San Diego-based Fate Therapeutics Enters Strategic Collaboration with Tokyo’s ONO Pharmaceutical Co.

San Diego-based Fate Therapeutics (Nasdaq: FATE) is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell therapies using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders.  For more information, please visit www.fatetherapeutics.com.

 

 

 

Fate’s proprietary iPSC product platform is reported to enable mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be reproducibly produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

On Monday, September 17th, Fate Therapeutics, Inc. announced that it has entered into a collaboration with Tokyo-based ONO Pharmaceutical Co., Ltd. (approximately 300-year-old organization) for the joint development and commercialization of two off-the-shelf CAR-T cell product candidates. Fate Therapeutics will receive an upfront payment and committed research funding during the preclinical option period, and is eligible to receive a preclinical option exercise fee, clinical, regulatory and commercialization milestone payments and tiered royalties on net sales by ONO in connection with the development and commercialization of each collaboration product by ONO in the ONO territory.

 

 

 

Using Fate Therapeutics’ proprietary induced pluripotent stem cell (iPSC) product platform, the two CAR T-cell collaboration candidates will each be derived from a clonal master iPSC line engineered to completely eliminate endogenous TCR expression, insert a chimeric antigen receptor (CAR) into the TRAC locus and incorporate other anti-tumor functionality. This transformative approach enables the cost-effective production of cell-based cancer immunotherapies that are uniformly engineered, extensively characterized and homogeneous in composition, and can be consistently and repeatedly mass produced and delivered to patients in an off-the-shelf manner.

Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics stated, “We are delighted to collaborate with ONO, a global leader in oncology with a long history of developing innovative breakthrough cancer drugs. This partnership with ONO enables Fate to further enhance its expertise in targeting solid tumors and to accelerate the global development of our pipeline of off-the-shelf, iPSC-derived CAR-T cell product candidates.”

Under the terms of the strategic option agreement, Fate Therapeutics and ONO will jointly advance each iPSC-derived CAR-T cell collaboration candidate to a pre-defined preclinical milestone.

  • The first iPSC-derived CAR T-cell candidate targets an antigen expressed on certain lymphoblastic leukemias, and Fate Therapeutics retains global responsibility for development and commercialization with ONO having an option to assume responsibilities in Asia.
  • The second candidate targets a novel antigen identified by ONO expressed on certain solid tumors, with ONO having an option to assume global responsibility for further development and commercialization and Fate Therapeutics retaining the right to co-develop and co-commercialize the candidate in the United States and Europe. For both collaboration candidates, Fate Therapeutics retains manufacturing responsibilities on a global basis.

Hiromu Habashita, Corporate Officer, and Executive Director of Discovery & Research of ONO stated, “ONO identified Fate Therapeutics as the partner of choice for the generation of off-the-shelf CAR T-cell cancer immunotherapies in our portfolio. We are excited to work with Fate Therapeutics and apply its industry-leading iPSC product platform to develop and deliver the next-generation of CAR T-cell therapies for cancer patients.”

If you found this story interesting you should consider reading about Seattle-based Atossa Genetics (Nasdaq: ATOS) which is is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions. To learn more please see the  dedicated coverage page at Vista Partners.

Fate Therapeutics Announces Strategic Collaboration with ONO Pharmaceutical to Develop Off-the-Shelf, iPSC-derived CAR-T Cell Cancer Immunotherapies

Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that it has entered into a collaboration with ONO Pharmaceutical Co., Ltd. for the joint development and commercialization..

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Atossa Advancing Into Phase 2 Study to Reduce Gynecomastia In Men Starting Prostate Cancer Therapy

Gynecomastia is male breast enlargement and accompanying pain, which according to the Mayo Clinic, affects 25% of men in the U.S. between the ages of 50-69, or approximately 10 million men. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone levels are lower than estrogen. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer, anti-anxiety medications, cancer treatments (chemotherapy), and some heart medications.

Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking their prescribed medication. In prostate cancer treatment, testosterone is suppressed resulting in higher estrogen levels that often triggers gynecomastia. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

There is no FDA-approved pharmaceutical to treat gynecomastia. Current therapeutic approaches in these patients include the use of daily oral estrogen-suppressing medications and prophylactic breast bud irradiation which is often repeated. Gynecomastia can create quality of life issues, with some patients attempting to hide the condition with compression garments and, in some cases, undergoing plastic surgery.

Seattle-based Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported earlier today their preliminary results from its Phase 1 dose- escalation study of its proprietary topical Endoxifen in male subjects. All objectives were announced to have been successfully met as follows:

  • Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen.
  • Tolerability: Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.
  • Pharmacokinetics: Blood samples showed no measurable topical Endoxifen.

 

 

 

 

 

Dr. Steven C. Quay, CEO, and President of Atossa stated, “Based on these positive preliminary results, we are advancing our topical Endoxifen into a Phase 2 study to reduce gynecomastia in men starting prostate cancer therapy. We anticipate retaining a clinical research organization to manage that study in the fourth quarter of 2018. In addition to advancing our mens’ program into a Phase 2 study, we also have multiple Phase 2 studies in women addressing large markets with significant unmet needs: breast cancer and a condition called mammographic breast density. We look forward to reporting progress on these programs in the fourth quarter of 2018 and into 2019.”

 

 

 

 

 

Conference Call

Atossa Genetics hosted a conference call to discuss preliminary results today at 10 am Eastern time. A replay of the call will be available approximately one hour after the end of the call through October 13, 2018. 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 access code is 10124008.

 

 

 

 

 

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Announces Preliminary Results from Male Phase 1 Study of Topical Endoxifen

Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported preliminary results from its Phase 1 dose- escalation study of its proprietary topical Endoxifen in male subjects…

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MARKET ALERT: Atossa To Discuss Preliminary Results of Phase 1 Study Of Proprietary Topical Endoxifen In Men On September 13th

Seattle -based Atossa Genetics Inc. (NASDAQ: ATOS) is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions.

Atossa announced today prior to the markets open that it will host a conference call on September 13, 2018, at 10 am EDT to discuss preliminary results from its Phase 1 dose-escalation study of its proprietary topical Endoxifen in male subjects. The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 24 healthy male subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of topical Endoxifen at varying dose levels over 28 days. The study was conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

To participate, investors may dial 1-844-824-3830 (domestic), 1-412-317-5140 (international) and Canada Toll Free: 1-855-669-9657. Callers should ask to be joined into the Atossa Genetics call. The conference call will also be available through a live webcast at https://services.choruscall.com/links/atos180913.html which is also available at www.atossagenetics.com 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 October 13, 2018. 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 access code is 10124008.

Atossa shares have spiked in early trading to a high of $2.30/share on ~1.33 million shares of trading. The day low is $1.81/share.

Atossa Genetics to Host Conference Call to Announce Preliminary Results from Male Phase 1 Study of Topical Endoxifen Thursday, September 13, 2018 at 10 am EDT

Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, will host a conference call on September 13, 2018 at 10 am EDT to discuss preliminary results from its Phase 1 dose-escalation..

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Listen to The Groundwork Forum Podcast Interview of Steven Quay CEO of Atossa Titled “What Is Gynecomastia?”

The Groundwork Forum Podcast aims to bring together leaders from all disciplines all over the world to join its Global Community to consider new perspectives on key issues; to create a powerful, global network in order to strengthen the influence throughout the world; to draw up innovative and concrete action plans to encourage contribution to society; and to promote diversity in the business world.

The most recent Groundwork Forum Podcast Episode features an interview with Atossa Genetics (ATOS) CEO Steven Quay MD, Ph.D. and is titled “What Is Gynecomastia?”  Up to 70 percent of boys in early to mid-puberty experience gynecomastia because of the normal hormonal changes that occur during puberty. Gynecomastia is also common among middle-aged and older men. In this population, up to 65 percent of men are affected.

