Transformational Therapies to Treat Lung Infections & Pulmonary Disease June 2018

Transcription

1 Transformational Therapies to Treat Lung Infections & Pulmonary Disease June 2018

2 This presentation is forconfidential and informational purposes only. This presentation shall notconstitute an offerto sell orthe solicitation of an offerto sell orthe solicitation of an offerto buy any securities of AIT Therapeutics, Inc. (the Company ) nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification underthe securities laws of any such jurisdiction. This presentation may not be reproduced, photocopied, redistributed, published or used for any purpose other than for the recipient s information. Each recipient of this presentation agrees that all information contained herein is of a confidential, material non-public nature, that it will treat such information in a confidential manner and that it will not, directly or indirectly, use or disclose, or permititsagentsoraffiliatesto use ordisclose, anysuch information withoutourpriorwritten consent. The Company files annual, quarterly and other reports with the Securities and Exchange Commission (the SEC ) including its Annual Report on Form 10-K for the year ended December 31, 2016 (the Form 10-K ) which was filed on March 31, You may get these documents for free by visiting EDGAR on the SEC s website at For a more complete discussion of the risk factors affecting ourbusiness, please refer to the Form 10-K. This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, estimates, anticipates, targets, expects, plans, projects, intends, predicts, may, could, might, will, should, approximately, potential or, in each case, their negative orothervariations thereon orcomparable terminology, although notall forward-looking statements contain these words. These statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the patient market size and market adoption of our products by physicians and patients, the timing and cost of clinical trials for our products or whether such trials will be conducted at all, completion and receiving favorable results of clinical trials for our products, the development and approval of the use of nitric oxide for additional indications, the use of the proceeds from this offering, FDA approval of, or other regulatory action with respect to, the timing, cost or other aspects of the commercial launch of our products and the commercial launch and future sales of ourproductsorany otherfuture productsorproductcandidates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may notoccur in the future or may occur on longer or shorter timelines than anticipated or atall. Although we believe that we have a reasonable basis for each forward-looking statement contained in this presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the developmentof the industry in which we operate may differmaterially fromthe forward lookingstatements contained in this presentation. Forward Looking Statement

3 Risks associated with our business include butare notlimited to the following: We have never generated any revenue from product sales and may never be profitable. We will need to raise substantial additional funding before we can expect to become profitable from sales of our products. We are heavily dependent on the success of our product candidates, which are in the early stages of clinical development. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized. Clinical drug and medical device development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results. Our delivery system may be classified as a Class III medical device by the FDA and require premarket approval (PMA) by the FDA, which is a rigorous, time-consuming and expensive process. We rely on third parties to conduct our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. The commercial success of any current or future product candidate will depend upon the degree of market acceptance by physicians, patients, third-party payers and others in the medical community. If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. We manage our business through a small number of employees and key consultants. We depend on them even more than similarly-situated companies. International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States or Israel. Our headquarters and other significant operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military instability in Israel. Risk Factors

4 AIT Therapeutics: Revolutionizing the Delivery of Nitric Oxide (NO) AIT is a medical device company that has developed a platform Nitric Oxide generator system Proprietary Nitric Oxide Technology Platform First 3 Indications Address Large Markets AIT s propriety generator and delivery system generates NO from room air, eliminating the need for expensive and cumbersome cylinders AIT s system allows for multiple significant advantages over current NO cylinder based systems currently used in hospitals around the world AND may allow for use in the home setting Target Patient Population Pulmonary Hypertension (in-hospital) US Sales Potential* WW Sales Potential* Launch Year** >$300m >$600m 2019 Bronchiolitis (in-hospital) >$500m >$1.2b 2021 Severe Lung Infections (e.g. NTM) >$1b >$2.5b 2022 Demonstrated Safety Profile More than 2,100 treatments in over 100 patients across 7 studies at high NO concentrations No Serious Adverse Events related to NO therapy Experienced Management Team Deep industry experience developing NO delivery systems Proven experience in gaining regulatory approvals for both drugs and devices *All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential ** Anticipated first launch on a global basis pending appropriate regulatory approvals 4

