On December 17, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT), reported that they have entered into a long-term strategic partnership for global collaboration between the two companies (Press release, Genfit, DEC 17, 2021, https://ir.genfit.com/news-releases/news-release-details/genfit-ipsen-and-genfit-enter-exclusive-licensing-agreement [SID1234597354]). The agreement gives Ipsen exclusive worldwide* license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor, for people living with Primary Biliary Cholangitis (PBC). The partnership also gives Ipsen access to future clinical programs led by GENFIT and combines GENFIT’s scientific expertise and proprietary technologies in liver disease with Ipsen’s development and commercialization capabilities. To underscore the long-term commitment represented by this partnership, Ipsen will also purchase newly issued GENFIT equity representing 8% post-issuance through a €28m investment in GENFIT, becoming one of the largest shareholders.

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The ongoing, pivotal Phase III global trial, ELATIVETM,i is evaluating the safety and efficacy of elafibranor in 150 people living with PBC who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA). Global recruitment is well underway. There is significant unmet medical need for people with PBC and, following positive Phase II data,ii elafibranor was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) and Orphan Drug Designation by the U.S. FDA and European Medicines Agency (EMA).iii,iv Results from the Phase II randomized double-blind, placebo controlled trial found that after 12 weeks of dosing with elafibranor, patients with PBC unresponsive to UDCA experienced significantly reduced levels of disease-activity markers including alkaline phosphatase (ALP) and composite endpoints with bilirubin as well as other markers of disease activity when compared to placebo.ii

David Loew, Chief Executive Officer, Ipsen, said "Today’s announcement marks an exciting new stage in Ipsen’s ambitions to expand our portfolio to support more people living with rare diseases around the world. We are excited by elafibranor’s data package, demonstrating the potential benefit of this first-in-class, innovative treatment option to help the PBC community. We look forward to the results of the ongoing Phase III program and regulatory submissions around the world to bring this potential new treatment option to patients. Ipsen is pleased to partner with GENFIT, a company that shares our common values and goals of bringing to market first-in-class treatments to improve the lives of people living with rare conditions like PBC."

Pascal Prigent, Chief Executive Officer of GENFIT, added: "We are excited to partner with Ipsen and launch this long-term strategic collaboration, with the goal to accelerate our growth and generate value for our shareholders. Ipsen’s world-class development capabilities, well-established global commercial footprint and excellent track record in delivering therapies to patient populations with unmet medical need makes it the ideal partner for GENFIT. Today’s landmark agreement demonstrates our ability to advance highly promising assets into late-stage development in-house and derive significant value. While we hope, above all, that this partnership with Ipsen will be a significant step towards having a positive impact on the lives of millions of patients suffering from life-threatening liver diseases, we also believe our shareholders will recognize the benefit offered by this collaboration model. The transaction proceeds indeed reinforce GENFIT’s long-term financial visibility, including further funding for GENFIT to expand its pipeline, and they also provide opportunities for targeted business development, as exemplified by today’s other announcement regarding our in-licensing of a new molecule."

PBC is a rare, progressive, chronic autoimmune disease of the liver.v Bile is a liquid produced inside the liver that is used to help digest fats and remove waste products from the body.vi PBC leads to a slow, progressive destruction of the small bile ducts of the liver, causing bile and other toxins to build up in the liver (known as cholestasis).v Further damage can lead to scarring, fibrosis and eventually cirrhosis of the liver.v Common symptoms of PBC include fatigue and pruritus (itching) which can be debilitating and, in more advanced cases, jaundice.v Untreated, PBC can lead to liver failure, or in some cases death. PBC is more common in women with nine women diagnosed for every man; it is also a leading cause of liver transplantation.v

GENFIT remains responsible for the Phase III ELATIVETM trial until the completion of the double-blind period. Ipsen will assume responsibility for all additional clinical development, including completion of the long-term extension period of the ELATIVETM trial, and global* commercialization. This newly established strategic partnership will also provide Ipsen with access to GENFIT’s research capabilities and other clinical programs through rights to first negotiation.

