Industry – Page 31 – Swanson Reed | Specialist R&D Tax Advisors

Nicox SA Announces Phase 2b Results

Wyoming Patent of the Month - August 2021

Nicox SA has recently released the results from their Mississippi Phase 2b clinical trials. This international ophthalmology company has dedicated themselves to the development of treatments to help maintain vision and improve ocular health.

One of their products in development is the once-daily dosed NCX 4251 – a fluticasone propionate ophthalmic suspension 0.1%. This product was trialed against placebos in patients with acute exacerbations of blepharitis.

Blepharitis is a condition leading to red, swollen, itchy eyelids which can lead to more serious conditions including conjunctivitis.

The primary measure of this Phase 2b trial looked at the proportion of patients achieving complete cure in all three hallmark signs and symptoms of blepharitis, eyelid redness, debris, and discomfort by day 15. Two separate secondary outcome measures were identified as signs and symptoms of dry eye.

The Results

The trial did not meet either primary or secondary efficacy endpoints. However, a signal of NCX 4251’s potential efficacy was seen in the trial. NCX 4251 at 0.1% showed a numerical improvement over a placebo outcome for the primary measure. It also showed a statistically significant difference against placebo surrounding the change from baseline in certain symptoms. They intend to further their data analysis to decide which key signs and symptoms should be the focus for future development.

It was also found safe and well tolerated over the 14 day treatment period, with no adverse or serious side events.

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.

Valent BioSciences and Kansas State University Form Agreement to Study Soil Health and Carbon Smart Farming

Valent BioSciences LLC is working with Kansas State University in a formal, long-term agreement to advance critical research in soil health and carbon smart farming. The project will be spearheaded by Dr. Charles W. Rice, a distinguished professor at Kansas State.

Valent BioSciences is a worldwide leader in the research, development, and commercialization of highly effective low-risk, environmentally compatible technologies and products for the agricultural, public health, forestry, and household markets. Their research develops biorational products including bioinsecticides and plant growth regulators of all kinds.

The partnership with the university will increase the potential to study the complex interactions that control soil carbon stability and carbon and nitrogen dynamics. The main focus for research is on the efficacy of MycoApply ® brand soil inoculants and soil conservation management practices combined and their impact on soil health. Soil cores from the university’s studies will be analyzed at the Donald Danforth Plant Science Center – another organization in collaboration with Valent BioSciences.

“This private/public partnership leverages global strengths for both organizations to address significant climate change research needs,” said David V. Rosowsky, Kansas State University Vice President for Research. “Dr. Rice’s unmatched expertise in soil health will be invaluable to this initiative, as will the tremendous assets our corporate partners can provide. This is a model for how the nation’s land-grant universities can address global issues.”

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.

MycroDose Therapeutics and HAVN Life Sciences Partner Up in Psychedelic Research

Kansas Patent of the Month - August 2021

MycroDose Therapeutics has announced their plans to partner with HAVN Life Sciences, a Vancouver based biotechnology company. Each of these companies are focused on research and development of psychedelic compounds. HAVN Life Sciences is specifically focused on the standardized extraction of psychedelic compounds for the creation of APIs.

MycroDose Therapeutics is one of the few private companies to be granted a Schedule 1 License to research four psychedelic compounds by the DEA.

Psilocybin
MDMA
DMT
LSD

This partnership will be apparent as HAVN Life Sciences will export their naturally derived psilocybin to MycroDose Therapeutics, where it will be used in the development of advanced drug delivery (ADD) systems. These ADD systems will aim to treat mental health and cognitive degenerative diseases.

This is the beginning of the formation of an important supply chain to support the growing field of psychedelic research. This supply chain will be important to beginning the legal and licensed distribution of naturally derived GMP psilocybin throughout the United States. Distribution will include pharmaceutical companies, research institutions, and nonprofits, effectively increasing the body of research and access to naturally derived products in the field.

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.

Navigating a Software R&D Tax Credit Claim

Alaska Patent of the Month - September 2021

Software development is a broad range of activities – from functional enhancements to app development. It becomes easy to confuse which aspects of software development are considered R&D in the eyes of the IRS, since all forms of it are referred to as development. But the IRS indeed has some pretty strict thoughts on what software activities are truly research and development.

As with any industry, the IRS follows the rules outlined in I.R.C. § 41. To summarize these rules, qualifying R&D refers to activities must:

Fundamentally rely on the principles of hard sciences (eg. physical or biological sciences, engineering, or computer science)
Involves the identification of technical uncertainties concerning the development or improvement of the business component
Use a process of experimentation to evaluate alternative solutions to overcome these uncertainties
- This process may involve modeling, simulation, systematic process methodologies etc

There is a very helpful guideline to follow to see if your activities will qualify for the R&D tax credit. This guideline has been curated based on the precedence set out in other cases and audits, so following this will surely help guide you in the right direction, and may help you understand what the IRS is really looking for.