5 Nitric Oxide (NO) is Naturally Occurring in the Human Body* ANTIBACTERIAL Nitric Oxide APOPTOSIS CELL PROLIFERATION ANGIOGENESIS IMMUNE RESPONSE CARDIOVASCULAR HEMOSTASIS NEUROTRANSMISSION * Bian K & Murad F. Nitric Oxide, (2014) Bodgan C. Trends in Immunol, (2015) 5

6 NO Delivery System: Generator Replaces Cylinder GENERATOR PROFILE: TYPICAL NO CYLINDER PROFILE IN THE US: Height 8, Width 12, Depth 14, Weight 15 lbs Height 45, Diameter 7.5, Weight 45 lbs (Weight for 2 cylinders on cart w/delivery system is 175 lbs) 6

7 First Indication: Pulmonary Hypertension (PH) Overview Nitric Oxide is an established therapeutic option for patients suffering from Pulmonary Hypertension worldwide Pulmonary Hypertension Overview Effects of Pulmonary Hypertension (1) Life-threatening syndrome resulting from restricted flow through the pulmonary arterial circulation, resulting in increased pulmonary vascular resistance Generally not diagnosed until disease is too advanced NO is the de facto standard of care for PH in the hospital setting Benefits of NO in Treatment of PH (2) NO has been used as a long-term therapeutic option for patients with pulmonary hypertension Approved in the U.S. by the FDA in 1999 for PPHN (3) Approved in the EU in 2001 for PPHN (3) and cardiac surgery Inhaled NO causes increase in the concentration level of intracellular Cyclic Guanosine Monophosphate (cgmp) and an activation of the soluble guanylate cyclase Muscles become more relaxed, enabling more fluid blood flow from the heart to the lungs Narrowing of the Pulmonary Arteries Failure of Right Ventricle (1) Pediatric Pulmonary Hypertension Guidelines from the American heart Association and American Thoracic Society (2) Pulmonary Hypertension News Pulmonary Hypertension and Nitric Oxide (3) Persistent Pulmonary Hypertension of the Newborn 7

8 PH Market Dynamics & AIT Plans Due to lack of innovation, one company has a >$500M (1) monopoly in the space: AIT plans to dominate the space In-hospital PH market in the US was $505m in 2017 with 1Q18 sales at $140m 1 AIT will expand the market Service hospitals that do not have NO today due to cylinder system Increase use with a lower price andease of use vs. cylinder systems AIT system has been granted a device designation at FDA (Not a drug) AIT plans on filing a 510(k) with FDA around the end of 2018 System for use with breathing circuit and mask has been manufactured at commercial scale process will be repeated for use with ventilators to facilitate 510(k) submission AIT to seek regulatory approval for PH on a global basis after US submission 2H19 launch in the US with a partner AIT anticipates launches ex-us with a partner beginningin2020 Ex-US < US market sales, but mayexceed the US with our system AIT anticipates garnering the majority of global market share with it s partner/s (1) MNK Company Reports 8

9 Losing the High-Pressure Cylinder is a Significant Gain Hospitals will have significant cost & logistics Advantages AIT will have significant cost Advantages Improved operating economics for the hospital No significant capital investment required No burdensome inventory and storage requirements No need for additional oxygen No special purging procedures or additional safety measures Functional in hospitals that are unable to use cylinder-based NO Reduced training burden Pregnant staff members not impacted AIT does not have any expenses associated with a manufacturing facility for nitric oxide AIT does not have any expenses associated with logistics related to nitric oxide cylinders 9

10 Pulmonary Hypertension in-hospital Development Timeline Work begins on viability of the generator Commercial scale of the generator clears major development milestone Funding secured to develop ventilator compatible system Projected initiation of commercial manufacturing run for the ventilator compatible device Regulatory filings in EU & other key markets anticipated 2017 H H H H H H2 FDA Designates generator as a device FDA Pre-sub meeting confirms additional clinical trial not required FDA 510(k) submission projected FDA Approval anticipated 10

