On August 8, 2018 Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with kidney disease, reported its financial results for the second quarter ended June 30, 2018 (Press release, Keryx Biopharmaceuticals, AUG 8, 2018, View Source [SID1234528540]). The company also reviewed its commercial progress with Auryxia and provided a general business update.

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"We are very pleased with the continued strong performance of Auryxia, which is a testament to the appreciation physicians have for the product profile and to the commitment and drive of our commercial and field-based teams," said Jodie Morrison, interim chief executive officer of Keryx Biopharmaceuticals. "On June 28th, we announced that Keryx had entered a definitive merger agreement with Akebia Therapeutics that will create a fully integrated company focused on the development and commercialization of therapeutics for patients with chronic kidney disease. We believe that the combined company will be well positioned to create significant shareholder value and accelerate growth beyond what either company would achieve separately."

Business Highlights

Net U.S. Auryxia product sales were $24.1 million in the second quarter of 2018, as compared to $14.1 million in the same quarter in 2017, representing growth of 71 percent.
Approximately 42,500 Auryxia prescriptions were reported in the second quarter of 2018, representing 8.4 million Auryxia tablets. This compares to approximately 21,100 prescriptions and 4.5 million Auryxia tablets in the second quarter of 2017.
The breadth and depth of physicians prescribing Auryxia continued to expand in the second quarter of 2018 compared to the same period in 2017, with approximately 50 percent more physicians writing Auryxia prescriptions and prescribers on average writing Auryxia for more of their patients.
On June 28, 2018, Keryx announced that it had entered a definitive merger agreement with Akebia Therapeutics, Inc. that is expected to close by the end of 2018, subject to shareholder approvals and customary closing conditions. If approved, Keryx shareholders would gain access to an innovative Phase 3 product candidate with the potential to compete in a complementary multi-billion-dollar market upon successful completion of its development program. Additionally, Keryx shareholders gain a seasoned executive with decades of experience in the renal field to lead the combined organization.
Second Quarter Ended June 30, 2018 Financial Results

"Revenue growth in the second quarter of 2018, as compared to the second quarter of 2017, was driven by significant increases in Auryxia prescription and tablet demand," said Scott Holmes, senior vice president and chief financial officer of Keryx Biopharmaceuticals. "Post the close of the second quarter we established an asset-based revolving credit facility with Silicon Valley Bank for up to $40 million. We believe this non-dilutive financing instrument will provide financial flexibility to our company as we continue to increase demand for Auryxia in both indications."

Total revenues for the quarter ended June 30, 2018 were $25.7 million, compared with $15.1 million during the same period in 2017. Total revenues for the second quarter of 2018 include $24.1 million in net U.S. Auryxia product sales, as compared to $14.1 million in the second quarter of 2017. Total revenues for the second quarter of 2018 also include $1.6 million in license revenue, as compared to $1.0 million during the same period in 2017.

Cost of goods sold for the quarter ended June 30, 2018 were $7.4 million, compared with $4.4 million during the same period in 2017.

Selling, general and administrative expenses for the quarter ended June 30, 2018 were $28.7 million, as compared to $25.0 million during the same period in 2017. Selling, general and administrative expenses for the quarter ended June 30, 2018 included $4.4 million in non-cash stock compensation expense, as compared to $3.2 million during the second quarter of 2017.

Research and development expenses for the quarter ended June 30, 2018 were $8.8 million, as compared to $9.0 million during the same period in 2017. Research and development expenses for the quarter ended June 30, 2018 included $0.6 million in non-cash stock compensation expense, as compared to $0.5 million during the same period in 2017.

Net loss for the quarter ended June 30, 2018 was $21.5 million, or $0.18 per share, as compared to a net loss of $86.5 million, or $0.77 per share, for the same period in 2017. Net loss for the quarter ended June 30, 2018 included $1.3 million in non-cash interest expense related to the amortization of a discount recognized in connection with the modification of the convertible senior notes. Net loss for the quarter ended June 30, 2017 included $63.0 million in non-cash charges related to the restructuring of our convertible debt.

Cash and cash equivalents as of June 30, 2018 totaled $49.5 million.

