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Prolog Ventures is a venture capital firm based out of St. Louis Missouri that was founded in 2001. The firm is currently making investments out of its vintage 2013 4th fund of approximately $100 million. The firm is looking to make equity investments in companies ranging from $500,000 to $3 million. The firm will invest in companies across the United States and plans to make approximately 3-4 investments over the next 6-9 months.

Correlation Ventures is a venture capital firm that founded in 2010 and is based in San Diego, California with an additional office in Palo Alto, California. The firm currently has approximately $165 million in total assets under management. The firm typically makes investments ranging from $0.25 million to $5 million over the life of the company, and the first investment will be not larger than $2.5 million. The firm’s preferred capital structure is convertible preferred equity or convertible loan. Correlation Ventures will consider invest in any industry segment at any stage, but there must be at least one other venture capital firm making their first investment in the company in this round. The firm only invests in US-based companies. 

Correlation is extremely opportunistic when it comes to investments in the life sciences space; with that being said the firm's specified sectors and sub sectors of interest may or may not be an area in which Correlation Ventures is currently looking to allocate capital to. The firm has made a number of investments in companies in the life sciences space, and has mainly invested in companies in the biotech therapeutics and diagnostics space. The firm's current portfolio includes biotech therapeutics and diagnostics firms developing products targeting endocrine, metabolic, and nutritional diseases, musculoskeletal system and connective tissue, neoplasms, cancer, and oncology, genitourinary system, and infectious and parasitic diseases.

20/20 GeneSystems is a revenue stage diagnostics company that markets a blood test for the early detection of lung cancer.  Several marketing partnerships entered in late 2014 should permit a nationwide expansion in 2015.  A JV with a multi-billion dollar Chinese company is expected to lead to commercialization of the lung cancer test in China in the near term.   20/20 also is developing companion tests to targeted cancer therapies.   

In 2014 we raised $1.2 million from our existing shareholders and members of the Keiretsu Forum, the nation's largest network of Angel investors.   A Term Sheet and Due Diligence package has been prepared by Keiretsu Forum members with expertise in healthcare investing and molecular diagnostics.  

Health Beacons is an early stage medical device company that is revolutionizing the standard of care for marking and surgically removing non-palpable breast tumors. Physicians are actively seeking an alternative procedure and are enthusiastic about ours, which employs RFID markers that are read with handheld readers, because it addresses all the shortcomings of the current method.  We have a fully functional prototype that has been used successfully in almost 40 human cases and are working on our 510K submission. Investment to date has been from founders, friends and family.  We are currently seeking $1.5M in an equity round to support regulatory clearance, and will require another $2-3M for commercialization which is planned for Q1 2016.

Company

Navitas Pharma (Navitas) is developing a new class of cardiovascular drug for the US.  On the basis of recent, proprietary research, Navitas has filed patents for use of its drug platform in three disorders for which no drugs are currently approved in the US.  Each has over 1,000,000 patients in the US:

> Portal hypertension (PHTN; hypertension of the liver)

> Heart failure with preserved ejection fraction (HFpEF)

> Group II pulmonary hypertension (Group II PH; lung hypertension secondary to left-sided heart failure)

Technology Platform

Navitas’ main platform is a new chemical class of compounds, known as furopyridines.  Cicletanine (CIC), the lead drug from this platform, has been launched for hypertension in France, and introduces a new mechanism of action to the US.  The drug activates endothelial nitric oxide synthase (eNOS), thereby reversing endothelial dysfunction, a root cause of hypertension and heart failure.  As part of this eNOS-activation mechanism, CIC has recently been shown to activate protein kinase G (PKG), an enzyme whose inactivation is important in HFpEF.

CIC is significantly de-risked:

> Launched in France for general hypertension, in which the drug has a long-established track record of efficacy and safety.

> Extensive safety data from

   > Clinical trials in >10,000 patients

   > Post-launch pharmacovigilance of ~2 million patient-years in France and Germany

> Clinical proof-of-concept data in several disorders, including

   > Hypertension

   > Group II pulmonary hypertension

   > Hypertensive hypertrophy (relevant to HFpEF)

   > Angina

   > Diabetic claudication

   > Diabetic microalbuminuria (early-stage kidney disease)

> Proof of relevance in an established animal model of portal hypertension

> Extensive data supporting new mechanism of action via eNOS

Target Markets

Portal Hypertension (PHTN; high blood pressure in the liver) is a significant, unmet medical need, with over 1 million patients in the US.  Current treatments involve decreasing blood flow into the liver, either with drugs or with surgery, rather than getting at the core problem of blood-flow resistance in the liver itself.  Recent laboratory research shows cicletanine directly (within the liver) reversing an accepted, reliable animal model of portal hypertension.  CIC looks promising as the first direct treatment of portal hypertension.  Conservative forecast puts revenues at $3 billion. 

