Lipocine Inc. · NASDAQ:LPCN
Lipocine — Investor Presentation (September 2020)
31 slides from Lipocine's investor presentation, Sep 21, 2020
Slide 1: Enabling Oral Drug Delivery to Improve Patient Compliance
Enabling Oral Drug Delivery to Improve Patient Compliance September 2020 Corporate Presentation Exhibit 99.1
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation contains forward - looking statements about Lipocine Inc . (the “Company”) . These forward - looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 . These forward - looking statements
Slide 3: Clinical Stage Biopharmaceutical Company
September Corporate Presentation I Clinical Stage Biopharmaceutical Company Innovative Product Candidates for Metabolic and Endocrine Disorders PRODUCT (Indication) PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA Propriety Drug Delivery Platform TLANDO™ (Oral Testosterone for Testosterone Replacement The
Slide 4: TLANDO: The First Oral TRT Without Titration Requirement
TLANDO™ The First Oral TRT Without Titration Requirement
Slide 5: Hypogonadism Affects Up to 20M Men
September Corporate Presentation I Hypogonadism Affects Up to 20M Men 1, 2 5 TLANDO Franchise has the Potential to Drive Market Expansion 1,2 1. US Census data. http:// www.infoplease.com /us/census/data/ demographic.html . 2. Mulligan T, et al. Int J Clin Pract . 2006 Jul;60(7):762 - 9. 3. Araujo,
Slide 6: TRT Market is Growing
September Corporate Presentation I 2020 2019 2018 2017 2016 2014 2015 350 375 400 425 450 475 500 525 550 575 600 625 650 675 700 Oct 14 Dec 14 Feb 15 Apr 15 Jun 15 Aug 15 Oct 15 Dec 15 Feb 16 Apr 16 Jun 16 Aug 16 Oct 16 Dec 16 Feb 17 Apr 17 Jun 17 Aug 17 Oct 17 Dec 17 Feb 18 Apr 18 Jun 18 Aug 18 Oc
Slide 7: Issues with Current TRT Options
September Corporate Presentation I Issues with Current TRT Options • Black box warning – Secondary exposure to testosterone – Pulmonary oil micro embolism (POME) and anaphylactic shock • Inconvenient application or painful injection • High incidence of erythrocytosis was reported in patients on non
Slide 8: Most TRTs Require Dose Titration in Majority of Patients
September Corporate Presentation I 0 X 37% 1 X 26% 2 X 20% 3 X 12% >3 X 5% Most TRTs Require Dose Titration in Majority of Patients Majority of Patients are NOT on Efficacious Dose at the Start of Therapy CONFIDENTIAL Number of Current TRT Dose Adjustments by Form* 0 X 47% 1 X 33% 2 X 15% 3 X 2% >3
Slide 9: Typical Titration for TRT Takes 3-6 Months
September Corporate Presentation I Physician Research Data* 9 9 Average titration time to steady state dose N = 402 physicians; 150 primary care, 102 urology, 150 endocrinology 11% 16% 8% 41% 45% 33% 28% 43% 9% 10%36% 6% Primary Care 3% 1% 100% Endo - 2% 2% 1% 2% Urology 3% 1% % physicians 3 - 4 mon
Slide 10: TLANDO Attributes
September Corporate Presentation I f TLANDO ™ Attributes TRT Without Titration Requirement Convenient Oral Route • No inadvertent transference or Pulmonary Oil Micro Embolism risks • Patient and physician preferred ‒ Single strength and dose, less confusing Expected to be Easy to Prescribe and Use •
Slide 11: TLANDO Regulatory Update
September Corporate Presentation I TLANDO Regulatory Update Near Term PDUFA Date CRL received November 9, 2019 One deficiency: Did not meet the three secondary endpoints for maximal testosterone concentrations ( Cmax ) Post Action Meeting January 16, 2020 NDA Filed February 28, 2020 PDUFA Date Augus
Slide 12: TLANDO XR Once Daily Oral TRT
TLANDO XR (Testosterone Tridecanoate ) Once Daily Oral TRT
Slide 13: TLANDO XR: An Innovative Opportunity
September Corporate Presentation I TLANDO XR: An Innovative Opportunity 13 Next Generation TRT Option Strong IP (new molecule & proprietary drug delivery technology) Positive Phase 2b study results Patients and physicians prefer once a day oral testosterone TLANDO XR is positioned to be the first Or
Slide 14: TLANDO XR: Development Milestones
September Corporate Presentation I TLANDO XR: Development Milestones 14 Regulatory Pre - IND Type B meeting held IND filed Type C meeting held FDA in agreement with Phase 3 dose and single pivotal PK study for registration CMC Formulation, dose, and dosage form have been identified in Phase 2b Analy
Slide 15: LPCN 1144 for Non-Cirrhotic NASH
LPCN 1144 for Non - Cirrhotic NASH
Slide 16: LPCN 1144: Rationale to Target Non-Cirrhotic Male NASH Patients
September Corporate Presentation I LPCN 1144: Rationale to Target Non - Cirrhotic Male NASH Patients 16 Currently No Approved Treatment 1. Estes et al., Hepatol 2018. 2. Williams et al., Gastroenterology 2011. *2015 data ~6.9 M Male NASH F2 - F3 in 2030 1,2 17 M NASH Patients 1 11 M NASH Male Patien
Slide 17: Association Between Testosterone and Liver Disease
