Quarterly Management Statement for the Perios Ending September 30, 2016

Quarterly Management Statement for the Perios Ending September 30, 2016

Encouraging Data for MP0250 in Oncology and New Phase 2 DME-Data for Abicipar in Ophthalmology Presented at Leading Scientific Conferences

R&D, Partnerships & Team Milestones:

  • Abicipar: Phase 3 trials in wet AMD (wet age related macular degeneration) progress as scheduled
  • Abicipar: Allergan presented phase 2 data in DME (diabetic macular edema) at AAO conference in Chicago on October 15 with data showing long duration of action in this indication and supporting progression to phase 3
  • MP0250: Additional, encouraging data on phase 1 trial for MP0250, a multi-DARPin®* drug candidate in oncology targeting VEGF and HGF, presented at ESMO Conference
  • MP0250: First regulatory submission for phase 2 in Multiple Myeloma planned for 4Q 2016 with first safety data expected in 2017 and efficacy data in 2018
  • MP0250: Commitment to run additional phase 2 trial for a solid tumor indication
  • MP0274: First regulatory submission for phase 1 with MP0274, a multi-DARPin® drug candidate for the treatment of HER2-positive solid tumor indications, planned for 1Q 2017
  • Immunology: Janssen returned full rights of the development-stage DARPin® drug candidate as the partner strategically decided to deprioritize pulmonary R&D

Financial Highlights:

  • Ongoing strong financial position with CHF 185.7 million in cash and short-term time deposits as of September 30, 2016
  • Net cash used from operating activities of CHF 27.5 million over the first three quarters of 2016, reflecting the ongoing scale-up of R&D activities and the growth of the company’s pipeline
  • Operating loss of CHF 13.1 million and net loss of CHF 14.8 million in the first nine months of 2016
  • Talent base with 103 full-time employees, up 21% year-over-year, reflecting the further build-up of clinical development expertise

Zurich-Schlieren, October 27, 2016. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company that is developing a new class of therapies, known as DARPin® therapies, today announced its Quarterly Management Statement for the period ending September 30, 2016 and key financial highlights for the third quarter 2016.

“We are very pleased with the development and progression of our broad and novel pipeline, based on our innovative DARPin® technology platform, and the ongoing strength of our financial position,” said Dr. Christian Zahnd, Chief Executive Officer of Molecular Partners. “We look forward to starting two phase 2 trials for our lead oncology asset MP0250 and initiating the phase 1 trial with MP0274. We are also pleased to see Allergan progressing the phase 3 trials for Abicipar fully in line with our expectations.”

Abicipar phase 3 trials in wet AMD progress according to plan

The company’s strategic partner Allergan is currently enrolling patients in a phase 3 trial for wet age-related macular degeneration (wet AMD) using an updated formulation of abicipar. Enrollment is progressing well and topline results are expected in 2018.

Additional phase 2 data supports abicipar progression into phase 3 for DME

Allergan presented phase 2 clinical trial data evaluating abicipar for diabetic macular edema (DME) at 2016 American Academy of Ophthalmology Annual Meeting (AAO) in Chicago. Abicipar for DME met its study end points and the efficacy of abicipar was shown in all three treatment groups. Over the 28 week trial period, abicipar with a 2 mg dose (and injected every 8 weeks, respectively every 12 weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (CRT) effects comparable with ranibizumab (Lucentis®) which was injected every 4 weeks into each eye. Overall, the safety profile of abicipar is acceptable. Intraocular inflammation occurred in 7, 5 and 4 patients in the three treatment groups respectively. The first two groups were treated with a 1 mg dose, respective a 2 mg dose of abicipar at an 8 weeks injection interval. The third group was treated with a 2 mg dose of abicipar every 12 weeks. The adverse events observed were mostly mild to moderate in severity, and resolved with treatment. These data show the long duration of action of abicipar and support its progression to phase 3 for DME.

The objective of this study was to assess the safety, efficacy, systemic pharmacokinetics, and immunogenicity profile of abicipar in patients with decreased vision due to centrally-involved DME compared to Lucentis® which is the standard of care.

Additional phase 1 data presented confirming potential of MP0250

On October 9, 2016, the company presented completed phase 1 dose escalation interim results of MP0250 at the Conference of the European Society of Medical Oncology (ESMO) in Copenhagen.