Dr. Quay is the  Chief Executive Officer, President, and Chairman of the Board of Directors of Atossa Genetics (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  Dr. Quay is certified in Anatomic Pathology with the American Board of Pathology, completed both an internship and residency in anatomic pathology at Massachusetts General Hospital, a Harvard Medical School teaching hospital, and is a former faculty member of the Department of Pathology, Stanford University School of Medicine.  Dr. Quay is a named inventor on 87 U.S. patents, 130 pending U.S. patent applications, and is named inventor on patents covering five pharmaceutical products that have been approved by the U.S. Food and Drug Administration.  

To listen to the podcast, visit https://www.vistapglobal.com/groundwork-forum/.

Fans of the podcast can contact inquiries@vistapglobal.com via email or provide feedback and ideas for the podcast.

Based in San Francisco the Groundwork Forum is hosted by John Heerdink, Managing Director of Vista Partners LLC. The Groundwork Forum is released periodically and is available for free at https://www.vistapglobal.com/groundwork-forum/.

Founded in 2005, Vista Partners LLC (“Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, The Groundwork Forum Podcast and Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

We encourage readers to view a complete list of disclaimers and disclosures on the Vista Partners website at VistaPGlobal.com/disclaimer.

Please follow Vista Partners on Twitter @VistaPResearch to receive updates, thoughts, and ideas on Dow 30 Components, Select Emerging Growth Companies, Vista’s Featured Companies, International Companies, Pre-IPO Companies & Strategic Companies.

Contact:

inquiries@VistaPGlobal.com

 

 




Check out the Programmable Shape-shifting Metal

Scientists at the University of Sussex and Swansea University have created a programmable, shape-shifting metal. Sounds unreal? The unreal sounding breakthrough is very real! Scientists use electrical charges, apply to liquid metal, and coax it into 3D shapes. This new, extremely promising material can be programmed to alter its shape.

Electric fields are used to shape the liquid and the areas are created using a computer so both the position of the metal and it’s form can be manipulated dynamically.

Professor Sriram Subramanian, head of the INTERACT Lab at the University of Sussex stated, “Liquid metals are an extremely promising class of materials for deformable applications; their unique properties include voltage-controlled surface tension, high liquid-state conductivity and liquid-solid phase transition at room temperature. One of the long-term visions of us and many other researchers is to change the physical shape, appearance, and functionality of any object through digital control to create intelligent, dexterous and useful objects that exceed the functionality of any current display or robot.”

Engineers at Carnegie Mellon University have also created a new metal alloy by marrying indium and gallium. The metal alloy exists in a liquid state at room temperature and can capacitate liquid metal transistors, flexible circuitry, and hopefully self-repair circuits in the future.

These new molten metals, which are being referred to as “electronic blood”, have the potential to completely change computing to generations to come. IBM has also joined in the development of electric sustenance with is REPCOOL or Redox flow electrochemistry that is used for power delivery and cooling. The project is based on the structure and power supply of the brain where the blood capillary system cools and supplies energy to the organ. They believe that in using electronic blood, the same effect can be applied to overheated computers.

The first applications of Electronic Blood are expected to take place in 2030.

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Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

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Scientists Have Created Shape Shifting Liquid Metal That Can Be Programmed

..

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Listen to The Groundwork Forum Podcast Interview of Steven Quay CEO of Atossa Titled “What Is Intraductal Immuno-oncology & CAR-T Cell Therapy?”

The Groundwork Forum Podcast aims to bring together leaders from all disciplines all over the world to join its Global Community to consider new perspectives on key issues; to create a powerful, global network in order to strengthen the influence throughout the world; to draw up innovative and concrete action plans to encourage contribution to society; and to promote diversity in the business world.

The most recent Groundwork Forum Podcast Episode features an interview with Steven Quay MD, PhD and is titled “What Is Intraductal Immuno-oncology & CAR-T Cell Therapy?” 

