Well-Chosen Biotech Stocks Could Payoff Big for Investors
The Biotech sector has been flatlined since September but is now suddenly showing significant signs of life already in 2023. It’s only the second week of the new year, and already three US-based public small-cap companies are to be acquired by cash-rich drugmakers looking to expand their portfolios. The stocks of biotechs Albireo (ALBO), Amryt (AMYT), and CinCor (CINC) are all up between 93% and 140% after the announcements. A case can easily be made that the beaten-down biotech sector and the cash-rich pharmaceutical giants, with aging patents on their current drug portfolios, are going to find they are stronger together – this could be a huge win for investors.
Details of Recent Announcements
Ipsen (IPN), a French drug company, agreed to buy liver drug maker Albireo Pharma for at least $952 million, or $42 per share, plus another $10 per share if the FDA approves its Bylvay drug.
Italy’s Chisi Farmaceutici agree to pay up to $1.5 billion for Amryt Pharma. Amryt makes drugs for rare diseases. The agreement requires at least $14.50 per share, plus another $2.50 depending on milestones for its Filsuvez product, which treats a skin disease.
AstraZeneca, an Anglo-Swedish pharmaceutical company, said it’s paying up to $1.8 billion for CinCor Pharma, a maker of a blood pressure medication. The deal calls for $26 per share in cash, plus as much as another $10 per share if it’s able to make a Food and Drug Administration submission for a product based on baxdrostat drug in development for hypertension and chronic kidney disease.
The one thing in common between all three deals is an incentive for management to meet milestones which could include getting approval of late-stage drugs. Presumably, with the additional resources, these goals could become much easier for the companies that are allowing themselves to be acquired.
Will Other Acquisitions Follow?
Investors have learned all too well about investment bubbles, a situation where so much money flows into a sector that it becomes substantially overvalued. Then, when money isn’t flowing so freely, prices fall apart. But, the inverse of a bubble can also occur. A sector can be ignored for so long that investors don’t see value; when activity begins to perk up, many recognize value all at once and suddenly the sector is on fire. This inverse bubble may be at the earliest stages in small-cap biotech.
In a story unrelated to the publicly traded companies being acquired, Reuters is reporting that private equity firms that had stayed uninvolved in what the firms believed to be the risk in the drug development business are now showing strong interest. “These firms are seeking to capitalize on the growing gap between the supply of capital for clinical research and the number of drugs competing for it, eight buyout executives and investors interviewed by Reuters said.”
The Reuters article highlights Blackstone (BX.N) as one company they explain is “leading the charge.” Carlyle is another investment group that, according to Reuters, is “now preparing to raise a dedicated life sciences fund,” the article explained the fund “could amass several billions of dollars, according to people familiar with the fundraising plans.” Reuters quoted Carlyle’s Global Head of healthcare as saying, “We are big believers in what we’ve called the biopharma revolution and in the explosion of discovery and science.”
These investment groups are not taking ownership in the companies they invest in, but rather a stake in clinical trials which stand a much greater chance with the injection of this new capital. The payoff arrangements are different for each deal.
What Should Self-Directed Investors Watch?
If there is a continued resurgence of activity among big pharma firms buying up publicly traded biotech firms, then small investors can expect to see more huge winners and, of course, others that never get off the ground. That is to say, while a few firms become the overnight 100% winners, many more languish and trade up and down without going any place. Increasing your chances of having at least one big winner among your holdings involves understanding the market, the companies, and the dynamics surrounding life sciences investments.
If you have already signed-up to have access to research and company information on Channelchek, then you have access to small-cap biotech stocks, and the research provided by the Senior Life Sciences Research Analyst at Noble Capital Markets. If you haven’t signed up, do this now by clicking here, and review the library of videos with interviews of management of biotechs and dig into the companies to learn where each is at in development and research.
Pharma’s Expensive Gaming of the Drug Patent System is Successfully Countered by the Medicines Patent Pool, Which Increases Global Access and Rewards Innovation
Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass Amherst
Drug Patents in the Global Landscape
Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, typically 20 years from the application filing date.
However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “evergreens” the company’s patent portfolio without requiring substantial new investments in research and development.
Furthermore, because patents are jurisdiction-specific, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.
To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.
The 2001 Doha Declaration clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.
One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court denied Novartis’s patent application for Glivec for obviousness, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been patented in 40 other countries. As a result of India’s landmark ruling, the price of Glivec dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88) for one month of treatment.
Patent Challenges and Pools
Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain multiple patented compounds, each of which can be owned by different companies. Overlapping patent rights can create a “patent thicket” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.
One solution to these drug access issues is patent pools. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization.
Patent pools were first used in 1856 for sewing machines and were once ubiquitous across multiple industries. Patent pools gradually disappeared after a 1945 U.S. Supreme Court decision that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later revived in the 1990s in response to licensing challenges in the information and communication technology sector.
Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market. Lucy Xiaolu Wang, CC BY-NC-ND
The Medicines Patent Pool
Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The Medicines Patent Pool, or MPP, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.
But how much has the MPP improved drug access?
I sought to answer this question by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.
The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs. Lucy Xiaolu Wang, CC BY-NC-ND i
I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.
I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.
The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.
Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.
Technology Licensing for COVID-19 and Beyond
Since May 2020, the Medicines Patent Pool has become a key partner of the World Health Organization COVID-19 Technology Access Pool, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an mRNA vaccine technology transfer hub in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.
Licensing COVID-19-related technologies can be complicated by the large amount of trade secrets involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as manufacturing details. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to close the licensing knowledge gap.
Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug nilotinib – the first time a cancer drug has come under a public health-oriented licensing agreement.
A team of scientists at the Whitehead Institute for Biomedical Research and the Broad Institute of MIT and Harvard has systematically evaluated the functions of over 5,000 essential human genes using a novel, pooled, imaged-based screening method. Their analysis harnesses CRISPR-Cas9 to knock out gene activity and forms a first-of-its-kind resource for understanding and visualizing gene function in a wide range of cellular processes with both spatial and temporal resolution. The team’s findings span over 31 million individual cells and include quantitative data on hundreds of different parameters that enable predictions about how genes work and operate together. The new study appears in the Nov. 7 online issue of the journal Cell.
“For my entire career, I’ve wanted to see what happens in cells when the function of an essential gene is eliminated,” says MIT Professor Iain Cheeseman, who is a senior author of the study and a member of Whitehead Institute. “Now, we can do that, not just for one gene but for every single gene that matters for a human cell dividing in a dish, and it’s enormously powerful. The resource we’ve created will benefit not just our own lab, but labs around the world.”
Systematically disrupting the function of essential genes is not a new concept, but conventional methods have been limited by various factors, including cost, feasibility, and the ability to fully eliminate the activity of essential genes. Cheeseman, who is the Herman and Margaret Sokol Professor of Biology at MIT, and his colleagues collaborated with MIT Associate Professor Paul Blainey and his team at the Broad Institute to define and realize this ambitious joint goal. The Broad Institute researchers have pioneered a new genetic screening technology that marries two approaches — large-scale, pooled, genetic screens using CRISPR-Cas9 and imaging of cells to reveal both quantitative and qualitative differences. Moreover, the method is inexpensive compared to other methods and is practiced using commercially available equipment.
“We are proud to show the incredible resolution of cellular processes that are accessible with low-cost imaging assays in partnership with Iain’s lab at the Whitehead Institute,” says Blainey, a senior author of the study, an associate professor in the Department of Biological Engineering at MIT, a member of the Koch Institute for Integrative Cancer Research at MIT, and a core institute member at the Broad Institute. “And it’s clear that this is just the tip of the iceberg for our approach. The ability to relate genetic perturbations based on even more detailed phenotypic readouts is imperative, and now accessible, for many areas of research going forward.”
Cheeseman adds, “The ability to do pooled cell biological screening just fundamentally changes the game. You have two cells sitting next to each other and so your ability to make statistically significant calculations about whether they are the same or not is just so much higher, and you can discern very small differences.”
