Lipella Pharmaceuticals Inc. United States

Development-stage pharmaceutical company with a platform technology to deliver novel therapeutics to the urinary bladder lumen for the treatment of inflammatory bladder conditions such as overactive bladder and interstitial cystitis. Our portfolio includes prodcuts in pase-I and phase-II clinical trials in the United States and overseas, as well as pre-clinical programs. We also have one program designated as orphan. In addition to therapeutics, Lipella also develops diagnostic agents to be used in connection with medical imaging.

Website:
www.lipella.com
Year Founded
2005
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
Platform technology for the local delivery of novel therapeutics to the urinary bladder
Alliance & Collaborations
Multiple
Current Financing Needs
Can be discussed
Current Investors
Private, non-institutional
IP Status
Multiple US patents, and US and international patent applications
Recent Milestones
LP-09 clinical trial completed 2013, LP-08 IND approved 2014
Management Team Highlights
Small, focused team
Jonathan Kaufman
CEO 

Longevity Biotech United States

Longevity Biotech is a privately held preclinical biotechnology company developing a new class of linear, stabilized, peptide therapeutics called Hybridtides®. 

Our objective for this meeting is to initiate fundraising (Series A) and partnership discussions to progress our preclinical neuroinflammation program into the clinic.  

To date, Longevity Biotech has demonstrated in vivo neuroprotection in a Parkinson's Disease animal model and established preliminary immunological-based biomarker end-point links to on-going clinical trials.     Longevity Biotech is encouraged to continue the development of this differentiated and potentially disease modifying therapeutic candidate to address the unmet needs across a variety of neurological disorders.  

More generally, Longevity Biotech is committed to the development of our current preclinical portfolio as well as expanding the platform breadth via licensing opportunities.  Currently, Longevity Biotech is developing GPCR based Hybridtides® for the treatment of metabolic, cardiovascular, neuroscience and oncology diseases.   In addition, preliminary data (in vitro &  in vivo) suggest the possibility of oral delivery of Hybridtide based therapeutics.

Biotech Subsector
Biotech Phase of Development
Technology Overview
Synthetic Peptide Scaffold that confers unique stability and biological activities
Alliance & Collaborations
University of Nebraska Medical Center,
Supporting Metrics or Evidence
Most recent paper: http://www.nature.com/nbt/journal/v32/n7/full/nbt.2920.html
Current Financing Needs
Series A - $15m
Current Timeline
approximately 18-24 months from clinical trials
Current Investors
Breakout Labs, NetScientific
IP Status
Several patents approved along with several still pending worldwide
Dr Scott Shandler
Dr Scott Shandler
LinkedIn logo CEO 

Medifruit Pty Ltd Australia

We are an Australian Biotechnology Company nearing completion on five year R&D programme into new, novel compounds from natural rare Australian extracts for both the prophylactic and treatment of giardiasis.

Current R&D programmes in both Australia and Boston, MA.

World’s first alternative natural treatment to antibiotic strength drugs of choice against bacteria and protozoa for animals envisages enormous market potential, including human, organic, veterinary and husbandry sectors   

Fast kill rate ‘within 5 minutes’  

Non-Toxic and safe for human and animal consumption.

No antibiotic resistance problems that plague current treatment modalities [due to multiple compounds]

Kills all the life cycle – Pluripotent and treats both the disease and the pathogenesis of the disease in multiple ways

MOA established and known [several]

Website:
TBA
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
Giardia
Current Financing Needs
seed angel to $1 million
Current Investors
Private
Giles Tilley
Director 

MitoDys Therapeutics United Kingdom

MitoDys Therapeutics is a start-up drug discovery company that has developed a highly innovative platform to uncover polypharmacological drugs with existing safety profiles that can be repositioned to a new indcation.  The company focuses on the discovery of disease-modifying drugs for neurodegenerative diseases; particularly Parkinson's disease, ALS and MSA.

