ABEOW Abeona Therapeutics Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT PURSUANT

TO SECTION 13 OR 15(D) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

 

Date of report (Date of earliest event reported): January 6, 2015

 

PLASMATECH BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware	0-9314	83-0221517
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

 

4848 Lemmon Avenue, Suite 517, Dallas, TX	75219
(Address of principal executive offices)	(Zip Code)

 

(214) 905-5100

(Registrant’s telephone number, including area code)

 

PLASMATECH BIOPHARMACEUTICALS, INC.

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 7.01. Regulation FD Disclosure

Item 8.01. Other Items

 

Presentations relating to our technology, business and corporate financial structure will be made to investors during January and February 2015. The presentation is attached as Exhibit 99.1 and is incorporated herein.

 

Item 9.01.  Financial Statements and Exhibits.

 

(d)  Exhibits.

 

99.1

Presentation entitled “PlasmaTech Biopharmaceuticals”

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	PlasmaTech Biopharmaceuticals, Inc.
	(Registrant)
	By:	/s/ Stephen B. Thompson
		Stephen B. Thompson
		Vice President Finance
		Chief Accounting Officer

 

 

Date: January 6, 2015

 

EXHIBIT INDEX

 

 

Exhibit Number

 

99.1

Presentation entitled “PlasmaTech Biopharmaceuticals”

 

 

 

 

Exhibit 99.1

 

Investor Presentation January 2015

This presentation contains certain statements that may be forward - looking within the meaning of Section 27 a of the Securities Act of 1933 , as amended, including statements relating to the product portfolio and pipeline and clinical programs of the company, the market opportunities for the Plasma Technologies fractionation technology, MuGard, ProctiGard, and the other mucoadhesive hydrogel products, and the company ’ s goals and objectives . These statements are subject to numerous risks and uncertainties, including but not limited to the risks detailed in the Company’s Annual Report on Form 10 - K for the year ended December 31 , 2013 , and other reports filed by the company with the Securities and Exchange Commission . This presentation does not constitute an offer or invitation for the sale or purchase of securities or to engage in any other transaction with PlasmaTech or its affiliates . The information in this presentation is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local laws or regulations . 1 Safe Harbor Statement

x Commercial stage biopharmaceutical company with two proprietary platform technologies, addressing large unmet medical needs x Patented, disruptive fractionation process generating multiple biosimilar protein therapeutics • Plasma protein market is large (>$15 billion WW) and growing at 11% annually • Critical Alpha - 1 supply shortage looming in 2017; antiquated Cohn fractionation process limits yields • Significant yield improvements address supply constraints, expand margins • Initial product target – Alpha - 1 Antitrypsin for COPD; follow - ons in IVIG and Ultra - orphan proteins x Polymer Hydrogel Technology – Commercial Products Launching 2014/15 • MuGard®, for oral mucositis, addressing $1 billion market opportunity • Four commercial partners launching 2014/15: US – AMAG Pharmaceuticals, Europe – Norgine BV, China – RHEI / Jian An Pharmaceuticals, and Korea – Hanmi Pharmaceuticals. Additional partners in discussion. • ProctiGard™ recently received marketing clearance (July 2014) for treatment of radiation proctitis; business development efforts ongoing. • Additional follow - on products being reviewed at FDA x Focus on Business Development – Partnering / M&A Investment Highlights 2

SDF Process: Salt Diafiltration Process Complete 2014 2015 2017 SDF Alpha™ (Alpha-1) Process Scale UpRegulatory > $ 2.5B SDF Gamma™ (IVIG) Process Scale UpRegulatory > $11.5B PlasmaTech™ Ultra-Orphan Discovery TBD TBD > $ 1B Plasma Protein Addressable Markets ~ $15B MuGard ® 510(k) Europe: Norgine, Korea: Hanmi > $1B US: AMAG, China: RHEI ProctiGard™ 510(k) Commercial > $500M BenzaGard™ > $500M Oncology Supportive Care Markets > $2B ongoing global commercial optimization FDA Discussions towards 510(k) Process validation, Patent PTBI License, Manufacturer Qualification 2016 Commercial Commercial Commercial PHT: Polymer Hydrogel Technology Platform 2015 Market Opportunity 2017 Market Opportunity Product Pipeline Targeting > $17B Market Opportunity by 2017 3

