Ember Therapeutics Completes Reverse Merger and Begins Trading as a Public Company
NEW YORK, February 3, 2016 /GLOBE NEWSWIRE/ –Ember Therapeutics, Inc., a New York-based biopharmaceutical company that is developing targeted therapies for osteoarthritis, kidney fibrosis, and other indications using Bone Morphogenetic Protein (BMP)-7, announced today the successful completion of its merger with American Home Alliance Corp. (AHLL). The combined company will be called Ember Therapeutics, Inc., and will trade on the OTC Markets under the symbol “AHLL”. The Company has submitted an application to change its trading symbol.
As a result of this transaction, the Company has a total of 40,000,000 shares outstanding.
We believe that our lead product candidate, BMP-7, presents a unique opportunity to address the large unmet medical need in the treatment of osteoarthritis and has significant potential in a variety of other indications. We expect that the transition to a public company will provide increased access to capital to accelerate the clinical development of BMP-7 both in OA and other areas,” said Joseph Hernandez, Director, and Executive Chairman of Ember Therapeutics.
Following the reverse merger, Ember Therapeutics will continue to develop BMP-7, which achieved promising results in a Phase II(a) trial, which evaluated the local administration of BMP-7 in patients with osteoarthritis of the knee.
About Bone Morphogenetic Protein-7 (BMP-7)
BMPs are a group of growth factors also known as cytokines and as metabologens. Originally discovered by their ability to induce the formation of bone and cartilage, BMPs are now considered to constitute a group of pivotal morphogenetic signals, orchestrating tissue architecture throughout the body. For example, previous studies have demonstrated that BMP-7 can facilitate effective joint cartilage formation, inhibit and reverse organ fibrosis in the kidney, heart, and lung due to injury or disease, and diabetic diseases related to glucose metabolism.
About Ember Therapeutics, Inc.
Ember Therapeutics, Inc. is a clinical stage biopharmaceutical company whose primary focus is on utilizing Bone Morphogenetic Protein-7 to catalyze cartilage regeneration for disease modification of Osteoarthritis (OA) and the inhibition and reversal of organ fibrosis in diseases such as Chronic Kidney Disease (CKD) and Alport Syndrome. In particular, Ember has acquired over 450 patents covering BMP-7 and its related family of BMPs, variants, novel formulations, delivery technologies, associated clinical data, and cGMP manufactured material from Stryker Corporation. For more information, please visit www.embertx.com.
Ember Therapeutics Forward-Looking Statements
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Ember Therapeutics’ business and Ember Therapeutics undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Contact Information:
The Ruth Group
Lee Roth
lroth@theruthgroup.com
(646) 536-7012
Ember Therapeutics Announce Initial Positive Results From a Phase 2 Trial of BMP-7 in Patients with Moderate Osteoarthritis of the Knee
NEW YORK, October 19, 2015 /PRNEWSWIRE/ –Ember Therapeutics, Inc., a privately held, New York-based biopharmaceutical company that is developing targeted therapies for osteoarthritis, kidney fibrosis, and other indications using Bone Morphogenetic Protein (BMP)-7, announced today initial results from the Phase II(a) trial of local BMP-7 administration in patients with moderate osteoarthritis of the knee. The company said that an initial analysis of 78 of the 320 total patients enrolled in the Phase 2 trial provided evidence that even a single local dose of BMP-7 could prevent cartilage loss and had potential anabolic effects.
Joseph Hernandez, the Company's Executive Chairman, said, "The initial results are very encouraging. We expect to observe a similar trend when analyzing the remainder of the Phase 2 data.Importantly, these clinical results represent a potential major advance for the entire osteoarthritis community. BMP-7 is expected to have a profound impact in the osteoarthritis field, where the only treatment options are pain relievers or knee replacement therapy. This therapy is expected to alter the course of the disease. Something that does not exist today."
The company is currently raising money and seeking partners for a Phase 3 pivotal trial.
