Arcadia Biosciences

ARCADIA BIOSCIENCES RECEIVES U.S. PATENT FOR EXTENDED SHELF LIFE TOMATOES

Technology Helps Vine-Ripened Tomatoes Stay Fresh from Farm to Table

DAVIS, Calif. (July 17, 2014) — Arcadia Biosciences, Inc., an agricultural technology company focused on developing technologies and products that benefit the environment and human health, today announced that the U.S. Patent and Trademark Office has granted the company a key technology patent for Extended Shelf Life (ESL) tomatoes.

The patent covers the non-transgenic modification of a gene in tomato plants that slows the post-harvest ripening of the tomato.  “Arcadia’s ESL technology allows tomatoes to maintain fresh quality, better flavor and nutrition while retaining the firmness needed during the shipping and marketing process,” said Eric Rey, president and CEO of Arcadia Biosciences. “This technology offers tremendous value for both producers and consumers of tomato food products, including fresh market tomatoes, canned tomatoes, ketchups, soups, sauces, pastes and juices.”

Globally, an estimated 10-35 percent of tomatoes are lost to post-harvest spoilage. Using a non-GM advanced screening and breeding technique called TILLING®, Arcadia has selected tomato lines with altered function of the non-ripening (nor) gene. This results in tomatoes that retain the desirable qualities of vine-ripened fruit, but are resistant to rapid post-harvest softening. Producers benefit from reduced waste and spoilage during production and shipping, providing consumers with fully ripe and fresh tomatoes.

Other alterations to the non-ripening gene in tomatoes are widely available, but they adversely impact tomato flavor because their effects are too severe. Arcadia’s technology uniquely offers intermediate levels of ripening that can be recombined using traditional breeding to produce tomatoes that are superior to existing elite commercial varieties for both producers and consumers.

Arcadia’s ESL technology was developed in part under a U.S. Department of Defense contract to develop longer-lasting fresh produce for field troops stationed in remote locations. Arcadia’s patent portfolio now includes more than 107 technology patents in the U.S., Europe, China, Vietnam, Australia, Mexico, and other key geographies for agricultural production.

About Arcadia Biosciences, Inc.

Based in Davis, Calif., Arcadia Biosciences is an agricultural technology company focused on the development of agricultural products that benefit the environment and enhance human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salt Tolerance, Heat Tolerance, and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition technologies and products create healthier ingredients and whole foods with lower production costs. The company was recently named one of MIT Technology Review’s 50 Smartest Companies and was previously recognized by AlwaysON as one of the GoingGreen Silicon Valley Global 200. For more information visit www.arcadiabio.com.

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

 

Neos Therapeutics

Neos Therapeutics Announces Positive Phase 3 Study Results for its Methylphenidate Extended-Release (XR) Oral Disintegrating Tablet (ODT) in ADHD Patients

Grand Prairie, TX (July 15, 2014) –  CMEA Capital portfolio company Neos Therapeutics, Inc. (“Neos” or “the Company”), a highly differentiated oral drug delivery company with a portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today that it has completed a positive Phase 3 study for its methylphenidate XR-ODT drug candidate, NT-0102, in children with ADHD.

The trial was a multicenter, randomized, double-blind, placebo-controlled laboratory classroom study in 87 children with a diagnosis of ADHD. NT-0102 met primary and secondary efficacy endpoints, showing statistically significant improvement on both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale, through 12 hours post-dose. No serious adverse events were reported during the study and the adverse event profile was consistent with the drug’s mechanism of action.

“ADHD is a condition that causes significant distress for patients and caregivers. Although, there are a number of effective long-acting medications currently on the market, most formulations consist of tablets or capsules that can be difficult for children to swallow. The positive data from this study is exciting. Hopefully, soon we will have a once-daily oral disintegrating tablet option that is easy to administer to patients,” said Dr. Ann Childress (Center for Psychiatry and Behavioral Medicine, La Vegas, NV), lead investigator for the study.

