Transformative safe effective oral anti-inflammatory

With compelling Phase 2 data in both ulcerative colis("UC") and rheumatoid arthritis ("RA") ABX464 looks well positioned as a potential broad range anti-inflammatory. Oral and safe ABX464 appears has efficacy on par and better sustained than competing drugs. Phase 2b UC data shows 58% of patients in clinical remission after 48 months of maintenance therapy. Phase 2a rheumatoid arthritis ("RA") data achieved the primary safety and tolerability endpoint and statistically significant improvement in

RA Phase 2a opens door to $90bn market

Phase 2a rheumatoid arthris ("RA") data not only achieved the primary endpoint of safety and tolerability, but also stascally significant improvement in the ACR20 and encouraging signals in other RA disease measures; despite being insufficiently powered. 60 paents with inadequate response to methotrexate and  or TNFα inhibitors were included in the trial. Adverse events ("AE") were mild and dose dependent. While there were some AE-related paent drop out, recent data in ulcerave colis ("U

ABX464 likely drug of choice in $18bn IBD market

First data from Phase 2b in ulcerave colis ("UC”) demonstrates stascally significant improvement in the Modified Mayo Score ("MMS") the primary endpoint. The 254-paent trial including 50% of paents refracve to exisng biologic or JAK therapies showed ABX464 to be effecve at all doses tested (25mg, 50mg, 100mg) with a rapid onset of acon detectable at day 8. Although not powered, the trial also achieved stascal significance in almost all secondary endpoints, except clinical remission a

ABX464 potential therapy of choice in bowel disease

With first ABX464 data from Phase 2b in ulcerave colis ("UC”) expected in midMay and from Phase 2a in rheumatoid arthris end Q2, the next two months could be transformave for Abivax. As highlighted in the recent KOL webinar, while there are already mulple therapies, diagnosed largely in younger paents there is sll a substanal and growing unmet need in UC for a safe, effecve, convenient and well tolerated drug that can be used over many years. Orally delivered and proven safe in mulple

COVID disappointment of little relevance to chronic programmes

While termination of the ABX464 COViD Phase 2b / 3 miRAGE trial is clearly a disappointment, we see little read-through to the core ABX464 programmes in chronic inflammation. The basis of the acute inflammatory storm in patients with severe COVID remains poorly understood. These negative data likely reflect the distinct natures of acute and chronic inflammatory disease, where strong Phase 2 data in ulcerative colitis already supports ABX464 safety and efficacy. Abivax remains substantially unde

Calming COVID and the inflammatory storm

Combining anti-viral and anti-inflammatory actions, ABX464 looks ideally placed for the COVID therapy. Data from the on-going COVID Phase 2b / 3 would be transformational with a still immediate need for treatment; effective vaccines still face substantial manufacturing and distribution hurdles. With strong Phase 2 safety and efficacy data in ulcerative colitis, Abivax also remains substantially undervalued on the basis of its ABX464 chronic inflammatory programme alone. Now fully funded to compl

ABX464 in COVID-19 - a potential game-changer?

Abivax announced today that ABX464 had been cleared to start Phase 2b / 3 clinical trials in the treatment of COVID-19 infection in diagnosed high risk patients. Orally delivered ABX464 has a combined anti-inflammatory and anti-viral action that could make it a game-changer in COVID-19 therapy. Developed originally as an HIV antiviral, ABX464 has already been shown in clinical trials in ulcerative colitis ("UC") to repress effectively many of the inflammatory mediators that also underlie the sev

ABX464: More impressive anti-inflammatory data

Data presented at the United European Gastroenterology Conference ("UEG") further support the impact of Abivax's ABX464 on ulcerative colitis ("UC"). While response to biologic therapies such as anti-TNFs often wains with time and alternatives including JAK inhibitors are associated with serious safety issues, 12-month Phase 2a extension endoscopic data indicate sustained and improving clinical remission with ABX464 in 75% of patients observed. Matched by improvements in both Mayo Score and faec

Financing provides strong endorsement

The €12m investment by a leading healthcare investor (Sofinnova Partners), is a strong endorsement of Abivax and anti-inflammatory ABX464 in particular. As highlighted in our recent report (25th June 2019), clinical data to date suggests that ABX464 could take a meaningful share of the $70bn anti-inflammatory market. The unmet potential of the inflammatory market is well illustrated by the recently announced $5.1bn deal between Gilead Sciences Inc. and Galapagos NV. With future financing expecte

Ready to deal with inflammation

Focussed on identification and exploitation of regulators of immunity and inflammation, Abivax has two major products in clinical trials. With Phase 2a efficacy on a par with recently approved tofacitinib, ABX464 shows sustained benefit in ulcerative colitis ("UC") without the safety concerns of JAK or anti-TNF drugs. Moving into confirmatory Phase 2b for UC and Phase 2a in Crohn's and rheumatoid arthritis ("RA"), ABX464 promises a meaningful share of the $70bn anti-inflammatory market and a sub

