On May 13, 2025 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, reported its first quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update (Press release, Lineage Cell Therapeutics, MAY 13, 2025, View Source [SID1234652976]).

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"Lineage has grown increasingly confident in OpRegen’s potential to address a significant medical need," stated Brian M. Culley, Lineage CEO. "Our optimism is driven in part by OpRegen’s uniquely durable treatment effects, lasting up to 24 months, with a 36-month data update from Roche and Genentech forthcoming next month. We are also encouraged by independent first-in-human results recently reported by competitors, which adds validation to an RPE transplant mechanism of action providing functional improvements beyond the reach of currently approved dry AMD therapies. Together, these findings lend support to one-time dosing, a key advantage over the compliance-challenged monthly injections required for anti-complement therapy. While advancing the OpRegen program and the GAlette Study remains a key area of attention, we are equally excited to have recently initiated the DOSED clinical study of OPC1, while progressing ReSonanceTM for the treatment of sensorineural hearing loss and evaluating other strategically selected early-stage initiatives. As our cell therapy platforms gain further validation, we believe our pipeline and expertise position us as a compelling partner and investment opportunity."

Select Business Highlights

RG6501 (OpRegen)
RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results to be featured at Clinical Trials at the Summit (CTS) 2025, and will be presented by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine, on behalf of Roche and Genentech, a member of the Roche Group.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study (the "GAlette Study") in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at sites in the U.S. and Israel.
In addition to testing of other surgical parameters, Genentech currently plans to evaluate two proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the GAlette Study.
Ongoing efforts to further support development of OpRegen RPE cell therapy under a separate services agreement with Genentech, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and currently enrolling GAlette Study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.
OPC1
DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study in subacute and chronic spinal cord patients initiated in February 2025; UC San Diego Health is the first participating study site.
Lineage and OPC1 program featured on CNN: "He was paralyzed his last day of high school. How an experimental trial is showing ‘unexpected improvement’."
3rd Annual Spinal Cord Injury Investor Symposium (3rd SCIIS) announced in partnership with the Christopher & Dana Reeve Foundation.
The 3rd SCIIS will be fully virtual, with interactive and on-demand sessions available starting June 27, 2025.
Event aims to bring together those working on treatments for spinal cord injury (SCI), including regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations and the investment community, to discuss perspectives on current and future treatments, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and importantly, broaden awareness of and investment capital into SCI.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $47.9 million as of March 31, 2025, is expected to support planned operations into Q1 2027.

First Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended March 31, 2025 were $1.5 million, a net increase of $0.1 million as compared to $1.4 million for the same period in 2024. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the collaboration and license agreement with Roche.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2025 were $8.0 million, a decrease of $0.1 million as compared to $8.1 million for the same period in 2024.

R&D Expenses: R&D expenses for the three months ended March 31, 2025 were $3.1 million, an increase of $0.1 million as compared to $3.0 million for the same period in 2024. The net increase was primarily driven by $0.2 million for our preclinical programs, partially offset by $0.1 million for our other research and development programs.

G&A Expenses: G&A expenses for the three months ended March 31, 2025 of $4.9 million were primarily in line with expenses for the same period in 2024.

Loss from Operations: Loss from operations for the three months ended March 31, 2025 was $6.5 million, a decrease of $0.2 million as compared to $6.7 million for the same period in 2024.

Other Income/(Expenses): Other income/(expenses) for the three months ended March 31, 2025 reflected other income of $2.4 million, compared to other income of $0.1 million for the same period in 2024. The net increase was primarily driven by changes in fair value of the warrant liabilities.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2025 was $4.1 million, or $0.02 per share (basic and diluted), compared to a net loss of $6.5 million, or $0.04 per share (basic and diluted), for the same period in 2024.

Conference Call and Webcast

Interested parties may access the conference call on May 13, 2025, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 20th, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 1789489.

On May 13, 2025 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter of 2025 (Press release, Leap Therapeutics, MAY 13, 2025, View Source [SID1234652975]).

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Leap Highlights:

· Reported positive data from the randomized, controlled Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) plus bevacizumab and chemotherapy in second-line colorectal cancer (CRC) patients demonstrating significantly higher overall response rate (ORR) and longer progression-free survival (PFS) across DKK1-high and VEGF-naïve subgroups

· Hosted virtual key opinion leader (KOL) event featuring Zev A. Wainberg, MD, to further discuss the positive data and patient benefit from the DeFianCe study

· Presented preclinical data of FL-501, a novel GDF-15 neutralizing antibody, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting

· Strategic restructuring to prioritize clinical development of sirexatamab in CRC and advancing FL-501 in preclinical development, resulting in an approximately 50% reduction in workforce

"In the first quarter of 2025, sirexatamab, our novel anti-DKK1 antibody, continued to demonstrate encouraging efficacy, including statistically significant higher ORR and longer PFS in both DKK1-high and VEGF-naïve second-line CRC patients. With 42 patients currently remaining on study drug, 25 in the sirexatamab arm and 17 in the control arm, we continue to be optimistic about the maturing dataset in the full population and look forward to upcoming data updates this quarter," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "In this difficult market environment, we focused our resources to position Leap to advance sirexatamab in CRC and FL-501 preclinically in order to provide the greatest value for our shareholders. I would like to personally thank all of our colleagues who have been impacted by this decision and express my appreciation for their contributions and dedication to provide meaningful new treatment options to cancer patients."

DKN-01 Development Update

· Reported updated clinical data from Part B of the DeFianCe Study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. In March 2025, the Company announced updated preliminary data from Part B of the DeFianCe study (NCT05480306), a Phase 2, open-label, global study of sirexatamab in combination with bevacizumab and chemotherapy (Sirexatamab Arm) compared to bevacizumab and chemotherapy (Control Arm) in patients with MSS CRC who have received one prior systemic therapy for advanced disease. Updated data from the study is expected this quarter.

o In patients with high DKK1 levels (upper quartile, n=44), the Sierxatamab Arm had a statistically significant 32% higher ORR, 3.5 month longer PFS, and OS compared to the Control Arm

o In patients who had not received prior anti-VEGF therapy (n=95), the Sirexatamab Arm had a statistically significant 22% higher ORR and 2.6 month longer PFS compared to the Control Arm, with OS not mature but favoring the Sirexatamab Arm

o With a higher number of patients remaining on study drug in the Sirexatamab Arm compared to the Control Arm (25 vs. 17), PFS in the full intent-to-treat population continues to mature with a tail population advantage for the Sirexatamab Arm

o The strong signal from the DeFianCe study supports a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high DKK1 levels or in patients who have not received prior anti-VEGF therapy

· Hosted a virtual KOL event featuring Dr. Zev Wainberg, Co-Director of the UCLA GI Oncology Program and a globally recognized leader in gastrointestinal cancer research, to discuss sirexatamab in second-line patients with advanced MSS CRC. Dr. Wainberg discussed the unmet need and how sirexatamab may improve upon the current treatment landscape for previously treated patients with advanced MSS CRC and reviewed the positive data from Part A and Part B of the Phase 2 DeFianCe study.

Pipeline Updates

· Presented new preclinical data of FL-501 at the AACR (Free AACR Whitepaper) 2025 Annual Meeting. FL-501 is a first-in-class GDF-15 neutralizing antibody targeting the cachexia pathway, a condition commonly associated with poor outcomes in cancer patients.

o In humanized FcRn mouse studies, FL-501 demonstrated a 2-3-fold longer half-life and 50% reduced clearance compared to its wild-type precursor and ponsegromab

o In mouse cachexia models using GDF-15-overexpressing colorectal cancer cells, FL-501 fully restored body composition, comparably or better than clinical-stage antibodies visugromab and ponsegromab

o In a non-small cell lung cancer patient-derived xenograft model, FL-501 effectively countered cisplatin-induced weight loss, restoring body weight, composition, and condition scores

o These findings, as well as a favorable safety profile and strong pharmacodynamic activity, support advancing FL-501 as a potentially best-in-class molecule

Business Updates

· Engaged leading financial advisor to explore business development opportunities to further the development of sirexatamab. Strong signals from the DeFianCe study supports a registrational Phase 3 clinical trial in second-line CRC, which represents a significant potential global market opportunity.

· Announced strategic restructuring to prioritize clinical focus on the development of sirexatamab in CRC. Leap is realigning its resources in order to prioritize the clinical development of sirexatamab in CRC and advancing FL-501 preclinically. As part of the strategic restructuring, the Company has reduced its workforce by approximately 50%.

Selected First Quarter 2025 Financial Results

Net Loss was $15.4 million for the first quarter 2025, compared to $13.8 million for the first quarter 2024. The increase was primarily due to an increase in research and development expenses.

Research and development expenses were $12.9 million for the first quarter of 2025, compared to $11.3 million for the same period in 2024. The increase was primarily due to an increase of $1.4 million in clinical trial costs due to the expansion of the size of Part B of the DeFianCe study and the increase in activity associated with the end of Part C of the DisTinGuish study. There was also an increase of $0.1 million in manufacturing costs related to clinical trial material and manufacturing campaigns and an increase of $0.1 million in consulting fees associated with research and development activities.

General and administrative expenses were $3.0 million for the first quarter 2025, compared to $3.5 million for the same period in 2024. The decrease was primarily due to a $0.4 million decrease in professional fees and a $0.1 million decrease in stock based compensation expense.

Cash and cash equivalents totaled $32.7 million at March 31, 2025.

On May 13, 2025 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Kezar Life Sciences, MAY 13, 2025, View Source [SID1234652974]).

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"We shared exciting results this quarter from the PORTOLA trial, the first successful randomized study in treatment-refractory AIH," said Chris Kirk, CEO and co-founder of Kezar. "There has been almost no change over the last three decades in the treatment of this serious chronic disease, and patients and physicians are in need of new and effective therapies. We are encouraged by the promising safety and efficacy data in this difficult-to-treat patient population, in particular the durable and steroid-sparing remissions observed in patients treated with zetomipzomib. We continue to respond to the FDA Division of Hepatology and Nutrition on the partial clinical hold and are working toward achieving alignment on an appropriate trial design to demonstrate the clinical benefit of zetomipzomib in AIH."
Zetomipzomib: Selective Immunoproteasome Inhibitor
PORTOLA – Phase 2a clinical trial of zetomipzomib in patients with AIH (ClinicalTrials.gov: NCT05569759)
•In March, Kezar reported topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis. In relapsed AIH patients who entered screening on steroid-based therapy, 36% (5 of 14) of zetomipzomib-treated patients achieved a complete biochemical response (CR) and clinically significant steroid taper to 5 mg/day or less, compared to 0 of 7 of placebo patients. In the intention-to-treat (ITT) population, 31% (5 of 16) of zetomipzomib patients achieved a CR and steroid taper (5 mg/day or less), compared to 1 of 8 placebo patients. The median duration of response in zetomipzomib patients achieving a CR was 27.6 weeks (including the ongoing open-label extension at the time of the data cutoff), and no disease flares were reported in any zetomipzomib-treated patient achieving CR during study. A favorable safety profile was observed during the 6-month blinded treatment period.

•Kezar is responding to the information request from the FDA Division of Hepatology and Nutrition to resolve the partial clinical hold on the PORTOLA Phase 2a clinical trial.

PALIZADE – Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (ClinicalTrials.gov: NCT05781750)
•In February, Kezar presented an update from the PALIZADE Phase 2b clinical trial evaluating zetomipzomib in patients with active LN. At the time of study termination, no patients had completed the full 52 weeks of treatment. Of the 12 patients receiving 60 mg of zetomipzomib who reached week 25, 42% achieved a urine protein-to-creatinine ratio (UPCR) of 0.5 or less, and the median UPCR was reduced by 79% from baseline. Marked improvements in serologic markers were observed in patients who received a 60 mg dose of zetomipzomib.
•In October 2024, Kezar made the strategic decision following a clinical hold by the FDA to terminate PALIZADE and focus the clinical development of zetomipzomib in AIH.
Financial Results
•Cash, cash equivalents and marketable securities totaled $114.4 million as of March 31, 2025, compared to $132.2 million as of December 31, 2024. The decrease was primarily attributable to cash used in operations.
•Research and development (R&D) expenses for the first quarter of 2025 decreased by $5.0 million to $12.2 million, compared to $17.2 million in the first quarter of 2024. This decrease was primarily due to the decreased clinical activities resulting from the Company’s strategic decision to terminate the PALIZADE trial in October 2024, a decrease in manufacturing expense related to the timing of drug manufacturing runs and a decrease in facility related expenses.
•General and administrative (G&A) expenses for the first quarter of 2025 decreased by $1.1 million to $5.4 million compared to $6.5 million in the first quarter of 2024. The decrease was primarily due to a decrease in legal and professional service expenses and non-cash stock-based compensation.
•Net loss for the first quarter of 2025 was $16.6 million, or $2.27 per basic and diluted common share, compared to a net loss of $21.7 million, or $2.98 per basic and diluted common share, for the first quarter of 2024.
•Total shares of common stock outstanding were 7.3 million shares as of March 31, 2025.
About PORTOLA
PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed from a previous CR. The trial enrolled 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. All patients were required to receive a starting daily steroid dose of 20-40 mg/day of prednisone (or budesonide equivalent) and physicians were encouraged to taper daily steroid usage to 5 mg/day consistent with AIH treatment guidelines established by the American Association for the Study of Liver Diseases (AASLD). The primary efficacy endpoint of PORTOLA, which was not powered for efficacy, evaluated the proportion of patients who achieved a CR by Week 24, measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline. A key secondary endpoint was the proportion of patients who achieved a CR by Week 24 with a steroid dose of 5 mg/day or less.

