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Initiated as "BUY".
6/27/2018 Nomura Initiated Coverage Buy $160.00 Medium
IBM
Agree. Mad at myself because 2 days ago had my sell price @ $16.45 when it went to $16.35. A sale at $16.35 would have been great. Since bought a few more shares and have a sell @ $16.30. Its candles have a lot of long wicks at the top, so it does like to run up, but then drops steadily.
Today it is following the $LABU so nothing out of ordinary that I can see:
DVAX
We're not alone, pretty much all bios are down again. Was hoping that some investors might rotate to the sector after the recent losses but not so. Maybe due to the Amazon Pillpac purchase?
DVAX
Impressive board. Good for the long run; hope it helps the short run:
________________________________________________________________
Dynavax Appoints Scientific Advisory Board to Support its Oncology and Vaccine Programs
Board Comprises Six Members with Notable Contributions to the Fields of Oncology and Immunology
June 28, 2018 06:30 ET | Source: Dynavax Technologies Corporation
BERKELEY, Calif., June 28, 2018 (GLOBE NEWSWIRE) --
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced the formation of a six-member Scientific Advisory Board with significant experience in research, development, and commercialization in the fields of oncology and immunology.
Scientific Advisory Board Members
Dennis Carson, M.D. - Director Emeritus, UC San Diego Moores Cancer Center; Professor Emeritus of Medicine, Division of Rheumatology, Allergy, and Immunology
Laura Q.M. Chow, M.D. - Professor of Medicine in the Division of Medical Oncology at the University of Washington
Miriam Merad, M.D., Ph.D. - Mount Sinai Chair professor in Cancer Immunology and the Director of the Precision Immunology Institute at Mount Sinai School of Medicine in New York
Drew M. Pardoll, M.D., Ph.D. - Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at the Johns Hopkins University, School of Medicine
Stanley A. Plotkin, M.D. - Emeritus Professor of the University of Pennsylvania and Adjunct Professor of the Johns Hopkins University
E. John Wherry, Ph.D. - Chair of the Department of Systems Pharmacology and Translational Therapeutics (beginning July 1, 2018), and the Richard and Barbara Schiffrin President's Distinguished Professor of Microbiology in the Perelman School of Medicine and Director of the UPenn Institute for Immunology
“We are excited to have assembled a Scientific Advisory Board with such great expertise,” said Robert L. Coffman, Ph.D., chief scientific officer of Dynavax. “These six individuals have all made significant contributions in oncology and immunology, including discoveries that have proven to be transformative to immuno-oncology and vaccine development. As we expand our oncology platform and explore new vaccine opportunities, this board will be an invaluable resource for Dynavax.”
Dennis Carson, M.D.
Dr. Carson is currently a member of the Board of Directors at Dynavax. He was at the Scripps Clinic for 14 years, where he advanced to become head of the clinical immunology division. While at Scripps, he developed the drug cladribine for the effective treatment of hairy cell leukemia, as well as two approved clinical diagnostic agents. Dr. Carson directed the Stein Institute for Research on Aging for thirteen years, and then the Moores Cancer Center for eight years. During this period, he also co-founded several biotechnology companies focused on vaccines and oncology which successfully developed new drugs, based upon patents from his research laboratory in the fields of DNA immunization, nucleoside analogs, and Wnt signaling. He received his M.D. from Columbia University and his B.A. from Haverford College. Dr. Carson completed his residency in internal medicine and a postdoctoral fellowship at the University of California, San Diego.
Laura Q.M. Chow, M.D.
Dr. Chow serves as the Associate Director of the Phase I Developmental Therapeutics Program and as an Attending Medical Oncologist at the Seattle Cancer Care Alliance. She has been at the University of Washington since 2010 and has been recently promoted to full Professor and is currently an Associate Member of Clinical Research at the Fred Hutchinson Cancer Research Center. Her clinical expertise is in head and neck cancers (including thyroid cancer), and lung cancers with a research focus on immunotherapy, novel therapeutics and early phase clinical trials. She has run, as the principal investigator, more than 35 clinical trials in both the phase I and thoracic head and neck cancer programs and has published close to 70 peer-reviewed publications. She teaches and presents nationally and internationally on immune-checkpoint inhibitors in lung cancer and head and neck cancers, immuno-oncology drug development and clinical trial design. Dr. Chow earned her M.D. at the University of British Columbia.
Miriam Merad, M.D., Ph.D.
Dr. Merad began at Mount Sinai in 2004, and was promoted to the rank of Associate Professor with Tenure in 2007 and to Full Professor in 2010. In 2014, she obtained an Endowed Chair in Cancer Immunology. Dr. Merad’s laboratory studies the contribution of macrophages and dendritic cells to cancer and inflammatory disease in mice and humans. Dr. Merad’s pioneering work mapping the regulatory network of dendritic cells (DCs) resulted in identification of a lineage of DC, the CD103+ DC, that is now considered a key target to improve antiviral and antitumor immunity. These insights, along with other significant discoveries, are now being used to develop novel macrophage and dendritic cell-specific targets for the treatment of cancer and inflammatory diseases. She has authored more than 160 primary papers and reviews in high profile journals. Dr. Merad receives funding from the National Institutes of Health (NIH) for her research on innate immunity and their contribution to human disease. Dr. Merad obtained her MD at the University of Algiers, Algeria. She did her residency in Hematology and Oncology in Paris, France and obtained her PhD in immunology in collaboration between Stanford University and University of Paris VII.
Drew M. Pardoll, M.D., Ph.D.
Dr. Pardoll is the Director of the Bloomberg~Kimmel Institute for Cancer Immunotherapy and Director of the Cancer Immunology Program at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. He joined the departments of oncology and medicine at Johns Hopkins University in 1988. Dr. Pardoll has published over 300 papers as well as over 20 book chapters on the subject of T cell immunology and cancer vaccines. He has served on the editorial board of the Journal of the National Cancer Institute and Cancer Cell, and has served as a member of scientific advisory boards for the Cancer Research Institute, the University of Pennsylvania Human Gene Therapy Gene Institute, the Biologic Resources Branch of the National Cancer Institute, the Harvard-Dana Farber Cancer Center, the American Association of Clinical Oncology and the American Association of Cancer Research, along with several successful biotech companies. He has made a number of advances in Cellular Immunology, including the discovery of gamma - delta T cells, NKT cells and interferon-producing killer dendritic cells. Over the past two decades, Dr. Pardoll has studied molecular aspects of dendritic cell biology and immune regulation, particularly related to mechanisms by which cancer cells evade elimination by the immune system. He is an inventor of a number of immunotherapies, including GVAX cancer vaccines and Listeria monocytogenes based cancer vaccines. Dr. Pardoll discovered one of the two ligands for the PD-1 inhibitory receptor and leads the Hopkins cancer immunology program that developed PD-1 pathway-targeted antibodies, demonstrating their clinical activity in multiple cancer types. Dr. Pardoll attended Johns Hopkins University where he earned his M.D., Ph.D., in 1982 and completed his Medical Residency and Oncology Fellowship in 1985.
Stanley A. Plotkin, M.D.
Prior to his current roles, Dr. Plotkin was Professor of Pediatrics and Microbiology at UPenn and Professor of Virology at the Wistar Institute, while also serving as Director of Infectious Diseases and Senior Physician at the Children’s Hospital of Philadelphia. He also served as a member of the Board of Directors at Dynavax until March 2018. In 1991, Dr. Plotkin left the University to join the vaccine manufacturer, Pasteur-Mérieux-Connaught (now called Sanofi Pasteur), where he served as Medical and Scientific Director. He has been chairman of the Infectious Diseases Committee and the AIDS Task Force of the American Academy of Pediatrics, liaison member of the Advisory Committee on Immunization Practices and Chairman of the Microbiology and Infectious Diseases Research Committee of the National Institutes of Health. He developed the rubella vaccine now in standard use, is co-developer of a rotavirus vaccine and has worked extensively on the development and application of other vaccines including polio, rabies, varicella, and cytomegalovirus. He earned his bachelor's degree from New York University and his MD at SUNY Downstate Medical Center. He received his GME from the School of Medicine, University of Pennsylvania.
E. John Wherry, Ph.D.
Dr. Wherry was appointed Assistant Professor in 2005 in the Immunology Program at The Wistar Institute and then joined the Department of Microbiology in the University of Pennsylvania’s Perelman School of Medicine in 2010. Dr. Wherry’s research has focused on pioneering work to define the cellular and molecular nature of Immune Exhaustion - or failure of normal immune system function – in chronic infection and cancer. His work helped identify the role of the “checkpoint” molecule PD-1 and the ability to block this pathway and reinvigorate the immune function from exhausted T cells. He also has identified novel combinations of immune treatments including one of the first to demonstrate the efficacy of co-inhibitory receptor blockade that may be future therapeutics for cancer and infections. Dr. Wherry received his Ph.D. at Thomas Jefferson University in 2000 then did postdoctoral research at Emory University from 2000-2004.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], was approved by the United States Food and Drug Administration in November 2017 for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.
