© AzurRx BioPharma < www.azurrx.com <

CORPORATE PRESENTATION

(NASDAQ:AZRX)

September 2020

2

Certain statements in this presentation constitute “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Any statements that refer to expectations or other characterizations of future events, circumstances or results are forward-looking statements. Such forward-looking statements include projections. Such projections were not prepared in accordance with public guidelines of the American Institute of Certified Public Accountants regarding projections and forecasts, nor have such projections been audited, examined or otherwise reviewed by independent auditors of the company. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company and its clinical trials to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

The views expressed are those of management and are based on currently available information. Estimates and projections contained herein have been prepared by management and involve significant elements of subjective judgment and analysis and are based on certain assumptions. No representation nor warranty, expressed or implied, is made as to the accuracy or completeness of the information contained in this document, and nothing contained herein is, or shall be relied upon, as a promise or representation, whether as to the past or the future. The projections are not intended to follow generally accepted accounting principles. Neither our accountants nor our legal counsel have compiled, audited, prepared, or contributed to the projections or the underlying assumptions. None of these parties express an opinion with respect to the projections.

You are cautioned not to place undue reliance on these forward-looking statements. Except for ongoing obligations of the company to disclose material information under the federal securities laws, the company does not undertake any obligation to release any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Company Disclaimer

3

MS1819 recombinant lipase for treatment of Exocrine Pancreatic Insufficiency (EPI)

• Targeting patients with Cystic Fibrosis (CF) and Chronic Pancreatitis (CP)

• Addressing established global market (>$2 billion) (1)

Synthetic alternative to porcine pancreatic enzyme replacement therapy (PERT)

• Clear unmet medical need

• Established POC in two therapeutic indications in CF and CP

Pursuing parallel monotherapy and combination therapy clinical pathways:

• Topline Phase 2b CF monotherapy data expected Q1 2021

• Topline Phase 2 CF combination (MS1819 + PERT) therapy data expected Q2 2021

(1) The CorStar Group 2019. Symphony Health 2019.

AzurRx BioPharma Biotechnology company focused on the development of therapeutic proteins for GI indications

4

Recent Developments

Financial (July 2020)• Raised gross proceeds of $15.2 MM in private placement of Series B Preferred Stock ($13.5 MM net proceeds)

• Exchanged $6.9 MM principal of convertible notes into Series B Preferred Stock

• Sufficient capital to fund Phase 2 programs and Phase 3 preparations for MS1819

• Clean balance sheet

Clinical

• Monotherapy

• Phase 2b OPTION 2 clinical trial initiated (July 2020)

• First three patients dosed and nine clinical trial sites activated (August 2020)

• Combination Therapy • Interim data on first five patients (25% of study) released (August 2020)

• Primary and secondary efficacy endpoints met, no safety issues

5

Management TeamEstablished track record of execution and value creation

James SapirsteinChief Executive Officer

James Pennington, MDChief Medical Officer

Martin KrusinSVP, Corporate Development

Image Image Image Image

Daniel SchneidermanChief Financial Officer

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Focus on two patient populations requiring treatment for EPI

Cystic Fibrosis Chronic Pancreatitis

Genetic disease

• ~30,000 patients U.S.

• Treatment begins for patients in first six months of life

Heterogeneous disease

• ~90,000 patients U.S.

• Pancreatic cancer

• Surgery

• Lifestyle related morbidity

EPI related morbidities• Abdominal discomfort

• Frequent bowel movements

• Poor fat absorption

• Unable to gain or retain weight

Sources: The CorStar Group 2019. Cystic Fibrosis Foundation 2020. National Pancreas Foundation 2020.

Exocrine Pancreatic Insufficiency (EPI)A chronic nutritional deficiency – the pancreas is damaged and does not produce the digestive enzymes needed to break up food in the GI tract so that nutrients can be absorbed

7Sources: Global Market Size: Symphony Health 2019. The CorStar Group (2019). U.S. Market Size 2019 10-K’s: AbbVie, Allergan and Vivus. Pertzye – Management estimates.

