On May 20, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported new data demonstrating that its next-generation Percepta Genomic Sequencing Classifier (GSC) provides expanded lung cancer risk information that can further guide next steps for patients with lung nodules (Press release, Veracyte, MAY 20, 2019, View Source [SID1234536483]).

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Researchers prospectively validated the Percepta GSC on 412 patients with lung nodules who had inconclusive results following bronchoscopy, a common nonsurgical procedure to diagnose lung cancer. Among patients with an "intermediate" pre-test risk of cancer – the group that accounts for the majority of lung nodules – the Percepta GSC demonstrated high accuracy when it down-classified patients to "low risk" for cancer (negative predictive value of 91 percent). The test also had a positive predictive value (PPV) of 65 percent when it up-classified patients to "high risk" for cancer. The American College of Chest Physicians recommends patients with a cancer risk of 65 percent or greater undergo surgical treatment.

The new findings will be shared this evening at a company event being held during the American Thoracic Society 2019 International Conference(ATS 2019) in Dallas.

"Determining whether lung nodules are benign or cancerous is often difficult, which can lead to unnecessary invasive procedures and treatment delays," said Giulia C. Kennedy, Ph.D., chief scientific and medical officer of Veracyte. "With its ability to both down-classify and up-classify patients with inconclusive lung nodules, the Percepta GSC should help physicians avoid invasive biopsies in patients who are at low risk of lung cancer, while helping to guide intervention steps for those at high risk."

The Percepta GSC utilizes novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is also Veracyte’s third clinical classifier to be developed on the company’s novel RNA whole-transcriptome sequencing and machine learning platform. Veracyte plans to begin making the Percepta GSC available to physicians by the middle of 2019.

"We are excited to unveil our Percepta GSC, which we believe will improve diagnosis and treatment decisions for patients undergoing evaluation for lung cancer," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Additionally, we believe that moving the Percepta classifier to our RNA whole-transcriptome sequencing platform – together with our Afirma and Envisia classifiers – will provide operational efficiencies and a robust foundation for continued innovation. This includes our development of the first nasal swab test for early lung cancer detection."

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking. Veracyte estimates that approximately 350,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 70 percent of these produce inconclusive results.

Also during the ATS 2019 conference, Kevin Flaherty, M.D., of the University of Michigan Health System, will present clinical utility data demonstrating that Veracyte’s Envisia Genomic Classifier improves diagnosis of idiopathic pulmonary fibrosis (Session D12, Abstract A5837). These data were published online in The Lancet Respiratory Medicine on April 1, 2019.

On May 20, 2019 STORM Therapeutics ("STORM"), the drug discovery company tackling disease through modulating RNA modifying enzymes, reported that it has raised an additional £14 million bringing the total Series A financing to £30 million (Press release, STORM Therapeutics, MAY 20, 2019, View Source [SID1234561042]).

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The financing includes funding from new investor, Seroba Life Sciences ("Seroba"). STORM’s existing investors, Cambridge Innovation Capital, M Ventures, Pfizer Ventures, Taiho Ventures and IP Group also participated in the fundraise.

This extension follows the company’s rapid progress to date. It will enable STORM to advance its broad pipeline further in preclinical development and accelerate its programmes towards the clinic, supporting STORM’s growth as the leading drug discovery company working on RNA modulating enzymes.

STORM has strengthened its team with the appointment of Dr Mark Albertella as VP Translational Oncology. Mark was previously Director of Biology at Medivir AB and has a successful track record in oncology drug discovery and development at Argenta, OSI Pharmaceuticals, Kudos and AstraZeneca, with over 20 years’ experience in biotech and pharma industry in the UK, US and Europe.

Commenting on the fundraising, Dr Keith Blundy, CEO of STORM Therapeutics, said: "I am pleased to welcome Seroba to our investor syndicate and I would like to thank our existing investors for their continued support. This investment strengthens our Series A and provides further validation and support for STORM’s strategy to continue building a world-leading company harnessing the power of RNA epigenetics – an emerging, innovative area of drug discovery. It comes at an exciting stage as STORM starts translating its unique platform into effective treatments in oncology and beyond. Mark’s expertise in cancer drug discovery and development, encompassing in vitro and in vivo biology, translational and clinical research, will be invaluable to STORM as it progresses its pipeline towards the clinical stage."

