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ImmuPharma recently announced an update on the FDA meeting with Avion, ImmuPharma’s partner for Lupuzor™, on 4 December 2020 (Type ‘A’ meeting request). Based on the positive guidance and feedback from FDA, there is now a clear regulatory pathway to commence the Phase III trial in H2 2021, fully funded by Avion. As part of this feedback, Avion and ImmuPharma will develop and validate a bioanalytical assay in order to confirm the unique pharmacokinetic profile of Lupuzor™. This will be presented at the final guidance meeting between Avion and the FDA in Q2 as well as confirming the previously submitted data on study design, clinical end points and the pathway to approval. ImmuPharma is also having a new batch of Lupuzor™ manufactured ready for use in the Phase III clinical trial. Given the strengthened balance sheet position following the £6.5m placing in September 2020, a cash runway to end 2023, a fully funded Phase III trial (by Avion with a US$25m investment) in an attractive market, and poorly met medical need, we believe the shares are oversold and reiterate our BUY rating and TP of 100p.
ImmuPharma plc
Following the recent announcement that Avion Pharmaceuticals has entered into a licence to pay up to $25m to develop (through the second phase III trial) and commercialise its major drug Lupuzor ™, ImmuPharma presents a very different opportunity compared to even a few weeks ago.
ImmuPharma announced a major US licensing deal on 28 November 2019 with Avion Pharmaceuticals (“Avion”), a US specialty business that has a focus on Rheumatology, Women’s health (Lupus afflicts women more) Dermatology and other therapeutic areas. Avion have a strong marketing and commercialisation operation (with over 100 specialist sales reps). Avion has exclusively in-licensed LupuzorTM for the US market for Lupus (SLE) and other indications and agreed to fund an international Phase III clinical trial for up to US$25m. In addition, Avion will pay up to US$70m in milestones and a royalty stream tiered to 17% has been agreed. We have always believed that ImmuPharma could deliver such a successful deal for the US market (given the track record of the previous deal executed with Cephalon). This deal with Avion was aided by the strength of the clinical data (and safety profile) from the Phase III trial announced last year. Our detailed analysis of the respective cohort data, driven by the performance of the peptide in the auto ds-DNA antibody positive patients validated our assumptions of the value of LupuzorTM. We now see LupuzorTM as having the ability to generate blockbuster sales in the US (US$1bn+) alone (previously US and EU combined) – which when coupled with a royalty stream of up to 17% on revenues, could see an annual royalty to ImmuPharma’s bottom line of US$170m per year. What is particularly impressive about this deal is not only ImmuPharma’s ability to identify and execute a new licensing partner for LupuzorTM but also the opportunity available for ImmuPharma to find new distribution and marketing partners outside the US for LupuzorTM, for e.g. in Europe, where a new trial would not even be required given Avion’s funding commitment. This means that there is a distinct possibility that further licensing deals could follow bringing in an attractive additional royalty stream, and additional upfront and milestone payments. Outside of LupuzorTM, we believe that ImmuPharma has the potential to generate news-flow on its other pipeline assets including Nucant and UreKa. Based on the financial assumptions for this deal, and a lower risk profile (reduction in risk premium in our DCF model) we increase our target price (which is 50% discounted) from 76p to 100p / share. BUY.
Yesterday, Biogen made a significant announcement for its shareholders and the broader sector alongside a strong set of Q3 results. Biogen announced that its Alzheimer’s drug, Aducanumab (monoclonal antibody), which it had been developing for early stage Alzheimer’s disease, and that had recently failed two Phase III (named: ENGAGE and EMERGE) clinical trials for futility (announced in March 2019), had gone on to demonstrate a strong signal of efficacy. In a subgroup of patients who elected to continue treatment at a higher dose, allowing sufficient exposure to the drug, it was clearly demonstrated that Aducanumab was able to achieve a statistically significant reduction of clinical decline in early Alzheimer’s Disease patients in a study called EMERGE (Biogen also stated that it believes that a sub-group of patients in ENGAGE also support the positive data seen). This is the first time that in the history of Alzheimer’s drug development, that a clinical study has demonstrated this type of effect. Further analysis of the ENGAGE study for Biogen does, we believe, potentially demonstrate a strong read-across for Lupuzor™, wherein Lupus patients who were ds-DNA positive (a sub-group – of European patients) and who were given Lupuzor™, a statistically and clinically meaningful reduction in Lupus disease symptoms were seen. Biogen believes that the lessons learnt from the EMERGE trial (with Aducanumab) could have positive implications for a number of other trials that the company is conducting in indications such as Tau-targeted Alzheimer’s, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). The receptiveness of the FDA in advice to Biogen, to file for regulatory approval for its Alzheimer’s drug Aducanumab, is a clear signal that regulators are willing to be pragmatic about how they assess clinical data from ‘failed’ trials in diseases where there is a significant unmet or poorly met medical need. We continue to expect positive updates from ImmuPharma from its pipeline and reiterate our BUY rating and a Target Price of 76p.
