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Xenetic Biosciences Announces Nasdaq Listing of its Common Stock and Pricing of $10M Public Offering

On November 1, 2016 Xenetic Biosciences, Inc. (OTCQB: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its common stock will begin trading on The Nasdaq Capital Market under the symbol "XBIO" on November 7, 2016 (Press release, Xenetic Biosciences, NOV 1, 2016, View Source [SID1234537811]). The Company also announced the pricing of its public offering of an aggregate of 2,424,242 units, consisting of (i) 484,849 units, consisting of one share of Convertible Series B Preferred Stock and a Class A Warrant to purchase one share of common stock and (ii) 1,939,393 units consisting of one share of Convertible Series B Preferred Stock and a Class B Warrant to purchase one share of common stock, at a public offering price of $4.125 per unit. The total expected gross proceeds of the public offering are approximately $10 million before the underwriter’s discount and expenses.

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In connection with its new listing on The Nasdaq Capital Market, November 4, 2016 will be the last day Xenetic’s common stock will trade on the OTCQB.

Ladenburg Thalmann & Co. Inc. acted as the sole book running manager for the offering.

The net proceeds from this offering will be used to fund the research and development of Xenetic’s product candidates, including Virexxa, as well as future development programs, potential in licensing of products or technology, capital expenditures, working capital, repayment of existing indebtedness, and other general corporate purposes.

The offering is expected to close on November 7, 2016, subject to customary closing conditions.

A registration statement on Form S-1 relating to the shares and warrants was filed with the Securities and Exchange Commission ("SEC") and has been declared effective. A preliminary prospectus relating to the offering has been filed with the SEC and is available on the SEC’s web site at View Source Copies of the final prospectus relating to the offering, when available, may be obtained from the offices of Ladenburg Thalmann & Co. Inc., 570 Lexington Avenue, 11th Floor, New York, NY 10022, telephone: (212) 409-2000 or email [email protected] or the above-referenced SEC website.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale is not permitted.

Phase 1 Study of CB-839, a Small Molecule Inhibitor of Glutaminase, In Combination with Everolimus in Patients with Clear Cell and Papillary Renal Cell Carcinoma

On November 1, 2016 Calithera Biosciences presented the corporate presentation (Presentation, Calithera Biosciences, NOV 1, 2016, View Source [SID1234535277]).

Regulus Reports Third Quarter 2016 Financial Results

On November 1, 2016 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, reported financial results for the three and nine months ended September 30, 2016 and provided a summary of corporate highlights (Press release, Regulus, NOV 1, 2016, View Source [SID1234516322]).

"Our focus in the third quarter included the advancement of the RG-012 development program and addressing the clinical hold for RG-101 while expanding the pre-clinical pipeline," said Paul Grint, M.D., President and Chief Executive Officer of Regulus. "We continue to be excited with the progress of our research programs, and look forward to sharing an update at our first R&D day on December 6th."

Financial Results

Revenue: Revenue was $0.2 million and $1.2 million for the three and nine months ended September 30, 2016, respectively, compared to $1.9 million and $9.9 million for the same periods in 2015. Revenue for the three and nine months ended September 30, 2016 and 2015 consisted of amortization of up-front payments from Regulus’ strategic alliances and collaborations. Revenue for the three and nine months ended September 30, 2015 included $0.9 million and $4.1 million, respectively, for research services under Regulus’ strategic alliances and collaborations. Preclinical milestones earned under Regulus’ strategic alliances and collaborations were $0.3 million and $3.2 million for the three and nine months ended September 30, 2015, respectively.

Research and Development (R&D) Expenses: R&D expenses were $14.6 million and $49.3 million for the three and nine months ended September 30, 2016, respectively, compared to $11.0 million and $43.6 million for the same periods in 2015. The increases in R&D expenses were primarily driven by the advancement of our clinical programs and increased investment in our preclinical pipeline.

General and Administrative (G&A) Expenses: G&A expenses were $4.8 million and $13.6 million for the three and nine months ended September 30, 2016, respectively, compared to $4.2 million and $13.7 million for the same periods in 2015.

Net Loss: Net loss was $19.5 million, or $0.37 per share, and $61.8 million, or $1.17 per share, for the three and nine months ended September 30, 2016, respectively, compared to a net loss of $13.0 million, or $0.25 per share, and $48.5 million, or $0.95 per share, for the same periods in 2015.

Cash Position: Cash, cash equivalents, and short-term investments were $91.7 million at September 30, 2016, compared with $108.0 million at June 30, 2016 and $115.3 million at December 31, 2015.

