CORPORATE PRESENTATION

Similar documents
CORPORATE PRESENTATION

CORPORATE PRESENTATION

CORPORATE PRESENTATION

Endoxifen Clinical Update February 1, 2018

1 NASDAQ: ATOS WWW. ATOSSAGENETICS. COM 2016, A TOSSA G ENETICS, I NC. A LL R IGHTS R ESERVED. C ORPORATE P RESENTATION M ARCH 20, 2017

Zacks Small-Cap Research Sponsored Impartial - Comprehensive

Zacks Small-Cap Research Sponsored Impartial - Comprehensive

Aviragen Therapeutics, Inc. and Vaxart Inc. Joint Conference Call UNLOCKING THE FULL POTENTIAL OF ORAL VACCINES

Actinium Pharmaceuticals, Inc.

Inovio Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter)

Diagnostics for the early detection and prevention of colon cancer. Publication of DeeP-C Study Data in New England Journal of Medicine March 2014

SAVARA CORPORATE PRESENTATION (NASDAQ: SVRA) NOVEMBER 2018

Actinium Pharmaceuticals Highlights Analysis of Pivotal Iomab-B Phase 3 SIERRA Trial Presented in Oral Session at ASH Annual Meeting

Corporate Overview. February 2018 NASDAQ: CYTR

36th Annual J.P. Morgan Healthcare Conference. Kevin Conroy, Chairman and CEO January 9, 2018

DS-8201 Strategic Collaboration

Q4 Report Webcast February 7, 2019 Presenters: Renée Aguiar-Lucander, CEO Fredrik Johansson, CFO

Determined to realize a future in which people with cancer live longer and better than ever before Q Conference Call

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics

DARA Reports Year-End 2012 Financial Results

PATENCY-1 Top-Line Results

Creating a Leading Global HBV Therapeutics Company. ARB-1467 Update Call December 12, 2016

CytoDyn Announces Initiation of Metastatic Triple Negative Breast Cancer Trial and Reiterates Phase 3 Goal in Cancer

Investor Presentation June 2012 NASDAQ: CEMI

N a s d a q : I N S Y

LION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology

REPROS THERAPEUTICS. Dedicated to Treating Male and Female Reproductive Disorders. Corporate Presentation. August 2017

Tumor Antigens in the Age of Engineered T cell Therapies

Sunesis Pharmaceuticals Reports Second Quarter 2011 Financial Results

Corporate Presentation. October 2017

World leader in navigated, non-invasive brain stimulation therapy and diagnosis

Corporate Update Simon Hubbert, CEO Bill Kullback, CFO June, 2015

Sunesis Pharmaceuticals Reports Third Quarter 2014 Financial Results and Recent Highlights

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics. Jefferies 2014 Global Healthcare Conference Cynthia L. Sullivan, President and CEO

Dynavax Corporate Presentation

Corporate Presentation Fourth Quarter 2017

Committed to Transforming the Treatment Paradigm for Migraine Prevention

Diagnostics for the early detection and prevention of colon cancer. Leerink Swann Global Health Care Conference February 2015

Avenue Therapeutics, Inc. August 2016

Corporate Overview June 2014 Jefferies Healthcare Conference NASDAQ: GLYC

REPROS THERAPEUTICS. Dedicated to Treating Male and Female Reproductive Disorders. Corporate Presentation. September 2017

N A S D A Q : E V F M

Diagnostics for the early detection and prevention of colon cancer. Fourth-Quarter 2014 Earnings Call February 24, 2015

Genomic Health. Kim Popovits, Chairman, CEO and President

Small-Cap Research. Diffusion Pharmaceuticals Inc. (DFFN-NASDAQ) DFFN: FDA Gives Final Guidance for Phase 3 Protocol for TSC in Inoperable GBM OUTLOOK

Forward-Looking Statements

Building a Leading Oncology Franchise

Business Update & Financial Results for Q1 2018

Diagnostics for the early detection and prevention of colorectal cancer.