Dr. Quay is the  Chief Executive Officer, President, and Chairman of the Board of Directors of Atossa Genetics (NasdaqCM: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.  Dr. Quay is certified in Anatomic Pathology with the American Board of Pathology, completed both an internship and residency in anatomic pathology at Massachusetts General Hospital, a Harvard Medical School teaching hospital, and is a former faculty member of the Department of Pathology, Stanford University School of Medicine.  Dr. Quay is a named inventor on 87 U.S. patents, 130 pending U.S. patent applications, and is named inventor on patents covering five pharmaceutical products that have been approved by the U.S. Food and Drug Administration.  

To listen to the podcast, visit https://www.vistapglobal.com/groundwork-forum/.

Fans of the podcast can contact inquiries@vistapglobal.com via email or provide feedback and ideas for the podcast.

Based in San Francisco the Groundwork Forum is hosted by John Heerdink, Managing Director of Vista Partners LLC. The Groundwork Forum is released periodically and is available for free at https://www.vistapglobal.com/groundwork-forum/.

Founded in 2005, Vista Partners LLC (“Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, The Groundwork Forum Podcast and Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.

We encourage readers to view a complete list of disclaimers and disclosures on the Vista Partners website at VistaPGlobal.com/disclaimer.

Please follow Vista Partners on Twitter @VistaPResearch to receive updates, thoughts, and ideas on Dow 30 Components, Select Emerging Growth Companies, Vista’s Featured Companies, International Companies, Pre-IPO Companies & Strategic Companies.

Contact:

inquiries@VistaPGlobal.com

 

 




Johnson & Johnson CEO to Participate in Wells Fargo 13th Annual Healthcare Conference

Dow 30 component Johnson & Johnson (JNJ) is a worldwide healthcare focused company that embraces research and science so that it can provide customers with innovative ideas, products, and services.

Alex Gorsky, the Chairman and Chief Executive Officer of Johnson & Johnson will participate in the 2018 Wells Fargo 13th Annual Healthcare Conference. The conference will be held Thursday, September 6th in Boston, MA at The Weston Boston Waterfront. Gorsky will represent Johnson & Johnson in a session set for 9:45 a.m. ET.

Group of People Sitting Near Table

For investors and those interested, a webcast will be available for access through the company’s website at . For those unable to tune in to the live webcast, a replay will be made available two hours after the live webcast.

To learn more about Johnson & Johnson (JNJ) and to continue to track its progress visit the Vista Partners Johnson & Johnson Coverage Page.

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Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.
Stay Informed! Stay Competitive!
Join us at Vista Partners! It’s FREE to receive email updates.

Johnson & Johnson to Participate in the 2018 Wells Fargo 13th Annual Healthcare Conference

NEW BRUNSWICK, N.J., Aug. 7, 2018 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) will participate in the 2018 Wells Fargo 13th Annual Healthcare Conference on Thursday, Sept. 6th, at The Westin Boston Waterfront in Boston, MA.  Alex Gorsky, Chairman and Chief Executive Officer will represent the Company in a session sched…..

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Breast Cancer Treatment Innovator Atossa Genetics Announces “A Productive First Six Months of 2018”

Seattle-based Atossa Genetics Inc. (ATOS) is  a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, announced their Q2 ended June 30, 2018, financial results and recent company developments which included the following:

  • August 2018 – Contracted with a US-based additional manufacturer of Endoxifen.
  • July 2018 – Announced intraductal microcatheter immunoOncology pre-clinical program.
  • July 2018 – Opened enrollment in phase 2 study of oral Endoxifen to treat breast cancer.
  • June 2018 – Opened phase 2 study of topical Endoxifen to treat mammographic breast density.
  • June 2018 – Completed all dosing and clinical visits in its phase 1 study of topical Endoxifen in men.
  • June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to the strategic advisory board.
  • May 2018 – Announced $13.4 million in gross proceeds from the rights offering.
  • May 2018 – Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim.
  • April 2018 – Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men.
    Q2 2018 Financial Results
  • For the three and six months ended June 30, 2018, and 2017, they had no revenue and no associated cost of revenue.
  • Total operating expenses were approximately $4.1 million and $6.0 million for the three and six months ended June 30, 2018, respectively, consisting of general and administrative (G&A) expenses of approximately $2.7 million and $4.1 million, respectively; and research and development (R&D) expenses of approximately $1.5 million and $1.9 million, respectively.
  • For the previous year, total operating expenses were approximately $1.9 million and $3.6 million for the three and six months ended June 30, 2017, respectively, consisting of G&A expense of approximately $1.1 million and $2.2 million, respectively, and R&D expenses of $0.8 million and $1.4 million, respectively.

