Reverse merger with Flerie

On May 27, 2024 InDex Pharmaceuticals Holding AB (publ) ("InDex Pharmaceuticals" or the "Company") reported to have entered into a conditional agreement to acquire all shares in Flerie Invest AB (Press release, InDex Pharmaceuticals, MAY 27, 2024, View Source [SID1234643716]). The acquisition is made through an issue in kind of 6,073,952,948 new shares in the Company, following which Flerie Invest AB’s shareholders will initially hold approximately 91.9 per cent of the shares and InDex Pharmaceuticals’ existing shareholders will initially hold approximately 8.1 per cent of the shares in the Company.

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The transaction in brief
InDex Pharmaceuticals has entered into an agreement with the shareholders of Flerie Invest AB ("Flerie") to acquire all shares in Flerie through an issue in kind of 6,073,952,948 new shares in the Company (the "Consideration Shares", and the "Transaction", respectively). Through the Transaction, Flerie will become a wholly-owned subsidiary of InDex Pharmaceuticals and Flerie’s shareholders will initially hold approximately 91.9 per cent of the total number of shares and votes in the Company, prior to the completion of the Capital Raise (as defined below). As a result of the Transaction, the Company will change its name to Flerie AB ("New Flerie").
Flerie is valued at approximately SEK 3,073 million in the Transaction, based on reported net asset value as of 31 March 2024 with a discount of 10 per cent. InDex Pharmaceuticals is valued at approximately SEK 269 million, corresponding to the Company’s estimated cash position after closing costs with a premium of 20 per cent, which entails a subscription price of approximately SEK 0.506 per Consideration Share.
As part of the Transaction and the continued financing of New Flerie, a number of institutional investors, including the Company’s existing shareholders the Fourth Swedish National Pension Fund, HBM Healthcare Investments, Linc AB and SEB Stiftelsen, have undertaken to subscribe for new shares in the Company in a directed share issue (the "Capital Raise"). Through the Capital Raise, the Company will raise in aggregate approximately MSEK 520 before transaction costs.
The Company intends to convene an Extraordinary General Meeting to be held on 10 June 2024, at 8:30 a.m. CEST, to resolve on approval of the Transaction, issue in kind of the Consideration Shares, authorization to issue shares for the Capital Raise, election of new Board members and auditor, and other resolutions that follow from the Transaction (the "Second EGM"). On 6 May 2024 the Company convened an Extraordinary General Meeting to be held on the same day, 10 June 2024 at 8:00 a.m. CEST, to resolve on the amendments to the articles of association that follow from the Transaction (the "First EGM", and together with the Second EGM, the "EGMs").
HBM Healthcare Investments, Linc AB, SEB Stiftelsen and S-E Bankens Utvecklingsstiftelse, who together represent approximately 27.9 per cent of the shares and votes in InDex Pharmaceuticals, have undertaken to vote in favour of the Transaction and related resolutions at the EGMs. Furthermore, the Fourth Swedish National Pension Fund, representing approximately 9.8 per cent of the shares and votes in the Company, has expressed its intention to vote in favour of the Transaction and related resolutions at the EGMs.
The completion of the Transaction is, among other things, conditional upon resolutions at the EGMs and that the Company receives approval for continued listing on Nasdaq First North Growth Market.
Further information about the Transaction, Flerie and New Flerie will be set out in a company description that is expected to be published no later than 27 May 2024.
Background and motive
Following the discontinuation of cobitolimod development and InDex Pharmaceuticals announcing that the Company will not continue the development of any of its other compounds, various options for the Company’s future have been evaluated to maximize shareholder value. This has resulted in the proposed Transaction.

Jenny Sundqvist, CEO of InDex Pharmaceuticals.
"I am very pleased that the evaluation has resulted in the proposed Transaction, as Flerie came out as the best option. Flerie has a highly regarded Board and management with excellent track record​ and a balanced risk profile. The attractive deal terms include a possibility for share redemption, in addition to being able to trade which ensures that we can offer shareholders optionality".

Ted Fjällman, CEO of Flerie and intended CEO of New Flerie.
"This broadening of our shareholder base and becoming listed is a key step in Flerie’s plan to create a new model for life science investing: We continue our long-term, active investment strategy, while offering new shareholders access to and liquidity in difficult-to-assess biotech companies. The Transaction and the Capital Raise allow accelerated development of a risk-diversified portfolio of product development and commercial growth companies spanning obesity, diabetes, heart disease, cancer and autoimmune disorders to pharmaceutical manufacturing services, diagnostics, medical devices and tools".

Estonia Develops Personalized CAR-T Cell Therapy for Blood Cancer Patients

On May 27, 2024 The Tartu University Hospital, North Estonia Medical Centre, and Icosagen reported to have joined forces to develop and introduce an innovative personalized cell therapy (CAR-T cell therapy) for patients in Estonia, offering hope to those with incurable blood cancer (Press release, Icosagen Cell Factory, MAY 27, 2024, View Source [SID1234643715]).

