UVA Licensing & Ventures Group 2020 Annual Report

Lives Enriched and Improved 2020 ANNUAL REPORT

GREAT AND GOOD THE 2030 PLAN

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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I believe that we should strive to be both great and good A Vision for the in all that we do...” – University of Virginia

STRATEGIC GOAL III.

Enable Discoveries that Enrich and Improve Lives

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2020 ANNUAL REPORT

M I S S I O N S TAT E M E N T

To maximize the intellectual, societal, and economic impact of UVA discoveries via commercialization to enrich and improve lives for the University, the Commonwealth and the world.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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TABLE OF CONTENTS

04 Mission Statement 06 Welcome 08 Responding to COVID-19 12 Lives Enriched & Improved 26 Enriching the Ecosystem 30 LVG Seed Fund 34 C elebrating Impact Through Innovation 42 LVG Staff

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2020 ANNUAL REPORT

Welcome The COVID-19 pandemic brought new meaning to the age-old proverb, “necessity is the mother of all invention.” As we remain in the throes of this pandemic, University of Virginia innovators continue to solve impossible problems at astonishing speed to protect our community and mitigate the spread of this deadly virus.

Even before the lock-down in mid-March 2020, UVA researchers had a sharp eye on the pneumonia cases emerging in Wuhan, China. A warning shared with Gilead Sciences, Inc. in December 2019 led to the company forming a task force to study, test, and plan for mass-production of remdesivir (Langreth, Robert. “All Eyes on Gilead.” Bloomberg Businessweek, May 14, 2020). More than ever, UVA and its research enterprise have a great responsibility to help the world understand and advance solutions for its biggest challenges.

The strength and brilliance of our UVA community during this extraordinary time has inspired a renewed sense of pride among our team as UVA’s partner in innovation and research commercialization. Despite a challenging fourth quarter migrating to remote work and navigating halted research projects, the Licensing & Ventures Group (LVG) broke new records reporting 241 new invention disclosures, and executing 83 new license and option agreements. We strengthened our commitment to building a new venture pipeline with the launch of an Entrepreneur in Residence program, and leveraged our network to bring experts to Charlottesville to elevate the burgeoning biotech industry with our community partner CvilleBioHub. At the same time, we were in the midst of fully reimagining the future of LVG – our mission, our values, and how to align our vision with that of the new strategic plan for the University put forth by President Jim Ryan. The 2030 Plan to become a great and good university includes a strategy to enable discoveries that enrich and improve lives. We believe it is our responsibility to act on this goal and enable discoveries for the purpose of enriching and improving lives.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

We are pleased to share our 2020 annual report which introduces our new mission statement, reflects our fiscal year performance, and highlights the lives enriched and improved by the University of Virginia. From faculty researchers whose innovation activity paved the way to react quickly and efficiently to create in-house COVID-19 testing at the UVA Health System within an astonishing two weeks, to the thousands of type 1 Diabetes patients who are now able to manage their disease with significant ease thanks to UVA-developed technology.

The LVG team is honored to support the UVA community of innovators in their work to ensure that the results of their research make our world a better place. Our efforts are rooted in the generosity and spirit of our Board of Directors, an esteemed group of individuals whose involvement and counsel is critical to our operation, now more than ever. Here is where we say “thank you,” for your continued support.

While much uncertainty remains, I feel optimistic that the University and the Licensing & Ventures Group can and will continue to rise to whatever challenges lie ahead.

MICHAEL P. STRAIGHTIFF EXECUTIVE DIRECTOR

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Welcome

Board of Directors Peter M. Grant II (COL ’78, DARDEN ’86) Chair Founding Partner, Anchormarck Holdings LLC John G. MacFarlane III (DARDEN ‘79) Board of Visitors Representative Managing Partner, Arrochar Management LLC Erik L. Hewlett, M.D. Professor Emeritus, Medicine, Infectious Disease and International Health UVA School of Medicine Don Laing (COL ‘69) Co-Founder of CornerStone Partners John S. Lazo, Ph.D. Associate Director for Basic Science UVA Cancer Center Michael J. Lenox, Ph.D. (ENGR ’93) Senior Associate Dean and Chief Strategy Officer, Tayloe Murphy Professor of Business Administration UVA Darden School of Business The Honorable Paul R. Michel, J.D. (LAW ’66) Former Chief Judge of the US Court of Appeals for the Federal Circuit Ron Newbold, Ph.D. Chief Business Officer, Spinogenix, Inc. Pamela M. Norris, Ph.D. Executive Dean, Frederick Tracy Morse Professor Department of Mechanical and Aerospace Engineering UVA School of Engineering & Applied Science Melur K. (Ram) Ramasubramanian, Ph.D. UVA Vice President for Research

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2020 ANNUAL REPORT

Responding to COVID-19 The COVID-19 pandemic has tested and strained research organizations across the world, and UVA has been no exception. But we are proud to say that in mid-March, when the world and University locked down, UVA innovators rose to the challenge. UVA researchers developed independent testing capabilities, utilized 3D printing to fulfill an unprecedented need for protective equipment, and were issued FDA emergency-use authorization for the anti-viral drug remdesivir. Alumni leaders and donors together created not one, but two philanthropically funded translational research

funds, aiding UVA’s brightest minds in creating solutions to the unique problems this year has presented. In all, the response to the pandemic has showcased some of the truly remarkable ways that our UVA innovation community continues to meet this urgent moment in history.

To ensure the rapid response and broad distribution of COVID-19 related technologies, LVG remains committed, alongside many of our peer institutions, to the licensing guidelines streamlined by the leading technology transfer industry organization, AUTM.

UVA faculty researchers from left to right: Madhav Marathe, Dr. Ebony Jade Hilton, Peter Kasson, Dr. Steven Zeichner, Dr. William Petri (MED ’82), Dr. Catherine Bonham Photos by: Sanjay Suchak, Dan Addison

Resp o n din g to COV ID -19

Leading COVID-19 Testing Efforts in Virginia During the onset of COVID-19, when symptomatic patients began flooding emergency departments across the country, federal health agencies quickly starting buckling under demand. In response, the UVA Health System rapidly began and expedited development of its own tests. Associate Professor of Medicine and Pathology and faculty innovator Dr. Amy Mathers was leading the effort to establish in-house testing. Her research using whole genome sequencing to characterize and track antibiotic resistant bacteria has been moving toward commercialization with the UVA startup Antimicrobial Resistance Services, Inc. since LVG launched the company in 2019.

In addition to being one of UVA’s leading epidemiologists, Dr. Mathers was able to leverage her previous innovation activity to navigate the countless challenges faced while building in-house COVID-19 testing capabilities. During those frenetic few weeks in the early spring, the team not only created tests to meet the demand at UVA, but also continued their efforts to support several additional hospitals across Virginia.

With robust operations in place, performing up to 750 tests per day in her lab, Dr. Mathers pivoted to address one of the many supply-chain roadblocks – a massive shortage of nasopharyngeal swabs used to conduct COVID-19 tests. In collaboration with Will Guilford, Ph.D., an associate professor of biomedical engineering, the team created a 3D-printed swab prototype that Dr. Mathers was able to safety test during a clinical trial.

As a result of their tremendous efforts, manufacturing partners, and FDA approval, 75,000 swabs are in production each week, with 15,000 reserved for testing at the UVA Health System, and 60,000 distributed to testing sites across the Commonwealth.

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DR. A M Y M ATHERS

The unusually strong spirit of collaboration that we enjoy at UVA was immeasurably helpful when it came to meeting this challenge.

We all understood the importance of working together to get this done, and to do it right.”

– William H. Guilford, Ph.D., Associate Professor, Biomedical Engineering

2020 ANNUAL REPORT

Resp o n din g to COV ID -19

This spring, when the Ivy Foundation and the Manning Family Foundation generously established COVID-19 translational research funds, LVG was uniquely positioned to support the project proposal evaluations. Our long-established relationships with the existing translational research funds through the Office of the Vice President for Research served as the foundation for our quick response enabling a 30-day window between the request for applications and the disbursement of funds.

UVA Translational Research Funds The Licensing & Ventures Group plays an integral role in UVA’s sophisticated translational research infrastructure.

Translational research involves moving knowledge and discovery gained from the basic sciences to its application in clinical and community settings.

UVA has three ongoing philanthropically funded translational research programs that support biomedical innovation.

While each fund has different parameters and oversight, all proposals are evaluated based on their potential path to delivering improvements in healthcare.

