Setrusumab partnered with Ultragenyx

Mereo Biophama has announced a licence and collaboration agreement with Ultragenyx for setrusumab (osteogenesis imperfecta, OI or brittle bone disease). The deal sees Ultragenyx pay $50m upfront and up to $254m on achievement of clinical, regulatory, and commercial milestones. Ultragenyx will lead the global development programme for both paediatric and adult patients, with a paediatric Phase II/III pivotal study expected to start in 2021.

Targeting TIGIT thoughtfully

Mereo BioPharma is set to progress its promising anti-TIGIT antibody, etigilimab, into Phase Ib/II trials for multiple solid tumour types in Q420. The study will focus on less common tumour types, including several rare cancers, and employ a flexible design to respond rapidly if data is promising. Phase II alvelestat results are expected in H221 for AATD, with Phase Ib data for COVID-19 likely in mid-21. A partner to progress setrusumab (osteogenesis imperfecta, OI) into the Phase III registrati

H120 results and corporate review

Mereo BioPharma is progressing the promising anti-TIGIT antibody, etigilimab, into Phase Ib/II trials for multiple solid tumour types in Q420 and intends to host an investor webinar focusing on this asset in a similar timeframe. Partnering discussions for setrusumab (osteogenesis imperfecta, OI), are ongoing with options sought to retain certain commercialisation rights. Clinical trials are underway again, with Phase II data for alvelestat in anti-alpha trypsin deficiency (AATD) is expected in H

H120 results and corporate review

Mereo BioPharma is progressing the promising anti-TIGIT antibody, etigilimab, into Phase Ib/II trials for multiple solid tumour types in Q420 and intends to host an investor webinar focusing on this asset in a similar timeframe. Partnering discussions for setrusumab (osteogenesis imperfecta, OI), are ongoing with options sought to retain certain commercialisation rights. Clinical trials are underway again, with Phase II data for alvelestat in anti-alpha trypsin deficiency (AATD) is expected in H

Interims set scene for pivotal 18-month period

Mereo BioPharma’s interims (Y/E Dec 31) are in line with management’s expectations, with operating losses of £16.7m vs. £18.8m prior year. Interims reflect the refinancing of the company in H1 2020 and the £56m fundraising (£51.4m net) in June 2020. The Company is now funded into early 2022, providing cash runway to deliver key clinical and business development milestones. These milestones include: i) the initiation of the 75-100 patient Phase Ib/II study for the lead candidate etigilimab in com

TIGIT programme starts the next chapter

Mereo BioPharma is entering a new, and exciting, stage in its journey. Following a successful $70m fund raise, the promising anti-TIGIT antibody, etigilimab, will be progressed into proof-of-concept Phase Ib trials. Other clinical assets, addressing oncology and rare diseases, are approaching key points and partners are sought. Setrusumab for osteogenesis imperfecta, is on track, subject to partnering, to initiate a Phase III registration study this year. The next 18-24 months should see several

Private placement raises $70m (£56m)

Mereo Biophama has successfully raised an impressive $70m (£56m) gross through a private placement with new and current US institutional investors. The fund raise was led by Orbimed and brought in Vivo Capital, Surveyor Capital (a Citadel company), Pontifax Venture Capital, Samsara BioCapital, Commodore Capital, and funds managed by Janus Henderson Investors. Existing investors such as Boxer Capital (Tavistock Group) and Aspire Capital Fund also participated.

