STOCKS TELEGRAPH

Tag: healthcare

  • Aligos Therapeutics, Inc. (ALGS) Stock Plummets Following Pricing of Public Offering of Common Shares

    Aligos Therapeutics, Inc. (ALGS) stock prices were down by a hefty 17.19% shortly after market trading commenced on July 1st, 2021, bringing the price per share down to USD$16.88 early on in the trading day.

    Public Offering

    June 30th, 2021 saw the company announce the pricing of its previously announced underwritten public offering, wherein ALGS will put up 4.4 million shares of its common stock for sale. As per the announcement, the public offering price will be USD$19.00 per share of common stock. Underwriters have also been granted a 30-day option to purchase up to an additional 660,000 shares of common stock in the case of over allotments.

    Details of the Offering

    The public offering is expected to generate gross proceeds in the amount of roughly USD$83.6 million before the deduction of any expenses related to the offering. This total also does not include capital generated from the exercising of the underwriters’ option to purchase addition shares. The offering is expected to close on July 6th, 2021, pending the satisfaction of customary closing conditions.

    Net Loss Reports

    Net loss for the quarter ended March 21st, 2021 was reported at USD$27.7 million, representing a net loss of USD$0.74 per basic and diluted common share. This is up from the USD$20 million reported for the same quarter of the prior year, representing a net loss of USD$7.56 per basic and diluted common share. The company reported cash, cash equivalents, and marketable securities in the amount of USD$213.4 million for the quarter, as compared to the USD$243.5 million reported as of December 31st2020.

    R&D Expenses

    Research and development costs were up to USD$22.9 million for the quarter ended March 31st, 2021, an increase from the USD$17.3 million reported for the prior-year quarter. This difference was largely driven by expenses related to the company’s ongoing development of ALG-010133 and ALG-000184 clinical trial activities. Further contributing to the year-over-year difference were increases in salaries and employee-related expenses and preclinical programs. The company reported USD$1.7 million in total R&D stock-based compensation expense for the 2021 quarter, as compared to the USD$0.2 million reported in the prior-year quarter.

    Future Outlook for ALGS

    Armed with a solid liquidity position that is to be further consolidated with the closing of its public offering, ALGS is poised to capitalize on the expanded opportunities in front of it. Investors are hopeful that management will continue to leverage the resource at their disposal to facilitate significant and sustained increases in shareholder value.

  • Orchard Therapeutics plc (ORTX) Stock on the Rise Following Collaboration with Pharming Group

    Orchard Therapeutics PLC (ORTX) stock prices were down by a marginal 2.44% as of the market closing on June 30th, 2021, bringing the price per share down to USD$4.39 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 8.66%, bringing it up to USD4.77.

    Collaboration with Pharming

    July 1st 2021 saw the company announce its strategic collaboration with Pharming Group N.V. to research, develop, manufacture, and commercialize OTL-105. The newly disclosed investigational ex vivo autologous hematopoietic stem cell (HSC) gene therapy is designed to treat hereditary angioedema (HAE), which is a rare disorder that causes recurring swelling attacks in the face, throat, extremities, and abdomen and can be fatal.

    OTL-105

    The investigational HSC gene therapy OTL-105 is designed to prevent hereditary angioedema attacks by increasing C1 esterase inhibitor (C1-INH). It inserts one or more functional replicas of the SERPING1 gene into the HSCs of patients ex vivo, which are then transplanted back into the patient for suitable durable C1-INH production. Preclinical studies to date have seen the treatment demonstrate high levels of SERPING1 gene expression via lentiviral-mediated transduction in multiple cell lines and primary human CD34+ HSCs.

    Details of the Agreement

    As per the terms of the agreement, Pharming has been granted worldwide rights to OTL-105 after having been also given the responsibility for its clinical development, regulatory filings, and commercialization of the investigational gene therapy, which will include covering associated costs. ORTX will oversee the completion of IND-enabling activities as well as the manufacturing of the treatment during pre-clinical and clinical development, with the funding being provided by Pharming. Furthermore, both companies will collaboratively explore the application of non-toxic conditioning regimen for use in tandem with OTL-105 administration.

