Year: 2018

This includes the full exercise of the underwriters’ option to purchase 1,185,000 additional shares of common stock.  On March 28, Precision’s shares began trading on the Nasdaq Global Select Market under the ticker symbol “DTIL.”

Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, “ARCUS.” Precision leverages ARCUS in the development of its product candidates, which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

Press Release

Precision BioSciences (Nasdaq:DTIL) (“Precision”), a genome editing company dedicated to improving life ( DTIL ) through its proprietary ARCUS genome editing platform, today announced the closing of its initial public offering of 9,085,000 shares of common stock, which includes the full exercise of the underwriters’ option to purchase 1,185,000 additional shares of common stock, at a public offering price of $16.00 per share.

The total gross proceeds to Precision were approximately $145.4 million, before deducting underwriting discounts and commissions and expenses payable by Precision. All of the shares were sold by Precision. The shares commenced trading on the Nasdaq Global Select Market under the ticker symbol “DTIL” on Thursday, March 28, 2019.

J.P. Morgan, Goldman Sachs & Co. LLC, Jefferies and Barclays acted as joint book-running managers for the offering.

A registration statement relating to the securities sold in this offering was declared effective by the Securities and Exchange Commission on March 27, 2019. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained by contacting: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204 or email: prospectus-eq_fi@jpmchase.com

[Originally posted by Nasdaq— April 1, 2019]

Two Duke spin-outs, Precision BioSciences and PhaseBio Pharmaceuticals, went public this past spring­­ bringing Duke’s total IPOs to nine. Located here in the Triangle, Precision’s recent opening of a new $26 million manufacturing facility is spurring economic growth and interest in the area, acting as an “anchor tenant”.

From TSA body scanning technology to software that can predict and overcome cancer drug resistance, 16 new start-up companies were added this year to the growing list formed from Duke research–bringing Duke’s overall start-up total to 142. 14 of this years 16 are staying in North Carolina, with 29 of 32 total start-ups remaining in the Triangle over the past two years.

Additionally, six of Duke’s ventures “graduated” this fiscal year–meaning they have procured the management and capital to move forward, either via financing or with sales revenue. Congratulations to Cellective Biotherapy, Gavilán Biodesign, MicroElastic Ultrasound, Phitonex, SV Analytics, and CCDS.

FY19 Duke Start-ups

The Duke New Ventures team has made over 115 introductions for our portfolio companies this year—to investors, management, service providers, and strategic partners. These introductions resulted in management team hires, partnerships, and sales for our startups.

“I’m excited about the role Duke New Ventures is playing in the Duke Entrepreneurial ecosystem and beyond,” said Hallford. “Our ties with I&E, Pratt, DIHI, Fuqua, ORAQ, CTSI, BioLabs NC, and the School of Medicine have never been stronger.”

Hallford feels this is largely due to his MIRs—the heart of the program. The culture of collaboration starts with them working behind the scenes to connect Duke startups and move things forward. This year, two new MIRs joined the team—Diane Ignar and Doreen Grech.

Ignar and Grech made an immediate impact in coaching Duke startups for Duke New Venture’s first ever Venture Day this past May. At this event, eight Duke companies pitched their novel ideas, along with five poster presentations, in front of a dozen venture capital (VC) firms, including 10 from out of town.

“Three of our companies have proceeded into due diligence with VC firms in attendance—a testament to the quality of startups coming out of Duke,” Hallford said.

Overall, $372 million was raised by Duke start-ups this past fiscal year, bringing the total capital raised in the past 25 years to just over $5.4 billion.

Another facet of Duke New Ventures is the New Venture Fellows program, which continues to make great strides. New Ventures had nine Fellows last Fall and 13 this Spring. NVF efforts have played a key role in advancing many startups this past year.

Jess Levitt, Assistant Director for Fuqua’s Health Sector Management (HSM) Program who works closely with many of the NVFs noted that the NVF program has been of increasing interest to both current and prospective HSM students. It appeals to students with a variety of career interests, from those looking to work with start-up companies, students interested in joining a venture capital firm, those hoping to work in strategy roles or on mergers and acquisitions, to individuals hoping to start their own company someday.

“All of these students benefit from working on meaningful projects where they have the ability to make a real impact and do so in a learning-based environment under the expert guidance of an MIR with the support of the New Ventures Program,” Levitt said.

The resources we put in place for our start-ups—the MIRs and New Venture Fellows—are one part of the equation, aimed at telling a clear story for every opportunity. “It’s only when these stories resonate with and engage the broader entrepreneurial ecosystem that Duke innovations can take off and move toward the market,” said Robin Rasor, Executive Director for OLV.

