STOCKS TELEGRAPH

Tag: PTE stock

  • PolarityTE Inc. (PTE) stock Bounces Back After Hours Following its Descent to New Low

    The regenerative tissue and biomaterials developer, PolarityTE Inc. (PTE) finally made a comeback in the after-hours on April 11, 2022. The stock had been in a long downtrend which culminated in its new 52-week in the prior session. Thus, after closing the regular session near the new low, PTE rebounded and rose by 42.67% in the after-hours. PTE then reached a value of $0.2999 per share at the end of the day.

    Source: Under the Radar

    What Happened with PTE?

    PTE stock had been in a downtrend well before the company shared not-so-impressive earnings on March 30, for the fiscal year 2021. Having declined by over 40% last month and nearly 14% in the past five days alone, the stock was posing for a comeback. Given that there is no other news from the company, the rebound was effectuated by external factors. It seems social media discussions and stock sentiment etc instigated the investors to buy the dip in the stock. Thus, as investors began to purchase the dip, the stock rebounded and surged up in late trading on Monday.

    Additionally, a recent SEC filing reported the date of its Special Meeting of Stockholders for effectuating a reverse stock split in order to regain compliance with Nasdaq listing rules. Other proposals up for a vote in the meeting include the election of class II directors, compensation of executive officers, and ratification of the appointment of PTE’s independent public accountant. The meeting will be held on May 12, 2022, at 10:00 a.m. Mountain Daylight Time.

    Market Outlook

    The wider global regenerative market, as well as the biomaterials segment, are both projected for a bullish outlook in the future. The global biomaterial market is expected to reach $47.5 billion by 2025 at a CAGR of 6.0% from 2020. While the increased funds and grants by government bodies and universities are contributing factors to the growth of the segment the stringent clinical and regulatory processes on the other hand are a restraint. Moreover, the growing healthcare market in emerging economies is expected to boost the segment growth.

    PTE’s Position & Future

    Although the emerging market of biomaterials is full of opportunities, PTE’s growth and future depend on the company’s PIPE and regulatory development. The company has been facing substantial operating losses since the beginning of 2017 with a regulatory clash with the FDA also on reports. Hence, the company then commenced a wind-down of its SkinTE commercial operations as a 361 HCT/P in 2021 and submitted IND after resolving the issues identified by the FDA. Currently, the company is on track to bringing its SkinTE to the clinic for use once again.

  • PolarityTE Inc. (PTE) Stock on the Rise Following Announcement of Positive Topline Data from SkinTE Clinical Trial

    PolarityTE Inc. (PTE) stock prices were up 4.84% as of the market opening on July 28th, 2021, bringing the price per share up to USD$0.85 early on in the trading day.

    SkinTE Clinical Trial

    July 28th, 2021 saw the company announce the final data from its multi-center, randomized, and controlled trial, designed to evaluate the treatment of Diabetic Foot Ulcers. PTE stock’s proprietary investigational product SkinTE, in combination with standard of care, was evaluated against just standard of care alone.

    PTE Stock’s Trial’s Success

    PTE stock reported having successfully met the primary endpoint of the trial of wound closure by the twelfth week of treatment. The secondary endpoint of Percent Area Reduction (PAR) was also met, having been assesses for every even-numbered week from the fourth to the twelfth. The trial had a total enrolment of 100 participants that were split into two equal groups, with one received SOC plus SkinTE, whereas the other cohort received only SOC. The trial was conducted and evaluated across 13 different sites.

    Trial Results

    35 out of the 50 patients, representing 70% of the cohort, who received SkinTE in conjunction with SOC exhibited wound closure at 12 weeks. This is comparable to the 17 patients out of 50, representing 34%, exhibiting wound closure by week 12 with SOC only. 45 out of the 50 patients who received the SkinTE plus SOC treatment received a single application of SkinTE. Treatment with SkinTE in tandem with SOC resulted in an increase in the odds of would closure by a massive 5.37 times versus SOC alone.

    Adverse Event Reports

    The trial reported 148 Adverse events that were attributable to 49 subjects. The SkinTE plus SOC treatment cohort reported 66 AEs among 21 subjects while the SOC treatment group reported 82 Adverse Events, attributable to 28 subjects. Of this total, 26 incidents were Serious Adverse Events, with 12 occurring in the SkinTE plus standard of care across 7 subjects. 14 Serious Adverse Events were reported for the standard of care cohort, allocated across a total of 9 subjects.

    Future Outlook for PTE Stock

    Armed with the resounding success of the results of its SkinTE clinical trial, PTE Stock is poised to capitalize on the opportunities for the proliferation of the treatment. The company is keen to allocate resources towards consolidating and expanding its market footprint. Current and potential investors are hopeful that management will be able to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.