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News Article | September 29, 2015
Site: www.latimes.com

The youngest billionaire in the world is Snapchat Inc.’s 25-year-old Chief Executive Evan Spiegel, at $2.1 billion, Forbes said Tuesday. Spiegel and his fellow Snapchat cofounder, Bobby Murphy, both made the Forbes 400 for the first time this year, among 25 new entrants. The financial magazine’s listing of the wealthiest Americans stretches from Microsoft cofounder Bill Gates, at $76 billion, to Richard Yuengling, president of beer maker D.G. Yuengling & Sons, at $1.7 billion. With the economy humming along well, the minimum wealth needed to make the cut set a record, Forbes said. Spiegel came in at No. 327. Raised in the Pacific Palisades, Spiegel attended Stanford to study engineering product design but dropped out in his senior year to work full time on what has become one of the most popular apps in the world. Murphy, Snapchat’s chief technology officer, was No. 375 at $1.8 billion. Hundreds of millions of people, mostly teens and young adults, use Snapchat to keep up with friends, read the news and watch a mix of professionally created and amateur videos. Investors worldwide have put more than $1 billion into the start-up, valuing the company at about $15 billion. Snapchat celebrated its fourth birthday last Friday with a party that included a cake decorated with smiling versions of its ghost mascot. Spiegel has cashed out some of his holdings in the company, but much of his wealth is likely tied up in shares that could fetch big prices if Snapchat goes public in the coming years as he has said it hopes to do. Forbes estimates he controls 13% of Snapchat and Murphy 11%. Spiegel, for one, has stayed in rich company. Paparazzi recently have photographed him with Miranda Kerr, one of the world’s wealthiest models, on his arm. Other young technology executives dot the 400 list, like Travis Kalanick, CEO of ride-hailing app Uber. His wealth doubled to $6 billion in the past year, making him the top gainer, percentage-wise, on the list, Forbes said. Oracle founder Larry Ellison and Facebook founder Mark Zuckerberg were the richest Californians, at No. 3 and No. 7, respectively. Ellison’s wealth was listed as $47.5 billion, and Zuckerberg’s $40.3 billion. SIGN UP for the free California Inc. business newsletter >> Irvine Co. Chairman Donald Bren, with $15.2 billion at No. 30, was the richest Southern Californian and richest real estate developer. In addition to Spiegel and Murphy, Los Angeles billionaires included Patrick Soon-Shiong, Eli Broad and Edward Roski Jr. Real estate developer Rick Caruso, at $3.5 billion, was a new Los Angeles entrant, as was Kieu Hoang, who owns a blood plasma company and a Napa winery, and now has a $3.8-billion fortune. Notably missing from last year’s list is Alan Auerbach, chief executive of Los Angeles biopharmaceutical company Puma Biotechnology. His net worth fell from $1.55 billion to $590 million as poor trial results have sunk the company’s share price about 70% to $72.32 in the last six months. Chat with me on Twitter @peard33


LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced the presentation of positive results from the Phase III clinical trial of Puma's investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer (ExteNET trial). The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in women with early stage HER2-positive breast cancer. The data was presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) 2015 Annual Meeting in Chicago, Illinois. The ExteNET trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial. The patient characteristics in the trial were well balanced between the neratinib and placebo arms of the trial. For the 1,420 patients in the neratinib arm of the trial, 1,085 (76.4%) were node positive while for the 1,420 patients in the placebo arm of the trial, 1,084 (76.3%) were node positive. Additionally, in the neratinib arm of the trial, 816 (57.5%) patients were hormone receptor positive, and in the placebo arm of the trial, 815 (57.4%) patients were hormone receptor positive. The median time from the last trastuzumab dose to entry into the trial was 4.4 months for the neratinib-treated patients and 4.6 months for the placebo-treated patients. The safety results of the study showed that the most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 (0.1%) patient had grade 4 diarrhea). Patients who received neratinib in this trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea. Puma’s recently reported clinical data from several trials have demonstrated that the use of high dose prophylactic loperamide greatly reduces the rate of grade 3 diarrhea with neratinib, with grade 3 diarrhea rates ranging from 0-17% in studies in which high dose loperamide prophylaxis was used. In all of its current ongoing studies Puma is instituting the use of high dose loperamide for the first cycle of treatment in order to continue to reduce the neratinib-related diarrhea. The primary endpoint of the trial was invasive disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year DFS rate for the neratinib arm was 93.9% and the 2-year DFS rate for the placebo arm was 91.6%. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% reduction of risk of disease recurrence including DCIS or death versus placebo (hazard ratio = 0.63, p = 0.002). The 2-year DFS-DCIS rate for the neratinib arm was 93.9% and the 2-year DFS-DCIS rate for the placebo arm was 91.0%. As an inclusion criteria for the ExteNET trial, patients needed to have tumors that were HER2 positive using local assessment. In addition, as a pre-defined subgroup in the trial, patients had centralized HER2 testing performed on their tumor as well. To date, centralized HER2 testing has been performed on 1,704 (60%) of the patients in the ExteNET trial, and further central testing on available samples is currently ongoing. For the 1,463 patients whose tumor was HER2 positive by central confirmation, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.002). The 2-year DFS rate for the centrally confirmed patients in the neratinib arm was 94.7% and the 2-year DFS rate for the centrally confirmed patients in the placebo arm was 90.6%. For the patients in the trial whose tumor was HER2 positive by central confirmation, the results of the trial demonstrated that treatment with neratinib resulted in a 51% reduction of risk of disease recurrence including DCIS or death versus placebo (hazard ratio = 0.49, p < 0.001). The 2-year DFS-DCIS rate for the centrally confirmed patients in the neratinib arm was 94.7% and the 2-year DFS rate for centrally confirmed patients in the placebo arm was 90.2%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 49% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.51, p = 0.001). The 2-year DFS rate for the neratinib arm was 95.4% and the 2-year DFS rate for the placebo arm was 91.2%. For the patients in the trial whose tumor was HER2 positive by central confirmation, the results of the trial demonstrated that treatment with neratinib resulted in a 75% reduction of risk of invasive disease recurrence or death (hazard ratio = 0.25, p < 0.001). The 2-year DFS rate for the centrally confirmed patients in the neratinib arm was 97.0% and the 2-year DFS rate for centrally confirmed patients in the placebo arm was 88.4%. “While the use of trastuzumab in the adjuvant setting has led to a reduction in disease recurrence in patients with early stage HER2-positive breast cancer, there remains an unmet clinical need for further improvement in outcome in order to attempt to further reduce this risk of recurrence,” said Professor Arlene Chan, medical oncologist at Mount Hospital and the Vice Chair of the Breast Cancer Research Centre WA. “The results of the ExteNET study demonstrate that we may be able to provide this type of improvement with neratinib to further help the patients with this disease.” “We are very pleased with the results of the ExteNET trial with neratinib. This represents the first trial with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER2 positive breast cancer,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “We are also intrigued by the activity in the hormone receptor positive subgroup of patients, which we believe may be the result of neratinib inhibiting the cross talk between the estrogen receptor and the HER2 receptor and which may help the tumor increase its sensitivity to endocrine therapy. We look forward to proceeding with the regulatory filing for neratinib for the extended adjuvant treatment of breast cancer currently anticipated in the first quarter of 2016.” The Company will host a meeting and webcast to discuss the results of the Phase III ExteNET trial beginning at approximately 7:00 p.m. CDT (8:00 p.m. EDT) on Monday, June 1, 2015. The webcast will be accessible through the Investor Relations section of Puma’s website at http://www.pumabiotechnology.com/ir_events.html and will be archived there for 30 days. Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. This press release contains forward-looking statements, including, but not limited to, statements regarding the development of our drug candidates and the anticipated timing of regulatory filings. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing; the Company’s dependence on PB272, which is still under development and may never receive regulatory approval; the challenges associated with conducting and enrolling clinical trials; the risk that the results of clinical trials may not support the Company’s drug candidate claims; even if approved, the risk that physicians and patients may not accept or use the Company’s products; the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates; the Company’s dependence on licensed intellectual property; and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


News Article | May 27, 2015
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 11:00 a.m. EDT on Wednesday, June 3, at the Jefferies 2015 Healthcare Conference. A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days. Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. Further information about Puma Biotechnology may be found at www.pumabiotechnology.com. This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


NEW YORK--(BUSINESS WIRE)--The following statement is being issued by Levi & Korsinsky, LLP: To: All persons or entities who purchased or otherwise acquired securities of Puma Biotechnology Inc. (“Puma Biotechnology”) (NYSE: PBYI) between July 23, 2014 and May 13, 2015. You are hereby notified that a securities class action lawsuit has been commenced in the United States District Court for the Central District of California. If you purchased or otherwise acquired Puma Biotechnology shares between July 23, 2014 and May 13, 2015, your rights may be affected by this action. To get more information go to: or contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972. There is no cost or obligation to you. The complaint alleges that defendants made false and/or misleading statements and/or failed to disclose that: (a) the Company’s New Drug Application filing would be for a positive early stage breast cancer indication, rather than the previously announced metastatic breast cancer; (b) Puma would need to submit additional safety data from preclinical carcinogenicity studies with its NDA filing, which Puma did not have; (c) the additional studies required would push the timelines for filing the NDA; and (d) the Company overstated results from its Phase III ExteNET Trial. If you suffered a loss in Puma Biotechnology you have until August 3, 2015 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn’t require that you serve as a lead plaintiff. Levi & Korsinsky is a national firm with offices in New York, New Jersey, Connecticut and Washington D.C. The firm’s attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities and shareholder lawsuits. Attorney advertising. Prior results do not guarantee similar outcomes.


