UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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): October 25, 2017
Atossa Genetics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35610 | 26-4753208 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
|
107 Spring Street Seattle, Washington |
98104 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (206) 325-6086
Not Applicable
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | 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
On October 25, 2017, Atossa Genetics Inc. (the “Company”) issued a press release announcing preliminary results from its Phase 1 study of oral Endoxifen. Also on October 25, 2017, the Company plans to hold a conference call to present information about the preliminary results from the Phase 1 study of oral Endoxifen. A copy of the press release and slides for the conference call are attached as Exhibit 99.1 and 99.2, respectively, to this current report and are incorporated herein by reference.
* * *
The Company is furnishing the information in this Current Report on Form 8-K to comply with Regulation FD. Such information shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.
“Safe harbor” statement under the Private Securities Litigation Reform Act of 1995: 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 based on management’s current expectations and are subject to risks and uncertainties that may cause actual 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, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of the Company’s products and services, performance of clinical research organizations and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission, 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.
Item 8.01 Other Events.
See item 7.01 above which is incorporated into this Item 8.01 by this reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated October 25, 2017 | |
| 99.2 | Oral Endoxifen Slide Presentation, dated October 25, 2017 |
* * *
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.
| Date: October 25, 2017 | Atossa Genetics Inc. | ||
| By: | /s/ Kyle Guse | ||
| Kyle Guse | |||
| Chief Financial Officer, General Counsel and Secretary | |||
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release, dated October 25, 2017 | |
| 99.2 | Oral Endoxifen Slide Presentation, dated October 25, 2017 |
Exhibit 99.1
Atossa Genetics Announces Preliminary Results from
Phase 1 Study of Oral Endoxifen
All Objectives Successfully Met
Conference Call To Be Held Today at 10 am Eastern Time
SEATTLE, October 25, 2017 -- Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported preliminary results from its Phase 1 study of its proprietary oral Endoxifen. All objectives were successfully met:
| – | Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen. |
| – | Tolerability: Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study. |
| – | Pharmacokinetics: Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer. |
These data demonstrate the suitability of oral Endoxifen for further clinical development.
The Phase 1 Study
The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 48 healthy female subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of both topical and oral Endoxifen dosage forms in varying dose levels over 28 days. The study was conducted in two parts based on route of administration. Preliminary results from the topical arm of the study were announced on September 14, 2017.
Atossa’s Proprietary Endoxifen
Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen is a “pro-drug” meaning that it must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. It is these active metabolites that have the therapeutic effect.
Oral Endoxifen. Although approximately one million breast cancer survivors take tamoxifen annually, up to half of them do not fully benefit from tamoxifen, meaning they are “refractory,” for a number of reasons including that they do not properly metabolize tamoxifen into its active metabolites. Low endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Thus providing oral Endoxifen directly to the patient without having to be metabolized may help to address this problem.
Topical Endoxifen. A condition called breast density (or, MBD), typically diagnosed by a mammogram, has been shown to be an independent breast cancer risk factor. To date, 30 states require that findings of MBD be directly communicated to the patient. We believe a topical form of Endoxifen could potentially reduce MBD. Although oral tamoxifen has been shown to reduce MBD, the benefit-cost ratio is not acceptable to most physicians and their patients. For example, it is estimated that less than 5% of women at an increased risk of developing breast cancer including those with MBD take oral tamoxifen to prevent breast cancer because of the risk of, or actual side-effects of, oral tamoxifen. We are planning a Phase 2 study of topical Endoxifen in Stockholm Sweden for the treatment of MBD.
Based on the number of women with MBD and the number of patients who have survived breast cancer but are not fully benefiting from tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could potentially exceed $1 billion in annual sales.
Next Steps
“Based on these positive preliminary results, we are advancing our oral Endoxifen into Phase 2 studies” commented Dr. Steven C. Quay, CEO and President. “We expect our initial Phase 2 study will be in women who are refractory to tamoxifen and we expect to begin that study in the first quarter of 2018,” continued Dr. Quay.
Breast Cancer Statistics
The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.
Conference Call
Atossa Genetics will host a conference call to discuss preliminary results today at 10 am eastern time.
To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830, International callers should call 1-412-317-5140 and Canadian callers should call 1-855-669-9657. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at http://ir.atossagenetics.com/ir-calendar.
A replay of the call will be available approximately one hour after the end of the call through November 24, 2017. The replay can be accessed via Atossa's website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10113835.
About Atossa Genetics
Atossa Genetics Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
Forward-Looking Statements
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa’s drugs under development and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.
Atossa Genetics Company Contact:
Atossa Genetics Inc.
Kyle Guse
CFO and General Counsel
(O) 866 893-4927
kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott Gordon
CoreIR
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: 516 222-2560
scottg@CoreIR.com
Source: Atossa Genetics Inc.
