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Tag: healthcare

  • Universe Pharmaceuticals Inc. (UPC) Stock Surges Following Progress on Partnership with Kitanihon

    Universe Pharmaceuticals Inc. (UPC) Stock Surges Following Progress on Partnership with Kitanihon

    Universe Pharmaceuticals Inc. (UPC) stock prices were down by 3.93% as of the market closing on June 29th, 2021, bringing the price down to USD$2.93 at the end of the trading day. Subsequent after-market fluctuations have seen the stock surge by 17.23%, bringing it up to USD$3.47.

    Collaboration with Kitanihon

    May 25th, 2021 saw the company announce having entered into a letter of intent for strategic cooperation with Kitanihon Pharmaceutical. UPC plans to strategically collaborate with a Japanese company that specializes in the research, development, manufacturing, and distribution of healthcare products.

    Details of the LOI

    As per the LOI, the partnership will seek to establish a flagship store on global.jd.com, which is a popular e-commerce platform in China that offers imported products. UPC will operate the flagship store and sell Kitanihon’s products as an exclusive distributor. Distribution of KP’s products will span Chinese and Southeast Asian markets through respective international e-commerce channels, with the aim of fostering growth opportunities for both companies.

    Strategic Partnership

    Furthermore, UPC and KP have agreed to collaborate on the establishing of a medical product research and development center, which will be named Universe Hanhe Medical Research Institute Co., Ltd. Scaffolding by favorable policy treatment from the Chinese government, UPC will make use of its R&D capacity and medicinal resources, while KP will utilize its quality control standards and advanced technologies. Together the two will pool resources towards the development of expanding their portfolio of medical products.

    Joint Venture Facility

    According to the LOI, the achievement of specific strategic goals will lead to the collaborative construction of a manufacturing facility in accordance with the market access requirements from Japan’s Pharmaceutical and Medical Devices Agency (PMDA). The companies will collaborate to ensure the facility will be recognized as a qualified foreign manufacturer of pharmaceutical products, as well as facilitate PMDA certification as a Chinese medicine brand.

    About UPC

    UPC is a pharmaceutical producer and distributor in China that specializes in traditional Chinese medicine derivative products. Its target consumer audience is the elderly, with the aim of addressing physical conditions through the aging process and to facilitate the promotion of their general well-being. With the company’s products being sold in 30 provinces in China, it also distributes and sells biomedical drugs, medical instruments, Traditional Chinese Medicine Pieces, and dietary supplements manufactured by third-party pharmaceutical companies.

    Future Outlook for UPC

    Armed with the expanded pool of resources from its ongoing partnership, UPC is poised to capitalize on the opportunities afforded to it and 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.

  • Exelixis, Inc. (EXEL) Stock Plummets Following Disappointing Interim Results for COSMIC-312 Clinical Trial

    Exelixis, Inc. (EXEL) Stock Plummets Following Disappointing Interim Results for COSMIC-312 Clinical Trial

    Exelixis, Inc. (EXEL) stock prices were down by a significant 19.46% as of the market opening on June 28th, 2021, bringing the price down to USD$18.86 early on in the trading day.

    COSMIC-312 Trial

    June 28th, 2021 saw EXEL announced that its COSMIC-312 Phase 3 pivotal trial met a primary endpoint, wherein the treatment demonstrated substantial improvement in progression-free survival at the planned primary analysis. The trial is designed to evaluate CABOMETYX in combination with atezolizumab versus sorafenib in patients reporting untreated advanced hepatocellular carcinoma.

    Interim Analysis

    Being conducted concurrently, a prespecified interim analysis for the secondary endpoint of overall survival indicated results that favored a CABOMETYX and atezolizumab combined treatment. The data did not reach statistical significant and the company does not expect a high probability of the final analysis resulting in the reaching of statistical significance. The trial is currently ongoing, with plans to continue through to the final analysis of OS, the results of which are forecasted for early 2022.

    Strength of Combined Treatment

    In the evaluation of the primary endpoint of PFS in the PFS intent-to-treat population, the risk of disease progression or death was 37% lower with CABOMETYX in conjunction with atezolizumab, as compared to treatment with CABOMETYX and sorafenib. The combined treatment’s safety was consistent with existing safety profiles of the individual medicines, with no new safety signals being identified. The company is discussing trial results while strategizing its next steps for regulatory filing with the U.S. FDA.

    Shortcomings of Treatment

    While the combined treatment of CABOMETYX in conjunction with atezolizumab has indicated encouraging results for the reduction of the risk of disease progression or death, it fell short of proving significant improvement in OS as compared to the comparator arm. The company is exploring the data it has generated, identifying factors that contributed to the results, including patient demographics, subsequent anti-cancer therapy, and the effects of the pandemic on the trial.

