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  • 11 Nov 19
MOLOGEN - IMPALA readout ends monotherapy strategy

MOLOGEN has announced that its pivotal Phase III IMPALA trial testing lefitolimod as a maintenance therapy in patients with metastatic colorectal cancer (mCRC) has missed its primary endpoint of overall survival (OS). As a result, we have removed from our valuation lefitolimod’s prospects as a monotherapy in mCRC and small cell lung cancer (SCLC) (previously 72% of our valuation). MOLOGEN will focus on the development of lefitolimod and EnanDIM in combination with other therapies. Announced restructuring measures should reduce monthly cash burn to €0.8m from the current rate of €1.4m. We note gross cash as of 30 June 2019 was €6.0m, which should enable funding into Q419. We value MOLOGEN at €50.4m (€4.1/share) vs €169m (€18.2/share) previously.

Companies: Mologen
  • 06 Sep 19
MOLOGEN - IMPALA readout ends monotherapy strategy

MOLOGEN has announced that its pivotal Phase III IMPALA trial testing lefitolimod as a maintenance therapy in patients with metastatic colorectal cancer (mCRC) has missed its primary endpoint of overall survival (OS). As a result, we have removed from our valuation lefitolimod’s prospects as a monotherapy in mCRC and small cell lung cancer (SCLC) (previously 72% of our valuation). MOLOGEN will focus on the development of lefitolimod and EnanDIM in combination with other therapies. Recently announced restructuring measures should reduce monthly cash burn to €0.8m from the current rate of €1.4m. We note gross cash as of 30 June 2019 was €6.0m, which should enable funding into Q419. We value MOLOGEN at €50.4m (€4.1/share) vs €169m (€18.2/share) previously.

Companies: Mologen
  • 04 Jan 19
Mologen - Retaining lefitolimod's value

Mologen has announced that it has terminated negotiations with Oncologie and will retain rights to lefitolimod. With the lefitolimod IMPALA Phase III readout now expected in H219, focus will likely shift to securing a partner for lefitolimod once data are available from this pivotal trial. We have updated our valuation to reflect the termination of Oncologie negotiations. We now forecast that lefitolimod will be out-licensed post the IMPALA trial and assume similar deal terms to those Oncologie presented. We value Mologen at €169m (€18.2/share).

Companies: Mologen
  • 21 Sep 18
Mologen - Global lefitolimod partnership close to completion

Mologen announced that it has signed term sheets for a global partnership with Oncologie for its lead asset, lefitolimod. The deal is expected to complete in Q119, and in the near term Mologen expects to receive €23m from the agreement in a combination of R&D funding, cash payment and bond issues. Sensitivity remains around Oncologie who are an early stage biotech with $16m in seed funding. Mologen announced a capital raise in which it could receive gross proceeds of €18m. Focus remains on data from the Phase III IMPALA trial in metastatic colorectal cancer (mCRC), expected in 2020. We value Mologen at €188m (€16.6/share).

Companies: Mologen
  • 29 May 18
IMPALA the focus as funding gap remains

Mologen’s Phase III pivotal trial (IMPALA) in metastatic colorectal cancer (mCRC) is now the focus for investors as both the Phase II trial (IMPULSE) in small cell lung cancer (SCLC) and Phase I trial in HIV (TEACH) are now complete. The company recently announced the results of a statistical forecast that has predicted the primary analysis of the data will most likely occur in April 2020 (95% CI: +/- five months). Cash reach has been prolonged to the end of 2018 by recent financing arrangements, and the signing of a licence and co-development agreement with Oncologie, in addition to R&D cost reductions. A new study with lefitolimod in HIV (TITAN) is expected to be initiated by Aarhus University Hospital in 2018. We value Mologen at €243m (€6.5/share).

Companies: Mologen
  • 10 Nov 17
Licensing and funding milestones in Q3

Mologen has announced two new sources of funding that will likely extend its cash reach into mid-2018. The signing of a share subscription facility with Global Corporate Finance (GCF) commits GCF to purchase up to 3.4m Mologen shares (c 10% of share capital). At the current share price, this approximates to €10m in funds which, in addition to the expected completion of the iPharma deal (worth up to €100m) by year end (€3m initial payment), will boost Mologen’s cash position. Furthermore, Mologen has a commitment to receive a $2.6m grant for further development of a leishmaniasis vaccine candidate, part of the MIDGE technology platform it is looking to divest. We value Mologen at €256m (€7.43/share).

Companies: Mologen
  • 25 Sep 17
Lefitolimod trial readouts hint at future potential

In the last six months, mixed readouts in the Phase II SCLC trial (IMPULSE) and the Phase Ib/IIa HIV trial (TEACH) weighed on the stock. Full data packages presented in the next 12 months may yet highlight potential in these indications. Our valuation is adjusted to take into account both the current trial data and visibility of the long-term strategy in certain geographical regions. While long-term potential lies in the lefitolimod Phase III mCRC trial (IMPALA, readout expected in 2019), Mologen has additionally signed a binding term sheet with Chinese iPharma, which could provide €100m+ in revenues over several years and boost the cash position. We value Mologen at €253m.

Companies: Mologen
  • 16 May 17
SCLC data - subgroup analysis hints at benefit

Top-line data from Mologen’s Phase II small cell lung cancer trial (IMPULSE) have been announced. Positive responses in two subgroups hint at a treatment-related benefit in certain subsets. However, the trial missed its primary endpoint of overall survival in the total study population. Additionally, in line with previous data, an agreeable safety profile was reported. We expect the data to further inform partnership discussions in the near term. The ‘Next Level’ strategy has now been implemented and the pipeline continues to move towards commercialisation. We value Mologen at €252m (€7.33/share).

Companies: Mologen
  • 14 Nov 16
Financed to inflection points

The recent completion of the €13.6m capital raise and the soon to be issued convertible bond of presumably €2.5m will enable Mologen, alongside its latest reported cash of €10.2m (at 30 September 2016), to reach key inflection points in the coming year. Analysis of its Phase II (IMPULSE) small cell lung cancer (SCLC) trial should begin by year end, with initial data expected to be presented in H117. Final data from the Phase I HIV study will be presented in mid-2017, while the ongoing Phase III trial (IMPALA) in metastatic colorectal cancer (mCRC) is expected to complete patient enrolment by Q117. We value Mologen at €261m or €7.67/share.

Companies: Mologen
  • 21 Jul 16
'Next Level' of development

Mologen’s strategic review has focused its efforts on the development and commercialisation of late and early clinical assets, notably lead candidate lefitolimod (oncology and HIV) and EnanDIM, a next-generation TLR9 agonist. Partnering opportunities for lefitolimod are being actively sought; we anticipate Phase III data in 2018. Manufacturing efforts will be out-sourced to achieve suitable scale. MGN1601 (renal cancer vaccine) is on hold. Mologen’s move to a more clinical development-focused company means preclinical R&D assets (MIDGE vector system) will be spun off or divested. We value Mologen at €201m or €8.87/share.

Companies: Mologen
  • 20 Apr 16
Executive Interview - Mologen
executive-interview-mologen-20-04-2016
  • 13 Apr 16
Lefitolimod trials on track

Mologen’s pipeline is focused around lead candidate lefitolimod (MGN1703). Patient enrolment for IMPALA, the pivotal Phase III study in metastatic colorectal cancer (mCRC), continues on track and we expect full enrolment by end 2016. Data due in H117 from the IMPULSE Phase II trial in lung cancer could trigger a licensing deal. FY15 net cash of €24.6m should ensure IMPALA patient recruitment by year-end 2016. We have lowered our valuation of Mologen to €337m, or €14.89 per share, on a more protracted market launch timeline across the product portfolio.

Companies: Mologen
  • 14 Dec 15
MGN1703 remains the focus

Mologen is developing novel immunotherapies for use in the post-chemo maintenance setting in cancer and for the treatment of infectious diseases. Lead candidate MGN1703 is in three clinical trials for different indications, including a pivotal Phase III study, IMPALA, in metastatic colorectal cancer (mCRC) with data due in H118. Meanwhile, initial data from the Phase II IMPULSE study in lung cancer in H117 could positively affect partnering or financing options. We value Mologen at €387m, or €17 per share.

