Tag: biotech

  • Is XERS Stock a Good Buy in 2025? Key Insights for Investors

    Is XERS Stock a Good Buy in 2025? Key Insights for Investors

    Xeris Biopharma Holdings (NASDAQ: XERS) has been gaining attention in the biotech industry due to its innovative drug pipeline and strong growth potential. As investors look toward 2025, many are wondering: Is XERS stock a good buy in 2025? This article explores Xeris’ business model, financials, growth drivers, risks, and expert opinions to help you determine if it’s a solid investment.

    Xeris Biopharma Overview & Business Model

    Xeris Biopharma is a biotech company specializing in ready-to-use injectable drug formulations that improve patient adherence and reduce the need for refrigeration. Its proprietary XeriSol™ and XeriJect™ technology platforms enhance the stability and delivery of various biologics and small molecules.

    Key Revenue Sources:

    • Gvoke HypoPen (glucagon for severe hypoglycemia treatment)
    • Keveyis (the first FDA-approved treatment for primary periodic paralysis)
    • Recorlev (for Cushing’s syndrome)
    • Partnerships and licensing agreements with pharmaceutical companies

    XERS Stock Performance & Financial Analysis

    Stock Snapshot:

    • Current Price: $5.03
    • 52-Week Range: $1.69 – $5.07
    • Market Cap: $774.32M
    • P/E Ratio: -13.55
    • EPS (TTM): -$0.37
    • Revenue (TTM): $182.68 million

    Financial Highlights – Q2 (Dec 2024) Report:

    • Revenue: $60.099 million (35.39% YoY growth)
    • Net Income: -$5.11 million (61.81% YoY improvement)
    • Diluted EPS: -$0.03
    • Cash & Equivalents: $71.62 million
    • Debt-to-Equity Ratio: -1.84

    Xeris has demonstrated strong revenue growth, fueled by increasing product adoption. However, profitability remains a challenge, primarily due to continued investments in R&D and operational expansion. The company’s financials indicate a steady trajectory toward reducing losses, a critical factor for investors evaluating long-term potential.

    Growth Drivers for XERS Stock in 2025

    Expanding Drug Pipeline

    • Xeris is advancing multiple clinical trials targeting endocrinology, neurology, and metabolic disorders.
    • Potential FDA approvals and label expansions in 2025 could drive revenue growth.

    Strategic Partnerships & Licensing Deals

    • Collaborations with big pharma companies could unlock new revenue streams.
    • Licensing out its XeriSol™ and XeriJect™ platforms may generate milestone payments.

    Rising Demand for Ready-to-Use Injectables

    • The biopharmaceutical industry is shifting toward patient-friendly drug delivery methods.
    • Xeris’ innovative formulations provide a competitive edge over traditional injectable medications.

    Potential Risks & Challenges

    Regulatory & Clinical Trial Risks

    • Any delays or failures in FDA approvals could negatively impact stock performance.

    Financial Sustainability

    • Xeris is not yet profitable, relying on external funding and debt to support operations.

    Competition from Larger Biotech Firms

    • Companies like Eli Lilly (LLY) and Novo Nordisk (NVO) dominate the diabetes and endocrinology market.
    • Xeris must differentiate its products to capture market share.

    Analyst Ratings & Price Target Predictions

    XERS Recent Analyst Ratings: Strong Bullish Sentiment

    Analysts remain optimistic about Xeris Biopharma Holdings (XERS), with several firms raising their price targets and maintaining bullish ratings. The latest analyst ratings suggest strong growth potential, reflecting confidence in the company’s expanding product pipeline and revenue trajectory.

