Tonix Pharmaceuticals Moves TNX-1900 into Phase 2 Studies After FDA Clearance

Sartorius AG to Open Center of Excellence in Michigan

Tonix Pharmaceuticals Holding Corp. has announced the successful FDA clearance of their investigational new drug (IND) for Potentiated Intranasal Oxytocin (TNX-1900). The treatment can be used to prevent migraine headaches for those chronically afflicted.

Tonix is a clinical-stage biopharmaceutical company based in New Jersey who has spent their time repurposing drugs for central nervous system conditions. 

The FDA clearance will allow TNX-1900 to be pushed into a Phase 2 study. The study is expected to qualify for the 505(b)(2) pathway for full FDA approval – a pathway available only to new formulations of an approved drug.

Migraines are a symptom of a neurological condition which manifests in throbbing headaches, light auras, and aversions to lights, smells, and noises. Tonix believes that by engaging and stimulating oxytocin receptors in the trigeminal ganglia, TNX-1900 could prevent migraines. The drug contains magnesium which potentiates the action of oxytocin at oxytocin receptors in animal models. 

Oxytocin is a naturally occurring human hormone with no recognized addiction potential. It has been observed that lowered oxytocin levels in the body can lead to increased migraine headache frequency. Some other chronic pain conditions are also associated with low oxytocin levels.

Tonix has further plans to develop TNX-1900 for craniofacial pain and insulin resistance.

Are you developing new pharmaceuticals for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

MDI Biological Laboratory Discovers Protection of Muscle During Dietary Restriction

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MDI Biological Laboratory, a Maine-based biomedical research institution, has discovered that muscle may be a protected tissue under dietary restriction conditions.

Dietary restriction has been a robust anti-aging intervention tool for a while now. This process has the patient restrict calories without reaching malnutrition. In face of the scarce nutrients, the organism conserves resources by lowering the translation of proteins. Protein translation is one of the most energetically costly processes in a cell.

By conserving these cellular resources, the organism can reproduce when food becomes available but comes at the cost of reduced anabolic function, growth, and reproduction.

Aric N. Rogers, PH.D. at MDI Biological Labs has studied the cellular and molecular mechanisms of aging. Rogers has worked with tiny nematode worms, C. elegans, to evaluate the impact of suppressed protein translation. Skin, nerve, and reproductive tissues responded as expected with enhanced survival and decreased growth and reproduction, muscle experienced the opposite effect.

Muscle tissue experienced accelerated growth and reproduction instead of suppression.  

  1. elegans is a popular model in aging research because it shares many of its genes with humans, including those governing nutrient-sensing pathways, and because its short lifespan allows scientists to rapidly assess the effects of anti-aging interventions.

This discovery could contribute to the development of anti-aging drugs without side effects. 

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

MDI Biological Laboratory Discovers Protection of Muscle During Dietary Restriction

MDI Biological Laboratory, a Maine-based biomedical research institution, has discovered that muscle may be a protected tissue under dietary restriction conditions.

Dietary restriction has been a robust anti-aging intervention tool for a while now. This process has the patient restrict calories without reaching malnutrition. In face of the scarce nutrients, the organism conserves resources by lowering the translation of proteins. Protein translation is one of the most energetically costly processes in a cell.

By conserving these cellular resources, the organism can reproduce when food becomes available but comes at the cost of reduced anabolic function, growth, and reproduction.

Aric N. Rogers, PH.D. at MDI Biological Labs has studied the cellular and molecular mechanisms of aging. Rogers has worked with tiny nematode worms, C. elegans, to evaluate the impact of suppressed protein translation. Skin, nerve, and reproductive tissues responded as expected with enhanced survival and decreased growth and reproduction, muscle experienced the opposite effect.

Muscle tissue experienced accelerated growth and reproduction instead of suppression.  

  1. elegans is a popular model in aging research because it shares many of its genes with humans, including those governing nutrient-sensing pathways, and because its short lifespan allows scientists to rapidly assess the effects of anti-aging interventions.