Companies: Mologen
  • 20 Aug 15
MGN1703 leading the way

Mologen’s lead product, MGN1703, is currently in three clinical trials for different indications. The €28.3m (gross) proceeds from the rights issue in April 2015 mean Mologen should have sufficient funds to reach full recruitment of IMPALA (Phase III in colorectal cancer) and top-line data from IMPULSE (Phase II in small-cell lung cancer). The IMPULSE data (H216) could have a positive impact on partnering or financing options for MGN1703. We value Mologen at €384m.

Companies: Mologen

Research, Charts & Company Announcements

Research Tree provides access to ongoing research coverage, media content and regulatory news on Mologen. We currently have 13 research reports from 1 professional analysts.

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25Sep17 15:22 EQS Edison issues outlook on Mologen (MGN)
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  • 10 Dec 19
Are these unprecedented results a major opportunity?

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).

Companies: Futura Medical
  • 11 Dec 19
On the road towards mainstream adoption

Rarely has Britain ever invented such world-beating technology as that developed by Kromek. Indeed its next generation radiation detectors are disrupting 3 major verticals - Medical Imaging (eg BMD & SPECT), Nuclear Detection (D3S) and Security Screening (Airport baggage/bottles) – each worth >$100m pa.

Companies: Kromek Group
  • 10 Dec 19
LIBERUM: Futura Medical* - Unexpected P3 result means shift in strategy but potential approval timelines likely unchanged

Futura announced P3 results from its FM57 study testing MED2005 in 3 doses (0.2%, 0.4% and 0.6%). None of the doses showed superiority in improving erectile dysfunction outcomes vs. placebo.

Companies: Futura Medical
  • 11 Dec 19
Cenkos: Kromek Group Plc -- Major increase in output expected

Recent investment in capital equipment has increased Kromek's CZT production capability seven-fold. Contracted medical imaging output will ramp up in H2E and revenue visibility for FY20E stands at over 90%. Kromek is on track for organic growth of +27% this year. We adjust our working capital assumptions to reflect a slightly slower cash recovery but momentum in the business and all time low share price support a Buy.

Companies: Kromek Group
  • 04 Dec 19
Cenkos: IXICO Plc -- Revenues growing and profitable

IXICO has reported a strong financial performance for FY19A built on continued commercial focus and a strengthened organisation. Revenues of £7.6m were up 40% and gross margin was up 600bps versus FY18A and the company delivered its first year of profitability since IPO. EBITDA of £0.5m was strongly ahead of our forecast (+£0.1m) and delivered an EBITDA margin of 6%. We have maintained our revenue growth expectations of 20% for FY20E and FY21E but have upgraded our profit expectations given the strong reported performance. We maintain our Buy recommendation.

Companies: IXICO
  • 21 Oct 19
Quarterly Research Outlook Autumn 2019

Following continued delays of a Brexit agreement, few sectors within the UK market have remained attractive to investors despite low valuations. One sector which has continued to outperform despite the political drama has been the UK video gaming sector (henceforth UK gaming), which we are fans of. We believe a combination of sector-leading growth, strong cash conversion and timely cyclical positioning support our positive view on the UK video gaming sector.

Companies: ABBY AMS ANX ARS ATYM AVON BLVN PIER BUR CGS CAML CDM CSRT TIDE CYAN DTG DEMG ELM EMR FPO FDEV GTLY GENL GHH GRI GEEC GKP HMI HAYD HEAD HILS HTG HUR IBPO IOG INDI JHD JOG KAPE KEYS KWS KCT KGH LAM LIT LOK MACF MANO MOD OXIG PCA PANR APP ESRE PHC PMO RBW RMM RBGP REDD RSW RNO ROR SUS SCPA SEN SHG SOLG SOM SUMO TM17 INCE TWD TRAK TRI VNET VTC ZOO ZTF

  • 06 Dec 19
H1 results: adjustments to clinical programmes

ReNeuron has announced its H1 2020 results; financials are slightly ahead of our expectations related to the identified slower recruitment of the Phase III PISCES trial. ReNeuron has made a number of positive clinical trial protocol changes to both the CTX and hRPC programmes to boost enrolment and accelerate clinical development, respectively, and we have included these changes into our forecasts.

