GLP-1R

Director Share Purchase LONDON, UK / ACCESSWIRE / February 22, 2024 / Poolbeg Pharma (AIM:POLB)(OTCQB:POLBF), 'Poolbeg' or the 'Company'), a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces that it has received notification that on 21 February 2024, Jeremy Skillington, Chief Executive Officer of the Company, purchased 154,764 ordinary shares at a price of 10.8 pence per share (the "Purchase"). Following the Purchase, Jeremy holds 873,497 ordinary shares representing approximately 0.17 per cent of the Company's issued share capital. The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) ("MAR"). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain. Enquiries Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O'Connell, CFO +44 (0) 207 183 1499 Cavendish Capital Markets Ltd (Nominated Adviser & Joint Broker) Geoff Nash, Charlie Beeson, Nigel Birks, Harriet Ward (ECM) +44 (0) 207 220 0500 Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher +44 (0) 207 496 3000 J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist +353 (0) 1 679 6363 Optimum Strategic Communications Nick Bastin, Vici Rabbetts, Elena Bates +44 (0) 208 078 4357 poolbeg@optimumcomms.com About Poolbeg Pharma Poolbeg Pharma plc is committed to the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need. Its model focusses upon developing its exciting clinical assets and commercialising approved and marketed drugs to fund the development of its robust pipeline of innovative products, thereby driving significant value creation. Poolbeg is led by an experienced leadership team with a history of delivering significant shareholder value. The team has been strengthened by the appointment of three former members of the Amryt Pharma plc leadership team, with the intention of repeating Amryt's success and generating near term revenues. Poolbeg's clinical programmes target large addressable markets including cancer immunotherapy-induced CRS, infectious disease, and metabolic conditions such as obesity with the development of an oral GLP-1R agonist. It uses a cost-effective development philosophy to generate high quality human data to support partnering and further development. Its AI-led infectious disease programmes analyse unique data from human challenge trials to identify clinically relevant drug targets and treatments, leading to faster development and greater commercial appeal. For more information, please go to or follow us on Twitter and LinkedIn @PoolbegPharma. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Poolbeg's present and future business strategies and the environment in which Poolbeg expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Poolbeg's ability to control or estimate precisely, such as future market conditions, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Poolbeg's ability to obtain financing, changes in the political, social and regulatory framework in which Poolbeg operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information. Notification and public disclosure of transactions by persons discharging managerial responsibilities and persons closely associated with them: 1 Details of the person discharging managerial responsibilities/person closely associated a. Name of PDMR Jeremy Skillington 2 Reason for notification a. Position/Status Chief Executive Officer b. Initial notification/ Amendment Initial notification 3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor a. Name Poolbeg Pharma plc b. LEI 213800UZ8WJLWYHBFL52 4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted a. Description of the financial instrument, type of instrument Identification Code Ordinary shares of £0.002 each ISIN GB00BKPG7Z60 b. Nature of the transaction Purchase of Ordinary Shares c. Price(s) and volume(s) Price(s) Volume(s) 10.8p 154,764 d. Aggregated information - Aggregated Volume - Price As in 4c) above e. Date of the transaction 21 February 2024 f. Place of the transaction London Stock Exchange, AIM Market (XLON) This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit . SOURCE: Poolbeg Pharma PLC View the original press release on accesswire.com

Pictured: Handshake in front of raining money / Taylor Tieden for BioSpace The slow pace of mergers and acquisitions in 2022 continued into 2023 but has since picked up steam, highlighted by a frenzy of big-dollar M&A announcements and the closing of Pfizer’s $43 billion purchase of Seagen, the largest pharmaceutical or biotech M&A agreement in three years. As M&A activity accelerates in early 2024, BioSpace looks back over the biggest deals in the biopharma sector over the past eight months. This list includes M&A transactions that have closed since July 1. 