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]).

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"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.

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]).

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Third quarter 2016 results:
•
As previously announced on October 10, 2016, revenue of $607 million, a 10% increase compared to $550 million in the third quarter of 2015
•
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
•
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
•
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
•
Appointed Philip W. Schiller to the company’s Board of Directors
•
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).

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]).

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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.

On November 1, 2016 Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) reported unaudited results for the three months ended September 30, 2016 (Press release, Shire, NOV 1, 2016, View Source [SID1234516161]).

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Financial Highlights Q3 2016(1) Growth(1) Non GAAP CER(1)(2)
Product sales $3,315 million +110% +111%
Product sales excluding Baxalta products $1,769 million +12% +13%
Total revenues $3,452 million +109% +109%
US GAAP operating loss from continuing operations ($406 million) (189%)
Non GAAP operating income(2) $1,254 million +73% +71%
US GAAP net income margin(3)(4) (11%) (38ppc)
Non GAAP EBITDA margin(2)(4) 38% (5ppc)
US GAAP net loss ($387 million) (185%)
Non GAAP net income(2) $962 million +50%
US GAAP diluted losses per ADS ($1.29) (156%)
Non GAAP diluted earnings per ADS(2) $3.17 (2%) (3%)
US GAAP net cash provided by operating activities $526 million (6%)
Non GAAP cash generation(2) $830 million +41%
Non GAAP free cash flow(2) $395 million (27%)

(1)Results include Baxalta Inc. (Baxalta) (acquired on June 3, 2016) and Dyax Corp. (Dyax) (acquired on January 22, 2016), unless otherwise noted. Percentages compare to equivalent 2015 period.
(2)The Non GAAP financial measures included within this release are explained on pages 27 – 28, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 21 – 23.
(3)US GAAP net income as a percentage of total revenues.
(4) Percentage point change ("ppc").

Financial highlights

Very strong launch results for XIIDRA; 64,732 scripts written through October 21, with a market share of 16%.
Product sales growth of 110% in Q3 2016 to $3.3 billion, driven by record legacy Shire product sales and the inclusion of legacy Baxalta franchises.
Underlying growth in Q3 2016 hematology and immunology businesses largely in line with overall market trends; pro forma sales growth of legacy Baxalta products impacted by the timing of large orders.
Q3 2016 year to date growth for legacy Shire product sales was 15% (16% on a Non GAAP CER basis) and legacy Baxalta was 7% on a pro forma basis (8% on a Non GAAP CER pro forma basis), in line with our expectations.
Baxalta integration

Operating expense synergy initiatives ahead of schedule, including manufacturing footprint optimization review.
Sharp focus on transitioning legacy Baxalta products onto Shire’s commercial platform and operating execution.
Issued $12.1 billion aggregate principal debt at a weighted average interest rate of 2.6%; net proceeds used to fully repay bridge facility for financing Baxalta transaction.
Pipeline progress

Pipeline continuing to deliver with U.S. Food and Drug Administration (FDA) approval of CUVITRU, and European Commission (EC) Marketing Authorization for ONIVYDE accompanied by Orphan Drug Designation.
Fully enrolled Phase 3 study for SHP643 in prophylaxis of hereditary angioedema with results expected in the first half of 2017.
FDA resubmission of SHP465 for the treatment of ADHD on track to be made in Q4 2016.
Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

"During the third quarter, we made rapid progress integrating our new company while delivering record quarterly product sales growth and remaining on track to meet our full year Non GAAP guidance. The launch of XIIDRA is off to a very strong start, and we are using this momentum to build a leadership position in pharmaceutical ophthalmics. Commercial execution remains a top priority across the business. Also, our robust pipeline is continuing to advance, and we look forward to highlighting key programs during our upcoming Investor Day. The changes we are applying to the legacy Baxalta business are similar to the One Shire initiative we undertook in 2013-2014, which set off a period of strong growth and profitability. I am highly confident about Shire’s future growth prospects."

On November 1, 2016 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported financial results for the third quarter and nine months ended September 30, 2016 (Filing, Q3, Rigel, 2016, NOV 1, 2016, View Source [SID1234516160]).

During the third quarter of 2016, Rigel accomplished a number of noteworthy milestones, most importantly, the announcement of topline results for its FIT Phase 3 clinical studies of fostamatinib in ITP. Additionally, the company undertook a restructuring to focus resources on building a commercial enterprise, and appointed executive-level members to the management team that will move Rigel forward toward its goals.

"We believe that the collective data from the FIT Phase 3 clinical program of fostamatinib support a clear treatment effect, a sustained clinical benefit and a positive benefit-risk profile," said Raul Rodriguez, president and chief executive officer of Rigel. "We look forward to discussing the top-line FIT program results with the FDA in the very near future, and obtaining their feed-back on our plan to submit an NDA. Assuming a successful discussion, we expect to submit the NDA in the first quarter of 2017."

For the third quarter of 2016, Rigel reported a net loss of $22.6 million, or $0.24 per basic and diluted share, compared to a net loss of $6.7 million, or $0.08 per basic and diluted share, in the same period of 2015.

Contract revenues from collaborations of $3.8 million in the third quarter of 2016 represent the remaining amortization of the $30.0 million upfront payment pursuant to Rigel’s collaboration and license agreement with Bristol-Myers Squibb (BMS). Contract revenues from collaborations of $13.0 million in the third quarter of 2015 were primarily comprised of an $8.0 million upfront payment from Aclaris Therapeutics International Limited pursuant to the license agreement executed in August 2015 for the development and commercialization of certain Rigel JAK inhibitors, as well as $4.8 million from the amortization of the upfront payment with BMS.

