H1 Results Conference Call - Polyphor · 2019-12-02 · EOP1 FDA Other combination studies in parallel Select pre-clinical candidate Target timeline Ph. Ib Potential for accelerated

© Polyphor Ltd 2018 Half Year Results Presentation

Business Progress and H1 Financial resultsSeptember 6th, 2018

H1 Results Conference Call

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This presentation (the “Presentation”) has been prepared by Polyphor Ltd. (“the Company” and together with its subsidiary, “we”, “us”or the “Group”) solely for informational purposes.

Certain statements in this Presentation are forward-looking statements, beliefs or opinions, including statements relating to, amongother things, the Company's business, financial condition, future performance, results of operation, potential new market opportunities,growth strategies, and expected growth in the markets in which the Group operates. In some cases, these forward-looking statementsmay be identified by the use of forward-looking terminology, including the terms “targets”, “believes”, “estimates”, “anticipates”,expects”, “intends”, “may”, “will” or “should” or, in each case, their negative or other variations or similar expressions. By their nature,forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differmaterially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions couldadversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ materiallyfrom those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economicconditions, changed market conditions, intense competition in the markets in which the Group operates, costs of compliance withapplicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting the Group’s markets, andother factors beyond the control of the Group). Neither the Company nor any of its respective directors, officers, employees, agents,affiliates, advisors or any other person is under any obligation to update or revise any forward-looking statements, whether as a resultof new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of thedate of this Presentation. Statements contained in this Presentation regarding past trends or events should not be taken as arepresentation that such trends or events will continue in the future. Some of the information presented herein is based on statementsby third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, thefairness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for anypurpose whatsoever.

This Presentation does not constitute or form part of, and should not be construed as, an offer or invitation or inducement to subscribefor, underwrite or otherwise acquire, any securities of the Company, nor should it or any part of it form the basis of, or be relied on inconnection with, any contract to purchase or subscribe for any securities of the Group, nor shall it or any part of it form the basis of, orbe relied on in connection with, any contract or commitment whatsoever. This Presentation is not a prospectus and is being madeavailable to you solely for your information and background and is not to be used as a basis for an investment decision in securities ofthe Company or the Group.

Disclaimer

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Financing

Key programs’ progress– Murepavadin– Balixafortide– OMPTA Platform

H1 Financials

Q and A

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Agenda

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Financing


H1 Financials

Q and A

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Agenda

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§ Significant fund raising- Gross proceeds: CHF 155M

§ Largest in Switzerland since 10 years, one of the top 3 in Europe in the last 3 years

§ Allows Funding of- Development of murepavadin in HAP/VAP towards regulatory approval- Balixafortide pivotal program in Advanced Metastatic Breast Cancer- Initial investment for the development of the inhaled formulation of

murepavadin- Continued development of the OMPTA program- General Corporate purposes

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IPO – May 15th, 2018


IPO

Shareholders’ structure as of 23 August, 2018

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Ingro Finanz AG

11%

Varuma AG

9%

Next 8 investors

(avg. 1.8%)*

14%

Remaining

investors

62%

Board & Management

3%

Source: Company information as of 23.08.2018 reflecting stabilized post-IPO shareholder structure

* Excluding Board and Management

§ 12 Months lockup for pre-IPO Investors, Board, Management Members and Employees - expiring May 15th, 2019

§ 85% Shares registered

100% = 10’857’263 shares


Financing


H1 Financials

Q and A

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Agenda

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§ Two trials- “PRISM-MDR” (EMA Study) - MPV+SoC vs. 2 SoC in Centers with high

MDR incidence

- “PRISM-UDR (FDA Study) – MPV vs. SoC as Pseudomonas aeruginosa monotherapy in UDR Centers (Centers with Low MDR incidence)

§ PRISM MDR substantially progressing- FPFV, March 2018- 72 Centers selected in 15 countries, 4 regions

- 50% of sites activated – including France, Spain, US

- Strong communication with Centers and minor protocol adjustments to secure steady recruitment

- Confirming timeline as per Prospectus

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Murepavadin program significantly progressingMurepavadin (MPV)

Notes:SoC: Standard of CareFPFV: First Patient First VisitMDR: Multi Drug ResistanceUDR: Usual Drug Resistance


§ PRISM UDR to start recruitment before YE- Protocol finalized, FDA submission done in July- Approval received from central IRB (Independent Review Board/ Ethics Committee)

for the US- Targeting ~100 sites, ~50% already selected- FPFV anticipated by YE- Confirming timelines as per Prospectus