On May 13, 2025 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, reported topline results from an updated interim analysis of GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer (NSCLC) (Press release, iTeos Therapeutics, MAY 13, 2025, View Source [SID1234652972]).

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The GALAXIES Lung-201 data continued to demonstrate clinically meaningful improvements in the trial’s primary endpoint of objective response rate (ORR), however the analysis did not meet established criteria for clinically meaningful improvements in the secondary endpoint of progression free survival in the belrestotug + dostarlimab combination cohorts versus dostarlimab monotherapy. Additionally, an interim analysis of the GALAXIES H&N-202 Phase 2 trial showed a trend below the meaningful threshold for ORR in the belrestotug combination cohorts vs. dostarlimab monotherapy in PD-L1 positive head and neck squamous cell carcinoma.

Based on these results, iTeos and GSK have made the decision to terminate the belrestotug development program and end the collaboration. All belrestotug-containing cohorts are ending, and any new enrollment in the ongoing GALAXIES Lung-301 Phase 3 trial is ending. GSK is communicating with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled patients.

"We are truly disappointed by the results from GALAXIES Lung-201," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "Following the analysis of the TIGIT data generated to-date with GSK, we have made the mutual decision to discontinue development of all ongoing TIGIT studies. We are grateful to all patients, caregivers, and investigators involved in the GALAXIES studies and believe it is important to share these data with the scientific community at an upcoming medical meeting in order to advance our collective understanding of immuno-oncology and TIGIT."

"Since founding this company over a decade ago, I could not be prouder of the team we have built, the quality of science produced, and our collective commitment to improving the lives of cancer patients in need. However, given current market conditions and our appreciation of the responsibility to our valued shareholders, we believe the best path forward is to promptly evaluate a full range of strategic alternatives to unlock the value of our assets. With a strong balance sheet and a commitment to disciplined execution, we are well positioned to pursue opportunities that maximize shareholder value," continued Dr. Detheux.

On May 13, 2025 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported first quarter 2025 financial results and provides a corporate update (Press release, Intensity Therapeutics, MAY 13, 2025, View Source [SID1234652971]).

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France.

In April 2025, the Company and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency has authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer. The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in breast cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia’s Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival.

In March 2025, the Company paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause.

April 2025 Public Offering: In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million.

"The first quarter saw continued progress in our important programs despite high volatility in the markets and funding constraints," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Several patients in our sarcoma study had their first follow-up scans, which showed high levels of necrosis in the injected tumors. Site contracting, site activation and patient enrollment were increasing nicely. However, due to cash needs, we made the necessary decision to pause the Phase 3 sarcoma enrollment and site activation until additional funding becomes available. We are working closely with our vendors and sites to treat those patients enrolled in INVINCIBLE-3, while maintaining the pharmacovigilance, site monitoring and the study database. Meanwhile, our partners SAKK and Unicancer will continue to work with the leading hospitals in Switzerland and France to seek patients for our breast cancer trial, INVINCIBLE-4. We believe in the potential for our drug to positively impact the lives of metastatic sarcoma and presurgical breast cancer patients worldwide. As cancer deaths increase, new and improved alternatives to current therapies are needed now more than ever."

First Quarter 2025 Financial Results

Research and development expenses were $2.2 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024. Clinical trial expenses increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025. In addition, stock-based compensation was $0.4 million lower as no new equity grants were awarded in the first quarter of 2025.

General and administrative expenses were $1.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024. Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas. In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025.

Overall, net loss was $3.3 million for the three months ended March 31, 2025, compared to a net loss of $4.6 million for the three months ended March 31, 2024.

As of March 31, 2025, cash and cash equivalents totaled $0.9 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy.