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Pipeline @ IMUC
http://www.imuc.com/pipeline
ICT-107
ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been awarded $19.9 million from the governing Board of the California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, for the phase 3 registration trial.
ICT-121
ICT-121 specifically targets CD133, a cancer stem cell marker that is overexpressed in a wide variety of solid tumors, including ovarian, pancreatic, and breast cancers.
Stem-to-T-Cell Program
n September 2014, ImmunoCellular entered into a licensing agreement with the California Institute of Technology (Caltech) for exclusive rights to novel technology for the development of stem cell immunotherapies for the treatment of cancer. The technology originated from the labs of David Baltimore, PhD, Nobel Laureate and President Emeritus at Caltech, and utilizes the patient’s own hematopoietic stem cells to create antigen-specific killer T cells to treat cancer. ImmunoCellular plans to utilize this technology to expand and complement its dendritic cell-based cancer immunotherapy platform, with the goal of developing new immunotherapies that kill cancer cells in a highly directed and specific manner and that can function as monotherapies or in combination therapy approaches.
Management Team @ IMNP
It has been a busy August with three exceutives buying shares of IMNP all of which is very positive news for those of us holding shares.
This large haul for D. Tepper already adds to his 187,600 shares at much higher prices in 2016 as well as his 312,100 shares he purchased in 2015 at much higher prices! CEO Tepper has accumulated over 1,436,700 shares in 2015/2016!
Take a look: August 4th,2016
1) CEO: D. Tepper: 937,000 shares @ .38 = $356,250.00 ( stock option)
2) CMO/EVP: Monica Luchi: 777,778 shares at .45 = $350,000
Shares issued upon repayment of a $350,000 promissory note at the conversion price of $0.45 per share.
3) Director: Daniel Kazado 666,667 .45 = $300,000
Shares issued upon repayment of a $300,000 promissory note at the conversion price of $0.45 per share.
Total: 2,381,935 / $1,006,250
GLTA
Investor 100
JMP Securities Conference
St Regis Hotel, New York
June 21, 2016
http://www.immunepharma.com/wp-content/uploads/2016/06/IMNPInvestorPresentationJMPJune212016.pdf
Investor 100
Highlights @ IMNP
Great video posted in June 2015
Opioid-related insurance claims rose more than 3,000 percent 2007 to 2014
http://www.cnbc.com/2016/08/01/opioid-related-insurance-claims-rose-more-than-3000-percent-2007-to-2014.html
"The United States is in the midst of an epidemic of opioid dependence, abuse and overdose," notes the analysis by Fair Health, a nonprofit group that focuses on transparency in health-care costs and health insurance information.
More than 28,000 people died from opioid overdose deaths in 2014, which was a record, and a prime reason that Congress in late July passed the Comprehensive Addiction and Recovery Act. CARA is aimed at supporting efforts to limit opioid addiction, increase treatment and recovery, and expand access to a drug, naloxone, that reverses opioid overdose
Investor 100
ImmunoCellular Therapeutics Treats First Patient in ICT-107 Phase 3 Registrational Trial in Newly Diagnosed Glioblastoma
http://www.marketwatch.com/story/immunocellular-therapeutics-treats-first-patient-in-ict-107-phase-3-registrational-trial-in-newly-diagnosed-glioblastoma-2016-06-07
LOS ANGELES, June 7, 2016 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (nyse mkt:IMUC) today announced that the first patient has been treated in the phase 3 registrational trial of ICT-107, the Company's lead cancer immunotherapy product candidate, in newly diagnosed glioblastoma. ICT-107 is a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. The phase 3 trial is designed as a randomized, double-blind, placebo-controlled study of 414 HLA-A2-positive subjects, which will be conducted at approximately 120 sites in the US, Canada and the EU. The primary endpoint in the trial is overall survival, which the FDA and EU regulators have identified as an appropriate endpoint for registrational clinical studies in glioblastoma. Secondary endpoints include progression-free survival and safety, as well as overall survival in the two pre-specified MGMT subgroups.
"Treating our first US patient in the phase 3 registrational trial for ICT-107 is a major milestone achievement for our Company, for patients with brain cancer and their families and for our shareholders," said Andrew Gengos, ImmunoCellular President and Chief Executive Officer. "ImmunoCellular is now one of the very few companies in the cancer immunotherapy arena that we believe to be in the final stage of clinical development. What we think differentiates our phase 3 program from any other in newly diagnosed glioblastoma is that it is based on data and insights from a placebo-controlled phase 2 trial, and it uses the overall survival primary endpoint which is the only efficacy endpoint US and EU regulatory authorities will currently accept for registration. We think we have designed into the phase 3 trial a set of protocol improvements that give ICT-107 the best probability of success. We want to express our sincere appreciation to the medical oncology community worldwide for their ongoing support of our phase 3 trial and look forward to treating our first patients in Canada and Europe in the third quarter of 2016."
The principal investigator on the trial is Prof. Dr. Michael Weller, Chairman, Department of Neurology, University Hospital Zurich, Switzerland. Dr. Weller serves as the Chairman of the German Glioma Network of the German Cancer Council, and serves as President of the European Association for Neuro-Oncology (EANO). He is also the Chairman of the Brain Tumor Group of the European Organisation for Research and Treatment of Cancer (EORTC). A world expert in glioblastoma treatment and research, Dr. Weller has provided extensive support to ImmunoCellular relative to interpretation of the phase 2 results and design of the phase 3 trial protocol, and served as the Company's clinical expert in our end of phase 2 presentation to the European Medicines Agency (EMA).
Dr. Weller commented: "Glioblastoma has remained to be one of the most difficult to treat type of cancer for decades. Conventional treatments such as radiotherapy and chemotherapy seem to have reached their limits. In contrast, there is now emerging evidence that harnessing the patient`s immune system to actively combat this deadly tumor may change this. Moreover, modern medicine increasingly tries to move away from "one-size-fits-all" approaches to more individualized approaches. ICT-107 meets these requirements in an ideal way, being an innovative design of immunotherapy taking into consideration biological characteristics of both the patients and their tumors. The phase 3 trial is well designed and will benefit from important insights from the encouraging results of the placebo controlled phase 2 trial."