In September 2016, Rigel announced that it had reduced its workforce by 46 positions, mostly in the research area. Rigel recorded restructuring charges during the third quarter of 2016 of approximately $5.8 million, which included $5.0 million of severance costs paid or to be paid in cash, $319,000 impairment of certain property and equipment, and $499,000 of non-cash stock-based compensation expense as a result of the modification of Rigel’s former executive’s stock options.

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Rigel reported total costs and expenses of $26.5 million in the third quarter of 2016, compared to $19.8 million for the same period in 2015. The increase in costs and expenses was primarily due to restructuring charges incurred in the third quarter of 2016.

For the nine months ended September 30, 2016, Rigel reported a net loss of $53.6 million, or $0.58 per basic and diluted share, compared to a net loss of $38.8 million, or $0.44 per basic and diluted share, for the same period of 2015.

As of September 30, 2016, Rigel had cash, cash equivalents and short-term investments of $85.3 million, compared to $126.3 million as of December 31, 2015. Rigel expects this amount to be sufficient to fund its operations through the end of 2017. In this forecast, Rigel has allocated substantial funds to continue efforts in preparation of the potential commercial launch of fostamatinib in ITP in the U.S. Rigel also continues to evaluate ex-U.S. partnerships for fostamatinib and other partnering opportunities across its pipeline.

Company and Portfolio Update

Fostamatinib FIT Phase 3 Program

In August and October 2016, respectively, Rigel announced results of two identical Phase 3 clinical studies, FIT 1 (Study 047) and FIT 2 (Study 048), of fostamatinib in adult chronic/persistent immune thrombocytopenia (ITP). Study 047 met the primary endpoint in a statistically significant manner, with 18% of the patients in the fostamatinib arm achieving stable platelet response of greater than 50,000 platelets per μL of blood on at least four of the last scheduled visits between weeks 14 and 24 of treatment and no patients on placebo meeting the stable platelet response criteria (p=0.0261). Study 048, which also had an 18% responder rate for the fostamatinib subjects, did not achieve a statistically significant distinction between the treatment and placebo cohorts (p=0.15) because a single placebo patient met the stable platelet response criteria. When the data from the two studies are combined (n=150), the difference between the fostamatinib and placebo groups would be statistically significant (p=0.007).

Rigel also announced in October 2016 that as of June 2016, the open-label long-term extension study (Study 049), was tracking the experience of 118 patients who opted to receive treatment with fostamatinib after completing either Study 047 or Study 048. Patients who responded to fostamatinib in the parent studies had achieved a median platelet count of 96,000/μL in Study 049. In addition, there were 36 patients out of 43 who were placebo non-responders in the parent studies who had a minimum of 12 weeks of follow-up in the extension study. Of those, 6 patients (17%) have achieved a prospectively defined stable platelet response, which is statistically significant and similar to the response rate fostamatinib achieved in the parent studies.

Rigel believes that the data from the FIT Phase 3 clinical program (comprised of Study 047, 048 and 049) demonstrate that fostamatinib works effectively for some ITP patients, providing a substantial and enduring clinical benefit in a disease that has proven difficult to manage for many physicians and patients. This benefit was consistent across all sub-groups analyzed including TPO (blood platelet production booster) experienced patients who have limited treatment options remaining.

Rigel is continuing its work on compiling the NDA, which it plans to file in the first quarter of 2017, pending positive feedback from discussions of the data with the FDA.

Restructuring to Focus on Commercialization

Following the release of the results for Study 047, Rigel announced a restructuring and plans to build a commercial organization to support the potential launch of fostamatinib. The restructuring reduced the size of the research department while maintaining Rigel’s most advanced and promising projects. The savings from the restructuring will be devoted to support the commercialization of the company’s first potential drug product as well as extending the company’s financial runway.

As part of the restructuring announcement in September, the first of Rigel’s new management team members was introduced; Eldon Mayer joined the company as its first chief commercial officer. Mr. Mayer will be responsible for establishing and managing a commercial organization that will lead the launch of fostamatinib. He brings pharmaceutical marketing and sales management experience to Rigel, having most recently led Questcor Pharmaceuticals’ commercial strategy and operations.

This quarter Rigel made additional key senior management appointments to drive the organization forward. Esteban Masuda, Ph.D. was appointed senior vice president research and will lead Rigel’s refocused research efforts. Joe Lasaga was appointed vice president business development and alliance management and will lead Rigel’s effort to partner certain assets including ex-U.S. partnerships for fostamatinib.

Clinical Portfolio Update

Fostamatinib Phase 2 Study in IgA Nephropathy (IgAN)

Rigel is conducting a global Phase 2, double blind, placebo-controlled study of fostamatinib in IgAN consisting of two sequential dose cohorts (100mg BID, followed by 150 mg BID). Enrollment for the first cohort has been completed and the company expects to report those results by the end of 2016. The second cohort is currently enrolling patients.

Fostamatinib Phase 2 Study in Autoimmune Hemolytic Anemia (AIHA)

Rigel is conducting a Phase 2, open-label, multi-center, two-stage study that will evaluate the safety and efficacy of fostamatinib in patients with warm antibody AIHA who have previously received treatment for the disorder, but have relapsed. Results of the Stage 1 segment of the trial are expected in 2017.