EYEN - Eyenovia: Countdown To May 8 2023

Summary

• I will update my previous two articles about Eyenovia.
• NDA accepted with no outside advisory committee formed to review their submission.
• FDA decision date for the NDA set for May 8, 2023.
• Eyenovia secures first outside drug company partnership potential for using their Optejet delivery system.

Background Information on Previous Articles:

On October 21, 2021, I began coverage of Eyenovia (EYEN), where I shared an article- Can You See Me Now? The catalyst for this article was that Eyenovia was expecting the FDA would deliver good news on October 28th, 2021. This date was the scheduled PFUDA for the FDA announcing their decision on the company's first drug candidate. They would now have a revenue stream to fund their operational expenses and create a profit-making corporation.

Instead of the FDA delivering good news, they gave Eyenovia the worst information any fledgling new biotech wants to hear-the FDA did not approve their NDA. But in the case of Eyenovia, there was no question that the drug worked as verified by the data submitted with their NDA. The issue was simply a court ruling that had no association with Eyenovia. Still, the nature of the company involved forced the FDA to change the protocols for how Eyenovia conducted its clinical trials for its drug delivery system. This change had no impact on the actual drug used by Eyenovia. The FDA required the company to go back and do more clinical testing for the new patented delivery system used by Eyenovia-the Optejet system that makes obsolete the standard eye dropper used to deliver drugs to the eye.

Instead of merely highlighting certain aspects of this original article, interested readers should use the above-cited link to get complete details of the event on October 28th, 2021. The stock dropped from the $5.97 level on the date of my article. The shares finally hit the bottom level of the 52-week range at the recent $1.80 level.

I wrote my second article about the company on December 13th, 2022, where I gave an update in the article- Hoping Eyenovia Has the Aye Voted From the FDA. At the time of this article, the stock was trading for $1.82 due to the massive market sell-off in 2022. The market's deterioration significantly impacted many biotechs that had no revenue stream. This included Eyenovia in the down draft of their stock's valuation.

As I write this article (2/22/23), the stock has increased by about 75% from the December 13th update. Going back to the original article and history of Eyenovia, and especially the unique issue that caused this FDA decision, it is necessary to update my readers with the vast number of events that have occurred since December 2022. These events explain why the stock has increased by 75%, making my most crucial account holding Eyenovia shares move into green territory. As I conveyed in comments for my articles, the massive drop in the share pricing gave investors a unique opportunity to average down their price based on holding the stock from the $5.00 level.

Interim Events for Eyenovia Since December 13th, 2022:

Readers might wonder why my article was published on December 13th and didn't include the most important events I'm now sharing. The SA article is time-stamped as posted at 1:27 a.m., before Eyenovia issued their press release on December 13th. I submitted the article to SA on December 12th for the SA editing process. It was not based on any insider information on my part other than knowing that the event was scheduled for the immediate time frame.

• NDA Accepted by the FDA:

The current event on December 13th, 2022, was when the FDA informed Eyenovia they had accepted their NDA that included the new data on the Optejet delivery system and a resubmission of the drug data that had previously been submitted.

• No Advisory Committee Panel Required:

The other good news the FDA shared was that their NDA submission would not call for an outside advisory committee to be formed to evaluate their submission. Forming and using such a committee indicates the FDA reviewers had critical issues concerning the NDA, and they needed outside experts to give their opinion for the NDA candidate.

• Firm PDUFA Date Set for FDA Decision:

And then the FDA's last good news was that the standard review time was given to them as May 8, 2023 , for them to decide about the NDA. Standard review times for most NDAs can take up to one year. This means we have only 78 days before the FDA is scheduled to make what is hoped as the approval of Eyenovia's first drug candidate. The countdown is on! And we know that the FDA didn't indicate any issues with the actual drug, but rather just the need from a court ruling their new delivery systems must comply with new evaluation rules.

• Tufts Medical School Validates the Optejet Delivery System:

To address this new evaluation requirement, on January 13, 2023, Eyenovia issued a press release concerning an outside academic study that showed that the Optejet delivery system reflected positive evidence that the system decreased inflammation from preserved glaucoma solution used in eye dropper delivery. This external reviewer was the Head of the Ophthalmology department at Tufts Medical Center in Boston. Many might need to learn that drugs administered by an eye dropper continue to see preservatives needed to produce sterility and prolong the drug's shelf life. In addition, the eye dropper delivery creates a great deal of wastage in the drug being dosed. When one has their annual visit to their eye doctor, one can view these doctors have a considerable supply of tissues to wipe away the dose not going into your eye or eye socket.

• Eyenovia Secures First Partnership for Company to Adopt the Optejet System With their Product:

And the last interim news is critical to Eyenovia's revenue growth. Eyenovia has an internal drug development program, with one on the cusp of getting FDA approval. Eyenovia ultimately wants to secure partnerships with many drug companies currently marketing their ophthalmic products to doctors seeing and treating patients with their drugs.

On February 15, 2023, they announced a development collaboration with Taiwan-based Formosa Pharmaceuticals. The goal is to determine how they can leverage Formosa's APNT® nanoparticle formulation platform for creating new topical ophthalmic therapeutics using the Optejet delivery system. With partnership deals, it is always great to see upfront monies coming into the company you are invested in their stock. With this initial venture for Eyenovia, no such funds are being exchanged. The plan is for both sides to work on seeing how Formosa's APNT® nanoparticle formulation can benefit from using the Optejet system.

