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EOD dumps stair casing PPS down a bit. Resistance is here somewhere.
wrong board EOM
The potential is there no doubt. THX
Thanks for info EOM.
some news out this morning: Heat Biologics Announces Agreement to Acquire Pelican Therapeutics.
Acquisition brings $15.2 million CPRIT grant to fund 70-patient Phase I trial
DURHAM, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Heat Biologics, Inc. (“Heat”) (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, announced that the company has entered into a definitive agreement with the holders of 75.5% of the outstanding capital stock of Pelican Therapeutics, Inc. (“Pelican”) to acquire an 80% controlling interest in Pelican. Headquartered in Austin, Texas, Pelican is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a highly differentiated and potentially “best-in-class” T cell costimulatory receptor.
Key highlights include:
Pelican was the recipient of a highly competitive $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT), which should enable the company to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial. The CPRIT grant is subject to customary CPRIT funding conditions and was awarded in 2016 following a rigorous scientific and clinical evaluation process.
Pelican’s T cell costimulator, PTX-25, in combination with other immunotherapies, including Heat’s ImPACT and ComPACT technologies, has the potential to enhance durability of responses due to its preferential specificity to ‘memory’ CD8+ T cells.
Preclinical studies demonstrate PTX-25 has superior “best-in-class” costimulatory activity for CD8+ cytotoxic T cells as compared to other costimulators.
“The acquisition of Pelican aligns with our strategic focus targeting exciting immuno-oncology combinations, strengthening Heat’s portfolio in the emerging T cell activation space,” said Jeff Wolf, Heat’s Founder and Chief Executive Officer. “Pelican’s two product candidates are transformative assets for us as there are compelling data indicating that targeting TNFRSF25 may have significant advantages over competing costimulatory receptors currently under development. This is important because many of the leading global pharmaceutical companies are focused on T cell costimulators to enhance the effectiveness of their existing immuno-oncology therapies.”
“Pelican’s PTX-25 has the potential to dramatically improve the durability of antigen-specific immune responses due to its preferential specificity for stimulating the production of ‘memory’ CD8+ T cells,” added Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. “We look forward to advancing these new product candidates with synergistic combinations including Heat’s existing T cell-activating platform technologies, ImPACT and ComPACT, vastly expanding our reach within oncology and possibly beyond.”
The acquisition is contingent upon certain closing conditions, including agreements of the holders of 80% of the outstanding capital stock of Pelican, on a fully diluted basis, to participate in the acquisition and enter into a stockholders agreement with respect to their remaining Pelican shares. As consideration for the sale of 80% of the Pelican Stock, Heat will pay the Pelican stockholders that participate in the acquisition an upfront cash payment not to exceed $500,000 and will issue an aggregate of 1,323,021 shares of Heat common stock, representing 4.99% of the outstanding shares of Heat common stock. In addition, Heat will cause Pelican to pay certain clinical and commercialization milestone payments, royalty and sublicensing income payments, and Heat will loan Pelican amounts sufficient to pay Pelican’s transaction expenses. Cassel Salpeter & Co. served as financial advisor to the Heat special committee and Geller Biopharm served as financial advisor to the Pelican special committee and Pelican stockholders.
The acquisition is expected to close no later than April 30, 2017, subject to applicable regulatory approvals and other customary terms and conditions.
About Pelican Therapeutics, Inc.
Pelican Therapeutics, Inc. is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a differentiated and potentially "best-in-class" T cell costimulatory receptor. TNFRSF25 has shown great promise due to its preferential specificity for stimulating the production of "memory" CD8+ T cells, the strongest predictive biomarker of clinical benefit from cancer immunotherapy. T cell costimulatory therapy, when combined with checkpoint inhibitors and other treatments, could significantly improve clinical responses for a broader range of patients. Pelican has conducted extensive preclinical studies and completed humanization of its lead monoclonal antibody, PTX-25.
