AzurRx BioPharma : January 2021 Investor Update

AzurRx Investor Update

January 4, 2021

C O N F I D E N T I A L | www.azurrx.com

• Clinical Stage Company Focused on Gastrointestinal Disease
• Pipeline Expansion with Exclusive Worldwide License from First Wave Bio for two GI therapeutic indications

C O N F I D E N T I A L | www.azurrx.com

Company Disclaimer

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.

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Overview

ØAzurRx BioPharma (NASDAQ: AZRX) is a clinical stage biotechnology company currently focused on the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases

• Current Pipeline:
  MS1819 for Exocrine Pancreatic Insufficiency (EPI)
• • Two Phase 2 clinical trials ongoing in Cystic Fibrosis (CF)
• Pipeline Expansion Opportunity:
  On Jan. 31, 2020 AzurRx in-licensed proprietary micronized formulations of niclosamide in two indications from First Wave Bio (FWB)
• 1. FW-424:Immune Checkpoint Inhibitor-Induced Colitis (Phase 1b/2a ready)
  2. FW-1022:COVID-19 GI infections (IND approved, Phase 2 ready)
• New assets leverage the Company's core competencies and expertise in developing targeted, safe, non-systemic oral GI therapies
• AzurRx begins 2021 with an expanded pipeline of three gut-targeted GI therapies that address significant unmet medical needs in billion dollar markets

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Licensing Transaction for FWB's ICI-AC and COVID-19 Assets

• $13MM Upfront Payment
• • $10.25 MM Cash
  • $3MM AzurRx Stock
• Up to $74MM in Milestone Payments
• • $37MM for ICI-AC program
  • $37MM for COVID program
• Mid Single-Digit Royalties

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AzurRx Management Team

Combined Experience in Developing and Launching more than 25 Drugs

James Sapirstein	James Pennington, MD	Daniel Schneiderman	Martin Krusin
Chief Executive Officer	Chief Medical Officer	Chief Financial Officer	SVP, Corporate Development

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AzurRx and FirstWave Joint Steering Committee (JSC) Significant Track Record of Value Creation and Multiple Exits

JAMES SAPIRSTEIN

President and Chief Executive Officer, AzurRx BioPharma

• CEO of multiple public biotech companies, with strong exits.
• Founding CEO - Tobira Therapeutics, sold to Allergan for $1.7B
• Serves on public company boards as well as BIO's Emerging Companies Board
• BS Pharmacy from Rutgers University where he met FWB founder. Also holds an MBA degree in management from Fairleigh Dickinson University.

GARY D. GLICK, PH.D.

Founder and Chief Executive Officer, FirstWave Bio

• Founded Scorpion Therapeutics to develop new targeted oncology therapeutics. Raised $108 million from Atlas Venture, Omega Funds, Vida Venture, Abingworth in Oct. 2020.
• Founded FirstWave Bio to develop new cost-effective treatments for inflammatory bowel disease.
• Founded Lycera Corp. and partnered three programs with Merck & Co. in deals collectively valued at over $600 million and advanced two programs into clinical testing.
• Founded IFM Therapeutics, Inc and sold two cancer assets to Bristol-Myers Squibb in a deal valued over $2.3 billion. In 2019, directed the sale of IFM's NLRP3 inhibitor program to Novartis for $1.6 billion and led the structuring and negotiation of a collaboration and option agreement with Novartis valued at over $840 million.
• Ph.D.- Organic Chemistry - Columbia University, NIH postdoctoral fellow at Harvard University. Author of over 100 papers and the inventor on 33 issued U.S. patents

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AzurRx Pipeline: Three Clinical Stage Programs in 2021

Program	2020	2021	2022	Anticipated Milestones
MS1819	Phase 2b			• OPTION 2 Topline Data: Q1'21
Exocrine			• Combination Trial Data: Q2'21
Ongoing			• FDA End Phase 2 Mtg: Q3'21
Pancreatic		Phase 3
		• Phase 3 Trial Launch: Q1'22
Insufficiency	Phase 2 Ongoing
		• Phase 3 Completion: Q4'22
in Cystic
Fibrosis
FW-424				• Phase 1b Trial Launch: 1H'21
			• Phase 2a Completion: Q4'21
Immune			Phase 1b/2a*
Checkpoint
Inhibitor -
Colitis
FW-1022				• Phase 2 Trial Launch: 1H'21
COVID-19 GI		Phase 2*	• Phase 2 Completion: Q1'22
Infections
*Anticipated FDA 505(b)(2) pathway

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In-Licensed Proprietary Formulations of Niclosamide from FirstWave Bio

C O N F I D E N T I A L | www.azurrx.com

History and Safety Profile of Niclosamide

• FDA approved (1982) small molecule anthelmintic drug used for intestinal tapeworm infections
• Clean safety history
• Ideal profile for GI-targeted agent
• • Low oral bio-availability with minimal systemic exposure
  • Niclosamide inhibits pro-inflammatory pathways
  • Non-steroidalanti-inflammatory option
  • Opportunities for combinations with standard of care for multiple indications without systemic immunosuppression

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Why License Niclosamide from FirstWave Bio?

• FirstWave Bio's proprietary formulation of micronized niclosamide has potential to be an ideal formulation in multiple GI indications:
• • Not systemically absorbed
  • Allows for higher local GI concentrations
  • Avoids steroid-related complications
• Promising preliminary efficacy results from FWB's ongoing Ulcerative Proctitis Low Dose Phase 1b/2a Trial
• Robust IP around use and method of delivery of niclosamide in the IBD, ICI- AC and COVID-19 indications and for its proprietary micronized formulation
• Expedited Regulatory Pathway: FDA 505(b)(2), potential for Breakthrough Designation

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Clinical remission efficacy with topical rectal niclosamide formulation superior to budesonide in Low Dose Phase 1b/2a Trial

• Clinical remission efficacy of 59% compares favorably to steroids as 2nd line therapy in mild-to-moderate Ulcerative Colitis (UC)
• Remission rate for budesonide in Ulcerative Proctitis (UP)/Ulcerative Proctosigmoiditis (UPS) is 38-44%
• Steroid use lowers patients' ability to fight infections and leads to complications including bleeding, nausea, heartburn, and headaches
• Treatment-emergentadverse event (TEAE) reported in 35% (6/17 subjects)
• • All but 1 TEAE was mild
• No serious or drug-related TEAEs

First Ever Proof of Principle for Treatment of IBD with Niclosamide

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Proprietary Micronized Formulations: Potentially Transformative Efficacy

• FWB's micronized niclosamide - a transformative treatment for multiple GI indications:
• • Reduced particle size (~7 ) compared to regular non-micronized (~60 ) niclosamide
  • Smaller particles have greater surface to solvent (GI fluids) ratio
  • Improved dissolution: broader distribution and higher local GI concentrations
  • Preclinical studies confirm higher GI concentrations (~200x) with micronized niclosamide
• Micronized formulation, similar to non-micronized niclosamide, is not systemically absorbed (animal studies)
• Historically clean safety profile

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Micronized Niclosamide has ideal profile for GI-targeted agent to treat Immune Checkpoint Inhibitor-Associated Colitis and COVID-19 in GI

Benefits of Micronized Niclosamide over Generic Niclosamide

	Generic Niclosamide	Micronized Niclosamide
Particle Size	~60	~7
Solubility	Low	Increased
Rate of dissolution	Slow	Faster
GI Concentration	Low	~200x higher
		(animal study)
Efficacy	Limited by solubility and	Increased efficacy
	distribution
Bioavailability	Not systemically	Not systemically
	absorbed	absorbed
Cost of Goods	Relatively low	Relatively low
Scale-Up	Feasible	Feasible

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FW-424: Immune Checkpoint

Inhibitor-Associated Colitis (ICI-AC)

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Immune Checkpoint Inhibitor-Associated Colitis