September Corporate Presentation I Association Between Testosterone and Liver Disease 17 Clinical Evidence 1. Sarkar et al., Gastroenterology 156(6):S - 1258 & Poster Sa1623, Digestive Disease Week 2019 2. Sumida et al., Gastroenterol Hepatol 2015; 3. Sinclair et al., Liver Trans 2016; 4. Sinclair M
Slide 18: Association Between Testosterone and Liver Disease – Clinical Evidence
September Corporate Presentation I Association Between Testosterone and Liver Disease – Clinical Evidence Liver Disease in Men Undergoing Androgen Deprivation Therapy (ADT) for Prostate Cancer 18 Gild et al. J Urol. 2018 Sep;200(3):573 - 581 Patients Receiving ADT were Significantly More L ikely to
Slide 19: LPCN 1144: Androgen Receptor Agonist
September Corporate Presentation I LPCN 1144: Androgen Receptor Agonist Differentiated NASH Treatment Candidate Targets Unmet Need Acceptable benefit to risk ratio • NASH resolution and/or fibrosis improvement • Tolerability for chronic use Improvement of sarcopenia Improvement of sexual/mood dysfun
Slide 20: LPCN 1144: Potential Mode of Action
September Corporate Presentation I LPCN 1144: Androgen Receptor Agonist Potential Mode of Action 20 Impact on pro - fibrotic inputs Anti - steatosis Anti - inflammatory Anti - oxidant LPCN 1144 (Oral Testosterone) Regeneration Booster ( ↑ IGF) Impact on fibrosis Anti - fibrosis ( ↓ TGF - β)
Slide 21: LPCN 1144: Liver Fat Imaging Study
September Corporate Presentation I LPCN 1144: Liver Fat Imaging Study (“LFS”) Study Design and Baseline Liver Fat Subject Distribution LFS was an open - label, multi - center single - arm 16 - week study (N=36) o f LPCN 1144 225 mg BID in hypogonadal males LF ≥ 10% N = 8 LF ≥ 8% N = 10 LF ≥ 5% N = 2
Slide 22: LPCN 1144: Liver Fat Reduction
September Corporate Presentation I LPCN 1144: Liver Fat Reduction Meaningful Relative Liver Fat % Change and Responder Rate - 42% - 40% -60% -50% -40% -30% -20% -10% 0% Mean BL LF = 18.3% Mean BL LF = 20.5% BL ≥ 8% BL ≥ 10% Relative % Change of Liver Fat % (n=10) (n=8) 80% 75% 0% 10% 20% 30% 40% 50%
Slide 23: LPCN 1144: LiFT Study Ongoing
September Corporate Presentation I LPCN 1144: LiFT (Liver Fat intervenTion ) Study* Ongoing 23 Phase 2 Paired - Biopsy Clinical Study in NASH Subjects (NCT04134091) * Website: www.lift - study.com SCREENING Topline MRI - PDFF Results By End of 2020 Dose Start Topline Biopsy Results by End of 2Q 2021
Slide 24: LPCN 1148 for Liver Cirrhosis
LPCN 1148 for Liver Cirrhosis
Slide 25: LPCN 1148: Oral T for Cirrhosis
September Corporate Presentation I Common Causes 5 Alcoholic liver disease Nonalcoholic Fatty Liver Disease (NAFLD) Chronic hepatitis B Chronic hepatitis C Cryptogenic LPCN 1148: Oral T for Cirrhosis 25 1. Bentley & Phillips, Milliman Research Report 2017 4. Sarkar et al. J Hepatol. 2015 2. Sinclair
Slide 26: Unmet Needs For Patients with Liver Cirrhosis
September Corporate Presentation I Unmet Needs For Patients with Liver Cirrhosis Improvement in quality of life while on waiting list Stay on transplant list Sarcopenia is a leading contributory cause of removal from the waitlist • 40 - 70% of cirrhotic patients are sarcopenic Improvement of post tr
Slide 27: Sarcopenia in Liver Cirrhosis Equivalent to Adding Points to MELD Score
September Corporate Presentation I Sarcopenia in Liver Cirrhosis Equivalent to Adding 10 Points to the MELD Score 27 References: Kim and J.W. Jang, World Journal of Gastroenterology, 2015; Sinclair et al., Journal of Gastroenterology and Hep ato logy (Australia), 2016; Moctezuma - Velazquez et al.,
Slide 28: Reduced Testosterone Associated with Complications of Cirrhosis
September Corporate Presentation I Progressive Drop in T Level with Increasing Disease Severity 1,3 28 Reduced Testosterone Associated with Complications of Cirrhosis 1. Sinclair et al., Liver Transplantation, 2016; 2. Sinclair et al., J Gastroenterol Hepatol . 2016; 3. Paternostro et al, Hepatol Re
Slide 29: LPCN 1148 in Cirrhotic Patients
September Corporate Presentation I LPCN 1148 in Cirrhotic Patients 29 References: Trivedi and Tapper, Gastroenterol Rep ( Oxf ), 2018; Berzigotti et al., Hepatology, 2017; Chen and Dunn, Clin Liver Dis (Hoboken), 2018; Sinclair et.al, Liver international, 2016; Neff et al., Digestive Diseases and Sc
Slide 30: Upcoming Milestones
September Corporate Presentation I Upcoming Milestones Near Term Value Drivers Event Expected Timing TLANDO™ PDUFA Date August 28, 2020* *Extended by FDA LPCN 1144 LiFT Primary Endpoint Results January 2021 LiFT Biopsy Results July 2021 IP Infringement Litigation Oral Jury Hearing February 2021 30
Slide 31: Key Financial Metrics
September Corporate Presentation I Key Financial Metrics 31 Stock Price, Market Cap, Cash Balance * $5M restricted and becomes unrestricted upon TLANDO approval Ticker Symbol LPCN (Nasdaq Capital Market) Closing Stock Price (9/18/20) $1.61/share Cash Balance (6/30/20) $23.3 million* Bank Debt (6/30/