“We are very pleased to have worked with Dr. Childress on this study. Having a potential treatment option for those who cannot swallow other dosage forms is important, especially in a chronic disorder like ADHD, in which children may struggle to take their medication or develop pill fatigue,” noted Dr. Carolyn Sikes, Vice President of Clinical Development at Neos.

Stimulant medications, such as methylphenidate, have been available for the treatment of ADHD for decades. Extended-release formulations of these medications allow for once-daily dosing, however recent data suggest that a significant percentage of children and adolescents struggle to ingest tablets or capsules. An XR-ODT formulation, which does not require swallowing an intact tablet or capsule and can be dosed once daily, may offer a practical alternative.

Dr. Vipin Garg, President and CEO of Neos, added that “We are delighted with these robust clinical results, as this data validates our XR-ODT technology. We believe that our methylphenidate and amphetamine XR-ODT formulations could provide a patient-friendly dosage form for both children and adults with ADHD. We are looking forward to filing the NDA for our NT-0102 drug candidate in the near future.”

About ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioral disorder characterized by excessive levels of inattention and/or hyperactivity/impulsivity for an individual’s age and level of development, which causes significant functional and social impairment. The disorder begins in childhood and up to 9.5% of children (ages 4-17) have received a diagnosis of ADHD (about 5.4 million school-aged children). For up to 50% of these individuals, the condition or symptoms of the condition persist into adulthood.

About Neos Therapeutics
Neos Therapeutics, Inc. is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary and patented delivery technologies. The Neos drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or oral disintegrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, an affiliate of Neos Therapeutics, Inc., and Rapidly Disintegrating Ionic MaskingTM and RDIMTM are trademarks of Neos Therapeutics, Inc.

This press release contains certain forward-looking statements that include projections and may also include words such as may, will, expects, believes, anticipates, plans, estimates, seeks, could, intends, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

CONTACTS

Vipin K. Garg, Ph.D.

President and CEO

(919) 434-6643

vgarg@neostx.com

Richard Eisenstadt, MBA

Chief Financial Officer

(972) 408-1389

reisenstadt@neostx.com

Baxano

Baxano Surgical Announces First Clinical Use of the Avance MIS Pedicle Screw System

Raleigh, NC – June 30, 2014 (GLOBE NEWSWIRE) —  CMEA Capital portfolio company Baxano Surgical, Inc. (Nasdaq:BAXS), a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the first case utilizing the AvanceT MIS Pedicle Screw System was recently performed by Dr. Sameer Mathur in Cary, NC.   The innovative design of Avance provides for an easy-to-use, percutaneous pedicle screw system that addresses single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma.  The Avance system will be in limited market release through the end of third quarter of 2014 and is planned for full launch in the fourth quarter of 2014.

“The first clinical use of the Avance pedicle screw system represents a major milestone in the evolution of Baxano Surgical,” stated Ken Reali, President and CEO of Baxano Surgical.  “Avance will significantly enhance our ability to service our surgeon customers’ lower lumbar fusion needs where we can now offer a complete fusion solution coupled with our AxiaLIF and VEO interbody fusion implants.  This is an important strategic initiative that increases our presence in the rapidly growing MIS spine arena.”

“The Avance system provides a step forward with a true MIS approach to spinal fixation by minimizing tissue trauma and eliminating additional rod insertion incisions,” stated spine surgeon Sameer Mathur, M.D.  “The system’s low-profile design, combined with Avance’s intraoperative flexibility and range of options to meet surgeon preferences makes for a durable, versatile, easy-to-use solution.”

About the Avance MIS Pedicle Screw System The Avance MIS Pedicle Screw System is intended for posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for the following indications: degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.  The Avance system accommodates single level degenerative procedures as well as multi-level, complex pathologies from T1 to S1.

