On January 13, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported a new credit facility for up to $150 million along with an equity investment of $7.5 million with Oberland Capital Management LLC (Oberland Capital) (Press release, Verastem, JAN 13, 2025, View Source [SID1234649679]). In addition, the Company announced a strategic collaboration with IQVIA Inc. (IQVIA) to leverage IQVIA’s world-class infrastructure and established commercialization solutions to complement its launch strategy for the investigational combination of avutometinib plus defactinib for the treatment of recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC) planned for mid-2025.

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"The Oberland Capital transaction, coupled with our strategic partnership with IQVIA, enables us to launch avutometinib plus defactinib for recurrent LGSOC from a position of financial strength and with commercialization solutions to accelerate our launch. The additional capital will help us create a commercial revenue stream to support our pipeline with new approaches for patients needing treatments for complex and rare cancers," said Dan Paterson, president and chief executive officer of Verastem Oncology.

Verastem’s commercialization efforts are in anticipation of potential U.S. Food and Drug Administration (FDA) approval of avutometinib plus defactinib in recurrent KRAS mutant LGSOC. The Company announced on December 30, 2024, that the FDA set a Prescription Drug User Fee Act (PDUFA) action date for its NDA submission of June 30, 2025.

Under the terms of the note purchase agreement with Oberland Capital, Verastem will issue an initial $75 million of notes at closing, which is expected to occur on January 13, 2025. The Company then has the ability to access up to an additional $75 million in notes upon achievement of certain pre-determined milestones related to the potential regulatory approval and commercialization of avutometinib plus defactinib for the treatment of LGSOC. The notes carry an interest-only period of six years and will bear interest at a floating rate, which is subject to both a floor and a cap. The note purchase agreement also provides for revenue participation pursuant to which Oberland Capital will initially be entitled to 1.0% of the first $100 million of net sales in each calendar year of certain of the Company’s products, subject to pro-rata increase upon potential future draw downs.

In addition, the Company has entered into a stock purchase agreement with affiliates of Oberland Capital for the private placement of 1,416,939 shares of the Company’s common stock issued at closing, representing $7.5 million of gross proceeds based on the trailing 30-trading days volume-weighted average price or VWAP of $5.2931 per share. Additionally, Oberland has the option to participate in certain future equity offerings that may be consummated by the Company within the three years from closing, for up to $2.5 million at the same price per share in such offering. Closing of the stock purchase agreement is expected to occur concurrently with the closing of the note purchase agreement on January 13, 2025. A portion of the proceeds from the notes and equity investment will be used to fully repay amounts owed under the Company’s existing loan with Oxford Finance ($42.7 million), which has been terminated.

The Company had a preliminary unaudited cash, cash equivalents, and short term investment balance of $88.8 million as of December 31, 2024. Taking into account the initial $75.0 million of notes and $7.5 million of equity to be purchased by Oberland Capital at closing, and the repayment of amounts owed under the Company’s existing loan with Oxford Finance, the Company would have had pro-forma cash, cash equivalents, and short-term investment balance of $128.6 million as of December 31, 2024. Both the actual and pro forma December 31, 2024 balances stated herein are preliminary, unaudited estimates and subject to revision upon completion of the Company’s closing and audit processes and do not present all information necessary for an understanding of the Company’s financial condition as of, and its results of operations for the fiscal year ended December 31, 2024. Additional details regarding this financing will be available in a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

The agreement between Verastem and IQVIA allows Verastem to tap into IQVIA’s industry-leading expertise and resources while maintaining strategic oversight through the commercialization process and launch. IQVIA will help accelerate key launch capabilities resulting in significant savings while delivering a world-class product launch.

About the Avutometinib and Defactinib Combination

Avutometinib is an oral RAF/MEK clamp that potentially inhibits MEK1/2 kinase activities and induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of the MEK-only inhibitors. 

Defactinib is an oral, selective inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and Pyk2 integrate signals from integrin and growth factor receptors to regulate cell proliferation, survival, migration, and invasion. FAK activation has been shown to mediate resistance to multiple anti-cancer agents, including RAF and MEK inhibitors. 

Verastem Oncology is currently conducting clinical trials with avutometinib with and without defactinib in RAS/MAPK-driven tumors as part of its Raf And Mek Program or RAMP. Verastem is currently enrolling patients and activating sites for RAMP 301 (GOG-3097/ENGOT-ov81/NCRI) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). 

