Background Data on Earlier Articles:
On October 21, 2021, I started protection of Eyenovia (NASDAQ:EYEN), the place I shared an article- Can You See Me Now? The catalyst for this article was that Eyenovia was anticipating the FDA would ship excellent news on October twenty eighth, 2021. This date was the scheduled PFUDA for the FDA asserting their choice on the corporate’s first drug candidate. They might now have a income stream to fund their operational bills and create a profit-making company.
As a substitute of the FDA delivering excellent news, they gave Eyenovia the worst data any fledgling new biotech desires to hear-the FDA didn’t approve their NDA. However within the case of Eyenovia, there was no query that the drug labored as verified by the information submitted with their NDA. The problem was merely a courtroom ruling that had no affiliation with Eyenovia. Nonetheless, the character of the corporate concerned compelled the FDA to alter the protocols for the way Eyenovia carried out its scientific trials for its drug supply system. This transformation had no affect on the precise drug utilized by Eyenovia. The FDA required the corporate to return and do extra scientific testing for the brand new patented supply system utilized by Eyenovia-the Optejet system that makes out of date the usual eye dropper used to ship medication to the attention.
As a substitute of merely highlighting sure facets of this authentic article, readers ought to use the above-cited hyperlink to get full particulars of the occasion on October twenty eighth, 2021. The inventory dropped from the $5.97 stage on the date of my article. The shares lastly hit the underside stage of the 52-week vary on the latest $1.80 stage.
I wrote my second article concerning the firm on December thirteenth, 2022, the place I gave an replace within the article- Hoping Eyenovia Has the Aye Voted From the FDA. On the time of this text, the inventory was buying and selling for $1.82 as a result of large market sell-off in 2022. The market’s deterioration considerably impacted many biotechs that had no income stream. This included Eyenovia within the down draft of their inventory’s valuation.
As I write this text (2/22/23), the inventory has elevated by about 75% from the December thirteenth replace. Going again to the unique article and historical past of Eyenovia, and particularly the distinctive situation that precipitated this FDA choice, it’s essential to replace my readers with the huge variety of occasions which have occurred since December 2022. These occasions clarify why the inventory has elevated by 75%, making my most vital account holding Eyenovia shares transfer into inexperienced territory. As I conveyed in feedback for my articles, the large drop within the share pricing gave buyers a novel alternative to common down their worth primarily based on holding the inventory from the $5.00 stage.
Interim Occasions for Eyenovia Since December thirteenth, 2022:
Readers would possibly marvel why my article was printed on December thirteenth and did not embody an important occasions I am now sharing. The SA article is time-stamped as posted at 1:27 a.m., earlier than Eyenovia issued their press launch on December thirteenth. I submitted the article to SA on December twelfth for the SA modifying course of. It was not primarily based on any insider data on my half aside from realizing that the occasion was scheduled for the speedy timeframe.
The present occasion on December thirteenth, 2022, was when the FDA knowledgeable Eyenovia they’d accepted their NDA that included the brand new knowledge on the Optejet supply system and a resubmission of the drug knowledge that had beforehand been submitted.
- No Advisory Committee Panel Required:
The opposite excellent news the FDA shared was that their NDA submission wouldn’t name for an out of doors advisory committee to be shaped to guage their submission. Forming and utilizing such a committee signifies the FDA reviewers had vital points in regards to the NDA, and so they wanted exterior consultants to provide their opinion for the NDA candidate.
- Agency PDUFA Date Set for FDA Determination:
After which the FDA’s final excellent news was that the usual evaluation time was given to them as Might 8, 2023, for them to determine concerning the NDA. Commonplace evaluation occasions for many NDAs can take as much as one yr. This implies we’ve solely 78 days earlier than the FDA is scheduled to make what’s hoped because the approval of Eyenovia’s first drug candidate. The countdown is on! And we all know that the FDA did not point out any points with the precise drug, however fairly simply the necessity from a courtroom ruling their new supply methods should adjust to new analysis guidelines.
