Mast Therapeutics, Inc.(MSTX)- NYSEMKT
  • Mon, Sep. 26, 11:38 AM
    • Mast Therapeutics (MSTX -1.8%), still smarting from last week's massive haircut to its valuation after vepoloxamer failed a Phase 3 study, announces that it will wind down the development of the once-promising drug and focus its development activities on AIR001 (sodium nitrite solution for intermittent inhalation) for the treatment of heart failure with preserved ejection fraction (HFpEF). Three ongoing Phase 2 studies, two in HFpEF and one in pulmonary hypertension, will continue as planned.
    • The company says the vepoloxamer wind-down will reduce its operating expenses ~70%, from $32M - 34M down to $9M - 10M. It will also make the $10M prepayment on its outstanding loan that was triggered by the failure of the Phase 3.
    • AIR001, obtained via its acquisition of Aires Pharmaceuticals in February, is a direct vasodilator that is recycled in vivo to form nitric oxide independent of the classical nitric oxide synthase pathway. In a Phase 2a study, HFpEF patients treated with AIR001 showed a statistically significant decrease in pulmonary capillary wedge pressure during exercise compared to control.
    | Mon, Sep. 26, 11:38 AM | 12 Comments
  • Tue, Sep. 20, 5:14 PM
    • Mast Therapeutics (NYSEMKT:MSTX) says phase-3 EPIC trial of vepoloxamer, which treats individuals with sickle cell disease experiencing vaso-occlusive crisis, did not meet its primary efficacy endpoint.
    • Endpoint was  statistically significant reduction in the mean duration of VOC (82 hours in the vepoloxamer group compared to 78 hours in the placebo group in the intent-to-treat population (p=0.09)). There were no statistically significant differences between treatment groups in the intent-to-treat population across the two secondary efficacy endpoints, rate of re-hospitalization for VOC and the occurrence of acute chest syndrome.
    • Company: "We are exceedingly disappointed with these top-line results... These analyses are limited to just top-line data, so in the coming weeks the Company intends to review the full data set from EPIC. In addition, we plan to perform an interim analysis of the ongoing heart failure trial of vepoloxamer.
    • "However, based on the data we've seen to date, we expect we will terminate all clinical development of vepoloxamer. Consequently, while we evaluate our options, we intend to significantly and immediately reduce our operating expenses and continue our efforts with AIR001, our lead asset in heart failure with preserved ejection fraction, which currently is the subject of a 100-patient phase 2 study expected to complete enrollment by the end of 2017."
    • Conference call tomorrow, September 21, 2016, at 8:00 a.m. ET / 5:00 a.m. PT to discuss the results.
    • Shares -78% to $0.13 AH.
    | Tue, Sep. 20, 5:14 PM | 83 Comments
  • Fri, Sep. 2, 3:12 PM
    • Micro cap Mast Therapeutics (MSTX +23.7%) heads north on a 4x surge in volume. No particular news accounts for the move, but data from a Phase 3 clinical trial, EPIC, assessing lead product candidate vepoloxamer for the treatment of patients with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) are expected this month.
    • Investors need to be cautious here. Enrollment was completed in February and the time periods to assess efficacy endpoints were 4 - 14 days which means the company has been "analyzing" the data for six months. If the results were clearly positive, the announcement would most likely have been made promptly. According to a July letter to shareholders, CEO Brian Culley said the company was working diligently to complete the data cleaning, validation and QA/QC work required to lock and unblind the database. Mast is under additional pressure for a positive outcome because it will have to prepay $10M of the principal balance of an outstanding loan if the trial fails.
    • VOC, a painful complication of SCD, occurs when the circulation of blood vessels is obstructed by sickled red blood cells. One of the most severe forms of VOC is acute chest syndrome which occurs when blood flow to the lungs is restricted.
    • Vepoloxamer is a purified form of a copolymer called poloxamer 188, which selectively adheres to hydrophobic (water repelling) portions of cells and molecules, creating a barrier that inhibits other adhesive hydrophobic interactions. The net pharmacologic effects are improved blood flow, blood clot prevention (fibrinolysis) and reductions in inflammation and thrombosis (blood clotting). On a damaged cell, vepoloxamer restores membrane integrity and provides time for the cell's natural repair mechanisms to restore normal function.
    • Previously: Mast completes enrollment in late-stage study of vepoloxamer in sickle cell disease (Feb. 22)
    • Clarification: In March, the company stated that it expected to report top-line data in Q2. In June, it revised its forecast for the database lock to July with the data readout to follow shortly thereafter. In July, it revised the time line again to September. It attributed the delays to the "multitude of data points in the study and QC/QA procedures "taking longer than expected." [this news item was originally published on Sept. 1]
    | Fri, Sep. 2, 3:12 PM | 138 Comments
  • Tue, Aug. 9, 8:07 AM
    • Mast Therapeutics (NYSEMKT:MSTX): Q2 EPS of -$0.05 beats by $0.01.
    • Cash and equivalents of $35.07M
    • Press Release
    | Tue, Aug. 9, 8:07 AM | 3 Comments
  • Fri, May 6, 9:30 AM
    • Mast Therapeutics (MSTX) Q1 results: Revenues: $0; R&D Expense: $7.9M (+31.7%); SG&A: $2.8M (-22.2%); Operating Loss: ($10.7M) (-10.3%); Net Loss: ($11.2M) (-16.7%); Loss Per Share: ($0.06) (unch); Quick Assets: $37.1M (-9.5%).
    • No guidance given.
    | Fri, May 6, 9:30 AM | 8 Comments
  • Fri, May 6, 8:09 AM
    | Fri, May 6, 8:09 AM | 1 Comment
  • Mon, Mar. 14, 8:59 AM
    • Mast Therapeutics (MSTX) Q4 results: Revenues: $0; R&D Expense: $7.5M (+53.1%); SG&A: $2.5M (+4.2%); Operating Loss: ($9.7M) (-31.1%); Net Loss: ($10.2M) (-39.7%); Loss Per Share: ($0.06) (-20.0%).
    • FY2015 results: Revenues: $0; R&D Expense: $28.3M (+45.9%); SG&A: $11M (+15.8%); Operating Loss: ($39.4M) (-34.5%); Net Loss: ($39.8M) (-38.7%); Loss Per Share: ($0.25) (-8.7%); Quick Assets: $41M (-28.4%).
    • No guidance given.
    | Mon, Mar. 14, 8:59 AM | 1 Comment
  • Mon, Mar. 14, 8:04 AM
    • Mast Therapeutics (NYSEMKT:MSTX): Q4 EPS of -$0.06 in-line.
    | Mon, Mar. 14, 8:04 AM | 16 Comments
  • Mon, Feb. 22, 3:30 PM
    • Mast Therapeutics (MSTX +7.7%) completes enrollment of 388 subjects in a Phase 3 clinical trial, EPIC, assessing lead product candidate vepoloxamer for the treatment of patients with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC). Top-line results should be available in Q2.
    • EPIC's primary endpoint is the reduction in duration of VOC. Secondary endpoints are rehospitalization rate for VOC and occurrence of acute chest syndrome.
    • Vepoloxamer is a purified form of a copolymer called poloxamer 188, which selectively adheres to hydrophobic (water repelling) portions of cells and molecules, creating a barrier that inhibits other adhesive hydrophobic interactions. The net pharmacologic effects are improved blood flow, blood clot prevention (fibrinolysis) and reductions in inflammation and thrombosis (blood clotting). On a damaged cell, vepoloxamer restores membrane integrity and provides time for the cell's natural repair mechanisms to restore normal function.
    • VOC, a painful complication of SCD, occurs when the circulation of blood vessels is obstructed by sickled red blood cells. One of the most severe forms of VOC is acute chest syndrome which occurs when blood flow to the lungs is restricted.
    | Mon, Feb. 22, 3:30 PM | 1 Comment
  • Wed, Feb. 10, 9:37 AM
    • Mast Therapeutics (MSTX -40.2%) prices its public offering of 29,090,910 units at $0.275 per unit. Each unit consists of one share of common stock and one five-year warrant to purchase one share of common at $0.42. Net proceeds will be ~$7.3M. Closing date is February 16.
    • Net proceeds will fund the clinical development and commercialization of vepoloxamer, working capital and general corporate purposes.
    • Previously: Mast initiates equity offering (Feb. 9)
    | Wed, Feb. 10, 9:37 AM | 3 Comments
  • Tue, Feb. 9, 4:42 PM
    • Mast Therapeutics (NYSEMKT:MSTX) commences a public offering of stock and warrants. Price, volume and terms have yet to be announced. Net proceeds will fund the clinical development and commercialization of vepoloxamer, working capital and general corporate purposes.
    | Tue, Feb. 9, 4:42 PM | 11 Comments
  • Nov. 12, 2015, 4:08 PM
    • Mast Therapeutics (NYSEMKT:MSTX): Q3 EPS of -$0.06 in-line.
    | Nov. 12, 2015, 4:08 PM
  • Oct. 26, 2015, 11:58 AM
    • Mast Therapeutics (MSTX -0.7%) commences a Phase 2 clinical trial assessing lead product candidate vepoloxamer for the treatment of chronic heart failure. The 150-subject, randomized, double-blind, placebo-controlled study will assess a new formulation of vepoloxamer (MST-188) in ambulatory patients, ages 18 to 74, diagnosed with Class II or III chronic heart failure who are stable and well-managed, on an established medication regimen for at least four months, have a left ventricular ejection fraction of no more than 35% and have an elevated cardiac troponin I level in the blood.
    • Patients will be randomized to receive one of two doses of vepoloxamer or placebo as a single intravenous infusion over three hours in a non-hospital setting. The study's objective is to assess if vepoloxamer provides a functional and biochemical benefit to damaged heart muscle cells as measured by echocardiograms and blood-based laboratory tests. It will also evaluate vepoloxamer's safety and pharmacokinetics.
    • Vepoloxamer is a purified form of poloxamer 188, which selectively adheres to hydrophobic (water repelling) portions of cells and molecules, creating a barrier that inhibits other adhesive hydrophobic interactions. The net pharmacologic effects are improved blood flow, blood clot prevention (fibrinolysis) and reductions in inflammation and thrombosis (blood clotting). On a damaged cell, vepoloxamer restores membrane integrity and provides time for the cell's natural repair mechanisms to restore normal function.
    • The estimated study completion date is not provided.
    | Oct. 26, 2015, 11:58 AM | 4 Comments
  • Aug. 12, 2015, 4:06 PM
    • Mast Therapeutics (NYSEMKT:MSTX): Q2 EPS of -$0.06 in-line.
    | Aug. 12, 2015, 4:06 PM | 4 Comments
  • May 11, 2015, 10:16 AM
    • Mast Therapeutics (MSTX) Q1 results: Revenues: $0; R&D Expense: $6M (+39.5%); SG&A: $3.6M (+56.5%); Operating Loss: ($9.7M) (-42.6%); Net Loss: ($9.6M) (-50.0%); Loss Per Share: ($0.06) (unch); Quick Assets: $49.9M (-12.9%).
    • No guidance given.
    | May 11, 2015, 10:16 AM
  • May 11, 2015, 8:26 AM
    • Mast Therapeutics (NYSEMKT:MSTX): Q1 EPS of -$0.06 in-line.
    | May 11, 2015, 8:26 AM | 5 Comments