Eyenovia, Inc. | November 30, 2022
Eyenovia, Inc. a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, announced that the company has entered into a $15 million credit facility with the Avenue Venture Opportunities Fund, L.P. The financing is intended to support manufacturing in anticipation of a MydCombi launch and clinical supply for ongoing programs.
Per the terms of the agreement, Eyenovia received $10 million of gross proceeds at closing. The additional $5 million will be available, at the company’s option, should MydCombi™ be approved for marketing in the U.S. by the Food and Drug Administration by August 2023. The Avenue facility replaces the company’s Silicon Valley Bank facility, which was recently paid off.
“We are pleased to have the support of Avenue through this credit facility at terms which create minimal dilution as compared to a traditional equity capital raise. Together with our existing cash on-hand, we expect the additional capital provided by this facility to fund our operations through at least late 2023 or early 2024, or through value creating milestones, including the potential approval of MydCombi™ and preparations for the possible submission of a New Drug Application for our novel presbyopia treatment, MicroLine™.”
Michael Rowe, chief executive officer of Eyenovia
“We are pleased to provide this financing to Eyenovia as we believe its Optejet dispensing technology truly differentiates the company from its peers and offers great potential across a broad range of high value ophthalmic indications,” stated Chad Norman, Senior Portfolio Manager of the Avenue Venture Debt Fund.
Eyenovia’s current pro-forma unrestricted cash balance, including approximately $9.5 million of net proceeds from this facility, is approximately $25.5 million.
About Eyenovia, Inc.
Eyenovia, Inc. is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression.
About Avenue Venture Opportunities
The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated to be approximately $12.3 billion as of October 31, 2022.
Ora, Inc. | September 29, 2022
Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th.
The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing.
“At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.”
Dr. De Moraes
About Ora, Inc.
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.
Anokion | October 19, 2022
Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance announced that Pfizer has made a $35 million equity investment in Anokion through the Pfizer Breakthrough Growth Initiative. In conjunction with the investment, Michael Vincent, M.D., Ph.D., senior vice president and chief scientific officer, Inflammation & Immunology, Pfizer, has joined the company’s scientific advisory board, which will be announced later this year, and Allison Kean, M.D., executive director, Worldwide Business Development, Pfizer has joined Anokion’s board of directors as an observer.
Separately, Anokion and Pfizer have entered into an agreement to leverage Pfizer’s development expertise and capabilities in support of the continued clinical development of KAN-101, Anokion’s lead candidate for the treatment of individuals with celiac disease.
“We are excited about these agreements with Pfizer as they provide us with important resources and expertise to advance our KAN-101 clinical program and our earlier-stage pipeline. People living with autoimmune diseases like celiac disease need additional treatment options, and we are excited to work with Pfizer to potentially develop these utilizing our immune tolerance platform. We also look forward to leveraging Pfizer’s insights and capabilities in support of our Phase 2 clinical program in patients with celiac disease.”
Deborah Geraghty, Ph.D., chief executive officer of Anokion
“We believe Anokion has a unique opportunity to develop potential durable and disease-modifying treatment options for people with celiac disease and other immune-mediated disorders, and we look forward to supporting them in the continued development of KAN-101,” said Dr. Vincent. “The agreements announced today are yet another example of our commitment to collaborating with biotechs to accelerate compelling external science that could lead to true breakthroughs for patients.”
Anokion intends to use a portion of the proceeds to fund its Phase 2 clinical program of KAN-101 for the treatment of individuals with celiac disease, a serious autoimmune disorder triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. Data from Anokion’s Phase 1 ACeD study (Assessment of KAN-101 in Celiac Disease) were presented at Digestive Disease Week (DDW) 2022, showing that treatment with KAN-101 was safe and tolerated, reduced T cell responses following gluten challenge, and demonstrated a dose-dependent inhibition of gluten-induced serum IL-2 (interleukin-2), a key disease biomarker that may correlate with the timing and severity of symptoms after gluten exposure in celiac disease. Based on favorable findings, Anokion is preparing to initiate patient dosing in a Phase 2 clinical trial in the second half of 2022, supported by Pfizer.
KAN-101 is an investigational therapy being evaluated as a treatment for individuals with celiac disease, a serious autoimmune disease triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. KAN-101 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of celiac disease.
Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.