News Article | May 11, 2015
Site: www.businesswire.com

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, announced financial results for the first quarter ended March 31, 2015. Unless otherwise stated, all comparisons are for the first quarter 2015 compared to the first quarter 2014. Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss applicable to common stock of $52.5 million, or $1.66 per share, for the first quarter of 2015, compared to a net loss of $19.8 million, or $0.67 per share, for the first quarter of 2014. Adjusted net loss applicable to common stock was $32.4 million, or $1.02 per share, for the first quarter of 2015, compared to adjusted net loss applicable to common stock of $14.7 million, or $0.50 per share, for the first quarter of 2014. Adjusted net loss applicable to common stock 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 adjusted net loss applicable to common stock to reported net loss applicable to common stock, please see the financial tables at the end of this news release. Net cash used in operating activities for the first quarter of 2015 was $50.0 million. At March 31, 2015, Puma had cash and cash equivalents of $155.5 million and marketable securities of $154.9 million, compared to cash and cash equivalents of $38.5 million and marketable securities of $102.8 million at December 31, 2014. Puma's current level of cash and cash equivalents and marketable securities includes net proceeds of approximately $205.0 million from a public offering of the Company's common stock, which was completed in January 2015. “We have continued to make significant progress with the neratinib clinical program thus far in 2015,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “In addition to continuing all of our ongoing neratinib clinical trials, we also initiated a new Phase II trial of PB272 in early-stage HER2-positive breast cancer patients who have received adjuvant treatment with trastuzumab (a population similar to the Phase III ExteNET trial), where patients will receive primary prophylaxis with high dose loperamide in order to attempt to reduce the neratinib-related diarrhea. We anticipate having initial results from this trial in late 2015, which will allow us to include this data in our NDA filing for neratinib in the extended adjuvant setting that is currently anticipated for the first quarter of 2016. In April 2015, we also expanded the second cohort from our Phase II clinical trial of PB272 in patients with solid tumors who have an activating HER2 mutation (basket trial), where the expanded cohort will include patients with HER2 mutated metastatic non-small cell lung cancer. “We expect the pace to continue through 2015 and beyond. In 2015, we expect to (i) present and publish Phase III ExteNET trial results in the extended adjuvant treatment of early stage HER2-positive breast cancer (anticipated mid 2015); (ii) present and publish Phase II results from our NEfERTT trial of PB272 as a first-line treatment for HER2-positive metastatic breast cancer (anticipated in mid-2015); (iii) complete our ongoing Phase II FB-7 trial of PB272 as a neoadjuvant treatment for patients with HER2-positive breast cancer (anticipated in the first half of 2015); (iv) report data from our Phase II trial of PB272 in HER2 non-amplified breast cancer that has a HER2 mutation (anticipated in the second half of 2015); (v) initiate a Phase III trial of the combination of PB272 plus temsirolimus in fourth-line HER2-positive metastatic breast cancer (anticipated in the second half of 2015); (vi) complete the ongoing Phase II trial of PB272 in patients with HER2-positive metastatic breast cancer that has metastasized to the brain (anticipated in the second half of 2015); and (vii) expand additional cohorts in our Phase II basket trial of PB272 in patients with solid tumors with activating HER2 mutations (anticipated in the second half of 2015). Based on GAAP, operating expenses were $52.6 million for the first quarter of 2015, compared to $19.8 million for the first quarter of 2014. Based on GAAP, general and administrative expenses were $7.9 million for the first quarter of 2015, compared to $3.5 million for the first quarter of 2014. Based on GAAP, research and development expenses were $44.7 million for the first quarter of 2015, compared to $16.3 million for the first quarter of 2014. Puma Biotechnology, Inc. is a development stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The Company is initially focused on the development of PB272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2-positive breast cancer and patients with non-small cell lung cancer, breast cancer and other solid tumors that have a HER2 mutation. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. This press release contains forward-looking statements, including statements regarding anticipated timing for regulatory filings and for the commencement and completion of various clinical trials and the announcement of data relative to these trials. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law. In addition to our operating results, as calculated in accordance with GAAP, we use certain non GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net loss and net loss per share, as calculated in accordance with GAAP, as adjusted to remove the impact of employee stock-based compensation. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures. We believe these non-GAAP measures enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods.

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