On August 5, 2025 Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, reported financial results for the second quarter ended June 30, 2025, and provided corporate updates (Press release, Terns Pharmaceuticals, AUG 5, 2025, View Source [SID1234654800]).

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"The Terns team continues to advance our clinical programs with strong momentum, a clear focus on execution and a strong balance sheet," said Amy Burroughs, chief executive officer of Terns. "We are on track for two key clinical readouts in CML and obesity by year-end. The fourth quarter data readout from the Phase 1 CARDINAL trial in 2L+ CML will enable comparison of the efficacy and safety results of TERN-701 with data from other Phase 1 CML trials, including asciminib’s."

"We are focusing the company in oncology and on rapidly advancing TERN-701 towards a pivotal trial, with the goal of ultimately bringing a potential best-in-class therapy to people living with CML. The company seeks to partner our portfolio of potentially best-in-class metabolic assets and does not plan to invest in clinical development in metabolic disease beyond year end 2025."

"We are encouraged by the rapid enrollment in the CARDINAL trial of TERN-701 in CML and initiation of dose expansion at the high end of the dose range based on the safety and efficacy data to date. The recently presented preclinical data at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) further supports TERN-701’s enhanced potency compared to asciminib across multiple clinically relevant BCR-ABL variants, including those with resistance mutations. These findings build upon previously reported data from the early dose escalation portion of the CARDINAL trial, which showed compelling molecular responses observed in heavily pre-treated patients, including those with treatment failure to asciminib. We look forward to sharing a CARDINAL data set in the fourth quarter that will provide a read through to the primary endpoint in a registrational trial – the achievement of a major molecular response at six months," concluded Ms. Burroughs.

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Oral, small-molecule next-generation allosteric BCR-ABL inhibitor for CML

•
Terns plans to report efficacy and safety data from the Phase 1 CARDINAL trial in the fourth quarter of 2025, including 6-month MMR achievement rate, and to inform the potential for a best-in-class product profile and path to a pivotal trial
o
In April 2025, Terns enrolled the first patient in the dose expansion portion of the CARDINAL trial in which patients are randomized to one of two dose cohorts (320 mg or 500 mg QD) with up to 40 patients per arm
o
Doses were selected based on the totality of safety, efficacy, and pharmacokinetic/pharmacodynamic data from the dose escalation portion of the trial
•
Terns to host an educational webinar in September 2025 detailing the unmet need in CML, how TERN-701 is building a potential best-in-class profile and relevant benchmarks for Phase 1 data. Webcast details will be available prior to the event
•
Early interim data released in December 2024 from the TERN-701 dose escalation portion of the CARDINAL trial showed:
o
Compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels, starting at the lowest doses
o
Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions at any dose
•
In addition, supportive preclinical data presented at EHA (Free EHA Whitepaper) 2025 highlighted greater potency of TERN-701 compared to asciminib against several resistance mutations in the active-site and allosteric domains

TERN-601: Oral, small-molecule glucagon-like peptide-1 receptor agonist (GLP1-RA) for obesity

•
Key objectives of the Phase 2 FALCON trial in patients with obesity or overweight are to demonstrate competitive weight loss at 12-weeks, a class-leading safety/tolerability profile, and the simplest dose titration among GLP1-RA therapies
•
The Phase 2 FALCON trial enrollment completed in the second quarter of 2025 and top-line 12-week data is expected in the early fourth quarter of 2025
o
U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601 as a treatment for obesity
o
Once-daily dosing with or without food in adults with obesity or overweight, without diabetes (BMI ranges from ≥30 to <50 kg/m2 or ≥27 to <30 kg/m2 with at least one weight-related comorbidity)
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Patients randomized to one of four active cohorts (n=30 per cohort): 250 mg, 500 mg, 500 mg slow titration, 750 mg or placebo
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Primary endpoint is percent change from baseline in body weight compared to placebo over 12 weeks
o
Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
•
Doses and titration schema for Phase 2 were selected based on positive results from the Phase 1 trial, announced in September 2024, which demonstrated weight loss over 28-days up to 5.5% and favorable safety and tolerability despite rapid dose titration every three days
•
In June 2025, Terns presented additional data from the completed 28-day Phase 1 trial of TERN-601 for obesity at the 85th Annual American Diabetes Association Scientific Sessions, which further demonstrated its differentiated profile among oral GLP1-RAs

