David Coats United States

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.

Year Founded
2010
Investor Type
Medtech Phase of Development
Capital Structure Preference
Investment Stage Preference
Correlation Ventures
Managing Director 

Jonathan Cohen United States

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.  

Biotech Phase of Development
Technology Overview
Multiplex immunoassays (tumor antigens and autoantibodies)
Alliance & Collaborations
Marketing and technology agreements with leading diagnostics companies
Supporting Metrics or Evidence
Extensive case-control studies (multi-center)
Current Financing Needs
$4 million round ($650,000 closed since November)
Current Timeline
on the market
Current Investors
Keiretsu Forum (largest Angel network in U.S.)
IP Status
issued patents and pending applications (worldwide)
Recent Milestones
Various lab send out agreements
Management Team Highlights
Veterans of leading diagnostics companies such as Ventana, Qiagen, and Celera
20/20 Genesystems
CEO 

J. Robert Coleman

Codagenix Inc.
COO 

Nancy Confrey United States

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.

Year Founded
2008
Main Sector
Medtech Phase of Development
Current Investors

Founders, friends and family

Health Beacons

Glenn Cornett United States

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. 

Year Founded
2004
Biotech Subsector
Biotech Phase of Development
Supporting Metrics or Evidence
Navitas's lead drug has clinical proof of concept in several indications. Further information is available under confidentiality.
Current Financing Needs
Navitas is raising $3 million to complete proof of concept trial in portal hypertension. Navitas is raising an additional $3 – 7 million to reach clinical proof of concept in at least two pilot clinical studies of HFpEF coincident with Group II pulmonary hypertension. At least one of these studies will also be designed to demonstrate the ability to decrease blood glucose, cholesterol and/or triglycerides; all three of these have been reduced significantly in hypertension trials. Further details are available under confidentiality
Current Timeline
Liquidity-driving, clinical proof of concept data in portal hypertension is expected 12 to 18 months out from funding or active partnership. Liquidity-driving, clinical proof of concept data in HFpEF (heart failure with preserved ejection fraction) coincident with Group II PH (lung hypertension secondary to left-sided heart failure) is expected 18 to 36 months out from funding or active partnership. The trials in HFpEF coincident Group II PH are also expected to provide prospective, proof-of-concept data in reduction of blood glucose, cholesterol and triglycerides among patients in whom these are elevated. At least one of these trials will focus specifically on metabolic patients.
IP Status
Navitas has active patent applications for the use of CIC in portal hypertension, Group II pulmonary hypertension and HFpEF – indications for which Navitas expects market exclusivity into 2034. Additionally, new formulations driven by patented, proprietary technology are being developed for specific indications, thereby allowing for independence of franchises and further protection of market exclusivity. Further details are available under confidentiality.
Glenn Cornett
Navitas Pharma
CEO 
BIO

Glenn Cornett, MD, PhD has over 20 years of consulting and industry experience.  His work at Eli Lily involved 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 Pharma in 2004 and led it through its first liquidity event 3.5 years later in 2008, yielding substantial, favorable returns to investors.

Glenn holds an MD with Distinction in Research from the University of Michigan, and a PhD in neuroscience from UCLA.  His dissertation was on human deep-brain responses to musical stimuli. 

His not-for-profit work includes running (with significant help from highly-competent staff) Spectrum, a performance venue / gallery / salon on Manhattan’s Lower East Side that supports innovation and virtuosity in the arts.  Spectrum has been covered favorably by the New York Times and with evident reluctance by the New Yorker.  He is an occasional composer/performer, playing electronics (i. e., various forms of computer music), guitar, keyboards, etc.

Dr. Cornett reluctantly admits that diet and exercise are more important important than the pharmaceutical industry to the health of many individuals.  He has a black belt in karate and has run ten marathons, including Istanbul in November 2013 and Cayman Islands in December 2014.

Jord Cowan

Parvus Therapeutics Inc.
VP, Business Development & Operations 

Lisa Coyne United States

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

 

Year Founded
2004
Unique Capabilities

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.
Symbient Product Development
Business Development Manager 

Tom Crosby

Life Science Nation (LSN) is the premier sourcing platform for market intelligence and prospect pipeline development in the life science arena. LSN enables life science professionals to generate a list of qualified global targets that are a fit for their company’s products, services, and fundraising efforts. The ability to generate these Global Target Lists (GTLs) makes life science professionals more effective and efficient. 