US-18-01-00127
Contact:
David Burke
Director, IR & Corporate Communications
510.665.7269
dburke@dynavax.com
Media Contact:
Rachel St. Martin
W2O wcg
646.894.5757
rstmartin@w2ogroup.com
_______________________________________________
DVAX
I have no idea. See no news and see no tweets suggestive of news. It has a high Beta suggesting high volatility so assuming it is just an early take down, but it should be recovering. Bought more @ $2.40.
Suppose some holders are just getting tired of the decline and selling.
Don't know the company well but have watched it a month or so. You know it?
CHFS
FWIW, I was sitting on the bid of $2.50 for 400 shares yesterday and did not get filled. MMs sold @ $2.5001. I will never understand how they work. Seems logical they would want to sell 400 shares while the pps was that low . Thankfully they sold shares at the ask at the EOD allowing for a nice recovery.
SNOA
Dynavax Presents Analysis of Data for Participants Aged 60 to 70 with Diabetes from its Phase 3 Trial of HEPLISAV-B®
By GlobeNewswire, June 25, 2018, 12:05:00 PM EDT
In a Post-Hoc Analysis of Elderly Diabetic Patients, HEPLISAV-B was Well-Tolerated and Induced Higher Rates of Seroprotection than Engerix-B
Data Presented at 2018 American Diabetes Association Annual Meeting
BERKELEY, Calif., June 25, 2018 (GLOBE NEWSWIRE) --
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced results of a post hoc analysis of data from HBV 23, the pivotal Phase 3 trial of its hepatitis B vaccine HEPLISAV-B® [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. HBV 23 was a randomized, observer-blinded, active-controlled, multi-center study that compared two doses of HEPLISAV-B over four weeks with three doses of Engerix-B® [Hepatitis B Vaccine (Recombinant)] over 24 weeks in 8,374 adults age 18 to 70. This post hoc analysis evaluated data from the trial for participants with type 2 diabetes aged 60 to 70. These data were presented at the 2018 American Diabetes Association (ADA) Annual Meeting in Orlando, FL on Monday, June 25 at 12:00pm ET.
Highlights from Poster Presentation
• In the per protocol (PP) analysis, the seroprotection rate at week 28 for HEPLISAV-B (n=274) was 85.8% compared to 58.5% for Engerix-B (n=130), a treatment difference of 27.3% (95% CI: 18.0% - 36.8%)
• HEPLISAV-B induced higher geometric mean concentration (GMCs) (137.3 mIU/mL) in the per-protocol analysis at week 24 than Engerix-B at week 28, with a GMC ratio of 2.7 (95%, [CI: 1.6 - 4.4])
• HEPLISAV-B had a similar safety profile compared to Engerix-B, regardless of study subgroup, which included smoking status, body mass index and sex
In the HEPLISAV-B group, 64.2% of the participants reported a medically attended adverse event (MAE), of those 23.5% experienced a grade 3 or 4 MAE; in the Engerix-B group 55.6% of participants experienced MAEs, of those 22.2% reported a grade 3 or 4 MAE
"These data in elderly diabetic patients show the benefit of HEPLISAV-B in a population that is more difficult to protect and, when infected, typically demonstrates a more severe hepatitis B disease," said Dr. Rob Janssen, chief medical officer of Dynavax. "We believe there is a great opportunity for Dynavax to contribute to the overall health of the adult population with diabetes."
The post hoc analysis consisted of participants from the randomized study that received either two doses of HEPLISAV-B (n=327) or three doses of Engerix-B (n=153). HEPLISAV-B was administered at 0 and 4 weeks, followed by placebo at 24 weeks to maintain blinding. Engerix-B was injected at 0, 4, and 24 weeks. Both vaccines were administered intramuscularly into the deltoid muscle.
The phase 3 trial included a total of 961 participants with type 2 diabetes aged 18 to 70. The primary endpoint for this subgroup compared the seroprotection rate at Week 28 for HEPLISAV-B (n= 640) with that at Week 28 for Engerix-B (n= 321). This analysis showed that HEPLISAV-B resulted in a 90.0% seroprotection rate compared to a 65.1% seroprotection rate from Engerix-B.
About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
For more information about HEPLISAV-B, visit http://heplisavb.com/.
Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.
Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).
For full Prescribing Information for HEPLISAV-B, click here.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company's first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the United States. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the commercial launch of HEPLISAV-B. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, including whether the company will be able to continue building the commercial infrastructure required to successfully launch HEPLISAV-B; whether payers will provide timely reimbursement for HEPLISAV-B; whether prescribers and other key decision-makers will switch to HEPLISAV-B; and whether potential claims against us, including those based on patent rights of others, will result in an injunction against sales or otherwise impact commercialization and sales. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Dynavax in general, see risks detailed in the "Risk Factors" section of our most recent current periodic report filed with the SEC. These statements represent our estimates and assumptions only as of the date of this press release. We do not undertake any obligation to update publicly any such forward-looking statements, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
Engerix-B is a registered trademark of the GSK group of companies.
US-18-01-00128
Contact:
Ryan Spencer
VP, Corporate Strategy & Communications
510.665.4618
rspencer@dynavax.com Media Contact:
Rachel St. Martin
W2O wcg
646.894.5757
rstmartin@w2ogroup.com
Source: Dynavax Technologies Corporation
_________________________________________
DVAX
Back in @ $62 and $63. Still not low enough with the biotech self-off continuing (LABU is down 9%).
BPMC
Happy hour gives me a chance to express my appreciation of your great work on this board. Look at it numerous times a day just like a news feed. Keep up the work and thanks.
Thinking may be time to get in. Not sure of short term but worth holding. Bid @ $15.80.
You in?
CORN
Two days of low volume and down over-all market and the chart set-up is now gone.
CHFS
Was watching the last dip, but never bought. 11 straight green candles is amazing. Cheers to you. I could never hold that long without taking profits.
Almost a double since last September -- real stong stock. Gotta buy the next dip.
PSTG
It went to $2.98 AH. See that it is now at all time lows. Didn't realize that it traded near $30 in early 2014. I've been trading it only the past year. Been a good trade if willing to sit on low bid for a time and then sit on a high ask again for some days.
Feel sorry for Dan Ward who supposedly had heavy positions in SNOA and SNOAW.
You trading it? Seems like next catalyst is a new Brazilian agreement on the other products.
SNOA
Out @ $3.99. Didn't want to hold for earnings after hours and $4.00 has been a strong resistance for several months.
SNOA
Out @ $73.60. May buy back if it dips, but was sitting on ask to preserve profits.
BPMC
Out for now @ $147.40. Look to re-enter again -- seems to be moving to over-bought. Great news about developing the world's fastest computer last week.
IBM
In at $68.50. Catalyst next week.
Analyst favorite:
Consensus Rating: Buy
Consensus Rating Score: 3.00
Ratings Breakdown:
0 Sell Rating(s)
0 Hold Rating(s)
10 Buy Rating(s)
0 Strong Buy Rating(s)
Consensus Price Target: $87.1111
Price Target Upside: 22.55% upside
____________________________________________
https://www.marketbeat.com/stocks/NASDAQ/BPMC/
BPMC
Back in @ $15.50. Sat on the bid for a long time, but once it broke it has become a big resistance.
Lot of chatter on another board about institutional manipulation regarding keeping the pps down or maybe driving it down to $14 hoping for a buyout.
DVAX
Out @ $6.45 for now. Met short term trading goal. Look to re-enter.
TENX
Daniel Ward, CFA Retweeted
MacWilkins
?
@MACDcurlingup
15h15 hours ago
More
$SNOA Brazil Summary - VERY BULLISH.... 1st year min. order already exceeded. Contract is for only 3 of 7 approved Brazil products. 4k - 6k dermatologist in http://U.SK portfolio with 70 reps. All pushing $SNOA as priority. "Deal speeds up timeline to profitability."
Daniel Ward, CFA Retweeted
SNOA
Don't know much about management, but was frustrating day to watch. No volume the 1st half of day, but when volume came was always someone selling. Don't believe there is a large short position here.
Not going to marry it as had an ask in all day.
Good luck with it.
CHFS
Out @ $16.40. Probably too focused on the $16.40 missed yesterday.
Sold before the upgrade:
AnalystRatingsNetwork Jun. 5 at 1:05 PM
Dynavax Technologies given $27.00 PT by Cantor Fitzgerald. buy rating. http://www.marketbeat.com/r/1033738 $DVAX · Reply
Back on the next dip.