Pipeline and Partnering Programs

TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators

•
Terns is prioritizing its discovery efforts on nominating a GIPR antagonist development candidate based on in-house discoveries and growing scientific rationale supporting the potential of GLP-1 agonist/GIPR antagonist combinations for obesity. Terns is seeking a strategic partner to advance this program

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

•
Based on non-clinical studies, THR-β is a complementary mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss. Terns is seeking a strategic partner to advance this program

Corporate Updates

Members of the Terns’ senior leadership team will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference, taking place in New York City, New York, September 8-10th, 2025.

Webcasts can be accessed at Terns’ IR website: View Source

Second Quarter 2025 Financial Results

Cash Position: As of June 30, 2025, cash, cash equivalents and marketable securities were $315.4 million, as compared with $358.2 million as of December 31, 2024. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2028

Research and Development (R&D) Expenses: R&D expenses were $20.4 million for the quarter ended June 30, 2025, as compared with $18.4 million for the quarter ended June 30, 2024

General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended June 30, 2025, as compared with $7.2 million for the quarter ended June 30, 2024

Net Loss: Net loss was $24.1 million for the quarter ended June 30, 2025, as compared with $22.7 million for the quarter ended June 30, 2024

On August 5, 2025 SynOx Therapeutics Limited ("SynOx"), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), reported completion of patient enrolment in the TANGENT study (Press release, SynOx Therapeutics, AUG 5, 2025, View Source [SID1234654799]). TANGENT is the company’s global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in patients with TGCT who are not amenable to or who would not benefit from surgery. SynOx expects to report top-line data from the study in the first quarter of 2026.

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Emactuzumab is a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody (mAb). Clinical evaluation to date has demonstrated the compound to be a promising, next-generation mAb therapy with the potential to offer a short treatment cycle, rapid onset and long duration of response that differentiates it from chronically administered oral agents. This potentially best-in-class profile helped drive strong interest in the TANGENT trial among patients and clinical investigators across sites in the United States, Canada, Europe and Asia, leading to rapid study enrollment.

"Completion of enrollment in our registrational TANGENT trial marks an important milestone for SynOx and for the TGCT community," said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. "We are deeply grateful to the patients, families, investigators, and clinical sites whose dedication has made this study possible and allowed SynOx to fully enroll the trial significantly ahead of our projected timeline. We remain committed, data permitting, to delivering a much-needed new treatment option for this debilitating condition."

"This is a transformational time for SynOx as we advance emactuzumab through its pivotal Phase 3 program," said Ray Barlow, Chief Executive Officer of SynOx. "We’re excited about the next steps and look forward to delivering top-line data that we hope demonstrate how emactuzumab can transform care for patients with this grievous disease."

About the TANGENT Study

TANGENT (ClinicalTrials.gov Identifier: NCT05417789) is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT who are not amenable to or would not benefit from surgery. Patients who consent and meet eligibility criteria are randomized in a 2:1 fashion to receive either emactuzumab (1000 mg every two weeks for five doses) or matched placebo.

The primary endpoint is objective response rate (ORR) as assessed by RECIST criteria at six months post-randomization. Key secondary endpoints include patient-reported outcomes (PROMIS-PF), functional assessments of range of motion, pain, stiffness, durability of response, and safety. Patients are followed for two years from randomization, with those demonstrating disease progression after the six-month assessment eligible to receive open-label emactuzumab during follow-up.

On August 5, 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 financial results for the second quarter 2025 and associated Company developments (Press release, Supernus, AUG 5, 2025, View Source [SID1234654798]).

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"Our strong operating performance in the first half of the year was driven by continued strong sales growth of Qelbree and GOCOVRI, which combined accounted for 72% of total net sales in the second quarter of 2025," said Jack Khattar, President and CEO of Supernus. "Our focus for the second half of the year remains on the launch of ONAPGO, the successful integration of Sage Therapeutics, and the continued performance of our growth products," said Jack Khattar, President and CEO of Supernus.

Acquisition of Sage Therapeutics, Inc.