Verastem was granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who received at least one prior systemic therapy. Verastem initiated a rolling NDA in May 2024 to the FDA and completed its NDA submission in October 2024. The FDA granted Breakthrough Therapy Designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in May 2021. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC. 

Verastem Oncology has established a clinical collaboration with Amgen to evaluate LUMAKRAS (sotorasib) in combination with avutometinib and defactinib in both treatment-naïve patients and in patients whose KRAS G12C mutant non-small cell lung cancer progressed on a G12C inhibitor as part of the RAMP 203 trial (NCT05074810). Verastem has received Fast Track Designation from the FDA for the triplet combination in April 2024. RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to the avutometinib and defactinib combination for the treatment of pancreatic cancer. 

On January 13, 2025 Syndax Pharmaceuticals (Nasdaq: SNDX) reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th at 10:30 a.m. PT/1:30 p.m. ET (Press release, Syndax, JAN 13, 2025, View Source [SID1234649678]). Ahead of the presentation, Syndax highlighted its recent accomplishments and anticipated 2025 milestones.

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"Building on a transformative 2024 with the FDA approvals of Revuforj and Niktimvo, we are focused on executing two outstanding U.S. launches for these first-in-class, practice-changing medicines," said Michael A. Metzger, Chief Executive Officer. "Syndax is well-positioned for continued success and long-term growth with two approved drugs launching into multi-billion-dollar markets, a clear strategy to expand into additional indications, and a strong cash position expected to fund operations through profitability."

2024 Key Accomplishments

Revumenib:

Launched Revuforj (revumenib), the first and only U.S. Food and Drug Administration (FDA) approved menin inhibitor, in late November 2024. Revuforj was approved by the FDA under the Agency’s Real-Time Oncology Review (RTOR) program for the treatment of relapsed or refractory (R/R) acute leukemia with a KMT2A translocation in adult and pediatric patients one year and older.
Revumenib was added to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) as a category 2A recommendation for R/R acute leukemia with a KMT2A rearrangement.1
Announced that the primary endpoint was met in the protocol-defined efficacy population of 64 adults with R/R mNPM1 AML in the Phase 2 cohort of the AUGMENT-101 trial of revumenib.
Reported additional positive results from a post-hoc efficacy analysis of all 77 R/R mNPM1 AML patients who met the efficacy evaluable criteria in the Phase 2 cohort of AUGMENT-101.
Published data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in adult and pediatric patients with R/R KMT2A-rearranged (KMT2Ar) acute leukemia in the Journal of Clinical Oncology.
Presented a larger data set with longer follow-up from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib in R/R KMT2Ar acute leukemia at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Presented data from multiple ongoing trials evaluating revumenib in mNPM1 and KMT2Ar acute leukemia across the treatment landscape. These trials include:
BEAT AML: A Phase 1 trial evaluating the combination of revumenib with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar AML patients. The trial is being conducted as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial. Updated data from the trial showed an overall response rate (ORR)2 of 100% (37/37) and a composite complete remission (CRc) rate of 95% (35/37).
SAVE: A Phase 1/2 trial evaluating an all-oral combination of revumenib with venetoclax and decitabine/cedazuridine in pediatric and adult patients with R/R AML or mixed-lineage acute leukemia (MPAL) harboring either mNPM1, KMT2Ar, or NUP98r alterations. The trial is being conducted by investigators from MD Anderson Cancer Center. Updated data that showed an ORR of 82% (27/33) and a CR/CRh rate of 48% (16/33) were presented at the 66th ASH (Free ASH Whitepaper) Annual Meeting.
Axatilimab:

Received U.S. Food and Drug Administration (FDA) approval for Niktimvo (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).
Announced axatilimab-csfr was added to the latest NCCN Guidelines as a category 2A recommendation for the treatment of GVHD after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Published results from the pivotal Phase 2 AGAVE-201 trial of axatilimab in adult and pediatric patients with recurrent/refractory active chronic GVHD in the New England Journal of Medicine.
Presented a secondary analysis of overall and organ-specific responses from the pivotal Phase 2 AGAVE-201 trial of axatilimab in adult and pediatric patients with recurrent/refractory active chronic GVHD who had received at least two prior lines of systemic therapy at the 66th ASH (Free ASH Whitepaper) Annual Meeting.
Initiated enrollment in the MAXPIRe trial, a 26-week randomized, double-blinded, placebo-controlled Phase 2 trial of axatilimab on top of standard of care in patients with idiopathic pulmonary fibrosis (IPF).
The Company’s partner, Incyte, initiated a Phase 2, open-label, randomized, multicenter trial of axatilimab in combination with ruxolitinib in patients ≥12 years of age with newly diagnosed chronic GVHD.
The Company’s partner, Incyte, initiated a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial that will investigate the use of axatilimab in combination with corticosteroids as initial treatment for chronic GVHD.
Corporate:

Announced a $350 million royalty funding agreement with Royalty Pharma based on U.S. net sales of Niktimvo. Syndax expects that its cash, cash equivalents and marketable securities, together with the $350 million from the royalty funding agreement and anticipated product revenue and interest income, will enable the company to reach profitability.
Expected 2025 Key Milestones

Revumenib:

Maximize U.S. adoption of Revuforj as the preferred menin inhibitor, leveraging our first mover advantage and robust clinical data.
Submit a supplemental NDA (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025, followed by a potential FDA approval around year-end 2025.
Publish pivotal data from AUGMENT-101 trial in R/R mNPM1 AML in the first half of 2025.
Initiate a pivotal trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed mNPM1 or KMT2Ar acute leukemia patients unfit to receive intensive chemotherapy in the first quarter of 2025.
Report Phase 1 data from a trial evaluating the combination of revumenib with intensive chemotherapy (7+3) followed by revumenib maintenance treatment in newly diagnosed patients with mNPM1 or KMT2Ar acute leukemias in the second half of 2025.
Initiate multiple frontline trials evaluating revumenib in combination with intensive chemotherapy, starting in 2025.
Present additional data at medical congresses from ongoing trials of revumenib in combination with standard-of-care agents.
Axatilimab:

Launch Niktimvo in the U.S. in early first quarter of 2025. In the U.S., Niktimvo will be co-commercialized by Syndax and Incyte.
Complete enrollment in MAXPIRe Phase 2 IPF trial in 2025 with topline data expected in 2026.
Presentation at the 43rd Annual J.P. Morgan Healthcare Conference

Syndax will webcast its presentation from the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025 at 10:30 a.m. PT (1:30 p.m. ET). A live webcast of the fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On January 13, 2025 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, reported its preliminary fourth quarter and full year 2024 U.S. net product revenue for OGSIVEO (nirogacestat) and provided additional company updates ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare conference (Press release, SpringWorks Therapeutics, JAN 13, 2025, View Source [SID1234649677]).

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Preliminary Fourth Quarter and Full Year 2024 Financial Results* and Recent Business Highlights

Preliminary fourth quarter and full-year 2024 U.S. net product revenue for OGSIVEO were $61.5 million and $172.0 million, respectively.
As of December 31, 2024, total preliminary cash, cash equivalents, and marketable securities was $461.9 million. SpringWorks expects its cash position to fund operations through profitability, which the Company anticipates achieving in the first half of 2026.
Presented long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with progressing desmoid tumors in the fourth quarter of 2024. These results showed that longer-term treatment with nirogacestat (median duration of treatment: 34 months) was associated with further reductions in tumor size, increase in objective response rate with additional partial responses and complete responses, sustained improvements in desmoid tumor symptoms including pain, and a consistent safety profile.
Obtained an exclusive, global license from Rappta Therapeutics Oy for a first-in-class molecular glue of specific Protein Phosphatase 2A (PP2A) complexes. PP2A mutations represent a class of targetable oncogenic drivers in molecularly defined subsets of uterine cancer patients with high unmet need. In preclinical models of PP2A mutant uterine cancer, SW-3431 (formerly RPT04402) showed rapid, deep and durable tumor regressions as a monotherapy. In exchange for the license, Rappta received a $13 million upfront payment and is eligible to receive further clinical, regulatory and commercial milestone payments, and tiered single digit royalties on net sales.
* The preliminary fourth quarter and full year 2024 financial results are unaudited and do not present all information necessary for an understanding of the Company’s results of operations and financial position for the fourth quarter and full year 2024. Such financial results are subject to adjustment and could differ from the Company’s announcement of complete financial results in February 2025.

