MacroGenics to Participate in Upcoming Investor Conference

On June 11, 2024 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following investor conference this month (Press release, MacroGenics, JUN 11, 2024, View Source [SID1234644259]):

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Goldman Sachs 45th Annual Global Healthcare Conference (Miami Beach). MacroGenics’ President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will provide a corporate presentation on Thursday, June 13, 2024, at 10:00am ET. MacroGenics’ management will also participate in one-on-one meetings.

A webcast of the above presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.

Flerie explores the conditions for carrying out a directed issue of ordinary shares of up to approximately SEK 600 million of which approximately SEK 520 million is pre-committed

On June 11, 2024 Flerie AB[1] ("Flerie" or the "Company") reported the completion of the acquisition of all shares in Flerie Invest AB through an issue in kind (the "Acquisition") (Press release, InDex Pharmaceuticals, JUN 11, 2024, View Source [SID1234644256]). Through the Acquisition, Flerie Invest AB will become a wholly-owned subsidiary of Flerie. As previously announced, Flerie intends to raise capital through a directed share issue and have therefore appointed Carnegie Investment Bank AB (publ) ("Carnegie") and DNB Markets, a part of DNB Bank ASA, Sweden branch ("DNB Markets)" as joint bookrunners (the "Joint Bookrunners") to investigate the conditions for carrying out a directed issue of ordinary shares of up to approximately SEK 600 million through a bookbuilding procedure (the "Capital Raise"), of which approximately SEK 520 million is pre-committed. The Capital Raise is intended to be primarily directed to Swedish and international institutional investors.

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Summary

As separately announced yesterday, on 10 June 2024, Flerie’s acquisition of all shares in Flerie Invest AB has been completed. The Acquisition was approved by an Extraordinary General Meeting held earlier on the same date (the "EGM"). The EGM also approved the issue in-kind of consideration shares for the Acquisition (the "Consideration Shares"), the authorization to issue shares for the Capital Raise, the election of new Board members and new auditor, as well as other matters that follow from the Acquisition.
Through the Capital Raise, the Company will raise at least approximately SEK 520 million as per pre-commitments from a number of institutional investors (see further below), prior to transaction costs. The total number of newly issued ordinary shares in the Capital Raise will be determined through a bookbuilding procedure, which will commence immediately following the announcement of this press release and is expected to end before trading commences on Nasdaq First North Growth Market on 14 June 2024.
The subscription price in the Capital Raise will be the same as for the Consideration Shares, i.e. SEK 0.506 per ordinary share. Flerie intends to use the net proceeds from the Capital Raise to fulfil its capital commitments, make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity.
As per 31 May 2024, the net asset value (NAV) per share of Flerie Invest AB was SEK 32.37[2], and hence, the net asset value (NAV) per share of Flerie was approximately SEK 0.60[3].
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 Capital Raise, and the aggregate pre-commitments received from investors amount to approximately SEK 520 million (the "Pre-Commitments"). Those investors who have provided the Pre-Commitments will receive full allocation.

Background

As previously announced, on 20 May 2024, InDex Pharmaceuticals Holding AB (publ) ("InDex Pharmaceuticals"), whose name will be changed to Flerie AB, entered into an agreement to acquire all shares in Flerie Invest AB. The consideration was to be 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 the existing shareholders will initially hold approximately 8.1 per cent of the shares in InDex Pharmaceuticals.

Flerie Invest AB was valued at approximately SEK 3,073 million in the Acquisition, based on reported net asset value as of 31 March 2024 with a discount of 10 per cent, and InDex Pharmaceuticals was valued at approximately SEK 269 million, which corresponded to InDex Pharmaceuticals estimated cash position after closing costs with a premium of 20 per cent. These valuations entailed a subscription price in the Acquisition of approximately SEK 0.506 per Consideration Share. As further announced on 10 June 2024, the EGM approved the Acquisition and the Acquisition was completed. As per 31 May 2024, the net asset value (NAV) per share of Flerie Invest AB was SEK 32.37, and hence, the net asset value (NAV) per share of Flerie was approximately SEK 0.60.