The Company completed the acquisition of Sage Therapeutics on July 31, 2025, strengthening its leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE (zuranolone), and a novel CNS discovery platform. The acquisition is expected to accelerate mid- to long-term revenue and cash flow growth and further diversify the Company’s revenue base.
Commercial Highlights

Total IQVIA prescriptions(2) for Qelbree were 225,254 for the second quarter 2025, an increase of 23% compared to the same period in the prior year. Qelbree continues to expand its base of prescribers, with approximately 36,000 prescribers in the second quarter of 2025, up by 23% compared to the same period last year.

In April 2025, the Company launched ONAPGO, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. ONAPGO demand is exceeding the Company’s expectations, with more than 750 enrollment forms submitted by more than 300 prescribers through the end of the second quarter of 2025.
Product Pipeline Update

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

The Company plans to initiate a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms. The Company expects to initiate the Phase 2b study by the end of 2025.
SPN-443 – Novel stimulant for ADHD/CNS

The Company completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated. The Company expects to disclose a lead indication for the product candidate by the end of 2025.
Financial Highlights

This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release.

Revenues

The following table provides information regarding total revenues (dollars in millions):

Three Months Ended
June 30, Six Months Ended
June 30,
2025 2024 Change % 2025 2024 Change %
(unaudited)
Net product sales
Qelbree $ 77.6 $ 59.4 31 % $ 142.3 $ 104.5 36 %
GOCOVRI 36.7 31.7 16 % 67.4 58.3 16 %
APOKYN 12.8 17.3 (26 )% 27.8 33.9 (18 )%
Trokendi XR 11.2 17.1 (35 )% 24.0 33.1 (27 )%
Oxtellar XR 11.6 29.5 (61 )% 21.8 56.5 (61 )%
ONAPGO 1.6 — 100 % 1.6 — 100 %
Other(3) 6.5 7.5 (13 )% 15.1 14.7 3 %
Total net product sales 158.0 162.5 (3 )% 300.0 301.0 — %
Royalty, licensing and other revenues(4) 7.5 5.8 29 % 15.3 11.0 39 %
Total revenues $ 165.5 $ 168.3 (2 )% $ 315.3 $ 312.0 1 %

Total revenues excluding Trokendi XR and Oxtellar XR net sales (non-GAAP)(1) $ 142.7 $ 121.7 17 % $ 269.5 $ 222.4 21 %

Other Financial Highlights

Operating earnings were $12.1 million and $1.9 million for the three and six months ended June 30, 2025, compared to operating earnings of $22.6 million and $19.4 million for the same periods in 2024. The change was primarily due to higher contingent consideration loss, mainly related to the achievement of ONAPGO-related milestones, and higher selling and marketing expenses.
Adjusted operating earnings (non-GAAP) were $40.9 million and $66.9 million for the three and six months ended June 30, 2025, compared to $45.5 million and $67.7 million for the same periods in 2024.
Net earnings and diluted earnings per share were $22.5 million and $0.40 for the three months and $10.7 million and $0.19 for the six months ended June 30, 2025, respectively, compared to net earnings and diluted earnings per share of $19.9 million and $0.36 for the three months and $20.0 million and $0.36 six months ended June 30, 2024, respectively.
At June 30, 2025, cash, cash equivalents, and current marketable securities were approximately $522.6 million compared to $453.6 million as of December 31, 2024. This increase was primarily due to cash generated from operations.

On August 5, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the second quarter 2025, and provided a corporate update (Press release, Sensei Biotherapeutics, AUG 5, 2025, View Source [SID1234654797]).

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"The second quarter was a key inflection point for Sensei, as we now transition from early response-focused readouts to longer-term and commercially relevant efficacy signals with the maturity of the data from our Phase 1/2 study of solnerstotug," said John Celebi, President and CEO of Sensei. "Solnerstotug has demonstrated a favorable safety profile and in combination with cemiplimab has not demonstrated significant additional toxicity relative to what is typically observed with PD-(L)1 monotherapy, which we believe could translate into better patient adherence and more meaningful long-term outcomes with continued treatment, as well as physician preference and payor interest."

