Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on MOLOGEN AG. We currently have 5 research reports from 1 professional analysts.
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Financed to inflection points
14 Nov 16
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.
'Next Level' of development
21 Jul 16
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.
Lefitolimod trials on track
13 Apr 16
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.
MGN1703 remains the focus
14 Dec 15
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.
MGN1703 leading the way
20 Aug 15
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.
20 Apr 17
Although the last two months have seen a broadly neutral performance from the UK healthcare sector compared to a significantly more volatile 6 months prior, we continue to expect macro-events and increased geo-political risk to result in an overall neutral performance from the sector over the next period. However, company specific news is likely to drive a strong outperformance from selected mid-market companies. We retain our neutral sector stance whilst highlighting those we expect to outperform.
Positive top-line results in first iclaprim phase III clinical trial (REVIVE-1)
18 Apr 17
Motif Bio (LSE: MTFB, NASDAQ: MTFB), a late clinical stage antibiotic development company, announced positive results this morning in the first of its two iclaprim phase III clinical trials, REVIVE-1, comparing iclaprim to vancomycin in the treatment of acute bacterial skin and skin structure infections (ABSSSI). Iclaprim, a next-generation antibiotic targeting an underutilised mechanism of action which causes rapid killing of bacteria, is being developed for the treatment of serious and life threatening bacterial infections. On the key primary endpoint in the study, early clinical response at 48-72 hours after drug treatment began, 80.9% of patients on iclaprim achieved a positive response compared to 81.0% of patients on vancomycin, well within the 10% non-inferiority margin required by the FDA. Iclaprim was also shown to be safe and well-tolerated compared to vancomycin. With these positive results from REVIVE-1 we have increased the probability of success for the iclaprim development program from 65% to 75% raising our risk-adjusted NPV for Motif Bio to almost £240m or 122p per share (previously £210m and 107p per share).
N+1 Singer - Sinclair Pharma - EBITDA upgrade for 2017, but lower TP due to warranty claim and costs
19 Apr 17
We have updated product-level forecasts and included the £10m SVB debt facility and £5m warranty claim settlement with Alliance Pharma in our forecasts. The 6.3% upgrade to our FY2017 sales estimate (from £46.0m to £48.9m) brings expected EBITDA profitability forward by one year (to FY2017 from FY2018). We remain positive on the ongoing rollout of Silhouette Instalift® in particular and retain our Buy recommendation. However, higher expected sales & marketing costs and the warranty claim weigh on our valuation: we downgrade our target price from 42p to 37p.
Positive REVIVE-1 Phase III study data
18 Apr 17
Motif Bio (MTFB) has announced positive top-line results from REVIVE-1, its global Phase III study comparing iclaprim to vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI). Iclaprim achieved the primary endpoint of non inferiority when compared to vancomycin, in both the early time point and test of cure endpoint. Iclaprim offers clinical advantages over existing hospital antibiotics that include the avoidance of renal toxicity, fixed dosage regimen and early response indications. With data from REVIVE-2 due out in H2 2017 we maintain our 125p price target and Buy recommendation.