Steve Quay, President, and CEO commented, “We have made tremendous progress with our clinical programs. We opened enrollment in two phase 2 clinical studies: one study using our proprietary topical Endoxifen for breast density reduction, and another study using our proprietary oral Endoxifen for reducing breast cancer tumor cell activity in the “window of opportunity” between diagnosis of breast cancer and surgery. We also completed dosing and patient visits in our phase 1 study of topical Endoxifen in men. Our intraductal microcatheter immunoOncology pre-clinical program was launched and we contracted with an additional manufacturer for Endoxifen. We have had a very busy and productive first six months of 2018 as we continue the momentum in the advancement of our clinical programs. We are looking forward to announcing preliminary results from our phase 1 study of topical Endoxifen in men by September 30, 2018.”

 

 

 

 

 

 

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report recently and maintained his “Buy rating” and his $10/price target.

 

 

 

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To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Announces Second Quarter 2018 Financial Results And Provides Company Update

SEATTLE, Aug. 13, 2018– Atossa Genetics Inc., a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced …..

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Breast Cancer Innovator Atossa Genetics Has Added Alchem Laboratories As Second Manufacturer to Supply “Increasing Need” Of Endoxifen

Seattle-based Atossa Genetics Inc. (NASDAQ: ATOS) a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, announced this week that is has added Alchem Laboratories as a U.S. contract manufacturer to supply Endoxifen. Subject to successful bioequivalence and other testing, the material will be used to produce both oral and topical drug product presentations.

Alchem Laboratories is located in Gainesville, Florida. It has supplied APIs for 16 active clinical studies, 13 of which were led by the National Cancer Institute (NCI) and that Alchem has been supporting through multiple R&D contracts for over fifteen years. In 2018, Alchem added oral and injectable products to its topical product manufacturing capabilities in its GMP clinical manufacturing facility expansion.

Alchem provides qualified infrastructure and trained personnel for all stages of drug development including design and synthesis of novel compounds, synthesis of analogs of lead compounds, process development and optimization, analytical method development and validation, stability studies for drugs and intermediates, cGMP manufacturing of APIs and products for clinical studies, and documentation for all stages of drug development. Its partners and collaborators include the NCI, part of the National Institutes of Health (NIH), the National Institute of Standards and Technology (NIST), the U.S. Army Medical Research Acquisition Activity (USAMRAA), the U.S. Department of Agriculture (USDA), the Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (ICP), Gemphire Therapeutics, Inc., Cerenis Therapeutics Holding SA, Brickell Biotech, Inc., FLUCEL LLC, Nanopharmaceutics, MRIGlobal, Pace Analytical Labs, Southern Research, and the University of Florida UF|INNOVATE – Sid Martin Biotech.

Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa. stated, “Our needs for the ongoing clinical supply of Endoxifen are dramatically increasing as we advance our clinical studies. As a second Endoxifen manufacturer, Alchem will begin supplying Endoxifen for one or more of our studies slated for later this year. They will be an excellent partner, with their experience and capabilities, to ensure we are poised to move our development programs forward quickly, particularly in the U.S.”

Here is a list of Atossa’s clinical programs that are using its proprietary Endoxifen include:

  • Phase 2 study to determine if oral Endoxifen reduces tumor activity in early stage breast cancer patients in the “window of opportunity” between diagnosis of breast cancer and surgery (now open for enrollment in Australia)
  • Phase 2 study to determine if topical Endoxifen reduces mammographic breast density (now open for enrollment in Sweden)
  • Phase 1 study of topical Endoxifen in men (enrollment and dosing complete; results to be announced this quarter)
  • Phase 2 study of topical Endoxifen to treat gynecomastia in men being treated for prostate cancer (study targeted to open in Q4 2018)
  • Phase 2 study of oral Endoxifen for patients who are “refractory” to Tamoxifen (study targeted to open in 2H 2018)

Analyst Update

Maxim Group’s Biotechnology Analyst Jason McCarthy issued an update report recently and maintained his “Buy rating” and his $10/price target.

