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Seelos Therapeutics Reports Q1 2019 Pipeline Update

On May 21, 2019 Seelos Therapeutics, Inc. (NASDAQ: SEEL), a clinical-stage biopharmaceutical company, provided an update on its pipeline (Press release, Apricus Biosciences, MAY 21, 2019, View Source [SID1234536499]).

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"We have made tremendous progress in our acquired programs as we are finalizing the phase 2b/3 design for Sanfilippo under a Seelos IND for SLS-005 and have initiated the in-vivo studies for SLS-007," said Raj Mehra, Ph.D., CEO of Seelos Therapeutics. "Additionally, due to the complex nature of the merger accounting, our first quarter financial report is taking longer than we anticipated but we wanted to update the street on our clinical and pre-clinical progress in the first quarter."

First Quarter Corporate Highlights

On January 24th, Seelos Therapeutics completed its merger with Apricus and began trading under the symbol "SEEL" on the NASDAQ. Seelos completed a capital raise in conjunction with the merger. Proceeds received at the closing were approximately $18 million, prior to payment of transaction costs.
In February, Seelos acquired the worldwide development and commercial rights to Bioblast’s proprietary Trehalose 90 mg/mL IV solution and all inventory of the drug. Seelos has named this program SLS-005.
In addition, in February, Seelos assumed a collaborative agreement with Team Sanfilippo Foundation (TSF) as part of the aforementioned acquisition.
In March, Seelos acquired a license to technology developed at UCLA that relates to a family of rationally-designed peptide inhibitors that target the aggregation of alpha-synuclein (α-synuclein). Seelos has named this program SLS-007.

Update on Pipeline Development

Seelos will webcast its presentation at the Jefferies 2019 Healthcare Conference at 8am (ET) on Friday, June 7th. Investors can access this presentation using this link:
View Source
SLS-002 (intranasal racemic ketamine)
In line with our investigational new drug (IND) program, preparations are underway to initiate our phase I in Q3 2019 to further evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) of SLS-002 in patients with post-traumatic stress disorder (PTSD) at imminent suicide risk (suicidality).
SLS-005 (Trehalose)
Seelos is finalizing the protocol for an FDA/EMA open-label phase IIb/III trial in Sanfilippo syndrome type A and B patients.
Based on an overwhelming response from the Sanfilippo community worldwide, TSF, in collaboration with Seelos Therapeutics, has decided to expand inclusion of Sanfilippo type C and D patients as well as type A and B patients who do not meet the trial entry criteria into a separate expanded patient access study.
SLS-007 (Peptidic inhibitors)
Seelos has initiated this peptide-based approach targeting the NACore (nonamyloid component core) in Parkinson’s Disease (PD) in a proof of concept, in-vivo delivery of SLS-007 in a PD transgenic mice model in Q2 2019.

Anixa Biosciences to Present at the Sachs Associates 5th Annual Immuno-Oncology BD&L and Investment Forum

On May 21, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system to fight cancer, reported that it will be presenting at the Sachs Associates 5th Annual Immuno-Oncology BD&L and Investment Forum to be held May 31, 2019 in Chicago (Press release, Anixa Biosciences, MAY 21, 2019, View Source [SID1234536498]).

Mike Catelani, COO and CFO of Anixa, will provide an overview of the company, its most recent accomplishments and upcoming milestones, with a focus on its chimeric endocrine receptor t-cell (CER-T) treatment for ovarian and other cancers. Management will also be available for one-on-one meetings with investors who are registered to attend the conference.

Details of Anixa’s presentation are as follows:

Event:

5th Annual Immuno-Oncology: BD&L and Investment Forum

Date:

Friday, May 31, 2019

Time:

12:10 p.m.

Location:

PR Track A – Room Sinclair Ballroom

Waldorf Astoria Chicago, Chicago, IL

The 5th Annual Immuno-Oncology BD&L and Investment Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment.

Protalix BioTherapeutics Appoints Dror Bashan as its New President and Chief Executive Officer and Director

On May 21, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX) reported that Dror Bashan has been appointed to serve as the Company’s new President and Chief Executive Officer, and a director, effective June 30, 2019, replacing Moshe Manor, who is stepping down from those roles for personal reasons (Press release, Protalix, MAY 21, 2019, View Source;p=RssLanding&cat=news&id=2399232 [SID1234536497]). Mr. Manor will assist with the transition and continue to work with the Company on a consultant basis.

"Dror brings valuable experience and knowledge in the pharmaceutical industry to our Company, and I am happy to welcome him to Protalix," said Shlomo Yanai, Chairman of Protalix’s Board of Directors. "Moshe has made a great contribution to our organization over the last four years, and has played a critical role in our development and success in advancing our pipeline. On behalf of Protalix and the Board of Directors, I would like to thank Moshe for his significant contributions and outstanding leadership and wish him great success in his future endeavors."

"I have the deepest gratitude to Protalix’s employees and its Board of Directors. I have decided that, for personal reasons unrelated to the Company, the time has come to hand over leadership to a new chief executive officer," said Mr. Manor. "I am very honored to have led this great organization and will continue to watch with excitement and anticipation as Protalix progresses in the development and commercialization of its promising pipeline."

"I am very proud to become Protalix’s President and Chief Executive Officer, and am looking forward to working with such a talented management team to continue the progress of Protalix’s future development," said Mr. Bashan. "I believe that my broad experience in the pharmaceutical industry, which covers a range of disciplines in the field, will be a valuable resource for the company. I am very excited about the potential path forward and glad to be part of Protalix’s future."

Mr. Bashan has over 20 years of experience in the pharmaceutical industry with roles ranging from business development, marketing, sales and finance providing him with both cross regional and cross discipline experience and a deep knowledge of the global pharmaceutical and health industries. From 1998 through 2018, he served in a number of senior positions at Teva Pharmaceutical Industries Ltd. Most recently, he served as Teva’s Senior Vice President, Global Business Development, and was involved in strategic alliances, cross-company strategic projects and the acquisition and divestiture of assets. Mr. Bashan holds a BA in Economics and Business Management from the Tel Aviv University in Tel Aviv, Israel, and an MBA from the Tel-Aviv University.

STORM Therapeutics extends Series A to GBP 30M (USD 38.43M) with new investor, Seroba Life Sciences

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]).

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.

Can-Fite BioPharma Announces $6 Million Registered Direct Offering

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]).

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.