BerGenBio - Termination of coverage

Edison Investment Research is terminating coverage on SandpiperCl (SANDPI), Mirriad Advertising (MIRI), Trackwise Designs (TWD), Lookers (LOOK) and BerGenBio (BGBIO). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

BerGenBio - No surprises as bemcentinib strategy progresses

BerGenBio’s (BGBIO’s) Q122 results are generally in line with recent trends, with a Q122 operating loss of NOK78.6m (-6% y-o-y). The reduction was largely due to lower clinical trial expenses as the company is now preparing for its next studies on lead candidate bemcentinib. Operating cash outflows increased year-on-year to NOK74.2m (vs NOK70.8m in Q121) primarily due to working capital movements, resulting in the company finishing the quarter with NOK367m in net cash, which, at current burn rat

BerGenBio - Focusing in on 1L NSCLC and COVID-19

BerGenBio (BGBIO) has announced an updated business strategy for its lead drug candidate, oral AXL inhibitor bemcentinib, which will focus on first-line (1L) non-squamous non-small cell lung cancers (NSCLCs) carrying the STK11 mutation and on hospitalised COVID-19 patients. The decision to move bemcentinib to the 1L setting could significantly broaden its target population among NSCLCs, given that c 20% of such cancers carry the STK11 mutation (~30,000 patients). Following encouraging data from

BerGenBio - Checking its course

With a new CEO at the helm, BGBIO has completed an internal review and outlined its strategic priorities for bemcentinib. Building on impressive Phase II BGBC003 data presented at both EHA and ASH in 2021, a randomised, placebo-controlled trial for second-line AML is due to start H222. We assume the trial will be registrational, but note this is subject to outcomes from its discussions with regulators. In NSCLC, data from the ongoing Phase II BGBC008 trial are expected during H122 and should p

BerGenBio - Martin Olin succeeds Richard Godfrey as CEO

BerGenBio (BGBIO) has announced the appointment of a new chief executive officer (CEO), Martin Olin, with effect from 8 September 2021. Martin Olin has more than two decades of executive experience in the pharmaceutical and biotechnology industry and previously served as CEO of Symphogen, a clinical-stage biotech developing monoclonal antibody based treatments for a variety of cancers, prior to its acquisition by Servier in 2020. While the timing of this announcement does come as a surprise, we

BerGenBio - Advancing towards pivotal studies

BerGenBio (BGBIO) has made continued progress in H121 in advancing the development of lead asset bemcentinib (an oral, once-a-day, highly selective AXL inhibitor). A deluge of data presentations from Phase II studies in COVID-19, AML and NSCLC continue to highlight the broad potential of this first-in-class treatment. Discussions with regulators are ongoing regarding a pivotal study in relapsed AML in combination with LDAC, which could enable potential approval and launch in 2024. COVID-19 prese

BerGenBio - FDA grants fast track designation

BerGenBio (BGBIO), a pioneer in AXL biology and the development of AXL inhibitors, has two clinical-stage assets: selective tyrosine kinase inhibitor bemcentinib and functional blocking monoclonal antibody tilvestamab. FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment. BGBIO has also presented data from the ong

BerGenBio - Bemcentinib preliminary data in COVID-19

BerGenBio (BGBIO) has announced preliminary data for lead asset bemcentinib, an oral once daily highly selective AXL inhibitor for the treatment of severe COVID-19 infections requiring hospitalisation. In the Phase II ACCORD-2 and BGBC020 trials, treatment with bemcentinib led to numerically fewer deaths versus standard of care up to day 29. Preliminary analysis of the primary endpoint, time to clinical improvement of at least two points on the WHO nine-point ordinal scale, or live discharge fro

BerGenBio - AXLeration of data catalysts in 2021

BerGenBio (BGBIO) has made steady progress during 2020. Lead asset bemcentinib (oral, once a day, highly selective AXL inhibitor) reported encouraging efficacy data from ongoing Phase II trials. Multiple catalysts expected in 2021 will define BGBIO’s clinical trial strategy in AML/MDS and/or NSCLC. The FY20 operating loss was significantly higher than in FY19 (NOK261.1m vs NOK204.4m) due to higher set-up costs and increased investment in programme expenses. We expect operating expenses to increa

BerGenBio - Progressing towards key inflection points

BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020. Following these data, we anticipate a registrational Phase III study of bemcentinib plus low-dose cytarabine (LDAC) in relapsed elderly AML patients to start in 2021. We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted). Bemcentinib is an oral, first-in-class, highly selective AXL tyrosine kina

Promising results in relapsed AML presented at ASH conference

Updated clinical data in MDS and AML studies presented this weekend Reported overall response rate of 45% (5/11) in relapsed AML Reported overall response rate of 36% (8/22) in HR-MDS The data continue to support the benefit of bemcentinib in MDS and AML

BerGenBio - Bemcentinib leading the AXL charge

BerGenBio (BGBIO) is a pioneer in AXL biology and the development of AXL inhibitors: selective tyrosine kinase inhibitor (TKI) bemcentinib and functional blocking monoclonal antibody tilvestamab. AXL expression is a negative prognostic marker in most cancers. Its upregulation drives aggressive disease including drug resistant, immune-evasive and metastatic cancers, as well as fibrosis and viral infection. AXL signalling is the essential mediator of EMT and immune suppression. Selective AXL inhib

Summary from SITC presentation

BerGenBio presented results from its ongoing study in NSCLC The presented data was in checkpoint refractory patients No new response data was presented Next data trigger is the ASH conference, December 6th, for the AML study

R&D Day Highlights with path to market

Clinical and pre-clinical data First route to market presented in AML 2L relapsed AML chosen as ideal path to registration Potential pivotal study to start in 2021

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

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

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

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

Morning Note – 24 April 2024

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

Hybridan Small Cap Feast - 25 April 2024

25th 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: Smart Metering Systems (SMS.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

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