STOCKS TELEGRAPH

Tag: oncology

  • Arvinas, Inc. (ARVN) Stock on the Rise Following Global Partnership with Pfizer

    Arvinas, Inc. (ARVN) stock prices were up by 8.68% some time after market trading commenced on July 22nd, 2021, bringing the price per share up to USD$84.28 early on in the trading day.

    Partnership with Pfizer

    July 22nd, 2021 saw the company announce its global collaboration with Pfizer in order to develop and commercialize ARV-471, an investigational oral PROTAC, estrogen receptor protein degrader. The estrogen receptor has been shown to drive diseases in most cases and forms of breast cancer. The treatment is currently in Phase 2 dose expansion clinical trial, designed to treat patients with estrogen receptor (ER) positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-).

    Details of the Agreement

    As per the agreement, the partnering company will make an upfront payment of USD$650 million to ARVN, as well as a USD$350 million equity investment in the company. Global development costs, commercialization expenses, and profits will be split equally between the partnering companies. The combination of the company’s leadership in targeted protein degradation with Pfizer’s global capabilities and extensive expertise in breast cancer is expected to prove transformational.

    Scope of ARV-471

    This, in turn, will substantially enhance and accelerate the development and eventual commercialization of ARV-471 while concurrently advancing the company’s strategy of building a global and integrated biopharmaceutical company. Despite the advancement of the oncology space over recent years, there is still a sizeable unmet need that persists in the treatment of HR+ breast cancer. The partnership with Pfizer will see the deployment of PROTAC technology in a bid to help mitigate the devastation caused by the disease.

    ARV-471’s Potential

    December 2020 saw the company present interim data for its Phase 1 dose-escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer. The treatment is indicated for its potential as a novel oral ER targeted therapy. Patients enrolled in the study were heavily pretreated, having been administered with cyclin-dependent kinase (CDK) 4/6 inhibitors. Despite the extensive pretreatment and the advanced stage of disease, the interim results demonstrated the treatment’s ability to promote substantial ER degradation and exhibits an encouraging clinical efficacy and tolerability profile.

    Future Outlook for ARVN Stock

    Armed with a massively expansive collaboration with Pfizer, the company is keen to make the most of the opportunities afforded to it as it expands and consolidates its market footprint. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal to usher in organic growth over the long term.

  • TRACON Pharmaceuticals, Inc. (TCON) Stock Plummets Following Upsizing of Underwritten Public Offering

    TRACON Pharmaceuticals, Inc. (TCON) stock prices were down 4.27% as of the market closing on July 21st, 2021, bringing the price per share down to USD$4.93 at the end of the trading day. Subsequent premarket fluctuations saw the stock plummet by 23.33%, bringing it down to USD$3.78.

    Upsizing of Public Offering

    July 21st, 2021 saw the company announce the upsizing of its previously announced public offering as a result of the level of demand. The upsizing will consist of a firm commitment to purchase 3,926,702 shares of common stock, with each share being priced at USD$3.82. Furthermore, the agreement comes equipped with a 30-day option to purchase up to an additional 589,005 shares of common stock at the public offering price. The closing of the public offering is expected to close on July 26th, 2021.

    Details of the Offering

    The public offering is expected to generate gross proceeds in the amount of roughly USD$15 million, before the deduction of expenses related to the offering and excluding the exercising of the over-allotment option. The capital raised is forecasted to be allocated towards the supporting of the continued clinical development of envafolimab, as well as for working capital and general corporate purposes.

    Orphan Drug Designation

    June 29th, 2021 saw the company announce the granting of Orphan Drug Designation to envafolimab by the U.S Food and Drug Administration. The innovative, single-domain antibody against PD-L1 is being developed for the treatment of patients with soft tissue sarcoma. This development followed the submissions of a revised application that consisted of data from the Phase 1 clinical trial from sarcoma patients treated with single-agent envafolimab.

    Basis of Envafolimab ODD

    The Orphan Drug Designation submission for the use of envafolimab in sarcoma included clinical data that signaled confirmed objective partial responses by RECIST with response durations exceeding six months. This promising development was observed in two out of five patients with refractory metastatic alveolar soft part sarcoma (ASPS), with the patients having been administered single-agent envafolimab in Phase 1 clinical trials. The trials were conducted by the company’s partner, 3D Medicines and Alphamab Oncology. The Phase 1 trials did not include patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) were not treated as part of Phase 1 trials.

    Future Outlook for TCON

    Armed with the added influx of capital generated from the company’s public offering, TCON is poised to capitalize on the opportunities afforded to it as a result of the granting of Orphan Drug Designation for its flagship treatment. Investors are hopeful that management will be able to facilitate the hasty commercialization and effective proliferation of the treatment as it continues to work closely with the FDA.

  • IMV, Inc. (IMV) Stock Plummets Following Announcement of Pricing of its Registered Public Offering

    IMV, Inc. (IMV) stock prices were down by 24.52% shortly after market trading commenced on July 15th, 2021, bringing the price per share down to USD$1.57 early on in the trading day.

    Public Offering

    July 15th, 2021 saw the company announce the pricing of its underwritten public offering, wherein the company would oversee the sale of 14,285,714 units to the public. Each unit will be priced at USD$1.75 per unit, with the offering expected to generate gross proceeds in the amount of roughly USD$25 million, before the deduction of expenses related to the offering. The capital generated is exclusive of ay proceeds expected from the exercising of underlying warrants.

    Details of the Offering

    Each unit will be comprised of a single common share and three quarter of one common share purchase warrant. Each warrant will allow its bearer to purchase one common share at a price of USD$2.10 per common shares, with an expiry date of 60 months following the closing date of the offering. Given the satisfaction of customary closing conditions, the offering is expected to close around July 20th, 2021.

    Allocation of Capital

    The company plans to use the net proceeds from the offering for the continued clinical development of maveropepimut-S in diffuse large B cell lymphoma, breast cancer, ovarian cancer, bladder cancer, and microsatellite instability high. The funds will also be allocated towards the start of the clinical development of a new product, DPC-SurMAGE, in bladder cancer, as well as the continued development of the company’s proprietary drug delivery platform (DPX).

    Solid Liquidity Position

    IMV reported a solid liquidity position of USD$30.5 million in cash and cash equivalents as of March 31st, 2021, in addition to having access to working capital in the amount of USD$31.6 million. This is up from the USD$26.3 million in cash and cash equivalents, and USD$25.6 million in working capital as of December 31st, 2020. As per its existing plan of operations, and discounting the USD$47.7 million remaining under its USD$50 million ATM facility executed in October 2020. The company expects its funds to see its operations through to Q1 2022.

    Future Outlook for IMV

    Armed with the influx of capital from its offering further consolidating an already strong liquidity position, IMV is poised to capitalize on the opportunities afforded to it. The company is keen to leverage its extensive resources to push for a continued trajectory of success. Investors are hopeful that the management will be able to facilitate significant and sustained increases in shareholder value.

  • Vyant Bio, Inc. (VYNT) Stock Undergoes Minor Volatility Ahead of Granting of US Patent for iPSCs

    Vyant Bio, Inc. (VYNT) stock prices were down by 5.22% at the end of the trading day on July 14th, 2021, bringing the price per share down to USD$3.27 at the end of the trading day. Subsequent premarket fluctuations have seen the stock recover by 5.81%, bringing it up to USD$3.46.

    StemoniX Granted US Patent

    July 13th, 2021 saw the company announce that StemoniX, its wholly-owned subsidiary, was issued a US Patent by the United States Patent and Trademark Office (USPTO). The patent is titled “High Throughput Optical Assay of Human Mixed Cell Population Spheroids” and covers a novel approach to the application of human-induced Pluripotent Stem Cells (iPSCs) as an effective tool in the illumination of the biology of complex human cell types, such as those of the central nervous system (CNS).

    Nature of iPSC Platform

    Human iPSC-based, high-throughput platforms that currently exist have lacked reliability and functional consistency. The patent also covers the use of 3D co-cultures of cortical neurons and astrocytes that display spontaneous, rhythmic, and highly synchronized neural activity. This activity can visualized as calcium oscillations on standard, high-throughput fluorescent readers as a platform for CNS-based discovery effects.

    Details of iPSC

    Spontaneous activity and spheroid structure proved to be highly consistent from well-to-well, which is a feature that is lacking in traditional 2D cultures. The technology facilitates a cost-effective method to perform high-throughput drug screening (HTS) in regard to 3D human tissue relevant models that have a higher degree of biological accuracy. This patent marks the third patent granted to StemoniX, with additional applications currently pending across globe.

    Competitive Advantage

    Existing conventional high-throughput drug screening typically makes use of recombinant cell lines that overexpress a drug target of interest. The technology is aimed to deliver the development of relevant cellular disease models that will be used in high-throughput screening. Human iPSCs have been proven to have significant advantages over recombinant cell lines or primary rodent cells that will be used in drug screening. Given that the cells are derived from human donors, human genetic diseases can be modelled more accurately, particularly when used in tandem with modern genome editing techniques.

    Future Outlook for VYNT

    Armed with the promising potential of the patent granted to StemoniX, VYNT is poised to capitalize on the expanded scope of opportunities presented to it. Keen to pioneer their segment of the healthcare system, the company is pushing for the continued development of their innovative technology. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to usher in significant and sustained increases in shareholder value.

  • INmune Bio, Inc. (INMB) Stock on the Rise Following First Patient Treatment in INKmune Phase 1 Clinical Trial

    INmune Bio, Inc. (INMB) stock prices were up by 12.67% as of the market closing on July 13th, 2021, bringing the price per share up to USD$26.68. Subsequent premarket fluctuations saw the stock rise by 7.01%, bringing it up to USD$28.55.

    INKmune

    July 12th, 2021 saw the company announce the use of INKmune, its Natural Killer (NK) cell priming platform, had been used to treat the first patient in Phase 1 clinical trial. The treatment is being explored as a viable option for patients with high-risk myelodysplastic syndrome. MDS is a hematopoietic stem cell disorder that is indicated by functionally defective NK cells, with the level of dysfunction being predictive of overall survival. Roughly 33% of MDS cases develop into acute myelogenous leukemia (AML). With no known cure for MDS, existing therapies like chemotherapy and bone marrow/stem cell transplantation have varying degrees of success.

    Research Conducted

    With levels of NK function in MDS patients being predictive of overall survival, 15 years of lab research into potential patient treatment has raised hopes. The enhancement of low-level NK activity in patients with poor prognosis to the level of those with better overall survival, thereby altering the course of the disease, could be highly commercially promising.

    Scope of Research

    Lab work has shown INKmune binding to multiple NK receptors and initiates the activation of more than 3000 genes associated with function, trafficking, proliferation, and overall survival. With not a single cytokine available that has such a myriad of physiological effects, INKmune is being referred to as a psuedokine.

    Expanded Opportunities

    The treatment of the first patient in the trial serves as a major milestone, with the company being the first to study the INKmune platform in a formal clinical setting. With it being widely known that dysfunctional NK cells in cancer patients are not effective at eradicating residual disease after chemotherapy, leading to relapse and poor outcomes. The company has shown that with the delivery of tumor-specific activating signals to NK cells with INKmune, autologous tumor killing can be initiated.

    Future Outlook for INMB

    Armed with the significant milestone of having treated the first patient in the study, INMB is poised to capitalize on the opportunities afforded to it as a result. The company is keen to push for the accelerated development and eventual commercialization and proliferation of the treatment. Current and potential investors are hopefully that management will continue to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.

  • Tempest Therapeutics, Inc. (TPST) Stock Skyrocketing as Meme Stock Phenomenon Continues to Spread Like Wildfire

    Tempest Therapeutics, Inc. (TPST) Stock Skyrocketing as Meme Stock Phenomenon Continues to Spread Like Wildfire

    Tempest Therapeutics, Inc. (TPST) stock prices skyrocketed by 98.18% shortly after market trading commenced on July 12th, 2021, bringing the price per share up to USD$31.05 early on in the trading day.

    W.B. 2021 Biotech Conference

    July 9th, 2021 saw the company announce that the Chief Medical Officer of the company, Sam Whiting, M.D., Ph.D., will be participating in a webcast panel at the William Blair 2021 Biotech Focus Conference. Titled “Developing Therapies for the Next Immuno-Oncology Targets” and will be held on July 14th, 2021. The announcement was met very positively by investors, who are hoping for a major announcement at the event.

    Rock Springs’ Stake in TPST

    Further driving the stock price higher is a recent SECSchedule 13-G filing that revealed Rock Springs Capital Management LP owned a 9.68% ownership stake in the company, having 642,155 shares under its control. The investment company is based in Baltimore and provides advisory services for businesses and institutional clients in regard to their security portfolios and portfolio management.

    Explaining TPST’s Meteoric Rise

    Nevertheless, the company’s recent stock price activity does not seem to be adequately contextualized by these developments. With the stock having risen as suddenly as it has, in the absence of concrete developments or changes in fundamentals, it seems likely that TPST has been selected as the latest target as a meme stock in the proliferation of the meme stock phenomenon that has been dominating the stock markets as of the start of the trading week.

    Meme Stock Phenomenon

    Driven by retail investors, underdog companies, sometimes on the brink of collapse, are artificially pumped with intentional disregard for any rational basis for the pump. Usually indicating a high short interest, these companies are selected as a means to take advantage of institutional investors’ confidence in the company’s stock prices falling. The coordinated short squeeze by retail investors has confounded Wall Street and has even resulted in the claiming of bankruptcy by some of the biggest names in finance.

    Future Outlook for TPST

    Rife with inherent risk and volatility, the recent fortuitous gains are not something that TPST can rely on to continue. Nevertheless, the increased exposure and skyrocketing of equity value afford the company opportunities to capitalize on in order to facilitate more organic increases in shareholder value.

  • Galectin Therapeutics, Inc. (GALT) Stock Surges Following Success of Topline Data from Belapectin Clinical Trial

    Galectin Therapeutics, Inc. (GALT) Stock Surges Following Success of Topline Data from Belapectin Clinical Trial

    Galectin Therapeutics, Inc. (GALT) stock prices were down by a marginal 1.43% as of the market closing on July 8th, 2021, bringing it down to USD$2.76. Subsequent premarket fluctuations have seen the stock skyrocket by 47.10%, bringing it up to USD$4.06.

    Positive Topline Data

    July 9th, 2021 saw the company report positive topline data from its Phase 1b Clinical Trial Extension of Belapectin in conjunction with KEYTRUDA in the treatment of advanced metastatic melanoma, as well as head and neck cancer. The combination immunotherapy showed a cancer control rate of 56% in melanoma patients and 40% in head and neck cancer.

    Details of the Study

    The melanoma patients enrolled in the study had exceptionally severe prognoses, with four out of nine patients reporting choroidal primary tumors and six out of nine having liver metastasis. The study found no toxicities that were deemed even possibly related to Belapectin. As per the findings from the Phase 1 study, the frequency and intensity of toxicities recorded with the combination were less than the expected toxicity with KEYTRUDA alone.

    Net Loss Reports

    The quarter ended March 31st, 2021 saw the company report USD$6.3 million in net loss applicable to common stockholders, representing a net loss of USD$0.11 per share. This is up from the USD$3.6 million in net loss reported in the same time period of the prior year, representing a net loss of USD$0.06 per share. The year-over-year difference was largely driven by increases in R&D expenses related to GALT’s NAVIGATE trial.

    R&D and G&A Expenses

    In accordance with costs associated with the NAVIGATE trial, research and development costs were up to USD$4.9 million for the 2021 quarter, up from the USD$2.1 million reported for the quarter ended March 31st, 2020. General and administrative costs for the quarter were reported at USD$1.4 million, the same as for the prior year quarter.

    Solid Liquidity Position

    The company reported USD$20.8 million in cash and cash equivalents as of March 31st, 2021, indicating a solid liquidity position. This was further consolidated by the receiving of USD$10 million in proceeds on April 16th, 2021 from an unsecured convertible promissory note from the Chairman of its Board of Directors.

    Future Outlook for GALT

    Armed with the massive success and promise of its clinical trial, GALT is poised to capitalize on the opportunities afforded to it in light of this recent development. The company is keen to leverage its stellar liquidity position in order to usher in sustained and significant growth over the long term.

  • Advaxis, Inc. (ADXS) Stock Skyrockets Ahead of Definitive Merger Agreement with Biosight Ltd

    Advaxis, Inc. (ADXS) Stock Skyrockets Ahead of Definitive Merger Agreement with Biosight Ltd

    Advaxis, Inc. (ADXS) stock prices skyrocketed by a massive 41.25% shortly after market trading commenced on July 6th, 2021, bringing it up to USD$0.667 early on in the trading day.