    Latest Analyst Ratings – March 7, 2025

    • Roanna Ruiz (Leerink Partners): Maintains an Outperform rating, raising the price target from $5.00 to $6.00, indicating potential upside.
    • Oren Livnat (HC Wainwright & Co.): Reiterates a Buy rating, with an aggressive price target jump from $6.60 to $8.00, reflecting strong conviction in Xeris’ growth outlook.
    • David Amsellem (Piper Sandler): Reiterates a Neutral rating, adjusting the price target from $3.00 to $4.00, signaling a cautious stance despite some upside.
    • Chase Knickerbocker (Craig-Hallum): Maintains a Buy rating, increasing the price target from $5.00 to $6.50, reinforcing a positive long-term outlook.

    The analyst consensus suggests a bullish trajectory for XERS stock, with multiple firms raising their price targets. While some remain cautious, the upward revisions indicate confidence in Xeris’ future performance, making it a compelling watchlist candidate for 2025.

    Institutional & Retail Investor Sentiment

    Institutional Ownership: Who’s Backing Xeris Biopharma (XERS)?

    Institutional investors play a crucial role in shaping market sentiment, and Xeris Biopharma Holdings (XERS) has gained solid backing from major financial institutions. Currently, 42.87% of XERS shares are held by institutional investors, reflecting strong confidence in the company’s prospects.

    Top Institutional Investors

    • Principal Financial Group Inc. leads the pack, holding 89.62K shares valued at $198.06K, representing a 0.06% stake in Xeris Biopharma.
    • AllianceBernstein L.P. follows closely, with 80.42K shares valued at $177.73K, also translating to a 0.06% stake in the company.

    Investor Sentiment on Xeris Biopharma (XERS) – What’s the Market Saying?

    Investor sentiment plays a critical role in determining short-term price movements, and Xeris Biopharma (XERS) stock has seen shifting sentiment trends over different timeframes.

    Short-Term Sentiment (1 Week & 1 Month)

    • The one-week sentiment score currently stands at 5.26, reflecting data from 22 social media posts but no news articles or opinion pieces.
    • This marks a significant decline of -15.78 points from 21.04 a week ago, indicating a drop in positive discussions surrounding XERS.
    • Over the past month, the sentiment trend has mirrored this movement, with the score falling from 21.04 to 5.26.
    • The sentiment score has fluctuated between 5.26 and 33.1 over the past month.

    Mid-Term Sentiment (6 Months)

    • The six-month sentiment score presents a more optimistic picture, currently at 39.2.
    • This figure is derived from 127 social media posts, 4 news articles, and 1 opinion article, reflecting higher investor engagement over the long term.
    • The sentiment score has ranged between 0 and 53.43, showing broad fluctuations in investor perception.

    The Verdict: Should You Buy, Hold, or Sell XERS Stock in 2025?

    With all the data analyzed—including financial performance, institutional ownership, sentiment trends, and analyst ratings—let’s break down whether Xeris Biopharma Holdings (XERS) stock is a buy, hold, or sell in 2025.

    Bullish Case: Why XERS Stock Could Be a Strong Buy

    Revenue Growth & Market Expansion
    Xeris reported strong YoY revenue growth of 35.39% in Q2 2024, indicating solid demand for its pharmaceutical products. Expanding partnerships and commercialization of innovative therapies could drive further revenue gains.

    Analyst Optimism & Price Target Upside
    Multiple analysts have maintained “Buy” or “Outperform” ratings on XERS stock, with price targets increasing from $5.00 to $8.00, indicating strong upside potential.

    Institutional Confidence
    Financial institutions hold 42.87% of XERS shares, with notable investors like Principal Financial Group and AllianceBernstein showing interest, which suggests institutional confidence in Xeris’ long-term growth.

    Potential for Profitability
    While Xeris still reports net losses, its reduced loss margins and higher gross revenue indicate the company is moving toward profitability. Continued cost management and revenue expansion could help Xeris break even sooner than expected.

    Bearish Case: Why XERS Stock May Face Challenges

    High R&D and Operating Costs
    Despite revenue growth, net losses remain a concern (-$5.11M in Q2 2024), primarily due to high research & development (R&D) and operational expenses. Investors should monitor whether Xeris can scale operations efficiently.