Under the agreement, Ipsen will pay GENFIT up to €480m, comprising upfront cash payment of €120m, as well as regulatory, commercial, and sales-based milestone payments up to €360m, plus tiered double-digit royalties of up to 20%. Ipsen also becomes a shareholder of GENFIT through the purchase of 3,985,239 newly issued shares representing 8% of GENFIT S.A after issuance, via a €28m investment. The new shares will be issued pursuant to the twentieth resolution of GENFIT’s 30 June 2021 shareholders’ meeting and will be subject, upon issuance, to a lock-up period ending, in the event of positive ELATIVE TM results, on the earlier of the date on which the EMA makes a formal recommendation to the European Commission for the marketing authorisation of elafibranor in PBC or the date on which the U.S. FDA grants approval of elafibranor in PBC. Issuance of the new shares is expected to take place on or about December 22, 2021. In addition, the Board of Directors of GENFIT will propose at the next shareholders’ meeting that Ipsen becomes a board member.

The transaction is expected to be dilutive to Ipsen’s profitability over the near term, primarily reflecting R&D and launch-preparation expenses. This is in line with Ipsen’s medium-term outlook regarding its strategic focus on building a high-value and sustainable pipeline through external innovation.

GENFIT will host a conference call on December 17, 2021 at 7:45am ET / 12:45pm GMT / 1.45pm CET in English and in French

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 800-289-0438 (toll-free U.S. and Canada), 0800 358 6377 (toll-free UK) or 0805 101 219 (France) five minutes prior to the start time (confirmation code: 9932717). A replay will be available shortly after the call.

Primary Biliary Cholangitis

Primary biliary cholangitis (PBC) is a chronic, autoimmune disease in which bile ducts in the liver are gradually destroyed. The damage to bile ducts can inhibit the liver’s ability to rid the body of toxins, and can lead to scarring of liver tissue, known as cirrhosis. PBC is a disease with high unmet medical needs, with many patients unable to benefit from existing therapies. The prevalence of people living with PBC in the US is estimated to be between 23.9-39.2 per 100,000.vii,viii

Elafibranor

Elafibranor, GENFIT’s lead therapeutic candidate, is currently under evaluation in ELATIVE, a Phase III clinical trial to evaluate its efficacy and safety in patients with PBC. Elafibranor is an oral, once-daily, first-in-class drug candidate acting via dual agonism of peroxisome proliferator-activated alpha/delta receptors. Data from a Phase II clinical trial demonstrated elafibranor has the potential to become an efficacious treatment in PBC, a rare liver disease. It was granted a Breakthrough Therapy designation by the FDA in this indication. Elafibranor is an investigational compound that has not been reviewed nor received approval by a regulatory authority.

ELATIVE Program

ELATIVE is a Phase III clinical trial evaluating the safety and efficacy of elafibranor 80mg versus placebo in 150 patients with Primary Biliary Cholangitis (PBC) with an inadequate response to ursodeoxycholic acid (UDCA), which is the existing first line therapy for PBC. ELATIVE is a multicenter, randomized, double blind study to evaluate the efficacy and safety of elafibranor versus placebo. Treatment duration until interim analysis for accelerated approval is 52 weeks. Top line data is expected in between the end of the first quarter and the middle of the second quarter 2023.

On December 17, 2021 Pulmatrix, Inc. (Nasdaq: PULM) ("Pulmatrix" or the "Company"), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has closed its previously announced registered direct offering with certain institutional investors for the issuance and sale of an aggregate of 6,745.008 shares of convertible preferred stock and warrants to purchase up to an aggregate of 5,620,834 shares of common stock for gross proceeds of $6.75 million, prior to deducting placement agent’s fees and other offering expenses (Press release, Pulmatrix, DEC 17, 2021, View Source [SID1234597373]). The shares of preferred stock have a stated value of $1,000 per share and are initially convertible into an aggregate of 11,241,668 shares of common stock at a conversion price of $0.60 per share at any time. The warrants have an exercise price of $0.70 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the date of issuance.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The Company currently intends to use the net proceeds from the offering for general corporate and working capital purposes.

The Company expects to call a special meeting of stockholders for the approval of a proposal to effect a reverse split of the common stock. The preferred stock has voting rights, with the common stock as a single class, equal to 5,000 votes per share of common stock underlying the preferred stock on the proposal, that, in accordance with Nasdaq listing rules, any votes cast by the preferred stock with respect to the proposal to effect a reverse split of the common stock must be counted by the Company in the same proportion as the aggregate shares of common stock voted on such proposal.