• Use of ICIs Lead to Recurrent Diarrhea and Colitis
• Treating with Systemic Immunosuppressants Reduces Progression Free Survival
• Unmet Clinical Need for a Non-Steroidal Treatment Option
• Unmet Clinical Need for Treatment for Grade 1 Diarrhea
• Unmet Clinical Need for an Outpatient Therapy - current treatments involve hospital-based infusions of biologics or IV-steroids

"Patients on ICI therapy who develop diarrhea require prompt evaluation to assess disease activity and risk of progression. Treatment should be started promptly, as the colitis can quickly progress in severity and potential death. A low threshold for hospitalization should be used for patients with grade 3 or 4 diarrhea." Emanuelle Bellaguarda, MD and Stephen Hanauer, MD. Am J Gastroenterology 2020;115:202-210

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Immune Checkpoint Inhibitor-Associated Colitis is Progressive Throughout the Duration of Checkpoint Therapy

Grade 1:	Grade 2:	Grade 3:	Grade 4:
Increase of <4	Increase of 4 - 6	Increase of >=7	Life-threatening
stools per day	stools per day	stools per day	consequences;
over baseline; mild	over baseline;	over baseline;	urgent intervention
increase in ostomy	moderate increase	hospitalization	indicated
output compared	in ostomy output	indicated; severe
to baseline	compared to	increase in ostomy
	baseline; limiting	output over
	instrumental ADL	baseline; limiting
		self care ADL

Source: ASCO 2018 Guideline Management of ICI-Associated Colitis

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ICI-AC Incidence

• Annual estimate - currently ~260,000 US incident cancer patients are eligible for treatment with ICI's (44% of patients with advanced and metastatic tumors).
• As ICI's use is increasing, we estimate that within the next 3 years ~300,000 US incident cancer patients will be treated with ICI's.
• The trend is towards the use of combination ICI therapies and this will lead to a concomitant increase in both diarrhea and colitis.
• Approximately 30% of ICI patients develop diarrhea and based on the above estimates, we project that there could be up to 7500-15,000 U.S. patients annually who develop ICI-AC.
• Onset of diarrhea in ICI-AC patients occurs within 6-7 weeks and progressively worsens, and the progression to colitis is rapid and unpredictable.

Source: Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and

meta-analysis.Oncoimmunology 2017; 10: e1344805

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Diarrhea and Colitis are Common ICI-associated Adverse Events

2018 Data from Wang et al.

Colitis with common immune checkpoint inhibitors: Incidence of diarrhea and colitis, and time to onset

Immune check-	Diarrhea (%) Colitis (%)	Time to onset
point inhibitor		of colitis

Ipilimumab	25.7%-30%	7.7%-11.6%	6-7 weeks
(BMS: Yervoy)
Nivolumab	11%-16%	0.5-1.1.%	6-18 weeks
(BMS: Opdivo)
Pembrolizumab	1.2%-8%	1%-2%	6-18 weeks
(Merck: Keytruda)

Note: Time to onset of colitis is within weeks. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes.

Wang et al., J Immunother Cancer. 2018; 6: 37.

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Diarrhea and Colitis are Common ICI-associated Adverse Events

2019 Data from Som et al.

Percentage ranges of all grade immune-related common adverse events by checkpoint inhibitor class

Class of	Approved	Rash	Diarrhea	Colitis	Elevated	Hypothyroidism	Hypophysitis
immune	Agents				ALT
checkpoint
inhibitors

Anti CTLA-4	•	Ipilimumab	12%-68%	31%-49%	7%-11.6%	3%-9%	4%-4.2%	4%-6%
	•	Tremelimumab
Anti PD-1	•	Nivolumab	11.7%-24%	2.9%-11.5%	1.3%-2.9%	1.8%-7.1%	3.4%-8.5%	0.25%
	•	Pembrolizumab
Anti PD-L1	•	Atezolizumab	7.4%	11.6%-23%	0.7%-19.7%	0.9%-4.0%	5.0-9.6%	0.2%
	•	Durvalumab
	•	Avelumab

