On March 4, 2025 Aadi Bioscience, Inc. (Nasdaq: AADI) ("Aadi"), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver advances in cancer treatment, reported the closing of its previously announced private placement (Press release, Aadi Bioscience, MAR 4, 2025, View Source [SID1234650890]). The private placement was led by Ally Bridge Group, with participation from new investors OrbiMed, Invus, Kalehua Capital and other accredited investors, Tae Han, co-founder of ProfoundBio, as well as existing investors, including Avoro Capital, KVP Capital and Acuta Capital Partners, for total gross proceeds of approximately $100 million.

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Aadi sold and issued an aggregate of 21,592,000 shares of its common stock ("Common Stock") at a price of $2.40 per share, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 20,076,500 shares of Common Stock at a purchase price of $2.3999 per Pre-Funded Warrant share in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").

Jefferies LLC acted as exclusive placement agent for the private placement.

Aadi intends to use the net proceeds from the private placement to fund certain upfront payments under its license agreement with WuXi Biologics (Shanghai FX) Co., Ltd. and for working capital and other general corporate purposes. The proceeds from this private placement and the sale of Aadi’s FYARRO business, together with Aadi’s existing cash, cash equivalents and marketable securities, are expected to fund operations into 2028, including anticipated clinical data readouts for its ADC portfolio.

The Common Stock and Pre-Funded Warrants sold in the private placement have not been registered under the Securities Act, or any state or other applicable jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. In connection with the private placement, Aadi and the investors entered into a registration rights agreement pursuant to which Aadi will file a registration statement (the "Resale Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of Common Stock sold in the private placement. Any offering of the shares sold in the private placement under the Resale Registration Statement will only be made by means of a prospectus.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy Aadi’s Common Stock, nor shall there be any offer, solicitation, or sale of Aadi’s Common Stock in any jurisdiction in which such offer, solicitation or sale would be unlawful.

On March 4, 2025 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that the company’s management will participate in the following investor conferences in March (Press release, AC Immune, MAR 4, 2025, View Source [SID1234650888]):

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Leerink Partners 2025 Global Healthcare Conference,
Management will participate in investor meetings on March 10, 2025

Barclays 27th Annual Global Healthcare Conference,
Management will participate in investor meetings on March 11, 2025

Please contact your Leerink or Barclays representative or AC Immune to request a one-on-one meeting with AC Immune’s management team at the conferences.

On March 4, 2025 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Y-mAbs Therapeutics, MAR 4, 2025, View Source [SID1234650887]).

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"We delivered on the strategic priorities we set out to achieve in 2024 across our business," said Michael Rossi, President and Chief Executive Officer. "In our DANYELZA business, we saw solid ex-U.S. growth in 2024 from our partners. In the U.S., while DANYELZA revenues stabilized in the face of increased competition from new market entrants and clinical trial activity, we remain committed to further penetrating high-volume centers and reaching more patients with high-risk relapsed/refractory neuroblastoma. In our Radiopharmaceutical business, we demonstrated the tolerability and validity of our SADA PRIT platform pre-targeting approach with the preliminary readout from Part A of our GD2-SADA Phase 1 trial, Trial 1001, in solid tumors, and we look forward to providing a complete data readout in the second quarter of this year. With our business realignment announced at the beginning of 2025, we expect to be in position to enhance our ability to execute on our business goals to drive future growth with DANYELZA while accelerating the preclinical and clinical advancement of our SADA PRIT platform and programs."