11 Safety First AIT s High Concentration NO Delivery for Lung Infections Our Nitric Oxide Delivery System Has a Demonstrated Safety Record at a concentration of 160 ppm NO 2, Treatments administered patients Different settings Serious Adverse Events (SAEs) related to NO Date Study Indication Primary Results 2011 Phase 1 Safety (n=10) All comers Safety No SAEs Phase 2 double blind randomized (n=43) Phase 2 open label (n=9) Compassionate use Israel (n=2) Compassionate use National Institute of Health (n=1) 2017 Pilot open label (N=9) 2018 Pilot study: double blind randomized (n=67) Bronchiolitis (all causes) Cystic Fibrosis (CF) NTM in CF patients NTM in CF patient Refractory NTM abscessus Bronchiolitis (all causes) Safety & Efficacy Safety & Efficacy Efficacy Efficacy Safety Efficacy No SAEs Length of hospital stay reduced by 24 hours in hospitalized infants No SAEs Lowered bacterial load No SAEs Improvements in clinical & surrogate endpoints No SAEs Improvements in clinical endpoints No SAEs Improvements in clinical & surrogate endpoints No SAEs Dosing complete, data pending 11

12 Second Indication: Bronchiolitis (BRO) Overview Bronchiolitis is the leading cause of hospitalization for infants worldwide (1) Bronchiolitis Overview & Market Dynamics 150,000 infant hospitalizations per year in the US (2) Significant impact on the elderly with 177,000 hospitalizations per year in the US (3) No drugs approved for the treatment of BRO patients (4) Market Size AIT estimates US market size is to be over $2 B and projects global market to be similar size to the US market with no real competition AIT s goal would be to reduce length of hospitalization Standard of care in the hospital is oxygen and hydration (5) (1) Scand J Trauma Resusc Emerg Med. 2014; 22: 23.; WHO (2) Pelletier et al. Direct medical costs of hospitalizations in the United States, Pediatrics 2006 (3) CDC (due to RSV only) (4) American Academy of Pediatrics 12

13 Completed Pilot Bronchiolitis Trial Results Pilot Bronchiolitis trial data demonstrated a significant reduction in length of hospitalization Trial Design Randomized, Prospective, Double-blind 43 patients (age: 2-12 months) with bronchiolitis (mostly due to RSV) N=21: 160 ppm NO + O₂ 5x/day for 30 minutes up to 5 days N=22: Supportive Care (O₂ & hydration) 3 follow up visits at 2, 3 & 4 weeks post discharge Trial Highlights Single center at Soroka University Medical Center in Israel Presented at ATS 2015 in an oral session Statistical significance achieved in proposed phase III primary endpoint (Clinical Composite endpoint) Reduced length of hospital stay by >24hrs No treatment related SAEs Published in the December 2017 Pediatric Pulmonology Journal (1) (1) : 13

14 Completed Pilot Bronchiolitis Trial Results Pilot Bronchiolitis trial data demonstrated a significant reduction in length of hospitalization Decrease in Hospitalization time (Per Protocol, N=24, minimum of one day of hospitalization) ~34% reduction in time of hospitalization, a validated end point On average patients stayed one day (24 hours) less in the hospital with Nitric Oxide treatment compare to standard treatment P-value

15 AIT Bronchiolitis (BRO) Second pilot Trial This trial is a dry-run for our pivotal study to be done in the United States in 2019 Trial Design Enroll 94 subjects at 3+ sites in Israel with a 1:1 randomization between 160 ppm NO + supportive care (O 2 + hydration) and supportive care alone Subjects will be 0-12 months old with acute bronchiolitis requiring hospitalization with at least 28 weeks of gestation PE (primary endpoint): the difference in hospital length of stay (discharge time based on physician decision) SE (secondary endpoint): the difference in time to clinical improvement based on the Modified Tal score (score 7 and <10 to enroll, 5 is goal) SE: the difference in time to SpO 2 of >92% SE: Safety (specifically methaemoglobinemia and NO 2 levels) and Tolerability Treatment will be five 30 minute sessions per day not to exceed 25 treatments Key Changes v. previous pilot trial Age was 2-12 months Gestation was a minimum of 36 weeks Tal score to enroll was 6 and <10 ITT analysis was not restricted to hospitalized subjects Length of Stay was based upon hospital discharge, not physician decision Analysis included 24 subjects Timeline & Plan for Registration in the US Topline reading of the 2 nd pilot trial Pivotal Trial completion planned Pivotal Trial initiation planned FDA approval anticipated 15