NASDAQ: ZGNX. Company Presentation. October 2017

Future Leaders in the Biotech Industry. Lee Bendekgey, SVP, CFO & General Counsel April 7, 2005

A company developing innovative, high-impact drugs for cancer

ADAPTIMMUNE INVESTOR PRESENTATION. August 2016

IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics

VAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients. September 2018

Corporate Update. NASDAQ: GALT April 9, 2018

Zacks Small-Cap Research

Prosensa Corporate Overview Jefferies Healthcare Conference London, UK November 19, Hans Schikan, CEO

Dicerna Pharmaceuticals Overview. Delivering RNAi-Based Breakthrough Therapies

Determined to realize a future in which people with cancer live longer and better than ever before

Avenue Therapeutics, Inc. May 2017

DelMar Pharmaceuticals Inc. (OTCQX: DMPI, Target Price: $5.75)

Two-stage study designed to evaluate tolerability and efficacy of pracinostat combined with azacitidine in patients with high and very high risk MDS

Avenue Therapeutics, Inc. September 2016

Idenix Pharmaceuticals Building a Leading Antiviral Franchise. Cowen & Company 27 th Annual Healthcare Conference March 13, 2007 Boston

Genta Incorporated. A Multiproduct Late-Stage Oncology Company

Evofem Biosciences Reports Second Quarter 2018 Financial Results and Provides Corporate Update

Determined to realize a future in which people with cancer live longer and better than ever before

Ipsen Acquisition of Clementia Pharmaceuticals. February 25, 2019

XXII: CTP Summarizes Scientific Case for Limiting Nicotine in Cigarettes. Company Update October 15, 2018 Industrial & Consumer Technology

Capricor Therapeutics

Breathtaking science. Developing respiratory drugs to improve health and quality of life

RespireRx Pharmaceuticals Inc. Executives Presenting at the International Cannabinoid Derived Pharmaceuticals Summit

Investor presentation. Bioshares Biotech Summit July 2017

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K CURRENT REPORT

Clovis Oncology Announces First Quarter 2017 Operating Results. May 3, :06 PM ET

Bobby W. Sandage, Jr., PhD President & Chief Executive Officer. Lazard Capital Markets 8 th Annual Healthcare Conference

Intercell and Novartis form world leading strategic partnership to drive vaccines innovation

Special Meeting in Lieu of Annual Meeting of Shareholders

Targeted Therapeutics for Inflammatory Disease Jefferies Healthcare Conference

Acquisition of Novartis Influenza Vaccines Business. 27 th October 2014

Jefferies Healthcare Conference

Merrimack Pharmaceuticals: A Refocused R&D Company January 2017

Corporate Deck JP Morgan January 2019

Emisphere Technologies, Inc. Announces 2008 Second Quarter Financial Results

Corporate Presentation. August 2016

Dawson James Conference

INTERIM RESULTS AS OF JUNE 30, 2014 CSE/OMX:BAVA, OTC:BVNRY

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K CURRENT REPORT

www. isotopeworld.com Advanced Medical Isotope Corporation

New Generation of T-cell Therapeutics

PIERIS PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter)

34 th Annual JP Morgan Healthcare Conference. January 13, 2016

Corporate Overview. July 2016 NASDAQ: CYTR

Q3 18 Earnings Supplemental Slides

Neovasc Inc. Alexei Marko, CEO. January 2012 OneMedForum

[ NASDAQ: MEIP ] Cowen and Company Health Care Conference March 2015

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE

2006 Annual Report. Anastomosis Made Simple

Transcription:

CORPORATE PRESENTATION MAY 16, 2018 NASDAQ: ATOS WWW.ATOSSAGENETICS.COM 1 2018 ATOSSA GENETICS, INC. ALL RIGHTS RESERVED.

