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.
Specifica | June 03, 2022
Specifica, a privately held antibody engineering company focused on innovative in vitro antibody libraries and discovery tools, announced an agreement with the global healthcare company Sanofi under which Specifica’s patented Generation 3 Antibody Discovery Platform will be transferred to Sanofi. The comprehensive technology transfer package will enable the integration of Specifica’s Gen 3 platform into Sanofi’s antibody discovery programs.
“We are absolutely delighted to partner with Sanofi and their cutting-edge antibody discovery teams by providing our complete antibody discovery platform through a combination of Gen 3 libraries, antibody optimization solutions, and integrated discovery tools. We look forward to the realization of our collaboration with Sanofi as they continue to pursue the development of life-changing treatments.”
Ken Sharples, CEO and co-founder of Specifica
Specifica’s Gen 3 libraries combine clinically validated antibody frameworks with compatible binding loop sequences (CDRs) from natural human antibodies that have been purged of sequence-based developability liabilities. The Gen 3 discovery platform consistently yields a broad diversity of specific and developable antibodies with very high affinities, thereby avoiding downstream hit-to-lead optimization bottlenecks such as affinity maturation and developability optimization.
Specifica is a rapidly growing antibody engineering company specializing in the creation of exceptional antibody libraries, using next-generation sequencing for quality control at all steps of construction and validation. Specifica’s patented Generation 3 Antibody Library Discovery Platform yields drug-like antibodies directly from selections, minimizing the need for downstream affinity and biophysical engineering. Specifica provides its partners with exclusive libraries, each created from a unique donor diversity set not used for any other library, ensuring that each Gen 3 library is one of a kind. Specifica offers antibody library platforms in Fab, scFv and VHH formats. In addition to in-house antibody library designs, Specifica also collaborates closely with partners to create custom libraries in which essential elements are optimized according to partner needs. The power of the Generation 3 Platform may be accessed by engaging Specifica to execute antibody discovery and optimization campaigns, or by full transfer of the platform technology. Additionally, Specifica recently introduced AbXtractTM, a powerful suite of antibody informatics tools, through its software partner OpenEye. Specifica is headquartered in Santa Fe, New Mexico
Salarius Pharmaceuticals, Inc. | August 03, 2022
Salarius Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options, and VolitionRx Limited a multinational epigenetics company, today announced the signing of a research and development collaboration to advance rapid epigenetic profiling using Volition’s Nu.Q® technology to support further development of Salarius’ clinical stage drug, seclidemstat.
Seclidemstat, a novel oral, reversible, targeted LSD1 inhibitor that affects gene expression, is currently in Phase 1/2 clinical studies for solid and hematologic cancers where LSD1 is implicated in disease progression. Nu.Q® has been developed as simple, easy-to-use, cost-effective blood tests to diagnose and monitor a range of life-altering diseases including cancer in humans and animals.
“We are delighted to collaborate with Volition and believe its Nu.Q® technology may provide valuable biomarker information as we seek to advance the development of seclidemstat in multiple clinical indications. Biomarkers allow for a noninvasive method for determining target engagement and potential drug activity in patients. So, this exciting research collaboration with Volition Rx Limited provides another tool to aid in the development of seclidemstat in clinic.”
David Arthur, Chief Executive Officer of Salarius
Gael Forterre, Chief Commercial Officer of Volition, added, “We are excited to be collaborating with Salarius as part of our Nu.Q® Discover program which offers biopharma companies and academia access to our state-of-the-art assays for rapid epigenetic profiling. We are looking forward to supporting Salarius in the development and release of their groundbreaking seclidemstat therapy, to directly benefit patients with cancer.”
VolitionRx Limited is a multinational epigenetics company that applies its Nucleosomics™ platform through its subsidiaries to develop simple, easy-to-use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including some cancers and diseases associated with NETosis such as sepsis and COVID-19. Early diagnosis and monitoring have the potential not only to prolong the life of patients but also to improve their quality of life. The tests are based on the science of Nucleosomics, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid to indicate that disease is present. Volition is primarily focused on human diagnostics and monitoring but also has a subsidiary focused on animal diagnostics and monitoring.
Volition's research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and additional offices in London and Singapore. For more information, please visit the Volition Rx Limited website.
About Salarius Pharmaceuticals
Salarius Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing therapies for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, Salarius’ lead candidate, which is being studied as a potential treatment for pediatric cancers, sarcomas and other cancers with limited treatment options, and SP-3164, an oral small molecule protein degrader. Seclidemstat is currently in a Phase 1/2 clinical trial for relapsed/refractory Ewing’s sarcoma and certain additional sarcomas that share a similar biology, also referred to as Ewing’s-related or FET-rearranged sarcomas. Seclidemstat has received fast track, orphan drug and rare pediatric disease designations for Ewing’s sarcoma from the U.S. Food and Drug Administration. Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center. Salarius has received financial support from the National Pediatric Cancer Foundation to advance the Ewing’s sarcoma clinical program and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas.