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Mendus has reported gross proceeds of c SEK69.1m from the exercise of series TO3 warrants that were issued in connection with the July 2023 raise of SEK317m. Management anticipates that these proceeds will extend the cash runway to Q325 and will be applied to progress its clinical pipeline, mainly in preparation for a registrational trial for lead cancer vaccine vididencel, targeting acute myeloid leukaemia (AML) in the maintenance setting. Management expects the registrational study to commence
Companies: IMMUNICUM (IMMU:STO)Mendus AB (IMMU:OME)
Edison
The Human Research Ethics Committee (HREC) has provided the green light to commence enrolment for Mendus’s AMLM22-CADENCE trial from April 2024. This Phase II trial in collaboration with the Australasian Leukaemia and Lymphoma Group, a clinical trial research group focused on haematological cancers, will evaluate lead cancer vaccine vididencel, in combination with standard of care oral azacitidine (Onureg) as a maintenance treatment for acute myeloid leukaemia (AML). A pivotal global registratio
Mendus is forging ahead with vididencel, its primary clinical asset, aiming to address a market niche: the acute myeloid leukaemia (AML) maintenance setting. The company is gearing up to launch the Phase II CADENCE combination trial assessing its lead cancer vaccine candidate, vididencel, in combination with oral azacitidine (Onureg), the only approved AML maintenance drug, to prevent relapse after remission for AML patients. This study is being conducted in collaboration with the Australasian L
Mendus has reported FY23 results, summarising an active period. For its lead asset, vididencel, long-term survival data from the ADVANCE II trial reinforce the drug’s potential as maintenance therapy in acute myeloid leukaemia (AML). We look forward to the launch of the Phase II CADENCE trial in Q124 to explore potential synergy with the standard of care (Onureg, oral azacitidine), which will be an important milestone. The interim results from this trial will guide plans for the pivotal stages o
Mendus wrapped up FY23 with a clinical pipeline update. Management is maintaining its plans to explore ilixadencel in soft tissue sarcomas (STS), with the Phase II trial due to start in H124 and the MERECA trial (ilixadencel) in metastatic renal cell carcinoma (mRCC) no longer being pursued. The MERECA long-term follow-up has confirmed findings from the initial study (no significant survival difference between the monotherapy and combination arms). Our valuation remains unchanged as our estimate
Mendus has presented positive survival data for the ADVANCE II trial with its lead asset, vididencel, at the American Society of Hematology (ASH) 2023 meeting. The presentation and follow-on KOL (investor) event showcased vididencel’s competitive profile to date over the standard of care, Onureg (oral azacitidine), as a potential maintenance therapy for acute myeloid leukaemia (AML) patients. The encouraging data are a step toward addressing an ongoing medical need, as we understand that roughly
Mendus has entered into a collaboration with the Australasian Leukaemia & Lymphoma Group (ALLG) to initiate the ALLG AMLM22 CADENCE trial for its lead asset, vididencel, in combination with Onureg (oral azacitidine) as a maintenance treatment in acute myeloid leukaemia (AML). This progression is encouraging for Mendus’s lead programme as there are very few maintenance treatment options currently available, and we expect the collaboration to support the programme’s development. The adaptive, rand
Mendus’s Q323 update was primarily focused on the clinical progression of its lead cancer vaccine, vididencel, which is being developed for acute myeloid leukaemia (AML) and ovarian cancer (OC). The latest interim data from the Phase II trial (ADVANCE II) demonstrated compelling efficacy, which, in our view, enhances the drug’s prospects as a potential AML maintenance therapy. Mendus’s key catalysts include: detailed data from the ADVANCE II trial, due to be presented at the 11 December American
Mendus has announced that it has been granted three abstracts, including an oral presentation at the American Society of Hematology (ASH) 2023 meeting, relating to the clinical development of vididencel as a maintenance therapy for acute myeloid leukaemia (AML). There are limited treatment options for AML maintenance, which is likely a key consideration in the selection of ADVANCE II data for an oral presentation. The update is anticipated to include relapse-free survival (RFS) and overall survi
Mendus has announced that the FDA has granted Fast Track designation to its lead cancer vaccine, vididencel, as a potential maintenance therapy in acute myeloid leukaemia (AML). This regulatory decision was based on interim results from the ADVANCE II trial (reported in December 2022), which showed encouraging survival data to support vididencel as a monotherapy in AML maintenance, as well as a desirable safety profile. Benefits of Fast Track designation include more frequent interactions with t
Mendus has shared its Q223 report, including a financial update and overview of its clinical activities. Highlights from the quarter include positive interim data for lead asset vididencel in ovarian cancer (OC) and the secured alliance with NorthX Biologics to establish large-scale manufacturing capabilities for pivotal-stage clinical development and commercialisation. At end-Q223, Mendus had net debt of SEK49m, but with the equity raise announced in August 2023 (rights issue: SEK227m; directed
Following its previous announcement of secured financing commitments, Mendus has raised SEK227m through a rights issue and SEK90m through a directed issue to Flerie Invest. Post shareholders’ approval at the extraordinary general meeting (held 10 July 2023) and completion of the fund-raise (announced 28 July 2023), Mendus’ total outstanding shares will increase from 202.7m to 863.1m, from 10 August 2023. Mendus intends to utilise the proceeds from the issue to finance crucial inflection points,
Mendus has provided an update on its development plans for its lead cancer vaccine, vididencel, primarily targeting the acute myeloid leukaemia (AML) maintenance setting. Management expects to share updated survival data in Q423 for its ongoing ADVANCE II trial, consistent with prior guidance; vididencel is being investigated as a monotherapy for AML maintenance. Management also intends to maximise the potential of vididencel by preparing for a Phase II combination study with Onureg, the only ap
Research Tree provides access to ongoing research coverage, media content and regulatory news on Mendus AB. We currently have 41 research reports from 1 professional analysts.