Significant Plasma Therapeutics Opportunity x Large, Fast - Growing Market • Plasma protein therapeutics derived from blood plasma • WW market >$15 billion, growing at approximately 11% annually • Growth driven by greater awareness of therapeutic potential plasma proteins, better and earlier diagnostics • Alpha - 1, Alpha - 1 antitrypsin (“AAT”), Alpha - 1 proteinase inhibitor (“A1PI”) x Unmet Medical Need – Supply Constraints Hampered by Cohn Process • Antiquated Cohn fractionation damages proteins, is ripe for innovation • Large fractionators slow to alter current process; plasma shortages looming & prices rising • PlasmaTech SDF ™ Process greatly enhances yields, enhancing margins • “Kinder, gentler” SDF Process yields commercial quantities of ultra - orphan proteins (new product opportunities) x Considerable M&A, Strategic Activity – Exit Strategy • Plasma processing: Grifols acquires Talecris, Bain Capital acquires PRUK • Baxter licenses Kamada Glassia ™ • Biologics deals: Roche/Intermune $8.3B, Sanofi/Genzyme $20B, Teva/Sicor $3.4B, Teva/CoGenesys ~$400M • China Biologics: CBPO launched in 2010, currently trading at ~$54 CAGR ~11% 4

Highly Optimized PlasmaTech SDF ™ Process PlasmaTech SDF Process x Simple 2 - Stage Sodium Citrate Precipitation + Diafiltration x No ethanol or PH changes vs. Cohn Fractionation x Significantly decreased adoption risk; reduced cost Benefits of PlasmaTech Process x Alpha - 1 yield increase ~10X x IVIG yield increase ~ 20% x Similar yields on Factor VIII x Potential for multiple ultra - orphan proteins Positive Margin Impact x Yield improvements could drive 80% product margins versus 40% Cohn process margin x Addresses anticipated shortages in key target proteins Shorten Pathways to Regulatory Approvals x Abbreviated approval pathway under Section 351(a) x Bio - equivalence and safety studies – fewer patients Proprietary Intellectual Property x Three issued US and WW patents, foreign counterparts pending; additional patent filings anticipated Enhancing Yields Drives Significant Value Per Liter of Plasma “The Cohn ethanol process utilizes multiple pH changes away from neutral which generates untoward side reactions which can alter (denature) the desired bio molecules.” Gene Zurlo 5

PlasmaTech will be the only company focused on “ Alpha - 1 First ” x Alpha - 1 Antitrypsin – Serving Large Underserved Medical Need • Alpha - 1 Antitrypsin Deficiency (“AATD”): Genetic condition whereby insufficient AAT protein made in the liver x Driving Growth in Alpha - 1 Market • Focus on early detection; newborn screening in NY and MA • Enhanced awareness of therapeutic potential of Alpha - 1 • Expanding global usage of plasma proteins, especially emerging markets x Looming Alpha - 1 Supply Shortage • Large fractionators slow to alter current processes • Cohn fractionation does not selectively target Alpha - 1 ; terrible Alpha - 1 yield “There is dramatic, continued increase in demand for plasma derived products globally; between 2017 and 2020, demand will outplace supply” Robert Sandhaus, M.D., Ph.D. • Market Data • ~$900m ww • ~400k potential patients in US & Europe • ~ 3 - 5% penetrated • Potential: $16 - 30bn fully penetrated • Revenue Dynamics • ~100k / patient per year • $100m per 1k patients • ~22 years/patient 6

COPD is a large and under - treated disease x AATD is an under - diagnosed hereditary condition • Alpha - 1 Antitrypsin Deficiency (“AATD”): Genetic condition whereby insufficient AAT protein made in the liver • Alpha - 1 protects lungs from inflammation and damage caused by infection and inhaled irritants • AATD may lead to liver disease x Prevalence – need to diagnose and treat • AATD has been identified in nearly all populations and ethnic groups • Roughly 1 in every 2,500 Americans have AATD • Up to 3% of all people diagnosed with COPD may have undetected AATD • The World Health Organization (WHO), American Thoracic Society (ATS), and the European Respiratory Society (ERS) recommend that everyone with COPD be tested for AATD “The incidence of COPD could be as high as 30 million in the US alone” Charlie Strange, M.D . 7