- Tufts Medical Faculty Validates the Optejet Supply System:
To handle this new analysis requirement, on January 13, 2023, Eyenovia issued a press launch regarding an out of doors tutorial research that confirmed that the Optejet supply system mirrored optimistic proof that the system decreased irritation from preserved glaucoma resolution utilized in eye dropper supply. This exterior reviewer was the Head of the Ophthalmology division at Tufts Medical Middle in Boston. Many would possibly must study that medication administered by an eye fixed dropper proceed to see preservatives wanted to supply sterility and delay the drug’s shelf life. As well as, the attention dropper supply creates quite a lot of wastage within the drug being dosed. When one has their annual go to to their eye physician, one can view these docs have a substantial provide of tissues to wipe away the dose not going into your eye or eye socket.
- Eyenovia Secures First Partnership for Firm to Undertake the Optejet System With their Product:
And the final interim information is vital to Eyenovia’s income progress. Eyenovia has an inner drug improvement program, with one on the cusp of getting FDA approval. Eyenovia in the end desires to safe partnerships with many drug firms at the moment advertising and marketing their ophthalmic merchandise to docs seeing and treating sufferers with their medication.
On February 15, 2023, they introduced a improvement collaboration with Taiwan-based Formosa Prescribed drugs. The purpose is to find out how they will leverage Formosa’s APNT® nanoparticle formulation platform for creating new topical ophthalmic therapeutics utilizing the Optejet supply system. With partnership offers, it’s at all times nice to see upfront monies coming into the corporate you might be invested of their inventory. With this preliminary enterprise for Eyenovia, no such funds are being exchanged. The plan is for either side to work on seeing how Formosa’s APNT® nanoparticle formulation can profit from utilizing the Optejet system.
It ought to be famous that Formosa at the moment has an ophthalmic drug that has efficiently concluded a Section III scientific trial. The drug is designed to handle ache associated to eye surgical procedure. Formosa is presently getting ready their NDA submission for the FDA. Although their Section III knowledge was profitable for this medical indication, this indication already has a crowded discipline of different medication within the market. They’re working rapidly within the present partnership to see the good thing about pairing the Formosa drug with the Optejet system. If there’s a profit, including Optejet to their medicine will give them a advertising and marketing edge over the present rivals. Formosa already has a advertising and marketing crew for the Chinese language markets.
Formosa’s proprietary and modern APNT™ platform reduces an energetic pharmaceutical ingredient’s particle measurement with excessive uniformity and purity, thereby permitting penetration to related compartments within the eye and in the end enhancing bioavailability. This discount in ingredient measurement might also increase to present and future medication that might profit from supply utilizing the Optejet®.
Each firms intend to collaborate on testing formulations and interact in discussions with the Meals and Drug Administration (FDA). Then it’s hoped they are going to execute a Growth and Commercialization Settlement underneath which the businesses would work to develop new medication leveraging APNT™ formulations within the Optejet® supply system.
The ophthalmic market is rising worldwide. It is a hyperlink to a market analysis agency that shares some knowledge on the North American markets with out you having to purchase their full report. I’ve but to find out the validity of this agency, however the charts and knowledge shared, if they’re legitimate, level out the necessity for brand new medication and supply methods for eye care merchandise.
And now we all know that a minimum of one different drug firm is working with Eyenovia to kind a mutual partnership that will probably be income pleasant for each events. Let’s hope many extra will profit from their Optejet supply system.
Caveats for Eyenovia:
As seen by the October twenty eighth occasion, till remaining approval by the FDA has occurred, something can occur within the decision-making course of by the FDA. Within the case of Eyenovia, they’ve been delayed for greater than a yr. However the excellent news is that they’re quickly approaching the important choice date for his or her NDA on file with the FDA. The irony is that if Eyenovia had been utilizing an eye fixed dropper for his or her supply, their drug may have been available on the market for over a yr. Hopefully, with the brand new complete knowledge for the Optejet system, the opposite medication of their pipeline is not going to require any future mandated scientific trials for the system.
