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AlitairPharmaceuticals,Inc.
James Hoyes – Chief Executive Officer
August 16, 2017
Forward-Looking Statements
THIS PRESENTATION (TOGETHER WITH ANY AMENDMENTS OR SUPPLEMENTS), THE ACCOMPANYING
MATERIALS, ANY FINANCIAL MODELS AND THE APPENDICES (WHICH ARE AVAILABLE FROM THE COMPANY ON
REQUEST), CONTAIN CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE
COMPANY THAT ARE BASED ON OUR BELIEFS, ASSUMPTIONS AND INFORMATION AVAILABLE TO US AS OF THE
DATE OF THIS PRESENTATION.
STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY’S BELIEFS,
DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING
STATEMENTS.
IN ADDITION, IN THIS PRESENTATION, THE WORDS “WILL,” “MAY,” “BELIEVE,” “ANTICIPATE,” “INTEND,”
“ESTIMATE,” “EXPECT,” “PROJECT,” “PLAN,” “SHOULD,” “COULD,” AND SIMILAR EXPRESSIONS, AND THEIR
VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE POSSIBLE PERFORMANCE OF THE
COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH STATEMENTS REFLECT OUR
VIEW WITH RESPECT TO FUTURE EVENTS AS OF THE DATE OF THIS PRESENTATION AND ARE SUBJECT TO
CERTAIN RISKS, UNCERTAINTIES AND ASSUMPTIONS, INCLUDING THE RISK FACTORS DESCRIBED IN THIS
PRESENTATION AND ANY ACCOMPYING MEMORANDUMS.
2Please visit www.alitair.com for more information
Alitair Corporate Overview
 Products & technologies compete in existing markets valued at over $35 billion
 Supported by strong intellectual property with a long period of exclusivity
 Two focus areas are ion-exchange resin formulations and respiratory disease
 Ion-exchange resins: Overdose Reduction Technology and Rx Cough
 Respiratory: Bronchiectasis (received FDA Orphan Drug designation in 20141)
 Proven, experienced management team – committed to executing the business plan
and effectively increasing the valuation of Alitair
 Monetize the portfolio over the next 18-30 months
 $5.3 million previously invested has driven the portfolio forward to this next
valuation inflection point … clear path forward over the next 18-30 months
31 Source: Alitair Press Release January 7, 2014
Required Investment
Seeking $30 million … to move Alitair assets forward over the next 18-30 months to the
next major clinical development milestones and position the assets for monetization
 ODRTM Proof of Concept completed -- ready for out-licensing to biopharma companies with
opioid, benzodiazepine and anti-anxiolytic products / portfolios
 Three (3) patent protected prescription cough products ready for FDA submission via the
505(B)(2) pathway1 – ready for asset sale or out-licensing deal
 Completed Phase II study for ALT-092; ready for Phase III – ready for asset sale, co-
development deal, or out-licensing deal
Targeted Founder’s Round and Private Placement: Net $5 million (2Q-3Q 2017)
Post Private Placement Round, Alitair Valuation ~$30 million
(~15 million shares @ $2.00 per share)
Next Step -- $25-30 million in additional funding and IPO Filing
41 Requires PK / bioequivalence studies only
2 IND open, FDA accepted Phase II Study design
Why Invest in Alitair?
Balanced approach: 3 late-state clinical development programs utilizing a mix of
proven ion-exchange resin formulations and late-stage, well characterized molecules
1. Technology to reduce the overdose risks associated with use and misuse of
prescription drugs which lead to over 15,000 deaths in 20151
2. Introduction of three oral, twice-a-day (BID) tablets for cough, the leading
specific reason patients seek a doctor visit in the US2
3. Development of the first potential FDA approved treatment for bronchiectasis
which affects 160,000 patients who face ~2x the risk of death (vs. a matched
population)
5
1
2
3
1 Source: CDC WONDER Database, 2016
2 CDC National Ambulatory Medical Care Survey, 2013
Why Invest in Alitair?
