kevinp - Pappas Capital

VelosBio Emerges with $58M in Funding to Steer Cancer Drugs to Clinic

VelosBio, a biotech startup researching new cancer drugs, has raised $58 million in financing. The new VelosBio cash, a Series A round of financing, was led by Arix Bioscience (LSE: ARIX) and Sofinnova Ventures. VelosBio joined Johnson & Johnson’s JLABS @ San Diego incubator in January. The company is developing antibody drug conjugates, a class of cancer drugs that link antibodies to potent cancer-fighting toxins. These drugs are meant to provide a targeted strike to tumors, sparing healthy tissue. The new VelosBio cash is earmarked for completing the work needed to proceed into human studies.

VelosBio - 10/01/2018

Milestone Pharmaceuticals Announces First Patient Randomized in the Phase 3 NODE-301 Clinical Trial Evaluating Etripamil for Termination of Paroxysmal Supraventricular Tachycardia (PSVT) Episodes

Montreal, Aug. 8, 2018 /PRNewswire/ -- Milestone Pharmaceuticals, a clinical-stage cardiovascular company, today announced that the first patient has been randomized in its Phase 3 clinical study of etripamil. Etripamil is a new investigational, rapid-onset, short-acting calcium channel blocker administered intranasally by the patient designed to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever they occur. PSVT is a recurring and sporadic heart arrhythmia caused by abnormalities in the cardiac conduction system. The current standard of care to terminate these episodes is intravenous medication delivered in the emergency department.

The Phase 3, multicenter, randomized, double-blind, placebo-controlled, event-driven study is planned to be conducted in more than 50 cardiology centers in the United States and Canada and will enroll up to 500 patients. Following an in-office test dose of etripamil, patients will take home either 70 mg of etripamil or placebo for when a PSVT episode occurs. Upon onset of an episode, patients will apply a wireless cardiac monitor to their chest to record their heart rhythm, perform a vagal maneuver, and if symptoms persist, administer study drug.

“The design of the NODE-301 study of etripamil will allow us to obtain more clinical evidence of the benefits of this potential treatment for PSVT in an outpatient, real-world setting,” said Bruce Stambler, MD, FHRS, Piedmont Heart Institute, Atlanta, GA. “PSVT is an unpredictable disorder and the potential for a fast-acting therapy to resolve the symptoms of PSVT wherever the episodes occur could significantly reduce the burden this condition puts on patients and the healthcare system.”

The primary endpoint of the NODE-301 study is time to conversion of PSVT to sinus rhythm after the administration of study drug as confirmed by a central independent adjudication committee. Secondary study endpoints include relief of symptoms commonly associated with an episode of PSVT such as heart palpitations, chest pain, anxiety, shortness of breath, dizziness, and fainting.

“The initiation of the NODE-301 study is an example of our ongoing commitment to improve the lives of patients with PSVT,” said Francis Plat, MD, Milestone’s Chief Medical Officer. “Etripamil, if approved by regulatory authorities, could empower patients to take control of this anxiety-producing arrhythmia without being reliant on chronic medications or trips to an acute-care facility for treatment.”

The study will enroll patients at least 18 years of age with a documented history of PSVT. Patients receiving study treatment in NODE-301 will be eligible to participate in an open-label extension study (NODE-302) where etripamil will be provided for subsequent PSVT episodes. Information regarding the NODE-301 clinical trial can be found here (clinicaltrials.gov study identifier NCT03464019).

“There are well over a million people in the US living with PSVT, resulting in hundreds of thousands of emergency department and doctor’s office visits each year,” said Eileen Handberg, PhD, ANP-BC, FAHA, FACC, FPCNA, Research Professor of Medicine at the University of Florida. “In addition, countless other patients exist who don’t seek care and suffer through their episodes in silence as the current approved treatment options are unpleasant, inconvenient, and/or costly. Providing a way to self-manage PSVT episodes could offer immediate relief for those living with this arrhythmia.”