    Stock Volatility & Sentiment Decline
    Investor sentiment dropped significantly from 21.04 to 5.26 in one week, reflecting short-term uncertainty. This could indicate near-term price fluctuations and risk.

    Negative EPS & Valuation Concerns
    Xeris still has a negative EPS (-$0.03 diluted EPS) and a P/E ratio of -13.55, suggesting it is not yet profitable. The stock remains speculative for investors seeking consistent earnings.

    Final Recommendation: Buy, Hold, or Sell?

    • Buy if you are a long-term investor willing to tolerate volatility and believe in Xeris’ growth trajectory, revenue expansion, and future profitability.
    • Hold if you are waiting for profitability improvements and cost reductions before making a stronger commitment.
    • Sell if you prioritize stable, dividend-paying stocks or want to avoid speculative biotech investments.

    Conclusion: Is XERS Stock a Good Buy in 2025?

    Given Xeris Biopharma’s impressive revenue growth, strong analyst support, and institutional confidence, the stock presents an attractive long-term opportunity. However, its ongoing losses and stock volatility make it a riskier short-term investment. Investors seeking high-growth potential may consider buying, while those preferring stable returns should wait for further financial improvements.

  • Relmada Therapeutics Inc. (RLMD) Stock Continues Downward Trend Despite Promising Top-line Data from REL-1017 Study

    Relmada Therapeutics Inc. (RLMD) stock prices were down 3.26% some time after market trading commenced on July 27th, 2021, bringing the price per share down to USD$24.30 early on in the trading day.

    Positive REL-1017 Topline Data

    July 27th 2021 announced the top-line results of the human abuse potential study with REL-1017, the company’s lead candidate. The novel NMDA receptor channel blocker is in Phase 3 development for the treatment of the major depressive disorder (MDD). Top-line results indicated all three doses of REL-1017 tested in recreational opioid users demonstrated a highly statistically significant difference from the control group. The 25mg, 75mg, and 150mg therapeutic, supratherapeutic, and maximum tolerated doses were compared to the active control drug, oxycodone 40 mg.

    RLMD Stock’s Study Endpoints

    The primary endpoint of the study was a measure of ‘likability’ with the subjects rating the maximum effect for Drug Liking “at the moment” using a 1=100 bipolar rating scale. The visual analog scale (VAS) has 100 as the highest likeability, 50 as the neutral, and the 0 as the highest dislike. The data clearly shows a very meaningful difference between the REL-1017 treatment and oxycodone at all three tested doses.

    Safety of REL-1017

    The results consolidate previous findings about the lack of opioid effects of REL-1017. RLMD stock is keen to continue the clinical development of REL-1017 as a novel, safe, and rapidly effective treatment for MDD. The findings have been consistent with RLMD stock’s development programs and confirms what has already been established by an extensive body of literature that indicates the lack of abuse potential of REL-1017. The results strongly support the ongoing REL-1017 late-stage development program.

    Consolidated Scope for RLMD Stock

    The results are in line with HAP results that have been seen for other drugs that affect the CNS and have been scheduled at Classes IV or V, or remain unscheduled, during the assessment and review period. RLMD stock is keen to address the large unmet need for patients suffering from depression in the absence of safe and rapidly effective treatments.

    Future Outlook for RLMD

    Armed with the promising topline results from its study of REL-1017, RLMD is poised to capitalize on the enormous marketspace it finds needing to be addressed. Current and potential investors are hopeful that management will be able to leverage the resources at their diposal to facilitate significant and sustained increases in shareholder value.

  • What Are Biotech Stocks And How To Invest In Them

    What Are Biotech Stocks And How To Invest In Them

    In this article, we are going to help you understand everything there is about biotech companies ranging from what they are- all the way to- how to invest in biotech stocks. This will help you hit the nail on the head with the trend analysis and strategically make investments in this type of stock.