§ Other studies (preclinical, other) as well as MPV inhaled progressing in parallel- Reprotox completed, no unexpected results- MPV Inhaled: stability and Physicochemical parameters under analysis

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Murepavadin program significantly progressingMurepavadin (MPV)

§ Overall positive progress§ Supportive reaction of physicians and investigators, strong interest in

the community.§ Timelines confirmed


§ One pivotal trial: BLX+ Eribulin vs. Eribulin for the treatment of advanced Metastatic Breast Cancer

§ CRO selected – PPD

§ FDA discussion progressing- Fast Track designation achieved

- EoP2 Meeting requested (foreseen around YE)

- Application for Breakthrough designation planned with interim analysis

§ EMA advice received- One study only sufficient

- Finalizing protocol, taking into account advice

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Study preparation in full swingBalixafortide (BLX)


§ Steering Committee identified ( Co-chairs: Cortes, Kaufmann)- Kick-off at ESMO, October 2018

§ Expecting- Study Start Q1 2019- FPFV by Q2 2019- US Filing in H1 2021

- Earlier if accelerated approval

§ Preclinical studies in other combination/indications started

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Study preparation in full swingBalixafortide (BLX)

§ Overall, significant progress and strong physicians’ support

§ Start Q1/19, US Filing H1/21


§ Lead preclinical candidate selected – POL7306- Strong activity against all most resistant Gram negative strains – including all

WHO priority 1 and colistin resistant- Potency confirmed in-vivo

- Process optimization started – to achieve optimal cost- IND planned H1/2020

§ In addition, backup program launched, to maximize pipeline/ chances of success

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Significant progress in OMPTAsOMPTA Platform

Neutropenic murine thigh infection models


§ Objective and Scope- Support the advancement of the OMPTA program*

- Accelerate new OMPTA development and de-risk it (also backup(s))- OMPTA Preclinical pipeline

- Lead preclinical compound (POL7306) and Backup program

§ Novo REPAIR** Impact Fund- Separate business area of Novo Holdings A/S

- Holding company of the Novo Group- Strong investment track record

- USD165M, established in Feb 2018. - Strong Scientific Experts’ Board- Objective of the fund:

“Back companies that can change the future of the antibiotic resistance battle: innovative science, driven by a clear product vision and a strong management team and comfortable in a changing regulatory environment”

- Focus: Discovery and early stage development of therapies targeting resistant micro-organisms

- Does not preclude further non-dilutive funding from other sources

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Up to CHF 11.5M financing of the OMPTA platformNovo OMPTA financing

* A previous stage of the program was financed by the Wellcome Trust** Replenishing and Enabling the Pipeline for Anti-Infective Resistance


§ Financing structure- Tranche 1: CHF 6.8M equity investment by Novo Holdings A/S

- CHF 38/share

- Tranche 2: CHF 4.7M royalty-bearing Project financing upon

- Achievement of preclinical milestones

- Customary closing conditions

§ Execution- Tranche 1

- Shares issued and filed for registration in the next few weeks

- Lock-up until May 15, 2019

- Tranche 2

- After reaching the milestone

- Following report submitted to Novo

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Up to CHF 11.5M financing of the OMPTA platformNovo OMPTA financing

§ First investment of the Novo REPAIR Impact Fund: a new, important, dedicated fund

§ Strong validation of our technology and of the OMPTA platform§ Valuable financial support to our OMPTA Research – as per our plan§ Entry of a distinguished member in our already strong shareholders’ group


2018 2019 2020 2021 2022

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OverviewKey Programs’ Progress

Notes:1 European Medicines Agency2 Food and Drug Administration3 Cystic Fibrosis4 Non-Cystic Fibrosis bronchiectasis

5 Assuming positive outcome for interim results, filing and approval can be accelerated

6 IND-= Investigational New Drug (also called CTA in Europe)7 PoC = Proof of Concept

Murepavadin

§ Inhaled formulation

Pivotal ProgramPreparationFDA2 Filing

EMA1 Filing EMA approval

FDA approval

Clinical development – CF3 / NCFB4Pre-clinical / Formulation

OMPTA Pre-clinical Phase I PoC7

Balixafortide

§Eribulin combo

§Other combo

EOP1 FDA

Other combination studies in parallel

Select pre-clinical candidate

Target timeline

Ph. Ib

Potential for accelerated approval on interim analysis5

US pivotal trial FDA approval

FDA Filing

Potential for accelerated approval on interim analysis and

Breakthrough application 9/10

Fast Track 8

Ant

ibio

tics

Imm

uno-

Onc

olog

y

Potential accelerated timeline

Preclin studies

Ph II

IND6 Phase II results

8 Conditional approval based on accelerated approval, timelines based on current estimates for recruitment

9 Fast track status granted10 Being reviewed to take into account EMA advice


Financing


H1 Financials

Q and A

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Agenda

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CHFm 30.06.18 30.06.17 Diff. (%)