About Baxano Surgical, Inc.
Baxano Surgical, Inc. is a medical device company focused on designing, developing, and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region. Baxano Surgical currently markets the AxiaLIF® family of products for single and two level lower lumbar fusion, the VEO® lateral access and interbody fusion system, the iO-Flex® system, a proprietary set of flexible instruments used by surgeons during spinal decompression procedures, the iO-Tome® instrument, which rapidly and precisely removes bone, specifically the facet joints, which is commonly performed in spinal fusion procedures and Avance, an MIS pedicle screw system used in lumbar fusion procedures. Baxano Surgical was founded in May 2000 and is headquartered in Raleigh, North Carolina. For more information, visit www.baxanosurgical.com.

AxiaLIF, VEO, iO-Tome and iO-Flex are all registered trademarks of Baxano Surgical.

Forward Looking Statements
This press release includes statements that are based on our current beliefs and assumptions. These statements constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the pace of adoption of our product technology by spine surgeons, the outcome of coverage and reimbursement decisions by the government and third party payors, the success of our continuing product development efforts, the effect on our business of existing and new regulatory requirements, our ability to raise additional capital, our ability to comply with our settlement agreement and Corporate Integrity Agreement with certain entities of the U.S. government, stockholder class action lawsuits, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with Baxano Surgical’s business, please review the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent reports. You are cautioned not to place undue reliance on these forward looking statements, which are based on Baxano Surgical’s expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.



CONTACT:
Baxano Surgical Inc.
Tim Shannon, Chief Financial Officer
919-926-8762

or

Stonegate, Inc.
Casey Stegman
214-987-4121
casey@stonegateinc.com

Velocity Pharmaceutical Development

Velocity Pharmaceutical Development, LLC and Tigercat Pharma, Inc. Announce Regulatory Clearance for Initiating Phase II Study with VPD-737 in Prurigo Nodularis

South San Francisco, California – June 23, 2013

Velocity Pharmaceutical Development, LLC (“VPD”) and Tigercat Pharma, Inc., (“Tigercat”) announced today that they have met all regulatory requirements from Germany’s BfArM to initiate a Phase II clinical trial of VPD-737 (serlopitant) in patients with prurigo nodularis. Separately, VPD is also conducting a Phase II clinical trial in the United States evaluating VPD-737 in patients with chronic pruritus.

“Prurigo nodularis is a chronic, debilitating dermatological condition that frequently leads to permanent changes to the skin and prevents patients from living a normal and productive lifestyle. Unfortunately, current therapy options for this orphan disease remain poor thus the unmet medical need for a successful treatment alternative for prurigo nodularis and chronic pruritus remains high” said Prof. Dr. Sonja Ständer, the Principle Investigator for the study. Dr. Ständer is professor for Dermatology and Neurodermatology at the Department of Dermatology, and head of the Interdisciplinary Competence Center Chronic Pruritus of the University Hospital Münster, Germany.

“We are excited about Tigercat achieving another important milestone by starting this new clinical trial and look forward to share top-line results from this study and our chronic pruritus trial in early 2015”, said Dr. Edward Schnipper, Tigercat’s Chief Medical Officer.

The trial is a double-blind, placebo-controlled Phase II study in patients with prurigo nodularis, an orphan disease. The study is designed to determine the safety, tolerability, and efficacy of VPD-737, an NK-1 receptor antagonist, and will be conducted at four sites in Germany.

VPD-737 (serlopitant) was exclusively licensed to VPD from Merck in 2012.

About Tigercat Pharma, Inc.

Tigercat Pharma, Inc., is a largely “virtual” company which was created to hold

the ownership of the VPD-737 development program. Tigercat is funded by

Velocity Pharmaceutical Holdings, LLC, and Remeditex Ventures, LLC. The VPD-737

development program is managed under contract by VPD.