    Scope of Treatment

    With more than 900,000 new cases of liver cancer being diagnosed around the world annually, 90% of the cases are HCC. HCC is a leading cause of cancer-related fatalities, with forecasts of the disease claiming 1 million lives every year by 2030. It is the fastest-rising cause of cancer-related death in the U.S, with patients having a median survival period of 1-1.5 years.

    Future Outlook for EXEL

    With the recent developments with its highly-anticipated trial, EXEL is poised to capitalize on the opportunities afforded to it in order for it to bounce back stronger than ever. 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.

  • CEL-SCI Corp. (CVM) Stock Prices on the Rise Following Continued Development of Multikine

    CEL-SCI Corp. (CVM) Stock Prices on the Rise Following Continued Development of Multikine

    CEL-SCI Corp. (CVM) stock prices were up by 5.20% as of the market closing on June 25th, 2021, bringing the price per share up to USD$25.08 at the end of the trading day. Subsequent premarket fluctuations have seen the stock rise by 7.42%, bringing it up to USD$26.94.

    Bought Deal

    June 11th, 2021 saw the company announce its entering into an underwriting agreement with Kingswood Capital Market. As per the agreement, the underwriter made a purchase of 1.4 million shares of CVM’s common stock. Each share was priced at USD$22.62, with gross proceeds amounting to USD$31.7 million before the deduction of expenses related to the offering. The agreement also included a 30-day option for underwriters to purchase up to an addition 210,000 shares to cover over-allotments.

    MultikineTrial

    December 2020 saw the company’s Phase 3 head and neck cancer study complete database lock and enter the statistical analysis phase. Independent contractors have been hired to conduct the analysis process so as to ensure CVM stays blind to the study data. The company hopes to meet FDA safety and efficacy requirements, with the statistical analysis plan following the protocol states objectives. Furthermore, the company is keen to compile the clinical benefits the Multikine has the potential to provide patients that are newly diagnose, but not yet treated, for advanced primary squamous cell carcinoma of the head and neck.

    Multikine Production Facility

    With the commercial launch of Multikine looming closer, CVM has been allocating resources towards the expansion and upgrading of its proprietary cGMP manufacturing facility for Multikine. Construction began in 2020, with completion anticipated for the next several months. Upon completion, the company plans to double the facility’s capacity to accommodate two shifts for maximum production of Multikine.

    Financial Reports

    The six month period ended March 2021 saw the company report an operating loss of USD$17.3 million, up from the USD$13.6 million reported for the six month period ended March 31st, 2020. Operating loss for the quarter ended March 31st, 2021 was USD$8.5 million, up from the USD$6.7 million reported for the same time period of the prior year. The six and three-month periods ended March 31st, 2021, respectively reported USD$6.9 million and USD$3.3 million in capitalized costs.

    Future Outlook for CVM

    Armed with the nearing commercialization of Multikine, CVM is poised to continue its trajectory of success by allocating resources towards Multikine’s proliferation in the U.S and global markets. 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.

  • CTI BioPharma Corp. (CTIC) Stock Trends Higher Following Progress in Commercialization of Pacritinib

    CTI BioPharma Corp. (CTIC) stock prices stayed stable over the course of the trading day on June 25th, 2021. After-hours trading saw the stock climb by 6.84%, bringing it up to USD$2.50.

    Pacritinib Progress

    The company recently announced progress in their goal of providing pacritinib to myelofibrosis patients with thrombocytopenia, with current treatments leaving a large unaddressed need. The U.S Food and Drug Administration set a PDUFA action date of November 30th, 2021, following the acceptance of an NDA for the innovative drug.

    Ready for Commercialization

    Pushing for the commercialization and proliferation of their treatment, CTIC forecasts launching the drug in the US later in fiscal 2021. The most recent quarter has seen the ramping up of essential pre-commercial activities to facilitate a successful launch. These activities include, but are not limited to, coordinating market access, distribution, and supply chain, disease education, and force field planning and deployment.

    Operating and Net Loss Reports

    Operating loss for the first quarter of the fiscal year 2021 came out to USD$17.1 million, up from the USD$11.9 million reported for the three-month period ended March 31st, 2020. This difference is largely attributable to increases in research and development costs, as well as expenses from general and administrative activities associated with the build to the commercial launch of pacritinib.Net loss for the quarter came out to USD$17.3 million, representing a net loss of USD$0.23 per basic and diluted share. This is up from the USD$12.2 million reported in the prior-year quarter, which represented a net loss of USD$0.20 per basic and diluted share.

    Solid Liquidity Position

    The company reported a solid liquidity position as of March 31st, 2021, with cash, cash equivalents, and short-term investments coming out to USD$37.2 million. Despite being lower than the USD$52.5 million reported as of December 31st, 2021, the company forecasts being set to see its operations through to the fourth quarter of 2021. Significant contributions to this momentum was the equity financing that culminated on April 6th, 2021, generating net proceeds of USD$53.8 million.

    Future Outlook for CTIC

    Armed with a solid liquidity position, CTIC is poised to continue its trajectory of success. The company is keen to continue pushing for the eventual commercialization and proliferation of pacritinib. 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.

  • Milestone Scientific Inc. (MLSS) Stock Surges Ahead of Expansion of Medical Sales Team

    Milestone Scientific Inc. (MLSS) stock prices surged by a hefty 14.15% some time after market trading commenced on June 25th, 2021, bringing the price per share up to USD$2.34. early on in the first half of the trading day.

    Financial Reports

    Revenue for the first quarter of the fiscal year 2021 was reported at USD$2.9 million, a 61% increase on the USD$1.8 million reported for the same quarter of the prior year. The company also reported a strong 32% sequential increase in sales for Q1 2021 as compared to the fourth quarter of the fiscal year 2020. Net loss was down significantly, as were operating expenses, as the company strove towards a leaner financial structure. The company’s dental segment continued to have a positive cash flow on a stand alone basis, ushering in continued growth opportunities.

    Flagship Technology

    The company continues to allocate resources and its primary focus towards the commercialization and proliferation of its CompuFlo Epidural System within our medical segment. As the prevalence of the CompuFlo Epidural Instrument and CathCheck System rises among medical institutions, the company continues to aggressively build the sales and market organization in preparation for the next phase of their growth.

    Snowballing Growth

    The latest commercial orders from various renowned hospitals serve to validate the safety and efficacy of MLSS’s technology, which set it apart from conventional syringe-based applications. 2021 is expected to be a year rife with transformative growth for the medical business, with the company keen to execute their goal of setting a new standard of care for epidural procedures in labor and delivery with their medical instruments and disposables.

    Strong Liquidity Position

    With the company reporting USD$17 million in cash and cash equivalents as of March 31st 2021, their strong liquidity positive offers them the ability to accelerate their sales and marketing activities, centering around both dental and medical instruments. MLSS is eager to advance the development and commercialization of their proprietary DPS Dynamic Pressure Sensing Technology, which they believe to indicate further growth opportunities. With the recent changes in leadership, the company is ready for an unprecedented rest of the year.

    Future Outlook for MLSS

    Armed with a solid liquidity position, MLSS is poised to continue its trajectory of success as it establishes itself as the new standard in healthcare. Current and potential investors are hopeful that management will continue leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Keros Therapeutics, Inc. (KROS) Stock Trending Lower Despite Success of Phase 2 Clinical Trial of KER-050

    Keros Therapeutics, Inc. (KROS) stock prices were down by 11.98% shortly after market trading commenced on June 23rd, 2021, bringing the price per share down to USD$46.28.

    Success of Phase 2 Trial

    June 22nd, 2021 saw the company announce preliminary results rom Cohorts 1 and 2 of its Phase 2 clinical trial. The trial is designed to evaluate KER-050 for the treatment of anemia and thrombocytopenia in patients with very low- to intermediate-risk myelodysplastic syndromes. Patients may or may not have ring sideroblasts and may or may not have been previously treated with an erythroid stimulating agent.

    Details of the Trial

    The ongoing trial is an open-label, two-part, multiple ascending dose trial that is designed to assess the trial’s safety, tolerability, pharmacokinetics, and pharmacodynamics of the treatment in MDS patients. 12 patients had received at least one dose of the treatment as of May 14th, 2021, 9 of whom had been administered the treatment for a period of 8 weeks. Patients in Cohort 1 were administered 0.75mg/kg of KER-050, while Cohort 2 patients received 1.5 mg/kg. Both cohorts were treated once every four weeks for 12 weeks.

    Scope of KER-050

    The preliminary results were promising, with increases being observed in hematological parameters in the two lowest Part 1 dose cohorts, who were dosed monthly, in both RS and non-RS patients with MDS. This initial success signals proof-of-concept of the treatment in patients with very low- to intermediate-risk MDS, which support the scope of KER-050 as a treatment for disease associated with ineffective hematopoiesis.