Forward-Looking Statements Some of the information presented herein may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are ased o a age e t s urre t e pe tatio s a d are su je t to risks a d u ertai ties that a ause a tual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies including failure to approve commencement of studies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Atossa's products and services, performance of clinical research organizations and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Co issio the SEC, including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time. This presentation does not constitute an offer to sell securities including but not limited to within any jurisdiction in which the sale of such securities would be unlawful. This presentation does not constitute a solicitation or offer to sell securities. Such offer and the information set forth herein have not been reviewed, approved or disapproved, nor has the accuracy or adequacy of the information set forth herein been passed upon, by the SEC or any state securities administrator. Any representation to the contrary is a criminal offense. An investment in the securities offered by the company is speculative and involves a high degree of risk. Investment in the securities offered hereby is suitable only for persons of substantial financial means who can afford a total loss of their investment. The Company has filed a Registration Statement and a prospectus with the SEC for the offering for which this presentation relates. Before you invest, you should read the Co pa s Registratio Statement and prospectus, and any amendments or supplements thereto, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. The Registration Statement and prospectus, as may be amended or supplemented from time to time, may be accessed through the SEC s e site at www.sec.gov. Alternatively, the Company, any underwriter or any dealer participating in the offering will arrange to send you the prospectus and any amendments or supplements thereto if you request it through Maxim Group LLC, 405 Lexington Ave, New York, NY 10174, Attn: Prospectus Department or by Tel: (800) 724-0761. This presentation contains statistics and other data that has been obtained from or compiled from information made available by third parties service providers. The Company has not independently verified such statistics or data. The information presented in this presentation is as of May 16, 2018, unless indicated otherwise. 2

Atossa Genetics (NASDAQ: ATOS) Clinical-stage company Novel pharmaceuticals Novel drug delivery methods Breast cancer, gynecomastia & other breast conditions 3

Seasoned Management Steven Quay, MD, PhD Chairman, CEO and President Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet R. Rea, MSPH, RAC SVP Regulatory, Quality and Clinical Affairs 4

Corporate Summary Issuer: Atossa Genetics Inc. (NASDAQ: ATOS) Our Mission: Develop novel pharmaceuticals and delivery systems to treat breast cancer and other breast conditions Debt Mar. 31, 2018: None Cash Mar. 31, 2018: $4.8 million Capital Structure Mar. 31, 2018: 2.65M common shares; no preferred stock 883K warrants exercisable at $3.78 31k warrants exercisable at >$225.00 Corporate Headquarters: Seattle, Washington 5

Drug Programs Drug Programs Using our Proprietary Endoxifen: Topical Endoxifen Mammographic breast density (MBD) reduction Gynecomastia (male) Oral Endoxifen - Adjuvant therapy in breast cancer patients 6

Drug Delivery Programs Programs Using Proprietary Microcatheter Technology: Microcatheters for Transpapillary CAR-T Delivery (TRAP CAR-T) - R&D program Intraductal Microcatheters for Drug Delivery Phase 2 study underway 7

Breast Cancer Timeline Prevention Window Neoadjuvant Phase Adjuvant Phase Diagnosis Biopsy Mammographic Breast Density Tamoxifen (5-10 years) Suspicious Lump Surgery and Radiation/ Chemotherapy Topical Endoxifen Intraductal: - Fulvestrant - TRAP CAR-T Oral Endoxifen 8

Program Pipeline Drug/Device Program Preclinical Phase 1 Phase 2 TRAP CAR-T R&D FulvestrantDCIS and BC Ph. 2 Underway MBD Ph. Pivotal Phase 3 NDA* Market Microcatheters Topical Endoxifen Oral Endoxifen start i H 8 2020 2021 2020 2021 Gynecomastia Ph. 1 Underway Refractory to Tamoxifen Ph. start i H 8 * Estimated FDA or Ex-US submission 9

