On November 13, 2017 Pfizer Inc. (NYSE: PFE) reported that Albert Bourla has been named Chief Operating Officer effective January 1, 2018 (Press release, Pfizer, NOV 13, 2017, View Source [SID1234522007]).

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"The naming of a Chief Operating Officer comes at a time when our business is strong as we continue to advance our strategy while also managing a dynamic and challenging external environment, said Ian Read, Pfizer Chairman and CEO.

"The addition of a COO will enable me to spend more time focusing on the company’s long term strategic direction, ensuring continued R&D productivity and engaging with government policy and industry leaders on key issues facing the future of the healthcare industry."

Albert Bourla, 56, has been the Group President of Pfizer’s Innovative Health Business since the beginning of 2016. Under his leadership revenues for the Pfizer Innovative Health business grew 11% operationally in 2016 and in the first nine months of 2017 have grown 9% operationally. Prior to his current position Dr. Bourla was the Group President for Pfizer’s Vaccines, Oncology and Consumer Healthcare businesses where he was instrumental in building a strong and competitive position in Oncology and expanded the company’s leadership in vaccines.

Over the course of his career Dr. Bourla has held a number of senior global positions across a range of businesses and geographies.

Read continued, "Albert is a proven and trusted leader with over two decades of leadership experience and a demonstrated track record for delivering strong business results. He possesses the right combination of skills, knowledge, strengths and a deep commitment to Pfizer’s culture that make him the clear choice to become Pfizer’s COO."

As General Manager of the company’s Established Products Business Unit he advanced the company’s efforts to build a strong post-patent business by spear-heading efforts that maximized the lifecycle of key brands following loss of exclusivity.

Prior to leading the Established Products business, Dr. Bourla was the Area President for Pfizer’s Animal Health business across Europe, Africa, and Asia Pacific where he successfully managed the integration of Wyeth’s Animal Health Business (Fort Dodge) with Pfizer in these global markets.

Dr. Bourla has significant scientific expertise. He is a Doctor of Veterinary Medicine and holds a PhD degree in the Biotechnology of Reproduction from the Veterinary School of Aristotle University.

Effective January 1, 2018 John Young, Group President, Pfizer Essential Health becomes Group President, Pfizer Innovative Health. Angela Hwang, Global President and General Manager for Pfizer Inflammation & Immunology will succeed John Young as Group President, Pfizer Essential Health.

Mr. Young has held a number of senior leadership positions across Pfizer including as President of the Primary Care Business. He is a scientist by training and has deep knowledge of the company’s innovative biopharmaceutical portfolio having led the commercial and clinical development of medicines in key therapeutic areas including cardiovascular disease, diabetes and pain.

Mr. Young received a BSc in Biological Science from Glasgow University and an MBA from Strathclyde Graduate Business School. He will report to Dr. Bourla and will continue to be a member of the company’s Executive Leadership Team.

Ms. Hwang joined the company in 1997 in the company’s Corporate Strategic Planning and Policy Group. Her experience includes leadership roles within the Innovative Health and Essential health businesses as Global President Pfizer Inflammation and Immunology, Regional head for U.S. Vaccines, Vice President of Emerging Markets for the Primary Care business and Vice President of the U.S. Brands business within Essential Health. In her current role she has been responsible for the growth of products such as Xeljanz and Eucrisa and building a strong pipeline around rheumatology, gastroenterology and dermatology.

Ms. Hwang received her Bachelor of Science in Microbiology and Biochemistry from the University of Cape Town and a Masters of Business Administration from Cornell University. She will become a member of the company’s Executive Leadership team and will report to Dr. Bourla.

Additional members of the Pfizer Executive Leadership team reporting to Dr. Bourla will be:

Kirsten Lund-Jurgensen – Executive Vice President and President Pfizer Global Supply

Rod MacKenzie – Executive Vice President, Chief Development Officer

Laurie Olson – Executive Vice President, Strategy and Commercial Operations

In addition to Dr. Bourla, the following members of Pfizer’s Executive Leadership team will continue to report to Ian Read:

Frank D’Amelio – Executive Vice President, Business Operations and Chief Financial Officer

Mikael Dolsten – Executive Vice President and President, Worldwide Research & Development

Chuck Hill – Executive Vice President, Worldwide Human Resources

Rady Johnson – Executive Vice President, Chief Compliance and Risk Officer

Doug Lankler – Executive Vice President, General Counsel

Freda Lewis-Hall – Executive Vice President and Chief Medical Officer

Sally Susman – Executive Vice President, Corporate Affairs

RestorGenex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, RestorGenex, 2017, NOV 13, 2017, View Source [SID1234521952]).

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PDL BioPharma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, PDL BioPharma, 2017, NOV 13, 2017, View Source [SID1234522022]).

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On November 13, 2017 Repros Therapeutics Inc. (Nasdaq:RPRX) reported financial results for the third quarter ended September 30, 2017 (Press release, Repros Therapeutics, NOV 13, 2017, View Source [SID1234521974]).