The securities described above were offered and sold by Pulmatrix in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-256502), including a base prospectus previously filed with the Securities and Exchange Commission (the "SEC") on May 26, 2021 and became effective on June 9, 2021. The securities were offered by means of a prospectus supplement and accompanying prospectus, forming part of the registration statement. The prospectus supplement dated December 17, 2021 and the accompanying base prospectus relating to and describing the terms of the registered direct offering were filed with the SEC on December 17, 2021. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained on the SEC’s website at or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at .

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 17, 2021 Iktos, a company specialized in Artificial Intelligence for new drug design, and The Drug Discovery Unit (DDU), School of Life Sciences, The University of Dundee, focused on the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery, reported entering a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of DDU’s drug discovery programs (Press release, Iktos, DEC 17, 2021, View Source [SID1234597433]). Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies, its AI-based retrosynthesis analysis and planning tool Spaya, and know-how complementing DDU’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties.

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The DDU was established in 2006 to respond to a lack of drug targets identified for neglected tropical diseases being translated into therapeutics for diseases impacting the poorest people in the world. The DDU translates basic science into lead compounds to validate putative drug targets, to use as tools to investigate disease pathways and, when appropriate, advance to pre-clinical drug candidates for multiple diseases, e.g. TB and cancer.

Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through Iktos’s other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate.

Iktos has recently diversified its R&D efforts into the development of an AI technology for retrosynthesis. Identifying and selecting synthetic pathways is one of the most challenging and time-consuming tasks in synthetic and medicinal chemistry. Iktos has developed AI based retrosynthesis analysis and planning tool Spaya by harnessing the power of data-driven retrosynthesis algorithm for systematic exploration and prioritisation of synthetic routes for a desired compound in minutes.

Professor Paul Wyatt, Head of the DDU said, "We are thrilled to be working with Iktos to drive our projects towards drug candidates. Iktos AI platform combined with our own in-house computational and medicinal chemistry design teams provide a powerful combination for innovative new drug design."

"We are thrilled and proud to join forces with DDU with the aim to help in the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery," commented Yann Gaston-Mathé, President and CEO of Iktos. "Pleased to have earned DDU’s trust, we are confident that together with DDU and their established R&D partners, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The feedback from DDU’s research team will be highly valuable as we improve our product offerings. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects."

On December 17, 2021 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, reported the strengthening of its cholestatic disease franchise through the acquisition of exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in cholangiocarcinoma in the United States, Canada and Europe, including the United Kingdom and Switzerland (Press release, Genfit, DEC 17, 2021, https://ir.genfit.com/news-releases/news-release-details/heels-global-strategic-partnership-announced-today-genfit [SID1234597355]). This announcement comes on the heels of today’s other announcement on our global strategic pharma partnership.

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GNS561 is a novel clinical-stage autophagy/PPT1 inhibitor developed by Genoscience Pharma and cholangiocarcinoma is an orphan disease. It has completed pre-clinical studies and a Phase 1b trial confirming the rationale for targeting cholangiocarcinoma, a rare liver malignancy with high mortality and with limited treatment options.

Under the agreement, Genoscience Pharma is eligible for clinical and regulatory milestone payments and tiered royalties. The first payable milestone is contingent on positive Phase 2 clinical trial results. GENFIT is also committed to take a €3 million equity stake in Genoscience Pharma through the subscription of new ordinary shares.

Pascal Prigent, CEO of GENFIT, stated: "This licensing agreement with Genoscience Pharma comes as an immediate follow-up to the global strategic partnership announced today. Proceeds from this strategic agreement will strengthen the trajectory of our long-term growth and pipeline expansion, which is exemplified by the acquisition of GNS561’s rights in cholangiocarcinoma. This decision fully aligns with our strategic roadmap by broadening our asset portfolio within our cholestatic disease franchise through the addition of an innovative drug candidate, with the potential to address considerable unmet needs for patients. The scientific rationale, together with preclinical and clinical evidence, support further development of the asset, and our plan is to start a Phase 2 program in the first half of 2022. We believe that GNS561’s mechanism of action is very promising. Given the current landscape, standard of care, lack of marketed options and, based on KOL opinions, we will interact with regulatory agencies to investigate accelerated paths to approval, post Phase 2."

Philippe Halfon, CEO of Genoscience Pharma, added: "This is a great step for the development of GNS561 as a new potential treatment option in liver cancer, as it offers an innovative mechanism of action for patients with high unmet needs. We believe that GENFIT is a highly qualified partner for the development of GNS561 in cholangiocarcinoma and we will provide GENFIT with our expertise to support their development plan. On our side, we will pursue, at Genoscience Pharma, the development of GNS561 in other oncology indications as well as research in other therapeutic areas."