Coulter Translational Research Partnership

Ivy Biomedical Innovation Fund

LaunchPad for Diabetes

Year Founded

2006

2008

2009

Applications

215

263

116

Projects Funded

85

57

64

Transactions

95 total transactions

Active Patent Applications

144 total applications

Issued Patents

216 total issued patents

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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Resp o n din g to COV ID -19

Ivy Foundation COVID-19 Translational Research Fund

32 Applications 8 Projects Funded 3 Transactions

The Charlottesville-based Ivy Foundation committed $2 million to accelerate biomedical research focused on COVID-19 diagnosis, treatment options, vaccine development, and healthcare worker protection needs. The review committee, including the LVG team, quickly reviewed 32 project proposals and helped select eight promising biomedical research projects including the development of biosensors, artificial intelligence for testing, and vaccine and treatment options.

Given the dramatic and unprecedented health effects that COVID-19 is having on the world, I can think of no better way to deploy the resources of the Ivy Foundation than to catalyze research that may lead to a vaccine and other treatments to combat this virus.”

– Dr. Robert W. “Bobby” Battle, Chairman of the Ivy Foundation and Director of UVA’s Adult Congenital Heart Clinic

The Manning Fund for COVID-19 Research A generous donation from the Manning Family Foundation, longtime supporters of the University and its research initiatives, funded projects dedicated to COVID-19 solutions with commercialization potential. Faculty across Grounds submitted over 50 proposals detailing research focused on testing, therapies, vaccines, and ways to reopen society. The review committee, including the LVG team, quickly reviewed 52 proposals and helped select 15 project proposals to improve antibody testing, find a vaccine, and to help patient outcomes.

52 Applications 15 Projects Funded

UVA researchers are already working on some of the most important issues of our day. I hope this fund promotes bold, innovative research applications with a frontline impact that can help mitigate the virus and its broader effects on our world.”

– Paul Manning, Chairman and CEO of PBM Capital

PAUL M A NNING

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2020 ANNUAL REPORT

I agreed to join the Board of the University of Virginia’s Licensing & Ventures Group, because the success of this kind of work is crucial to the nation’s future prosperity, jobcreation and security. I also wanted to learn more about how it is done on a first-hand basis. And try to help shape improvements in the effectiveness of the tech-transfer function. As a graduate of its law school, The University of Virginia was the appropriate institution for me to connect with. Although new to the Board, I am so impressed already with the quality of the Board members and the staff and their combined work product.”

– The Honorable Paul R. Michel (LAW ‘66) Excerpt from AUTM 2020 Fireside Chat UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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Lives Enriched & Improved 13

2020 ANNUAL REPORT

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Live s Enriched + Improved

CHAD ROGERS

STE VE PATEK

M A RC BRE TON

BORIS KOVATCHE V

Improving the Lives of Patients with Diabetes

We are investing heavily in research and development efforts that explore new diagnostic tools and treatments. By partnering with a top-tier research institution like the University of Virginia, we hope to bring better CGM solutions to patients much faster than we could alone.”

– Kevin Sayer, Chairman, President, Chief Executive Officer, Dexcom

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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155,000+

The concept of an artificial pancreas, based on a complex algorithmic combination of pumps and monitors into one closed-loop system, has been around as long as pumps and monitors themselves.

And yet, for decades, remained unsolvable, a farflung hope flying the face of the reality that emulating organic pancreatic function presents impossibly complex problems.

UVA researchers led by Boris Kovatchev, Ph.D. and Marc Breton, Ph.D. (ENGR ’04) have been working for years to understand the physiology of the disease and explored mathematical theories as the foundation for a closed-loop system.

In 2013, LVG harnessed decades of interdisciplinary research to launch TypeZero Technologies, Inc., licensing the single largest patent portfolio from our organization, leveraging more than 30 clinical trials with more than 500 patients and 12 sites, one of which was at UVA. LVG recruited Chad Rogers (COM ’97) as CEO and TypeZero translated the research into a software platform that attracted Dexcom, Inc. and Tandem Diabetes Care as partners for a large-scale, multi-site NIH funded clinical trial. In 2015, the LVG Seed Fund made its first investment in TypeZero.

The staggering success of the clinical trials led to Dexcom, Inc.’s acquisition of TypeZero in 2018, marking the first exit for the LVG Seed Fund. Nearly two decades after this diabetes technology research began at UVA, the closed-loop system made its commercial debut in January 2020 as Control-IQ™ with Tandem Diabetes Care, and has since improved the lives of 155,000 patients with Type 1 diabetes.

The system is the first of its kind to gain FDA approval and integrates with the Dexcom G6 Continuous Glucose Monitoring system.

The increasing potential of Control-IQ™ motivated a five-year sponsored research agreement with Dexcom that LVG helped secure in 2020 to advance Type 1 and Type 2 diabetes technology research at UVA.

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TIMELINE

Living with Type 1 diabetes (T1D) requires constant management. Due to deficiencies in the pancreas, food and exercise must be manually balanced against blood sugar and regular insulin injections. Even for patients with insulin pumps and compact monitors, managing T1D creates daily medical decisions that burden basic activities with the disease’s lifethreatening nature.

TYPE1 DIABETES PATIENTS USING CONTROL-IQ™ 2020 Dexcom, Inc. signs five-year sponsored research agreement with UVA for continued diabetes technology research 2020 Boris Kovatchev inducted into the National Academy of Inventors 2020 Commercial launch of Control-IQ™ 2019 Tandem Diabetes Care receives FDA approval of Control-IQ™ 2018 Dexcom, Inc. acquires TypeZero Technologies, Inc. 2017 TypeZero Technologies, Inc. partners with Tandem Diabetes Care 2015 TypeZero receives first LVG Seed Fund Investment 2013 LVG launches TypeZero Technologies, Inc. 2013 LaunchPad funds ‘Artificial Pancreas’ technology research 2011 LVG honors Boris Kovatchev as Edlich-Henderson Innovator of the Year 2004 First patent related to ‘Artificial Pancreas’ technology issues in the U.S. 2001 Coulter Translational Research Partnership funds ‘Artificial Pancreas’ technology research 1999 LVG receives first invention disclosure related to ‘Artificial Pancreas’

2020 ANNUAL REPORT

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Improving the Lives of Patients with Insomnia

JOE JENNINGS (COL ‘8 5), F R A N CES THORNDIK E (COL ’93), LEE RIT TERBA ND

Instead of the hundreds of people we might be able to help in a clinic, we can scale these platforms to help thousands, tens of thousands, or maybe millions at some point by making these kinds of interventions available. They’re lower cost, they’re more accessible, they’re empirically validated.”

– L ee Ritterband Ph.D. Professor, Psychiatry and Neurobehavioral Sciences

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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To pursue its commercial potential, LVG licensed the SHUTi technology to launch BeHealth Solutions in 2011, co-founded by Lee Ritterband, Ph.D., Joe Jennings (COL ‘85) and Frances Thorndike, Ph.D. (COL ’93). Years of continued research and development, clinical trials, and refining the technology helped attract one of the biggest names in the field.

In 2018, Pear Therapeutics, the leader in prescription digital therapeutics expressed interest in the license for SHUTi. Their Chief Medical Officer Dr. Yuri Maricich completed medical residency training at UVA and previously held a leadership role with UVA startup Cavion, Inc. The LVG team helped negotiate the agreement that allowed Pear to acquire and exclusively license the technology. In March 2020, Pear announced that they had obtained FDA market authorization for the digital therapeutic for insomnia commercially known as Somryst™ based on SHUTi research.

Highly effective digital solutions like Somryst™ can be deployed on an enormous scale to improve the lives of an estimated 30 million people in the U.S who suffer from chronic insomnia. As an affordable and accessible alternative to traditional therapy, digital therapeutics also stand to significantly reduce the overall economic burden of behavioral health care, which is roughly $100 billion per year.

1,400

INSOMNIA PATIENTS USING SOMRYST ™ TIMELINE

In 2019, the Licensing & Ventures Group recognized Lee Ritterband, Ph.D., as the Edlich-Henderson Innovator of the Year Award for his work creating and advancing a digital therapeutic for the treatment of chronic insomnia. The technology, formerly known as SHUTi – Sleep Healthy Using the Internet – is a web based platform that guides users through sleep diaries, video prompts, and surveys to create a personalized cognitive restructuring of sleep habits. For many suffering from insomnia, psychological treatment can be cost prohibitive and largely unavailable. Ritterband and his research collaborators shared a vision for widespread access to behavioral healthcare and therapy via the Internet.