Exhibit 99.2
Preliminary Oral Endoxifen Phase 1 Results All Objectives Successfully Met October 25, 2017 107 Spring Street • Seattle, WA 98104 USA
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 based on management’s current expectations and are subject to risks and uncertainties that may cause actual 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, 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 Commission, 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 . Forward - looking Statements 2
Discussion Topics • Atossa Genetics Overview • Endoxifen • Phase 1 Study Summaries – Safety – Tolerability – Pharmacokinetics • Upcoming Milestones 3
Atossa Genetics Overview 4
About Atossa Genetics (NASDAQ: ATOS) 5 - Clinical - stage company - Novel pharmaceuticals - Novel drug delivery methods - Breast cancer & other breast conditions
Corporate Update 6 Recent capitalization improvements: • April 2017 financing included 6M warrants and convertible Preferred • All April warrants have now been exercised • All April preferred stock has now been converted • Outstanding capital now includes only 14M shares of common stock
Tamoxifen (Rarely used) Factors that Increase Breast Cancer Risk Lifestyle Genetic Dense Breasts Increased mammograms Enhanced imaging Risk Mitigation Lifestyle Modification Breast Cancer Diagnosis & Treatment Diagnosis _______ Treatment (Surgery, Chemo, Radiation) Routine Screening Long - term Therapy Tamoxifen or AI* Breast Cancer Risk Factors & Treatment Approaches *AI = Aromatase Inhibitors 7
Our Drug and Delivery Programs 8 Drug Programs Using our Proprietary Endoxifen : • Topical Endoxifen For mammographic breast density (MBD) reduction All Phase 1 objectives met Phase 2 for MBD in Sweden commencing Q1 2018 • Oral Endoxifen For “ tamoxifen - refractory” patients All Phase 1 objectives met Phase 2 for refractory patients commencing in Q1 2018
Our Drug and Delivery Programs, Cont. 9 Two Programs Using Proprietary Microcatheter Technology: • Microcatheters for Transpapillary CAR - T Delivery (TRAP CAR - T) – In R&D phase with goals of reducing toxicity, improving efficacy and the potential of T - cells migrating along the lymphatic pathway • Intraductal Microcatheters for Drug Delivery Enrollment underway in Phase 2 study for delivery of fulvestrant for treatment of ductal carcinoma in - situ (DCIS) and breast cancer
The Unmet Need 10 Intraductal Microcatheters Provides alternative to Systemic delivery, which has: • 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 Topical Endoxifen for Density • No FDA approved treatment • 10 million women (1) • Tamoxifen use minimal Oral Endoxifen for Refractory • Up to 500,000 tamoxifen patients under - treated (too - little E ndoxifen ) (2, 3) • Raising E ndoxifen levels may reduce risk of recurrent or new lesions (1) National Cancer Inst.: Prevalence of Mammographically Dense Breasts in the United States (Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200066 / ) (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) Cancer.net: Hormonal Therapy for Early - Stage Hormone Receptor - Positive Breast Cancer (Retrieved from: https://www.cancer.net/research - and - advocacy/asco - care - and - treatment - recommendations - patients/hormonal - therapy - early - stage - hormone - receptor - positive - breast - cancer )
Suspicious Lump Biopsy Surgery and Radiation/ Chemotherapy Diagnosis Breast Cancer Timeline Tamoxifen (5 years) Intraductal : - Fulvestrant - TRAP CAR - T Oral Endoxifen Neoadjuvant Phase Adjuvant Phase Prevention Window Topical Endoxifen High Density via Mammography 11
Program Pipeline 12 Pivota l Preclinical Phase 1 NDA* Market Drug/Device Program * Estimated FDA or Ex - US submission Phase 2 Phase 3 TRAP CAR - T Microcatheters Ph. 2 Underway Microcatheters Fulvestrant - DCIS and BC R&D 2019 2020 Ph. 2 starts in Q1 ‘18 Breast Density Refractory t o Tamoxifen Ph. 2 starts in Q1 ‘18 Topical Endoxifen Oral Endoxifen 2019 2020
Endoxifen 13
Endoxifen - Overview 14 • Most active metabolite of tamoxifen • Tamoxifen has been widely studied • Tamoxifen is a pro - drug • Up to 50% of patients can’t make enough E ndoxifen (1) Tamoxifen 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 / )