 

About Velocity Pharmaceutical Development, LLC

VPD is a pharmaceutical development organization dedicated to rapidly advancing

promising drug candidates to clinical proof of concept using a highly virtual

management model. VPD seeks to acquire promising drug candidates, generally

within a year of their entering human clinical trials or after initial human clinical

data have been generated. VPD then manages a development program for each drug

candidate intended to generate convincing human proof of concept data (generally

by conducting a phase 2 clinical trial). Following successful human proof of concept,

VPD then seeks a large pharmaceutical company acquirer for each program. VPD

is staffed by a seasoned team of clinical drug developers with expertise identifying

attractive drug candidates, target markets, and designing and managing outsourced

clinical trials. This expert team manages multiple single asset companies to remove

the costly overhead and misaligned incentives present in traditional biotechnology

company structures. VPD believes this new capital-efficient model will yield

attractive new drugs to treat patients with significant unmet clinical needs. The

company is located in South San Francisco, California. More information is available

at www.vpd.net.

 

About Velocity Pharmaceutical Holdings, LLC

Velocity Pharmaceutical Holdings, LLC, is an entity funded by CMEA Capital that

makes investments in highly virtual, project-focused pharmaceutical development

companies that are managed by Velocity Pharmaceutical Development, LLC. More

information is available at www.vpd.net and www.cmea.com.

 

About Remeditex Ventures, LLC

Remeditex is a company that seeks to develop opportunities in need of commercial

validation, guidance, and capital. Its mission is to develop early stage biomedical

science and make Texas and Colorado a preferred location for biotechnology

companies, venture capitalists, and entrepreneurs by accelerating the pace of

commercialization of biomedical research; help create and support a thriving

biotechnology industry; attract biotech venture capital to Texas and Colorado; and

achieve significant returns to support the next generation of promising science.

More information is available at www.remeditex.com.

 

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

 

Contact

Leslie Loven

1-415-524-7326

leslie@vpd.net

Ardelyx

Ardelyx Announces Pricing Of Its Initial Public Offering

FREMONT, Calif., June 18, 2014  — CMEA Capital portfolio company Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, GI and metabolic diseases, today announced the pricing of its initial public offering of 4,286,000 shares of common stock at a public offering price of $14.00 per share. The shares are expected to begin trading on The NASDAQ Global Market under the ticker symbol “ARDX” on June 19, 2014. In addition, Ardelyx has granted the underwriters a 30-day option to purchase up to an additional 642,900 shares of common stock at the initial public offering price to cover over-allotments, if any. The offering is expected to close on June 24, 2014 subject to customary closing conditions.

Citigroup and Leerink Partners are acting as joint book-running managers for the proposed offering. JMP Securities is acting as the lead manager and Wedbush PacGrow Life Sciences is acting as co-manager.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on June 18, 2014. The offering is being made only by means of a prospectus forming part of the effective registration statement. A copy of the final prospectus relating to these securities will be filed with the SEC and may be obtained, when available, from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at batprospectusdept@citi.com or by phone at (800) 831-9146 or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by email at syndicate@leerink.com, or by phone at (800) 808-7525, ext. 4814.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, 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 Ardelyx, Inc.

Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, non-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat cardio-renal, gastrointestinal and metabolic diseases. The Company has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and designed tenapanor, a product currently in Phase 2 clinical trials that has consistently demonstrated the ability to reduce the absorption of dietary sodium and phosphorus, both of which are recognized as key factors in the progression of kidney disease. Ardelyx formed a collaborative partnership with AstraZeneca in October 2012 to develop and commercialize tenapanor. In addition to tenapanor, the Company is evaluating small molecule NaP2b inhibitors for the treatment of hyperphosphatemia in ESRD, a program licensed to Sanofi, and independently is advancing three additional research programs focused in cardio-renal, GI and metabolic diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx’s website at www.ardelyx.com.

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

 

 

Source: PRNewswire

Arcadia Biosciences

ARCADIA BIOSCIENCES LAUNCHES SONOVA® ULTRA GLA SAFFLOWER OIL

Next-Generation Dietary Supplement Offers the Highest Concentration of Oilseed GLA Available

DAVIS, Calif. (June 17, 2014) – CMEA Captial portfolio company Arcadia Biosciences, Inc., an agricultural biotechnology company focused on developing technologies and products that benefit the environment and enhance human health, announced the commercial launch of SONOVA® ULTRA GLA Safflower Oil. With 55 percent gamma linolenic acid (GLA), this addition to the company’s nutritional oils portfolio offers a GLA concentration more than twice as high as produced in any other commercial oilseed.