Revenue

Total revenue 7.0 2.8 150

Costs and operating expenses

Research and development (21.7) (15.3) 42

Marketing and sales (0.6) (1.3) -55

General and administrative (2.8) (2.0) 38

Capitalized costs of Technology Platforms and other income 0.2 0.9 -77

Net operating expenses (24.9) (17.7) 41

Operating loss (18.0) (14.9) 20

Other Income/(expenses)

Financial result (2.9) (0.2) n.m.

Net loss for the period (20.8) (15.1) 37

Financial highlightsP&L overview

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Income statement Comments

§ CHF 6.4m received in form of Santhera shares for POL6014

§ Increase driven by the clinical trials and extraordinary costs:– CHF 1.1m related to the IPO– CHF 2.8m impairment of technology

platforms and leasehold improvements

§ Increase in H1-18 due to IPO costs and change in the allocation key

§ Includes CHF 2.3m loss on Santhera shares, mostly unrealized, interest expense and foreign exchange gains and losses

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CHFm 30.06.18 31.12.17 Diff. (%)

AssetsCash equivalents and financial assets 155.6 24.6 n.m.Accounts receivable and prepaid expenses 1.6 3.1 -48

Total current assets 157.2 27.6 n.m.Property, plant and equipment (PPE) 3.3 4.4 -23Technology Platforms 4.9 7.8 -37

Total non-current assets 8.7 12.6 -31Total assets 165.9 40.3 n.m.Liabilities and shareholders' equity

Total current liabilities 11.8 11.4 4Pension liabilities 6.4 7.3 -12Other non-current liabilities 2.5 4.3 -42

Total non-current liabilities 8.9 11.5 -23Total shareholders’ equity 145.3 17.3 n.m.

Total liabilities and shareholders’ equity 165.9 40.3 n.m.

Cash flow and balance sheet overview

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Selected cash flow items Comments

§ Increase due to higher R&D costs and IPO-related expenses

§ Includes maintenance of infrastructure and IT, capitalized costs of technology platforms in H1-17 and CHF 1.2m proceeds from sale of financial assets in H1-18

§ H1-18 includes CHF144.2m net proceeds from IPO; H1-17 includes CHF9.8m net proceeds from private placement

§ Includes impairment of CHF0.5m in H1-18 due to rebuilding of some laboratories into offices (consolidation in one building)

§ Includes impairment charge on technology platforms of CHF 2.3m in H1-18 and CHF 5.7m per 31.12.2017

§ Defined contribution plan under Swiss pension accounting framework. Classified as defined benefit plan under IAS19. The decrease reflects the release of 35 employees

§ H1-17 includes CHF4.8m interest bearing liabilities of which CHF1.3m relate to a convertible loan, which was converted into shares at IPO

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Selected balance sheet items

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CHFm H1-18 H1-17 Diff. (%)

Net cash from operating activities (17.9) (13.8) 30Net cash from investing activities 1.1 (1.0) n.m.Net cash flow from financing activities 144.9 10.2 n.m.Net increase/decrease in cash equivalents 128.1 (4.5) n.m.Cash and cash equivalents as of June 30 152.6 10.0 n.m.Average net cash burn* (2.8) (2.5) 14

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Note: * represents the average monthly cash used for operating and investing activities


A first half of year of strong progress on many frontsSummary

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* According to Bloomberg, net cash as at 31.12.2018 of CHF 126 million

Substantial IPO, allowing the full execution of the plan 1

Murepavadin trials positive progress and strong physicians’ support2

Balixafortide in preparation to start pivotal study in Q1/193

OMPTA Platform progressing well- Strong validation with the investment of Novo A/S4

H1 results showing increase in R&D costs due to trials launch5

Expected year end cash position substantially in line with consensus*, adjusted for the Novo investment6


Questions and Answers

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Polyphor Ltd | Hegenheimermattweg 125 | 4123 Allschwil | SwitzerlandT +41 61 567 16 00 | [email protected] | www.polyphor.com

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Documents

H1 Results Conference Call - Polyphor · 2019-12-02 · EOP1 FDA Other combination studies in parallel Select pre-clinical candidate Target timeline Ph. Ib Potential for accelerated