Learn More

To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.

Atossa Genetics Contracts with Additional Manufacturer of Endoxifen

Atossa Genetics Inc. (ATOS) (“Atossa” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced that is has added Alchem Laboratories as a U.S. contract manufacturer to supply Endoxifen..

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Discover Why Short-Term Health Insurance Provider HIIQ’s Shares Have Risen To New All-Time Highs This Week

Tampa-based Health Insurance Innovations, Inc. (NasdaqGM: HIIQ), a leading cloud-based technology platform and distributor of affordable individual and family health insurance and supplemental plans, has seen its shares rise to all-time new highs this week. The 52-week range is now $12.65/sh to $44.40/sh and Thursday, August 2, 2018’s close was $44.15/share up +16.03%. We have been covering (see our coverage page) HIIQ since the early part of 2016 when the company was trading the $3-$4/share range. It has been an amazing ride so far.

This week’s move seems to be squarely on the backs of a much-anticipated final ruling that is restoring the maximum duration of Short-Term, Limited-Duration Insurance (STLDI) from 3 months to less than 12 months from the original effective date, with the ability to be renewed or extended for a maximum duration of up to 36 months in total. In addition,  HIIQ announced its financial results for the second quarter ended June 30, 2018 on August 2nd which beat street estimates and saw the company increase its annual guidance.

Note that Cantor Fitzgerald Analyst Steven Harper Maintained his Overweight rating and $60 target on HIIQ shares this week.

Mr. Gavin Southwell, Chief Executive Officer and President of HIIQ stated, “HIIQ shares the Departments’ concern with respect to the rising cost of health insurance in the individual market and welcomes any measures taken to improve the availability of insurance products that meet consumer demands and needs. We also believe that this rule change will improve consumer choice and increase competition and affordability in the individual health insurance market. As result of this final rule, STLDI plans can help decrease the number of currently uninsured Americans while increasing choice and competition in the individual market.  We believe these plans make available more coverage options and broader access to providers than current individual ACA health insurance coverage has. In addition, while we continue to analyze the business impacts of this final rule, we expect the expanded market for STLDI plans to yield significant upside in our business including an overall increase in sales and policies in force driven in part by the enhanced persistence of members associated with longer plan durations.”

STLDI plans overview

STLDI plans have lower deductibles on average than exchange plans and are paired with very broad PPO networks. A key feature of typical STLDI plans is that plan benefits are paid for covered expenses incurred from any provider in the U.S. and there is no referral required if a member would like to see a specialist. Members have the added benefit of receiving discounted network rates if they choose to use an in-network provider. In addition to the valuable benefits and broad provider networks, STLDI plans are considerably more affordable than ACA-compliant exchange plans.

HIIQ believes that the April 2017, three-month rule implementation decreased the availability of health benefits for consumers even as the cost of insurance for these same consumers increased.  For example, HIIQ’s analysis of plans available for plan year 2018 on the federal exchange found that a family of three with parents age 40, earning the average U.S. household income, would not be able to find an affordable Bronze or Silver plan anywhere in the United States. Looking ahead to plan year 2019, available preliminary rate filings show that benchmark plan premiums will increase by double-digit percentages in many states, with premiums in certain states increasing as much as 36% year over year. Consumers who are ineligible for subsidies are hit hardest by premium increases each year, which has caused unsubsidized enrollment to decrease at an alarming rate. In 2017, unsubsidized enrollment decreased by 20% nationally. Additionally, six state markets experienced a drop in unsubsidized enrollment of more than 40% in 2017.

