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Mologen

'Next Level' on track

Update | Pharmaceutical & healthcare | 01 Sep 2016

Mologen's interim results have confirmed the implementation of its ‘Next Level' strategic review. This is focused on the development and commercialisation of lead candidate lefitolimod (oncology and HIV) across its four clinical trial programmes and the next-generation molecules EnanDIM (TLR9 agonist), effectively evolving Mologen into a more product-focused company. Partnering opportunities for lefitolimod are being actively sought. We anticipate Phase II IMPULSE (SCLC) data in early/mid-2017 and initial Phase III IMPALA (mCRC) data 24 months after final patient recruitment to drive the shares. We value Mologen at €201m (€8.87/share).

Mologen

Global lefitolimod partnership close to completion

Outlook | Pharmaceutical & healthcare | 21 Sep 2018

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 EUR 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 EUR 18m. Focus remains on data from the Phase III IMPALA trial in metastatic colorectal cancer (mCRC), expected in 2020. We value Mologen at EUR 188m (EUR 16.6/share).

Mologen

IMPALA the focus as funding gap remains

Update | Pharmaceutical & healthcare | 29 May 2018

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 EUR 243m (EUR 6.5/share).

Mologen

Licensing and funding milestones in Q3

Update | Pharmaceutical & healthcare | 10 Nov 2017

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 EUR 10m in funds which, in addition to the expected completion of the iPharma deal (worth up to EUR 100m) by year end (EUR 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 EUR 256m (EUR 7.43/share).

Mologen

Lefitolimod trial readouts hint at future potential

Outlook | Pharmaceutical & healthcare | 25 Sep 2017

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 EUR 100m+ in revenues over several years and boost the cash position. We value Mologen at EUR 253m.

Mologen

SCLC data - subgroup analysis hints at benefit

Update | Pharmaceutical & healthcare | 16 May 2017

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).

Mologen

Financed to inflection points

Update | Pharmaceutical & healthcare | 14 Nov 2016

The recent completion of the EUR 13.6m capital raise and the soon to be issued convertible bond of presumably EUR 2.5m will enable Mologen, alongside its latest reported cash of EUR 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 EUR 261m or EUR 7.67/share.

Mologen

'Next Level' on track

QuickView | Pharmaceutical & healthcare | 09 Nov 2016

Mologen are focused on the development and commercialisation of leadcandidate lefitolimod (oncology and HIV) and the next-generationmolecules EnanDIM (TLR9 agonist). Partnering opportunities forlefitolimod are being actively sought. We anticipate Phase II IMPULSE(SCLC) data in early/mid-2017 and initial Phase III IMPALA (mCRC) data 24months after final patient recruitment to drive the shares. Following thecapital raise we now value Mologen at €251m (€7.39/share).

Mologen

'Next Level' of development

Update | Pharmaceutical & healthcare | 21 Jul 2016

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.

Mologen

Lefitolimod trials on track

Update | Pharmaceutical & healthcare | 13 Apr 2016

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.

Mologen

MGN1703 remains the focus

Outlook | Pharmaceutical & healthcare | 14 Dec 2015

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.

Mologen

Pivotal cancer immunotherapy player

QuickView | Pharmaceutical & healthcare | 09 Nov 2015

Mologen is developing cancer immunotherapies for the post-chemo maintenance setting. Lead product, MGN1703, is in three clinical trials for different indications. Following the €28.3m (gross) proceeds from the rights issue in April 2015, Mologen should have sufficient funds to reachfull recruitment of IMPALA (Phase III in colorectal cancer) and top-line data from IMPULSE (Phase II in lung cancer); the latter could positively affect partnering or financing options for MGN1703. We value Mologen at €384m.