Products enter into large pre-established markets
 $3 billion Rx Cough market
 $3 billion Bronchiectasis market
 $30-$35 billion in annual revenues in opioid,
benzodiazepine and anti-anxiolytics – upfront
payments, milestone payment and royalty
opportunities
Product development can leverage well defined
pathways to FDA approval – 505(b)(2) and Orphan
Drug guidelines … higher chances of success, less
costly, faster time to approvals
 Late-stage, well characterized molecules
6
5 patents issued in 2012-2015
 Additional IP possibilities being
explored
Why Invest in Alitair?
Experienced and Proven Executive Team
Core Adams Respiratory Team that
developed the Mucinex brand leading to a
$2.3 billion acquisition
General Management and Functional
Experience Across Pharma
 Building talented teams
 New Product Development
 Clinical Trial Management
 Business Development
 Revenue growth & P/L Management
Board Membership Experience at PhRMA
and BIO
 Broad industry insights and issues
management
James Hoyes | Chief Executive Officer1
(formerly President & Head of US Operations at EMD Serono2)
William Howard, PhD, MBA | President and Founder1
(formerly SVP, New Products/Business Development, Adams
Respiratory Therapeutics)
Helmut H. Albrecht, MD, MS, FFPM | Chief Scientific Officer
(formerly Head of R&D, Adams Respiratory Therapeutics)
Frank Koos | SVP Business Development
(formerly VP, Sales, Adams Respiratory Therapeutics)
Russ Somma, PhD | SVP R&D
(formerly R&D, Novartis)
Bob Casale| Member, Board of Directors1
(formerly COO, Adams Respiratory Therapeutics)
7
1 Indicates Board Membership
2 Head Operating Unit of Merck Serono
Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Overdose Reduction (ODRTM): Patent protected technology addressing the
growing opioid overdose crisis facing the US
 183,000 lives lost to prescription drug overdose from 1999-
2015; overdose deaths in 2015 quadrupled vs. 1999!
 Over 1,000 ER treatments per day for misusing prescription
opioids as directed resulting in a $2-3 billion healthcare cost
burden
8
1
1st Priority
In 2015, there were 52,400 drug overdose deaths; 33,000 involved an
opioid. Of these, over 15,000 deaths involved a prescription opioid. !
Alitair Overdose Reduction (ODRTM) Technology
A Potential Game-Changer within the Opioid Overdose Crisis
 This slide illustrates the principle of overdose
reduction -- the same formulation releases a
progressively lower amount of drug at higher
doses
 ODR™ technology cannot be
circumvented by crushing the capsules
or tablets and smoking or snorting the
active ingredients
 ODR™ uses approved excipients and
well established manufacturing
technology
 ODR™ is a life saving technology!
9
1st Priority
Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Chronic cough is one of the leading reasons patients seek a doctor visit – 26 million
visits per year
 Clear need for a twice-a-day, oral, tablet formulation
 88% of physicians are ‘likely to prescribe‘ due to the differentiated profile
 Prescription market long dominated by narcotic formulations; however, the recent high growth
segment is non-narcotic benzonatate  Alitair has both product types: codeine and
hydrocodone, each combined with pseudoephedrine, and benzonatate
 Clear development pathway utilizing the FDA 505(b)(2) guideline which requires
pharmacokinetic (PK) testing only to confirm bioequivalence
 Patent protected ion-exchange resin formulation
 4 issued patents including a composition of matter patent on benzonatate
 Market potential approaching $3 billion
10
2
Fastest FDA Approvals
Source: IMS - Rx’s in millions Dec 2015
Benzonatate Tablet Opportunity
Strong Growth with Little Promotion --
Prescribing More than Tripled over the Last
10 Years
Compelling Reasons to Prescribe
 BID tablets formulation reduces safety
risks with current GelCap formulations
 Nothing new in the cough market for
many years
 Very few branded competitors – highly
fragmented market
 Non-narcotic segment experiencing
fastest rate of growth
11
Fastest FDA Approvals
Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
The 160,000 patients suffering from bronchiectasis have no FDA approved
treatments and face a death rate twice the normal population
 ALT-09 has received Orphan Drug designation from the FDA for bronchiectasis patients with
and without Cystic Fibrosis; 130,000 and 30,000 patients respectively
 Treatment costs for bronchiectasis are high and uncontrolled symptoms lead to costly
hospitalizations and chest physiotherapy
 Orphan Drug status provides 7 years of market exclusivity, improved approval rates and
financial benefits related to tax credits, FDA filing fee waiver, etc.
