Halozyme To Participate In 2019 Wells Fargo Healthcare Conference

On August 26, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Wells Fargo Healthcare Conference in Boston, MA (Press release, Halozyme, AUG 26, 2019, View Source [SID1234538971]). Dr. Helen Torley, president and chief executive officer, will provide an overview of the company on Wednesday, September 4 at 10:50 a.m. ET / 7:50 a.m. PT.

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

Ivy Brain Tumor Center and Salarius Pharmaceuticals Launch Collaborative Partnership to Develop New Cancer Treatment for Glioblastoma

On August 26, 2019 The Ivy Brain Tumor Center at the Barrow Neurological Institute and Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), reported a collaborative partnership to test Salarius’ therapeutic candidate, Seclidemstat, for the treatment of glioblastoma (Press release, The Ivy Brain Tumor Center, AUG 26, 2019, View Source [SID1234538970]). The organizations will launch what they believe is the most comprehensive pre-clinical study to date, evaluating the effect of targeting LSD1 (lysine-specific histone demethylase 1A), a key enzyme that has increased expression in tumors of brain cancer patients.

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Seclidemstat is a reversible LSD1 inhibitor that works by inhibiting LSD1’s enzymatic and protein-scaffolding functions. It is currently being tested by Salarius in a Phase 1 study for refractory or relapsed Ewing’s sarcoma and a Phase 1 study for Advanced Solid Tumors. Seclidemstat is among the most clinically advanced reversible LSD1 inhibitors in development, and its potential effect on glioblastoma represents a promising new therapeutic treatment option.

"Seclidemstat is highly differentiated LSD1 inhibitor with unique properties that may enable efficacy in a broader range of cancer types. Seclidemstat and/or its analogs have shown the potential for synergies with chemotherapies and other targeted agents. This gives us hope that Seclidemstat may be effective in treating a number of aggressive cancers, including glioblastoma," said Dr. Nader Sanai, director of the Ivy Brain Tumor Center. "Our shared goal with Salarius is to address the lag in new drug development for malignant brain tumors by accelerating early-phase clinical trials for first-in-class agents like Seclidemstat."

The Ivy Brain Tumor Center’s advanced pre-clinical capabilities include well-characterized patient-derived xenograft animal models and state-of-the-art pharmacokinetics and pharmacodynamics core facilities. A key component to this latest endeavor will be to leverage the Ivy Center’s core capabilities in collaboration with Salarius to perform in-house survival studies, advanced animal imaging, toxicology assessment, and in vivo pharmaco-metabolic analyses.

Should the pre-clinical phase provide sufficient evidence for positive drug effects, the program will move to the subsequent clinical evaluation of Seclidemstat. This will take place within the context of a Phase 0 clinical trial, in which researchers will quickly learn if the new regimen is having the desired impact on a patient’s individual tumor.

"Salarius is well positioned and highly-motivated to provide a new therapeutic option for a number of cancers with high unmet medical need," said David Arthur, President and Chief Executive Officer of Salarius Pharmaceuticals. "We are inspired by the Ivy Brain Tumor Center’s unwavering commitment to pursuing advances in glioblastoma treatment and look forward to this creative and vital research partnership."

For more information about the Ivy Brain Tumor Center and the drug development partnership, please visit, www.ivybraintumorcenter.org.

CStone announces first patient dosed in China for Phase I/II registrational bridging trial of avapritinib in advanced GIST

On August 25, 2019 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported that the first patient in China has been dosed in the Phase I/II bridging study of avapritinib, which was discovered by CStone’s partner Blueprint Medicines (Press release, CStone Pharmaceauticals, AUG 25, 2019, View Source [SID1234538983]). This stand-alone registrational bridging study in China includes a Phase I dose-escalation study and Phase II dose-expansion study, with the aim of evaluating the safety, pharmacokinetics and efficacy of avapritinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). This study consists of patients with PDGFRA D842V-driven GIST, as well as second- and third-line or later GIST patients.