GENFIT will host a conference call on December 17, 2021 at 7:45am ET / 12:45pm GMT / 1.45pm CET in English and in French

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 800-289-0438 (toll-free U.S. and Canada), 0800 358 6377 (toll-free UK) or 0805 101 219 (France) five minutes prior to the start time (confirmation code: 9932717). A replay will be available shortly after the call.

ABOUT CHOLANGIOCARCINOMA

Cholangiocarcinoma is a type of cancer that forms in the slender tubes (bile ducts) that carry the digestive fluid bile. Cholangiocarcinoma occurs mostly in people over the age of 50. Cholangiocarcinoma is divided into intrahepatic and extrahepatic types based on where the disease occurs in the bile ducts. Cholangiocarcinoma is often diagnosed when it is advanced, making successful treatment difficult to achieve. Several risk factors of chronic inflammatory damage and increased cellular turnover have been established, such as primary sclerosing cholangitis (a cholestatic liver disease), liver flukes, biliary tract cysts, hepatolithiasis and toxins. Treatment options for Cholangiocarcinoma are limited and associated with high rates of tumor recurrence, and short survival times.

ABOUT GNS561

GNS561 is a PPT-1 (Palmitoyl Protein Thioesterase-1) inhibitor that blocks autophagy. Autophagy is activated in tumor cells in response to certain conditions, due to a tumor cell growth in advanced cancers. One of the key organs implicated in the autophagy process is the lysosome. By entering the lysosomes and binding to its target, GNS561 has an important inhibiting activity on late-stage autophagy, which leads to tumor cell death. GNS561 is an investigational compound and has not been registered by any regulatory authority.

On December 17, 2021 Sareum Holdings plc (AIM: SAR), the specialist small molecule drug development company, reported that it has raised approximately £1.63 million, before expenses, through a subscription by new and existing high net worth individuals (the "Subscribers") for 32,636,311 new ordinary shares of 0.025p each in the capital of the Company ("Ordinary Shares") (the "Subscription Shares") at a price of 5.0p per share (the "Subscription Price") (the "Subscription") (Press release, Sareum, DEC 17, 2021, View Source [SID1234597374]).

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The Subscription Price represents a discount of approximately 3.8 per cent to the closing middle market price for Sareum shares on 16 December 2021.

The net proceeds from the Subscription will enable the Company to advance its two proprietary TYK2/JAK1 inhibitor programmes: SDC-1801, which is targeting autoimmune diseases, including the potentially life-threatening hyper-inflammatory response (the "cytokine storm") that affects some Covid-19 patients, through Phase 1a clinical development; and SDC-1802, which is targeting cancers, through preclinical development; as well as for working capital purposes.

As noted in its Final Results Statement of 25 October 2021, the Company is targeting the application for a Clinical Trials Authorisation for SDC-1801 in mid-2022, subject to successful progress. Clinical trial plans, including priority autoimmune indications and potential Covid-19 application, will also be developed in parallel. Preclinical development of SDC-1802 will be accelerated and is expected to complete in 2023, again subject to successful progress.

Application will be made for the 32,636,311 Subscription Shares, which will rank pari passu with the Company’s existing Ordinary Shares, to be admitted to trading on the AIM market of the London Stock Exchange ("AIM") ("Admission"). It is anticipated that Admission will become effective at 8.00 am on 23 December 2021. The Subscription is subject to normal conditions including, inter alia, Admission.

Total Voting Rights

For the purpose of the Disclosure Guidance and Transparency Rules, following the above issue of equity, the issued share capital of the Company will comprise 3,403,470,791 Ordinary Shares. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company, under the Disclosure Guidance and Transparency Rules.

Dr Tim Mitchell, CEO of Sareum Holdings plc, said: "This new subscription brings the funds raised by Sareum this year to over £6 million, reflecting the strong and continuing interest in our proprietary TYK2/JAK1 development programmes. Our significantly strengthened financial position will now enable us to take SDC-1801 through Phase 1a clinical development to assess its safety in healthy human volunteers. We also have the resources to complete the preclinical development for SDC-1802 for cancer. 2021 has been a significant year for Sareum and we look forward to reporting progress with our TYK2/JAK1 inhibitor development programmes in 2022."

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018.