    Financial Details

    The company will be given an upfront payment of USD$17.5 million, which will consist of USD$10 million in cash and USD$7.5 million equity investment from Pharming. The equity investment will include a premium to the company’s recent share price. ORTX is also eligible to receive up to USD$189.5 million in regulatory, development, and sales milestones, as well as royalty payments on future worldwide sales in the range of mid-single to low double-digits.

    Future Outlook for ORTX

    Armed with the recent collaboration that is likely to expand the scope of ORTX’s operations over the future, the company is poised to capitalize on the increased opportunities afforded to it. Investors are hopeful that company will be able to continue its trajectory of success and usher in unprecedented growth.

  • Alterity Therapeutics Ltd. (ATHE) Stock Skyrockets as Meme Stock Phenomenon Continues to Proliferate Stock Exchange

    Alterity Therapeutics Ltd. (ATHE) stock prices were down by 1.52% as of the market closing on June 30th 2021, bringing the price per share down to USD$1.30 at the end of the trading day. Subsequent pre-market fluctuations saw the stock skyrocket by a massive 66.92%, bringing it up to USD$2.17.

    EMA Guidance

    June 23rd, 2021 saw the company announce guidance it had received from the European Medicines Agency (EMA) in regard to key aspects of ATHE’s Phase 2 clinical trial for the treatment of Multiple System Atrophy (MSA) with its investigational drug ATH434. The company is actively preparing for the impending launch of the Phase 2 trial, which is scheduled to commence in the second half of 2021.

    About the EMA

    The EMA is an agency with jurisdiction in the European Union, with the responsibility of evaluating and supervising medicinal products. The agency plays a crucial role in the timely support of the sound development of high-quality, effective, and safe medicines for the treatment of respective patients. With their advice not being binding, the EMA influences improved trial designs to facilitate more robust and complete data in the evaluation of treatments.

    Scope of ATH434

    With MSA affecting a sizeable portion of the U.S population and the absence of any approved treatments for MSA, the scope of ATH434 is extensive. There is no regulatory precedence for defining clinical endpoints or guiding patient enrollment, thus requiring greater consideration in developing a trial design that is most suitable. Accordingly, the company has recruited clinical experts and global regulatory authorities for input. ATHE is also conducting BioMUSE, a natural history study designed to identify biomarkers and clinical endpoints most appropriate to capture efficacy signals in the Phase 2 study.

    Meme Stock Phenomenon

    Despite the promising development of the course of the ATH434 trial, the recent surge in ATHE’s stock price seems unmerited. Such drastic movement in the absence of news coverage or changes in fundamentals likely signals the company having been the latest target of the meme stock phenomenon that has resurged in the stock market. Driven by Reddit-based retail investors, underperforming companies with high short interest are selected for a coordinated short squeeze.

    Future Outlook for ATHE

    Armed with the recent surge in its equity value, ATHE finds itself with a fortuitous influx of resources to leverage in order to ensure more organic growth. Investors are hopeful that the company will manage to use the resources at its disposal to continue its trajectory of success.

  • Check-Cap Ltd. (CHEK) Stock Plummets Following News of Registered Direct Offering

    Check-Cap Ltd. (CHEK) Stock Plummets Following News of Registered Direct Offering

    Check-Cap Ltd. (CHEK) stock prices were down by 19.5364% some time after market trading commenced on June 30th, 2021, bringing the price per share down to USD$1.2150 early on in the trading day.

    Registered Direct Offering

    The company announced on June 30th, 2021 that it had entered into various definitive agreements with institutional and accredited investors. As per the agreement, the company would put up 25,925,926 ordinary shares of the company for sale, along with warrants to purchase up to the same number of ordinary shares. The registered direct offering is seeing each ordinary share being sold in conjunction with one short-term warrant to purchase one ordinary share at a combined offering price price of USD$1.35 per ordinary share and accompanying warrant.

    Share Warrants

    The short-term warrants will have an expiry date of two and a half years following the date of issuance and will be exercisable immediately with an exercise price of USD$1.50 per ordinary share. The closing of the registered direct offering is expected to close on July 2nd, 2021, pending the satisfaction of customary closing conditions.

    Capital Generation

    CHEK forecasts generating roughly USD$35 million in gross proceeds from the offering, before the deduction of expenses related to the offering. This number does not include proceeds received from the exercising of warrants, the full exercising of which will generate additional gross proceeds of roughly USD$38.9 million before the deduction of offering-related expenses. The capital generated from the offering is planned on being allocated towards advancing the ongoing clinical development of C-Scan, including the company’s upcoming U.S pivotal study.

    Manufacturing Hickups

    Technical issues with a single source supplier resulted in delays in manufacturing, but the company continues to develop and expand its entire production process in order to meet its target manufacturing capacity. Consequently, the company forecasts delays in its clinical trials, at the forefront of which is the U.S. pivotal trial which has an updated commencement date in the first quarter of 2022. The company is continuing to scale its manufacturing up to support the upcoming clinical trials once production returns to normal.

    Future Outlook for CHEK

    Armed with an influx of capital generated from its registered direct offering, CHEK is poised to initiate clinical trials that the company hopes to see through to commercialization. Investors are keen for the company to resume normal manufacturing and allocate resources efficiently, so as to ensure maximum possible growth and increases in shareholder value.

  • Streamline Health Solutions, Inc. (STRM) Stock on the Rise Following Acquisition of New Contract

    Streamline Health Solutions, Inc. (STRM) Stock on the Rise Following Acquisition of New Contract

    Streamline Health Solutions, Inc. (STRM) stock prices were up by 7.02% shortly after market trading commenced on June 30th, 2021, bringing the price per share up to USD$1.84 early on in the trading day.

    New Contract

    June 30th, 2021 saw the company announce the signing of a contract with a 2,367-bed, Epic EMR-based health system serving the Midwest U.S. STRM’s eValuator cloud-based automated pre- and post-bill coding analysis technology will be used by the health system to improve revenue integrity, as well as a financial performance from both inpatient and outpatient services.

    Scope of eValuator

    The company is revolutionizing the industry with a movement to facilitate financial improvement with the use of pre-bill technology. eValuator offers providers the chance to address coding issues before they contribute to lower revenues, denied claims, and non-compliance exposure. STRM combines this innovative technology with expert auditing services in order to provide its clients with a comprehensive Revenue Integrity Program. The eValuator program substantially improves current financial performance by helping users optimize coding and documentation accuracy for pre-billing patient encounters. The program also serves to assist providers in making the transition to new payment models.

    PPP Forgiveness

    STRM announced on June 16th, 2021 that it had received a notice from Western Alliance Bank, the lender of the company’s Paycheck Protection Program loan which approved the forgiveness of the PPP loan. A total of USD$2,300,600 had been approved to be written off by the U.S. Small Business Administration. The financial support stemming from the implementation of the CARES Act has helped U.S businesses stay afloat over the course of the devastating coronavirus pandemic. The loan-turned-grant allowed the company to maintain its workforce despite the effects of the Covid-19 situation.

    Revenue Reports

    Revenues for the first quarter of the fiscal year 2021 were reported at USD$3 million, up from the USD$2.9 million reported in the prior-year quarter. SaaS revenue was up a very healthy 32% as compared to reports from the first quarter of the fiscal year 2020, largely contributing to the growth in total revenues for the quarter. The increase was partially offset by lower revenue from professional services, audit services, and maintenance and support.

  • Diffusion Pharmaceuticals, Inc. (DFFN) Stock Undergoes Minor Volatility Ahead of TCOM Trial Findings

    Diffusion Pharmaceuticals, Inc. (DFFN) Stock Undergoes Minor Volatility Ahead of TCOM Trial Findings

    Diffusion Pharmaceuticals, Inc. (DFFN) stock prices were down by 3.33% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.7557 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 5.99%%, bringing it up to USD$0.801.

    Phase 1 Trial

    The company announced topline results from its Phase 1 trial of trans sodium crocetinate (TSC), its lead product candidate, on June 30th, 2021. Transcutaneous oxygen monitoring (TCOM) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers enrolled for the trial. Topline results were founded on analyses of the primary endpoint data, indicating a positive dose-response trend in TCOM readings after TSC administration during the measurement period, as compared to a placebo.

    Trial Results

    Statistical significance was not reached in the magnitude of the treatment’s effect, largely because of the small number of healthy subjects in each cohort, as well as the inherent variability of tcp02 measurement. Despite this, primary endpoint data trends indicated improved peripheral oxygenation as compared to the placebo, with no evidence of hyperoxygenation. TSC was found to be safe and well-tolerated at all doses tested in the trial, with no major adverse events or dose-limiting toxicities.

    Scope of TSC Data

    The data collected served to further elucidate TSC’s exposure-response relationship, which the company will use to build on their clinical development strategy. Upcoming study designs for future trials will be informed by the collected data, as will the ongoing investigation of the timing of administration to maximize clinical efficacy. DFFN believes the data will complement findings from the company’s Covid-19 trial, as well as supporting the ongoing execution of its three well-controlled Oxygenation Trials.

    Supporting TSC Trials

    Each trial is uniquely designed to differentially explore TSC’s unique mechanism of action, with the individual and collective data from these studies forecasted to inform the company’s late phase programs and clinical indications in the push for the commercialization of TSC. The first of the trials was the TCOM Trial, with the primary endpoint evaluating the relative change in TCOM readings from baseline after TSC administration as compared to the placebo.

    Future Outlook for DFFN

    Armed with the recent results of their most recent clinical trial, DFFN is poised to capitalize on the opportunities afforded to it by the expanded scope of options made available to it. Investors are confident that the company will continue to ensure a continued trajectory of success by making use of the resources at their disposal and trial findings as they arise.

  • HUTCHMED (China) Ltd. (HCM) Stock Surges Following Listing on Hong Kong Exchange

    HUTCHMED (China) Ltd. (HCM) Stock Surges Following Listing on Hong Kong Exchange

    HUTCHMED (China) Ltd. (HCM) stock prices were up down by a minor 0.81% as of the market closing on June 29th, 2021, bringing the price per share down to USD$33.23 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 14.35%, bringing it up to USD$38.00.

    Hong Kong Listing

    The company had a massively successful first day of trading in Honk Kong, having been listed after a delayed previous attempt earlier in 2019. The earlier plan to list was shelved amid market uncertainties at the time. The biopharmaceutical company’s shares that were already trading on in the U.S and U.K jumped a massive 51%, with the company raising USD$537 million in their offering.

    Global Offering

    June 23rd2021 saw the company announce the pricing of its global offering which comprises an international offering and a Hong Kong public offering in connection with a primary listing of its ordinary shares on the Stick Exchange of Hong Kong Ltd.’s Main Board. The offering will see the sale of up to 104 million new ordinary shares of HCM.

    Pricing of Global Offering

    Both the International Offering and the Hong Kong Public Offering final offer price has been set at roughly USD$25.82 per American depositary share (ADS), with each ADS representing 5 ordinary shares of the company. The offer price was determined by the closing price of the company’s ADSs on the Nasdaq Global Select Market and shares on the AIM market of the London Stock Exchange on June 22nd, 2021. Shares are expected to begin trading on June 30th, 2021, pending approval from the SEHK.

    Offering Details

    The offering is expected to generate USD$0.54 billion in gross proceeds, before the deduction of expenses related to the offering. The agreement also comes equipped with an option for international underwriters to buy up to 15.6 million new issued Shares at the offer price, in case of over-allotments. This option is available for 30 days after the last day of lodging applications under the Hong Kong Public Offering.

    Allocation of Resources

    Net proceeds generated from the global offering are forecasted to be allocated towards the advancement of the company slate-stage clinical programs, as well as its pipeline of clinical-stage and preclinical stage candidates. This move serves to consolidate the company’s commercialization, clinical, regulatory, and manufacturing capability, as well as fund future opportunities and acquisitions.

    Future Outlook for HCM

    Armed with a solid liquidity position, HACM is poised to capitalize the added resources generated from its global offering. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) stock prices were down by a marginal 0.52% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.93 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 5.91%, bringing it up to USD$0.98.

    Sofpironium Bromide Gel, 15%, Study

    The company’s U.S Phase 3 clinical program is comprised of two pivotal studies designed to evaluate sofpironium bromide gel, 15%. Cardigan I and Cardigan II each have approximately 350 subjects enrolled, each of which is above the age of 8 and has primary axillary hyperhidrosis. The efficacy and safety of topically applied sofpironium bromide gel will be evaluated in the multicenter, randomized, double-blinded, vehicle-controlled studies, with safety and tolerability assessments being performed throughout the studies.

    Details of the Study

    The regimen consists of subjects applying the treatment or a placebo to their underarms once daily before sleeping at night for a period of six consecutive weeks, with a 2-week post-treatment follow up. The co-primary efficacy endpoints of both studies include the demographic of patients that exhibited at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, which is a proprietary and validated patient-reported outcome measure. The studies will also evaluate changes in gravimetric sweat production (GSP) from baseline to the end of treatment.

    Scope of Clinical Study

    Topline results from each of the Cardigan clinical studies is expected for the fourth quarter of 2021. The success of these results will form the basis of a potential NDA in the U.S for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.

    Phase 1 PPH Clinical Study

    June 24th, 2021 had seen the company announce that its development partner, Kaken Pharmaceutical, had initiated a Phase 1 clinical study to assess the pharmacokinetics of sofpironium bromide gel. The Study would assess the efficacy and safety of the treatment in patients with primary palmoplantar hyperhidrosis in Japan. PPH is a medical disorder that is very common, resulting in excessive sweating from the palms and soles. Primary palmar hidrosis is estimated to affect 5.33% of the Japanese population, while primary plantar hyperhidrosis is thought to affect 2.79% of the population. With no existing approved topical prescription treatments available for PPH in Japan, the study’s scope is potentially massive.

    Future Outlook for BBI

    Armed with a solid liquidity position, BBI is poised to capitalize on the strides made in its clinical studies, with the company pushing for the commercialization and proliferation of sofpirinium bromide gel, 15%. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • VBI Vaccines Inc. (VBIV) Stock Dips Despite Promising Data from Covid-19 Vaccine Trial

    VBI Vaccines Inc. (VBIV) Stock Dips Despite Promising Data from Covid-19 Vaccine Trial

    VBI Vaccines Inc. (VBIV) stock prices were down by 8.5586% some time after market trading commenced on June 29th 2021, bringing the price up to USD$3.6668 earlier on in the trading day.

    Positive Trial Data

    The company announced on June 29th the positive Phase 1 data from its Phase 1/2 of its Covid-19 vaccine candidate, VBI-2902a. The trial saw the administering of the enveloped virus-like particle (eVLP) in healthy adults between the ages of 18 and 54. The 5µg dose expressed an optimized Covid-19 spike antigen, having been adjuvanted with aluminum phosphate.

