|Bid||3.5700 x 800|
|Ask||3.6600 x 4000|
|Day's Range||3.4300 - 3.7100|
|52 Week Range||1.1100 - 6.9200|
|Beta (5Y Monthly)||2.24|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||12.00|
Company to host conference call and webcast today, November 10, at 4:30pm ETNEW YORK, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Eyenovia, Inc., (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today reported its financial results for the third quarter ended September 30, 2020. “During the third quarter and subsequent period, we continued to execute on our growth strategy to advance our late-stage ophthalmic portfolio while in parallel securing global development and commercialization partnerships to further extend the reach of our proprietary Optejet® microdosing technology,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “We announced important licensing agreements with both Bausch Health and Arctic Vision. We believe these companies can help introduce MicroPine and MicroLine to some of the biggest eyecare markets in the world, while at the same time providing us with non-dilutive capital to advance our corporate initiatives.”“We remain on track to file an NDA for Mydcombi™, our intended brand name for MicroStat, for pharmacologic mydriasis by the end of this year and plan to initiate our Phase 3 presbyopia program imminently, subject to any impacts of COVID-19. Presbyopia is one of the leading therapeutic opportunities in ophthalmology, estimated to affect more than 100 million people in the U.S. alone. And while there are other companies working on new treatments for presbyopia, we believe Eyenovia could be among the first to deliver Phase 3 results, potentially in the first quarter of 2021. With a current cash position of approximately $31 million, which includes a $10 million upfront payment from Bausch Health last month, we believe we are well funded to pursue these important milestones,” Dr. Ianchulev concluded.Third Quarter 2020 and Recent Business Highlights * Licensed our atropine ophthalmic solution, MicroPine, an investigational treatment for the reduction of pediatric myopia progression in children ages 3-12, to Bausch Health for an upfront payment of $10 million, up to $35 million in milestone payments, and royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the U.S. and Canada. * Closed a public offering of our common stock for net proceeds of approximately $12.5 million. * Announced an exclusive collaboration and license agreement with Arctic Vision to develop and commercialize MicroPine and MicroLine, our Phase 3-ready treatment for presbyopia in Greater China and South Korea, with potential licensing and development payments of up to $41.75 million, and additional royalty or supply payments. * Presented positive clinical study results on our Phase 3 MIST-1 and MIST-2 studies, evaluating a novel microdosed fixed combination of tropicamide and phenylephrine for touchless pharmaceutical mydriasis, at the American Academy of Optometry Annual Meeting and remain on track to file an NDA for Mydcombi by the end of this year.Third Quarter 2020 Financial ReviewFor the third quarter of 2020, net loss was approximately $5.1 million, or $(0.23) per share, compared to a net loss of approximately $4.6 million, or $(0.29) per share for the third quarter of 2019.Research and development expenses totaled approximately $3.4 million for the third quarter of 2020, compared to approximately $3.2 million for the same period in 2019, an increase of approximately 5.1%.For the third quarter of 2020, general and administrative expenses were approximately $1.7 million compared to approximately $1.5 million for the third quarter of 2019, an increase of approximately 16.0%.Total operating expenses for the third quarter of 2020 were approximately $5.1 million, compared to total operating expenses of approximately $4.7 million for the same period in 2019, an increase of approximately 8.6%.As of September 30, 2020, the Company’s cash balance was approximately $22.9 million.Conference Call and WebcastThe conference call is scheduled to begin at 4:30pm ET today, November 10, 2020. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with the conference code 13713084. A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on the Company’s website for one year.About Eyenovia, Inc.Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, please visit www.eyenovia.com.About MicroLine for PresbyopiaMicroLine is a pharmacologic treatment for presbyopia. Presbyopia is the non-preventable, age related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Current treatment options are typically device-based, such as reading glasses and contact lenses. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the Company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability.About MicroPine for Progressive MyopiaMicroPine (atropine ophthalmic solution) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure.About Mydcombi for MydriasisMydcombi is Eyenovia's first-in-class fixed-combination micro-formulation product (tropicamide 1% - phenylephrine 2.5%) candidate for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 80 million office-based comprehensive and diabetic eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed for use without anesthetic, we are developing MicroStat to improve the efficacy and tolerability of pharmacologic mydriasis.About Optejet® and MicroRx Ocular TherapeuticsEyenovia's Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver 6-8 μL of drug, consistent with the capacity of the tear film of the eye. We believe the volume of ophthalmic solution administered with the Optejet is less than 75% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery, where solution is dispensed to the ocular surface in approximately 80 milliseconds, beating the ocular blink reflex. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and any potential revenue from licensing transactions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: fluctuations in our financial results; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic and uncertainties arising from the recent U.S. elections; our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19 and resulting social distancing), timing, progress and results of such trials; the timing and our ability to submit applications for, obtain and maintain regulatory approvals for our product candidates; the potential impacts of COVID-19 on our supply chain; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our ability to raise additional capital; intellectual property risks; our ability to attract and retain key personnel; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.Eyenovia Contact: Eyenovia, Inc. John Gandolfo Chief Financial Officer email@example.comEyenovia Investor Contact: Eric Ribner LifeSci Advisors, LLC firstname.lastname@example.org (646) 751-4363Eyenovia Media Contact: Diana Soltesz Pazanga Health Communications email@example.com (818) 618-5634 Eyenovia, Inc.Condensed Balance Sheets September 30, December 31, 2020 2019 (unaudited) Assets Current Assets: Cash and cash equivalents$22,864,578 $14,152,601 Deferred license costs 1,600,000 - Prepaid expenses and other current assets 903,090 196,680 Total Current Assets 25,367,668 14,349,281 Property and equipment, net 360,956 230,538 Security deposit 119,035 117,800 Total Assets$25,847,659 $14,697,619 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable$1,464,762 $1,541,358 Accrued compensation 744,555 916,873 Accrued expenses and other current liabilities 373,609 453,430 Deferred rent - current portion 7,809 - Deferred license revenue 4,000,000 - Notes payable - current portion 145,942 - Total Current Liabilities 6,736,677 2,911,661 Deferred rent - non-current portion 36,423 45,351 Notes payable - non-current portion 424,338 - Total Liabilities 7,197,438 2,957,012 Commitments and contingencies Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2020 and as of December 31, 2019 - - Common stock, $0.0001 par value, 90,000,000 shares authorized; 24,884,251 and 17,100,726 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively 2,488 1,710 Additional paid-in capital 91,881,790 69,409,949 Accumulated deficit (73,234,057) (57,671,052) Total Stockholders' Equity 18,650,221 11,740,607 Total Liabilities and Stockholders' Equity$25,847,659 $14,697,619 Eyenovia, Inc.Condensed Statements of Operations (unaudited) For the Three Months Ended For the Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Operating Expenses: Research and development$3,363,759 $3,201,196 $9,913,296 $10,778,114 General and administrative 1,728,366 1,489,739 5,669,311 5,241,608 Total Operating Expenses 5,092,125 4,690,935 15,582,607 16,019,722 Loss From Operations (5,092,125) (4,690,935) (15,582,607) (16,019,722) Other Income: Small Business Administration Economic Injury Disaster grant - - 10,000 - Interest expense (4,945) - (14,977) - Interest income 540 41,557 24,579 104,448 Net Loss $(5,096,530) $(4,649,378) $(15,563,005) $(15,915,274) Net Loss Per Share \- Basic and Diluted$(0.23) $(0.29) $(0.79) $(1.19) Weighted Average Number of Common Shares Outstanding \- Basic and Diluted 22,206,195 16,270,728 19,802,999 13,422,667
NEW YORK, NY / ACCESSWIRE / November 10, 2020 / Eyenovia, Inc.
