8-K
Lipella Pharmaceuticals Inc. (LIPO)
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UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 11, 2023
Lipella Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 005-93847 | 20-2388040 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation) | (Commission File Number) | (IRS Employer<br><br>Identification No.) |
| 7800 Susquehanna St., Suite 505<br><br>Pittsburgh, PA | 15208 | |
| --- | --- | |
| (Address of registrant’s principal executive office) | (Zip code) |
Registrant’s telephone number, including area code: (412) 901-0315
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications<br>pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br>to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications<br>pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications<br>pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br><br>registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | LIPO | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
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Reference is made to the disclosure in Item 8.01 of this Current Report on Form 8-K (this “Form 8-K”), which disclosure is incorporated herein by reference. The Press Release (as defined below) and the Investor Presentation (as defined below) are furnished herewith as Exhibits 99.1 and 99.2, respectively, and incorporated herein by reference.
The information contained in this Form 8-K under Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is deemed to be ”furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference to this Form 8-K in such filing. The information set forth in this Item 7.01 of this Form 8-K and Exhibits 99.1 and 99.2 attached hereto shall not be deemed an admission as to the materiality of any information in this Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.
| Item 8.01 | Other Events. |
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On January 11, 2023, Lipella Pharmaceuticals Inc. (the “Company”), issued a press release (the “Press Release”) announcing results for LP-10 Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for hemorrhagic cystitis and commenced using an investor presentation (the “Investor Presentation”) in connection with presentations to prospective investors, analysts and others and expects to post such presentation on its website at https://lipella.com/wp-content/uploads/2023/01/Lipella-Biotch-Showcase-2023-Deck-4881-8628-2045.1.pdf. Information contained on the Company’s website is not incorporated by reference into this Form 8-K and should not be considered to be part of this Form 8-K. The Press Release and the Investor Presentation are attached hereto as Exhibits 99.1 and 99.2, respectively, and incorporated herein by reference.
Forward-LookingStatements
Exhibits 99.1 and 99.2 attached hereto contain, and may indicate, forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and as defined in the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the Company’s future activities, or future events or conditions, including without limitation, those statements relating to the Company’s clinical trial results for LP-10 in its Press Release and Investor Presentation attached hereto, or the Company’s clinical trials and/or trial results for its other products now or in the future, which can be identified by terminology such as “may,” “will,” “expects,” “anticipates,” “aims,” “potential,” “future,” “intends,” “plans,” believes,” “estimates,” “continue,” “likely to,” and other similar expressions intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are not historical facts and are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by its management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict, many of which are beyond the Company’s control. Any forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date of this Form 8-K, except as required by applicable law.
| Item 9.01 | Financial Statements and Exhibits. |
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(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release, dated January 11, 2023. |
| 99.2 | Lipella Pharmaceuticals Inc. Biotech Showcase 2023. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: January 11, 2023 | Lipella Pharmaceuticals Inc. | |
|---|---|---|
| By: | /s/ Jonathan Kaufman | |
| Name: Jonathan Kaufman<br><br>Title: Chief Financial Officer |
Exhibit 99.1
LipellaPharmaceuticals Announces Successful Top Line Results of Phase 2A Clinical Trial of LP-10
Resultsto be Presented at BIOTECH SHOWCASE^TM^ 2023 on Wednesday, January 11^th^ at 2:00pm PST
Pittsburgh, PA -- January 11, 2023 – Lipella Pharmaceuticals Inc. (Nasdaq: “LIPO”) (“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 top line results of the Company’s recently completed Phase 2a clinical trial evaluating the safety and efficacy of its drug candidate LP-10 for Hemorrhagic Cystitis, a rare but highly morbid disease for which there are currently no FDA approved treatments.
Jonathan Kaufman, Chief Executive Officer, will present a corporate overview including the top-line results, at Biotech Showcase 2023™ on Wednesday, January 11th at 2:00pm PST at the Hilton San Francisco - Union Square, 333 O'Farrell Street, San Francisco, CA.
“The successful completion of the Phase 2a clinical trial of LP-10 is a critical milestone in Lipella’s development,” said Jonathan Kaufman, Ph.D., Chief Executive Officer of Lipella. “We’re gratified with the results and look forward to our next step, which will be to communicate with the FDA on the study’s results and the pathway forward to seeking regulatory approval for LP-10. The achievement of this milestone brings Lipella one step closer to providing a first-in class treatment for the cancer survivor community with hemorrhagic cystitis.”
Aboutthe LP-10 Phase 2a Trial and Top Line Results
The LP-10 Phase 2a clinical trial was a multi-center, dose-escalation study (clinicaltrials.gov: NCT01393223). The study recruited 13 subjects with moderate to severe refractory hemorrhagic cystitis. These subjects were treated with up to two courses of LP-10 intravesical bladder instillations.
The top line results indicated:
| • | All<br> subjects tolerated LP-10 instillations and completed the study without report of product<br> related serious adverse events. |
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| • | LP-10<br> pharmacokinetic analysis demonstrated short duration of systemic uptake. |
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| • | A<br> dose response was noted and there were |
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| ° | Decreased<br> hematuria |
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| ° | Decreased<br> cystoscopic bleeding and ulceration sites |
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| ° | Improved<br> patients’ urinary symptoms |
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| • | Responder<br> analysis noted complete response in 3 subjects, partial response in 7 subjects and no response<br> in 3 subjects. |
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| 1 |
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AboutHemorrhagic Cystitis
Lipella received Orphan Disease Designation LP-10 for the treatment of moderate to severe hemorrhagic cystitis, a disease with great unmet need and no currently approved drug treatment. Radiation used to treat prostate, colon, uterine, cervical and other pelvic cancers can cause chronic, painful urinary inflammation and blood loss called radiation hemorrhagic cystitis. Certain chemotherapies (such as cyclophosphamide) can also cause this painful form of urinary bleeding. The blood loss associated with hemorrhagic cystitis can lead to surgery and can be fatal.
AboutLipella Pharmaceuticals Inc.
Lipella is 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. We believe that this strategy combines many of the cost efficiencies and risk abatements derived from using existing generic drugs with potential patent protections for our proprietary formulations; this strategy allows us to expedite, protect, and monetize our product candidates. Additionally, we maintain a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists, believing that this focus can potentially help reduce the cost, time and risk associated with obtaining marketing approval. For more information, please visit: www.lipella.com
Forward-LookingStatements
This press release contains forward-looking statements. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the completion, timing and anticipated size of Lipella's initial public offering and the expected commencement of trading on the Nasdaq Capital Market.
Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, completion of Lipella's initial public offering on the anticipated terms, or at all, market conditions and the satisfaction of customary closing conditions related to such initial public offering. These and other risks concerning our product candidates and operations are described in additional detail in the Registration Statement on file with the SEC. We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.
IRContact Details:
Chuck Harbey
PCG Advisory
150 East 58th Street 16th Floor
New York, NY 10155 U.S.
Ph: (646) 863-6341
Email: charbey@pcgadvisory.com
CompanyContact Details:
Info@Lipella.com
1-412-894-1853
Exhibit 99.2
Liposomal Drug Delivery to Mucosal Surfaces Biotech Showcase 2023TM January 11, 2023 Wednesday, 2:00 PM ET Track: Yosemite A (Ballroom Level) (Nasdaq: LIPO) 1
2 Disclaimers Forward-Looking Statements The information in this presentation is being provided so you can familiarize yourself with Lipella Pharmaceuticals Inc. (together with its subsidiaries, “Lipella” the “Company,” “we,” “us,” or “our”) during this informational meeting. The presentation includes certain “forward-looking statements.” All statements, other than statements of historical fact, included in this presentation regarding, among other things, our strategy, future operations, financial position, anticipated dividends, projected costs, prospects, pipeline and opportunities, sources of growth, successful implementation of our proprietary technology, plans and objectives are forward-looking statements. Forward-looking statements can be identified by words such as “may,” “will,” “could,” “continue,” “would,” “should,” “potential,” “target,” “goal,” “anticipates,” “intends,” “plans,” “seeks,” “believes,” “estimates,” “predicts,” “expects,” “projects” and similar references to future periods. Forwardlooking statements are based on our current expectations and assumptions regarding future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short- and long-term business operations and objectives, and financial needs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. We caution you, therefore, against relying on any of these forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. There are risks, uncertainties and other factors, both known and unknown, that could cause actual results to differ materially from those in the forward-looking statements which include, but are not limited to, regional, national or global political, economic, business, competitive, market and regulatory conditions, and other factors. Any forward-looking statement made by us is based upon the reasonable judgment of our management at the time such statement is made and speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any forwardlooking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law. Nothing contained herein is, or shall be relied upon as, a promise or representation as to the past or future. The Company expressly disclaims any and all liability relating to or resulting from the use of this presentation. In addition, the information contained in this presentation is as of the date hereof, and the Company has no obligation to update such information, including in the event that such information becomes inaccurate. You should not construe the contents of this presentation or other information we provide at this meeting as legal, tax, accounting or investment advice or a recommendation. You should consult your own counsel and tax and financial advisors as to legal and related matters concerning the matters described herein. (Nasdaq: LIPO)
Executive Summary Emerging, clinical-stage, proprietary 505(b)(2) opportunity Overview of Opportunity LP-10 is a phase-2a, 505(b)(2) drug candidate for hemorrhagic cystitis A platform proprietary drug delivery technology optimized for use with epithelial tissue Issued patents in US, Canada, and Australia (valid to 2034), and an application pending in Europe. Potential applications include bladder, urethra, oral cavity, esophageal, and colonic The LP-10 drug candidate for hemorrhagic cystitis has orphan drug designation from the FDA Completion of LP-10’s open-label, dose-ranging, phase 2(a) clinical trial is expected in 4Q 2022 LP-10 peak annual revenue estimates in hemorrhagic cystitis exceed $1 billion LP-10 is developed by an experienced management team having decades of biotech industry experience Drug-Delivery Focused Biotech Impressive Revenue Potential (4) American Cancer Society Cancer Treatment and Survivorship Fact and Figures 2019-2021, (5) based on the Company’s 30% estimate (6) 8% estimate, (7) based on the Company’s estimate, (8) $20,000 average revenue per each of an estimated 60,000 patients treated per year. (Nasdaq: LIPO) 3
Company History Born out of an NIH funded research collaboration on liposomal drug delivery to become a clinical-stage pharmaceutical company with a growing pipeline. 2005 2007 2008 2010 2019 2021 2021 2022 2012 2020 2021 2022 Platform patent awarded Jonathan Kaufman co-founds Lipella Michael Chancellor joins Management Michele Gruber Operations initial NIH funding received LP-10 FDA Orphan Designation LP-10 FDA IND Approval Janet Okonski Clinical Director Doug Johnston VP. Finance FDA advice re. LP-310 8 clinical sites initiated ongoing LP-10 recruitment 4 (Nasdaq: LIPO)
Hemorrhagic Cystitis, Uncontrolled Urinary Blood Loss Hemorrhagic cystitis is a serious, life-threatening bladder damage from pelvic radiation therapy and/or bladder-toxic chemotherapy. Millions of patients are increasingly diagnosed with pelvic malignancies including prostate cancer, and cancers of the uterine corpus, requiring treatment. 20% of such patients receive pelvic radiation therapy during the treatment of their cancer, in addition to surgery and chemotherapy. An increasing US population is surviving cancer therapies, including pelvic radiation, and chemotherapies that damage DNA. Years after receiving treatment, many patients acquire hemorrhagic cystitis, uncontrolled bladder blood loss. Hemorrhagic cystitis is a potentially chronic, highly morbid condition with no approved drug therapy, and a four percent mortality rate. (Nasdaq: LIPO) 5
Prostate Cancer Cancer Survivorship & Hemorrhagic Cystitis Expected annual revenue per patient is $20,000 Market penetration of 60,000 patients (45%) yields $1.2 billion annual revenue The current phase-2a is focused on radiation cystitis. LP-10 is also expected to address hemorrhagic cystitis from chemotherapy. Breast Cancer Leukemia & Lymphoma Other Tumors Uterine Corpus Cancers Rectal & Other Pelvic Pelvic Radiation Survivors Pelvic Radiation Survivors Pelvic Radiation Survivors 700,0001 200,0001 300,0001 x-DNA Chemotherapy Survivors x-DNA Chemotherapy Survivors x-DNA Chemotherapy Survivors 360,0001 180,0001 60,0001 Severe HC Survivors Severe HC Survivors Severe HC Survivors Severe HC Survivors Severe HC Survivors Severe HC Survivors 42,0002 12,0002 18,0002 36,0002 18,0002 6,0002 6 (1) American Cancer Society Cancer Treatment and Survivorship Fact and Figures 2019-2021. (2) Based on the Company’s estimate. (Nasdaq: LIPO)
LP-10 for Hemorrhagic Cystitis LP-10 : Liposomal tacrolimus for hemorrhagic cystitis, phase-2a drug candidate Economics Indication Technology Platform technology Serious condition Large economics Serious and life threatening Orphan designation No adequate therapy High morbidity 505(b)(2) focus Liposomal tacrolimus Patent protection through 2034 Cancer survivorship Hemorrhagic cystitis 7 (Nasdaq: LIPO)
LP-10 Stops Bleeding via Two Modes of Action Tacrolimus’ molecular mechanism includes calmodulin mediated t-cell inhibition • LP-10 is a potent vasoconstrictor • reduces blood flow to the bladder lumen • LP-10 is a potent anti-inflammatory • Reduces tissue injury in the bladder Well-known pharmacologic mechanisms increase the probability of efficacy. Reduce capillary blood flow Inhibits cytokine cascade Increased efficacy probability 8 (Nasdaq: LIPO)
LP-10 Product Form Liposomal tacrolimus treatment for hemorrhagic cystitis Sterile powder Easy to deliver In-house CMC Low COGS 9 (Nasdaq: LIPO)
LP-10 Expected Regulatory Pathway Given the severity of the disease and the lack of adequate treatment, we anticipate that LP-10 will be a good candidate for multiple accelerated regulatory pathways. LP-10 Regulatory Pathway Reformulated generic with new IP Fast-track designation candidates Breakthrough therapy candidates LP-10 Development Progress Ongoing phase-2a Dose escalation Multiple active sites Safety and efficacy endpoints 505(b)(2) approval pathway 10 (Nasdaq: LIPO)
LP-10: an Outstanding Drug Candidate Multiple reasons increase LP-10 probability of success Well known mechanism of action Pre-clinical efficacy 505(b)(2) pathway FDA Orphan Designation US FDA IND approval Ongoing clinical evidence Potential $1.2 billion revenue Accelerated pathway candidate 11 (Nasdaq: LIPO)
Asset Pipeline and LP-310 LP-310: Liposomal tacrolimus for oral lichen planus Oral rinse formulation of LP-10 Increased local concentration in oral cavity while minimalizing systemic toxicity 505(b)(2) pathway, platform technology expansion Low COGS and fast development plan Large market size opportunity (6 million US) with no current approved therapy Comparator: AFYX’s buccal steroid patch in Phase 3 trial Completed Type B pre-IND meeting (PIND 155011) April 08, 2021 IND preparation for Phase 2a multicenter dose escalation study LP-310 Oral Lichen Planus Mouth Rinse 12 Product Candidate Target Indication Preclinical Phase 1 Phase 2 Phase 3 Next Anticipated Milestone Report top-line Jan 11, 2023 IND submission 3Q23 LP-10 LP-310 Oral Lichen Planus Hemorrhagic Cystitis Marketing Approval (Nasdaq: LIPO)
Key inclusion criteria: Key Exclusion criteria: LP-10 Phase 2a Trial Design Summary 13 1. Males and females, at least 18 years 2. History of sterile moderate to severe HC (Grades 2-4) for at least 3 months with at least 1 episode of hematuria with or without clot 3. Previous use of medications and/or treatment(s) for HC symptom relief 1. Patients taking immunosuppressive therapy 2. History of interstitial cystitis/bladder pain syndrome or hemorrhagic cystitis due to infection (bacterial, viral or fungal) 3. Life expectancy less than 12 months 4. PSA > 4 ng/ml (measured within the last 3 months) The primary efficacy endpoint of LP-10 therapy will be evaluated by assessing pre-post treatment changes in hematuria at baseline and primary endpoint at 1 week, and 2 weeks after final instillation The primary safety endpoint is the incidence of treatment-related serious adverse events (SAEs) and the incidence of protocol-defined treatment or procedure related adverse events associated with the use of LP-10 as well as assess the pharmacodynamic (PD) effects and pharmacokinetic (PK) profile The top line data (additional slides) to be presented in-person at Biotech Showcase 2023 on Wednesday, January 11, 2023 at 2:00PM (5:00 PM/EST) Track: Yosemite A (Ballroom Level) Hilton San Francisco - Union Square, 333 O'Farrell Street, Ballroom Level, San Francisco, CA 94102 (Nasdaq: LIPO)
LP-10 Development Team LP-10 is developed by an experienced team with complementary skillset and years of experience working together. Jonathan Kaufman, PhD Michael Chancellor, MD Michele Gruber Janet Okonski Chief Executive Officer Chief Medical Officer Director of Operations Director Clinical Operations Co-founded Lipella in 2005 Co-founder of Knopp Biosciences. CFO of Semprus Biosciences. CSO LaunchCyte LLC. PhD Penn. MBA Wharton. 23+ Years Experience Lipella co-founder. Joined Lipella in 2008 Co-founder of Cook- Myosite. Professor of Urology, William Beaumont Medical Center. MD University of Michigan. 30+ Years Experience Joined Lipella in 2009 CMC development, facilities, R&D management. BS Carnegie Mellon 12+ Years Experience Joined Lipella in 2021 Clinical trial management, safety monitoring BS Indiana University of Pennsylvania 20+ Years Experience 14 (Nasdaq: LIPO)
Liposomal Drug Delivery to Mucosal Surfaces 15 (Nasdaq: LIPO)
16 Lipella Pharmaceuticals Inc. 7800 Susquehanna Street, Suite 505 Pittsburgh, PA 15208 412-894-1853 www.lipella.com (Nasdaq: LIPO)