On April 28, 2016. Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPins, today provided its Quarterly Management Statement and key financial highlights for the period ending March 31, 2016 (Press release, Molecular Partners, APR 28, 2016, View Source [SID:1234511576]). Schedule your 30 min Free 1stOncology Demo! "We are very pleased with the development and further fortification of our broad and novel pipeline, the renewed commitment of our strategic partners to our innovative DARPin technology platform, as well as the continued strength of our financial position during the first quarter," said Dr. Christian Zahnd, Chief Executive Officer of Molecular Partners. "We look forward to continue to focus on the remainder of 2016 with several additional milestones expected, including clinical milestones."
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Business highlights in the first quarter 2016
Proprietary oncology pipeline progressing with the phase II development plan for lead asset MP0250 in multiple myeloma disclosed
In the first quarter of 2016, Molecular Partners provided guidance on the Phase II development strategy for MP0250, the lead oncology DARPin. The company will initiate the first Phase II study of this compound in the second half of 2016 in patients with multiple myeloma. The study will investigate MP0250 in combination with bortezomib and dexamethasone in patients whose cancers became refractory while on bortezomib therapy, and who have received at least two prior regimens including bortezomib and an immunomodulatory drug.
Beyond MP0250, Molecular Partners is advancing a growing proprietary pipeline of DARPin therapies. The pipeline includes MP0274, a multi-DARPin that targets HER2, providing broad blockade of HER1, HER2 and HER3-mediated signaling and inducing apoptosis (programmed cell death) in HER2-overexpressing cells. MP0274 is currently in preclinical development.
Concepts for immuno-oncology pipeline and two early-stage programs announced
In March 2016, the company announced its strategy in immuno-oncology, including the disclosure of two multi-DARPin programs. The first program targets the validated immune checkpoint PD-1 as well as VEGF-A, aiming to enhance PD-1 efficacy. The second program is designed to potently activate T-cells in the tumor only without activating circulating T-cells, thus circumventing systemic toxicities.
Immuno-oncology is a revolutionary approach to anti-cancer treatment that redirects the body’s immune system to fight cancer cells. Investigators are studying many different ways to modulate immune checkpoints used by the body to regulate the immune system. While many of these clinical studies are yielding promising results, novel approaches are needed.
Abicipar advances in phase III trials, reiterated commitment of strategic partner Allergan
Molecular Partners is pleased to see abicipar advancing in its Phase III trials in wet AMD which started in July 2015. The company remains confident to see further development of this product candidate in additional indications such as diabetic macular edema (DME) as well as progress of other DARPins in the ophthalmology alliance with Allergan, which also includes an earlier stage VEGF/PDGF multi-DARPin in wet AMD. In the context of the withdrawn merger of Allergan with Pfizer, Allergan management publicly stated on April 6, 2016, that abicipar "continues to progress in clinical development and could be a true game changer for people suffering with this disease by lowering the injection burden significantly."
Financial Highlights in 1Q 2016: Financial development as expected, ongoing strong position
In the first quarter of 2016, Molecular Partners recognized total revenues of CHF 6.8 million (1Q 2015: CHF 5.8 million) and incurred total expenses of CHF 9.0 million (1Q 2015: CHF 6.2 million). This led to an operating loss of CHF 2.2 million for the quarter (1Q 2015: operating loss of CHF 0.4 million). The company recognized net financing expenses of CHF 2.0 million (1Q 2015: net financing expenses of CHF 2.0 million), mainly driven by negative FX effects on USD and EUR cash positions. This resulted in a net loss of CHF 4.2 million for the first quarter 2016 (1Q 2015: net loss of CHF 2.4 million).
The net cash used from operating activities during the first quarter 2016 was CHF 7.2 million (1Q 2015: net cash used from operating activities of CHF 3.8 million). Including the time deposits, the cash and cash equivalents position of the company decreased by CHF 9.5 million versus year-end 2015 to CHF 205.9 million as of March 31, 2016 (December 31, 2015: CHF 215.4 million). The total shareholders’ equity position decreased by CHF 4.8 million to CHF 147.0 million as of March 31, 2016 (December 31, 2015: CHF 151.8 million).
