First trial in Rigel's multi-year strategic development alliance with MD Anderson Phase 1b/2 trial of decitabine and venetoclax in combination with Rigel's targeted mIDH1 inhibitor REZLIDHIA for patients with mIDH1 AML SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first patient has been enrolled in a Phase 1b/2 triplet therapy trial of decitabine ...

Kissei gains exclusive rights to develop and commercialize olutasidenib in all current and potential indications in Japan, the Republic of Korea and Taiwan Rigel will receive an upfront cash payment of $10.0 million with the potential for up to $152.5 million in future development, regulatory, and commercial milestone payments Rigel to receive product transfer price payments in the mid-twenty to lower-thirty percent range based on tiered net sales for exclusive supply of REZLIDHIA SOUTH SAN FRANCISCO, Calif ...

SOUTH SAN FRANCISCO, Calif., Aug. 29, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced that Dean Schorno, the company's chief financial officer, will participate in the following investor conferences in September: 2024 Wells Fargo Healthcare Conference, Boston, MA Mr. Schorno will participate in one-on-one meetings on Thursday, September 5th. H.C. Wainwright 26th Annual Global Investment Con ...

Financial Data and Key Metrics - Net product sales for Q2 2024 were $33.5 million, a 40% increase compared to $23.9 million in Q2 2023 [6] - TAVALISSE net product sales reached $26.4 million in Q2 2024, a 24% increase from Q1 2024 and 25% growth year-over-year [10] - REZLIDHIA net product sales were $5.2 million in Q2 2024, doubling compared to $2.6 million in Q2 2023 [12] - GAVRETO contributed $1.9 million in net product sales in Q2 2024, with 228 bottles shipped to stock the distribution channel [17][18] - Total cost and expenses for Q2 2024 were $36.4 million, up from $32.2 million in Q2 2023, driven by higher product sales costs and R&D expenses [32] Business Line Performance - TAVALISSE achieved its seventh consecutive quarterly record, with 2,672 bottles shipped to patients and clinics, an 8% increase from Q1 2024 and 18% growth year-over-year [10] - REZLIDHIA shipped 424 bottles to patients and clinics in Q2 2024, a 30% increase from Q1 2024 and more than double the demand from Q2 2023 [11] - GAVRETO became commercially available on June 27, 2024, with a smooth transition and early shipments contributing to Q2 revenue [15][17] Market and Strategic Developments - GAVRETO, an FDA-approved therapy for RET fusion-positive cancers, was added to the portfolio, leveraging existing commercial and medical expertise [4][5] - Strategic collaborations with MD Anderson Cancer Center and CONNECT aim to explore REZLIDHIA in IDH1-mutant cancers and advance olutasidenib in AML and glioma [6][19][23] - The company is progressing with its IRAK1/4 inhibitor R289 in a phase 1b trial for lower-risk MDS, with preliminary data expected by the end of 2024 [6][27] Management Commentary - The company is approaching net income break-even, driven by record sales and financial discipline [6][33] - Management highlighted the potential for future growth through in-licensing deals and acquisitions, similar to REZLIDHIA and GAVRETO [33][46] - The focus remains on expanding the hematology and oncology portfolio, with ongoing clinical trials and strategic partnerships [19][23] Q&A Session Question: IRAK1/4 Dose Escalation - The addition of twice-daily dosing cohorts for R289 was based on emerging data to explore optimal dosing for phase 2 expansion [36] Question: MD Anderson Collaboration - The goal is to evaluate olutasidenib in combination with other agents for IDH1-mutated AML, potentially leading to an all-oral triplet therapy [38][39] Question: Revenue Guidance - Management is evaluating the possibility of providing revenue guidance in the future as the business solidifies and approaches break-even [40][41] Question: TAVALISSE Growth Drivers - Growth in TAVALISSE sales is driven by new patient starts and increased prescriber adoption, including earlier-line usage [43][44] Question: Future Deals and Financial Discipline - The company plans to pursue deals that leverage existing capabilities and provide near-term market entry, similar to REZLIDHIA and GAVRETO [46][47] Question: Impact of Voracitinib Approval - The FDA approval of voracitinib for glioma validates the role of IDH inhibitors, with olutasidenib positioned in a different treatment setting [52][53]

Group 1 - Rigel Pharmaceuticals reported a quarterly loss of $0.06 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.37, representing an earnings surprise of 83.78% [1] - The company posted revenues of $36.84 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 13.79% and up from $26.89 million a year ago [2] - Rigel has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Group 2 - The stock has underperformed, losing about 39.3% since the beginning of the year, while the S&P 500 has gained 8.7% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.47 on revenues of $37.19 million, and for the current fiscal year, it is -$1.33 on revenues of $142.03 million [7] - The Medical - Drugs industry, to which Rigel belongs, is currently ranked in the top 42% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company's website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website. Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing n ...

Core Insights - Rigel Pharmaceuticals, Inc. (RIGL) is a microcap biotech company focused on innovative therapeutics for hematological conditions and cancers, with three main FDA-approved products: Tavalisse, Rezlidhia, and Gavreto [23][24][36] - The company is projected to generate approximately $191.5 million in revenues by 2025, representing a 28.0% year-over-year increase in 2024 revenues, driven by the sales of its products [6][34] - RIGL's current market cap is $177.5 million, with a significant undervaluation compared to its sector's median forward price-to-sales (P/S) multiple of 3.9, as RIGL trades at a 0.9 forward P/S [6][34] Financial Performance - In Q1 2024, RIGL reported net product sales of $26.0 million, with Tavalisse contributing $21.1 million and Rezlidhia $4.9 million [3][31] - The company has a cash position of $49.6 million against $59.7 million in financial debt, resulting in a negative book value of $31.7 million [6][34] - RIGL's quarterly cash burn is estimated at $4.9 million, indicating a cash runway of approximately 2.5 years, which is considered healthy for projected revenue growth [34] Product Pipeline and Development - RIGL's product pipeline includes promising candidates such as R289 for lower-risk myelodysplastic syndromes, targeting IRAK1/4, and milademetan, which completed Phase 1 trials for cancer [15][30][45] - Gavreto, recently acquired by RIGL, is indicated for RET fusion-positive non-small cell lung cancer (NSCLC) and advanced thyroid cancer, with FDA approval requiring confirmatory trial results [2][30] - Rezlidhia has shown efficacy in treating relapsed or refractory acute myeloid leukemia (AML) with a median duration of response of 25.9 months [26][39] Market Outlook - The acute myeloid leukemia market is projected to reach $3.0 billion by 2029, providing a significant opportunity for RIGL to carve out a niche with its products [27][39] - The overall market for RIGL's therapeutic areas is expected to grow at a compound annual growth rate (CAGR) of 10.15%, reaching $2.97 billion by 2029 [27] - RIGL's partnerships with companies like BerGenBio, Eli Lilly, and Daiichi Sankyo enhance its research capabilities and product offerings [17][41]

Core Points - Rigel Pharmaceuticals, Inc. has granted 79,890 stock options to eleven non-executive employees as part of its Inducement Plan approved by the Compensation Committee [1] - The stock options will vest over four years with a one-year cliff, which is a common structure in employee compensation plans [1] - This action is in accordance with NASDAQ Listing Rule 5635(c)(4), indicating compliance with regulatory requirements [4] Company Overview - Rigel Pharmaceuticals, Inc. is a biotechnology company focused on discovering and developing novel therapies for hematologic disorders and cancer [2] - The company was founded in 1996 and is headquartered in South San Francisco, California [2] - For more information on Rigel's marketed products and pipeline, the company provides resources on its website [2]

Core Viewpoint - Rigel Pharmaceuticals, Inc. will implement a 1-for-10 reverse stock split to increase the per-share trading price of its common stock, effective June 27, 2024, aiming to enhance marketability and compliance with Nasdaq listing requirements [3][8]. Group 1: Reverse Stock Split Details - The reverse stock split was approved by stockholders on May 24, 2024, and the final ratio was confirmed by the Board on June 15, 2024 [1]. - The number of shares outstanding will decrease from approximately 175,582,945 to about 17,558,294 [1]. - The reverse stock split will not change the number of authorized shares or the par value of the common stock [1]. Group 2: Market Impact and Compliance - The primary objective of the reverse stock split is to raise the per-share trading price, which is currently low and affects the company's appeal to institutional investors [8]. - The split is also intended to help maintain compliance with Nasdaq's minimum bid requirement of $1.00 per share [8]. Group 3: Shareholder Actions - Registered stockholders with shares in book-entry form will not need to take action to receive post-split shares [4]. - Stockholders holding shares in "street name" will have their positions automatically adjusted, while those with certificate shares will receive instructions from Equiniti Trust Company [4].

Core Viewpoint - Rigel Pharmaceuticals has completed the transfer of U.S. commercial rights for GAVRETO (pralsetinib) and will make it available for prescription starting June 27, 2024, targeting patients with specific types of cancer [1][2][4]. Group 1: Product Information - GAVRETO is indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and for adult and pediatric patients aged 12 and older with advanced or metastatic RET fusion-positive thyroid cancer [5][6]. - The recommended dosage for GAVRETO is 400 mg taken orally once daily [3]. - GAVRETO is the only once-daily oral RET-inhibitor therapy designed to selectively target RET in mNSCLC and advanced or metastatic thyroid carcinoma [3]. Group 2: Pricing and Support - GAVRETO will be supplied in two configurations: 100 mg bottles of 60 capsules priced at $11,144.58 and 100 mg bottles of 90 capsules priced at $16,716.85 [3]. - Rigel offers patient assistance programs through RIGEL ONECARE, which provides support for insurance coverage and financial assistance for eligible patients [3]. Group 3: Market Context - Rigel acquired the U.S. commercial rights to GAVRETO from Blueprint Medicines Corporation in February 2024, marking a strategic expansion in its hematology and oncology business [4][2]. - The NSCLC market is significant, with over 230,000 adults expected to be diagnosed with lung cancer in the U.S. in 2024, where NSCLC accounts for 80-85% of all lung cancer cases [5].