On May 6, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the first quarter ended March 31, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance (Press release, Halozyme, MAY 6, 2025, View Source [SID1234652575]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in U.S. and Europe, Tecentriq Hybreza in U.S. and Europe, Opdivo Qvantig in U.S. and Rybrevant SC in Europe are just beginning their contributions as our partners focus on gaining and expanding coverage and reimbursement. This broadened portfolio is resulting in an unprecedented set of 11 additional growth catalysts that have happened recently or are expected to happen in the coming months. These opportunities include multiple new European and U.S. product approvals, multiple new indication approvals and multiple key reimbursement milestones supporting access for an even greater number of patients, all creating new near and longer-term growth opportunity. As a result of this momentum, I am pleased to announce we are increasing our full year 2025 financial guidance ranges and a new $250 million share buyback," said Dr. Helen Torley, president and chief executive officer, of Halozyme.

"In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS’ nivolumab plus relatlimab SC and Takeda’s 20% immune globulin SC, continue in Phase 3 and where ViiV and Acumen announced development progress and data in the quarter. I am also pleased to announce that we have signed our first HVAI development agreement with a current ENHANZE partner and that a different ENHANZE partner is now moving our SVAI into clinical testing," concluded Dr. Torley.

First Quarter and Recent Corporate Highlights:
•On May 6, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024.
•In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme’s patented MDASE subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck’s infringement of Halozyme’s MDASE intellectual property.
•In March 2025, Halozyme completed the first $250 million Accelerated Share Repurchase of its common stock under the $750 million approved program from February 2024.

First Quarter and Recent Partner Highlights:
•In April 2025, Roche received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting.
•In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART 1000mg (efgartigimod alfa) developed with ENHANZE for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins.
•In April 2025, argenx received U.S. Food and Drug Administration ("FDA") approval of VYVGART Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP.
•In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT (amivantamab) with ENHANZE, in combination with LAZCLUZE (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE to be commercialized.
•In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility.
•In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo (nivolumab) with ENHANZE across multiple solid tumor indications.
•In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development.
•In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment.

•In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults.

First Quarter 2025 Financial Highlights:
•Revenue was $264.9 million, compared to $195.9 million in the first quarter of 2024. The 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included $168.2 million in royalties, an increase of 39% compared to $120.6 million in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART Hytrulo, DARZALEX SC, and Phesgo.
•Cost of sales was $48.4 million, compared to $28.3 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales.
•Amortization of intangibles expense remained flat at $17.8 million, compared to the first quarter of 2024.
•Research and development expense was $14.8 million, compared to $19.1 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE related to the development of our new high-yield rHuPH20 manufacturing process.
•Selling, general and administrative expense was $42.4 million, compared to $35.1 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense.
•Operating income was $141.5 million, compared to $95.5 million in the first quarter of 2024.
•Net income was $118.1 million, compared to $76.8 million in the first quarter of 2024.
•EBITDA and Adjusted EBITDA were $162.0 million, compared to $115.7 million in the first quarter of 2024.1
•GAAP diluted earnings per share was $0.93, compared to $0.60 in the first quarter of 2024. Non-GAAP diluted earnings per share was $1.11, compared to $0.79 in the first quarter of 2024.1
•Cash, cash equivalents and marketable securities were $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations.

Financial Outlook for 2025
The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented.
For the full year 2025, the Company expects:

•Total revenue of $1,200 million to $1,280 million, representing growth of 18% to 26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $750 million to $785 million, representing growth of 31% to 37% over 2024.
•Adjusted EBITDA of $790 million to $840 million, representing growth of 25% to 33% over 2024.
•Non-GAAP diluted earnings per share of $5.30 to $5.70, representing growth of 25% to 35% over 2024. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2025 Financial Guidance

Previous Guidance Range
New Guidance Range
Total Revenue
$1,150 to $1,225 million
$1,200 to $1,280 million
Royalty Revenue
$725 to $750 million
$750 to $785 million
Adjusted EBITDA
$755 to $805 million
$790 to $840 million
Non-GAAP Diluted EPS
$4.95 to $5.35
$5.30 to $5.70