CTLA-4: Cytotoxic T-lymphocyte-associated antigen 4: PD-1: Programmed cell death protein 1; PD-L1: Programmed death-ligand 1; ALT: Alanine aminotransferase

Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418

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ASCO 2018 Guideline Management of ICI-Associated Colitis

Potential for Grade 1 Niclosamide treatment to prevent potentially fatal Colitis

	Description	Drug Treatment
Grade 1
Increase of <4 stools per day over baseline;	• None
	mild increase in ostomy output compared to
	baseline
Grade 2	Increase of 4 - 6 stools per day over	• Concurrent immunosuppressant maintenance therapy (<10 mg
	baseline; moderate increase in ostomy	prednisone equivalent dose) may be offered only if clinically
	output compared to baseline; limiting	indicated in individual cases
	instrumental ADL	• Administer corticosteroids, unless diarrhea is transient, starting with
	initial dose of 1 mg/kg/day prednisone
		• When symptoms improve to G1 or less, taper corticosteroids over at
		least 4-6 weeks before resuming treatment, although resuming
		treatment while on low-dose corticosteroid may also be an option
		after an evaluation of risk-benefit
Grade 3	Increase of >=7 stools per day over baseline;	• Administer oral corticosteroids (initial dose 1-2 mg/kg/day
	hospitalization indicated; severe increase in	prednisone)
	ostomy output over baseline; limiting self	• If symptoms persist >= 3-5 days or recur after improvement,
	care ADL	consider IV corticosteroid or TNF blocker
	• Vedolizumab may be considered in patients refractory to infliximab
		and/or contraindicated to TNF-a blocker
Grade 4	Life-threatening consequences;	• Administer IV steroid (1-2 mg/kg/day methylprednisolone) until
	urgent intervention indicated	symptoms improve to G1, and then start taper over 4-6 weeks
		• Consider early infliximab 5-10 mg/kg if symptoms refractory to
		corticosteroid within 2-3 days
		• Vedolizumab may be considered in patients refractory to infliximab
		and/or contraindicated to TNF-a blocker

J. Clin. Oncol. 2018;36:1714-68

Niclosamide as a safe alternative to immunosuppressant steroids

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Immune Checkpoint Inhibitor - Associated Colitis Resembles IBD

• Both IBD and anti-CTLA-4-associated colitis are dominated by of expansion of lamina propria CD4 cells
• Both IBD and anti-CTLA4-associated colitis are linked to Th17 activation
• • anti-CTLA-4increases numbers of circulating Th17 cells
  • higher baseline serum IL-17 levels correlates with the incidence of grade 3 diarrhea and colitis
  • anti-CTLA-4-associatedcolitis is characterized >10-fold increase in mucosal IL-17A and IFNγ expression

Gut 2018; 67:2056-2067.J. Crohn Colitis 2017;1238-1246.J. Immunother. Cancer 2015;3:39. J. Transl. Med. 2009;7:35. Cancer Invest. 2017;35:443-455

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The Potential Solution: A gut targeted drug to treat the colitis with little or no systemic bioavailability that could counteract the activity of the ICI

• Niclosamide has the potential to prevent GI disease damage and stop disease progression to colitis in patients on ICIs by attacking the cell populations in the colon that cause this problem
• • Agent can induce (with fast onset of action) and maintain long term remission
• GI-targeted
• • Reduces systemic immune suppression
  • Reduces off-target adverse effects
• Functions through clinically validated mechanisms
• • Mitigates pathogenic lamina propria T cells
  • Decreases the production of pro-inflammatory cytokines
• Enables Outpatient Treatment - may reduce hospital admissions for ICI- induced diarrhea
• Breakthrough Designation Potential - increases the therapeutic window for checkpoint inhibitors and the population of patients who benefit from checkpoint inhibitors.