ImmuPharma released its interim results this morning. The results statement highlights key activities around the Company’s lead drug, Lupuzor including: the successful conclusion of the open label study, meeting its primary endpoint (safety), and the important work in fully understanding the Phase III data from the Lupuzor study which concluded in H1 2018. Taken together, the overall data (incl. the European data from the Phase III clinical trial) around Lupuzor continues to mature positively. Against a backdrop of progress in the Lupus field as highlighted in our update notes (See TLSD reports: 09/09/2019 and 23/09/2019), we believe the company is making significant progress in fully exploiting the potential for Lupuzor as a novel therapeutic; this is strengthened and complemented by recent updates by competitors in the market. Further value is being generated as broader pipeline products such as Ureka Sarl (platform peptide) and Elro Pharma (Nucant), create further value for investors through a potential partnering or divestment approach. Importantly, given the clinical data behind Lupuzor and its unique mechanism of action, there are other indications that will be available for development within the auto-immune space for Lupuzor beyond Lupus. We believe that the coming months will further demonstrate the progress the company is making towards these goals. BUY.
The Lupus field continues to experience renewed upward momentum, especially in the past few days with a new update from Roche for its drug Obinutuzumab in Lupus Nephritis, an organ specific complication of Lupus. This follows AstraZeneca’s announcement (29/08/2019) of having met its primary and secondary endpoints in its second Phase III study in Lupus with antibody product Anifrolumab in the TULIP II study (see TLSD research report dated: 09/09/2019). We note in a recent broker call with the CEO of AstraZeneca, Pascal Soriot, stated that AstraZeneca was excited about the opportunity to file for Anifrolumab with the FDA. This is despite having completed the Phase III TULIP II study with an endpoint that we believe is not generally accepted by FDA – he went on to state that AstraZeneca was yet to discuss next steps with US FDA, however, he believed the ‘chances of approval on existing data are good, considering the unmet medical need and the limitations of current treatment’ (read: Benlysta). We believe that AstraZeneca will rely on presenting all its data from the TULIP II study, as well as a previous Phase II study that was successful. We await data from both the TULIP I and TULIP II studies – And re-iterate this situation is not dissimilar to ImmuPharma for its novel drug Lupuzor™.
LupuzorTM owned and developed by ImmuPharma is a valuable late-stage asset and is potentially a key peptide therapeutic drug in the fight against Lupus. Last year, the drug completed the first of two-Phase III clinical trials; we commented on the data and analysis of the trial result, in extensive detail in our initiation report dated: 28 May 2019. The second LupuzorTM Phase III clinical trial, could begin after the agreement of the trial design with regulators (possibly based on a targeted group encompassing Lupus patients that are anti-dsDNA auto-antibody positive) and once a licensing partner or funding route is identified. In this note, we comment on and evaluate the results of AstraZeneca’s recently disclosed Phase III Lupus trial, (Tulip II), which we believe will potentially have a positive impact on the Lupus field and the prospects for partnering LupuzorTM, as well as its path report. We reiterate our BUY rating on ImmuPharma plc and a Target Price of 76p.