    Biotech stocks have been in the public’s portfolio right since the inception of the stock market and exchange platforms. But just like the recent surge in Green Energy stocks, EV stocks, and Crypto stocks, we are seeing a new rise and shift in the Biotech stocks’ popularity.

    This both excites the investors as well as creates curiosity over what actually is prompting the rise in biotech company stocks and biotech stock prices. This curiosity is essential for looking into the reasons why the Biotech stocks are trending and analyzing the patterns which are making this type of stock boom. This gives investors and stock analysts an edge in predicting and identifying signals and hints in the market shifts due to internal and external reasons.

    What are biotech stocks?

    Biotech Stocks are essentially publicly traded companies that focus on the development, production, and commercialization of pharmaceutical products and services that are used in the treatment of diseases. The therapeutics and treatments that you consume or apply in daily life, acquiring from pharmacies or hospital dispensaries exist because a Biotech company developed them.

    From a stock perspective, the biotech stock value ranges from triple-digit share prices all the way to under $1 price per share. The ones that are under $5 share prices are known as biotech penny stocks. These, just like every other penny stock are attributed to a lot of volatility however Biotech stocks have their own intrinsic share of volatility and risks (which come along with rewarding outcomes as well). Before we get into that let us first explain what really is creating the hype in this kind of stock, in the first place.

    How Biotech Industry became very popular among investors

    We mentioned before that the trend in the biotech stock is growing as it is in Green energy, Crypto, and EV stocks. But the reason behind this trend is completely different and associated to unique factors.

    Covid-19 Pandemic

    One major reason for the rise is the COVID-19 pandemic, specifically the race for vaccine production. When the pandemic had gripped the world in its virus, it had paralyzed many markets and business; the overall global economy was halted. In fact, even the most successful biotech companies had been forced to shut down. But Pandemic being human health and medical crisis had prompted responses from the very biotech industry that it had halted. The Biotech industry decided to push for solutions to the Pandemic and the virus, in the form of Vaccines. The vaccines became a huge market space in the healthcare industry and biotech stocks immediately started filling it up.

    The aging population

    According to the Rural Health Information Hub, The US population has more than 46 million citizens above or at the age of 65 which is expected to grow to 90 million almost in 2050. Every one in five Americans will be aged over 65 years old. The context of this is important when you correlate the use of prescribed medicines and drugs with old age; the older population uses prescribed medicines and drugs more often to treat their chronic illnesses and complications, as compared to younger generations. This means demand and innovation required from the Biotech Companies will increment in the following years and push the companies to focus on targeting innovative and niche spaces in the pharmaceutical market as competition concentrate between biotech companies.

    Exposure to Biotech stock

    The former factor is a more prevalent cause of exposure in the biotech market in the current market trend than the latter because the US and the overall world economy is slowly coming out of the Pandemic and rolling out vaccines. The pandemic had crippled many portfolios for the investors in various stocks and companies. During this time, the biotech stock was prevailing due to public, government, and private investors nudging the biotech companies to create vaccinations. This made investment profiles in the Biotech stock especially the ones in the vaccination race, more attractive.

    What are the types of Biotech Stocks?

    Now that we have established the roots of the developing trend in the Biotech industry, let’s focus on what exactly are the cues to look for when you are investing in the Biotech companies stock.

    There are three main types of Biotechnology companies; Medical, Agriculture, and industrial ( or referred to as Red, Green, and White respectively).

    The primary thing to focus on when you invest in Biotech companies is to have a bird’s eye view of all the metric and indicator for the stages and process that are related to Biotech stock’s operations/performances. This helps ensure, that your investment decision is based on solid evidence that can hopefully turn out to be incredibly rewarding.

    Biotech operations and drug development, especially in the Medical type, goes through rigorous testing that are subject to stringent approvals and regulatory standards. These operations, based on the development and approval are broken down into 5 stages.