    Expansion of Trial

    Furthermore, based on the success of the preliminary results, the company plans to extend the duration of the trial from 12 weeks to up to two years. This is to better facilitate the defining of response rate following six months of treatment with KER-050, as well as to confirm the durability of response. KROS also plans to update the protocol to expand the size of Part 2 of the trial to consolidate response rates, as well as to help guide the design of the expected registration program. Part 2 trial designs are expected by the end of 2021.

    Future Outlook for KROS

    Armed with the success of its clinical trial, KROS is poised to capitalize on the opportunities afforded to it to push for the commercialization and proliferation of KER-050. The company is keen to usher in further growth with the potential of its expanded footprint. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Surgaline Holdings, Inc. (SRGA) Stock Exhibits Continued Volatility Ahead of Collaboration with Inteneural

    Surgaline Holdings, Inc. (SRGA) stock prices were down by a marginal 2.92% as of the market closing on June 22nd, 2021, bringing the price per share down to USD$1.33 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock climb 4.51%, bringing it up to USD$1.39.

    Registered Direct Offering

    June 14th, 2021 saw the company announce the closing of its ongoing registered direct offering, wherein the company issued and sold a total aggregate of 28,985,508 million shares of its common stock at a purchase price of USD$1.725.. In addition to the shares, warrants were issued for the sale of the same number of shares of common stock, with the warrants also being priced the same as the shares. The warrants are exercisable immediately and will expire three years from the date they are issued. As pr Nasdaq rules, the registered direct offering was priced at-the-market.

    Purpose of Offering

    The gross proceeds generated from the offering came out to almost USD$50 million before the deduction of expenses related to the offering, such as placement agent fees. The company plans to allocate the capital from the offering towards working needs and general corporate purposes. This includes preparation for the approval, utilization, and ongoing development of its digital surgical guidance system.

    Collaboration with Inteneural

    Earlier on June 7th, 2021, the company had announced its strategic collaboration agreement with Inteneural Networks Inc. As per the agreement, the company would gain access to Inteneural’s proprietary technology, allowing for the evaluation of eventual integration within the Surgaline digital surgery portfolio. With the application of digital surgery in spine procedures being the company’s initial focus, it has a much broader vision of the potential it hopes to untap.

    Scope of Partnership

    The collaboration is built on a foundation of overwhelmingly positive feedback the company has garnered from spine surgeons, many of whom also specialize in neurosurgery. The feedback was based on SRGA’s demonstrations of its proprietary Holosurgical platform. The agreement has a period during which SRGA will evaluate its partner’s technology on an exclusive basis. The two will also discuss the feasibility of a more comprehensive collaboration.

    Future Outlook for SRGA

    Armed with the extra capital from its registered direct offering and a partnership that will significantly expand the company’s scope, SRGA is poised 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.

  • Tenax Therapeutics (TENX) Stock Skyrockets Ahead of Inclusion in Russell Microcap Index

    Tenax Therapeutics (TENX) stock prices opened and closed at USD$1.90 on June 22nd, 2021. After-hours trading saw the stock surge by 21.05%, bringing it up to USD$2.30.

    Russell Microcap Index

    The company recently announced that it was set to join the Russell Microcap Index as of the culmination of the 2021 Russell indexes annual reconstitution effect, which should be in place as of the U.S markets opening on June 28th, 2021. The membership will remain in place for at least one year, pending repeated inclusion in the following year. Consequently, the membership entails automatic inclusion in relevant growth and value style indexes. Membership for its Russell indexes is determined by FTSE primarily on the basis of objective, market-cap rankings, and style attributes.

    Scope of Inclusion

    Membership into the Russell Microcap Index comes at a particularly opportune time for the company, as it continues to advance its two lead drug development programs, imatinib, and levosimendan. The programs are anticipated to progress to Phase 3 clinical trials soon. The next several months will also see the company welcome important research publications that will serve to support the company’s pioneering approach towards the treatment of Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction.

    Advantages of Inclusion

    Inclusion in the index means increased visibility of the company among institutional investors during a critical stage of the company’s development. The Russell indexes are broadly used for index funds and as benchmarks for active investment strategies by investment managers and institutional investors. There are currently almost USD$10.6 trillion worth of assets benchmarked against Russell’s US indexes, which are a part of Russell indexes, a leading global index provider.

    FTSE Russell

    FTSE Russell provides innovative benchmarking, analytics, and data solutions for a global consumer-base of investors. Russell calculate a massive number of indexes that serve to measure and benchmark markets and asset classes spanning more than 70 countries. 98% of the investable market on a global scale is covered by FTSE Russell.

    Future Outlook for TENX

    Armed with the significant achievement that will open many more doors for the company, TENX is poised to capitalize on the opportunities afforded to it. The company is keen to continue its trajectory of success and usher in further growth. 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.