ImmunoCellular has reached agreement with the US FDA on a Special Protocol Assessment (SPA) relative to the primary and secondary endpoints as well as the statistical plan for the phase 3 trial. ImmunoCellular has also been honored with a $19.9 million award from the governing Board of the California Institute for Regenerative Medicine (CIRM), California's stem cell agency, to implement the phase 3 registration trial. To support timely patient enrollment at participating sites across ten countries, ImmunoCellular has established agreements with the European Organisation for Research and Treatment of Cancer (EORTC), the Alliance for Clinical Trials in Oncology (the Alliance) in the US, and the Canadian Brain Tumor Consortium.
For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The phase 3 registrational trial of lead product candidate, ICT-107, a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells, has been initiated. ImmunoCellular's pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting the CD133 antigen on cancer stem cells in recurrent glioblastoma; ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which engineers the patient's hematopoietic stem cells to generate antigen-specific cancer-killing T cells. To learn more about ImmunoCellular, please visit www.imuc.com
ImmunoCellular Therapeutics Reports Progress in Two Lead Cancer Immunotherapy Programs
http://www.marketwatch.com/story/immunocellular-therapeutics-reports-progress-in-two-lead-cancer-immunotherapy-programs-2016-07-25-618300
Over 100 Patients Screened in Phase 3 ICT-107 Trial in Newly Diagnosed Glioblastoma;CIRM Award Payment of $1.5 Million Received;ICT-121 Phase 1 Trial in Recurrent Glioblastoma Fully Enrolled
LOS ANGELES, July 25, 2016 /PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (nyse mkt:IMUC) today reported progress in its two lead cancer immunotherapy clinical programs: the phase 3 registrational trial of ICT-107 for newly diagnosed glioblastoma and the phase 1 trial of ICT-121 for recurrent glioblastoma.
In the ICT-107 phase 3 registrational trial, as of July 21, 2016, 109 patients have been screened in the US and Canada, with plans to randomize qualifying patients once they have completed standard of care and are re-screened (patients randomized in the trial are treated approximately 90 days following initial screening). In addition, clinical supplies (ICT-107 and placebo) for 12 patients have been manufactured. ImmunoCellular also reported that 56 clinical sites in the US and two sites in Canada have been activated, representing almost half the total number of the planned 120 sites for the trial.
ImmunoCellular has made progress toward initiating patient recruitment in Europe. The first clinical sites in Europe are anticipated to be activated in the third quarter of this year, and regulatory approval to begin the trial has now been received in the UK, the Netherlands and Spain. ImmunoCellular anticipates receiving regulatory approvals from all eight European countries participating in the trial in the third quarter of this year. In addition, ImmunoCellular's European manufacturer, PharmaCell B.V., has notified it that their process is now qualified to manufacture ICT-107 under Good Manufacturing Practices (cGMP).
As previously disclosed, in September of 2015, The California Institute of Regenerative Medicine (CIRM) awarded ImmunoCellular up to $19.9 million toward financing the ICT-107 phase 3 trial. This award is distributed to ImmunoCellular in milestone payments that are primarily dependent on patient enrollment and randomization. In June 2016, ImmunoCellular amended the terms of its award from CIRM to (i) increase the project initial payment by $1.5 million, and (ii) reduce the potential future milestone payments by a corresponding $1.5 million. The potential total amount of the award from CIRM remains at $19.9 million, inclusive of amounts received to date. On July 18, 2016, ImmunoCellular received the $1.5 million payment from CIRM related to the increase in the project initial payment. To date, ImmunoCellular has received $5.5 million from CIRM.
ImmunoCellular also reports that the phase 1 open-label trial of ICT-121 in patients with recurrent glioblastoma has completed enrollment, reaching the target of 20 patients. The trial is being conducted at six sites in the US and preliminary results are expected within the next 12 months.
"I am pleased with the progress ImmunoCellular has made in implementing our ICT-107 and ICT-121 clinical programs," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "We continue to work diligently to advance these programs, as glioblastoma remains a high unmet medical need for which new treatments are needed. We appreciate the interest in our programs from the oncology community and our collaborators."
For patients, families and physicians seeking additional information about the ICT-107 phase 3 trial, please consult www.clinicaltrials.gov.
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The phase 3 registrational trial of lead product candidate, ICT-107, a patient-specific, dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells, has been initiated. ImmunoCellular's pipeline also includes: ICT-121, a patient-specific, dendritic cell-based immunotherapy targeting the CD133 antigen on cancer stem cells in recurrent glioblastoma; ICT-140, a patient-specific, dendritic cell-based immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which engineers the patient's hematopoietic stem cells to generate antigen-specific cancer-killing T cells. To learn more about ImmunoCellular, please visit www.imuc.com
I would suggest that you contact the company directly rather than give you my opinion.
I am confident that they can provide you specifics!
http://www.immunepharma.com/contact-us/
Investor 100
A Personalized Approach to Treating Autoimmune Disease
http://www.futureofpersonalhealth.com/prevention-and-treatment/a-personalized-approach-to-treating-autoimmune-disease
It’s a targeted treatment with the best efficacy-safety ratio,” says Dr. Daniel Teper, the founder and CEO of IMMUNE Pharmaceuticals. “It’s a treatment where both the physicians and the patients will have greater confidence in the drug right from the first time.”
This new, injectable treatment is still several years away from being available, but this personalized medicine approach may offer significant relief.
“It’s the future of medicine to provide the right drugs to the right patients,” says Teper.
New Eczema Treatments Could Be Available Soon
Interesting as IMNP is among one of many players in this field that has tremendous needs!
http://www.pharmacist.com/new-eczema-treatments-could-be-available-soon
http://www.immunepharma.com/products/bertilimumab/
May 31, 2016
New drugs are on the horizon for the treatment of severe eczema. FDA could approve at least two new eczema medications in 2017, while six more treatments are undergoing clinical tests. Eczema affects about 12% of children in the United States and 7%–10% of adults, according to estimates.
