Pharma Tech | August 09, 2022
Pharma Tech Holding SA announced it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries.
Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.
This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA a JV between PTH and listed company IGEA PHARMA NV IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil.
LDA Capital agreed to commit an amount of up to CHF 30 million in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion.
“We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,”
Sabina Del Nigro, CEO at PTH
About Pharma Tech Holding
Pharma Tech Holding SA is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food.
About LDA Capital
LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion.
Silverback Therapeutics and ARS Pharmaceuticals | July 22, 2022
Silverback Therapeutics, Inc. and ARS Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which ARS will merge with Silverback in an all-stock transaction. The combined company will focus on the potential regulatory approval and commercialization of neffy, ARS’s investigational epinephrine nasal spray for the treatment of Type I allergic reactions including anaphylaxis. The combined company is expected to have approximately $265M in cash, cash equivalents and marketable securities at closing. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq Capital Market under the ticker symbol “SPRY.” The merger is currently expected to close in the fourth quarter of 2022.
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.
ARS designed neffy to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device. With its needle-free administration, neffy may help eliminate the anxiety and hesitation associated with using an autoinjector.
“We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy. neffy is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray. We have completed a comprehensive registration program with neffy and based on a favorable pre-NDA meeting with the U.S. Food and Drug Administration (“FDA”), we are preparing to submit our New Drug Application (“NDA”) in the third quarter of 2022. This merger positions ARS and our experienced team to execute on the potential launch of neffy in 2023 by providing the requisite capital needed for launch. ARS was founded with a mission of solving many of the issues that patients and caregivers express about their epinephrine autoinjectors. Today is an important step toward bringing this novel treatment to patients and caregivers to improve their treatment options for these serious and potentially life-threatening allergic reactions.”
Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS
Data across three registration studies supports that neffy should meet all clinical endpoints recommended by regulators and that its pharmacokinetics are within the range of approved efficacious epinephrine injection products. In addition, neffy has been well-tolerated to date with more than 500 individuals having received at least one dose, and many with repeat administration. The majority of adverse events in clinical trials were mild in nature and comparable to injection products. Based on the totality of data, ARS is preparing to submit its NDA for neffy for use in adults and pediatric patients who are 30 kg or greater in the third quarter of 2022. If approved, ARS is planning to launch neffy in the United States in 2023.
“This transaction represents the result of a thorough and thoughtful strategic review process by Silverback,” said Laura Shawver, Ph.D., chief executive officer of Silverback. “ARS is an exciting late-stage company with compelling clinical data demonstrated with neffy, a path to near-term commercialization in a large and dissatisfied market, and an expert team with proven experience in launching and commercializing market-leading nasal spray products, such as NARCAN. I believe we have found the optimal partner to provide value for our stockholders, and even more so, the potential to transform treatment for millions of people with or at-risk for Type I severe allergic reactions.”
About the Proposed Merger
Under the terms of the merger agreement, assuming that Silverback’s net cash at closing is $240 million, Silverback equity holders are expected to own approximately 37% of the combined company and pre-merger ARS equity holders are expected to own approximately 63% of the combined company on a fully-diluted basis on a treasury stock method. The percentage of the combined company that Silverback’s equity holders will own as of the close of the transaction is subject to certain adjustments as described in the merger agreement, including the amount of Silverback’s net cash at closing.
Upon closing of the transaction, Silverback will be renamed ARS Pharmaceuticals, Inc. and will be headquartered in San Diego, California. Richard Lowenthal, M.S., MBA, will serve as chief executive officer and president of the combined company. The merger agreement provides that the Board of Directors of the combined company will be comprised of ten members, including seven from ARS and three from Silverback. The merger agreement has been approved by the Board of Directors of each company, and the transaction is expected to close in the fourth quarter of 2022, subject to approvals by the stockholders of each company and other customary closing conditions.
About Silverback Therapeutics, Inc.
Silverback Therapeutics, Inc. is a biopharmaceutical company focused on leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered and tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases. Silverback’s platform enables the strategic pairing of proprietary payloads that modulate key disease modifying pathways with monoclonal antibodies directed at specific disease sites. Silverback Therapeutics is located in Seattle, Washington.
Aditxt | July 11, 2022
Aditxt, Inc. a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, today announces that its therapeutic program Adimune™, has successfully completed a toxicology study that indicates the safety profile of ADI™-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies.
The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug application with the regulatory agencies.
“Our drug is truly antigen-specific in the treatment of autoimmune diseases. In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.”
Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity
ADI™-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved.
“These findings are very promising,” said Dr. Kapp.
Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI™-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures.
“We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.”
“In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.”
Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.