STOCKS TELEGRAPH

Tag: biotech

  • Larimar Therapeutics, Inc. (LRMR) Stock on the Rise as Resolution of FDA Clinical Hold Continues to Develop

    Larimar Therapeutics, Inc. (LRMR) stock prices were up by a marginal 1.54% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$9.89 at the end of the trading day. After hours trading saw the stock surge by 10.21%, bringing it up to USD$10.90.

    Clinical Hold for CTI-1601

    May 25th 2021 saw the company announce that the U.S. Food and Drug Administration had placed a clinical hold on LRMR’s ongoing CTI-1601 clinical program. As a result, the company did not complete its previously announced private placement financing. The clinical trial is for the treatment of patients with FA who are unable to produce enough human frataxin, with CTI-1601 serving is a recombinant fusion protein that is delivered to patients’ mitochondria.

    Contextualizing the Hold

    The clinical hold came after the company’s reporting to the FDA in regard to mortalities occurring at the highest dose levels in an ongoing 180-day non-human primate toxicology study. The study was designed to support extended CTI-1601 treatment in patients. The FDA implemented the hold in light of needing a full study report from the company’s NHP study, with a restriction on the initiation of additional clinical trials until the report has been submitted and approved by the FDA.

    Effects of FDA Decision

    The disappointing formal clinical hold notification does not, however, change the company’s previously stated strategy for the clinical development of CTI-1601. LRMR plans to complete its NHP toxicology study, assess the data, and discuss the data with the FDA in order to obtain prior consent for the commencement of their Jive and pediatric MAD trial. Patient safety continues to be a top priority, with the company confident that despite the hiccup, the path forward is still in place.

    Deferral of Trials

    With the added regulatory requirements associated with the formal clinical hold, the company is entertaining the possibility of deferring the initiation of its clinical trials. The trials are being considered to be pushed up to 2022. Despite the termination of the planned private placement financing, the company reported a solid cash position as of March 31st, 2021. Having reported USD$81.4 million in cash and cash equivalents, the company anticipates being able to fund its operations through to the first half of 2022.

    Future Outlook for LRMR

    Confident in the timely resolution of the speedbumps in the road towards the commercialization of its treatment candidates, LRMR is poised to continue its trajectory of success. The company is keen to address the FDA’s requirement so it can continue pushing for the development of its various clinical trials.

  • 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.

  • Cocrystal Pharma, Inc. (COCP) Stock Trends Higher Following Announcement of Covid-19 Treatment Potential

    Cocrystal Pharma, Inc. (COCP) stock prices stayed stable over the course of the market day on June 17th, 2021. Subsequent pre-market fluctuations have seen the stock climb by 3.85%, bringing it up to USD$1.35.

    CDI-45205

    The company announced on June 14th, 2021 that it had successfully demonstrated that its lead preclinical Covid-19 3CL protease inhibitor CDI-45205 is active against SARS-CoV-2, as well as two of its primary variant strains. The company contracted a third party lab to conduct in vitro studies designed to evaluate the antiviral activity of CDI-45205 and its analogs in VeryE6-eGFP cells that were infected. Infected cells were affected by the Wuhan strain, the United Kingdom strain, and the South African variant.

    Scope of CDI-45205

    CDI-45205 and its analogs exhibited exceptional antiviral activity against each of the variant strains, going so far as to surpass the activity observed with the Wuhan strain. The FDA-approved Covid-19 RNA-dependent RNA polymerase inhibitor, remdesivir, and PF-00835231, a second protease inhibitor, were both reference inhibitors that the study was compared against. Results demonstrated CDI-45205’s excellent activity against the UK variant, with an EC50 of 1.9 uM, while activity against the South African variant exhibited an EC50 of 2.5 uM. As absence of a P-glycoprotein efflux, inhibitor is assumed in both cases.

    Cumulative Growth

    The company intends to continue conducting research into antiviral activity against other emerging variants, such as the up-and-coming Indian strain. The latest disclosed results add to the growing body of preclinical data findings of CDI-45205. Evidence suggests the new data implies the use of the protease inhibitor as an effective treatment of the coronavirus and its variants that have taken the world by storm for over a year now. Furthermore, company scientists continue to use COCP’s proprietary structure-based drug discovery platform technology to facilitate the investigation of broad-spectrum oral protease inhibitors and replication inhibitors for the treatment of Covid-19.

    Agreement with KSURF

    CDI-45205 was announced to have been selected by COCP on December 2020 as its lead Covid-19 development candidate. It was picked from a group of protease inhibitors that came into COCP’s possession through an exclusive license agreement with Kansas State University Research Foundation, which was announce earlier in 2020.

    Future Outlook for COCP

    With the world hurtling towards universal immunizations in the interest of a return to economic and social normalcy, COCP is primed to capitalize on the urgent demand for coronavirus treatments around the world. 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.

  • BriaCell Therapeutics Corp. (BCTX) Stock Undergoes Volatility Ahead of Expanded Cancer Platform Technology Announcement

    BriaCell Therapeutics Corp. (BCTX) Stock Undergoes Volatility Ahead of Expanded Cancer Platform Technology Announcement

    BriaCell Therapeutics Corp. (BCTX) stock prices were up by a hefty 8.96% as of the market closing on June 16th, 2021, bringing the price per share up to USD$6.57 at the end of the trading day. After-hours trading, however, saw the stock drop by 9.28%, bringing it down to USD$5.96.

    Oncology Therapeutics

    The company announced on June 16th, 2021 the advancement of its targeted oncology therapeutics into various respective immunotherapy cell lines. Among these are Bria-Pros for prostrate cancer, Bria-Mel for melanoma, and Bria-Lung for lung cancer. The treatment was most effective in breast cancer when patient HLA-type matched with the targeted immunotherapy, owing to the potential afforded to Briacell to identify patients most likely to respond to the treatment.

    HLA-Type Testing

    This innovative approach makes use of human leukocyte antigen (HLA-type) testing, which is both simple to use and widely available, making it a highly accessible resource. With the use of its proprietary cell engineering technology, the company is now developing off-the-shelf personalized immunotherapy for various cancer indications, which utilizes the HLA-matching platform technology.

    Bria-Pros

    Bria-Pros is an off-the-shelf personalized treatment for prostate cancer, which is the second most common cancer among men in the US and one of the leading causes of cancer deaths in men. Existing treatments for metastatic prostate cancer include immunotherapy, hormone therapy, chemotherapy, and targeted treatments. However, there is much ground left to be broken in prostate cancer therapies, seeing how none of the existing ones are curative.

    Bria-Mel

    Bria-Mel is personalized immunotherapy for melanoma, with off-the-shelf availability. With more than 80,000 melanoma diagnoses being administered in the US alone, the disease claims the lives of more than 8000 patients every year. Immunotherapy, targeted therapy, and chemotherapy are options in the treatment for advanced melanoma, with there being a large unaddressed need for new safe and effective therapies for melanoma.

    Bria-Lung

    Bria-Lung is designed as personalized immunotherapy for lung cancer, being available off-the-shelf. Being the third most common type of cancer in the world, more than 130,000 Americans succumb to it every year. The most common form of lung cancer is called non-small cell lung cancer (NSCLC) and its spread (metastasis). With treatments including targeted therapies, immunotherapy, and chemotherapy, no treatment is likely to cure the cancers, indicating a large unmet need.

    Future Outlook for BCTX

    Armed with the development of accessible treatments that the company hopes will address large sections of unmet need, BCTX is poised to push for the proliferation of the treatments to expand and consolidate their market footprint. 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.

  • Innate Pharma S.A. (IPHA) Stock Surges During After Hours Trading Ahead of Progress Update Meeting

    Innate Pharma S.A. (IPHA) stock prices were down by a marginal 1.87% as of the market closing on June 16th, 2021, bringing the price per share down to USD$3.9350. After-hours trading saw the stock rally by an impressive 10.55%, bringing it up to USD$4.40.

    Disclosure of New Data

    The company announced on June 10th, 2021 that it will present the most recent preclinical data from it’s next-gen, proprietary, multi-specific NK cell engager platform, ANKET. The presentation will be held at the Federation of Clinical Immunology Societies (FOCIS) meeting, showcasing Antibody-based NK cell Engager Therapeutics.

    FOCIS Presentation

    The presentation will see IPHA share new data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage both NKp46 and CD16, the former of which is a tumor antigen and the latter a cytokine (IL-2 variant) in a single molecule. This newest development makes use of the advantages of harnessing NK cell effector functions against cells affected by cancer. It also facilitates the provision of the proliferation and activation The data set generated is founded on the company’s existing tri-specific NK cell engager technology. This technology has a proven track record of potent NK cell activation, cytotoxicity, and efficient management of tumor growth in preclinical models.