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GIST is a sarcoma most commonly found in the stomach wall or small intestine. Most GIST patients are diagnosed between the ages of 50 to 80. Approximately 90% of GIST cases are associated with dysregulation of cell growth due to mutations of KIT and PDGFRA tyrosine kinases. Currently, there are no effective therapies for patients with PDGFRA D842V-driven GIST.

Avapritinib is an orally available, potent and highly selective inhibitor of KIT and PDGFRA. Previously published preclinical results have shown that avapritinib has potent activity against KIT and PDGFRA mutant kinases associated with GIST.

In June 2018, CStone entered into an exclusive collaboration and license agreement with Blueprint Medicines to develop and commercialize three therapeutic candidates, including avapritinib, in Mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for the three therapeutic candidates in the rest of the world.

Dr. Frank Jiang, Chairman and CEO of CStone, commented: "GIST is a rare disease with rising incidence rates in recent years, and PDGFRA D842V-mutant GIST patients still lack effective treatments. CStone is committed to the development of innovative therapies to meet urgent clinical needs. Our partner Blueprint Medicines has submitted an NDA for avapritinib in the U.S. and a marketing authorization application in the European Union. We are following their footsteps in seeking to make this novel precision therapy accessible to patients in Greater China as soon as possible. "

CStone’s Chief Medical Officer Dr. Jason Yang noted: "Early symptoms of GIST are relatively unpronounced; as a result, some GIST patients are undiagnosed until advanced stages. Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting demonstrated an objective response rate (ORR) of 86% and favorable tolerability in patients with PDGFRA Exon 18 mutant GIST in the global Phase I NAVIGATOR study of avapritinib. We have already initiated two registrational studies on avapritinib in China, both of which have enrolled their first patients. We will do our best to accelerate the development of this drug candidate and successfully bring it to the market in Greater China."

About Avapritinib

Avapritinib is an investigational, oral precision therapy that selectively and potently inhibits KIT and PDGFRA mutant kinases. It is a type 1 inhibitor designed to target the active kinase conformation; all oncogenic kinases signal via this conformation. Avapritinib has demonstrated broad inhibition of KIT and PDGFRA mutations associated with GIST, including potent activity against activation loop mutations that are associated with resistance to currently approved therapies.

Blueprint Medicines is initially developing avapritinib for the treatment of advanced GIST, advanced systemic mastocytosis (SM), and indolent and smoldering SM. The U.S. FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia.

Data presented at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting from the global Phase I NAVIGATOR study of avapritinib are based on a data cutoff date of November 16, 2018.

[PDF]Cantargia and BioWa extend ongoing collaboration around the POTELLIGENT® Technology

On August 23, 2019 Cantargia AB and BioWa Inc. reported that it have signed an extension of the license agreement around the BioWa proprietary POTELLIGENT Technology for production of Cantargia’s antibody drug candidate CAN04, which gives Cantargia broader rights to use the technology (Press release, Kyowa Hakko Kirin, AUG 23, 2019, View Source [SID1234539061]). Since the original agreement allowing use of POTELLIGENT Technology was signed in 2015, Cantargia has advanced CAN04 to phase IIa clinical development for potential use in the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer (PDAC).

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Cantargia develops antibody-based pharmaceuticals against the interleukin 1 receptor accessory protein (IL1RAP). The POTELLIGENT technology generates antibodies with enhanced antibody dependent cellular cytotoxicity (ADCC). The investigational antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of interleukin 1 signaling. CAN04 is currently produced in a Chinese Hamster Ovary (CHO) cell line provided by BioWa which has been engineered using POTELLIGENT Technology. The extended agreement enables Cantargia to create and use additional CHO cell lines engineered using POTELLIGENT Technology and develop and commercialize CAN04 made through such CHO cell line.