Conference Call Information
Keryx Biopharmaceuticals will host an investor conference call today, August 8, 2018, at 8:00 a.m. ET to discuss financial results for the second quarter of 2018. To participate in the conference call, please dial (888) 584-2172, (774) 264-7578 (international) and refer to conference ID: 9756999. The call will be webcast live with slides and accessible through the Investors section of the company’s website at www.keryx.com for a period of 15 days after the call.

About Auryxia (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration (FDA) on September 5, 2014 for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis. Auryxia tablets were designed to contain 210 mg of ferric iron, equivalent to 1 gram of ferric citrate, and offers convenient mealtime dosing. The starting dose of Auryxia for the treatment of hyperphosphatemia for patients on dialysis is six tablets per day (two per meal) and for the treatment of iron deficiency anemia in patients not on dialysis is three tablets per day (one per meal). For more information about Auryxia and the U.S. full prescribing information, please visit www.Auryxia.com.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate)

CONTRAINDICATION

AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS

Most common adverse reactions with AURYXIA were:

Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)
SPECIFIC POPULATIONS

Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact Keryx Biopharmaceuticals at 1-844-445-3799.

Please click here to view the Full Prescribing Information for Auryxia.

On August 8, 2018 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported financial and operating results for the six months ended June 30, 2018 (Press release, Trillium Therapeutics, AUG 8, 2018, View Source [SID1234528539]).

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"We are continuing to build upon the observed single-agent activity of TTI-621, our lead CD47 blocking agent, in T cell lymphoma patients, and are also now dosing patients with TTI-622, our second SIRPaFc decoy receptor," said Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics. "With two unique CD47-directed therapies in clinical testing, and strong support and enthusiasm from our clinical collaborators, we continue our role as a leader in the field of CD47 research."

2018 Second Quarter Highlights:

Based on clinical observations in the TTI-621 intravenous trial, the company has refined its monotherapy efforts to focus on T cell malignancies, specifically T cell lymphomas. Combination cohorts with rituximab and nivolumab continue to enroll. Patients with cutaneous T cell lymphoma and Sezary syndrome are being enrolled in the expansion phase of the intratumoral trial, receiving continued weekly injections. In both trials, new clinical investigators and sites with experience in the treatment of T cell lymphoma are being added.
The company initiated dosing in its two-part, multicenter, open-label, phase 1a/1b clinical trial of TTI-622 (SIRPaFc-IgG4), a checkpoint inhibitor of the innate immune system, in relapsed or refractory lymphoma or myeloma. In the phase 1a dose-escalation part, patients will be enrolled in sequential dose cohorts to receive TTI-622 once weekly to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose. In the phase 1b part, patients will be treated with TTI-622 in combination with rituximab, a proteasome inhibitor-containing regimen, or a PD-1 inhibitor.
Yaping Shou MD, PhD, joined Trillium as Chief Medical Officer. Dr. Shou has more than 18 years of industry experience spanning clinical development and translational medicine, with a strong focus in oncology. She most recently served as Executive Medical Director at Takeda Pharmaceuticals, where she also held several other clinical leadership positions over the past seven years.
Trillium entered into a Second Amended and Restated License Agreement with the licensors of the SIRPaFc technology and removed the sublicense revenue sharing provisions in return for a payment to the Licensors of $3.0 million in the form of 369,621 common shares. Trillium believes the amendments to the agreement provide the company with greater financial potential and flexibility in any future partnership discussions.
Second Quarter 2018 Financial Results:

As of June 30, 2018, Trillium had cash and cash equivalents and marketable securities, and working capital of $64.7 million and $53.4 million, respectively, compared to $81.8 million and $68.9 million, respectively at December 31, 2017. The decrease in cash and cash equivalents and marketable securities was due mainly to cash used in operations of $20.0 million, net of an unrealized foreign exchange gain of $3.0 million. The decrease in working capital was due mainly to cash used in operations, an increase to prepaid expenses, and a decrease to accounts payable and accrued liabilities due to clinical trial payments.

Net loss for the six months ended June 30, 2018 of $20.9 million was lower than the loss of $23.1 million for the six months ended June 30, 2017. The net loss was lower due mainly to a net foreign currency gain of $3.0 million for the six months ended June 30, 2018, compared to a net foreign currency loss of $2.6 million in the prior year period, and lower manufacturing costs, partially offset by higher clinical trial expenses and the expense relating to the amendment of the SIRPaFc license agreement.

On August 8, 2018 German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) and I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech company focused on innovative biologics in oncology and autoimmune diseases, reported that I-Mab has submitted an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody directed against CD38 for the treatment of multiple myeloma (Press release, MorphoSys, AUG 8, 2018, View Source [SID1234528538]).

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Multiple myeloma is the second most common blood cancer worldwide. The patient number has gradually increased in China in recent years due to an increasingly aging population. Yet there are no effective biologics approved in China for this indication and current therapies have been associated with serious side effects and limited treatment efficacy.

TJ202/MOR202 is a monoclonal antibody derived from MorphoSys’s HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, and, according to its suggested mode of action, recruits cells of the body’s immune system to kill the tumor. Scientific research suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers, as well as autoimmune diseases.

China recently issued a new round of reform initiatives to accelerate clinical trial approval for new drugs, especially in oncology. "The IND submission was done after a successful pre-submission consultation meeting with Center for Drug Evaluation (CDE) of CNDA, which is required under China’s new drug regulation, unless waived," said Dr. Joan Shen, Head of R&D at I-Mab.

"CNDA has endorsed the overall clinical and regulatory strategy, as well as the study designs, which should lead to the biologics license application (BLA)," said Dr. Joan Shen.

Through a licensing agreement with MorphoSys AG in November 2017, I-Mab gained exclusive rights to develop and commercialize TJ202/MOR202 in Greater China territory, including mainland China, Hong Kong, Macau and Taiwan.

After observing patient responses in an interim analysis from an ongoing Phase 1/2a trial in patients with relapsed/refractory multiple myeloma in Germany and Austria, MorphoSys decided to support I-Mab to lead clinical development of TJ202/MOR202 in Greater China. MorphoSys will continue to evaluate additional other suitable indications for further global development of TJ202/MOR202.

Dr. Malte Peters, Chief Development Officer of MorphoSys AG commented: "We are delighted that our partner I-Mab has taken this important step in advancing TJ202/MOR202 into clinical development in China. We look forward to supporting I-Mab in developing this investigational compound with the goal of helping Chinese patients in multiple myeloma, an indication with a high unmet medical need."

"With a fast-to-market strategy under the new drug regulation, we hope to bring this innovative treatment to patients as soon as possible," Dr. Shen commented. "MorphoSys and I-Mab plan to continuously evaluate the potential and further development of TJ202 in other indications."

On August 8, 2018 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the second quarter ended June 30, 2018 (Press release, Nektar Therapeutics, AUG 8, 2018, View Source [SID1234528537]).

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Cash and investments in marketable securities at June 30, 2018 were $2.1 billion as compared to $353.2 million at December 31, 2017. This includes the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our Bristol-Myers Squibb collaboration for the global development and commercialization of NKTR-214.

"Over the past few months, we have reported significant progress across all areas of our pipeline, with notable milestones for our immuno-oncology, immunology and pain programs," said Howard W. Robin, President and CEO of Nektar. "Together with Bristol-Myers Squibb, we plan to initiate 20 registrational studies in nine tumor settings under our joint development plan with the first wave of studies in melanoma, renal cell carcinoma, and urothelial cancers starting this year. We initiated our first study of NKTR-358 in patients with lupus with our partner Eli Lilly. And importantly, we recently achieved a significant milestone for our pain program, with the FDA’s acceptance of the NDA filing for NKTR-181, a first-in-class opioid analgesic."