Heart failure with preserved ejection fraction (HFpEF) accounted for a minority of diagnosed heart failure until recently.  With about 3 million US patients, it now accounts for 50 – 60% of heart failure diagnoses.   The increasing prevalence of HFpEF is driven to a large degree by metabolic syndrome (“pre-diabetes”) and diabetes.  This is important, as retrospective analysis of hypertension trials have associated CIC with significant decreases in glucose, cholesterol and triglycerides among patients in whom these were elevated.  Additionally, HFpEF is now thought to be driven by inactivation of protein kinase G (PKG), an enzyme recently shown to be activated by CIC.  Navitas therefore believes that CIC has the potential to reverse the root, molecular basis underlying much of the pathology of HFpEF.

Group II Pulmonary Hypertension (Group II PH) is hypertension of the lungs associated with left-sided heart failure.  A small CIC study showed marked improvements in functional status vs. placebo and significant improvement of pulmonary pressures.  The drug appears to have a dual action directly on both heart failure and hypertension within the lungs.  With over 1 million Group II PH patients in the US and no approved drugs, CIC has breakthrough-treatment potential.

Management

Glenn Cornett, MD, PhD (founder, CEO) has over 20 years of consulting and industry experience.  His work at Eli Lily included strategy and financial modeling, including work on licensing Cialis, establishment of a competitive-strategy unit in R&D and a corporation-wide assessment of new therapeutic targets.  At McKinsey, he consulted on engagements in health care, technology and manufacturing.  He also served on the Core Groups for Complexity and Business Dynamics at McKinsey.  While consulting at Los Alamos National Laboratory, Dr. Cornett authored a book on plutonium and public policy.

Running his own consulting firm, Glenn has done financial modeling and structuring for strategic transactions driving the addition of several hundred million dollars of market capitalization to his clients.  Dr. Cornett founded Navitas in 2004 and led it through its first liquidity event 3.5 years later in 2008.  He has run ten marathons (most recently: Cayman Islands in December 2014), and holds a black belt in karate.  He has a neuroscience PhD (UCLA) and an MD (Distinction in Research, U. Michigan).

Mark Alvino (corporate development) has extensive experience in investor relations, public relations and investment banking.  He held senior investment banking positions at Bradley Woods, Griffin and SCO Capital.  At the latter institution, he was responsible for over 20 transactions, driving in aggregate over $500 million of private financings in the biotech / pharma sector.  He was SVP at Ogilvy’s Feinstein Kean Healthcare, a pubic relations business focused on health care.   He was a Vice President at the investor relations firm Allen & Caron.  As an entrepreneur, he founded Advent Consumer Healthcare, where he holds multiple patents on a consumer-health product now available at 7200 CVS stores.  He remains active in competitive sailing.  He holds a degree form George Washington University.

Jim Page, MD, JD, MPH (founder, senior advisor) is a board-certified psychiatrist (residence: Stanford) and graduated first in his law school class.  Earlier, he was in natural resources, where he was a strategist and analyst for Fortune 500 corporations. 

Rapid Development of Injection Molded Medical Devices
From Concept Through Transfer-to-Manufacturing

Symbient specializes in engineering research and development, prototyping and design-for-manufacturing of innovative medical devices that use injection molded components. Our highly experienced team consists of mechanical and biomedical engineers, industrial designers, machinists and molding technicians. They leverage our in-house rapid prototyping, and prototype tooling fabrication and injection molding to create proven, manufacturable designs with unmatched speed, efficiency and precision. These designs make up our deep portfolio of over 300 successful devices that have collectively generated hundreds of millions of dollars. They include FDA Class I, II and III devices, developed under our ISO 13485 certified quality management system.

Our Services Include:

• Concept Development
• Development Engineering
• Design-for-Manufacturing
• Industrial Design
• Project Rescue
• Design Control per IOS 13485
• Finite Element Analysis (FEA)
• Design Verification Testing
• Test Method Development
• Transfer to Manufacturing

Our In-House Capabilities and Expertise Include:

• Stereolithography (SLA) Prototyping
• CNC Machining / Fabrication
• Prototype Mold Fabrication
• Prototype Injection Molding of Devices for Testing, Trials and Studies
• Liquid Injection Molded (LIM) Silicone Prototype Molding
• Product Reliability Testing
• Plastics Assembly Expertise: Ultrasonic and Laser Welding, Heat Sealing, Pressure Sensitive Adhesives, Swaging, Snap Fits, Press Fits, Interlocks.
• Speed: Prototype Molds in as little as 1 week and Modifications in as little as 1 Day
• Material Selection Expertise, Research and Testing to Ensure All Product Requirements Are Met.

Our Portfolio Includes:

• Diagnostics / Molecular Diagnostics
• Sample collection / preparation
• Life Sciences / Microfluidics
• OTC Consumer products
• Respiratory
• Surgical devices and clinical tools
• Drug Delivery

Phoenix PharmaLabs, Inc. (PPL) is a privately held, preclinical drug discovery company focused on the development and commercialization of new potent, non-addictive treatments for pain and new therapies for the treatment of opiate addiction.

PPL has developed a novel family of New Molecular Entities (NMEs) with high binding affinity at all three opiate receptors: mu, kappa and delta.  These unique ligands, derived from opioid backbones using proprietary technology, have high binding affinity at all three opioid receptors (mu, delta and kappa) and more balanced receptor activity than morphine and other opioids, with partial agonist / antagonist activity at mu, somewhat higher, but not full, kappa agonist activity, and moderate delta activity.  This profile results in first-ever opiate analgesics that appear to be non-addicting and free of all significant dangerous side effects. 

Studies of the drugs have been conducted by prominent scientists at leading institutions including Lou Harris and colleagues at Virginia Commonwealth University (VCU), Jim Woods and colleagues at the University of Michigan, and Larry Toll and colleagues at SRI International and Torrey Pines Institute for Molecular Studies.  Study results in rodents and monkeys performed by the National Institutes of Health (NIH) / National Institute on Drug Abuse (NIDA) and SRI International Laboratories demonstrated the following:

• Robust analgesic potency (10-20x stronger than morphine)
• Little or no euphoric reward / abuse and addiction potential in rodents and monkeys (multiple studies)
• No dysphoria in rodents and monkeys (multiple studies)
• Only moderate signs of respiratory depression – even at 150x dosage
• No death from overdose - even at 350x dosage
• LD50 = 500x dosage
• No physical dependence in naive rodents
• No inhibition of GI transport - even at 350x dosage
• No Long QT syndrome risk – hERG assay
• No significant diuresis in rodents
• Does not precipitate withdrawal in dependent monkeys

Since the drugs do not precipitate withdrawal, they offer very promising use for addiction therapy as a preferred substitute for methadone and buprenorphine, as well as for pain. 

The drugs are orally active and inexpensive to manufacture using PPL's patented manufacturing process.  A key patent on the lead molecule for Composition, Methods and Use will be issued in the US by January, 2015, and it is currently being internationalized.

The cost and risk of achieving a New Drug Approval (NDA) from the FDA is substantially lower than other NMEs with equivalent market potential.  Few drug classes have more longitudinal testing data than opioids for use as a predictor of success in trials.  Therefore, the risk of pharmaceutical product development is significantly reduced compared to the risk of developing less understood and potentially problematic drug classes.  As described above, the assets have been effectively de-risked in animal studies covering all risks that typically manifest themselves in opioids.

Furthermore, a vast amount of opioid testing data is available concerning the transition of effects of pure opioid compounds from animals to humans.  Consequently, our scientific experts and advisors predict that the risk of problems in toxicology and safety pharmacology is very low.  The prediction correlation from animals to humans is very high, and thus there is a high level of confidence that the compounds will be safe, effective and beneficial for humans.   

Recently our drug family has also attracted attention for Animal Health applications, primarily due to the lack of respiratory depression and GI tract side effects as well as the likelihood that the drugs would likely be unscheduled (or at most scheduled as Class IV or V).

The strategic objective of our company is to enter into one or more license agreements with appropriate market leader(s) that have the resources and motivation to further develop, commercialize, and maximize the market potential of PPL’s family of drugs.  We are making steady progress towards the achievement of that objective. Following submission of a BAA grant proposal to the DoD, we were invited by the U.S. Army Medical Research and Material Command (USAMRMC) to submit a full application for a $3.6 million grant for the advancement of our PPL-103 compound for pain, and we are currently awaiting the results. In the meantime we are exploring other potential funding opportunities and strategic collaborations. 

Westwood & Wilshire is a premier provider of executive search services to the Pharmaceutical, Biotechnology, Medical Devices and Diagnostics sectors.  Services include:

-Direct Hire Executive Search
-Interim Executive Search and Consultant Placement
-Board of Director and Advisory Group Development

Our clients range from Venture Capital-backed portfolio start ups to Fortune 500 Big Pharma. Our success encompasses executive level placements across Clinical, Medical, Regulatory, R&D, Quality and Commercial.

Cynvenio has developed a new LiquidBiopsy technology to sequence the DNA of tumor cells isolated from peripheral blood. Key applications include longitudinal patient monitoring throughout the cancer care cycle, the detection of resistance mutations, and providing physicians with accurate molecular evidence to select the best targeted therapy for a given patient.

Cynvenio's technology can be accessed as a CLIA lab service, or  can be installed and operated inside hospital labs and cancer research centers. Cynvenio's lab has been CLIA certified since 2013 and LiquidBiopsy system deployments began in the second half of 2014.

The majority of medical devices get cleared for commercial deployment through the FDA’s 510(k) clearance process, which is the fastest and most economical route to market for a new medical device. ZeroTo510 has developed a unique program that enables entrepreneurs with ideas for innovative medical devices to take advantage of the fast path to market. ZeroTo510 is a first-of-its-kind cohort-based medical device accelerator. Hosted in Memphis, Tennessee, the program leverages key regional strengths in biomedical research and medical device manufacturing to create a unique program.