Recent Corporate Highlights

● On January 10, 2025, Y-mAbs announced the internal realignment and establishment of two business units: DANYELZA and Radiopharmaceuticals. The business realignment is designed to support the optimization of internal resources and provide flexibility and agility to advance the Company’s novel Self-Assembly DisAssembly Pre-targeted Technology platform (SADA PRIT) programs through clinical development while simultaneously driving commercial growth of DANYELZA.
● In conjunction with the business realignment, Y-mAbs appointed Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit. Mr. Gentilcore has over two decades of strategic leadership experience in the pharmaceutical industry.
● Y-mAbs presented translational pharmacokinetics data of GD2-SADA at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Mid-Winter and American College of Nuclear Medicine (ACNM) Annual Meeting on January 31, 2025. The poster titled "Preclinical and Translational Pharmacokinetics of GD2-SADA, a Self-Assembling and Disassembling (SADA) Bispecific Fusion Protein for Pre-targeted Radioimmunotherapy (PRIT)" characterizes the plasma levels of GD2-SADA in animal models over time and a range of doses, while also presenting the concentration- and time-dependent equilibrium between GD2-SADA tetramers and monomers in vitro. Incorporated within translational PK simulations, the data have provided insights into GD2-SADA tumor exposure and plasma elimination, key parameters for minimizing systemic exposure to 177Lutetium-DOTA.
● Interim data from a Phase 2 clinical trial evaluating naxitamab with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with relapsed/refractory high-risk neuroblastoma in the journal Nature Communications. The article, titled "The anti-GD2 monoclonal antibody naxitamab plus GM-CSF for relapsed or refractory high-risk neuroblastoma: a phase 2 clinical trial," details the results of a single-arm, global Phase 2 trial (Trial 201, NCT03363373) of patients with relapsed/refractory high-risk neuroblastoma and residual disease in the bone/bone marrow who received naxitamab on days 1, 3, and 5 (3 mg/kg/day) with GM-CSF (days -4 to 5) every 4 weeks, until a complete response (CR) or partial response (PR) was achieved, followed by 5 additional cycles every 4 weeks. Overall, naxitamab demonstrated statistically significant efficacy with a manageable safety profile.
Fourth Quarter 2024 Key Highlights

● Y-mAbs entered into an exclusive license and distribution agreement with Nobelpharma Co. Ltd. for the development and commercialization of DANYELZA in Japan. Y-mAbs received an upfront payment of $2.0 million in the fourth quarter of 2024. In addition, Y-mAbs is entitled to receive up to $31.0 million in regulatory-based and sales-based milestone payments in addition to royalty payments on commercial sales of DANYELZA by Nobelpharma, if successfully approved and commercialized in Japan.
● Continued commercial success with the named patient program for DANYELZA in Turkey with partner INPHARMUS (formerly named TRPharm İlaç Sanayi Ticaret A.Ş. and TRPharm FZ-LLC).
● Y-mAbs received notification of the accepted patent extension for DANYELZA, US 9,315,585, through February 2034.

Financial Results

Revenues

Total revenues for the quarter ended December 31, 2024 were $26.5 million, which was a 13% increase over the $23.4 million of total revenues for the quarter ended December 31, 2023, primarily driven by a $2.0 million increase in license revenue, and a $1.1 million increase in net product revenues.

Total revenues for the year ended December 31, 2024 were $87.7 million, a 3% increase over the total revenues for the year ended December 31, 2023 of $84.8 million. The $2.9 million increase was driven by a $2.0 million increase in license revenue, and a $0.9 million increase in net product revenues.

The Company’s U.S. DANYELZA net product revenues for the quarter and year ended December 31, 2024 were $16.8 and $66.0 million, representing decreases of 12% and 3%, respectively, from the same periods in 2023. The decline in the U.S. DANYELZA net product revenues was driven by an unfavorable price mix for the quarter and year ended December 31, 2024, compared to 2023. The decline for the quarter ended December 31, 2024, was partially offset by slightly increased volume, compared to 2023.

The Company’s international DANYELZA net product revenues for the quarter and year ended December 31, 2024 were $7.7 million and $19.2 million, representing increases of 78% and 16%, respectively, from the same periods in 2023. The increase in the international DANYELZA net product revenues was driven by the named patient program launch in Western Asia in 2024 and increased net product sales in the Eastern Asia, where our distribution partner purchased inventory in 2024 to avoid potential supply disruption in advance of a planned post-marketing labeling change in 2025, and Latin America regions, partially offset by decreased sales in Western Europe.

As of December 31, 2024, Y-mAbs had delivered DANYELZA to 69 centers across the U.S. since initial launch, with 11 new accounts added in the U.S. in 2024. During the quarter ended December 31, 2024, approximately 64% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center ("MSK"), compared to 65% in the third quarter ended September 30, 2024.

During the quarter and year ended December 31, 2024, the Company recognized license revenue of $2.0 million upon the execution of a license agreement with Nobelpharma in October 2024. The Company had license revenues totaling $2.5 million for the year ended December 31, 2024, which included license revenue from the Latin America distribution partner, Adium, related to price approval for DANYELZA in Brazil from the Brazilian Medicines Market Regulation Chamber, and from Nobelpharma, as noted above. The Company did not have any license revenue for the quarter ended December 31, 2023. The Company had license revenues of $0.5 million for the year ended December 31, 2023 from Adium, recognized upon the September 2023 achievement of marketing authorization for DANYELZA in Mexico.

Cost of Goods Sold

Cost of goods sold were $7.6 million and $2.0 million for the quarters ended December 31, 2024 and 2023, respectively, and were $15.0 million and $11.4 million for the years ended December 31, 2024 and 2023, respectively. Cost of goods sold included $0.6 million inventory write-off for the quarter and year ended December 31, 2024. The Company did not have any inventory write-off for the quarter ended December 31, 2023, and the Company had $0.8 million inventory write-downs in the year ended December 31, 2023.

Gross Profit

Gross profit was $18.9 million and $21.3 million for the quarters ended December 31, 2024 and 2023, respectively. Gross profit was $72.7 million and $73.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in gross profit was driven by the unfavorable price mix in connection with increased net product revenue from Eastern Asia, which generally has lower gross margins.

Operating Costs and Expenses

Research and Development

Research and development expenses were $12.2 million and $13.4 million for the quarters ended December 31, 2024 and 2023, respectively. The decrease in research and development expenses was primarily due to a $1.8 million decrease in outsourced manufacturing, a $0.4 million reduction of future milestone payments as the Company entered into an amendment with MSK to return the licensed patent rights related to omburtamab, and related drug substance inventory and regulatory work products, partially offset by a $1.0 million expense related to severance benefits and stock-based compensation charges associated with our business realignment.

Research and development expenses were $49.0 million for the year ended December 31, 2024, a decrease of $5.2 million when compared with the same period in 2023. The decrease in research and development expenses was primarily attributable to the recognition of $4.1 million of milestone and license acquisition costs related to the Company’s SADA license agreement during the year ended December 31, 2023, as certain time-based clinical milestones within the agreement were determined to be probable based on the availability of necessary data and the assessment of clinical progress in the third quarter of 2023.

Selling, General, and Administrative

Selling, general, and administrative expenses were $12.4 million and $11.1 million for the quarters ended December 31, 2024 and 2023, respectively. The $1.3 million increase in the selling, general and administrative expenses was primarily attributable to a $0.8 million increase in personnel cost, inclusive of stock-based compensation, and a $0.6 million expense related to severance benefits and stock-based compensation charges associated with our business realignment.

For the year ended December 31, 2024, selling, general, and administrative expenses were $54.6 million, an increase of $9.7 million compared with the same period in 2023. The increase was primarily attributable to a net impact of $3.8 million related to legal settlements, a $1.2 million charge related to separation and consulting agreements with a former executive and a $2.2 million increase in personnel cost, inclusive of stock-based compensation.