2020 C ommercial launch of Somryst™ 2020 P ear Therapeutics receives FDA approval of Somryst™, the first digital therapeutic for the treatment of insomnia 2019 L VG honors Lee Ritterband as Edlich-Henderson Innovator of the Year 2018 L VG executes exclusive license agreement with Pear Therapeutics for SHUTi technology 2017 J AMA Psychiatry publishes SHUTi clinical trial data 2011 LVG launches BeHealth Solutions 2010 L VG receives first invention disclosure related to SHUTi

Pear Therapeutics conducted two studies of SHUTi as an experimental precursor to Somryst™ and published their findings in August 2020. More than 1,000 adults with chronic insomnia saw a marked reduction in the severity of their insomnia, and also maintained those reductions over 12 month periods.

These results build on dozens of previous SHUTi clinical trials wherein thousands of insomnia patients from more than 50 countries around the world have shown significant improvements.

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2020 ANNUAL REPORT

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Steward ship

Improving the Lives of Cervical Cancer Patients

The treatment involves placing a radiation applicator near the tumor, and administering a high radiation dose to the tumor while minimizing exposure to the surrounding healthy tissue. There are currently only two options available for stabilizing the radiation applicator during these procedures; uncomfortable vaginal gauze packing, and an expensive, highly engineered balloon device.

Driven by his personal frustrations with the limited options available and a desire to improve patient care, Dr. Showalter is charting the course for an effective, affordable, and personalized hydrogel material alternative. The first company product, the BrachyGel Packing System, stands to transform cervical cancer treatment by attenuating the radiation dose and thereby improving patient outcomes, significantly increasing patient comfort during procedures, and doing so in a far more cost-effective way than the comparable alternative.

Since Dr. Showalter first disclosed his idea for an expanding foam material in 2013, the LVG team has fully engaged its network and resources to steward the creation of this medical device that could enrich and improve the lives of cervical cancer patients while advancing the field of radiation oncology. By tapping into the sophisticated translational research infrastructure at UVA, Dr. Showalter identified collaborators to engineer the hydrogel and the delivery applicator.

The research and prototype development continued as the LVG team pursued additional invention disclosures and patent protection of Dr. Showalter’s intellectual property. Dr. Showalter founded the medical device startup company, BrachyFoam, LLC, in 2016. The LVG team connected Dr. Showalter with Michelle Wieczorek, a local research consultant, who helped him secure a Phase I Small Business Technology Transfer (STTR) award from the National Cancer Institute in 2017, as well as a CIT grant made available by the Commonwealth Research Commercialization Fund. Ms. Wieczorek was recruited as the Chief Operating Officer of BrachyFoam, and she and Dr. Showalter went on to secure a $1.5M Phase II STTR award in 2019.

In 2020, LVG issued an exclusive technology license to BrachyFoam, allowing the company to take another important step toward commercialization of their first product in cervical cancer care. Later that same year, LVG and BrachyFoam partnered in a company rebrand, in an effort to better represent the company’s expanding product suite. The company, now known as Advaray, will begin clinical trials of the first hydrogel product in 2021, and has three funding proposals under consideration toward the development of additional products and in support of commercialization activities.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

DR. TIM SHOWALTER

Dr. Tim Showalter (MED ’04), a radiation oncologist at the UVA Cancer Center, uses a radiation implant procedure known as brachytherapy to treat cervical cancer patients. Patients with locally advanced cervical cancer typically undergo a minimum of five brachytherapy treatments, an outpatient procedure conducted while the patient is awake.

10,000 CERVICAL CANCER

PATIENTS RECEIVE 60,000 BRACHYTHERAPY PROCEDURES IN THE US EACH YEAR

TIMELINE 2020 B rachyFoam, Inc. rebrands to Advaray 2020 L VG executes exclusive license agreement with BrachyFoam, LLC 2019 B rachyFoam, LLC converts to BrachyFoam, Inc. 2019 NIH STTR: Phase II Grant Awarded 2017 NIH STTR: Phase I Grant Awarded 2016 LVG launches BrachyFoam, LLC 2013 L VG receives first invention disclosure from Dr. Showalter 18

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A M A NDA WILLF ORD

Enriching the Lives of Young Learners

In 2015, the UVA School of Education conducted a study that showed 40 percent of children entering kindergarten in Virginia were unprepared in at least one critical skill.

To address this gap in kindergarten readiness, a team of UVA researchers led by Amanda Williford, Ph.D. (COL ’96) from the Center for Advanced Study of Teaching and Learning (CASTL) including Kate Matthew, M.S., and Bridget Hamre, Ph.D. (COL ’98, EDUC ’02), created the STREAM: Integrated, Intentional, Interactions (STREAMin3) Curriculum.

STREAMin3 is a comprehensive curriculum model in English and Spanish for infant/toddler and preschool classrooms that seamlessly blends a focus on academic and social-emotional learning. It provides a novel approach to early childhood education with a single all-inclusive curriculum, integrated across early childhood learning, and strong teacher supports.

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Pilot studies of STREAMin3 in 100+ classrooms across the Commonwealth began in 2018 with support from the Virginia Department of Social Services, the Obici Healthcare Foundation, and expanded in 2019 with support from the Alleghany Foundation.

The overwhelmingly positive feedback from participants in the STREAMin3 pilot studies encouraged the research team to consider how to expand access to the curriculum. Like the researchers, LVG was challenged to think outside of a traditional license agreement and find a solution that best served the end-users of these materials, the educators.

Our solution is an online marketplace for researchers to license their materials – papers, curriculums, and assessment tools – directly to consumers. In partnership with Williford and her team, LVG created an eCommerce platform for online sales of the curriculum packages.

Educators interested in purchasing STREAMin3 for their school districts or classrooms can digitally accept

an end-user agreement through the website, as well as stay connected with the research team for updates to the materials and professional development opportunities.

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CLASSROOMS IN VIRGINIA USE STREAMin3 TIMELINE 2020 S TREAMin3 curriculum available via LVG direct licensing platform 2019 L VG receives first STREAMin3 related disclosure 2018-2020 S TREAMin3 Pilot Study Conducted Across Virginia 2020 ANNUAL REPORT

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Improving Diagnostic Capabilities for Prostate Cancer

There is still a lot of research to do on how HULLK functions in order to realize the potential of DA N GIOELI this discovery in the clinic.

We are excited to do that research and translate our basic science discovery into the clinic.”

According to the American Cancer Society, prostate cancer kills more than 30,000 American men every year, and UVA cancer researchers are working to get ahead of it. Dan Gioeli, Ph.D., associate professor of microbiology, immunology and cancer biology at the UVA School of Medicine has discovered a novel ‘noncoding’ RNA that could potentially reveal early detection of prostate cancer, and regulate prostate cancer cell growth.

The novel RNA that Gioeli uncovered during his research – and named “HULLK” – has shown it can be detected in urine of prostate cancer patients. This discovery unlocks the potential to address the unmet medical need for early diagnostics for prostate cancer while also significantly improving patient care by

avoiding invasive sample collections from biopsy. In addition to its potential to inform diagnostic tools, this discovery also shows promise of HULLK functioning as a therapeutic target.

A UK-based diagnostics company took early interest in Gioeli’s research. APIS Assay Technologies develops new tests for the prediction, prevention, and diagnosis of disease from discovery to regulatory approval with specific interest in biomarkerbased tools. LVG helped secure an agreement with APIS to sponsor Gioeli’s research in December 2019, and since the discovery of HULLK, LVG has executed an exclusive option agreement with the company to license and pursue commercialization of the technology.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

– Dan Gioeli, UVA Department of Microbiology, Immunology and Cancer Biology

TIMELINE 2020 L VG files second U.S. patent application 2020 L VG receives second HUULKrelated disclosure 2019 L VG files first U.S. patent application 2019 L VG executes exclusive option agreement with APIS Assay Technologies alongside sponsored research agreement with UVA Department of Microbiology 2019 L VG receives first HUULKrelated disclosure 20

2020 Performance

241

*

Invention Disclosures

83

*

Licensing Deals

234 Patents Filed

University of Virginia research, across disciplines, schools, and institutes on Grounds, yields discoveries and inventions with commercial potential every year. LVG engages these ideas and stewards them toward the marketplace through evaluation, business development, patent protection, transactions with new and existing companies, and seed fund investments to yield returns for the University of Virginia and enrich and improve lives. * Denotes an LVG record

56

U.S. Patents Issued

6

New Ventures

$1.2MM Invested from the LVG Seed Fund

$14.1MM Leveraged by the LVG Seed Fund

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2020 ANNUAL REPORT

2020 Per formance

Invention Disclosures In FY2020, UVA innovators brought forward 241 ideas and discoveries with the potential to enrich and improve lives.

