On February 7, 2020, Integra LifeSciences Holdings Corporation ("Integra") reported that it completed a private unregistered offering of $575 million aggregate principal amount of its 0.50% Convertible Notes due 2025 (the "Notes"), which amount includes the full exercise of the initial purchasers’ option to purchase additional Notes (Filing, 8-K, Integra LifeSciences, FEB 7, 2020, View Source [SID1234554049]).

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The net proceeds from this offering were approximately $558.4 million, after deducting the initial purchasers’ discounts and commissions and the estimated offering expenses payable by Integra. Integra used approximately $59.7 million of the net proceeds to pay the cost of the convertible note hedge transactions described below (after such cost was partially offset by the proceeds to Integra from the warrant transactions described below).

Integra used $100 million of the net proceeds from this offering to repurchase shares of Integra’s common stock, par value $0.01 per share ("Common Stock"), including approximately $7.6 million from certain purchasers of Notes in privately negotiated transactions effected through one of the initial purchasers as Integra’s agent concurrently with the completion of this offering and approximately $92.4 million through an accelerated share repurchase program, which Integra entered into with JPMorgan Chase Bank, National Association, New York branch on February 5, 2020, as described below. Integra expects to use the remainder of the net proceeds for general corporate purposes, which may include repayment of a portion of the indebtedness under Integra’s senior credit facility.

On February 7, 2020 An innovative approach to tackling the challenges of pediatric sarcomas is being pursued by researchers at St. Jude Children’s Research Hospital (Memphis, Tennessee) with a new grant from Alliance for Cancer Gene Therapy (ACGT) (Press release, ACGT Alliance For Cancer Gene Therapy, FEB 7, 2020, View Source [SID1234554033]).

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The $500,000 ACGT grant supports Stephen Gottschalk, MD, chair of Bone Marrow Transplantation and Cellular Therapy at St. Jude’s, in exploring the use of genetically engineered immune cells to attack pediatric sarcoma. Dr. Gottschalk and his team target not only the cancer, but the blood vessels supporting tumor growth. Dr. Gottschalk has conducted more than 25 previous clinical trials and most recently worked on gene therapies for treating infants with the "bubble boy" disease.

"There is an urgent need to develop meaningful treatments for children with solid tumors," says Kevin Honeycutt, CEO and president of ACGT. "Dr. Gottschalk’s research combines state-of-the-art technologies and methodologies to attack two targeted gene proteins found in pediatric sarcomas. The members of the ACGT Scientific Advisory Council are enthusiastic about Dr. Gottschalk’s vision and very promising preliminary data."

"Pediatric sarcoma, which comes back after initial therapy or is present at multiple sites, is difficult to treat even with the most aggressive, currently available therapies," noted Dr. Gottschalk. "Because Sarcomas are a relatively uncommon group of cancers, accounting for about 15 percent of childhood cancers, improving outcomes has been challenging. This ACGT grant enables me to further investigate how we can leverage different proteins to attack not only abnormal sarcoma cells but also the blood vessels that provide nutrients to tumors. We’ve seen this approach work in mice. Given the resources from ACGT, we can move ahead much faster to complete all the preclinical studies that are needed to evaluate our approach in the clinic."

Dr. Savio Woo, chairman emeritus of the ACGT Scientific Advisory Council and recently retired from the Icahn School of Medicine at Mount Sinai (New York, New York), dedicated his career to the pursuit of fundamental science and technology development in gene and cell therapy, and translating those laboratory advances into direct patient benefit. Dr. Gottschalk, who did a post-doctoral session with Dr. Woo from 1992 to 1995, acknowledges that it was Dr. Woo’s commitment to ACGT that drove his quest to secure a grant from the organization.

"Being connected to the organization that Dr. Savio Woo helped direct on the scientific side, is a great honor," said Dr. Gottschalk.

To learn more about Alliance for Cancer Gene Therapy (ACGT), visit acgtfoundation.org, call 203-358-5055, or join the ACGT community on Facebook, Twitter, Instagram and YouTube. To learn more about St. Jude Children’s Research Hospital, visit stjude.org or follow St. Jude on social media at @stjuderesearch.