This can be seen in the Digital Innovations (DI) portfolio for Duke’s Office of Licensing & Ventures (OLV) ­–which only includes software, data, and content from across the university, medical center, and health system.  These innovations have inherent protectable IP and despite their rapidly evolving nature can have significant value and potential for commercialization.

This year, almost 30% of the 354 FY19 invention disclosures were DI. Additionally, 14 of 32 exclusive licenses and 7 of 16 start-ups were DI.

Reflecting on the evolving nature of research and innovation at the university, health system, and across the country, DI disclosures have more than quadrupled with a corresponding growth in licensing and startups. Additionally, DI disclosures come from departments, schools, institutes, and centers spanning the breadth of Duke University and Duke Health including administrative and service groups such as Duke Libraries, Duke OIT, DHTS, and Duke PRMO.

The combination of Duke innovators being at the forefront of the use of AI, machine learning, the Internet of Things (IoT), and data analytics is improving health care.

“Education has led to a rapid increase in collaborations–both internal and external–and the development of new technologies,” said Dinesh Divakaran, Associate Director of Software Licensing at OLV. “OLV works with our innovators in creative ways to protect and commercialize these new technologies while catalyzing startups and also identifying licensing partnerships with companies to develop products and services.”

Protecting & Licensing DI

Digital Innovations can be protected under different types of intellectual property laws, with each affording a different type and level of legal protection. Computer programs (source code, object code, scripts), screen materials, and databases may be protected under copyright laws, or even maintained as proprietary information (universities generally do not have trade secrets).

Certain methods and algorithms underlying software could be patentable, and although trademarks don’t necessarily protect the technology, they could protect the names or symbols that make the technology-based product or service unique within a market.

Intellectual property due diligence and selecting the optimal model for licensing software can be a critical determination that can drive business and provide the right protection for intellectual property rights. OLV’s knowledge and expertise in these areas help to guide innovators down the right path.

“OLV was open to discussing different licensing options for the software developed at Duke and, in the end, both Quadridox and Duke walked away happy with the terms and a newly established partnership,” said Joel Greenburg, President and CEO of Quadridox, a software spinout company specializing in the use of X-ray physics to develop real-world solutions in the security arena, such as airport screening.

Greenburg, a Pratt School of Engineering Associate Research Professor of Electrical and Computer Engineering, further stated, “We are particularly excited about leveraging the mentorship opportunities available to Duke spinout companies.”

OLV’s Duke New Ventures (DNV) is a 2-year-old initiative that helps new start-ups think through opportunities, craft a business plan, and connect with the management, mentors, and investors to ensure the success of the new venture.

DNV’s Mentors-in-Residence program involves using seasoned entrepreneurs to bring their insights, experiences, and numerous connections to nascent companies. One example is assistance given to Duke software startup, Gavilán Biodesign, that has pioneered an algorithm to anticipate and overcome drug resistance.

“Duke’s tech transfer team helped us every step of the way as we moved from academic researchers to entrepreneurs. Our first meetings with OLV got us early investor conversations and even one of our first partnerships,” said Jonathan Jou, co-founder of Gavilán.

Digital Health and Health IT at Duke

DI has been driving a revolution in the health care industry. At Duke, most of the DI disclosures are in the field of digital health and Healthcare IT. From SaMD and digital therapeutics to clinical decision support tools and screening tools that improve clinical decisions, DI is empowering both clinicians and patients to make better decisions in health care.

However, these improvements are not without their challenges, especially when thinking beyond the campus and our hospitals.

“The challenge with health care innovations is achieving dissemination and scale. OLV helped us translate a good idea to improve patient care at Duke into a sustainable idea that could improve patient care across the world,” said Arif Kamal, CEO of Prepped Health, a Duke start-up that created a mobile health platform to help patients prepare for their journey with serious illness.

There is tremendous growth in digital health and healthcare IT innovations. Duke is uniquely positioned to help reshape the technology landscape in health care, especially with the move towards value-based healthcare delivery and the need to measure healthcare outcomes.

The University’s transdisciplinary teams of innovators work closely with OLV during the technology development process. Together they identify and select optimal approaches to protect intellectual property and map commercialization pathways, while improving adoption of digital solutions that support our clinicians in providing the best care to our patients.

Last year, Duke Health developed and deployed Sepsis Watch, an augmented intelligence solution for early detection of sepsis. “We needed help to scale our technology beyond Duke. OLV was instrumental in securing our licensing deal with Cohere Med, thus helping this Duke-developed technology to reach global markets and have a broader impact,” said Suresh Balu, Director of the Duke Institute for Health Innovation (DIHI). “With strong support from OLV, we continue to explore a partnership model with Cohere Med.”

There are additional factors to consider when developing digital health ideas at Duke, such as conflict of interest questions–data sensitivity of patient health records or personal information.

“There are many privacy and information security questions you’ll need to think through, especially with regard to data obtained from Duke. However, OLV has developed relationships across campus and outside to help you navigate these processes,” said Divakaran.

Digital Innovation has come a long way since the 1990s and we’re on an accelerated path of innovation growth.  With greater connectivity, we can access a greater amount of data, providing us with better decisions.

“From our relationships formed on campus to partnerships formed off, Duke is taking cutting edge technologies to the forefront of the innovation ecosystem,” said Robin Rasor, Executive Director of OLV. “We are leading the way to transfer Duke’s knowledge and expertise with the clear goal of reaching the public market for the benefit society.”

PRESS RELEASE: 3 JULY 2019

Sepsis strikes more than a million Americans every year and 15 to 30 percent of those affected die. Caused by an overwhelming immune response to infection, sepsis rates have steadily been on the rise in the country. This is a major challenge in hospitals, where it is one of the leading causes of death. It is also a main reason why people are readmitted to the hospital. Sepsis occurs unpredictably and can progress rapidly. It often involves a prolonged stay in the intensive care unit and complex therapies with high costs. Sepsis as the most expensive condition treated in U.S. hospitals, costing nearly $24 billion in 2013.

Late last year, Duke Health developed and deployed an Artificial Intelligence (AI) system for early detection of sepsis. “Significant progress has been made since then to validate the accuracy of the model that we developed,” said Suresh Balu, Director of the Duke Institute for Health Innovation (DIHI). “With a deep learning model ingesting over 50,000 patient records and more than 32 million data points, we are able to identify patients at risk for developing sepsis with greater than 90% accuracy,” he added. Traditional scoring mechanisms such as NEWS, SIRS, and QSOFA usually start with high detectability from the time a patient presents to Emergency Department (ED) but their accuracy decrease over time making detectability of sepsis harder with a large number of false positives.

To scale the solution further across the globe, Cohere Med, a clinical analytics company based in the US and India has licensed technology from Duke University. Cohere Med’s CoMeT- Coherence of Medical Things® platform is built to deploy enterprise-class AI solutions for health systems in critical care. CoMeT further is expected to enhance the technology with real-time processing of events using internet of things (IoT) for high fidelity clinical data, interoperability standards such as Fast Healthcare Interoperability Resources (FHIR), electronic medical records (EMR) extensions to ease the integration of sepsis detection, and management into already installed information systems along with a host of other deep learning-based algorithms. “Identifying and predicting patient decompensation for critically ill is a key focus area as we bring in high fidelity information across systems together in real-time,” said Srikanth Muthya, CEO, Cohere Med.

For more information: www.cohere-med.com and contact@cohere-med.com

References:

https://www.nigms.nih.gov/education/pages/factsheet_sepsis.aspx#1

https://www.beckershospitalreview.com/quality/duke-university-hospital-to-roll-out-ai- system-for-sepsis.html

PhaseBio is a clinical-stage biopharmaceutical company founded by Duke inventors Drs. Chilkoti and Setton. Committed to developing new and improved biotherapeutics for the treatment of serious rare diseases, their proprietary technology platform uses recombinant elastin-like polypeptide (ELP) biopolymers to control the half-life, bioavailability and physical characteristics of molecules for ease of administration.

In Sept. 5, the company announced the closure of a Series D financing round worth $34 million, with participation from new investors Cormorant Asset Management, Rock Springs Capital and Mountain Group Partners. Existing investors include New Enterprise Associates, Hatteras Venture Partners, AstraZeneca, Johnson & Johnson Innovation – JJDC, Syno Capital and Fletcher Spaght Ventures.

Three days after the S-1 filing, the company announced positive results from the Phase I study of PB2452, a reversal agent for the antiplatelet drug ticagrelor, a drug used in patients with acute coronary syndrome to reduce the rate of cardiovascular death, heart attack and stroke. The trial was a safety study in healthy volunteers and showed PB2452 achieved rapid, complete and sustained reversal of ticagrelor’s activity, with potential for customizable duration of reversal based on dosing regimen.

PhaseBio in-licensed the drug from AstraZeneca last year, announcing a global license agreement with MedImmune, the latter company’s biologics research and development arm, where the drug had been developed under the name MEDI2452. The drug is a fragment antigen-binding antibody fragment that the company said is designed to rapidly reverse ticagrelor’s antiplatelet effects in emergency situations. While approved for reducing the rate of cardiovascular events, ticagrelor’s label also carries a boxed warning stating that, like other antiplatelet agents, it can cause significant and sometimes fatal bleeding.

