(LIPO) Has 4 Key Potential Catalysts To Note Ahead Of The Opening Bell (Nasdaq Tiny Float Idea)

Let's dive in head first with a little history lesson. (LIPO) Has 4 Key Potential Catalysts To Note Ahead Of The Opening Bell (Nasdaq Tiny Float Idea) December 21st Dear Reader, Let's dive in head first with a little history lesson. At the beginning of the month, the Nasdaq was trading at over $11.4K. Since then, it has dropped nearly $1K down to roughly $10.4K (on Monday). Woof. That said, I've been able to spot 3 separate Nasdaq, short term champs since the start of December. Here's what you may have missed: Champ #1: Delivered after closing December 5th at $7.80, it hit $8.95 the following day (approx. $1.00+ move). Champ #2: Brought to your attention after closing Friday, December 9th at $2.86, this profile surged to a Monday high of $3.58 (approx. 25% move). Champ #3: After closing December 13th at $1.90, this Nasdaq idea popped to a $2.24 high a few sessions later (approx. 17% move). But that was then and this is now. Now it's time to turn to a profile with a low float under 2Mn shares that is coming off an IPO that saw them join the Nasdaq Global Market (major exposure could follow). Pair that knowledge with the fact that this Biotech just announced in their S-1 filing that they could eventually be looking at over $1Bn in gross revenue if the treatment they are working on proves successful. That's why there is only one Nasdaq profile to have at the top of your watch-list Wednesday: *Lipella Pharmaceuticals Inc. (LIPO)* Lipella Pharmaceuticals a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. And right now, LIPO has 4 potential breakout catalysts to know before Wednesday's opening bell. Check them out: No. 1 - Joining The Nasdaq Global Market Could Provide Game-Changing Global Exposure No. 2 - A Low Float Could Allow For Mind-Blowing Volatility No. 3 - 2 Massive Addressable Markets (LP-10 and LP-310) No. 4 - Could A Future FDA Approval Draw The Spotlight Of Spotlights On LIPO? But more on those in a second... Lipella Pharmaceuticals Overview (1) As mentioned above, Lipella is a clinical-stage biotech company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. They believe that this strategy combines many of the cost efficiencies and risk abatements derived from using existing generic drugs with potential patent protections for their proprietary formulations; this strategy allows them to expedite, protect, and monetize their product candidates. Additionally, they maintain a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. The company believes that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval. Consistent with their strategy, the initial indication that they are currently addressing is “hemorrhagic cystitis,” which is chronic, uncontrolled urinary blood loss that results from certain chemotherapies (such as alkylating agents) or pelvic radiation therapy (also called “radiation cystitis”). Many radiation cystitis patients experience severe morbidity (and in some cases, mortality), and currently, there is no therapy for their condition approved by the FDA, or, to our knowledge, any other regulatory body. LP-10 is the development name of the company's reformulation of tacrolimus (an approved generic active agent) specifically optimized for topical deposition to the internal surface of the urinary bladder lumen using a proprietary drug delivery platform that they have developed and that they refer to as their Platform. They are developing LP-10 and their Platform to be, to their knowledge, the first drug candidate and drug delivery technology that could be successful in treating cancer survivors who acquire HC. The company expects to report summary results from LP-10’s phase 2a clinical trial in the fourth quarter of 2022. In a second program, the company is developing another product candidate, LP-310, which employs a formulation similar to LP-10 and is intended to treat OLP. OLP is a chronic, T-cell-mediated, autoimmune oral mucosal disease, and LP-310 contains tacrolimus which inhibits T-lymphocyte activation. OLP can also be a precursor to cancer, predominately squamous cell carcinoma, with a malignant transformation rate of approximately one percent. LP-310 is the development name of oral, liposomal formulation of tacrolimus (the same approved generic active agent in LP-10) specifically optimized for local delivery to oral mucosa. Lipella has completed a pre-IND meeting with the FDA and intend to submit the full IND to the FDA for LP-310 in the first half of 2023. The company's Platform includes proprietary drug delivery technologies optimized for use with epithelial tissues that coat lumenal surfaces, such as the colon, the various tissues lining the mouth and esophagus and the tissues lining the bladder and urethra. The Company has two issued patents in the U.S. that should exclude competitors from making, selling or using their LP-10 and LP-310 formulations in the U.S. until July 11, 2035. They also have issued patents in Australia and Canada that do not expire until October 22, 2034. Corresponding patent applications are pending in the U.S. and the European Patent Offices. They also have a pending U.S. patent application on an improvement to the technology. LIPO - Company Strategy The company shares, to its knowledge, that they are currently developing the first drug candidate and proprietary drug delivery platform that could be successful in treating cancer survivors who acquire HC and they intend to apply their proprietary drug delivery technology to the oral mucosa for the treatment of OLP. LIPO's development programs are designed to address opportunities for capital efficient drug discovery and development, especially research programs that reposition existing therapeutics for new indications that exploit new