On February 7, 2020 UCLB spinout companies Odin Vision and Echopoint Medical reported that received awards at the 2019 SEHTA MedTech Business Awards on Thursday 6 February, alongside guest speaker Dr Eric Mayes, CEO, Endomag (Press release, UCLB, FEB 7, 2020, https://www.uclb.com/2020/02/07/two-uclb-spinout-companies-announced-winners-at-the-2019-sehta-medtech-business-awards/ [SID1234554050]).

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Echopoint Medical took home the Investment of the Year Award. This was for their achievements in receiving equity investment from UCL Technology Fund and Parkwalk Advisors, as well as significant InnovateUK grants to develop their technology. The spinout is developing optical sensing technology to help heart disease patients in a grey zone where the need for treatment is unclear.

Odin Vision, a spinout arising from the UCLB Portico Ventures Programme, took home the Start-Up Award and was named as a runner up in the Investment of the Year category. The AI start-up is using advanced computer vision and machine learning to help clinicians improve the detection and treatment of colorectal cancers during endoscopic procedures.

As winners of 2019 SEHTA MedTech Business Awards, both spinouts will be entered into the national Medilink UK Awards taking place on 1st April.

On February 6, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development and a developer of liquid biopsies reported consolidated financial results for the fiscal first quarter ended December 31, 2019 (Press release, Applied DNA Sciences, FEB 6, 2020, View Source [SID1234553927]).

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"During our fiscal first quarter, we made meaningful progress on our strategic priorities for fiscal 2020 to position the company for long-term growth while raising capital to support our growth strategy. Our revenue performance reflects a difficult comparison to the year-ago period, which included revenue related to a Department of Defense contract since completed, as well as our historical revenue pattern that troughs in the first quarter and builds over the balance of the year," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"In our biotherapeutics business that utilizes our proprietary linear DNA production platform for application in adoptive cell therapies; DNA vaccines, such as cancer vaccines; CRISPR and other nucleic acid-based therapies, we continued to build proof points for a new paradigm in linear DNA production with our patented PCR processes ahead of traditional plasmids production. During the quarter, we signed an agreement with Tyme Technologies for our Vita-AssayTM invasive Circulating Tumor Cell ("iCTC") capture assay and services that enable Tyme to monitor disease progression in its pivotal trial for metastatic pancreatic cancer. In our industrials business that utilizes the same platform to illuminate supply chains in large commercial ecosystems for authenticity and traceability, the launch of Colorcon’s on-dose authentication platform powered by our taggant technology demonstrates execution of our pharmaceutical strategy to partner with Colorcon, who will be marketing the platform to its expansive customer base. Strategic progress has continued in this sector into our fiscal second quarter with our entry into the nutraceuticals market with a multi-year CertainT contract with Nutrition 21."

Concluded Dr. Hayward, "Looking ahead, we are placing greater emphasis on positioning our platform for biotherapeutic and diagnostic applications where there is a growing imperative for our capabilities while also nurturing key industrials applications to commercial-scale deployments. Our recently acquired liquid biopsy technology – the iCTC liquid biopsy platform – we believe allows us to detect primary cancer tumors often before they are visible to other diagnostic technologies, when preventive care for impending cancer may still be an option. Our iCTC platform is potentially transformative to cancer care, and our relationship with Tyme establishes a partnering model that is applicable to other companies pursuing therapies for such cancers as breast, pancreatic, ovarian, colorectal, among others, that we are actively pursuing."

Fiscal First Quarter 2020 Financial Results:

·Revenues decreased 28% for the first quarter of fiscal 2020 to $634 thousand, compared with $884 thousand reported in the same period of the prior fiscal year and decreased 62% from $1.7 million for the fourth quarter of fiscal 2019. This decrease in revenue year over year is due to a decrease of $167 thousand in service revenue and a decrease of $84 thousand in product revenues. The decrease in service revenues was primarily attributable to a decrease from a government contract award that ended during fiscal 2019. The decrease in product revenues was primarily related to a decrease of approximately $200 thousand in textiles, related to a cotton customer offset by an increase of $135 thousand in biopharmaceutical revenues.