Does high risk mean high reward? Not necessarily, so say the pros on Wall Street. Specifically citing penny stocks, or stocks that trade for less than $5 per share, analysts advise caution as these names might still be in the early innings, or it could be that they face an uphill battle that is just too steep.Luring investors with their bargain price tags, these stocks might be up against overpowering headwinds or have weak fundamentals.However, analysts argue there are early-stage companies that reflect promising opportunities, with the low share prices meaning you get significantly more bang for your buck. What’s more, even what seems like minor share price appreciation can result in massive percentage gains.The bottom line? Not all risk is created equal. To this end, the pros recommend doing some due diligence before making an investment decision.With this in mind, we turned to investment firm Roth Capital for some inspiration. The firm’s analysts have pinpointed three compelling penny stocks, noting that each could climb over 100% higher in the year ahead. Using TipRanks’ database, we found out what makes all three such exciting plays even with the risk involved. CohBar (CWBR)Focused on developing mitochondria-based therapeutics (MBTs), CohBar wants to find new treatments for diseases associated with aging and metabolic dysfunction. Based on the strength of its technology and its $0.96 share price, Roth Capital thinks that now is the time to pull the trigger.Writing for the firm, analyst Elemer Piros points out that CWBR was able to turn over 100 mitochondrial peptides into 1,000 mitochondrial-based therapeutics (MBT). Company scientists and researchers from around the world have found that mitochondrial peptides regulate multiple physiological systems, including risk factors which lead to cardiovascular and neurodegenerative diseases, obesity, diabetes, fatty liver disease fibrotic and inflammatory conditions and cancer.It should be noted that peptides are either continually or intermittently released to modulate biological functions, but it’s difficult to deliver them as therapies. Additionally, they also tend to have shorter half-lives. “CohBar developed methods to modify peptides and plan to use modified analogues for clinical development,” Piros commented.Up first for CWBR is CB4211, its optimized analog of the MOTS-c mitochondrial-derived peptide. The company’s first clinical candidate is wrapping up a Phase 1b trial in patients with fatty liver disease. According to management, there are 10 patients who will be randomized for treatment with CB4211 and 10 for placebo, with the results expected in Q1 2021.Nonalcoholic Fatty Liver Disease (NAFLD) is a condition defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver in individuals who consume little or no alcohol. What’s more, the company will also target non-alcoholic steatohepatitis (NASH), which is the most severe form of NAFLD.Piros acknowledges that competition in the space is fierce, but says “no winners can be identified, yet.” Expounding on this, the analyst stated, “CB4211 offers a yet unexplored mechanism of action, which is foundational, based on the natural control of homeostasis, which is lost due to environmental or genetic insults. The compound was derived from naturally occurring mitochondrial peptides, with the purpose of restoring, rebalancing homeostasis with the goal of reversing disease processes.”Based on the above, Piros sees an attractive risk/reward in CWBR shares. “[We] value CohBar based on a comparable universe of early- to mid-stage companies with platforms that could yield multiple drug candidates. The average enterprise value of this group of companies is $268MM vs. CohBar at $38MM. We project that CohBar shares could trade in line with the average,” the analyst concluded.To this end, Piros rates CWBR a Buy along with an $8 price target. Should his thesis play out, a potential twelve-month gain of 741% could be in the cards. (To watch Piros’ track record, click here)Overall, CWBR has a small, but vocal camp of bullish analysts with positive expectations for its stock. Out of the 2 analysts polled by TipRanks, both rate the stock a Buy. With a return potential of 557%, the stock's consensus price target stands at $6.25. (See CWBR stock analysis on TipRanks)Eyenovia (EYEN)By utilizing its patent piezo-print delivery technology, Eyenovia is developing a pipeline of micro-dose therapeutics. With shares changing hands for $3.41 apiece, Roth Capital sees an attractive entry point for investors.In October, Eyenovia announced that an affiliate of Bausch Health Companies had acquired an exclusive license in the U.S. and Canada for the investigational microdose formulation of atropine ophthalmic solution (MicroPine), designed for the reduction of myopia progression in children aged 3-12. MicroPine, which is delivered via EYEN's proprietary Optejet dispenser, is progressing