DVAX
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) June 4, 2018
SONOMA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-33216 68-0423298
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
1129 N. McDowell Blvd.
Petaluma, CA 94954
(Address of principal executive offices)
(Zip Code)
(707) 283-0550
(Registrant’s telephone number, including area code)
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 ( see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 1.01 Entry into a Material Definitive Agreement.
On June 4, 2018, we entered into a 5-year exclusive license and distribution agreement with EMS S.A., headquartered in Sao Paulo, Brazil. Pursuant to the license and distribution agreement with EMS, we granted EMS the exclusive right to purchase, import, distribute, sell and promote certain of our dermatology products within Brazil for a period of five years, with the possibility of renewal. We also agreed to assign our trademarks filed or registered in Brazil to EMS on a royalty-free basis for the purpose of marketing, distributing, and selling our products in Brazil. EMS agreed to minimum annual purchase amounts of $100,000 in year one; $250,000 in year two; $500,000 in year three; $750,000 in year four; and $1,000,000 in year five, respectively.
This report does not constitute an offer to sell or the solicitation of an offer to buy, and these securities cannot be sold in any state or jurisdiction in which this offer, solicitation, or sale would unlawful prior to registration or qualification under the securities laws of any state or jurisdiction. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
This report contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements related to our future activities, our planned spin-off, or future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performances and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including those risks discussed in our Annual Report on Form 10-K and in other documents that we file from time to time with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this report, except as required by law.
The foregoing description of the exclusive license and distribution agreement is qualified in its entirety by reference to the full text of the exclusive license and distribution agreement, which is attached to this Current Report on Form 8-K as Exhibit 10.1, with confidential information redacted, and incorporated herein by reference in its entirety.
Item 9.01 Financial Statements and Exhibits.
10.1† Exclusive License and Distribution Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and EMS S.A. dated June 4, 2018.
† Confidential treatment is being sought for portions of this agreement.
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.
Sonoma Pharmaceuticals, Inc.
(Registrant)
Date: June 5, 2018 By: /s/ Robert Miller
Name:
Title:
Robert Miller
Chief Financial Officer
2
Exhibit 10.1
EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT
This Agreement is made and entered into as of June 4, 2018 (hereinafter the “Effective date”) by and between:
Sonoma Pharmaceuticals, Inc ., a company incorporated and existing under the laws of the State of Delaware, USA, having its registered offices at 1129 North McDowell Boulevard, Petaluma, California, 94954, United States of America, hereby represented by its legal representatives
hereinafter referred to as « SONOMA », on the one hand
and
EMS S.A., a private corporation duly incorporated and existing under the laws of the Federative Republic of Brazil, with head office located at Rodovia Jornalista Francisco Aguirre Proença, KM 08, Bairro Chácara Assay, CEP 13186-901 Hortolândia, São Paulo – Brazil, enrolled with CNPJ/MF under number 57.507.378/0003-65, hereby represented by its legal representatives
hereinafter referred to as « EMS », on the other hand.
SONOMA and EMS are herein individually referred to as a “ Party ” and collectively referred to as “Parties”.
WHEREAS :
A. SONOMA manufactures, through its wholly-owned subsidiary, Oculus Technologies of Mexico, S.A. de C.V. the product described in Schedule 4 hereto (hereinafter referred to as the “ Product ”) and currently holds all rights to the Product, including in particular in the country listed in Schedule 2 hereto (hereinafter referred to as the “T erritory ”).
B. SONOMA currently markets the Product internationally, but outside of Brazil, and has obtained marketing authorizations for the Product in various countries.
C. EMS wishes that SONOMA grant to EMS the exclusive right to purchase, import, distribute, sell and promote the Products in the Territory under its own Trademark (as defined in Article 1.1(xiv) of the Agreement).
D. In order to enable EMS to Market and Distribute the Product in the Territory, SONOMA has obtained from the competent Governmental Authorities in the Territory all Regulatory Approvals which are required under local Laws to Market and Distribute the Product.
E. The Parties may discuss the possibility that EMS comes to register the Product by itself and obtain the Regulatory Approvals in its own name to Market and Distribute the Product in the Territory under certain circumstances described in this Agreement.
F. EMS has all suitable resources and shall hold all necessary administrative permits to register, import, handle, store, sell, distribute and promote the Product in the Territory.