The IRS splits software activities into three risk categories:

High risk means that these activities usually fail to constitute qualified research under I.R.C. § 41(d).
- Activities that don’t advance or create new system architectures and, instead, apply slight modifications or integrations with existing architectures and systems are often high risk.
- Quality control, bug detection, and minor updates do not have sufficient technical uncertainty, and often involve routine or standard modifications/updates.
- These maintenance activities involve work that is well known in the industry and does not contribute new knowledge or require a process of experimentation.
Moderate risk means that these activities often fail to constitute qualified research under I.R.C. § 41(d).
- These activities are split down the middle and it often comes down to the details of the project. Many of these categories could effectively describe projects that have no uncertainty, or much technical uncertainty
Low risk means that these activities rarely fail to constitute qualified research under I.R.C. § 41(d).
- These activities are often new developments, creating novel architectures and involve high technical uncertainty.

We have collated this audit guide into an easy to follow Risk Matrix, though you can browse the expanded version of the guideline for examples of each point.

Likely Eligible	Likely Ineligible
Initial development and release of a new software product Development of new system softwares Development of specialized technologies (eg. AI, speech recognition, image processing) Software developed as part of a hardware product, interacting directly with that hardware	Maintenance of existing software applications/products Software Application Configuration Reverse engineering Detecting Flaws and bugs in software Modifying existing software to make use of new or existing standards or devices, or to be compliant (i.e., certified, validated, etc.) with another product or platform. Developing a business component that is substantially similar in technology, functionality and features to the capabilities already in existence at other companies. Upgrading to newer versions of hardware/software, or installing vendor fix releases. Re-hosting or porting an application to a new hardware/software platform or rewriting an existing application in a new language Writing hardware device drivers to support new hardware (e.g., disks, scanners, printers, modems, etc.). Data quality, data cleansing, and data consistency activities. Bundling existing individual software products into product “suites” Expanding product lines by purchasing other products. Interfaces, Graphical User Interfaces Y2K Program Changes. Vendor Product Extensions.
Possibly Eligible
Functional enhancements to existing software applications/products. Software developed as an embedded application (eg in cell phones, automobiles, airplanes. Development of software utility programs, such as debuggers, backup systems, performance analyzers, data recovery, etc. Changing from a product based on one technology to a product based on a different or newer technology (e.g., switching from a hierarchical database technology to a relational database technology). Adaptation and commercialization of a technology developed by a consortium or an open software group.

.

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.

Parallax Advanced Research Receives Next Disbursement of $9.6M in Funding

Washington Patent of the Month - August 2021

Parallax Advanced Research has received $9.6 million in federal funding to help expand their Academic Partnership Engagement Experiment (APEX). This expansion will bring APEX out to West Virginia and the Appalachian region, from the southern tier of New York State to Georgia. This funding was approved in an effort to bring talent in these regions to the Department of the Air Force as they work to advance national defense.

This $9.6 million represents the second major disbursement from the original $49 million APEX Partnership Intermediary Agreement (PIA), which Parallax was selected to lead in 2019. APEX is trying to connect universities, businesses, and the government in these R&D efforts, highlighting the importance of collaboration.

Parallax’s expansion effort into the State of West Virginia will be led by U.S. Air Force Retired Colonel Sean Frisbee. Frisbee is president & CEO of the West Virginia University Alumni Association and will transition out of this role to take on the expansion effort in summer 2021. In addition to this expansion, APEX helps small businesses focused on relevant R&D through the SBIR and STTR application programs. They offer resources including national engagement, collaborative challenges, blue-sky events, webinars, education and training, process navigation consulting, team matchmaking, technology transition facilitation, and expanding the U.S. wide network of traditional and non-traditional defense contractors to develop and commercialize new dual-use products and services focusing particularly on small business.

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.

Scientists Find Potential Non Hormonal Treatment for Endometriosis

Researchers at the University of Wisconsin, Baylor College of Medicine, Bayer AG, and the University of Oxford have discovered an alternative therapeutic option for the treatment of painful endometriosis without using surgery or hormones. Following a genetic study, these scientists have found a promising new non-hormonal target they intend to further investigate. It seems this target may allow treatment to address the inflammatory and pain components of the disease.

They designed and conducted genetic analyses on humans and rhesus macaques – two species which have spontaneously developed endometriosis – and uncovered the gene NPSR1 (neuropeptide S receptor 1) associated with the disease.

The endometrium is the inner lining of the uterine wall that builds up and sheds periodically during the reproductive lifespan in women. In women suffering from endometriosis, endometrium-like tissue grows outside the uterus leading to inflammation, intense abdominal pain usually associated with menstrual periods, and infertility.

Although the molecular causes of endometriosis are not known, heritability is estimated at about 50% indicating a strong genetic component. Current treatment options are hormone therapy and surgery with a dire need for non-hormonal therapeutics.

The scientists have worked towards therapeutic efficacy by inhibiting NPSR1 in mouse models. Inhibition was achieved using the small molecular inhibitor SHA 68R, and saw a successful reduction of abnormal infiltration of the endometrial tissue outside the uterus. If corroborated in nonhuman primate and human trials, this may lead to a non hormonal drug for endometriosis.

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.