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The Issue:

Each year, over 600 individuals in Estonia are diagnosed with blood cancer, with many succumbing within the first few years post-diagnosis.

Dr. Ain Kaare from Tartu University Hospital explains: "Significant progress has been made in cancer treatment. However, despite rapid advancements, we can only offer long-term disease-free periods to a few blood cancer patients. This means that many still experience disease progression. The new personalized CAR-T cell therapy could potentially save up to 50% of patients with certain hematological malignancies who currently have no curative options."

Dr. Annett Vapper from North Estonia Medical Centre adds: "CAR-T is a groundbreaking treatment that has revolutionized the approach to malignant blood diseases worldwide, offering a chance for recovery or longer disease-free survival for many patient groups for whom other treatments have been exhausted or proved ineffective. In the future, the potential of CAR-T technology could extend beyond blood diseases, providing therapeutic options for various oncological and rheumatological conditions based on ongoing research. This is a crucial step towards personalized medicine and more effective cancer treatment. Additionally, we can modernize treatment centers, train staff, and build medical infrastructure that enables clinical trials and enhances scientific competence."

Innovative Solution:

Tanel Mahlakõiv, PhD, from Icosagen, elaborates: "CAR-T cell therapy is an innovative treatment where a patient’s own immune cells (T-cells) are genetically modified to identify and destroy cancer cells. Unfortunately, this therapy is not yet available in Estonia due to its complexity, limited production capacity by pharmaceutical companies, and high cost. We aim to make this personalized cell therapy accessible to Estonian patients within a few years. Initially, we will focus on leukemia and lymphoma patients, followed by other types of cancer and certain autoimmune diseases."

The Plan:

The collaboration project to launch CAR-T cell therapy involves Tartu University Hospital, North Estonia Medical Centre, and Icosagen. Icosagen will develop the manufacturing processes, conduct preclinical trials, and produce therapy-grade cells meeting all quality standards. Tartu University Hospital and North Estonia Medical Centre will jointly prepare the clinical protocol and related procedures, select patients in need of treatment, collect and isolate patient cells, and conduct cell therapy. Both medical institutions will ensure treatment quality and monitor patients post-treatment through coordinated efforts.

Fresenius Announces FDA Acceptance for Review of Denosumab Biosimilar Application

On May 27, 2024 Fresenius, via its Operating Company Fresenius Kabi, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia (denosumab) and Xgeva (denosumab) (Press release, Fresenius, MAY 27, 2024, View Source [SID1234643714]).

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The denosumab biosimilar is indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

This BLA submission acceptance is the latest development in Fresenius Kabi’s continuing commitment to improving patient access to high-quality biological products through expanding its biosimilars development capabilities and product portfolio. Expanding the company’s Biopharma platform is a substantial cornerstone of #FutureFresenius.

Ferring Pharmaceuticals successfully launches its third Swiss Franc Bond offering for CHF 330 million

On May 27, 2024 Ferring Pharmaceuticals reported the successful launch of its third Swiss Franc Bond offering for an amount totalling CHF 330 million (Press release, Ferring, MAY 27, 2024, View Source [SID1234643713]). This senior unsecured bond transaction issued by Ferring Holding SA comprised two tranches, CHF 210 million with 5-year maturity to 28th June 2029 at a fixed coupon rate of 2.25% per annum, and CHF 120 million with 9-year maturity to 28th June 2033 at a fixed coupon rate of 2.50% per annum. The bonds will be listed on the SIX Swiss Exchange.

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The offering attracted interest from high-quality institutional investors and banks, demonstrating continued recognition of the company’s successful track record and solid cash generation from its core business. The company is rated as BBB (UBS) and Baa (Fedafin), both with a stable outlook.

Dominic Moorhead, Chief Financial Officer of Ferring Pharmaceuticals, said: "We are pleased with the successful outcome of our third bond offering and the proceeds will be used for general corporate purposes, as we continue to invest in the launch and development of our new product opportunities."

The issue was lead-managed by UBS AG and Basler Kantonalbank, with Banque Cantonale Vaudoise acting as co-manager.

Verastem Oncology Announces Updates on Avutometinib Development

On May 27, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Verastem Oncology (Nasdaq: VSTM) issued a press release on May 24 that Verastem Oncology has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the combination of avutometinib, a RAF/MEK inhibitor, and defactinib, a selective FAK inhibitor, for adult patients with recurrent KRAS mutant low-grade serous ovarian cancer, who received at least one prior systemic therapy (Press release, Chugai, MAY 27, 2024, View Source [SID1234643712]). Avutometinib was created by Chugai, and its clinical development is being conducted by Verastem Oncology.

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Please refer to the link below for details of the Verastem Oncology’s press release:
Verastem Oncology Announces the Initiation of a Rolling Submission of NDA to FDA Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
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