On May 8, 2025 Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported financial results for the first quarter ended March 31, 2025, and provided recent business updates (Press release, Cidara Therapeutics, MAY 8, 2025, View Source [SID1234652738]).

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"Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have established April 30, 2025 as the data cutoff for the primary efficacy analysis of the 5,041 subjects dosed in the Phase 2b NAVIGATE clinical trial. We are expecting top-line results in late June of this year. The severity of the 2024-2025 flu season has provided an opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA to evaluate the potential statistical significance of CD388 versus placebo," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "We believe CD388 is highly differentiated from vaccines and monoclonal antibodies and we believe these differences can significantly improve upon the protective efficacy against influenza in healthy, high-risk, and immunocompromised patients with a single dose per flu season."

Recent and Expected Corporate Highlights

Phase 2b NAVIGATE trial evaluating CD388 for prevention of seasonal influenza ongoing. Dosing of 5,041 subjects in the Phase 2b NAVIGATE study were completed in early December of 2024 across clinical sites in the U.S. and UK. This is a randomized, double-blind, controlled trial designed to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of seasonal influenza. Three CD388 dose groups, comprised of 150mg, 300mg and 450mg doses, and one placebo group were randomized and dosed in a 1:1:1:1 ratio at the beginning of the 2024-25 influenza season. Subjects were followed for efficacy through the end of April 2025 to monitor for breakthrough cases. Rates of laboratory and clinically confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo.
Phase 2b NAVIGATE efficacy data expected in late June 2025. Due to the severity of the 2024-25 flu season, Cidara has the opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA, to evaluate possible statistical significance of CD388 versus placebo. Assuming agreement with the FDA on the changes to the statistical analysis plan, we expect that data from this trial will enable dose selection for Phase 3 as well as the determination of statistically meaningful comparisons of each dose to the placebo arm of the study.
Published preclinical data of CD388 in Nature Microbiology in March 2025. The article, entitled "Drug-FC Conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice," highlighted the potential of CD388 as a potent, universal antiviral for influenza A and B prevention regardless of immune status. The full press release can be found here.
Presented two posters on CD388 in influenza at the 38th International Conference on Antiviral Research (ICAR) in March 2025. The Company’s presentations highlighted the study design, demographic information, and preliminary safety data from the ongoing Phase 2b NAVIGATE trial of CD388, as well as dose optimization models for its planned Phase 3 development program. The preliminary safety profile shows that CD388 is well-tolerated and the majority of injection site reactions are considered mild in severity.
Promoted Nicole Davarpanah to Chief Medical Officer and Corrina Pavetto to Senior Vice President, Clinical Development. In May 2025, Cidara announced the promotions of Nicole Davarpanah, M.D., J.D., to Chief Medical Officer and Corrina Pavetto to Senior Vice President, Clinical Development. Dr. Davarpanah and Ms. Pavetto have shown exceptional leadership in the execution of the Phase 2b NAVIGATE Study, the revision of its statistical analysis plan, and the design of the Phase 3 development and regulatory strategy for CD388. Their continued guidance and oversight will be invaluable for the successful development of CD388 as a novel option for the universal prevention of influenza.
First Quarter 2025 Financial Results

Cash, cash equivalents and restricted cash totaled $174.5 million as of March 31, 2025, compared with $196.2 million as of December 31, 2024.
Collaboration revenue was zero for the three months ended March 31, 2025, compared to $1.0 million for the same period in 2024. Collaboration revenue related to research and development (R&D) and clinical supply services provided to J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), under our license and collaboration agreement with Janssen (the Janssen Collaboration Agreement). The Janssen Collaboration Agreement was terminated upon the effectiveness of our license and technology transfer agreement with Janssen on April 24, 2024.
R&D expenses were $24.6 million for the three months ended March 31, 2025, compared to $5.9 million for the same period in 2024. The increase in R&D expenses is primarily driven by higher expenses associated with our ongoing CD388 Phase 2b NAVIGATE study and higher one-time personnel costs, partially offset by lower nonclinical expenses associated with our Cloudbreak platform.
General and administrative (G&A) expenses were $6.2 million for the three months ended March 31, 2025, compared to $3.6 million for the same period in 2024. The increase in G&A expenses is primarily due to higher personnel costs, partially offset by lower legal costs.
Net loss from discontinued operations for the three months ended March 31, 2025 was zero, compared to net loss from discontinued operations of $2.1 million for the same period in 2024. On April 24, 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), an affiliate of Mundipharma Medical Company, pursuant to which all rezafungin assets and related contracts were sold to Napp. All conditions of the sale were completed on April 24, 2024, and the financial results of rezafungin have been reported separately as discontinued operations.
Net loss for the three months ended March 31, 2025 was $23.5 million, compared to a net loss of $10.3 million for the same period in 2024.
First Quarter 2025 Conference Call and Webcast Details

