- Therapix Biosciences is a clinical-stage pharmaceutical company focusing on proprietary synthetic cannabinoid technologies for central nervous system indications.
- They are developing novel sublingual and nasal formulations of FDA-approved synthetic THC (dronabinol) for indications like Tourette Syndrome and Mild Cognitive Impairment.
- For Tourette Syndrome, they are combining THC with PEA in a proprietary combination therapy called THX-TS01 that has begun Phase II clinical trials based on a 505(b)(2) regulatory pathway.
- For Mild Cognitive Impairment, they are developing an "Ultra-Low Dose THC" therapy called THX-ULD
How to Have a Successful Engagement and a Happily Ever After: “New Age” Nuanc...PYA, P.C.
PYA’s Tynan Olechny and Valerie Rock presented “How to Have a Successful Engagement and a Happily Ever After: ‘New Age’ Nuances to Physician Hospital Arrangements” with R. Ross Burris III of Polsinelli at the Health Care Compliance Association’s (HCCA) Regional Annual Conference.
Marpai is an AI tech company revolutionizing the self-funded health plan
market representing over $1 trillion in health claims, $20 billion in
administrative fees, and 95 million Americans. Just as Netflix, Amazon,
Uber, and Tesla use artificial intelligence to transform and lead industry
sectors, Marpai (pronounced Mar-pay) is using deep learning, the most
advanced artificial intelligence, to transform health plan administration
for companies who self-fund their health plans. As a next-generation
TPA (Third Party Administrator) using SMART technology (deeplearning powered), Marpai’s mission is to save lives, improve lives, and
radically reduce the costs of healthcare for employers and plan
members.
Fair Market Value: What Rural Providers Need to Know PYA, P.C.
PYA Principal Tynan Olechny and Senior Manager Annapoorani Bhat provided important information for rural providers related to fair market value and commercial reasonableness considerations during a National Rural Health Association webinar, “Valuations: What Rural Providers Need to Know."
How to Have a Successful Engagement and a Happily Ever After: “New Age” Nuanc...PYA, P.C.
PYA’s Tynan Olechny and Valerie Rock presented “How to Have a Successful Engagement and a Happily Ever After: ‘New Age’ Nuances to Physician Hospital Arrangements” with R. Ross Burris III of Polsinelli at the Health Care Compliance Association’s (HCCA) Regional Annual Conference.
Marpai is an AI tech company revolutionizing the self-funded health plan
market representing over $1 trillion in health claims, $20 billion in
administrative fees, and 95 million Americans. Just as Netflix, Amazon,
Uber, and Tesla use artificial intelligence to transform and lead industry
sectors, Marpai (pronounced Mar-pay) is using deep learning, the most
advanced artificial intelligence, to transform health plan administration
for companies who self-fund their health plans. As a next-generation
TPA (Third Party Administrator) using SMART technology (deeplearning powered), Marpai’s mission is to save lives, improve lives, and
radically reduce the costs of healthcare for employers and plan
members.
Fair Market Value: What Rural Providers Need to Know PYA, P.C.
PYA Principal Tynan Olechny and Senior Manager Annapoorani Bhat provided important information for rural providers related to fair market value and commercial reasonableness considerations during a National Rural Health Association webinar, “Valuations: What Rural Providers Need to Know."
PYA Presents Intro to Healthcare Valuation PYA, P.C.
PYA Principal Jim Lloyd, along with other presenters, provided a “Healthcare Valuation 101” during a pre-conference workshop at the 2013 AICPA Healthcare Industry Conference.
Presentation Covers Physician Practice CompliancePYA, P.C.
PYA Consulting Manager Valerie Rock presented “Compliance in the Physician Practice.” She discussed the importance of having a compliance plan, coding and billing monitoring, audit schedules, and provider expectations.
Healthcare Valuations in an Era of Reform and UncertaintyPYA, P.C.
PYA Principal Jim Lloyd's AICPA Health Care Industry Conference presentation explored reform and current environment highlights, healthcare transactions and affiliations, valuation considerations, and regulatory issues.
Don’t Stumble Coming Out of the Gate –Top Ten Issues to Address When Acquirin...PYA, P.C.
PYA Consulting Principal Carol Carden co-presented with Charlene McGinty of McKenna Long. They examined the top issues to address when acquiring a physician practice and some of the common and more complex issues hospitals face during the acquisition.
