On March 31, 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 quarter ended December 31, 2024 (Press release, Curis, MAR 31, 2025, View Source [SID1234651668]).

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Operational Highlights

Emavusertib (IRAK4 Inhibitor)

TakeAim Lymphoma

Curis 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.
Curis also announced that emavusertib has been granted Orphan Drug Designation for PCNSL in both the US and Europe.
Curis provided a data update for 27 patients enrolled in the ongoing TakeAim Lymphoma study in relapsed/refractory (R/R) PCNSL as of January 2, 2025 (data cutoff).
In 20 BTKi-experienced patients:
13 patients had change in tumor burden data available as of data cutoff;
9 of these 13 patients demonstrated a reduction in tumor burden, including 6 objective responses, 4 complete responses (CR) and 2 partial responses (PR), with 3 of 4 CRs lasting more than six months.
In 7 BTKi-naïve patients:
6 patients had change in tumor burden data available as of data cutoff;
5 of these 6 patients demonstrated a reduction in tumor burden, including 5 objective responses, 1 CR and 4 PRs.
TakeAim Leukemia

In December 2024, the Company announced data from the TakeAim Leukemia study (NCT 04278768) in R/R Acute Myeloid Leukemia (AML) at the 66th ASH (Free ASH Whitepaper) annual meeting for 21 patients with a FLT3 mutation who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID.
19 patients were response-evaluable:
10 of 19 patients achieved objective response, including 6 CRs, 2 CRs with incomplete hematological recovery or partial hematological recovery (CRi/CRh) and 2 morphologic leukemia-free state (MLFS);
7 of the 10 objective responses were reported at the first assessment.
2 patients were not response-evaluable, as they discontinued treatment prior to first disease assessment (death occurred at Day 8 and Day 13, respectively).
Ema-Ven-Aza Triplet Study in Frontline AML

The Company initiated a Phase 1 clinical study of emavusertib in combination with venetoclax and azacitidine (ema-ven-aza) in frontline AML (CA-4948-104, 2023-505828-58). The study is currently being conducted in Spain, Germany, and Italy to assess the safety and tolerability of different dosing regimens by adding emavusertib to a patient’s ven-aza regimen after they have achieved a CR on ven-aza but remain positive for minimal residual disease. The first dosing cohort was completed and well tolerated, with no unexpected adverse events. As a result, the external Clinical Safety Review Committee recommended escalation to the next dosing cohort. Enrollment for this cohort is currently ongoing.

Corporate

On March 28, 2025, Curis priced a registered direct offering of common stock and concurrent private placement of pre-funded warrants and warrants ("March 2025 Offerings") with gross proceeds of approximately $10.0 million. The offerings are expected to close concurrently on March 31, 2025, subject to the satisfaction of customary closing conditions.

In October 2024, Curis completed a registered direct offering and concurrent private placement with net proceeds of approximately $10.8 million.

"Curis had a very productive 2024. We started the year seeing early responses in our PCNSL trial. As more patients enrolled, and we continued to see positive data, we initiated discussions with the FDA and EMA to discuss the possibility of pursuing an accelerated approval path for emavusertib. We are pleased to announce today that we have received supportive feedback from both agencies. Over the next 12-18 months, we will be focused on enrolling 30-40 additional patients to support the regulatory filing for accelerated approval," said James Dentzer, Chief Executive Officer of Curis.

Additional details of the Company’s discussions with EMA and FDA and the March 2025 Offerings were reported on Form 8-K filed by the Company with the SEC on March 28, 2025.

Fourth Quarter 2024 Financial Results

For the year ended December 31, 2024, Curis reported a net loss of $43.4 million, or $6.88 per share on both a basic and diluted basis, as compared to a net loss of $47.4 million, or $8.96 per share on both a basic and diluted basis in 2023. For the fourth quarter of 2024, Curis reported a net loss of $9.6 million or $1.25 per share on both a basic and diluted basis as compared to a net loss of $11.7 million or $2.03 on both a basic and diluted basis for the same period in 2023.

Revenues, net were $10.9 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively. Revenues are comprised of royalty revenues related to Genentech and Roche’s net sales of Erivedge. Revenues were $3.3 million and $2.7 million for the fourth quarters of 2024 and 2023, respectively.

Research and development expenses were $38.6 million and $39.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily attributable to lower clinical and consulting costs, partially offset by higher manufacturing costs. Research and development expenses were $9.0 million and $10.0 million for the fourth quarters of 2024 and 2023, respectively.