Cidara Therapeutics management will host a conference call and webcast beginning at 5:00 pm ET / 2:00 pm PT today, May 8, 2025. A live webcast may be accessed here. The conference call can be accessed by dialing toll-free (800) 717-1738 or (646) 307-1865 (international). The passcode for the conference call is 90743.

A replay of the webcast will be archived on www.cidara.com for one year under the "Events & Presentations" tab in the Investors section of the company’s website.

On May 8, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the first quarter 2025 and provided a business update for its lead oncology clinical programs CB-010 and CB-011 with data disclosure for each planned for H2 2025 (Press release, Caribou Biosciences, MAY 8, 2025, View Source [SID1234652737]).

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"Caribou’s two lead Phase 1 clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to demonstrate encouraging efficacy and have the potential to benefit individuals living with hematologic malignancies," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "We look forward to disclosing two robust clinical datasets from these programs in the second half of this year as we focus on our goal to deliver these off-the-shelf allogeneic CAR-T cell therapies that offer the potential for broad access and rapid availability to both patients and healthcare systems."
Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou is enrolling a 20-patient confirmatory cohort using the Company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL) patients. In H2 2025, Caribou expects to present data from this cohort with at least six months of follow up for the majority of patients.
•To date, data demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.
•Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•In the dose escalation portion of the CaMMouflage Phase 1 clinical trial for patients with relapsed or refractory multiple myeloma (r/r MM), Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple dose levels following a lymphodepletion regimen that includes a deeper dose of cyclophosphamide.
•Caribou is rapidly enrolling additional patients with the deeper lymphodepletion regimen to make a data-driven decision on the recommended doses for expansion. The Company plans to present data in H2 2025 with at least three months of follow up on a minimum of 25 patients at multiple dose levels.
Corporate updates
Recently announced pipeline prioritization with workforce and cost reduction initiatives
•As previously reported on April 24, 2025, Caribou implemented a strategic pipeline prioritization to focus resources on its lead oncology programs, CB-010 and CB-011. The Company discontinued its Phase 1 clinical trial of CB-010 for lupus, Phase 1 clinical trial of CB-012 for relapsed or refractory acute myeloid leukemia (r/r AML), and preclinical research. Patients treated in the CB-012 phase 1 clinical trial will continue to be followed as part of the Company’s long-term follow up study. Caribou also reduced its workforce by approximately 32%. Cash payments resulting from the reduction in force and strategic pipeline prioritization are estimated to be $2.5 to $3.5 million. These changes are expected to extend Caribou’s cash runway by one year, funding the Company’s current operating plan into H2 2027, compared to into H2 2026 as previously reported.
2025 anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
◦Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
◦Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data and share the recommended doses for expansion from its ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:
◦Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
◦Recommended doses for expansion and plans for dose expansion.
First quarter 2025 financial results
Cash, cash equivalents, and marketable securities: Caribou had $212.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025, compared to $249.4 million as of December 31, 2024. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into H2 2027.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.4 million for the three months ended March 31, 2025, compared to $2.4 million for the same period in 2024.

R&D expenses: Research and development expenses were $35.5 million for the three months ended March 31, 2025, compared to $33.8 million for the same period in 2024. The increase was primarily due to costs associated with the ongoing CB-010 ANTLER and CB-011 CaMMouflage Phase 1 clinical trials and the recently discontinued CB-012 AMpLify and CB-010 GALLOP Phase 1 clinical trials; facility and other allocated expenses; and personnel-related expenses, including stock-based compensation; partially offset by a reduction in expenses relating to licenses, other R&D expenses, and consulting services.

G&A expenses: General and administrative expenses were $9.7 million for the three months ended March 31, 2025, compared to $14.6 million for the same period in 2024. The decrease was primarily due to lower legal expenses, including the accrual of a litigation settlement expense in 2024, other service-related expenses, and personnel-related expenses, including stock-based compensation and salary and benefit expenses.

Net loss: Caribou reported a net loss of $40.0 million for the three months ended March 31, 2025, compared to $41.2 million for the same period in 2024.

About CB-010

CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011

CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

On May 8, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the first quarter ended March 31, 2025, and provided a business update (Press release, Cardiff Oncology, MAY 8, 2025, View Source [SID1234652736]).

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"Our lead program for onvansertib has remained on track in 2025 with the successful completion of enrollment in our trial in first-line RAS-mutated mCRC, underscoring our deep commitment to serving a patient population that has seen no therapeutic advancements in decades," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "Furthermore, we expanded our intellectual property portfolio through the issuance of a second patent covering all mCRC, regardless of tumor mutational status, across all lines of therapy. As we continue to generate clinical data and move toward regulatory discussions with the FDA, we remain focused on our mission to deliver a transformative therapy that could redefine the standard of care for RAS-mutated mCRC and for other cancers."

Upcoming expected milestones

•
Additional clinical data from the ongoing CRDF-004 trial in mCRC expected in 1H 2025
Company highlights for the quarter ended March 31, 2025, and subsequent weeks include:

•
Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC
o
The Phase 2 CRDF-004 trial has reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. Patients in the trial have mCRC and a documented KRAS or NRAS mutation with unresectable disease. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab (bev) or FOLFOX plus bev. Patients are randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety.
•
Announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients
o
U.S. patent No. 12,263,173 has an expiration date of no earlier than 2043. The claims of the new patent cover the method of using onvansertib in combination with bev in any line of therapy for the treatment of mCRC patients who have not previously been treated with bev.

The newly issued patent encompasses all mCRC patients, with RAS-mutated or RAS wild-type mCRC.
First Quarter 2025 Financial Results:

Liquidity, cash burn, and cash runway

As of March 31, 2025, Cardiff Oncology had approximately $79.9 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2025 was approximately $12.8 million, an increase of approximately $5.1 million from $7.7 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $14.5 million for the three months ended March 31, 2025, an increase of $3.4 million from $11.1 million for the same period in 2024. The increase in operating expenses was primarily due to costs associated with our CRDF-004 clinical trial, other clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, as well as professional fees related to strategic advisory services.

On May 8, 2025 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata" or the "Company"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a business update and announced financial results for the three months ended March 31, 2025 (Press release, Lisata Therapeutics, MAY 8, 2025, View Source [SID1234652735]).

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"Lisata maintains momentum into 2025 despite a challenging market for small cap healthcare companies as we continue to make notable progress in both our clinical development portfolio and partnering initiatives," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "Overall, our focus remains on evaluating certepetide in multiple clinical and preclinical studies across a variety of solid tumors and non-cancer indications. In January, positive results stemming from both Cohort A of the ASCEND trial as well as the iLSTA trial were presented at ASCO (Free ASCO Whitepaper)-GI and we maintain our forecast of a data-rich period for the remainder of 2025 and into 2026. Heading the list of anticipated results are those from Cohort B of the ASCEND trial as well as results from Catalent’s preclinical evaluation combining certepetide with their SMARTag antibody-drug conjugate (ADC) platform."

Dr. Mazzo added, "Based on concentrated efforts to manage our finances prudently, we now project having operational cash into the third quarter of 2026 as we finalize next steps in certepetide development, based on upcoming conversations with various regulatory agencies including the FDA, TGA and EMA."

Development Portfolio Highlights

Certepetide as a treatment for solid tumors in combination with other anti-cancer agents
Certepetide (formerly LSTA1) is a proprietary, internalizing RGD, or iRGD, (arginylglycylaspartic acid) cyclic peptide designed to activate the C-end rule active transport mechanism in a tumor specific manner, resulting in systemically co-administered anti-cancer agents more efficiently penetrating and accumulating in the tumor. Additionally, certepetide has been shown to modify the tumor microenvironment (TME), diminishing its immunosuppressive nature, enhancing cytotoxic T cell concentration in the TME and inhibiting the metastatic cascade. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced efficacy of various existing and emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapeutics in solid tumor models. In addition, to date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to demonstrate its ability to enhance the effectiveness of standard-of-care (SoC) chemotherapy for pancreatic cancer as well as the combination of chemotherapy and immunotherapy in a variety of solid tumors. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma, osteosarcoma, and cholangiocarcinoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.). Currently, certepetide is the subject of multiple ongoing or planned preclinical and clinical studies being conducted globally across several solid tumor types in combination with a variety of anti-cancer regimens, including:

•ASCEND: Phase 2b double-blind, randomized (2:1 ratio), placebo-controlled trial evaluating two dosing regimens of certepetide in combination with SoC chemotherapy (gemcitabine/nab-paclitaxel) in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial is being conducted across 25 sites in Australia and New Zealand led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney. Cohort A, with 95 patients receiving a single intravenous (IV) dose of certepetide 3.2 mg/kg or placebo in combination with SoC, completed enrollment in the third quarter of 2023. Preliminary Cohort A data presented at the 2025 ASCO (Free ASCO Whitepaper)-GI Symposium showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo treated group. Data from Cohort B, with 63 patients receiving two IV doses of certepetide 3.2 mg/kg or placebo administered 4 hours apart in combination with SoC, is expected in the coming months with a final analysis of both cohorts available thereafter. Preliminary results from Cohort B data have been accepted for presentation at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress being held July 2-5, 2025.

•BOLSTER: Phase 2a double-blind, placebo-controlled, multi-center, randomized trial in the U.S. evaluating certepetide in combination with SoC chemotherapy in first- and second-line cholangiocarcinoma (CCA). The Company achieved complete enrollment in first-line CCA nearly six months ahead of plan, accelerating anticipated topline data readout to mid-2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line CCA treatment, a second cohort was added to the BOLSTER trial evaluating certepetide in combination with SoC in subjects with second-line CCA. In September 2024, Lisata announced first patient treated in the second-line CCA cohort and recently decided to stop enrollment at approximately 20 patients to accelerate data read out and optimize capital allocation.

•CENDIFOX: Phase 1b/2a open-label trial in the U.S. evaluating certepetide in combination with neoadjuvant FOLFIRINOX based therapies in pancreatic, colon and appendiceal cancers. In December 2024, the Company announced enrollment completion in all three cohorts. The single-center study, conducted solely at the University of Kansas Cancer Center, was designed with a 3-cycle run-in period to ensure patients met specific criteria before receiving treatment. Of the 66 patients enrolled, 50 patients met the criteria and were treated with certepetide across three cohorts, including 24 with resectable or borderline resectable pancreatic cancer, 15 with high-grade colon or appendiceal cancer and peritoneal metastasis, and 11 with oligometastatic colon cancer. The trial is expected to provide Lisata with valuable pre- and post-treatment tumor tissue data for immune profiling, along with long-term patient outcome information. CENDIFOX data are expected in the coming months; however, given that this is an investigator-initiated study, the exact timing is not in Lisata’s control. The trial is funded by the University of Kansas Cancer Center and Lisata is supplying certepetide.
•Qilu Pharmaceutical, the licensee of certepetide in the Greater China territory, is currently evaluating certepetide in combination with gemcitabine and nab-paclitaxel as a treatment for first-line mPDAC. During the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, Qilu Pharmaceutical presented an abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase 1b/2a trial of certepetide plus gemcitabine and nab-paclitaxel conducted in Australia in patients with first-line mPDAC. Qilu has completed enrollment in its Phase 2 trial and data are expected in the near future. Progression of Qilu’s certepetide development program into Phase 3 in China will trigger a $10 million milestone payment due to Lisata under the terms of the license agreement with Qilu.