Interest and Other (Loss)/Income

The Company experienced interest and other loss of $1.6 million for the quarter ended December 31, 2024, as compared to interest and other income of $2.4 million for the quarter ended December 31, 2023. The decrease of $4.0 million was primarily due to a $3.7 million decrease in foreign currency transactional gains in the three months ended December 31, 2024, and a $0.3 million decrease in interest earned on the Company’s cash and cash equivalents.

For the years ended December 31, 2024 and 2023, the interest and other income was $1.4 and $4.8 million, respectively. The decrease of $3.4 million was primarily due to $2.6 million decrease of foreign currency transactional gains, partially offset by a $0.7 million decrease in interest earned on the Company’s cash and cash equivalents.

Net Loss

Y-mAbs reported a net loss for the quarter ended December 31, 2024, of $6.8 million, or ($0.15) per basic and diluted share, compared to a net loss of $1.0 million, or ($0.02) per basic and diluted share, for the quarter ended December 31, 2023. For the year ended December 31, 2024, the Company reported a net loss of $29.7 million, or ($0.67) per basic and diluted share, as compared to net loss of $21.4 million, or ($0.49) per basic and diluted share, for the year ended December 31, 2023. The increase in net loss for the quarter and year ended December 31, 2024 was primarily driven by increased operating expenses and decreased foreign currency transactional gains, partially offset by increased total revenues.

Cash and Cash Equivalents

As of December 31, 2024, Y-mAbs had approximately $67.2 million in cash and cash equivalents. Total annual cash investment in 2024 was $11.4 million, which was favorable relative to the Company’s corporate guidance for the full year 2024, which was between $15 million and $20 million. The Company continues its efforts to be capital efficient in its operations.

2025 Financial Guidance

Management announces its guidance for the full year 2025:

● Anticipated Total Revenues expected to be between $75 million and $90 million;
● Anticipated Total Operating Costs and Expenses, excluding cost of goods sold, expected to be between $116 million and $121 million (Total Operating Costs and Expenses including cost of goods sold is anticipated to be between $129 million and $134 million);
● Anticipated Total Annual Cash Investment expected to be between $25 million and $30 million; and
● Cash and Cash Equivalents anticipated to be sufficient to fund operations as currently planned into 2027.
Management announces its guidance for the first quarter 2025:

● Anticipated Total Revenues expected to be between $18 million and $21 million.
Webcast and Conference Call

Y-mAbs will host a conference call on Tuesday, March 4, 2025, at 8:00 a.m. ET. To participate in the live conference call, register here:

https://register.vevent.com/register/BIc0434de7d34443d1a7e4c7635d2c9faa

To listen to the live webcast, please use this link. Prior to the call and webcast, a slide presentation pertaining to the Company’s quarterly earnings will be made available on the Investor Relations section of the Y-mAbs website, www.ymabs.com, shortly before the call begins.

On March 4, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack Khattar, President and CEO of Supernus Pharmaceuticals, will participate in the following March investor conferences (Press release, Supernus, MAR 4, 2025, View Source [SID1234650885]):

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Barclays Global Healthcare Conference
Date: Tuesday, March 11, 2025
Fireside chat: 12:30 p.m. ET
Place: Loews Miami Beach Hotel, Miami, Fla.

Jefferies Biotech on the Beach Summit
Date: Wednesday, March 12, 2025
Place: Ritz-Carlton South Beach, Miami, Fla.

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live audio webcast of the Company’s fireside chat at the Barclays Global Healthcare Conference can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

On March 4, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the fourth quarter and full year ended December 31, 2024, including sales of TAVALISSE (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP); REZLIDHIA (olutasidenib) for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML); and GAVRETO (pralsetinib) for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) and advanced or metastatic thyroid cancer, and recent business progress (Press release, Rigel, MAR 4, 2025, View Source [SID1234650884]).

