Partnering drives turn-round

Insufficiently financed to implement its integrated model, Curetis has opted to market its infection diagnostic Unyvero platform through established players. In Europe, Curetis will now leverage the extensive sales and marketing infrastructure of Menarini. While maintaining a direct sales capability for now, we anticipate that Curetis will also move towards a co-distribution model to exploit the substantial US opportunity. Prospects in China remain bright with partner Beijing Clear Biotech ("BCB

Convertible secures room to manoeuvre

While convertible instruments of this type can be expensive, the €20m financing facility secured with Yorkville Advisors provides necessary room to manoeuvre. Immediate access to €3.5m (net €3.22m) and a further €1.5m (net €1.38m) fulfils the company's short-term cash needs. This should allow the company to pursue alternative financing in the capital markets or by securing strategic and / or non-dilutive financing from larger corporates, as it delivers on its strategy. A further €17.5m in conver

On track to exceed our expectations

Curetis's H1/2018A statement suggests upsides beyond our current expectations. On track to deliver its 6 - 12 month US installed base guidance, Curetis is already indicating possible US system occupancy and cartridge usage in excess of our current projections. With the Chinese regulatory strategy progressing and an increasingly active global distribution network, we see significant product revenue growth moving forwards. Further deal flow with major global partners is expected near term and coul

European growth highlights US opportunity

Growth in Europe in Q1/2018 strengthens our optimism for the US Unyvero launch. Less fragmented and more innovative the US presents a major opportunity. Infection and antibiotic resistance are increasing issues in commercially-driven US healthcare; threatening both patients and bottom line. Unyvero's unique capability and product pipeline should speed US adoption in severe disease. Longer term Curetis's unmatched anti-microbial resistance ("AMR") platform should secure market share for the lower

FDA opens door to opportunity

The much anticipated FDA approval of the Unyvero platform and first lower respiratory tract ("LRT") cartridge is clearly transformative, opening the door to substantial opportunities in the US and beyond. While growth in Europe has disappointed, we believe clear differences between the markets should see significantly faster growth in the US. We are optimistic that the first US launch and the prospect of a pipeline of additional US cartridge approvals should have a positive impact on both instal

Focus on US launch

Sluggish EU sales growth and slippage in the installed base target into Q1/2018 were sure to disappoint. While exact timing can never be assured, we remain confident that FDA approval will take place within the next month or two. While it is always possible that approval may drop into next year, the 2018 US launch of the Unyvero platform remains the major Curetis driver. We believe clear differences between the markets should see significantly faster growth in the US compared with Europe. We rem

FDA approval major catalyst in H2

Although early revenues from Unyvero platform in Europe remain lumpy and perhaps disappointing the market in the first half, FDA approval and US launch appear on track and should provide major catalyst towards end H2. With first deal flow from GEAR antibiotic marker platform as early as year end and the prospect of additional deals from the Gyronimo platform during 2018 / 2019, 12 month news flow looks positive. The installed base is expected to reach >200 in line with guidance and European sale

Positive outlook for first approval in US

The focus of Curetis's Q1 update was on the status of the company's first 510(k) application for its lower respiratory tract cartridge ("LRT") following the 'Submissions Issues' meeting last month. While feedback on the tracheal aspirate component was positive, the bronchial lavage ("BAL") still needs fine-tuning. Curetis has sensibly decided to move forward with the approval and launch of the tracheal aspirate on its own, thus avoiding an Advisory Committee Panel and keeping launch on track for

On the cusp

The promise of first US approval and accelerating growth in Europe places Curetis on the cusp of an inflection point. Prospects for US approval H2/2017 look bright. The now fully established European sales team is expected to drive the total installed base to 200 - 240 as well as boost cartridge sales; with increased cartridge volumes per installation already reported. The potential of the GEAR and Gyronimo platforms to propel differentiated products into an expanded market remains unappreciated

Building momentum for 2017

Today Curetis announced the installation of its 150th system. Curetis sees growing momentum for the worldwide commercialisation of its Unyvero platform over the coming year. With its European sales team fully in place since Q3/2016 and an expanding global distributor network, the company is increasingly positive as to new system placements as well as increasing diagnostic cartridges sales from existing customers. With US FDA approval also anticipated during the year, the prospects look bright fo

Going global from specialist to routine

Growing in Europe and with launches anticipated in the US in 2017 and China in 2018, Curetis is establishing a worldwide presence with its specialist Unyvero infectious disease platform. The company is now seeking to leverage its growing installed base, double its long term market potential and consolidate its competitive position. The addition of the fast and flexible Gyronimo platform combined with the GEAR database will allow Curetis's customers to perform a full range of both specialist as w

Major step towards US market

Curetis announced this morning that the US FDA trial for its lower respiratory tract cartridge (LRT55) had met its primary endpoint, achieving overall weighted average sensitivity and specificity of 90% and 99% respectively. While the company is seeking confirmation for some of the rarer pathogens through the ongoing analysis of contrived samples, Curetis is confident that these data are already sufficient to form the basis for the FDA approval of a commercially viable test. This is clearly a ma

GEARed up against antibiotic resistance

Curetis is strengthening its position as a leader in antibiotic resistance. Having acquired perhaps the most comprehensive antibiotic resistance database GEAR (GEnetic Antibiotic Resistance) from Siemens, the company believes it is now well placed to strengthen and extend its competitive position in infectious disease diagnostic screening, whilst at the same time building a high value platform for collaborative development of new much needed antibiotics and companion diagnostics.

US on-track with a positive view

Curetis reported today that it had now completed enrolment for the prospective arm of the FDA trial of its second generation lower respiratory tract panel LRT55. In line with expectations, the company is on track for US regulatory clearance and launch by mid-2017. Also following on from our recent initiation, we have spoken to a senior clinical scientist using Curetis's Unyero infectious disease diagnosis platform. Based in a leading UK University hospital the scientist trialed the platform for

Getting Personal with Pathogens

Health systems and hospitals are increasingly struggling to cope with microbial infections and associated antibiotic resistance. Curetis is a molecular diagnostics company focussed on the identification of pathogenic microbes and antibiotic resistance in patients with complex infections to help physicians more effectively meet this threat.

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