Large Market Opportunities Program Opportunity Topical Endoxifen 10M High MBD (BI-RAD C/D)(1) 10M Gynecomastia (25% of all 50-69 yrs)(2) Oral Endoxifen 1M ER+ Survivors/5 Yrs(3) Intraductal Fulvestrant $800M U.S. sales for pre-surgery and surgery replacement therapy(4) TRAP-CAR-T 35K Triple Negative Breast Cancer/Yr.(5) (1) Nat l Cancer Inst.: Prevalence of Mammographically Dense Breasts in the United States (Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4200066/) (2) Mayo Clinic (retrieved from: https://www.mayoclinic.org/diseases-conditions/gynecomastia/symptoms-causes/syc-20351793) (3) American Cancer Society, Inc: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-andfigures/2018/estimated-number-of-new-cancer-cases-and-deaths-by-sex-us-2018.pdf. See also Nat l Ca er I st.: https://www.cancer.gov/types/breast/breasthormone-therapy-fact-sheet (4) Data from Defined Health: SERM Report January 2017 (5) Data from Breastcancer.org (Retrieved from: http://www.breastcancer.org /diagnosis/tripneg/behavior) 10

The Unmet Need Topical Endoxifen for MBD No approved treatment Oral Endoxifen for Refractory Up to 500k tamoxifen patients have low Endoxifen(1, 2) Tamoxifen delay (50-200 days)(3) Gynecomastia No approved treatment Intraductal Microcatheters Provides alternative to systemic delivery, which can have: - Systemic adverse effects - Limited tumor drug level ATOS microcatheter technology may: - Increase drug to tumor ratio - Improve efficacy - Reduce toxicity - CAR-T cells may follow lymphatic migration of cancer (1) Patient reluctance toward tamoxifen for breast cancer primary prevention, Ann. Surg Oncol, 2001 Aug 8(7):580-5 (2) Breast Care (Basel): Clinical Relevance of CYP2D6 Genetics for Tamoxifen Response in Breast Cancer (Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2931018/) (3) Sour e: Nat l Ca er I st.; retrie ed fro : https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3357105/ 11

Endoxifen - Overview Most active metabolite of tamoxifen Tamoxifen has been widely studied Tamoxifen is a pro-drug Up to 5 % of patie ts a t Endoxifen(1) Tamoxifen ake e ough Endoxifen (1) Breast Care (Basel): Clinical Relevance of CYP2D6 Genetics for Tamoxifen Response in Breast Cancer (Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc2931018/) 12

MBD Can Mask Tumors Source: http://woodtv.com/2015/05/11/are-you-dense-know-your-numbers/ 13

MBD Correlates with Cancer Incidence Source: http://slideplayer.com/slide/1557508/ 14

Endoxifen Phase 1 Clinical Trial Female Phase 1: Completed Q3 2017 Pharmacokinetics; safety and tolerability Placebo controlled, double-blinded 49 female volunteers Oral (single and repeat dose) and topical (28-day repeat dose) arms at varying dose levels 15

Endoxifen Phase 1 Results Safety: no clinically significant safety signals and no clinically significant adverse events. Tolerability: tolerated at each dose level through out the study. Pharmacokinetics: Topical - crossed the skin barrier when applied daily to the breast, as demonstrated by low but measurable Endoxifen blood levels detected in a dose-dependent fashion. Oral - demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer. 16

Topical Endoxifen for Men Underserved markets in Gynecomastia Gynecomastia (breast enlargement and pain): Affects 25% of men ages 50-69(1), approx. 10m men Causes: androgen deprivation therapy to treat prostate enlargement and prostate cancer; antianxiety medications; cancer treatments (chemotherapy), and some heart medications Treatments: breast bud irradiation, compression garments and plastic surgery No FDA-approved therapeutic (1) Mayo Clinic (retrieved from: https://www.mayoclinic.org/diseases-conditions/gynecomastia/symptoms-causes/syc-20351793) 17