    Trial Results

    It was generally well-tolerated and exhibited potent immune responses from subjects that were significantly higher than those seen in human convalescent sera. The potency of the eVLP particulate delivery platform against Covid-19 was demonstrated with the findings establishing a robust human proof-of-concept at a low dose and without the use of a next-generation adjuvant.

    Developing eVLPs

    The highly encouraging data furthers the development of the treatment that is being pushed towards commercialization with the support of the Canadian government, CEPI, and the National Research Council of Canada. The next phase of the ongoing adaptive Phase 1/2 study involved the assessment of VBI-2905a, with the commencement of this part of the trial anticipated for the third quarter of 2021.The company is also allocating resources towards developing multivalent eVLP candidates, which are designed to increase the scope of protection against Covid-19. A clinical study of one of these candidates is expected to commence in the first half of 2022.

    Details of the Trial

    The ongoing adaptive Phase 1/2 clinical study is randomized and placebo-controlled, with observers also being blind. Phase 1 assessed a 5µg dose of VBI-2902a, adjuvanted with aluminum phosphate. Treatment regimens included both one and two doses, with the second being administered 28 days after the initial jab. The Phase 1 part of the study saw a total of 61 healthy adults between the ages of 18 and 54, with no history of having been vaccinated against Covid-19.

    Future Outlook for VBIV

    With the world hurtling towards universal immunizations, VBIV is poised to continue its trajectory of success. The company is keen to usher in further growth as it continues to push for increased market penetration. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value

  • PLx Pharma Inc. (PLXP) Stock Trends Lower as Preparations for VAZALORE Launch Continue

    PLx Pharma Inc. (PLXP) Stock Trends Lower as Preparations for VAZALORE Launch Continue

    PLx Pharma Inc. (PLXP) stock prices were down by 4.03% as of the market closing on June 28th, 2021, bringing the price per share down to USD$13.58 at the end of the trading day. Subsequent pre-market fluctuations saw the stock fall by a significant 5.30%, bringing it down to USD$12.86.

    Public Offering

    March 2021 saw the company complete an underwritten public offering wherein PLXP sold 8,924,700 shares of its common stock. Each share was priced at USD$8.00, with the offering having generated gross proceeds in the amount of USD$71.4 million, before the deduction of expenses related to the offering. The company plans to allocate the resources raised towards general corporate purposes, which include, but are not limited to, additions to working capital and capital expenditures.

    Revenue and R&D Expenses

    The company reported no revenue for the first quarter of fiscal 2021, as compared to the USD$2,523 reported for the first quarter of the prior year. The absence of revenue serves as the company’s baseline, with revenue in the 2020 period being attributable to operations under an award of a NIH grant, which concluded in the second quarter of 2020. Research and development expenses for the first quarter of 2021 were up to USD$1 million from the USD$0.5 million reported in the same quarter of the previous year. This difference is largely driven by increases in manufacturing-related activities for the company’s flagship VAZALORE.

    G&A Costs

    Q1 2021 saw the company report USD$2.6 million in general and administrative expenses, marginally higher than the USD$2.5 million reported for Q1 2020. The difference is largely driven by increased pre-launch marketing costs, as well as higher non-cash stock-based compensation. Lower compensation-related expenses and absence of travel costs because of the pandemic resulted in a partial offsetting of the initial year-over-year difference in G&A costs.

    FDA Approval

    The U.S Food and Drug Administration approved PLXP’s sNDA for its lead products, VAZALORE 325 mg and VAZALORE 81 mg. the company is allocating resources towards their commercialization as it strengthened its balance sheet by paying off the balance for a term loan that was due in February of 2021. The commercial launch of VAZALORE is scheduled for the third quarter of 2021

    Future Outlook for PLXP

    Armed with a consolidated balance sheet and the upcoming launch of its new VAZALORE products, PLXP is poised to expand its market footprint with the proliferation of its offerings. The company is poised to capitalize on the opportunities afforded to it and to continue its trajectory of success.Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.