Futura Medical confirms the timelines for the regulatory filings for MED3000, its novel erectile dysfunction (ED) treatment, are on track. Dialogues with both the US FDA and European Notified Body have been constructive. The EU Notified Body has begun its review of the supporting documentation and the FDA filing is still expected by end-Q320. There have been no COVID-19 related delays but, in our view, these remain a consideration. We assume the review processes will take a minimum of 12 months in both cases, so have approvals pencilled in for Q421. Commercialisation discussions are expected to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.
Companies: Futura Medical
Futura Medical is approaching a key point as the first of the regulatory filings for its novel erectile dysfunction (ED) treatment, MED3000, is expected within the next few months. MED3000 is a fast-acting gel that has proven clinical efficacy, a fast onset of action, and an attractive commercial profile. The ED market opportunity is sizeable, especially once MED3000 becomes widely available over the counter (OTC). Optimally addressing the various elements of the demographic segments and needs of the different geographies will, in our view, require careful selection of commercial partners. We expect the partnering discussions to start in earnest once the status of the regulatory approvals is known. Our DCF-based model, using conservative assumptions, values Futura Medical at £153.8m, equivalent to 60.9p a share.
Companies: SYS DDDD CCS ANGS ODX RENX YGEN FUM BARK ENET
Novacyt* (NCYT.L): COVID-19 test update | Futura Medical (FUT.L): Confirmation of FDA minutes
Companies: Novacyt Futura Medical
Ixico plc (IXI.L): Expansion of client contracts | Futura Medical (FUM.L): Conditional £3.25m fundraise
Companies: IXICO Futura Medical
Futura Medical has presented details of the pivotal Phase III study (FM57) results for its lead compound, MED2005. All doses achieved all primary endpoints against baseline (p<0.001) throughout the 12-week period, with secondary endpoints also being met. However, the placebo arm, consisting of the DermaSys formulation alone, achieved similarly impressive results. Dose-dependent variation in side-effects should allay fears that administration errors may be to blame. These data suggest that the DermaSys gel alone has a significant clinical effect across the three severities of ED (Erectile Dysfunction) examined. Clearly the data needs to be digested, but this would appear to open up new opportunities, especially in terms of regulatory pathways, patent life, and commercial potential. Until we have greater visibility, we suspend our valuation and forecasts; for context we valued Futura Medical at £127m (62p a share).
Oxford Biodynamics (OBD.L): Final-results for 2019 | Futura Medical plc (FUM.L): Lead candidate misses primary endpoint vs placebo in Phase 3 trial
Companies: Oxford Biodynamics Futura Medical
Futura Medical has reported the results of the pivotal Phase III study (FM57) for its lead compound, MED2005. Whilst all doses achieved all primary endpoints against baseline (p<0.001) at 12 weeks, there was no differentiation between any active arms and placebo. The placebo arm consisted of the DermaSys formulation and these results suggest that this proprietary gel has an effect comparable to the active arms at all three glyceryl trinitrate doses (0.2%, 0.4%, and 0.6%). This data is clinically relevant and suggests that DermaSys alone may be effective in treating Erectile Dysfunction (ED). Clearly the data needs to be digested before licensing discussions with possible partners continue. Equally, the commercial opportunity, especially the OTC potential, will need to be assessed. Until we have greater visibility, we suspend our valuation and forecasts; for context our model valued Futura Medical at £127m (62p a share).
MJ Hudson Group PLC, the financial services support provider to Alternatives fund managers and asset owners, is planning an AIM IPO. Deal details TBC.
Companies: EAI FOG ERIS ZYT JNEO MIND FUM KWG ZIN OTMP
Futura Medical is rapidly approaching a major inflection point as the results of a pivotal Phase III study (FM57) for its lead compound, MED2005, are due to read out in December. MED2005 is a fast-acting glyceryl trinitrate gel that addresses erectile dysfunction (ED). The FM57 data is expected to be positive and will influence the design of the remaining Phase III trial (FM59) required for US approval (and possibly Europe too). This data will also fuel licensing discussions with potential partners. The commercial opportunity in ED is sizeable, although addressing the various elements of the market segments and different geographies optimally will, in our view, be critical. Our DCF-based model employs conservative assumptions and currently values Futura Medical at £127m, equivalent to 62p a share.
AMRYT PHARMA PLC— a biopharmaceutical company focused on developing and delivering innovative new treatments to help improve the lives of patients with rare or orphan diseases have raised $60m before expenses and will relist on the AIM Market on the 25/09/2019
Companies: IMMO MERC IQG DUKE ZIN FUM AGL ULS ODX IKA
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Novacyt (NCYT.L): Trading update | Avacta (AVCT.L): COVID-19 wastewater detection sensor collaboration with Integumen
Companies: Novacyt Avacta Group
A number of REITs have the ability to thrive in current market conditions and thereafter. Not only do they hold assets that will remain in strong demand, but they have focus and transparency. The leases and underlying rents are structured in a manner to provide long visibility, growth and security. Hardman & Co defined an investment universe of REITs that we considered provided security and “safer harbours”. We introduced this universe with our report published in March 2019: “Secure income” REITs – Safe Harbour Available. Here, we take forward the investment case and story. We point to six REITs, in particular, where we believe the risk/reward is the most attractive.
Companies: AGY ARBB ARIX BUR CMH CLIG DNL HAYD NSF PCA PIN PXC PHP RE/ RECI SCE SHED VTA
Laboratory Services Contracts Signed
Companies: Open Orphan
Diaceutics is expected to report 20% YoY revenue growth in H1E. This strong performance against a difficult global backdrop reinforces the recession proof growth qualities of the business model. With the launch of the DXRX platform this year, we expect further operational benefits to flow through the business.