About Bone Morphogenetic Protein-7 (BMP-7)
BMPs are a group of growth factors also known as cytokines and as metabologens. Originally discovered by their ability to induce the formation of bone and cartilage, BMPs are now considered to constitute a group of pivotal morphogenetic signals, orchestrating tissue architecture throughout the body. For example, previous studies have demonstrated that BMP-7 can facilitate effective joint cartilage formation, inhibit and reverse organ fibrosis in the kidney, heart, and lung due to injury or disease, and diabetic diseases related to glucose metabolism.
About Ember Therapeutics, Inc.
Ember Therapeutics, Inc. is a clinical stage biopharmaceutical company whose primary focus is on utilizing Bone Morphogenetic Protein-7 to catalyze cartilage regeneration for disease modification of Osteoarthritis (OA) and the inhibition and reversal of organ fibrosis in diseases such as Chronic Kidney Disease (CKD) and Alport Syndrome. In particular, Ember has acquired over 450 patents covering BMP-7 and its related family of BMPs, variants, novel formulations, delivery technologies, associated clinical data, and cGMP manufactured material from Stryker Corporation. For more information, please visit www.embertx.com.
SOURCE: Ember Therapeutics, Inc.
Ember Therapeutics Raises up to $6M and Establishes Commercial Partnership with Knight Therapeutics
MONTREAL and NEW YORK, August 6, 2015 /PRNEWSWIRE/ –Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading Canadian specialty pharmaceutical company and Ember Therapeutics, Inc. ("Ember"), a privately held, New York-based biotechnology company developing targeted therapies for osteoarthritis, kidney fibrosis and other indications using Bone Morphogenetic Protein (BMP)-7 announced today that Knight has extended a secured loan of US$1 million and may provide additional equity commitments to Ember valued up to US$5 million. In addition, Knight has entered into an exclusive distribution agreement with Ember, a cutting-edge U.S.-based biopharmaceutical company, to commercialize its promising Bone Morphogenetic Protein-7 ("BMP-7") pipeline in Canada and select international markets.
Joseph Hernandez, Executive Chairman of Ember's Board of Directors, commented, "In Knight, we have found the perfect financial and strategic partner to ensure Ember realizes its goal of addressing the large unmet therapeutic needs of patients suffering from osteoarthritis and fibrotic diseases."
About Ember Therapeutics, Inc.
Ember Therapeutics, Inc. is a clinical stage biopharmaceutical company whose primary focus is on utilizing Bone Morphogenetic Protein-7 to catalyze cartilage regeneration for disease modification of Osteoarthritis (OA) and the inhibition and reversal of organ fibrosis in diseases such as Chronic Kidney Disease (CKD) and Alport Syndrome. In particular, Ember has acquired over 450 patents covering BMP-7 and its related family of BMPs, variants, novel formulations, delivery technologies, associated clinical data, and cGMP manufactured material from Stryker Corporation. For more information, please visit www.embertx.com.
About Knight Therapeutics, Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the Company's web site at www.gud-knight.com or www.sedar.com.
SOURCE: Ember Therapeutics, Inc.
Ember and Mariel Therapeutics Enter Definitive Merger Agreement Creating a Strong Diversified Company
NEW YORK and BOSTON, March 12, 2015 – Ember Therapeutics, Inc., a Boston-based biotechnology company dedicated to the discovery and development of novel obesity and diabetic related therapies, and Mariel Therapeutics, a privately held, New York-based biotechnology company developing targeted therapies for osteoarthritis and kidney fibrosis using Bone Morphogenetic Protein (BMP)-7, jointly announce today that they have entered into a definitive agreement to merge the two companies. The combined entity, to be named Ember Therapeutics, Inc., is expected to create a leader in innovative drug discovery and development in osteoarthritis, kidney fibrosis and diabetic related diseases including obesity. The combined company's clinical pipeline will include four drugs in development – one of which has completed Phase II clinical trials in osteoarthritis and three of which are near to entering Phase I. Financial details of the transaction were not disclosed.
"This transaction further enhances the clinical utility and efficacy of BMP-7 in diverse applications and gives us access to novel delivery technologies for BMP-7," said Joseph Hernandez, Chairman of Mariel Therapeutics. "The combined pipeline and intellectual property are expected to have a profound impact in areas of unmet medical needs."