8 • Alpha - 1 CAGR: 35%, Other plasma protein CAGR: 11% • Global plasma processing capacity assumed growth: 3.2%/year, 24.5 million liters ww in 2005, with only 70% of total capacity app licable for AAT processing • Dose calculation: 5g/week “This is an underappreciated problem that will affect the entire alpha - 1 community. There is no current solution with the current systems and approach These numbers are accurate and make a compelling case for PlasmaTech’s approach” Robert Sandhaus, MD PhD Alpha1 Market Size, $m M a r k e t 2012 2013 2014 2015 2016 2017 2018 2019 2020 600 700 900 1,215 1,640 2,214 2,989 4,036 5,448 # Patients ww M a r k e t 7,189 7,839 9,419 11,884 14,993 18,917 23,867 30,112 37,992 Liters sourced for A1, M L A l p h a 1 S u p p l y 21.4 22.1 22.8 23.5 24.3 25.0 25.8 26.7 27.5 A1 treatment capacity: # patients Treatment Δ: # excess (untreated) Missed Revenue Opp, $m if PTBI treated all patients who were not served by Cohn Process A l p h a 1 S u p p l y P l a s m a T e c h 14,401 14,862 15,338 15,829 16,335 16,858 17,397 17,954 18,529 5,919 3,945 1,342 (2,059) (6,470) (12,158) (19,464) (241) (810) (1,629) (2,791) 2012 2013 2014 2015 2016 2017 2018 2019 2020 if PTBI treated all patients who were not served by Cohn Process A1 Revenue, $m IVIG Revenue, $m Total Revenue, A1, IVIG P l a s m a T e c h 241 810 1,629 2,791 109 355 693 1,154 350 1,165 2,323 3,946 -25 -20 -15 -10 -5 0 5 10 15 2012 2013 2014 2015 2016 2017 2018 2019 2020 Annual Alpha1 COHN Supply, M g Annual Alpha1 Demand @5g/week, M g Treatment Δ: # excess (untreated) Looming Alpha - 1 Supply Shortage

Why is Alpha - 1 a lower priority for fractionators? x IVIG represents significantly larger opportunity for Cohn fractionators • For above example of 150,000 L plasma processed, costing ~$21m • Cohn produces ~$9.8m Alpha - 1 vs. ~195m for IVIG IVIG represents a 20X larger opportunity • SDF produces ~$100m Alpha - 1, > 10x x Smaller Alpha - 1 market (for now) • Alpha - 1 market is just beginning to grow x Cost, regulatory disruption of changing manufacturing facilities • Most changes to plasma processing for one molecule change the process for many others • Any material change in process requires regulatory rework • No disruption in supply is tolerable by patients or governments • 2014 Pricing / Costs: Plasma: $149/L, Alpha - 1: $421/g, IVIG: $78/g, processing: $160/L process example: 150 k liters Plasma $,'000 A1, kg A1 $,'000 Patients IVIG, kg IVIG $,'000 Cohn 22,275 26 11,045 101 600 46,800 SDF 22,275 270 113,607 1,038 728 56,768 Difference - 244 102,562 938 128 9,968 2016 Price, $/g Alpha-1 IVIG 9

351(a) BLA pathway follows previous AAT approval pathway x Abbreviated Regulatory Pathway • BLA approval pathway 351(a) – estimate $ 5 to 9 million per protein to regulatory approval • 9 to 12 month scale - up and analytical method development • Replacement therapy efficacy and safety studies (50 target patients to 135 patients theoretical limit) • PlasmaTech will work with the PlasmaTech SAB clinicians and Alpha - 1 Foundation to expedite study process x Collaborative Development & Commercial Strategy • Ongoing discussions with multiple contract manufacturers and fractionators • Multiple product opportunities enhance partnering opportunities globally • Anticipate announcing initial collaborations in 1H2015 10 Kamada Glassia package insert: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/Appro vedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM217890. pdf

Scientific Advisory Board Leaders in Alpha - 1 and Mucositis Eugene Zurlo, BS, MS Pharmacy, Chairman ▪ 56 years experience ▪ Founder/Chairman/ Inventor Plasma Technologies, LLC (Licensor) ▪ Baxter Hyland, Millipore, NY Blood Center, Alpine Biologics, Ayerst Laboratories ▪ Launched first commercial AHF concentrate: Hemofil (Baxter) Charlie Strange, MD ▪ Professor Pulmonary, Critical Care, Allergy, and Sleep Medicine, University S Carolina, Charleston SC ▪ Director: Alpha - 1 Foundation Research Registry ▪ Clinical trial design & rare diseases expert Robert Sandhaus, MD, PhD ▪ Professor of Medicine: National Jewish Health, Denver CO ▪ Clinical Director: Alpha - 1 Foundation ▪ Medical Director, Founder: AlphaNet ▪ Extensive pharma industry expert: pathogenesis of emphysema. ▪ Extensive plasma therapeutics industry experience Charles Heldebrant, PhD ▪ CSO PSC Biotec ▪ Alpha Therapeutic Corporation, ▪ Grifols: development, regulatory clearance, production of AAT product (sold to Baxter) ▪ Extensive experience in biological & pharmaceutical product development, regulatory, quality, validation, ▪ Holds 14 patents, author/co - author of 31 scientific / technical papers, extracts Stephen T. Sonis, DMD, DMSc ▪ Clinical Professor of Oral Medicine, Harvard, Senior Surgeon, Brigham and Women’s Hospital and Dana - Farber Cancer Institute ▪ Founder, Partner, CSO Biomodels ▪ Expert in epithelial injury due to cancer therapy ▪ Established basic basis of mechanistic paradigm for mucosal injury ▪ Author >200 original publications, 9 books, 5 patents 11