With CAN04 having reached phase IIa clinical development, the next step in the production development is to further reduce production costs using various process improvements as well as scaling up, and Cantargia and BioWa have agreed to extend the current license to include additional opportunities.

"We are extremely pleased with our collaboration with BioWa and the amended agreement is a logical step in our long-term relationship. Given the successful advances of CAN04, optimization of the production process to reduce cost is part of the CAN04 development plan", Göran Forsberg, Cantargia’s CEO says.

"We believe that this extension of the license agreement would add benefits into the fruitful collaboration between Cantargia and BioWa." said Takeshi Masuda, BioWa’s President and CEO. "We are very pleased that this amended agreement could support the innovative program going forward".

For further information, please contact
Cantargia:
Göran Forsberg
CEO
Telephone: +46(0)46-275-62-60
E-mail: [email protected]

BioWa:
Shintaro Hasegawa
Director, Business Development
Telephone: +1-609-580-7340
E-mail: [email protected]

This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on August 23, 2019.

Entry into a Material Definitive Agreement

On August 23, 2019, Seelos Therapeutics, Inc. (the "Company") reported that it has entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain accredited investors identified on the signature pages thereto (the "Purchasers") pursuant to which the Company agreed to issue and sell an aggregate of 4,475,000 shares (the "Shares") of its common stock, par value $0.001 per share (the "Common Stock"), in a registered direct offering (the "Registered Direct Offering") (Filing, 8-K, Apricus Biosciences, AUG 23, 2019, View Source [SID1234539043]). The Shares were offered by the Company pursuant to its shelf registration statement on Form S-3 (File No. 333-221285) filed with the Securities and Exchange Commission (the "Commission") on November 2, 2017, as amended by Amendment No. 1 thereto filed with the Commission on December 1, 2017 and declared effective on December 7, 2017 (as amended, the "Registration Statement").

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In a concurrent private placement, the Company also agreed, pursuant to the Securities Purchase Agreement, to issue and sell to each of the Purchasers a warrant to purchase half of a share of Common Stock (the "Warrants") for each share of Common Stock purchased by a Purchaser in the Registered Direct Offering (the "Private Placement" and, together with the Registered Direct Offering, the "Offerings"). The exercise price of the Warrants is $1.78 per share, subject to adjustment as provided therein, and will be exercisable beginning on February 27, 2020 through August 28, 2023. Each holder of a Warrant will not have the right to exercise any portion of its Warrant if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of the holder prior to the date of issuance, 9.99%) of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that upon 61 days’ prior notice to the Company, the holder may increase the Beneficial Ownership Limitation, but not to above 9.99%. The exercise price and number of shares of Common Stock issuable upon the exercise of the Warrants will be subject to adjustment in the event of any stock dividend, stock split, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Warrants. After February 27, 2020, if a registration statement covering the issuance or resale of the shares of Common Stock issuable upon exercise of the Warrants (the "Warrant Shares") is not available for the issuance or resale, as applicable, the holders may exercise the Warrants by means of a "cashless exercise."

The Warrants are not and will not be listed for trading on any national securities exchange. The Warrants and the Warrant Shares are not being registered under the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the Registration Statement.

The combined purchase price for one Share and one Warrant to purchase half of a share of Common Stock in the Offerings was $1.50. The closing of the Offerings occurred on August 27, 2019. The Company expects the aggregate net proceeds from the Offerings, after deducting the placement agent’s fees and other estimated offering expenses, to be approximately $5.9 million. The Company intends to use the aggregate net proceeds for general corporate purposes and to advance the development of its product candidates.

The Company also agreed, pursuant to the Securities Purchase Agreement, to file a registration statement on Form S-1 by November 21, 2019 to provide for the resale of the Warrant Shares, and will be obligated to use commercially reasonable efforts to keep such registration statement effective from the date the Warrants initially become exercisable until the earlier of (i) the date on which the Warrant Shares may be sold without registration pursuant to Rule 144 under the Securities Act during any 90 day period, and (ii) the date on which no purchaser owns any Warrants or Warrant Shares.