Website:
www.mitodys.com
Year Founded
2012
Biotech Subsector
Biotech Phase of Development
Technology Overview
Network Pharmacology platform combined with pluripotent stem cell-derived assays
Current Financing Needs
$1m
Current Timeline
12-18 months to validated candidate
Current Investors
Angels and Charitable foundations
IP Status
None yet...focused on drugs at the end of the proecess
Management Team Highlights
Highly experienced individuals from Industry and finance
Steven Zimmer
CEO 

MyeloRx United States

MyeloRx is a northern California based biotechnology company. Our lead compound, MRx102, is a small molecule inhibitor of RNA polymerase II. Molecules related to MRx102 have shown clinical efficacy in AML patients in Europe and China.  MRx102 is covered by issued composition of matter patents in the U.S., E.U., China and Japan.  While AML is the initial indication, MRx102 has also been found active in stringent models of pancreatic and lung cancer. Our collaborators include clinical oncologists from MD Anderson Cancer Center, JHU School of Medicine and City of Hope Medical Center. R&D activities have been funded primarily by a $2M NCI SBIR contract. Our strong scientific and management team is lead by Dr. John Musser; it has brought multiple products to market. We are seeking funding to complete an IND which is projected to take less than a year based on the extensive studies completed to date (manufacturing, formulation, toxicology/ PK in rats and dogs etc.)  and a Phase 1 clinical trial in AML patients.

 

Website:
www.myelorx.com
Year Founded
2007
Biotech Subsector
Technology Overview
The lead compound is termed MRx102. It is a prodrug of a purified natural product triptolide that has shown clinical activity in patients with acute myeloid leukemia (AML). Intellectual property MRx102 is covered by issued matter patents in the U.S., E.U., Japan and China. Molecular target The molecular target of the natural product, triptolide, is XPB, a subunit of the transcription factor TFIIH. Binding of XPB by triptolide leads inhibition of transcriptional activation resulting in the blockade of a number of signaling pathways that drive cancer cell proliferation. Safety Triptolide and earlier prodrugs of triptolide have shown toxicity in a variety of clinical studies. We therefore set out to design and develop a safe prodrug, viz. MRx102, using the learning from these earlier studies. In a direct comparative toxicology study performed in rats MRx102 was at least 20 times safer than triptolide. This was due to a favorable pharmacokinetic profile seen both in rats and dogs. Pilot toxicology/PK studies have been completed in rats and dogs; NOAELs have been determined in both species. Thought Leader Studies with MRx102 In collaboration with Dr. Michael Andreeff of the MD Anderson Cancer Center we demonstrated that MRx102 was extremely potent in killing human blast cell and stem cell populations from AML patients. The activity against the stem cell populations may indicate an activity in preventing relapse in these patients. MRx102 was likewise effective in a variety of in vivo xenograft models of AML. Dr. James Eshleman and his colleagues from the JHU School of Medicine have demonstrated the activity of MRx102 in killing pancreatic cancer cells having a variety of genetic abnormalities. Dr. Dan Raz of the City of Hope Medical Center has shown MRx102 effective in models of non-small cell lung cancer and identified a potential biomarker for susceptible cells. Current status MyeloRx has completed a $2M NCI Fast Track SBIR contract that enabled many preclinical activities required for an IND filing. Major remaining activities include the GMP manufacture of drug substance, performance of GLP toxicology in rats and dogs and then completion of the clinical plan for Phase 1 studies in AML and solid tumors. These could be completed to allow IND filing in less than a year.
Alliance & Collaborations
Option agreement for China territories
Current Financing Needs
$5-7M for IND filing/Phase 1 trial
Current Timeline
IND completion in less than one year
IP Status
Issued matter patents worldwide
Recent Milestones
Completion of tox/PK studies in rats/dogs
Neil Ackerman
Vice President Business Development 
John Musser
CEO 

N8 Medical United States

N8 Medical is a development-stage medical device company focused upon commercializing antimicrobial medical devices and coatings to address the multibillion dollar public health and economic burden associated with medical device-related hospital acquired infections and healthcare associated infections (HAIs).  N8 Medical’s key differentiator from competitors is the application of a novel, proprietary class of pharmaceutically active compounds known as ceragenins, Cationic Selective Antimicrobials, or CSAs (ceragenins or CSAs) to medical devices for the purpose of providing antifouling or anti-infective properties. N8 Medical believes that ceragenins offer unparalleled efficacy and cost advantages over other coatings and means of addressing HAIs. Further, the use of ceragenins as a platform technology under its CONTEGO™ brand across numerous device segments with multiple coating options provides N8 Medical with a unique, sustainable competitive advantage over other medical device companies.  