Cheeseman, Blainey, lead authors Luke Funk and Kuan-Chung Su, and their colleagues evaluated the functions of 5,072 essential genes in a human cell line. They analyzed four markers across the cells in their screen — DNA; the DNA damage response, a key cellular pathway that detects and responds to damaged DNA; and two important structural proteins, actin and tubulin. In addition to their primary screen, the scientists also conducted a smaller, follow-up screen focused on some 200 genes involved in cell division (also called “mitosis”). The genes were identified in their initial screen as playing a clear role in mitosis but had not been previously associated with the process. These data, which are made available via a companion website, provide a resource for other scientists to investigate the functions of genes they are interested in.
“There’s a huge amount of information that we collected on these cells. For example, for the cells’ nucleus, it is not just how brightly stained it is, but how large is it, how round is it, are the edges smooth or bumpy?” says Cheeseman. “A computer really can extract a wealth of spatial information.”
Flowing from this rich, multi-dimensional data, the scientists’ work provides a kind of cell biological “fingerprint” for each gene analyzed in the screen. Using sophisticated computational clustering strategies, the researchers can compare these fingerprints to each other and construct potential regulatory relationships among genes. Because the team’s data confirms multiple relationships that are already known, it can be used to confidently make predictions about genes whose functions and/or interactions with other genes are unknown.
There are a multitude of notable discoveries to emerge from the researchers’ screening data, including a surprising one related to ion channels. Two genes, AQP7 and ATP1A1, were identified for their roles in mitosis, specifically the proper segregation of chromosomes. These genes encode membrane-bound proteins that transport ions into and out of the cell. “In all the years I’ve been working on mitosis, I never imagined ion channels were involved,” says Cheeseman.
He adds, “We’re really just scratching the surface of what can be unearthed from our data. We hope many others will not only benefit from — but also build upon — this resource.”
This work was supported by grants from the U.S. National Institutes of Health as well as support from the Gordon and Betty Moore Foundation, a National Defense Science and Engineering Graduate Fellowship, and a Natural Sciences and Engineering Research Council Fellowship.
A team of scientists at the Whitehead Institute for Biomedical Research and the Broad Institute of MIT and Harvard has systematically evaluated the functions of over 5,000 essential human genes using a novel, pooled, imaged-based screening method. Their analysis harnesses CRISPR-Cas9 to knock out gene activity and forms a first-of-its-kind resource for understanding and visualizing gene function in a wide range of cellular processes with both spatial and temporal resolution. The team’s findings span over 31 million individual cells and include quantitative data on hundreds of different parameters that enable predictions about how genes work and operate together. The new study appears in the Nov. 7 online issue of the journal Cell.
“For my entire career, I’ve wanted to see what happens in cells when the function of an essential gene is eliminated,” says MIT Professor Iain Cheeseman, who is a senior author of the study and a member of Whitehead Institute. “Now, we can do that, not just for one gene but for every single gene that matters for a human cell dividing in a dish, and it’s enormously powerful. The resource we’ve created will benefit not just our own lab, but labs around the world.”
Systematically disrupting the function of essential genes is not a new concept, but conventional methods have been limited by various factors, including cost, feasibility, and the ability to fully eliminate the activity of essential genes. Cheeseman, who is the Herman and Margaret Sokol Professor of Biology at MIT, and his colleagues collaborated with MIT Associate Professor Paul Blainey and his team at the Broad Institute to define and realize this ambitious joint goal. The Broad Institute researchers have pioneered a new genetic screening technology that marries two approaches — large-scale, pooled, genetic screens using CRISPR-Cas9 and imaging of cells to reveal both quantitative and qualitative differences. Moreover, the method is inexpensive compared to other methods and is practiced using commercially available equipment.
“We are proud to show the incredible resolution of cellular processes that are accessible with low-cost imaging assays in partnership with Iain’s lab at the Whitehead Institute,” says Blainey, a senior author of the study, an associate professor in the Department of Biological Engineering at MIT, a member of the Koch Institute for Integrative Cancer Research at MIT, and a core institute member at the Broad Institute. “And it’s clear that this is just the tip of the iceberg for our approach. The ability to relate genetic perturbations based on even more detailed phenotypic readouts is imperative, and now accessible, for many areas of research going forward.”