These data, based on the enrollment of a total of 24 patients, are an important milestone in the development of DARPin® proteins as anticancer agents and expand the results that had been published in November 2015. MP0250, used as single agent, is the first DARPin® drug candidate to be studied in humans as systemic treatment. MP0250 was well tolerated at the higher dose levels (up to the maximally tolerated dose of 8 mg/kg administered every 2 weeks). This is an important milestone because it proves that DARPin® proteins do not negatively impact the immune system of humans and can be engineered to have a systemic half-life of around two weeks. The drug is well tolerated and the side effect profile is consistent with profound inhibition of the VEGF pathway. MP0250 has the potential to become a new therapeutic in treating various tumor types.

Update on phase 2 strategy for MP0250: Initiation for two phase 2 trials planned for 2017

The first phase 2 study will examine MP0250 in combination with bortezomib (Velcade®) and dexamethasone in patients with multiple myeloma who have failed standard therapies. The first regulatory submission for such study is planned for 4Q 2016 with first safety data expected in 2017 and efficacy data in 2018.

Based on the encouraging data from phase 1 in solid tumors, Molecular Partners committed to run an additional phase 2 trial for a solid tumor indication. Study details will be disclosed in H1 2017.

First regulatory submission for MP0274 scheduled for 1Q 2017

The company plans the first regulatory submission for the envisaged phase 1 trial of MP0274, a proprietary, single-pathway DARPin® drug candidate for the treatment of HER2-positive solid tumor indications, for 1Q 2017.

Full rights to a multi-DARPin® drug candidate in immunology regained from Janssen

In October 2016, Molecular Partners regained the full rights to a multi-DARPin® drug candidate targeting both IL-13 and IL-17 with long systemic half-life and potential use in pulmonary indications following the discontinuation of a Collaboration and License Agreement entered into with Janssen in 2011. Under the collaboration, Molecular Partners and Janssen and generated a multi-DARPin® drug candidate that is ready to enter into preclinical development. The research and development costs of this drug candidate were supported by Janssen. The termination of the collaboration with Janssen in immunology is the result of a strategic decision not related to the DARPin® drug candidate and Molecular Partners is now evaluating if the program will be re-partnered or added to its proprietary pipeline.

Financial highlights: Ongoing strong cash position, increased development expenses

Molecular Partners’ financial development for the first nine months of 2016 continued in line with management’s expectations and reflects the increase in development expenses and the ongoing investments to further expand the company’s proprietary pipeline. In the first nine months of 2016, Molecular Partners recognized total revenues of CHF 19.2 million (1Q-3Q 2015: CHF 21.1 million) and incurred total expenses of CHF 26.8 million (1Q-3Q 2015: CHF 17.7 million). This led to an operating loss of CHF 13.1 million for the first three quarters 2016 (1Q-3Q 2015: Operating loss of CHF 1.7 million). The company recognized a net financing expense of CHF 1.7 million for the first nine months 2016, mainly driven by adverse FX effects on its USD and EUR cash positions (1Q-3Q 2015: Net financing income of CHF 0.2 million). This resulted in a 1Q-3Q 2016 net loss of CHF 14.8 million (1Q-3Q 2015: Net loss of CHF 1.5 million).

Key figures as of September 30, 2016

Key Financials
(CHF million, except per share, FTE data)
3Q
2016
3Q
2015

change
1Q-3Q
2016
1Q-3Q
2015

change
Total revenues 5.7 9.9 -4.2 19.2 21.1 -1.9
R&D expenses -8.7 -5.9 -2.8 -26.8 -17.7 -9.1
G&A expenses -1.6 -1.8 0.2 -5.5 -5.1 -0.4
Operating profit (loss) -4.6 2.2 -6.8 -13.1 -1.7 -11.4
Net finance income (expenses) -0.5 3.3 -3.8 -1.7 0.2 -1.9
Net profit (loss) -5.1 5.5 -10.6 -14.8 -1.5 -13.3
Basic net profit (loss) per share (in CHF) -0.25 0.28 -0.53 -0.73 -0.08 -0.65
Diluted net profit (loss) per share (in CHF) -0.25 0.25 -0.50 -0.73 -0.08 -0.65
Net cash from (used in) operating activities -10.0 43.3 -53.3 -27.5 34.1 -61.6
Net increase (decrease) in cash & cash equiv. -20.1 45.4 -65.5 -38.7 32.6 -71.3
Cash balance (incl. time deposits)
as of Sep 30
185.7 221.0 -35.3
Total shareholders’ equity at Sep 30 136.7 149.4 -12.7
Number of total FTE as of Sep 30 103.4 85.6 17.8
– thereof in R&D 93.4 77.4 16.0
– thereof in G&A 10.0 8.2 1.8

The cash and short term time deposits came down by CHF 10.6 million since June 30, 2016 to CHF 185.7 million as of September 30, 2016 (June 30, 2016: CHF 196.3 million) and continue on a very solid level with a cash runway of multiple years. The total shareholders’ equity position decreased to CHF 136.7 million as of September 30, 2016 (June 30, 2016: CHF 141.4 million).

The third quarter 2015 had been positively impacted by the USD 15 million milestone payment received from the company’s strategic partner Allergan for the start of the phase 3 trials for abicipar in wet AMD as well as the USD 35 million in accelerated milestone payments tied to the research collaboration also paid by Allergan in 3Q 2015.

As of September 30, 2016, the company employed 103 FTEs, with 90% of employees in R&D (September 30, 2015: 86 FTEs). The increase of 21% of R&D employees year-on-year reflects the strong investments by the company in its research and development capabilities in order to advance its proprietary pipeline.

“Over the course of the first nine months of 2016, Molecular Partners’ financial position developed in line with our projections amid the ongoing commitment to increase our research and development expenses and to invest into value creating proprietary pipeline assets,” said Andreas Emmenegger, Chief Financial Officer of Molecular Partners. “We will close the full year 2016 with an ongoing strong cash position which provides us with the envisaged financial flexibility going forward.”

Business Outlook and priorities

In ophthalmology, Molecular Partners will continue to support its strategic partner Allergan in advancing abicipar through phase 3 trials in patients with wet AMD, and possibly in initiating phase 3 trials of abicipar in patients with DME, the next logical retinal indication.

For the company’s proprietary oncology pipeline, plans for the remainder of 2016 include the first regulatory submission of the envisaged phase 2 trial of MP0250 for patients with Multiple Myeloma (MM). First safety data of this trial are expected in 2017 and efficacy data in 2018. With respect to the additional phase 2 trial for a solid tumor indication, the company will disclose further details in H1 2017. Molecular Partners envisages initiating a phase 1 trial of MP0274, a proprietary, single-pathway DARPin® drug candidate for the treatment of HER2-positive breast cancer with first regulatory submission expected in 1Q 2017.

The company will continue to advance its immuno-oncology pipeline, an area in which Molecular Partners has demonstrated the potential utility of targeting immune checkpoint modulators (ICMs) via combination therapy (e.g., joint inhibition of PD-1 and VEGF) or activating agonists while localizing its effects.

Financial Outlook 2016

For the full year 2016, at constant exchange rates, the company expects total expenses of around CHF 50 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 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 2 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 are not disclosed.

Financial Calendar

Publication of Full-year Results 2016 (unaudited) February 09, 2017
Expected Publication of Annual Report 2016 March 29, 2017
Annual General Meeting May 11, 2017

http://investors.molecularpartners.com/financial-calendar-and-events/

About the DARPin® technology

Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin® drug candidates. The most advanced assets globally is abicipar, a molecule currently in phase 3 which is being advanced by Allergan. Abicipar is being followed by several DARPin® molecules for various ophthalmic indications. The most advanced systemic DARPin® molecule, MP0250, is in clinical development for solid tumors and is moving to phase 2 for hematological and solid tumors. The second most advanced oncology
DARPin® drug candidate is MP0274, which has broad anti-HER activity, inhibiting HER1, HER2, and HER3-mediated downstream signaling via Her2 and leading to induction of apoptosis. MP0274 is currently in preclinical development. There is a growing pipeline of immune-oncological treatments following the two proprietary lead assets.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. DARPin® therapies are potent, specific, and versatile small proteins, 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 the DARPin® therapies to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPin® therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. DARPin® is a registered trademark owned by Molecular Partners AG.

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 establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

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

S.A. Noonan
Susan A. Noonan Communications, LLC
susan@sanoonan.com
Tel: +1 212 966 3650

 

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.

Abicipar Pegol PALM Study Phase 2 Data in Diabetic Macular Edema (DME) Presented at 2016 AAO Annual Meeting

  • Abicipar meets its study end points
  • Safety profile of abicipar acceptable
  • Data supports progression to phase 3

Zurich‐Schlieren, October 15, 2016. Molecular Partners AG (SIX: MOLN) today announced that Tarek S. Hassan, MD, Professor of Ophthalmology at Oakland University William Beaumont School of Medicine and Senior Partner and Director of the Vitreoretinal Fellowship Training Program at Associated Retinal Consultants in Royal Oak, Michigan, presented the data of PALM, A Multicenter, Double Masked Phase 2 Clinical Trial Evaluating Abicipar Pegol (abicipar) for Diabetic Macular Edema (DME) at the American Academy of Ophthalmology Annual Meeting (AAO) 2016 in Chicago.

A total of 151 patients with DME (BCVA ≤75 and ≥24 letters) were enrolled. The efficacy of abicipar was demonstrated in all treatment groups. Abicipar 2 mg (Q8weeks and Q12weeks, following three monthly loading doses) demonstrated functional (BCVA) and anatomical (CRT) effects comparable with monthly ranibizumab, and with fewer injections over a 28 week period. The most common ocular adverse events were vitreous floaters and conjunctival hemorrhage in the abicipar arms. Intraocular inflammation occurred in 7, 5 and 4 patients treated with abicipar 1Q8, 2Q8 and 2Q12 groups, respectively and none with ranibizumab. These adverse events were mostly mild to moderate in severity, and resolved with treatment. These data support progression to phase 3.

Allergan is currently enrolling patients in a phase 3 trial for AMD using an updated formulation of abicipar. Enrollment is progressing well and topline results are expected in 2018.

Christian Zahnd, CEO of Molecular Partners, commented: “We are very pleased to see that abicipar may help certain patients suffering from DME. We look forward to Allergan initiating the phase 3 study in DME.”

The objective of the PALM study was to assess the safety, efficacy, systemic pharmacokinetics, and immunogenicity profile of abicipar in patients with decreased vision due to centrally-involved DME compared to standard of care, ranibizumab. In the double‐masked trial, a total of 151 patients were randomized to abicipar 1mgQ8 (n=43), abicipar 2mgQ8 (n=42), abicipar 2mgQ12 (n=45) or ranibizumab 0.5mgQ4 (n=21) and were followed for 28 weeks. All patients received doses at the start of the trial and at 4 and 8 weeks. Patients who were treated with abicipar received sham injections at 12, 16, 20 and 24 weeks, as applicable. Patients in all arms of the study were well matched at baseline.

The analysis of the primary endpoint showed that after 28 weeks the mean change in BCVA from baseline was 7.2 letters for abicipar 2mgQ12, 7.1 letters for abicipar 2mgQ8, 4.9 letters for abicipar 1mgQ8, and 9.6 letters for ranibizumab. The mean change in BCVA for abicipar includes all patients irrespective of adverse events. The mean change in CRT from baseline, which was the secondary endpoint of the study, was -159.4 mm for abicipar 2mgQ12, -162.0 mm for abicipar 2mgQ8, – 176.4 mm for abicipar 1mgQ8, and -158.8 mm for ranibizumab. The study was not powered to show statistically significant differences between treatment groups.

Additional details on the study are available on the website of the American Academy of Ophthalmology Annual Meeting 2016.

About Abicipar

Abicipar is a long-acting mono-DARPin® drug candidate that inhibits vascular endothelial growth factor A (VEGF-A) and is currently under investigation for the treatment of two major causes of blindness worldwide: neovascular, or wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Abicipar has the potential to require less frequent injections into the eye than the current anti-VEGF standards of care, while providing equal or better improvements in vision, both seen as major patient benefits in these indications. Molecular Partners exclusively licensed abicipar to Allergan in May 2011.

About the DARPin® technology

Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin® drug candidates. The most advanced assets globally is abicipar, a molecule currently in phase 3 which is being advanced by Allergan. Abicipar is being followed by several DARPins® for various ophthalmic indications. The most advanced systemic DARPin® molecule, MP0250, is in clinical development for solid tumors and is moving to phase 2 for hematological and solid tumors. The second most advanced oncology DARPin® drug candidate is MP0274, which has broad anti-HER activity, inhibiting HER1, HER2, and HER3-mediated downstream signaling via Her2 and leading to induction of apoptosis. MP0274 is currently in preclinical development. There is a growing pipeline of immune-oncological treatments following the two proprietary lead assets.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new class of therapies known as DARPin® therapies. DARPin® therapies are potent, specific, and versatile small proteins, 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 the DARPin® therapies to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPin® therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. DARPin® is a registered trademark owned by Molecular Partners AG.

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 establishes research and development partnerships with leading pharmaceutical companies 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

PD Dr. Andreas Harstrick, CMO
andreas.harstrick@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

S.A. Noon
Susan A. Noonan Communications, LLC
susan@sanoonan.com
Tel: +1 212 966 3650

 

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.

Molecular Partners’ Strategic Partner Allergan to Present Abicipar Phase 2 Data of PALM Study in Diabetic Macular Edema (DME) at the 2016 AAO Annual Meeting

Zurich‐Schlieren and Dublin, Ireland, October 10, 2016. Molecular Partners AG (SIX: MOLN) and Allergan (NYSE: AGN) today announced that Tarek S. Hassan, MD, Professor of Ophthalmology at Oakland University William Beaumont School of Medicine and Senior Partner and Director of the Vitreoretinal Fellowship Training Program at Associated Retinal Consultants in Royal Oak, Michigan, will present the data of PALM, A Multicenter, Double Masked Phase 2 Clinical Trial Evaluating Abicipar Pegol for Diabetic Macular Edema on Saturday, October 15, 2016 at 11:27 AM Central Time during the 2016 American Academy of Ophthalmology Annual Meeting (AAO) in Chicago.

About Abicipar

Abicipar is a long-acting mono-DARPin® drug candidate that inhibits vascular endothelial growth factor A (VEGF-A) and is currently under investigation for the treatment of two major causes of blindness worldwide: neovascular, or wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Abicipar has the potential to require less frequent injections into the eye than the current anti-VEGF standards of care, while providing equal or better improvements in vision, both seen as mayor patient benefits in these indications. Molecular Partners exclusively licensed Abicipar to Allergan in May 2011.

About the DARPin® technology

Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin® drug candidates. The most advanced assets globally is abicipar, a molecule currently in phase 3 which is being advanced by Allergan. Abicipar is being followed by several DARPin® proteins for various ophthalmic indications. The most advanced systemic DARPin® molecule, MP0250, is in clinical development for solid tumors and is moving to phase 2 for hematological and solid tumors. The second most advanced oncology DARPin® drug candidate is MP0274, which has broad anti-HER activity, inhibiting HER1, HER2, and HER3-mediated downstream signaling via Her2 and leading to induction of apoptosis. MP0274 is currently in preclinical development. There is a growing pipeline of immune-oncological treatments following the two proprietary lead assets.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new, class of therapies known as DARPin® therapies. DARPin® therapies are potent, specific, and versatile small proteins, 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 the DARPin® therapies to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPin® therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. DARPin® is a registered trademark owned by Molecular Partners AG.

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 establishes research and development partnerships with leading pharmaceutical companies and is backed by established biotech investors.

For more information regarding Molecular Partners AG, go to: www.molecularpartners.com.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical com-pany and a leader in a new industry model – Growth Pharma.  Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.

Allergan is an industry leader in Open Science, the Company’s R&D model, which defines the company’s approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs in development.

Allergan’s success is powered by the company’s more than 16,000 global colleagues’ commitment to being Bold for Life. Together, the company builds bridges, powers ideas, acts fast and drives results for its customers and patients around the world by always doing what is right.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treat-ments that help people around the world live longer, healthier lives every day.

For more information, visit Allergan’s website at www.Allergan.com.

 

For further details please contact:

Dr. Christian Zahnd, CEO
christian.zahnd@molecularpartners.com
Tel: +41 (0) 44 755 77 00

PD Dr. Andreas Harstrick, CMO
andreas.harstrick@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

S.A. Noon
Susan A. Noonan Communications, LLC
susan@sanoonan.com
Tel: +1 212 966 3650

 

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.

Molecular Partners Presents Data of MP0250 in an All-Comer Phase 1-Study in Solid Tumor Patients and Updates on Phase 2 Studies

Zurich‐Schlieren, October 9, 2016. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company that is developing a powerful new class of therapies known as DARPin® therapies, announces additional details about its ongoing clinical oncology program MP0250.

M.R. Middleton, Professor of Experimental Cancer Medicine, Department of Oncology at the University of Oxford, UK presents today the completed phase 1 dose escalation interim results of MP0250 at the poster session ‘Developmental Therapeutics’ at the Conference of the European Society of Medical Oncology (ESMO).  The poster is available under this link.

MP0250 is a multi-DARPin® product consisting of four domains targeting vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF) and also binds to human serum albumin (HSA) to increase the plasma half-life and potentially tissue penetration.

Prof. M.R. Middleton commented:  “MP0250 used as single agent is the first DARPin® drug candidate to be studied in humans as systemic treatment. The drug is generally well tolerated and the side effect profile is consistent with profound inhibition of the VEGF pathway. We have seen encouraging signs of clinical activity in these heavily pretreated patients, with two patients showing significant reduction of tumor burden and 6 patients having prolonged stable disease. MP0250 has the potential to become a new therapeutic in treating various tumor types.”