The Securities Purchase Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. Under the Securities Purchase Agreement, the Company has agreed, subject to certain exceptions, not to enter into any agreement to issue or announce the issuance or proposed issuance of any Common Stock or Common Stock equivalents for a period of 90 days following the closing of the Offerings.

Roth Capital Partners, LLC (the "Placement Agent") acted as the placement agent for the Offering. On August 23, 2019, the Company entered into a Placement Agency Agreement with the Placement Agent (the "Placement Agency Agreement"), pursuant to which the Placement Agent agreed to serve as the placement agent for the issuance and sale of the Shares and the Warrants, and the Company agreed to pay the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds received by the Company in the Offerings. The Placement Agency Agreement includes indemnity and other customary provisions for transactions of this nature. Subject to certain conditions, the Company

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also agreed to reimburse all expenses of the Placement Agent actually incurred in connection with the Offerings, which expenses shall be limited to, in the aggregate, $80,000.

In addition, each institutional investor in the Offering has entered into a Leak-Out Agreement with the Company (each, a "Leak-Out Agreement" and collectively, the "Leak-Out Agreements") wherein each investor who is party to a Leak-Out Agreement (together with certain of its affiliates) has agreed to not sell, dispose or otherwise transfer, directly or indirectly (including, without limitation, any sales, short sales, swaps or any derivative transactions that would be equivalent to any sales or short positions), on any trading day from the public announcement of the Offering and ending at 4:00 pm (New York City time) on September 20, 2019, shares of Common Stock, or shares of Common Stock underlying any Common Stock equivalents held by such investor on the date of the Leak-Out Agreements, including the Warrant Shares, in an amount more than its pro rata portion of 35% of the trading volume of the Common Stock, subject to certain exceptions. This restriction will not apply to any actual "long" (as defined in Regulation SHO promulgated under the Securities Exchange Act of 1934, as amended) sales by such investor (together with certain of its affiliates) at or above $3.00 or to any actual "long" sales of shares of Common Stock purchased in open market transactions by such investor (together with certain of its affiliates) during the restricted period. Further, this restriction will not apply to sales or transfers of any such shares of Common Stock in transactions which do not need to be reported on the Nasdaq consolidated tape so long as the purchaser or transferee executes and delivers a Leak-Out Agreement. After such sale or transfer, future sales of the securities covered by the Leak-Out Agreement by the original owner (together with certain of its affiliates) and the purchaser or transferee will be aggregated to determine compliance with the terms of the Leak-Out Agreements.

The foregoing summaries of the Securities Purchase Agreement, the Warrants, the Placement Agency Agreement and the Leak-Out Agreements do not purport to be complete and are qualified in their entirety by reference to the full texts of the Form of Warrant, the Form of Securities Purchase Agreement, the Placement Agency Agreement and the Form of Leak-Out Agreement that are filed herewith as Exhibits 4.1, 10.1, 10.2 and 10.3, respectively.

The representations, warranties and covenants contained in the Securities Purchase Agreement, the Warrants, the Placement Agency Agreement and the Leak-Out Agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to the Securities Purchase Agreement, the Warrants, the Placement Agency Agreement and the Leak-Out Agreement, respectively, and may be subject to limitations agreed upon by the contracting parties. Accordingly, the Securities Purchase Agreement, the Warrants, the Placement Agency Agreement and the Leak-Out Agreements are incorporated herein by reference only to provide investors with information regarding the terms of the Securities Purchase Agreement, the Warrants, the Placement Agency Agreement and the Leak-Out Agreements, and not to provide investors with any other factual information regarding the Company or its business, and should be read in conjunction with the disclosures in the Company’s periodic reports and other filings with the Commission.

The legal opinion, including the related consent, of Brownstein Hyatt Farber Schreck, LLP relating to the issuance and sale of the Shares is filed as Exhibit 5.1 hereto.

This report does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.