Anesthesiology Biochemistry & Molecular Genetics Biomedical Engineering Cellular Biology Medicine Microbiology, Immunology, and Cancer Biology (MIC) Molecular Physiology & Biological Physics Neurology Neurosurgery Ophthalmology Orthopaedic Surgery Otolaryngology Pathology Pediatrics Pharmacology Plastic and Maxillofacial Surgery Psychiatry and Neurobehavioral Sciences

School of Medicine

50%

24

Public Health Sciences Radiation Oncology Radiology and Medical Imaging Surgery Urology

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

22

2020 Per formance

Applied Research Institute Athletics Biocomplexity Institute McIntire School of Commerce Medical Center School of Architecture School of Data Science

Curry School of Education & Human Development Other

7%

4%

College of Arts & Sciences

9%

41 23

School of Engineering & Applied Science

30%

Graduates/Undergraduates Biology Chemistry Institute for Advanced Studies in Culture Physics

Biomedical Engineering Chemical Engineering Computer Science Electrical & Computer Engineering Engineering Systems & Environment Materials Science & Engineering Mechanical & Aerospace Graduates/Undergraduates

2020 ANNUAL REPORT

56 U.S. Patents Issued US Patent Number

Title

Inventors

10,369,120

T Type Calcium Channel Inhibitors

Macdonald, Timothy L.; Gray, Lloyd S.; Haverstick, Doris M.; McCalmont, William; Patterson, Jaclyn R.

RE47863

Non-Ferromagnetic Amorphous Steel Alloys Containing Large-Atom Metals

Gu, Xiaofeng; Poon, Joseph S.; Shiflet, Gary J.

10,582,873

Analysis Of Cardiac Rhythm Using Rr Interval Characterization

Lake, Douglas E.; Moorman, Randall J.

10,546,659

Method, System And Computer Simulation Environment For Testing Of Monitoring And Control Strategies In Diabetes

Breton, Marc D; Cobelli, Claudio; Kovatchev, Boris P.; Man, Chiara D.

10,550,162

Compositions And Related Methods For Modulating Transcriptional Activation By Incorporating Gag Motifs Upstream Of Core Promoter Elements

Bokewiec, Marta T.; Rushton, Paul J.; Timko, Michael P.

10,507,315

Systems And Methods For Ultrasound Imaging And Insonation Of Microbubbles

Hossack, John A.; Klibanov, Alexander L.; Wamhoff, Brian R.

10,533,226

Serotonin Transporter Gene And Treatment Of Alcoholism

Johnson, Bankole

10,619,209

Serotonin Transporter Gene And Treatment Of Alcoholism

Johnson, Bankole

10,533,226

Serotonin Transporter Gene And Treatment Of Opioid-Related Disorders

Johnson, Bankole

10,619,209

Serotonin Transporter Gene And Treatment Of Opioid-Related Disorders

Johnson, Bankole

10,656,146

Detection Of Polymeric Analytes

Landers, James P

10,426,340

Self-Illuminated Handheld Lens For Retinal Examination And Photography And Related Method Thereof

Yates, Paul A

10,426,330

Self-Illuminated Handheld Lens For Retinal Examination And Photography And Related Method Thereof

Yates, Paul A

10,426,340

Self-Illuminated Handheld Lens For Retinal Examination And Photography And Related Method Thereof

Yates, Paul A

10,426,330

Self-Illuminated Handheld Lens For Retinal Examination And Photography And Related Method Thereof

Yates, Paul A

10,420,489

System Coordinator And Modular Architecture For Open-Loop And ClosedLoop Control Of Diabetes

Breton, Marc D.; Kovatchev, Boris P.; Patek, Stephen D.

10,431,342

Tracking The Probability For Imminent Hypoglycemia In Diabetes From SelfMonitoring Blood Glucose (Smbg) Data

Breton, Marc D.

10,689,392

Anti-Cancer Compounds Targeting Ral Gtpases And Methods Of Using The Same

Meroueh, Samy; Schwartz, Martin; Theodorescu, Dan

10,368,834

Bone Surface Image Reconstruction Using Ultrasound

Hossack, John A.; Mauldon, William F.; Owen, Kevin

10,358,528

Viscoelastic Silicone Rubber Compositions

Bloomfield, Louis

10,603,307

Molecular Genetic Approach To Treatment And Diagnosis Of Alcohol And Drug Dependence

Johnson, Bankole

10,610,154

Unified Platform For Monitoring And Control Of Blood Glucose Levels In Diabetic Patients

Breton, Marc D.; Kovatchev, Boris P.; Patek, Stephen D.; Keith-Hynes, Patrick T

10,536,036

Energy Harvesting And Control For Sensor Node

Calhoun, Benton H; Otis, Brian P

10,654,908

Isolated T Cell Receptors And Methods Of Use Therefor

Cummings, Kara L.; Englehard, Victor H.; Obeng, Rebecca C.; Zarling, Angela L.

10,479,800

Compositions And Methods For Regulating Glucose Homeostasis And Insulin Action

Hoehn, Kyle; Kenwood, Brandon

10,683,306

Compositions And Methods For Regulating Glucose Homeostasis And Insulin Action

Hoehn, Kyle; Kenwood, Brandon

10,479,800

Compositions And Methods Of Regulating Glucose Homeostasis And Insulin Action

Hoehn, Kyle; Kenwood, Brandon

10,683,306

Compositions And Methods Of Regulating Glucose Homeostasis And Insulin Action

Hoehn, Kyle; Kenwood, Brandon

10,438,700

Computer Simulation For Testing And Monitoring Of Treatment Strategies For Stress Hyperglycemia

Breton, Marc D.; Kovatchev, Boris P.; Patek, Stephen D.; Farhi, Leon S.; Ortiz, Edward A

10,340,972

Ultra Low Power Sensing Platform With Multimodal Radios

Calhoun, Benton H.; Klinefelter, Alicia; Oh, Seunghyun; Roberts, Nathan E.; Shakhsheer, Yousef; Wentzloff, David D.; Zhang, Yanqing

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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2020 Per formance

US Patent Number

Title

Inventors

10,682,399

Target Peptides For Colorectal Cancer Therapy And Diagnostics

Abelin, Jennifer G.; Cobbold, Mark; Hunt, Donald F.; Penny, Sarah; Shabanowitz, Jeffrey

10,382,448

Methods, Systems And Computer Readable Media For Detecting Command Injection Attacks

Co, Michele; Davidson, Jack W.; Hiser, Jason; Knight, John; Nguyen-Tuong, Anh

10,401,488

Real-Time Rfid Localization Using Uniform, High-Performance Tags And Related Method Thereof

Chawla, Kirti; Robins, Gabriel

10,415,547

2-D Fairing For A Wind Turbine Tower

Loth, Eric; Selig, Michael

10,450,259

Compositions And Methods For Hydrocarbon Functionalization

Boaz, Nicholas C.; Fortman, George; Groves, John T.; Gunnoe, Thomas B.

10,533,959

Device And Related Method For Solution Scattering And Diffraction Sample Holders

Horanyi, Peter; Wiener, Michael C.

10,482,210

System, Method, And Computer Readable Medium For Walking Pads: Fast Power-Supply Pad-Placement Optimization

Skadron, Kevin; Stan, Mircea R.; Wang, Ke; Zhang, Runjie

10,393,755

Compositions And Methods For Treating Eye Infections And Disease

Hirata, Harumitsu; Laurie, Gordon W.; MacNamara, Nancy; Wang, Ningning

10,483,448

Fflexible Thermoelectric Devices, Methods Of Preparation Thereof, And Methods Of Recovering Waste Heat Therewith

Hopkins, Patrick E.; Jur, Jesse S.; Losego, Mark

10,417,367

System For Placement Optimization Of Chip Design For Transient Noise Control And Related Methods Thereof

Skadron, Kevin; Stan, Mircea R.; Wang, Ke; Zhang, Runjie

10,562,890

Cancer Therapeutics

Bushweller, John H.; Illendula, Anuradha

10,425,040

Balanced Unilateral Frequency Quadrupler

Alijabbari, Naser; Weikle, Robert M.

10,378,861

Impulse Mitigation Systems For Media Impacts And Related Methods Thereof

Deshpande, Vikram; Wadley, Haydn N.

10,401,327

Systems And Methods For Multispectral Photoacoustic Microscopy

Cao, Rui; Hossack, John A.; Hu, Song; Kilroy, Joe

10,640,549

Recombinant Antibodies That Recognize The C-Terminal Domains Of Ebola Virus Nucleoprotein

Derewenda, Zygmunt S.; Engel, Daniel A.; Kossiakoff, Anthony

10,453,555

Parameterizing Cell-To-Cell Regulatory Heterogeneities Via Stochastic Transcriptional Profiles

Bajikar, Sameer S.; Fucks, Christiane; Janes, Kevin; Theis, Fabian J.