Cheeseman adds, “The ability to do pooled cell biological screening just fundamentally changes the game. You have two cells sitting next to each other and so your ability to make statistically significant calculations about whether they are the same or not is just so much higher, and you can discern very small differences.”
Cheeseman, Blainey, lead authors Luke Funk and Kuan-Chung Su, and their colleagues evaluated the functions of 5,072 essential genes in a human cell line. They analyzed four markers across the cells in their screen — DNA; the DNA damage response, a key cellular pathway that detects and responds to damaged DNA; and two important structural proteins, actin and tubulin. In addition to their primary screen, the scientists also conducted a smaller, follow-up screen focused on some 200 genes involved in cell division (also called “mitosis”). The genes were identified in their initial screen as playing a clear role in mitosis but had not been previously associated with the process. These data, which are made available via a companion website, provide a resource for other scientists to investigate the functions of genes they are interested in.
“There’s a huge amount of information that we collected on these cells. For example, for the cells’ nucleus, it is not just how brightly stained it is, but how large is it, how round is it, are the edges smooth or bumpy?” says Cheeseman. “A computer really can extract a wealth of spatial information.”
Flowing from this rich, multi-dimensional data, the scientists’ work provides a kind of cell biological “fingerprint” for each gene analyzed in the screen. Using sophisticated computational clustering strategies, the researchers can compare these fingerprints to each other and construct potential regulatory relationships among genes. Because the team’s data confirms multiple relationships that are already known, it can be used to confidently make predictions about genes whose functions and/or interactions with other genes are unknown.
There are a multitude of notable discoveries to emerge from the researchers’ screening data, including a surprising one related to ion channels. Two genes, AQP7 and ATP1A1, were identified for their roles in mitosis, specifically the proper segregation of chromosomes. These genes encode membrane-bound proteins that transport ions into and out of the cell. “In all the years I’ve been working on mitosis, I never imagined ion channels were involved,” says Cheeseman.
He adds, “We’re really just scratching the surface of what can be unearthed from our data. We hope many others will not only benefit from — but also build upon — this resource.”
This work was supported by grants from the U.S. National Institutes of Health as well as support from the Gordon and Betty Moore Foundation, a National Defense Science and Engineering Graduate Fellowship, and a Natural Sciences and Engineering Research Council Fellowship.
A Blood Test that Screens for Multiple Cancers at Once Promises to Boost Early Detection
Detecting cancer early before it spreads throughout the body can be lifesaving. This is why doctors recommend regular screening for several common cancer types, using a variety of methods. Colonoscopies, for example, screen for colon cancer, while mammograms screen for breast cancer.
While important, getting all these tests done can be logistically challenging, expensive and sometimes uncomfortable for patients. But what if a single blood test could screen for most common cancer types all at once?
This is the promise of multicancer early detection tests, or MCEDs. This year, President Joe Biden identified developing MCED tests as a priority for the Cancer Moonshot, a US$1.8 billion federal effort to reduce the cancer death rate and improve the quality of life of cancer survivors and those living with cancer.
This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Colin Pritchard, Professor of Laboratory Medicine and Pathology, University of Washington.
As a laboratory medicine physician and researcher who develops molecular tests for cancer, I believe MCED tests are likely to transform cancer screening in the near future, particularly if they receive strong federal support to enable rapid innovation.
How MCED Tests Work
All cells in the body, including tumor cells, shed DNA into the bloodstream when they die. MCED tests look for the trace amounts of tumor DNA in the bloodstream. This circulating “cell-free” DNA contains information about what type of tissue it came from and whether it is normal or cancerous.
Testing to look for circulating tumor DNA in the blood is not new. These liquid biopsies – a fancy way of saying blood tests – are already widely used for patients with advanced-stage cancer. Doctors use these blood tests to look for mutations in the tumor DNA that help guide treatment. Because patients with late-stage cancer tend to have a large amount of tumor DNA circulating in the blood, it’s relatively easy to detect the presence of these genetic changes.
MCED tests are different from existing liquid biopsies because they are trying to detect early-stage cancer, when there aren’t that many tumor cells yet. Detecting these cancer cells can be challenging early on because noncancer cells also shed DNA into the bloodstream. Since most of the circulating DNA in the bloodstream comes from noncancer cells, detecting the presence of a few molecules of cancer DNA is like finding a needle in a haystack.
Making things even more difficult, blood cells shed abnormal DNA naturally with aging, and these strands can be confused for circulating cancer DNA. This phenomenon, known as clonal hematopoiesis, confounded early attempts at developing MCED tests, with too many false positive results.
Fortunately, newer tests are able to avoid blood cell interference by focusing on a type of “molecular barcode” embedded in the cancer DNA that identifies the tissue it came from. These barcodes are a result of DNA methylation, naturally existing modifications to the surface of DNA that vary for each type of tissue in the body. For example, lung tissue has a different DNA methylation pattern than breast tissue. Furthermore, cancer cells have abnormal DNA methylation patterns that correlate with cancer type. By cataloging different DNA methylation patterns, MCED tests can focus on the sections of DNA that distinguish between cancerous and normal tissue and pinpoint the cancer’s origin site.
DNA contains molecular patterns that indicate where in the body it came from. (CNX OpenStax/Wikimedia Commons)
Testing Options
There are currently several MCED tests in development and in clinical trials. No MCED test is currently FDA-approved or recommended by medical societies.
In 2021, the biotech company GRAIL, LLC launched the first commercially available MCED test in the U.S. Its Galleri test claims to detect over 50 different types of cancers. At least two other U.S.-based companies, Exact Sciences and Freenome, and one Chinese company, Singlera Genomics, have tests in development. Some of these tests use different cancer detection methods in addition to circulating tumor DNA, such as looking for cancer-associated proteins in blood.
MCED tests are not yet typically covered by insurance. GRAIL’s Galleri test is currently priced at $949, and the company offers a payment plan for people who have to pay out of pocket. Legislators have introduced a bill in Congress to provide Medicare coverage for MCED tests that obtain FDA approval. It is unusual for Congress to consider legislation devoted to a single lab test, and this highlights both the scale of the medical market for MCED and concerns about disparities in access without coverage for these expensive tests.
How Should MCED Tests be Used?
Figuring out how MCED tests should be implemented in the clinic will take many years. Researchers and clinicians are just beginning to address questions on who should be tested, at what age, and how past medical and family history should be taken into account. Setting guidelines for how doctors will further evaluate positive MCED results is just as important.
There is also concern that MCED tests may result in overdiagnoses of low-risk, asymptomatic cancers better left undetected. This happened with prostate cancer screening. Previously, guidelines recommended that all men ages 55 to 69 regularly get blood tests to determine their levels of PSA, a protein produced by cancerous and noncancerous prostate tissue. But now the recommendation is more nuanced, with screening suggested on an individual basis that takes into account personal preferences.
Another concern is that further testing to confirm positive MCED results will be costly and a burden to the medical system, particularly if a full-body scan is required. The out-of-pocket cost for an MRI, for example, can run up to thousands of dollars. And patients who get a positive MCED result but are unable to confirm the presence of cancer after extensive imaging and other follow-up tests may develop lifelong anxiety about a potentially missed diagnosis and continue to take expensive tests in fruitless search for a tumor.
Despite these concerns, early clinical studies show promise. A 2020 study of over 10,000 previously undiagnosed women found 26 of 134 women with a positive MCED test were confirmed to have cancer. A 2021 study sponsored by GRAIL found that half of the over 2,800 patients with a known cancer diagnosis had a positive MCED test and only 0.5% of people confirmed to not have cancer had a false positive test. The test performed best for patients with more advanced cancers but did detect about 17% of the patients who had very-early-stage disease.
MCED tests may soon revolutionize the way clinicians approach cancer screening. The question is whether the healthcare system is ready for them.