  • Aytu BioPharma, Inc. (AYTU) Stock Surges Following Developments Stemming from Merger with Neos

    Aytu BioPharma, Inc. (AYTU) Stock Surges Following Developments Stemming from Merger with Neos

    Aytu BioPharma, Inc. (AYTU) stock prices were up a significant 13.85% shortly after market trading commenced on June 21st, 2021, bringing the price up to USD$5.39 early on in the trading day.

    Net Revenue Reports

    Net revenue for the third quarter of the fiscal year 2021 was reported at USD$13.5 million, up from the USD$8.2 million reported for the same quarter of the prior fiscal year. This increase is largely attributable to the continued increase in sales through organic product growth, as well as through the realization of the recently completed Neos transaction.

    Net Revenue Breakdown

    Net revenue generated from the consumer health division was reported at USD$8.4 million, a significant increase over the USD$3.5 million reported for the same quarter of the prior fiscal year. This increase was largely attributable to the multiple product launches over the 2021 quarter. Further compounding the year-over-year increases, the growth of the company’s e-commerce channel has greatly increased its scope. The Rx division reported generating net revenue in the amount of USD$5.1 million, up from the USD$4.7 million reported in the year-ago quarter.  The increase was largely driven by product revenue arising from the transaction with Neo, which closed on March 19th, 2021.

    Net Loss Reports

    Net loss for the first quarter of fiscal 2021 came in at USD$25.5 million, representing a net loss of USD$1.41 per share of common stock The year-over-year increase primarily resulted from expenses related to the Neos merger, amounting to a total of USD$10.6 million. A USD$7.1 million write-offs in slow-moving inventory for the quarter also contributed to the yearly difference.

    Solid Liquidity Position

    The company reported a solid liquidity position, with cash, cash equivalents, and restricted cash amounting to USD$46.8 million as of March 31st, 2021. This report comes after the company made a principal payment of USD$15 million toward the Deerfield Note held by Neos.

    Future Outlook for AYTU

    Armed with a solid liquidity position, AYTU is poised to continue its trajectory of success in light of the opportunities afforded to it by its merger with Neos. 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.

  • ReShape Lifesciences Inc. (RSLS) Stock Undergoes Minor Volatility Following Closing of Merger with Obalon

    ReShape Lifesciences Inc. (RSLS) Stock Undergoes Minor Volatility Following Closing of Merger with Obalon

    ReShape Lifesciences Inc. (RSLS) stock prices were down by 7.64% as of the market closing on June 18th, 2021, bringing the price per share down to USD$5.44 at the end of the trading day. Subsequent pre-market fluctuations have seen the stick climb by 2.02%, bringing it up to USD$5.55.

    Merger with Obalon

    June 16th, 2021 saw the company announce the completion of its previously announced merger with Obalon Therapeutics, after which Obalon changed its name to ReShape Lifesciences Inc. The combined company’s stock name began trading under the ticker symbol on the Nasdaq Capital Market beginning on June 16th, 2021.

    Regaining of Nasdaq Listing

    Having regained the Nasdaq listing requirements, the company is situated to take advantage of the new numerous benefits that come with being listed on the Nasdaq. This includes the chance to increase shareholder value and the expanded visibility in the wider investment community. The completion and reaching of this significant milestone are representative of a pivotal moment in the company’s lifecycle.

    Company Priorities

    The completion of the merger signals the strengthening of the company’s ability to allocate resources towards growth priorities. These priorities include global commercial operations, the integration from this transaction, and the company’s internal technologies that are currently in development. The company is poised to capitalize on its expanded opportunities to be an elite and diversified leader in the physical led weight loss space. The company is dedicated to facilitating a better quality of life for its patients through safe, effective, and accessible medical treatment.

    Leadership Team

    After the closing of the merger, the combined company’s Board of Directors is comprised of five current members of the Board of Directors of Reshape. The current executive officers of Reshape will continue on to be executive officers of the combined company. ReShape shareholder went on to own 51% of the combined company’s stock after the merger, while the other 49% was held by Obalon stockholders.

    Scope of RSLS

    The premier weight-loss solutions company as an impressive integrated catalogue of proven products and services that are designed to manage and treat obesity and metabolic disease. The Lap-Band has been approved by the FDA and provides minimally invasive, long-term treatment of obesity. The program is an alternative to surgical stapling procedures that are much more invasive, such as gastric bypass and sleeve gastrectomy.

    Future Outlook for RSLS

    Armed with the expanded resources offered to it by its recent merger, the company is poised 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.