It should be noted that Formosa currently has an ophthalmic drug that has successfully concluded a Phase III clinical trial. The drug is designed to address pain related to eye surgery. Formosa is presently preparing their NDA submission for the FDA. Even though their Phase III data was successful for this medical indication, this indication already has a crowded field of other drugs in the marketplace. They are working quickly in the current partnership to see the benefit of pairing the Formosa drug with the Optejet system. If there is a benefit, adding Optejet to their medication will give them a marketing edge over the current competitors. Formosa already has a marketing team for the Chinese markets.

Formosa's proprietary and innovative APNT™ platform reduces an active pharmaceutical ingredient's particle size with high uniformity and purity, thereby allowing penetration to relevant compartments in the eye and ultimately enhancing bioavailability. This reduction in ingredient size may also expand to existing and future drugs that could benefit from delivery using the Optejet®.

Both companies intend to collaborate on testing formulations and engage in discussions with the Food and Drug Administration (FDA). Then it is hoped they will execute a Development and Commercialization Agreement under which the companies would work to develop new drugs leveraging APNT™ formulations in the Optejet® delivery system.

The ophthalmic market is growing worldwide. This is a link to a market research firm that shares some data on the North American markets without you having to buy their full report. I have yet to determine the validity of this firm, but the charts and data shared, if they are valid, point out the need for new drugs and delivery systems for eye care products.

And now we know that at least one other drug company is working with Eyenovia to form a mutual partnership that will be revenue friendly for both parties. Let's hope many more will benefit from their Optejet delivery system.

Caveats for Eyenovia:

As seen by the October 28th event, until final approval by the FDA has occurred, anything can happen in the decision-making process by the FDA. In the case of Eyenovia, they have been delayed for more than a year. But the good news is that they are rapidly approaching the vital decision date for their NDA on file with the FDA. The irony is that if Eyenovia had been using an eye dropper for their delivery, their drug could have been on the market for over a year. Hopefully, with the new comprehensive data for the Optejet system, the other drugs in their pipeline will not require any future mandated clinical trials for the system.

Eyenovia is a micro-cap stock where the stock is currently selling well below $5.00 a share. The company now carries a market capitalization of $107.7 million. These two metrics hinder brokerage firms and mutual funds from considering the stock as an investment opportunity due to their limited liquidity, whether buying or selling their shares. Eyenovia is a reasonably new corporation; before the October 28th event, the stock was trading as high as $7.00. In the near term, we need to see the stock take out the most recent 52-week high--$3.33. As I finalize this article (2/22/23), that level is only $0.14 away from achieving this goal. Upon reaching this goal, investors can set their eyes and hopes to see the $5.00 level for the shares. Then we may see significant money flowing into the stock as we await the FDA decision. I'm just telling my readers to be cautious when buying micro-cap stocks. In recent days the trading volume has increased in significant amounts, and with the stock rapidly growing in its valuation, this means that currently, there are major buyers of their stock.

As of September 30th, 2022, the 3rd Quarter results reflected that Eyenovia had $25.3 million in cash. Management indicated, at the time, that this cash position would fund them through 2023. If the FDA approves this first product, they will make a secondary offering is a likely situation and safe assumption. Eyenovia plans to maintain complete control of this product and thus market it to professional doctors needing to dilate their patient's eyes. With them having a built-out manufacturing facility in the Silicon Valley area, production of samples and the product for sale must immediately start upon approval. This means the current cash level will be diminishing, and why a second probably will happen later in 2023. With the current SEC reporting of their 4th-Q and Annual Financials pending, readers should look closely at the current burn rate concerning their cash position.

Conclusion Comments:

Eyenovia suffered an unusual setback since my initial article was shared here on Seeking Alpha. The steep drop in the share price devastated those of us holding their stock at the time. Due to the nature of the delay demanded by the FDA, I always retained my faith in their business model and the data associated with their clinical trials. With the interim events I've delineated in this new article, and the reaction to the stock being depressed to such low levels, I consider their shares a prime candidate for income averaging down the cost should your initial entry be at a level much higher than the share price currently.

• NDA Accepted by the FDA.
• No Advisory Committee Panel Being Required for the Final Review Decision Date by the FDA Set for May 8, 2023.
• Tufts Medical School Validates Optejet Delivery System.
• Eyenovia Secures First Partnership Deal with Formosa Pharmaceuticals.
• Based on Successful Phase III Clinical Results for Their MicroLine Drug, They Have a Pre-NDA Meeting Set with the FDA for March 29, 2023.
• MicroLine is Planned to Compete in the $ 7.7 billion Market Place.
• There is no issue with insurance companies being involved in using MydCombi. The attending physician orders, stores, and pays for the drug where they use it in their practice.

MydCombi: Eye Pupil Dilation System for Drug Delivery Uniqueness

• If approved, the only fixed drug combination of the two leading mydriatic medications in the US.
• The device delivers the drug with the push of a button, saving up to ten minutes of technician time.
• The touch-free, comfortable application does not require anesthetic, with fewer than 1% of patients experiencing stinging discomfort.
• Lower drug and preservative exposure, including systemic phenylephrine absorption, can be problematic in hypertensive patients.
• Reliable in numerous patient practices. 60% of patients quickly achieved clinically significant mydriasis at 20 minutes, and nearly 95% did so at 35 minutes post-dosage.

The following is a link to a comprehensive presentation that Eyenovia made available on January 30th, 2023. It will be well worth your time to review this presentation.

Good luck with your future investing decision!

For further details see: