0001347242 true For the purpose of correcting the investor presentation furnished as Exhibit 99.2. 0001347242 2023-01-11 2023-01-11 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K/A

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 2, 2023 (January 11, 2023)

 

Lipella Pharmaceuticals Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   005-93847   20-2388040
(State or other jurisdiction
of incorporation)		   (Commission File Number)   (IRS Employer
Identification No.)

 

7800 Susquehanna St.,Suite 505

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 pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which
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. ☐

 

 

 

 

Explanatory Note

 

This Current Report on Form 8-K/A is being filed as an amendment (this “Amendment No. 1”) to the Current Report on Form 8-K filed by Lipella Pharmaceuticals Inc. (the “Company”) with the U.S. Securities and Exchange Commission on January 12, 2023 (the “Original Filing”), solely for the purpose of correcting the investor presentation furnished as Exhibit 99.2 thereto (the “Investor Presentation”). The Original Filing mistakenly included an earlier version of the Investor Presentation and did not include the version that was used at the presentation, which included additional slides.

 

The information contained in this Amendment No. 1, including Exhibit 99.1 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 (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference to this Amendment No. 1 in such filing. The information set forth in this Amendment No. 1 and Exhibit 99.1 attached hereto shall not be deemed an admission as to the materiality of any information in this Amendment No. 1 that is required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Forward-Looking Statements

 

Exhibit 99.1 attached hereto contains, 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 the updated Investor Presentation attached as Exhibit 99.1 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 Amendment No. 1, except as required by applicable law.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   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: February 2, 2023 Lipella Pharmaceuticals Inc.  
       
  By:  /s/ Jonathan Kaufman  
   

Name: Jonathan Kaufman

Title:   Chief Executive Officer

  

 

 

 

Exhibit 99.1

 

 
Biotech Showcase 2023 San Francisco, CA January 11, 2003
 
Liposomal Drug Delivery to Mucosal Surfaces1
 
 
 
 

 
Disclaimers
 
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. We request that you keep any information we provide at this meeting confidential and that you do not disclose any of the information to any other parties without the Company’s prior express written permission. Although the Company believes the information contained herein is accurate in all material respects, the Company does not make any representation or warranty, either express or implied, as to the accuracy, completeness or reliability of the information contained in this presentation.
 
Forward-Looking Statements
 
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. Forward-looking 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 forward-looking 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.
 
2
 
 
 
 

 
Executive Summary
 
Emerging, clinical-stage, proprietary 505(b)(2) opportunity
 
Overview of Opportunity Drug-Delivery Focused Biotech
 
505(b)(2) Optimized for
 
LP-10 is a phase-2a, 505(b)(2) drug candidate for  epithelial tissues
 
hemorrhagic cystitis Patented liposomal  Lower systemic local drug delivery drug exposure
 
A platform proprietary drug delivery technology optimized for use with epithelial tissue efficient development strategy NDA
 
Issued patents in US, Canada, and Australia (valid to  Potential for accelerated 2034), and an application pending in Europe.  Pilot manufacturing approval pathways
 
Transferrable CMC Approved phase-2a IND
 
Potential applications include bladder, urethra, oral cavity, esophageal, and colonic
 
Impressive Revenue Potential
 
The LP-10 drug candidate for hemorrhagic cystitis has orphan drug designation from the FDA
 
$20,000 annual $1.2 billion annual
 
Completion of LP-10’s open-label, dose-ranging,  revenue per patient7 revenue potential8 phase 2(a) clinical trial is expected in 4Q 2022 prostate and other pelvic  radiation-
 
pelvic malignancies radiation therapy hemorrhagic cystitis
 
LP-10 peak annual revenue estimates in hemorrhagic cystitis exceed $1 billion
 
over 3,000,000  over 900,000  over 60,000 LP-10 is developed by an experienced management  survivors in US4 survivors in US5 patients per year6 team having decades of biotech industry experience (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
 
360,000 patients treated per year.
 
 
 
 

 
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 2008 2012 2020 2021 2022
 
Jonathan Kaufman Michael Chancellor LP-10 FDA Orphan  Platform patent  Doug Johnston  Initial Public co-founds Lipella joins Management Designation awarded VP. Finance Offering
 
Nasdaq: LIPO
 
2007 2010 2019 2021 2021 2022
 
initial NIH funding  Michele Gruber  LP-10 FDA  Janet Okonski  FDA advice LP-10 phase-2a received Operations IND Approval Clinical Director re. LP-310 completed
 
4
 
 
 
 

 
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 20% of such  An increasing US  Years after  Hemorrhagic are increasingly  patients receive  population is  receiving  cystitis is a diagnosed with  pelvic radiation  surviving cancer  treatment, many  potentially pelvic malignancies therapy during  therapies,  patients acquire  chronic, highly including prostate  the treatment of  including pelvic  hemorrhagic  morbid condition cancer, and cancers their cancer, in  radiation, and  cystitis,  with no approved of the uterine  addition to  chemotherapies  uncontrolled  drug therapy, and corpus, requiring  surgery and  that damage  bladder blood  a four percent treatment. chemotherapy. DNA. loss. mortality rate.
 
5
 
 
 
 

 
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.
 
Prostate Cancer Uterine Corpus Cancers Rectal & Other Pelvic
 
700,0001 200,0001 300,0001
 
Pelvic Radiation Survivors Pelvic Radiation Survivors Pelvic Radiation Survivors
 
42,0002 12,0002 18,0002
 
Severe HC Survivors Severe HC Survivors Severe HC Survivors
 
Breast Cancer Leukemia & Lymphoma Other Tumors
 
360,0001 180,0001 60,0001
 
x-DNA Chemotherapy Survivors x-DNA Chemotherapy Survivors x-DNA Chemotherapy Survivors
 
36,0002 18,0002 6,0002
 
Severe HC Survivors Severe HC Survivors Severe HC Survivors
 
(1) American Cancer Society Cancer Treatment and Survivorship Fact and Figures 2019-2021. (2) Based on the Company’s estimate.
 
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LP-10 Stops Bleeding via Two Modes of Action
 
Tacrolimus’ molecular mechanism includes calmodulin mediated t-cell inhibition
 
Reduce capillary  Inhibits cytokine  Increased efficacy blood flow cascade probability
 
• LP-10 is a potent  • LP-10 is a potent  Well-known vasoconstrictor anti-inflammatory pharmacologic mechanisms • reduces blood  • Reduces tissue  increase the flow to the  injury in the probability of bladder lumen bladder efficacy.
 
7
 
 
 
 

 
LP-10 Product Form
 
Liposomal tacrolimus treatment for hemorrhagic cystitis
 
Sterile  Easy powder to deliver
 
Low
 
COGS In-house CMC
 
8
 
 
 
 

 
LP-10 Phase 2a Trial Design Summary
 
Multi-center, dose-ranging study
 
Details
 
Refractory moderate-to-severe hemorrhagic
 
Indication
 
cystitis (HC)
 
Dose ranging study to evaluate safety,
 
Protocol design
 
tolerability, and efficacy of LP-10
 
Subjects 12 Male and Female subjects from 5 sites Up to 2 instillations of LP-10 ( 2, 4 and 8 mg)
 
Treatment
 
given within 3-7 days
 
Patient Participation Time  6 weeks following the initial procedure
 
9
 
 
 
 

 
LP-10 Phase 2a Trial Design Summary
 
Key inclusion criteria: Key Exclusion criteria:
 
1.Males and females, at least 18 years  1. Patients taking immunosuppressive
 
2.History of sterile moderate to severe HC  therapy
 
(Grades 2-4) for at least 3 months with at 2. History of interstitial cystitis/bladder pain least 1 episode of hematuria with or  syndrome or hemorrhagic cystitis due to without clot  infection (bacterial, viral or fungal)
 
3.Previous use of medications and/or  3. Life expectancy less than 12 months treatment(s) for HC symptom relief 4. PSA > 4 ng/ml (measured within the last
 
3 months)
 
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 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
 
10
 
 
 
 

 
LP-10 Phase 2a Trial Design Summary
 
Recruitment sites and subject disposition
 
Patient Disposition Number Comments
 
Screened, n 15 14 male, 1 female Enrolled, n 13 13 male 2 instillations (n=10) Number of instillations 23 1 instillation (n=3) Discontinued, % 0 Withdrew consent, % 0 Lack of compliance, % 0 Lost to follow-up, % 0
 
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LP-10 Phase 2a Trial Design Summary
 
Patient Demographics
 
Mean  Comment
 
Age, years 67 Range 25-89 Race White  9 Non-White 4
 
Radiation induced HC 11 Chemotherapy induced HC 2 Cancer Prostate cancer 9 Bladder cancer 2 Lymphoma 2
 
Duration of HC years 4 Range 1 -14 years medication, HBO, catheters, Prior HC treatment 13 surgical procedures
 
12
 
 
 
 

 
LP-10 Safety
 
Adverse events (AE)
 
Number Comment
 
Product related significant adverse events 0 Subject discontinuations 0
 
Number of subjects with adverse events 5/13 11 AEs reported in 5 subjects
 
2 mg: 3 AEs in 2 subjects 4 mg: 2 AEs in 1 subject 8 mg: 6 AEs in 2 subjects
 
Bladder spasm, urinary urgency, pain and
 
4
 
dysuria
 
Weakness and dizziness 1 Low blood pressure 1 Flank pain 1 Urinary retention due to bladder blood clot 1 Headache 1 Arthralgia 1 Urinary tract infection 1
 
13
 
 
 
 

 
LP-10 Pharmacokinetics and Safety
 
Local delivery of tacrolimus limits systemic distribution
 
Subject Group baseline 1 hour 2 hours 4 hours 48 hours
 
• < 1.5 ng/ml  1 2 mg - - 1.5 - -
 
considered  2 2 mg - 2.3 - - -undetectable 3 2 mg - 3.0 1.7 - -
 
4 2 mg - 2.8 1.8 - -
 
• All Levels were  5 4 mg - 4.8 1.8 - -within the safe  6 4 mg - 6.1 4.0 - -range, < 15 ng/ml 7 4 mg - 2.9 2.0 - -
 
8 4 mg - 3.9 2.0 - -
 
•The 2 mg and 4 mg
 
9 8 mg - 2.2 2.1 - -
 
doses peaked at 1  10 8 mg - 3.0 - - -hour and cleared  11 8 mg - 3.0 5.4 2.7 -by 4 hours in all  12 8 mg - 5.0 3.6 1.6 -
 
subjects 13 8 mg - 7.3 3.8 - -
 
14
 
 
 
 

 
LP-10 Responder Analysis
 
Evaluating cystoscopy, hematuria, and symptoms
 
(NR=“no response”, PR=“partial response”, CR=“complete response”) (normalized rank, 0 to 9)
 
cystoscopy hematuria
 
•Efficacy  CR in all subjects symptoms
 
improvement reported by principal  9
 
8
 
investigators,  7 patients and  6 laboratory assays  5
 
4
 
•Improvement of  3 hematuria consistent  2
 
with cystoscopic  normalized response rank 1
 
evidence of bleeding  0
 
and ulceration NR in all subjects 2 mg 4 mg 8 mg
 
treatment group
 
15
 
 
 
 

 
LP-10 Phase 2a Trial Conclusion
 
Trial Summary
 
•LP-10 safety:
 
•No Product related SAEs
 
•Instillation procedure well tolerated by all subjects
 
•LP-10 pharmacokinetic analysis demonstrated very short duration of systemic uptake
 
•Signal of efficacy and dose response
 
•Hematuria improved, decreased cystoscopic bleeding and ulceration sites and improved patients’ urinary symptoms
 
Next Step
 
•Successful completion of first in man Phase 2a multicenter clinical trial
 
•Minimal effective dose data to report to the FDA
 
•Request Accelerate/breakthrough P3 Design
 
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Asset Pipeline and LP-310
 
LP-310: Liposomal tacrolimus for oral lichen planus
 
Product Target Marketing Next Anticipated Candidate Indication Preclinical Phase 1 Phase 2 Phase 3 Approval Milestone
 
Hemorrhagic FDA Meeting LP-10 Cystitis 3Q23
 
Oral Lichen IND submission LP-310 Planus 2Q23
 
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 LP-310 Large market size opportunity (6 million US) with no current approved therapy Comparator: AFYX’s buccal steroid patch in Phase 3 trial Oral Lichen Planus Completed Type B pre-IND meeting (PIND 155011) April 08, 2021 Mouth Rinse IND preparation for Phase 2a multicenter dose escalation study
 
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Liposomal Drug Delivery to Mucosal Surfaces
 
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Lipella Pharmaceuticals Inc. 7800 Susquehanna Street, Suite 505 Pittsburgh, PA 15208 412-894-1853 www.lipella.com
 
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