Saskatoon, Saskatchewan–(Newsfile Corp. – October 11, 2022) – MustGrow Biologics Corp. (CSE: MGRO) (OTCQB: MGROF) (FSE: 0C0) (the “Company” or “MustGrow“), is pleased to announce that it has received conditional approval to list its common shares on the TSX Venture Exchange (the “TSXV”). The listing is subject to the Company fulfilling certain requirements of the TSXV in accordance with the terms of its conditional approval letter dated October 6, 2022.
MustGrow is actively working to satisfy the requirements and conditions that were highlighted in the approval letter and management is confident that all conditions for listing will be met in the coming weeks. Upon obtaining final approval, the Company will issue an additional news release to inform shareholders when it anticipates that its common shares will commence trading on the TSXV.
Upon completion of the final listing requirements, the Company’s common shares will be delisted from the Canadian Securities Exchange (the “CSE”) and commence trading on the TSXV under the trading symbol “MGRO”. MustGrow’s common shares will continue to trade on the OTCQB market under the symbol “MGROF” and on the Frankfurt Stock Exchange under the symbol “0C0”.
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About MustGrow
MustGrow is an agriculture biotech company developing organic biopesticides and bioherbicides by harnessing the natural defense mechanism of the mustard plant to protect the global food supply from diseases, insect pests, and weeds. MustGrow and its leading global partners – Janssen PMP (pharmaceutical division of Johnson & Johnson), Bayer, Sumitomo Corporation, and Univar Solutions’ NexusBioAg – are developing mustard-based organic solutions to potentially replace harmful synthetic chemicals. Over 150 independent tests have been completed, validating MustGrow’s safe and effective approach to crop and food protection. Pending regulatory approval, MustGrow’s patented liquid products could be applied through injection, standard drip, or spray equipment, improving functionality and performance features. Now a platform technology, MustGrow and its global partners are pursuing applications in several different industries from preplant soil treatment and weed control, to postharvest disease control and food preservation. MustGrow has approximately 49.7 million basic common shares issued and outstanding and 55.6 million shares fully diluted. For further details, please visit www.mustgrow.ca.
Certain statements included in this news release constitute “forward-looking statements” which involve known and unknown risks, uncertainties and other factors that may affect the results, performance or achievements of MustGrow.
Generally, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might”, “occur” or “be achieved”. Examples of forward-looking statements in this news release include, among others, statements MustGrow makes regarding: (i) potential product approvals; (ii) anticipated actions by partners to drive field development work including dose rates, application frequency, application methods, and the regulatory work necessary for commercialization; (iii) expected product efficacy of MustGrow’s mustard-based technologies; (iv) expected outcomes from collaborations with commercial partners, (v) the ability of the Company to satisfy the TSXV’s requirements and conditions for final approval to list its common shares on the TSXV; and (vi) the timing and commencement of trading of the Company’s common shares on the TSXV.
Forward-looking statements are subject to a number of risks and uncertainties that may cause the actual results of MustGrow to differ materially from those discussed in such forward-looking statements, and even if such actual results are realized or substantially realized, there can be no assurance that they will have the expected consequences to, or effects on, MustGrow. Important factors that could cause MustGrow’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) the preferences and choices of agricultural regulators with respect to product approval timelines; (ii) the ability of MustGrow’s partners to meet obligations under their respective agreements; and (iii) other risks described in more detail in MustGrow’s Annual Information Form for the year ended December 31, 2021 and other continuous disclosure documents filed by MustGrow with the applicable securities regulatory authorities which are available at www.sedar.com. Readers are referred to such documents for more detailed information about MustGrow, which is subject to the qualifications, assumptions and notes set forth therein.
This release does not constitute an offer for sale of, nor a solicitation for offers to buy, any securities in the United States.
Neither the CSE, the TSXV, nor their Regulation Services Provider (as that term is defined in the policies of the CSE and TSXV), nor the OTC Markets has approved the contents of this release or accepts responsibility for the adequacy or accuracy of this release.
A silver bullet cure, with possible indications for 150 illnesses or more, is now being researched by a few small biotech companies. The results have gotten the attention of big pharmaceutical companies.
