David Oldach, MD, FIDSA - PowerPoint Presentation

David Oldach, MD, FIDSAChief Medical OfficerCempra, Inc. Developing Well-Differentiated Antibiotics Results of the SOLITAIRE-U Phase 3 Trial: Solithromycin vs Ceftriaxone+Azithromycin for Treatment of Uncomplicated Urogenital Gonorrhea

4th generation macrolide, the first fluoroketolideExhibits in vitro activity against a number of urogenital pathogens Neisseria gonorrhoeae MIC90s of 0.12 and 0.25 µg/mL (Golparian 2012, Olsen 2013)maintains activity against azithromycin-resistant strains and intracellular pathogens (Mallegol 2013) Chlamydia trachomatis MIC90 = 0.25 µg/mL and demonstrated bactericidal activity (Roblin 2010) Mycoplasma spp. in vitro activity against M. hominis, M. fermentans, M. genitalium maintains activity against (most) azithromycin-resistant M. genitalium (Jensen 2014)Ureaplasma spp. MIC90 = 0.12 µg/mL (Furfaro 2015)Efficacy in a U. parvum intrauterine infection sheep pregnancy model (Miura 2014) Solithromycin: Introduction

Two U.S. sites:Ned Hooke, MD - University of Alabama at BirminghamMatthew Golden, MD - University of Washington, Seattle, WA Uncomplicated gonorrhea in adults N = 59 Oral solithromycin 1200 mg or 1000 mg single doseFor all 54 sites of culture-proven N. gonorrhoeae infection at baseline, 100% eradication at the Test-of-Cure (TOC) visitSolithromycin Phase 2 Urethritis StudyHooke et al 2015 Outcomes at TOC in the ME population; NAAT, nucleic acid amplification test Organism Site SOLITHROMYCIN 1200 mg(N = 24)SOLITHROMYCIN1000 mg(N = 22)CultureNAATCultureNAATN. gonorrhoeae Urogenital22/2221/2320/2016/20 Pharyngeal5/56/93/36/7 Rectal2/29/92/211/11 Total29/2936/4125/2532/37C. trachomatis Urogenital - 7/8 - 1/2 Pharyngeal - 0/1 - 0 Rectal - 1/1 - 1/1

Drug related Treatment Emergent Adverse Events (TEAEs), mostly GI related Solithromycin Phase 2 Urethritis Study Hooke et al 2015 Summary of Drug Related TEAEs, Safety population

Marcus Chen, PhDAssociate Professor, University of MelbourneMelbourne Sexual Health Centre Melbourne, Australia Anna McNulty, MBBS, MMedAssociate Professor, University of New South Wales Sydney Sexual Health CenterSydney, Australia Solithromycin Phase 3 Urethritis Study: SOLITAIRE-USites and Investigators – Part A Enrollment Supplemental enrollment (ongoing) of females and adolescent males through collaboration with Division of Microbiology and Infectious Diseases (DMID)/NIAID at 2 additional sites: University of Toledo and Johns Hopkins University Ann Avery, MD Associate Professor, Case Western Reserve University MetroHealth Medical Center Cleveland, OH AustraliaUnited StatesPart B Enrollment

Trial Profile Solithromycin Phase 3 Urethritis Study: SOLITAIRE-U Screening/Baseline/ TreatmentFUVwindowOral Solithromycin1000 mgN=130 Randomization IM Ceftriaxone 500 mg Oral Azithromycin 1000 mg N=131Day12345-9…19-23TOCwindowIM = intramuscular, TOC = Test-of-Cure Day 7 (±2), FUV = follow-up visit Day 21 (±2), NAAT = nucleic acid amplification testN. gonorrhoeae by culture, NAATC. trachomatis and M. genitaliumby NAATKeyMicrobiological Assessments

Primary objective:To assess the non-inferiority (NI) of solithromycin vs. ceftriaxone/azithromycin based on the eradication rate of urogenital N. gonorrhoeae by culture in the microbiological intent-to-treat (microITT) population at TOC / Day 7 (±2) (NI margin = 10 %) Secondary objectives: Bacterial eradication of N. gonorrhoeae by culture at all body sites in the microbiologically evaluable (ME) population at TOC / Day 7 (±2)Clearance of N. gonorrhoeae / C. trachomatis by NAAT at all body sites in the ME-NAAT populations at TOC / Day 7 (±2) and FUV / Day 21 (±2)Safety and tolerability of a single oral dose of solithromycinExploratory objective: Clearance of urogenital M. genitalium by NAAT at FUV / Day 21 (±2) SOLITAIRE-U: Primary Objective