    Investment and the five stages of Biotech Stock operations

    The first stage of drug development is known as Research and Discovery, where concepts and theories of new products are formed along with a given conceptual framework to back up the attributes and potential of the new product.

    The second stage is known as Preclinical Stage, where the drug’s pharmacological profile is created to assess the strategies and planning of human testing and effects that are expected to result from the early and late clinical stages. This profile is assessed by the regulatory bodies like the US FDA, to be approved and taken to the next stage human trials and tests. These trials and tests take place in 4 phases;

    • Phase 1: The safety of the drug is evaluated in human trials with determination to predict dosage range.
    • Phase 2: The efficacy of the drug is tested relevant to the disease it is targeting. This phase is known as proof of concept (PoC).
    • Phase 3: The proof of concept and previous phases are tested again in large population batches with several thousand people. This phase is known as regulatory proof which when approved requires the next step of New Drug Application (NDA) approval in order for the drug to be marketed.
    • Phase 4: Once the drug is marketed, the companies voluntarily or as per the requirement of the FDA will undertake post approval studies to validate and add additional information about the drug’s safety and efficacy.

    The third stage is known as Early-clinical stage in which the companies start initiating the phases of the testing and study. The first two phases mentioned above are what comes into this stage of Biotech companies. These companies that are in the first two phases are known as Early-stage biotech companies.

    The fourth stage is known as the late-clinical stage and the company is known as late-stage biotech. This stage consists of the regulatory approvals and NDA signing of the drug from the FDA.

    The fifth and final stage is the Commercial Stage, in which the companies have been approved for the NDA and begin rolling out the commercial strategies for the market. This stage also includes Phase 4 study as per requirement or voluntary basis.

    How to Invest in Biotech Stocks

    It may click to you up till this point that the biotechnology companies out there are in different stages of the Biotech lifecycle and thus have different risks associated with each stage for investment. The more progressed and approved the company is, in its stages, the more profitable and attractive its stock looks- however it still remains risky. Biotech Industry Organization (BIO) researched that the likelihood of success and regulatory approval to be received for a company from Phase I to Commercial stage has been 9.6% from data stretching 2006-2015. However, in the 2011-2020 data study, it was reduced to 7.9% which is mainly attributed to the concentration and new entrants in the market.

    The report also showed that even the hottest areas of a biotech investment portfolio which are Neurology, Cardiovascular, and Oncology have an approval rate of 8.4%, 6.6%, and 5.5% respectively. This report was also discussed by the Motley Fools team on their Youtube Channel in which they broke down the approval and success rating according to phases 1 to 4 (Commercialization), which was 70%, 33%, 30%, and less than 10% respectively.

    Failure is the big bad wolf in the biotech stock investment

    The investors need to lookout for the stage that the companies are in, in order to assess if the Biotechnology Company is worth investing into. Furthermore, it is important to heed for investors that companies can fail at any one of these stages which is what makes Biotech stocks volatile and risky. However, while looking into the track record of previous drug approvals of the company as well as the financials of the company, you can make a strong investment. The opposite is also true, once the company has been approved for any one of these stages and progresses, the stock price shoots up to double and triple digit percentages, while in some cases it can shoot up to quadruple digit percentages!

    Other proven ways to invest in Biotech Stock

    Looking at one biotech company’s stock for investment may seem to be tricky sometime, if there aren’t enough indicators to decide if the stock is valuable or not. In cases like these, especially if you are a new investor looking for exposure into the Biotech Industry, the safest bet is to opt for Exchange Traded Funds (ETFs) for biotechnology stocks. Biotech ETFs provide a great space for a new investor to get an exposure into Biotech stocks. Depending on your curiosity and preference you may opt for an equal-holding weight ETF or a market weighted ETF. The former will give you equal exposure to small new biotech stocks as you would get from big blue chip Biotech stocks.