About Etripamil

Etripamil is a new, potent, short-acting, investigational calcium channel blocker being developed as a rapid-onset nasal spray that can be administered by the patient to terminate paroxysmal supraventricular tachycardia (PSVT) episodes wherever and whenever they occur. A Phase 2 clinical trial (NODE-1) was completed in the United States and Canada and published in the Journal of the American College of Cardiology[1]. Milestone is actively recruiting patients and clinical sites globally for the Phase 3 program of etripamil in the at-home setting enrolling patients with confirmed diagnosis of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular re-entry tachycardia (AVRT). Etripamil is not currently approved for the treatment of PSVT or for any other indication anywhere in the world.

About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia is a condition that afflicts more than 1.7 million people and results in at least 600,000 healthcare claims per year in the U.S. alone[2]. During a PSVT episode, patients may feel palpitations while heart rate increases dramatically, sometimes exceeding 250 beats per minute[3]. Although the condition is not life threatening, it causes great distress to the patient and can result in an emergency department visit where a patient is usually administered intravenous medication.

About Milestone Pharmaceuticals

Milestone, headquartered in Montreal, Canada with a US subsidiary in Charlotte, NC, is a clinical-stage drug development company focused on developing an investigational new drug intended to provide rapid-onset and short-acting treatment of PSVT episodes and other episodic conditions. For more information, please visit www.milestonepharma.com.

Contact:

David Pitts
Argot Partners
212-600-1902
david@argotpartners.com

^[1] Stambler, B.S. et al.; Etripamil Nasal Spray for Rapid Conversion of Supraventricular Tachycardia to Sinus Rhythm; J Am Coll Cardiol. 2018;72(5):489–97

[2] Sacks, N.C. et al; Prevalence of Paroxysmal Supraventricular Tachycardia (PSVT) in the US in Patients Under 65 Years of Age; Abstract and Oral Presentation at the International Academy of Cardiology Annual Scientific Sessions 2018, 23rd World Congress on Heart Disease; Precision Xtract, Boston, MA, USA

[3] Colucci, R.A.; Common types of supraventricular tachycardia: diagnosis and management.; Am Fam Physician. 2010;82(8), 942-952.

SOURCE Milestone Pharmaceuticals USA, Inc.

Related Links
https://www.milestonepharma.com

Milestone Pharmaceuticals - 08/08/2018

Liquidia Technologies Announces Pricing of Initial Public Offering

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Liquidia Technologies, Inc. (the “Company”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT^® technology to transform the lives of patients, today announced the pricing of its initial public offering of 4,545,455 shares of common stock at a public offering price of $11.00 per share, before underwriting discounts and commissions, for gross proceeds of $50.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 681,818 additional shares of common stock at the initial public offering price, less the underwriting discount. The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the ticker symbol “LQDA” on July 26, 2018. The offering is expected to close on July 30, 2018 subject to customary closing conditions.

Jefferies and Cowen are acting as joint book-running managers for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on July 25, 2018. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2^nd Floor, New York, NY 10022, by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com; or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by fax at (631) 254-7140.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ABOUT LIQUIDIA TECHNOLOGIES

Liquidia Technologies, Inc. (“Liquidia”) is a late-stage clinical biopharmaceutical company focused on the development and commercialization of human therapeutics using its proprietary PRINT^® technology to transform the lives of patients. PRINT® is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension and LIQ865 for the treatment of local post-operative pain. Liquidia’s lead product candidate, LIQ861, currently being evaluated in a Phase 3 clinical trial (INSPIRE), is designed to improve the therapeutic profile of treprostinil by enhancing deep-lung delivery and achieving higher dose levels than current inhaled therapies by using a convenient, disposable dry powder inhaler. LIQ865, for which Liquidia has recently completed a U.S. Phase 1b clinical trial, is designed to deliver sustained-release particles of bupivacaine, a non-opioid anesthetic, to treat local post-operative pain for three to five days through a single administration. In addition to developing its own product candidates, Liquidia collaborates with leading pharmaceutical companies to develop their own product candidates across a wide range of therapeutic areas, molecule types and routes of administration, leveraging Liquidia’s PRINT^®technology.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180725005966/en/

Source: Liquidia Technologies, Inc.