Companies: CNC RNO MAI IUG CUSN POLB
Cavendish
Companies: STX FADL POLB
Poolbeg Pharma has announced FY 2023 results to end December 2023, which positively reflect the company’s capital-efficient operating model with net cash of £12.2m being reported, significantly ahead of our expectations (2023E: £10.9m). Meaningful R&D progress whilst maintaining financial prudence means that Poolbeg enters 2024 with a strong balance sheet in absolute terms and relative to many biotech peers, with a cash runway (to fund the existing R&D pipeline) we forecast will extend into 2026
Companies: Poolbeg Pharma PLC
Companies: Warpaint London PLC
Shore Capital
Companies: Inspiration Healthcare Group PLC
Liberum
1st May 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: REDX Pharma (REDX.L) has delisted from the AIM Market What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing
Companies: TXP CNC RNO MAI ANX IUG CUSN POLB
Hybridan
Companies: 88E CNC FTC TRCS HEIQ CREO ZAM
Companies: Destiny Pharma Plc
Edison Investment Research is terminating coverage on ABC Arbitrage (ABCA), paragon (PGN), Foresight Solar Fund (FSFL), Kendrion (KENDR), Lithium Power International (LPI), Triple Point Energy Transition (TENT), 4iG (4IG), e-therapeutics (ETX), Pharnext (ALPHA) and Shield Therapeutics (STX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant. Previously published reports can still be accessed via our web
Companies: Shield Therapeutics Plc
26th April 2024 A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: C4X Discovery Holdings (C4XD.L) has left AIM. What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admission to trading on AIM, Electric Guitar is proposing to acqu
Companies: ROQ SOU PRM ITM THRU LGRS KIBO ADF
Companies: TheraCryf PLC (TCF:LON)Poolbeg Pharma PLC (POLB:LON)
Creo Medical has presented real-world evidence of the economic utility of its minimally invasive electrosurgical devices, based on NHS data from 130 submucosal dissection procedures using Creo’s flagship Speedboat Inject device. The data demonstrated net cash savings of £687k for the NHS trust, driven by a significant reduction in both hospitalisation and critical care costs. We believe this provides external validation to Creo’s pursuit of improving patients’ outcomes through its novel suite of
Companies: Creo Medical Group Plc
FY23 was a transitional year for Biodexa, following the restructuring announced in March 2023 into a therapeutic company from a drug delivery specialist, and the implementation of cost-saving initiatives in light of the macroeconomic environment. The pipeline expansion primarily de-risks the business, partially fulfilled with the acquisition of lyn kinase activator tolimidone, for type 1 diabetes (T1D), in late 2023. Management estimates gross cash of £5.97m at end-FY23 to provide a runway into
Companies: Biodexa Pharmaceuticals plc Sponsored ADR
30th April 2024 * A corporate client of Hybridan LLP ** Arranged by type of listing and date of announcement *** Alphabetically arranged **** Potential means Intention to Float (ITF) has been announced Dish of the day Admissions: Delistings: Wincanton (WIN.L) has left the Premium list of the Main Market Byotrol (BYOT.L) has left the AIM Market What’s baking in the oven? ** Potential**** Initial Public Offerings: Reverse Takeovers: 16 April 2024: Electric Guitar (ELEG.L) Concurrent with its Admis
Companies: KOO CLCO TRT AVCT KIBO POLB
Futura Medical’s investment case has shifted firmly onto commercial execution. The highly successful initial launches of Eroxon, its novel topical gel for ED (erectile dysfunction), by partner Cooper Consumer Health in the UK and Belgium are now being followed by roll-outs across the major European markets. The much-anticipated launch in the commercially important US market by consumer healthcare giant Haleon is expected before February 2025. Launches in Other Regions are anticipated throughout
Companies: Futura Medical plc
Trinity Delta
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