This discovery could contribute to the development of anti-aging drugs without side effects. 

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

List Biotherapeutics to Build Large-Scale Microbiome Facility

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List Biotherapeutics, Inc. has announced plans to build a large-scale microbiome production facility in Indiana, set to open by the end of 2023. List Bio is an offshoot of a South Korea-based clinical stage biotechnology company, Genome & Company.

The microbiome production facility will require the investment of more than $125 million to establish a new 110,000 sq ft facility which will be situated in the Fishers Life Science & Innovation Park. Alongside financial investment in the community, the facility will open 210 new jobs ranging from biologics manufacturing to quality and regulatory compliance.

This facility will provide a key connection point between List Bio and their sister company, List Labs. The new facility in Fishers expands List Lab’s ability to offer an end-to-end manufacturing solution from early-stage development to late-stage clinical trials and commercialization.

Jonathan Yongwan Jo, President and CEO of List Biotherapeutics said “Our objective with the investment for this new facility is to manufacture live biotherapeutic products (LBP) for Phase 3 clinical trials and for commercial use.” 

Indiana is already an epicenter for medical innovation, and adding a company whose focus rests on the reintroduction of beneficial microorganisms for clinical therapies will only expand this. 

Are you developing new products for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Skretting and Atlantic Sapphire Announce Partnership to Develop Zero Marine Ingredient Salmon Diet

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Skretting, a Vancouver-based feed manufacturing company, has announced an agreement with Atlantic Sapphire to build a state of the art RAS feed facility in Florida.

This feed facility will serve Atlantic Sapphire’s recirculation system (RAS) operations. Skretting will build and finance the feed plant while Atlantic Sapphire will source the majority of its salmon feed demand. The  contract has a 10 year life span, wherein Atlantic Sapphire will continue to source the salmon the entire decade.

This local feed source will reduce production costs and GHG emissions significantly.

Skretting has a stellar history of R&D, influencing Atlantic Sapphire’s decision in partnering up with them. This R&D record is set to continue as the two companies commit to developing specialist RAS salmon diets while reducing carbon footprints. This requires the testing and integration of novel ingredients and formulas. The ultimate goal is to use zero marine ingredients in the salmon diet without reducing the required levels of omega-3 fatty acids in the final product.

Are you developing new processes or formulas for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Nepra Prepares to Bring Textured Hemp Protein to the Plant-Based Protein Market

Iowa Patent of the Month - August 2021

Nepra Foods, Ltd., a Colorado-based vegan food company, has recently announced the expansion of their facility with the installation of proprietary THP™ production equipment.

The company has focused on the formulation, development, and production of plant-based and allergen-free food. With the addition of this new equipment, they are better equipped to produce their proprietary THP (textured hemp protein) – the basis of their PROPASTA™ product line. PROPASTA is a line of ready-to-eat frozen meals and meat analogues. 

This step towards self-sufficient production processes should help the company combat shipping lead times which are at an all-time high due to the global supply chain disruptions. It will provide the tools needed for large-scale production processes as Nepra Foods aims to scale up their processes in preparation for their PROPASTA™ product launch in early 2022. This will require the continuation of in-house testing and accelerated product innovation leading to national distribution.

Nepra Foods is committed to developing plant-based foods that provide the necessary nutrition without compromising quality or taste. They take this mission one step further by formulating food that is allergen-free.

Are you developing new formulas for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Implications of the New IRS rules for R&D credits

Alaska Patent of the Month - September 2021

The Internal Revenue Service released a memorandum in September from its Office of Chief Counsel which states they want more detailed information about all the business components for which the research credit claims relate for that year. 

An additional IRS Release suggests that the “IRS will provide a grace period (until January 10, 2022) before requiring the inclusion of this information with timely filed Section 41 research credit claims for refund.” IR-2021-203 (Oct. 15, 2021).