    Another great strategy that has been evolving in the Biotech stock investment is the focus on Contract Research Organizations. Many Biotech stocks discover an idea for their drug candidate and then proceed to outsource the administrative, regulatory, experimentation, and clinical procedures to a CRO which is well equipped for exactly this sort of specialization in the Biotech space. These CROs generate revenue for their services despite the approval or disapproval of the product in any of the stages. Furthermore, big-fish CROs focus on the M&A action where they realize the potential of a new product candidate for which it merges, acquires or partners with the product’s Biotech company and reaps the gains from owning the candidate through its development and approvals. Therefore, investing in Biotech CROs may prove to be a better investment than just the developing Biotech Companies.

    Biotech Penny Stocks under $1

    A great way to start exposing yourself to Biotech stocks is to find biotech penny stocks which are $1 or under. Usually, investors invest in multiple under $1 portfolios to broaden their exposure. Here is a list of Biotech Penny stocks under $1.

    Ticker Company Market Cap Performance (YTD) Price Change
    AEZS Aeterna Zentaris Inc. 109.74 106.82% 0.88 2.11%
    ACST Acasti Pharma Inc. 116.17 71.54% 0.56 -1.24%
    ADXS Advaxis, Inc. 85.82 66.91% 0.58 23.31%
    ZSAN Zosano Pharma Corporation 95.38 64.01% 0.86 -3.94%
    OGEN Oragenics, Inc. 78.24 48.33% 0.67 -1.33%

    Biotech Stocks under $5

    Similarly, if you want to upgrade your investment portfolio from $1 biotech stocks, investors opt for bigger share price and market cap range for their portfolio and as such, focus on $5 or under Biotech stocks to invest in. This adds slightly more reward and risk but still provides great exposure.

    Ticker Company Market Cap Performance (YTD) Price Change
    SESN Sesen Bio, Inc. 755.67 203.70% 4.10 -3.53%
    PTIX Protagenic Therapeutics, Inc. 38.77 152.38% 2.65 -1.85%
    CTXR Citius Pharmaceuticals, Inc. 353.83 111.76% 2.16 0.47%
    MRKR Marker Therapeutics, Inc. 234.82 89.66% 2.75 -1.79%
    OTLK Outlook Therapeutics, Inc. 441.29 86.15% 2.42 1.68%
  • Lexaria Bioscience Corp. (LEXX) Stock Showing Increased Volatility Ahead of Success of Antiviral Drug Studies

    Lexaria Bioscience Corp. (LEXX) stock prices soared by 28.07% at the end of the trading day on July 21st, 2021, bringing the price per share up to USD$8.44 at the end of the trading day. Subsequent premarket fluctuations have seen the stock fall by 11.14%, bringing it down to USD$7.50.

    DehydraTECH Evaluation

    The company reported having successfully met its objectives for its 2021 antiviral drug examination program designed to evaluate DehydraTECH. The technology exhibited evidence of superior oral absorption of its processed compounds of leading classes of antiviral drugs for Covid-19, HIV/AIDS, and other infection diseases. DehydraTECH was also evaluated in regard to its processing of those compounds managing to preserve expected viral inhibitory performance, guided by efficacy testing in infected mammalian cells. The treatment was also proven to not adversely affect the drug molecules chemically, thereby creating new molecular entities that would prove to be difficult in guiding through the regulatory approval process.

    Continued Development

    To this end, LEXX is allocating resources towards a comprehensive multi-pronged program. It is designed to demonstrate essential proof-of-concept safety, efficacy, and formulation/scalability feasibility data to potential pharmaceutical industry partners. This is in line with the company’s strategy to create additional value-adding opportunities for further collaborative product development.

    Expanding Market Footprint

    The company is keen to leverage its DehydraTECH technology to pursue strategic collaboration opportunities with established industry partners who may be incorporating the technology with antiviral drugs. The company is striving to prove DehydraTECHworks to enhance oral delivery characteristics of relevant drugs, with its scope extending to other related treatments as well. Cumulatively, the company hopes to help develop treatments to fight a myriad of virus triggered diseases, including, but not limited to, shingles, influenza, viral forms of gastroenteritis, hepatitis, meningitis, and pneumonia.