New drugs are on the horizon for the treatment of severe eczema. FDA could approve at least two new eczema medications in 2017, while six more treatments are undergoing clinical tests. Eczema affects about 12% of children in the United States and 7%–10% of adults, according to estimates. While the condition is most common in children and often disappears on its own prior to adolescence, many adults also have eczema, including some 1.6 million with severe forms of the disease that can negatively affect their emotional and mental health.
Wall Street Journal (05/30/16) Walker, Joseph
http://www.wsj.com/articles/new-eczema-treatments-could-be-available-soon-1464637182
Investor 100
My guess / speculation is that first and foremost to raise additional funds which as we know is required in this endeavor and given this price which is a high risk/reward propsotion they may have not had many other choices at this time ( I think 12-18 months the picture at IMNP looks a lot different). All in my opinion!
Investor 100
Prospectus Supplement Filed Pursuant to Rule 424(b)(5)
(To Prospectus Dated October 28, 2014) Registration No. 333-198647
https://www.sec.gov/Archives/edgar/data/1208261/000114420416115386/v445479_424b5.htm
IMMUNE PHARMACEUTICALS INC.
3,174,603 Shares of Common Stock
We are offering up to 3,174,603 shares of our common stock to institutional investors pursuant to this prospectus supplement and the accompanying prospectus and a stock purchase agreement with such investors, at a negotiated price of $0.315 per share.
In a concurrent private placement, we are selling to the purchasers of shares of our common stock offered under this prospectus supplement, warrants to purchase up to a number of shares of common stock equal to 50% of the purchasers’ subscription amounts divided by the exercise price of the warrants of $1.00 per share (collectively, the “Warrants”). The Warrants and the shares of our common stock issuable upon the exercise of the Warrants are not being registered under the Securities Act of 1933, as amended, (the “Securities Act”), are not being offered pursuant to this prospectus supplement and the accompanying prospectus and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
Our common stock is traded on The NASDAQ Capital Market, or NASDAQ, under the symbol “IMNP”. On July 28, 2016, the last reported sale price of our common stock was $0.39 per share. The Warrants being issued in the concurrent private placement are not listed on any securities exchange and we do not expect to list the Warrants.
As of July 29, 2016, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $31.6 million, based on 63,576,143 shares of outstanding common stock, of which 5,057,528 were held by affiliates, and a per share price of $0.54 based on the closing price of our common stock on June 21, 2016. During the prior 12 calendar month period that ends on, and includes, the date of this prospectus supplement, and including this offering, we have offered securities with an aggregate market value of approximately $7.4 million pursuant to General Instruction I.B.6 on Form S-3.
Investor 100
Alder Reports Positive Top-Line 24-Week Data Demonstrating Persistent Migraine Prevention in Phase 2b Study of ALD403 in Patients with Chronic Migraine
https://finance.yahoo.com/news/alder-reports-positive-top-line-120000216.html
Investor 100
Immune Pharma (IMNP) Files Patent Application for Ceplene/Checkpoint Inhibitors Combo
Guest includes the CEO and CMO Interview ( taped February 2016 )
Congratulations on your purchase and think management is working on a host of opportunities ( see pipeline) that will impact valuations and perhaps partnerships/ buy-out during the next 12-18 months. GL Investor 100
Stockcharts @ IMNP
I took advantage and loaded up on thsi dip...this have been several times the past 60 days to buy low and sell high so it has been a winner for both traders and investors...I am accumulating for much bigger gains!
Pipeline:
http://www.immunepharma.com/what-we-do/products-3/
Recap some news on IMNP:
July 2016:
http://immunepharmaceuticals.investorroom.com/2016-07-19-IMMUNE-Pharmaceuticals-to-Form-Pain-and-Neurology-Spin-Off-Company-around-AmiKet
IMMUNE Pharmaceuticals to Form Pain and Neurology Spin Off Company around AmiKet
June 2016:
http://immunepharmaceuticals.investorroom.com/2016-06-28-New-Data-Suggests-Improved-Tumor-Response-For-The-Combination-of-AZIXA-and-Immune-Checkpoint-Inhibitors-in-The-Treatment-of-Cancer
New Data Suggests Improved Tumor Response For The Combination of AZIXA® and Immune Checkpoint Inhibitors in The Treatment of Cancer
Investor 100
Dips @ IMNP
Had a strong run up the past week and took some profits but with this dip the opportunity to to buy a few more shares.
GL
Investor 100
Immune Pharmaceuticals Inc. (NASDAQ:IMNP) Annual EBIT At $-15.724 Millions
We run tomorrow!
http://theenterpriseleader.com/analyst-research/immune-pharmaceuticals-inc-nasdaqimnp-annual-ebit-at-15-724-millions/126540/
EBITDA and EBITDA margins
Immune Pharmaceuticals Inc. (NASDAQ:IMNP) reported EBITDA of $-15.724 millions for the fiscal closed 2015-12-31. For the quarter closed 2015-12-31, it was -15.724 millions. EBITDA margin stood at -15.724% for the fiscal ended 2015-12-31.
Investor 100
Immune Pharmaceuticals Inc (NASDAQ:IMNP) Finally Bounces
http://www.insiderfinancial.com/immune-pharmaceuticals-inc-nasdaqimnp-finally-bounces/115659/
Shares of Immune Pharmaceuticals Inc (NASDAQ:IMNP) are finally bouncing after being on a downtrend all year. Bottom fishers are waking up to the fact that Immune is a cheap lotto ticket at current levels. We look at IMNP as a great risk/reward play with the upside potentially being several times your money. That’s why it’s a worthwhile look at these levels.
Immune Pharmaceuticals describes itself as “a clinical stage biopharmaceutical company specializing in the development and commercialization of novel targeted therapeutics in the fields of immuno-inflammation and immuno-oncology. The company focuses on a precision medicine approach to treatment of diseases by incorporating methods for better patient selection in its clinical trials and the potential for development of companion diagnostics. The company’s immuno-inflammation product pipeline includes: bertilimumab, a clinical-stage first-in-class fully human antibody, targeting eotaxin-1, a key regulator of immuno-inflammation, a portfolio of clinical-stage immune oncology products and NanoCyclo, a topical nanocapsule formulation of cyclosporine-A, for the treatment of atopic dermatitis and psoriasis.”