10,452,370

System, Method And Computer Readable Medium For Space-Efficient Binary Rewriting

Davidson, Jack W.; Hiser, Jason; Nguyen-Tuong, Anh; Zephyr Software, LLC

10,363,299

Compositions And Methods For Preventing And Treating Rhinovirus Infections

Agrawal, Rachana; Kwok, William; Muehling, Lyndsey M.; Turner, Ronald B.; Wisniewski, Julia A.; Woodfolk, Judith Ann; Wright, Paul W.

10,638,981

Method, System And Computer Readable Medium For Assessing Actionable Glycemic Risk

Patek, Stephen D.

10,639,240

Feeding Nipple Systems For Cleft Palate Or Lip

Blemker, Silvia S.; Borowitz, Kathleen; Pelland, Catherine; Read, Katherine E.; Shah, Katrina; Tran, Thanh

10,445,323

Association Rule Mining With The Micron Automata Processor

Skadron, Kevin; Wang, Ke

10,463,789

System, Method, And Computer Readable Medium For Dynamic Insulin Sensitivity In Diabetic Pump Users

Breton, Marc D.; Jiang, Boyi

10,446,329

Process Of Forming Electrodes And Products Thereof From Biomass

Gao, Zan; Li, Xiaodong C.

10,678,505

Subset Encoding Method: Increasing Pattern Density For Finite Automata

Guo, Deyuan

10,410,330

System And Method For Comparison-Based Image Quality Assessment

Liang, Haoyi; Weller, Daniel S.

10,456,086

Method, System And Computer Readable Medium For Predictive Hypoglycemia Detection For Mild To Moderate Exercise

Brahim, Najib B.; Breton, Marc D.

10,561,337

Rapid 3d Dynamic Arterial Spin Labeling With A Sparse Model-Based Image Reconstruction

Meyer, Craig H.

10,474,690

Disjunctive Rule Mining With Finite Automaton Hardware

Sandredini, Elaheh; Skadron, Kevin; Wang, Ke

10,557,908

Magnetic Field Monitoring Of Spiral Echo Train Imaging

Fielden, Samuel W.; Kiefer, Berthold; Meyer, Craig H.; Mugler, John P. III.; Pfeuffer, Josef; Ruyters, Gudrun;

10,664,241

Memory Systems Including Support For Transposition Operations And Related Methods And Circuits

Aly, Mohamed E.; Guo, Xinfei; Margala, Martin; Skadron, Kevin; Stan, Mircea R.

10,418,304

Ion-Implanted Thermal Barrier

Hopkins, Patrick E.; Ihlefeld, John

10,580,481

Methods, Circuits, Systems, And Articles Of Manufacture For State Machine Interconnect Architecture Using Embedded Dram

Rahimi, Gholamreza; Sandredini, Elaheh; Skadron, Kevin; Stan, Mircea R.

25

2020 ANNUAL REPORT

Enriching the Ecosystem

This year, LVG launched an ‘EIR’ program of experts, entrepreneurs, and executives in residence to accelerate startup formation from the UVA research portfolio. We were able to significantly scale the program and contribute to the growth of the Charlottesville innovation ecosystem thanks to our strategic partners.

New venture creation is one of the pillars of economic development that drives job creation and helps attract and retain industry in Charlottesville.

We are thrilled to support LVG as they elevate this program with expert industry veterans to launch new ventures from the UVA research portfolio.”

Supported by the UVA Office of Economic Development, Albemarle County Economic Development, and the City of Charlottesville Office of Economic Development (OED), the LVG EIR program is now a powerful resource offering UVA faculty innovators access to seasoned professionals with experience in early-stage technology commercialization and new venture creation.

By formalizing this program and expanding its scope, we have also been able to extend our resources in support of our community partner, CvilleBioHub, to launch their own EIR program. In December 2019, CvilleBioHub was awarded $548,000 from the GO Virginia initiative to lead the growth and expansion of the biotechnology innovation cluster in Central Virginia.

– Pace Lochte (EDUC ’05, DARDEN ’08), Assistant VP for Economic Development

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

26

Enriching the Ecosystem

Entrepreneurs in Residence

Our first cohort of EIRs includes leaders who are UVA alumni, founders, and investors who possess business acumen, industry experience with early tech commercialization, strategic planning, and fundraising. Two of the EIRs in our first cohort have successfully launched and sold UVA startup companies in the last decade.

COL ‘99

Helen Boyd

Kevin Combs

Weston Fox

Executive in Residence

Entrepreneur in Residence

Executive in Residence

Helen Boyd has 9 years of experience in the Energy industry, working in various finance positions at different subsidiaries of the Royal Dutch / Shell Group in both the U.K. and U.S. Helen’s experience at Shell included working in Corporate Strategy, Shipping, and as Finance Advisor, Finance Manager and Risk Control Manager in several different trading subsidiaries.

Kevin Combs is a founder, entrepreneur, and investor with experience in building operating companies to produce outsized value, while maintaining fiscal conservativeness. He is currently the CEO and Managing Director of Keswick Pharmaceuticals, a privately held company focused on commercializing Rx pharmaceutical products for areas of unmet or under-met disease states.

Weston is a healthcare entrepreneur with extensive experience in the industry, including with TARGET PharmaSolutions, Novartis and IQVIA. He has held senior management positions in business development, corporate development, operations and strategy with a general focus on the application of data and analytics to enhance the capabilities of healthcare companies. He previously worked at Carousel Capital and The Boston Consulting Group.

ENGR ‘00

COM ‘97

Andrew Krouse

Mike Raker

Chad Rogers

Entrepreneur in Residence

Entrepreneur in Residence

Entrepreneur in Residence

Andrew Krouse has over a decade of biotech investing and leadership experience with a track record of success as the founder and CEO of Tau Therapeutics, LLC, Xdynia LLC, and venture backed Cavion, Inc. Prior to his experience in the pharmaceutical industry, he worked as an analyst for Goldman Sachs, NYC, and served as Vice President of the UVA Darden Graduate School of Business.

Most recently, he led the acquisition of UVA startup, Cavion, to industry leader Jazz Pharmaceuticals.

Mike Raker is Vice President, Tech Fellow, and Director of Mission Software at Leidos, a Fortune 300 science and tech company.

Mike developed and oversees Leidos’ global network of software factories and leads research and development of discriminating technologies with a focus on software for mission critical systems. Mike is also an active member of both the Charlottesville Angel Network and the Country Roads Angel Network.

Chad Rogers is a serial entrepreneur with more than 20 years of experience in medical device technology, early stage startup management, and venture capital. Chad founded TypeZero Technologies, Inc. in 2013 and has led several successful startups throughout the course of his career as an investor, consultant, and corporate executive.

In 2018, TypeZero was acquired by medical device company Dexcom (DXCM), a leader in continuous glucose monitoring technology.

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2020 ANNUAL REPORT

Enriching the Ecosystem

NIKKI HASTINGS (BME ’09) JOE LEE, BOB CREEDEN PE TER ME ATH (COM ’99)

with J.P. Morgan Life Sciences For the third and final event of LVG’s Entrepreneur’s Edge series, in partnership with CvilleBioHub, we invited Peter Meath (COM ’99), Industry Head, Healthcare & Life Sciences and Joe Lee, Executive Director, Life Sciences from J.P. Morgan Life Sciences to Charlottesville to share their trend reports and insights on challenges facing the biotech industry. More than 100 guests from our combined network of innovative thinkers, entrepreneurs, and investors joined us at the Darden School of Business for an evening of discussion and networking.

COvergence 2019

RON NE WBOLD (LVG BOARD MEMBER), PAUL SARTORI (GR AD ’70, ’75, DARDEN ’79)

In July 2019, LVG hosted Innovosource’s second annual COvergence conference at the Darden School of Business for leaders in university gap and startup funding, accelerator programs, and proof of concept funds. While technology transfer offices emerged in the 1980s after the Bayh-Dole Act passed, university backed funding sources like the LVG Seed Fund exist in a young, niche industry that has taken shape in the last few decades.

Among the 40+ organizations that were represented at the conference were senior and executive directors of technology transfer offices, VPs for research and business development from UVA peer institutions including TechLaunch Arizona, Emory University, UNC-Chapel Hill, and the University of Michigan, among others.

During the conference, universities presented their programs, shared best practices, and discussed how gap funds and accelerators can best engage with industry partners and investors.