    Scope of DehydraTECH

    Despite the efficacy and accessibility of vaccines to prevent many viral infections, thousands of people die annually from viral infections while being unvaccinated. Current estimations peg more than 99% of the 200,000 US death since January 1st, 2021 as a result of the Covid-19 pandemic being in people who were unvaccinated. This demonstrates the vital and expansive existing need for successful treatment options for those who are unvaccinated.

    Future Outlook for LEXX

    Armed with the continued proliferation of its flagship DehydraTECH technology, LEXX is poised to capitalize on the opportunities arising from its expanding network of strategic partners. Current and potential investors are hopeful that management will continue to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.

  • Trinity Biotech PLC (TRIB) Stock Surges Higher Following Announcement of Proliferation of Covid-19 Testing Space

    Trinity Biotech PLC (TRIB) Stock Surges Higher Following Announcement of Proliferation of Covid-19 Testing Space

    Trinity Biotech PLC (TRIB) stock prices were up 11.70% shortly after market trading commenced on July 16th, 2021, bringing the price per share up to USD$2.229 early on in the trading day.

    Rapid Antigen Test

    The company reported being at an advanced stage in the development of an antigen test for the coronavirus that has been devastating the globe. The company leverages its core lateral flow technology to develop the test, which can be utilized without any specialized equipment, providing a result in 12 minutes. Accessibility is further enhanced with its easy-to-use anterior nasal swab sample.

    Scope of Antigen Test

    With the onset of the global coronavirus having signaled an unfathomable long-term toll on economies across the world, the world’s ongoing efforts to mitigate and eventually nullify its effects persist. As public health efforts continue with full force, antigen tests have played a critical role in the overall diagnostic response. As the world hurtles towards universal immunization, the company expects antigen tests to be a part of the core response to the pandemic, in combination with Covid-19 vaccinations.

    Rapid Antibody Test

    June 2021 saw the company submit a EUA application to the FDA for the UniGold Covid-19 rapid antibody test, which detects IgG antibodies against the coronavirus. The antibody test demonstrated a 100% sensitivity and a specificity of 95% over the course of the validation studies. The test was measured against a comparator PCR method which facilitated the confirmation of prior infection.

    EUA Application

    July 2021 saw the FDA inform TRIB that its application for the Emergency Use Authorization of the serological test would not currently be prioritized, on account of the sheer volume of EUA requests currently being processed by the government agency. In order to facilitate the timely commercialization and proliferation of its treatment, the company is exploring additional prospective pathways that would see it gain regulatory approval, thus allowing sales of the test in the U.S. Hitherto, any such potential options have required too significant and additional investment for them to be viable.

    Future Outlook for TRIB

    With the world’s continued efforts towards the aim of making the coronavirus a thing of the past, TRIB is poised to capitalize on the access it has gained to a burgeoning market. The company is keen to leverage its resources in order to drive increased market penetration. Current and potential investors are hopeful for the stock price to recover and increase over the long term.

  • 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.

  • Qualigen Therapeutics, Inc. (QLGN) Stock on the Rise Following IND Submission for Novel Covid-19 Treatment, QN-165

    Qualigen Therapeutics, Inc. (QLGN) stock prices were up 1.6854% as of the market opening on July 14th, 2021, with premarket trading having seen the stock rise sharply. As of writing, the price per share of QLGN stock was USD$1.81.

    IND Submission

    July 14th, 2021 saw the biotechnology company announce the submission of an Investigational New Drug Application to the U.S Food and Drug Administration with an initial target indication for the treatment of hospitalized Covid-19 patients with the company’s QN-165. The DNA aptamer is a broad-based antiviral drug candidate that has shown antiviral activity in various in vitro assays against a plethora of viruses.