    Scope of ANKET

    Preclinical studies demonstrated the ability of in vitro tetra-specific ANKET to induce human NK cell proliferation, cytokine production, and cytolytic activity against cancer cells expressing the targeted antigen. Tetra-specific ANKET was also reported to have demonstrated in vivo anti-tumor efficacy in several tumor models, which allows for the regression of exiting tumors. Control of metastasis is also facilitated, with its associations with increased NK cell infiltration, and cytokine and chemokine production at the tumor site. The treatment also exhibited the pharmacodynamic effect, low systemic cytokine release, and a manageable safety profile in non-human primates.

    IPH6101

    The company’s leading ANKET asset is IPH6101, which has exhibited anti-tumor activity in preclinical models, including, but not limited to, facilitating pharmacokinetic pharmacodynamic and safety data in preliminary non-human primate studies. January 2021 saw the progression of the program into IND-enabling studies, with a recently announced research collaboration facilitating a second research program.

    Future Outlook for IPHA

    Armed with the development of their proprietary ANKET NK cell engager platform, IPHA is poised to continue its trajectory of success. The company is keen to continue working towards the commercialization and proliferation of their technology to usher in further gains. 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.

  • 22nd Century Group, Inc. (XXII) Stock Trending Down as Changes to Tobacco Regulation Still Pending

    22nd Century Group, Inc. (XXII) stock prices were down 1.74% as of the market closing on June 15th, 2021, bringing the price per share down to USD$4.52 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock rally by a marginal 1.11%, bringing it up to USD$4.57.

    MTRP Authorization

    The company is allocating efforts towards the securing of Modified Risk Tobacco Product (MRTP) authorization for the company’s proprietary VLN. XXII is confident that its MRTP application submitted to the U.S Food and Drug Administration is in its final stages of review, with no currently outstanding requests for further information or filing.As such the company is poised to capitalize on the commercial launch of its VLN King and VLN Menthol King products, which it will do so within 90 days of securing the MRTP designation. This includes the use of marketing campaigns to raise brand awareness.

    Impending Changes in Nicotine Regulation

    XXII also believes that the FDA is considering implementing a product standard that would require all cigarettes to be minimally or non-addictive. Of course, this sets VLN up to capitalize on the increased market space, given that it already meets that requirement. The company is confident that the paradigm shift in conjunction with the enactment of a nicotine cap will result in favorable market conditions. XXII has reported being ready and willing to license its reduced nicotine tobacco technology to all the cigarette manufacturers hoping to regain compliance with the newly imposed mandate.

    Promising Financial Reports

    Net sales revenue reported for the first quarter of the fiscal year 2021 came in at USD$6.8 million, as compared to the USD$7.1 million reported in the same time period of the prior fiscal year. Gross profits were up to USD$647,000 in Q1 2021, representing a USD$360,000 year-over-year increase. Accordingly, gross profit margins improved by 540 basis points. This represents the fifth consecutive quarter that has seen year-over-year improvements, signaling XXII’s ability to successfully execute its ongoing business plans.

    Stellar Liquidity Position

    XXII reported a strong liquidity position, with USD$30.9 million in cash, cash equivalents, and short-term investment securities as of the end of the first quarter of 2021. This is a massive improvement on the USD$22.3 million reported as of March 31st, 2020. This difference is primarily attributable to the USD$11.8 million generated from the completion of the cash exercise of warrants during February and March of 2021. The company currently has no further warrants outstanding.

    Future Outlook for XXII

    Armed with a solid liquidity position and stellar financial reports, XXII is poised to capitalize on the increasingly likely changes in tobacco regulation. 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.

  • Novavax, Inc. (NVAX) Stock on the Rise Following Massive Success of PREVENT-19 Study

    Novavax, Inc. (NVAX) Stock on the Rise Following Massive Success of PREVENT-19 Study

    Novavax, Inc. (NVAX) stock prices were up by a marginal 2.31% as of the market closing on June 11th, 2021, bringing the price per share up to USD$209.68 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock surge by 6.57%, bringing it up to USD$223.45.