G. On December 19, 2017, EMS S/A and SONOMA entered into a non-binding Term Sheet (the “ Term Sheet ”) for the negotiation of EMS S/A as SONOMA´s exclusive licensee and distributor of the Product in the Territory, pursuant to this Agreement, when signed;
Agreement Sonoma - EMS Page 1 / 28
H. EMS wishes to appoint its Affiliate Luxbiotech Farmacêutica Ltda. to Market and Distribute the Product under such Affiliate’s trade name Underskin or USK and SONOMA agrees with such appointment.
Now, therefore, in consideration of the above and the mutual promises set forth below, SONOMA and EMS agree as follows:
CONTINUES
SNOA
Their new 8-K contains the poster and the analyst presentations slides:
https://ih.advfn.com/p.php?pid=nmona&article=77594222
Lot of info, far more than I'll understand.
DVAX
In @ $2.75. 1st time trading.
Seems to have solid financials (Cash, Book and Current/Quick ratios:
https://finviz.com/quote.ashx?t=CHFS&ty=c&ta=1&p=d
CHFS
Dynavax Reports Data for Phase 1b/2 Trial of SD-101 in Combination with KEYTRUDA® (pembrolizumab) in Advanced Melanoma at th...
Overall Response Rate (ORR) of 70% and 6-month Progression Free Survival (PFS) rate of 76% in Patients Naïve to Anti-PD-1 Treatment who Received the ≤ 2mg Dose of SD-101
Dynavax Technologies Corporation (NASDAQ:DVAX) today announced data from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada) in patients with advanced melanoma.
The company reported results on a total of 69 patients comparing two doses of SD-101, ≤ 2mg (n=30) versus 8mg (n=39) administered by intratumoral injection. These data are being presented in poster and discussion session today at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, in Chicago, IL. The primary endpoints of this dose-expansion/dose-finding study are safety and preliminary efficacy. The results of this study showed a 70% overall response rate (ORR) in advanced melanoma patients who received the ≤ 2 mg dose of SD-101 in up to four lesions versus a 38% ORR in the group receiving the 8 mg dose of SD-101 in one lesion. The combination of SD-101 and KEYTRUDA was well tolerated with adverse events related to SD-101 being transient, mild to moderate flu-like symptoms.
“These data provide further evidence of the potential for SD-101 to improve responses in first-line advanced melanoma patients in combination with an anti-PD-1 therapy,” commented Eddie Gray, Chief Executive Officer. “Our studies continue to demonstrate the potential value of SD-101 across multiple tumor types. We plan to build upon this momentum and update our progress with additional data planned for a medical conference later in the year.”
Highlights from Poster Presentation (Abstract #9513)
Overall response rate (ORR) of 70% (21 of 30), with a complete response (CR) rate of 17%, for advanced melanoma patients who received the ≤ 2 mg dose of SD-101 in up to four lesions
ORR of 38% (15 of 39) in patients who received the 8 mg dose of SD-101 in one lesion
Durable response in patients who received ≤ 2 mg dose of SD-101 with 74% 6-month progression free survival (PFS) rate
Observed responses in injected lesion(s) and distant lesions, including visceral metastases in the liver
Responders included 8 of 10 PD-L1 negative patients in the ≤ 2 mg dose cohort
AEs related to SD-101 treatment were transient, mild to moderate flu-like symptoms at both the ≤ 2mg and the 8 mg dosing levels
No increase in the frequency of immune-related adverse events over individual monotherapies reported in other studies1,2 nor evidence of any new safety signals
Additional details on response rates based on patient characteristics including stage of disease, ECOG score, and PD-L1 status are also included in the poster presentation which can be accessed here.
“We are moving forward with the 2mg dose of SD-101 for our Phase 3 trial which we believe is the optimal dose based on these efficacy, safety and biomarker data showing increased immune activation consistent with the biology of TLR9 activation. We continue to collect and analyze data from this trial to finalize details of the Phase 3 study design,” stated Rob Janssen, Chief Medical Officer.
The details of the poster presentation and discussion session are as follows:
Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy
Session Title: Melanoma/Skin Cancers
Abstract: 9513
Poster Board: 340
Poster Session Date/Time: Monday, June 4, 2018, 1:15 PM - 4:45 PM CDT
Poster Session Location: McCormick Place South, Hall A, Advanced Disease Poster Section
Discussion Session Date/Time: Monday, June 4, 2018, 4:45 PM - 6:00 PM CDT
Discussion Session Location: McCormick Place Lakeside Center, Level 4 - E451
Analyst/Investor Presentation
Today at 6:30pm CDT, Dynavax will host a presentation for analysts and investors. The presentation will be available via live webcast only and can be accessed in the "Investors and Media" section of the company's website at www.dynavax.com.