16 Losing the High-Pressure Cylinder makes home use a technical reality Losing high pressure cylinder makes NO accessible in a number of settings Our system is simple to use and patients can self-administer 3 simple steps: Plug in any standard electrical outlet Position mask on face Insert AIT Smart Filter and press GO Light-weight and easy to transport Can be used almost anywhere with a standard electrical outlet Potential use in both acute and chronic lung disease 16

17 Third Indication: Pulmonary Infections, eg, Non Tuberculosis Myobacteria (NTM) NTM is a disease area of focus for FDA. No effective treatment available. Patients can die within a few years (1) How is NTM Caused? (2) Who is at risk? (2) Acquired by inhalation from the environment Water thought to be the main source Warmer climates have higher infection rates Patient to patient transmission possible NTM Market Dynamics? Underlying lung disease and/or genetic predisposition Cystic Fibrosis (CF) patients COPD (chronic obstructive pulmonary disease) Bronchiectasis patients Immunosuppressive therapy There is no competition in MABSC and limited competition in MAC Median survival for MAC is 13 years while for non- MAC NTM it is 4.6 years (6) 20% - 25% of all NTM cases in a South Korean database are MABSC (5) AIT is initially targeting NTM abscessus (MABSC), the most aggressive and difficult to treat form of NTM. AIT expects to seek approval in NTM MAC (mycobacterium avium complex) following MABSC approval Over 180k NTM cases were estimated for 2014 in the United States (3) NTM costs estimated at $1.7b (3) with MABSC costs > 2x MAC costs 37% of NTM confirmed Cystic Fibrosis patients in the US are MABSC (4) (1) (2) Data: FDA (3) Strolloet al. The Burden of Pulmonary Nontuberculous Mycobacterial. Pub 27-July-2015 (4) Data presented at ATS 2017 (Derek Low et al, Medical University of South Carolina) (5) Data presented at ATS 2017 (Keun Burn Chung et al, Seoul National University College of Medicine) (6) Kotilainen, H. et al. Clinical Findings in Relation to Mortality in Non-Tuberculous Mycobacterial Infections: 17 Patients with Mycobacterium Avium Complex Have Better Survival than Patients with Other Mycobacteria. European Journal of Clinical Microbiology & Infectious Diseases 34.9 (2015)

18 Pulmonary Infections: eg. Nontuberculous Mycobacteria (NTM) Proprietary NO formulation yielded positive clinical results in humans in its single arm pilot NTM study 9 CF patients with refractory MABSC were treated at 3 centers in Israel with NO added to background antibiotic therapy 160 ppm NO was given via mask for 30 min 5x/day for 14 days and 3x/day for 7 days Primary endpoint of safety was met, with no NO-related serious adverse events (SAEs) observed Key secondary endpoints of 6-minute walk (6MW) and FEV1 are shown in the charts below Bacterial load, as measured by qpcr showed a 65% reduction at day 81 versus baseline One patient was culture negative at Day 51 and Day 81 Quality-of-Life data showed positive trends on relevant questions (SF-36 used) Tolerability not an issue as no patient requested that any treatment be stopped or not administered 6MW Mean Inc. in Distance (meters) v. Baseline Mean % change in FEV1 from Baseline On Therapy Off Therapy On Therapy Off Therapy % 4.0% 3.0% 2.0% 1.7% 2.8% 4.1% 3.2% % % % 0 Day 7 Day 14 Day 21 Day 51 Day % -1.6% Day 7 Day 14 Day 21 Day 51 Day 81 DATA PRESENTED IN AN ORAL SESSION AT AMERICAN THORACIC SOCIETY (ATS) 2018 Source: AIT management 18

