On May 14, 2026 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, reported financial results for the first quarter ended March 31, 2026 and other recent business developments.

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"With positive results in both cohorts of the pivotal VIKTORIA-1 study, we believe gedatolisib regimens have the potential to advance the standard of care in the second-line setting for a significant number of patients with HR+/HER2- advanced breast cancer, regardless of PIK3CA status," said Brian Sullivan, CEO and co-founder of Celcuity. "We are on track to launch gedatolisib commercially in anticipation of its potential FDA approval in the third quarter of 2026, and we look forward to bringing this important therapy to physicians treating patients with advanced breast cancer."

Mr. Sullivan added, "Our positive Phase 3 results, combined with our promising Phase 1b clinical trial results in treatment-naive late-stage patients, provide a strong scientific rationale to evaluate gedatolisib combinations as first-line therapy. By expanding our VIKTORIA-2 study to enable evaluation of treatment-naive patients who have endocrine-sensitive breast cancer, we are positioning gedatolisib regimens to potentially be available for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status."

First Quarter 2026 Business Highlights and Other Recent Developments

● Celcuity reported positive topline results from the PIK3CA mutant-type ("MT") cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-") ("HR+/HER2-"), PIK3CA MT locally advanced or metastatic breast cancer ("ABC").

○ The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib ("gedatolisib triplet") demonstrated a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") compared with alpelisib, a PI3Kα inhibitor, and fulvestrant.

○ The secondary endpoint comparing gedatolisib in combination with fulvestrant ("gedatolisib doublet") versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS.

○ Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

○ Detailed data for the gedatolisib triplet and doublet regimens will be presented in a late-breaking abstract ("LBA") oral session on June 2, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting in Chicago, Illinois.

○ Celcuity intends to submit these data to the FDA in the third quarter as a supplemental New Drug Application ("sNDA") and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

● The Phase 3 VIKTORIA-2 clinical trial now includes two studies, Study 1 and Study 2, each with independent statistical analysis plans that include primary endpoints for their respective intent-to-treat populations. Study 1, which is ongoing, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and fulvestrant in approximately 440 patients with endocrine-resistant HR+/HER2- ABC. Study 2, which was added in conjunction with a VIKTORIA-2 protocol amendment, is evaluating the efficacy and safety of gedatolisib in combination with palbociclib and letrozole in approximately 740 patients with treatment-naive endocrine-sensitive HR+/HER2- ABC. Eligible patients include those whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. Approximately 60,000 adults are newly diagnosed each year in the United States with endocrine-sensitive HR+/HER2- ABC.1

● To support its long-term lifecycle development plan, Celcuity submitted its first patent application to the United States Patent and Trademark Office ("USPTO") for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.

● In January 2026, the FDA accepted the submission of Celcuity’s New Drug Application ("NDA") for gedatolisib in HR+/HER2- PIK3CA wild-type ("WT") ABC. The FDA granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") goal date of July 17, 2026.

First Quarter 2026 Financial Results

Unless otherwise stated, all comparisons are for the first quarter ended March 31, 2026, compared to the first quarter ended March 31, 2025.

Net loss for the first quarter of 2026 was $52.8 million, or $0.97 per share, compared to a net loss of $37.0 million, or $0.86 per share, for the first quarter of 2025. Non-GAAP adjusted net loss for the first quarter of 2026 was $46.8 million, or $0.86 per share, compared to non-GAAP adjusted net loss of $34.7 million, or $0.81 per share, for the first quarter of 2025. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States ("GAAP") to non-GAAP financial measures, please see the financial tables at the end of this press release.

Total operating expenses were $50.5 million for the first quarter of 2026, compared to $36.1 million for the first quarter of 2025.

Research and development ("R&D") expenses were $33.1 million for the first quarter of 2026, compared to $29.8 million for the prior year period. The $3.3 million increase in R&D expenses was primarily due to a $3.0 million increase in employee-related and consulting expenses. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial.

Selling, general and administrative ("SG&A") expenses were $17.4 million for the first quarter of 2026, compared to $6.3 million for the prior year period. The $11.1 million increase in SG&A expenses was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million was due to commercial headcount additions and other launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.

Net cash used in operating activities for the first quarter of 2026 was $55.1 million, compared to $35.9 million for the prior year period. Cash, cash equivalents and short-term investments were $387.1 million at the end of the first quarter of 2026. We expect cash, cash equivalents, investments and drawdowns on our debt facility to finance our operations through 2027.

Webcast and Conference Call Information

To participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865.

A live webcast presentation can also be accessed using this weblink: View Source;tp_key=2f73ec65ba. A replay of the webcast will be available on the Celcuity website following the live event.

(Press release, Celcuity, MAY 14, 2026, View Source [SID1234665699])

On May 14, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"We made strong progress in the first quarter as we continued to execute across our lead program TPST-2003," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We advanced key activities supporting the planned initiation of our U.S. registrational study of TPST-2003 in patients with rrMM, including announcing our lead manufacturing partner AGCTC and taking delivery of the TPST-2003 lentiviral vector, a critical component in the manufacturing of TPST-2003. At the same time, we strengthened our ability to unlock value across our remaining portfolio with the appointment of Andrew Fang, Ph.D., as our Head of Business Development, whose focus on strategic partnerships, licensing and corporate transactions will help position us for long-term growth. We believe these milestones further reinforce our momentum and our path toward delivering meaningful impact for patients and shareholders alike."

Recent Highlights

TPST-2003
Positive interim results across two ongoing clinical trials (REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, and POEMS-1 Phase 1 trial evaluating TPST-2003 in the rare disease, POEMS syndrome), both of which are being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:
100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients treated with TPST-2003 across REDEEM-1 and POEMS-1 trials.
Favorable safety profile with no Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) in REDEEM-1 trial appears to be emerging as a potentially differentiating attribute in its class.
Prior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease.
44 patients with rrMM treated to date across three studies.
The selection of Cincinnati Children’s AGCTC as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest’s dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma (rrMM). Further to the selection of AGCTC as lead partner, AGCTC took delivery of the TPST-2003 lentiviral vector, a critical component used in the manufacturing of TPST-2003, supporting plans to initiate the first potentially registrational study to evaluate a dual-targeting CAR-T therapy in patients with rrMM, including patients who are experiencing extramedullary disease (EMD), later this year.
Corporate:
Announced the appointment of Andrew Fang, Ph.D., as Head of Business Development. In his role, Dr. Fang will lead Tempest’s global business development efforts, including strategic partnerships, cross-border licensing and corporate transactions, with a particular focus on expanding Tempest’s outreach and partnering efforts in China.
Announced closing of strategic asset acquisition of new dual-targeting CAR-T assets from Factor Bioscience Inc. and Erigen LLC ("Asset Acquisition").
The transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application ("BLA") filing in China planned for 2027.
In March 2026, Tempest announced up to $6 million private placement (the "2026 Offering") of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants, subject to shareholder approval.
Financial Results

First Quarter 2026

Tempest ended the quarter with $1.8 million in cash and cash equivalents, compared to $7.7 million on December 31, 2025. The decrease was primarily due to one-time transaction-associated costs incurred prior to or upon closing the Asset Acquisition, offset by net proceeds from the 2026 Offering of $1.7 million.
Net loss and net loss per share for the quarter were $27.7 million and $2.53, respectively, compared to $10.9 million and $3.16, respectively, for the three months ended March 31, 2025.
Research and development expenses for the quarter were $0.1 million compared to $7.6 million for the three months ended March 31, 2025. The $7.5 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025 and resulting in the Asset Acquisition completed in February 2026.
General and administrative expenses for the quarter were $5.4 million compared to $3.3 million for the same period in 2025. The $2.1 million increase was primarily due to one-time costs resulting from the Asset Acquisition completed in February 2026.
Acquired in-process research and development expenses for the quarter were $22.1 million compared to nil for the three months ended March 31, 2025. Costs incurred prior to or upon closing the Asset Acquisition in the three months ended March 31, 2026 were expensed as acquired in-process research and development.

(Press release, Tempest Therapeutics, MAY 14, 2026, View Source [SID1234665716])

On May 14, 2026 Senti Biosciences Holdings, Inc. (Nasdaq: SNTI) (Senti Bio), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

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"We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development," said Timothy Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. "Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 – a Regenerative Medicine Advanced Therapy (RMAT) designated product – regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn."

Dr. Lu added, "We believe the recent FDA interactions and feedback represent an important milestone for the program and further support the potential of SENTI-202 in relapsed/refractory hematologic malignancies. We remain focused on advancing SENTI-202 efficiently toward the next stage of pivotal development in R/R AML and exploring future combinations with standard of care chemotherapy in newly diagnosed AML patients. We also aim to use our differentiated gene circuit platform to create therapies for additional ex vivo and in vivo CAR therapies."

Recent Business Highlights

SENTI-202 Program Update

Senti Bio concluded a Type B Initial Comprehensive Multidisciplinary RMAT meeting with FDA. Based on the positive outcome of this meeting, Senti Bio has finalized its pivotal clinical and chemistry, manufacturing and controls (CMC) strategy for SENTI-202, which includes a single-arm, multi-center pivotal trial to support registration in R/R AML with SENTI-202 administered after LD chemotherapy. The Company believes the FDA interaction supports continued advancement of SENTI-202 and provides important clarity around a potential registrational development strategy.

In addition, Senti announced that it identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a composite CR (cCR) when they received any SENTI-202 doses manufactured from Donor X-characteristic derived NK cells in Cycle 1. The Donor X attribute is found in ~50% of adult donors, is independent of HLA or KIR matching, and will be used in all future SENTI-202 manufacturing, thus supporting SENTI-202’s allogeneic off-the-shelf usage. Senti Bio also announced that SENTI-202 continues to achieve durable MRD-negative responses in the full 22 patient Phase 1 trial that compares favorably with current FDA approved therapies for R/R AML.

Additional details can be found on Senti Bio’s website.

Strategic Financing Agreement

In April 2026, Senti Bio entered into a securities purchase agreement with an affiliate of Celadon Partners SPV 24, pursuant to which Senti Biosciences, Inc., the Company’s wholly owned subsidiary, may issue up to $40 million aggregate principal amount of senior secured convertible notes in up to two tranches.

The financing includes:

An initial $10 million tranche, expected to close in May subject to specified closing conditions;
An additional tranche of up to $30 million, subject to investor election and additional conditions; and
Future potential contingent value rights tied to regulatory and commercial milestones for SENTI-202 that could provide up to an aggregate of $60 million in additional value to stockholders.
The Company expects to use proceeds from the financing to support general corporate purposes and advance clinical and manufacturing activities for SENTI-202.

Operational and Financial Restructuring Progress

During the first quarter, Senti Bio completed amendments to its Alameda lease and related GeneFab sublease arrangements, significantly reducing future lease obligations and streamlining operations.

These actions contributed to a $6.9 million gain from lease modification during the quarter and are expected to further reduce the Company’s ongoing operating expense profile.

First Quarter 2026 Financial Results

Cash Position: Cash and cash equivalents were $8.9 million as of March 31, 2026, compared to $16.4 million as of December 31, 2025.
Research and Development Expenses: Research and development expenses were $5.3 million for the first quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease was primarily driven by lower external services and supplies costs.
General and Administrative Expenses: General and administrative expenses were $6.2 million for the first quarter of 2026, compared to $7.1 million for the same period in 2025. The decrease was primarily driven by lower external services and supplies costs.
Net Loss: Net loss was $4.2 million, or $0.14 per basic and diluted share, for the first quarter of 2026, compared to a net loss of $14.1 million, or $1.41 per basic and diluted share, for the first quarter of 2025. Net loss for the three months ended March 31, 2026 included non-cash stock-based compensation expense of $1.3 million, offset by a non-recurring $6.9 million gain on lease modification.
Cash Burn: Net cash used in operating activities was $7.5 million during the first quarter of 2026, compared to $14.1 million during the same period in 2025, reflecting continued operational discipline and restructuring actions.
About SENTI-202

SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE, which is an activating CAR that recognizes and kills CD33 and FLT3 expressing cells. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts (that largely express CD33) and leukemic stem cells (that predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE, which is an inhibitory CAR that is designed to recognize EMCN selectively expressed on healthy hematopoietic stem and progenitor cells and protect those healthy cells from being killed even if they express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15, which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, cryopreserved and available off-the-shelf for use as needed. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic treatment for AML/MDS patients.

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.

(Press release, Senti Biosciences, MAY 14, 2026, View Source [SID1234665742])

On May 14, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.

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"The first part of 2026 was a pivotal period for Cellectar as we executed across our pipeline and capital strategies to position the company for value creation," said James Caruso, president and chief executive officer of Cellectar. "With the support of industry-leading healthcare focused investors, we successfully completed a financing of up to $140 million, providing the necessary resources to advance iopofosine through key U.S. regulatory milestones and potential commercialization. The recently reported positive 12-month follow-on data from our CLOVER WaM study reinforce our confidence that iopofosine can provide meaningful patient benefits and meet regulatory expectations, supporting our plans to initiate a Phase 3 confirmatory study and file for accelerated approval with the FDA," Mr. Caruso continued.

"In parallel, we expanded our radio-conjugate pipeline with the enrollment of the first patients in our Phase 1b study of CLR 125 in triple negative breast cancer, a challenging solid tumor cancer with a substantial unmet medical need. Together, these advances underscore the strength of our radiopharmaceutical platform and potential to deliver meaningful new treatment options to patients battling a variety of difficult-to-treat cancers," concluded Mr. Caruso.

First Quarter 2026 and Recent Corporate Highlights

Iopofosine I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted delivery of iodine-131 (radioisotope)
Reported positive 12-month follow-up data from all patients in the Phase 2b CLOVER WaM study evaluating iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia, which demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. The minimum 12-month follow-up data aligns with the expectations set by the U.S. Food and Drug Administration (FDA) and positions the company for accelerated approval submission and the initiation of the confirmatory study.
Notably, the primary and secondary endpoints were both achieved in the protocol study population (n=55), with 61.8% achieving a major response rate (MRR) and a median duration of response (DoR) of 17.8 months. Additional data points included:
Overall response rate (ORR): 83.6%
Median progression-free survival (PFS): 13.5 months
Very good partial response/complete response rate (VGPR/CR): 14.5%
Disease control rate (DCR):98.2
Selected to present data from the CLOVER WaM study of iopofosine I 131 in r/r WM patients at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) taking place May 29 – June 2, 2026. The poster presentation will highlight efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy. Details of the poster presentation are as follows:
Title: "Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety"
Poster: 592
Date/Time: June 1, 2026, 9:00 AM – 12:00pm CDT
Presenter: Jarrod Longcor
Advancing plans to initiate a Phase 3 confirmatory trial of iopofosine I 131 as a treatment for WM and file for accelerated approval with the U.S. FDA in alignment with the FDA requirements. This Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm, with full patient enrollment projected within 18-24 months of the first patient admitted to the study.
Continuing to work with the European Medicines Agency (EMA) to file for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment option for post-BTKi refractory patients with WM.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
Announced the enrollment of the first patient in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast cancer (TNBC). The Company anticipates activating additional study sites throughout the second quarter and will provide dosimetry, safety and efficacy updates in the second quarter and throughout the balance of 2026.
Corporate
In May 2026, the Company entered into a securities purchase agreement with certain institutional investors to issue and sell an aggregate of approximately $35 million upfront and up to $105 million of milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants.
The oversubscribed financing was led by Nantahala Capital, with participation from Balyasny Asset Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management and other dedicated healthcare funds. In connection with the Offering, Andrew Gu of Nantahala Capital Management, LLC will join Cellectar’s Board of Directors.
2026 Financial Highlights

Cash and Cash Equivalents: As of March 31, 2026, the company had cash and cash equivalents of $8.3 million, compared to $13.2 million as of December 31, 2025, which does not reflect net proceeds of approximately $31 million from the May 2026 offering. The company believes its cash balance as of March 31, 2026, along with funds from the May 2026 financing, are adequate to fund its budgeted operations into the second quarter of 2027, including the initiation costs for the iopofosine I 131 confirmatory study in WM.
Research and Development Expenses: R&D expenses for the three months ended March 31, 2026, were approximately $3.0 million, compared to approximately $3.4 million for the three months ended March 31, 2025. The overall decrease was primarily a result of reduced clinical and preclinical study costs, partially offset by increased spending for product manufacturing processes.
General and Administrative Expenses: G&A expenses for the three months ended March 31, 2026, were approximately $2.8 million, compared to approximately $3.0 million for the same period in 2025. The decrease was primarily a result of reduced personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2026, was $5.7 million, or $1.33 per share, compared to $6.6 million, or $4.30 per share, in the three months ended March 31, 2025.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, May 14, 2026, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the "Events & Presentations" section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the Company’s website for approximately 90 days.