Biotech Phase of Development
Medtech Phase of Development
Unique Capabilities

Life Science Investor Profiles, LSN has sourced validated and maintains the largest global database of investor profiles. LSN defined 10 categories of Life Science Investor;

·         Private Equity

·         Venture capital

·         Family Offices

·         Corporate VC

·         Angel Groups

·         Large Pharma/ Biotech

·         Alternative Institutional Investors: Pensions, Endowments

·         Endowments/Foundations

·         Hedge Funds

·         Government Grants

Marketing Services, LSN consults on branding, messaging, and outbound marketing strategies. This includes developing a tagline, elevator pitch, executive summary, corporate power point presentation, and new or updated website design to fit your brand and message. LSN will develop a Global Target List of prequalified candidates to target for marketing initiatives.

Life Science Nation

Michael Cross Canada

Fusion Pharmaceuticals is a clinical stage company committed to developing next generation precision radiopharmaceuticals for the diagnosis and treatment of human cancers with unmet medical needs.  The Company’s lead product, FPX-01, combines an alpha radionuclide with the precise targeting of an antibody to cause selective cytotoxicity of tumor cells.  FPX-01 will be entering Phase 2 clinical development in H2, 2015.

Year Founded
2014
Biotech Phase of Development
Technology Overview
The FPX-01 program represents a true theranostic approach. By leveraging its expertise in radiochemistry and biology, and utilizing different isotopes, Fusion has produced variants of FPX-01 that act as either diagnostic or therapeutic agents. For human proof-of-concept, Fusion initiated a Phase I imaging trial in Canada. Using Iodine-124 as a probe, this trial was designed to confirm that FPX-01 binds and internalizes to solid tumors expressing the receptor target as determined through PET/CT imaging. Initial results from this trial demonstrate that FPX-01 can identify metastatic lesions not previously identified through other imaging techniques. These data corroborate previous preclinical in vivo data which indicated that the radioactivity-associated with FPX-01 accumulated within tumours over several days. Following the completion of the Phase 1 imaging trial and additional preclinical studies planned for H1 2015, Fusion will file an IND in H2 2015 that will be designed to achieve breakthrough status in NSCLC. For therapy, FPX-01 will be radiolabeled with an alpha-emitting isotope. Preclinical xenograph studies, using only a single administration of isotope demonstrated tumor regression, with minimal toxicity at any dose level. It is expected that the IND-opening trial will be a Phase I/II therapeutic study in approximately 100 patients with non-small cell lung cancer (NSCLC), addressing a major unmet medical need.
Alliance & Collaborations
Ontario Institute for Cancer Research
Supporting Metrics or Evidence
Clinical and pre-clinical data.
Current Financing Needs
Series A $15M
Current Timeline
H2 2015: Phase 2 IND
Current Investors
Centre for Probe Development and Commercialization
IP Status
The FPX-01 antibody is protected worldwide via multiple granted patents. Additional combinations of delivery vehicles, conjugation/chelation technologies and radioisotope variation are routinely considered and evaluated for their proprietary nature and if appropriate, patent applications are filed. Regulatory exclusivity will extend FPX-01 protection in the US market.
Management Team Highlights
Frank Gleeson, CEO. Founding CEO of Fusion Pharma, DVLR Therapeutics, Verio Therapeutics (sold to Fate Therapeutics in 2010) and former Partner with MDS Capital Corp. Mr. Gleeson has raised over $200M in syndicated financings.
Fusion Pharma

William Crossman United States

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. 