Traditional sources of GLA oil contain relatively low amounts of the important omega-6 fatty acid and are often difficult to cultivate, making supply erratic and expensive. Evening primrose oil contains approximately 10 percent GLA, and borage oil contains approximately 20 percent GLA. In 2011, Arcadia launched SONOVA® 400 GLA Safflower Oil, containing 40 percent GLA, to give consumers and formulators a more highly concentrated and cost-effective source of GLA. Consumers benefit by having to take fewer capsules per day to achieve a health benefit, and dietary supplement and medical food companies benefit through more efficient formulations.

Gamma linolenic acid is an important nutritional omega-6 fatty acid with documented health benefits that are similar and complementary to those of omega-3 fatty acids.

  • GLA provides dietary support for a wide range of conditions such as weight management, skin health and women’s health (hormonal balance), with the core of its health benefits related to its anti-inflammatory attributes.
  • GLA, in combination with the important omega-3 fatty acids EPA and DHA that are typically found in fish oil, has been shown to support heart and eye health and to reduce inflammation, asthma, diabetic neuropathy and rheumatoid arthritis.
  • Current GLA research is focused on childhood and adolescent ADHD/ADD, adult diabetes and metabolic syndrome, inflammation and cardiovascular disease, atopic dermatitis and acne.

“Consumers seeking to maximize the benefits of functional ingredients are demanding increased efficacy with smaller doses,” said Eric Rey, president and CEO of Arcadia. “SONOVA® ULTRA features the most highly concentrated commercial source of GLA produced in a seed oil today, offering dietary supplement companies greater flexibility in the development of nutritional and functional food products.”

When SONOVA® 400 GLA Safflower Oil was first introduced commercially in 2011, it represented a significant increase in GLA concentration over other dietary sources: four times the GLA concentration of evening primrose oil and twice the concentration of borage oil. SONOVA® ULTRA GLA Safflower Oil is the next generation product for applications requiring even higher levels of GLA.

Both SONOVA® 400 and SONOVA® ULTRA GLA Safflower Oil are grown and produced in the United States under strict Identity Preservation (IP) protocols. SONOVA® ULTRA GLA Safflower Oil is currently available in bulk oil and softgels. Arcadia also offers retail-ready packaged softgels.

Dietary supplement companies looking for a cost-efficient and sustainable source of highly concentrated GLA may find SONOVA® ULTRA GLA Safflower Oil to be their optimal solution.

For samples and more information, visit www.SonovaGLA.com.

###
About Arcadia Biosciences, Inc.
Based in Davis, Calif., with additional facilities in Seattle, Wash. and Phoenix, Ariz., Arcadia Biosciences is focused on the development of agricultural products that benefit the environment and enhance human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salt Tolerance, Heat Tolerance and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition technologies and products create healthier ingredients and whole foods with lower production costs. The company was recently named one of MIT Technology Review’s 50 Smartest Companies

About CMEA Capital

CMEACapital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. They believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

Neos Therapeutics

Neos Therapeutics, Inc. Announces the Appointment of Richard I. Eisenstadt as Chief Financial Officer

Dallas/Fort Worth, TX  (May  22, 2014) – CMEA Capital portfolio company Neos Therapeutics, Inc. (“Neos” or “the Company”), a highly differentiated oral drug delivery company with an exciting portfolio of proprietary technologies and a late-stage pipeline of innovative controlled release (CR) products for ADHD, announced today the appointment of Richard I. Eisenstadt to the role of Chief Financial Officer, effective immediately.

 

Mr. Eisenstadt has over twenty-five years of finance leadership experience in the healthcare, life sciences and emerging technology industries.  Before joining Neos Therapeutics, he served as Chief Financial Officer of ArborGen Inc., a leader in the development and commercialization of technologies that improve the productivity of trees.  Prior to ArborGen, Mr. Eisenstadt was Vice President of Finance and Chief Financial Officer of Tranzyme Pharma (NASDAQ: TZYM), a drug discovery and development company, where he raised over $100 million in both private and public equity and debt financings, including an initial public offering of the company’s stock in April 2011.