19 Pulmonary Infections: Nontuberculous Mycobacteria (NTM) AIT s Goal is to initiate a pivotal trial in United States in 2019 AIT Plans for Approval FDA is asking for evidence of efficacy for a clinically meaningful outcome evaluated in adequate and well controlled trials AIT believes that a placebo controlled trial with a primary endpoint of 6MW, plus relevant secondary endpoints, will be adequate for approval Secondary endpoints would include FEV1, bacterial load in sputum, QoL and safety Length of therapy would potentially extend beyond 21 days The use of our proprietary generator as the source for NO provides the potential flexibility to have patients self-administer at home Make our NO therapy available to NTM patients in the US by the end of 2022 AIT must execute and work closely with FDA to make this happen Potentially other severe, chronic and refractory infections can be targeted with NTM FDA Guidance (1) Timeline & Plan for Registration in the US Meet with FDA on Pivotal Design Pivotal Trial initiation planned FDA approval anticipated Pivotal Trial completion planned (1) 19

20 AIT Active Pipeline & Market Size Product Indication Development Status Key Dates* US Sales Potential ** Worldwide Sales Potential** AIT-PH (Pulmonary Hypertension) In-Hospital Use Commercial system in development Regulatory filings expected ~year end 2018 Launch 2019* >$300m >$600m AIT-BRO (Bronchiolitis) Bronchiolitis in Infants (elderly to follow) 94 patient study ongoing Data expected in 2Q18 Launch 2021* >$500m >$1.2b AIT-SLI (Severe Lung Infections) NTM: Mycobacterium Abscessus Complex (MABSC) 9 patient pilot study dosing complete Meet with FDA by mid-year 18 to discuss potential pivotal trial design Launch 2022* >$1b >$2.5b * All dates are based on projections, anticipated first launch on a global basis pending appropriate regulatory approvals ** All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential 20

21 AIT Inactive* Pipeline & Status Product Indication Development Status Worldwide Sales Potential** AIT-SLI Various bacterial infections Pivotal study initiation anticipated in 2020 AIT-COPD (Chronic Obstructive Pulmonary Disease) AIT-PH Exacerbation caused by any type of infection (treatment and prevention) At-Home Use Proof of concept initiation anticipated in 2019 Proof of concept initiation anticipated in 2020 Multi Billion $ Opportunities CF (Cystic Fibrosis) Acute infections and Chronic Therapy Trials to begin in 2020 * Development of this pipeline is conditional on obtaining additional financing. ** All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential 21

22 Patent Portfolio >20 Issued Patents and >10 Pending Patents Across Major Global Markets Issued patent expirations 2019 through 2033 Pending patents, if issued, may extend the last expiration through 2037 AIT believes that its patent portfolio is strong and broad The generator The breathing circuit NO concentration NO action in the body NO dosing NO2 filter Method of Use * Development of this pipeline is conditional on obtaining additional financing. ** All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential 22

23 Financial Profile Ticker: AITB Exchange: OTCBB Share Price: $3.00 (as of June 5, 2018) Shares Outstanding: 8.5m As of February 28, 2018 Cash Debt $0 $9.3 million Expected Monthly Burn is $500,000-$600,000 Corporate HQs in New York Pulmonary Hypertension 510k filing anticipated around year end 2018 NTM data presented at ATS 2018 BRO data anticipated in 2Q18 $9.8m raised in a February 2018 financing allows for PH and BRO programsto continue through 2Q19 Financing for NTM will be secured post agreement with FDA on a potential pivotal trialdesign Contact: Steve Lisi, Chairman & CEO at steve@ait-pharm.com 23