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"2024 was a year of significant accomplishments for Rigel. We continued to focus on commercial expansion and execution, achieving record net product sales of $144.9 million, an increase of 39% compared to 2023. Coupled with Rigel’s commitment to financial discipline, for the first time we generated full-year net income of more than $17 million and increased our cash balances by more than $20 million," said Raul Rodriguez, Rigel’s president and CEO. "These outstanding commercial and financial results provide us the resources to advance our promising internal development programs in 2025, including our ongoing Phase 1b clinical study of R289 for the treatment of lower-risk MDS and the initiation of a Phase 2 clinical study of olutasidenib for the treatment of recurrent glioma."

Business Update

Commercial

Commercial strength continued in the fourth quarter for all products with record bottles shipped to patients and clinics and total bottles sold.
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

Rigel’s partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced in January that The Korean Ministry of Food and Drug Safety approved TAVALISSE for the treatment of thrombocytopenia in adult patients with chronic idiopathic thrombocytopenic purpura who have had an insufficient response to a previous treatment. In the first quarter of 2025, Rigel will recognize a $3.0 million regulatory milestone earned from Kissei in connection with the approval.
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 who have had an insufficient response to a previous treatment.
Rigel entered into an exclusive license agreement with Dr. Reddy’s Laboratories Ltd. (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 received an upfront cash payment of $4.0 million with the potential for up to $36.0 million in future regulatory and commercial milestone payments.
Clinical Development

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 complete and the new sixth dose level (500 mg twice daily) is now open for enrollment.
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 with preliminary signs of efficacy in this heavily pretreated R/R lower-risk MDS patient population, the majority of whom were high transfusion burden (HTB) at baseline. 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.
CONNECT, an international collaborative network of pediatric cancer centers, in collaboration with Rigel, opened for enrollment the "TarGet-D" study, a Phase 2 study (NCT06161974) evaluating olutasidenib in combination with temozolomide, followed by olutasidenib monotherapy, as maintenance therapy for newly diagnosed adolescent and young adult patients (ages 12 to 39 years) with a high-grade glioma (HGG) harboring an IDH1 mutation.
Rigel and The University of Texas MD Anderson Cancer Center (MD Anderson) have now opened for enrollment the four studies outlined in the multi-year strategic development alliance. Olutasidenib will be studied in disease areas where mIDH1 can play a role, including AML; higher-risk MDS, chronic myelomonocytic leukemia (CMML) and advanced myeloproliferative neoplasms (MPN); clonal cytopenia of undetermined significance (CCUS) and lower-risk MDS/CMML; and as post-transplant maintenance therapy.
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.

Publication Highlights

A paper titled "Long‑term safety and efficacy of fostamatinib in Japanese patients with primary immune thrombocytopenia," was published in January by Masataka Kuwana, M.D., Ph.D., professor and chairman of the Department of Allergy and Rheumatology at Nippon Medical School Graduate School of Medicine in the International Journal of Hematology. The paper reported the 3-year safety and efficacy data from the Phase 3 trial of fostamatinib in Japanese patients with ITP, which included no new safety signals and a sustained platelet response during treatment.
A paper titled "Olutasidenib in combination with azacitidine induces durable complete remissions in patients with relapsed or refractory mIDH1 acute myeloid leukemia: a multicohort open-label phase 1/2 trial," was published in January by Jorge E. Cortes, M.D., Director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, and Phase 2 trial investigator, in the Journal of Hematology and Oncology.
A paper titled "Olutasidenib demonstrates significant clinical activity in mutated IDH1 acute myeloid leukaemia arising from a prior myeloproliferative neoplasm," was published in December by Stéphane de Botton, M.D., Ph.D., head of translational research in hematology, Institut Gustave Roussy, France, in the British Journal of Haematology.
Fourth Quarter and Full Year 2024 Financial Update
For the fourth quarter ended December 31, 2024, total revenues were $57.6 million, consisting of $31.0 million in TAVALISSE net product sales, $7.4 million in REZLIDHIA net product sales, $8.1 million in GAVRETO net product sales, and $11.1 million in contract revenue from collaborations. TAVALISSE net product sales grew 21% compared to $25.7 million in the same period of 2023. REZLIDHIA net product sales grew 92% compared to $3.9 million in the same period of 2023. GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations primarily consisted of a $4.0 million upfront cash payment from Dr. Reddy’s; $3.6 million of revenue from Grifols S.A. (Grifols) 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 (Medison) related to delivery of drug supplies and earned royalties.