Year Founded
2002
Biotech Subsector
Biotech Phase of Development
Technology Overview
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. 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.
Alliance & Collaborations
Research alliances: SRI International, Torrey Pines Institute for Molecular Studies, Virginia Commonwealth University (VCU), the University of Michigan, The Rockefeller University, and BioDuro / PPD; Synthesis alliance: Mallinckrodt, Inc.; Preclinical toxicology alliance: Calvert Labs
Supporting Metrics or Evidence
Opioid Receptor Binding Affinities of PPL-103 Ki (nM): Mu: 0.36 +/- 0.11; Delta: 2.47 +/- 0.105; Kappa: 0.29 +/- 0.03. Functional Activities of PPL-103 – EC50 (nM) and % Stimulation: Mu: 4.30 +/- 2.13 and 22.60% +/- 0.05%; Delta: 9.01 +/- 2.64 and 39.80% +/- 3.9%; Kappa: 2.99 +/- 0.92 and 41.7% +/- 5.0%. Antinociception of PPL-103: Compared to morphine's ED50 of 2.0 to 4.0 mg/kg, PPL-103's ED50 of 0.2 mg/kg was ten-fold to twenty-fold more potent than morphine. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Several Self Administration studies as well as Conditioned Place Preference (CPP) and Conditioned Place Aversion (CPA), Physical Dependence and Drug Discrimination studies in rodents and monkeys have been conducted to assess the degree to which PPL’s novel opioid compounds elicit either euphoric reward (which can lead to abuse and addiction) or dysphoria. The results of all studies show no significant signs of either euphoric reward / abuse potential or dysphoria. Studies showed no death from overdose at 350x dose and no constipation at 350x dose. LD50 = 500x dose.
Current Financing Needs
Approximately $3.6 million will be needed to complete preclinical studies, obtain IND and produce GMP material to support human clinical trials. (This may be funded by a USAMRMC grant.) Subsequently, approximately $3 million will be required to advance the compound through simultaneous Phase I / II trials in Australia to reach POC in humans prior to licensing.
Current Timeline
Completion of preclinical trials and IND approval in 2016. Completion of simultaneous Phase I / II trials in Australia to reach POC in humans in 2017.
Current Investors
Founders and angel investors
IP Status
For the lead molecule a Composition, Methods and Use patent application was filed in 2010 and will be issued in the US by January, 2015. It is currently being internationalized. Other Methods and Use patents on related molecules have been issued as well.
Recent Milestones
Completed de-risking studies of lead molecule; patent approval of Composition, Methods and Use patent of lead molecule
Management Team Highlights
Management Team & Board of Directors: John Lawson, Ph.D., Founder, Board Chairman and Chief Scientist - the primary developer of PPL’s intellectual property; formerly headed the Neurochemistry R&D Group at SRI International; William Crossman, President, CEO and Board Member - launched and developed numerous emerging technology companies; served as CEO, CFO and CDO of enterprises ranging from start-ups to Fortune 100 level companies; Timmy Chou, Vice President, CFO and Board Member - founding partner of Spectra Consulting Group; experience as CEO and CFO of numerous emerging companies, serves on the Boards of several public and private companies; Lawrence Toll, Ph.D., Chief Neuropharmacologist and Board Member; Director of the Neuropharmacology Department of Torrey Pines Institute for Molecular Studies and SRI International; co-discoverer of the nociceptin opioid peptide; Chris Tew, Vice President, Board Member - senior sales and marketing executive of bioscience companies including VP Sales for Protocol Systems (Welch Allyn); Theodore Stanley, M.D., Board Member - Chairman and Founder of ZARS Pharma; formerly Director of Research of the University of Utah. Board of Advisors: Louis Harris, Ph.D. - Harvey Professor at VCU; member of the Drug Evaluation Committee for the NIH; founding member of the Committee on Problems of Drug Dependence (CPDD) for the National Institute on Drug Abuse (NIDA); a preeminent researcher in behavioral testing of opioids in animal models; Anthony Fox, M.D., Ph.D. – a recognized expert in strategic clinical planning and the evaluation and selection of contract research organizations (CROs); President of EBD Group, a pharmaceutical consulting firm; Mary Jeanne Kreek, M.D., Senior Attending Physician and Patrick E. and Beatrice M. Haggerty Professor, Head of Laboratory of Biology of Addictive Diseases, The Rockefeller University; recipient of numerous professional awards; John Mendelson, M.D., Senior Scientist, California Pacific Medical Center Research Institute; specific expertise in the design and supervision of human clinical trials of controlled substances; Shayne Gad, Ph.D., Principle, Gad Consulting; recipient of the American College of Toxicology Lifetime Contribution Award; 35 years experience in toxicology, statistics and risk assessment; authored or edited 44 published books in the fields.
Phoenix PharmaLabs Inc.
President & CEO