OUR NEW PROFILE IS: (NASDAQ: LIPO)
Today is the First Day the LIPO is Trading
We have another exciting situation in front of us for today’s session.
Pull up LIPO immediately.
This one just IPO’d and today is the first day of trading.
These first few sessions after a company IPO’s can be volatile with double digit swings one way or another so watch it close.
Lipella is a biotechnology company with a focus on supportive care to cancer survivors who acquire hemorrhagic cystitis, also called radiation cystitis, when hemorrhagic cystitis occurs after pelvic radiation, as well as improved surveillance and imaging of patients with a history of transitional cell carcinoma. We are also applying our proprietary drug delivery to the oral mucosa for the treatment of oral lichen planus.
Their lead product, LP-10 for hemorrhagic cystitis is currently in a phase-2, multi-center clinical trial, and our pipeline asset, LP-310, recently received FDA Type-B Pre-IND guidance. They maintain a pipeline of additional product candidates consistent with their strategy of developing proprietary 505(b)(2) assets that address highly-morbid indications where no adequate treatment(s) exists.
They are 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.
Their two lead product candidates are:
-LP-10, which we are developing to treat “hemorrhagic cystitis” (“HC”), 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 U.S. Food and Drug Administration (“FDA”), or, to our knowledge, any other regulatory body. LP-10 is the development name of our 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 we have developed and that we refer to as our metastable liposome drug delivery platform (our “Platform”). We are developing LP-10 and our Platform to be, to our knowledge, the first drug candidate and drug delivery technology that could be successful in treating cancer survivors who acquire HC. We expect to report top-line data from LP-10’s Phase 2a clinical trial in the fourth quarter of 2022.
–LP-310, which we are developing to treat oral lichen planus (“OLP”). OLP is a chronic T-cell-mediated autoimmune oral mucosal disease, and LP-310 contains tacrolimus, which inhibits T-lymphocyte activation. Symptoms of OLP include painful burning sensations, bleeding and irritation with tooth brushing, painful thickened patches on the tongue, and discomfort when speaking, chewing or swallowing. These symptoms frequently cause weight loss, nutritional deficiency, anxiety, depression and scarring from erosive lesions. OLP can also be a precursor to cancer, predominately squamous cell carcinoma, with a malignant transformation rate of approximately 1 percent. LP-310 is the development name of our oral liposomal formulation of tacrolimus (the same approved generic active agent in LP-10) specifically optimized for local delivery to oral mucosa. We believe that our approach of using metastable liposomal tacrolimus as a treatment for OLP is novel. To date, upon review of relevant FDA public data resources on approved drugs and biologics, we are not aware of any other liposomal products developed to treat such disease. We have completed a pre-investigational new drug (“IND”) meeting with the FDA and intend to submit the full IND application to the FDA for LP-310 in the first half of 2023.
Our Platform includes proprietary drug delivery technologies optimized for use with epithelial tissues that coat lumenal surfaces such as 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 our LP-10 and LP-310 formulations in the U.S. until July 11, 2035. We also have an issued patent in Australia that does not expire until Oct. 22, 2034. A corresponding patent application in Canada has been allowed. Corresponding patent applications are pending in the U.S. and European Patent Offices.
Lipella Pharmaceuticals Announces Pricing of Initial Public Offering of Common Stock
PITTSBURGH, Dec. 19, 2022 /PRNewswire/ — Lipella Pharmaceuticals, Inc. (“Lipella,” “our, “us” or the “Company”), 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, today announced the pricing of its initial public offering of 1,217,391 shares of its common stock at a price to the public of $5.75 per share. The gross proceeds from the offering to Lipella, before deducting underwriting discounts and other offering expenses payable by Lipella, are expected to be approximately $7 million. In addition, the underwriters have been granted a 45-day option to purchase up to an additional 182,608 shares of common stock, at the initial public offering price, less underwriting discounts.
The shares are expected to begin trading on The Nasdaq Capital Market on December 20, 2022, under the ticker symbol “LIPO” and the offering is expected to close on December 22, 2022, subject to customary closing conditions.
Spartan Capital Securities, LLC is acting as sole book-running manager for the offering. Northland Securities, Inc. is acting as the qualified independent underwriter for the offering.
The offering is being made only by means of a prospectus. Copies of the final prospectus, when available, will be filed with the U.S. Securities and Exchange Commission (“SEC”) and will be available on the SEC’s website at www.sec.govand may be obtained from: Spartan Capital Securities, LLC, Attn.: Prospectus Department, 45 Broadway, 19th Floor, New York, NY 10006, by telephone at (212) 293-0123 or by email at firstname.lastname@example.org.
The shares of common stock described above are being offered by Lipella pursuant to a registration statement on Form S-1, as amended (File No. 333- 266397), declared effective by the SEC on December 19, 2022 (the “Registration Statement”). This press release shall not constitute an offer to sell or the solicitation of an offer to buy such shares, nor shall there be any sale of such shares in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Dr. Kaufman co-founded Lipella, helped co-found Knopp Biosciences, which signed a deal with Biogen Idec for $345M, and served as CFO of Semprus Biosciences, which sold to Teleflex for $80M. Prior to academia, Dr. Kaufman held leadership positions Merck’s & Co. Inc., and served as consultant to Smithkline Beecham (now GSK).
Dr. Kaufman earned his PhD in Biophysics from the University of Pennsylvania School of Medicine and his MBA in Finance from the Wharton School.
As an internationally recognized expert in the treatment of urinary bladder dysfunction, Dr. Michael Chancellor is a key opinion leader in the field. He has conducted over 75 clinical trials and has consulted with numerous biotech companies developing urology products. He has extensive experience in clinical trial design and FDA communications.
A board-certified urologist, Dr. Chancellor earned his MD from the University of Michigan.