Local service providers and community partners helped sponsor the event including the Center for Innovative Technology, Buchanan Ingersoll & Rooney PC, and Knobbe Martens Intellectual Property + Technology Law.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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Enriching the Ecosystem

Enriching Students Lives

LVG maintains experiential learning opportunities for students to engage in our business processes which require broad scientific expertise, business insight, and legal acumen to convert scientific research into practical applications. Using real examples from our pipeline, students gain hands-on professional experience while providing tangible support to our team.

My internship with the LVG licensing team coincided with the end of my Ph.D. program at UVA when I was exploring post-graduation career opportunities. It was a great experience that gave me insight into different aspects of technology transfer from licensing to intellectual property. It helped me decide to pursue a career in the field and following graduation, I joined Ice Miller LLP as a Technical Advisor. I currently work at the firm as a Patent Agent, and enjoy applying my technical knowledge to the role and learning about different biotech inventions” –Sarah Pollock, Ph.D. (BIMS ’19)

Technology Commercialization Workshop In FY20, LVG formalized our licensing educational programming and internships into a comprehensive Technology Commercialization Workshop which serves as a prerequisite for a spring internship with the LVG licensing team. UVA graduate students and post-doc fellows gain a basic understanding of technology commercialization and learn to identify the value of scientific and technological innovations to the world of industry, business, and entrepreneurship.

Led by LVG Director of Licensing Patrick Klepcyk, the workshop covers everything from intellectual property management and effectively protecting and commercializing the results of scientific research to business development and licensing negotiations.

In collaboration with the UVA Law School and the UVA Darden School of Business, LVG offers accredited curriculum coursework opportunities and internships for professional students throughout the year.

Patent Law & Licensing Clinic

Due Diligence in Seed Fund Investing

Each semester, approximately 15 enrolled UVA Law students work directly with our Senior Patent Attorney & General Counsel, Rob Decker. Students learn how to evaluate inventions and computer software for patentability and commercial value; counsel inventors regarding patentability; determine inventorship; and prepare, file and prosecute provisional U.S. and international patent applications.

Due Diligence in Seed Fund Investing is an elective course offered within the entrepreneurship, innovation, and strategy discipline of Darden’s MBA curriculum.

Each year, 12 second-year students join the class led by Bob Creeden, Managing Director of the LVG Seed Fund & New Ventures. Students gain exposure to the operations of the LVG Seed Fund and learn an industry proven diligence process using real examples from our pipeline.

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2020 ANNUAL REPORT

LVG Seed Fund Our fourth year of operation was truly unlike any other. In an inspiring effort, our portfolio companies quickly pivoted to use their expertise and technologies to solve the new problems presented by the COVID-19 pandemic.

Ceres Nanosciences adapted their Nanotrap® technology to enhance the sensitivity of COVID-19 testing and began offering a Nanotrap® Virus Capture Kit, and BrightSpec’s analytical tools that test and quantify compound efficacy can support the production of anti-viral drugs.

Amidst the uncertainty, we were able to adapt and find a path forward. The LVG Seed Fund closed six investments totaling $1.2MM and celebrated our second exit. We welcomed Matt Rannals, Ph.D. (GRAD ’11) to our team as a Venture Associate, and Kristin Gunther (DARDEN ’09), a Principal at Revolution Growth and Darden Alum to our Investment Committee. We also had the distinct pleasure of hosting our counterparts from institutions around the country for the second annual COvergence conference.

While returns are one indication of impact, the impact our portfolio companies make on their customers – how the products and services enrich and improve lives through the identification, development, and commercialization of novel UVA discoveries - remains our priority.

As we continue to navigate the world with COVID-19, we are grateful for the support and flexibility of our Investment Committee, our students, and our broader community.

After shifting our Darden course online in March, we said farewell to the class of 2020 at UVA’s virtual graduation celebration. This summer, we welcomed three rising second-year MBA students and a rising third-year undergraduate from the College of Arts & Sciences as interns in collaboration with the Batten Institute.

We closed the 2020 fiscal year with two new companies in our portfolio, Merand Pharmaceuticals and Astraea, and closed follow-on investments in TearSolutions, BrightSpec, and Mission Secure. The LVG Seed Fund also recorded its second exit when Keystone Heart, a leading medical device company in the cardiovascular space, acquired 510Kardiac.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

BOB CRE E DE N M A N AGING DIRECTOR

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LV G S e e d F u n d

Investment Committee Gerry Brunk (COL ’90), Managing Director, Lumira Capital Jonathan Ebinger (DARDEN ’93), General Partner, Blue Run Ventures Dayna Grayson (ENGR ’99), Co-founder and General Partner of Construct Capital Peter M. Grant II, Partner (COL ’78, DARDEN ’86), Anchormark Holdings Rob Paull (ARCH ’98), Co-Founder, Partner, Lux Capital Melur K. (Ram) Ramasubramanian, Vice President for Research, UVA (ex-officio) Dr. K. Craig Kent, Executive Vice President for Health Affairs (ex-officio)

There is such a need for early-stage capital, particularly outside of the traditional tech hubs. Any vehicle that expands access to capital when companies are just getting off the ground is worthwhile, and to have one that can tap into the talent and ideas within the University seems like a win-win.”

– Kristin Gunther (DARDEN ’09), Principal, Revolution Growth (Gunther joined the LVG Seed Fund Investment Committee in July 2020) 31

2020 ANNUAL REPORT

LV G S e e d F u n d

LVG Seed Fund Portfolio

U VA FA C U LT Y- F O U N D E D C O M PA N Y

U VA A L U M N I - F O U N D E D C O M PA N Y

BRENDAN RICHARDSON (COM ‘88)

ROS S DUNL AP (COM ‘96)

Astraea is a technology startup building the first integrated platform for global scale geospatial analytics. The company’s earthAI technology uses machine learning, big data computing, and Earth-Observing satellites to easily access, analyze, and extract actionable insights about the planet, providing global understanding for local impact.

Ceres Nanosciences is a life sciences company focused on incorporating its novel Nanotrap® particle technology into a range of diagnostic products and workflows with the ultimate goal of providing better patient outcomes. The Nanotrap® particle technology can improve diagnostic testing by capturing, concentrating, and preserving low abundance analytes from biological samples.

Syndicate Partners: Greybird Ventures, Pactolus Ventures, Bay Area Lyme Foundation

F O U NDE D T O C OMME RC I A L IZ E T HE

FOUNDED TO COMMERCIALIZE

PAT E N T E D T EC HN OL O G IE S OF U VA

R E S E A R C H C O N D U C T E D B Y U VA

C HE MI S T RY PR OF E S S OR B R O OK S

ENGINEERING PROFESSOR BARRY

PAT E , PH.D. (C OL ‘87 )

H O R O W I T Z , P H . D.

BrightSpec is a life science instrumentation company offering fast, precise analysis of trace level chemical components for applications in R&D, pharmaceuticals, fine chemicals, food, and advanced manufacturing sectors.

Mission Secure is a leading control system cybersecurity company. The company’s patented MSi Platform and cyber advisory services protect clients in the energy, defense, autonomous systems, maritime, and critical infrastructure industries prepare for and protect against cyber-attacks.

Syndicate Partners: MedVest

Syndicate Partners: Energy Innovation, Blue Bear, Chevron

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

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LV G S e e d F u n d

Exits Merand Pharmaceuticals F O U NDE D T O C OMME RC I A L IZ E A N OV E L T HE R A PE U T IC DI S C OV E RE D AT U VA BY F ORME R FAC U LT Y ME MB E R DR . B RI A N A NNE X Merand Pharmaceuticals is developing a novel microRNA therapeutic (MicroRNA93 or miR-93), shown to promote angiogenesis, to treat patients suffering from Peripheral Arterial Disease (PAD), a progressive circulatory issue affecting over 200 million people globally.

Founded by Chad Rogers (COM ‘97) to commercialize diabetes technology research from the Center for Diabetes Technology at the UVA School of Medicine and acquired by Dexcom, Inc. in August 2018.

Acquired by: Dexcom, Inc.

Direct Spinal Therapeutics, Inc. FOUNDED TO COMMERCIALIZE THE INTELLECTUAL PROPERT Y OF UVA RESEARCH PROFESSOR EMERITUS GEORGE GILLIES, PH.D. (ENGR ‘76, ‘80) Direct Spinal Therapeutics, Inc. is a medical device company developing a Spinal Cord Stimulation (SCS) product-platform to enhance treatment for chronic back pain and other spinal cord injuries.