About the Cancer Prevention and Research Institute of Texas (CPRIT)
Beginning operations in 2009, CPRIT has to-date awarded $1.78 billion in grants to Texas researchers, institutions and organizations. CPRIT provides funding through its academic research, prevention, and product development research programs. Programs made possible with CPRIT funding have reached all 254 counties of the state, brought more than 123 distinguished researchers to Texas, advanced scientific and clinical knowledge, and provided more than three million life-saving education, training, prevention and early detection services to Texans. Learn more at www.cprit.texas.gov.
About Heat Biologics, Inc.
As my late MOM would say "there is enough stuff in the kettle to make a good stew". Thanks to posters like CJ, CP, BIO, Sunstar, MH, and many others for enumerating all of the ingredients.
CP your POST captures all of what us investors are excited about.
Nice notice as BIO would say some possible dot connecting emerging.
Item: provides clues.
Item 4. Purpose of Transaction
Ronin Capital, LLC acquired the above reported shares of Common Stock and Series E Convertible Preferred Stock based on its belief that the securities represent an attractive investment opportunity, and such purchases have been made in the ordinary course of business. John S. Stafford, III is the indirect beneficial owner of all of the securities of Peregrine Pharmaceuticals, Inc. held of record by Ronin Capital, LLC.
SW Investment Management LLC acquired the above reported shares of the Common Stock and Series E Convertible Preferred Stock based on its belief that the securities represent an attractive investment opportunity, and such purchases have been made in the ordinary course of business. Stephen White is the indirect beneficial owner of all of the securities of Peregrine Pharmaceuticals, Inc. held of record or beneficially owned by SW Investment Management LLC by virtue of his having sole voting and dispositive power over such shares.
SWIM Partners LP acquired the above reported shares of the Common Stock and Series E Convertible Preferred Stock based on its belief that the securities represent an attractive investment opportunity, and such purchases have been made in the ordinary course of business. SW Investment Management LLC is the indirect beneficial owner of all of the securities of Peregrine Pharmaceuticals, Inc. held of record by SWIM Partners LP by virtue of its having sole voting and dispositive power over such shares. Stephen White is the indirect beneficial owner of all of the securities of Peregrine Pharmaceuticals, Inc. held of record or beneficially owned by SW Investment Management LLC by virtue of his having sole voting and dispositive power over such shares.
Ronin Capital, LLC, SW Investment Management LLC and SWIM Partners LP each intend to continue to review their respective equity interests in the Issuer. In addition, depending on their respective evaluations of the factors described below, the Reporting Persons may from time to time purchase additional securities of the Issuer, dispose of all or a portion of the securities then held by it, or cease buying or selling such securities. Any such additional
8
purchases or sales of securities of the Issuer may be in the open market, in privately negotiated transactions, or otherwise.
The Reporting Persons may also wish to engage in a dialogue with officers, directors, and other representatives of the Issuer, as well as the Issuer’s shareholders; topics of discussion may include, but are not limited to, the Issuer’s markets, operations, competitors, prospects, strategy, personnel, directors, ownership and capitalization. The Reporting Persons may also enter into confidentiality or similar agreements with the Issuer and, subject to such an agreement or otherwise, exchange information with the Issuer. The factors that the Reporting Persons may consider in evaluating their equity interest in the Issuer include the following: (i) the Issuer’s business and prospects; (ii) the performance of the Common Stock and the availability of the Common Stock for purchase at particular price levels; (iii) the availability and nature of opportunities to dispose of the Reporting Persons’ interests; (iv) general economic conditions; (v) stock market conditions; (vi) other business and investment opportunities available to the Reporting Persons; and (vii) other plans and requirements of the Reporting Persons.
Depending on his or its assessment of the foregoing factors, each Reporting Person may, from time to time, modify its present intention as stated in this Item 4.
A BP PR would cure all of that see saw action for a bit. IMO
Lot's of potential for upward SP move in foreseeable future. Huge win IF RS is not in the cards for shareholders during this process.