 ALT-09 is a well known and well characterized small molecule approved in European
markets for COPD
 ALT-09 has received the green light from the FDA to initiate a Phase II study at 2 dosages for
treatment of bronchiectasis
 Market potential of at least $3 billion
12
3
Highest Peak
Sales Potential
ALT-09 as a Potential Treatment for Bronchiectasis
ALT-09 Appears to be a Multi-Factorial Drug
 Improves mucus clearance within the
airways
 Inhibits bacterial growth, synergistic with
antibiotics
 Exhibits both anti-oxidant and anti-
inflammatory properties
ALT-09 Showed Consistent Effects in Bronchiectasis
Patients in Several Small Studies Related to FEV1
Changes from Baseline – Larger Studies are
Warranted Based on these Findings
13
Alitair 18-30 Month Milestones
News Flow and Monetization Opportunities
Phase III Start
(PK Study Only)
Phase III Completion
NDA Submission via 505(b)(2)
Pathway
Overdose Reduction
(ODR) Technology
Narcotic Cough Products
(Codeine w/ Pseudo and
Hydrocodone w/ Pseudo)
Non-Narcotic Cough
Product (Benzonatate)
Orphan Drug Candidate
(ALT-09) - Erdosteine
14
Phase II Start
(Single Dose Study – PK
Only)
Phase II
Completion
Phase III Start
(Multiple Dose Study –
PK Only)
Phase III
Completion
NDA Submission via
505(b)(2) Pathway
Successful IND / Start of Proof of
Concept Study in Humans
Successful POC Study1 Data Package Ready
for Out-licensing
Test Unique Formulation Additional Patents Pending
Start Phase II Complete Phase II
1 Include confirmation that FDA Abuse Deterrence Guidelines are met.
2 Confirm Lupin formulation work, single dose PK data and reopen IND.
ConfirmPriorPKData2
andComplete
FormulationWork
Key Take-Away Messages
Unique opportunity to invest -- Seeking $25-$30 million in
new funding
 Late stage, well characterized suite of products and
technologies that can compete effectively in large multi-billion
dollar markets in the near term
 All supported by a strong patent portfolio – 5 patents issued;
other patents pending
 Proven management team – committed to the business plan
execution
 Following successful financing, will provide a series of
meaningful milestones over the next 18-30 months
15Please visit www.alitair.com for more information
[1]
ODRTM
[2]
Cough
Portfolio
[3]
Orphan
Drug
Thank You!
16
Legal Disclaimer
FOR DISCUSSION PURPOSES ONLY – NOT FOR USE IN PROMOTIONAL ACTIVITIES
This presentation is a draft for discussion purposes only.
This presentation contains information with respect to future products and/or indications that are not presently approved by the FDA and
thus can not be promoted by Alitair. Off-label promotion is against company policy. Information about non-approved prescription products is
to be used only for legitimate business planning purposes (e.g., investments/ fund-raising, discussions of ongoing or potential clinical
development plans, considerations of promotional strategies if and when new indications are approved, production planning, and for
budgeting and forecasting revenues). All revenue assumptions or projections assume strict compliance with the company policy prohibiting
any promotion of off-label uses of Alitair products.
This document may also contain forecasts and market assessments regarding Alitair products that have been prepared for confidential
business analysis and planning purposes and may consider various business scenarios; be aware that none of these analysis may hold true as
the markets and regulatory policy evolves over time. Product forecasts and the assumptions used do not reflect or constitute a legal analysis
or a legal assessment as to which scenario(s) is/are more likely. They reflect a clinical development, regulatory and/or commercial position
based on currently available information. They do not represent a final agreed course of action and any inference to that effect is not
intended and is hereby expressly disclaimed.