About Mariel Therapeutics, Inc.
Mariel Therapeutics, Inc. (Mariel) is a clinical stage biopharmaceutical company focused on the clinical application of Bone Morphogenetic Protein-7 (BMP-7) in osteoarthritis (OA), chronic kidney disease (CKD), and Alport Syndrome. Mariel acquired the rights to over 450 issued and pending patents as well as BMP-7-related clinical and research data, and the associated biologic materials from Stryker Corporation.
Human recombinant BMP-7 has previously been used in reconstructive bone applications in over 40,000 patients. Previous Phase I and Phase IIa trials have been completed in osteoarthritis. Mariel intends to advance clinical trial in osteoarthritis (OA) and for chronic kidney disease (CKD) and Alport disease, a genetic kidney fibrosis disease.
About Ember Therapeutics
Ember Therapeutics is a product-focused company harnessing breakthroughs in brown fat biology and insulin sensitization to revolutionize the treatment of metabolic disease. Today's rising epidemic of obesity and Type 2 diabetes coupled with the lack of innovation in the industry's metabolic disorder treatment pipeline underscores the need for novel, peripherally-acting treatments with improved safety profiles. Ember's unique approach leverages recent research breakthroughs in brown fat biology to develop a pipeline of proprietary molecules, including BMP-7, designed to amplify the body's innate ability to efficiently burn fuels like glucose. Ember Therapeutics is a private company launched in 2011 by renowned scientific founders, and an experienced leadership team.
Contact Information:
Mariel Therapeutics, Inc.
646-612-4000; info@marieltherapeutics.com
SOURCE: Mariel Therapeutics, Inc.; Ember Therapeutics, Inc.
Mariel Therapeutics Announces Definitive Agreement to Acquire Stryker's BMP-7 Assets for Potential Use in Osteoarthritis and Organ Fibrosis
NEW YORK, NY, July 7, 2014 – Mariel Therapeutics, Inc. today announced that it has entered into a definitive agreement to acquire Stryker Corporation's (NYSE: SYK) Bone Morphogenetic Protein-7 (BMP-7) assets for the potential treatment of osteoarthritis (OA), chronic kidney disease (CKD) and other organ fibrosis conditions, lupus, and obesity. Under the terms of the agreement, Mariel acquired the rights to over 450 issued and pending patents, Stryker's BMP-7-related clinical and research data, and the associated biologic materials. Stryker will have a right of first negotiation for commercial rights in the area of osteoarthritis. Financial terms of the transaction were not disclosed. Human recombinant BMP-7 has previously been used in reconstructive bone applications in over 40,000 patients. Previous Phase I and Phase IIa trials have been completed in osteoarthritis. Mariel intends to pursue a Phase IIb/III clinical trial for osteoarthritis (OA) and Phase I trials for chronic kidney disease (CKD) and Alport disease, a genetic kidney fibrosis disease.
About Mariel Therapeutics, Inc.
Mariel Therapeutics, Inc. (Mariel) is a clinical stage biopharmaceutical company focused on the clinical application of Bone Morphogenetic Protein-7 (BMP-7) in osteoarthritis (OA), chronic kidney disease (CKD), and Alport Syndrome. Mariel acquired the rights to over 450 issued and pending patents as well as BMP-7-related clinical and research data, and the associated biologic materials from Stryker Corporation.
Human recombinant BMP-7 has previously been used in reconstructive bone applications in over 40,000 patients. Previous Phase I and Phase IIa trials have been completed in osteoarthritis. Mariel intends to advance clinical trial in osteoarthritis (OA) and for chronic kidney disease (CKD) and Alport disease, a genetic kidney fibrosis disease. For more info, please visit www.embertx.com
Forward-Looking Statements
These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on Mariel Therapeutics' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Mariel Therapeutics does not undertake an obligation to update or revise any forward-looking statement. The information set forth herein speaks only as of the date hereof.
Contact Information
For more information on Mariel Therapeutics please contact Mariel Therapeutics at 646-829-1281 or info@embertx.com