The highlight of the recent update was that IMNP executed an exclusive 60-day option with Novel Pain Therapeutics (“NPT”) to enter into a worldwide license agreement for AmiKet and AmiKet Nano for the treatment of peripheral neuropathic pain. Upon execution of the license agreement pursuant to agreed material terms in the option, NPT will assume all research and development costs and Immune will be eligible to receive up to $160 million, comprised of an upfront fee of at least $15 million in the form of equity in NPT, up to $25 million in development milestones, and up to $120 million in commercial milestones, as well as product sales royalties. Immune will also be eligible to receive 25% and up to 50% of sublicense fees received by NPT.
While the news is indeed positive, it’s still just a 60-day option and needs to be executed. That’s why shares ultimately sold off after the news was announced. The recent bounce has us thinking that the deal may be happening and some in the know are buying in anticipation of the option being executed. Shares also put in a triple bottom at $.20 per share and that signaled to momentum players to pile in and drive the shorts to cover their positions.
In terms of the first quarter results, Immune reported a loss attributable to common stockholders of $6.0 million, or $0.17 per share, for the quarter ended March 31, 2016, compared to a loss attributable to common stockholders of $3.6 million, or $0.15 per share, for the quarter ended March 31, 2015. R&D expenses increased by $0.9 million, due to higher salaries and employee benefits, license fees and clinical trial expenses. Salaries and employee benefits increased due to higher R&D employee head count for the three months ended March 31, 2016 compared with the three months ended March 31, 2015.
There are two ways to look at the results. Either management is trying to burn through the money or management believes the increase in R&D will pay off. We’re betting on the former and think IMNP is closer to some major developments than many are thinking. As CEO Dr Daniel Teper said:
“We are structuring the Company strategically to ensure long term comprehensive financing of our product pipeline and enable focused execution. We continue to progress in our clinical trials with bertilimumab as we increase patient enrollment and we are on track to achieve our operational and financial objectives for 2016.”
Currently trading with a market cap of $13 million, IMNP exploded up the charts by over 57% on the highest volume we’ve seen so far this year. Data from the Phase 2a program in BP is expected later this year. IMNP is continuing to enroll patients in two Phase 2 clinical trials with bertilimumab for the treatment of ulcerative colitis and bullous pemphigoid (BP). A third Phase 2 program in atopic dermatitis is planned for later this year. We will be updating Insider Financial as soon as we know more. For continuing coverage on IMNP, sign up for our free newsletter today and get our next hot stock pick!
Disclosure: We have no position in IMNP and have not been compensated for this article.
Sold shares @ IMNP
Nothing wrong taking some profit after a strong run...30% gain ..holding shares for a bigger upward movement!
Investor 100
PM @ IMNP
Looking like a strong day with a jump of .07 at .64 !
Investor 100
AH @ IMNP
.54 with over 19K shares traded.
Investor 100
Stockcharts @ IMNP
Solid Chart...lots of MOM with 4.7M shares traded closing at .527 up 17.61% Allindicators moving up..RSI..MACD..MFI..follow the money!
No questions that this stock is getting lots of attention and I believe we are just getting started...trying to add more shares on dips!
Investor 100
Stoxline (Stock Analysis Research)
Interesting stat's on IMNP!
http://www.stoxline.com/quote.php?symbol=imnp
Investor 100
Immune Pharmaceuticals, Inc. (NASDAQ:IMNP) Insiders Look Optimistic About Prospects
No question this stock is getting some solid PR in the markets.
Strong inside buying as reflective in this article and one that I have highlighted as well...
http://reviewfortune.com/2016/07/12/immune-pharmaceuticals-inc-nasdaqimnp-insiders-look-optimistic-about-prospects/
Immune Pharmaceuticals, Inc. (NASDAQ:IMNP) up 10.84 per cent in the past week, is under coverage of 3 analysts who collectively recommend a buy rating on stock. 3 of the analysts have a buy or better rating; the 0 sells versus 0 underperforms. The 2 equity analysts who rate the stock have an average target price at $2, with individual targets ranging between $1 and $3. The shares closed last trade at $0.46, implying that analysts see shares rising about 334.78 per cent in 12 months’ time.
Insider Activity: Insiders look optimistic about the prospects of the company that they seem to accumulate shares while they are -36.99 down so far this year. A CEO, 10% Owner at Immune Pharmaceuticals, Inc. (IMNP) purchased shares in the company in a transaction completed on Tuesday January 26, 2016. Teper Daniel Gedeon accumulated 42,000 shares in the company at an average price of $0.59 and ended up spending $24,780 in the investment. Teper Daniel Gedeon now have 4,810,905 shares in the company after this transaction. A CEO, 10% Owner in the company, Teper Daniel Gedeon, on Tuesday January 19, 2016 spent $25,190 from the purchase of 44,200 shares at $0.59 each. Insiders are expected to know better about the health and prospects of their company, which is why insiders’ move deserves attention.
Earnings Roundup: In the last fiscal quarter alone, Immune Pharmaceuticals, Inc. generated around $0 in revenue and net income of -$0.17/share. That compares with the consensus estimate $0 and -$0.15/share, respectively. For the prior quarter revenue for the company hit $0, with earnings at -$0.27/share.
Immune Pharmaceuticals, Inc. (IMNP) Analyst Coverage
ROTH Capital has been a brokerage house following shares of Immune Pharmaceuticals, Inc. (IMNP), so its rating change is noteworthy. The stock was initiated at Buy, wrote analysts at ROTH Capital, in a note issued to clients on Thursday October 08, 2015. There was another key note issued by Chardan Capital Markets on Monday March 09, 2015. The firm launched coverage on IMNP at Buy.