Capital Raise

Flerie’s intention is to carry out the Capital Raise with deviation from the shareholders’ preferential rights, based on the authorization granted by the EGM. The subscription price in the Capital Raise will be SEK 0.506, which is the same as the subscription price of the Consideration Shares.

The total number of newly issued shares in the Capital Raise will be determined through a bookbuilding procedure, which will commence immediately following the announcement of this press release and is expected to end before trading commences on Nasdaq First North Growth Market on 14 June 2024. The bookbuilding procedure may close earlier or later and may be cancelled at any point in time without prior notification. Flerie will announce the outcome of the Capital Raise through a press release after the closing of the bookbuilding procedure.

The purpose of the Capital Raise, and the reasons for the deviation from the shareholders’ preferential right, is to diversify the shareholder base of the Company in order to meet the liquidity requirements for a listing on, initially, Nasdaq First North Growth Market and, subsequently, Nasdaq Stockholm (for more information, please see section "Admission to trading on Nasdaq Stockholm"), to ensure continued financing of Flerie in immediate connection to the implementation of the Acquisition, and to have flexibility to make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity, as well as, strengthen the shareholder base with Swedish and international institutional investors. With the above considered, the Board of Directors of Flerie has made the assessment that a directed issue of ordinary shares with deviation from the shareholders’ preferential rights is the most favourable alternative for the Company to carry out the capital raising and is in the best interest of the Company’s shareholders. The Board of Directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.

Since the subscription price in the Capital Raise corresponds to the subscription price for the Consideration Shares, which was based on a valuation of InDex Pharmaceuticals as standalone listed entity (i.e. prior to the Acquisition) that has been subject to arm’s-length negotiations with the sellers of Flerie Invest AB, the Board of Directors of Flerie considers that the subscription price in the Capital Raise is market-based.

Through the Capital Raise, the Company will raise at least approximately SEK 520 million as per the Pre-Commitments, prior to transaction costs. Flerie intends to use the net proceeds from the Capital Raise to fulfil its capital commitments, make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity.

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 Capital Raise, and the aggregate pre-commitments received from investors amount to approximately SEK 520 million. Those investors who have provided the Pre-Commitments will receive full allocation.

Investors in the Capital Raise are required to undertake not to utilise the right as a shareholder in the Company to request conversion of ordinary shares into shares of series C in the Company under the redemption program until 2026 (for more information, please see section "Voluntary share redemption program" below).

Lock-up

Flerie will undertake towards the Joint Bookrunners, for a period of 360 days from and including today, 11 June 2024, not to, without Carnegie’s approval, propose or take measures that entail an increase in the share capital, new share issues and similar measures, with certain exceptions, for example in connection with acquisitions or establishment of incentive programs. Thomas Eldered’s directly and indirectly wholly-owned companies T&M Förvaltning AB and T&M Participation AB (the "Major Shareholders"), as well as Flerie’s Board and management will undertake towards the Joint Bookrunners not to, without Carnegie’s approval, sell or otherwise transfer or dispose of their shares in Flerie, subject to certain exceptions. This lock-up period will last for 360 days from completion of the Acquisition for the Major Shareholders, and 180 days from completion of the Acquisition for Flerie’s Board and management.

Admission to trading on Nasdaq Stockholm

The Company intends to carry out an uplisting from Nasdaq First North Growth Market to Nasdaq Stockholm. Provided that Nasdaq Stockholm approves the Company’s application for admission to trading, the first day of trading on Nasdaq Stockholm is planned to take place around 27 June 2024.

Voluntary share redemption program

The Company has established an annual voluntary share redemption program from and including 2025 in order to increase the liquidity of the shares of Flerie. Through the redemption program, shareholders are proposed to have the right during an annual conversion period, to occur during the last week of March, to request the conversion of their ordinary shares into a new class of shares, convertible and redeemable class C shares. Conversion can take place of up to five (5) per cent of the total number of outstanding shares. If the number of ordinary shares notified for conversion exceeds this limit, distribution shall be made in proportion to the number of ordinary shares that each shareholder has requested for conversion.

As soon as possible following announcement of the interim report for the first quarter, Flerie shall redeem all outstanding class C shares at a redemption amount per share corresponding to the net asset value (NAV) per share as of 31 March. During 2025, certain different time periods will apply for the redemption program.

