Herantis Pharma - A new pharmaceutical company

Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.

Herantis – new pharmaceutical company

Company overview and future prospects CEO Pekka Simula

12 May 2014 1

Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved. Copyright © 2014 HERANTIS PHARMA Plc. All rights reserved.

Disclaimer •  Hermo Pharma Ltd (”Company”) has prepared this presentation of the Company as

background material only. This presentation is intended for use only with the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta).

•  This presentation does not intend to provide a thorough and detailed view of the Company. The information provided in this presentation shall not be considered sufficient for making any investment decisions related to the Company. Anyone considering an investment in the Company shall read and consider carefully all information provided in the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta).

•  This presentation may include forward-looking statements, estimates, and calculations related e.g. to the Company and its markets. Such forward-looking statements, estimates, and calculations are based on expectations and assumptions of the Company, which may be inaccurate or untrue. They also involve known and unknown risks and other factors, which might cause any estimates made by the Company to materially deviate from those actualized, including the operations, financial situation, and achievements of the Company. The Company cannot be held liable for any such deviations or for any actions taken by any party based on this presentation. Known risks related to the future of the Company and its business have been described in the formal prospectus approved by Finand’s Financial Supervisory Authority (Finanssivalvonta).


Herantis Pharma Plc •  Drug development company formed through Hermo Pharma Ltd’s

acquisition of 99% of shares in Laurantis Pharma Ltd in Apr 2014

•  Develops medicinal products especially for the treatment of inflammatory, CNS, and lymphatic diseases –  Emphasis in areas of unmet clinical need

•  Expertise in early clinical development –  Obtaining drug candidates based on scientific research –  Preclinical research –  Early clinical research –  Proof-of-Concept in clinical development

•  Expert organization with a light cost structure

12 May 2014 3


Herantis’ background •  Herantis formed in 2014 through the merger of two pharmaceutical

companies, Hermo Pharma and Laurantis Pharma –  Hermo Pharma’s development based on Academy Professor Mart Saarma’s

scientific research –  Laurantis Pharma’s drug candidates are based on research by e.g.

Academy Professor Kari Alitalo, and Professor Kai Kaarniranta

•  Companies’ justifications on merger: –  Scientific research in Finland in the field of medicine is internationally

appreciated –  As a merged company Herantis has a broader portfolio and better financial

and other resources

12 May 2014 4


5

Board of directors and management

Jonathan Knowles"PhD, Board member, Ex-Management team Roche, Ex-Board member Genentech, Ex-Chairman IMI, Professor"

Timo Veromaa"MD, PhD, Board member, CEO Biotie Therapies""

Pekka Mattila"MSc, Chairman, CEO Desentum, Ex-CEO Finnzymes"

Frans Wuite"MD, MBA, Board member, CEO Oncos Therapeutics, Ex-CEO Araim Pharma, Ex-CEO Warren Pharma""

James Phillips"MD, MBA, Board member, CEO Midatech, Board member Insense, Ex-Chairman Prosonix""

Aki Prihti"MSc, Board member, Chairman Inveni, Chairman Medeia, Board member Medtentia, Onbone""

Pekka Simula"MSc, CEO, Ex-CEO Oncos Therapeutics, Ex-director CRF Health, Ex-Global program manager Varian Medical Systems"

Burkhard Blank"MD, CMO, Ex-CEO Laurantis Pharma, Ex-director Boehringer-Ingelheim, Board member Riemser Pharma"


Introduction to clinical development

Preclinical stage"

Research and development searching for and assessing new drug candidates for safety and efficacy in appropriate models. Preclinical models can be based on cell or animal models"

Early clinical development: Phase 1 and Phase 2 clinical studies"

Phase 1 and Phase 2 clinical studies aim at suggesting e.g. the initial safety, efficacy, and optimal dosing of the drug candidate. This involves typically in the range of 10-300 subjects per clinical study."

Late stage clinical development: Phase 3"

Phase 3 clinical studies aim at establishing the safety and efficacy of the drug candidate with high statistical significance. This typically involves 300-1000 subjects per clinical study. Market approvals can be applied for based on the results."