Second quarter 2018 Financial Highlights

  • Record revenue was $71.7 million, compared to $61.8 million in the second quarter of 2017, an increase of 16.0%.
  • Record total collections from members (premium equivalents) of $111.2 million compared to $98.9 million in the second quarter of 2017, an increase of 12.4%.
  • Net income was $4.0 million, compared to $7.0 million in the second quarter of 2017, a decrease of 42.9%. Drivers include severance expense payable to the founder and several other employees and higher stock-based compensation in the second quarter of 2018.
    Record adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) was $14.2 million, compared to $12.6 million in the second quarter of 2017, an increase of 12.7%.
    GAAP diluted earnings per share was $0.22, compared to $0.35 in the second quarter of 2017, down 37.1% YOY. Drivers include severance expense payable to the founder and several other employees and higher stock-based compensation in the second quarter of 2018.
  • Record adjusted earnings per share, also referred to as adjusted net income per share, or adjusted EPS, was $0.61 compared to $0.46 in the second quarter of 2017, an increase of 32.6%.
  • Record policies in force as of June 30, 2018, totaled approximately 389,600, compared to 359,500 in the second quarter of 2017, an increase of 8.4%.
  • Premium equivalents, adjusted EBITDA, and adjusted EPS are non-GAAP financial measures. See the reconciliations of these measures to their respective most directly comparable GAAP measure included within this press release.
  • Second quarter revenues of $71.7 million increased 16.0%, compared to the second quarter in 2017, driven by an increase in policies in force, favorable commission margins, and improved discount benefit plan offerings.
  • Total selling, general & administrative expense (“SG&A”) was $19.7 million (27.5% of revenues) in the second quarter of 2018, compared to $14.7 million (23.8% of revenues) in the same period in 2017. Q2 SG&A included cash based severance expense of $3.0 million and $0.8 million of non-cash based severance expense primarily related to the termination of the Company’s founder and several other employees. Core SG&A, defined as total SG&A adjusted for stock-based compensation, transaction costs, indemnity and other related legal costs, severance, restructuring and other costs, and marketing leads and advertising expense, was $10.2 million (14.2% of revenues) in the second quarter of 2018, compared to $11.1 million (18.0% of revenues) in the same period in 2017. A reconciliation of Core SG&A to SG&A is included within this press release.
  • Net income was $4.0 million in the second quarter of 2018, compared to $7.0 million in the same period in 2017, a decrease of 42.9%. Second quarter 2018 included a cash-based severance expense of $3.0 million. Additionally, stock-based compensation was $2.6 million higher in the second quarter of 2018 as compared to the prior year period. EBITDA was $6.7 million in the second quarter of 2018, compared to $10.7 million in the same period in 2017, a decrease of 37.4%.
  • Adjusted EBITDA was $14.2 million in the second quarter of 2018, an increase of 12.7% compared to $12.6 million in the same period in 2017. Adjusted EBITDA as a percentage of revenue was 19.8% in the second quarter of 2018, compared to 20.3% in the same period in 2017. Adjusted EBITDA is calculated by taking EBITDA and adjusting for items such as stock-based compensation and related costs and items that are not part of regular operating activities, including indemnity and other related legal costs, severance, restructuring, and acquisition costs. A reconciliation of net income to EBITDA and adjusted EBITDA for the three and six months ended June 30, 2018, and 2017 is included within this press release.
  • GAAP diluted EPS for the second quarter of 2018 was $0.22, compared to $0.35 in the same period in 2017. Second quarter 2018 GAAP diluted EPS was unfavorably impacted by the previously described severance expense. Additionally, the higher stock-based compensation in the second quarter of 2018 had an unfavorable impact on GAAP diluted EPS.
  • Adjusted EPS for the second quarter of 2018 was $0.61, compared to $0.46 in 2017. The increase in Adjusted EPS was driven by higher revenue from greater policies in force, continued scalability as well as a lower pro-forma statutory tax rate of 24%, compared to 38% used in the prior period. A reconciliation of net income to adjusted net income per share is included within this press release.
  • The Company makes advances to distributors based on actual sales. These advanced commissions assist distributors with working capital. The Company recovers advances on an ongoing basis from future commissions on premiums, which are collected over the period in which policies renew. At June 30, 2018, the short- and long-term advanced commission balance was $37.6 million, a $1.9 million decrease from the December 31, 2017, year-end balance of $39.5 million.
  • Cash and cash equivalents as of June 30, 2018, totaled $49.2 million, an increase of $8.3 million from the December 31, 2017, year-end balance. The Company repurchased 115,245 shares of its common stock in the second quarter of 2018 for $3.8 million as part of its previously announced share repurchase program. The company expects to continue to execute on its buyback authorization for the remainder of 2018 and beyond. On June 7, 2018, the Company terminated without cause Michael Kosloske, founder and Chief of Product Innovation. Mr. Kosloske will continue to serve as a director of the Company. Additionally, on June 7, 2018, the Company was informed by Mr. Kosloske that entities controlled by Mr. Kosloske sold an aggregate of 1,300,000 shares of the Company’s Class A common stock.

