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TLANDO , Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men Anthony DelConte, MD 1,2 ; Nachiappan Chidambaram, PhD 1 ; Kongnara Papangkorn,

Key Takeaway: TLANDO , Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men Anthony DelConte, MD 1,2 ; Nachiappan Chidambaram, PhD 1 ; Kongnara Papangkorn, PhD 1 ; Benjamin J. Bruno, PharmD, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 1 Lipocine

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TLANDO , Oral Testosterone Replacement Therapy without Dose Titration Requirement in Hypogonadal Men Anthony DelConte, MD 1,2 ; Nachiappan Chidambaram, PhD 1 ; Kongnara Papangkorn, PhD 1 ; Benjamin J. Bruno, PharmD, PhD 1 ; Kilyoung Kim, PhD 1 ; Mahesh V. Patel, PhD 1 1 Lipocine Inc., Salt Lake City, UT; 2 Saint Joseph's University, Philadelphia, PA 1 SMSNA 2020 *Dr. DelConte is a medical director and paid consultant at Lipocine, Inc, ** Drs Chidambaram, Papangkorn, Bruno, Kim, and Patel are employees of Lipocine, Inc Exhibit 99.1
Background Most marketed testosterone replacement therapy (TRT) products require multiple titration visits to achieve desired eugonadal testosterone (T) levels Typical titration for TRT takes 3 - 6 months to reach efficacious dose for majority of patients 2
TLANDO* Unique Delivery System Enables Effective Oral TRT Performance Not known to produce adverse events that are associated with 17 - methylated testosterone Consistent intra & inter - day T restoration* * LPCN 1021 - 14 - 001 Study * LPCN 1021 - 13 - 001 Study: 225mg BID 3 Not prone to lower exposure with low fat meal - allows for meal fat flexibility x Avoids abnormal levels post accidental meal fat changes *TLANDO is currently under FDA review for marketing approval
Objective and Study Designs The objective was to assess whether TLANDO, to - be - marketed oral TRT option without need for any dose adjustment, can safely and effectively restore testosterone levels in hypogonadal men 4 Two P3 studies with TLANDO without dose titration were performed Study 16 - 002 : A 24 - day, open - label, single - arm, multicenter study with in hypogonadal men (N=95, NCT03242590) Study 18 - 001 : A 4 - month, open - label, single - arm, multicenter study with in hypogonadal men (N=138, NCT03868059) 20% of uncontrolled hypertensive patients (SBP > 140 mmHg) were tested Demographics 16 - 002 (N=95) 18 - 001 (N=138) Age, mean ( yrs ) 56.0 53.8 % for 65 yrs 83.2 87.0 % for > 65 yrs 16.8 13.0 BMI, mean (kg/m 2 ) 32.8 33.1 Baseline T, mean (ng/dL) 202 204
TLANDO Efficacy & Tolerability Daily dose 450mg without requiring dose adjustment Efficacy* 81% (95% CI: 72 - 88%) Mean T Cavg : 478 ng/dL Adverse Events No death, no drug - related SAEs Mild to moderate Adverse Reaction 2% (STUDY 18 - 001) Overall (N=138) n (%) Hematocrit increased/Polycythemia 6 (4.3) Adverse Reaction 2% (STUDY 16 - 002) Overall (N=95) n (%) Blood prolactin increased 4 (4.2) 5 Nighttime peak Daytime peak * PK measured at efficacy day (Day 24) in Study 16 - 002
Summary & Conclusions Safety and efficacy of TLANDO (Oral Testosterone Undecanoate) was confirmed TLANDO is a novel oral TRT option without requiring dose titration Start of therapy with the effective dose without delay Devoid of accidental T transference and pulmonary oil micro - embolism risks No burden of additional dose adjustment visits/invasive samplings Potential to improve compliance and persistence rates 6
Last updated: Nov 9, 2020