Price Momentum: Despite the 15.14% increase in value, the stock’s new closing price represents a -76.41% fall in value from company’s one year high of $1.95. The stock is currently holding below its 50 day moving average of $23.5 and above its 200 day moving average of $0.39. Over the last three months and over the last six months, the shares of Immune Pharmaceuticals, Inc. (IMNP), have changed -31.19% and 0.46%, respectively.
Investor 100
AH @ IMNP
Moving higher at .53 with 58 shares trading...this train is rolling along at a nice pace!
Investor 100
License Option Agreement
This Agreement made this day of May 15, 2016 by and between Immune Pharmaceuticals Inc. (“Immune”) with a principal place of business at 430 East 29th Street, Suite 940, New York, NY 10016 and Novel Pain Therapeutics LLC (“NPT”), a newly formed limited liability company with an office at 52 East End Avenue #12A New York, NY 10028
Whereas Immune has intellectual property rights pertaining to its product AmiKet™ and Amiket™ Nano, which are proprietary combinations of amitriptyline and ketamine in topical formulations to treat neuropathic pain, and related product formulations, technical information, clinical data, know-how, patents and patent applications, and trademarks (“Product”).
Whereas, NPT wishes to obtain, and Immune is willing to provide NPT with, an option to negotiate an exclusive license for rights to Product, during the Term set forth below;
1. License Option
1.1 Immune hereby grants NPT an exclusive option to negotiate an exclusive worldwide royalty-bearing license (the “License”), including the right to grant sublicenses, to make, use, sell, offer for sale and import products under all Immune’s right, title and interest in Product. Such right shall apply during the “Term” beginning from the day of signing of this Agreement by both Parties and extending for 60 days unless otherwise extended by the Parties in writing.
1.2 Immune hereby represents and warrants that Immune has good title to all rights pertaining to the Product, free and clear of all liens, encumbrances and adverse claims, subject to the terms of any license agreements pertaining thereto, which Immune represents and warrants are in full force and effect and as to which there are no breaches or defaults thereunder.
1.3 During the Term of the Agreement, beginning on May 15, 2016 and extending for 60 days unless otherwise extended in writing by the Parties:
1.3.1 Immune shall continue to conduct ongoing Product research and development;
.
1.3.2 Immune shall not enter into any other contract that would affect NPT potential rights to the Product or take any action that would interfere in any material respect with Immune’s ability to perform any of its obligations hereunder;
1.3.3 NPT shall diligently pursue obtaining equity funding to be used to conduct initial Product development and commercialization as described below; and
1.3.4 The Parties shall negotiate in good faith a license agreement with material terms as outlined in Exhibit A (the “License Agreement”). In the event the Parties have not executed a License Agreement by the end of the Option Period, the Agreement shall terminate and the Parties shall have no further obligation to each other in connection with the negotiation and execution of a License Agreement.
1.3.5 Immune shall provide NPT with full access to all material information, documents and data pertaining to the Product, including without limitation copies of all license agreements, patent applications and submissions to and responses from each patent office, trademark registrations, clinical data and reports, submissions to and responses from each regulatory authority, including the US Food and Drug Administration, and market studies and surveys, research reports, and a schedule of Product costs incurred,
1.4 In consideration for Immune’s grant of the option to NPT, NPT shall within 15 days prior to the expiration of the Option Period (the “Escrow Due Date”) establish a $500,000 escrow account to be held during the Term, unless terminated prior to the Escrow Due Date by NPT. The escrow balance shall be paid to NPT should the Parties fail to execute a License Agreement during the Term or to Immune at execution of the License Agreement as provided in the License Agreement.
1
2. General Terms and Conditions
2.1 Any Immune information that is marked “Confidential” or, if oral, confirmed in writing within a reasonable period of time following initial disclosure, shall not be disclosed by NPT and shall not be used for any purposes other than in connection with and as contemplated by this Agreement and shall be subject to the same terms of confidentiality and nondisclosure as set forth in the Confidentiality Agreement executed by NPT and Immune on May 10, 2016. Until the second anniversary of the date hereof, Immune, without NPT’s consent, shall not solicit funds for Immune or any of its affiliates (other than NPT) from, or enter into any agreement with, any potential investor in NPT introduced by the principals of NPT (and with whom Immune does not have a prior relationship).
2.2 Any notices permitted or required pursuant to this Agreement shall be deemed effective if made in writing and sent, postage prepaid, return receipt requested, or by overnight delivery, as follows:
If to Immune: Immune Pharmaceuticals Inc.
430 East 29th Street, Suite 940
New York, NY 10016
Attn.: Daniel Teper, CEO
If to NPT : Novel Pain Pharmaceuticals LLC
c/o 52 East End Avenue #12A
New York, NY 10028
Attn.: Mark S. Fawer
Or such other or additional address as may be notified from time to time to the other Party. Notices shall be deemed given as of the date sent.
2.3 This Agreement embodies the entire understanding of the Parties and supersedes any other agreement or understanding between the Parties relating to its subject matter. No waiver, amendment or modification of this Agreement shall be valid or binding upon the Parties unless made in writing and signed on behalf of each Party by its respective officers who are duly authorized to do so.
2.4 This Agreement shall in all respects be interpreted and construed in accordance with the laws of the State of New York.
2.5 Either Party may terminate this Agreement in the event of a material breach by the other Party; provided only, that the offending Party is given notice of the breach a reasonable time, not to exceed thirty (30) days, in which to cure such breach.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized representative.
Novel Pain Therapeutics LLC Immune Pharmaceuticals, Inc.
By: Mark S. Fawer By: Daniel G. Teper
Title: Authorized Signatory Title: CEO
Date: May 15, 2016 Date: May 15, 2016
Recap Amiket @ IMNP
Immune Pharmaceuticals Signs License & Research Agreement for AmiKet™ Nano (June 29, 2015)
http://www.prnewswire.com/news-releases/immune-pharmaceuticals-signs-license--research-agreement-for-amiket-nano-300105977.html
NEW YORK, June 29, 2015 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) announced today that it has entered into a definitive license and research agreement with Yissum, the Technology Transfer Company of the Hebrew University of Jerusalem, to license certain of Yissum's patents for the development and commercialization of a topical nano-formulated version of AmiKet, pursuant to the parties' existing binding memorandum of understanding from March 2015.