Note: Please direct any questions on this document to James Hoyes, CEO, Alitair Pharmaceuticals, Inc.
Supporting Material
18
Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Overdose Reduction (ODRTM): Patent protected technology addressing the
growing opioid overdose crisis facing the US
 ODRTM is based on a proprietary ion-exchange resin that can be out-licensed to
many potential companies with products in the opioid, benzodiazepine and anti-
anxiety therapeutic areas – represent a $30-35 billion market opportunity
 ODRTM technology uniquely addresses both overdose reduction and abuse
deterrence aspects of the opioid crisis
 Patent issued in December 2015
19
1st Priority
Market Potential for Alitair ODRTM Technology
Licensing Opportunity for ODRTM – Mix of upfront payments, milestone payments and
ongoing royalties
 366 million prescriptions in narcotic (including opioid), benzodiazepine and anti-anxiety
classes valued at $35 billion
 Opioid products – 1st priority
 Also benzodiazepines & anti-anxiety classes
 Wide range of target companies
 Variety of life cycle management options
 Branded and generics
20
1st Priority
US Cough/Cold Market Totals 37.1 Million Prescriptions, Up
1.5% Since 2010
21
Fastest FDA Approvals
Bronchiectasis Causes Permanent Damage
 There are both young and elderly
bronchiectasis patients, and all
Cystic Fibrosis patients suffer from
bronchiectasis
 Bronchiectasis causes devastating lung
damage: repetitive lung infections lead
to excessive scar tissue and degraded
lung function, and it can cause death
 Bronchiectasis patients
have double the death rate of the
general population
22
Highest Peak
Sales Potential
ALT-09 Market Research and
Pricing Study Completed by Medical Marketing Economics
 Medical Marketing Economics is one of the premier pricing and
reimbursement consulting company in the USA
 Interviewed pulmonologists who treat bronchiectasis patients
 Use in 80% of bronchiectasis patients
 Pricing estimated at $25-30K per year
 FDA stated indication will be for both CF and non-CF bronchiectasis : about
160,000 patients total
 Market potential of $3.4 billion
23
Highest Peak
Sales Potential
Clear Regulatory Pathways
Overdose Reduction Technology (ODRTM)
 Proof of concept in humans required prior to out-licensing
 Utilize patent protected ion-exchange resin formulation
Cough Portfolio
 505(B)(2) approval pathway … no additional safety and efficacy studies required
 Utilize patent protected ion-exchange resin formulations
 PK “steady-state” and “fed/fast” studies (bioequivalence) needed for 2 narcotic combinations
 PK “single dose”, “steady-state”, and “fed/fast” studies (bioequivalence) needed for the non-
narcotic (benzonatate)
ALT-09
 Orphan Drug Status Granted
 Phase II study design approved by FDA (two dosing arms, placebo)
24
ALT-09 End of Phase 1 Meeting Completed at FDA
 Ready to start a Phase 2 Study, an open IND at FDA
 Extensive human efficacy data in COPD
 Excellent safety profile
 Three published studies on use in bronchiectasis
 FDA alignment on our proposed Phase 2 study
 FDA gave us the green light for the study at all planned dose levels, 600mg and 900mg per
day
 Ready to start Phase 2 clinical study in bronchiectasis
25
Quantitative Market Research: Likelihood to Prescribe at 88%
 The physicians’ likelihood to prescribe is a key measure of the overall breadth of physician
interest, in that it indicates the adoption of Benzonatate into the physicians’ portfolios of
treatment tools
 Physician responses were compared to the TNSfyi database of physician responses for new
drugs or new indications for acute conditions.