N8 Medical is seeking $6 million in investment capital, which it believes will be sufficient to fund development, FDA approval and CE Marking of its proprietary coated CONTEGO™ endotracheal tube (ETT), and initial commercialization activities. N8 Medical has designed its antimicrobial ETT to reduce ICU stays by a single day or more, thereby saving the hospital $3,000 to $5,000 in non-reimbursable costs per ICU patient, and, significantly, by freeing up an ICU bed one day earlier for a new revenue-generating patient and resulting in better profitability for providers and substantial opportunity cost savings.  Thus, N8’s CONTEGO™ ETT presents a compelling value proposition for hospitals.  N8's internal valuation model aligns with relevant market data and comparable companies, indicating a successful antimicrobial device company could achieve a value of over $100 million.  

 

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
Novel antimicrobial small molecule mimetics of antimicrobial peptides applied to medical devices
Alliance & Collaborations
Engaged with leading medical device companies for technology feasibility evaluations
Supporting Metrics or Evidence
in vitro and in vivo efficacy and safety studies
Current Financing Needs
$6 million
Current Timeline
Clinical study planned for Q4 2015/ Q1 2016
IP Status
Patent protection into the 2030's
Management Team Highlights
Successful track record medical technology commercialization, including an IPO
Carl Genberg
CTO 
Michael Triplett
Michael Triplett
CEO 

Naegis Pharmaceuticals Inc. Canada

Naegis, based in Vancouver, British Columbia, is developing novel, small-molecule leukotirene synthesis inhibitors (LTSIs) for serious inflammatory conditions.  The Company is currently focused on two proprietary programs: 

topical and oral therapy for Uveitis, a condition that is responsible for 10% of legal blindness in the US and for which there are limited therapeutic options. 

o oral therapy for Chronic Obstructive Pulmonary Disease (COPD),  a serious lung disease with increasing rates of mortality.

Naegis has developed a large library of LTSIs that are potent inhibitors of either 5-LO or LTA4H.  The Company is currently identifying a lead compound for selection for futher development for ocular disease, in particular Uveitis.

The Company is also advancing a series of compounds that are novel structures and highly selective and potent inhibitors of LTA4H, which are expected to be developed as new therpaies for COPD

Naegis is seeking pharmaceutical partners and capital investment to advance more rapidly their novel programs.

Year Founded
2010
Biotech Subsector
Biotech Phase of Development
Technology Overview
Leukotrienes are key inflammatory mediators implicated in many diseases. There is growing evidence of their central role in Uveitis. 5-LO inhibitors have been shown to reduce the clinical signs of uveitis in animal models. Naegis is developing potent 5-LO inhibitors that are both topically and orally active, with unique structures that are not expected to have the limitations of earlier 5-LO inhibitors. In COPD recent evidence has demonstrated the critical role for LTA4H in the progression and persistence of the disease. However it has recently been shown that LTA4H has a dual role and functions as both a pro and anti-inflammatory. Thus it is necessary to identify compounds that are active only against the pro-inflammatory function of the enzyme, whilst sparing its anti-inflammatory effects. Naegis is developing highly specific inhibitors of LTA4H that inhibit only the anti-inflammatory activity of LTA4H.
Alliance & Collaborations
In discussion
Current Financing Needs
$500,000 - $1,000,000
Current Timeline
Lead
Current Investors
Private.
IP Status
Proprietary compounds
Management Team Highlights
CEO - Dr. David Burgoyne an experienced medicinal chemist who has developed compounds that are in current human clinical trials. Also on the Board are Dr. Philip Davies, formerly Executive Director of Research and Area Head of Immunology at Merck, New Jersey. Also Dr Julia Levy, founder of QLT and developer of the first effective therapy for macular degeneration.
Ian McBeath
Ian McBeath
Corporate Development 

Navitas Pharma 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
Glenn Cornett
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.

