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 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 9, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today reported its financial and operational results for the first quarter ended March 31, 2017 (Press release, Sierra Oncology, MAY 9, 2017, View Source [SID1234519049]).

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"During the quarter, we continued to advance our lead DDR-targeting drug candidate, SRA737, in two ongoing Phase 1 clinical trials, while concurrently proposing design amendments to these studies that we believe could augment their potential for success," said Dr. Nick Glover, President and CEO of Sierra Oncology. "As we prepare to implement these enhancements, we also remain focused on driving patient enrollment with the objective of providing an initial update from these trials in early 2018."

During the first quarter, Sierra successfully transferred sponsorship of the two ongoing Phase 1 clinical trials for its checkpoint kinase 1 (Chk1) inhibitor, SRA737, to the company. This transfer positioned Sierra to submit protocol amendments seeking to incorporate the prospective enrollment of patients with genetically-defined tumors, determined using Next-Generation Sequencing, that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

First Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.6 million for the first quarter of 2016. The increase was primarily due to an increase in third-party manufacturing and research costs related to SRA737 and SRA141. These costs were partially offset by a decrease in clinical trial and personnel-related costs due to the discontinuation of PNT2258. Research and development expenses included non-cash stock based compensation of $1.0 million for both the first quarter of 2017 and of 2016.

General and administrative expenses were $3.1 million for the first quarter of 2017, compared to $4.0 million for the first quarter of 2016. This decrease was primarily due to a decrease in professional fees, business development expenses and personnel-related costs. General and administrative expenses included non-cash stock based compensation of $0.5 million for the first quarter 2017, compared to $0.4 million for the first quarter 2016.
Net loss was $11.1 million for the first quarter of 2017, compared with a net loss of $10.5 million for the first quarter of 2016.

Cash and cash equivalents totaled $125.0 million as of March 31, 2017, compared to $109.0 million as of December 31, 2016. This increase was due to an underwritten public offering of 21,847,636 shares of common stock in February 2017, pursuant to which the company raised net proceeds of $27.4 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019. At March 31, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,615,052 shares of common stock issued and outstanding.

Akebia has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Akebia, 2017, MAY 9, 2017, View Source [SID1234521594]).

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On May 9, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported that it will report its financial results for the quarter ended March 31, 2017 in a press release that will be issued pre-market on Tuesday, May 16, 2017 (Press release, Xenetic Biosciences, MAY 9, 2017, View Source [SID1234537806]). Xenetic’s management team also announced that it will host a quarterly update conference call with a live audio webcast that same day at 8:30 AM ET to review its operational progress, expected near-term milestones and financial report.

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The conference call and live webcast will be accompanied by a slide presentation. To participate in the call, please dial (877) 407-6914 (domestic) or (201) 493-6709 (international). The live webcast and accompanying slides will be available by accessing the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com). A replay of the webcast will be available for 90 days, starting approximately two hours after the presentation ends.