The Major Shareholders and investors that have provided Pre-Commitments have undertaken not to exercise the redemption program prior to 2029 and 2026, respectively, and any additional investors in the Capital Raise will, by subscribing for shares in the Company, undertake not to exercise the redemption program prior to 2026.

Advisors

Carnegie is Sole Global Coordinator and Joint Bookrunner and DNB Markets is Joint Bookrunner in connection with the Capital Raise. Setterwalls Advokatbyrå is legal advisor to Flerie in connection with the Capital Raise. White & Case is legal advisor to Carnegie and DNB Markets in connection with the Capital Raise.

Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma

On June 11, 2024 Essential Pharma, an international specialty pharma group focused on ensuring that patients have sustainable access to low volume, clinically differentiated, niche pharmaceutical products across key therapeutic areas, reported its rare disease business has signed a strategic agreement with AGC Biologics (Press release, Essential Pharma, JUN 11, 2024, View Source [SID1234644255]). As a leading global biopharmaceutical contract development and manufacturing organisation (CDMO), AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB).

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Under the agreement, AGC Biologics will support the process development, scale-up and manufacturing as Essential Pharma plans to commence clinical activities and ongoing regulatory agency interactions over the coming months.

Simon Ball, Vice President of the rare disease business at Essential Pharma, commented: "This partnership is a tremendous milestone in the development of Hu14.18 and its path to commercialization. The prospect of building an inventory of Hu14.18 is very exciting. Ahead of us is a period of intense regulatory agency interaction, which will take place alongside late-stage clinical development, and we are a step closer to providing this high-potential antibody to a patient group that is desperately in need of more optimal treatments and better outcomes."

"AGC Biologics is a global leader in contract antibody development and manufacturing," stated Emma Johnson, CEO of Essential Pharma. "This partnership will help us to accelerate the late-stage development of Hu14.18, which shows therapeutic promise for high-risk neuroblastoma patients, the majority of whom are young children. We look forward to working closely with AGC to deliver this potentially transformative therapy in an area of significant unmet need."

Christoph Winterhalter, CBO at AGC Biologics, said: "We are very pleased that Essential Pharma has chosen us to manufacture this innovative therapy. Our Copenhagen site has the expertise and experience in therapeutic antibodies to accelerate the late-stage development and manufacturing of Hu14.18. We look forward to partnering with Essential Pharma and working together to ensure the product meets the high level of quality, yield and all data packages needed to successfully master future clinical trials and regulatory agency submissions to supply patients across the globe with this life-saving product."

Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for the development of Hu14.18. A Phase II trial incorporating Hu14.18 into first-line therapy, and additionally within post-consolidation therapy for HRNB patients, demonstrated positive patient outcomes with 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%. Data from this study were published in the Journal of Clinical Oncology in December 2021 and are approaching five-year OS readouts.

Enterome to Present Data on OncoMimics™ Approach to Cancer Immunotherapy at EACR 2024

On June 11, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that it will present data on its innovative OncoMimics approach to cancer therapy at the 2024 Annual Congress of the European Association for Cancer Research (EACR 2024), taking place June 10-13 in Rotterdam, Netherlands (Press release, Enterome, JUN 11, 2024, View Source [SID1234644253]). The presentation describes Enterome’s OncoMimics peptide-based immunotherapy, designed to harness the patient’s immune system to target and eliminate cancer cells.

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Dr. Alice Talpin, lead researcher, commented: "The OncoMimics approach offers a promising strategy to enhance cancer immunity by overcoming the limitations of current vaccines. Our preclinical and clinical data underscore the ability of OncoMimics peptides to elicit strong, durable immune responses, which could significantly improve patient outcomes."

Peptide-based immunotherapy offers significant potential against cancer by leveraging the body’s immune system to eliminate cancer cells, targeting tumor-associated antigens (TAAs) or tumor-specific antigens (TSAs). Enterome innovative OncoMimics therapies are based on the concept of molecular mimicry and cross-reactivity between commensal-derived synthetic peptides and tumor-associated antigens-derived peptides (TAAps) to evoke a CD8+ T cell response against tumors.