These changes state that for a research credit refund claim to be valid, the following must be met:

  • The claim itself must:
    • Identify all business components that the credit relates to for this year
    • For each of these business components:
      • Identify all research activities performed
      • Identify all individuals who performed each research activity
      • Identify all the information each individual sought to discover
  • The cost collection must provide:
    • total qualified employee wage expenses
    • total qualified supply expenses
    • Total qualified contract research expenses for the claim year

The costs can be presented through the Form 6765 – Credit for Increasing Research Activities. The cost portion should be no surprise to anyone who has previously filed for this credit, as these components are already asked for on the form.

The concern from most in the industry surrounds the first requirements. Some companies may have many many projects in the process in any given year, and many staff on each of these projects. This could result in a report stretching into the thousands of pages. 

In a previous court case, Premier Tech, Inc. v. United States, No. 2:20-CV-890-TS-CMR, 2021 WL 2982064 (D. Utah July 15, 2021), the government asserted that the taxpayer must include documents addressing every element in Section 41. The court had ruled in favor of the taxpayer, based on the fact that Form 6765 does not ask for these more in depth details and “if the IRS wants more information about the research tax credits, the IRS could require that information on Form 6765.” 

The same could be said in this case. If the IRS intends to modify the rules outlined in Section 41, the accompanying form should match in order to outline a very clear set of rules to follow. Without this authority or clear guidance, taxpayers are left to guess at the correct method.

These new changes do not address what a taxpayer who used a valid statistical sample under Rev. Proc. 2011-42 must produce. By definition, one who uses sampling only has the supposedly necessary information for units in the sample and then extrapolates from that to the rest of the population. 

One additional change notes that the IRS may waive its right to treat a claim as deficient if it proceeds to examine the merits of the claim. This has raised concern that it may encourage agents to immediately reject a claim as deficient if it lacks these new details rather than initiating an audit process. 

Despite the grace period afforded by the IRS, this could have serious implications for the number of R&D credits claimed and potentially on the rate of innovation within the country. Taxpayers who are unable to submit their claims prior to this grace period date, and for all future claims, will have to carefully consider whether they can contribute the time and expense of preparing Section 41 refund claims with these extensively detailed reports. There will be three key choices – (1) commit the time to file a claim with these extensive details, (2) file a claim as usual, have it rejected, and address the issue with the IRS Appeals court, (3) do not file a claim for the credit. Each option has clear limitations.

Working with an R&D tax specialist may help some taxpayers reduce the burden of time spent on the claim, and smaller companies may find it easier than larger, as they often focus on just a few projects at a time.

Are you conducting research and development activities? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

AIM Photonics Secures New 7 Year Agreement

Arkansas Patent of the Month - September 2021

New York-based AIM Photonics (American Institute of Manufacturing Photonics) has secured a new seven-year cooperative agreement with the Air Force Research Laboratory (AFRL) and the Research Foundation of the State University of New York.

This agreement includes $321 million in funding and support with $165 million from AFRL and $156 million from other sources.

These funds will be directed towards the manufacturing readiness of advanced photonics. These photonics products are critical to national security and high-performance microelectronics. 

New York State Governor Kathy Hochul believes focusing R&D efforts into merging technology sectors is key to rebuilding the state’s economy. “With this funding in hand, we are now better able to ensure New York and the nation will remain at the forefront in the world of technological innovation, research and development.”

AIM Photonics, headquartered at the Albany Nanotech Complex in Upstate New York, will continue its work to develop advanced integrated photonics capabilities for a wide array of existing products and will enable critical applications such as data communications, telecommunications, LiDAR, chemical and biological sensing, artificial intelligence, quantum applications and custom DoD applications.

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Lantern Pharma Collaborates with Code Ocean

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Lantern Pharma has announced a collaboration that will power their AI driven research by partnering with Code Ocean

Lantern Pharma is an emerging, oncology-focused, clinical stage pharma at the intersection of Artificial Intelligence, Genomics, and Machine Learning. They use genomic data, computational biology modeling and AI techniques to develop therapies by clarifying the potential mechanism of action to guide development. This further helps to identify the patient groups most likely to respond toa therapy, helping to bring patients to the right treatment faster.