    Success of PREVENT-19

    The company announced a massively positive outcome for NVX-CoV2373, demonstrating 100% protection against moderate and severe forms of the disease. The treatment also reported an overall efficacy of 90.4% and met its primary endpoint in the PREVENT-19 pivotal Phase 3 trial. The study consisted of a total of 29,960 participants, spanning 119 sites across Mexico and the U.S. The study was designed to evaluate the efficacy, safety, and immunogenicity of the treatment, with an emphasis on representation in the recruitment of communities and demographic groups most impacted by the disease.

    Treatment Poised to Proliferate

    With the world hurtling towards global immunizations as the global coronavirus pandemic continues to take its toll on economies, Novavax is closer to addressing the critical and persistent global public health need. The company continues to work at full capacity to facilitate the completion of regulatory submissions and deliver the vaccine. NVAX has secured a well understood platform with an established track record, through which they will facilitate the provision of the much needed vaccines.

    Next Steps for NVAX

    NVAX anticipates filing for regulatory authorizations in the third quarter of 2021, following the completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls (CMC) requirements. Following the approval, the company will see growth to a manufacturing capacity of 100 million doses per month by the end of the third quarter of 2021. The end of the fourth quarter is expected to mark the ramping up of manufacturing capacity to 150 million doses a month.

    Government Support

    PREVENT-19 has consolidated the tolerability and safety profile of NVX-CoV2373, with data having shown consistent, high levels of efficacy and reaffirm the treatment’s capability to prevent Covid-19 as increasing variants of the virus proliferate international communities. To this end, the treatment has received support from the U.S government, including the DoD, BARDA, parts of the HHS, the NIAID, and more. As per a DoD agreement, BARDA will provide NVAX with USD$1.75 billion.

    Future Outlook for NVAX

    Armed with the fortuitous surge in the value of their equity, NVAX is poise to push for the commercialization and proliferation of its proprietary treatment. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Progenity Inc. (PROG) Stock Skyrockets as Next Target of Reddit-Driven Meme Stock Phenomenon

    Progenity Inc. (PROG) Stock Skyrockets as Next Target of Reddit-Driven Meme Stock Phenomenon

    Progenity Inc. (PROG) stock prices soared by a massive 28.92% as of the market closing on June 11th, 2021, bringing the price per share up to USD$3.21 at the end of the trading day. Pre-market fluctuations saw the stock surge by another 12.77%, bringing it up to USD$3.62.

    Meme Stock Phenomenon

    The past several trading days have seen the stock market being dominated by the meme stock phenomenon that spurred the GME and AMC developments earlier in the year. In the absence of any significant news or developments, the recent surge in PROG stock prices is likely to be attributable to the coordinated pump by investors who are users of the popular social media platform, Reddit. With a relatively high percentage of shorted shares, at 6.7%, the company is a prime target for Reddit-driven retail investors.

    Private Placement

    Concurrent with the surge in stock price, PROG announced on June 10th, 2021 that it had entered into a definitive securities purchase agreement with two leading healthcare-focused investment funds. The agreement will see the sale of units comprised of shares of common stock and warrants. The stocks are interchangeable with pre-funded warrants to purchase common stock and the warrants are for the purchase of common stock.

    Details of the Placement

    The private placement is expected to result in the generation of gross proceeds amounting to USD$40 million before the deduction of expenses related to the offering. As per the agreement, the closing of the placement will be followed by the issuance of units representing 16,194,332 shares of common stock (or pre-funded warrants. Warrants will also be issues concurrently, which will allow for the purchase of an aggregate of another 16,194,332 shares of common stock.

    Pricing of Placement

    Each unit issues by PROG will consist of one share of common stock, as well as one warrant to purchase one share of common stock. The price of each combined unit has been set at USD$2.47. Each warrant will have an exercise price of USD$2.84 per share with the option to be exercised at any time within 5 years of the issuance.

    Closing of the Placement

    The price per unit was partially determined by the average of the last five closing price of PROG’s common stock on the Nasdaq Global Market. Should the warrants be exercise for cash, the company will see the generation of additional gross proceeds of almost USD$46 million. The closing date of the placement is expected for June 14th, 2021, pending the satisfaction of customary closing conditions.

    Future Outlook for PROG

    Armed with a solid liquidity position from their private placement, as well as the fortuitous surge in value of their equity, PROG is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.