On July 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 its results for the quarter ended June 30, 2025 (Press release, Corcept Therapeutics, JUL 31, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-3 [SID1234654671]).

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Financial Results

"The second quarter marked another period of robust growth in our hypercortisolism business. Once again, we had a record number of new prescribers and a record number of new patients receiving treatment. Physicians increasingly recognize hypercortisolism’s true prevalence and the necessity of appropriate treatment, which has led to increased screening and diagnosis. Our financial results don’t fully reflect this surge in demand, which outpaced our specialty pharmacy vendor’s capacity. We expect improved performance by our current vendor, as well as contribution from a second pharmacy that is coming online soon, in the coming quarters and have modified our 2025 revenue guidance to $850 – $900 million," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s second quarter 2025 revenue was $194.4 million, compared to $163.8 million in the second quarter of 2024. Second quarter 2025 operating expenses were $167.8 million, compared to $128.2 million in the same period last year. Net income per common share (diluted) was $0.29 in the second quarter of 2025, compared to $0.32 in the second quarter of 2024.

Cash and investments were $515.0 million at June 30, 2025, compared to $570.8 million at March 31, 2025. The balance at June 30, 2025 reflects the acquisition of $115.4 million of common stock in the second quarter pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants.

Clinical Development

"We achieved many important clinical development milestones in the second quarter. Results of Part 1 and Part 2 of our CATALYST study were published in Diabetes Care in April and June. Our ROSELLA study’s results were published in The Lancet in June. We have two New Drug Applications (NDAs) in progress – one in hypercortisolism and another in platinum-resistant ovarian cancer. We are discussing with regulators the optimal development and regulatory path for dazucorilant which, in our Phase 2 DAZALS trial, prevented early death in patients with ALS. In addition, we continue to investigate how cortisol modulation can benefit patients with a broad range of serious disorders, including Metabolic Dysfunction-Associated Steatohepatitis (MASH)," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

Relacorilant for patients with hypercortisolism – FDA review of NDA continues, with Prescription Drug User Fee Act (PDUFA) date of December 30, 2025
CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care (Buse et al, April 2025)
CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes – Results presented at the American Diabetes Association’s 85th Scientific Sessions; published in Diabetes Care (DeFronzo et al, June 2025)
MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension – Results expected by year-end
"CATALYST is a landmark study in hypercortisolism, a serious and deadly disease that too often goes undetected," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "CATALYST Part 1 showed that one in every four patients with difficult-to-control type 2 diabetes has hypercortisolism. CATALYST Part 2 showed that treatment with a cortisol modulator can be highly effective in improving their signs and symptoms. These powerful findings provide important guidance for physicians and will accelerate screening and treatment of patients with hypercortisolism."

"We continue to work toward relacorilant’s approval. In our studies, patients who received relacorilant exhibited clinically and statistically significant improvements in a wide array of hypercortisolism’s signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments," added Dr. Guyer. "Relacorilant has the potential to become the standard of care for patients with this devastating disease."

Oncology

NDA submitted in July 2025 for relacorilant to treat patients with platinum-resistant ovarian cancer – Submission of European Marketing Authorization Application (MAA) expected this quarter
ROSELLA – Primary endpoint met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 annual meeting and published in The Lancet (Olawaiye et al, June 2025)
BELLA – Enrollment continues briskly in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer
Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
"Our NDA for relacorilant to treat patients with platinum-resistant ovarian cancer is based on the results of our pivotal ROSELLA study, which confirmed the positive results of our Phase 2 study. The progression-free and overall survival improvements in patients who received relacorilant, with no increase in safety burden and without the requirement of biomarker screening, are groundbreaking," said Dr. Guyer. "We look forward to working with the FDA as it reviews our NDA and submitting our MAA later this quarter."

"The BELLA study builds on ROSELLA’s findings, assessing the safety and efficacy of combining relacorilant with two medications – nab-paclitaxel and bevacizumab – to treat patients with platinum-resistant ovarian cancer. Separately, we expect that relacorilant can help treat earlier stages of ovarian cancer and other solid tumors and will soon initiate additional clinical trials."

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Exploratory analysis showed that patients receiving dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients receiving placebo (hazard ratio: 0.16, p-value: 0.0009)
DAZALS – Results presented at European Network to Cure ALS (ENCALS) annual meeting in June 2025
"ALS is a devastating disease. In DAZALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R). However, patients who received dazucorilant 300 mg daily had an 84 percent lower chance of dying during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009)," said Dr. Guyer. "Reducing mortality from the start of treatment, when many patients retain considerable function, is an important benefit. We are working with regulatory authorities to determine the fastest path forward."

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment nearly complete in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our Phase 2b MONARCH study. Enrollment will complete in the coming weeks with first results expected by the end of next year," said Dr. Guyer.

Conference Call

We will hold a conference call on July 31, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

On July 31, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported the successful completion of targeted enrollment for its Phase 2 HARMONIC clinical trial in Japan (Press release, Lantern Pharma, JUL 31, 2025, View Source [SID1234654696]). The company enrolled 10 patients ahead of schedule across five clinical sites in Japan, including the National Cancer Center Japan.

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The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs). The successful Japanese enrollment validates Lantern’s strategic decision to expand the trial internationally to regions with significantly higher rates of never-smoker NSCLC patients such as Japan and Taiwan.

"Completing our targeted enrollment in Japan ahead of schedule demonstrates excellent execution of our international expansion strategy and validates our decision to focus on regions where never-smoker NSCLC has the highest prevalence," said Panna Sharma, President and CEO of Lantern Pharma. "This achievement builds momentum as we continue enrollment in Taiwan and the United States, bringing us closer to generating the clinical data that could establish LP-300 as a treatment option for this underserved patient population with significant unmet medical need."

The completion of Japanese enrollment represents an important milestone in the global HARMONIC trial, which is designed to enroll approximately 90 patients across multiple regions. Japan’s notably higher rate of never-smoker NSCLC patients (33-40% of new cases) compared to Western populations (typically 15%) makes it a strategically important region for the trial. Similarly, Taiwan, where more than 50% of lung cancer cases occur in never-smokers, represents another key enrollment region.

The HARMONIC trial previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States. Notably, recent data revealed that one patient has achieved a durable complete response in target cancer lesions with survival continuing for nearly two years, demonstrating the potential for LP-300 to deliver meaningful long-term outcomes for never-smoker NSCLC patients.

Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics1, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients, highlighting the significant unmet medical need this population faces.

Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300’s commercial potential in multiple geographies. Lantern is scheduled to provide further clinical and outcome data from the HARMONIC trial later this quarter, with updates covering both Asian and U.S. patient cohorts.

About LP-300 LP-300 is a disulfide small molecule and investigational drug candidate with a multimodal mechanism of action directed toward tyrosine kinase receptors and cell redox enzymes. It modulates cellular redox in key signaling pathways in NSCLC and directly engages with TKI receptors via cysteine modification. LP-300 has been evaluated in multiple Phase 1, 2, and 3 clinical trials in over 1,000 subjects, with retrospective analysis showing significant survival benefit in never-smoker lung adenocarcinoma patients.

About the HARMONIC Trial The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone in never-smoker NSCLC patients who have relapsed following TKI treatment. The trial is expected to enroll approximately 90 patients across sites in the United States, Japan, and Taiwan. The primary endpoints are progression-free survival (PFS) and overall survival (OS). For more information about the trial, visit www.harmonictrial.com or clinicaltrials.gov (NCT05456256).

On July 31, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported second quarter 2025 financial results and provided a corporate update (Press release, FibroBiologics, JUL 31, 2025, View Source [SID1234656320]).

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Recent Highlights

Successfully closed third $5 million tranche of a $25 million total financing, with proceeds used to advance research and development efforts and support the upcoming Phase 1/2 clinical trial in diabetic foot ulcers (DFUs).
Strengthened leadership team with the appointment of Jason D. Davis, CPA, as Chief Financial Officer, who brings over 25 years of experience in building and leading organizations.
Presented pre-clinical evidence at the Society for Investigative Dermatology Annual Meeting supporting the potential of fibroblast spheroids to reduce psoriasis severity. Findings showcased the fibroblast-based candidate’s ability to enable sustained remission and reduce relapse, accompanied by a significantly lower adverse side effects profile.
Highlighted potential of fibroblast-based therapies for chronic disease treatments at the BIO International Convention 2025.
Confirmed the use of the CYWC628 master cell bank for the manufacturing of CybroCell, FibroBiologics’ investigational intradiscal administered allogeneic fibroblast cell-based therapy in development for degenerative disc disease.
Upcoming Milestones

Initiate Phase 1/2 clinical trial in Australia evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients in the first quarter of 2026.
Complete Phase 1/2 clinical trial in Australia in DFU patients in the third quarter of 2026.
Complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317, FibroBiologics’ fibroblast spheroid product candidate, by the end of 2025.
Pete O’Heeron, Founder and Chief Executive Officer of FibroBiologics, said, "Backed by our strong research and development efforts, we are continuing to progress toward entering the clinic with our Phase 1/2 trial evaluating CYWC628 in diabetic foot ulcer patients, while simultaneously advancing IND-enabling studies for CYPS317 in psoriasis. Our robust intellectual property portfolio, which now includes more than 275 issued or pending patents, is reinforced by the growing pre-clinical evidence supporting the potential of our fibroblast-based therapies. We believe this expanding IP position enhances our competitive advantage and supports our long-term strategy for innovation. As always, we remain focused on executing our clinical milestones and delivering meaningful value to both patients and shareholders as we advance toward our goal of transforming chronic disease treatments."

Financial Highlights for the Six Months Ended June 30, 2025

Research and development expenses were approximately $3.8 million for the six months ended June 30, 2025, compared to approximately $1.9 million for the same period in 2024. The increase was primarily due to increased chemistry, manufacturing and control costs of $0.2 million for cell manufacturing activities; increased CRO costs of $0.9 million to prepare for a clinical trial; increased personnel related expenses of $0.3 million due to hiring additional research scientists; and increased research materials and supplies expenses of $0.5 million due to increased laboratory personnel and preclinical studies.
General and administrative expenses were approximately $5.2 million for the six months ended June 30, 2025, compared to approximately $4.7 million for the same period in 2024. The increase was primarily due to increased expenses of $0.5 million for added personnel in 2025, which includes stock-based compensation expense; increased professional fees of $0.3 million for accounting, legal and marketing expenses; increased travel expenses of $0.1 million; and decreased Direct Listing related expenses of $0.4 million.
For the six months ended June 30, 2025, FibroBiologics reported a net loss of approximately $9.6 million compared to a net loss of approximately $7.6 million for the same period in 2024. The net loss for the six months ended June 30, 2025, was primarily due to the increase in both research and development expenses and general and administrative expenses discussed above.
Cash and cash equivalents totaled approximately $8.8 million at June 30, 2025.
For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected].

On July 31, 2025 Kyowa Hakko Kirin reported consolidated Financial Summary (IFRS) Fiscal 2025 (Press release, Kyowa Hakko Kirin, JUL 31, 2025, View Source [SID1234656876]).

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On July 31, 2025 Crescent Biopharma, Inc. ("Crescent" or the "Company") (Nasdaq: CBIO), a biotechnology company dedicated to rapidly advancing the next wave of therapies for cancer patients, reported financial results for the second quarter ended June 30, 2025, and recent business highlights (Press release, Crescent Biopharma, JUL 31, 2025, View Source [SID1234654680]).

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"The second quarter of 2025 was momentous for Crescent. We bolstered our leadership team, completed our merger and began trading on Nasdaq while also closing a substantial financing with a premier group of healthcare investors that will support the advancement of our portfolio of next generation therapeutics for solid tumors to important inflection points," said Joshua Brumm, chief executive officer of Crescent. "Our lead program, CR-001, a PD-1 x VEGF bispecific antibody, is designed to transform the immuno-oncology standard of care, and we are on track to submit an IND by the end of 2025. This would enable dosing the first patients in our global Phase 1 trial in early 2026, with proof-of-concept data expected later that year. In addition, we expect the first of our two ADCs to enter the clinic in mid-2026. We have a tremendous opportunity ahead of us, and we remain focused on rapidly advancing our programs as we work toward delivering the next wave of treatments to those living with cancer."
Recent Business Highlights & Upcoming Milestones

Corporate
•Crescent appointed new leadership bringing experience in oncology drug development, clinical operations and building biotech companies, including Joshua Brumm as chief executive officer and member of the board of directors; Jonathan McNeill, M.D., as president and chief operating officer; Ellie Im, M.D., as chief medical officer; Rick Scalzo, MBA, as chief financial officer; Jan Pinkas, Ph.D., as chief scientific officer; Amy Reilly as chief communications officer; and Tanya Sengupta, MBA, as executive vice president, chief of strategy and operations.
•The Company appointed David Lubner to Crescent’s board of directors.
•Crescent completed its merger with GlycoMimetics, Inc. and began trading on the Nasdaq Capital Market on June 16, 2025, under the ticker symbol "CBIO." The Company also closed a previously announced private financing of $200 million in gross proceeds.

Pipeline
CR-001, a PD-1 x VEGF bispecific antibody
•Crescent’s lead program, CR-001, is a tetravalent PD-1 x VEGF bispecific antibody intentionally designed to replicate the cooperative pharmacology of ivonescimab, which demonstrated superior efficacy compared to the current market leader, pembrolizumab, in a large third-party Phase 3 trial in non-small cell lung cancer.1 Crescent remains on track to submit an Investigational New Drug (IND) application in the fourth quarter of 2025 and expects to report proof-of-concept clinical data from a global Phase 1 trial in patients with solid tumors in the second half of 2026.
CR-002 and CR-003, novel antibody-drug conjugates (ADCs)
•CR-002 and CR-003 are novel ADCs with topoisomerase inhibitor payloads that are being developed as single agents and in combination with CR-001. Crescent expects to submit an IND application for CR-002 in mid-2026.
Second Quarter 2025 Financial Results
Cash position: Cash was $152.6 million as of June 30, 2025, which is anticipated to fund operations through 2027.
Research and development (R&D) expenses: R&D expenses were $12.1 million for the three months ended June 30, 2025.
General and administrative (G&A) expenses: G&A expenses were $8.9 million for the three months ended June 30, 2025.
Net loss: Net loss was $21.8 million, or $4.93 per basic and diluted share, for the three months ended June 30, 2025.