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.
PHARMACY MARKET, PHARMA TECH
Prescryptive Health | December 16, 2022
Prescryptive Health, a healthcare technology company on a mission to rewrite the script for the U.S. pharmaceutical market, today announced a partnership with Eli Lilly and Company on a new and first-to-market subscription model to help lower costs for people who pay for their Lilly insulin through their employer-sponsored benefits. Through a flat, per-member, per-month subscription fee, employers can offer insulin to their employees with predictable, affordable, and transparent costs. This unique value-based program is designed to create price stability related to insulin utilization, with Lilly refunding a portion of the subscription fee if an employer's total medical spend increases over time for their employees who live with diabetes.
"We are proud to partner with Lilly on this unique and first-to-market value-based program. This solution challenges the traditional drug pricing model and reduces the burden on employers who sponsor pharmacy benefits. The result is that it insulates employers against increased drug prices and aligns interests to focus on patient access and health outcomes."
Chris Blackley, Prescryptive Health CEO
This new program can help address controversial rebates in the pharmacy benefit manager pricing model and will be available through Prescryptive free of any margin or price mark-up, further reducing the cost to employers, health plans, and ultimately healthcare consumers. Additionally, the program offers opportunities for employers to supply insulin at lower costs, or at no cost, to their employees. Added benefits for employers participating in the program include the Prescryptive mobile experience that supports patient engagement and adherence for diabetes care.
"In the U.S., more than 34 million people have diabetes, and some people who have employer-based insurance still need affordability solutions to ensure they don't pay too much out-of-pocket for their insulin," said Mike Mason, President, Lilly Diabetes. "At Lilly, we strive to provide new solutions to help lower costs at the pharmacy, including partnering with Prescryptive Health to ensure people with diabetes have access to affordable options to help them reach their treatment goals."
According to the American Diabetes Association
people with diagnosed diabetes spend about 2.3 times more on medical costs than those without diabetes, which impacts not only every individual patient and plan member, but also employers who sponsor their benefits coverage. Additionally, costs related to the condition include $3.3 billion in increased absenteeism.
About Prescryptive Health
Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.
PHARMACY MARKET, PHARMA TECH
Sanofi and Innate Pharma | December 19, 2022
Innate Pharma SA and Sanofi announced an expansion of their collaboration, with Sanofi licensing a natural killer cell engager program targeting B7H3 from Innate’s ANKETTM. Sanofi will also have the option to add up to two additional ANKETTM targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Innate and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofi’s R&D team, with one of these molecules already in clinical studies.
“At Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of next-generation NK cell engagers, highly synergistic with Sanofi’s allogeneic NK cell platform, engineered lymphokines that stimulate NK cells, and growing Immuno-oncology pipeline. As a leading global company with roots in France, we are proud to collaborate to support the French healthcare ecosystem.”
Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi
Yannis Morel, Ph.D., Executive Vice President, Product portfolio strategy & Business development at Innate Pharma
“Building on the success of our existing collaboration on hematologic targets, we are pleased to expand and strengthen our partnership with Sanofi on NK Cell Engagers with the addition of up to three new programs, including in solid tumors. Sanofi’s investment in Innate further validates the value of our ANKETTM platform and its potential to address multiple tumor types. By incorporating various tumor antigen binders, NK Cell Engagers are a versatile technology that may provide new options for patients and offer clinical benefit across multiple cancers, whilst also maintaining a good safety profile. This agreement also highlights Innate’s strategy to build a broad portfolio of ANKET programs addressing different types of cancer.”
Under the terms of the new license agreement, Innate will receive €25m upfront payment and up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Closing of the transaction is subject to HSR approval.
ANKETTM is Innate's proprietary platform for developing next-generation, multi-specific natural killer cell engagers to treat certain types of cancer.
This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.
Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors a tumor antigen and an interleukin-2 receptor via a single molecule.
About 2016 Sanofi/Innate research collaboration and licensing agreement
In 2016, Sanofi and Innate entered into a research collaboration and licensing agreement for the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi’s proprietary bispecific antibody format as well as tumor targets.
A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579 the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
In the summer 2022, Sanofi had made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM proprietary platform.
Under the terms of the original license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. To date, €13m milestone payments to Innate have been announced.
About Sanofi’s approach to NK therapies in oncology
At Sanofi, we are exploring the intrinsic abilities of Natural Killer cells to create new immunotherapies for patients with cancer. Natural Killer cell-based therapies are a key pillar within Sanofi’s Oncology strategy. By activating the innate power of NK cells, Sanofi is advancing a diverse and complementary range of NK-based therapeutics to transform immune biology. The breadth of our modalities and unique strength to innovate end-to-end maximizes the therapeutic possibilities for more people with cancer.
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.