Low levels of circulating Endoxifen during tamoxifen adjuvant therapy correlate to an increased risk of recurrent or new breast cancers • Identified as an independent risk factor • Known and unknown causes for low endoxifen levels during tamoxifen therapy • Most active tamoxifen metabolite • It may save more lives Why Endoxifen? 15
Endoxifen – Rationale for Development 16 • Develop TWO formulations for two large unmet medical needs: – Topical to reduce density – less than 5% of high risk patients will take oral t amoxifen because of actual or perceived side effects (1) – Oral – up to 50% of patients taking tamoxifen are refractory (1) • Extensive existing data on tamoxifen (1) Data from DefinedHealth : SERM Report January 2017
High Breast Density Masks Tumors Source: http ://woodtv.com/2015/05/11/are - you - dense - know - your - numbers / 17
High Breast Density Correlates With Breast Cancer http://slideplayer.com/slide/1557508/ 18
Current Paradigm for Tamoxifen Use in U.S. 1 million breast cancer patients take oral tamoxifen for at least five years 10 million patients with a high risk of breast cancer are indicated for chemoprevention with oral tamoxifen Source: Freedman AN, Graubard BI, Rao SR, McCaskill - Stevens W, Ballard - Barbash R, Gail MH. Estimates of the number of US women who could benefit from tamoxifen for breast cancer chemoprevention. J Natl Cancer Inst. 2003;95:526 – 32 Tamoxifen Use in the U.S. 19
Many Drugs Limit Liver Endoxifen Production from Tamoxifen • SSRI drugs like Prozac and Paxil (paroxetine) stop liver metabolism of tamoxifen to endoxifen • Before : 20 mg/day tamoxifen yields 12.4 ng/mL plasma endoxifen • After : four weeks of 10 mg/day of paroxetine is administered • Plasma endoxifen is reduced in 11/12 women in this study • Mean endoxifen levels decreased from 12.4 ng/mL (28 nM ) to 5.5 ng/mL (14 nM ) • Source: J Natl Cancer Inst. 2003 Dec 3;95(23):1758 - 64 . Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine . Stearns V1, Johnson MD, Rae JM, Morocho A, Novielli A, Bhargava P, Hayes DF, Desta Z, Flockhart DA 20
• Tamoxifen Refractory Patients – Up to 50% of patients fail to achieve therapeutic endoxifen blood levels • Approximately 30 nM is therapeutic threshold – Only option is aromatase inhibitors • Significant adverse drug effects Emerging Unmet Medical Need 21
Large Market Opportunities 22 Intraductal Fulvestrant : $800M U.S. market in DCIS pre - surgery and replacement to surgery (Defined Health 1/17) TRAP CAR - T: TBD U.S. Market Triple neg. – 37k patients/yr.; can’t use hormone therapy The Need: Breast Cancer Statistics • 250,000+ cancers and 60,000 DCIS in U.S. in 2017 • 40,000+ deaths in U.S. in 2017 • 15% of BC are triple negative; 3x deadlier in 5 years Endoxifen: $1B U.S market For treatment and chemoprevention of breast cancer (Defined Health 1/17)
Phase 1 Study 23
• Study objectives achieved • Demonstrated: - Safety - Tolerability - Verification of therapeutic blood levels Supports continued development Preliminary Phase 1 Oral Results 24
Q2 2016 • Contracted to develop endoxifen API Q3 2016 • First batch of API for clinical use Q4 2016 • Topical formulation development in US • Retained CRO in Australia Q1 2017 • Retained CMO in Australia (for topical and oral presentations) Q2 2017 • Approval to start study • First cohort enrolled • Shipped drug product to CRO Q3 2017 • Last cohort completed Product Development Timeline 25
• All study objectives successfully achieved – Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen . – Tolerability: Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study . – Pharmacokinetics : Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer Preliminary Study Conclusions 26
Two - part double - blinded, placebo controlled, dose escalation trial investigating the safety and pharmacokinetics of (Z) - Endoxifen in healthy female volunteers – Part A: Topical – liquid applied to the breasts – Part B: Capsule – taken orally Study Design Summary 27
PART A (Topical). Cohorts, dose levels and number of participants. Cohort Dose Level Number of Participants (mg per breast) (Total mg) (Z) - Endoxifen Placebo 1 1 2 6 2 2 3 6 6 2 3 5 10 6 2 PART B (Oral). Cohorts, dose levels and number of participants. Dose Level (mg/day) (Z) - Endoxifen Placebo 4 1 6 2 5 2 6 2 6 4 6 2 Phase 1 Study Design 28
Oral Study Demographics 29
Safety Summary 30 There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen.