ABX464: sustained safety and benefit in inflammatory bowel

Data presented at the ECCO (European Crohn's and Colitis Organisation) support the potential of Abivax's ABX464 in ulcerative colitis ("UC") While response to biologic therapies such as anti-TNF often wains with time and alternatives including JAK inhibitors are associated with serious safety issues, six month Phase 2a extension data indicate safety and progressive improvements from ABX464 in key UC disease markers, including Mayo Score and faecal calprotectin over the eight months since the ori

Getting a brake in inflammation

With proof-of-concept trials in ulcerative colitis ("UC") suggesting efficacy on a par Abivax's ABX464 looks a real alternative to approved therapies. A new class of oral drug releasing a natural inflammatory brake, ABX464 could alleviate the treatment failures and possibly safety issues of existing drugs. This would open a significant opportunity in a > $70bn market. We are optimistic that clinical studies planned for 2019E should confirm the UC results and may suggest efficacy in Crohn's Disea

Remarkable data opens door to $15bn IBD market

Phase 2a ulcerative colitis ("UC") data indicates real promise for the ABX-464 in the $15bn inflammatory bowel disease ("IBD") market. A small early stage trial, positive read-out on all key parameters suggests real benefits from this oral once a day drug for patients seeking to avoid repeated intravenous infusions or at worst surgical bowel removal. Already showing promise in the depletion of latent HIV reservoirs, these new data should significantly de-risk the drug's path to market potentiall

ABX464 reduces HIV DNA in latent viral gut reservoir

Data released from the second cohort of the ABX-464-005 trial indicates that ABX-464 can reduce the latent HIV reservoir in gut as well as in peripheral blood in patients receiving anti-retroviral therapy. Compared to the first trial cohort, these data suggest that the drug is safe when used over a longer period (3 months vs. 28 days) and has an impact on multiple latent viral reservoirs in HIV-infected patients; even when u sed at a third of the dose (50mg/day vs. 150mg/day). While full data fr

HIV: Draining the reservoir; cooling the flame

While retroviral therapy now sees patients survive into their seventies, latent residual infection still condemns the HIV-infected to life time therapy, chronic health problems and shortened lives. Compelling preclinical data now supported by two Phase II human trials indicate that Abivax's ABX464 could be the first drug to drain the latent HIV reservoir. With its novel mode of action ("MoA"), the drug may not only act to reduce or even eradicate residual infection untouched by existing antiretr

Warpaint London+ (W7L, House Stock at 470p) - Outstanding FY23A - Upgrades!

Shield Therapeutics - Termination of coverage

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

Cambridge Nutritional Sciences - Operational efficiencies; adjusted EBITDA profi

Cambridge Nutritional Sciences (CNS) has provided a trading update for the 12 months to 31 March 2024, noting that a combination of strong sales growth and significant margin improvements, driven by operational efficiencies, have played key factors in the group’s expectation of being adjusted EBITDA positive in FY 2024. Revenues are expected to be £9.8m (30% YoY growth), ahead of our £9.0m forecast, with gross profits expected to exceed £6m, which is again ahead of our year-end forecast of £5.6m

Creo Medical Group - Speedboat savings validated

An official NHS Supply Chain case study has quantified the savings made by an NHS Trust from adopting Creo Medical’s Speedboat device to perform Speedboat Submucosal Dissection (SSD) in comparison to surgical alternatives. In total, the net cash saving from 130 SSD procedures for the NHS Trust was calculated at £687k, including savings from reduced length of hospital stay and reduced theatre costs. Notably, these savings did not include the patient and financial benefits associated with reduced

Futura Medical: Eroxon poised for launch in key US market

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

Morning Note – 24 April 2024

Destiny Pharma plc+ (DEST, House Stock at 22p) - All eyes on XF-73

Creo Medical - NHS data validates Speedboat’s economic merit

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

Hybridan Small Cap Feast - 24 April 24

24th 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: 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 acquire the entire issued share capital of 3radi

Warpaint London+ (W7L, House Stock at 375p) - Trading ahead of expectations - +10% upgrade implied

Hybridan Small Cap Feast - 22 April 2024

22nd 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: 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 acquire the entire issued share capital of 3radi

Cambridge Nutritional Sciences - H1 2024 interims: Executing a newly focussed st

Cambridge Nutritional Sciences (CNS) has published its H1 2024 results to end September 2023. Group revenues grew 44% to £4.9m and gross profits increased by 63% to £3.1m, with the company benefitting from newfound operational efficiencies. With its now streamlined strategy focussing on the core Health & Nutrition business and the initial signs of an encouraging uptick in sales momentum, we believe the company is well positioned for growth that will help create future value for shareholders. We

e-therapeutics - Termination of coverage

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

Venture Life Group - Strong organic growth; focus on EBITDA

Venture Life has reported FY23 results to December 2023, following the February trading update. Revenues grew 17% in the year to £51.4m (our est. £50.7m) and adjusted EBITDA was £11.6m (our est. £11.6m). Cash conversion was 85%, generating £9.8m of cash from operations. Cash generation and no M&A in 2023 allowed the company to de-lever, closing FY23 with net debt to adjusted EBITDA at 1.3x. Management have focused on growth with three therapy areas generating double-digit revenue growth and onli

Warpaint London (W7L, House Stock, 196p) - Strong foundation, even stronger upgrade momentum