PlasmaTech SDF Gamma Process produces IVIG: a high value protein x PlasmaTech IVIG – increases IVIG yield by ~20% • Intravenous immunoglobulin (IVIG) is the high value plasma protein with multiple uses in patients with decreased or abolished antibody production capabilities • ~50% of the total $15 billion plasma protein market x Multiple targets for IVIG Neurology Hematology Dermatology Other x Guillain Barre x Immune thrombo - cytopenia x Kawasaki Syndrome x Primary antibody deficiencies x Lambert Eaton Syndrome x Post BMT x Dermatomyositis x Vasculitis x Multifocal motor neuropathy x Myeloma and CLL x Toxic epidermal necrolysis x Autoimmune uveitis x Myasthenia gravis x Immune neutropenia x Atopic dermatitis x Birdshot retinochoro - idopathy x Stiff person syndrome x Parovirus B19 associated aplasia x Blistering diseases x Mucous membrane pemphigoid 12

Ultra Orphan Proteins x Multiple High Value Ultra - Orphan Protein Products • >200 additional proteins in human plasma with therapeutic potential • Denaturing impact of ethanol in Cohn process could create multiple product opportunities for PlasmaTech x Other Possible Plasma Products • C - 1 - esterase inhibitor • Protein C • Anti - thrombin III • Alpha - 2 - Macroglobulin • Transferrin • Plasminogin • Haptoglobin • Plasma gelsolin 13

PHT Products & Platform x Unique aqueous pseudoplastic liquid : beneficial in inhibition / treatment of mucositis & other oral cavity disorders x Patented mucoadhesive hydrogel delivery system enables extended delivery of drugs to mucosal tissue x System enables multiple products in patented delivery system - patent includes claims on formulations with actives against mucocutaneous disorders x Broad patent coverage and claims (six patents granted, multiple pending) . Patent extension opportunity for generic active drugs ; multiple regulatory pathway via ANDA, 505 (b)( 2 ), 510 (k) or IND/NDA pathways Proprietary Mucoadhesive Hydrogel Delivery System 14

Significant Medical Issue Often Unrecognized, Undiagnosed and Undertreated Well - Being x Pain x Problems with eating, drinking, speaking and swallowing x Weight loss x Impairment of quality of life (e.g. mood) Infection x Reduces infection barrier Compromised Treatment x Reduced dosage x Breaks or delays in therapy affecting treatment outcomes Economic Impact x Prolonged hospital stays x Increased use of resources (e.g. feeding tube placement) The MuGard Patient Solution x User - friendly ready to use rinse x Reduces pain x Improves speech MuGard for Oral Mucositis: unique and differentiated 15

MuGard for Oral Mucositis: Strong Progress x MuGard for Oral Mucositis (“OM”) • Received FDA Marketing Clearance / launching now • No competing products with demonstrated clinical benefit x $1B+ Global Market Opportunity: • > 400K diagnosed OM cases: US alone 1 • 90% of radiation patients / 40% of cycled chemo patients x Healthcare Cost Impact: • Studies show OM costs $17,000 to $40,000 per patient 2,3 x Global Launch in 2014 & 2015 • US - AMAG Pharmaceuticals (AMAG) • European Union - Norgine B.V. • China - RHEI / Jian An • Korea - Hanmi Pharmaceuticals • Discussions ongoing in Japan, Australia, others 1. Cawley MM, Benson LM. Current trends in managing oral mucositis. Clin J Oncol Nurs. 2005;9(5):584 - 592 2.. Sonis ST, Oster G, Fuchs H, et al. Oral mucositis and the clinical and economic outcomes. J Clin Oncol 2001;19:2201 – 2205 . 3. Barasch A et. Al. Palifermin for oral mucositis Biologics: Targets & Therapy 2009:3 111 – 116 16