Companies: Reneuron Group
  • 09 Dec 19
ImmuPharma Quick Reference Sheet following new Lupuzor licence

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.

Companies: ImmuPharma
  • 04 Nov 19
THE MONTHLY November 2019

The trade-off in the risk/reward for gold and gold mining equities is improving, as central banks push the current iteration of the post-World War II Bretton Woods financial order towards its limits.

Companies: AVO AJB AGY ARBB BUR CLIG DNL DPP FLTA GTLY GDR MCL MUR NSF PCA PIN ESRE PHP RE/ RECI RMDL STX SCE TON SHED VTA W7L

  • 09 Dec 19
Encouragement from interims

After a momentous year for ReNeuron catalysed by the clinical results from their hRPC program for retinitis pigmentosa (RP), the H1’20 financial results brought the year to a positive close. A strong cash position enables the expansion of both of its clinical programs and notably the scale of the hRPC program has been expanded in order to accelerate the product’s regulatory approval. Further clinical data on the hRPC program is expected in 2020 before the first pivotal study on the CTX program in chronic stroke reads-out in H1’21.

Companies: Reneuron Group
  • 05 Dec 19
US licensing deal: Major Opportunity Within LupuzorTM Unlocked

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.

Companies: ImmuPharma
  • 05 Dec 19
Avacta Group - Executive interview

In this video, Alastair Smith, CEO of Avacta Group, discusses the progress the company has made this year. This includes new and expanded partnerships, operational and financial achievements, and the advancement of AVA6000 towards the clinic.

Companies: Avacta Group
  • 02 Dec 19
Acquisition – 7% accretive in first full year

SDI has announced the acquisition of Chell Instruments; paying c.£4.3m for the business (FY 2018 EV/Sales and EV/EBIT of 0.9x and 5.5x) funded from cash and a new debt facility with net debt at year-end now expected to be c.£5.0m. SDI has shown that it can source and execute another accretive acquisition in what was a competitive tender bid process. We expect the acquisition to be c.7% accretive to EPS in FY 2021 and raise our target price by 25% to 75p to reflect the accretion as well as rolling forward our target year, implying an EV/EBITDA of 11.9x and adjusted P/E of 17.3x.

Companies: Scientific Digital Imaging
  • 04 Dec 19
Proving the accuracy and superiority of minibeams

The goal of Advanced Oncotherapy (AVO) is to deliver an affordable and more effective proton beam therapy (PBT) system, based on state-of-the-art technology developed originally at the world-renowned CERN. In the past 18 months, the project has been de-risked through important technical milestones. AVO is now working on the verification and validation phase, prior to CE marking and LIGHT being used on the first patients. Meanwhile, AVO has entered into a research collaboration with the Cleveland Clinic aimed at proving the accuracy of targeting cancerous tissue, and sparing normal tissue, with proton minibeams in comparison with other methodologies.

Companies: Advanced Oncotherapy
  • 02 Dec 19
Interims – VISITECT CD4 starts to deliver on potential

Interim results were in line with the 22 October trading update, reflecting the financial benefits of closing its German business and selling the infectious disease business. Revenues from continuing operations increased 6% to £4.5m, largely reflecting the growth in Food Intolerance (+6% to £4.1m). This resulted in an adjusted EBITDA and pre-tax loss of c.£0.25m (vs. -£0.3m) and c.£0.35m (vs. -£0.5m), respectively. Omega also announced a further order from Nigeria for VISTECT CD4, which is contingent on approval in that market, but could be shipped by the FY year-end. We are not changing CD4 forecasts at this time until there is clarity over MoH approval. We make minor changes, however, to our FY forecasts to reflect the adoption of IFRS 16, which reduces adjusted pre-tax profits by c.£60k in both years. Year-end net debt is unchanged at c.£0.8m. We leave our target price unchanged at 25p.

Companies: Omega Diagnostics Group