Guarding Your Client's Valuation from Attack--Dos and Don'ts for Requesting, ...PYA, P.C.
During an AHLA webinar series roundtable discussion, “Guarding Your Client’s Valuation from Attack—Dos and Don’ts for Requesting, Reviewing, Using, and Discarding FMV Opinions,” PYA Principal Carol Carden joined other legal experts to explore the practical issues for counsel to consider when balancing the arguments for scrutinizing valuation reports with the arguments for ensuring valuator independence.
Affiliation Strategies for At-Risk Community HospitalsPYA, P.C.
PYA Senior Healthcare Consulting Manager Michael Ramey presented “Affiliation Strategies for At-Risk Community Hospitals” with Jay Hardcastle, partner at Bradley Arant Boult Cummings at the AHLA Health Care Transactions Program. The presentation helped:
1. Identify factors affecting the continued financial viability of community hospitals.
2. Introduce the importance of board/management being proactive in evaluating potential affiliation alternatives before reaching a dire state.
3. Discuss the request-for-proposal process.
4. Explore legal structures to retain the best value for the community via appropriate models (i.e., management agreement, lease, acquisition, joint operating agreement, joint venture, affiliation).
5. Provide lessons learned from recent hospital transactions.
Payer Analytics In A Shifting Healthcare Landscape - June Presentation To Chi...Dan Wellisch
This is the June 2018 presentation to the Chicago Technology For Value-Based Healthcare https://www.meetup.com/Chicago-Technology-For-Value-Based-Healthcare-Meetup/
Big Data: Implications of Data Mining for Employed Physician Compliance Manag...PYA, P.C.
PYA Principal Denise Hall presented “Big Data: Implications of Data Mining for Employed Physician Compliance Management” at Becker’s Annual CEO & CIO Strategy Roundtables, November 18-19, 2015.
The presentation explored:
Data being aggregated by the government, as well as new approaches by regulators.
Public relations and litigation risk from the public dissemination of data by the government.
Big data connections to payment through quality metrics and the potential for new theories of False Claims Act (FCA) suits.
Internal use of broad spectrum analytics in employed physician compliance management.
Determination of risk tolerance and the customization of “outside the box” analytics.
Benchmarking, monitoring, and defining physician-focused risk area reviews.
Presentation Uncovers Trends in the Unpredictable Healthcare IndustryPYA, P.C.
With the healthcare industry in a state of flux, not much is known about what lies ahead; but trends across the industry have become apparent and are likely to stick. These trends were the subject of a presentation given by PYA Principal David McMillan at the PKF North America Healthcare Fly-In.
Catasys, Inc. harnesses proprietary big data predictive analytics, artificial intelligence and telehealth, combined with human intervention, to deliver improved member health and cost savings to health plans through integrated technology enabled treatment solutions. It is our mission to provide access to affordable and effective care, thereby improving health and reducing cost of care for people who suffer from the medical consequences of behavioral health conditions; helping these people and their families achieve and maintain better lives
The Heartaches Associated with Billing for Cardiac DevicesPYA, P.C.
PYA Principal Denise Hall-Gaulin and Consulting Manager Joanna Malcolm presented a free webinar for the Georgia chapter of the Healthcare Financial Management Association, on Tuesday, December 6, 2016.
The presentation was geared toward C-suite hospital leaders, compliance officers, in-house counsel, operational leaders, and patient accounting leadership, and covered:
The criteria for implantable cardioverter defibrillators (ICDs), pacemakers, and other devices
The documentation requirements for payment
The prerequisites for a clean audit
Accounting Update Overview with a Healthcare SlantPYA, P.C.
PYA Principal and Director of Audit Services Doug Arnold presented during East Tennessee State University’s 38th Annual Accounting, Auditing, and Tax Updating CPE conference. His presentation covered many recent Accounting Standards Updates, but leaned toward their applications in healthcare.
PYA Principal Jim Lloyd was among the faculty who spoke at the 2013 Mid-South Commercial Law Institute during a panel discussion on “Healthcare Facilities in Bankruptcy.” The presentation provided an overview of healthcare facilities and key issues, healthcare regulatory environment, valuation of healthcare facilities, and red flags for healthcare businesses in bankruptcy or distress.
As public and private insurers move away from traditional fee-for-service payments, healthcare organizations are struggling to make the leap. Market share, regional characteristics, financial health and an organization’s mission and culture are shaping the path as the flow of money shifts and the skills to manage and measure risk are being redirected in largely untested ways.