Funding deals worth up to $33m announced

Mereo Biophama has announced two deals - a $5m convertible financing with Novartis and an up to $28m equity issue with Aspire Capital - that total up to $33m and effectively address the short term funding requirement and the facility provides flexibility for the medium term. ▪ The Novartis convertible financing consists of a three-year $5m Convertible Loan Note that can be converted at any time before maturity at 26.5p per ordinary share. There is also a warrant element, which allows for up to 1

Additional ASTEROID data supports progression

Mereo Biophama has released further positive data from the Phase IIb ASTEROID study. This pivotal trial evaluated setrusumab, a monoclonal antibody targetting sclerostin, in OI (osteogenesis imperfecta). OI, better known as brittle bone disease, is an orphan disease with different genotypes characterized by varying degrees of skeletal fragility. ▪ The top-line data from the 112 adult patient study were announced in November 2019 (see Update note). This showed the outcomes for secondary endpoints

Underappreciated but not unloved

Mereo BioPharma is developing a portfolio of rare disease therapies that have been sourced from larger drug players. An appropriate selection of these will be retained for self-commercialisation. The longer-term goal is the creation of a self-sustaining speciality pharmaceutical company that addresses Orphan and rare diseases. In the near term these clinical assets are progressed to value-inflection points and then partners are sought. The partnering deals will likely be structured to provide fu

Setrusumab ready to advance into pivotal studies

Mereo BioPharma’s Phase II ASTEROID study with setrusumab in osteogenesis imperfecta (OI) failed to achieve its primary endpoint, but the overall data was compelling. The gold standard for measuring bone mineral density (BMD) and indirectly bone strength, DXA, was a secondary endpoint and this achieved clear positive outcomes. There were significant increases in BMD in various bones, which were materially greater than that seen with teriparatide or bisphosphonates. Consistent with the total BMD

Setrusumab set to advance

▪ The Phase II ASTEROID trial with setrusumab in osteogenesis imperfecta (OI) disappointingly missed the primary endpoint of an improvement in trabecular volumetric bone mineral density (Tr vBMD) of the radius (wrist) measured by HR-pQCT, but did hit various secondary endpoints. ▪ There was unexpected heterogeneity in patient’s trabecular bone baseline values in their wrists (high and low), which contributed to the primary endpoint being missed. ▪ There were, however, significant increases i

Entering an important 12 month period

Mereo BioPharma made significant progress strategically during H119 with the completion of the merger with OncoMed, and now is entering a critical 12-month period. Full 12-month data from the Phase II study in osteogenesis imperfecta (OI) with setrusumab (BPS-804) is due in Q419; promising 6-month data in the open-label arm has already been reported. Phase II data with its second rare-disease asset, alvelestat (MPH-966), in α-1 antitrypsin deficiency (AATD) is expected in mid-2020. The company w

Encouraging interim BPS-804 data in OI

Mereo BioPharma has reported encouraging interim results from BPS-804’s Phase IIb trial in osteogenesis imperfecta (OI). Interim data from the open label arm of the 112- patient ASTEROID study showed a 1.4% improvement over baseline in the primary endpoint at three months and a 3.2% improvement at six months. The secondary endpoint showed a 3.5% improvement at six months. Clearly the sample size in this study arm is small (11 and 12 patients), but these data suggest the 12 month results (expecte

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

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

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

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

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

The Hardman & Co Monthly: April 2024

Feature article: Steady as she goes, but could be better: A review of investment company liquidity since 2016 Liquidity is the lifeblood of equity markets. The measurement of liquid asset availability to a market or company is a way of gauging a market’s health. This article builds on our previous work, which analysed the liquidity data for non-financial trading companies, by applying the same analytical techniques to the investment companies (IC) space. We analyse liquidity for ICs as a whol

Morning Note – 8 April 2024

Hybridan Small Cap Feast - 17 April 24

17th 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

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

LIBERUM: Futura Medical: An increasing degree of confidence

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

Creo Medical - Solid FY23 lays the groundwork for 2024

Creo Medical has released a trading update for FY23, an active year for the company, with progress made across all business segments. Traction improved in H223, following Speedboat Inject’s European clearance for upper gastrointestinal (GI) procedures and the accelerated approval and launch of Creo’s slimmest electrosurgical device, Speedboat UltraSlim. Top-line growth was supported by continued streamlining of the cost structure, resulting in a better-than-expected underlying EBITDA loss (impro

Hardman & Co Healthcare Index: 2023 – Capital demands dent performance

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 (

Morning Note – 7 December 2023

Morning Note – 22 March 2024