ImmuPharma is a European, late-stage biotechnology company, focused on delivering major new autoimmune therapies. It is developing the novel drug LupuzorTM (forigerimod) a first-in-class autophagy modulator, a late-stage asset with blockbuster potential, that has already shown itself to be safe across multiple trials in what now amounts to hundreds of lupus (Systemic Lupus Erythematosus, SLE) patients. The drug (LupuzorTM) was previously licensed to Cephalon (now Teva) for US$45m (upfront and option), US$500m in potential milestones and a high double-digit royalty stream before regaining global rights. The heterogeneity of lupus disease can be viewed as a spectrum of severity in patients, thus identifying and classifying the disease itself, opens up the opportunity for ImmuPharma to pivot and drive towards a precision-medicine biomarker approach and to provide a stratified disease approach that could help to improve healthcare economics for payors. We initiate with a BUY rating based on what we believe are strongly oversold shares and a target price of 92p.
IMMUPHARMA (IMM.L) | CONNEMARA MINING COMPANY (CON.L) | PETREL RESOURCES (PET.L)
IMM ARK PET
IMMUPHARMA (IMM.L)
IMMUPHARMA (IMM.L) | SKINBIOTHERAPEUTICS (SBTX.L)
ImmuPharma plc SkinBioTherapeutics Plc
ImmuPharma Flash : Placing to raise £10m
IMMUPHARMA (IMM.L) | ALEXANDER MINING (AXM.L)
ImmuPharma plc Alexander Mining
ImmuPharma Flash : Phase III completed, top-line results still due Q1 2018
ImmuPharma : Phase III completed, top-line results still due Q1 2018 (18-Jan-2018)
IMMUPHARMA (IMM.L) | STARCOM (STAR.L)
ImmuPharma plc t42 IoT Tracking Solutions PLC
ImmuPharma Flash : Change of recommendation
ImmuPharma : Change of recommendation (08-Jan-2018)
Immupharma (IMM): Last patient completes dosing on Lupuzor (BUY) | Independent Oil & Gas* (IOG): Skipper creditor resolution (CORP) | CityFibre* (CITY): Major contract win (CORP)
IMM CITY IO7
IMMUPHARMA (IMM.L) | VELTYCO GROUP (VLTY.L) | COLLAGEN SOLUTIONS (COS.L) | CONNEMARA MINING COMPANY (CON.L)
IMM B90 COS ARK
Immupharma (IMM) is a drug discovery company whose lead product Lupuzor, is in Phase III trials for the treatment of Systemic Lupus Erythematous (SLE). Previous IIb trial demonstrated both efficacy and safety through novel immune system modulation that offers benefits to the only approved treatment, a monoclonal antibody (mAb) called Benlysta with £400m annual sales. Phase III pivotal study readout (n=200) expected Q1-18 (finnCap est. approval of 63%) follows on from Lupuzor being given Special Protocol Assessment (SPA) status by the FDA with existing global patent protection until 2032. Blockbuster status (sales >$1bn) could be achieved within 8 years and historical licence deal (Cephalon, 2009) suggestive of licence/partner agreement potential. Unusual upside potential from binary readout leads us to initiate coverage with a Buy recommendation and 237p price target (increasing 87% on +ve Phase III, which excludes the value of potential upfront (c.50p) and milestone payments that could amount to c£500m or 386p per share).
Immupharma (IMM): Magic bullet with butterfly wings? (BUY) | OptiBiotix* (OPTI): SlimBiome agreement in US (CORP) | President Energy* (PPC): Licence extension approval (CORP) | Abzena (ABZA): Interims in line with expectations (BUY) | Joules Group (JOUL): Marginal upgrade to FY numbers (BUY) | Alliance Pharma (APH): EPS-enhancing product acquisitions (BUY) | K3 Business Technology* (KBT): Trading update – the three boxes ticked (CORP)
IMM OPTI ABZA JOUL KBT PPCGF DVL
IMMUPHARMA (IMM.L) | MOTIF BIO (MTFB.L) | ADEPT TELECOM (ADT.L) | EVGEN PHARMA (EVG.L) | EDENVILLE ENERGY (EDL.L)
IMM MTFB ADT TCF SKA
Interims are much of a muchness and recent updates – surrounding Lupuzor in terms of regulatory preparations and continuation of the Phase III study – all rather highlight the limited news flow elsewhere from the company. ImmuPharma points, once again, to the expected read-out from the trial in Q1 2018.