1 Adjusted EBITDA and non-GAAP Diluted EPS are non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

On May 6, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported it has entered into an exclusive patent license agreement with UTHealth Houston granting Genprex exclusivity and commercial rights relating to its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid) for the potential treatment of glioblastoma (Press release, Genprex, MAY 6, 2025, View Source [SID1234652574]). The subject patent is co-owned by Genprex and UTHealth Houston, and the license provides Genprex with patent exclusivity.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to expand our portfolio of licensed patents and add a technology that uses REQORSA to treat glioblastoma," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. "With this license agreement, Genprex has obtained exclusive commercial rights to REQORSA in glioblastoma while also adding to our patent estate. The role of TUSC2 in lung cancer has been well established, and this latest license enables Genprex to expand the use of REQORSA into a new indication, in which the cancer can be difficult to treat and there are unmet medical needs."

REQORSA may be a potential therapeutic treatment for glioblastoma.

REQORSA may be a potential therapeutic treatment for glioblastoma. Genprex previously reported positive preclinical data on the efficacy of REQORSA in glioblastoma in October 2024 at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics. Research collaborators from UTHealth Houston previously reported TUSC2 as a novel tumor suppressor for glioblastoma, the most common and deadliest primary brain tumor in adults which is associated with a poor prognosis. In their latest study, UTHealth Houston researchers used patient-derived glioblastoma (GBM) cell lines and patient-derived glioma stem cell (PD-GSC) lines. REQORSA was used to restore TUSC2 expression.

Researchers at UTHealth Houston observed that REQORSA significantly reduced GBM cell viability, and the results of a migration assay demonstrated that REQORSA suppressed GBM cell migration independent of its ability to suppress cell viability. In conclusion, REQORSA demonstrates promising in vitro efficacy in GBM and PD-GSCs, and these results support further evaluation of its in vivo anti-tumor efficacy in malignant gliomas using mouse models.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at The University of Texas MD Anderson Cancer Center show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On May 6, 2025 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological therapeutics, reported that the first set of oncology studies has shown that Aramchol enhances the liver / colorectal cancer-approved therapeutic Regorafenib effects in liver and colon cancers in-vitro and in-vivo models (Press release, Galmed Pharmaceuticals, MAY 6, 2025, View Source [SID1234652573]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Aramchol interacted with the multi-kinase inhibitors Sorafenib, Regorafenib and Lenvatinib, to kill GI tumor cells, with Regorafenib exhibiting the greatest effect. Aramchol enhanced both flux and autolysosome formation caused by Regorafenib, activating ATM and AMPK and inactivating mTORC1 and mTORC2 pathways. In addition, Regorafenib and Aramchol interacted to suppress tumor growth in hepatoma models without normal tissue toxicities.

Paul Dent, Ph.D. Professor School of Medicine Biochemistry and Molecular Biology Virginia Commonwealth University commented: "The key molecular mechanisms by which Aramchol and Regorafenib killed GI tumor cells were defined in the study. Aramchol acts to enhance autophagy through mechanisms that are different to those of Regorafenib. The interaction between Aramchol and Regorafenib, causing more autophagic flux and autolysosome formation, is required for the enhanced killing of tumor cells by the drug combination."

Allen Baharaff, President and CEO of Galmed Pharmaceuticals commented: "Targeting lipid metabolism with Aramchol, a potent SCD1 inhibitor, is a promising emerging strategy to overcome TKIs, such as Sorafenib, Regorafenib or Lenvatinib, for therapy resistance in HCC and colorectal cancers. A combination of Bayer’s Regorafenib and Aramchol could potentially become a cost-effective first line treatment for HCC and other liver and colorectal cancers. The mechanisms by which the combination of Aramchol and Regorafenib kills tumor cells provide the scientific foundation for a Phase Ib clinical trial in GI tumors. We look forward to taking these findings forward in a new clinical program, alongside the recently announced Semaglutide GLP-1 sublingual development."

On May 6, 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 first quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, MAY 6, 2025, View Source [SID1234652572]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We continued our successful launch of OJEMDA in 2025 and are energized by the growing impact we are bringing to patients every day," said Jeremy Bender, Ph.D., chief executive officer of Day One. "This is an exciting time of growth for Day One. We remain focused on creating value at every level of the organization, and we are executing on our objectives with urgency and fiscal discipline."