PhaseBio’s lead product candidate is PB1046, in Phase IIb testing for PAH, with data expected in the first half of 2020.

On Wednesday, May 1^st, over a dozen venture capital firms gathered for the first Duke Venture Day at the newly refurbished Chesterfield Building in downtown Durham.

The day-long event showcased therapeutic innovations currently coming out of Duke. This year’s goal was to engage the venture investing community in the drug and biotech arena to advance fundable ideas and develop deeper connections with Durham.

“What we’re seeing is more and more biotech investors interested in exploring outside the traditional biotech hubs of Boston and the Bay Area,” said Rob Hallford, Director of Duke New Ventures. “Duke Venture Day is about raising the profile of not just Duke spin-outs, but the Triangle in general as a place to find exciting new companies and put capital to work.”

Eight Duke start-up investment opportunities were presented at the Venture Day–from highly targeted radiotherapy for brain metastasis to therapies for ocular graft-versus-host disease.

As a former cigarette factory turned medical and engineering research lab, The Chesterfield set the stage to promote Durham’s transformation from a tobacco town to an innovation hub. Additionally, with a fishbowl-like view right off the open atrium, the NC Biolabs easily elucidated how its shared lab facilities can help launch a newly formed start-up from just a single bench.

The Biolabs currently has 36 start-ups working in the shared lab space, 15 of them are Duke newcos. An early tenant and Duke spinout, Element Genomics, has already had a successful exit, having been acquired by UCB for $30 million.

Entrepreneur turned venture capitalist, Clay Thorp from Hatteras Venture Partners was on hand to moderate a panel on Doing Biotech Business in North Carolina. Panelists included Mark Velleca from G1 Therapeutics, Meg Booth Powell from TARGET Pharmasolutions, and Matt Kane from Duke start-up Precision Biosciences.

“I firmly believe that Durham’s unique combination of a highly skilled community and relatively low cost of doing business, makes it the ideal place to start and build a biotechnology company,” said Matt Kane, CEO and co-founder of Precision Biosciences.

Precision, a genome editing company dedicated to improving life through its proprietary ARCUS genome editing platform located in downtown Durham, recently went public last month raising over $145M.

MEET THE FEATURED INNOVATORS

Each of the presenting start-up companies had the opportunity to speak in front of venture capitals, both local and from as far north as Boston.

Cereius, which aims to improve the lives and survival of patients facing solid tumor brain metastasis through the use of personalized and highly targeted radiotherapy, was presented by Michael Zalutsky, Professor of Neuro-Oncology Research and a Professor in the Departments of Radiology, Radiation Oncology, Pathology and Biomedical Engineering

Gavilán Biodesign, founded out of Bruce Donald’s laboratory in Computer Science, Chemistry, and Biochemistry, was recently selected as one of 11 early-stage biotech companies at the Silicon Valley biotech accelerator, IndieBio. Their technology combines state of the art physics-based modeling with a unique high accuracy AI platform to computationally screen trillions of molecules in order to find therapeutics that can overcome resistance.

Tellus Therapeutics, founded by neonatologist Eric Benner, is developing novel small molecules derived from human maternal breast milk demonstrated to induce regeneration of myelin-producing oligodendrocytes and reverse white matter injury in animal models of perinatal brain injury.

Cellective BioTherapy, founded by veteran entrepreneur and noted immunologist Tomas Tedder, is developing first-in-class regulatory B10 cell-based immunotherapies for treating cancers, autoimmunity, and immunodeficiency that can either enhance or inhibit immune responses as needed for disease treatment.

Sisu Pharma, Inc. recently founded by Dennis Thiele, Professor of Molecular Genetics & Microbiology and Jiaoti Huang, Chair for the School of Medicine’s Department of Pathology, is developing drugs against a new target to treat prostate cancer in patients who have exhausted all therapeutic options.

Mastezellen Bio, Inc., started by fellow pathologists, Herman Staats and Soman Abraham, is developing novel therapeutics to inhibit mast cell activation, potent proinflammatory cells that cause symptoms of allergy and anaphylaxis in a wide range of disease states such as adverse drug reactions, food allergy, mastocytosis, and seasonal rhinitis.

Basking Bio, founded by endovascular neurosurgeon and research scientist, Shai Nimjee, is developing a drug-antidote pair for treatment of patients with ischemic stroke using technologies founded out of Duke Professor of Surgery, Bruce Sullenger’s Cardiovascular Biology Lab.

Pulsar Life Sciences is another company started by ophthalmologist Scott Cousins developing an eye drop formulation for the treatment of inflammatory dry eye disease, including ocular graft versus host disease that occurs after hematopoietic stem cell transplantation.