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Initiating CoverageMay 25, 2017

Lipocine (LPCN)Initiation Report

LifeSci Investment Abstract

Lipocine (NasdaqCM: LPCN) is a specialty pharmaceutical Company focused on applyingtheir oral drug delivery technology to develop new treatments in the men’s and women’s healthspace. The Company’s lead program is LPCN1021, an oral testosterone replacement therapy(TRT), which has potential to become the first oral therapeutic option for hypogonadal men.The Company expects to report Phase III results from two studies in June and plans toresubmit an NDA in the third quarter of 2017. Lipocine is also developing LPCN1107, anoral reformulation of the only approved drug, for preterm births. Lipocine had an End-of-Phase II (EOP2) meeting with the FDA and plans to submit a Phase III protocol via a SpecialProtocol Assessment (SPA) in the second quarter of 2017.

Key Points of Discussion

■ Lipocine is Developing Therapies to Address Unmet Needs in the Men’s andWomen’s Health Space. Lipocine is a specialty pharmaceutical Company in the area ofmen’s and women’s health. The Company is harnessing their oral drug delivery technology,which allows for oral administration of therapies that normally have low oral bioavailability,to develop several promising drug candidates. Lipocine’s lead program is LPCN1021, anoral testosterone replacement therapy (TRT), which has the potential to become the firstoral therapeutic option for hypogonadal men. An oral formulation would solve many of theshortcomings with existing products. LPCN1021 could capture significant market share aspatients seek safer and more convenient treatment options.

■ Wide Open Opportunity for an Oral TRT Agent. TRTs are typically administered astopical or injectable agents, and the market is currently dominated by the topical agent,AndroGel, which has a 64% share of TRT sales. Topicals have become favored overinjectable TRTs, likely in part due to patients seeking to avoid risks such as injectionsite reactions and pain. In addition, long-acting injectable TRTs carry a boxed warningfor serious pulmonary oil microembolism (POME) reactions and anaphylaxis. However,topical agents have limitations as well, and carry a boxed warning for risk of secondaryexposure to testosterone.

Expected Upcoming Milestones

■ June 2017 – Topline data expected from fixed-dose Phase III studies for LPCN1021.■ Q2 2017 – Submit Phase III SPA protocol to the FDA for LCPN1107.■ Q3 2017 – NDA re-submission for LPCN1021.■ Q3 2017 – Expected preclinical toxicity study.■ Q4 2017 – EOP2 meeting with the FDA for LPCN1111.■ 2018 – Initiation of Phase III trial for LPCN1111.

Analysts

David Sherman, Ph.D. (AC)(212) [email protected]

Market Data

Price $3.64Market Cap (M) $70EV (M) $43Shares Outstanding (M) 19.3Fully Diluted Shares (M) 21.6Avg Daily Vol 157,92752-week Range: $2.51 - $9.59Cash (M) $26.8Net Cash/Share $1.39Annualized Cash Burn (M) $12.6Years of Cash Left ~2.0Debt (M) $0.0Short Interest (M) 1.96Short Interest (% of Float) 10.8%

Financials

FY Dec 2015A 2016A 2017AEPS Q1 (0.23)A (0.38)A (0.26)A

Q2 (0.26)A (0.32)A NAQ3 (0.35)A (0.18)A NAQ4 (0.27)A (0.16)A NAFY (1.11)A (1.04)A NA

For analyst certification and disclosures please see page 22

▪ Ongoing Phase III Studies Expected to Support NDA Resubmission for LPCN1021. Lipocine is currently

evaluating LPCN1021 in dose validation and dosing flexibility studies, which are expected to read out in June. These

trials were launched in response to concerns raised in a Complete Response Letter, received in June 2016, regarding

the Company’s dosing algorithm. The Company expects to file an NDA resubmission for LPCN1021 supported by

data from these studies as well as prior clinical trials.

▪ Lipocine is Developing the First Oral Drug for the Treatment of Recurrent Preterm Births. LPCN1107 is an

oral drug candidate in development as a preventative treatment for recurrent preterm births and contains the same

API as the only approved therapy, Makena (hydroxyprogesterone caproate). As an oral therapy, LPCN1107 may offer

greater convenience to patients and eliminate the pain and site reactions associated with weekly intramuscular

injections required for standard-of-care Makena. Makena is the only FDA-approved preventative therapy for preterm

births and requires 18-22 intramuscular injections given weekly. An oral treatment option could capture a large share

of the market as a more patient-friendly approach than existing injectables.

▪ Clear Regulatory Path for LPCN1107. Lipocine had an End-of-Phase II (EOP2) meeting with the FDA to discuss

the design of a Phase III development plan for LPCN1107. The FDA agreed to a randomized, open-label, two-arm

pivotal study comparing LPCN1107 to an active comparator for up to 23 weeks of treatment. The Company received

positive feedback on the proposed 800 mg dose and the planned dosing regimen. The FDA confirmed the possibility

of an approval using a surrogate primary endpoint—using a gestational age endpoint as opposed to clinical infant

outcomes—but noted that it would likely lead to consideration under a subpart H pathway. This would likely require

a confirmatory post-marketing study.

Financial Discussion

In the first quarter ended on March 31, 2017, Lipocine reported research and development expenses for the first

quarter of $3.1 million, up from $2.7 million in the prior year. In the first quarter of 2017, general and administrative

expenses were $1.8 million, down from $4.4 million during the same period of 2016. Net loss for the first quarter was

$4.9 million, as compared to $7.0 million for the first quarter of 2016. Cash and cash equivalents as of March 31, 2017

were $26.8 million.