About SYNERGY-001 (KEYNOTE-184)
SYNERGY-001, previously referred to as MEL-01, is the dose-escalation and expansion study of SD-101 in combination with KEYTRUDA which includes patients with histologically or cytologically confirmed unresectable Stage IIIC/IV melanoma. The primary endpoints of the trial are safety and preliminary efficacy of intratumoral SD-101 in combination with KEYTRUDA.
About SD-101
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], was approved by the United States Food and Drug Administration in November 2017 for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.
Forward Looking Statement
This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of SD-101, including results from the Phase 1b/2 trial, planned optimal dosage for the Phase 3 trial, and potential value of SD-101 across multiple tumor types. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; and whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and in Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
1. Ribas A, et al. JAMA. 2016;315(15):1600-1609.
2. Specenier P. Expert Opin Biol Ther. 2017;17(6):765-780.
Contact:
David Burke
Director, IR & Corporate Communications
510.665.7269
dburke@dynavax.com Media Contact:
Rachel St. Martin
W2O wcg
646.894.5757
rstmartin@w2ogroup.com
____________________________________________________
Still in after missing selling @ $16.40 earlier. Suppose will not recover today.
DVAX
Tenax Therapeutics Announces Study Design for Phase 2 Trial of Levosimendan in PH-HFpEF Patients
Date : 06/01/2018 @ 8:30AM
Source : Business Wire
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, today announced the registration of their Phase 2 clinical trial in the use of levosimendan for treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) on ClinicalTrials.gov.
The Phase 2 PH-HFpEF study is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that chronic, intermittent doses of levosimendan will significantly improve hemodynamic measures of exercise performance in patients suffering from Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction. PH-HFpEF patients will be enrolled at a targeted 20-25 sites, in an open-label lead-in phase of the study. Subjects who have responded positively to the first hospital-administered dose of levosimendan will be randomized in the study and receive levosimendan or placebo for four additional weekly treatments. The study is expected to be initiated in the third quarter.
“We are very pleased to begin this new Phase 2 study, which has been designed in collaboration with - leading pulmonary hypertension and HFpEF experts to efficiently evaluate the effectiveness of levosimendan in this patient population,” said Michael Jebsen, Interim CEO of Tenax. “The estimated prevalence of PH-HFpEF in the US is high, with some estimates exceeding 1.5 million patients. PH-HFpEF patients have increased mortality and morbidity, as well as suffer from reduced exercise capacity and quality of life. There are no drugs approved to treat this condition. If levosimendan can improve their hemodynamic function, the improvements in their quality of life could be significant.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on licensing, development, and commercialization of drugs that address conditions with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan and is conducting a Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements, and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on April 2, 2018 and its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180601005198/en/
IRTH Communications
Robert Haag, 800-439-1433
TENX@irthcommunications.com
_______________________________________________
TENX
Sonoma Pharmaceuticals Announces Fiscal Year/Fourth Quarter 2018 Financial Results and Conference Call
May 31, 2018 07:05 ET | Source: Sonoma Pharmaceuticals, Inc.
PETALUMA, Calif., May 31, 2018 (GLOBE NEWSWIRE) --
Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), today announced that financial results for its fiscal fourth quarter 2018, ended March 31, 2018, will be released after the U.S. markets close on June 13, 2018. The earnings release will be followed by a conference call at 1:30 p.m. PDT on June 13, 2018, to discuss fiscal fourth quarter and year-end results.
Individuals interested in participating in the conference call may do so by dialing 877-303-7607 for domestic callers or 973-638-3203 for international callers. Those interested in listening to the conference call live via the internet may do so at https://edge.media-server.com/m6/p/ufhciggt.
A telephone replay will be available for seven days following the conclusion of the call by dialing 855-859-2056 for domestic callers, or 404-537-3406 for international callers, and entering conference code 3495907. A webcast replay will be available on the site at http://ir.sonomapharma.com/events.cfm for one year following the call.
About Sonoma Pharmaceuticals, Inc.
Sonoma Pharmaceuticals is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com
Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.
Bob Miller
CFO
(925) 787-6218
_____________________________________________
SNOA
Back in @ $6.05. Chart a little less positive, but good potential. Hopefully not long. Wide spread here.
TENX
Sold @ $6.25. Looking to get back in given the chance. Taking profits on volatile stock.
TENX
In @ $15.90. Presenting at ASCO:
Dynavax to Present New Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) at the 2018 American Society for Clinic...