"As we look to next steps in the clinical advancement of solnerstotug, we envision multiple Phase 2 studies across PD-(L)1 resistant tumor types, aligned with unmet need and commercial potential. We view these differentiated opportunities as potentially derisking overall, while positioning solnerstotug for multiple indications in high-value immunotherapy segments of the ~$50 billion PD-(L)1 market," added Mr. Celebi. "We continue to work on finalizing the Phase 2 strategy for solnerstotug, which will be strongly influenced by the full dose expansion dataset we plan to present later this year."

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei’s ongoing multi-center Phase 1/2 clinical trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Clinical Program Highlights:

Full dose expansion data, including 6-month progression free survival (PFS), from the Phase 1/2 study continues to be expected by year-end 2025.
Enrollment in the Phase 1/2 dose expansion cohort is complete with a total of 64 patients, including:
10 "cold" MSS CRC patients in the monotherapy arm
54 patients in the cemiplimab combination arm consisting of 10 "cold" MSS CRC patients and 44 "hot" tumor patients. 41/44 patients in the "hot" tumor cohort had received and progressed on a prior PD-(L)1 inhibitor.
On March 27th, Sensei announced favorable preliminary clinical data in PD-(L)1 resistant patients from the dose expansion stage of its ongoing Phase 1/2 trial, demonstrating favorable activity in patients with PD-(L)1 resistant "hot" tumors. Solnerstotug continued to be well tolerated, with no dose-limiting toxicities, and the majority of AEs Grade 1 or 2 in severity.
A replay of the March 2025 webcast related to the preliminary data, featuring study investigator Dr. Shiraj Sen, is available on the Sensei website.
Corporate Updates:

On July 30th, the Company announced that clinical data from the dose expansion cohort of the Phase 1/2 trial of solnerstotug alone and in combination with cemiplimab will be presented in a mini oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21, 2025 in Berlin, Germany.
Sensei regains Nasdaq compliance following the 1-for-20 reverse split of its common stock, which became effective at 5:00 p.m. ET on June 16th, and subsequent 10-day bid price remaining above $1.
On April 7th, John Celebi participated in a panel discussion titled "New Radiotherapy and Targeted Therapy Approaches" at the Canaccord Genuity Horizons in Oncology Virtual Conference. The panel focused on emerging innovations in cancer treatment and Sensei’s approach to selectively modulating the tumor microenvironment.
Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $28.6 million as of June 30, 2025, as compared to $41.3 million as of December 31, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the quarter ended June 30, 2025, compared to $4.6 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to lower personnel and facilities costs, and reduced manufacturing cost.

General and Administrative (G&A) Expenses: G&A expenses were $2.7 million for the quarter ended June 30, 2025, compared to $3.2 million for the quarter ended June 30, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs.

Net Loss: Net loss was $4.9 million for the quarter ended June 30, 2025, compared to $7.1 million for the quarter ended June 30, 2024.

On August 5, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the second quarter ended June 30, 2025, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress (Press release, Rigel, AUG 5, 2025, View Source [SID1234654796]).

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"Our strategic and disciplined approach to building our business has generated another strong quarter for the company. In the second quarter, we grew net product sales by 76% year-over-year, generated $59.6 million in net income and increased our cash balance to $108.4 million. This strong performance has enabled us to raise our 2025 financial guidance," said Raul Rodriguez, Rigel’s president and CEO. "We’re also excited by the continued advancement of our hematology and oncology development pipeline. In July, we completed enrollment in the dose escalation part of our ongoing Phase 1b study evaluating R289 in patients with relapsed or refractory lower-risk MDS. Later this year, we plan to share updated data from that study and initiate the dose expansion part of the study."

Second Quarter 2025 Business Update

Commercial

· Net product sales were $58.9 million, an increase of 76% from the same period of 2024.
· Rigel’s partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that its licensing partner, JW Pharmaceutical Corporation, commercially launched TAVALISSE in South Korea in early July.

Corporate

· In April, Rigel notified Eli Lilly and Company (Lilly) that it would not exercise its opt-in right related to the development and commercialization of ocadusertib (previously R552) for the treatment of non-central nervous system (CNS) diseases. As a result of the notification, Rigel recognized $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability in the second quarter. Per the agreement with Lilly, Rigel will continue to be entitled to receive milestone and tiered royalty payments on future net sales of ocadusertib and the companies’ CNS penetrant program.