formulations. The key elements of the strategy that LIPO is employing to achieve their goals are: - Advance the development of their lead product candidate, LP-10, to treat HC patients. - Leverage their differentiated research and discovery approach to expand their product candidate pipeline. - Maximize the clinical impact and value of their pipeline by relying on the 505(b)(2) regulatory pathway and, accordingly, deliver value to the stockholders. - Continue to seek new therapies for rare diseases that can be evaluated with relatively small clinical trials, with an intent to minimize clinical development costs. LIPO's Pipeline (2) ----- And as I mentioned above, LIPO has multiple potential catalysts to know right now. Check them out: No. 1 LIPO Potential Catalyst - Joining The Nasdaq Global Market Could Provide Game-Changing Global Exposure Nasdaq listing news could become a major breakout catalyst for LIPO near term and into 2023. Filed on 12/15/22, an [S-1 Registration]( and IPO paperwork has been filed with the SEC for Lipella Pharmaceuticals, Inc. (LIPO) to begin trading on the Nasdaq exchange under the ticker symbol "LIPO." What could happen from this? Exposure. With the Nasdaq Global Market being one of the most watched markets worldwide, tons of new eyes will be recognizing this company's existence for the first time. Where they go from there... ----- No. 2 LIPO Potential Catalyst - A Low Float Could Allow For Mind-Blowing Volatility According to its [S-1 filing]( LIPO has an incredibly low float. The S-1 filing shares that there are approximately 1.16Mn IPO shares available. 1.16Mn! That's tiny. Why is that important? It's important on one crucial level. Volatility. Could more positive company news before the end of the year help provide the fuel for a near term spark combined with this potential volatility? ----- No. 3 LIPO Potential Catalyst - 2 Massive Addressable Markets (LP-10 and LP-310) (1) LP-10 has been designed for the approximately one million cancer survivors in the United States today who have had pelvic radiation therapy and are at risk for HC. Based on the managed care database study that LIPO sponsored in 2012 as part of their approved request for FDA “orphan drug” designation of tacrolimus for HC, approximately 72,000 of these patients annually experience severe chronic bladder bleeding that is often fatal. LP-10 has been developed to address this form of bleeding, as well as bladder bleeding associated with breast cancer patients who are taking systemic cyclophosphamide or ifosfamide, leading to chemotherapy-related cystitis experienced by an estimated 60,000 patients annually in the United States, inferring an addressable market in excess of 120,000 patients annually. If clinical development is successful and LIPO receives marketing approval for LP-10, they estimate the average LP-10 price to exceed $20k per patient-year domestically. LIPO estimates the peak demand, at this price, to be approximately 60,000 patients annually, which represents an approximate 50% market penetration in the U.S. Based on such price and demand estimates, we believe there is potential to receive up to $1.2Bn in annual gross revenue. If clinical development is successful and LIPO receives marketing approval for LP-310, based upon the economics of existing oral cavity drug products, they project that the treatment of OLP will cost approximately $4k annually per patient. Most OLP patients are treated by dentists, who are relatively accessible compared to other medical specialists (in the United States there are approximately 200,000 dentists and ENT physicians). Given the absence of FDA approved treatment of OLP, LIPO estimates revenue of approximately $4k per course of therapy, resulting in a total addressable market that exceeds $980Mn. ----- No. 4 LIPO Potential Catalyst - Could A Future FDA Approval Draw The Spotlight Of Spotlights On LIPO? The FDA approves new human drugs and biological products. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use. LP-10’s Regulatory Status - In 2019, the company completed the required manufacturing and toxicology program to submit an IND request to the FDA to begin testing LP-10 in human subjects. - LIPO submitted the IND request in September 2019 and received approval from the FDA within 30 days of submission to begin a clinical study involving LP-10. - LIPO expects to report summary results from LP-10’s phase 2a clinical trial in the fourth quarter of 2022. LP-10’s FDA “Orphan Drug” Designation Status - In 2010, the company submitted a request to the FDA for “orphan drug” designation covering LP-10 and subsequently received approval for such designation in July 2012. - This provides LIPO with marketing exclusivity and permits them to benefit from shorter FDA review periods and reduced regulatory fees for LP-10. With LP-10 appearing to trend in the right direction, could a future (potential) FDA approval put a major spotlight on LIPO? And if that happens, wouldn't it make sense to have this little-known profile on your radar ahead of this potential game-changing catalyst? ----- LIPO Recap - 4 Potential Catalysts For This New Nasdaq Breakout Idea No. 1 - Joining The Nasdaq Global Market Could Provide Game-Changing Global Exposure No. 2 - A Low Float Could Allow For Mind-Blowing Volatility No. 3 - 2 Massive Addressable Markets (LP-10 and LP-310) No. 4 - Could A Future FDA Approval Draw The Spotlight Of Spotlights On LIPO? ----- Coverage is officially initiated on LIPO. When time permits, do this: Get LIPO on your radar now. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer [Source 1]( [Source 2]( (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Ownership of FI has now moved to a single individual. Disclosure: I am not a lic-ensed fina-ncial adviser. 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