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Rationale for using Oral and/or Topical Niclosamide to Treat ICI-AC Inflammation of the distal and lower colon

Ulcerative		• ICI-Associated Colitis		Pancolitis
Proctitis		• Ulcerative Proctosigmoiditis

Can be reached	Can be reached
via rectal	via oral drugs
drugs

Rectal		Oral Capsule,		Oral
Enema		Rectal Enema, or Both		Capsule

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Phase 1b Study Design: Oral and Rectal Niclosamide for the Treatment of Immune Checkpoint Inhibitor-Associated Colitis

Primary	• To examine the safety and tolerability of Niclosamide enema for the treatment of immune checkpoint
Objective	inhibitor-associated colitis
Secondary	• To identify clinical, endoscopic, microscopic and molecular markers of response of ICI-associated colitis
Objective	to Niclosamide
Design	• Single-arm safety study with Niclosamide in oral and enema form
Key Eligibility	• ICI-associated Grade 1 diarrhea
Criteria	• Not on systemic steroid therapy
	• Willing to undergo endoscopic, pathologic and molecular examination during the study period
Duration	• Up to 6 weeks of treatment or progression to ≥grade 2 diarrhea/colitis or requirement of corticosteroid
	use
Primary	• Serious adverse reactions (i.e. treatment-related) during 6 weeks of treatment with Niclosamide
endpoints	enemas;
	• Grade ≥ 3 adverse reactions during treatment with Niclosamide enemas;
	• Grade ≥ 2 adverse reactions during treatment with Niclosamide enemas.
Secondary	• Progression to ≥grade 2 diarrhea/colitis or requirement of corticosteroid use
endpoints
Exploratory	• Endoscopic improvement/resolution
endpoints	• Correlation of histologic or endoscopic subtypes with primary and secondary endpoint
	• Lactoferrin or fecal calprotectin or other biomarker correlation with primary and secondary endpoints
	• Gene expression signature of response
	• Comparison with real-world control
Sample Size	• 36 - 40 patients

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FW-1022: Micronized Niclosamide for

treatment of severe GI symptoms related to COVID-19 infections

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COVID-19: The Medical Problem of our time

Acute Need for Treatment of COVID-19 GI Infections

18%	48%
of patients	of patients' stool
experienced	samples were
GI symptoms	virus RNA positive

• Gastrointestinal Infections with COVID-19:
• • GI symptoms reported in 18% of cases; 48% of all patients have viral RNA positive stool samples
  • Symptoms include: severe diarrhea, vomiting, abdominal pain
  • Possible reservoir for recurrence and/or fecal spread
  • ACE2, entry receptor for COVID-19, is highly expressed on GI cells
• No treatment for COVID diarrhea currently available
• Urgent need to reduce hospital burden of patients and potential hospital spread

The Potential Solution: A targeted drug to destroy COVID-19 in the gut that is fast-acting and can be administered in an out-patient setting

Source: (35) Gut Journal: Vol 69, Issue 6: 2020; (36) Gut Journal: Vol 69, Issue 6: 2020; (37) JAMA Network: Vol 3, Issue 6:

2020; (38) Lancet Gastroenterol Hepatol: Vol 5, Issue 5: 2020; (40) Cheung Gastroenterology: Vol 159, Issue 1: 2020.

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Micronized Niclosamide: The Potential Key to Killing COVID-19 in the GI Tract

Advantages of Micronized Niclosamide for Treatment of COVID-19 Diarrhea:

• Niclosamide: Best activity against COVID-19 in Institut Pasteur Korea screen
• Mechanism of Action: Induces 'autophagy' in COVID-infected cells, reduces COVID propagation
• Local GI niclosamide concentration now reaches levels needed to kill COVID-19 (confirmed in animal study)
• Animal study shows micronization does not lead to systemic absorption
• FDA reviewed protocol and animal data; IND cleared Sept. 2020
• Low COGS and scalable manufacturing are attractive

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Phase II: Micronized Niclosamide Clinical Trial for COVID Diarrhea Study design allows for rapid recruitment and execution