1. Pfizer Snatches Up Seagen to Expand Oncology Pipeline Closing date: Dec. 14, 2023 Deal value: $43 billion Pfizer acquired Seattle-based Seagen for $43 billion, the largest M&A agreement in the sector in three years and just missing the list of top 10 biopharma deals of all time. With this move, Pfizer took control of Seagen’s antibody-drug conjugate (ADC) technology, fortifying the pharma giant’s standing within the oncology market. Pfizer’s offering came in at $229/share, outbidding others, including Merck and Sanofi. The deal took nine months to consummate after scrutiny by the Federal Trade Commission as well as European regulators. In response to FTC concerns, Pfizer decided to donate the rights of royalties from U.S. sales of its anti-PD-L1 checkpoint inhibitor Bavencio to the American Association for Cancer Research. 2. AbbVie Acquires ADC Developer Immunogen Closing date: Feb. 12, 2024 Deal value: $10.1 million The antibody-drug conjugate (ADC) market is hot, and AbbVie is now in the race after acquiring ImmuoGen for $31.26 per share. The deal offers AbbVie access to ImmunoGen’s ADC Elahere (mirvetuximab soravtansine-gynx), which was granted FDA accelerated approval in 2022, as well as the smaller company’s follow-on pipeline of ADCs, including several in development for treatments such as solid tumors, acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. 3. Biogen Boosts Neuro, Rare Disease Pipelines with Reata Acquisition Closing date: Sept. 26, 2023 Deal value: $7.3 billion Biogen scooped up Reata Pharmaceuticals to bolster its neurological and rare disease businesses. Biogen paid $172.50 per share to score the Texas-based firm. Last year, Reata gained FDA approval for Skyclarys (omaveloxolone), the first authorized treatment for Friedreich’s ataxia in the U.S., and new owner Biogen followed with European Commission approval this month. The purchase also gave Biogen access to Reata’s developmental pipeline, which includes the Hsp90 modulator cemdomespib, being developed for diabetic peripheral neuropathic pain, and the Nrf2 activators RTA 415 and RTA 417, both being assessed for their potential in treating diseases associated with mitochondrial dysfunction, oxidative stress and chronic inflammation. 4. Roche Buys Telavant from Roivant to Acquire IBD Candidate Closing date: Oct. 23, 2023 Deal value: $7.1 billion Roche made an upfront payment of $7.1 billion to secure Telavant Holdings, a company that Roivant previously owned 75% of. The acquisition agreement also includes an additional short-term milestone payment of $150 million. Telavant has the rights in the U.S. and Japan to investigational anti-TL1A antibody RVT-3101, which is being developed for inflammatory bowel conditions, including ulcerative colitis and Crohn’s disease. RVT-3101 is a monoclonal antibody that works by inhibiting the TL1A cytokine, which modulates the site and severity of inflammation and fibrosis by stimulating the TH1 and TH17 pathways. 5. Astellas Nabs Iveric Bio and Its Blindness Therapies Closing date: July 11, 2023 Deal value: $5.9 billion Astellas acquired New Jersey–based Iveric Bio for $5.9 billion in its largest acquisition to date. Under the terms of the agreement, Astellas paid $40 per share. The acquisition grants Astellas access to multiple programs for the treatment of geographic atrophy due to age-related macular degeneration, including Izervay, a complement C5 inhibitor that received FDA approval in August. 6. Danaher Scoops Up Abcam After Shareholder Pushback Closing date: Dec. 6, 2023 Deal value: $5.7 billion Danaher paid $5.7 billion to acquire Abcam, a U.K.-based supplier of antibodies, reagents and other proteomic research tools. The transaction was valued at $24 per share, a price initially deemed too low by Abcam founder-turned-investor Jonathan Milner, who tried to have himself installed as executive chairman last year. 7. BMS Acquires Mirati Therapeutics to Boost Cancer Business Closing date: Jan. 23, 2024 Deal value: $4.8 billion Bristol Myers Squibb took over cancer-focused biotech Mirati Therapeutics in a bid to grow its oncology franchise, at a cost of $58.00 per share. Additionally, Mirati shareholders received nontradeable value rights worth up to $12.00 per share, contingent on the FDA accepting the New Drug Application for Mirati’s candidate MRTX1719 within seven years of the acquisition. That puts the potential total value as high as $5.8 billion. MRTX1719 is a potentially first-in-class PRMT5 inhibitor in early-stage development for several tumor types, including non-small cell lung cancer. The compound is expected to enter Phase II studies in the first half of 2024. 8. Novartis Expands in the Renal Space, Acquiring Chinook Therapeutics Closing date: Aug. 11, 2023 Deal value: $3.2 billion Novartis acquired Seattle-based Chinook Therapeutics, a prominent player in kidney therapeutics, in a deal valued at up to $3.5 billion, or $40 per share. Specifically, Novartis provided an initial cash payment of $3.2 billion and has committed to additional contingent value rights of up to $300 million. Novartis gained access to Chinook's two advanced-stage assets currently under late-stage clinical development for immunoglobulin A nephropathy (IgAN), a rare, progressive autoimmune kidney disease. 