 

 

 

 

 

2018 Full Year Guidance

The Company raised its annual guidance of revenue for 2018 to be between $293 million and $303 million or grow approximately 17% to 21% year-over-year, adjusted EBITDA to be between $55 million and $58 million or grow approximately 21% to 27% year-over-year, and adjusted EPS to be between $2.47 and $2.57 or grow approximately 50% to 56% year-over-year. These guidance numbers are based on the Company’s current method of accounting for revenue. As an emerging growth company, it will be adopting the revised revenue recognition standard, known as ASC 606, in the fourth quarter of 2018 for the full year ended December 31, 2018.

Gavin Southwell, HIIQ’s Chief Executive Officer and President stated, “Q2 was a strong quarter with record revenue, record earnings and record policies in force. We are pleased to have beaten market expectations and following a strong first half of the year, to be able to raise guidance for the rest of 2018. We look forward to launching the next generation of our technology platform later in the year and we are prepared for the expanding opportunities in our market.”Second quarter 2018 Financial Discussion

Regulatory Update

The departments of Health and Human Services, Labor and the Treasury issued a final rule to help Americans struggling to afford health coverage find new and more affordable options. The rule allows, starting October 1st, 2018, for the sale and renewal of short-term, limited duration plans to cover an initial period of less than 12 months. Additionally, carriers will be able to make these plans renewable for up to 36 months. Previously, the rule limited duration to less than three months. “HIIQ shares the Departments’ concern with respect to the rising cost of health insurance in the individual market and welcomes any measures taken to improve the availability of insurance products that meet consumer demands and needs,” Mr. Gavin Southwell said. “We also believe that this rule change will improve consumer choice and increase competition and affordability in the individual health insurance market.”

As previously disclosed, the Company is the subject of a multistate market conduct examination. The Company has been cooperating with all regulatory inquiries and is engaged in ongoing discussions towards resolution.

Conference Call and Webcast

The Company hosted an earnings conference call on August 2, 2018, at 8:30 A.M. Eastern time.  A webcast of the call may be accessed in the Investor Relations section of Health Insurance Innovations’ website at http://investor.hiiquote.com/events-and-presentations. An archive of the call will be available for 30 days through the same website.

To learn more about HIIQ and to track its ongoing progress please visit the Vista Partners HIIQ Coverage Page.

Vista Partners LLC (”Vista”) is a California Registered Investment Advisor based in San Francisco. Vista delivers timely and relevant insights via the website: www.vistapglobal.com with daily stories, weekly market updates, monthly macroeconomic newsletters, podcasts, & Vista’s proprietary equity and market research to help you stay informed and stay competitive. Vista’s mission is to invest partner capital while arming investors with a comprehensive global financial perspective across all market sectors. Vista also seeks to provide select issuers with actionable advice regarding fundamental development, corporate governance, and capital market directives.
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Health Insurance Innovations, Inc. Reports Second Quarter 2018 Financial and Operating Results

Raises Annual Guidance Record Revenues of $71.7 million, up 16.0% YOY Record Policies in Force totaled approximately 389,600, up 8.4% YOY GAAP Diluted Earnings per Share of $0.22, down 37.1% YOY Record …..

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