Recent Events

In October, Dr. Timothy Wright joined Regulus as its Chief R&D Officer.
In September, Regulus initiated the HERA study, an international randomized, double-blind, placebo-controlled, multi-center Phase 2 clinical trial designed to evaluate the safety, pharmacodynamics, pharmacokinetics, dose selection, and preliminary efficacy of weekly RG-012 injections in approximately 30 patients with Alport syndrome. In order to address study design comments from European regulators, a multiple-ascending dose (MAD) study in healthy volunteers will be implemented (4-week repeat dosing) prior to expanding to Alport patients. Regulus anticipates the MAD study will be completed in the first half of 2017. Based on predicted enrollment rates, Regulus anticipates interim results from HERA in the first half of 2018.
In July, as anticipated, Regulus received written communication from the U.S. Food and Drug Administration (FDA) outlining information required to resolve the clinical hold for its Investigational New Drug (IND) for RG-101, which was announced on June 27, 2016. Based on the completion of additional mechanistic pre-clinical studies, Regulus expects a response to its submission from the FDA in the first quarter of 2017.
Upcoming Events

On November 13, 2016, Regulus will present three posters at American Association for the Study of Liver Disease (AASLD) in Boston.
On November 15, 2016 at 4:30 pm Eastern Time, Regulus will present a corporate overview at the Stifel 2016 Healthcare Conference in New York.
On November 18 and 19, 2016, Regulus will present two posters at American Society of Nephrology (ASN) Kidney Week in Chicago.
On December 6, 2016, Regulus will host its first R&D Day.
On December 13, 2016, Regulus will participate in the 4th Annual Boston Healthcare Conference.
On December 14, 2016, Regulus will participate in the BMO Capital Markets Prescriptions for Success Healthcare Conference.

Illumina Reports Full Financial Results for Third Quarter of Fiscal Year 2016

On November 1, 2016 Illumina, Inc. (NASDAQ:ILMN) reported its full financial results for the third quarter of fiscal year 2016 (Filing, Q3, Illumina, 2016, NOV 1, 2016, View Source [SID1234516299]).

Third quarter 2016 results:
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As previously announced on October 10, 2016, revenue of $607 million, a 10% increase compared to $550 million in the third quarter of 2015
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GAAP net income attributable to Illumina stockholders for the quarter of $129 million, or $0.87 per diluted share, compared to $118 million, or $0.79 per diluted share, for the third quarter of 2015
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Non-GAAP net income attributable to Illumina stockholders for the quarter of $144 million, or $0.97 per diluted share, compared to $120 million, or $0.80 per diluted share, for the third quarter of 2015 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
•
Cash flow from operations of $150 million and free cash flow of $93 million for the quarter, compared to $181 million and $152 million in the prior year period

Gross margin in the third quarter of 2016 was 70.2% compared to 70.4% in the prior year period. Excluding the effect of non-cash stock compensation expense and amortization of acquired intangible assets, non-GAAP gross margin was 72.5% for the third quarter of 2016 compared to 73.2% in the prior year period.

Research and development (R&D) expenses for the third quarter of 2016 were $125.9 million, or 20.7% of revenue, compared to $99.2 million, or 18.1% of revenue, in the prior year period. R&D expenses included $11.5 million and $9.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges and contingent compensation, R&D expenses as a percentage of revenue were 18.8%, including 2.4% attributable to GRAIL and Helix. This compares to 16.4% in the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2016 were $139.1 million, or 22.9% of revenue, compared to $136.6 million, or 24.8% of revenue, in the prior year period. SG&A expenses included $20.0 million and $20.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges, amortization of acquired intangible assets, and contingent compensation, SG&A expenses as a percentage of revenue were 19.3%, including 1.5% attributable to GRAIL and Helix. This compares to 20.9% in the prior year period, including 0.9% attributable to Helix.

Depreciation and amortization expenses were $35.9 million and capital expenditures for free cash flow purposes were $57.1 million during the third quarter of 2016, which excludes an increase of $83.9 million in property and equipment recorded under build-to-suit lease accounting since such expenses were paid for by the landlord.

At the close of the quarter, the company held $1.54 billion in cash, cash equivalents and short-term investments, compared to $1.39 billion as of January 3, 2016.

"While sequencing sample volume growth remains robust, our lowered revenue outlook reflects our updated expectations for HiSeq 2500, HiSeq 4000 and HiSeq X instrument purchases, as well as HiSeq 2500 reagent sales," stated Francis deSouza, President and CEO. "Over the last few weeks it has become clear that certain academic funding practices were modified in the third quarter, limiting our customers’ ability to make HiSeq X capital commitments. Further, HiSeq 2500 and 4000 demand has been impacted by a migration to NextSeq, for enhanced workflow flexibility and HiSeq X, given its beneficial pricing for whole genome sequencing."

Updates since our last earnings release:
•
Announced a partnership with FlowJo, LLC to develop and co-market analysis software for single cell next-generation sequencing data
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Received orders for an additional 2 million samples of the Infinium Global Screening Array, for a total of more than 5 million samples ordered to date
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Appointed Philip W. Schiller to the company’s Board of Directors
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Announced that Christian Henry, Executive Vice President and Chief Commercial Officer, will be leaving the company. Appointed Mark van Oene, currently Senior Vice President and General Manager, Americas, as Interim Chief Commercial Officer
•
Announced that Illumina’s Board of Directors has authorized the company to repurchase up to $250 million of outstanding common shares in the open market or in privately negotiated transactions, subject to market conditions and other factors. The company repurchased $13 million of common stock under this new stock authorization

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

The company continues to project fourth quarter revenue to be flat to slightly up compared to the third quarter. For fiscal 2016, non-GAAP earnings per diluted share attributable to Illumina stockholders is forecasted to be $3.27 to $3.32.

Quarterly conference call information
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, November 1, 2016. Interested parties may listen to the call by dialing 888.771.4371 (passcode: 43579048), or if outside North America

by dialing +1.847.585.4405 (passcode: 43579048). Individuals may access the live teleconference in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on November 1, 2016 through November 8, 2016 by dialing 888.843.7419 (passcode: 43579048), or if outside North America by dialing +1.630.652.3042 (passcode: 43579048).

Synthetic Biologics Reports Third Quarter 2016 Operational Highlights and Financial Results

On November 1, 2016 Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics focused on the gut microbiome, reported an operational update and reported financial results for the three months ended September 30, 2016 (Press release, Synthetic Biologics, NOV 1, 2016, View Source [SID1234516162]).

Synthetic Biologics, Inc. www.syntheticbiologics.com (PRNewsFoto/Synthetic Biologics, Inc.)
"Clinical progress for our two lead gut microbiome-focused drug candidates represent critical milestones for the company as we continue our evolution from an early-stage development company to a late-stage clinical development company focused on commercialization," said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. "During the third quarter, we completed enrollment in our Phase 2b proof-of-concept clinical trial to evaluate the ability of ribaxamase to protect the gut microbiome from the effects of certain commonly used intravenous beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. We were also the only commercial company pursuing drug development to receive a government contract from the Centers for Disease Control and Prevention to investigate antimicrobial resistance. This grant will support our clinical research aimed at determining whether ribaxamase may prevent antibiotic-mediated microbial resistance in the gut microbiomes of participants in our Phase 2b study. We look forward to sharing top-line results from this trial during the first quarter of 2017."

Mr. Riley continued, "SYN-010, our therapeutic designed to reduce methane in the gut and treat the underlying cause of irritable bowel syndrome with constipation (IBS-C), continues its rapid clinical progress. We held a held an End of Phase 2 meeting with the FDA to determine the optimal clinical pathway to advance SYN-010 into pivotal trials. We continue to collaborate with the FDA and are developing a protocol for our Phase 2b/3 adaptive clinical study which we plan to initiate during the first quarter of 2017."

Clinical Program Progress

SYN-004 (ribaxamase): Prevention of CDI, AAD and the emergence of antibiotic-resistant organisms:

Completed enrollment in global Phase 2b placebo-controlled, proof-of-concept clinical trial intended to evaluate the ability of ribaxamase to prevent CDI, C. difficile-associated diarrhea (CDAD), AAD and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone
Enrolled 413 patients across global clinical sites
Anticipate announcing topline results from Phase 2b proof-of-concept clinical trial (1Q 2017)
Awarded government contract from the Centers for Disease Control and Prevention to determine SYN-004’s ability to prevent the emergence of antibiotic-resistant organisms in the gut microbiome of patients enrolled in the Company’s Phase 2b proof-of-concept clinical trial
SYN-010: Treatment of irritable bowel syndrome with constipation (IBS-C) – SYN-010:

Held End of Phase 2 meeting with FDA and received guidance for clinical study design and requirements for Phase 3 development
Submitted Phase 2b/3 adaptive study protocol and corresponding statistical analysis plan to FDA for first pivotal clinical trial (3Q 2016)
Plan to initiate Phase 2b/3 pivotal clinical trial (1Q 2017)
Third Quarter 2016 Financial Results

General and administrative expenses increased to $2.1 million for the third quarter of 2016, from $1.6 million for the third quarter of 2015. This increase is primarily the result of increased stock-based compensation, investor relations expenses and employee salaries and benefits costs offset by lower consulting and legal expenses. The charge related to stock-based compensation expense was $524,000 for the third quarter of 2016, compared to $387,000 for the third quarter of 2015.

Research and development expenses decreased to $7.0 million for the third quarter of 2016, from $10.0 million for the third quarter of 2015. This decrease is primarily the result of charges related to our Exclusive Channel Collaboration (ECC) agreement with Intrexon that we entered into in August 2015. In 2015, we issued 937,500 shares of our common stock to Intrexon as payment of the technology access fee that resulted in a non-cash charge of $3.0 million for the third quarter of 2015. Research and development expenses also include a charge related to non-cash stock-based compensation expense of $422,000 for the third quarter of 2016, compared to $259,000 for the same period last year.

Other income was $0.7 million for the third quarter of 2016, compared to other income of $4.1 million for the third quarter of 2015. Other income for the third quarter of 2016 is due to non-cash income of $0.7 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter. Non-cash income related to the decrease of fair value of warrants for the third quarter of 2015 was $4.1 million.

Cash and cash equivalents as of September 30, 2016 were $4.5 million.