These data, now based on the total enrollment of 24 patients, are an important milestone in the development of DARPin® proteins as anticancer agents and expand the results that were published at the AACR-NCI-EORTC conference in November 2015:

  • MP0250 was well tolerated at the higher dose levels (up to 8 mg/kg administered every 2 weeks). This was assigned as the maximally tolerated dose (MTD). Toxicities came primarily from the inhibition of VEGF, including dose-limiting toxicities of acute left ventricular failure, nephrotic syndrome and hypertension, gastrointestinal hemorrhage and thrombotic microangiopathy.
  • MP0250 had a half-life of about 12 days and shows full exposure in all patients over the whole treatment period at all doses.

Update on phase 2 strategy for MP0250

The first phase 2 study will examine MP0250 in combination with bortezomib and dexamethasone in patients with multiple myeloma who have failed proteasome and IMiD based standard therapies. The first regulatory submission for such study is planned in Q4 2016.

Based on the encouraging data from phase 1 in solid tumors, Molecular Partners decided to initiate an additional phase 2 study for a solid tumor indication. Study details will be disclosed in H1 2017.

 

About the DARPin® technology

Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin® drug candidates. The most advanced assets globally is abicipar, a molecule currently in phase 3 which is being advanced by Allergan. Abicipar is being followed by several DARPins® for various ophthalmic indications. The most advanced systemic DARPin® molecule, MP0250, is in clinical development for solid tumors and is moving to phase 2 for hematological and solid tumors. The second most advanced oncology DARPin® drug candidate is MP0274, which has broad anti-HER activity, inhibiting HER1, HER2, and HER3-mediated downstream signaling via Her2 and leading to induction of apoptosis. MP0274 is currently in preclinical development. There is a growing pipeline of immune-oncological treatments following the two proprietary lead assets.

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new, class of therapies known as DARPin® therapies. DARPin® therapies are potent, specific, and versatile small proteins, 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 the DARPin® therapies to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPin® therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. DARPin® is a registered trademark owned by Molecular Partners AG.

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 establishes research and development partnerships with leading pharmaceutical companies 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

PD Dr. Andreas Harstrick, CMO
andreas.harstrick@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

S.A. Noon
Susan A. Noonan Communications, LLC
susan@sanoonan.com
Tel: +1 212 966 3650

 

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.

Molecular Partners Regains Rights to Multi-DARPin® Drug Candidate Targeting IL-13 & IL-17 for Pulmonary Indications from Janssen

Zurich‐Schlieren, October 6, 2016. Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company that is developing a powerful new class of therapies known as DARPin® therapies, regained the full rights to a multi-DARPin® drug candidate targeting both IL-13 and IL-17 with long systemic half-life and potential use in pulmonary indications following the discontinuation of a Collaboration and License Agreement entered into with Janssen Biotech, Inc. (Janssen) in 2011.

Under the collaboration, Molecular Partners and Janssen and generated a multi-DARPin® drug candidate that is ready to enter into preclinical development. The research and development costs of this drug candidate were supported by Janssen.

“We are proud to have successfully applied our DARPin® platform to generate this highly differentiated multi-DARPin® drug candidate for Janssen, and respect their strategic decision not related to the DARPIN® drug candidate. Molecular Partners will thoroughly evaluate if this drug candidate should be added to our proprietary pipeline, partnered or discontinued,” said Dr. Christian Zahnd, Chief Executive Officer of Molecular Partners.

The termination of the collaboration with Janssen in immunology does not impact Molecular Partners‘ strategy. Molecular Partners is progressing programs in ophthalmology in partnership with Allergan and in oncology with a proprietary pipeline of DARPin® drug candidates. The most advanced programs are Abicipar currently in phase 3 and MP0250 which is moving into phase 2 clinical studies in hematological malignancies.

 

About Molecular Partners AG

Molecular Partners AG is a clinical-stage biopharmaceutical company that is developing a new, class of therapies known as DARPin® therapies. DARPin® therapies are potent, specific, and versatile small proteins, 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 the DARPin® therapies to target multiple pathways, or multiple epitopes on a single target to achieve substantial patient benefit. DARPin® therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. DARPin® is a registered trademark owned by Molecular Partners AG.

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 establishes research and development partnerships with leading pharmaceutical companies 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

Dr. Patrick Amstutz, COO
patrick.amstutz@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

S.A. Noon
Susan A. Noonan Communications, LLC
susan@sanoonan.com
Tel: +1 212 966 3650

 

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.