*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)