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new discussion board after the merger MSTX SVRA : https://investorshub.advfn.com/Savara-SVRA-32068/
Savara Announces Closing Of Merger With Mast Therapeutics
Commences Trading on Nasdaq Capital Market on April 28, 2017 Under Ticker Symbol "SVRA"
Conference Call Scheduled for Tuesday May 2nd, 2017 at 4:30 p.m. ET / 3:30 p.m. CT
Savara Inc. (PRNewsfoto/Mast Therapeutics)
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Savara Inc.
16:15 ET
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AUSTIN, Texas, April 27, 2017 /PRNewswire/ -- Savara Inc. (NASDAQ: SVRA), a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases, today announced the closing of its previously announced merger with Mast Therapeutics, Inc. (NYSE MKT: MSTX), under which the stockholders of Savara have become the majority owners of Mast, and the operations of Mast and Savara have combined. The post-merger company, named Savara Inc., is based in Austin, TX and features three inhaled product candidates, each in advanced stages of clinical development. The company will be led solely by Savara's current management team. Two independent members of the Mast board remain on the post-merger board together with all five members of the Savara board. Savara's common stock will commence trading on April 28th, 2017 on the Nasdaq Capital Market under the trading symbol "SVRA".
"Savara's transition to the public market marks a significant milestone for us, and serves as testament to the determination of our team as well as the support of our investors to date," stated Rob Neville, Chairman and CEO of Savara. "Savara's team is passionate about helping those who suffer from rare and debilitating lung diseases and will dynamically pursue opportunities to develop impactful products to treat such conditions. We believe Savara presents an attractive business opportunity with our pipeline of unique products with considerable market potential, as well as significant value-driving clinical milestones."
Savara began the development of AeroVanc in 2010 and is now in preparation for a pivotal Phase 3 study. In July 2016, Savara acquired Serendex Pharmaceuticals adding Molgradex to its pipeline. Molgradex is currently in Phase 2/3 development. With the closing of the Mast merger, Savara adds the Aironite program to its pipeline (also known as AIR001). Savara intends to continue its growth strategy focused on indication expansion, strategic development partnerships and product acquisitions.
In connection with the closing of the merger, Mast effected a 1 for 70 reverse split of its common stock. Post-merger and post-reverse split, Savara has approximately 15 million shares of common stock issued and outstanding with prior Savara stockholders collectively owning approximately 77% of the combined company, and prior Mast stockholders collectively owning approximately 23% of the combined company. Prior to the merger closing, Savara stockholders exercised certain previously issued warrants to purchase Savara shares and invested additional capital into the company, resulting in aggregate net proceeds of approximately $4 million.
Savara's pipeline now includes:
Molgradex, an inhaled nebulized GM-CSF to treat pulmonary alveolar proteinosis (PAP) currently in Phase 2/3 development;
AeroVanc, an inhaled dry-powder vancomycin to treat chronic methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in cystic fibrosis (CF) in preparation for a pivotal Phase 3 study; and
Aironite, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction (HFpEF) currently in Phase 2 development.
Select Development Milestones
Completing negotiations with the U.S. Food and Drug Administration (FDA) on the requirements for a pivotal clinical study of Molgradex in the U.S. in Q2/2017;
Initiating a pivotal Phase 3 study of AeroVanc in Q3/2017;
Announcing an indication expansion strategy of Molgradex for the treatment of a rare lung infection in Q3/2017;
Announcing top-line results from a Phase 2/3 study of Molgradex, expected to be registration-enabling in Europe and Japan, in Q1/2018; and
Announcing results from an ongoing Phase 2 study of Aironite being conducted by the Heart Failure Clinical Research Network in H1/2018.
Conference Call and Webcast
Savara will hold a conference call on Tuesday May 2nd, 2017, at 4:30 p.m. Eastern Time / 3:30 p.m. Central Time to provide an overview and business update. Interested parties may access the conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from outside the U.S. and should request the Savara Inc. Call. A live webcast of the conference call will be available online from the Investors section of Savara's website at http://www.savarapharma.com/investors/events/. Replays of the webcast will be available on Savara's website for 30 days and a telephone replay will be available through May 9th, 2017 by dialing (877) 344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. and entering replay access code 10104600.
the Mast nightmare's over: merger closed . From tomorrow the ticker will be SVRA and the CEO Neville
management of the merger in Culley's style: awful, as usual
pain for long until Culley is the CEO , also the last day or even the last hours.
The website is up and runing i have no problem getting into the site ,,
I would guess they will put out the news after hours ,i am hoping for blow out for a change DREAM BABY GO M $ T X ..........
Dreams Due come true sometimes lets hope and dream that this is one of them , Go M $ T X ,,,,
Two things:
1. The increased price if the merger is approved will dilute the retail price. There will be initial pull back.
2. Reverse mergers are 90% plus ineffective.
But in saying that, I wish all of you luck. Penny's are def hard, so the longs deserve this :)
OHH YES new high of the day,,,,,,, i guess someone knows something that we don't know yet ,,,,,,,,,,next we need to break the .1490 mark,,,, LET'S GOOO
I guess so , might go KABOOOOM
Seems like traders waiting for some kind of update before buying or selling ....
We have to break the resistance wall @.14!!!
I hope they are calling all the shareholders that have not yet voted. Still 2 days to vote
I get that feeling too. The vote has been poorly managed: quite late and inadequately. I hear some votes had not been recorded or not entirely,they did it only after voters recalled.
If it doesn't pass there's a possibility of lawsuit.
Even though I have position in this, I can understand where you are coming from.
Only way MSTX will benefit at this point in my opinion is a buyout not a merger.
Trying to recoup my money and bounce.
Really hope I am wrong, but IMO Cully does not desire merger either. He is just seeking to cover bases because of lawsuits. Then he will began suckering new investors.
I feel like Hillary watching the election results, remembering the popular vote doesnt mean sh*t.
I'd hate to admit, but after the merger news got pushed back to Thursday, I am beginning to doubt if this company has any more left in them to go farther. I am exiting hopefully tomorrow when it bounce.
If you define good by management benefits, share options, salary increase's you are absolutely correct.
If you have been a shareholder here you can not really see any benefit to this stock. RS, 4 offerings, dilution, share count tripling in last 7 years. Add to that nothing but 5 failed drug tests in 7 years with 5 new drugs. If you invested $100 7 years ago, management has absorbed all but a dime.
In all fairness can you share one benefit a long shareholder has experienced?
Even management could not plan a successful merger. Thus far along with every "botched" test they could not achieve one simple goal .... merger. The 90% voting are not voting for merger, RS, or name change. They are voting to get rid of management in a worthless CEO Cully ....period.
* * $MSTX Video Chart 04-21-17 * *
Link to Video - click here to watch the technical chart video
No not really . MSTX good company been I have had for 15 years I would recommend buy .
Thank you pray.
The nightmare continues, let's hope it's only for a few days.
Have spoken to Cully personally twice. He is the type that covers bases for that reason. He know how to take advantage of both shareholders as well as institutions, he has made a life from it.
In the case of Savara, he knows Neville has both character and integrity, two items Cully knows nothing about. Rather than drag a company through needless court costs I personally feel Neville would just walk away to save shareholders money and not wasting time. Cully knowing that has set his scheme into motion. If vote passes he gets bonus and praise, it fails Savara walks away with no major losses. In the second case Cully will wine that shareholders just would not get out to vote, not his fault.
Remember management could also care less about shareholders. Cully has rewarded them with bonuses, options and everything at the cost of shareholders. They will never get rid of Cully, that worthless piece of trash.
It has been several years but I stated when Cully added Air it was because he knew EPIC would fail and he could proclaim "we still have a possible Multi Million Dollar Drug" in pipeline with cash. Well it ended just as I predicted. Epic had a 70-80% success rate by Cully, and after failure no follow up why failure? Why Cully knew failure from start. He controlled it.
Cully is the lowest of scum. He is puse of inner cancer hiding itself until it is to late. There was a "Rodney" on this board couple years back that controlled the boards by deleting any non praise of Cully or Mast. Cully mentioned his name in our second conversation. I personally believe he was employed by Mast to pump Cullys schemes.
I think after today MSTX becomes a going concern with a likely selling of assets and a breakup of MSTX
If this time Cully screws over Savara, Neville and investors will take him to court.
Your definitely right about that. I've been watching Mstx from the sidelines out of curiosity ever since I sold a year ago for a decent profit. Mstx is a cash cow to culley, he doesn't care about shareholder value. If the merger doesn't pass Airs will be just another excuse for him to continue this cycle all over again. R/s, dilution, selling false hope. He needs to be replaced.
Cully screws up again. Seven years ago institutional investment was at 53%. You would not even need shareholders, just institutions vote but because of Cullys first RS, dilution, yearly offering, and share count doubling every year Cully can not even get enough votes for merger.
Five failed drug tests in 5 tries in seven years. Over 95% of votes for merger. Do not believe the lie. The 95% are voting to get rid of this worthless advertisement for a CEO that has taken a dollar invested and given shareholders just over a dime in return.
Buys to sells. = 6 to 4.Once people understand progress MSTX is making they will come aboard in numbers.Do your DD this is a winner.
That's a plus for us.It scares some novice buyers and give us time to load up.Wich I did this am In the green already.All I can say is WOW.When this merger takes place we fly.IMO
To date the 44% voted,still not enough to reach the quorum (50% + 1), that are 112 million share-votes out of 255 million shares entitled.
There are therefore 143 million shares without vote, and about 15 million of votes (6%) are still needed for the quorum, likely some hundreds of voters.
I'm not worried because this is not a mission impossible by Friday and surely easy by next week, but Culley's organisation has once again failed!
http://masttherapeutics.com/investors/news/?releaseid=2263203
See your point, would not put it past Culley to somehow screw this up. That is what he is great at.
Read this today .....
"Mast Therapeutics reminds shareholders to vote for the proposed merger with Savara; of the votes received to date, more than 90% are voting in favor of the mergerFont
"The overwhelming majority of Mast stockholders who have submitted their votes have voted in favor of the merger.
However, more votes are needed to meet the required threshold for the merger to be completed," stated Brian M. Culley, Chief Executive Officer of Mast."
Point noted Masala. I respect and understand your decision. Wish you luck and hope we both make a little some some in the weeks to come!
For me selling makes sense, buying back after the split and after the price has stabilized...
Lux1, you make a good and correct point about the R/S. Unfortunately, people don't get the entire R/S thing and assume they are all bad. I've had luck with Reverse Splits in the past, and assuming this merger gets approved , , , it will have a positive effect.
At this point the split ratio is irrelevant. Do you prefer 1 billion shares at one Cent or 10 million shares at one dollar?
It is the same as changing coins in notes, actually a lower float is surely positive for the PPS. In any case it is needed by NYSEMKT rules of the merger that requires 4 or 5 dollar minimum.
Let's think instead of the very positive effects of the merger on this devastated Company: a new pipeline with 3 drugs added and not last a new CEO.
Out today at 1:50 or 1:70 split it doesn't make sense to hold the shares, failure of merger is kind of a scary thought too.....best of luck
the R/S PPS should be $8-$10, to satisfy the AMEX rules of the merger and to attract institutional investors and funds, most of them have $5 as lower limit to invest in the NASDAQ stocks.
IMO
Again, appreciate your response. I have poked around for the info, but not as much to get to thee numbers.
B/R
Shareholders Need To Vote
If you hold or held shares prior to March 15 call 206-265-0326 and ask for Karen.
If you do not vote for merger your vote will be automatic "no." Which is like giving worthless criminal Cully another 7 years to screw investors more.
Also asked her the RS ration. She shared it will be between 50:1 and 70:1 pending on price at vote.
Also asked if I knew shareholders could I give out number. Reply "yes." The number above is for voting purpose only.
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We are a publicly traded biopharmaceutical company headquartered in San Diego, California.
We are leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer, our lead product candidate, for serious or life-threatening diseases with significant unmet needs.
To learn more about our company, please see our Letter from the CEO.
http://www.masttherapeutics.com/investors/
Purpose
Condition | Intervention | Phase |
---|---|---|
Vaso-occlusive Crisis Sickle Cell Disease | Drug: Saline Drug: MST-188 | Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
Official Title: | Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis |
Estimated Enrollment: | 388 |
Study Start Date: | May 2013 |
Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: MST-188 MST-188 injection administered as a continuous infusion 100 mg/kg for 1 hour followed by 30 mg/kg/hr for up to 48 hours. | Drug: MST-188 Other Name: vepoloxamer |
Placebo Comparator: Saline Saline administered as a continuous infusion for up to 49 hours | Drug: Saline |
Ages Eligible for Study: | 4 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mast Therapeutics CT.gov Call Center | 1-888-965-1238 |
Study Director: | Edwin L. Parsley, D.O. | Mast Therapeutics, Inc. |
Responsible Party: | Mast Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT01737814 History of Changes |
Other Study ID Numbers: | MST-188-01 |
Study First Received: | November 27, 2012 |
Last Updated: | September 24, 2015 |
Health Authority: | United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: National Committee of Ethics in Research Dominican Republic: Consejo Nacional de Bioetica en Salud Jordan: Jordanian Food and Drug Administration Lebanon: Institutional Review Board Oman: Academic Accreditation Authority Panama: Ministry of Health Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad Saudi Arabia: Saudi Food and Drug Administration Turkey: Drug and Medical Device Institution Jamaica: Ministry of Health |
sickle cell disease vaso-occlusive crisis |
Anemia, Sickle Cell Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital | Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies |
MST-188 (purified poloxamer 188) is an investigational agent that has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. We initially are developing MST-188 as a treatment for complications arising from sickle cell disease.
AIR001 is a sodium nitrite solution for intermittent inhalation via nebulizer. Nitrite is a direct vasodilator and can be recycled in vivo to form nitric oxide (NO) independent of the classical NO synthase (NOS) pathway. Nitrite mediated NO formation has several beneficial effects, including dilation of blood vessels and reduction of inflammation and undesirable cell growth. Generation of NO from sodium nitrite is not dependent upon endothelial function and is enhanced in the setting of tissue hypoxia and acidosis, conditions in which NOS activity typically is depressed. In early clinical studies, AIR001 demonstrated positive hemodynamic effects with reductions observed in right atrial pressure and pulmonary capillary wedge pressure, as well as improvements in mean pulmonary artery pressures and cardiac output.
We are developing AIR001 for treatment of heart failure with preserved ejection fraction (HFpEF), a condition that affects millions in the U.S. and for which no proven therapeutic agent is available. Numerous lines of evidence suggest that HFpEF is a disease of NO deficiency. We are supporting two institution-sponsored Phase 2a studies in patients with HFpEF to evaluate acute hemodynamic effects of AIR001 and to evaluate its acute effects versus placebo on submaximal oxygen consumption and exercise hemodynamics.
AIR001 Inhalation Solution is sodium nitrite formulated with a phosphate buffer into an inhalation solution. Nitrite is a physiological signaling molecule with roles in intravascular endocrine nitric oxide (NO) production, hypoxic vasodilation, signaling, and cytoprotection after ischemia-reperfusion. Nitrite serves as the largest physiologic reservoir of NO and can be converted to NO independent of NO synthase (NOS) activity.
In experimental models, nitrite use demonstrated improved remodeling both in the pulmonary vasculature and right ventricle. Hemodynamic effects include venodilation with reductions in right atrial pressures, pulmonary and systemic vasodilation with reductions in pulmonary vascular resistance and left atrial pressures, and improved cardiac relaxation. In addition, recent clinical and nonclinical studies have demonstrated that nitrite can stimulate mitochondrial biogenesis and mitochondrial fusion and decrease mitochondrial oxygen consumption through a mechanism distinct from that of NO, which may have utility in treating heart failure.
We obtained the AIR001 program through our acquisition of Aires Pharmaceuticals, Inc. in February 2014. Prior to the acquisition, AIR001 had been tested in more than 120 healthy volunteers and patients with various forms of pulmonary hypertension in three Phase 1 studies and in one Phase 2 study in patients with pulmonary arterial hypertension. While the Phase 2 study was prematurely terminated due to Aires’ capital constraints prior to the acquisition, preliminary data from the study are positive, showing improvements in hemodynamic parameters and in exercise capacity from baseline. There were no treatment-related serious adverse events and methemoglobin levels remained normal (< 1.5%), which distinguishes AIR001 from safety concerns associated with intravenously-administered nitrite.
Data from these early clinical studies support continued clinical development of AIR001. Given the observed hemodynamic improvements of decreased right arterial pressure, decreased pulmonary capillary wedge (or left atrial pressure), as well as improvements in pulmonary vascular resistance and cardiac lusitropic effects, AIR001 may benefit patients with exercise impairment due to heart failure with preserved ejection fraction (HFpEF), for whom these are all desirable effects.
Hemodynamic improvements, improvements in pulmonary artery pressures, and cardiac lusitropic effects observed in earlier studies of AIR001 support AIR001’s potential to benefit patients with heart failure with preserved ejection fraction (HFpEF). We currently are pursuing clinical development of AIR001 for that patient population.
Event Timing
Initiate tQT/QTc Study Completed
Secure Orphan Designation for MST-188 for SCD in EU Completed
Activate First Site in Phase 3 Study Completed
File New Patent Applications Completed
Dose First Subject in Phase 3 Study Completed
Report data from tQT/QTc Study Q3 Completed and Primary Endpoints Met
Request Orphan Designation for MST-188 for ALI in U.S. Q3 Completed and Designation Granted By FDA
Initiate Nonclinical Proof-of-Concept Study in Heart Failure Q3 Completed and POC Data to be released Q1 '14
2014 Activities
Event Timing
Present Data From Nonclinical Proof-of-Concept Study In Heart Failure Q1 '14 Data Released 01/06/14'Showed Significant Statistical Improvement"
Initiate Phase 2 Study in ALI Q1 '14 Initiated
Outcome of review of application for Unique Name Designation For Purified Poloxamer 188 From U.S. Adopted Names Counsel Q1 '14 Granted and Named VEPOLOXAMER
Open First Ex-U.S. Clinical Sites in Phase 3 Trial Q1 '14. Initiated and On Schedule
Submit Abstract with Heart Failure Study Biomarker Data to Major Medical Conference Q2 '14
Request Orphan Designation for ALI in EU Q2 '14 Application Submitted
Initiate Nonclinical POC Study in Stroke Q2 '14 Study Initiated
Initiate EPIC Sub-Study Q2 '14 Initiated On Schedule 06/14/14
Report Results from Phase 2 Study of AIR001 in PAH Q3 '14 Positive Top line Data released 9/8/14
Initiate study with Dept of Defense: MST-188 Resuscitation from major trauma '14 CRADA with US Military Initiated Q3 '14
Receive protocol from FDA for Phase 2 Heart Failure Study Q4'14 FDA Approves Heart Failure Study 12/9/14
2015 Event Schedule
Initiate dosing Phase2a study in AIR001 Q1 '15. INITIATED 2/4/15
Nonclinical Study EMBOLIC STROKE Data Q1 '15: POSITIVE DATA RELEASED 2/11/15
Report nonclinical data for repeat dose on Vepoloxamer in Heart Failure Q1 '15 POSITIVE DATA RELEASE 03/02/15
Phase 2 Study HEART FAILURE Initiate Enrollment Q2 '15 INITIATED 3/23/15
EPIC EXTENSION STUDY (Repeat Exposure) Initiate Enrollment 1st Half '15 INITIATED 5/26/15
Phase 2a Study of AIR001 (WHO GROUP 2) in HFpEF Preliminary Data 2nd Half '15
Phase 2 Study Heart Failure Interim Safety Analysis 2nd Half '15
EPIC STUDY COMPLETE ENROLLMENT Q4 '15
2016 EVENTS
EPIC Top Line Data Q1 2016
Video of Management of Mast Therapeutics $MSTX speaking about MST-188 for Sickle Cell Disease ,orphan drug
http://www.youtube.com/watch?v=eI7inPOiyZM&feature=youtu.be
http://www.masttherapeutics.com/wp-content/uploads/2013/04/EPIC-An-Ongoing-Pivotal-Phase-3-Study-in-Patients-with-Sickle-Cell-Disease-Aug-21-2013.
Filing Company | Date of Filing | Total Reported Shares Owned | Shares Reported on 13F | |
---|---|---|---|---|
Baker Bros LLC | 12/31/14 | 4,774,434 | 4,774,434 | |
BVF Inc. | 3/31/15 | 7,241,600 | 7,241,600! | |
SC 13G | FRANKLIN RESOURCES INC | 02/04/15 | 11,946,100 | 11,946,100 |
Reported via | Event Date | Name | Ticker | Shares * | Change | % of Portfolio |
---|---|---|---|---|---|---|
13F MPM Asset Management | MSTX | 2,551,851 | ||||
13F Vanguard Group | MSTX | 3,382,483 |
http://stockcharts.com/h-sc/ui?s=MSTX&p=D&b=2&g=0&id=p32395513381
http://stockcharts.com/h-sc/ui?s=MSTX&p=D&b=9&g=0&id=p36778398928
http://stockcharts.com/freecharts/gallery.html?MSTX
P: 858-552-0866 F: 858-552-0876
General Inquiries
info@mastthera.com
Investor Relations Contact
ir@mastthera.com
Business Development Contact
busdev@mastthera.com
Careers Contact
hr@mastthera.com
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