Clinical Development

· Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor, in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose escalation part of the study was completed in July. The company expects to share updated data from the study later this year and plans to initiate the dose expansion part of the study in the second half of this year.

· Rigel presented 4 posters at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 3 posters at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress. Presentations included the final data from the GAVRETO (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive non-small cell lung cancer (NSCLC) and other solid tumors, and supportive data for REZLIHDIA (olutasidenib) in patients with mutated isocitrate dehydrogenase-1 (mIDH1) relapsed or refractory (R/R) acute myeloid leukemia (AML).

Key Publications

· A paper titled "Effectiveness of Olutasidenib versus Ivosidenib in Patients With Mutated Isocitrate Dehydrogenase 1 Acute Myeloid Leukemia Who Are Relapsed or Refractory to Venetoclax: The 2102-HEM-101 Trial Versus a US Electronic Health Record-Based External Control Arm," was published in June by Catherine Lai, M.D., MPH, lead author and associate professor of Clinical Medicine, Division of Hematology-Oncology, Department of Medicine at University of Pennsylvania, in Leukemia & Lymphoma.
· A paper titled "Olutasidenib Alone or Combined with Azacitidine in Patients with Mutant IDH1 Myelodysplastic Syndrome," was published in July by Jorge E. Cortes, M.D., lead author and director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, in Blood Advances. This is the first full report of the safety and clinical activity of an mIDH1 inhibitor plus hypomethylating agent (HMA) combination in patients with treatment-naïve and R/R MDS. The paper showed olutasidenib, alone or in combination with azacitidine, induced a high rate of clinically meaningful complete remission and hematologic improvement responses with durable remission duration, accompanied by low rates of serious treatment-emergent-adverse events in patients with intermediate-, high- or very high-risk MDS harboring mIDH1.

Second Quarter 2025 and Year-to-Date Financial Update

For the second quarter ended June 30, 2025, total revenues were $101.7 million, consisting of $58.9 million in net product sales and $42.7 million in contract revenues from collaborations. Net product sales grew 76% compared to $33.5 million in the same period of 2024. TAVALISSE net product sales were $40.1 million, growth of 52% compared to $26.4 million in the same period of 2024. GAVRETO net product sales were $11.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $7.0 million, growth of 36% compared to $5.2 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $2.0 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $0.4 million of revenue from Kissei related to the delivery of drug supplies, and $0.2 million of revenue from Medison Pharma (Medison) related to delivery of drug supplies and earned royalties.

Total costs and expenses were $40.6 million compared to $36.4 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs and stock-based compensation expense.

Rigel reported net income of $59.6 million, or $3.33 basic and $3.28 diluted per share, compared to a net loss of $1.0 million, or $0.06 basic and diluted per share, for the same period of 2024.

For the six months ended June 30, 2025, total revenues were $155.0 million, consisting of $102.5 million in net product sales and $52.5 million in contract revenues from collaborations. Net product sales grew 72% compared to $59.5 million in the same period of 2024. TAVALISSE net product sales were $68.5 million, growth of 44% compared to $47.5 million in the same period of 2024. GAVRETO net product sales were $20.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $13.1 million, growth of 31% compared to $10.0 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $6.7 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $5.1 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.6 million of revenue from Medison related to delivery of drug supplies and earned royalties.

Total costs and expenses were $81.1 million compared to $72.9 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs. These increases were partially offset by decreased stock-based compensation expense primarily from performance-based stock awards.

Rigel reported net income of $71.1 million, or $3.98 basic and $3.91 diluted per share, compared to a net loss of $9.3 million, or $0.53 basic and diluted per share, for the same period of 2024.

Cash, cash equivalents and short-term investments as of June 30, 2025 was $108.4 million, compared to $77.3 million as of December 31, 2024.

2025 Outlook

Rigel is updating its 2025 total revenue guidance to approximately $270 to $280 million, an increase from the previous range of approximately $200 to $210 million, which includes:

· Net product sales of approximately $210 to $220 million, an increase from the previous range of approximately $185 to $192 million.
· Contract revenues from collaborations of approximately $60 million, an increase from the previous range 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.

The above total revenues and contract revenues from collaborations are inclusive of $40 million in non-cash contract revenue related to Rigel’s agreement with Lilly.

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 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.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

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 2025.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.5,6 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.7 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 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 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).