Total costs and expenses were $40.9 million compared to $33.8 million for the same period of 2023. The increase in costs and expenses was mainly due to higher research and development costs driven by timing of clinical activities, increased personnel-related costs and increased commercial-related activities. In addition, cost of product sales increased, driven primarily by increased products sales, higher royalties and a sublicensing revenue fee, and higher amortization of intangible assets.

Rigel reported net income of $14.3 million, or $0.81 basic and $0.80 diluted per share, compared to a net income of $0.7 million, or $0.04 basic and diluted per share, for the same period of 2023. The basic and diluted share and per share amounts for the prior period have been restated to reflect the 1-for-10 reverse stock split effected on June 27, 2024 on a retroactive basis.

For the full year 2024, total revenues were $179.3 million, consisting of $104.8 million in TAVALISSE net product sales, $23.0 million in REZLIDHIA net product sales, $17.1 million in GAVRETO net product sales, and $34.4 million in contract revenue from collaborations. TAVALISSE net product sales grew 12% compared to $93.7 million in the same period of 2023. REZLIDHIA net product sales grew 118% compared to $10.6 million in the same period of 2023. As mentioned above, GAVRETO became commercially available from Rigel in June 2024. Contract revenue from collaborations primarily consisted of $20.4 million from Kissei related to an upfront fee from sublicensing olutasidenib and delivery of drug supplies; $9.1 million from Grifols and $0.5 million from Medison related to delivery of drug supplies and earned royalties; and $4.0 million from Dr. Reddy’s related to an upfront fee from sublicensing olutasidenib.

Total costs and expenses were $155.1 million compared to $137.4 million for the same period of 2023. The increase in costs and expenses was mainly due to higher cost of product sales driven primarily by increased products sales, sublicensing revenue fees and increased royalties and amortization of intangible assets. In addition, there were increases in personnel-related costs, stock-based compensation expense and commercial-related expenses. These increases were partially offset by decreased research and development costs due to the timing of clinical trial activities related to R289, Rigel’s dual IRAK 1/4 inhibitor program, as well as reduced trial activities related to the completed Phase 3 clinical trial of fostamatinib in patients with warm antibody hemolytic anemia (wAIHA).

Rigel reported net income of $17.5 million, or $0.99 basic and diluted per share, compared to a net loss of $25.1 million, or $1.44 basic and diluted per share, for the same period of 2023. As discussed above, the share and per share amounts have been restated to reflect the 1-for-10 reverse stock split on a retroactive basis for the respective periods presented.

Cash, cash equivalents and short-term investments as of December 31, 2024 was $77.3 million, compared to $61.1 million as of September 30, 2024 and $56.9 million as of December 31, 2023.

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.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call 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 after the call via the Rigel website.

About ITP
In patients with immune thrombocytopenia (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. Patients 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 (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,010 new cases in the United States, most in adults, in 2025.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About NSCLC
It is estimated that over 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. Lung cancer is the leading cause of cancer death in the U.S, with non-small cell lung cancer (NSCLC) being the most common type accounting for 85-90% of all lung cancer diagnoses.5 RET fusions are implicated in approximately 1-2% of patients with NSCLC.6

About TAVALISSE
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.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About REZLIDHIA
REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA.

About GAVRETO
GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).*

*Thyroid indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Please click here for Important Safety Information and Full Prescribing Information for GAVRETO.

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

TAVALISSE, REZLIDHIA and GAVRETO are registered trademarks of Rigel Pharmaceuticals, Inc.