On January 30, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the multicenter Phase 1 triple combination trial of ublituximab (TG-1101), the Company’s anti-CD20 monoclonal antibody, umbralisib (TGR-1202), the Company’s oral once-daily PI3K delta inhibitor, and ibrutinib, the oral Bruton’s tyrosine kinase (BTK) inhibitor, in The Lancet Haematology (Press release, TG Therapeutics, JAN 30, 2019, View Source [SID1234532958]).

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The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 23 patients with non-Hodgkin lymphoma (NHL). Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate (ORR) amongst all evaluable patients was 84%, with 100% (22 of 22) of patients with CLL/SLL achieving a response, including 36% achieving a Complete Response (CR). Among patients with NHL, 68% (15 of 22) achieved a response, including a 71% Overall Response Rate (ORR) in follicular lymphoma (FL) (n=7), a 100% ORR in marginal zone lymphoma (MZL) (n=3), and a 100% ORR in mantle cell lymphoma (MCL) (n=6).

These data are described further in the manuscript entitled, "Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial," which was featured as the cover article in the February issue of The Lancet Hematology published yesterday. The online version of the article can be accessed at https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30216-3/fulltext

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated "We want to thank Dr. Loretta Nastoupil and the MD Anderson Cancer Center, as well as each of the participating trial sites and most importantly the patients who participated in this study. Umbralisib has demonstrated unique combinability with other targeted agents, and the data included in this publication further support our goal of developing a proprietary triple combination of ublituximab, umbralisib and our own BTK inhibitor, TG-1701, for which we target commencing clinical trials later this year."

On January 30, 2019, Pieris Pharmaceuticals, Inc. (the "Company") and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., and Biotechnology Value Trading Fund OS, L.P. (collectively, "BVF") reported that it has entered into an Exchange Agreement (the "Exchange Agreement") pursuant to which BVF agreed to exchange (the "Exchange") an aggregate of 5,000,000 shares of the Company’s common stock, par value $0.001 ("Common Stock"), owned by BVF for an aggregate of 5,000 shares of the Company’s newly-designated Series B Convertible Preferred Stock, par value $0.001 per share ("Series B Preferred Stock"). The Exchange closed on February 1, 2019 (Filing, 8-K, Pieris Pharmaceuticals, JAN 30, 2019, View Source [SID1234533049]).

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As described below, the Series B Preferred Stock has substantially the same terms as the Company’s Series A Convertible Preferred Stock, par value $0.001 per share ("Series A Preferred Stock"), issued in June 2016 and currently held by entities affiliated with BVF. The shares of Series B Preferred Stock issued in the Exchange are convertible into an aggregate of 5,000,000 shares of Common Stock (subject to adjustment as provided in the Series B Certificate of Designation, as defined below), subject to a 9.99% beneficial ownership blocker provision described below.
As of the date of the Exchange Agreement, BVF represented to the Company that it beneficially owned 7,457,921 shares of Common Stock, representing approximately 13.77% of the shares of Common Stock outstanding as of such date. In addition, BVF holds 2,907 shares of Series A Preferred Stock, which are convertible into 2,907,000 shares of Common Stock (subject to adjustment as provided in the Certificate of Designation of Series A Convertible Preferred Stock of Pieris Pharmaceuticals, Inc. (the "Series A Certificate of Designation")), subject to a 9.99% beneficial ownership blocker provision set forth in the Series A Certificate of Designation.
A copy of the Exchange Agreement is attached hereto as Exhibit 10.1 and is incorporated herein by reference. The foregoing is only a brief description of the material terms of the Exchange Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of the Exchange Agreement. The representations, warranties and covenants made by the Company in the Exchange Agreement were made solely for the benefit of the parties to the Exchange Agreement, including, in some cases, for the purpose of allocating risk among the parties thereto, and should not be deemed to be a representation, warranty or covenant to investors. Moreover, such representations, warranties or covenants were made as of January 30, 2019. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of the Company’s affairs.

On January 30, 2019 Novartis reported strong sales growth with core margin expansion, building leading advanced therapy platforms and focusing the company in 2018 (Press release, Novartis, JAN 30, 2019, View Source [SID1234532959])·

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Full year net sales up 5% (cc1, +6% USD) driven by strong performance of growth drivers:

o Pharmaceuticals BU grew 7% (cc) driven by Cosentyx USD 2.8 billion (+36% cc) and Entresto USD 1.0 billion (+102% cc)

o Oncology BU grew 9% (cc) driven by AAA2 (USD 0.4 billion) including Lutathera, Promacta/Revolade USD 1.2 billion (+35% cc) and Tafinlar + Mekinist USD 1.2 billion (+31% cc)

· Full year core1 operating income grew 8% mainly driven by higher sales and gross margin expansion

· Net income was USD 12.6 billion (+64%) including a USD 5.7 billion net gain from the divestment of OTC JV. Operating income declined 5% mainly due to M&A transactions and restructurings

· Free cash flow1 grew 12% to USD 11.7 billion driven by strong operating cash flows

· Focused the company with transformational deals during 2018:

o Consumer healthcare JV stake divested to GSK for USD 13.0 billion

o Announced proposal to spin-off Alcon Division3; on track for H1 2019

o Sandoz began transformation with reshaping the portfolio4, geographic focus and a leaner cost structure

· Built leading advanced therapy platforms:

o Gene therapy – Acquired AveXis and in-licensed Luxturna

o Radioligand therapy – Acquired AAA and Endocyte

o Cell therapy – Expanding Kymriah global manufacturing including multiple collaborations

· Four additional products reached blockbuster status in 2018; Lutathera, Aimovig and Kymriah for DLBCL were launched; additional ten key launches on track by 2020

· Alcon sales grew 5% (cc, +6% USD) and core operating income grew 10%; expanding core margin

· Sandoz sales down -3% (cc, -2% USD) due to US price pressure; Biopharmaceuticals grew 24% (cc)

· Dividend of CHF 2.85 per share, an increase of 2%, proposed for 2018

· 2019 Group guidance5:

o New focused medicines company6 – Net sales expected to grow mid single digit (cc); core operating income expected to grow mid to high single digit (cc)

o Current Group structure7 – Net sales expected to grow low to mid single digit (cc); core operating income expected to grow mid single digit (cc)

On January 30, 2019 Eli Lilly and Company (NYSE: LLY) has reported that revised the date for its fourth-quarter and full-year 2018 financial results announcement (Press release, Eli Lilly, JAN 30, 2019, View Source [SID1234532960]). The company will now announce results on Wednesday, February 6, 2019, one week earlier than previously scheduled. Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 30, 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 Drug Design, Development and Therapy has published an article titled, "Targeting the A3 Adenosine Receptor to Treat Cytokine Release Syndrome in Cancer Immunotherapy (Press release, Can-Fite BioPharma, JAN 30, 2019, View Source [SID1234532976])." The article presents data from numerous studies that show adenosine’s role in inhibiting inflammatory cytokine production. Can-Fite’s Piclidenoson, a Phase III drug candidate, and Namodenson, a Phase II drug candidate, both target the A3 adenosine receptor (A3AR), which the Company believes may treat cytokine release syndrome (CRS) while also promoting an anti-cancer effect.

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CRS is a potentially life threatening side effect of cancer immunotherapies including CAR-T. The market for CAR-T drugs is estimated to reach approximately $5.4 Billion in 2024 according to Evaluate Pharma.

"While CAR-T and other cancer immunotherapies are saving lives, as their use increases, there is growing concern about the drugs’ life threatening side effects including the high incidence of CRS. With the publication of this article in Drug Design, Development and Therapy, we are advancing the scientific community towards delivering immunotherapies that offer a high degree of efficacy with a greater degree of safety for the patient. Our platform technology, through Namodenoson, has already displayed its anti-cancer effects in humans, and therefore it is a candidate to not only protect patients from CRS, but to also boost the body’s fight against cancer," stated Dr. Pnina Fishman, Can-Fite’s CEO. "We look forward to implementing our development strategy for our drugs in the treatment of CRS."

Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation by reducing elevated levels of pro-inflammatory cytokines such as IL-6, IL-1β, NF-Kβ, TNF-α, and more.