Idea Medicine"0-5 years" 3-5 years" 3-5 years"


Herantis’ strategy Herantis’ field of activity is pharmaceutical research and development in collaboration with its academic and commercial partners and: •  Aiming at profitable growth in the long term:

–  Possible income from commercial partnership agreements is largely invested in new development programs

–  New drug candidates are screened for e.g. from academic research in Finland

•  Focus on early stage development: Preclinical, Phase 1, and Phase 2 •  Seeking commercial partnerships with large pharmaceutical companies

for late stage clinical development beyond Proof-of-Concept

12 May 2014 7


Herantis portfolio (drug candidates)

12 May 2014 8

Drug candidate Indication Preclin Phase 1 Phase 2 Phase 3 Launch

Cis-UCA Eye Drops Dry Eye *

CDNF growth factor

Parkinson’s disease *

Lymfactin Secondary lymphedema *

Cis-UCA Emulsion Cream Atopic dermatitis**

CDNF growth factor

Amyotrofic lateral sclerosis (ALS)**

*This stage of clinical development in planning and scheduled **Currently not one of the main products of the Company. The next steps are pending later decisions. Not a funding priority.


Cis-UCA Eye Drops for dry eye Based on preclinical and Phase 1 clinical results the Company believes that

Cis-UCA Eye Drops have the potential of being the most efficacious and best tolerated prescription medicine in the treatment of dry eye.

12 May 2014 9

•  Dry eye syndrome is the most common cause of irritation in

the eye –  Estimated 45 million people in the USA and Europe suffer from

dry eye syndrome •  Herantis’ target is to launch its Phase 2 clinical study in 2014

–  Randomized study with estimated 150 patients •  With a positive outcome Proof-of-Concept is reached 2015 •  Restasis® is the only approved prescription drug in the USA for

the treatment of Dry eye syndrome (in Europe there are none) –  Restasis®: Annual sales $ 900M

Illustration is not related to the text on this page.


CDNF for Parkinson’s disease Based on preclinical data the Company believes that CDNF is one of the most promising new compounds for the treatment of Parkinson’s disease.

•  Parkinson’s disease is a progressive neurodegenerative disease, which cannot be cured

–  Estimated seven million patients worldwide –  Caused by the death of dopamine producing neurons for an unknown reason –  Available treatments help the motor symptoms caused by disease

•  Herantis’ goal: Phase 1 clinical study started in 2015 –  At least 12 patients, randomized setup

•  In preclinical models CDNF has protected dopamine producing neurons and recovered dysfunctional neurons

•  Estimated sales of pharmaceutical products for treatment of Parkinson’s disease in 2018: $ 3.5 Bn

12 May 2014

Figure: Illustration of a possible way to administer CDNF

Please cite this article in press as: Barua NU, et al. Intermittent convection-enhanced delivery to the brain through a novel transcutaneousbone-anchored port. J Neurosci Methods (2013), http://dx.doi.org/10.1016/j.jneumeth.2013.02.007

ARTICLE IN PRESSG Model

NSM 6570 1–10

8 N.U. Barua et al. / Journal of Neuroscience Methods xxx (2013) xxx– xxx

Fig. 7. (a) A successful BAHA implanted in a patient shows no evidence of adverse skin reaction (Courtesy of Science Photo Library). Based on long term success with BAHAsurgery, the TBAP for intermittent CED could be implanted in a similar position on the skull. A schematic diagram shows the proposed relationship of the TBAP with implantedin-line filters and catheters in a clinical application (b).