SOLITAIRE-U: Microbiological Populations and Assessments Microbiological Assessment N. gonorrhoeae C. trachomatis M. genitalium microITT Received study drug Baseline positive urogenital culture for N. gonorrhoeae culture - - MEReceived correct study drugBaseline positive culture for N. gonorrhoeae for ≥1 body siteRepeat culture at TOC for ≥1 body site that was positive at baselineNo confounding antibiotics receivedculture - - ME-NAAT-TOCReceived correct study drugBaseline positive NAAT for ≥1 body siteRepeat NAAT at TOC for ≥1 body site that was positive at baselineNo confounding antibiotics receivedNAATNAAT - ME-NAAT-FUVReceived correct study drugBaseline positive NAAT for ≥1 body siteRepeat NAAT at FUV for ≥1 body site that was positive at baselineNo confounding antibiotics received - NAATNAAT

Inclusion≥ 15 yrs of ageLaboratory evidence of urogenital gonorrhea: Positive lab test (culture or NAAT) Gram stain demonstrating Gram-negative intracellular diplococci + leukocytes Willingness to return for TOC visit and abstain from unprotected sexual contact on study ExclusionEvidence of complicated/systemic gonococcal infectionReceived antibiotic treatment for gonorrhea within previous 7 daysKnown neuromuscular disorders or renal/hepatic/hematologic impairmentPregnancy/nursingSOLITAIRE-U: Key Inclusion / Exclusion Criteria

SOLITAIRE-U: Patient Demographics SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ITT (N = 262)131131Australia98 (74.8%)98 (74.8%)United States 33 (25.2%) 33 (25.2%) Adolescents (<18 yrs ) 01 (0.8%)Adults (≥18 yrs)131 (100.0%)130 (99.2%)Females9 (6.9%)7 (5.3%)Males122 (93.1%)124 (94.7%) Heterosexual Males27 (22.1%) 29 (23.4%) Men who have sex with men (MSM)95 (77.9%)95 (76.6%)Race White84 (64.1%)80 (61.1%) Black or African American31 (23.7%)37 (28.2%) Asian12 (9.2%)11 (8.4%) Other4 (3.1%)3 (2.3%)

SOLITAIRE-U: Patient Disposition SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ITT (N = 262)131131Completed study115114Premature withdrawal from study16 17 Adverse Event 0 0 Development of a clinically significant lab abnormality00 Clinical failure00 Lost to follow-up1114 Withdrew consent00 Unwilling to comply with study procedures12 Death00 Other4 a1 bReceived additional antibiotics prior to Day 21 visit (3); site error, treated with SOC in error (1) Ineligible, negative for all tests at baseline (1)

SOLITAIRE-U: Baseline Microbiological Results SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ITT (N = 262)131131No. of males122124No. of females9 7 Culture Positive – N. gonorrhoeae 126 (96.2%) 129 (98.5%) Urogenital124 (94.7%)129 (98.5%) Urethral (% of males)118 (96.7%)123 (99.2%) Cervical (% of females)6 (66.7%)6 (85.7%) Pharyngeal 25 (19.1%)21 (16.0%) Rectal9 (6.9%)13 (9.9%)NAAT Positive – N. gonorrhoeae127 (96.9%)127 (96.9%) Urogenital124 (94.7%)126 (96.2%) Urine (% of males)118 (96.7%)119 (96.0%) Vaginal (% of females)6 (66.7%)7 (100.0%) Pharyngeal 41 (31.3%)42 (32.1%) Rectal17 (13.0%)25 (19.1%)

SOLITAIRE-U: Baseline Microbiological Results SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ITT (N = 262)131131No. of males122124No. of females9 7 NAAT Positive – C. trachomatis 30 (22.9%) 23 (17.6%) Urogenital17 (13.0%)14 (10.7%) Urine (% of males)14 (11.5%)13 (10.5%) Vaginal (% of females)3 (33.3%)1 (14.3%) Pharyngeal 4 (3.1%)4 (3.1%) Rectal12 (9.2%)12 (9.2%)