Founded to commercialize a novel cardiovascular device to improve surgical accuracy developed by UVA Associate Professor of Cardiovascular Medicine Dr. Scott Lim and acquired by Keystone Heart in June 2020.

Acquired by: Keystone Heart

FOUNDED TO COMMERCIALIZE A NOVEL THER APY DISCOVERED BY UVA PROFES SOR OF CELL BIOLOGY AND OPHTHALMOLOGY GORDON L AURIE, PH.D. TearSolutions’ first-in-class therapy is a synthetic form of the protein lacritin, called Lacripep™, which targets the causes of dry-eye disease. The company completed Phase II clinical trials focused on patients with Primary Sjogren’s Syndrome concluded in October 2020.

Syndicate Partners: Virginia Tech Carillion, Pharmstandard, Santen Pharma

33

2020 ANNUAL REPORT

Celebrating Impact Through Innovation THE

Edlich-Henderson Innovator of the Year Award

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

34

Named for UVA Professor Emeritus Dr. Richard F. Edlich and Christopher J. (“Goose”) Henderson, a veteran of privately owned financial services businesses, the award is a tribute to their enduring support of and commitment to the University and its innovators.

35

PREVIOUS WINNERS

The highest honor bestowed on University of Virginia innovators, the Edlich-Henderson Innovator of the Year award recognizes an individual or team each year whose research discovery is making a major impact.

2019 2018 2017 2016

Lee Ritterband, Ph.D. Jeffrey Elias, M.D. Brooks H. Pate, Ph.D. John A. Hossack, Ph.D. N. Scott Barker, Ph.D. Arthur W. Lichtenberger, Ph.D. Robert M. Weikle II, Ph.D.

2015

Benton H. Calhoun, Ph.D. James A. Smith, Ph.D.

2014

J. Randall Moorman, M.D. Douglas E. Lake, Ph.D.

2013

Marcia A. Invernizzi, Ph.D.

2012

Robin A. Felder, Ph.D.

2011

Boris P. Kovatchev, Ph.D.

2010

Kevin R. Lynch, Ph.D. Timothy L. Macdonald, Ph.D.

2009

John P. Mugler, Ph.D. James R. Brookeman, Ph.D.

2008

George T. Rodeheaver, Ph.D.

2007

Wladek Minor, Ph.D.

2006

George T. Gillies, Ph.D.

2005

Benjamin M. Gaston, M.D. John F. Hunt, Ph.D.

2004

Haydn N.G. Wadley, Ph.D.

2003

William A. Petri Jr., M.D., Ph.D. Barbara J. Mann, Ph.D.

2002

Joel M. Linden, Ph.D.

2001

Doris Kuhlmann-Wilsdorf, Ph.D.

2000

Ronald P. Taylor, Ph.D.

1999

John C. Herr, Ph.D.

1997

Richard L. Guerrant, M.D. Timothy L. Macdonald, Ph.D.

1996

Jessica J. Brand Patrice G. Guyenet, Ph.D. Richard D. Pearson, M.D. Janine C. Jagger, Ph.D.

1995

Donald F. Hunt, Ph.D. Jeffrey Shabanowitz, Ph.D. George C. Stafford Jr., Ph.D

1994

Gerald L. Mandell, M.D. Gail W. Sullivan

1993

Joseph Larner, M.D., Ph.D.

1992

Robert M. Berne, M.D. Luiz Belardinelli, M.D. Rafael Rubio, Ph.D.

2020 ANNUAL REPORT

2020 Innovators of the Year

Improve Care Retention and Outcomes Among HIV Patients with Innovative Mobile Health Technology On January 23, 2020, the UVA Licensing & Ventures Group announced Rebecca Dillingham, M.D./M.P.H., Harrison Distinguished Teaching Associate Professor of Medicine, and Karen Ingersoll, Ph.D., Professor of Psychiatry and Neurobehavioral Sciences, as the 2020 Edlich-Henderson Innovators of the Year.

This endowed award recognizes University faculty members or a team of faculty researchers whose work is making a major impact on society.

LVG recognizes Drs. Dillingham and Ingersoll for their efforts directed toward ending the HIV epidemic through innovations in HIV care delivery. Their mobile health (mHealth) technology, PositiveLinks, is a sustainable and scalable solution to promote engagement in HIV care. It is a HIPPA-compliant mobile platform that helps people living with HIV to manage their health better, in partnership with their clinical providers.

To date, nearly 600 people living with HIV in Virginia are enrolled in PositiveLinks. The app is commercially available through Warm Health Technology, a company founded to support the dissemination of the mobile platform across the U.S. “HIV is a treatable disease. In many ways, it is easier to manage than other chronic diseases, like diabetes.

Unfortunately, only about 50% of people living with HIV in the U.S. engage consistently with care,” said Dr. Dillingham. “Using mobile health solutions, we have seen improvements in engagement with care, even amongst our patients facing the most challenges.

PositiveLinks members can engage with the platform to seek information, support, or care coordination when and where it is most convenient for them.”

In December 2019, PositiveLinks earned national best practice recognition from the Centers for Disease Control (CDC) and from the National Association of State and Territorial AIDS Directors (NASTAD).

“Drs. Dillingham and Ingersoll have continuously innovated their original text-messaged-based

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

intervention for nearly a decade alongside the rise of the digital health industry,” said Michael Straightiff, executive director of the Licensing & Ventures Group.

“PositiveLinks pushes the boundaries on new-age solutions for the HIV care community and stands to significantly lower transmission rates among users of the app. This interdisciplinary research team has and will continue to enrich and improve lives with PositiveLinks, and we are thrilled to honor their accomplishments with this award.”

The PositiveLinks app features self-monitoring tools for medication adherence, daily stress, and mental health check-ins, appointment reminders, and secure messaging with the healthcare team. Users gain access to an anonymous community message board where they can share experiences, seek and provide social support, and build connections, all of which improve the management of a chronic disease.

“PositiveLinks includes proven psychological tools that engage patients and provide support for specific health behaviors that promote better self-management of HIV,” said Dr. Ingersoll. The platform also includes tools for physicians and administrative staff to support improved self-management.

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Accolades

University President Jim Ryan and Executive Vice President and Provost Liz Magill presented Drs. Dillingham and Ingersoll with the award at the inaugural UVA Research Achievement Awards ceremony at the end of January. The 2020 recipients also delivered a keynote address at LVG’s celebratory Innovator of the Year event in the Rotunda Dome Room in February. Dr. Eric Houpt, Chief of the Division of Infectious Diseases and International Health introduced the research team who shared a compelling presentation on their work developing PositiveLinks and their vision for the future.

Many Virginians using the app lack access to even basic care; PositiveLinks allows them to have daily touchpoints with the deep clinical expertise of our specialist physicians and nursing staff here at UVA.” – Jeff Keller (COL ’97), Chief Innovation Officer, UVA Health System

P OSITIVELINKS RESE A RCH TE A M

DR. ERIC HOU P T

37

K A REN INGERSOLL, DR. REBECCA DILLINGHA M

2020 ANNUAL REPORT

Accolades

MRI Pioneer John Mugler Named to National Academy of Inventors This story was originally published by the UVA Health System on Feb 5, 2020 By: Joshua Barney

The University of Virginia’s John P. Mugler III, PhD (ENGR ’80, ’88), and Vice President for Research Ram Ramasubramanian have been named a fellow by the National Academy of Inventors in recognition of his game-changing work in medical imaging, particularly MRI.

“John earned this recognition because he has invented multiple major technologies in the field of MRI. All major MRI manufacturers currently provide multiple brain imaging techniques that John invented,” said Frederick H. Epstein, PhD, chairman of UVA’s Department of Biomedical Engineering.

Mugler, of UVA’s School of Medicine and School of Engineering, is one of 168 academic innovators being recognized by the National Academy of Inventors (NAI).

The NAI Fellows Program salutes “academic inventors who have demonstrated a spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development and the welfare of society.”

“ The simplest way to describe the impact of John’s work is to say, without exaggeration, that if you or anyone you know has ever had a brain MRI, their resulting diagnosis probably benefitted from John’s inventions.”

“It is a great honor for my work to be recognized in this way by the National Academy of Inventors. Getting to this point would not have been possible without the support and collaboration of wonderful colleagues at UVA and in the medical-imaging industry,” said Mugler, of UVA’s Department of Radiology and Medical Imaging and the Department of Biomedical Engineering. “It is very gratifying to see that techniques developed at UVA have made a difference in the clinical care of patients. As a medical-imaging developer, this is the most satisfying outcome that one can achieve.”

