Jason Laufer Israel

RDD Pharma, a clinical stage company with programs in:
1. Fecal incontinence (Phase 2a)
2. Chronic anal fissure (Phase 3 ready).
3. Pruritus Ani - preclinical development
4. Radiation Colitis - animal studies

- All rograms utilize a 505(b)2 strategy .
- Anal Fissure IP goes out to 2030.
Year Founded
2009
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview

Company focused on ano-rectal diseases

Experienced management team

Lead product targets $600M market with poorly
addressed needs

Follow on product targets a $3B US market

Pipeline - Three clinical stage products:

  • PHASE III READY – ANAL FISSURE
  • PHASE IIa – FECAL INCONTINENCE ONGOING
  • PHASE II READY – PRURITUS ANI

De-risked 505(b)2 regulatory path

Supporting Metrics or Evidence

Fecal Incontinence - P1 Proof of Concecpt + Phase 2a Ongoing

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Current Financing Needs

OrbiMed Israel (invested $4M in 2012) is a lead investor and has committed to $3M of a $15M Series B.

Current Timeline

Anal Fissure  - Phase 3 to commence 1Q2015

Fecal Incontinence - Phase 2a data read March/April 2015

Current Investors

OrbiMed

Ofakim Hi-Tech Ventures

Corporate Finance Holding GmbH

Mor Research

IP Status

Nifedipine Capository™ - Device for Treating the Anal Sphincter

–      Japan                         Granted (new)

–      Australia                   Granted

–      Korea          Allowed (new)

–      Israel           Allowed (new)

–      USA            Granted

–      Canada                     Allowed

Fecal Incontinence

–      US – National Phase

Radiation Colitis

–      Methods for Treating and Ameliorating Radiation-induced Gastrointestinal Tract Injury

Pruritus Ani

–      Method of Treating Anal Pruritus and Other Perianal Disorders

–      USA-issued patent: April 1, 2014

Recent Milestones

Chronic Anal Fissure - completed two (2) Phase II studies evaluating Nifedipine in CAF.

  • RDD Study 104 - 20 Patients
  • RDD Study 112 - 33 Patients
Management Team Highlights

Jason Laufer CEO 

•       Over 25 years in healthcare clinical and commercial operations

•       Global BD & Licensing at URL Pharma (acquired by Takeda for $800M), Managing Director at CELLGRO® (acquired by Corning , and CEO at Elutex

Nir Barak, MD CMO and Founder

•       More than 10 years as internal medicine physician

•       Career integrating R&D and clinical medicine

•       Formerly CSO/Founder of OBEcure Ltd.

 

Robert Niecestro PhD Regulatory Affairs

  • Over 25 years of experience in the healthcare industry
  • Managing Director of Accelapharm, VP Reg. of Axsome Rx and EVP of Clinical & Reg. Affairs at TG Rx
  • VP Clinical & Reg. Affairs at Keryx Biopharma

 

Monil Shah, PharmD MBA Clinical Advisor

  • VP, Clinical Affairs at Ventrus Biosciences
  • Over 15 years in clinical management roles at BMS, Celgene, Amgen, and Novartis

RDD Pharma
CEO 

Albert Lauritano

BD (Becton Dickinson and Company) based in Franklin Lakes NJ is a leading medical technology company that partners with customers and stakeholders to address many of the world?s most pressing and evolving health needs. Their innovative solutions are focused on improving drug delivery enhancing the diagnosis of infectious diseases and cancers supporting the management of diabetes and advancing cellular research. The firm has nearly 3 associates in 5 countries who strive to fulfill our purpose of ?Helping all people live healthy lives? by advancing the quality accessibility safety and affordability of healthcare around the world. For more information please visit www.bd.com. BD partners with companies from their formation through to commercialization including expansion of operations and channel access. BD considers a variety of engagement models including research collaborations licenses investments and acquisition when partnering with companies aligned with BD?s core businesses and new areas of strategic interest seeking opportunities from around the globe.
Becton Dickinson (BD)
Director Strategic Technology Partnerships 

Mr Charles Leahy United States

Amorphex Therapeutics is an early clinical stage company that was founded to develop products for sustained ophthalmic drug delivery using patented TODDD™ technology. Topical ophthalmic pharmaceuticals are a $5+Billion market, but inaccurate and inefficient delivery systems, poor compliance and excessive side effects undermine their clinical benefits and true sales potential. TODDD™ is a soft, non-invasive device that is completely concealed under the eyelid and continuously delivers therapeutic levels of drug 24/7 over several months. While TODDD™ is soft and flexible, unlike soft contact lenses, it doesn’t contain appreciable water and avoids the surface drying and resulting deposits that irritate and deter many contact lens wearers. In recognition of the potential benefits and their developmental progress, the company’s founders have been awarded three National Institutes of Health (NIH-SBIR) grants for the TODDD™ technology totaling $2.5 million.

TODDD™ has issued patents in major markets and has been successfully tested in safety studies, animal trials with drugs and without drug in humans.

Amorphex is seeking to fund small, 30 - 40 subject, human clinical trials of TODDD™ delivering timolol, prostaglandin and both drugs simultaneously. This funding will also support pre-clinical development of TODDD™ for ocular allergy and inflammation applications.  These milestones will drive dramatic increases in valuation and corporate partner interest.