·Total operating expenses decreased to $3.0 million for the first fiscal quarter of 2020, compared with $3.9 million in the prior fiscal year’s first quarter. This decrease was primarily attributable to an approximate $352 thousand decrease in payroll and a decrease of $93 thousand in consulting fees, which are both due to a realignment of the sales force and reductions in overall headcount. In addition, there was a decrease of $285 thousand in stock-based compensation expense and a reduction of $145 thousand in research and development expenses.

·Net loss for the quarter ended December 31, 2019 was $2.7 million, or $1.12 per share, compared with a net loss of $3.2 million, or $4.25 per share, for the quarter ended December 31, 2018, an improvement of 18%, and a net loss of $1.2 million, or $1.44 per share, for the quarter ended September 30, 2019.

·Excluding non-cash expenses, Adjusted EBITDA was negative $2.4 million and a negative $2.6 million for the quarters ended December 31, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

·On February 5, 2020, Applied DNA entered into an amendment to its existing joint development agreement with Takis S.R.L and Evvivax S.R.L.to include pre-clinical development of a potential linear DNA vaccine against 2019-nCoV, the new coronavirus;

·On January 27, 2020, Applied DNA bolstered its patent portfolio when the U.S. Patent and Trademark Office granted it a U.S. patent that covers methods of tagging man-made cellulosic fibers or materials during production and later authenticating the fiber or materials to confirm provenance and/or authenticity. This newly issued patent extends the Company’s addressable market within textiles to include cotton, synthetic fibers and materials, and, now, man-made cellulosic fibers and materials;

·On January 13, 2020, the Company announced a licensing agreement with LifeSensors, Inc. whereby it will incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications. The Company believes that the incorporation of the SUMO-fusion technologies into Applied DNA’s linear amplicons may further optimize protein expression and deliver yet another strength to linear DNA; and

·On December 23, 2018, Colorcon, Inc., a world leader in the development and supply of film coating systems and excipients for pharmaceuticals, formally launched its On-Dose Authentication capability utilizing the Company’s technology to provide track and trace functionality for supply chain security. Applied DNA’s molecular taggants are integrated into Colorcon’s Opadry film coating system to significantly reduce the risks associated with the global problem of counterfeit and falsified medications entering the supply chain.

Fiscal First Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal first quarter-end 2020 results on Thursday, February 6, 2020 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free:1-844-887-9402

·Participant Toll: 1-412-317-6798

·Please ask to be joined to the Applied DNA call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through February 7, 2020):

·Participant Toll Free: 1-877-344-7529

·Participant Toll: 1-412-317-0088

·Participant Passcode: 10138146

·Webcast replay: View Source

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source

On February 5, 2020 Genprex reported that after receiving the US Food and Drug Administration’s fast track designation last month for its immunogene therapy Oncoprex in combination with the EGFR tyrosine kinase inhibitor (TKI) osimertinib (AstraZeneca’s Tagrisso), the clinical-stage gene therapy company is prioritizing development of this therapy combination for EGFR-mutated non-small cell lung cancer and will start enrollment in Phase I/II clinical trials in mid-2020 (Press release, Genprex, FEB 5, 2020, View Source [SID1234553943]).

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Enrollment will start after the FDA accepts Genprex’s amendment to its investigational new drug application.

The company also said last month that it intends to start a new Phase I clinical trial investigating Oncoprex in combination with a checkpoint inhibitor. This is supported by preclinical studies indicating that TUSC2 increases the effectiveness of anti-PD1 checkpoint blockade combined with chemotherapy for lung metastases with KRAS and LKB1 mutations in mice.

Oncoprex is Genprex’s lead product candidate and it uses the active agent TUSC2 (Tumor Suppressor Candidate 2) gene combined with a lipid nanovesicle. TUSC2 has been shown to disrupt replication and proliferation of cancer cells, re-establish programmed cell death, as well as modulate the immune response against cancer cells. It’s also been observed to block mechanisms that create drug resistance.

Additionally, the company is putting its current Phase I/II trial investigating Oncoprex in combination with EGFR inhibitor erlotinib (Genentech/Roche’s Tarceva) ─ which provided support for the fast track designation ─ on hold, citing the reason that osimertinib is now considered the new standard of care of NSCLC patients with an EGFR mutation. Genprex has treated more than 50 lung cancer patients with Oncoprex in Phase I/II trials.