Neurodyn Life Sciences Inc.

Neurodyn Inc. (neurodyn.ca) is a Canadian biotechnology company using a portfolio approach to identifying, validating and developing natural bioactives into both prescription drugs and natural products for the early treatment of Alzheimer's Disease, Parkinson's Disease and other neurodegernative disorders. 

Memogain® is a patented pro-drug of an existing major Alzheimer's cognition enhancement drug, offering improved side effect profile and increased bioavailability. Initial Phase 1A results have been positive, showing no significant side effects and improved working memory in young and elderly volunteers. Memogain may qualify for a new US FDA accelterated pathway or Eu equivalent.

Cerbella is a treatment for early stage Parkinson's disease which has demonstrated in-vivo pre-clinical efficacy in acute models as well as Neurodyn's proprietary chronic model of Parkinson's disease. A product is expected to launch in Canada, USA or other countries in 2015.

NeuroPro® is a professionally-oriented supplement launched in October 2013, designed for neuroprotection and bansed on 5 years of animal model research.

Nerve Pain Treatment (PN34) is a rare first-in-class neuromodulator, being prepared for a topical orphan status nerve paincondition, with clinical trials to begin in 2015.

Progranulin (ND602) is a novel therapeutic demonstrating in-vivo pre-clinical efficacy in ALS, PD< Alzheimer's disease and Spinal Muscular Atrophy. The company is in its third year of collaboration (late stage pre-clinical evaluation) with the Michael J. Fox Foundation.

Kenneth Cawkell
CEO 

Novelogics Biotechnology Inc. Canada

Novelogics Biotechnology Inc. has developed unique next generation antibody immunotherapies for treating multiple types of advanced cancers including colon and prostate cancers.  Immunotherapies for cancer are anticipated to be a $35B per year industry in the upcoming years.  

Cancer Drugs with Safety in Mind

From the beginning the novel and specific design of the therapeutic antibody drug minimizes the potential for autoimmune diseases or harming good cells with the bad.  We are dedicated to making cancer treatments that won't make you sick to get you better.

Unecumbered, Founder Owned

Novelogics has developed their assets in an unecumbered envriornment allowing investors to work directly with the team.  At this time the companyis 100% founder owned and undiluted.  Novelogics is anticipating an early exit and has begun discussions with pharmaceutical companies interested in this area.

In addition; a related Medical Device

In addition to the drug, Novelogics has a second PCT Patent pending for a related medical device with a readily available "go to" market in place. 

Year Founded
2013
Biotech Subsector
Medtech Subsector
Biotech Phase of Development
Medtech Phase of Development
Technology Overview
We have developed a panel of patent-protected monoclonal antibodies which bind members of the NKG2D ligand family for use as novel cancer immunotherapies. Studies have shown that cancer cells in part evade the immune system by releasing biologically active molecules, such as NKG2D ligands that interfere with immune cells ability to fight cancer. These ligands are capable of shutting down tumour killing immune effector cells by overwhelming the important activation-type NKG2D receptors, basically putting them to sleep, so tumors can continue to grow undetected. Using our specifically designed antibody drug, we now have the potential to clear out these ligands and restore the immune system in a more balanced way to destroy tumor cells without over-stimulating the immune system or causing adverse side effects.
Alliance & Collaborations
None
Supporting Metrics or Evidence
Proof of concept studies in progress
Current Financing Needs
$2M
Current Timeline
Within 2 years of IND
Current Investors
Founder Funded
IP Status
Two PCT patents pending
Recent Milestones
Have developed a panel of monoclonal antibodies,filed two PCT patents (pending), assembled management and scientific advisory team, completed preliminary invitro and invivo studies and will continue with further characterization before moving on to humanization of the Ab (antibody).
Management Team Highlights
Dr. Cheney, President & CSO has 26 years in R&D (10 years in oncology) including 16 years in drug discovery and has contributed to successful drugs that are either on the market or in late stage clinical trials. Co-Founder, Elaine Allison has 25+ years of corporate management experience.
Ms Elaine Allison
Ms Elaine Allison
LinkedIn logo VP, Business Development