• No safety signals observed in weekly assessments of/in: – Blood chemistry – Coagulation parameters – Hematology parameters – Urinalysis – Vital Signs – Heart – Physical Examinations Safety Summary – Oral Study 31
Serious Adverse Events None Reported Safety Summary – Oral Study 32
• AEs deemed Probable as relationship to study drug: – in 5 of 18 subjects receiving oral Endoxifen (28%, 7 AEs ) – in 3 of 6 subjects receiving oral placebo (50%, 6 AEs) – All were assessed as “Mild” • AEs deemed probably related to study drug for oral administration were: – 1 mg : Vomiting (n = 1 or one subject) – 2 mg : 3 x Menstruation delayed (n = 3), Metrorrhagia (n = 1) – 4 mg : Hot flush, Polymenorrhea * (n = 1) – Placebo : Acne, Breast tenderness, Nausea, Hyperesthesia , Vulvovaginal dryness, Dysmenorrhea (n = 3) *The medical term for cycles with intervals of <22 days Safety Summary – Oral Study 33
Tolerability Summary 34 Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.
Tolerability Summary – Oral Study Based on responses from a validated questionnaire, oral endoxifen was well tolerated and similar to the placebo capsules Question: “I am bothered by side - effects of treatment” 35
FACT - ES Validated Questionnaire of Endocrine Symptoms Current therapy has a substantial effect on the FACT - ES Score Tolerability Summary – Oral Study 36
Pharmacokinetics Summary 37 Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer.
Pharmacokinetics Objective • The typical plasma endoxifen levels after 20 mg daily tamoxifen in women who are poor metabolizers of tamoxifen (PM), intermediate metabolizers (IM), and excellent metabolizers (EM) • Reference : https:// www.ncbi.nlm.nih.gov/pubmed/22955113 Therapeutic level is reported by others to be approximately 30 nM Pharmacokinetic Summary – Oral Study 38
Single Dose Pharmacokinetics Time, hours Pharmacokinetics Summary – Oral Study 39
Pseudo - Steady State Levels: 21 Day Sample EM IM PM Plasma endoxifen levels after 20 mg/day tamoxifen, based on CYP2D6 status, published data Pharmacokinetics Summary – Oral Study 40
Preliminary Study Conclusions • All primary and secondary endpoints successfully met – Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral endoxifen. – Tolerability: Oral endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study . – Pharmacokinetics : At doses between 1 and 4 mg/day, oral endoxifen produced significant plasma levels of endoxifen; doses of 2 and 4 mg/day exceeded endoxifen levels in “excellent metabolizers” taking 20 mg/day tamoxifen Therefore, oral Endoxifen is suitable for continued development Pharmacokinetics Summary – Oral Study 41
Oral Endoxifen – Refractory Clinical Trial Design 42 Entry Criteria: ER + breast cancer patients on tamoxifen Measure Endoxifen Levels >TBD nM Endoxifen Continue on tamoxifen (20 mg/day) ≤TBD nM Endoxifen Add Oral Endoxifen (1 - 2 mg/day)
Endoxifen Regulatory Pathway 43 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 Leverage published clinical study data Multi - year market exclusivity possible
Intraductal Microcatheters 44
Intraductal Microcatheters 45 • Potential advantages: higher local drug/CAR - T exposure; lower systemic concentrations (lower toxicity) vs systemically delivered agents; potential for lymphatic migration of T - cells • 1 issued and 3 pending patent app’s (US and PCT) for intraductal delivery of drugs and CAR - T • Kite Pharma acquisition by Gilead; FDA approved Novartis's Kymriah ™ for B - cell Acute Lymphoblastic Leukemia
Intraductal Microcatheters - Fulvestrant 46 • Phase 2 study for delivery of fulvestrant in patients with DCIS or breast cancer (initiated at Columbia; transferred to Montefiore) • Advantages: potentially higher local drug exposure and lower systemic concentrations vs systemically delivered agents • Fulvestrant is FDA approved for intramuscular admin (AstraZeneca); opportunities with other drugs and biotherapeutics
Microcatheter Fulvestrant - Clinical Trial Study Design Thirty women with ER + DCIS or Invasive Breast Cancer 6 24 Drug Administered 30 - 45 days B efore S urgery Assessments Efficacy Safety Pharmacokinetics Pathological Response, Ki - 67 Expression FACT - ES Tolerability Tissue and Blood Levels of Fulvestrant Intramuscular Administration Intraductal Administration 47
Microcatheters – TRAP CAR - T 48 Source: NIH Step 1 : Remove blood and genetically modify T - cells to kill cancer Step 2 : Atossa’s Transpapillary (TRAP) microcatheters delivery CAR modified T - cells to breast ducts containing cancer cells
TRAP CAR - T - Seeking partners Topical Endoxifen: Phase 2 study of MBD to start in Q1 ‘18 with Karolinska Institute Investigator in Stockholm Oral Endoxifen : Phase 2 study for patients refractory to Tamoxifen is planned to start Q1 ‘18 Upcoming Milestones 49
50 Seasoned Management Steven Quay, MD, PhD Chairman, CEO and President Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet Rose Rea, MSPH, RAC VP Regulatory, Quality and Clinical Affairs
NASDAQ: ATOS 51