Date : 05/16/2018 @ 5:15PM
Source : GlobeNewswire Inc.
Dynavax to Present New Data for SD-101 in Combination with KEYTRUDA® (pembrolizumab) at the 2018 American Society for Clinic...
Dynavax Technologies Corporation (NASDAQ:DVAX) announced today that data will be presented from its ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada). Data on patients with advanced melanoma who are naïve to anti-PD-1 therapy is the subject of a poster presentation and will be highlighted in a poster discussion session at the 2018 American Society for Clinical Oncology (ASCO) Annual Meeting, being held June 1-5, 2018 in Chicago, IL.
The abstract for the poster titled “Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD1 therapy” has been posted on the 2018 ASCO Annual Meeting website, here. The abstract summarizes efficacy data on 25 patients that were available at the time of abstract submission in early February and shows an overall response rate (ORR) of 60%. The combination reported low rates of Grade 3-4 treatment-related adverse events and no evidence of an increased rate of immune-related adverse events. The poster at ASCO in June will present efficacy data from over 50 patients comparing two doses of SD-101, 2mg in 1-4 lesions versus 8mg in a single lesion.
The details of the poster presentation and discussion session are as follows:
Phase 1b/2, open label, multicenter, study of the combination of SD-101 and pembrolizumab in patients with advanced melanoma who are naïve to anti-PD-1 therapy
Session Title: Melanoma/Skin Cancers
Abstract: 9513
Poster Board: 340
Poster Session Date/Time: Monday, June 4, 2018, 1:15 PM - 4:45 PM CDT
Poster Session Location: McCormick Place South, Hall A, Advanced Disease Poster Section
Discussion Session Date/Time: Monday, June 4, 2018, 4:45 PM - 6:00 PM CDT
Discussion Session Location: McCormick Place Lakeside Center, Level 4 - E451
About MEL-01 (KEYNOTE-184)
The dose-escalation and expansion study of SD-101 in combination with KEYTRUDA includes patients with histologically or cytologically confirmed unresectable Stage IIIC/IV melanoma. The primary endpoints of the trial are safety and preliminary efficacy of intratumoral SD-101 in combination with KEYTRUDA. In addition, biomarkers are being evaluated.
About SD-101
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.
About Dynavax
Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor (TLR) stimulation. Dynavax discovers and develops novel vaccines and immuno-oncology therapeutics. The Company’s first commercial product, HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the United States. Dynavax's lead immunotherapy product, SD-101, is an investigational cancer immunotherapeutic currently being evaluated in Phase 1/2 studies and its second cancer immunotherapeutic, DV281, is in Phase 1 development. For more information, visit www.dynavax.com.
Forward Looking Statement
This press release contains "forward-looking" statements, including statements regarding the conduct of clinical trials of SD-101. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies; initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; and whether or not Dynavax and parties with whom we are collaborating may reach any future agreement on further studies or a more extensive collaboration beyond the clinical trials contemplated under the existing agreements, as well as other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Contact:
David Burke
Director, IR & Corporate Communications
510.665.7269
dburke@dynavax.com
Media Contact:
Rachel St. Martin
W2O wcg
646.894.5757
rstmartin@w2ogroup.com
______________________________________________
DVAX
Great trade for profit and good timing to be out.
Bought today @ $5.95.
Super low float and seems to be in good financial shape:
https://finviz.com/quote.ashx?t=tenx&ty=c&ta=1&p=d
TENX
Out @ $7.70 for small profit after having averaged down to $7.55. Had left the computer with a sell order for several hours and came back to find them sold. Will get back in because the chart is great.
ADT
Win some, lose some. Felt the earnings report would be positive but didn't want to take risk because can't trade outside regular hours. Had a lot of close ones, for example my ask yesterday was .60 and it went to .59 bid but the .60 never got bought and a lower ask moved in. Dropped ask but never retraced to .59.
Hope you are having better luck.
ALT
5/14/2018 Andrew Africk Director Buy 130,000 $7.46 $969,800.00
ADT
Out @ .53 near the end of day for pretty big loss which erased previous recent gains with this stock. Sure could have done better today as dropped the ask steadily from .60 at open. Just didn't want to be in for the results given I can't trade until 9:30 am.
I believe many trades are being made on Level III because watching Level II in no way accounts for what goes on throughout the day.
Hope it will be a nice surprise for those who hung on.
ALT
Update -- see the results now. Pays to have conviction!