May 25, 2017

Table of Contents

Company Description .................................................................................................................................................................... 4 LPCN1021: Potentially the First Oral Testosterone Replacement Therapy ......................................................................... 5

Safety Profile ............................................................................................................................................................................... 5 Hypogonadism ................................................................................................................................................................................ 5

Diagnosis and Treatment of Hypogonadism ........................................................................................................................ 5 Market Information ........................................................................................................................................................................ 8 Clinical Data Discussion ................................................................................................................................................................ 9 Other Drugs in Development ..................................................................................................................................................... 13 Competitive Landscape ................................................................................................................................................................ 13 LPCN1111: A Next-Generation, Once-Daily Oral Testosterone Replacement Therapy ................................................ 14

Clinical Data Discussion ......................................................................................................................................................... 14 LPCN1107: An Oral Treatment to Prevent Pre-Term Births ............................................................................................... 15 Preterm Births ............................................................................................................................................................................... 15

Current Treatments for Preterm Birth ................................................................................................................................. 17 Market Information ................................................................................................................................................................. 17

Clinical Data Discussion .............................................................................................................................................................. 18 Phase III Program ................................................................................................................................................................... 19

Other Drugs in Development ..................................................................................................................................................... 19 Intellectual Property & Licensing ............................................................................................................................................... 20 Management Team ....................................................................................................................................................................... 21 Risk to an Investment .................................................................................................................................................................. 22 Analyst Certification ..................................................................................................................................................................... 23 Disclosures ..................................................................................................................................................................................... 23

May 25, 2017

Company Description

Lipocine is a specialty pharmaceutical Company in the area of men’s and women’s health. The Company is harnessing

their oral drug delivery technology, which allows for oral delivery of drugs that normally have low oral bioavailability,

to develop several promising drug candidates. Lipocine’s lead program is LPCN1021, an oral testosterone replacement

therapy (TRT), which has the potential to become the first oral therapeutic option for hypogonadal men. TRTs are

typically administered as topical or injectable agents, and the market is currently dominated by the topical agent,

AndroGel, which has a 64% share of TRT sales. Topicals have become favored over injectable TRTs, likely in part due

to patients seeking to avoid the risks of injection, including injection site reactions, and pain. In addition, long-acting

injectable TRTs carry a boxed warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis.

However, the topical agents have limitations as well. The topicals carry a boxed warning on the risk of secondary

exposure to testosterone. An oral formulation would solve many of the shortcomings with existing products.

LPCN1021 is well-positioned to potentially become the first oral agent to enter the market and could capture

significant market share as patients seek safer and more convenient treatment options.

Lipocine is currently evaluating LPCN1021 in dose validation and dosing flexibility studies, which are expected to

read out in June. These trials were launched in response to concerns raised in a Complete Response Letter, received

in June 2016, regarding the Company’s dosing algorithm. The Company expects to file an NDA resubmission for

LPCN1021 supported by data from these studies as well as prior clinical trials. Lipocine’s full development pipeline is

shown in Figure 1. Lipocine’s LPCN1111 is the Company’s next-generation oral TRT in a once-daily formulation, as

opposed to either twice-daily or three times per day dosing with LPCN1021. This added convenience would allow for

Lipocine to maximally differentiate their product.

LPCN1107 is an oral drug candidate in development as a preventative treatment for recurrent preterm births and

contains the same API as the only approved therapy, Makena (hydroxyprogesterone caproate). As an oral therapy,

LPCN1107 may offer greater convenience to patients and eliminate the pain and site reactions associated with weekly

intramuscular injections required for standard-of-care Makena. Makena is the only FDA-approved preventative therapy

for preterm births and requires 18-22 intramuscular injections. An oral treatment option could capture a large share

of the market as a more patient-friendly approach than existing injectables.

Figure 1. Lipocine’s Development Pipeline

Source: LifeSci Capital

May 25, 2017

LPCN1021: Potentially the First Oral Testosterone Replacement Therapy

LPCN1021 is an oral formulation of testosterone undecanoate that Lipocine is developing as a novel testosterone

replacement therapy (TRT). Testosterone undecanoate is the API in Endo Pharmaceuticals’ (NasdaqGS: ENDP)

Aveed, a long-acting injectable (LAI) that was approved in 2014. Lipocine is positioning LPCN1021 as potentially the

first oral TRT to enter the market. A reliable oral therapy would increase patient convenience and compliance, while

eliminating the transference and injection risks associated with gels and injectables, respectively. Lipocine is currently

evaluating a fixed-dose formulation of LPCN1021 in two Phase III studies that are expected to read out in June. These

readouts, if positive, are likely to be major catalysts for the Company. Lipocine expects to file the NDA resubmission

for LPCN1021 in the third quarter of 2017.

Safety Profile. LPCN1021 has been safe and well-tolerated. In the SOAR Phase III study, which tested 52 weeks of

exposure, AEs were comparable between groups treated with LPCN1021 and active control, the market leader

AndroGel, and there were no cardiac, hepatic, or drug-related SAEs in the study. In addition, cardiac AEs were similar

between groups, and none of these cardiac AEs occurred in more than 1% of the LPCN1021-treated individuals. The

FDA did issue a CRL, noting a discrepancy between the dosing regimen proposed in Lipocine’s original NDA

submission and the regimen tested in the SOAR trial. The dose validation study and the dosing flexibility study are

designed to provide further confirmation of the safety and tolerability of LPCN1021 and validation of the proposed

dosing regimen.

Hypogonadism

Low serum testosterone causes significant clinical impact and can result in erectile dysfunction, low libido, decreased

muscle mass and strength, increased body fat, decreased bone density, decreased vitality and depressed mood.

Furthermore, low serum testosterone concentrations have been found to be an independent predictor of a number of

cardiovascular risk factors including obesity, dyslipidemia, hypertension, type 2 diabetes, and systemic inflammation.

Well-designed, prospective clinical trials have determined that low testosterone levels are also independently associated

with mortality risk. These findings have generated interest amongst the medical community and general public

regarding the importance of maintaining appropriate serum testosterone levels, which has in turn stimulated growth

of the testosterone replacement therapy market.

Hypogonadism typically refers to a permanent deficiency of sex hormones rather than a temporary deficiency that

may be related to acute/chronic illnesses or other medical, personal, or environmental factors. Primary hypogonadism

describes disease states that intrinsically affect the gonads. Examples of these include the genetic disorders Turner

syndrome and Kleinfelter syndrome. Secondary hypogonadism refers to conditions that affect gonadal-related

structures such as the hypothalamus and pituitary gland that directly impact the development of gonads and as such

the release of testosterone and other sexual hormones. Kallmann syndrome, in which patients fail to undergo all of

the changes associated with puberty, is a type of secondary hypogonadism. Although a number of inherited diseases

are known to affect the gonads either directly or indirectly, these cases are rare and comprise a minority of treatable

cases of hypogonadism. The majority of individuals with hypogonadism develop the condition as a result of acquired

conditions or age-related declines in testosterone.

Diagnosis and Treatment of Hypogonadism. Epidemiological studies have determined that total testosterone

follows an age-related decline with mean serum concentration at the age of 75 years approximately two thirds that at

May 25, 2017

25 years old. Because endogenous testosterone exists at low concentrations, with normal testosterone levels in the

range of 300 to 1100ng/dL, automated platform-based assays for the diagnosis of hypogonadism have been found to

lack specificity. The lack of reliable laboratory tests is only complicated further by the inter-individual variability seen

in an unaffected population. Thus, in order to accurately diagnose hypogonadism in a male, multiple morning serum

testosterone levels are performed in conjunction with a clinical assessment of patient symptoms. Patients can only be

diagnosed when they present with symptomatology that is directly related to more than one low morning serum

testosterone level.

The treatment for both primary and secondary male hypogonadism is testosterone replacement therapy (TRT). The

benefits of TRT include improved libido, sexual function, increased bone density, muscle development, and cognition,

as well as a reduction in other risk factors caused by low testosterone. Although there are some adverse effects

associated with the use of testosterone replacement, the benefits generally outweigh the risks in patients being treated

for hypogonadism. Figure 2 highlights the approved TRTs in the US. Testosterone gels have come to dominate the

TRT market in terms of sales. While gels are more convenient than some other available types of TRT, there is still a

risk of transference, the gels are messy, and for men requiring large doses of testosterone, the gels must be spread

over a large area of the body. A reliable oral therapy would increase patient convenience and compliance, while

eliminating the transference risk associated with gels.

Figure 2. Approved TRTs in the US

Drug Delivery Company Approval

Delatestryl

(testosterone enanthate) intramuscular generic 1953

Androderm

(testosterone) transdermal Allergan (NYSE: AGN) 1995

AndroGel

(testosterone) transdermal AbbVie (NYSE: ABBV)/generic 2000

Testim

(testosterone) transdermal generic 2002

Striant

(testosterone) buccal Endo International (NasdaqGS: ENDP) 2003

Axiron

(testosterone) transdermal Eli Lilly (NYSE: LLY) 2010

Fortesta

(testosterone) transdermal Kyowa Hakko Kirin 2010

Bio-T-Gel

(testosterone) transdermal ANI Pharmaceuticals (NasdaqGM: ANIP) 2012

Testosterone Gel 1% transdermal Perrigo Company (NYSE: PRGO) 2013

Aveed

(testosterone undecanoate) intramuscular LAI Endo International (NasdaqGS: ENDP) 2014

Natesto

(testosterone) intranasal Aytu BioScience (Other OTC: AYTU) 2014


May 25, 2017

Figure 3 outlines some of the advantages and disadvantages of currently approved testosterone products.1 Topicals

have become favored over injectable TRTs, likely in part due to patients seeking to avoid the risks of injection,

including injection site reactions, and pain. In addition, long-acting injectable TRTs carry a boxed warning for serious

pulmonary oil microembolism (POME) reactions and anaphylaxis. However, the topical agents have limitations as

well. The topicals carry a boxed warning on the risk of secondary exposure to testosterone. An important note is that

a safe and efficacious oral testosterone product would provide all of the important advantages of the different methods

of delivery, without the disadvantages.

Figure 3. Advantages and Disadvantages of Approved Testosterone Products

Method of

Delivery Advantages Disadvantages

Injection

▪ Reliable delivery.

▪ Good dosing flexibility.

▪ Cost of therapy.

▪ Need for intramuscular injection.

▪ Peaks and troughs in serum drug levels,

which may cause mood changes and

polycythemia.

▪ Low cost of the therapy itself is offset by

frequent office visits as injections must be

administered by a doctor or nurse.

▪ Boxed warning on embolism and

anaphylaxis risk

Transdermal

patch ▪ Infrequent office visits.

▪ Contact dermatitis.

▪ Poor absorption in some patients.

Gels

▪ Infrequent office visits once

titrated to correct dose.

▪ Not visible once absorbed.

▪ Good dosing flexibility.

▪ Boxed warning on transfer risk.

▪ Poor absorption in some patients.

▪ May cause skin irritation.

Implants ▪ May last up to 6 months.

▪ Requires visit to doctor.

▪ Risk of site infection.

▪ Hard to control dose.

▪ Not easily reversed without surgery.

Source: Tenover, 2003.

1 Tenover, J.S., 2003. Prevalence and management of mild hypogonadism: introduction. International Journal of Impotence Research,

15(Suppl 4), ppS1-S2.

May 25, 2017

Market Information

There are roughly 6 million men with diagnosed hypogonadism in the US, and approximately 2.2 million receive

treatment.2 Sales of TRT products have decreased in the last few years following updated FDA labeling. Sales of

AndroGel have fallen from $934 million in 2014 to $675 million in 2016. In total, the TRT market is thought to be

worth roughly $2 billion. Figure 4 displays the current market breakdown for TRT products. AndroGel remains the

market leader with a 64% share of TRT sales, highlighting the extent to which transdermal TRT products currently

dominate the market.

Figure 4. Market Breakdown for TRT Products


2 Araujo, AB, 2007. Prevalence of symptomatic androgen deficiency in men. Journal of Clinical Endocrinology and Metabolism, 92(11),

pp4241-4247.

Androgel, 63.8%

Axiron, 14.5%

testosterone, 13.6%

Androderm, 4.4%Testim, 3.2%

Androgel Axiron testosterone Androderm Testim Fortesta

Natesto Testopel Striant Vogelxo Testoderm

May 25, 2017

The median persistency on a branded TRT product is roughly 3-4 months. Figure 5 highlights the percentage of

patients remaining on therapy within one year of treatment onset. Surprisingly, a larger percentage of individuals using

injectable TRTs remain on therapy compared with individuals using topical TRTs. The low rate of treatment

persistence with the topical TRTs suggest that these agents have not fully addressed the needs in the market. The

entrance of an oral TRT could substantially lengthen the average duration of time that patients are willing to remain

on therapy. Market research on prescriber attitudes confirm that an oral formulation would be an important advantage

for any novel entrant into the market.

Figure 5. Duration of Therapy for New-to-Market Cohorts

Source: Corporate Presentation

Clinical Data Discussion

Phase II Study

The Phase II study for LPCN1021 enrolled 84 hypogonadal men. Four doses were tested, starting at 75 mg and

increasing to 150, 225, and then 300 mg as needed to attain the desired serum level of testosterone. For patients

receiving 75 or 150 mg as well as a subset of patients receiving the 225 mg dose, study duration was 15 days and doses

were administered twice daily, 30 minutes after breakfast and dinner. Full pharmacokinetic profiles were taken the day

prior to the first dose (day 0) and on day 1, day 8, and day 15. For the remaining patients receiving 225 mg or individuals

taking 300 mg doses, study duration was 29 days and the treatment was administered twice daily on the same schedule.

Full pharmacokinetic profiles were obtained on day 0, day 1, day 15, and day 29. In this cohort, pharmacokinetic

profiles were also obtained in the mornings of days 8 and 22.

The FDA criteria for approval of a TRT include successful completion of a pivotal trial with two primary endpoints

and three secondary endpoints. Primary endpoints at optimal dose include 24-hour average serum testosterone levels

between 300 and 1140ng/dL in at least 75% of patients, and the lower bound 95% confidence interval in greater than

65% of patients. Secondary endpoints include a maximum serum testosterone level less than 1500 ng/dL in at least

85% of patients, maximum serum testosterone level between 1800 to 2500 ng/dL in < 5% of patients, and no patients

May 25, 2017

who experience maximum serum testosterone greater than 2500 ng/dL. These requirements are outlined in the table

in Figure 6.

Figure 6 also contains data for the optimal dose of LPCN1021, as determined in this trial, as it relates to each of the

FDA requirements. Prior to any dose titration, which is typical in TRT, the optimal dose was found to be 225 mg of

testosterone undecanoate, with which the drug exceeded the FDA’s stated requirements for a successful Phase III

trial. Additionally, there were no major clinical adverse events or significant changes in liver enzymes or DHT/T, E2

LDL, and HDL changes were within the range of other approved testosterone replacement therapies.

Figure 6. FDA Requirements for TRT Approval and LPCN1021 Phase II Results

FDA Criteria for

Approval of TRT

LPCN1021 Phase II

Result

Dose 225 mg

Number of subjects 24

Primary endpoints

Cave 300-1140 ng/dL ≥ 75% 83%

Lower bound 95% CI ≥ 65% 69%

Secondary endpoints

Cmax < 1500ng/dL ≥ 85% 88%

Cmax 1800-2500ng/dL ≤ 5% 0%

Cmax > 2500ng/dL 0% 0%


Figure 7 details the Phase II data for all doses tested. These data suggest that 225 mg may be the optimal dose.

Figure 7. LPCN1021 Phase II Results for All Doses

Parameter Percent of Subjects Achieving the Criteria on Day 15

Dose 75 mg 150 mg 225 mg 300 mg

Number of subjects 16 15 24 9

Primary endpoints

Cave 300-1140ng/dL 44 47 83 100%

Lower bound 95% CI 27 35 69 79%

Secondary endpoints

Cmax < 1500ng/dL 100 100 88 44%

Cmax 1800-2500ng/dL 0 0 0 11%

Cmax > 2500ng/dL 0 0 0 33%


May 25, 2017

In addition to determining efficacy and exceeding FDA criteria, a post-titration analysis revealed that, given the

pharmacokinetic properties of LPCN1021, average serum testosterone concentration (Cave) and Cmax were highly

correlated and there was a high probability of titrating to acceptable Cmax levels by maintaining Cave below 580 ng/dL.

This finding helped inform the appropriate design for the Phase III study.

SOAR Phase III Trial

Trial Design. This randomized, open-label, active-controlled Phase III study tested the safety and efficacy of

LPCN1021 in the treatment of hypogonadal men.3 315 subjects were randomized to receive either LPCN1021 or

AndroGel (1.62% topical testosterone gel) as an active comparator. Subjects treated with LPCN1021 received an initial

dose of 225 mg of LPCN1021 twice daily and were titrated up to 300 mg twice daily or titrated down to 150 mg twice

daily based on serum testosterone levels at weeks 3 and 7. Subjects applying the topical gel received an initial dose of

40.5 mg once daily and were titrated up to 81 mg or titrated down to 20.25 mg depending on serum testosterone at

week 2 and week 4. The primary endpoint was the proportion of subjects achieving a total testosterone concentration

(Cavg) between 300 and 1140 ng/dL after 13 weeks of therapy. Secondary endpoints included patient-reported

outcomes scuh as the International Prostate Symptom Score (I-PSS), Psychosexual Daily Questionnaire (PDQ), Short

Form-36 Questionnaire (SF-36), number of adverse events, and the proportion of subjects with testosterone levels

after 13 weeks of therapy that are:

▪ Less than 1500 ng/dL

▪ Between 1800 and 2500 ng/dL

▪ Greater than 2500 ng/dL (Following 13 weeks of treatment).

Trial Results. The findings of this study were favorable, and generally consistent with FDA requirements for TRT

approval. 87% of subjects achieved the primary endpoint of total testosterone concentration (Cavg) between 300 and

1140 ng/dL after 13 weeks of therapy, with the lower bound of the 95% CI at 82%. This surpasses the FDA’s

requirement and sheds light on the potential of LPCN1021 to normalize testosterone levels in hypogonodal males.

Data on key secondary endpoints were split, as one of the endpoints was achieved while the other two were near FDA

approval criteria. While FDA requires that 85% or more of patients have testosterone Cmax of < 1500ng/dL, 83% of

patients receiving LPCN1021 achieved this result. Similarly, 2% of patients receiving LPCN1021 had testosterone

Cmax of > 2500 ng/dL, which was also slightly off the FDA stipulated mark of 0%. However, these discrepancies were

not cited in the complete response letter (CRL) that the Company received in relation to this program following New

Drug Application (NDA) submission. Full results on the primary and secondary endpoints, along with FDA

requirements for TRT approval are presented in Figure 8.

3 http://clinicaltrials.gov/show/NCT02081300

May 25, 2017

Figure 8. FDA Requirements for TRT Approval and LPCN1021 Phase III Results

FDA Criteria for

Approval of TRT LPCN1021

Number of subjects 210

Primary endpoints

Cave 300-1140 ng/dL ≥ 75% 87%

Lower bound 95% CI ≥ 65% 82%

Secondary endpoints

Cmax < 1500ng/dL ≥ 85% 83%

Cmax 1800-2500ng/dL ≤ 5% 4.6%

Cmax > 2500ng/dL 0% 2%


This trial enrolled participants to receive either LPCN1021 or AndroGel (1.62% topical testosterone gel), which served

as an active comparator to assess drug safety. Investigators reported that LPCN1021 was well tolerated throughout

the 52-week dosing period, and its safety profile was similar to active control. The cardiac AE profiles of LPCN1021

and active comparator were also similar, and this type of AE was not severe in patients receiving LPCN1021 and

occurred in less than 1% of participants. There were no hepatic, cardiac, or drug-related SAEs.

Phase III Dosing Validation Study

This trial was launched in response to concerns raised in the Complete Response Letter that was received in June

2016. The goal of this trial is to validate the fixed-dose BID regimen that Lipocine has proposed to the FDA. Topline

results are expected in June 2017.

Trial Design. This single-arm open-label Phase III dose validation study is evaluating the safety, efficacy, and

pharmacokinetics of a fixed-dose of LPCN1021 in 100 hypogonadal men. Enrolled subjects are receiving a fixed dose

of 225 mg LPCN1021 twice daily (450 mg total) for 24 days. The primary endpoint is the proportion of patients with

an average 24-hour serum testosterone level within the normal range. The key secondary endpoint of the trial is the

maximum serum testosterone level (Cmax).

Phase III Dosing Flexibility Study

Lipocine also initiated a Phase III dosing flexibility study to test three times a day dosing. Topline data from this study

are expected in June 2017. The Company expects to file an NDA for LPCN1021 supported by data from one or bth

of the ongoing studies as well as prior clinical trials.

May 25, 2017

Trial Design. This single-arm, open-label Phase III study is evaluating three times a day dosing instead of twice daily

dosing for a total of 450 mg of LPCN1021 per day. This study plans to enroll 100 patients. The primary endpoint is

the proportion of patients with an average 24-hour serum testosterone level within the normal range. The key

secondary endpoint of the trial is the maximum serum testosterone level (Cmax).

Other Drugs in Development

Figure 9 highlights the other products in development to treat hypogonadism. The most advanced product is Anteres

Pharma’s (NasdaqCM: ARTS) Vibex QST (testosterone enanthate), for which the Company has submitted an NDA

to the FDA and awaits an October 20th PDUFA date. All of the other development-stage candidates are oral

formulations, highlighting that the lack of oral TRT is recognized as an unmet need. Lipocine is potentially the most

advanced oral testosterone candidate and is well-positioned to be the first to market. Phase III readouts are expected

from a dosing validation study and a dose flexibility study in June 2017. Clarus Therapeutics (private) is also in Phase

III, although a timeline for data has not been provided.

Figure 9. Other Drugs in Development

Drug Company Delivery Stage Status

Vibex QST

(testosterone enanthate)

Antares Pharma

(NasdaqCM: ATRS) SC NDA

NDA submitted; PDUFA

date on October 20, 2017

LPCN1021

(testosterone undecanoate)

Lipocine

(NasdaqCM: LPCN) Oral III

Phase III readouts in June

2017

Jatenzo

(testosterone undecanoate)

Clarus Therapeutics

(private) Oral III Phase III trial ongoing

Androxal

(enclomiphene citrate)

Repros Therapeutics

(NasdaqCM: RPRX) Oral III

FDA meeting to discuss Phase

III design; decision on MAA

LPCN1111 Lipocine

(NasdaqCM: LPCN) Oral IIb EOP2 meeting H2 2017

BGS649 Novartis

(NYSE: NVS) Oral II Phase II studies ongoing

DITEST

(testosterone)

Diurnal Group

(LSE: DNL.L) Oral I

Topline Phase I data expected

in mid-2017


Competitive Landscape

Commercially available testosterone replacement therapies have been available for over 70 years and have followed a

progression of delivery systems that included subcutaneous, intramuscular, oral, and finally topical gels, which initially

surfaced in 1999. The difficulty in creating an easy to use and clinically effective testosterone therapy is related to the

molecule’s complex pharmacodynamics. For example, oral therapies, which are ideally the most popular route of

delivery, require multiple, high daily doses due to low bioavailability. Additionally, the few oral therapies that were

May 25, 2017

used off-label in the US quickly went out of favor after significant side effects were revealed, most notably

hepatotoxicity.

Currently, the U.S. testosterone replacement market consists of therapies that exist in three forms: 1) transdermal, 2)

injectable, and 3) buccal. Although transdermal patches were previously the most desirable application type, gel-based

testosterone replacement therapies have gained increasing popularity due to improved comfort. Despite becoming the

most popular approach to male hypogonadism treatment, topical gels are not without limitations. Topical gels place

women and children at risk of transference (secondary exposure to gels), which has prompted the FDA to issue boxed

warnings. Furthermore, the costs of gels far surpass that of other treatment types. Despite these limitations, gels

continue to achieve significant market penetration and show no signs of slowing; 64% of the total value of the

testosterone replacement market are accounted for by gels. The success of gels in the face of their drawbacks highlights

the potential of a safe and effective oral therapy.

Updated FDA Guidance Cautions Against Use for Age-Related Hypogonadism. In early 2015, the FDA

provided an update on labeling requirements for TRTs related to safety and use of these products for the treatment

of age-related hypogonadism. The agency announced that the labeling of all approved prescription testosterone

products must now stipulate that the safety and efficacy has not been established in men with age-related

hypogonadism. Furthermore, manufacturers must also include that those taking testosterone also have a heightened

risk for heart attack and stroke, which represent substantial considerations for older individuals. The FDA also has

discouraged off-label prescribing, noting that healthcare professionals should only be treating patients with low

testosterone due to certain medical conditions such as primary or hypogonadotropic hypogonadism. This

development in the TRT space likely had an adverse impact on sales of approved agents beginning in early 2015,

although we note that the market has remained robust despite stricter prescribing requirements.

LPCN1111: A Next-Generation, Once-Daily Oral Testosterone Replacement Therapy

LPCN1111 is an oral formulation of a novel testosterone prodrug based on Lipocine’s Lip’ral technology that the

Company is developing for men with hypogonadism. One of the big differentiators of LPCN1111 relative to

LPCN1021 or other approved or development-stage therapies is its pharmacokinetics profile that is supportive of

once-daily dosing. In addition, unlike LPCN1021, LPCN1111 is a New Chemical Entity (NCE) with substantial IP

protection. Lipocine has successfully completed a Phase IIa trial and a Phase IIb study and expects to have an End-

of-Phase II (EOP2) meeting with the FDA in the fourth quarter of 2017. This may set the Company up for the

initiation of a Phase III trial in 2018.


Phase IIa Study. Lipocine conducted an open-label Phase IIa single and multiple-dose escalation study to test the

safety and tolerability as well as the pharmacokinetics in order to evaluate the feasibility of once-daily dosing. The trial

enrolled 12 hypogonadal men. The drug was safe and well-tolerated with no drug-related severe or serious adverse

events (SAE), and there was a dose response observed. In addition, no subjects reached a maximum concentration

(Cmax) of 1500 ng/dL

Phase IIb Study. Lipocine next completed a randomized, open-label, two-period Phase IIb dose-finding study in the

third quarter of 2016 in order to determine the optimal dose to use in Phase III. The trial successfully identified a

May 25, 2017

once-daily dose to use for pivotal studies. The target dose for Phase III met the primary and secondary endpoints of

the trial, which is an encouraging sign for the likelihood of success.

LPCN1107: An Oral Treatment to Prevent Pre-Term Births

LPCN1107 is an oral drug candidate that contains 17 alpha-hydroxyprogesterone caproate (17OHPC), the API found

in Makena, only FDA-approved treatment, that is being developed as a preventative treatment for recurrent preterm

births. As an oral therapy, LPCN1107 may offer greater convenience to patients and eliminate the pain and site

reactions associated with weekly intramuscular injections for the standard-of-care, Makena (hydroxyprogesterone

caproate). Makena is the only FDA-approved preventative therapy for recurrent preterm births and requires 18-22

intramuscular injections. In a clinical study, roughly 35% of patients reported site reactions. An oral treatment option

could capture a large share of the market as a more patient-friendly approach than existing injectables.

Preterm Births

A birth is considered preterm when it occurs before 37 weeks of gestation. According to the CDC, this affects roughly

1 in 10 babies born in the US each year and accounts for 35% of deaths in the first year of life in the United States.4,5

Preterm birth can interfere with important developmental steps and growth during the final weeks of pregnancy that

can have far-reaching effects, particularly on the brain, lungs, and liver. In addition, preterm babies are at a higher risk

for serious disability or death.6 Preterm babies that survive can have breathing problems, trouble with feeding,

developmental delays, vision and hearing problems, and can develop cerebral palsy.

As weeks of gestation increases at or after 24 weeks of gestation, the probability of neonate mortality and morbidity

decline. As shown in Figure 10, neonates born before 24 weeks of gestation rarely survive with significant handicaps.

Neurodevelopment for neonates born after 32 weeks of gestation is common, however it is common that neonates

born after 36 weeks of gestation display difficulties with respiration, thermoregulation, and feeding, and are at

increased risk for other health problems and death in childhood.7

4 Callaghan WM, et al., The contribution of preterm birth to infant mortality rates in the United States. Pediatrics 2006;118:1566-

1573 5 Mathews TJ and MacDorman MF., Infant mortality statistics from the 2009 period linked birth/infant death data set. Natl

Vital Stat Rep 2013;61:1-27 6 Ananth, CV, et al., 2006. Epidemiology of preterm birth and its clinical subtypes. Journal of Maternal-Fetal & Neonatal Medicine,

19(12), pp773-782. 7 Boyle EM, Poulsen G, Field DJ, et al. Effects of gestational age at birth on health outcomes at 3 and 5 years of age: population

based cohort study. BMJ 2012;344:e896-e896

May 25, 2017

Figure 10. Preterm Birth Defects during Fetal Development


Risk Factors for Preterm Births. Risk factors associated with preterm birth may be identified before pregnancy, at

conception, or during pregnancy. The major risk factors for spontaneous preterm birth in the cases of singleton

pregnancies include previous pregnancy with adverse outcomes, genitourinary infection, smoking, being severely

under or overweight, maternal depression, stress, assisted fertility and poor diet.Error! Bookmark not defined. Among these,

the greatest risk factor for preterm birth is a history of previous preterm birth, where 30.7% of mothers with a single

previous preterm birth repeated in the second, and up to 60% of mothers with two preterm births repeated in the

third.8

The race/ethnicity of the mother is also a major risk factor to consider. Mothers of a black ethnic background have

the highest incident rate of preterm birth of 13.3%, followed by American Indian/Alaska Natives (10.4%), Hispanic

(9.1%), White (9.0%), Asian/Pacific Islander (8.5%).9 Even after adjustments for social, educational, economic, and

medical risk factors, mothers with a black ethnic background still have the highest incidence rate for preterm birth.Error!

Bookmark not defined.

One of the most consistent predictors of increased risk of preterm delivery is a short cervical length, regardless of

other risk factors.10,11 As cervical length decreases in the second trimester, the risk of preterm birth increases. The

incidence rate of preterm birth when cervical length below the 10th percentile (25mm) is between 25-30%, while

cervical lengths below the 3rd percentile (15mm) is 50%.12

8 McManemy J, Cooke E, Amon E, et al. Recurrence risk for preterm delivery. Am J Obstet Gynecol 2007;196(6):576.e1-576.e6. 9 http://www.marchofdimes.org/materials/premature-birth-report-card-united-states.pdf 10 Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. N Engl J

Med 1996;334:567-572 11 Yost NP, Owen J, Berghella V, et al. Number and gestational age of prior preterm births does not modify the predictive value

of a short cervix. Am J Obstet Gynecol 2004;191:241-246 12 Iams JD, Goldenberg RL, Meis PJ, et al. The length of the cervix and the risk of spontaneous premature delivery. N Engl J

Med 1996;334:567-572

May 25, 2017

Current Treatments for Preterm Birth. Current treatments are focused manipulating levels of progesterone activity

and cervical length. For women who have not had a previous preterm birth but are in a high-risk percentile after

cervical ultrasonography, vaginal progesterone is prescribed either as a gel or a capsule. Women who have had previous

preterm birth are either prescribed Makena (17 alpha-hydroxyprogesterone caproate), a synthetic progesterone, or

cerclage (an encircling suture placed around the cervix to correct structural weakness or defects). Below we will provide

an overview of using Makena as a progesterone therapy, and discuss a potential future oral product candidate to treat

preterm births.

Makena – AMAG Pharmaceuticals (NasdaqGS: AMAG). Makena, or also known as 17 alpha-

hydroxyprogesterone caproate (17OHPC), is a synthetic progestin injection therapy administered once a week into

the mother’s buttocks. While the full mechanism of action by which Makena causes inhibition of preterm birth is

unknown, Makena is hypothesized to maintain progesterone and estrogen activity ratios as to inhibit two things: 1)

cervical ripening, and 2) myometrial contractility, via suppression of oxytocin-receptor synthesis and function.13 A

study by Keirse MJ14 reported that 17OHPC treatment protects pregnant mothers who have previously had a preterm

birth against miscarriage and preterm birth. Furthermore, a larger study involving 463 pregnant women adjusted for

age, ethnicity and medical history, demonstrated that women treated with Makena reduced preterm birth at <37 weeks

by 17.8% from 54.9% in placebo groups to 37.1%.15 However, some of the major side effects of weekly injection of

17OHPC include itching, nausea, diarrhea, hives, blood clots and injection site reactions such as bruising, pain, itching,

swelling or a hard lump.

Market Information

Nearly 12% of all US pregnancies result in a preterm birth, which are associated with medical costs in the first-year

that are 10 times higher than that of a full-term baby. Overall, preterm births are responsible for over $26 billion in

healthcare expenditure. Figure 11 displays the quarterly sales for Makena in 2015 through the first quarter of 2017. In

2016, Makena sales totaled $334 million.

13 Norwitz ER, Mahendroo M, Lye SJ. Biology of parturition. In: Creasy RK, Resnik R, Iams JD, Lockwood CJ, Moore TR,

Greene MF, eds. Creasy and Resnik's maternal fetal medicine: principles and practice. 7th ed. Philadelphia: Saunders/Elsevier,

2013:66-79. 14 Keirse MJNC. Progestogen administration in pregnancy may prevent preterm delivery. Br J Obstet Gynaecol 1990;97:149-154 15 Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N

Engl J Med. 2003;348(24):2379-85.

May 25, 2017

Figure 11. Quarterly Sales of Makena 2015-2017



Phase I/II Pharmacokinetics Study

This open-label, four-period dose-finding study evaluated 4 treatments: 400 mg, 600 mg, or 800 mg of LPCN1107

twice daily, or a once-weekly injection of 250 mg of Makena. The trial enrolled 12 healthy pregnant women between

the ages of 18 and 35. The women were randomized to one of 4 treatment sequences. Figure 12 highlights the key

result of the study, showing that oral LPCN1107 could achieve higher average concentrations (Cavg) of

hydroxyprogesterone caproate (HPC) than intramuscular injection of Makena. The 800 mg dose led to a Cavg that was

roughly three times greater than the Cavg observed with Makena. None of the women receiving the 800 mg dose of

LPCN1107 remained below 8.2 ng/mL, which is a considered a clinically meaningful threshold below which preterm

birth rates rise substantially. 20% of women remained below this threshold when receiving Makena treatment.

0

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Q32015

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May 25, 2017

Figure 12. LPCN1107 Dose-Finding Results

Source: Company Presentation

Phase III Program

Lipocine had an End-of-Phase II (EOP2) meeting with the FDA to discuss the design of a Phase III development

plan for LPCN1107. The FDA agreed to a randomized, open-label, two-arm pivotal study comparing LPCN1107 to

an active comparator for up to 23 weeks of treatment. The Company received positive feedback on the proposed 800

mg dose and the planned dosing regimen. The FDA confirmed the possibility of an approval using a surrogate primary

endpoint—using a gestational age endpoint as opposed to clinical infant outcomes—but noted that it would likely

lead to consideration under a subpart H pathway. This would likely require a confirmatory post-marketing study.

The FDA also agreed to a 7% non-inferiority margin, which the Company expects would require 1,100 women per

treatment arm to achieve 90% powering. Lipocine is considering an adaptive trial design that may reduce the numbers

needed.

Other Drugs in Development

Other drugs candidates currently in development include drugs that generally focus on inhibiting uterine

contractibility, inflammation and other cervical changes associated with preterm birth. As shown in Figure 13, the

pharmacological intervention targets 1) progesterone receptor, 2) oxytocin receptor, or 3) prostaglandin F-alpha

(PGF2α) receptor to prolong pregnancy. Many of the drugs in development seek to eliminate the need for painful

weekly injections like the regimen required Makena. At present, LPCN1107 is the most advanced oral agent targeting

the progesterone receptor, the same receptor targeted by Makena. Thus, Lipocine is well-positioned to provide

comparable treatment efficacy in a more convenient dosing form.

May 25, 2017

Figure 13. Other Drugs in Development

Drug Company Delivery Stage Target

Prochieve (progesterone gel) Allergan (AGN) Transdermal III Progesterone receptor

retosiban GlaxoSmithKline (GSK) IV III Oxytocin receptor

OBE001

(nolasiban) ObsEva (OBSV) Oral II Oxytocin receptor

LPCN 1107

(hydroxyprogesterone caproate) Lipocine (LPCN) Oral I/II Progesterone receptor

OBE002 ObsEva (OBSV) Oral I Prostaglandin F receptor


Prochieve is a bioadhesive vaginal gel containing progesterone that is currently being tested in Phase III studies by

Allergan. Prochieve is designed to restore progesterone levels in the uterus, much like Makena. The efficacy of Prochieve

in preventing preterm birth remains controversial and have been weakly associated with adverse reactions such as

cramps, headaches and breast pains.16 Unlike Prochieve, GSK’s retosiban was designed to target the oxytocin receptor

as a mode of inhibiting uterine contraction. Orally administered retosiban has been shown to prolong pregnancy by

>1 week without serious AEs for the mother, fetus, or newborn.17 Ongoing Phase III clinical studies (NCT02377466)

aim to establish the safety and efficacy of retosiban, although GSK has not advanced its oral candidate and instead

designed this trial to test an intravenous (IV) formulation of the drug. Phase III data readouts for retosiban are

expected in the first half of 2019.18 Lastly, OBE022 is a novel orally active small molecule antagonist of the

prostaglandin F2α (PGF2α) receptor that aims to inhibit cervical changes, inflammation, and uterine contractility that

contribute to preterm labor. Preclinical studies in animal models have demonstrated a statistically significant delay in

artificially-induced preterm labor. Interestingly, the Phase I study also demonstrated a synergistic effect of calcium

channel antagonists with OBE022 in the prevention of preterm birth.19

Intellectual Property & Licensing

As of March 6, 2017, Lipocine owns or controls 18 issued patents and 31 pending applications in the US, as well as

16 issued foreign patents, 32 foreign pending applications, and 7 pending Patent Cooperation Treaty (“PCT”)

applications.

16 https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20701s014lbl.pdf 17 Thornton S. et al. 2015. Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study. Br J Clin

Pharmacol. 80(4):740-9. doi: 10.1111/bcp.12646 18 https://clinicaltrials.gov/ct2/show/NCT02377466 19 http://www.obseva.com/news/obseva-to-present-pharmacology-results-demonstrating-obe022-exerts-a-synergistic-effect-in-

combination-with-standard-of-care-in-animal-model-for-preterm-labor

May 25, 2017

LPCN1021. Lipocine has 11 issued patents and 19 pending applications in the US, as well as 13 issued foreign patents,

5 foreign pending applications, and 3 pending PCT applications. Additionally, Lipocine has 6 U.S. patents that could

be listed in the FDA Orange Book for LPCN 1021 are expected to expire in 2019, 2020, 2029, and 2030.

LPCN1111. Lipocine has one issued US patent related to LPCN1111 that provides IP protection out to 2035. In

addition, the Company has a number of pending patent applications that if approved, would provide protection

through 2029 in the US and 2034 abroad.

LPCN1107. There are 5 issued US patents and 3 pending US patent applications related to LPCN 1107. This would

provide patent protection until 2031. Foreign IP would provide protection until 2032 for this product.

Management Team

Mahesh V. Patel, Ph.D.

Chairman, President, and Chief Executive Officer

Dr. Patel has more than 20 years of technology and product development experience in the area of drug discovery

support, drug delivery and product line extensions. Prior to co-founding Lipocine in 1997, Dr. Patel led drug delivery

research and development at Pharmacia and Upjohn, Kalamazoo, MI. He received his MS in Physical Pharmacy at

the University of Cincinnati and his Ph.D. in Pharmaceutics from the University of Utah. His areas of expertise include

lipid drug delivery, lymphatic targeting, strategic planning, technology assessment/development, technical

management and product research and development.

Morgan Brown

Executive Vice President and Chief Financial Officer

Mr. Morgan Brown has more than 20 years of finance and accounting experience with the last thirteen years servicing

biotechnology, pharmaceutical, medical device and clinical research companies. Prior to joining Lipocine, Mr. Brown

served in a similar capacity at Innovus Pharmaceuticals, Inc. (OTCBB: INNV), an emerging pharmaceuticals company,

at World Heart Corporation (NASDAQ: WHRT), a medical device company, and Lifetree Clinical Research, a clinical

research organization. During Mr. Brown's tenure at World Heart Corporation, he was involved in numerous

financings in addition to the ultimate sale of World Heart Corporation to Heartware International Inc. (NASDAQ:

HTWR). Previously he worked for NPS Pharmaceuticals Inc. (NASDAQ: NPSP), a biotechnology company where

he served as Vice President Finance and Treasurer. During his tenure at NPS Pharmaceuticals, Inc., Mr. Brown was

involved in numerous financings as well as merger and acquisition activities. Before NPS Pharmaceuticals, Inc., Mr.

Brown worked for KPMG LLP in Salt Lake City for over seven years and managed multiple audit engagements,

servicing private and publicly owned clients. Mr. Brown is a licensed certified public accountant in Utah. Mr. Brown

earned a Master of Science degree in Business Administration from the University of Utah and a Bachelor of Science

degree in Accounting from Utah State University.

Greg Bass

Executive Vice President and Chief Commercial Officer

May 25, 2017

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May 25, 2017

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