PYA Presents Intro to Healthcare Valuation PYA, P.C.
PYA Principal Jim Lloyd, along with other presenters, provided a “Healthcare Valuation 101” during a pre-conference workshop at the 2013 AICPA Healthcare Industry Conference.
Presentation Covers Physician Practice CompliancePYA, P.C.
PYA Consulting Manager Valerie Rock presented “Compliance in the Physician Practice.” She discussed the importance of having a compliance plan, coding and billing monitoring, audit schedules, and provider expectations.
Healthcare Valuations in an Era of Reform and UncertaintyPYA, P.C.
PYA Principal Jim Lloyd's AICPA Health Care Industry Conference presentation explored reform and current environment highlights, healthcare transactions and affiliations, valuation considerations, and regulatory issues.
Don’t Stumble Coming Out of the Gate –Top Ten Issues to Address When Acquirin...PYA, P.C.
PYA Consulting Principal Carol Carden co-presented with Charlene McGinty of McKenna Long. They examined the top issues to address when acquiring a physician practice and some of the common and more complex issues hospitals face during the acquisition.
Guarding Your Client's Valuation from Attack--Dos and Don'ts for Requesting, ...PYA, P.C.
During an AHLA webinar series roundtable discussion, “Guarding Your Client’s Valuation from Attack—Dos and Don’ts for Requesting, Reviewing, Using, and Discarding FMV Opinions,” PYA Principal Carol Carden joined other legal experts to explore the practical issues for counsel to consider when balancing the arguments for scrutinizing valuation reports with the arguments for ensuring valuator independence.
Affiliation Strategies for At-Risk Community HospitalsPYA, P.C.
PYA Senior Healthcare Consulting Manager Michael Ramey presented “Affiliation Strategies for At-Risk Community Hospitals” with Jay Hardcastle, partner at Bradley Arant Boult Cummings at the AHLA Health Care Transactions Program. The presentation helped:
1. Identify factors affecting the continued financial viability of community hospitals.
2. Introduce the importance of board/management being proactive in evaluating potential affiliation alternatives before reaching a dire state.
3. Discuss the request-for-proposal process.
4. Explore legal structures to retain the best value for the community via appropriate models (i.e., management agreement, lease, acquisition, joint operating agreement, joint venture, affiliation).
5. Provide lessons learned from recent hospital transactions.
Payer Analytics In A Shifting Healthcare Landscape - June Presentation To Chi...Dan Wellisch
This is the June 2018 presentation to the Chicago Technology For Value-Based Healthcare https://www.meetup.com/Chicago-Technology-For-Value-Based-Healthcare-Meetup/
Big Data: Implications of Data Mining for Employed Physician Compliance Manag...PYA, P.C.
PYA Principal Denise Hall presented “Big Data: Implications of Data Mining for Employed Physician Compliance Management” at Becker’s Annual CEO & CIO Strategy Roundtables, November 18-19, 2015.
The presentation explored:
Data being aggregated by the government, as well as new approaches by regulators.
Public relations and litigation risk from the public dissemination of data by the government.
Big data connections to payment through quality metrics and the potential for new theories of False Claims Act (FCA) suits.
Internal use of broad spectrum analytics in employed physician compliance management.
Determination of risk tolerance and the customization of “outside the box” analytics.
Benchmarking, monitoring, and defining physician-focused risk area reviews.
Presentation Uncovers Trends in the Unpredictable Healthcare IndustryPYA, P.C.
With the healthcare industry in a state of flux, not much is known about what lies ahead; but trends across the industry have become apparent and are likely to stick. These trends were the subject of a presentation given by PYA Principal David McMillan at the PKF North America Healthcare Fly-In.
Catasys, Inc. harnesses proprietary big data predictive analytics, artificial intelligence and telehealth, combined with human intervention, to deliver improved member health and cost savings to health plans through integrated technology enabled treatment solutions. It is our mission to provide access to affordable and effective care, thereby improving health and reducing cost of care for people who suffer from the medical consequences of behavioral health conditions; helping these people and their families achieve and maintain better lives
The Heartaches Associated with Billing for Cardiac DevicesPYA, P.C.
PYA Principal Denise Hall-Gaulin and Consulting Manager Joanna Malcolm presented a free webinar for the Georgia chapter of the Healthcare Financial Management Association, on Tuesday, December 6, 2016.
The presentation was geared toward C-suite hospital leaders, compliance officers, in-house counsel, operational leaders, and patient accounting leadership, and covered:
The criteria for implantable cardioverter defibrillators (ICDs), pacemakers, and other devices
The documentation requirements for payment
The prerequisites for a clean audit
Accounting Update Overview with a Healthcare SlantPYA, P.C.
PYA Principal and Director of Audit Services Doug Arnold presented during East Tennessee State University’s 38th Annual Accounting, Auditing, and Tax Updating CPE conference. His presentation covered many recent Accounting Standards Updates, but leaned toward their applications in healthcare.
PYA Principal Jim Lloyd was among the faculty who spoke at the 2013 Mid-South Commercial Law Institute during a panel discussion on “Healthcare Facilities in Bankruptcy.” The presentation provided an overview of healthcare facilities and key issues, healthcare regulatory environment, valuation of healthcare facilities, and red flags for healthcare businesses in bankruptcy or distress.
As public and private insurers move away from traditional fee-for-service payments, healthcare organizations are struggling to make the leap. Market share, regional characteristics, financial health and an organization’s mission and culture are shaping the path as the flow of money shifts and the skills to manage and measure risk are being redirected in largely untested ways.
Explorations Ventures (EV) is a hand-on seed VC investment fund (board seat and expertise deployment) in innovative lifestyle & wellness consumer brands, technologies, platforms and business models mainly in the US and Europe and focused on 3 market segments: apparel & equipment, food & beverage and beauty & personal care. Targeting businesses with experienced and ambitious teams with great cultures, solid margins, global branding potential, and IP under the form of patents, trade secrets and trademarks, and scalable businesses where the EV team can bring its expertise to maximize value and potential. Target stage allocation: 10% late seed 70 % A rounds 20% B and + rounds. Checks of USD 500K to 2.5M.
Marpai is an AI tech company revolutionizing the self-funded health plan
market representing over $1 trillion in health claims, $20 billion in
administrative fees, and 95 million Americans. Just as Netflix, Amazon,
Uber, and Tesla use artificial intelligence to transform and lead industry
sectors, Marpai (pronounced Mar-pay) is using deep learning, the most
advanced artificial intelligence, to transform health plan administration
for companies who self-fund their health plans. As a next-generation
TPA (Third Party Administrator) using SMART technology (deeplearning powered), Marpai’s mission is to save lives, improve lives, and
radically reduce the costs of healthcare for employers and plan
members.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Dócola is a social good organization with the only free care communication platform that consolidates thousands of free and low-cost patient education resources from the leading nonprofit, government, and commercial organizations in one marketplace. Plus, you can easily create and upload your own resources.
INNO HOLDINGS INC. is an innovative building-technology company with a mission to transform the construction industry with our proprietary cold-formed steel- framing technology and other building innovations
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a global innovation company focused on discovering and developing precision medicine innovations and deploying them into high-performing businesses. Aditxt’s diverse innovation portfolio includes: Adimune™, Inc., developing and designing a new class of therapeutics for retraining the immune system to address organ rejection, autoimmunity, and allergies; Adivir™, Inc., focused on identifying, developing and commercializing new ways to treat infectious diseases; and Pearsanta™, Inc., offering convenient, rapid, personalized, and high-quality lab testing —anytime and anywhere at its CLIA certified and CAP accredited clinical laboratory based in Richmond, VA.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
2. 2
Forward-Looking Statements
This presentation constitutes a “free writing prospectus,”
or a portion thereof, required to be filed by the Company
with the Commission or retained by Therapix
Biosciences Ltd. (“we”, “us” or “our”) under Rule 433 to
the Securities Act of 1933, as amended, or the Act.
All statements in this communication, other than those
relating to historical facts, are "forward‐looking
statements.” These forward‐looking statements may
include, but are not limited to, statements relating to our
objectives, plans, and strategies, the expected timing of
trials, statements relating to the research, development,
and use of our platform technologies, technologies,
products and product candidates; and all statements
(other than statements of historical facts) that address
activities, events, or developments that we intend,
expect, project, believe, or anticipate will or may occur in
the future.
Forward‐looking statements are not guarantees of future
performance and are subject to risks and uncertainties.
