On August 5, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its financial and operating results for the second quarter ended June 30, 2025 (Press release, Curis, AUG 5, 2025, View Source [SID1234654783]).

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"We are pleased with our progress in the TakeAim Lymphoma study and are continuing to enroll PCNSL patients in both Part B (BTKi-experienced patients) and Part C (BTKi-naïve patients) to enable accelerated approval filings in the US and EU. We look forward to providing updated data later this year," said James Dentzer, President and Chief Executive Officer. "We are also excited to add a clinical study of emavusertib in combination with a BTK inhibitor in Chronic Lymphocytic Leukemia, as part of our strategy to expand across CLL and NHL and bring this novel treatment option to broader patient populations with unmet needs. For CLL patients in particular, this could represent a fundamental change in the treatment paradigm, with the potential of an emavusertib-BTKi combination to enable time-limited treatment. We look forward to beginning enrollment later this year."

Operational Highlights

NHL/CLL

Presented at the 2025 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting the poster titled, Analysis of genetic mutation profile and CNS pharmacokinetics in relapsed/refractory primary CNS lymphoma patients responding to novel emavusertib (IRAK4i) and BTKi combination.
Continued to enroll relapsed/refractory Primary Central Nervous System Lymphoma (R/R PCNSL) patients in the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is now enrolling patients to support registration. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL.
Adding a proof-of-concept clinical study of emavusertib in combination with a BTKi in 20-30 patients with R/R CLL with the goal of improving upon the current standard of care (BTKi) with its limitations of partial responses and life-long therapy. The combination of emavusertib with a BTKi has the potential to enable patients to achieve complete remission or minimal residual disease (MRD) negativity and time-limited treatment, which would be a paradigm shift in the management of CLL.
Leukemia

Completed enrollment in the TakeAim Leukemia Phase 1/2 study of emavusertib as a monotherapy in patients with R/R Acute Myeloid Leukemia (AML) or R/R Myelodysplastic Syndrome (MDS) and are following several patients still on study treatment.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress on the design of a head-to-head registrational trial vs. gilteritinib in R/R AML based upon encouraging data, Preliminary Safety, Efficacy and Molecular Characterization of Emavusertib (CA-4948) in Relapsed/Refractory Acute Myeloid Leukemia Patients, presented by Dr. Eric Winer at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) on the design of a Phase 1/2 study in frontline high-risk MDS (hrMDS) in combination with azacitidine based upon encouraging R/R MDS clinical data at ASH (Free ASH Whitepaper) 2024 in the poster, Preliminary Safety, Efficacy and Molecular Characterization in Higher-Risk Myelodysplastic Syndrome Patients Treated with Single Agent Emavusertib (CA-4948).
Ongoing triplet study evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine in frontline AML, with data expected at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December.
Corporate

Completed a registered direct offering and concurrent private placement extending cash runway to the first quarter of 2026.
Upcoming Presentations and Conferences

Cantor Global Healthcare Conference 2025 – September 2-5, 2025
H.C. Wainwright 27th Annual Global Investment Conference – September 8-10, 2025
Upcoming Milestones

Additional data in R/R PCNSL patients from the TakeAim Lymphoma study is expected later this year.
Second Quarter 2025 Financial Results

For the second quarter of 2025, Curis reported a net loss of $8.6 million or $0.68 per share on both a basic and diluted basis as compared to $11.8 million or $2.03 per share on both a basic and diluted basis, for the same period in 2024. Curis reported a net loss of $19.2 million or $1.82 per share on both a basic and diluted basis, for the six months ended June 30, 2025, as compared to a net loss of $23.7 million or $4.08 per share on both a basic and diluted basis for the same period in 2024.

Revenues for the second quarter of 2025 were $2.7 million as compared to $2.5 million for the same period in 2024. Revenues were $5.1 million for the six months ended June 30, 2025, as compared to $4.6 million for the same period in 2024. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $7.5 million for the second quarter of 2025, as compared to $10.3 million for the same period in 2024. The decrease was primarily attributable to lower employee related, research, consulting, and clinical costs. Research and development expenses were $16.0 million for the six months ended June 30, 2025, as compared to $19.9 million for the same period in 2024.

General and administrative expenses were $3.5 million for the second quarter of 2025, as compared to $4.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $7.5 million for the six months ended June 30, 2025, as compared to $9.7 million for the same period in 2024.

Other expense was $0.3 million for the second quarter of 2025, as compared to other income of $0.7 million for the same period in 2024. The decrease was primarily attributable to a decrease in interest income and an increase in the expense related to the sale of future royalties. Other expense was $0.8 million for the six months ended June 30, 2025, compared to other income of $1.3 million for the same period in 2024.