Liquidia Technologies, Inc.
Jennifer Almond, 919-328-4389
media@liquidia.com

Liquidia Technologies - 07/25/2018

Former CoLucid CEO Thomas P. Mathers joins Pappas Capital as Partner

RESEARCH TRIANGLE PARK, N.C., April 10, 2018 — Pappas Capital announced today that Thomas P. “Tom” Mathers has joined the firm as a partner. Mathers previously served as CEO of CoLucid Pharmaceuticals (NASDAQ: CLCD), a Pappas Capital portfolio company that was acquired in early 2017 by Eli Lilly & Company for nearly $1 billion. Mathers’ initial mandate will be to spearhead the formation of a new biopharmaceutical company that is expected to be backed by Pappas and other venture capital investors. In addition to launching the new company, he will source new deals, assist in evaluating prospective investment opportunities and provide expertise and oversight to Pappas portfolio companies. He will be based in Boston.

Pappas Capital - 04/10/2018

Nanotechnology firm Liquidia plans new ophthalmology company

MORRISVILLE, N.C. — Nanotechnology company Liquidia Technologies plans to form a new ophthalmology company with an experimental glaucoma treatment expected to start clinical trials in 2014.

Morrisville-based Liquidia said today that the new company would be able to advance Liquidia’s efforts to create products in ophthalmology and other therapeutic areas while also maximizing the return for the company’s investors. WRAL Tech Wire reported in February that Liquidia was considering spinning out one or more companies this year.

Liquidia offered few other details in today’s announcement, other than to say it would have more information later in the second quarter. In a statement, CEO Neal Fowler said that the structure for creating and financing the new company will be considered for other assets and therapeutic areas.

Liquidia’s proprietary “PRINT” technology enables a nanoparticle manufacturer to control the size and shape of the nanoparticles. Changing the size and shape of a nanoparticle can improve drug delivery and reduce side effects. Vaccines were Liquidia’s first target, a pursuit that GlaxoSmithKline liked enough to strike a licensing deal that gave GSK exclusive rights to develop new vaccines with the technology.

Liquidia said in today’s announcement that it independent from the new ophthalmology business, Liquidia will continue to focus on vaccine and pulmonary product development, including the work that has already begun under the GSK partnership.

Liquidia’s technology is a platform technology that has medical as well as consumer product applications. Fowler has acknowledged a partnership with Proctor & Gamble (NYSE: PG). In February, Fowler said that Liquidia’s PRINT technology can be used to make nanoparticles that improve how a product is delivered to the skin. At the time, he said an ophthalmology company could be spun out first, followed by a consumer product with P&G.

Liquidia Technologies - 05/02/2013

Ultragenyx Appoints Eric Yuen, MD as Chief Medical Officer and Senior Vice President

NOVATO, CA –May 1, 2013 - Ultragenyx Pharmaceutical Inc., a biotechnology company focused on the development of treatments for rare and ultra-rare genetic disorders, today announced it has appointed Eric Yuen, MD as its Chief Medical Officer and Senior Vice President. In this new role, Dr. Yuen will provide leadership and direction to Clinical Operations, Clinical Affairs, Clinical Sciences, Data Management/Biometrics, and Drug Safety. He will report to Dr. Emil Kakkis, CEO, and will serve on the Senior Management Team.

Dr. Yuen brings over 19 years of clinical development experience in academia and industry. In 2004, Dr. Yuen joined Johnson & Johnson as Senior Director and Neurology Franchise Medical Leader. During his tenure at J&J, he also held several executive positions including Vice President, Therapeutic Area Head, CNS in 2006 and Vice President, Scientific Licensing from 2008 to 2009. Dr. Yuen joins Ultragenyx from Janssen Alzheimer Immunotherapy R&D, LLC, a J&J affiliate, where he was the Head of Clinical Development since 2009. Prior to J&J, Dr. Yuen also served as Director of Clinical Research, Department of Clinical Neuroscience at the Merck Research Laboratories.