Revenue in the second quarter of 2018 was $1.088 billion as compared to $34.6 million in the second quarter of 2017. Year-to-date revenue for 2018 was $1.126 billion as compared to $59.3 million in the first half of 2017. Revenue was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

Total operating costs and expenses in the second quarter of 2018 were $114.1 million as compared to $85.2 million in the second quarter of 2017. Total operating costs and expenses in the first half of 2018 were $238.9 million as compared to $164.4 million in the first half of 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the second quarter of 2018 was $88.3 million as compared to $60.3 million in the second quarter of 2017. For the first half of 2018, R&D expense was $187.8 million as compared to $121.3 million in the first half of 2017. R&D expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of NKTR-214 in Phase 1/2 studies and Phase 3 preparatory activities, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $20.3 million in the second quarter of 2018 as compared to $16.0 million in the second quarter of 2017. G&A expense in the first half of 2018 was $38.9 million as compared to $28.0 million in the first half of 2017. G&A expense was higher in the second quarter and first half of 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock based compensation expense.

Net income in the second quarter of 2018 was $971.5 million or $5.33 diluted earnings per share as compared to a net loss of $59.9 million or $0.39 basic and diluted loss per share in the second quarter of 2017. Net income in the first half of 2018 was $875.7 million or $4.91 diluted earnings per share as compared to a net loss of $123.7 million or $0.80 basic and diluted loss per share in the first half of 2017.

Second Quarter 2018 and Recent Business Highlights

In July, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. The NDA has been assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 29, 2019 by the FDA.
In June, Nektar presented data for NKTR-181 at the 80th Annual Scientific Meeting of the College on Problems of Drug Dependence. The data show that NKTR-181 consistently demonstrates low abuse potential.
In June, Nektar presented data from the Phase 1 dose escalation and preliminary data from the Phase 2 dose expansion phase of the ongoing PIVOT study for NKTR-214 in combination with Opdivo (nivolumab) at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. This data showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. Nektar and Bristol-Myers Squibb expect to initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.
In May, Nektar announced a clinical collaboration with Syndax Pharmaceuticals to evaluate NKTR-214 in combination with entinostat, an oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 agent.
In May, Nektar began dosing patients with systemic lupus erythematosus in a Phase 1b multiple ascending dose study of NKTR-358, a first-in-class regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.
The company also announced the following upcoming presentations during the second half of 2018:

American Chemical Society Annual Meeting, Boston, MA:

Oral Presentation: "Confronting the Opioid Epidemic: Novel Treatments for Chronic Pain"
Presenter: Stephen Doberstein, Ph.D., Nektar Therapeutics
Date: Monday, August, 20, 2018, 1:35 p.m. – 2:05 p.m., Eastern Daylight Time
SMI Immuno-Oncology Conference, London, UK:

Oral Presentation: "Enhanced cancer vaccine effectiveness with NKTR-214, a CD122-biased cytokine"
Presenter: Loui Marakamutil, Ph.D., Nektar Therapeutics
Date: September 26, 2018, 11:00 a.m., British Summer Time
Ninth American Conference on Pharmacometrics, San Diego, CA:

Poster: "NKTR-255 Exhibits Target Mediated Drug Disposition and Stimulates Proliferation of Cytotoxic Immune Cells in Cyonomolgous Monkeys", Bhasi, K., et al.
Date: October 6-12, 2018
ESMO 2018 Congress, Munich, Germany:

Poster 362TiP: "ATTAIN: Phase 3 study of etirinotecan pegol (EP) vs treatment of physician’s choice (TPC) in patients (pts) with metastatic breast cancer (MBC) who have stable brain metastases (BM) previously treated with an anthracycline, a taxane, and capecitabine (ATC).", Tripathy, D., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Poster 446TiP: "REVEAL: A phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-262 [TLR 7/8 agonist] plus NKTR-214 [CD122-biased agonist] with or without nivolumab (nivo) in patients (pts) with locally advanced or metastatic solid tumor malignancies.", Diab, A., et al.
Date: October 22, 2018, 12:45-13:45 p.m. Central European Summer Time
Conference Call to Discuss Second Quarter 2018 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Wednesday, August 8, 2018.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, September 10, 2018.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)

Passcode: 7099844 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On August 8, 2018 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), reported financial results for the second quarter of 2018 and provided an update on the commercial launch of TAVALISSE and the clinical development pipeline (Press release, Rigel, AUG 8, 2018, View Source [SID1234528536]).