Program Highlights

•
OJEMDA net product revenue was $30.5 million in the first quarter of 2025.
o
U.S. OJEMDA net product revenue increased 11% from the fourth quarter of 2024.
o
OJEMDA prescriptions increased to over 900 (+16%) in the first quarter of 2025.

•
Achieved $87.7 million in OJEMDA net product revenue since launch, representing over 2,500 OJEMDA prescriptions.

•
In April 2025, Ipsen announced the regulatory filing for tovorafenib was accepted by the European Medicines Agency for review in the European Union, marking an important step forward for tovorafenib’s development outside of the U.S.

•
DAY301, our PTK7-targeted ADC, cleared the first dose cohort (a single-patient accelerated titration cohort) in the Phase 1a portion of the Phase 1a/b clinical trial.

•
Day One’s pivotal Phase 3 FIREFLY-2 clinical trial is expected to be fully enrolled in the first half of 2026.

•
Day One presented two posters at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, April 25-30, 2025.

o
A preclinical study provided evidence for the efficacy of sequencing of MEK inhibitor treatment after tovorafenib by demonstrating mice bearing AGK::BRAF fusion tumors maintained significant tumor regression with no emergent tumors when treated with tovorafenib (25 mg/kg) once daily followed by MEK inhibitor treatment. Additionally, long-term efficacy was maintained with continuous dosing of tovorafenib in vivo; significant tumor regression was maintained with no emergent tumors indicating no evidence of emerging resistance. The study results demonstrate that anti-tumor activity with MEK inhibitors is observed after treatment with tovorafenib and suggest that acquired resistance may be less common in BRAF fusion-driven tumors treated with tovorafenib. (Abstract 1727: Sequencing MEK inhibitor therapy after tovorafenib in BRAF fusion-driven cancers: Preclinical evidence of sustained tumor regression)
o
A clinical trial-in-progress poster on DAY301-001 the first-in-human Phase 1a/1b trial with DAY301 to evaluate its safety, tolerability, pharmacokinetics (PK) and antitumor activity in patients with locally advanced or metastatic solid tumors. (Abstract CT196: Phase I dose escalation and expansion study of the PTK-7 targeted antibody-drug conjugate DAY301 in patients with locally advanced or metastatic solid tumors)

First Quarter 2025 Financial Highlights

•
Product Revenue, Net: OJEMDA net product revenue was $30.5 million for the first quarter of 2025.

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

•
R&D Expenses: Research and development expenses were $39.6 million for the first quarter of 2025 compared to $40.2 million for the first quarter of 2024. The difference was primarily due to a decrease in license agreement payments and employee compensation costs.

•
SG&A Expenses: Selling, general and administrative expenses were $29.3 million for the first quarter of 2025 compared to $26.6 million for the first quarter of 2024. The increase was primarily due to employee compensation costs and professional service expenses to support the launch of OJEMDA.

•
Net Loss: Net loss totaled $36.0 million for the first quarter of 2025 with non-cash stock-based compensation expense of $12.9 million, compared to a net loss of $62.4 million for the first quarter of 2024, with non-cash stock-based compensation expense of $12.6 million.

•
Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $473.0 million as of March 31, 2025.

Upcoming Events

•
Bank of America Securities 2025 Health Care Conference
o
Management will participate in a fireside chat on Tuesday, May 13 at 8:00 a.m. PT. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.

•
Society for Neuro-Oncology’s 8th Biennial Pediatric Neuro-Oncology Conference, May 15-17, 2025
o
A poster sponsored by Day One, "Managing side effects of MAPK inhibitor therapies in pediatric populations: a Delphi consensus initiative," will be presented on May 16 at 6:15 p.m. PT.

•
2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 30-June 3, 2025
o
Abstract #10029 titled "Growth recovery in patients with BRAF altered pediatric low-grade gliomas (LGG) after discontinuation of tovorafenib" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.
o
Abstract #10037 titled "Post hoc analysis of rashes reported in patients (pts) with BRAF-altered relapsed/refractory (r/r) pediatric low-grade glioma (pLGG) treated with the type II RAF inhibitor tovorafenib in FIREFLY-1" will be presented in a poster session on Saturday, May 31 from 9:00-12:00 p.m. CDT in Hall A.