24 Management Team Highly experienced and successful team of industry experts Steve Lisi Chairman and CEO Amir Avniel President & COO Frederick Montgomery VP, Medical Systems Rhona Shanker VP, Regulatory Affairs 18 years experience as a Healthcare investor 3 years as SVP Head of Strategy and BD at Avadel (AVDL) Previously worked at Mehta and Isaly, SAC Capital, Millennium Management, and was a partner at Deerfield 15 years of executive-level experience in finance, business development and operations, including M&A Previously worked at Rosetta Genomics (Founder) Rosetta Green (sold to Monsanto) and Monsanto Developed all FDA approved NO systems used by Ino Therapeutics, Ikaria and Mallinckrodt Author on over 30 NO related patents including InoPulse Previously worked at Ikaria and NitricGen 35 years of FDA experience 22 years at the Device Division of FDA, with the final 6 years as an expert device reviewer Ali Ardakani SVP, Device & BD Giora Davidai CMO Asher Tal SVP Research 20 years of development of therapeutics & devices including two FDA approved NO systems Responsible for multiple drug & device global partnerships incl. CareFusion, Bayer, Eisai, etc. Prior to industry, was a pediatric nephrologist at Duke 23 years experience in clinical research with >10 drugs approved, including Phase 2-IV development of Spiriva Previously worked at Boehringer Ingelheim and Glaxo 30yrs clinical research in pediatric respiratory disorders Inventor of the Tal score Founder of the Pediatric Pulmonary Unit at Soroka Medical Center, Ben-Gurion University of the Negev 24

25 Board of Directors Board of Directors with vast industry experience Steve Lisi Chairman and CEO Amir Avniel President & COO Ron Bentsur Director Erick Lucera Director Yoori Lee Director David Grossman Director Ari Raved Director 18 years experience as a Healthcare investor 3 years as SVP Head of Strategy and BD at Avadel (AVDL) Previously worked at Mehta and Isaly, SAC Capital, Millennium Management, and was a partner at Deerfield 15 years of executive-level experience in finance, business development and operations, including M&A Previously worked at Rosetta Genomics (Founder) Rosetta Green (sold to Monsanto) and Monsanto Director since August 2015 CEO and Director of UroGen Pharma since 2015 Previous CEO and Director of Keryx Biopharmaceuticals Previous CEO of XTL Biopharmaceuticals Director since August 2017 CFO at Valeritas Previous CFO of Viventia Bio Previous VP Corporate Development at Aratana Co-founder and President of Trio Health Advisory Group 15 years at Leerink Partners LLC Helped found the MEDACorp network Director since January 2017 Also serves on AIT audit and compensation Previous Chairman and CEO at D-Pharm Ltd. Board member at Gefen Biomed Investments Director since 2012 Served as SVP of IDB Development Corporation Ltd. Previous VP of IDB Development Corporation Ltd. Previous Director of Modiin Energy Ltd. Partnership 25

26 Scientific Advisory Board Scientific Advisory Board comprised of world renowned thought leaders Hugh O Brodovich, MD Hannah Blau, MD Andrew Collin, MD David Greenberg, MD John P. Clancy, MD Prof. Yossef Av-Gay, PhD Richard Malley, MD 26

27 AIT Therapeutics: Revolutionizing the Delivery of Nitric Oxide (NO) AIT is a medical device company that has developed a platform Nitric Oxide generator system Proprietary Nitric Oxide Technology Platform First 3 Indications Address Large Markets AIT s propriety generator and delivery system generates NO from room air, eliminating the need for expensive and cumbersome cylinders AIT s system allows for multiple significant advantages over current NO cylinder based systems currently used in hospitals around the world AND may allow for use in the home setting Target Patient Population Pulmonary Hypertension (in-hospital) US Sales Potential* WW Sales Potential* Launch Year** >$300m >$600m 2019 Bronchiolitis (in-hospital) >$500m >$1.2b 2021 Severe Lung Infections (e.g. NTM) >$1b >$2.5b 2022 Demonstrated Safety Profile More than 2,100 treatments in over 100 patients across 7 studies at high NO concentrations No Serious Adverse Events related to NO therapy Experienced Management Team Deep industry experience developing NO delivery systems Proven experience in gaining regulatory approvals for both drugs and devices *All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential ** Anticipated first launch on a global basis pending appropriate regulatory approvals 27

28 Transformational Therapies to Treat Lung Infections & Pulmonary Disease For more information contact: Steve Lisi, CEO