x Protocol – Multi - center, randomized, placebo controlled study in 120 head and neck cancer patients x Positive - MuGard was statistically significant with regard to : • Primary endpoint of reduction in mouth and throat soreness ( p= 0 . 034 ) • Reduction in OM disease severity by WHO score at end of radiation treatment (p= 0 . 038 ) x Secondary Endpoints – Clinically important trends for MuGard • 10 . 0 day decrease in opioid use ; duration of opioid use < 50 % less in MuGard arm • MuGard patient weight loss 3 . 9 kg less • Delayed onset of oral mucositis by 9 days • Overall MuGard very well tolerated with no SAEs x First trial to show clinical benefit in oral mucositis for tough - to - treat head and neck cancer patients . Published in CANCER – May 1, 2014 x Novartis’ Afinitor (everolimus), approved in various breast, pancreatic, renal and brain cancers x Approximately 70% of Afinitor patients experience severe (painful, ulcerative) stomatitis that presents like oral mucositis x Initiated by UCLA breast cancer clinician who have had success with MuGard in Afinitor patients experiencing OM; trial supported by Novartis, PlasmaTech, and AMAG x Afinitor’s approval in breast cancer should drive revenues by an additional $1.5 billion (analyst estimates for 2018 exceed $3.5 billion); reducing mucositis side effect could be an important value driver Novartis / UCLA MuGard Trial Mucoadhesive Oral Wound Rinse (MuGard) in Preventing and Treating Stomatitis in Patients with ER - or PR - Positive Breast Cancer Receiving Everolimus 17

ProctiGard for Radiation Proctitis x Radiation Proctitis - Large Unmet Medical Need • Inflammation & damage to the lower portion of the colon post exposure to x - rays or ionizing radiation as part of radiation therapy. M ost common after treatments for cancer such as cervical, prostate & colon cancer • Rectal mucositis, a broader condition, may be caused by bacterial or viral infections, parasites, food or contact allergies, & surgery • >250k new cases of prostate, cervical, rectal, testicular, bladder, and endometrial cancer diagnosed annually • ~50 % of these patients require radiation therapy, ~75 % of patients undergoing pelvic irradiation experience radiation proctitis 1 ; addressable market of over 100,000 potential patients annually in US alone. x ProctiGard™ - 90 Days from Filing to Marketing Clearance • Product line extension highlights potential for mucoadhesive polymer hydrogel patented technology • Developed in response to feedback in oncology market, where oncologists were using MuGard in off - label applications on mucosal tissue outside of the oral cavity • PlasmaTech retains global commercialization rights; has had preliminary discussions with potential global marketing partners Received FDA Marketing Clearance – July 2014 1. Hayne D, Vaizey C J, Boulos P B. Anorectal injury following pelvic radiotherapy. Br J Surg. 2001;88:1037 – 1048 . Radiation Proctitis 18

Board of Directors Management Management & Board of Directors Scott Schorer - CEO ▪ 18+ years leadership - healthcare biologics, devices, healthcare IT ▪ President, CEO: CentriMed , IST ▪ President: Systagenix Wound Management Harrison Wehner - President & CFO ▪ 20+ years healthcare & biotech IB, financial advisory, M&A ▪ Senior positions: Canaccord Genuity, CitiGroup, UBS David Nowotnik, Ph.D. - SVP R&D ▪ 40+ years experience pharmaceutical R&D, quality systems, regulatory affairs ▪ Bristol - Myers Squibb, Amersham International, Guilford Pharmaceuticals Steven Rouhandeh , Chairman ▪ SCO Capital Partners ▪ Founder SCO Financial Group ▪ Deutsche Bank, Cravath Mark Ahn, Ph.D. ▪ Genentech, Galena Biopharma, Bristol - Myers Squibb, Amgen Mark Alvino ▪ Bradley Woods, Griffin Securities Stephen Howell, M.D. ▪ UCSD, UCSD Cancer Center ▪ Miliken Foundation prize: cancer chemo Jeffrey Davis ▪ Former CEO Access (PlasmaTech) ▪ PlasmaTech consultant ▪ Phillips Medical Systems, Deutsche Bank 19 Stephen Thompson – VP Finance, Treasurer, Sec ▪ 25+ years financing and accounting ▪ Prior CFO and Controller experience