Eyenovia is a micro-cap inventory the place the inventory is at the moment promoting effectively under $5.00 a share. The corporate now carries a market capitalization of $107.7 million. These two metrics hinder brokerage companies and mutual funds from contemplating the inventory as an funding alternative attributable to their restricted liquidity, whether or not shopping for or promoting their shares. Eyenovia is a fairly new company; earlier than the October twenty eighth occasion, the inventory was buying and selling as excessive as $7.00. Within the close to time period, we have to see the inventory take out the latest 52-week high–$3.33. As I finalize this text (2/22/23), that stage is simply $0.14 away from reaching this purpose. Upon reaching this purpose, buyers can set their eyes and hopes to see the $5.00 stage for the shares. Then we may even see vital cash flowing into the inventory as we await the FDA choice. I am simply telling my readers to be cautious when shopping for micro-cap shares. In latest days the buying and selling quantity has elevated in vital quantities, and with the inventory quickly rising in its valuation, which means that at the moment, there are main patrons of their inventory.
As of September thirtieth, 2022, the third Quarter outcomes mirrored that Eyenovia had $25.3 million in money. Administration indicated, on the time, that this money place would fund them by means of 2023. If the FDA approves this primary product, they are going to make a secondary providing is a possible scenario and secure assumption. Eyenovia plans to take care of full management of this product and thus promote it to skilled docs needing to dilate their affected person’s eyes. With them having a built-out manufacturing facility within the Silicon Valley space, manufacturing of samples and the product on the market should instantly begin upon approval. This implies the present money stage will probably be diminishing, and why a second most likely will occur later in 2023. With the present SEC reporting of their 4th-Q and Annual Financials pending, readers ought to look intently on the present burn price regarding their money place.
Eyenovia suffered an uncommon setback since my preliminary article was shared right here on In search of Alpha. The steep drop within the share worth devastated these of us holding their inventory on the time. Because of the nature of the delay demanded by the FDA, I at all times retained my religion of their enterprise mannequin and the information related to their scientific trials. With the interim occasions I’ve delineated on this new article, and the response to the inventory being depressed to such low ranges, I think about their shares a primary candidate for earnings averaging down the price ought to your preliminary entry be at a stage a lot greater than the share worth at the moment.
- NDA Accepted by the FDA.
- No Advisory Committee Panel Being Required for the Ultimate Evaluation Determination Date by the FDA Set for Might 8, 2023.
- Tufts Medical Faculty Validates Optejet Supply System.
- Eyenovia Secures First Partnership Cope with Formosa Prescribed drugs.
- Primarily based on Profitable Section III Medical Outcomes for Their MicroLine Drug, They Have a Pre-NDA Assembly Set with the FDA for March 29, 2023.
- MicroLine is Deliberate to Compete within the $ 7.7 billion Market Place.
- There is no such thing as a situation with insurance coverage firms being concerned in utilizing MydCombi. The attending doctor orders, shops, and pays for the drug the place they use it of their apply.
MydCombi: Eye Pupil Dilation System for Drug Supply Uniqueness
- If permitted, the one mounted drug mixture of the 2 main mydriatic drugs within the US.
- The machine delivers the drug with the push of a button, saving as much as ten minutes of technician time.
- The touch-free, comfy software doesn’t require anesthetic, with fewer than 1% of sufferers experiencing stinging discomfort.
- Decrease drug and preservative publicity, together with systemic phenylephrine absorption, could be problematic in hypertensive sufferers.
- Dependable in quite a few affected person practices. 60% of sufferers rapidly achieved clinically vital mydriasis at 20 minutes, and practically 95% did so at 35 minutes post-dosage.
The next is a hyperlink to a complete presentation that Eyenovia made out there on January thirtieth, 2023. It is going to be effectively value your time to evaluation this presentation.
Good luck along with your future investing choice!