General and administrative expenses were $16.8 million and $18.6 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily attributable to lower consulting, legal, facility, insurance and employee-related costs. General and administrative expenses were $3.4 million and $4.9 million for the fourth quarters of 2024 and 2023, respectively.

Other income, net was $1.2 million and $0.9 million for the years ended December 31, 2024 and 2023, respectively. The increase was attributable to a decrease in expense related to the sale of future royalties partially offset by a decrease in interest income. Other expense, net was $0.6 million for the fourth quarter of 2024 and other income, net was $0.5 million for the fourth quarter of 2023.

As of December 31, 2024, Curis’s cash and cash equivalents totaled $20.0 million, and the Company had approximately 8.5 million shares of common stock outstanding.

Cash Runway Guidance

Curis expects its cash and cash equivalents as of December 31, 2024, together with the expected proceeds from the March 2025 Offerings will enable the Company to fund its planned operations into the fourth quarter of 2025.

Conference Call Information

Curis management will host a conference call today, March 31, 2025, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 8:30 a.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

On March 31, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, reported fourth quarter and full year 2024 financial results (Press release, Cue Biopharma, MAR 31, 2025, View Source [SID1234651667]).
•
Prioritized resources on potentially disruptive autoimmune programs while enabling maturation of clinical data from oncology programs to further support prospective strategic partnerships
•
Appointed key industry leaders to management team and board of directors
•
Lucinda Warren, Chief Business Officer
Industry veteran, with extensive experience and proven expertise in strategic transactions, portfolio optimization and alliance management.
•
Daniel Baker, M.D., Interim Chief Development Officer
Over 20 years of drug development experience in the pharmaceutical industry.

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•
Pasha Sarraf, M.D., Ph.D., Member of Board of Directors
Physician-scientist with extensive experience in the business of science and biotechnology.
•
Successfully regained worldwide development and commercialization rights for CUE-401, the Company’s lead autoimmune program with potential to transform treatment across a broad spectrum of autoimmune and inflammatory diseases
•
Advanced research and development of CUE-501 as lead program of the CUE-500 series, demonstrating the potential to harness anti-viral specific T cells against pathogenic cells in both autoimmune and oncology
•
Company plans to announce business update call and webcast within the next couple of weeks

"During 2024 and Q1 2025, we made significant progress shaping the company for success," said Daniel Passeri, chief executive officer of Cue Biopharma. "We believe that the ongoing advancement of our prioritized autoimmune programs and the implementation of a highly focused strategic business model, support our ability to exploit the potentially disruptive opportunity of our Immuno-STAT platform, specifically CUE-401."

Fourth Quarter 2024 Financial Results

The Company reported collaboration revenue of $1.6 million and $1.8 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was due to revenue earned from the strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.

Research and development expenses were $7.2 million and $10.9 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in both drug substance manufacturing and clinical trial costs.

General and administrative expenses were $4.0 million and $4.6 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to a decrease in professional fees.

Full Year 2024 Financial Results

The Company reported collaboration revenue of $9.3 million and $5.5 million for the years ended December 31, 2024 and 2023, respectively. The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.

Research and development expenses were $36.3 million and $40.8 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in clinical trial costs, employee compensation, which includes stock-based compensation, and manufacturing costs.

General and administrative expenses were $14.6 million and $16.7 million for the years ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in employee compensation, which includes stock-based compensation, and professional fees.

As of December 31, 2024, the Company had $22.5 million in cash and cash equivalents.

Cue Biopharma, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

Three Months Ended December 31,

Years Ended December 31,

2024

2023

2024

2023

Collaboration revenue

$

1,576

$

1,821

$

9,287

$

5,490

Operating expenses (income):

General and administrative

4,021

4,609

$

14,585

16,680

Research and development

7,184

10,887

$

36,295

40,802

(Gain) loss on fixed asset disposal

4

157

$

(93

)

157

Total operating expenses

11,209

15,653

50,787

57,639

Loss from operations

(9,633

)

(13,832

)

(41,500

)

(52,149

)

Other income (expense):

Interest income

290

905

1,622

2,661

Interest expense

(153

)

(507

)

(796

)

(1,245

)

Total other income, net

137

398

826

1,416

Net loss

$

(9,496

)

$

(13,434

)

$

(40,674

)

$

(50,733

)

Unrealized gain from available-for-sale securities

96

Comprehensive loss

$

(9,496

)

$

(13,434

)

$

(40,674

)

$

(50,637

)

Net loss per common share – basic and diluted

$

(0.13

)

$

(0.28

)

$

(0.72

)

$

(1.11

)

Weighted average common shares outstanding – basic and diluted

74,238,329

47,181,633

56,328,348

45,754,794

Cue Biopharma, Inc.