 Physician responses are above average for a Benzonatate formulation
 42% of Physicians definitely would prescribe
 46% of Physicians probably would prescribe
26

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Alitair presentation august 7 2017

  • 1. AlitairPharmaceuticals,Inc. James Hoyes – Chief Executive Officer August 16, 2017
  • 2. Forward-Looking Statements THIS PRESENTATION (TOGETHER WITH ANY AMENDMENTS OR SUPPLEMENTS), THE ACCOMPANYING MATERIALS, ANY FINANCIAL MODELS AND THE APPENDICES (WHICH ARE AVAILABLE FROM THE COMPANY ON REQUEST), CONTAIN CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE COMPANY THAT ARE BASED ON OUR BELIEFS, ASSUMPTIONS AND INFORMATION AVAILABLE TO US AS OF THE DATE OF THIS PRESENTATION. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY’S BELIEFS, DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING STATEMENTS. IN ADDITION, IN THIS PRESENTATION, THE WORDS “WILL,” “MAY,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “ESTIMATE,” “EXPECT,” “PROJECT,” “PLAN,” “SHOULD,” “COULD,” AND SIMILAR EXPRESSIONS, AND THEIR VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE POSSIBLE PERFORMANCE OF THE COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH STATEMENTS REFLECT OUR VIEW WITH RESPECT TO FUTURE EVENTS AS OF THE DATE OF THIS PRESENTATION AND ARE SUBJECT TO CERTAIN RISKS, UNCERTAINTIES AND ASSUMPTIONS, INCLUDING THE RISK FACTORS DESCRIBED IN THIS PRESENTATION AND ANY ACCOMPYING MEMORANDUMS. 2Please visit www.alitair.com for more information
  • 3. Alitair Corporate Overview  Products & technologies compete in existing markets valued at over $35 billion  Supported by strong intellectual property with a long period of exclusivity  Two focus areas are ion-exchange resin formulations and respiratory disease  Ion-exchange resins: Overdose Reduction Technology and Rx Cough  Respiratory: Bronchiectasis (received FDA Orphan Drug designation in 20141)  Proven, experienced management team – committed to executing the business plan and effectively increasing the valuation of Alitair  Monetize the portfolio over the next 18-30 months  $5.3 million previously invested has driven the portfolio forward to this next valuation inflection point … clear path forward over the next 18-30 months 31 Source: Alitair Press Release January 7, 2014
  • 4. Required Investment Seeking $30 million … to move Alitair assets forward over the next 18-30 months to the next major clinical development milestones and position the assets for monetization  ODRTM Proof of Concept completed -- ready for out-licensing to biopharma companies with opioid, benzodiazepine and anti-anxiolytic products / portfolios  Three (3) patent protected prescription cough products ready for FDA submission via the 505(B)(2) pathway1 – ready for asset sale or out-licensing deal  Completed Phase II study for ALT-092; ready for Phase III – ready for asset sale, co- development deal, or out-licensing deal Targeted Founder’s Round and Private Placement: Net $5 million (2Q-3Q 2017) Post Private Placement Round, Alitair Valuation ~$30 million (~15 million shares @ $2.00 per share) Next Step -- $25-30 million in additional funding and IPO Filing 41 Requires PK / bioequivalence studies only 2 IND open, FDA accepted Phase II Study design
  • 5. Why Invest in Alitair? Balanced approach: 3 late-state clinical development programs utilizing a mix of proven ion-exchange resin formulations and late-stage, well characterized molecules 1. Technology to reduce the overdose risks associated with use and misuse of prescription drugs which lead to over 15,000 deaths in 20151 2. Introduction of three oral, twice-a-day (BID) tablets for cough, the leading specific reason patients seek a doctor visit in the US2 3. Development of the first potential FDA approved treatment for bronchiectasis which affects 160,000 patients who face ~2x the risk of death (vs. a matched population) 5 1 2 3 1 Source: CDC WONDER Database, 2016 2 CDC National Ambulatory Medical Care Survey, 2013