Year Founded
2010
Main Sector
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Supporting Metrics or Evidence
Successful safety studies, animal trials and human proof of concept studies.
Current Financing Needs
$1.1M to regulatory milestone, $2.1M to clinical milestone, $4.6+ M to complete plan
IP Status
Patents issued in US, Europe, Japan and Canada
Amorphex Therapeutics
VP of Clinical Affairs 

Anton Leighton United States

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Current Financing Needs
Initial
IP Status
Issued US patents
Recent Milestones
Identification of novel MOA
Management Team Highlights
Founder experienced in drug development
Rhamnopharma, Inc.
CEO 

Michael Leonard

Trigemina
CFO 

Boris Leschinsky

CorInnova Inc.
Vice President of Product Development 

Dr Michel Levesque United States

Siragen Pharmaceuticals is a drug discovery and development company, focused on novel approaches to treat Aging and Neurodegenerative Disorders such as Alzheimer’s Disease. Siragen is developing a group of small lead molecules that tackles Alzheimer’s Disease and aging neurons by novel strategy different from current unsuccessful approaches.   Siragen Pharmaceuticals, based in San Diego, California, was incorporated in May 2014, and is a spin off of Neurogeneration Inc. Siragen's products will be for the brain what cholesterol agents are for the heart.

Website:
www.siragen.com
Year Founded
2014
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Technology Overview

Sira-9 targets a specific pathway of the stress response due to oligomer toxicity. Siragen has identified targets within this pathway that prevents the synapse loss induced by synaptic dysfunction and synaptotoxicity. Siragen has also identified another target, which alleviates age-associated phenotypes and extends the life span of neurons by reducing inflammation. These small molecules are specific and can be easily delivered as a pro-drug.

Alliance & Collaborations
UCSD, Duke University, UCLA, Salk Institute
Current Financing Needs

$5M

Current Timeline

Siragen’s development programs are focused on 1) target identification 2) target validation 3) hit to lead identification and optimization 4) in vivo studies and 5) begin clinical trials on identified compounds. The Company aims to develop its pipeline of novel molecules to clinical proof of concept and partner with industry leaders for late stage development and commercialization

Current Investors

Private

IP Status

•  expanding IP portfolio

Recent Milestones

• Target identified and validated for drug discovery in Alzheimer’s disease • Successful assay development for hits • Lead candidate Sira-9 currently in development for Alzheimer’s disease

Management Team Highlights

The team consists of CEO and Founder: Michel Levesque, MD, entrepreneur and neuroscientist, CSO and Co-Founder: Mohamedi Kagalwala, neurochemist and neurobiologist. Scientific advisory board consists of prominent scientist Dr. Eliezer Masliah (neuropathologist and neurodegenerative disorders expert, UCSD), Dr. Kalpana Merchant (Ex CSO, Translation Science at Eli Lilly Pharmaceuticals) and Dr. Anthony Means (pharmacologist, Baylor College of Medicine)

Siragen Pharmaceuticals, LLC
Founder 

Mr Andy Levien United States

Did you know that 10-15% of LASIK patients are turned away due to inadequate eye measurement equipment?  This laser refractive eye surgery market has a crying need for the next generation measurement tool now to capture these additional patients and improve on existing procedures and outcomes.

Did you know that ophthalmologists suffer significant measurement problems in accurately predicting the ELP (Effective Lens Position) in cataract surgery/Intra-Ocular Lens (IOL) procedures?

The ArcScan Artemis-3 system addresses both of these market needs and more.

ArcScan has already raised all funding needed ($3 million) to enter the laser refractive surgery market, with product introduction expected in 12 months.

The ArcScan Series A Preferred funding round of $3 million currently has $1 million available to investors from now through February, 2015, or until sold-out, whichever occurs first.

ArcScan is attending the RESI conference to raise the final $1,000,000 in Series A Preferred share subscriptions, which will allow us to accelerate entry into the large cataract surgery/IOL market and nearly double the size of the business.

Please request a meeting at RESI or contact ArcScan CEO Andy Levien for an executive summary and further investment details.

Website:
www.ArcScan.com
Year Founded
2007
Main Sector
Medtech Phase of Development
Technology Overview
Very high frequency ultrasound combined with precision control of scanner motion
Current Timeline
12 months to US product launch
IP Status
6 issued patents, 3 licensed (from Cornell), 12 applications
Mr Andy Levien
ArcScan
LinkedIn logo CEO & President 
BIO

Andy’s career in industrial and medical device instrumentation and automation and controls, spans companies from startup to Fortune 100. His diverse experience from shop floor to the C-Suite and as a leader in product and business development, global operations, supply chain and manufacturing operations, equips him with the skills that expertly guide leadership teams to breakthrough strategies and their implementation, delivering new pathways to customer value creation, revenue growth and operating profits.

A collaborative leadership style and keen technical, business, and emotional intelligence is underpinned by his passion to create a transparent, shared vision through a planning process encompassing lean management principles: accountability to clearly defined performance metrics, a detailed plan to execute, and effective communication of the plan to stakeholders at all levels in the organization.

Alexander Levy

Chematria, Inc.
COO 

Judith Li China

Lilly Asia Ventures is the venture capital arm of Eli Lilly that focuses on investments in the life sciences in Asia, particularly China. The firm was established in 2008 and is based in Shanghai, China. The firm is stage agnostic; investing in early, growth, and up to pre-IPO opportunities. The firm’s investment size is USD 5-20 million per company. The firm primarily invests in companies in China, but is open to companies across Asia-Pacific as long as there is some sort of China angle. The firm is actively seeking new investment opportunities.

Lilly Asia Ventures primarily focuses on therapeutics but is also interested in medical devices, diagnostics, animal health, and biotech other. The firm is most interested in products that will have a significant impact on medical care in China. For therapeutics, the firm seeks best-in-class or first-in-class products. The firm is opportunistic to the indication and the phase of development and will consider products in pre-clinical up to NDA. Historically, the firm invests in therapeutics for oncology, inflammatory diseases, and metabolic disorders.

Biotech Phase of Development
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Lilly Asia Ventures
Principal