Cannot answer the question but the prospects are potentially there.
Sure makes holding shares of PPHM extra worthwhile.
Reminder
Q3 2017 Earnings Release Mar 7
9 business days away
Well thought out Thanks EOM
Eventual possibility of Partnership on Exosomes for early cancer diagnosis should continue to move PPS up. The upcoming Q won't hurt either.IMO
Peregrine Pharmaceuticals Inc. (PPHM) Charges Ahead 5.14%, Just After Opening Bell on February 16 to Bolster Health Care Stocks
Molly Stephens Healthcare, Market Movers
Peregrine Pharmaceuticals Inc. (PPHM) is one of the best performing stocks in the health care sector for companies listed on the New York Stock Exchange or NASDAQ exchange shortly after the opening bell on February 16. Shares of PPHM have climbed 5.14% about 30 minutes into the session to $0.4 after closing the day prior at $0.39. It’s early, but the stock has traded as high as $0.41 and as low as $0.4 so far. Today’s quick advance has come with about 426,776 shares changing hands, compared to an average 30-day volume of 2.25 million for Peregrine Pharmaceuticals Inc.. The price is currently below the 30-day volume weighted average price of $0.4 for PPHM.
The share appreciation gives the company a market capitalization of $99.0 million based upon 257.14 million shares outstanding. It also means that PPHM has a price-to-book ratio of 2.35:1 and a price-to-earnings ratio of :1.
In the past 52 weeks, shares of PPHM have traded as low as $0.282 and as high as $1.12. Technical traders will take note that at $0.4, shares of PPHM are trading above their 200-day MA at $0.36 and above their 50-day MA at $0.32. Technical analysts pay close attention to these key moving averages because they often serve as technical support and resistance levels and because a move through or holding above them is typically regarded as bullish.
Sizzle?
PPHM Feb 17 2017 3 Days to Expiration
1.0 Call -- 0.20 -- 0.00 0 0
2.0 Call -- 0.20 -- 0.00 0 0
Strike
1.00
2.00
Vol
Op Int
1.0 Put 0.45 0.85 -- 0.00 0 0
2.0 Put 1.45 1.85 -- 0.00 0 0
Should be a PR on new protocol relatively soon.
FDA guides Immune Pharma on design on late-stage study of Ceplene/IL-2 in AML; trial should commence in 2017; shares up 38%
Oct. 27, 2016 1:09 PM ET|About: Immune Pharmaceuticals... (IMNP)|By: Douglas W. House, SA News Editor
Nano cap Immune Pharmaceuticals (IMNP +38.4%) moves up on more than a 5x surge in volume in response to its announcement that it has received guidance from the FDA on the design of a Phase 3 study to assess Ceplene, in combination with low-dose interleukin 2 (IL-2), for the maintenance of remission in patients with acute myeloid leukemia (AML).
The company intends to submit the final study protocol in early 2017 and, if approved, to initiate the trial shortly thereafter. The primary endpoint will be overall survival (OS).
Ceplene (histamine dihydrochloride) acts by enhancing the immunostimulatory effects of IL-2. It was developed by EpiCept and approved in the EU in October 2008. Immune merged with EpiCept in August 2013.
Will see soon enough. EOM
They have already had there second extension but however they can request a meeting to present an argument to extend again. Example: What IMNP did recently after extension was in process of expiring.
Should be closing in on this deal
Detection of phosphatidylserine-positive exosomes as a diagnostic marker for ovarian malignancies: a proof of concept study.
Lea J1, Sharma R2, Yang F2, Zhu H1, Ward ES3,4, Schroit AJ1,3.
