Rigel Announces Second Quarter 2017 Financial Results And Provides Company Update
Published: Aug 02, 2017
SOUTH SAN FRANCISCO, Calif., Aug. 1, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial results for the second quarter and six months ended June 30, 2017.
- On June 19, 2017, Rigel announced the U.S Food & Drug Administration (FDA) had accepted for filing its New Drug Application (NDA) for the use of TAVALISSE (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP).
- The FDA has set the date of April 17, 2018 to complete its review of fostamatinib in ITP under the Prescription Drug User Fee Act (PDUFA).
- Strengthened leadership team with three key hires to support its commercial and regulatory efforts.
"The FDA acceptance of our NDA for our lead product candidate, TAVALISSE, in ITP is a significant milestone for us," said Raul Rodriguez, Rigel's president and chief executive officer. "Over the next nine months, we will work collaboratively with the FDA as they review our application. In addition, we will continue to prepare for the commercial launch of fostamatinib as well as explore its potential across other indications."
For the second quarter of 2017, Rigel reported a net loss of $19.1 million, or $0.16 per basic and diluted share, compared to a net loss of $13.5 million, or $0.15 per basic and diluted share, in the same period of 2016.
There were no contract revenues from collaborations in the second quarter of 2017. Contract revenues from collaborations of $8.6 million in the second quarter of 2016 were comprised of $4.8 million from the amortization of the $30.0 million upfront payment, which was fully amortized in September 2016, and $95,000 in FTE fees earned pursuant to Rigel's collaboration and license agreement with Bristol-Myers Squibb, as well as payments of $3.7 million that Rigel received pursuant to its license agreement with BerGenBio AS.
Rigel reported total costs and expenses of $19.3 million in the second quarter of 2017, compared to $22.2 million for the same period in 2016. The decrease in costs and expenses was primarily due to the decreases in personnel costs and research-related costs as a result of the reduction in workforce in September 2016, partially offset by the increase in costs related to the preparation for the potential commercial launch of fostamatinib in ITP.
For the six months ended June 30, 2017, Rigel reported a net loss of $34.5 million, or $0.29 per basic and diluted share, compared to a net loss of $31.0 million, or $0.34 per basic and diluted share, for the same period of 2016.
As of June 30, 2017, Rigel had cash, cash equivalents and short-term investments of $82.3 million, compared to $74.8 million as of December 31, 2016. Rigel expects that its cash, cash equivalents and short-term investments as of June 30, 2017 will be sufficient to support its current and projected funding requirements, including the preparation for the potential U.S. commercial launch, through at least the next 12 months. Rigel continues to evaluate ex-U.S. partnerships for fostamatinib and other partnering opportunities across its pipeline.
In support of its regulatory process and commercial launch efforts, Rigel recently made three key hires. Dana Pizzuti, who was Vice President of Regulatory Affairs at Gilead Sciences since 2007 and facilitated the approval of 14 new medicines during her tenure there, joins as Senior Vice President of Regulatory Affairs and Clinical Quality Assurance; Giovanna Matthews joins as Executive Director, Market Access, bringing with her many years of great experience in Market Access and reimbursement; and, later this month Sandra Tong, M.D., most recently Vice President of Clinical Research at Plexxikon Inc. will join Rigel as Vice President, Clinical Science & Drug Safety.
TAVALISSE (fostamatinib disodium) in ITP
On June 19, 2017, Rigel announced that the FDA had accepted for filing its NDA for fostamatinib for the treatment of patients with chronic and persistent ITP. The NDA is supported by data from the Phase 3 clinical program, which was comprised of three studies, two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension study (Study 049). Together with an initial proof of concept study, the NDA included 163 ITP patients. Across all indications, fostamatinib has been evaluated in over 4,600 patients. Data from all studies, including preclinical evaluation and drug manufacturing data, were included in the NDA submission.
Fostamatinib in autoimmune hemolytic anemia (AIHA)
Enrollment remains on track for Stage 1 (n=17) of Rigel's Phase 2, open-label, multi-center, two-stage study of fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia (AIHA). Also known as the SOAR study, it will evaluate the safety and efficacy of fostamatinib (150mg BID, twice a day for 12 weeks) in patients with warm AIHA who have previously received at least one treatment for this disease, but have not benefited from it and are still anemic. Rigel expects to report preliminary results for Stage 1 of the study, which is over 70% enrolled, by the end of 2017. Rigel will evaluate the results from Stage 1 before proceeding to Stage 2 of the study, which would enroll another 20 patients using the same protocol.
Fostamatinib in IgA nephropathy (IgAN)
Enrollment continues in Rigel's second cohort in its Phase 2 study of fostamatinib (150mg BID) in IgAN. Similar to the first cohort, which reported results in January 2017, the study will evaluate the efficacy, safety, and tolerability of fostamatinib as measured by change in proteinuria, renal function, and histology (comparing the pre- and post-study renal biopsies). However, the second cohort evaluates a higher dose of fostamatinib, 150mg BID, whereas the first cohort evaluated 100mg BID. The primary efficacy endpoint is the mean change of proteinuria from baseline at 24 weeks. Rigel expects the second cohort will finish enrollment in 2017 with results in 2018.
Additional Product Development
During the second quarter, Rigel selected a molecule from its IRAK program for preclinical development. The molecule is differentiated in that it inhibits both the IRAK 1 and IRAK 4 signaling pathways, with potential to treat autoimmune and inflammatory diseases such as lupus, gout, psoriatic arthritis and multiple sclerosis. Rigel expects to initiate clinical trials in the first half of 2018.
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 increased risk of severe bleeding events that can result in serious medical complication, 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.
AIHA is a rare, serious blood disorder where the immune system produces antibodies that result in the destruction of the body's own red blood cells. AIHA affects approximately 40,000 adult patients in the US and can be a severe, debilitating anemia. To date, there are no FDA approved disease-targeted therapies for AIHA, despite the tremendous medical need that exists for these patients as disease relapse is common. Instead, physicians generally treat acute and chronic cases of the disorder with corticosteroids, IV immunoglobulin infusion, other immuno-suppressants, or splenectomy (the surgical removal of the spleen).
IgAN (also known as Berger's disease) is a chronic autoimmune disease associated with inflammation in the kidneys that diminishes their ability to filter blood. It is the most common primary glomerular disease affecting an estimated 82,500 to 165,000 cases in the US, with a higher prevalence in Asia. For as many as 25 percent of those living with IgAN, the disease results in end-stage renal failure requiring dialysis or kidney transplantation. Other than angiotensin blockade (primarily for blood-pressure control), there are no disease-targeted therapies for IgAN.
Conference Call and Webcast 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 55352069. The conference call will also be webcast live and 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.
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