As of March 31, 2016, the company employed 94 FTEs, more than 90% of whom are employed in R&D functions (December 31, 2015: 89 FTEs; March 31, 2015: 75 FTEs).
Key figures as of March 31, 2016
Key Financials (unaudited)
(CHF million, except per share, FTE data)
1Q 2016
1Q 2015
change
Total revenues
6.8
5.8
1.0
R&D expenses
-7.5
-4.6
-2.9
G&A expenses
-1.5
-1.6
0.1
Operating loss
-2.2
-0.4
-1.8
Net loss
-4.2
-2.4
-1.8
Basic net loss per share (in CHF)
-0.21
-0.13
-0.08
Net cash from (used in) operating activities
-7.2
-3.8
-3.4
Cash & cash equivalents as of March 31
196.3
182.3
14.0
Cash balance (incl. time deposits) as of March 31
205.9
182.3
23.6
Total shareholders’ equity as of March 31
147.0
146.5
0.5
Number of total FTE as of March 31
93.7
74.8
18.9
– thereof in R&D
85.5
67.9
17.6
– thereof in G&A
8.2
6.9
1.3
"In the first quarter of 2016, Molecular Partners’ financial position developed fully in line with our projections and expectations amid the substantial scale-up of our R&D and operational activities," said Andreas Emmenegger, Chief Financial Officer of Molecular Partners. "We reiterate our previously provided financial guidance for 2016."
Successful placement of shares
After the end of the first quarter, on April 13, 2016, employees, consultants, members of the board of directors of the company as well as certain venture capital shareholders successfully placed 1.1 million shares in an accelerated bookbuilding transaction at a price of CHF 27.50 per share. This share placement was done in order to provide employees, consultants and members of the board of directors the necessary funds to pay taxes and social securities resulting from the exercise of stock options which were approaching expiration. Following the option exercise and transaction, the executive management team holds an increased position of Molecular Partners’ shares compared to the situation before the share placement.
Business outlook and priorities
With the announcement of the share placement transaction on April 13, 2016, Molecular Partners AG fully confirmed its outlook and priorities for the financial year 2016.
In ophthalmology, the company will remain focused on supporting its partner Allergan in progressing abicipar through Phase III trials in wet AMD, and possibly in initiating Phase III trials for abicipar in DME.
In oncology, Molecular Partners AG reiterated during the first quarter 2016 its commitment to conduct a Phase II trial of MP0250 in the treatment of multiple myeloma (MM) in combination with bortezomib and dexamethasone, and continues to expect the enrolment of the first patient in the second half of 2016. The company’s management team also remains committed to advancing MP0274 into clinical development in 2016, and plans to initiate a Phase I trial of MP0274 by the end of the year.
On March 7, 2016, Molecular Partners AG reinforced its key priority on contributing to the rapidly evolving field of immuno-oncology as the DARPin platform is ideally suited to develop differentiated immuno-oncology therapies with the potential to overcome some of the limitations of first-generation approaches. The company announced initial strategies of its proprietary immuno-oncology pipeline, including two multi-DARPin programs which are evaluating new principles that were previously difficult to achieve.
Financial Outlook 2016
Molecular Partners reiterates all elements of the financial outlook 2016 as provided in the company’s 2015 full-year results on February 4, 2016.
For the full year 2016, at constant exchange rates, the company expects total expenses of CHF 50-60 million, of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciations. However, this may change substantially depending on the progress of the pipeline, mainly driven by the speed of enrollment of patients in clinical trials and data from research and development projects. Additionally, the company expects around CHF 3 million of capital expenditures, mainly for laboratory equipment.
No guidance can be provided with regard to net cash flow projections. Timelines and potential milestone payments for existing and potentially new partnerships cannot be disclosed.