ORYZON receives approval to start ETHERAL: a Phase IIa clinical trial in Alzheimer's Disease with ORY-2001

MADRID, SPAIN and CAMBRIDGE, MA—(Marketwired – April 04, 2018) – Oryzon Genomics (ISIN Code: ES0167733015) (MAD: ORY), a public clinical–stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has announced today that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a Phase IIa clinical study with ORY–2001 in patients of Alzheimer's disease (AD). The study will be conducted in different European hospitals in Spain, and also in UK and France once the corresponding approvals from the UK and French regulatory authorities are obtained.

The study, named ETHERAL (Epigenetic THERapy in ALzheimer's Disease), is designed as a randomised, double–blind, placebo–controlled, 3–arm, 26 weeks parallel–group study to evaluate the safety and tolerability of ORY2001 in patients with mild and moderate Alzheimer's disease. The study will involve 90 patients and incorporates measurements in the different domains of the disease as secondary endpoints, including memory and behavior alterations. It will also monitor the variations of diverse, yet significant CSF biomarkers. The company is aiming to launch a twin study in the US soon with a, yet to be determined, number of additional patients.

After the safety Phase I trial carried out in 106 healthy volunteers last year, where the drug proved to be safe and well tolerated under the conditions of the study and where CNS penetrance was established the investigational drug was ready to start trials in the patient population. The company has already started a Phase IIa clinical study with ORY–2001 in patients of Multiple Sclerosis (MS). The study, named SATEEN, is currently being conducted in nine Spanish hospitals, and is designed as a randomised, double–blind, placebo–controlled, 3–arm, 36 weeks parallel–group study to evaluate the safety and tolerability of ORY–2001 in patients with Relapsing–Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS). The FPI was enrolled in January and the recruitment is proceeding.

ORY–2001 is an oral and brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule acts on several levels, reduces cognitive impairment, memory loss and neuroinflammation, and at the same time has neuroprotective effects. The company has recently reported in several scientific conferences that ORY–2001 exerts a holistic action on different types of alterations also seen in patients with AD and other neurodegenerative disorders. ORY–2001 may act as a disease modifying drug. In AD patients and other neurodegenerative disorders, cognitive deterioration is often accompanied by episodes of agitation, aggression, psychosis, apathy and depression. In preclinical studies, ORY–2001 not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer's disease, to normal levels and also reduces social avoidance in rat models maintained in isolation. In addition, ORY–2001 exhibits fast, strong and durable efficacy in several preclinical models of MS.

Roger Bullock, Oryzon's Chief Medical Officer, commented, “The approval of ETHERAL, the first Phase IIa clinical trial for an epigenetic agent in AD, represents an important milestone for the company and the scientific community. Preclinical studies validate the potential of ORY–2001 to treat cognitive defects and neuroinflammation by increasing the plasticity and functionality of neurons. This is the first step in exploring this novel approach and we have chosen to study this in mild to moderate AD patients where we believe there is still physiological room to make a significant therapeutic intervention, as this is a patient population that is underserved with the conventional approaches.”

Carlos Buesa, Oryzon's President and Chief Executive Officer, commented, “ORY–2001 is a molecule with disease modifying potential that acts on different domains that are presented in AD patients. We have identified CSF biomarkers altered in AD that can be modulated by ORY–2001 and whose evolution will be monitored. This opens an important range of possibilities not only for a better understanding of the biology of the disease but also in terms of regulatory development for the drug. We expect to be able soon to start further exploratory studies and we keep committed to explore this epigenetic approach in other neurodegenerative disorders.”

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field. Oryzon's LSD1 program has resulted in + 20 patent families and has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon's strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case by–case basis to either keep the development in–house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Spain and USA. For more information, visit www.oryzon.com.


This communication contains forward–looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward–looking statements are statements that are not historical facts and are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates” and similar expressions. Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward–looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward–looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward–looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public. Forward–looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward–looking statements, which speak only as of the date they were made. All subsequent oral or written forward–looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward–looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward–looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.

Florida Company Orders Three Tecochill RT-50 Chillers for New HQ

WALTHAM, MA—(Marketwired – April 04, 2018) – Tecogen Inc. (NASDAQ: TGEN) a leading manufacturer of clean energy cogeneration products that, through patented technology, nearly eliminate criteria pollutants and significantly reduce a customer's carbon footprint, is pleased to announce that a major corporation in Florida's Tampa Bay area has decided to purchase three Tecochill RT–50 series chillers that will be installed at its new headquarters, currently under construction. The units are expected to ship by the end of the second quarter.