We have based these forward‐looking statements on
assumptions and assessments made by our
management in light of their experience and their
perception of historical trends, current conditions,
expected future developments, and other factors they
believe to be appropriate
Important factors that could cause actual results,
developments, and business decisions to differ
materially from those anticipated in these
forward‐looking statements include, among other things:
the overall global economic environment; the impact of
competition and new technologies; general market,
political, and economic conditions in the countries in
which we operate; projected capital expenditures and
liquidity; changes in our strategy; government
regulations and approvals; and litigation and regulatory
proceedings. We caution you that forward-looking
statements are not guarantees of future performance
and that our actual results of operations, financial
condition and liquidity, and the development of the
industry in which we operate may differ materially from
the forward-looking statements contained in this
presentation as a result of, among other factors, the
factors referenced in the “Risk Factors” section of the
prospectus contained in our preliminary prospectus
dated March 20, 2017, field with the Securities and
Exchange Commission as part of our Registration
Statement on Form F-1 on March 20, 2017 (the
“Preliminary Prospectus”).
You should read carefully the factors described in the
“Risk Factors” section of the prospectus contained in the
Preliminary Prospectus to better understand the risks
and uncertainties inherent in our business and
underlying any forward-looking statements.
These statements are only current predictions and are
subject to known and unknown risks, uncertainties, and
other factors that may cause our or our industry’s actual
results, levels of activity, performance, or achievements
to be materially different from those anticipated by the
forward‐looking statements. You should not rely upon
forward‐looking statements as predictions of future
events. Although we believe that the expectations
reflected in the forward‐looking statements are
reasonable, we cannot guarantee future results, levels of
activity, performance, or achievements. These
forward‐looking statements speak only as of the date of
this presentation, and we assume no obligation to
update or revise these forward‐looking statements for
any reason.
3. 3
Free Writing Prospectus Statement
This presentation highlights basic information about us and the offering to which this communication relates. Because it
is a summary, it does not contain all of the information that you should consider before investing in our securities.
We have filed a registration statement (including a prospectus, which currently is in preliminary form) with the U.S.
Securities and Exchange Commission, or the SEC, for the offering to which this presentation relates. The registration
has not yet become effective. Before you invest, you should read the preliminary prospectus in the registration
statement (including the risk factors described therein) and other documents we have filed with the SEC for more
complete information about us and this offering.
You may access these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov.
The preliminary prospectus, dated March 20, 2017, is available on the SEC Web site at www.sec.gov/edgar.
Alternatively, we or any underwriter participating in the offering will arrange to send you the preliminary prospectus and,
when available, the final prospectus and/or any supplements thereto if you contact Laidlaw & Company (UK) Ltd., 546
5th Avenue, New York, New York 10036, via e-mail at syndicate@laidlawltd.com or via telephone at (212) 953-4917.
4. Clinical-stage pharmaceutical company
Repurposing FDA approved synthetic THC (dronabinol)
Proprietary formulations, dosage and delivery platforms
Novel sublingual and nasal THC formulations
Focused on high-reward CNS indications
Combining two development programs:
Tourette Syndrome - combination drug therapy
THC & PEA: increased efficacy ,lower dosage and side effects (pre-clinical data)
POC Phase II clinical trial recently initiated
Mild Cognitive Impairment (MCI) - Ultra-Low Dose THC
First subset of MCI patients to be evaluated for the treatment of cognitive
impairment in traumatic brain injuries & concussion
Additional indications being assessed:
Potentiation of antibacterial agents for the eradication of resistance strains
Pain
Company Highlights
4
5. Dr. Ascher Shmulewitz, Chairman
- Prolific inventor and serial entrepreneur in
biomedical technologies
- Has founded over two dozen life science
companies and led multiple companies to
successful exits
Dr. Elran Haber, CEO
- Served more than 10 years as Chairman and
on Board Directors of several publicly traded,
private companies and various associations
- Held key roles at various life science start-ups
& private investment firm
Mr. Doron Ben Ami, Chief Strategy Officer
- Seasoned executive with more than 20
years of management experience
- Held various senior leadership roles in
multinational pharmaceutical companies
(Merck, Lundbeck)
Dr. Adi Zuloff-Shani, CTO
- Has more than 15years of vast experience
as an R&D Executive
- Has served as Vice President Development
at Macrocure Ltd. (NASDAQ(
Mr. Guy Goldin, CFO
- Has over 20 years of experience in a wide
variety of managerial, financial, tax and
accounting related positions
Experienced
Management Team
5
6. Dr. Yafit Stark, Independent Director
- VP & Global Clinical Advisor, Global Clinical Development at
Teva Pharmaceuticals Ltd .