Large Established Global Market Of ~$2 Billion (U.S. ~$1.4 B)Porcine-derived pancreatic enzyme replacement therapy (PERT)

8

PERT MS1819

Drug Substance

Porcine-derived pancreatic enzyme replacement therapy (PERT)

Recombinant yeast (Yarrowia lipolytica) lipase-derived replacement therapy

Stability in acidic GI environment

Limited More stable

Safety Adverse event: fibrosing colonopathy at high doses

Safe and well tolerated and no risk of fibrosing colonopathy

Pill Burden 25-40 pills per day (CF) 8-16 pills per day (CF)

Sourcing & Supply

• Subject to pig herd management

• Risk of transmission of animal pathogens

• Manufacturing + supply chain inconsistency

• GRAS (Generally Regarded as Safe)

• No risk of animal pathogens

• Manufacturing + supply chain consistency

Sources: Results from the Company’s clinical trials, internal studies and management estimates.

MS1819: Fulfilling an Unmet Medical Need

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Primary Efficacy Endpoint

Coefficient of Fat Absorption (CFA) ≥80%

Secondary Efficacy Endpoints

• Stool Consistency (Bristol Scale)

• Stool Quantity (Weight)

• Bowel Movements

• Steatorrhea

• Abdominal Discomfort (Visual Analog Scale)

• Weight Gain

• Coefficient of Nitrogen Absorption (CNA)

MS1819 Clinical Trial Efficacy Endpoints Pursuing a Non-Inferiority Pathway

10

EPI Therapeutic IndicationPhase 2 Clinical Trials

Development Phase

Discovery Pre-Clinical Phase 1 Phase 2 Phase 3

CP patients (doses up to 2.2g)Dose Escalation Study

CF patients (2.2g)Bridging Dose Safety Study

CF patients (2.2g & 4.4g in enteric capsules)Dose Escalation Study

Severe CF patients (doses up to 2.2g)Dose Escalation Study

Topline Results Expected Q1 2021Current Status

GI Therapeutic Product PipelineMS1819 – Yeast recombinant lipase

Ongoing

Ongoing

Completed

Completed

Completed

Completed

11

Phase 2 MS1819 Clinical Trials

MS1819 Doses

# Patients Safety Primary EfficacyEndpoint Results

Secondary EfficacyEndpoints Results

Status

CP patients

Dose Escalation Study

• 280 mg• 560 mg• 1120 mg• 2240mg

11France, Aus,

NZ

• Statistically significant 21.8% CFA improvement at highest dose of 2.2 g

Statistically Significant and Clinically Meaningful• # bowel movements• stool consistency• steatorrhea

Completed 2018

CF patients

Bridging Dose Safety Study

• 2240 mg

32 U.S., Poland

• CFA: MS1819 56% vs. PERT 86%

• ~50% of patients reached non-inferiority

• CNA: MS1819 93% vs. PERT 97% - no need for protease

Completed 2019

CF patients

Dose Escalation Study

• 2240 mg + Enteric Capsule

• 4480 mg + Enteric Capsule

30*U.S., Poland

Initiated Q3 2020

Topline Data Q1 2021*

CF patients

Dose Escalation Study

Daily Dose PERT + • 700 mg• 1120 mg• 2240 mg

20* Hungary,

Spain, Turkey

• Positive CFA Data on 1st five patients in study

• Clinically Meaningful Data on 1st five patients in study

Initiated Q4 2019

Topline Data Q2 2021*

* Anticipated

MS1819 Clinical Trials Safety, Primary and Secondary Endpoint Efficacy, No Need for Protease

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MS1819 Doses # Patients Safety Primary EfficacyEndpoints