•iLSTA: Phase 1b/2a randomized, single-blind, single-center, safety and pharmacodynamic trial in Australia, funded by WARPNINE Inc., evaluating certepetide in combination with SoC chemotherapy (nab-paclitaxel and gemcitabine) plus SoC immunotherapy (durvalumab) versus SoC alone in patients with locally advanced non-resectable PDAC. An interim analysis of the iLSTA trial, presented at the 2025 ASCO (Free ASCO Whitepaper) GI Symposium, showed preliminary results from the first 17 of the 30 targeted patients, corroborating preclinical data that certepetide enhances the effectiveness of immunotherapy treatment. With 27 of the 30 patients enrolled, enrollment remains on track to be completed by the first half of 2025.
•A Lisata-funded Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide in combination with SoC temozolomide versus temozolomide alone in patients with newly diagnosed glioblastoma multiforme (GBM) is being conducted across multiple sites in Estonia and Latvia and is planned to also include a site in Lithuania. The study is targeted to enroll 30 patients with a randomization of 2:1 in favor of the certepetide treatment group. Enrollment completion is now expected in 2026.

•FORTIFIDE: A proposed Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study in the U.S. evaluating the safety, tolerability, and efficacy of a 4-hour continuous infusion of certepetide in combination with SoC in subjects with first-line mPDAC. As part of this study, Lisata has engaged Haystack Oncology to use its MRD technology to measure circulating tumor DNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. Initiation of the study remains on hold as the Company is investigating a potentially faster and more cost-effective alternative to achieve the study’s objective, which may become the preferred strategy.
Preclinically, Lisata has entered into multiple research collaborations, including a sponsored research agreement with the University of Cincinnati to assess certepetide in combination with bevacizumab (a VEGF inhibitor) in a preclinical murine model for the treatment of endometriosis. Lisata is also partnering with Valo Therapeutics (ValoTx) to investigate the benefits of combining certepetide with ValoTx’s platform technology, PeptiCRAd, an oncolytic virus, and a checkpoint inhibitor in a preclinical murine model for the treatment of melanoma.
Additionally, Lisata recently entered into a research license with Catalent, Inc. ("Catalent"), to evaluate the efficacy of certepetide in a preclinical setting with Catalent’s SMARTag ADC dual payload technology platform for the treatment of various difficult-to-treat diseases. Lisata also entered into an exclusive license and collaboration agreement with Kuva Labs, Inc. ("Kuva"), in which Lisata granted Kuva an exclusive license to explore the synergistic potential of certepetide as a targeting and delivery agent for Kuva’s NanoMark imaging technology in solid tumors.
First Quarter 2025 Financial Highlights
For the three months ended March 31, 2025, operating expenses totaled $5.8 million, compared to $6.6 million for the three months ended March 31, 2024, representing a decrease of $0.8 million or 11.4%.
Research and development expenses were approximately $2.6 million for the three months ended March 31, 2025, compared to $3.2 million for the three months ended March 31, 2024, representing a decrease of $0.6 million or 19.7%. This was primarily due to a reduction in clinical research organization expenses and site expenses associated with our Phase 2a proof-of-concept Bolster trial and lower spend on chemistry, manufacturing and controls.
General and administrative expenses were approximately $3.2 million for the three months ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2024, representing a decrease of approximately $0.1 million or 3.4%. This was primarily due to one-off settlement costs in the prior year partially offset by an increase in consulting expenses and severance costs in the current year.
Overall, net losses were $4.7 million for the three months ended March 31, 2025, compared to $5.4 million for the three months ended March 31, 2024.

Balance Sheet Highlights

As of March 31, 2025, Lisata had cash, cash equivalents, and marketable securities of approximately $25.8 million. Based on its existing and planned activities, the Company believes available funds will support current operations into the third quarter of 2026.

Conference Call Information

Lisata will hold a live conference call today, May 8, 2025, at 4:30 p.m. Eastern Time to discuss financial results, provide a business update and answer questions.

Those wishing to participate must register for the conference call by way of the following link: CLICK HERE TO REGISTER. Registered participants will receive an email containing conference call details with dial-in options. To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
A live webcast of the call will also be accessible under the Investors & News section of Lisata’s website and will be available for replay beginning two hours after the conclusion of the call for 12 months.

On May 8, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported that Kim Kelderman, President and Chief Executive Officer, will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025, at 10:40 a.m. PDT (Press release, Bio-Techne, MAY 8, 2025, View Source [SID1234652734]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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