  • 6. Why Invest in Alitair? Products enter into large pre-established markets  $3 billion Rx Cough market  $3 billion Bronchiectasis market  $30-$35 billion in annual revenues in opioid, benzodiazepine and anti-anxiolytics – upfront payments, milestone payment and royalty opportunities Product development can leverage well defined pathways to FDA approval – 505(b)(2) and Orphan Drug guidelines … higher chances of success, less costly, faster time to approvals  Late-stage, well characterized molecules 6 5 patents issued in 2012-2015  Additional IP possibilities being explored
  • 7. Why Invest in Alitair? Experienced and Proven Executive Team Core Adams Respiratory Team that developed the Mucinex brand leading to a $2.3 billion acquisition General Management and Functional Experience Across Pharma  Building talented teams  New Product Development  Clinical Trial Management  Business Development  Revenue growth & P/L Management Board Membership Experience at PhRMA and BIO  Broad industry insights and issues management James Hoyes | Chief Executive Officer1 (formerly President & Head of US Operations at EMD Serono2) William Howard, PhD, MBA | President and Founder1 (formerly SVP, New Products/Business Development, Adams Respiratory Therapeutics) Helmut H. Albrecht, MD, MS, FFPM | Chief Scientific Officer (formerly Head of R&D, Adams Respiratory Therapeutics) Frank Koos | SVP Business Development (formerly VP, Sales, Adams Respiratory Therapeutics) Russ Somma, PhD | SVP R&D (formerly R&D, Novartis) Bob Casale| Member, Board of Directors1 (formerly COO, Adams Respiratory Therapeutics) 7 1 Indicates Board Membership 2 Head Operating Unit of Merck Serono
  • 8. Alitair Portfolio of Technologies and Products to Address Urgent Unmet Medical Needs Overdose Reduction (ODRTM): Patent protected technology addressing the growing opioid overdose crisis facing the US  183,000 lives lost to prescription drug overdose from 1999- 2015; overdose deaths in 2015 quadrupled vs. 1999!  Over 1,000 ER treatments per day for misusing prescription opioids as directed resulting in a $2-3 billion healthcare cost burden 8 1 1st Priority In 2015, there were 52,400 drug overdose deaths; 33,000 involved an opioid. Of these, over 15,000 deaths involved a prescription opioid. !
  • 9. Alitair Overdose Reduction (ODRTM) Technology A Potential Game-Changer within the Opioid Overdose Crisis  This slide illustrates the principle of overdose reduction -- the same formulation releases a progressively lower amount of drug at higher doses  ODR™ technology cannot be circumvented by crushing the capsules or tablets and smoking or snorting the active ingredients  ODR™ uses approved excipients and well established manufacturing technology  ODR™ is a life saving technology! 9 1st Priority
  • 10. Alitair Portfolio of Technologies and Products to Address Urgent Unmet Medical Needs Chronic cough is one of the leading reasons patients seek a doctor visit – 26 million visits per year  Clear need for a twice-a-day, oral, tablet formulation  88% of physicians are ‘likely to prescribe‘ due to the differentiated profile  Prescription market long dominated by narcotic formulations; however, the recent high growth segment is non-narcotic benzonatate  Alitair has both product types: codeine and hydrocodone, each combined with pseudoephedrine, and benzonatate  Clear development pathway utilizing the FDA 505(b)(2) guideline which requires pharmacokinetic (PK) testing only to confirm bioequivalence  Patent protected ion-exchange resin formulation  4 issued patents including a composition of matter patent on benzonatate  Market potential approaching $3 billion 10 2 Fastest FDA Approvals
  • 11. Source: IMS - Rx’s in millions Dec 2015 Benzonatate Tablet Opportunity Strong Growth with Little Promotion -- Prescribing More than Tripled over the Last 10 Years Compelling Reasons to Prescribe  BID tablets formulation reduces safety risks with current GelCap formulations  Nothing new in the cough market for many years  Very few branded competitors – highly fragmented market  Non-narcotic segment experiencing fastest rate of growth 11 Fastest FDA Approvals