Stephen Lafaille, Tecogen's Product Manager, stated, “The air–cooled RT–50 occupies a market segment that has good potential for growth, for example relatively small commercial and industrial facilities that do not require the cooling capacity of our larger STx and DTx chillers. Being air–cooled, the RT does not require the added complexity of a cooling tower, which reduces both installation and operational costs. This in turn can also make it a cost–effective option for distributing cooling capacity across a campus.”

Tecogen CEO Benjamin Locke commented, “Growing concerns about rising electric rates and grid resiliency are making Florida an increasingly attractive market for our products. Importantly, the state's Governor Rick Scott just last month signed into law two bills (SB 7028 and HB 7099) that require all nursing homes and assisted living facilities in the state to have an emergency back–up power source that can keep the air conditioning running in case of a power outage. Both our Tecochill line of natural gas–powered chillers and our flagship InVerde e+ cogeneration product can be an integral part of the solution to meet the new requirement as the law allows for machines powered by pipeline gas. I would note that our chillers require less than 1% of the electricity to operate as a competing electrical chiller, which a small retail back–up generator can easily provide.”

About Tecogen
Tecogen Inc. designs, manufactures, sells, installs, and maintains high efficiency, ultra–clean, cogeneration products including natural gas engine–driven combined heat and power, air conditioning systems, and high–efficiency water heaters for residential, commercial, recreational and industrial use. The company is known for cost efficient, environmentally friendly and reliable products for energy production that, through patented technology, nearly eliminate criteria pollutants and significantly reduce a customer's carbon footprint.

In business for over 30 years, Tecogen has shipped more than 2,500 units, supported by an established network of engineering, sales, and service personnel across the United States. For more information, please visit www.tecogen.com or contact us for a free Site Assessment.

Tecogen, InVerde, InVerde e+, Ilios, Tecochill, and Ultera are registered trademarks or trademarks pending registration of Tecogen Inc.

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MagneGas Completes Acquisition of Trico Welding Supply

TAMPA, FL—(Marketwired – April 04, 2018) – MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA), a leading clean technology company in the renewable resources and environmental solutions industries, announced today the completion of the previously announced acquisition of Trico Welding Supply, a leading independent industrial gas and welding supply distributor in the Sacramento market in California.

“We are pleased to welcome the Trico team to our combined companies. As we previously announced, this is an important next step in our growth plans,” commented Ermanno Santilli, CEO of MagneGas. “We have worked very hard to develop a meaningful growth strategy in the largest industrial gas markets in the US, and California is critical to our strategic growth plans. We now have the sales force, infrastructure and access to thousands of new clients. We plan to undertake a comprehensive marketing initiative to fully launch the MagneGas2® product in this market. We have had excellent success with clients in San Diego and East Texas, and we expect to quickly generate strong results in Northern California.”

“This acquisition was a major financial milestone for MagneGas,” commented Scott Mahoney, CFO of MagneGas. “Increasing our revenue run rate by over 500% in the first three months of 2018 alone has put us substantially closer to steady, consistent positive EBITDA.”

About MagneGas Corporation

MagneGas® Corporation (MNGA) owns a patented process that converts various renewables and liquid wastes into MagneGas fuels. These fuels can be used as an alternative to natural gas or for metal cutting. The Company's testing has shown that its metal cutting fuel “MagneGas2®” is faster, cleaner and more productive than other alternatives on the market. It is also cost effective and safe to use with little changeover costs. The Company currently sells MagneGas2® into the metal working market as a replacement to acetylene.

The Company also sells equipment for the sterilization of bio–contaminated liquid waste for various industrial and agricultural markets. In addition, the Company is developing a variety of ancillary uses for MagneGas® fuels utilizing its high flame temperature for co–combustion of hydrocarbon fuels and other advanced applications. For more information on MagneGas®, please visit the Company's website at http://www.MagneGas.com.

The Company distributes MagneGas2® through Independent Distributors in the U.S and through its wholly owned distributors, ESSI, Green Arc Supply, Trico Welding Supply and Complete Welding of San Diego. ESSI has three locations in Florida, Green Arc has two locations in Texas and one location in Louisiana, Trico has two locations in northern California, and Complete Welding has one location in southern California. For more information on ESSI, please visit the company's website at http://www.weldingsupplytampa.com.


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