MaxCyte’s new clinical and commercial licence agreement with Apeiron Biologics allows the use of MaxCyte’s proprietary Flow Electroporation technology for manufacturing Apeiron’s gene-silencing siRNA therapy, APN401, for clinical studies. The deal is the latest in a series of clinical and commercia
ReNeuron has released further follow-up data from the ongoing human retinal progenitor cell (hRPC) trial, which shows a robust sustained averaged response. This data set completes the six-month data on eight patients and extends, for one individual, to 18 months, who showed a good net gain. The next dose level, two million cells in nine patients, remains delayed due to COVID-19. A filing to start a pivotal study is expected in the second half of CY21. Our indicative value remains at £107m.
Companies: Reneuron Group
SDI announced that it expects to meet market expectations for FY 2020, which are for adjusted pre-tax profit of £4.2m. Despite taking decisive action to reduce costs following the lockdown on 23 March, and confirmation that it has traded profitably in March and April, the lack of long-term visibility prompts a withdrawal of FY 2021 guidance. That said, we believe the company to have sufficient liquidity to weather the COVID-19 crisis with end markets still viable, and the improved 2020 margins are positive.
Companies: Scientific Digital Imaging
RenalytixAI (RENX.L): Proposed dual-listing on Nasdaq | e-therapeutics (ETX.L): Covid-19 project update | RedX (REDX.L): Appointment of Non-Executive Director
Companies: RENX ETX REDX
Today Ergomed held its annual general meeting (AGM). As expected, no new financial details were provided, although the executive chairman released a statement with a general business update. Q120 trading was good with ‘solid overall growth in revenue’ and cash generation ‘remained strong’. In Q220, Ergomed continued to grow the order book across the business and maintained its ‘revenue growth trend’. Its staff successfully adapted to remote working conditions and no employees were made redundant or furloughed. The H120 trading update will be released in July 2020 as usual, but Ergomed stated within its AGM update (June 10) that it is confident the results will be ‘in line with current market expectations’.
Inspiration Healthcare has announced its intention to acquire SLE Limited (SLE), a leading neonatal ventilator designer and manufacturer for consideration of £18.0m. Inspiration Healthcare has conditionally raised £16.5m (gross, ahead of an open offer) via an oversubscribed equity placing to support the acquisition. We believe the acquisition represents a transformation deal, virtually doubling the size of the business and providing significant new revenue growth opportunities. We expect the acquisition, on a 12-month proforma basis to be accretive to adjusted earnings in the near-term and increasingly so in the medium-term. We reiterate our Buy recommendation.
Companies: Inspiration Healthcare Group
Having taken time to assess the potential impact of COVID-19, IXICO has today provided a trading update for FY20E and an expectation for FY21E revenue growth. Revenues and EBITDA for FY20E are expected to be at least £9.1m and £0.9m respectively. Revenue growth for FY21E is expected to remain at double-digit levels. We view the trading update as a display of confidence in the ability of the company's remote access business model, proprietary technologies, and centralised AI data analytics capabilities to continue to serve its client base. We have re-instated forecasts for IXICO and reinstate our Buy recommendation.
4D pharma has treated the first cancer patients in Part B of the Phase I/II trial of MRx0518 in combination with Keytruda (pembrolizumab). Four additional trial sites are to open in the US through July and August to accelerate patient recruitment. MRx0518 is a single strain (Enterococcus gallinarum) live biotherapeutic product that has shown encouraging first-in-class proof of concept clinical data in an oncology setting. A clinical benefit (2 partial responses and 1 stable disease >6 months) was observed in 25% of treated patients in Part A. We remind investors that MRx0518 has potential to be the first approved live biotherapeutic in an oncology setting. The study is open label and an interim update is anticipated later in the year.
Companies: 4D Pharma
Hutchison China MediTech (HCM) is on the brink of global launches of two assets from its internally developed oncology portfolio. In 2022 we expect US launches of surufatinib (broad NET indication) two years earlier than forecast as well as savolitinib (NSCLC). Recently the FDA granted fast-track designation to fruquintinib in mCRC and we forecast global launch in 2023. In China, HCM has laid the foundations to capitalise on the slew of additional novel oncology drugs (expected by end 2021). HCM is well funded (following the recent $100m equity investment from General Atlantic, plus warrants granted for an additional $100m in 18 months) as it accelerates the global development of its unpartnered assets and expands its global commercial outreach. Beyond 2024 we expect sustainable profitability and margin expansion. Our increased valuation is $6.3bn.
Companies: Hutchison China Meditech
Hutchison China MediTech (HCM) is on the brink of global launches of two assets from its internally developed oncology portfolio. In 2022 we expect US launches of surufatinib (broad NET indication) two years earlier than forecast as well as savolitinib (NSCLC). Recently the FDA granted fast-track designation to fruquintinib in mCRC and we forecast global launch in 2023. In China, HCM has laid the foundations to capitalize on the slew of additional novel oncology drugs (expected by end 2021). HCM is well funded (following the recent $100m equity investment from General Atlantic, plus warrants granted for an additional $100m in 18 months) as it accelerates the global development of its unpartnered assets and expands its global commercial outreach. Beyond 2024 we expect sustainable profitability and margin expansion. Our increased valuation is $6.3bn.
Collagen Solutions (COS.L): Supply agreement with NovaBone
Companies: Collagen Solutions