9. Roche Acquires Carmot Therapeutics to Enter Weight-Loss Drug Arena Closing date: Jan. 29, 2024 Deal value: $2.7 billion Roche took over Berkeley, California–based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. The Swiss pharma made an upfront payment of $2.7 billion when the deal closed last month, and privately held Carmot’s investors equity holders are eligible for up to $400 million in additional milestone payments. With the purchase, Roche gains access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists aimed at treating obesity. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready for Phase II testing. 10. Lilly Obtains DICE Therapeutics and Its Drug Discovery Platform Closing date: Aug. 9, 2023 Deal value: $2.4 billion To expand its range of treatments for autoimmune diseases, Eli Lilly acquired DICE Therapeutics, a biopharma company based in San Francisco. Lilly reported that the deal is valued at $48 per share. The purchase grants Lilly the opportunity to use DELSCAPE, DICE’s drug discovery and development platform. This platform is designed to optimize the creation of small molecule drugs, allowing for efficient disruption of protein-protein interactions. Deals to Watch On Dec. 22, BMS entered into a definitive $14 billion merger agreement with Karuna Therapeutics, followed four days later by the planned purchase of RayzeBio for $4.1 billion. Neither deal has closed yet. Abbvie announced another monster acquisition late last year: the $8.7 billion deal with Cerevel Therapeutics. This month, Novo Nordisk made a splash with a $16.5 billion offer to take over troubled CDMO Catalent. Also this month, Gilead Sciences announced plans to acquire CymaBay Therapeutics for $4.3 billion. Neil Versel is a senior editor at BioSpace. You can reach him at neil.versel@biospace.com. Follow him on LinkedIn or X. 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Innovent plans to release detailed results from the study at future medical conferences or in journals. Innovent Biologics is hoping that a phase 3 win for its thyroid eye disease (TED) treatment will provide a first shot at the Chinese equivalent of a market that has already been conquered by Amgen’s Tepezza in the U.S. Like Tepezza, Innovent’s candidate IBI311 targets the insulin-like growth factor 1 receptor (IGF-1R). The candidate hit the primary endpoint of the phase 3 Restore-1 trial by showing a greater reduction in eyeball protrusion—known as proptosis—than placebo. The percentage of subjects with a reduction in proptosis of 2 mm or more in one eye without the equivalent increase in proptosis in the other eye was 85.8% among the IBI311 group, compared with just 3.8% among those who received placebo. The candidate also showed “significant” improvement on key secondary endpoints for the trial, including overall response rate, percentage of subjects with a clinical activity score of 0 or 1, and mean change in proptosis from baseline, Innovent said in a Feb. 20 release. No serious adverse events occurred, added the biotech, which plans to release detailed results from the study at future medical conferences or in journals. Lei Qian, vice president of clinical development at Innovent, said the company plans to submit a new drug application to Chinese regulators “as soon as possible” based on the results. TED occurs in 16 out of every 100,000 women and 2.9 in every 100,000 men, according to Innovent. The condition is clearly a tempting target, with Horizon Pharma’s Tepezza quickly securing blockbuster sales. Horizon noticed a drop off in uptake in the drug’s third year on the market, with Amgen making this a top priority when it acquired the biotech in October 2023. Still, as the only approved treatment for TED in the U.S., Tepezza garnered sales of $1.66 billion in its first full year on the market and $1.97 billion in 2022 before stalling out. Amgen also sees an international opportunity for Tepezza. The drug is under review in Japan and the company will file this year for approval in Europe. A subcutaneous version of the treatment is also in development. "There are no targeted drugs approved in the field of TED in China so far, while the treatment costs of overseas targeted drugs are beyond many patients' reach,” Qian explained in Innovent’s release this morning. The clinical success of IBI311’s comes a month after mazdutide, a GLP-1/glucagon receptor agonist that Innovent licensed from Eli Lilly, demonstrated weight loss abilities in a phase 3 trial. Qian aligned these recent wins with the Chinese approval of its hypercholesterolemia injection Sintbilo in August 2023 as proof of the strength of Innovent’s late-stage strategy. “With the approval of Sintbilo, the NDA acceptance of mazdutide and the endpoints met in phase 3 study of IBI311, Innovent is strategically establishing its innovative commercial and late-stage portfolio in the fields of cardiovascular and metabolic diseases, endocrinology and ophthalmology,” Qian added. Innovent isn’t the only biotech looking to stake out a piece of TED territory. Last month, Kriya Therapeutics announced plans to get a gene therapy into the clinic for the condition next year, while Lassen Therapeutics has already dosed the first patient in a phase 1 trial of an interleukin-11 receptor targeted at TED.