Bruno Montanari, Partner at Seroba, added: "We have been closely following the RNA space for some time tracking a number of key players. We believe STORM is maintaining its first-mover advantage in RNA epigenetic modulation and is progressing rapidly in its development, making this an exciting time for us to partner with management and co-investors. We continue to be impressed by the quality and depth of STORM’s science and the significant progress made by the team to advance its platform and pipeline in this fast-moving area of emerging biology."

STORM Therapeutics CEO Keith Blundy will be presenting at the BioEquity Europe 2019 meeting in Barcelona. STORM will present at 9am CEST on Tuesday 21st May as part of the Next Wave sessions.

On May 20, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the International Liver Cancer Association (ILCA) has accepted Can-Fite’s abstract describing the latest data from the Company’s Phase II Liver Cancer study of Namodenoson for an oral presentation at its annual conference (Press release, Can-Fite BioPharma, MAY 20, 2019, View Source [SID1234536467]). The oral presentation titled "The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled" will be delivered on September 22, 2019 during the Novel Targets and Prognostic Markers Session from 11:00 am to 12:30 pm. The ILCA’s 13th Annual Conference will take place from September 20 to 22, 2019 in Chicago, Illinois.

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The ILCA is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines. Its mission is to lead a global community of physicians, scientists and allied professionals through education and research with the goal to better prevent and treat liver cancer.

"This is a very prestigious conference that brings together the leading thought leaders, researchers, and physicians in the treatment of liver cancer. Governing members of the ILCA thoroughly research each abstract submission and select those that are most relevant to the advancement of treating liver cancer. We are pleased that the selection committee sees the potential of Namodenoson as a treatment for advanced liver cancer patients with severe liver dysfunction. Based on both safety and efficacy in this Phase II study, Can-Fite is preparing a Phase III trial," stated Can-Fite CEO Pnina Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On May 20, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported development updates regarding the Company’s lead compound for OM, AG013 (Press release, Oragenics, MAY 20, 2019, View Source [SID1234536484]). These developments include the enrollment of over 80 patients in the Company’s Phase 2 clinical of AG013 and, in addition, the World Health Organization has provided the Company with the generic name of dapatifagene navolactibac for the AG013 compound.

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"We continue to increase the number of clinical sites across the globe with 48 of the 61 identified clinical sites actively enrolling patients for our Phase 2 clinical trial of AG013," stated Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics, Inc. "In the meantime, we are pleased to have an agreed upon generic designation for AG013, which will now also be referred to as dapatifagene navolactibac, to allow us a more specific way of referring to the compound moving forward. We anticipate providing further updates as developments warrant."

The ongoing Phase 2 trial is a double-blind, placebo-controlled, two-arm, multi-center trial, in which approximately 200 patients will be randomized in a 1:1 ratio to receive either dapatifagene navolactibac or placebo. The purpose of the study (NCT03234465) is to evaluate the safety, tolerability and efficacy of topically administered dapatifagene navolactibac compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer. Key measures include duration, time to development, and overall incidence of OM (using a World Health Organization scale) during the active treatment phase, which begins from the start of chemoradiation therapy and ends two weeks following its completion.

Dapatifagene navolactibac, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an Intrexon Actobiotics therapeutic candidate formulated to deliver the therapeutic molecule, human Trefoil Factor 1, to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in these tissues’ subsequent regeneration. The compound was designed by the Company’s strategic partner, Intrexon Actobiotics NV, a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON) whereby Oragenics, Inc. holds an exclusive world-wide license.

On May 20, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with certain institutional investors to receive gross proceeds of $6 million (Press release, Can-Fite BioPharma, MAY 20, 2019, View Source [SID1234536504]).

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In connection with the offering, the Company will issue 1,500,000 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $4.00 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $4.00 per ADS, will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about May 22, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.