“As a board-certified neurologist, Dr. Yuen’s addition to the management team at Ultragenyx will provide critical support in advancing our clinical programs,” said Dr. Kakkis. “His clinical vision and proven leadership, as well as his extensive medical and research experience, will strengthen our clinical development efforts and support the progress of our product pipeline.”

Dr. Yuen commented, “I am excited about being a part of a dedicated team focused on developing novel treatments for rare disease patients who have no approved treatments and applying my experiences in clinical development and neuromuscular diseases to help solve the devastating medical problems of these metabolic genetic diseases.”

Dr. Yuen received his undergraduate training at Stanford University and his M.D. from the University of Chicago, Pritzker School of Medicine. He completed his residency in Neurology and post-doctoral fellowships at the University of California, San Francisco. Before joining industry in 2000, Dr. Yuen was a faculty member at the University of Washington, serving as a clinical investigator, studying treatments for ALS, neuropathy and multiple sclerosis.

About Ultragenyx

Ultragenyx is a privately held, development-stage biotechnology company committed to bringing to market life-transforming therapeutics for patients with rare and ultra-rare metabolic genetic diseases. The company focuses on diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no effective treatments.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’ strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.

Ultragenyx Pharmaceutical - 05/01/2013

Two Pappas Ventures' Portfolio companies make FierceMedicalDevices' 2012 Fierce 15 list: CardioDx and TyRx

FierceMedicalDevices named two Pappas Ventures' portfolio companies to the 2012 Fierce 15 list, the inaugural list of the most innovative and exciting medical device companies. CardioDx is a cardiovascular molecular diagnostics company based in Palo Alto and TyRx is a New Jersey device company developing a range of drug-eluting implantable devices.

"CardioDx scored a major victory in August, securing Medicare reimbursement for Corus CAD, and the company is optimistic that private insurers will follow suit, opening up an even larger market for the diagnostic."
"Four years after gaining initial FDA clearance and three years after hitting the market, Tyrx has already sold more than 30,000 units. And the company is waiting for FDA clearance of a fully bioresorbable version of Aigis that dissolves within 90 days (version one is partially dissolvable)."

Click here to read the full report.

Uncategorized - 10/02/2012

TyRx Press Release - TYRX(R) Receives New Product Innovation Award

AIGISRx Antibacterial Envelope for Pacemakers and Defibrillators Recognized by Frost & Sullivan

MONMOUTH JUNCTION, N.J., Sep 14, 2012 (BUSINESS WIRE) -- TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced today that Frost & Sullivan has named the AIGISRx(R) Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

"To date TYRX's AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the surgical site in the first 7 to 10 days following implantation," said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:

spend an average of two extra weeks in the hospital
undergo repeat surgical procedures to treat the infection
cost the facility an average of $72,485
experience significant increases in morbidity & mortality, with 1-year mortality rates of 26.5% to 35.1%, depending on device type

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry's leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

"Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes," remarked Robert White, President and CEO of TYRX. "Our team appreciates Frost & Sullivan's acknowledgement of our product leadership and innovation."

About TYRX, Inc.

TYRX, Inc., headquartered in Monmouth Junction, New Jersey, is a pioneer in the development, manufacture, and distribution of innovative, implantable combination drug-device products including the AIGISRx(R) Antibacterial Envelope. The AIGISRx Envelope is specifically designed to aid in the stabilization of CIED placement as well as to help reduce surgical-site infections associated with Cardiac Implantable Electronic Devices (CIEDs). AIGISRx products contain the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing the majority of the infections reported in CIED-related endocarditis, including "superbugs" or MRSA.