FastWave Medical Closes Series Pre-A Financing

FastWave Medical has recently closed their Series Pre-A financing round, following its recent acquisition by China Grand Pharmaceutical and Healthcare Holdings.

Minneapolis-based FastWave Medical is a biomedical company focused on developing novel intravascular devices that are safe, efficacious, and cost-effective.They have announced that these funds will be directed towards advancing their research and development and to achieve key regulatory initiatives for its endovascular therapies to treat calcific artery disease.

The acquisition by China Grand Pharmaceutical was previously announced on August 2. China Grand Pharmaceutical will acquire 100% equity of FastWave Medical with up to a total of $72 million by phases and will invest up to total $8 million for supporting and jointly developing an intravascular shockwave calcification treatment system.

The acquisition, along with the funding, will be contingent on FastWave Medical’s progress and completion of key technical, clinical and regulatory milestones.

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.

DarkPulse, Inc. to Acquire TJM Electronics West

Wisconsin Patent of the Month - June 2021

DarkPulse, Inc. has officially signed an LOI to acquire TJM Electronics West. This strategic acquisition will help further advance DarkPulse’s R&D and manufacturing capabilities in Arizona. DarkPulse, Inc. uses advanced laser-based monitoring technology to provide rapid and accurate monitoring of temperatures, strains, and stresses. These specialties are highlighted when applied to live, dynamic critical infrastructure and structural monitoring. Their patented BOTDA dark-pulse sensor technology provides a data stream of critical metrics for assessing health and security of infrastructure.

TJM Electronics West, Inc. is an ISO9001 and AS9100 certified electronics and electro-mechanical assembly operation based in Arizona. They are an industry leader in comprehensive turnkey electronic contract manufacturing. Their Surface Mount Technology launched them to the forefront in 1999.

“Acquiring TJM will bring DarkPulse immediate expansion of our Research and Development capabilities including prototyping while allowing us to develop additional proprietary components and manufacture those components in house.” Said DarkPulse Chairman and CEO Dennis O’Leary, “The facility will also house a team dedicated to Aerospace and Robotics development.” He continued, “We expect that DarkPulse will be expanding our team in Arizona into the TJM facility in the coming days.”

Under the terms of the LOI , DarkPulse will acquire 100% of TJM for $450,000 in cash. The Company will invest additional resources for TJM’s ongoing operations and expansion of the business.

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.

EPA to Award $9M from their STAR Program to 7 Universities

The EPA will award $1.26 million in funding to Natalia Soares Quinete – an assistant professor in chemistry at FIU – from their $9 million STAR Program. This program aims to support innovation and scientific research focused on advancing the EPA’s mission to protect human health and the environment. $9 million will be awarded across seven universities to research exposure to toxic chemicals via soil and dust ingestion.

Six universities will collaborate with FIU to work on this project, including Emory University in Atlanta, Ga., Johns Hopkins University in Baltimore, Md., New York University, North Carolina Agricultural and Technical State University in Greensboro, University of California Davis, and University of Nevada-Reno.

This collaboration will use this grant to identify specific tracers of dust and soil exposure combined with the relevant environmental information in an effort to estimate soil and dust ingestion rates in children. It may be surprising to learn how toxic these ingestion rates may really be. Young children are especially vulnerable to this exposure method as they often play on the ground and put their hands in their mouths after touching random objects or dirt.

Toxic chemicals are deposited in soil and dust as they are carried through by water and left behind. At present, there is no way to accurately estimate chemical exposure by soil and dust ingestion. Identifying chemical tracers through analytical methodologies will help develop this method. This can then help understand the impacts on underrepresented groups of children.

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.

Seqirus to Begin Dedicated sa-mRNA Program

Seqirus is one of the world’s largest influenza vaccine companies, working to develop new vaccines every single year. Recently, this New Jersey-based company has announced plans to expand and accelerate their capabilities to develop next-gen self amplifying mRNA (sa-mRNA) vaccines. To achieve this goal, they will create a dedicated sa-mRNA program.

Last year the FDA green lit Audenz for the protection against influenza A (H5N1) in the event of a pandemic and won approval for Fluad Quadrivalent just three weeks later. This is the first and only quadrivalent adjuvanted flu vaccine to help protect adults over 65 years of age. Shortly after, their Flucelvax Quadrivalent was approved for a broader set of patients (ages two and up).

mRNA has been a notably well researched topic, but its implication and authorization of use in vaccines came with research done to fight COVID-19. mRNA based vaccines work by providing instructions to cells to make a protein that stimulates the immune response to fight future infections. Seqirus’ sa-mRNA tech also teaches the body to replicate mRNA, taking it a step further and amplifying the amount of protein made. This development suggests that the future of vaccines may be smaller doses, less negative reaction, and higher efficacy.

Seqirus is already developing multiple sa-mRNA-based influenza vaccine candidates with promising preclinical results but are hoping their dedicated sa-mRNA program will speed this along. If all goes well, they may even have clinical trials beginning for both seasonal and pandemic influenza vaccine candidates in the second half of 2022.

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.