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Financial Results

Net loss for the three month period ended September 30, 2017, was ($1.6) million or ($0.04) per share as compared to a net loss of ($4.2) million or ($0.17) per share for the same period in 2016. The decreased loss for the three month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased clinical development expenses related to the Company’s Proellex and enclomiphene product candidates, as well as decreased R&D payroll and benefits expenses and legal expenses. The Company recorded, in other income, a change in fair value of the warrant liability for the three month period ended September 30, 2017, in the amount of $295,000.

Net loss for the nine month period ended September 30, 2017, was ($9.7) million or ($0.32) per share as compared to a net loss of ($13.3) million or ($0.55) per share for the same period in 2016. The decreased loss for the nine month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased clinical development expenses related to the Company’s Proellex and enclomiphene product candidates, as well as decreased R&D payroll and benefits expenses and legal expenses, partially offset by expenses associated with the departure of the Company’s former President and Chief Executive Officer.

For the three month period ended September 30, 2017, research and development ("R&D") expenses decreased 69%, or approximately $2.2 million, to $979,000, as compared to $3.2 million for the same period in the prior year. For the nine month period ended September 30, 2017, R&D expenses decreased 59%, or approximately $6.0 million, to $4.2 million, as compared to $10.2 million for the same period in the prior year. The decreases in both the three and nine month periods were primarily due to the decreased expenses related to the Company’s Proellex and enclomiphene product candidates in 2017, as well as decreased R&D payroll and benefits expenses and legal expenses.

General and administrative ("G&A") expenses decreased 6%, or approximately $57,000, to $940,000 for the three month period ended September 30, 2017, as compared to $997,000 for the same period in the prior year and increased 81%, or approximately $2.6 million, to $5.7 million for the nine month period ended September 30, 2017, as compared to $3.1 million for the same period in the prior year. The decrease in the three month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to decreased non-cash stock based compensation, partially offset by an increase in professional services. The increase in the nine month period ended September 30, 2017, as compared to the same period in the prior year, was primarily due to a charge of $2.8 million related to the departure of the former officer, partially offset by a decrease in non-cash stock based compensation.

Total revenues and other income increased to $304,000 for the three month period ended September 30, 2017 as compared to $10,000 for the same period in the prior year. Total revenues and other income increased to $158,000 for the nine month period ended September 30, 2017 as compared to $41,000 for the same period in the prior year. The increases in revenues and other income in both periods were primarily due to the change in the fair value of the warrants issued by the Company in May 2017 during the three and nine month periods ended September 30, 2017. Excluding the change in the fair value of the warrants, revenues and other income decreased in both periods primarily due to lower cash balances during the three and nine month periods ended September 30, 2017, as compared to the comparable periods in the prior year.

Liquidity and Capital Resources

The Company had cash and cash equivalents of approximately $1.8 million as of September 30, 2017 as compared to $8.7 million as of December 31, 2016. Net cash of approximately $8.5 million and $12.5 million was used in operating activities during the nine month periods ended September 30, 2017 and 2016, respectively. The major use of cash for operating activities for the nine month period ended September 30, 2017 was to fund our clinical development programs and associated administrative costs. No cash was used in investing activities during the nine month period ended September 30, 2017. Cash provided by financing activities for the nine month period ended September 30, 2017 was approximately $3.5 million primarily from the May Public Offering.

Nasdaq Listing

As disclosed by the Company in a Current Report on Form 8-K filed with the Securities and Exchange Commission on November 13, 2017, on November 8, 2017, the Company received notification from The NASDAQ Stock Market LLC that, pending a hearing, the Company’s common stock will be delisted from Nasdaq. As further described in the Form 8-K, the Company intends to timely request a hearing before the Nasdaq Hearings Panel, which request will stay any suspension or delisting action by Nasdaq at least until the hearing process concludes and any extension granted expires. As such, the November 8, 2017 notice has no immediate effect on the listing of the common stock and the common stock will continue to trade on the NASDAQ Capital Market under the symbol "RPRX" at least until the hearing process concludes and any extension granted by the hearings panel expires.

As of September 30, 2017, we had 39,489,807 shares of common stock outstanding.

On November 13, 2017 Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2017, and provided an update on the Company’s business and product development programs (Press release, Reata Pharmaceuticals, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316419 [SID1234521972]).

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Financial Highlights

The Company incurred operating expenses of $24.6 million for the quarter ended September 30, 2017, with research and development accounting for $18.3 million. This compares to operating expenses of $13.5 million for the same period of the year prior, when research and development accounted for $9.3 million. A net loss of $12.3 million was reported by the Company for the quarter ended September 30, 2017, equating to a loss of $0.50 per share, compared to net loss of $0.9 million or $0.04 per share in the same period of the year prior.

The Company incurred operating expenses of $68.5 million for the nine months ended September 30, 2017, with research and development accounting for $50.8 million. This compares to operating expenses of $40.0 million for the same period of the year prior, when research and development accounted for $27.7 million. A net loss of $31.0 million was reported by the Company for the nine month period ended September 30, 2017, equating to a loss of $1.34 per share, compared to net loss of $2.1 million or $0.11 per share in the same period of the year prior.

Corporate Highlights

As of September 30, 2017, the Company had $154.6 million in cash and cash equivalents.