 

Neos Therapeutics’ President and Chief Executive Officer, Vipin Garg, stated, “I am excited to welcome Rich to the Neos team. He brings an extensive track record of finance and business experience and a broad understanding of funding and managing growth companies. Rich will work closely with the organization and financial community to ensure funding of our existing pipeline, and expansion of the use of our proprietary controlled release technologies to create additional CR orally disintegrating tablets and CR liquids to bring to market.”

 

Prior to joining Tranzyme, Mr. Eisenstadt served as Director of Finance at Cogent Neuroscience, and held financial leadership positions at Nimbus CD International and Genicom Corporation.  Mr. Eisenstadt received his MBA from James Madison University and his BA in Economics from the University of North Carolina at Chapel Hill. He was the recipient of the Triangle Business Journal CFO of the Year award in 2011.

 

About Neos Therapeutics

 

Neos Therapeutics Inc., is a specialty pharmaceutical company focused on the development and manufacture of FDA approved drug products that utilize the Company’s proprietary and patented delivery technologies. The Neos drug products are being developed using the Dynamic Time  Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies that deliver controlled release (CR) small molecule active pharmaceutical ingredients (APIs) in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are already FDA-approved, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA’s New Drug Application (NDA) approval process. For more information, visit www.neostx.com.

 

This press release contains certain “forward-looking statements” that include projections and may also include words such as “may”, “will”, “expects”, “believes”, “anticipates”, “plans”, “estimates”, “seeks”, “could”, “intends”, and other similar expressions. These forward-looking statements involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements.

 

 

CONTACT

Vipin K. Garg, Ph.D.

Chief Executive Officer

(919) 434-6643

vgarg@neostx.com

 

 

Richard I. Eisenstadt

Chief Financial Officer

(972) 408-1389

reisenstadt@neostx.com

 

Ardelyx

Ardelyx Receives $25 Million Milestone From AstraZeneca For Commencement Of Phase 2b Clinical Trial Of Tenapanor

Study will evaluate tenapanor for the treatment of hyperphosphatemia in ESRD patients on hemodialysis

 

FREMONT, Calif., May 15, 2014 /PRNewswire/ — Ardelyx, Inc., a clinical-stage biopharmaceutical company focused on cardio-renal, GI and metabolic diseases, today announced that it has received a $25 million milestone payment from AstraZeneca (NYSE:AZN, LON:AZN) for the initiation of a Phase 2b clinical trial evaluating tenapanor for the treatment of hyperphosphatemia, or elevated serum phosphorus, in patients with end-stage renal disease on hemodialysis (ESRD-HD). With this payment, Ardelyx has received a total of $75 million in upfront and milestone payments from AstraZeneca under a worldwide exclusive license agreement announced in October 2012.

 

“We are excited to embark with AstraZeneca on our first study specifically designed to evaluate the ability of tenapanor to reduce hyperphosphatemia in ESRD patients, which remains one of the key challenges in the management of patients on dialysis,” commented Mike Raab, President and Chief Executive Officer of Ardelyx. “We believe that tenapanor, as a small molecule inhibitor of phosphate absorption with a significantly reduced pill burden, could be a paradigm shift for the treatment of hyperphosphatemia in patients with ESRD if tenapanor is successfully developed and commercialized.”

 

The Phase 2b clinical trial in ESRD-HD patients with elevated serum phosphorus is a randomized, double-blind, placebo-controlled, multicenter, dose-finding study being conducted in the United States, United Kingdom, Poland, and Slovakia with an estimated enrollment of 150 subjects to evaluate the efficacy, safety and tolerability of tenapanor for the treatment of hyperphosphatemia. The clinical trial is part of a broad development program established pursuant to Ardelyx’s license agreement with AstraZeneca, under which AstraZeneca paid to Ardelyx $35 million upfront, and could pay up to $237.5 million in total potential development milestones, as well as milestones related to launch and commercialization. Ardelyx expects results from this clinical trial in the first half of 2015. More information about the hyperphosphatemia trial can be found at clinicaltrials.gov.