Dr. Daniel Teper, CEO of Immune, commented: "We believe that the new formulation of AmiKet may increase value to potential commercial partners and to Immune. As a result of this agreement, we have had a number of discussions with potential partners over in the last two months, and some of these talks are advancing to the due diligence stage and terms negotiations. We believe that we may be able to better maximize revenues from AmiKet out-licensing through separate US and EU transactions, and then by forging regional agreements in other territories."
AmiKet is a topical drug for the treatment of Neuropathic Pain and has completed trials in more than 1700 patients, demonstrating comparable efficacy to the high dose of the oral standard of care, gabapentin, in a double-blind, placebo-controlled Phase II clinical trial. The Neuropathic Pain market is currently worth $ 3.5 billion according to a Global Data Report.
The newly formulated nano-topical AmiKet has the potential to provide longer exclusivity up to 2036, allow for the development of multiple chronic pain indications and support an improved product profile.
Immune Pharmaceuticals has an extensive strategic partnership with Professor Benita, the former Director of the Institute for Drug Research and Dean of the School of Pharmacy at the Hebrew University of Jerusalem and Yissum, for the development of nano-pharmaceuticals. In addition to the new formulation of AmiKet, the collaboration includes NanomAbs®, antibody nano-particle conjugates for the targeted delivery of chemotherapy and a topical nano-formulated cyclosporine A for the treatment of psoriasis and atopic dermatitis.
WallStreet Analyzer @ IMNP
Dr D. Teper CEO) has purchased over 187K shares or $124,395 in 2016 at much higher prices than Friday's close. His total share count is 4.8M shares
http://openinsider.com/search?q=imnp
Interview dated July 9th, 2015.
http://wallstreetanalyzer.com/2015/07/09/immune-pharmaceuticals-inc-nasdaq-imnp-ceo-interview/
INTERVIEW TRANSCRIPTS:
WSA: Good day from Wall Street. This is Juan Costello, Senior Analyst at the Wall Street Analyzer. Joining us today is Dr. Daniel Teper, the CEO of Immune Pharmaceuticals Incorporated. The company trades on NASDAQ, ticker symbol IMNP. Thanks for joining us today Dr. Teper.
Dr. Teper: It’s a pleasure to be back with you.
WSA: Great. So for some of our listeners that are new to the story and didn’t catch our last interview, can you give us a history and overview there of Immune Pharma?
Dr. Teper: So Immune Pharma is focused on immunology as our name indicates and specifically on monoclonal antibodies based drugs for the treatment of autoimmune diseases and cancer. We started operations in 2011. We became public in 2013 and uplisted to NASDAQ in 2014.
WSA: Great and so can you go over some of the recent news there, you had a license agreement with AmiKet Nano, you also initiated the Phase II clinical trial.
Dr. Teper: Yes. I think that the single most important news in the recent months is the, the initiation of the patient enrollment process in our two Phase II clinical studies with Bertilimumab, our lead monoclonal antibody. So the first study is in ulcerative colitis. And the second study is in bullous pemphigoid. Bullous pemphigoid is an orphan autoimmune disease of the skin that occurs in about thirty thousand people in the United States, primarily in patients over 60 years old. So those are two studies that were successfully initiated in that past month, and that’s the most important news.
You mentioned the licensing agreement for AmiKet Nano. This is also very important, because we provided guidance that we were in active partnership discussions regarding AmiKet. We’ve improved the AmiKet package significantly with this novel topical nano-particle formulation, which essentially increases the patent life of the product by over ten years. So as a result of this agreement, we have I would say new and better companies coming at the table. So the transaction is taking a little bit more time than what we expected initially, but we’re creating significantly more value for the company and for our investors and obviously for our partner, because they can now look at a good 15 years of AmiKet being on the market without generic competition.
WSA: Great and, so what are some of the key trends that you’re targeting right now in this sector and how is the company positioned to capitalize?
Dr. Teper: Well, you know, immunology is not the core of the medicine and drug development, everybody’s been talking about immuno-oncology. And, and clearly this is not our number one focus, but we’re playing immuno-oncology to our NanomAbs, is a platform where we have antibody nano-particle conjugate in drugs for the treatment of cancer. But there’s also big trend in immune-dermatology, several drugs that regulate the immune system and many of them monoclonal antibodies have been approved for the treatment of diseases such as psoriasis. So we’re developing Bertilimumab for this, which is also monoclonal antibody for bullous pemphigoid and we’re looking at other indications in dermatology, such as atopic dermatitis.
Additionally, something that may not have been seen by many people, was we also licensed in a topical nano-particle formulation of Cyclosporine A. Cyclosporine A also called Neoral, is a drug which was originally developed by Novartis. It’s a drug that has been used over twenty years to prevent transplant rejection, but it’s also been used extensively for severe cases of psoriasis and atopic dermatitis, so the ability for a topical form is extremely promising for dermatologists and it would be used in mild to moderate cases of psoriasis and atopic dermatitis. Although this is not a monoclonal antibody, this is a gold standard drug that regulates the immune system in dermatology, so we expect that Immune Pharma will have the potential to become a leader in Immuno-dermatology, with Bertilimumab for bullous pemphigoid and potentially atopic dermatitis, but also with the topical nano-particle formulation of Cyclosporine.
WSA: Great and so what are some of the keys factors Daniel that you feel make Immune Pharma unique from some of the other players in the sector?
Dr. Teper: Well, Immune Pharma is very focused on leveraging drugs that regulate the immune system to treat severe diseases. We have an extremely rich pipeline of core products such as, first Bertilimumab, but also topical nano-particle Cyclosporine and the NanomAbs for treatment of cancer, antibody nano-particle conjugate. At the same time we have several non-core drugs such ad AmiKet, but also some small molecule oncology drugs and that we are actively partnering. Our focus today is on partnering AmiKet and once we’ve partnered AmiKet, we have several other drugs that we also intend to partner, as a source of additional non dilutive capital.