IMMUPHARMA (IMM.L) | NQ MINERALS (NQMI.PL) | KERAS RESOURCES (KRS.L) | ALEXANDER MINING (AXM.L)
IMM KRS AXM NQMLF
IMMUPHARMA (IMM.L) | VENTURE LIFE GROUP (VLG.L) | ACTIVE ENERGY GROUP (AEG.L) | URU METALS (URU.L) | CONNEMARA MINING COMPANY (CON.L)
IMM VLG AEG ARK URU
IMMUPHARMA (IMM.L) | ACTIVE ENERGY GROUP (AEG.L)
ImmuPharma plc Active Energy Group plc
IMMUPHARMA (IMM.L) CLONTARF ENERGY (CLON.L)
ImmuPharma plc Clontarf Energy PLC
Lupuzor Phase III trial continues per recent updates (the most recent was 17 May 2017). Company reports year-end cash of £1.9m and highlights the postperiod funding activities (already announced). With the main focus on Lupuzor at present, there is limited potential for significant ‘new’ news from the remainder of the portfolio. While the company focuses on the trial, investors will need to keep the faith as significant additional news flow opportunities will naturally be limited.
IMMUPHARMA (IMM.L) | EVGEN PHARAMA (EVG.L)
ImmuPharma plc TheraCryf PLC
ImmuPharma plc (IMM.L) – BUY*: L&G increases its holding | SalvaRx (SALV.L) – BUY*: New investment
ImmuPharma plc Salvarx Group
ImmuPharma plc (IMM.L) – BUY*: £4.1m fund raise
ImmuPharma plc (IMM.L) – BUY*: Lupuzor update | Sunrise Resources (SRES.L) – CORP: Pozz Project update
ImmuPharma plc Sunrise Resources plc
ImmuPharma plc (IMM.L) – BUY*: Appointment of Northland as Nomad
ImmuPharma plc (IMM.L) – BUY*: Oncology programme update | Savannah Resources (SAV.L) – CORP: Oman update
ImmuPharma plc Savannah Resources Plc
ImmuPharma plc (IMM.L) | Premier African Minerals (PREM.L) | Sunrise Resources (SRES.L)
IMM PREM SRES
Last Friday ImmuPharma announced the placing of 7.1m existing shares held by Lanstead Capital L.P. to new and existing institutional investors, alongside the placing of £1m (gross) via the issue of new ordinary shares, at a placing price of 35p via accelerated book-build. The proceeds of the new share placing are to be used for additional working capital purposes.
ImmuPharma plc (IMM.L) | Savannah Resources (SAV.L) | VELTYCO GROUP PLC (VLTY.L) | PREMIER AFRICAN MINERALS
IMM PREM B90 SAV
ImmuPharma has announced interim results for the half-year to 30 June 2016. As anticipated, the financials are dominated by the focus on development activities and, given the wealth of updates from the company in recent months we remind investors that the company remains on-track to recruit the planned 200 patients in the pivotal Phase III Lupuzor™ trial. With work progressing as expected, we retain our investment thesis and reiterate our Buy recommendation.
This morning’s update on progress with the Lupuzor™ pivotal Phase III trial gives further colour on sites and recruitment. 11 sites are now open and active in the US and 5 European countries are recruiting, with the additions of the final two sites – UK and Italy – expected within the ‘next few weeks’. Mauritius, of course, was a recently announced addition to the programme (see our note from last week). On current timelines, the continued progress sees the company on track to meet the 200 patient target in 2016 and suggests we should expect top-line results around the end of 2017. A positive reference point, we maintain our Buy recommendation.
ImmuPharma (IMM.L) | Premier African Minerals (PREM.L)
ImmuPharma plc Premier African Minerals Ltd.
ImmuPharma has announced that it has been invited to open an additional site in Mauritius as part of its Phase III clinical trial of Lupuzor™, its lead programme for the treatment of auto-immune disease Lupus. Up to 30 lupus patients are reportedly ready for enrolment – these will comprise part of the original 200 patients expected to be recruited for the Phase III trial – in a country where the relative incidence of the disease is high. Today’s news further illustrates, in our view, the continued lack of affordable and effective treatments for the disease, reflecting demand which is global in nature. We retain our investment thesis unchanged, repeating our Buy recommendation and 100p target price.