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Recent Highlights:

On May 29, Rigel launched TAVALISSE (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
The TAVALISSE commercial team, at over 50 employees strong, is fully deployed and supporting ITP-prescribing physicians across the United States.
RIGEL ONECARE, Rigel’s comprehensive physician and patient support center, is assisting patients with access to TAVALISSE through insurance coverage and other patient support programs.
"The second quarter of 2018 marked Rigel’s pivotal transition to a commercial stage company with the successful launch of TAVALISSE. We are truly excited to be communicating TAVALISSE’s attractive value proposition to patients, physicians and payers: namely, its unique mechanism of action that targets an underlying cause of the disease, efficacy, oral dosing, safety profile, and comprehensive patient support and access programs", stated Raul Rodriguez, president and CEO of Rigel. "Beyond executing on our goal of making TAVALISSE a commercial success in chronic ITP following steroid treatment, the company continues to make exciting pipeline progress that we expect will fully leverage the commercial capabilities we now have in place. We look forward to providing a comprehensive corporate and pipeline update at our upcoming Investor and Analyst Day, which will be held in New York City this fall."

Financial Update
For the second quarter of 2018, Rigel reported a net loss of $25.6 million, or $0.16 per share, compared to a net loss of $19.1 million, or $0.16 per share, in the same period of 2017.

For the second quarter of 2018, Rigel reported net product sales from TAVALISSE of $1.8 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its distributors. TAVALISSE was made available by prescription for the treatment of chronic ITP on May 29, 2018. There were no product sales or contract revenues from collaborations in the second quarter of 2017.

Rigel reported total costs and expenses of $27.9 million in the second quarter of 2018, compared to $19.3 million for the same period in 2017. The increase in costs and expenses was primarily due to the increases in personnel costs for Rigel’s customer-facing team, as well as third party costs related to Rigel’s commercial launch of TAVALISSE in chronic ITP.

For the six months ended June 30, 2018, Rigel reported a net loss of $49.9 million, or $0.32 per share, compared to a net loss of $34.5 million, or $0.29 per share, for the same period of 2017.

As of June 30, 2018, Rigel had cash, cash equivalents and short-term investments of $135.0 million, compared to $115.8 million as of December 31, 2017. Rigel expects that its cash, cash equivalents and short-term investments will be sufficient to support its current and projected funding requirements, including the on-going commercial launch of TAVALISSE for chronic ITP in the U.S., into the fourth quarter of 2019.

Development Pipeline Update
In the second quarter, Rigel continued to support the investigation of fostamatinib for other serious, autoimmune conditions including autoimmune hemolytic anemia (AIHA) and IgA nephropathy (IgAN). Updates regarding pivotal programs in both indications are expected by the fall of 2018.

In June, Rigel announced the initiation of a Phase 1 study in healthy subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamics of R835, a proprietary molecule from its interleukin receptor associated kinase (IRAK) program. Preclinical studies show that R835 inhibits both the IRAK1 and IRAK4 signaling pathways, which play a key role in inflammation and immune responses to tissue damage. Dual inhibition of IRAK1 and IRAK4 allows for more complete suppression of pro-inflammatory cytokine release. The Phase 1 study is a randomized, placebo-controlled, double-blind trial in up to 91 healthy subjects, ages 18 to 55. The study design will assess the tolerability and safety of R835 in both single ascending and multiple ascending doses.

Rigel reported that its clinical stage partnerships continue to make progress. BerGenBio (with bemcentinib) and Daiichi-Sankyo (with DS-30232) continue to enroll patients in numerous clinical trials in various solid tumors and AML. In June, Aclaris Therapeutics announced positive interim data from their Phase 2 study of the licensed topical JAK inhibitor, ATI-502, in patients with alopecia areata. Bristol Myers Squibb has informed Rigel that they will be terminating their preclinical collaboration.

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About R835
The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that blocks inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 family receptor (IL-1R) signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout.

Conference Call and Webcast With Slides Today at 5:00PM Eastern Time
Rigel will hold a live conference call and webcast today at 5:00pm Eastern Time (2:00pm Pacific Time).

Participants can access the live conference call by dialing 855-892-1489 (domestic) or 720-634-2939 (international) and using the Conference ID number 8192317. The webcast, with slide presentation, can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and RIGEL ONECARE are trademarks of Rigel Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.