Transforming MRI Mugler was instrumental in developing innovative pulse sequences that revolutionized magnetic resonance imaging, making it practical to create high-contrast 3D images quickly and with high resolution. Previously, MRI machines produced primarily two-dimensional “slices” for clinical imaging, but Mugler’s research allowed for the creation of detailed images that can be viewed from any angle. The increased detail allows doctors to identify subtle abnormalities earlier, leading to better diagnoses and treatment for patients.

Mugler, UVA’s director of medical imaging research, also has been conducting cutting-edge work with hyperpolarized gases for imaging the lungs. These nontoxic, helium- and xenon-based approaches provide high-resolution images far superior to any existing clinical method. UVA is one of the top research and training institutions for lung research using these gases.

Mugler was previously recognized, with his colleague James R. Brookeman, as the 2009 Edlich-Henderson Inventors of the Year by the UVA Patent Foundation, now known as the UVA Licensing & Ventures Group.

“This recognition from the National Academy of Inventors is well deserved in light of John Mugler’s transformative work that has had concrete benefits for countless patients,” said David Wilkes, MD, dean of the School of Medicine. “We congratulate him and look forward to seeing what he develops next to better the human condition.”

Mugler’s work proved so important that it has been implemented in MRIs in hospitals and research institutions around the world.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

38

Accolades

“John is a world-class researcher who has leveraged UVA’s strong collaborations between engineers and medical professionals to make the university an international center of excellence for medical imaging,” said Craig H. Benson, PhD, dean of the School of Engineering and himself an NAI fellow. “Thanks to innovations from John and other UVA faculty, people who suffer from cancer, lung disease, neurological disorders, cardiovascular conditions, among other issues, are receiving better diagnoses and care than ever before.

John is an excellent addition to the National Academy of Inventors.”

Inspiring the Next Generation The National Academy will induct the new fellows at a ceremony in April.

In announcing the latest fellows, NAI President Paul R. Sanberg said, “The breadth and scope of their discovery is truly staggering. I’m excited not only see their work continue, but also to see their knowledge influence a new era of science, technology and innovation worldwide.”

National Academy of Inventors Class of 2020 Boris Kovatchev Robin Felder Class of 2019

John P. Mugler III

Class of 2018

George T. Gillies

Class of 2017

Craig H. Benson

Class of 2016

Barry W. Johnson

Class of 2015 Joe C. Campbell Jayakrishna Ambati Class of 2014 Thomas C. Skalak John C. Herr*

39

2020 ANNUAL REPORT

Accolades

Notable Portfolio Activity AgroSpheres, Inc., an agricultural biotechnology company, was awarded a National Science Foundation (NSF) Small Business Technology Transfer (STTR) grant for $225,000 in July 2019.

The grant supports the company’s collaborative research with North Carolina State University on an RNAi biological insecticide for the western flower thrips.

In July 2019, the Catalyst Accelerator Program launched to provide staff, workspace, advisors, programming, and $20,000 in grant funding for Charlottesville-area startup companies.

ZielBio, Inc., an early-stage biotechnology company founded by UVA Biomedical Engineering Professor Kim Kelly, closed a $25.1 Million Series A financing round (September 2019) to enable development of a Monoclonal antibody – ZB131.

HemoSonics, a medical device company in point-of-care Viscoelastic hemostasis testing, registered their QStat Cartridge device for CE Mark, and announced its commercial availability in Europe and Hong Kong in September 2019. The device, previously available for cardiovascular and major orthopedic

surgeries can now also be used in trauma surgery and liver transplant settings.

Mission Secure, Inc. (MSi), an industry-leading industrial control system (ICS) cybersecurity company, was named one of the Most Promising Energy & Clean Tech Companies at the 17th Annual Energy and Clean Technology Venture Forum held by the Rice Alliance for Technology and Entrepreneurship.

Virginia Catalyst awarded $3.3 million in grants to six innovative life science and bioscience collaborations in November 2019.

Grants were awarded to LVG portfolio companies CytoRecovery, Lytos Technologies, and RIVANNA Medical.

In December 2019, LVG community partner CvilleBioHub received a GO Virginia Award for $548,000 to lead expansions of the biotech sector in the Charlottesville region. The partnership includes an EIR program to accelerate startup formation in the community.

Tandem Diabetes Care, a leading insulin delivery and diabetes technology company, brought the t:slim X2 Insulin Pump with ControlIQ Technology to the U.S. commercial market in January 2020. The closedloop technology was developed at UVA by a team of interdisciplinary researchers including Boris Kovatchev, Stephen Patek, Marc Breton, Stacey Anderson, and others, since 2006.

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

Ceres Nanosciences, Inc. received a $225,000 National Institute of Health (NIH) SBIR (Small Business Innovation Research) Phase I Grant in January 2020. The grant supports the company applying their proprietary Nanotrap® technology for improved quality testing and for the decontamination of animal serum used in cell and tissue culture applications.

Pear Therapeutics obtained FDA Authorization for SOMRYST, a prescription digital therapeutic for the treatment of adults with chronic insomnia developed by UVA’s 2019 Innovator of the Year, Lee Ritterband and licensed to the company through UVA LVG. The American Academy of HIV Medicine and the Institute for Technology in Health Care awarded the 2020 Caceres Award for Technology in HIV Practice to Drs. Rebecca Dillingham and Karen Ingersoll of the UVA Ryan White Clinic for their PositiveLinks (PL) digital application.

HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA).

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The Center for Innovation Technology (CIT) CRCF matched a $75,000 Small Business Innovation Research (SBIR) Grant for KeViRx, Inc., an early stage drug discovery company co-founded by LVG board member John Lazo.

Benton H. Calhoun (ENGR ‘00), Professor of Electrical and Computer Engineering at the University of Virginia and co-founder of Everactive, has been elected as a Fellow by the Institute of Electrical and Electronics Engineers (IEEE) for “original and fundamental contributions in integrated circuit design.”

Everactive, the pioneer of wireless, batteryless IoT (Internet of Things) systems based on Benton Calhoun’s work, partnered with steam systems giant Armstrong to bring the first ever self-powered sensors to market in the field of steam-trap monitoring. The startup was also selected to participate in MIT’s STEX25 Startup Exchange Accelerator in May 2020, and an investment from Fluke in September 2020 raised their series C funding round to $35MM.

John P. Mugler III, Biomedical Engineering Director of Medical Imaging Research, Robin Felder, Professor of Pathology, and Boris Kovatchev, Professor of Psychiatry and Neurobehavioral Sciences were inducted into the National Academy of Inventors (NAI). Together with previous Fellows, they make twelve UVA researchers now elected into the Academy, which distinguishes “inventors who have demonstrated a spirit of innovation in creating or facilitating outstanding inventions that have made a tangible impact on quality of life, economic development and the welfare of society.”

510 Kardiac Devices’ Lim Transseptal System has been approved for use by the FDA. This comes after Keystone Heart, a Venus Medtech company, acquired the startup cofounded by Scott Lim, MD, Director of the UVA Advanced Cardiac Valve Center, and Jaime Sarabia, former CEO of 510 Kardiac and current Director of New Business Operations at Keystone Heart. UVA LVG Seed Fund was an investor in the company.

Adial Pharmaceuticals added six new European countries to its landmark ONWARD™ Phase 3 pivotal trial in December 2019, and in June 2020 closed a $5.2 million registered direct offering of 2.82 million shares.

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2020 ANNUAL REPORT

Te a m

LVG Staff Leadership

Michael P. Straightiff Executive Director

Patrick J. Klepcyk Director, Licensing

Claudine R. Wispelwey Director, Operations

Licensing GRAD ’08

Joshua P. Mauldin, Ph.D. Licensing Manager

Robert J. Creeden Managing Director, UVA LVG Seed Fund & New Ventures

ENGR ’13

Marc Oettinger Licensing Manager

Heather B. Young, Ph.D. Licensing Manager

Cortney L. Mushill, Ph.D. Licensing Analyst

LVG Seed Fund

Legal

GRAD ’11

Robert J. Decker, J.D. Senior Patent & General Counsel

G. Eden Para Senior Patent Paralegal

Ashley M. Williams, Ph.D., Legal & Finance Assistant

UNIVERSITY OF VIRGINIA Licensing & Ventures Group

Matthew D. Rannals, Ph.D., Venture Associate

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Te a m

Operations GRAD ’17

Megan R. Bartels Manager, Strategic Communications

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John R. Carpenter Executive Assistant

Nicole L. Leister Information Manager

Courtney J. Shearer, CPA Manager, Financial Operations 2020 ANNUAL REPORT

434-924-2175 Phone 434-982-1583 Fax

lvg@virginia.edu lvg.virginia.edu

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