•
46th Annual Goldman Sachs Global Healthcare Conference
o
Management will participate in a fireside chat on Tuesday, June 10 at 8:40 a.m. ET. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website.

Conference Call

Day One will host a conference call and webcast today, May 6 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 May 6, 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 business update and financial results for the first quarter ended March 31, 2025 (Press release, Curis, MAY 6, 2025, View Source [SID1234652571]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"I am pleased to announce the expansion of the Curis Executive Team with the addition of Dr. Ahmed Hamdy as our Chief Medical Officer. Dr. Hamdy is a well-known and respected leader in the industry and brings a wealth of experience as CMO of Pharmacyclics, CMO and CEO of Acerta, and CEO of Vincerx. We look forward to his contributions to Curis."

"Also, as we announced at the end of March, we have made exciting progress with both the FDA and EMA on the potential for accelerated approval of emavusertib in R/R PCNSL. We are currently enrolling patients in the TakeAim Lymphoma study to enable accelerated approval filings in both the EU and US. We expect to provide additional data for both BTK-naïve and BTK-experienced patients from the TakeAim Lymphoma study at ASH (Free ASH Whitepaper) later this year," said James Dentzer, President and CEO of Curis.

"Curis has made great progress developing IRAK4 as a novel oncology target and emavusertib as the first-in-class IRAK4 inhibitor. I am excited to be joining the Curis team at this critical time of advancement toward regulatory filing in PCNSL in the US and EU and expansion beyond PCNSL into additional indications in NHL, AML, and solid tumors. Given my experience developing both ibrutinib and acalabrutinib, I have a special appreciation for the potential of emavusertib in combination with BTK inhibition in NHL, and the importance of targeting IRAK4 and the toll-like receptor pathway in NHL, AML and solid tumors. I look forward to working with the Curis Team to bring this novel therapy to patients," said Dr. Hamdy.

Operational Highlights

TakeAim Lymphoma

Successfully concluded meetings with both the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) on the suitability of using the ongoing TakeAim Lymphoma study (NCT 03328078) to support a potential accelerated approval path in PCNSL.
Announced emavusertib had been granted Orphan Drug Designation for PCNSL in both the U.S. and Europe.
Provided data update for 27 patients enrolled in the ongoing TakeAim Lymphoma study in relapsed/refractory (R/R) PCNSL, 20 BTK-experienced patients and 7 BTK-naïve patients.
Ema-Ven-Aza Triplet Study in Frontline AML

Announced successful completion of the first dosing cohort and the commencement of dosing in the second cohort. Enrollment is currently ongoing.
Corporate

Completed a registered direct offering and concurrent private placement with net proceeds of approximately $8.8 million.
First Quarter 2025 Financial Results

For the first quarter of 2025, Curis reported a net loss of $10.6 million or $1.25 per share on both a basic and diluted basis as compared to $11.9 million or $2.05 per share on both a basic and diluted basis for the same period in 2024.

Revenues for the first quarter of 2025 were $2.4 million, as compared to $2.1 million for the same period in 2024. Revenues for both periods consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $8.5 million for the first quarter of 2025, as compared to $9.6 million for the same period in 2024. The decrease was primarily attributable to lower employee related costs.

General and administrative expenses were $4.0 million for the first quarter of 2025, as compared to $4.9 million for the same period in 2024. The decrease was primarily attributable to lower employee related and professional, legal and consulting costs.

Other expense, net was $0.5 million for the first quarter of 2025, as compared to other income, net of $0.6 million for the same period in 2024. The decrease was primarily attributable to an increase in the expense related to the sale of future royalties and a decrease in interest income.

Curis’s cash and cash equivalents totaled $20.3 million as of March 31, 2025, and the Company had approximately 10.5 million shares of common stock outstanding. Curis expects its existing cash and cash equivalents will enable its planned operations into the fourth quarter of 2025.

Conference Call Information

Curis management will host a conference call today, May 6, 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, or login here shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at the Events and Presentations section of the Investors page.