Topical Endoxifen Phase 1 Study - Male Cohort 1 2 3 Dose Level Number of Participants (mg/breast) (Total mg) (Z)-Endoxifen Placebo 1 3 5 2 6 10 6 6 6 2 2 2 18

Oral Endoxifen Potentially Faster Therapy Atossa Oral E do ife Ma Solve the Ta o ife Dela Endoxifen Source Time to Steady State Oral Tamoxifen (daily) Approx. 50 to 200 days(1) Atossa Oral Endoxifen (daily) 7 days (1) https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3357105/ 19

Pharmacokinetics Summary Oral Study Single Dose Pharmacokinetics Potential Therapeutic Level Time to maximum Time, hours Endoxifen level is less than 8 hours 20

Oral Tamoxifen Pharmacokinetics Oral Tamoxifen Yields Much Slower Blood Levels of Endoxifen The difference is metabolizer status 50 to >200 days to reach endoxifen steady-state levels Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3357105/ 21

Endoxifen/Tamoxifen Treatment Timeline This is 25th percentile on breast cancer growth rate in women 50-59, as measured by mammography(1) 29 Days +29 Days Oral Endoxifen Oral Tamoxifen (1) https://breast-cancer-research.biomedcentral.com/articles/10.1186/bcr2092 22

Oral Endoxifen Refractory Clinical Trial >35 nm Endoxifen Continue on tamoxifen Entry Criteria: ER+ breast cancer patients on tamoxifen Measure Endoxifen Levels 35 nm Endoxifen Add Oral Endoxifen (4 mg/day) 23

Endoxifen Regulatory Pathway Program could qualify for designation under the 505(b)(2) status. Advantages: A single clinical study of safety and efficacy Limited additional clinical or pre-clinical studies Multi-year market exclusivity possible 24

Intraductal Microcatheters Potential advantages - higher local drug/car-t exposure; lower systemic concentrations (lower toxicity) vs systemically delivered agents; potential for lymphatic migration of T-cells Recent Activity - Kite Pharma acquisition by Gilead; Juno acquired by Celgene; FDA approved Novartis's Kymriah for B-cell Acute Lymphoblastic Leukemia Phase 2 study - fulvestrant for DCIS or breast cancer (Montefiore) Fulvestrant - FDA approved (AstraZeneca); opportunities with other drugs and immunotherapies 25

Microcatheter Fulvestrant - Clinical Trial Study Thirty women with ER+ DCIS or Invasive Breast Cancer 6 Intramuscular Administration Efficacy Pathological Response: BioMarker Expression 24 Drug Administered 30-45 days Before Surgery Assessments Intraductal Administration Safety Pharmacokinetic FACT-ES: Side Effects Tissue and Blood Levels of Fulvestrant 26

Local Delivery of CAR-T for Breast Cancer Safety: Reduced risk of systemic complications Efficacy: Delivery of CAR-T cells to the site of the cancer cells. Greater CAR-T to cancer cell ratio. Dose: Fewer cells would be required Reduced cost Increased access (due to production, cost) Indication: Disease localized to the breast 27

Microcatheters TRAP CAR-T Step 1: Remove blood and genetically modify T-cells to kill cancer Source: NIH Step 2: Atossa s Transpapillary (TRAP) microcatheters deliver CAR modified T-cells to breast ducts containing cancer cells 28

Upcoming Milestones Oral Endoxifen: 2Q 2018 Open Phase 2 study in patients refractory to Tamoxifen Topical Endoxifen: (1) 2Q 2018 Open Phase 2 study for MBD (Sweden) (2) 2Q 2018 Complete enrollment in Phase 1 study in men TRAP CAR-T - Seeking partners 29

FOR MORE INFORMATION: KYLE GUSE, CFO AND GENERAL COUNSEL KYLE.GUSE@ATOSSAGENETICS.COM NASDAQ: ATOS WWW.ATOSSAGENETICS.COM 2018, ATOSSA GENETICS INC. ALL RIGHTS RESERVED. 30