    Merger with Biosight

    July 6th, 2021 saw the company announce its definitive merger agreement with Biosight Ltd, which will see shareholders of Biosight become majority holders of the combined company upon the closing of the transaction. The resulting entity will be a public company, with a focus on the clinical advancement and commercialization of Biosight’s lead product, BST-236. As of closing, the combined company forecasts a solid liquidity position with roughly USD$50 million in cash, cash equivalents, and marketable securities. The closing of the transaction is expected for the second half of 2021, with the combined company being renamed Biosight Therapeutics, to be traded on the Nasdaq Capital Market under the BSTX ticker symbol.

    Aspacytarabine

    The company anticipates topline results from its ongoing Phase 2 trial of aspacytarabine within 12-18 months. Enrollment has been completed for the trial of first-line therapy in AML patients who cannot undergo traditional chemotherapy. Recent data indicated complete remission rates of 39% across all evaluable patients, with 63% of cases with negative minimal residual disease and median overall survival of 10 months.

    R&D Costs

    Research and development costs for the second quarter of fiscal 2021 were reported at USD$4.34 million, up from the USD$3.92 million for the prior year quarter. The year-over-year difference was largely attributable to the winding down of some legacy studies. Further compounding the difference were losses on disposal of research-related property and equipment in connection with the termination of the office lease at ADXS’s former location.

    Solid Liquidity Position

    ADXS reported USD$48.1 million in cash and cash equivalents as of April 30th 2021, with the company confident that it is enough to fund its obligations as they arise. The solid liquidity position will see the ordinary course of the business through to the third fiscal quarter of 2023.

    Future Outlook for ADXS

    Armed with a solid liquidity position and a lucrative merger, ADXS is poised to capitalize on the opportunities afforded to it. The company is keen to facilitate the commercialization and proliferation of BST-236 in order to usher in further growth.

  • Odonate Therapeutics, Inc. (ODT) Stock Skyrockets as Latest Potential Target of Meme Stock Phenomenon

    Odonate Therapeutics, Inc. (ODT) stock prices were up by 2.97% as of the market closing on July 2nd 2021, bringing the price per share up to USD$3.47 at the end of the trading day. Subsequent premarket fluctuations saw the stock skyrocket by 32.85%, bringing it up to USD$4.61.

    Cessation of Texetaxel Development

    The company recently announced the discontinuation of the development of its flagship tesetaxel treatment, along with the intent to wrap up operations related to the treatment’s development. ODT is collaborating with clinical sites to transition patients from their ongoing studies to relevant and applicable alternative therapies. Compassionate use programs will see the continuation of treatment with tesetaxel, as deemed appropriate in extreme cases.

    Financial Reports

    March 31st 2021 saw the company announce USD$133.2 million in cash, indicating a stellar liquidity position. December 31st 2020 had reported USD$157.3 million, with the difference being largely attributable to a USD$24.9 million cost of operating activities for the three month period ended March 31st 2021. Net loss at the end of the quarter was reported at USD$33.8 million, representing a net loss of USD$0.90 per share. The same time period over the previous year saw the company reported USD$30.2 million in net loss, representing a net loss of USD$0.99 per share.

    Meme Stock Phenomenon

    With the company having closed operations for its primary driving force, the recent surge in equity value is truly confounding. In the absence of recent news developments or changes in the company’s fundamentals, it seems ODT has become the latest target of the meme stock phenomenon that has been raging through stock markets since the AMC and GME debacles earlier in the year.

    About Meme Stocks

    With very little reason to invest in the company, ODT owes its fortuitous surge in equity value to the proliferation of meme stocks. Meme stocks are underperforming companies, with little to no reason to justify an investment in, that are heavily pumped by retail investors. These investors target underdog companies with high short interests in a coordinated short squeeze on the social media platform, Reddit. Understandably, meme stocks come packed with high risk and volatility. Upward movement relies on the strength of each link in the chain of coordination. While many profit heavily on this confounding stock movement, as many or more investors lose their investments if they are late to the pump and dump.

    Future Outlook for ODT

    As it stands, ODT is poised to collapse, but it seems to be kept afloat by its recent surge in equity value. Unless it comes out with significant news in the very near future or manages to leverage its additional capital to generate more organic growth, the future for ODT does not look bright.

  • 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.