Based on this approach, Enterome has developed a pipeline of drug candidates for the treatment of cancer, including EO2463, which is demonstrating a favorable safety profile with encouraging early signs of efficacy in a Phase 2 clinical trial (EONHL1-20/SIDNEY) for indolent non-Hodgkin lymphomas, and EO2401, which has successfully completed a Phase 2 clinical trial (EOGBM1-18/ROSALIE) in patients with recurrent glioblastoma.

Highlights from the EACR 2024 poster presentation, entitled Innovative immunotherapy based on commensal-derived peptides for enhancing CD8+ T cell activation against Tumor-Associated Antigens:

In humanized HLA-A2 murine models, OncoMimics peptides (OMPs) trigger the expansion of cross-reactive OMP-/TAAp- specific CD8+ T cells with specific cytotoxic activity against tumor cells. Experiments conducted on HLA-A2+ healthy human peripheral blood mononuclear cells revealed a high prevalence of cross-reactive OMP-/TAAp-specific CD8+ T cells when stimulated in vitro. In addition, those cross-reactive CD8+ T cells exhibit cytolytic activity against target cells presenting homologous TAAs.

Abstract #1155 is published in an online supplement to Molecular Oncology (Volume 18, Issue S1, DOI: 10.1002/1878-0261.13683) and the Poster will be available on Enterome’s website following the session.

Poster #1155 Presentation details

Title: Innovative immunotherapy based on commensal-derived peptides for enhancing CD8+ T cell activation against Tumor-Associated Antigens

Presenting Author: Alice Talpin, PhD, Enterome researcher

Poster Session: Immunotherapy (odd Abstract Numbers)

Poster Board: P-285

Session Date and Time: June 12, 18:40 to 20:15 CET (poster displayed from 11:00 CET)

Ono Announces Results of Tender Offer to Acquire Deciphera Pharmaceuticals and Completion of Acquisition of Deciphera (a Wholly Owned Subsidiary of Ono)

On June 11, 2024 Ono Pharmaceutical, Co., Ltd. (Chairman and CEO: Gyo Sagara, "Ono") reported that it has successfully completed the tender offer, previously announced on April 30, 2024 to acquire all outstanding shares of common stock of a US biopharmaceutical company, Deciphera Pharmaceuticals, Inc. (Nasdaq: DCPH, CEO: Steven L. Hoerter, "Deciphera") for US$25.60 per share (total amount of approximately US$2.4 billion) net to the seller in cash, without interest thereon and less any applicable withholding taxes, through its wholly owned subsidiary, Topaz Merger Sub, Inc. ("Merger Sub"), established in the State of Delaware, United States, solely for the purpose of engaging in the transactions contemplated in the Merger Agreement (Press release, Deciphera Pharmaceuticals, JUN 11, 2024, View Source [SID1234644250]).

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The tender offer commenced on May 13, 2024, New York City time, and, as set forth below, expired at one minute after 11:59 p.m., New York City time, on June 10, 2024.

On June 11, 2024, following the completion of the tender offer, Merger Sub merged with and into Deciphera with Deciphera continuing as the surviving corporation and a wholly owned subsidiary of Ono. In connection with the acquisition, Deciphera shares ceased to be traded on Nasdaq as of the date of closing of the acquisition and shares of Deciphera’s common stock will be delisted from Nasdaq.

"We are very pleased to welcome Deciphera into the family," said Gyo Sagara, Chairman and CEO of Ono. "Through this acquisition, we will leverage Deciphera’s excellent research and development capabilities in the oncology field and its sales power in Europe and the United States, and work to further accelerate the expansion of our pipeline and global expansion, which are part of our growth strategies."

"We are excited to enter a new phase as part of the family of Ono Pharmaceuticals, that has as its mission to contribute to society through the discovery and development of innovative drugs, under the corporate philosophy "Dedicated to the Fight against Disease and Pain,"" said Steven L. Hoerter, President and CEO of Deciphera. "By fully leveraging the research and development capabilities and commercialization platforms of both companies, we look forward to significantly contributing to the growth of the Ono Group as a global specialty pharma company."