attachment (Fig. 6e). In contrast, no such bony attachments were387

present on the loosened port (Fig. 6f).388

4. Discussion389

Convection-enhanced delivery has the potential to improve the390

treatment of a wide range of neurological disorders by facilitat-391

ing bypass of the blood-brain barrier, distribution of therapeutic392

agents through clinically-relevant brain volumes and highly accu-393

rate anatomical targeting.394

The translational potential of non-gene therapies including395

neurotrophins and chemotherapies may be impaired by the396

requirement for chronic or intermittent drug infusions, which397

are currently achieved by using subcutaneous pumps or repeated398

catheter insertions. The use of subcutaneous devices is associated399

with infectious and immunological complications (Bogdahn et al.,400

2011; Gill et al., 2003; Lang et al., 2006), and acute catheter insertion401

and removal requires patients to undergo repeated neurosurgical402

interventions. In this study, we aimed to determine the feasibility of403

performing intermittent drug delivery to the brain through a novel404

permanently implanted transcutaneous bone-anchored port.405

There is a substantial need for long-term transcutaneous bone-406

anchored devices in healthcare for a wide range of applications407

including attachment of limb and facial prostheses (Fitzpatrick408

et al., 2011; Kang et al., 2010; Pendegrass et al., 2006a,b, 2008),409

dental prostheses (Branemark and Albrektsson, 1982) and hearing410

aids (Colquitt et al., 2011a; Doshi et al., 2010; McDermott et al.,411

2009a,b; McDermott et al., 2008; Snik et al., 2005). This has led to412

a significant research effort aimed at overcoming the major bar-413

riers to the success of such devices. It is evident that the correct414

choice of materials and implantation method can overcome the415

three main failure modes of transcutaneous implants, which are416

marsupialisation, infection and avulsion.417

In the present study we successfully performed intermittent418

infusions to the brain via a transcutaneous bone-anchored port over419

a 3 month period in a large animal (porcine) model. Our aims were420

to design and test a port with a number of specific requirements421

– a low internal volume, MRI compatibility, multichannel capabil-422

ities, the facility to achieve repeated drug infusions and long-term423

implantation without infection.424

The success of this study is likely to have been a product425

of appropriate choice of biomaterials, meticulous surgical tech-426

nique and daily cleansing. The importance of daily cleansing of427

the skin/device interface should not be underestimated as regular428

cleaning of BAHAs is known to be important for the avoidance of 429

irritation and infection (Arnold et al., 2011). 430

The use of a titanium implant combined with the skin flap 431

dermatome technique allowed us to achieve robust cutaneous inte- 432

gration, thus preventing adverse skin reactions and infection at the 433

skin/device interface. Robust osseointegration was achieved in 3 434

out of 4 animals, as evidenced by en bloc resection of a port with 435

surrounding bone and the significant pull-out forces required to 436

explant the ports at 3 months post-implantation. We found the 437

surgical robot to be a useful adjunct as it provided a more sta- 438

ble platform than free-hand drilling of port holes. The accuracy 439

of the port holes may have contributed to achieving an optimal 440

interference fit between bone and device. 441

Loosening of the port in the fourth animal occurred as a result 442

of inadvertent use of excess force on removal of the needle admin- 443

istration set during the healing phase. The thickness of bone at the 444

site of port implantation in these juvenile pigs was only 3 mm. 445

The greater thickness of the human skull might reduce the risk 446

of inadvertent loosening by providing a greater surface area for 447

osseointegration. It seems likely that continuous movement of the 448

port prevented osseointegration over the subsequent months. Fail- 449

ure of osseointegration did not adversely affect the skin/device 450

interface, which remained intact without evidence of infection or 451

adverse reaction. This adverse event has driven us to develop a new 452

“zero stress” needle administration device which will eliminate the 453

risk of loosening the port during re-infusion. This new design facili- 454

tates insertion and removal of the needles on a screw thread, whilst 455

maintaining counter-torque on the port. 456

Skull growth in this animal model placed significant limitations 457

on the longevity of this study due to gradual pull-out of catheters 458

from target and soft tissue deposition around the port, which pre- 459

vented re-application of the needle administration set beyond 3 460

months. Despite these limitations, repeated infusions were suc- 461

cessfully performed for 3 months with real-time MRI monitoring 462

(in all implants suitable for re-infusion) confirming the patency 463

of the port and catheter system. However, gradual pull-out of the 464

catheters also prevented analysis of the repeatability of infusions 465

performed with this catheter system. 466

Long-term data on the safety of transcutaneous skull-mounted 467

implants is available from follow up studies of BAHAs, which report 468

infection rates as low as 0.7% (de Wolf et al., 2009a, 2009b), high 469

rates of osseointegration (Colquitt et al., 2011b) and improvements 470

in quality of life (de Wolf et al., 2011; Dutt et al., 2002). BAHA 471

implantation has been successful following cranial radiotherapy, 472

which has important implications for use of the TBAP for drug 473

Barua et al. J. Neurosci. Methods. 214: 223-232, 2013."


Lymfactin for secondary lymphedema Based on scientific studies Herantis believes that damage to lymphatic

system leading to secondary lymphedema can be treated with Lymfactin.

