes that its existing cash and cash equivalents should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the second quarter of 2025.

Celyad Oncology has relocated from September 25, 2023 into a new research facility which fits better its current needs after the strategic shift. The Company remains headquartered at the Axis Parc, MontSaint-Guibert, Belgium but with its new business location at Dumont 9.