2025 Priorities and Anticipated Milestones

OGSIVEO (nirogacestat)

Continue strong commercial execution of the OGSIVEO launch in the U.S.
Secure regulatory approval for OGSIVEO in the European Union (EU) and launch OGSIVEO following reimbursement authorization in individual EU countries, beginning with Germany in mid-2025.
Publish long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors in a peer-reviewed journal by the end of 2025.
Report initial data from the Phase 2 trial evaluating nirogacestat as a monotherapy in patients with ovarian granulosa cell tumors in the first half of 2025.
Continue to support several industry and academic collaborator studies evaluating nirogacestat as part of B-cell maturation antigen (BCMA) combination therapy regimens across treatment lines in patients with multiple myeloma.
Mirdametinib (NF1-PN)

Secure FDA approval in adults and children with NF1-associated plexiform neurofibromas, or NF1-PN (PDUFA: February 28, 2025), and launch in the U.S.
Obtain regulatory approval in the EU for mirdametinib for the treatment of adults and children with NF1-PN and begin initial launch in 2025.
Emerging Pipeline

SpringWorks expects additional data to be presented by MapKure from the brimarafenib monotherapy trial in the second half of 2025.
Continue enrolling patients in Phase 1 trial of SW-682 in Hippo-mutant solid tumors.
File an Investigational New Drug (IND) application for SW-3431 by the end of 2025.
"2025 is set up to be another transformative year for SpringWorks. With the potential launch of our second medicine and global expansion to serve patients with two devastating diseases, we are energized by the opportunity to continue delivering on the commitments we have made to the patient communities we are dedicated to serving," said Saqib Islam, Chief Executive Officer of SpringWorks. "In parallel with our commercial launches, we are advancing our pipeline of oncology programs for heavily underserved patient populations and are confident that our strong foundation will drive our long-term growth and success."

Presentation at the 43rd Annual J.P. Morgan Healthcare Conference

SpringWorks will webcast its presentation from the 43rd Annual J.P. Morgan Healthcare Conference today, Monday, January 13, 2025 at 11:15 a.m. PT (2:15 p.m. ET). To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.

On January 13, 2025 Sana Biotechnology presented its corporate presentation (Presentation, Sana Biotechnology, JAN 13, 2025, View Source [SID1234649676]).

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On January 13, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported a business update including preliminary total revenue and net product sales for the fourth quarter of 2024, ongoing activity from the commercial business and development pipeline, and its financial outlook for 2025 (Press release, Rigel, JAN 13, 2025, View Source [SID1234649675]).

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"2024 was a transformational year for Rigel as we successfully executed on our corporate strategy to grow our hematology and oncology focused organization. We generated record sales of both TAVALISSE and REZLIDHIA and welcomed a third product to our commercial portfolio, GAVRETO, which made a substantial contribution to our sales in the latter half of the year. This commercial success, combined with our commitment to financial discipline, enabled Rigel to reach financial breakeven, a key milestone for the company," said Raul Rodriguez, Rigel’s president and CEO. "In addition, we advanced our development pipeline, with the Phase 1b study of R289 in lower-risk MDS continuing to enroll patients and publishing promising initial safety and efficacy data. Building on this progress, we will continue to implement effective strategies that further grow and advance our portfolio in 2025, thereby generating significant value for Rigel and our shareholders."

Preliminary 2024 Financial Results and Business Update

Preliminary Financial Results

While Rigel is still determining final results for the fourth quarter of 2024, the company expects to report fourth quarter total revenue of $57.6 million, compared to $35.8 million for the same period of 2023.
Rigel expects to report fourth quarter net product sales of $46.5 million, compared to $29.5 million for the same period of 2023, including:
TAVALISSE (fostamatinib disodium hexahydrate) net product sales of $31.0 million compared to $25.7 million for the same period of 2023.
REZLIDHIA (olutasidenib) net product sales of $7.4 million compared to $3.9 million for the same period of 2023.
GAVRETO (pralsetinib) net product sales of $8.1 million. GAVRETO became commercially available from Rigel in June 2024.
The following table summarizes total bottles shipped for the fourth quarter:

TAVALISSE

REZLIDHIA

GAVRETO*

Bottles shipped to patients and clinics

2,855

503

874

Change in bottles remaining in distribution channel

317

62

64

Total bottles shipped

3,172

565

938

*GAVRETO bottle count represents 60-count bottle equivalent

Contract revenues from collaborations for the fourth quarter of 2024 is expected to be approximately $11.1 million, including a $4.0 million upfront cash payment from Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s); $3.6 million of revenue from Grifols S.A. related to delivery of drug supplies and earned royalties; $2.9 million of revenue from Kissei Pharmaceutical Co., Ltd. (Kissei) related to delivery of drug supplies; and $0.3 million of revenue from Medison Pharma Trading AG related to delivery of drug supplies and earned royalties.
For the full year, Rigel expects to report total revenue of $179.3 million, including net product sales of $144.9 million and contract revenues from collaborations of $34.4 million, compared to total revenue of $116.9 million in 2023, which included net product sales of $104.3 million, contract revenues from collaborations of $11.5 million and government contract revenue of $1.1 million.
Rigel expects to report cash, cash equivalents, and short-term investments of approximately $77.3 million as of December 31, 2024, compared to $56.9 million as of December 31, 2023.
The above information is preliminary, has not been audited, and is subject to change upon the audit of Rigel’s financial statements for the year ended December 31, 2024. Rigel expects to provide complete fourth quarter and full year 2024 financial results in March 2025.

Commercial Update

TAVALISSE surpassed $100 million in net product sales in 2024, reporting $104.8 million in net product sales.
Rigel entered into an exclusive license agreement with Dr. Reddy’s in November to develop and commercialize REZLIDHIA in all potential indications throughout Dr. Reddy’s territory, which includes Latin America, South Africa, certain countries in the Commonwealth of Independent States (CIS), India, certain countries in Southeast Asia and North Africa, Australia and New Zealand. Rigel is entitled to receive an upfront cash payment of $4.0 million with the potential for up to $36.0 million in future regulatory and commercial milestone payments.
In December, Rigel’s partner Knight Therapeutics announced Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios approved TAVALISSE for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Clinical and Development Update

R2891, a novel and selective dual IRAK1/4 inhibitor, has been granted Fast Track designation for the treatment of previously-treated transfusion dependent lower-risk MDS and Orphan Drug designation for the treatment of MDS by the U.S. Food and Drug Administration (FDA).
Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R289 in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the fifth dose level (500mg / 250mg split dose) is ongoing.
Rigel presented initial data from the ongoing Phase 1b clinical study of R289 at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December, demonstrating that R289 was generally well tolerated in this heavily pretreated R/R lower-risk MDS patient population, the majority of whom were high transfusion burden (HTB) at baseline.
In an ad-hoc analysis of the R289 Phase 1b initial data, responding patients (those achieving transfusion independence) appeared to have a greater increase in hemoglobin level over time compared to non-responding patients.
Also at the ASH (Free ASH Whitepaper) Annual Meeting, four posters were presented on olutasidenib, which included data that adds to the growing body of evidence supporting the benefits of its use in patients with mIDH1 AML.
As part of a multi-year strategic development alliance, Rigel and The University of Texas MD Anderson Cancer Center (MD Anderson), opened enrollment for two trials in December. The trials are a Phase 2 study in patients with IDH1-mutated clonal cytopenia of undetermined significance (CCUS), lower-risk MDS and chronic myelomonocytic leukemia (CMML), and a Phase 1/2 study of olutasidenib maintenance therapy following an allogeneic stem cell transplant for patients with IDH1-mutated myeloid malignancies. The Phase 1b/2 triplet therapy trial of decitabine and venetoclax in combination with olutasidenib in patients with mIDH1 AML is ongoing.
In December, in a paper titled "Olutasidenib demonstrates significant clinical activity in mutated IDH1 acute myeloid leukaemia arising from a prior myeloproliferative neoplasm", was published by Stéphane de Botton, M.D., Ph.D., head of translational research in hematology, Institut Gustave Roussy, France, in the British Journal of Haematology.
In November, the National Comprehensive Cancer Network (NCCN) added olutasidenib to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Myelodysplastic Syndromes. Olutasidenib was added as a recommended option to the following treatment algorithms: Management of Lower-Risk Disease, Management of Lower-Risk Disease – Evaluation of Related Anemia and Management of Higher-Risk Disease, and was recommended as NCCN Category 2B in all circumstances. If mIDH1 positive, olutasidenib was either recommended as a single agent, in combination with azacitidine, or both.*
*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

2025 Outlook

Rigel anticipates 2025 total revenue of approximately $200 to $210 million, including:

Net product sales of approximately $185 to $192 million
Contract revenues from collaborations of approximately $15 to $18 million.
The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs.

In addition, Rigel plans to initiate a Phase 2 clinical study in recurrent glioma in 2025.

Additional information is included in Rigel’s corporate presentation, which can be found in the Investor Relations section of the company’s website at www.rigel.com.