ImmuPharma (IMM.L) – BUY*: Update on Phase 3 trial | Savannah Resources (SAV.L) – CORP: Finland update | Amphion Innovations plc (AMP.L) – CORP: Interims | Starcom (STAR.L) – BUY*: H116 Results
IMM AMP SAV TRAC
ImmuPharma plc is grossly undervalued. The company’s flagship drug, Lupuzor—a potential treatment for Lupus—is currently completing a Phase 3 clinical trial which is expected to read-out top line results before the end of 2017. The drug has been looked upon favourably by US regulators, which have deemed it a priority treatment. Should the drug be approved, we estimate it could achieve multi-billion dollar annual sales. We initiate coverage with a 171p target price, indicating substantial upside to the current share price.
IMM WRES AEG
ImmuPharma (IMM.L) – CORP*: Appointment of Northland
Last week, ImmuPharma hosted a symposium featuring Prof Sylviane Muller, the inventor of Lupuzor, detailing the discovery, mechanism of action and wider opportunity for the use of Lupuzor in the treatment of Lupus and a variety of other autoimmune indications. A presentation from the event can be viewed online and offers investors a chance to look further into the detail of the molecule which, while by no means ImmuPharma’s only development programme, is clearly the most important near-term value driver for the business. We reiterate our Buy recommendation.
ImmuPharma (IMM.L): Trial update | Stratex International (STI.L) – BUY*: Goldstone update | ValiRx (VAL.L) – CORP*: Quarterly update
IMM ORR VAL
This morning ImmuPharma has announced the commencement of dosing in the first European patients in the company’s pivotal Phase III clinical study for Lupuzor™. This means that both US and European sites are now dosing patients in the Phase III trial (recruitment is expected in up to 45 investigator sites) and with Lupus continuing to represent a major unmet medical need we consider the ongoing demand for an effective treatment – highlighted by still torpid sales of GSK’s Benlysta – represents a major opportunity for ImmuPharma and Lupuzor™ (see our note of 04 May 2016 for more detail). We repeat our Buy recommendation.
Mariana Resources (MARL.L) – BUY*: Hot Maden update | ImmuPharma (IMM.L): Alto invests | Savannah Resources (SAV.L) – CORP: Oman update | TechFinancials Inc. (TECH.L) – BUY*: Prelims | Sunrise Resources (SRES.L) – CORP*: Placing
IMM SAV TECH MARL
Lupuzor - Orion, the final step before regulatory approval. Patient recruitment is anticipated to occur in up to 45 investigator sites, 10 in the United States and 35 in Europe. In the US the first patient dosing commenced in February 2016. In Europe, the first sites have opened in France and patient recruitment has commenced. The trial progress can be tracked on the www.ClinicalTrials.gov/lupuzor website and the key milestone for this year is for the recruitment of the 200 Lupus patients, with top-line results from the trial expected to be available in late 2017.
With February’s placing and share subscription having raised c.£8.4m (before expenses) ImmuPharma is now pressing ahead with the pivotal Phase III trial of its 100%-owned lead asset for the treatment of Lupus, Lupuzor™. The company announced the first dosing of patients in the US in mid-February, soon followed by the opening of the first European trial site in France in early March. We consider the ongoing need for an effective treatment – highlighted by still torpid sales of GSK’s Benlysta – represents a major opportunity for ImmuPharma. We outline the key elements of our central case reinstate a Buy recommendation, with a SOTPderived target price of 100p.
This morning ImmuPharma has released prelims for the year-ending 31 December 2015. Today’s numbers reflect a business in development-phase – the pivotal phase III study for Lupuzor™ now having commenced – with the fund-raising process (£8.4m fundraising and EIS/VCT qualifying status) having been completed after the period-end. We currently have the stock Under Review, applied in light of the recent capital raise exercise, and following the announcement of today’s prelims we will be updating our forecasts imminently.
Immupharma has updated this morning on the Lupuzor pivotal phase III trial, announcing the first European site (Bordeaux, France) is open and that the patient recruitment process in Europe has now commenced.