In the world of biology, medicine, and biotechnology, there’s a new and extremely promising field of research in inflammasomes. Since the discovery 20 years ago, increasing understanding of what causes inflammation or an inflammatory response in humans and the knowledge of the mechanisms and role of inflammasomes has developed into a race to design potential drugs which target the culprit in many diseases. The problem to be solved is an overly zealous inflammatory response.
The activation of the inflammation system is to protect the body from pathogens, injury, or other dangers or irritants. While insufficient inflammation can lead to persistent infection or problems related to the initial trigger, excessive inflammation can cause chronic or systemic inflammatory diseases. While there are many medications, both over-the-counter and by prescription, to help reduce inflammation and problems associated with it, a therapy or therapies upstream could prevent an over-inflammation response at the source.
Currently, the rapid expansion of knowledge of inflammasomes’ role in various diseases has uncovered links to neurological diseases such as Parkinson’s, Alzheimer’s, and MS; metabolic disorders including type2 diabetes, and obesity; and cardiovascular diseases.
Currently, there are no approved inflammasome inhibitors; however, there are several promising early-stage trials occurring at a few focused companies. Development of therapies is the goal, with expectations of them being able to treat a myriad of ailments. Success could be similar to the discovery of penicillin when many infections quickly ceased being worrisome. The breakthrough could provide therapy or a mechanism to control one or two key inflammasomes that could suddenly provide cures or relief from many chronic problems.
Over the past few years, these inflammasome-related transactions, acquisitions, and partnerships have taken place:
Ventus Therapeutics- On September 29, 2022, Ventus received $70 million upfront, with the agreement for additional milestones of up to $633 million, also royalty payments and R&D funding from Novo Nordisk to license Ventus’s brain penetrant inflammasome (NLRP3) inhibitor – Ventus is a privately held company that retains full rights.
Cerevance – August 9, 2022 Cerevance received $25 million upfront, with the agreement for additional milestones up to $1.1 billion, with potential for royalty payments from Merck on sales of approved products derived from the strategic research collaboration of Alzheimer’s targets using Cerevance’s NetSseq platform. (Pre-clinical phase)
Inflamazome – September 21, 2020 Inflamazome was fully acquired for $451 million upfront with R&D milestones that could be worth up to $1.125 billion from Roche. Roche will own full rights to the acquired company’s portfolio of oral NLRP3 small molecule inflammasome inhibitors. (Pre-clinical phase and Phase 1)
IFM Therapeutics – Quattro & IFM Discovery (Incubator) – December 2019, Has raised $55.5 million to launch its third drug subsidiary as well as an incubator, both of which are focused on developing new therapies for inflammatory diseases and cancers. Omega Funds was the lead, with Atlas Ventures also participating. Financing lead: Omega Funds also participating: Atlas Ventures. (Discovery Phase)
Inflammasome Therapeutics – September 2019, Is entitled to receive up to $160 million in milestone and gated development payments and tiered royalties and other milestones due on commercialization from Boehringer Ingelheim. (Development Phase)
IFM Therapeutics – September 2019, Agreement provides sufficient funding for research and development costs through late-stage pre-clinical development of the lead program with an option to acquire IFM Due. IFM is a Privately held company. (Discovery Phase)
IFM Therapeutics- April 1, 2019, the subsidiary IFM Tre was acquired by Novartis. Novartis will pay $310 million upfront and up to roughly $1.3 billion in milestones to access three early-stage NLRP3 antagonists: IFM-2427, a systemically acting compound that began its first human studies last week, and two pre-clinical compounds: one gut-penetrating, and the other directed at the central nervous system. (Clinical Phase and Pre-clinical Phases)
Most of the small companies involved in inflammasome research are privately held and raise capital privately. From time to time, Noble Capital Markets may be involved in raising capital for non-public biotech firms and companies in other industries. To determine in advance if you qualify to invest in non-public capital raises, visit here to request accreditation.
Take Away
There are huge amounts of capital coming primarily from big pharma and venture capital firms with the expectation that R&D on inflammasomes could yield big results. Therapies that could regulate a primary culprit across many diseases would be a significant boost to investors and mankind.