 

About Tenapanor

 

Tenapanor, also known as AZD1722 and RDX5791, is a small-molecule, orally administered, non-

systemic inhibitor of the NHE3 sodium transporter being studied for the treatment of patients with ESRD-HD and chronic kidney disease (CKD), as well as for constipation-predominant irritable bowel syndrome (IBS-C). Ardelyx and AstraZeneca have evaluated tenapanor in eight human clinical trials in over 750 individuals. In Phase 1 and Phase 2 clinical trials, tenapanor was well-tolerated and has shown the ability to divert sodium into the stool in both healthy adult subjects and patients with ESRD-HD. In

Phase 1 clinical trials in healthy adults, tenapanor also inhibited the absorption of dietary phosphorus, as

demonstrated by increased phosphorus in the stool. In these studies, tenapanor demonstrated this effect with 15mg of tenapanor orally administered twice daily. Sodium and phosphorus are both key factors inthe progression of kidney disease. Additionally, tenapanor has demonstrated activity consistent with an IBS-C drug to increase the frequency of bowel movements in IBS-C patients in a Phase 2a clinical trial.

 

About Hyperphosphatemia

 

Hyperphosphatemia is a significant medical problem worldwide in ESRD-HD patients. Phosphorus is present in almost every food in the Western diet, but it can accumulate to high levels in ESRD-HD patients, who cannot efficiently remove the mineral through hemodialysis. In ESRD-HD, excess levels of phosphorus have been shown to lead to increased risk of renal osteodystrophy, a condition of abnormal bone growth characterized by brittle bones, as well as increased risk of both cardiovascular disease and death. ESRD-HD patients are often prescribed phosphate binders, the only approved therapies for the treatment of hyperphosphatemia. About 270,000 ESRD-HD patients are currently prescribed phosphate binders in the United States. According to Infiniti Research Limited – TechNavio, the worldwide market for phosphate binders in 2011 was approximately $1.5 billion and is projected to reach $2.3 billion by 2015.

 

Phosphate binders, including salts such as calcium and lanthanum, and polymers such as sevelamer, often result in tolerability issues and large pill burden. The phosphate binder-related pill burden for ESRD-HD patients is significant, consisting on average of around nine pills per day. Large pill burden often leads to non-compliance and lack of full efficacy of phosphate binders. Tenapanor is currently being evaluated at once and twice daily dosing of 45 mg or less per dose.

 

About Ardelyx

 

Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, non-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat cardio-renal, gastrointestinal and metabolic diseases. The Company has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, Ardelyx has discovered and designed tenapanor, a product currently in Phase 2 clinical trials that has consistently demonstrated the ability to reduce the absorption of dietary sodium and phosphorus, both of which are recognized as key factors in the progression of kidney disease. In addition to tenapanor, the Company is evaluating small molecule NaP2b inhibitors for the treatment of hyperphosphatemia in ESRD, a program licensed to Sanofi, and independently is advancing three additional discovery and lead development programs focused in cardio-renal, GI and metabolic diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx’s website at www.ardelyx.com.

 

About AstraZeneca

 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

 

Investor and Media Contact:

Mark Kaufmann

Chief Business Officer

mkaufmann@ardelyx.com

Tel: 510-745-1751

 

For investors:

Kimberley Minarovich

Burns McClellan on behalf of Ardelyx

212-213-0006

 

SOURCE Ardelyx, Inc.