For more information, please visit www.TYRX.com

Uncategorized - 09/14/2012

Liquidia CEO to Participate in Biotech Panel to Explore “How to Create 54 Liquidias”

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Liquidia Technologies today announced the Company’s CEO, Neal Fowler, will participate in a panel discussion titled “How to Create 54 Liquidias” at the upcoming Nanotech Commercialization Conference (NCC) on April 4th, 2012. The concept of the panel is to explore how North Carolina can further create opportunities and provide resources that will lay the foundation for innovators to build successful companies like Liquidia in the region. The NCC is the preeminent nanotechnology conference in the region and is being held this year in Research Triangle Park, North Carolina April 4-5, 2012.

“Through this panel we want to explore the opportunities that exist for our next generation of innovators and how they too can find success in North Carolina”

Over the next decade, nanotechnology has the potential to influence every aspect of our lives, including our energy, food, medicines, water, buildings, and much, much more. According to a published report by BCC Research, the market value of the worldwide nanomedicine industry is estimated to grow at a CAGR of 12.5% to reach $130.9 billion by the fiscal year 2016. The acceptance and application of nanotechnology to everyday products is a foreshadowing of the growth expected across a multitude of fields including medicine, devices, and diagnostics.

“Liquidia’s success continues to be a shining example of what is possible for startup companies that make roots in North Carolina”, said Jim Roberts, Director of Business Development at COIN, “Through this panel we want to explore the opportunities that exist for our next generation of innovators and how they too can find success in North Carolina”.

Chris William, Managing Director of the Private Client Group at Wells Fargo and Executive Producer of the PBS television series, Carolina Business Review, will host the NCC panel that will also include the Chairman of The Hamner Institutes for Health Sciences, Charles E. Hamner, D.V.M., Ph.D., and Executive Director of the Office of Science & Technology for the North Carolina Department of Commerce, John Hardin. Conference details can be found at http://www.nanoevent.org.

ABOUT LIQUIDIA

Liquidia Technologies, founded in 2004, is a privately held biotechnology company located in Research Triangle Park, North Carolina. By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has become the only company in the world with the ability to rapidly design and manufacture precisely engineered particles of virtually any size, shape, or composition using a unique particle engineering and manufacturing platform know as PRINT®. This unique ability to precisely engineer particles enables scientists to explore new product frontiers that, until now, have otherwise been out of reach for the life sciences industry. In addition to the development of its own products, Liquidia licenses its PRINT particle technology and its GMP manufacturing capabilities to support proprietary programs advanced by collaborators. For more information, please go to www.liquidia.com.

Liquidia Technologies - 04/03/2012

A look back, and forward

This past year has held some pleasant surprises for me. I was particularly intrigued by the Plexxikon buyout for $935 million, the bulk of it upfront. In a sane world, Plexxikon--which developed the remarkable new skin cancer drug Zelboraf (vemurafenib)--would have gone public. But as far as the IPO market for biotech companies is concerned, this isn't a sane world.

Plexxikon helped illustrate the potential biotechs have to distinguish themselves with great science and a sharp development focus. That kind of expertise is clearly worth a considerable sum; a maxim other companies like Pharmasset have clearly learned how to profit by. Plexxikon's experience also demonstrated the limitations developers face in a world where investors will typically turn a cold shoulder to all the risks involved in drug development.

I'm wrapping this year's run of FierceBiotech reports with a look back, and forward. The key trends of 2011--with a wide array of venture capitalists complaining loudly, the R&D revolution still at the midway point, deal-making more important than ever, and regulators feeling the heat from a disgruntled industry--will all play into 2012.

Fundamental changes can't occur quickly in biotech. It took years to get where we are today. Years more are required to see if new strategies can work or new biotechs can navigate the hazards of clinical development. Now that we've passed the 10th anniversary of FierceBiotech, we can say we've reached the second generation of the publication. And we're planning to take our coverage of the industry up a notch or two in 2012. Call it FierceBiotech 2.0.

We'll be taking our traditional holiday break next week, returning the Tuesday after New Year's Day. It's a chance for us to retool some aspects of our coverage and come back stronger than ever. We hope you enjoy your own break and will see you in the new year.

- John Carroll

Plexxikon - 12/23/2011

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Solu Therapeutics Closes $41M Series A…