Author information
Abstract
There are no suitable screening modalities for ovarian carcinomas (OC) and repeated imaging and CA-125 levels are often needed to triage equivocal ovarian masses. Definitive diagnosis of malignancy, however, can only be established by histologic confirmation. Thus, the ability to detect OC at early stages is low, and most cases are diagnosed as advanced disease. Since tumor cells expose phosphatidylserine (PS) on their plasma membrane, we predicted that tumors might secrete PS-positive exosomes into the bloodstream that could be a surrogate biomarker for cancer. To address this, we developed a highly stringent ELISA that detects picogram quantities of PS in patient plasma. Blinded plasma from 34 suspect ovarian cancer patients and 10 healthy subjects were analyzed for the presence of PS-expressing vesicles. The nonparametric Wilcoxon rank sum test showed the malignant group had significantly higher PS values than the benign group (median 0.237 vs. -0.027, p=0.0001) and the malignant and benign groups had significantly higher PS values than the healthy group (median 0.237 vs -0.158, p<0.0001 and -0.027 vs -0.158, p=0.0002, respectively). ROC analysis of the predictive accuracy of PS-expressing exosomes/vesicles in predicting malignant against normal, benign against normal and malignant against benign revealed AUCs of 1.0, 0.95 and 0.911, respectively. This study provides proof-of-concept data that supports the high diagnostic power of PS detection in the blood of women with suspect ovarian malignancies.
If there was some assurance we would get back to a buck and hold in near term I'd purchase a lot more shares.
Good perspective after all it is cancer were dealing with. EOM
Now we need that mid finger to hit $20 and will all oblige.
Regarding conference.
Second Quarter Fiscal Year 2017 Financial Results Conference Call
Monday, December 12, 2016, 1:30 pm PST
I read the transcript but just got around to listening to conference call. During Q&A, I only heard one caller Thomas Yip I believe. The next in queue was followed by a " no no no" from somebody and the conference concluded with no more questions. Ok I know this has been discussed a lot on this board and it seems most intriguing not sure what to make of it. I have no conclusions but could speculate that something may be in the works?.
Proof of concept negates that. IMO
Imaging partnership around the corner?
Extracellular Apoptosis Biomarkers
Plasma Membrane Phospholipids
The plasma membrane of healthy mammalian cells has an asymmetric distribution of phospholipids. The membrane outer leaflet is comprised primarily of the zwitterionic phospholipids, phosphatidylcholine and sphingomyelin, and the exterior membrane surface is close to charge-neutral. Sequestered within the plasma membrane inner leaflet are phosphatidylethanolamine (PE) (20–40% of total phospholipid) and the major anionic phospholipid, phosphatidylserine (PS) (2–10% of total phospholipid). Loss of this asymmetric distribution during cell death, cell activation, or cell transformation, leads to PS and PE exposure and the cell surface becoming anionic. The appearance of PS and PE on the cell surface appears to be a universal indicator of most types of cell death processes and thus high abundance biomarkers for cell death imaging. There has been extensive effort to develop targeted imaging probes for exposed PS using appropriately labeled PS-binding proteins.......
Sunstar this insight did not register with me on that trial until this explanation was provided so that answers another head scratchier for me as well. THX
Partnership developments should be forth coming....
In studies of women at average risk of ovarian cancer, using TVUS and CA-125 for screening led to more testing and sometimes more surgeries, but did not lower the number of deaths caused by ovarian cancer. For that reason, no major medical or professional organization recommends the routine use of TVUS or the CA-125 blood test to screen for ovarian cancer.
CA-125 is a protein in the blood. In many women with ovarian cancer, levels of CA-125 are high. This test can be useful as a tumor marker to help guide treatment in women known to have ovarian cancer, because a high level often goes down if treatment is working.
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/detection.html
ABSTRACT
There are no suitable screening modalities for ovarian carcinomas (OC) and repeated imaging and CA-125 levels are often needed to triage equivocal ovarian masses. Definitive diagnosis of malignancy, however, can only be established by histologic confirmation. Thus, the ability to detect OC at early stages is low, and most cases are diagnosed as advanced disease. Since tumor cells expose phosphatidylserine (PS) on their plasma membrane, we predicted that tumors might secrete PS-positive exosomes into the bloodstream that could be a surrogate biomarker for cancer. To address this, we developed a highly stringent ELISA that detects picogram quantities of PS in patient plasma. Blinded plasma from 34 suspect ovarian cancer patients and 10 healthy subjects were analyzed for the presence of PS-expressing vesicles. The nonparametric Wilcoxon rank sum test showed the malignant group had significantly higher PS values than the benign group (median 0.237 vs. -0.027, p=0.0001) and the malignant and benign groups had significantly higher PS values than the healthy group (median 0.237 vs -0.158, p<0.0001 and -0.027 vs -0.158, p=0.0002, respectively). ROC analysis of the predictive accuracy of PS-expressing exosomes/vesicles in predicting malignant against normal, benign against normal and malignant against benign revealed AUCs of 1.0, 0.95 and 0.911, respectively. This study provides proof-of-concept data that supports the high diagnostic power of PS detection in the blood of women with suspect ovarian malignancies.
Peregr your statement below needs to repeated you captured it so well.
There is limited pre clinical work that needs to be done anymore. Even Hutchins said that after proof of concept, no more pre clinical work would be done for exosomes. Next phase would be the partnering. They should be well into those discussions as they had a pretty good roadmap laid out in the July PR. It now makes sense when reread. Just a heavy lift on the assay to get this approved. And no incremental personnel or capital to get this done. Any Bavituximab trials will be partnered, such as AZN. Pre clinical is done internally Not much more for Hutchins to do. They probably vested him on the options so he will be rewarded.
Now if these guys can get the biomarker analysis done (still not sure why we haven't heard anything since ESMO) and get this partnership done, we are easily over $1 and probably closer to $2.50.
At this point, Worsley can finally do some deal closing, as he was brought in to do.
Can Tustin execute, is the question......
HD you keep us grounded to the reality that exist and give us perspective on the other side of our investment we share in your observations because it is what it is. Nothing personal but I hope we blow the LID off the SP and as LOOF would say "send that rocket up and away". This is my sentiment for this morning over a cup of coffee. GLTA shareholders.
I feel the same he nailed it. EOM
Moved some shares over with JH so will see. EOM
Details have been provided and Proof of Concept reached. Now partnering discussions for commercialization of this program in 2017 to commence. JH not in picture not sure what that entails.
____________________________________________________________________
7-14-16 CC JH comments (excerpt)
Once we have successfully validated this assay, we plan to establish proof-of-concept through an efficient preclinical & clinical testing program. We have no intention of conducting further development work beyond the proof-of-concept stage. Rather, we expect to initiate partnering discussions for commercialization of this program in 2017. We're very excited to begin this work on this new program and we'll have more details to offer in the coming months.
_____________________________________________________________________
Thanks that was timely I was actually researching this myself. EOM
I'll take that! EOM
Wook That's you buying up all of the shares. Right? Admit it.
Corp I believe that went to the back burner. Viruses was not their best pursuit evidently verses cancer.IMO
ANTIVIRAL PROGRAM HIGHLIGHTS
Bavituximab Phase II HCV Program
In December, Peregrine announced preliminary data from a randomized Phase II trial evaluating bavituximab plus ribavirin versus pegylated interferon alpha-2A, plus ribavirin in patients infected with genotype-1 chronic hepatitis C virus (HCV). Analysis of data from the 12-week trial indicated that the combination of bavituximab and ribavirin appeared safe and well tolerated, with patients reporting fewer side effects than in the interferon-containing arm. The trial also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, with a higher early viral response (EVR) rate in patients receiving the 0.3 mg/kg dosing level. While the EVR rate was greatest in the interferon-containing group by the end of the study, based on the nature of late EVR development in the bavituximab containing arms, a longer-term evaluation is needed to adequately compare the effectiveness of bavituximab versus interferon. Peregrine is seeking a partner to further advance the program.