WSA: Great and perhaps you can walk us through your background experience and talk about some of the key management there once again for some of our listeners that didn’t catch our previous interview.
Dr. Teper: I am Dr. Daniel Teper/ have been in the industry for over twenty years. I started at Novartis and I’ve worked both at the corporate headquarters in Basel and then in the U.S. in sales and marketing and in new product development. I later held general management positions, helped launched several industry blockbusters and advised top management from successful pharma and biotech companies. As a result, I was exposed to a number of breakthrough drugs, both from the research and development standpoint and from a commercialization standpoint.
I am very happy to have a strong management team.
Gad Berdugo is our Executive Vice President for Corporate Development and Chief Financial Officer, he also has industry background at companies like Abbott and Baxter. He was a banker at Lazard and more recently at a boutique M&A shop. So he’s really strong in both corporate development and finance, which is important for the company.
Paul Nadler, our Chief Medical Officer and head of R&D, we worked together at Novartis and he’s a well-known drug developer in oncology and immunology. And we recently brought on board’s executives, had experience at companies like Retrophin as well as Regeneron and Pfizer, so we’re really strengthening our management team.
We also have a Board of people that have significant experience in biotech pharma and on Wall Street. So we are a young company with a lot of energy and at the same time we bring the experience from the industry.
WSA: Certainly and what are some of the key milestones that you’re hoping to accomplish over the course of the next twelve months?
Dr. Teper: Well we have a number of milestones–we’ve initiated the Bertilimumab clinical trials. The first data that we expect is from the bullous pemphigoid study and although we do not control the pace of patient recruitment, we expect to have initial data late this year or in the beginning of 2016. The second study, which is more patient double blind, placebo control in ulcerative colitis data will probably be in mid to late 2016 as we can plan today. Additionally Bertilimumab has a number of potential additional indications. So we expect to have data from pre-clinical studies in those new indications that, by the way, includes liver diseases such as NASH., In later 2016 we plan to initiate clinical studies in NASH as well as severe asthma and Crohn’s Disease.
From a partnering standpoint, I would say the significant milestone that everybody is waiting for is AmiKet and we’re now expecting to have a U.S. transaction first and that’s our top priority and we have active discussions followed by European transaction and potentially bi-regional partnership for other territories. We also expect partnerships for the other in non-core drugs as well as for the NanomAbs, which are antibody drug conjugates. As we can see, it is always difficult to time exactly each of the milestones, but if you look at the next twelve months, you have a good number of pre-clinical, as well as clinical milestones, particularly for our lead drugs Bertilimumab and you have a number of partnering milestones for core and non-core products.
WSA: Great and so as far as investors and the financial community are concerned Daniel, do you believe that the Immune Pharma story and your message are completely understood and appreciated by them and if not, what do you wish investors better understood about the company?
Dr. Teper: Well the fact that we’re listed on NASDAQ and we recently rang the bell at NASDAQ, I think has significantly increased our exposure as well as the daily trading volume, which currently is between two and three hundred thousand shares a day. But on peak days it’s gone as much as a million plus shares. So that’s good for a microcap stock on NASDAQ and obviously we expect that it will improve with the upcoming milestones.
And at the same time there is still a disconnect between the market cap of Immune Pharma which is currently around $50 million and the value of each of the assets in our pipeline and the diversity of that pipeline. We have to go step by step, but we anticipate that the market will recognize the very significant potential of Immune as we execute the first few milestones and then we like Bertilimumab as a potential, to become an immunology blockbuster drug. Bertilimumab, plays in the same category as drugs like Humira and Remicade as well as the recently launched Novartis drug, Cosentryx, for psoriasis. So I think we are in very good company and that the market over the next few months will recognize the great potential of Immune Pharma.
WSA: Great and so once again joining us today is Dr. Daniel Teper, the CEO of Immune Pharma Incorporated, the company trades on NASDAQ, ticker symbol IMNP, currently trading at 1.88 a share, 52-week high of 4.25 and as mentioned a market cap of around 50 million. And before we conclude here Dr. Teper, to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Dr. Teper: I think the number one reason to consider Immune Pharma is Bertilimumab. This is really a first in class drug in multiple indications with two clinical trials ongoing in Phase II with data expected in the next six to eighteen months. I would say, six for the first study and twelve to eighteen months for the second study,. The second reason is the diversity of the pipeline and the opportunity to partner in promising drugs like AmiKet and others. And certainly we have a strong management, which is growing stronger by the day with people that have proven experience in pharma and biotech companies as well as on Wall Street. That should guarantee the best possible execution to our milestones over the next 12 months.
WSA: Well we certainly look forward to continuing to track the company’s growth and report on your upcoming progress and we’d like to thank you for taking the time to join us today Dr. Teper and update our investor audience on IMNP. It was great to have you on again.
Dr. Teper: Thank you.
Investor 100
Links and Stockcharts @ IMNP
Bought a bunch on the dip this week!
Some good reading and like the chart!
Products:
http://www.immunepharma.com/what-we-do/products-3/
License Option Agreement:
https://www.sec.gov/Archives/edgar/data/1208261/000114420416102729/v439810_ex10-3.htm
Form 8-K (July 6th,2016)
https://www.marketvis.io/news/us-imnp-8-k-0001144204-16-111745
Press Release:Immune Pharmaceuticals Inc. (NASDAQ: IMNP)’S License Agreement Could Unlock Up To $160 Million
http://scibilitymedia.com/immune-pharmaceuticals-inc-nasdaqimnps-license-agreement-unlock-160-million/
Stockcharts: Like RSI & MFI indicators!
Investor 100
License Option Agreement @ IMNP
https://www.sec.gov/Archives/edgar/data/1208261/000114420416102729/v439810_ex10-3.htm
May 15,2016
This Agreement made this day of May 15, 2016 by and between Immune Pharmaceuticals Inc. (“Immune”) with a principal place of business at 430 East 29th Street, Suite 940, New York, NY 10016 and Novel Pain Therapeutics LLC (“NPT”), a newly formed limited liability company with an office at 52 East End Avenue #12A New York, NY 10028
Whereas Immune has intellectual property rights pertaining to its product AmiKet™ and Amiket™ Nano, which are proprietary combinations of amitriptyline and ketamine in topical formulations to treat neuropathic pain, and related product formulations, technical information, clinical data, know-how, patents and patent applications, and trademarks (“Product”).