- Established the Innovative R&D Division of Teva USA
- Was responsible for the clinical development of Copaxone
Mr. Avi Meizler, Director
- Experienced businessman and entrepreneur in Brazil since
1979 in the fields of pharmaceuticals, engineering &
construction
Mr. Amit Berger, Independent Director
- Serves as CEO of Dolphin I Investment Ltd.
- Served as the Chairman of Dash Investments Ltd.
- Served as Chairman, CEO and a Director in various companies
Mr. Zohar Heiblum, Independent Director
- Co-founder of TeFen Ltd. ,a leading consulting firm in Israel
- Has been involved in various companies as investor, consultant,
board member and chairman
Mr. Micha Jesselson, Director
- Part of the Jesselson Family Office that operates from Tel Aviv
& New York
- Manages Jesselson Investments Ltd. involved in variety of
sectors including VC investments, private equity transactions
and real estate development in NYC
Board of Directors
6
Mr. Stephen M. Simes, Director
- Extensive experience in US public BioPharma companies
(BioSante, Unimed)
- Expertise includes management, product development,
financing and M&A
Mr. Donald P. Dizon, Director
- Investor in both private and public companies
- Served as Director of High Yield and Distressed Bond Sales at
Knight Capital Group
- Served as Senior Vice President at Jefferies High Yield Trading, LLC
Mr. Mark E. Groussman, Director
- Investor in both private and public companies
- Served as the President of Melechdavid, Inc.
- Served as the CEO of American Strategic Minerals Corporation
- Served as a director of Muscle Pharm Corp.
Mr. M. David Silverman, Director
- Founded NFM, Inc. (now NFM Lending), and has served as its CEO
- Owned and operated several small businesses
Dr. Ascher Shmulewitz, Chairman
- Prolific inventor and serial entrepreneur in biomedical
technologies
- Has founded over two dozen life science companies and led
multiple companies to successful exits
7. Medicinal use of cannabis and derivatives is well known1
Best known agents in cannabis :THC and CBD
Potential benefits shown in multiple indications: antispastic, analgesic,
antiemetic, neuroprotective, anti-inflammatory and in certain psychiatric
diseases1
Sourced botanically (complex) or synthetically (simpler & pure)
Therapix utilizes an FDA approved compound: Dronabinol (synthetic THC)
Stand-alone therapies or combination agents (“Entourage Effect“)
Cannabis and
Cannabinoid Overview
1. The Therapeutic Potential of Cannabis and Cannabinoids, Franjo Grotenhermen, Dr. med. and
Kirsten Müller-Vahl, Prof. Dr. med., Dtsch Arztebl Int. 2012 Jul; 109(29-30): 495–501
7
8. Repurposing FDA Approved
Cannabinoid (THC) For New Indications
8
Tourette Syndrome Therapy based on the
“Entourage Effect”
The “Entourage Effect” first described by
Prof. Raphael Mechoulam1
Cognitive Deterioration / Pre-Alzheimer's
“Ultra-Low Dose THC”
A systemic cannabinoid-based therapy for brain
related conditions targeting the multi-billion CNS
drug market
1An entourage effect: inactive endogenous fatty acid glycerol esters enhance 2-arachidonoyl-glycerol
cannabinoid activity, Ben-Shabat S. et al., Eur J Pharmacol. 1998 Jul 17;353(1):23-31
9. “Entourage Effect” – THC and PEA
9
THC and PEA, a Proprietary Combination
The Entourage Effect
10. Primary near-term indication for Therapix: Tourette Syndrome - A
neuropsychiatric tic disorder characterized by motor and vocal tics
To date, only three drugs have been approved by the FDA to treat Tourette
Syndrome - limited use due to severe side effects
THC shown to reduce Tourette’s symptoms2
Filed an Orphan Drug Designation - FDA has requested additional data
Targeting Tourette Syndrome -
an Orphan Disease1
10
1. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/OrphanDrugAct/
2. Treatment of Tourette syndrome with cannabinoids, Muller-Vahl KR , Behavioural Neurology 27 (2013) 119–124
11. Tourette Syndrome -
Joint Pharma Solution THX-TS01
Several studies suggest that cannabis and THC may be effective in the
treatment of Tourette Syndrome
THX-TS 01- combines a synthetic endocannabinoid analog, PEA, with
THC
Taking a 505 (b)(2) regulatory strategy for FDA approval, based on
Marinol® (dronabinol)
POC Phase IIa clinical study initiated in December 2016 at Yale Medical
Center
11
12. Tourette Syndrome -
THX-TS01 Development Plan
J
o
i
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative described
milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and
regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be substantially
different than assessed and estimated previously. 12
2016 2017
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Pre-Clinical studies
ODD Submission
POC Phase IIa Clinical Study -
Tourette Syndrome
Phase IIb Clinical Study
COMPLETED
COMPLETED
13. THX-TS01 - Additional Opportunities
Antimicrobial resistance has been defined as a global threat1,2
Urgent unmet need for new anti-bacterial agents2
THC may possess antibacterial properties, which were assessed in
number of clinically relevant applications3
Therapix intends to use its entourage technology to potentiate the
efficacy of existing antibiotic drugs, especially in antibiotic-resistant
bacteria strains
13
Antibacterial Therapy
Pain
Cannabis and cannabinoids are used in patients with chronic pain
conditions4
Therapix signed a non-binding memorandum of understanding for
strategic cooperation in pain conditions with Rafa Laboratories Ltd.
1Antimicrobial Resistance Global Report on Surveillance WHO 2014
2The Antibiotic Resistance Crisis, P&T Vol. 40 No. 4 April 2015
3Antibacterial Cannabinoids from Cannabis sativa: A Structure-Activity Study, Appendino G et al., J. Nat. Prod. 2008, 71, 1427–1430
4The Analgesic Potential of Cannabinoids Elikottil J. et al., J Opioid Manag. 2009 ; 5(6): 341–357.
14. In 2015, there were an estimated 46.8 million people with
dementia worldwide and is estimated to increase by 2030 to
74.7 million1
The global societal economic cost of dementia for 2015 is
estimated at $818 billion, a 35% increase from the cost estimate
for 20101
The prevalence of Mild Cognitive Impairment (MCI) increases with
age, at a rate of 10% in those aged 70-79 years and 25% in those
aged 80-89 years2
There is no FDA approved treatment or therapy for MCI3
Mild Cognitive Impairment (MCI)
and Alzheimer’s Disease
14
1. World Alzheimer Report 2015, https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf
2. E-Health and Telemedicine: Concepts, Methodologies, Tools, and applications,
https://books.google.co.il/books?isbn=1466687576
3. http://www.alz.org/professionals_and_researchers_13518.asp
15. Cannabis has been shown to cause long-term cognitive
deficits in chronic users manifested as impairment in
attention, memory or executive functions
Paradoxically, Ultra-Low Doses of THC have been
shown to prevent and reverse cognitive decline in
preclinical trials1 as demonstrated by Prof .Yosef Sarne
at the Tel Aviv University
Cannabis and Cognition
15
1. Ultralow doses of cannabinoid drugs protect the mouse brain from inflammation-induced cognitive
damage, Fishbein-Kaminietsky M., et al. The Journal of Meuroscience Research, Volume 92, Issue
12, December 2014, Pages 1669–1677
http://onlinelibrary.wiley.com/doi/10.1002/jnr.23452/full
16. Recent pre-clinical research demonstrates Ultra-Low Doses of THC can prevent
cognitive impairment
THX-ULD01 - Therapix is developing a unique drug based on an FDA approved
synthetic cannabinoid for delaying memory loss and potential progression to
early stages of Alzheimer’s
Regulatory path to be streamlined using 505(b)(2) strategy
based on Marinol® (dronabinol(
Phase I-type study with healthy volunteers to demonstrate safety
and bioavailability to be initiated in Q22017
POC Phase II study to demonstrate efficacy to be initiated in H1 2018
First subset of MCI patients to be evaluated for the treatment of cognitive
impairment is in traumatic brain injuries & concussion
Mild Cognitive Impairment (MCI) -
BrainBright Solution THX-ULD01
BrainBright
Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and
development of the product and the relative described milestones, including without limitation, the regulatory path required to obtain FDA approval and the
indications for said R&D, depend, among other factors, on successful results from pre-clinical experiments and regulatory approvals, and other circumstances
and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control and which actual results may be
substantially different than assessed and estimated previously.
16
17. Note: The Company’s assessments and estimations regarding the abovementioned time table and regulatory approvals required for the research and development of the product and the relative
described milestones, including without limitation, the regulatory path required to obtain FDA approval and the indications for said R&D, depend, among other factors, on successful results from
pre-clinical experiments and regulatory approvals, and other circumstances and risk factors which apply to the Company’s activity in the field of life sciences, which are not in Company’s control
and which actual results may be substantially different than assessed and estimated previously.
Mild Cognitive Impairment (MCI) -
THX-ULD01 Development Plan
17
2016 2 0 1 7
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Pre-Clinical studies*
Phase I - PK &
Bioavailability
POC Phase IIa
Clinical Study - MCI
* Further pre-
clinical studies may
be conducted
18. Prof. Raphael Mechoulam
- A Professor Emeritus of the
School of Pharmacy at the
Faculty of Medicine of the
Hebrew University in
Jerusalem
- A recipient of the Israel Prize
Prof. James Leckman
- A child Psychiatrist at Yale
University
- Served as Director of the
Child Study Center at Yale for
over two decades
- A prominent international
expert in the field of research
and treatment of Tourette
Syndrome
Prof. Kirsten Müller-Vahl
- Professor of Psychiatry the
Hannover Medical School,
Germany
- Recognized as the leading
researcher in the field of
cannabinoid use in treatment of
Tourette Syndrome
- Served as a member of the
scientific advisory board of the
German Tourette Syndrome
Association
Prof. Michael Davidson,
- Professor of Psychiatry
- Served as Chief Psychiatrist at
the Department of Psychiatry of
the Sheba Medical Centre Tel-
Hashomer
- Chairman of the Stuckinski
Centre for Alzheimer's Disease
Research in Ramat Gan
Dr. Michael Bloch
- Associate training director of
the Child Study Center's
Solnit Integrated Program,
Yale School of Medicine
- Noted researcher on the
study of Tourette Syndrome,
obsessive- compulsive
disorder and trichotillomania
Prof. Daniele Piomelli
- The Editor-in-Chief of
Cannabis and Cannabinoid
Research
- Serves as Louise Turner
Arnold Chair in Neurosciences
- Professor of Anatomy and
Neurobiology, Pharmacology,
and Biological Chemistry at
University of California, Irvine
Prof. Avi Weizman,
- Professor of Psychiatry at the
Sackler School of Medicine Tel
Aviv University
- Head of the Laboratory of
Biological Psychiatry at the
Felsentein Medical Research
Center
- Director and Head of Geha
Mental Health Center's
Research Unit
Strong Scientific Advisory Board
18
19. FDA-regulated drugs vs. medical marijuana:
Medical marijuana: variable dosing; therapeutic
and psychoactive effects; poor compliance;
abuse potential; political issues
(still considered as Schedule 1 drug)
FDA-regulated drugs: Rigorous GMP
manufacturing; clinical efficacy/safety studies;
controlled dosing
FDA option for 505(B)(2) regulatory route-
abbreviated development and shorter time to
market
Examples of approved Drugs:
AbbVie: Marinol capsules (synthetic THC) for
CINV (Schedule 3 drug(
GW Pharma: Sativex sublingual spray (botanical
THC and CBD (to reduce Multiple Sclerosis
(MS) spasticity (not approved in the US)
In Development:
GW Pharma (GWPH, Market Cap~ 3.3B
USD): Sativex sublingual spray for MS
spasticity ;Epidiolex sublingual spray
(botanical CBD) for Epilepsy
Insys (INSY, Market Cap ~0.8B USD:(
Syndros synthetic THC oral solution for
CINV, anorexia in AIDs patients (recently
approved) ;Synthetic CBD oral solution for
Epilepsy
Zynerba (ZYNE, Market Cap ~275M USD :(
Developing transdermal gel cannabinoid
treatments (synthetic)
Cannabinoid Market:
Landscapeand Opportunities
19
20. Summary
20
Focused on high value CNS indications with unique combinations,
formulations and delivery methods
Two indications with potential for shorter regulatory paths due to:
Orphan Drug Designation (Tourette’s) and 505(b)(2) pathway using
approved active ingredients (Tourette's, MCI)
Phase IIa (POC) clinical trial for Tourette Syndrome initiated in
December 2016
Phase I clinical trial in MCI program scheduled to start in Q2 2017 with
POC Phase II clinical trial to start in H1 2018
Additional indications being assessed:
Potentiation of antibacterial agents
Pain
Experienced Management Team, Board of Directors and Strong
Scientific Advisory Board