(Press release, Cellectar Biosciences, MAY 14, 2026, View Source [SID1234665700])

On May 14, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"This quarter was marked by the positive data update from our randomized Phase 2 CRDF-004 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, along with key leadership additions that prepare the Company to deliver on the clinical milestones ahead," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology.

"In April, we had a successful End‑of‑Phase 2 meeting with the FDA and aligned on the key design elements for our Phase 3 registrational trial. We plan to share additional Phase 3 details and our regulatory strategy in mid-2026. At the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, we will present updated CRDF-004 data, which we believe will provide further insight into onvansertib’s potential in the first-line RAS-mutated metastatic colorectal cancer (mCRC) setting. In parallel, we continue to strengthen the scientific foundation of our PLK1 inhibition strategy, supported by new preclinical data evaluating combination use with an antibody-drug conjugate, as well as ongoing single-agent and combination investigator-initiated studies across multiple cancer settings. With strong clinical momentum, we remain focused on disciplined execution throughout the year."

Clinical Highlights

Upcoming Event: Reporting Updated Onvansertib Data in Rapid Oral Presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2026

•
The Company will report detailed updated data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib in combination with FOLFIRI/bev or FOLFOX/bev in patients with first-line RAS-mutated mCRC in a rapid oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2 in Chicago. More information about the presentation is available here.

Completed End-of-Phase 2 Meeting with the FDA and Aligned on the Design of the Phase 3 Registrational Trial in Patients with First-line RAS-mutated mCRC

•
In consultation with the U.S. Food and Drug Administration (FDA), Cardiff selected the 30 mg dose of onvansertib for evaluation with FOLFIRI/bev chemotherapy regimen for the Phase 3 trial in patients with first-line RAS-mutated mCRC. Additional details of the clinical trial will be shared by mid-2026.

Key Opinion Leader Engagements Highlight Onvansertib Clinical Data and Opportunity in mCRC

•
In March, Cardiff hosted a KOL webinar featuring internationally recognized leaders in colorectal cancer research, Drs. Scott Kopetz and Heinz-Josef Lenz. The webinar focused on the evolving treatment landscape in first-line RAS-mutated mCRC and onvansertib’s potential as a novel therapeutic approach in the management of RAS-mutated mCRC. A replay of the webcast is available in the Events section of the Company’s website.

Announced Positive Update from our Randomized Phase 2 Trial of Onvansertib in First-line RAS-mutated mCRC

•
In January, Cardiff provided topline data from its ongoing CRDF-004 Phase 2 randomized clinical trial in first-line RAS-mutated mCRC. The 30 mg onvansertib + FOLFIRI/bevacizumab (bev) arm achieved a confirmed objective response rate (ORR) of 72.2% compared to 43.2% across the combined standard-of-care (SoC) arms. The 30 mg onvansertib dose in combination with FOLFIRI/bev also demonstrated marked improvement in progression-free survival (PFS) versus FOLFIRI/bev (HR: 0.38) and combined SoC of FOLFOX/bev and FOLFIRI/bev (HR: 0.37, p<0.05), with no significant added toxicity observed. More details available here.

Preclinical Highlights

Company Presented New Preclinical Data at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting Supporting Rationale for Onvansertib in Combination with Antibody Drug Conjugates

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Cardiff presented new preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting in April demonstrating that onvansertib enhanced the activity of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd), driving tumor regression and overcoming resistance in HER2-low breast cancer models. More details are available here.

Corporate Update

Key Leadership Appointments Strengthen Executive Team to Support Company’s Next Phase of Growth

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In April, the Company announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO. She will continue as a member of the Board of Directors. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

First Quarter 2026 Financial Results

Liquidity, cash burn, and cash runway

As of March 31, 2026, Cardiff Oncology had approximately $46.1 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the first quarter of 2026 was approximately $12.3 million, a decrease of approximately $0.5 million from $12.8 million for the same period in 2025.

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

Operating results

Total operating expenses were approximately $12.9 million for the three months ended March 31, 2026, a decrease of $1.6 million from $14.5 million for the same period in 2025. The decrease in operating expenses was primarily due to a decrease of $3.7 million in R&D expenses, mainly clinical trial expenses and preclinical activities, partially offset by an increase of $2.1 million in SG&A expenses, primarily for employee severance agreements and corresponding modifications of stock options.

(Press release, Cardiff Oncology, MAY 14, 2026, View Source [SID1234665726])