through Phase 3, with the launch potentially coming in 2025.As per the terms of the agreement, Bausch will assume the oversight and expenses related to the ongoing Phase 3 CHAPERONE trial. In turn, Eyenovia will receive a $10 million upfront payment and up to $35 million in approval and launch-based milestones, along with royalties ranging from mid-single digit to mid-teen percentages of gross profit on sales in the U.S. and Canada.Roth Capital’s Jonathan Aschoff tells clients that “the deal validates the technology and the market.” He adds that this agreement and the recent Asian MicroPine deal with Arctic Vision, “combined with the roughly $25 million in R&D savings for EYEN that these two deals provide, should improve EYEN's cash flow by about $100 million over the next several years.” To this end, he argues that the company’s cash position should support its operations into 1H22.On top of this, assuming there aren’t any COVID-related delays, Aschoff believes EYEN should be able to initiate both Phase 3 VISION trials for MicroLine, its piezo-formulation of pilocarpine designed to replace reading glasses for three to four hours while addressing instillation and tolerability issues associated with traditional eye drops, by YE20. This means that trials will be able to enroll in a few weeks, and the results could be published in 2021.If that wasn’t enough, the company is planning to file the MicroStat (its mydriasis candidate) NDA by YE20, with the U.S. launch potentially coming in late 2021. “MicroStat commercialization should be aided by the current pandemic, given that physicians are more reluctant that ever before to reuse the same eyedropper for multiple patients, and with reuse generally encompassing about 20-30 patients, the eyedropper just became about 20-30 times more expensive for the physician,” Aschoff explained.It should come as no surprise, then, that Aschoff left a Buy rating and $11 price target on the stock. Given this target, shares could soar 223% in the next year. (To watch Aschoff’s track record, click here)Looking at the consensus breakdown, 2 Buys and no Holds or Sells have been issued in the last three months. Therefore, EYEN gets a Moderate Buy consensus rating. Based on the $8.50 average price target, shares could gain 150% in the coming months. (See EYEN stock analysis on TipRanks)Boqii Holding (BQ)Last but not least we have Boqii Holding, which operates the largest online platform for pet products in China, with its primary focus on online retail through third-party Chinese online platforms and its own e-commerce site (Boqii Mall). Currently going for $4.45 apiece, Roth Capital believes its share price presents a chance to get in on the action.Representing the firm, analyst Darren Aftahi told clients, “BQ represents an early-stage opportunity for investors to gain exposure to China’s leading ecosystem for all things pets, which uniquely blends ‘community’ and ‘commerce’ into an omni-channel, verticalized online and offline platform.”Part of what makes BQ so compelling is that although it primarily operates as an e-commerce company, it boasts an omni-channel, verticalized platform for pet products, in Aftahi’s opinion. Additionally, the company has integrated into offline channels like pet stores and hospitals. The analyst argues this not only expands the consumer access points, but the online community also keeps users engaged with various forms of content and marketing, “enhancing overall platform value to end customers.”According to Frost & Sullivan, China’s pet population growth is projected to be among the fastest over the next several years, with it expected to match U.S. ownership (400 million pets) by 2024 from approximately one-third that rate currently. “We believe BQ can see accelerated growth when we layer on the continued adoption of e-commerce spend, with online pet retail spend expected to reach 52% of total pet retail by 2024,” Aftahi commented.It should be noted that over 60% of sales come from BQ stores on third-party sites like Tmall, JD.com and Pinduoduo, which Aftahi thinks “broadens BQ’s brand reach.”Offering further explanation, the analyst stated, “These sites are often the initial touchpoint, and users can then be funneled into BQ’s online community for re-targeting, giving BQ an upper hand in customer ownership. In our view, BQ is set to capture growth from the shift to e-commerce, diversified across access points, but under the BQ brand regardless.”Everything that BQ has going for it prompted Aftahi to keep his Buy rating as is. Along with the call, he leaves the price target at $10, suggesting 123% upside potential. (To watch Aftahi’s track record, click here)When it comes to other analyst activity, it has been quiet. As Aftahi is the only analyst that has published a review recently. (See BQ stock analysis on TipRanks)To find good ideas for penny stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.