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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
Companies: IMMUNICUM (IMMU:STO)Mendus AB (IMMU:OME)
Edison
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
Mendus has announced that it has secured financing commitments of c SEK317m, realised through an equity issue. The proposed capital raise consists of a SEK90m directed issue to Flerie Invest and a SEK227m fully secured rights issue. Through both subscriptions, shares will be offered at SEK0.48 per share, resulting in the issuance of c 660m new shares. Shares in both the directed issue and rights issue are attached with warrants that, if fully exercised at the strike price of SEK0.48/share, could
On the heels of Mendus’s recent Q123 results, we take a deep dive into the company’s lead cancer vaccine candidate, vididencel, and the acute myeloid leukaemia (AML) maintenance treatment landscape. On closer inspection of the current AML pipeline and standard of care (SoC), vididencel’s clinical profile and the potential advantages associated with the vaccine’s ‘off-the-shelf’ characteristics may enable more timely and wider access of treatment to patients compared to individualised therapy app
Mendus’s Q123 report provided an insight into the strategic next steps for its lead cancer vaccine, vididencel (DCOne), as the company pursues a clinical path in the acute myeloid leukaemia (AML) maintenance setting. Following the positive results from the Phase II ADVANCE II study, Mendus intends to initiate a follow-on Phase II study in H223, investigating the combination of vididencel with oral azacitidine (current standard of care, SoC) as an AML maintenance treatment regime. It had previous
Mendus recapped highlights of the positive clinical readouts from its ADVANCE II study in acute myeloid leukaemia (AML) in an investor update in conjunction with its annual filing. Management intends to continue focusing on the development of vididencel (DCP-001) and broaden its positioning as an AML maintenance therapy with two additional studies in AML, a Phase I study in AML patients post-hematopoietic stem cell transplantation (HSCT) and a Phase II trial in combination with standard-of-care
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Companies: BILN IGP RBN SBTX
Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
Companies: BIRD MBH CHRT INSE KMK FNTL HDD JNEO CCS
Hybridan
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
Companies: CLBS GHH NANO TRX SAVE TMT GELN
The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Hardman & Co
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
Companies: NTQ KMK JNEO DCTA
LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
Companies: Warpaint London PLC
Shore Capital
Evgen Pharma has acquired Chronos Therapeutics Ltd for a total upfront consideration of c£0.9m, payable in Evgen shares. Accompanying this, Evgen has conditionally raised gross proceeds of £0.85m through an equity placing with the potential to raise a further £1.0m through a retail open offer and additionally up to £2.0m. The proceeds will fund several initiatives including maintenance of the acquired Chronos Therapeutics patent portfolio and to continue support manufacturing for lead clinical a
Companies: Evgen Pharma Plc
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