Whereas, NPT wishes to obtain, and Immune is willing to provide NPT with, an option to negotiate an exclusive license for rights to Product, during the Term set forth below;
1. License Option
1.1 Immune hereby grants NPT an exclusive option to negotiate an exclusive worldwide royalty-bearing license (the “License”), including the right to grant sublicenses, to make, use, sell, offer for sale and import products under all Immune’s right, title and interest in Product. Such right shall apply during the “Term” beginning from the day of signing of this Agreement by both Parties and extending for 60 days unless otherwise extended by the Parties in writing.
1.2 Immune hereby represents and warrants that Immune has good title to all rights pertaining to the Product, free and clear of all liens, encumbrances and adverse claims, subject to the terms of any license agreements pertaining thereto, which Immune represents and warrants are in full force and effect and as to which there are no breaches or defaults thereunder.
1.3 During the Term of the Agreement, beginning on May 15, 2016 and extending for 60 days unless otherwise extended in writing by the Parties:
1.3.1 Immune shall continue to conduct ongoing Product research and development;
.
1.3.2 Immune shall not enter into any other contract that would affect NPT potential rights to the Product or take any action that would interfere in any material respect with Immune’s ability to perform any of its obligations hereunder;
1.3.3 NPT shall diligently pursue obtaining equity funding to be used to conduct initial Product development and commercialization as described below; and
1.3.4 The Parties shall negotiate in good faith a license agreement with material terms as outlined in Exhibit A (the “License Agreement”). In the event the Parties have not executed a License Agreement by the end of the Option Period, the Agreement shall terminate and the Parties shall have no further obligation to each other in connection with the negotiation and execution of a License Agreement.
1.3.5 Immune shall provide NPT with full access to all material information, documents and data pertaining to the Product, including without limitation copies of all license agreements, patent applications and submissions to and responses from each patent office, trademark registrations, clinical data and reports, submissions to and responses from each regulatory authority, including the US Food and Drug Administration, and market studies and surveys, research reports, and a schedule of Product costs incurred,
1.4 In consideration for Immune’s grant of the option to NPT, NPT shall within 15 days prior to the expiration of the Option Period (the “Escrow Due Date”) establish a $500,000 escrow account to be held during the Term, unless terminated prior to the Escrow Due Date by NPT. The escrow balance shall be paid to NPT should the Parties fail to execute a License Agreement during the Term or to Immune at execution of the License Agreement as provided in the License Agreement.
1
2. General Terms and Conditions
2.1 Any Immune information that is marked “Confidential” or, if oral, confirmed in writing within a reasonable period of time following initial disclosure, shall not be disclosed by NPT and shall not be used for any purposes other than in connection with and as contemplated by this Agreement and shall be subject to the same terms of confidentiality and nondisclosure as set forth in the Confidentiality Agreement executed by NPT and Immune on May 10, 2016. Until the second anniversary of the date hereof, Immune, without NPT’s consent, shall not solicit funds for Immune or any of its affiliates (other than NPT) from, or enter into any agreement with, any potential investor in NPT introduced by the principals of NPT (and with whom Immune does not have a prior relationship).
2.2 Any notices permitted or required pursuant to this Agreement shall be deemed effective if made in writing and sent, postage prepaid, return receipt requested, or by overnight delivery, as follows:
If to Immune: Immune Pharmaceuticals Inc.
430 East 29th Street, Suite 940
New York, NY 10016
Attn.: Daniel Teper, CEO
If to NPT : Novel Pain Pharmaceuticals LLC
c/o 52 East End Avenue #12A
New York, NY 10028
Attn.: Mark S. Fawer
Or such other or additional address as may be notified from time to time to the other Party. Notices shall be deemed given as of the date sent.
2.3 This Agreement embodies the entire understanding of the Parties and supersedes any other agreement or understanding between the Parties relating to its subject matter. No waiver, amendment or modification of this Agreement shall be valid or binding upon the Parties unless made in writing and signed on behalf of each Party by its respective officers who are duly authorized to do so.
2.4 This Agreement shall in all respects be interpreted and construed in accordance with the laws of the State of New York.
2.5 Either Party may terminate this Agreement in the event of a material breach by the other Party; provided only, that the offending Party is given notice of the breach a reasonable time, not to exceed thirty (30) days, in which to cure such breach.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized representative.
Novel Pain Therapeutics LLC Immune Pharmaceuticals, Inc.
By: Mark S. Fawer By: Daniel G. Teper
Title: Authorized Signatory Title: CEO
Date: May 15, 2016 Date: May 15, 2016
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BIOWORLD TODAY TM@ IMNP
THE DAILY BIOPHARMACEUTICAL NEWS SOURCE
BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS
http://www.bioworld.com/report/BWT062216Immune.pdf
Teper said Immune’s “number one asset” is bertilimumab,
designed to block the infl
ammatory protein eotaxin-1,
enrolling patients in two phase II trials, one for ulcerative
colitis and another in bullous pemphigoid. A third phase II
program in atopic dermatitis (AD) is planned for later this year.
Summit, N.J.-based Celgene Corp. recently put $7.2 billion on
the table for Receptos Inc., of San Diego, to add the highly
touted late-stage S1P modulator ozanimod to its immunology
and infl
ammatory franchise. “We’re not saying we’ll be taken
out,” he said, but bertilimumab “could be partnered with big
pharma or big biotech in the next year or next year and a half.”
Investor 100
That is a vote of confidence!
Investor 100
More Good News @ IMNP
Yesterdays news was again another positive news front on this companies progress as I continue to buy shares on the dip.
The CEO has acquired over 187K shares this year well above these prices as another strong indication his confidence in the companies progessive moves.
GLTA
Investor 100