On May 10, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the first quarter ended March 31, 2017 (Press release, Puma Biotechnology, MAY 10, 2017, View Source [SID1234519047]).

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Unless otherwise stated, all comparisons are for the first quarter 2017 compared to the first quarter 2016.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $72.9 million, or $1.97 per share, for the first quarter of 2017, compared to a net loss applicable to common stock of $71.0 million, or $2.19 per share, for the first quarter of 2016.

Non-GAAP adjusted net loss was $43.1 million, or $1.16 per share, for the first quarter of 2017, compared to non-GAAP adjusted net loss of $41.5 million, or $1.28 per share, for the first quarter of 2016. Non-GAAP adjusted net loss excludes stock-based compensation expense, which represents a significant portion of overall expense and has no impact on the cash position of the Company. For a reconciliation of GAAP net loss to non-GAAP adjusted net loss and GAAP net loss per share to non-GAAP adjusted net loss per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2017 was $36.0 million. At March 31, 2017, Puma had cash and cash equivalents of $105.1 million and marketable securities of $88.9 million, compared to cash and cash equivalents of $194.5 million and marketable securities of $35.0 million at December 31, 2016.

"We made significant progress with our lead investigational drug, neratinib, during the first quarter of 2017," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We look forward to continuing to work with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as they review our New Drug Application (NDA) and Marketing Authorization Application (MAA) filings, respectively, and we look forward to presenting the data on neratinib at the upcoming FDA Oncologic Drugs Advisory Committee on May 24th.

"Data on neratinib was also presented at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April which included data on the use of antidiarrheal prophylaxis to reduce the diarrhea with neratinib in the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy (CONTROL trial). There was also clinical data presented on neratinib in the treatment of patients who have solid tumors with activating HER2 or HER3 mutations (SUMMIT trial). Additional data was also presented on the combination of T-DM1 and neratinib in patients with HER2 positive metastatic breast cancer (MBC) that has previously been treated with pertuzumab and trastuzumab. We look forward to continuing to achieve our objectives and believe that Puma is very well-positioned to build value for our shareholders."

Mr. Auerbach added, "During 2017, we anticipate the following key milestones with neratinib: (i) reporting data from the Phase III trial in third-line HER2-positive MBC patients in the second quarter of 2017; (ii) reporting data in the second quarter of 2017 from the TBCRC-022 Phase II trial of neratinib plus capecitabine in HER2-positive MBC patients with brain metastases; (iii) reporting final 5-year disease free survival (DFS) data during the second quarter of 2017 from the ExteNET Phase III trial of neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer; and (iv) announcing regulatory decisions in the United States and European Union on neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017."

Operating Expenses

Operating expenses were $73.2 million for the first quarter of 2017, compared to $71.2 million for the first quarter of 2016.

General and Administrative Expenses:

General and administrative expenses were $18.4 million for the first quarter of 2017, compared to $11.0 million for the first quarter of 2016. The approximately $7.4 million increase resulted primarily from increases of approximately $1.4 million for stock-based compensation, $3.9 million for professional fees, $1.3 million for payroll and related costs, and $0.5 million for facility and equipment costs. These increases reflect overall corporate growth.

Research and Development Expenses:

Research and development (R&D) expenses were $54.8 million for the first quarter of 2017, compared to $60.2 million for the first quarter of 2016. The approximately $5.4 million decrease resulted primarily from decreases of approximately $1.1 million for stock-based compensation and $5.0 million for clinical trial expenses, partially offset by an increase of $0.6 million for consultants and contractors. For our existing clinical trials, we expect R&D expenses to decrease in subsequent quarters as clinical trials wind down.

On May 10, 2017 Progenra, Inc. reported that it has received the Official Notice of Allowance (dated March 30, 2017) of its patent application entitled "Methods of treating cancer through the inhibition of USP7 and immune system modulation (Press release, Progenra, MAY 10, 2017, View Source [SID1234519053])." The patent, based on work described in a recent publication, is related to a new immune oncology therapy based on the inhibition of the ubiquitin-deconjugating enzyme USP7 by a small molecule. USP7 is a master positive regulator of cancer as it both directly supports the growth and survival of cancer cells and prevents the patient’s immune cells from recognizing and eradicating the tumor. Progenra is developing small molecule inhibitors of USP7 for clinical trial and, according to its President, Dr. Tauseef Butt, hopes to initiate Phase I in early 2018. He stated that "we continue to obtain data showing that our USP7 inhibitors have the potential to eliminate cancer by both direct cytotoxic and indirect immunological mechanisms. This class of drug could become a powerful alternative to the biological immune checkpoint inhibitors currently on the market (such as Opdivo and Keytruda), as well as a component of combination therapy with these agents." In animal efficacy models, Progenra compounds have demonstrated anti-cancer activity that was superior to that of Yervoy, Opdivo, or Keytruda. These results point to a potentially radical development in cancer treatment — a small molecule single agent that works as well as or better than combination protocols.

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On May 10, 2017 InhibOx reported that it has relaunched as Oxford Drug Design to reflect its transition to a biotechnology company focused on internal drug discovery (Press release, Oxford Drug Design, MAY 10, 2017, View Source [SID1234533622]). Our lead antibacterial programme has identified compounds with the potential to be developed into therapies for Gram-negative bacterial infections, including against strains resistant to multiple current antibacterial drug classes. In the European Union alone, drug-resistant bacteria are estimated to cause 25,000 deaths and cost more than .5 billion every year in healthcare expenses and productivity losses. Compound design is supported by a proprietary technology platform in cheminformatics, 3D molecular similarity and computer-aided drug design that has been built up over 10 years of research and development.
The potential of our programme has been validated by the award of a prestigious Innovate UK Biomedical Catalyst grant to accelerate programme progression.

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On May 10, 2017 Otic Pharma, Ltd., a pharmaceutical company focusing on the development of ear, nose, and throat (ENT) products, reported the close of the previously announced combination with Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI, through May 10, 2017). In connection with the previously announced transaction, Tokai changed its name to Novus Therapeutics, Inc. and effected a 1-for-9 reverse split of its common stock (Press release, Novus Therapeutics, MAY 10, 2017, View Source [SID1234521947]). The common stock is expected to commence trading on a post-reverse split basis upon the opening of trading on May 11, 2017 on the NASDAQ Capital Market under the symbol "NVUS."

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"The completion of this transaction and emergence of Novus as one of the few publicly-listed ENT companies marks a significant milestone," said Gregory J. Flesher, President and CEO of Novus Therapeutics, Inc. "Our pipeline provides a compelling opportunity for value creation as we move our product candidates through development. With the capital obtained through this transaction and continued access to the capital markets, we will be able to accelerate development of OP-01 for acute otitis externa and OP-02 for chronic and recurrent otitis media."

The combined company has approximately $30 million in cash at close, excluding $7 to 8 million in estimated transaction-related expenses. Following the completion of the transaction, together with the $7 million concurrent financing and reverse stock split, the company has approximately 7 million shares of common stock outstanding.

Novus Therapeutics will operate under the leadership of Gregory J. Flesher, President and Chief Executive Officer; Christine G. Ocampo, Chief Financial and Chief Compliance Officer; and Dr. Catherine C. Turkel, Chief Development Officer. The Board of Directors of the company is initially comprised of seven directors: Keith A. Katkin (Chairman), Gregory J. Flesher, Gary A. Lyons, Erez Chimovits, Cheryl Cohen, John S. McBride, and Jodie P. Morrison. The corporate headquarters is located in Irvine, California.

On May 10, 2017 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering the specific route of administration for Livatag, which is currently in a phase III clinical trial (ReLive) for the second-line treatment of hepatocellular carcinoma (primary liver cancer) (Press release, Onxeo, MAY 10, 2017, View Source [SID1234519054]).

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Livatag (doxorubicin Transdrug) is based on an innovative technology allowing the formulation of doxorubicin (a chemotherapeutic agent) within nanoparticles composed of polyalkylcyanoacrylate, cyclodextrin, and poloxamer. This nanoparticle formulation provides new and promising properties, including overcoming the mechanisms of chemoresistance developed by tumor cells that affect the efficacy of chemotherapy agents.

"The United States represents a significant target market for Livatag. This new U.S. patent significantly strengthens our Livatag intellectual property portfolio, and enhances the value of this late-stage product candidate. We look forward to the availability of data from our ReLive trial in mid-2017," said Judith Greciet, CEO of Onxeo.

The new patent provides protection of the associated claims in the U.S. until 2032, and is in addition to the previously issued patents for the same patent family in other major territories, such as Europe and Japan. An additional patent family has also been filed based on a specific composition of Livatag nanoparticles that, if granted, would extend the patent protection of Livatag to 2036.