Numerous Valuable Near - Term Milestones Events & Milestones Estimated Timing Global roll - out of MuGard for oral mucositis - ongoing x FDA 510(K) marketing approval: ProctiGard™ x MuGard ® Partnerships: Norgine ( Europe), Hanmi (Korea) x SDF License Executed, New Management Team x Norgine/Hanmi MuGard ® commercial launches 1H 2015 BenzaGard™ : anticipated FDA marketing clearance 2015 SDF Alpha™ validation, characterization 2015 SDF Alpha, SDF Gamma development and marketing partnership(s) 2015 - 16 SDF Alpha, SDF Gamma regulatory approvals and revenue 2016 - 17 Follow - on plasma product targets: ultra - orphan proteins, and additional hydrogel platform products 2016 - 17+ 20

Valuation Comparables Relative Valuations of Drug Delivery Companies / Related Companies Market Analysis (figures in millions, except per share data) Price (1) Revenue Ent. Value / Revenue Company Ticker @ 12/4/14 Equity Value Enterprise Value (2) LTM 2014 2015 LTM 2014 2015 GRIFOLS SA - ADR GRFS $33.10 $14,132 $13,524 $4,252 $4,155 $4,439 3.2 x 3.3 x 3.0 x NEKTAR THERAPEUTICS NKTR $12.67 $2,005 $1,899 $212 $200 $264 8.9 x 9.5 x 7.2 x CHINA BIOLOGIC PRODUCTS INC CBPO $54.67 $1,703 $1,809 $228 $241 $279 7.9 x 7.5 x 6.5 x DEPOMED INC DEPO $14.88 $940 $608 $236 $243 $244 2.6 x 2.5 x 2.5 x PROMETIC LIFE SCIENCES INC PLI CN $1.77 $939 $961 $16 $23 $41 59.3 x 41.9 x 23.7 x BIODELIVERY SCIENCES INTL BDSI $15.90 $750 $678 $40 $42 $90 16.8 x 16.3 x 7.5 x AMAG PHARMACEUTICALS INC AMAG $30.98 $867 $647 $93 $107 $367 7.0 x 6.1 x 1.8 x FLAMEL TECHNOLOGIES - SP ADR FLML $12.68 $644 $721 $30 $39 $203 23.7 x 18.3 x 3.6 x ROCKWELL MEDICAL INC RMTI $10.14 $398 $406 $54 $53 $85 7.6 x 7.6 x 4.8 x ANTARES PHARMA INC ATRS $1.98 $325 $277 $23 $26 $63 12.13 x 10.6 x 4.4 x KAMADA LTD KMDA $4.11 $118 $75 $71 $70 $82 1.1 x 1.1 x 0.9 x Mean $2,074 $1,964 $478 $473 $560 13.6 x 11.3 x 6.0 x Source: Bloomberg and Wall Street Research Note: LTM = Latest Twelve Months (1) Stock price as of December 4, 2014 (2) Enterprise Value equals Equity Value plus debt less cash 21

Recent events: PTBI recently completed a $14 million financing and up listing to NASDAQ No long term debt, no convertible preferred stock Capitalization Table January 1, 2015 Shares Outstanding WAEP Common shares out (primary) 20,683,248 - Warrants (PTBIW) 3,500,000 $5.00 Warrants (non - traded) 577,756 $46.50 Options 233,834 $23.60 Fully Diluted Total 24,994,838 22

x Commercial stage biopharmaceutical company with two proprietary platform technologies, addressing large unmet medical needs x Patented, disruptive fractionation process generating multiple biosimilar protein therapeutics • Plasma protein market is large (>$15 billion WW) and growing at >10% annually • Critical Alpha - 1 supply shortage looming in 2017; antiquated Cohn fractionation process limits yields • Significant yield improvements address supply constraints, expand margins • Initial product target – Alpha - 1 Antitrypsin for COPD; follow - ons in IVIG and Ultra - orphan proteins x Polymer Hydrogel Technology – Commercial Products Launching 2014/15 • MuGard®, for oral mucositis, addressing $1 billion market opportunity • Four commercial partners launching 2014/15: US – AMAG Pharmaceuticals, Europe – Norgine BV, China – RHEI / Jian An Pharmaceuticals, and Korea – Hanmi Pharmaceuticals. Additional partners in discussion. • ProctiGard™ recently received marketing clearance (July 2014) for treatment of radiation proctitis; business development efforts ongoing. • Additional follow - on products being reviewed at FDA x Focus on Business Development – Partnering / M&A Investment Highlights PlasmaTech Biopharmaceuticals 23