Code Ocean is the leading computational research environment for sharing scientific discoveries. The collaboration will allow Lantern Pharma to leverage Code Ocean’s Compute Capsule technology to expand the power of their RADR platform resulting in faster, more collaborative discoveries from the billions of RADR data points.

The key limitation faced by computational researchers today are the complexities of analyzing big data when the available tools are disparate, cumbersome, and lack security. Through this collaboration, Lantern Pharma is expected to benefit from significant efficiencies in development time and cost, as well as increased reproducibility from Code Ocean’s platform. The Code Ocean platform will offer an easy to use, collaborative research experience with an integrated development environment, secure repository, and portable Compute Capsule® technology for guaranteed reproducibility.

Are you developing new software for an existing application? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative.

Review of R&D Funding by Sector

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Research and Development funding throughout the United States has historically come from 5 distinct sectors. These include the federal government, state governments, businesses, academia, and nonprofit organizations. The composition of funding from these sectors has changed over the years as R&D has shifted from a primarily federal activity to a commonplace component of individual businesses. To see a detailed breakdown of R&D funding compositions and performance in 2019, see the Congressional Research Service report.

The federal and business sectors dominated the funding, accounting for more than 90% of R&D funding since 1955. In 1964, federal funding reached its peak, accounting for 88.8% of R&D expenditures on its own. From this point on, business funding began to rise and overtake federal funding as the business sector experienced a boom in innovation and self-funded R&D endeavors. By 2019, the business sector accounted for 70.7% of the U.S. R&D expenditures on its own.

Character of R&D

There are 3 unique types of R&D. Total estimated U.S. R&D expenditures in 2019 (the most recent year for which data are available) were $656.0 billion. Of this amount, $107.8 billion (16.4%) was for basic research, $124.8 billion (19.0%) was for applied research, and $423.4 billion (64.5%) was for development.

Basic Research: experimental or theoretical work which aims to acquire new knowledge of the underlying foundations of phenomena. These often have no particular application or use in view.

Applied Research: Original investigations undertaken to acquire new knowledge and with a specific and practical objective.

Development: Systematic work which draws on knowledge gained from research and practical experience. This ultimately produces new knowledge directed to producing new or improved  products or processes.

Federally Funded R&D

Federal R&D funding grew from $3.5 billion in 1955 to $138.9 billion in 2019 (in current dollars). This growth was not consistent over the years, as the nation saw a drop in funding between 2011-2014 with an $8.6 billion decline in funding. Similar drops were seen between 1987 and 1994. In more recent years, there has been an effort to increase this funding, getting innovation back on track and supporting the investment into R&D. 

Federal funding accounts for the largest share of basic research. The federal government performs some of the research it funds, but also funds research performed by business, universities and colleges, and other organizations.

Business Funded R&D

This sector has seen growth in R&D funding nearly every year since 1955, growing from $2.2 billion to $463.7 billion in 2019. The rate of growth has slowed down in recent years, reaching the beginning of a plateau. This continuous increase is a direct result of the benefits of investing in R&D. When a company commits $1 to their own R&D practices they often see a hefty return on investment.

The business sector accounts for 55% of applied research and 85.5% of development. This is largely due to the greater ROI on these research types, allowing businesses to advance their own objectives and expand their stake in the industry.

Are you conducting research and development activities? Did you know your development work could be eligible for the R&D Tax Credit and you can receive up to 14% back on your expenses? Even if your development isn’t successful your work may still qualify for R&D credits (i.e. you don’t need to have a patent to qualify). To find out more, please contact a Swanson Reed R&D Specialist today or check out our free online eligibility test.

Who We Are:

Swanson Reed is one of the U.S.’ largest Specialist R&D tax advisory firms. We manage all facets of the R&D tax credit program, from claim preparation and audit compliance to claim disputes.

Swanson Reed regularly hosts free webinars and provides free IRS CE and CPE credits for CPAs. For more information please visit us at www.swansonreed.com/webinars or contact your usual Swanson Reed representative. Click here for more information about our technical expertise.