Consolidated Balance Sheets

(In thousands)

December 31,
2024

December 31,
2023

Assets

Cash and cash equivalents

$

22,459

$

48,514

Other assets

9,732

13,016

Total assets

$

32,191

$

61,530

Liabilities and stockholders’ equity

Liabilities

$

14,692

$

24,445

Stockholders’ equity

17,499

37,085

Total Liabilities and stockholders’ equity

$

32,191

$

61,530

On March 31, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR) (Press release, Corcept Therapeutics, MAR 31, 2025, https://ir.corcept.com/news-releases/news-release-details/primary-endpoint-met-corcepts-pivotal-phase-3-rosella-trial [SID1234651666]).

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In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.70; p-value: 0.008). Their median PFS-BICR was 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. At an interim evaluation of overall survival (OS), patients treated with relacorilant plus nab-paclitaxel had a significant improvement in OS, with a median OS of 16.0 months, compared to 11.5 months for patients receiving nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.012). Relacorilant was well-tolerated and no new safety signals were observed. As was the case in the company’s Phase 2 trial, safety and tolerability were comparable in the two groups.

Complete results from ROSELLA will be presented at a medical conference this year. Results from Corcept’s Phase 2 trial of relacorilant in patients with platinum-resistant ovarian cancer were published in the Journal of Clinical Oncology in June 2023.

The ROSELLA trial enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia; biomarker selection was not required. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. ROSELLA has dual primary endpoints — PFS-BICR and OS. A positive outcome is achieved if either endpoint is met.

"Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies. The ROSELLA results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer," said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women’s Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial.

"Platinum-resistant ovarian cancer poses a significant treatment challenge. The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano and investigator in the ROSELLA trial.

"The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "We deeply appreciate the patients and investigators who participated in the trial, and we look forward to presenting the trial’s full results in the coming months. We expect to submit our NDA in the third quarter and our MAA shortly thereafter."

The ROSELLA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing’s syndrome) and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

On March 31, 2025 Circle Pharma, a clinical-stage biopharmaceutical company focused on developing cell-permeable macrocycle therapeutics, reported that Chief Executive Officer David Earp, JD, Ph.D., will present at the following investor conferences (Press release, Circle Pharma, MAR 31, 2025, View Source;utm_medium=rss&utm_campaign=circle-pharma-to-present-at-the-upcoming-investor-conferences [SID1234651665]):

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24th Annual Needham Virtual Healthcare Conference
April 9, 2025

11:45 – 12:25 pm ET

Stifel 2025 Virtual Targeted Oncology Forum
April 9, 2025

1:30 p.m. – 1:55 p.m. ET

On March 31, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the fourth quarter ended December 31, 2024 and other recent business developments (Press release, Celcuity, MAR 31, 2025, View Source [SID1234651664]).

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"We expect 2025 to be a transformational year for Celcuity as we anticipate reporting several clinical data readouts, including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial. We expect to share topline data in Q2 2025," said Brian Sullivan, CEO and co-founder of Celcuity. "In addition, we anticipate reporting topline data for the Phase 1b/2 trial in metastatic castration resistant prostate cancer in late Q2 2025, and topline data for the PIK3CA mutant-type cohort of the VIKTORIA-1 trial in Q4 2025. We also remain on track to enroll the first patient for our VIKTORIA-2 Phase 3 trial in Q2 2025."

Fourth Quarter 2024 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 clinical trial evaluating gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received prior treatment with a CDK4/6 inhibitor is 100% enrolled for the PIK3CA wild-type cohort. We expect to provide topline data in Q2 2025.

○ Enrollment for the PIK3CA mutant cohort remains on track and topline data is expected in Q4 of 2025.

● The VIKTORIA-2 Phase 3 open-label randomized study evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant remains on track to enroll its first patient in Q2 2025.

○ A safety run-in study preceding the initiation of the Phase 3 portion of the study will be conducted in 12-36 participants to assess the safety profile of gedatolisib in combination with ribociclib and fulvestrant.
○ Site selection activities are completed. We expect to activate approximately 200 sites across North America, Europe, Latin America, and Asia-Pacific.
○ The Phase 3 portion of the study is expected to enroll approximately 638 patients.

● The Phase 1b/2 clinical trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients with metastatic castration resistant prostate cancer ("mCRPC"), is ongoing and remains on track to report preliminary data in late Q2 2025.

○ The study is expected to enroll up to 54 patients with mCRPC whose disease progressed while on or after treatment with an androgen receptor signaling inhibitor.

● In December 2024, Celcuity presented overall survival data from a Phase 1b trial, which evaluated gedatolisib in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2- advanced or metastatic breast cancer during a poster session at the 2024 San Antonio Breast Cancer Symposium (SABCS). Median overall survival was 77.3 months among patients with HR+, HER2- advanced breast cancer who were treatment-naïve in the advanced setting and 33.9 months among patients previously treated with a CDK4/6 inhibitor.

○ Results compare favorably to published data for currently available first- or second-line standard-of-care treatment regimens for patients with HR+, HER2- advanced breast cancer and highlight the promising clinical development strategy of simultaneously inhibiting the ER, CDK4/6, and PAM (PI3K/AKT/mTOR) signaling pathways.

Fourth Quarter and Full Year 2024 Financial Results

Unless otherwise stated, all comparisons are for the fourth quarter and full year ended December 31, 2024, compared to the fourth quarter and full year ended December 31, 2023.

Total operating expenses were $36.4 million for the fourth quarter of 2024, compared to $19.7 million for the fourth quarter of 2023. Operating expenses for the full year 2024 were $113.3 million, compared to $66.2 million for the full year 2023.

Research and development ("R&D") expenses were $33.5 million for the fourth quarter of 2024, compared to $18.1 million for the prior-year period. Of the approximately $15.4 million increase in R&D expenses, $9.9 million primarily related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 trial, along with the commencement of the VIKTORIA-2 Phase 3 trial. The remaining $5.5 million primarily relates to increased employee and consulting expenses.

R&D expenses for the full year 2024 were $104.2 million, compared to $60.6 million for the prior year. Of the approximately $43.6 million increase in R&D expenses, $30.7 million was related to costs supporting ongoing activities for the VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase 1b/2 clinical trial, along with the commencement of the VIKTORIA-2 Phase 3 trial. The remaining $12.9 million increase in R&D expenses was primarily related to increased employee and consulting expenses.

General and administrative ("G&A") expenses were $3.0 million for the fourth quarter of 2024, compared to $1.6 million for the prior year period. Of the approximately $1.4 million increase, $1.1 million was related to increased employee-related expenses, and $0.3 million was related to professional fees, expanding infrastructure costs and other administrative expenses.

G&A expenses for the full year 2024 were $9.1 million, compared to $5.6 million for the prior year. Of the approximately $3.4 million increase in G&A expenses, $2.6 million was related to increased employee-related expenses, and $0.8 million was related to professional fees, expanding infrastructure costs, and other administrative expenses.

Net loss for the fourth quarter of 2024 was $36.7 million, or $0.85 loss per share, compared to a net loss of $18.8 million, or $0.65 loss per share, for the fourth quarter of 2023. Net loss for the full year 2024 was $111.8 million, or $2.83 loss per share, compared to a net loss of $63.8 million, or $2.69 loss per share, in 2023. Non-GAAP adjusted net loss for the fourth quarter of 2024 was $32.3 million, or $0.75 loss per share, compared to non-GAAP adjusted net loss of $17.6 million, or $0.61 loss per share, for the fourth quarter of 2023. Non-GAAP adjusted net loss for the full year 2024 was $101.9 million, or $2.58 loss per share, compared to non-GAAP adjusted net loss of $57.8 million, or $2.44 loss per share, for 2023. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the fourth quarter of 2024 was $27.8 million, compared to $18.5 million for the fourth quarter of 2023. Net cash used in operating activities for the full year 2024 was $83.5 million, compared to $53.8 million for the full year 2023. Cash, cash equivalents and short-term investments were approximately $235.1 million at the end of fiscal year 2024 and are expected to fund current clinical development program activities through 2026.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the fourth quarter and full year 2024 financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=f99d4186f3. A replay of the webcast will be available on the Celcuity website following the live event.