Micronized niclosamide is entering into Phase II, with an expected indication for the treatment of GI tract infection in both outpatient and non-ventilated hospitalized adults with moderate to severe COVID-19

Description

Stage of Development

Potential Indication

Dosing

Product Fit

Micronized niclosamide immediate-release tablet

505(b)(2) pathway, Phase II, IND approved (Sept. 2020)

For the treatment of gastrointestinal tract SARS-CoV-2 infection in outpatient and non-ventilated hospitalized adults with moderate to severe COVID-19

400 mg tablets TID for fourteen days with the use of concomitant systemic antiviral SOC

There is currently no treatment for COVID-19 GI Infection

19 patient safety study followed by 90 patient randomized placebo control study in out-patient setting with endpoint being time to resolution of diarrhea

Sources: IND application: Aug 17, 2020; Phase II Study Protocol: Aug 17, 2020

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MS1819 Clinical Program

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MS1819 Clinical Trials

On Track for Top-Line Data Readouts in Q1 and Q2 2021

Phase 2 MS1819	MS1819 Doses	# Patients	Safety	Primary Efficacy	Secondary Efficacy	Status
Clinical Trials					Endpoint Results	Endpoints Results
CF patients	•	2240 mg +					Initiated Q3
	Enteric Capsule					2020
				Topline Data Q1 2021*
	•	4480 mg +	30*
		Enteric Capsule	U.S., Poland		Protocol Amendment Submitted Nov. 2020
Dose Escalation
	Daily Dose PERT +			• Positive CFA Data on	• Clinically Meaningful	Initiated Q4
CF patients	•	700 mg			1st five patients in	Data on 1st five	2019
•	1120 mg	20*		study	patients in study	Data on 1st
	•	2240 mg
			Hungary,				five patients
			Turkey				Sept. 2020
Dose Escalation							Topline Data
							Q2 2021*

• OPTION 2 Trial: topline data Q1 2021*
• Combination Trial: topline data Q2 2021*

* Anticipated

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Intellectual Property

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Intellectual Property

AzurRx

• MS1819
• • U.S. Patent No. 8,334,130. Yarrowia Lipolytica lipase compositions and corresponding methods of production.
  • Granted 2008, expires September 2028, with potential Hatch-Waxman extension up to September 2033.
  • FDA grants 12 years of clinical exclusivity for novel biologics from first approval; EMA grants clinical exclusivity for 10 years from first approval.
  • Additional IP filed in 2020 for life cycle management with anticipated expiration of 2041.

FirstWave BIO License

• IBD
• • U.S. Patent No. 10,292,951. Niclosamide formulation and use claims allowed for:
  • • Oral (tablet/capsule) and Enema Formulations
    • Colitis due to use of immune checkpoint inhibitors

• COVID-19	.

• • U.S. 16/835,307 filed March 16, 2020 (allowed) for use of niclosamide to treat GI symptoms of
    COVID
• Micronized Niclosamide
• • U.S. 16/842,695 filed April 7, 2020 claims for niclosamide with a reduced particle size

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Summary

• AzurRx BioPharma (NASDAQ: AZRX) is a clinical stage biotechnology company currently focused on the development of therapeutics for gastrointestinal diseases
• Three safe, targeted, non-systemic clinical stage GI therapeutic programs in pipeline
• 1. MS1819 for Exocrine Pancreatic Insufficiency (EPI) in Cystic Fibrosis
  • Recombinant synthetic lipase (oral biologic)
  • Topline data from two Phase 2 clinical trials in Cystic Fibrosis in Q1 & Q2 2021
  1. FW-424for Immune Checkpoint Inhibitor-Associated Colitis (ICI-AC)
  • Micronized oral and topical niclosamide
  • Phase 1b/2a trial to initiate in 1H 2021, potential breakthrough designation
  1. FW-1022for COVID-19 GI infections
  • Micronized oral niclosamide
  • IND approved, Phase 2 trial to initiate in 1H 2021, potential 505(b)(2) pathway

• Clinical programs address significant unmet medical needs in billion dollar markets

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