  • 12. Alitair Portfolio of Technologies and Products to Address Urgent Unmet Medical Needs The 160,000 patients suffering from bronchiectasis have no FDA approved treatments and face a death rate twice the normal population  ALT-09 has received Orphan Drug designation from the FDA for bronchiectasis patients with and without Cystic Fibrosis; 130,000 and 30,000 patients respectively  Treatment costs for bronchiectasis are high and uncontrolled symptoms lead to costly hospitalizations and chest physiotherapy  Orphan Drug status provides 7 years of market exclusivity, improved approval rates and financial benefits related to tax credits, FDA filing fee waiver, etc.  ALT-09 is a well known and well characterized small molecule approved in European markets for COPD  ALT-09 has received the green light from the FDA to initiate a Phase II study at 2 dosages for treatment of bronchiectasis  Market potential of at least $3 billion 12 3 Highest Peak Sales Potential
  • 13. ALT-09 as a Potential Treatment for Bronchiectasis ALT-09 Appears to be a Multi-Factorial Drug  Improves mucus clearance within the airways  Inhibits bacterial growth, synergistic with antibiotics  Exhibits both anti-oxidant and anti- inflammatory properties ALT-09 Showed Consistent Effects in Bronchiectasis Patients in Several Small Studies Related to FEV1 Changes from Baseline – Larger Studies are Warranted Based on these Findings 13
  • 14. Alitair 18-30 Month Milestones News Flow and Monetization Opportunities Phase III Start (PK Study Only) Phase III Completion NDA Submission via 505(b)(2) Pathway Overdose Reduction (ODR) Technology Narcotic Cough Products (Codeine w/ Pseudo and Hydrocodone w/ Pseudo) Non-Narcotic Cough Product (Benzonatate) Orphan Drug Candidate (ALT-09) - Erdosteine 14 Phase II Start (Single Dose Study – PK Only) Phase II Completion Phase III Start (Multiple Dose Study – PK Only) Phase III Completion NDA Submission via 505(b)(2) Pathway Successful IND / Start of Proof of Concept Study in Humans Successful POC Study1 Data Package Ready for Out-licensing Test Unique Formulation Additional Patents Pending Start Phase II Complete Phase II 1 Include confirmation that FDA Abuse Deterrence Guidelines are met. 2 Confirm Lupin formulation work, single dose PK data and reopen IND. ConfirmPriorPKData2 andComplete FormulationWork
  • 15. Key Take-Away Messages Unique opportunity to invest -- Seeking $25-$30 million in new funding  Late stage, well characterized suite of products and technologies that can compete effectively in large multi-billion dollar markets in the near term  All supported by a strong patent portfolio – 5 patents issued; other patents pending  Proven management team – committed to the business plan execution  Following successful financing, will provide a series of meaningful milestones over the next 18-30 months 15Please visit www.alitair.com for more information [1] ODRTM [2] Cough Portfolio [3] Orphan Drug
  • 17. Legal Disclaimer FOR DISCUSSION PURPOSES ONLY – NOT FOR USE IN PROMOTIONAL ACTIVITIES This presentation is a draft for discussion purposes only. This presentation contains information with respect to future products and/or indications that are not presently approved by the FDA and thus can not be promoted by Alitair. Off-label promotion is against company policy. Information about non-approved prescription products is to be used only for legitimate business planning purposes (e.g., investments/ fund-raising, discussions of ongoing or potential clinical development plans, considerations of promotional strategies if and when new indications are approved, production planning, and for budgeting and forecasting revenues). All revenue assumptions or projections assume strict compliance with the company policy prohibiting any promotion of off-label uses of Alitair products. This document may also contain forecasts and market assessments regarding Alitair products that have been prepared for confidential business analysis and planning purposes and may consider various business scenarios; be aware that none of these analysis may hold true as the markets and regulatory policy evolves over time. Product forecasts and the assumptions used do not reflect or constitute a legal analysis or a legal assessment as to which scenario(s) is/are more likely. They reflect a clinical development, regulatory and/or commercial position based on currently available information. They do not represent a final agreed course of action and any inference to that effect is not intended and is hereby expressly disclaimed. Note: Please direct any questions on this document to James Hoyes, CEO, Alitair Pharmaceuticals, Inc.