    Milestone for QLGN

    The significant milestone is the first IND application submitted by the company for its most advanced therapeutics program. The IND application submission for Phase 1b/2a clinical trials for QN-165 represents another step in the company’s evolution from a globally patented and commercially successful diagnostics company to a clinical-stage therapeutics company with multiple programs.

    QN-165

    QN-165 is a unique drug candidate that presents an entirely novel approach to combating viruses, which the company thinks it will be able to work against all virus strains and variants. The treatment is a piece of synthetic DNA that does not target the coronavirus directly, as existing treatments do. Rather, it targets and binds to the nucleolin protein and has the capacity to enter cells that overexpress nucleolin. Nucleolin is exploited by viruses such as Covid-19 to gain access to a cell, manipulating it for its own viral replication purposes.

    Scope of QN-165

    By tying up nucleolin, QN-165 is anticipated to block the mechanism entirely, thus preventing the virus replication process. Because of this, even the mutation of the virus is not expected to result in a loss of efficacy of the treatment, on account of nucleolin being targeted instead of the virus itself. This is what the company believes will make the treatment effective against a plethora of viral mutations, including all strains and variants of the novel coronavirus.

    Future Outlook for QLGN

    With the world hurtling towards global immunizations, the onslaught of variants and strains that pop up across the globe are becoming an increasingly significant concern. Treatments such as QN-165 are set to address those concerns, thereby signaling the massive potential for commercialization and proliferation of the expansive market. Investors are hopeful that management will leverage its resources to deliver the treatment as quickly as possible, thus ensuring maximum 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.

  • Origin Agritech Ltd. (SEED) Stock Surges Following Expansion of GMO Trait Portfolio

    Origin Agritech Ltd. (SEED) Stock Surges Following Expansion of GMO Trait Portfolio

    Origin Agritech Ltd. (SEED) stock prices were up by 29.22% some time after market trading commenced on July 12th, 2021, bringing the price per share up to USD$11.63 early on in the trading day.

    Exclusive Rights Agreement

    July 12th, 2021 saw the company announce that it had entered into an exclusive rights agreement with the Biology Research Institute of the Chinese Academy of Agricultural Sciences, in regard to its proprietary drought resistant GMO trait. The agreement will see the company gain exclusive global rights to the GMO trait for the entire duration of the patent. The Chinese Ministry of Agriculture and Rural Affairs approved the drought tolerance corn for production trials, representing the fourth stage in a five stage process to receive a bio-safety certificate.

    Drought Resistant Traits

    With the company already having successfully converted its elite corn hybrids into drought resistant  traits, which express excellent performance under water stress conditions throughout the growing period. Multi year experiments have indicated drought tolerance corn yield that is 9.2 to 16.2% higher than non-GMO corn under water stress conditions. In the case of irrigation, the GMO enhanced corn increases water use efficiency by 33-47%.

    Approval for Hybrid Corn Breeds

    July 8th, 2021 had seen the company announce its approval from the Ministry of Agriculture and Rural Affairs for four of its new hybrid corn breeds. This move has seen the company expand its product pipeline and increase its competitiveness in the Chinese corn seed market. The company also has GMO enhanced versions of the newly approved hybrids that are currently in the approval pipeline.

    Scope of Approval

    The Ministry of Agriculture and Rural Affairs recently increased the national standards required for the approval of corn and rice varieties, thus further promoting further innovation in germplasm development. Being on of the few participating companies in the Green Pass program, the company is in a unique position to streamline the approval process, resulting in the submission of more hybrids for approval per year. This will, in turn, strengthen the company’s ability to add multiple new hybrids to market annually, which will include many GMO enhanced hybrids.

    Future Outlook for SEED

    Armed with the recent development of its product pipeline, SEED is poised to push for the accelerated commercialization and effective proliferation of its corn hybrids in the Chinese market space. 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.

  • 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.