ImmuPharma has announced the successful completion of a fundraising, which has conditionally raised in aggregate £8.3m before expenses, by way of a placing and subscription at a price of 26p. The fundraising was well supported by existing shareholders as well as introducing new investors. In addition Simbec-Orion, the international CRO conducting the Lupuzor participated in the placing. The placing of 14.9m new shares will raise £3.9m with the subscription of 17.0m new shares by Lanstead Capital LP raising £4.4m. A value payment of 0.85m new shares will also be issued to Lanstead. Of the subscription proceeds £0.66m (15%) will be retained by ImmuPharma with the remaining c£3.76 m being pledged to Lanstead under a Sharing Agreement. Lanstead will make monthly settlements over a period of 18 months with the proceeds determined by a measured market price prior to each settlement and compared to a benchmark price of 34.6667p. If the measured market price exceeds the benchmark price, the Company will receive more than 100% of the settlement due, on a pro rata basis. If the measured market price is below the benchmark price ImmuPharma will receive less than 100% of the settlement also on a pro rata basis. This will allow the Company to benefit from a rising share price. Completion of the above placing and subscription is held on 22 February 2016.
This morning Immupharma has announced a proposed conditional fund raise of not less than £7.5m. This includes a proposed conditional non-pre-emptive placing of not less than 11,824,877 Placing Shares at 26p to raise approximately not less than £3.1m, and the proposed entry by the company into a subscription agreement with Lanstead Capital L.P., an institutional investor, together with a related sharing agreement, to raise approximately £4.4m. The placing price of 26p represents a 10.3% discount to the closing mid-market price yesterday. The proceeds of the placing will be used primarily to fund the pivotal Phase III clinical trial of Lupuzor; and working capital requirements through to 2018. The placing and subscription, being conditional on shareholder approval, are subject to a general meeting scheduled for 22 February 2016. For regulatory purposes we place our recommendation Under Review.
The Investigators Meeting was jointly organised by ImmuPharma and Simbec-Orion, its development partner for Lupuzor brought together over 70 Lupus Specialists who will be actively involved in the pivotal Phase III clinical trials for Lupuzor involved about the protocol and the required procedures to assess efficacy in the Lupus trial. This will provide consistency across the trial sites and make sure the clinical practitioners are all working towards the same goals and objectives.
This morning, Immupharma has provided an update on the Lupuzor phase III investigators meeting which was held in Paris on 11th and 12th December. With the first US sites now opened for recruitment of Lupus patients, as confirmed on the ClinicalTrials.gov website, we see the news as reflecting good momentum in its lead programme with an asset – we remind investors – fully owned by Immupharma. We look forwards to further updates during 2016 and repeat our Buy recommendation.
Following the approval in the United States by the Central Institutional Review Board (IRB), the Company has now announced that the first United States recruitment of lupus patients for this pivotal Phase III trial of Lupuzor information will shortly be available on the US National Institute of Health www.ClinicalTrials.gov. The study is entitled -Week, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus Patient recruitment for the trial is expected to occur in up to 45 investigator sites, 10 in the United States and 35 in Europe to enable the screening of 270 potential patients, in order to recruit the 200 patients required for the trial. This a further major step forward for these important trials. It is currently estimated that the trial will be completed by the end of 2017.
Following last month's detailed update on the progress of its phase III clinical trial of Lupuzor, progressing in conjunction with Simbec-Orion, Immupharma announces today that the first US sites are now open for recruitment of patients.
This morning Immupharma has announced a detailed update on the progress of its phase III clinical trial of Lupuzor, progressing in conjunction with Simbec-Orion. The first sites in the US are expected to be fully initiated in late November/early December and will commence recruiting patients thereafter, with European sites expected to follow in January. We consider the progress provides evidence of momentum within the programme – completion expected by the end of 2017 – and look forward to further updates in due course.
ImmuPharma has released interim results with financials reflecting continued clinical and research development. On the numbers, the company reports balance sheet cash at the half year of £3.29m (31 Dec 14: £5.42m) with the operating loss of £1.54m (1H14: £1.82m) driven by R&D expenditure of £0.49m (1H14: £0.82m) predominantly due to development activities in the Urelix peptide technology collaboration and the Nucant programme. The start of the pivotal phase III trial in Lupuzor represents continued progress. Stay with Buy.
