On July 31 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported its financial results for the first half of 2025, as approved by the Board of Directors on July 31, 2025 (Press release, Oncodesign Precision Medicine, JUL 31, 2025, View Source [SID1234654695]).

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Philippe GENNE, Chairman and CEO of Oncodesign Precision Medicine, comments: "To date, it remains impossible to raise funds on Euronext for a biotechnology company that needs to conduct clinical proof-of-concept trials. As a result, our hopes for revenue and therefore cash availability rest primarily on discussions with potential buyers of our assets. The various cost-cutting measures we have taken since the beginning of this year are enabling us to continue these discussions over time, and the last quarter will be crucial in this regard."

Karine LIGNEL, Managing Director and COO of Oncodesign Precision Medicine adds: "In a very difficult financial environment, we have taken management decisions that have enabled us to significantly reduce our expenses and thus extend our cash flow horizon as much as possible. We have also set up an equity financing line to deal with market uncertainties. Nevertheless, the situation remains complicated, and we are making every effort to secure a partnership for one of our assets."

Oncodesign Precision Medicine – Income Statement

in M€
Audited data

H1 2025

H1 2024

Evolution

In %

in value

Revenues

0.14

0.14

0%

+0.00

Other revenues and operating income

0.60

0.50

21%

+0.10

Total revenues and operating income

0.74

0.64

16%

+0.10

Stock variation

13.00

–

NS

+13.00

Purchases consumed

(2.24)

(3.33)

-33%

+1.09

Personnel costs

(1.51)

(1.35)

12%

-0.16

Other operating expenses

(0.02)

(0.03)

-19%

+0.01

Taxes and duties

(0.03)

(0.03)

19%

-0.01

Net change in depreciation and amortization

(0.15)

(0.13)

16%

-0.02

Total operating expenses

9.05

(4.86)

NS

+13.91

Operating result

9.79

(4.22)

-332%

+14.01

Financial income and expenses

(0.26)

(0.06)

342%

-0.20

Income from ordinary activities of consolidated companies

9.53

(4.28)

-323%

+13.81

Extraordinary income and expenses

0

(0.01)

NS

+0.01

Income tax

0.31

0.65

-52%

-0.34

Net result

9.85

(3.64)

NS

+13.48

Key financial data

A cost reduction program was implemented in the first half of 2025:

Negotiations were held with the banks and BPI that granted the loan, resulting in a six-month deferral of principal repayments starting in April 2025
Expenses were reduced through
The layoff of five employees in early 2025
A 50% reduction in the compensation of non-salaried corporate officers
A freeze on salaries and bonus payments for the 2024 fiscal year
A reduction in spending on non-priority programs.
In terms of cash flow, rather than from an accounting perspective, this results in a reduction in payroll costs of €242k in the first half of 2025 and a projected reduction of €440k in the second half of this year. The reduction in expenditure is particularly significant for the item "subcontracting and fees," which will fall from €2,900k in the first half of 2024 to €1,773k in the first half of 2025.

R&D expenses amounted to €1.74 million in the first half of 2025, compared with €3.61 million in the same period last year, as the company focused its efforts on the clinical development of OPM-101.

Oncodesign Precision Medicine – R&D expenditure

in M€
Analytical data

H1 2025

H1 2024

Evolution

In %

in value

Partnerships

0.46

0.68

-32%

-0.2

Licensing

1.28

2.93

-56%

-1.7

Total R&D expenses

1.74

3.61

-52%

-1.9

Reintegration, in close collaboration with Servier, of all OPM-201 data and product stocks

The most significant financial item in the first half of 2025 is the reintegration, as provided for in the partnership agreement, of the stock of OPM-201 GMP material produced by Servier. As this reintegration is being carried out without financial competing, OPM has called upon an external expert to determine fair value for these stocks. This expert carried out three different valuations to arrive at this fair value.

A summary of these valuations is shown in the table below:

in M€

Min.

Centrale

Max.

Valuation of inventories based on cost price

7.2

7.2

7.2

Valuation of inventories using the "milestone economy" method

13.0

13.0

13.0

Valuation of inventories using rNPV discounting

15.3

15.7

16.2

The expert concluded that the fair value of these inventories falls within a range of €13 million to €16.2 million. OPM used the lower end of this range.

OPM’s revenue for the first half of 2025 was €0.1 million, the same as in the first half of 2024.

Other income mainly consists of subsidies amounting to €0.3 million and €0.3 million in provision reversals.

OPM’s financial result was (€0.26) million, compared with (€0.1) million in the same period last year, mainly due to interest on outstanding loans and financial income from cash investments.

OPM recorded €0.4 million in R&D tax credits in the first half of 2025, down 52% compared to last year. The amount of R&D tax credits was reduced by the amount of public aid, the R&D expenditure base decreased, and the rules for collecting R&D tax credits changed (exclusion of technology watch patents, etc.).

OPM’s half-year net income thus stands at €9,846k, due to the integration of OPM-201 inventories at an estimated value of €13m.

Cash position of €2.5m at June 30, 2025

As of June 30, 2025, OPM had cash reserves of €2.5 million, before receiving the Research Tax Credit, compared to €9.6 million (including the Research Tax Credit) as of June 30, 2024.

The Research Tax Credit, amounting to €1.1 million, was received in July 2025.

OPM has access to a maximum €5 million equity financing facility, which it has not yet used. The Company is in discussions with financial and pharmaceutical partners with the goal of signing a partnership agreement or raising funds.

2025 perspectives

OPM has submitted its Phase 1b/2a protocol for the REVERT study evaluating OPM-101 in patients with advanced melanoma resistant to anti-PD1 and is awaiting a response from Swiss ethics institutions. The first patient is expected to be enrolled by the end of 2025.

Work on radioligands is continuing as part of the COMETE project.

Partnership prospects or transfer mainly focus on the two most advanced molecules to date (OPM-101 and OPM-201).

OPM’s goal is to license or transfer OPM-101 at the end of Phase 2a to a pharmaceutical partner who will complete its development and commercialization. While we do not anticipate licensing or sales before the end of this phase in 2027, we are considering the possibility of a pharmaceutical partner taking a licensing option with the payment of an exclusivity fee, giving them first refusal on the results.

For OPM-201, the objective is to find a partnership similar to the one we found with Servier in 2019 or a buyer.

Availability of the 2025 half-year financial report

The 2025 half-year financial report will be available on the company’s website, within the legal deadline, before October 31, 2025.

On July 31, 2025 ImmuneOnco Biopharmaceuticals reported preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510 in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China (Press release, ImmuneOnco Biopharma, JUL 31, 2025, View Source [SID1234655712]).

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As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in 62% of efficacy evaluable patients, comprising partial responses in 80% (8/10) of patients with squamous NSCLC and 46% (5/11) of patients with non-squamous NSCLC. The majority of efficacy evaluable patients had only one tumor assessment at data cut-off. ImmuneOnco expects to present safety and efficacy data in the IMM2510 chemotherapy combination trial in front-line NSCLC at a future medical conference.

The IMM2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.

Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of IMM2510 in 1L NSCLC said： "IMM2510 has demonstrated early but compelling activity in front-line NSCLC patients. The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with IMM2510 in this setting."

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are delighted to witness the progress of IMM2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications."

Bronson Crouch, CEO of Instil said: "We are pleased with the preliminary clinical results of the combination of IMM2510/AXN-2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class. We look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year."

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].