Arcadia Biosciences

ARCADIA BIOSCIENCES RAISES $33 MILLION SERIES D INVESTMENT

DAVIS, Calif. (May 8, 2014) – CMEA Capital portfolio company Arcadia Biosciences, Inc., an agricultural biotechnology company focused on developing technologies and products that benefit the environment and human health, announced today that it has closed on a $33 million round of Series D preferred share equity financing. The round was led with an investment of $30 million from Mandala Capital Limited, a dedicated agribusiness private equity fund focused on seed technology, among other sectors, in India. Nine existing investors, including CMEA Capital, BASF Venture Capital, and Saints Capital, also are participating in the round. Piper Jaffray & Co. served as Arcadia’s exclusive financial advisor for the transaction. With completion of the Series D round, total equity capital raised by Arcadia amounts to $101 million.

Arcadia plans to use proceeds from the financing to accelerate the development and commercial launch of products based on the company’s agronomic performance and product quality trait technologies.

Arcadia has recently announced the achievement of key performance and commercial development milestones by technology licensees in multiple crops. Based on results with the company’s Nitrogen Use Efficiency technology, Arcadia is developing core data for regulatory submissions. Verdeca LLC, Arcadia’s soybean joint venture with Bioceres S.A. of Argentina, recently announced the granting of a commercial development license for stress tolerance technology to GDM Seeds, a leading South American soybean seed company. Regulatory field trials of Verdeca’s stress tolerant soybeans have been completed in Argentina and the US to generate data for regulatory submissions, the first of which is anticipated during 2014.

“Multiple products based on Arcadia’s agronomic performance and product quality traits are currently in late-stage commercial development, and our SONOVA® 400 GLA Safflower Oil is already on market,” said Eric Rey, president and CEO of Arcadia. “The Series D funding enables us to continue working closely with our licensees and partners to accelerate progress, provide key data for commercial regulatory approvals, and pursue opportunities with new partners.”

“We are very pleased to have completed this investment in Arcadia Biosciences,” said Uday Garg, Managing Director of Mandala Capital Limited. “Our investment benefits from exposure to Arcadia’s highly developed, global seed technology platform that touches every major agricultural economy. We are particularly excited about the products in advanced development at Arcadia that address the acute need for crops with traits of water and nitrogen use efficiency, and abiotic stress including drought tolerance in our fund’s target market, India.”

 

About Arcadia Biosciences, Inc.

Based in Davis, Calif., Arcadia Biosciences is an agricultural technology company focused on the development of agricultural products that benefit the environment and human health. Arcadia’s agronomic performance traits, including Nitrogen Use Efficiency, Water Use Efficiency, Salt Tolerance, Heat Tolerance, and Herbicide Tolerance, are all aimed at making agricultural production more economically efficient and environmentally sound. Arcadia’s nutrition technologies and products create healthier ingredients and whole foods. Arcadia has granted more than 70 technology licenses worldwide to major seed and consumer product companies. The company was recently named one of MIT Technology Review’s 50 Smartest Companies and was previously recognized by AlwaysON as one of the GoingGreen Silicon Valley Global 200.

For more information, visit www.arcadiabio.com.

 

About Mandala Capital Limited

Mandala Capital Limited manages a dedicated agribusiness private equity fund focused on investments in selected agricultural sectors including technology, seed, sugar, and cold storage, with a geographical focus on companies based in India or addressing the needs of the Indian market. The Mandala Agribusiness Fund, which is aiming for the final close of its first fund later this year, is backed by University of Texas Investment Management Company (UTIMCO) and TIAA-CREF as its anchor investors. For further information and comment, please contact investor relations at IR@mandala-capital.com.

 

About CMEA Capital

CMEA Capital is a San Francisco-based venture capital firm with a clear focus on life sciences, high technology, and energy and materials investments. We believe that the most successful venture backed companies are those that are science based, with experienced teams that have a vision. As a result, CMEA Capital typically invests in companies that have cutting edge and highly differentiated technology at their core and founding teams of the highest caliber still in place. These are companies that have the potential to transform their industries.

CMEA Capital invests in both early and late stage ventures, and has a strong network of corporate, investment, and entrepreneurial relationships that it leverages on behalf of its portfolio companies. Over its history, the firm has managed seven venture capital funds representing investments in excess of $1.2 billion.