Phase II strategy for MP0250 laid-out, strategy about immuno-oncology pipeline disclosed, business and financial outlook 2016 fully confirmed
R&D and Operating Highlights:
- Proprietary oncology pipeline progressing with phase II development plan for lead asset MP0250 in multiple myeloma disclosed
- Concept for immuno-oncology pipeline and two early-stage programs announced:
a VEGF/ PD-1 multi-DARPin and tumor-localized agonists - Abicipar advances in phase III trials, as strategic partner Allergan reiterated its firm commitment to DARPins
Financial Highlights:
- Ongoing strong financial position with CHF 205.9 million cash balance (including short-term time deposits) as of March 31, 2016, down CHF 9.5 million versus December 31, 2015, and up 13% year-over-year
- Net cash used from operating activities of CHF 7.2 million, up CHF 3.4 million year-on-year, reflecting ongoing scale-up of R&D, operational activities and the company’s pipeline
- Operating loss of CHF 2.2 million and net loss of CHF 4.2 million in the first quarter 2016
- Growing talent base with 94 full-time employees as of March 31, 2016, up 25% year-over-year and an increase of 5% compared to year-end 2015
Zurich-Schlieren, 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.
“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.”
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) |
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.
Financial Calendar 2016
|
Publication of Half-year Results 2016 |
September 1, 2016 |
|
Publication of Quarterly Management Statement Q3 2016 |
October 27, 2016 |
http://investors.molecularpartners.com/financial-calendar-and-events/
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new, class of therapies known as DARPins. DARPins are potent, specific, and versatile small-protein therapies, which have the potential to offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology has the potential to offer a multi-specific approach to treatment, which enables DARPins to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPins have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders.
Molecular Partners has four compounds in various stages of clinical and preclinical development and several more in the research stage, with a current focus on ophthalmology and oncology. The company has ongoing research and development partnerships with leading pharmaceutical companies, including Allergan and Janssen, and is backed by established biotech investors. For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.
For further details, please contact:
Dr. Christian Zahnd, CEO
christian.zahnd@molecularpartners.com
Tel: +41 (0) 44 755 77 00
Andreas Emmenegger, CFO
andreas.emmenegger@molecularpartners.com
Tel: +41 (0) 44 755 77 00
Rolf Schläpfer
Hirzel.Neef.Schmid.Counselors
rolf.schlaepfer@konsulenten.ch
Tel: +41 (0) 43 344 42 42
Disclaimer
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Molecular Partners AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.