On November 3, 2017, the Company amended its loan agreement (Amended Loan Agreement) with Oxford Finance LLC and Silicon Valley Bank to increase its Term B Loan amount from $15.0 million to either $20.0 million or $25 million. The Company may, at its sole discretion, borrow $20 million under Term B Loan. An additional $5 million will be available under the Term B Loan for a total of $25 million upon the achievement of one of two milestones. The Company may borrow the Term B Loan by the earlier of 90 days after the achievement of a milestone or June 29, 2018. If the Term B Loan is drawn, the interest-only payment period would be extended by six months.

Product Development Highlights

Bardoxolone Methyl in Rare Kidney Diseases

Chronic Kidney Disease (CKD) Caused by Alport Syndrome

In August, 2017, Reata began enrolling patients in the Phase 3 portion of CARDINAL, a double-blind, randomized, placebo-controlled, multi-center, international trial in patients with CKD caused by Alport syndrome. The trial will enroll approximately 150 patients randomized evenly to either bardoxolone methyl or placebo. The primary endpoint of the trial will be the change from baseline in estimated glomerular filtration rate (eGFR) at 48 weeks while the patient is on treatment, or on-treatment eGFR, and again at 52 weeks after the patient has stopped taking the study drug for a four-week withdrawal period, or retained eGFR. Based upon guidance from the United States Food and Drug Administration (FDA), the year one retained eGFR benefit data may support accelerated approval under subpart H. After withdrawal, patients will be restarted on study drug with their original treatment assignments and will continue on study for a second year, with on-treatment eGFR change measured at 100 weeks, and the retained eGFR benefit after withdrawal of drug for four weeks at week 104. Based upon guidance from the FDA, the year two retained eGFR benefit data may support full approval.

On November 3, 2017, the Company presented positive primary and other 12-week data from the 30 patients in the Phase 2 portion of CARDINAL at the 2017 American Society of Nephrology Kidney Week Annual Meeting (ASN). The Phase 2 study met its primary efficacy endpoint with bardoxolone significantly increasing eGFR after 12 weeks of treatment (p<0.000000001). All patients had an increase from baseline, with a mean increase of 13.4 mL/min/1.73 m2, and 87% had an increase of at least 4 ml/min/1.73 m2, which is the approximate annual rate of decline in kidney function in patients with Alport syndrome. The increases in eGFR translated to an improvement in CKD stage for 22/30 (73%) patients. No serious adverse events were reported, and adverse events were generally mild to moderate in intensity.

On November 4, 2017, Reata’s partner, Kyowa Hakko Kirin, presented results of the TSUBAKI study at ASN. In TSUBAKI, bardoxolone demonstrated statistically significant and clinically meaningful increases in directly-measured glomerular filtration rate (GFR) in patients with type 2 diabetes and CKD using the "gold standard" inulin clearance method. The observed increase in GFR demonstrates that historical increases in eGFR produced by bardoxolone in various forms of CKD, including Alport syndrome, reflect a true increase in kidney function. Bardoxolone demonstrated a favorable safety profile with no effect on blood pressure, urinary volume or sodium retention, and no evidence of overt fluid overload or cardiac toxicity.

Bardoxolone Methyl in Other Rare Kidney Diseases

Based upon results of the Phase 2 portion of CARDINAL, Reata began activating sites in October, 2017 for PHOENIX, a Phase 2 trial of bardoxolone methyl in various rare forms of CKD, including autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic CKD, and focal segmental glomerulosclerosis. Similar to the Phase 2 portion of CARDINAL, PHOENIX is an open-label trial of bardoxolone orally-administered once-daily for 12 weeks. The primary efficacy endpoint is change from baseline in eGFR at week 12. Approximately 20 to 30 patients will be enrolled per cohort.

Omaveloxolone in Friedreich’s Ataxia (FA)

In October, 2017, the Company began enrolling patients in part 2 of the Phase 2 MOXIe trial, a double-blind, randomized, placebo-controlled, multi-center, international trial in patients with FA. The trial will enroll approximately 100 FA patients randomized evenly to either omaveloxolone or placebo. The primary endpoint of the trial will be the change from baseline in modified Friedreich’s Ataxia Rating Scale (mFARS) of omaveloxolone compared to placebo at 48 weeks. Based upon communications with the FDA, it may consider either accelerated or full approval of omaveloxolone for FA based upon the overall results of the trial and strength of the data.

Bardoxolone Methyl in Pulmonary Arterial Hypertension associated with Connective Tissue Disease

In October, 2016, Reata began enrolling patients in CATALYST, an international, randomized, double-blind, placebo-controlled Phase 3 trial in patients with pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH). Patients will be on up to two standard-of-care vasodilator therapies and will be randomized evenly to either bardoxolone methyl or placebo. The trial will enroll between 130 and 200 patients, with the final sample size determined by a pre-specified, blinded sample size re-calculation based upon 6MWD variability and baseline characteristics of the first 100 patients enrolled in the trial. The primary endpoint of the study is the change from baseline in 6-minute walk distance (6MWD) relative to placebo at Week 24.