  • 19. Alitair Portfolio of Technologies and Products to Address Urgent Unmet Medical Needs Overdose Reduction (ODRTM): Patent protected technology addressing the growing opioid overdose crisis facing the US  ODRTM is based on a proprietary ion-exchange resin that can be out-licensed to many potential companies with products in the opioid, benzodiazepine and anti- anxiety therapeutic areas – represent a $30-35 billion market opportunity  ODRTM technology uniquely addresses both overdose reduction and abuse deterrence aspects of the opioid crisis  Patent issued in December 2015 19 1st Priority
  • 20. Market Potential for Alitair ODRTM Technology Licensing Opportunity for ODRTM – Mix of upfront payments, milestone payments and ongoing royalties  366 million prescriptions in narcotic (including opioid), benzodiazepine and anti-anxiety classes valued at $35 billion  Opioid products – 1st priority  Also benzodiazepines & anti-anxiety classes  Wide range of target companies  Variety of life cycle management options  Branded and generics 20 1st Priority
  • 21. US Cough/Cold Market Totals 37.1 Million Prescriptions, Up 1.5% Since 2010 21 Fastest FDA Approvals
  • 22. Bronchiectasis Causes Permanent Damage  There are both young and elderly bronchiectasis patients, and all Cystic Fibrosis patients suffer from bronchiectasis  Bronchiectasis causes devastating lung damage: repetitive lung infections lead to excessive scar tissue and degraded lung function, and it can cause death  Bronchiectasis patients have double the death rate of the general population 22 Highest Peak Sales Potential
  • 23. ALT-09 Market Research and Pricing Study Completed by Medical Marketing Economics  Medical Marketing Economics is one of the premier pricing and reimbursement consulting company in the USA  Interviewed pulmonologists who treat bronchiectasis patients  Use in 80% of bronchiectasis patients  Pricing estimated at $25-30K per year  FDA stated indication will be for both CF and non-CF bronchiectasis : about 160,000 patients total  Market potential of $3.4 billion 23 Highest Peak Sales Potential
  • 24. Clear Regulatory Pathways Overdose Reduction Technology (ODRTM)  Proof of concept in humans required prior to out-licensing  Utilize patent protected ion-exchange resin formulation Cough Portfolio  505(B)(2) approval pathway … no additional safety and efficacy studies required  Utilize patent protected ion-exchange resin formulations  PK “steady-state” and “fed/fast” studies (bioequivalence) needed for 2 narcotic combinations  PK “single dose”, “steady-state”, and “fed/fast” studies (bioequivalence) needed for the non- narcotic (benzonatate) ALT-09  Orphan Drug Status Granted  Phase II study design approved by FDA (two dosing arms, placebo) 24
  • 25. ALT-09 End of Phase 1 Meeting Completed at FDA  Ready to start a Phase 2 Study, an open IND at FDA  Extensive human efficacy data in COPD  Excellent safety profile  Three published studies on use in bronchiectasis  FDA alignment on our proposed Phase 2 study  FDA gave us the green light for the study at all planned dose levels, 600mg and 900mg per day  Ready to start Phase 2 clinical study in bronchiectasis 25
  • 26. Quantitative Market Research: Likelihood to Prescribe at 88%  The physicians’ likelihood to prescribe is a key measure of the overall breadth of physician interest, in that it indicates the adoption of Benzonatate into the physicians’ portfolios of treatment tools  Physician responses were compared to the TNSfyi database of physician responses for new drugs or new indications for acute conditions.  Physician responses are above average for a Benzonatate formulation  42% of Physicians definitely would prescribe  46% of Physicians probably would prescribe 26

Notas do Editor

  1. At one hour, 10 mg release 43.4% or 4.34 mg 4 x 10 mg releases 20.1%, or 8.04 mg (vs. expected 17.36 mg; 4 x 4.34 mg) 8 x 10 mg releases 13.5%, or 10.8 mg (vs. expected 34.88 mg; 8 x 4.34 mg)