•  Lymphedema is a chronic progressing disease with no approved medicines –  Secondary lymphedema develops in estimated 15,000 – 18,000 breast cancer

patients annually in the USA as a consequence of breast cancer therapy; the Company assumes a similar number of new cases in Europe

–  Symptoms include permanent swelling of the affected limb, limited functioning, susceptibility to infections

–  Significant impact on the patients’ quality of life •  In preclinical models Lymfactin has promoted new lymphatic growth in the

damaged area •  Herantis’ goal: Phase 1 clinical study with 24 patients launched in 2015 •  Market size estimated in € hundreds of millions

12 May 2014


Target development schedule

2014 •  Initial public offering and listing in NASDAQ OMX First North Helsinki •  Cis-UCA Eye Drops: Phase 2 clinical study launched

2015 •  Lymfactin Phase 1 clinical study launched •  Cis-UCA Eye Drops: Phase 2 clinical study completed •  CDNF / Parkinson’s disease: Phase 1 clinical study launched

2016 •  Cis-UCA Eye Drops: commercial partnership •  CDNF / Parkinson’s disease and Lymfactin: Phase 1 studies ongoing

2017 •  CDNF / Parkinson’s disease: initial results and commercial partnership •  Lymfactin: Initial results and commercial partnership

•  Company profitable if at least one product candidate reaches commercial partnership


Risks* In addition to normal financial risks, risks related to securities, and other related risks there are essential risks related to Herantis and its business.

•  No commercial products –  The Initial Public Offering in First North Helsinki aims to fund the Company to

develop its three main product candidates through commercialization •  Product development includes e.g.

–  Clinical risks –  Risks related to regulatory authorities –  Production related risks

•  Commercialization includes e.g. –  IPR risks –  Risks related to the pharmaceutical industry and third parties

12 May 2014 13

*Risks are described in detail in the formal prospectus approved by Finland’s Financial Supervisory Authority (Finanssivalvonta)


Strengths •  Three drug candidates

–  Independent development programs, each individually with potential to reach a strong position in the global market for pharmaceutical products

•  Experienced team and international network of collaborators –  International experience in each phase of drug development –  Commercialization of pharmaceutical products –  Regulatory processes in Europe and USA –  Network of experts related to each drug in development

•  Strong background of drug candidates –  Internationally acclaimed, widely published research scientists

•  Acceptable cost structure and need for capitalization –  6-person expert organization capable of adjusting to changes

12 May 2014 14


Herantis IPO in First North Helsinki – HRTIS: Selected details •  Offering at most 1,600,000 new shares for 10.50 € per share

–  Approximately 37% of shares and votes in Herantis –  Over-allotment option of at most additional 1.000.000 new shares, in which

case the total amount is approximately 49% of shares and votes in Herantis –  Expected net proceedings approximately € 16.0 million (+ possible over-

allotment option approximately € 10.1 million)

•  The proceedings are intended to be used for product development of Herantis, in specific the clinical studies of the three main products –  Successful IPO in First North Helsinki (without over-allotment option) funds

Company’s operations until end of 2017, enables reaching commercial partnerships for each successful product

•  Subscription period begins 14 May.2014 •  Subscription period ends 30 May 2014 (by latest) •  Trading commences 11 Jun 2014 (estimated)

12 May 2014 15


Main shareholders at the time of IPO*

12 May 2014 16

Shareholder # of shares

% votes/ shares*

Inveni Life Sciences Fund I Ky 614.271 22,8 %

Helsingin yliopiston rahastot (Helsinki University Funds) 473.638 17,6 %

Aloitusrahasto Vera Oy 449.660 16,7 %

Mart Saarma 159.000 5,9 %

Eero Castrén 155.000 5,8 %

Heikki Rauvala 155.000 5,8 %

Eläkevakuutusyhtiö Veritas 126.346 4,7 %

Inveni Pre-Exit Financing Vehicle Ky 81.773 3,0 %

Henri Huttunen 74.000 2,7 %

Pergamum AB 68.268 2,5 %

Broadview Ventures I, LLC 48.467 1,8 %

Lasse Leino 41.736 1,5 %

Erkki Etola 25.435 0,9 %

Oy Etra Invest Ab 22.183 0,8 %

Start Fund I Ky (Finnish Industry Investment) 20.505 0,8%

Total 2.515.282 93,4 % *All shares owned at the time of the IPO are under a 12-month lock-up agreement


Thank you!

12 May 2014 17

Herantis Pharma - A new pharmaceutical company

Healthcare

Transcript of Herantis Pharma - A new pharmaceutical company