Curis’s cash and cash equivalents totaled $10.1 million as of June 30, 2025, and the Company had approximately 10.7 million shares of common stock outstanding. We believe that our existing cash and cash equivalents, together with the net proceeds of $6.0 million from the July 2025 Offerings, should enable us to fund our existing operations into the first quarter of 2026.

Conference Call and Webcast Information

Curis management will host a conference call today, August 5, 2025, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations. To access the webcast login here shortly before 8:30 a.m. ET. The webcast can also be accessed on the Curis website at the Events and Presentations section of the Investors page.

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.

Cogent Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On August 5, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its second quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, AUG 5, 2025, View Source [SID1234654784]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We have strong momentum going into the second half of 2025. We continue to focus on our three core priorities: accelerating revenue growth with OJEMDA, advancing our pipeline, and pursuing value-driving portfolio expansion anchored in financial discipline," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With strong execution across the organization and a solid financial foundation, we’re building a company that aims to deliver meaningful value to patients and to shareholders."

OJEMDA Commercial Performance

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OJEMDA net product revenue was $33.6 million in the second quarter of 2025, an increase of 310% from the second quarter of 2024.

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U.S. OJEMDA net product revenue increased 10% from the first quarter of 2025.

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OJEMDA prescriptions exceeded 1,000 in the second quarter of 2025, representing a 15% increase compared to the first quarter of 2025 and a 346% increase compared to the second quarter of 2024.

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Achieved $113.1 million in OJEMDA net product revenue for the most recent 12-month period ended June 30, 2025.

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The Company is providing 2025 net product revenue guidance of $140 to $150 million.

Program Highlights

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DAY301, the Company’s PTK7-targeted ADC, is actively enrolling patients in the Phase 1a portion of the Phase 1a/b clinical trial; the trial is progressing as planned.

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Day One expects to present 3-year follow-up data from the FIREFLY-1 clinical trial in the fourth quarter of 2025.

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Day One published additional data characterizing growth velocity recovery and effective rash management at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Abstract 10029: Growth recovery in patients with BRAF-altered pediatric low-grade gliomas (pLGGs) after discontinuation of tovorafenib
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Abstract 10037: Post hoc analysis of rashes reported in patients with BRAF-altered relapsed/refractory pediatric low-grade glioma treated with the type II RAF inhibitor tovorafenib in FIREFLY-1

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Patient enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial is on track to achieve completion of trial enrollment in the first half of 2026.

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Day One terminated its research collaboration and license agreement with Sprint Bioscience AB following careful consideration of the current development status for the VRK1 program and the Company’s overall strategic objectives.

Corporate Highlights

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Industry leader Michael Vasconcelles, M.D., joined Day One in June 2025 as Head of Research and Development. Dr. Vasconcelles brings more than 25 years of extensive oncology research and development experience to the Company, most recently as Executive Vice President and Head of Research, Development and Medical Affairs at ImmunoGen.

Second Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $33.6 million for the second quarter of 2025 compared to $8.2 million for the second quarter of 2024.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.3 million for the second quarter of 2025.

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R&D Expenses: Research and development expenses were $36.1 million for the second quarter of 2025 compared to $92.1 million for the second quarter of 2024. The decrease was primarily due to the MabCare Therapeutics license agreement upfront payment of $55.0 million in the second quarter of 2024.

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SG&A Expenses: Selling, general and administrative expenses were $29.0 million for the second quarter of 2025 compared to $30.2 million for the second quarter of 2024. The decrease was primarily due to lower employee compensation costs.

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Net Loss: Net loss totaled $30.3 million for the second quarter of 2025 with non-cash stock-based compensation expense of $10.9 million, compared to a net loss of $4.4 million for the second quarter of 2024, with non-cash stock-based compensation expense of $13.0 million and gain from sale of priority voucher of $108.0 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $453.1 million as of June 30, 2025.

Conference Call

Day One will host a conference call and webcast today, August 5 at 4:30 p.m. ET. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

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

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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
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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
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Doses were selected based on the totality of safety, efficacy, and pharmacokinetic/pharmacodynamic data from the dose escalation portion of the trial
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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
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Early interim data released in December 2024 from the TERN-701 dose escalation portion of the CARDINAL trial showed:
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Compelling molecular responses in heavily pre-treated CML patients with high baseline BCR-ABL transcript levels, starting at the lowest doses
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Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations or dose reductions at any dose
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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

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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
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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
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U.S.-based, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of TERN-601 as a treatment for obesity
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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
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Secondary endpoints include safety, tolerability and proportion of patients achieving 5% weight loss or greater
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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
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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

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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

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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