SOLITAIRE-U: Baseline MIC Distributions N. gonorrhoeae isolates from all body sites of infection, N = 313 MIC summary statistics for Ceftriaxone range: ≤0.001 – 0.12 µg/mL MIC 50 : 0.008 µg/mLMIC90: 0.03 µg/mLMIC µg/mLIsolate Count

SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN microITT (N = 252) N = 123 N = 129 Eradication 99/123 ( 80.5%)109/129 (84.5%) Difference (95% CI)a-4.0% (-13.6, 5.5)Persistence8/123 (6.5%)0/129 (0.0%)Indeterminate16/123 (13.0%)20/129 (15.5%)a. Confidence interval calculated using the method of Miettinen and Nurminen without stratificationSOLITAIRE-U: Primary Objective Eradication of urogenital N. gonorrhoeae by culture at TOC / Day 7 (±2) in the microITT population (NI margin = 10%)

SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ME (N = 213) N = 106 b N = 107 Overall, by-patient aEradication95/104 (91.3%)107/107 (100.0%)Persistence9/104 (8.7%)0/107 (0.0%)Assessed on a patient level, where all baseline positive body sites had an available result at TOC2 patients on the solithromycin arm did not have available culture results for all body sites that were positive at baseline and were therefore excluded from the by-patient analysisSOLITAIRE-U: Efficacy in the Microbiologically Evaluable (ME) populationN. gonorrhoeae culture result at TOC in the ME population

SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ME (N = 213) N = 106 b N = 107 Overall, by-patient aEradication95/104 (91.3%)107/107 (100.0%)Persistence9/104 (8.7%)0/107 (0.0%)Females (n=10)Eradication5/5 (100.0%)5/5 (100.0%)Persistence 0/5 (0.0%)   0/5 ( 0.0% ) Males (n=201) Eradication 90/99 ( 90.9% ) 102/102 ( 100.0% ) Persistence   9/99 ( 9.1% )   0/102 ( 0.0% ) Heterosexual Males (n=45) Eradication 20/21 ( 95.2% ) 24/24 ( 100.0% ) Persistence   1/21 ( 4.8% )   0/24 ( 0.0% ) MSM (n=156) Eradication 70/78 ( 89.7% ) 78/78 ( 100.0% ) Persistence 8/78 ( 10.3% ) 0/78 ( 0.0% ) SOLITAIRE-U: Efficacy in the Microbiologically Evaluable (ME) population N . gonorrhoeae culture result at TOC in the ME population and in subgroups Assessed on a patient level, where all baseline positive body sites had an available result at TOC 2 patients on the solithromycin arm did not have available culture results for all body sites that were positive at baseline and were therefore excluded from the by-patient analysis

SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ME (N = 213) N = 106 N = 107 Urogenital (n=212) Eradication 97/105 ( 92.4% )107/107 (100.0%)Persistence 8/105 (7.6%)  0/107 (0.0%)Cervical (n=10)Eradication5/5 (100.0%)5/5 (100.0%)Persistence0/5 (0.0%)0/5 ( 0.0%) Urethral (n=202) Eradication 92/100 ( 92.0% ) 102/102 ( 100.0% ) Persistence 8/100 ( 8.0% ) 0/102 ( 0.0% ) Pharyngeal (n=35) Eradication 15/16 ( 93.8% ) 19/19 ( 100.0% ) Persistence   1/16 ( 6.3% )   0/19 ( 0.0% ) Rectal (n=18) Eradication 5/6 ( 83.3% ) 12/12 ( 100.0% ) Persistence 1/6 ( 16.7% ) 0/12 ( 0.0% ) SOLITAIRE-U: Efficacy in the Microbiologically Evaluable (ME) population N . gonorrhoeae culture result at TOC in the ME population by body site a Assessed by body site , where individual baseline positive body sites had an available result at TOC

No apparent relationship between outcome and soli MIC SOLITAIRE-U: Treatment Success by Solithromycin MIC ISOLATES FROM SOLITHROMYCIN PATIENTS Success by MIC, ME Population (N = 106) Body site Urogenital PharyngealRectalNo. Isolates102146MIC (µg/mL) 0.004 - 1/1 (100.0%) - 0.008 - - - 0.0153/3 (100.0%) - - 0.0311/11 (100.0%) - - 0.0628/31 (90.3%)4/4 (100.0%)2/3 (66.7%) 0.1242/47 (89.4%)6/7 (85.7%)3/3 (100.0%) 0.2510/10 (100.0%)2/2 (100.0%) -

SOLITAIRE-U: N. gonorrhoeae Isolate Pairs from Solithromycin Treatment Failures – Baseline to TOC comparisons Decreasing susceptibility to solithromycin was not detected Defined as : at least a 4-fold increase in the MIC of the study drug received of the isolate recovered at the TOC visit compared to the baseline isolate All MICs at TOC were the same or within one 2-fold dilution of the baseline MIC

SOLITAIRE-U: N. gonorrhoeae Isolate Pairs from Solithromycin Treatment Failures – Baseline to TOC comparisons “ New” isolates recovered at TOC were not detected Baseline/TOC isolates from a selection of solithromycin treatment failure patients – genome sequencing and phylogenetic comparison using SNPs

Clearance of N. gonorrhoeae by NAAT at TOC/Day7 (±2) by body site a SOLITAIRE-U: Secondary Efficacy Outcomes SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN ME-NAAT-TOC (N = 212) N = 107 N = 105 Urogenital (n=210) Clearance 95/105 (90.5%)102/105 (97.1%)Persistence10/105 (9.5%)  3/105 (2.9%)Vaginal (n=10)Clearance5/5 (100.0%)5/5 (100.0%)Persistence0/5 (0.0%) 0/5 ( 0.0 % ) Urine, males (n=200) Clearance 90/100 ( 90.0 % ) 97/100 ( 97.0 % ) Persistence 10/100 ( 10.0 % ) 3/100 ( 3.0 % ) Pharyngeal (n=64) Clearance 22/29 ( 75.9% ) 33/35 ( 94.3% ) Persistence 7/29 ( 24.1% )   2/35 ( 5.7% ) Rectal (n=35) Clearance 13/15 ( 86.7% ) 19/20 ( 95.0% ) Persistence 2/15 ( 13.3% )   1/20 ( 5.0% ) Assessed by body site, where individual baseline positive body sites had an available result at TOC

SOLITAIRE-U: Secondary Efficacy Outcomes Clearance of C. trachomatis by NAAT at Follow-Up ( FUV)/ Day 21 (±2) by body site a Assessed by body site, where individual baseline positive body sites had an available result at TOCSOLITHROMYCINCEFTRIAXONE + AZITHROMYCINME-NAAT-FUV (N = 38) N = 22N = 16Urogenital (n=18)Clearance8/10 (80.0%)8/8 (100.0%)Persistence2/10 (20.0%)0/8 (0.0%)Vaginal (n=3) Clearance 2/2 ( 100.0% ) 1/1 ( 100.0% ) Persistence 0/2 ( 0.0% ) 0/1 ( 0.0 % ) Urine, males (n=15) Clearance 6/8 ( 75.0 % ) 7/7 ( 100.0 % ) Persistence 2/8 ( 25.0 % ) 0/7 ( 0.0 % ) Pharyngeal ( n=1) Clearance 0/1 ( 0.0% ) - Persistence 1/1 ( 100.0% )   - Rectal ( n=15 ) Clearance 7/10 ( 70.0% ) 4/5 ( 80.0% ) Persistence 3/10 ( 30.0% ) 1/5 (20.0%)

More TEAEs reported for solithromycin patients, largely driven by gastrointestinal disordersAll AEs from solithromycin patients were mild to moderateNo SAEs or TEAEs leading to study discontinuation in either group SOLITAIRE-U: Treatment Emergent Adverse Events (TEAEs) SOLITHROMYCIN CEFTRIAXONE + AZITHROMYCIN Safety (N = 261) N = 130 N = 131 TEAEs 69 (53.1%) 45 (34.4%)TEAEs related to study drug56 (43.1%)33 (25.2%) GI Disorders54 (41.5%)28 (21.4%)Diarrhea29 (22.3%)20 (15.3%)Nausea27 (20.8%)14 (10.7%)Vomiting 2 (1.5%)0Abdominal pain/discomfort 12 (9.2%) 4 (3.1%)

ALT/AST No post-baseline ALT/AST ≥ 3× ULN for either treatment groupTotal Bilirubin One ceft / azi patient with a post-baseline total bilirubin of 1.6×ULN No solithromycin patients with post-baseline total bilirubin ≥ 1.5×ULN No liver-related TEAEsNo patients met laboratory criteria for Hy’s Law SOLITAIRE-U: Liver Safety Laboratory Parameters

Solithromycin was not non-inferior to SOCSuccess in ME population of 91.3%Promising, did not match Phase 2 success rates Why? Study population No relationship between outcome and solithromycin MICs; no decrease in susceptibility to solithromycin No evidence of reinfection with new strainsTreatment failures may be related to PK and insufficient drug exposure at the site of infectionAddress with a dose adjustment or combination treatment strategy SOLITAIRE-U: Conclusions

SOLITAIRE-U: Solithromycin Phase 3 Urethritis Program Contributors and Collaborators Investigators Marcus Chen, PhD Associate Professor, University of Melbourne Melbourne Sexual Health Centre, Australia Anna McNulty, MBBS, MMed Associate Professor, University of New South Wales Sydney Sexual Health Center, Australia Ann Avery, MD Associate Professor, Case Western Reserve University MetroHealth Medical Center, Cleveland, OH Division of Microbiology and Infectious Diseases (DMID) / National Institute of Allergy and Infectious Diseases (NIAID)LaboratoriesDwight Hardy, PhD Professor, University of Rochester Clinical Microbiology Laboratories, Rochester, NYSepehr Tabrizi, PhD Professor, University of Melbourne Molecular Microbiology Laboratory, Australia David Whiley, PhD Associate Professor, University of Queensland Queensland Paediatric Infectious Diseases Lab, AustraliaBen Howden, PhD Professor, University of MelbourneSponsorAshley Nenninger, PhD Senior Scientist, Drug Development Cempra, Inc., Chapel Hill, NC

Solithromycin Phase 3 Urethritis: Backup Slides

SOLITAIRE-U: Exploratory Efficacy Outcomes Clearance of M. genitalium by NAAT at Follow-Up ( FUV)/ Day 21 (±2) SOLITHROMYCINCEFTRIAXONE + AZITHROMYCINME-NAAT-FUV (N = 38) N = 22N = 16Urogenital (n=13)Clearance3/7 (42.9%)2/6 (33.3%)Persistence4/7 (57.1%)4/6 (66.7%)Vaginal (n=2)Clearance0/1 (0.0%)0/1 ( 0.0%) Persistence 1/1 ( 100.0% ) 1/1 ( 100.0% ) Urine, males (n=11) Clearance 3/6 ( 50.0 % ) 2/5 ( 40.0 % ) Persistence 3/6 ( 50.0 % ) 3/5 ( 60.0 % )

SOLITHROMYCIN FAILURES FOR N. gonorrhoeae @ TOC BY CULTURE: PATIENT PROFILES ID   Cx + site T rue TOC Day TOC presentationCx + sites@TOCSexual contact D1 - TOC?AEsCon meds, OTC, otherSoli ASTΔ from D1 to D7 isolateOther Abx AST Δ > 1 dilution or > 2mmNg MLST/MASTComments001-1007UGD9Urethral discharge; High ALT/ASTUGYESDiarrhea on D1anabolic steroids by IM, ongoing no Δ 0.12 ug/ml Spect : 29 to 23 mm no Δ P ossible UG reinfection; Admission of sexual activity with regular partner on D5; possible same pathogen (by AST and MAST) 001-1010 UG, P D7 Asymp . P no N ausea and diarrhea on D1-2 cocaine ( oral ) 1 week prior no Δ in pharyngeal isolate 0.12 ug /ml Minor , if any, Δes for the pharyngeal isolate no Δ UG infection resolved and asymptomatic @ TOC, but pharyngeal Cx + 003-1049 UG D8 U rethral discharge; Dysuria ; High ALT/AST UGnoVomiting on D1nono MIC Δ 0.12 ug/mldisc zone 36 to 41 mm All MICs identical all disc zones increased from 1 to 9 mm no Δ/ NDAcross the board disc zone differences indicative of a different strain and a reinfection? But all MICs the same Note: “Symptoms cleared initially then recurred" on D6 001-1113 UG D8 U rethral discharge UG no no Hep B vax on D6 0.06 to 0.12 ug /ml and 39 to 37 mm Most MICs decrease by 1 dilution; however, all KBs decrease 1-9 mm no Δ / ND Multiple differences in MIC/KB – indicative of a different strain? 002-1135 UG D9 Asymp . UG no no Combivir & Tenofovir , Ongoing 0.06 to 0.12 ug /ml and 35 to 37 mm Spect : 24 to 27 mm Ceft : 0.03 to 0.06 mg/ml and 40 to 38 mm IND/ ND Asymptomatic @ TOC; minimal differences in Soli, Spectinomycin , Ceftriaxone MIC/KB 001-1209 UG D8 Urethral discharge; dysuria UG no no Numerous allergy/asthma meds no Δ 0. 12 ug /ml Penicillin: 34 to 31 mm Tet: 33 to 29 mm no Δ / ND Note: “Symptoms improved but not resolved.” Minimal abx differences, indicative of same strain? 003-1217 UG D8 Urethral discharge; dysuria UG no Diarrhea on D1 Allergy meds (Claritin/ Waldryn ) no Δ 0. 06 ug /ml Cefixime : 44 to 47 mm no Δ / ND Minimal abx differences, indicative of same strain? Subject also had persistent pharyngeal Ng by NAAT (not culture positive) 002-1237 UG D6 Urethral discharge; dysuria; high ALT UG no tbd Carbocisteine (inhaler for asthma), esomeprazole no Δ 0. 12 ug /ml Minor , if any, Δes no Δ / ND Persistent M. genitalium - positive at D1/D6/D20 001-1248 UG, R D8 Urethral discharge; dysuria UG, R no Vomiting on D6 no All 4 isolates 0.06 and 0. 12 ug /ml Minor , if any, Δes across all 4 isolates no Δ / ND Persistent chlamydia positive (urine NAAT) D1 and D8

TREATMENT FAILURES FOR C. trachomatis @ DAY 21 BY NAAT: PATIENT PROFILES ID   TreatmentBaseline Ct NAAT+ Sites TOC and FU Ct NAAT+ Sites Ng, Mg resultsSexual contact?AEsCon meds, OTC, otherComments003-1141SoliUrineUrineat TOC (D8) and atFU (D22)Urethral Ng by Cx and NAAT,all resolved at TOC D1 – TOC: NoTOC – FU: Yes, w/ condom, vaginal (male subject)D1: stomach upsetD22: presumptive TrichomoniasisAlevePresumptive Trichomoniasis noted at FU visit on Day 22, metronidazole prescribed in addition to azithromycin. 003-1163SoliUrineUrine at TOC (D8) and atFU (D20)Urethral and Pharyngeal Ng (Cx and NAAT) and Urethral Mg (NAAT) at baseline; all resolved but pharyngeal Ng by NAAT at TOCnoD1: NauseaMetronidazolePresumptive Trichomoniasis noted at Day 1, metronidazole prescribed/dosed on Day 1. Subject had multiple infections, multiple sites at baseline – urethral Ng, Ct, Mg and Trich as well as pharyngeal Ng. All but urethral Ct and pharyngeal Ng resolved. 002-1185 Soli Pharyn-geal , rectal Pharyngeal, rectal at TOC (D9) and FU (D21) Urethral Ng by NAAT, resolved by TOC no no mupirocin Impetigo diagnosed 17 days prior to baseline, treating with topical mupirocin since that time and during study, as needed; location of infection not noted in Express. 002-1224 Soli Rectal Rectal at TOC (D7) and FU (D22) Urethral Ng by Cx and NAAT, and rectal Ng by NAAT; all resolved at TOC D1 – TOC: No TOC – FU: Yes, NO condom oral and w/ condom, anal no no 003-1233 Soli Rectal Negative at TOC (D8) and rectal positive at FU (D22) Urethral Ng by Cx and NAAT, and rectal Ng by NAAT; all resolved at TOC no no no Ct cleared at TOC visit, but positive again by FU visit; patient claims no sexual activity. 001-1177 Azi + Ceft Rectal Rectal negative at TOC (D8), but rectal positive again at FU (D22)Urethral and Rectal Ng (Cx and NAAT) at baseline, resolved at TOCD1 – TOC: NoTOC – FU: Yes, NO condom, oralD1: diarrhea“Swiss Mens Multivitamin”, glucosamine, fish oilHemorrhoid noted at baseline, ongoing through study.