Secondary EfficacyEndpoints

Status

• 280 mg• 560 mg• 1120 mg• 2240mg

11France, Aus, NZ

• Statistically Significant 21.8% CFA improvement at highest dose of 2.2 g

Statistically Significant and Clinically Meaningful• # bowel movements• stool consistency• steatorrhea

Completed 2018

Baseline @ Highest Dose of MS1819-SD (2240 mg)

Mean Change p-value

Coefficient of Fat Absorption (CFA)* 41.2 63.3 21.8% 0.002

Stool Consistency (Bristol Scale) 5.1 4.1 -19.6% 0.006

Bowel Movements 2.8 1.9 -32% 0.006

Steatorrhea 12.3 10.1 -18% 0.008

Abdominal Discomfort (Visual Analog Scale) 21.0 14.5 -31% 0.148

MS1819 Phase 2 Chronic Pancreatitis Dose Escalation Study

13

MS1819 Doses # Patients Safety Primary EfficacyEndpoints

Secondary EfficacyEndpoints

Status

2240 mg 32 U.S.,

Poland

• CFA: MS1819 56% vs. PERT 86%

• ~50% of patients reached non-inferiority

• CNA: MS1819 93% vs. PERT 97% - no need for protease

Completed 2019

MS1819 Phase 2 Cystic Fibrosis OPTION Bridging Dose Safety Study

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MS1819 Doses in Enteric Capsules

# Patients Safety Primary Efficacy

Endpoints

Secondary EfficacyEndpoints

Status

• 2240 mg • 4480 mg

30 U.S.,

Poland

CFA: MS1819 vs. PERT

• Stool Consistency• Stool Quantity• Bowel Movements• Steatorrhea• Abdominal Discomfort• Weight Gain• CNA

Initiated Q3 2020

Topline Data Anticipated Q1 2021

Open Label 2x2 Crossover Trial of MS1819 to assess the Safety and Efficacy in Enteric Capsules in Patients with Exocrine Pancreatic Insufficiency due to CF

MS1819 Phase 2b Cystic Fibrosis OPTION 2 StudyInitiated Q3 2020

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MS1819 Doses # Patients Safety* Primary EfficacyEndpoints*

Secondary EfficacyEndpoints*

Status

Daily Dose PERT +

• 700 mg• 1120 mg• 2240 mg

24Hungary,

Spain,Turkey

Positive CFA Data on 1st five patients

Clinically Meaningful Data on 1st five patients

Initiated Q4 2019

Topline Data Anticipated Q2 2021

* On 1st five patients

MS1819 Phase 2 Cystic Fibrosis Combination Therapy Dose Escalation Study in Patients with Severe EPI

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Trial Design

• Bridging dose safety study

• N = 32

Results

• Safety confirmed in CF patients at 2.2g per day. No serious adverse events observed

• Modified ITT showed MS1819 CFA results of 56% vs. PERT CFA of 86%

• Approximately 50% of patients showed CFAs sufficient to reach non-inferiority with PERT

Additional findings

• No need for protease

• Coefficient of Nitrogen Absorption (CNA) of 93% MS1819 vs 97% PERT

Phase 2 CF OPTION Study

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2x2 Crossover study design enables rapid study execution

2.2 gram MS1819 safe and well tolerated

2.2 gram• MS1819 dose

insufficient to achieve 80% CFA for all CF patients in study

• Results consistent with CP study

~50% of patients Showed CFAs sufficient to reach non-inferiority with PERT

Next Steps

• Additional study to dose escalate to 4.4g/day

• Use of enteric capsules to delay release of MS1819 in lower GI to preserve activity

Lessons from OPTION to Support Phase 2b Clinical Trial Design

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Oral PhasepH 7

Gastric Phase 2 hours, pH 3

Duodenal PhaseDigestion, pH 6

• MS1819 ~50% inactivated in Stomach

• MS1819 released early

• MS1819 in delayed-release enteric capsules

• ⇧ Lipase Released in Duodenum

• MS1819 Activity Protected

Enteric Capsules Deliver More MS1819 API to Duodenum for Digestion

19

4480mg +Enteric Capsule

In vitro

Animal Studies

Rats4700 mg/kg/day

Mini-Pigs1175 mg/kg/day

Phase I CP

180mg

Phase II CP

280mg

560mg

1120mg

2240mg

Phase IIa CF

2240mg

Phase IIb CF

2240mg +Enteric Capsule

Phase III CF*

2240mg or 4480mg + Enteric Capsule

Monotherapy

Combination Therapy

Phase II CF

Daily Dose PERT +

700mg

1120mg

2240mg

* Based on results of Phase IIb clinical trial

Completed Ongoing & Initiating

MS1819 Clinical PathwayOngoing Phase 2 CF trials to determine optimal dose

20

.

20

• Covered up to September 2028, with Hatch-Waxman extension to Sept. 2033

• FDA grants additional 12 years of exclusivity for novel biologics from first approval; EMA grants additional 10 years

• No blocking patents identified to date

• Potential to file additional IP for life cycle management

MS1819 Intellectual Property

21

Firm AnalystArgus Research Steve SilverDawson James Jason KolbertH.C. Wainwright & Co. Yi Chen, Ph.D.Maxim Group Jason McCarthy, PhD.Roth Capital Jonathan Aschoff, Ph.D.Trickle Research David LavigneZacks Research John D. Vandermosten

Analyst Coverage

22

Nasdaq AZRX

Stock Price $0.81(1)

Common Shares Outstanding 28.5 MM

Market Cap $23.1 MM(1)

Preferred Stock (SV) (CP: $0.77) $22.4 MM(1)

Debt $0

(1) As of market close 9/1/2020(2) As of 7/31/2020(3) Includes 29.1 MM shares issuable upon conversion of Series B Preferred Stock at $0.77/share; 25.2 MM shares issuable upon

exercise of warrants (WAEP: $1.23); 4.3 MM shares issuable upon exercise of options (WAEP: $1.38).

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Cash $13.5 MM(2)

Enterprise Value $27.6 MM(1)

Shares Out/Fully Diluted 87.6 MM(3)

Avg. Daily Volume (3 months) 409,701

Avg. Daily Volume (10 days) 265,717

Full-Time Employees 11

Financial Overview

23

MS1819 recombinant lipase for treatment of Exocrine Pancreatic Insufficiency (EPI)

• Targeting patients with Cystic Fibrosis (CF) and Chronic Pancreatitis (CP)

• Addressing established global market (>$2 billion) (1)

Potential synthetic alternative to porcine pancreatic enzyme replacement therapy (PERT)

• Clear unmet medical need

• Established POC in two therapeutic indications in CF and CP

Pursuing parallel monotherapy and combination therapy clinical pathways:

• Topline Phase 2b CF monotherapy data expected Q1 2021

• Topline Phase 2 CF combination (MS1819 + PERT) therapy data expected Q2 2021

New Management Team with combined experience in developing and launching over 25 drugs

• Established track record of execution and value creation

(1) The CorStar Group 2019. Symphony Health 2019.

Investment HighlightsBiotechnology company focused on the development of therapeutic proteins for GI indications

© AzurRx BioPharma < www.azurrx.com <

APPENDIX

2525

Note: In normal subjects, physiological pH in duodenum is between approximately 5 and 6. In CP and CF pH is lowered to a more acidic range, approximately pH 4 to 5. MS1819 not inactivated by bile salts.

SA (U

/mg

of p

urifi

ed e

nzym

e eq

uiva

lent

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

2 3 4 5 6 7 8 9pH

MS1819 Porcine PERT

BasicAcidic

MS1819

Lipa

sePorcine Pancreatic

Lipase

MS1819 lipase shows superior activity to porcine lipase at the relevant intestinal pH range of 4 to 6

HealthyPatients

CF Patients

MS1819 Shows Strong Activity at Normal pH RangeIn vitro lipolytic activity of MS1819 lipase in the presence of bile salts in the European and US Pharmacopeia test (U/mg, Pure Enzyme)

2626

PPI:Proton-pump inhibitors Source: Results of interviews of 10 pulmonologists, The CorStar Group 5/2019, and 10 gastroenterologists, Campbell Alliance 8/2014

Presenting CF Patient (often at birth)

Treatment and Therapy Options

Mild (25%, ~7K) Moderate (42%, ~11K) Severe (33%, ~9K)

Diet Modification

Fat Soluble Vitamin Supplementation

PERTs

Diet Modification

Fat Soluble Vitamin Supplementation

PPIs

PERTs

Diet Modification

Fat Soluble Vitamin Supplementation

PPIs

PERTs

2nd

Line

(1

0%)

1st L

ine

(25%

)

(Percent ending line of therapy)

2nd

Line

(7

5%)

1st L

ine

(100

%)

1st L

ine

(90%

)

CF Treatment Approach CF EPI patients progress through different lines of therapy. Progressive EPI requires enzyme replacement therapy to treat the underlying deficiency.

27

Trial conducted in France, Australia and New Zealand; 11 patients enrolled

(C)Open-label phase 12-15 days each step

(D)Follow-up

12-15 days

(A)Screening0-30 days

(B)Washout

12-15 days

Usual PPE treatment

Previous PPE treatment

Screening

MS1819-SD2240mg/day

Baseline

MS1819-SD280mg/day

MS1819-SD560mg/day

MS1819-SD1120mg/dayInclusion

V1 V2 V3

V4

V5

V6 V7

V8

Fecal elastase-1 at screening <100 µg/gInpatient CFA measurement (mean of 3 consecutive days)Outpatient CFA measurement (mean of 3 consecutive days)

120 days

N = 11 patients

Multi-Center Trial Sites(France, Australia, NZ)

Clinical Trial Design for MS1819 Phase 2 in Chronic Pancreatitis

28

Trial Design

• N = 11 CP patients

• 2-week wash-out period; ascending doses of MS1819, with the highest daily dose being 2.2 grams per day

Primary endpoints: Safety and CFA change from baseline

Secondary endpoints: Number of bowel movements, stool consistency and steatorrhea, also showed statistically significant and clinically meaningful improvements with MS1819 treatment.

Results

• Statistically significant improvements in CFA on an ITT (Intent To Treat) and PP (Per Protocol) basis.

• Favorable safety profile with no serious adverse events

MS1819 Phase 2 Chronic Pancreatitis Trial (Completed 2018)

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• Per Protocol AnalysisSource: University of Adelaide, Adelaide, Australia; 2. AzurRx, Langlade, France; 3. Syneos Health, London, UK; 4. AzurRx, New York, NY, USA. Nam Q Nguyen,1 Luc Lebreton,2Gary Smith,3 Philippe Jais,2 Mathieu Schue,2 and Thijs Spoor4 “Impact of a spray dried recombinant lipase, MS1819, For the treatment of exocrine pancreatic insufficiency in patients with chronic pancreatitis: Results of a multicenter, Phase II, open-label, non-randomized study”. Presented by Dr. Nam Q. Nguyen, et al., at Digestive Disease Week on May 20, 2019. * Per Protocol Analysis. Intent to Treat Analysis showed a Mean Change of 15.7%, p value <0.001

Baseline @ Highest Dose of MS1819-SD (2240 mg)

Mean Change p-value

Coefficient of Fat Absorption (CFA)* 41.2 63.3 21.8% 0.002

Stool Consistency (Bristol Scale) 5.1 4.1 -19.6% 0.006

Bowel Movements 2.8 1.9 -32% 0.006

Steatorrhea 12.3 10.1 -18% 0.008

Abdominal Discomfort (Visual Analog Scale) 21.0 14.5 -31% 0.148

MS1819 Phase 2 Study in CP: Primary and Secondary Efficacy Endpoints

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Open-Label, Multicenter, 2x2 Crossover Trial to assess the Safety and Efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis

≥ 18 yearsMS1819 2240 mg/dayStable PERT doseN=32

32 patients across 14 sites in the U.S. and Poland completed the study

DSMBReview

MS1819

CFA

MS1819

PERT

3 Weeks 3 Weeks

PERT

CFA

Phase 2a CF OPTION Bridging Dose Safety Study (Completed 2019)

31

Open-Label, Multicenter, 2x2 Crossover Trial to assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis

DSMBReview

30 patients across 15 sites in the U.S. and Poland anticipated

Phase 2b CF OPTION 2 Enteric Dose-Escalation Trial (Initiated Q3 2020)

32

1/3 of all CF patients on

PERT achieve less than

80% CFA

Majority of severe EPI

patients are at maximum

(tolerated or recommended)

daily PERT dose

Risk of fibrosing colonopathy

at high daily

PERT doses

Adding MS1819 to daily PERT may get

patients to CFA goal

Efficacy endpoint of increasing CFA above 80% in patients with severe EPI

Phase 2 Combination Therapy Trial in CF Patients with Severe EPISubstantial unmet need in patients not to goal on chronic PERT therapy

33

Open-label PERT + MS181915 days each dose

Follow-up12-15 days

V4

VisitInpatient CFA measurement

V7

Eligibility criteria CFA < 80%

Screening0-15 days

Inclusion15 days

Inclusion

+ MS1819700mg/d

+ MS18191120mg/d

+ MS18192240mg/d

V1 V3 V5 V6V2

ScreeningStable PERT dose

M/F ≥12 years

N = 24 patients

Duration: 100 Days

European Trial Sites(Hungary, Spain, Turkey)

Phase 2 Combination Therapy (PERT + MS1819) Trial DesignStudy Initiated Q4 2019, Anticipated Completion Q2 2021

34

Interim Data from the First Five Patients in Combination StudyPrimary and Secondary Efficacy Endpoints Met, No Safety Issues

V2 V4 V5 V6PERT

(Baseline)+ 700mg/day

MS1819+ 1120mg/day

MS1819+ 2240mg/day

MS1819

CFA (%) 78.4 88.4 87.2 86.5

CNA (%) 96.6 97.7 98.0* 97.4*

Stool Weight(g/72h) 784.2 566.6 565.0 526.6

Steatorrhea(g/24h) 21.0 11.5 12.7 13.6

# Stools per day 6.8 4.8 4.8 4.8

Body Weight (Kg) 47.6 48.6 48.6 49.4

Mean Values

* CNA data not available for one patient on V5 and one patient on V6.

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V2 (Baseline) AVG V4-V6 Change

CFA (%) 78.4 87.4 9

CNA (%) 96.6 97.7* 1.1

Stool Weight (g/72h) 784.2 552.7 -231.5

Stools/Day 6.8 4.8 -2.0

Steatorrhea (g/24h) 21.0 12.6 -8.5

Interim Data from the First Five Patients in Combination StudyPrimary and Secondary Efficacy Endpoints Met

* CNA data not available for one patient on V5 and one patient on V6.

36

V2 (Baseline) V6 Change

Body Weight (kg) 47.6 49.4 1.8

Body Weight (lbs) 105 109 4

Body Weight increased by 1.8kg (~ 4 lbs.) over the 45 days of MS1819 dosing

37

Summary of Key Combination Therapy Trial Interim Findings

Primary Efficacy Endpoint

• CFA > 80% for all patients, across all visits

Secondary Efficacy Endpoints

• Stool Weight decreased

• The number of Stools/Day decreased

• Steatorrhea improved

• Body Weight increased

Safety

• Safe - no Serious Adverse Events