On February 27, 2025 Domain Therapeutics ("Domain" or "the Company"), the GPCR experts harnessing deep receptor biology to develop breakthrough treatments for patients, reported its participation and presentation in a series of forthcoming high-profile healthcare conferences (Press release, Domain Therapeutics, FEB 27, 2025, View Source [SID1234650701]).

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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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The Company’s expert leadership team will showcase its latest progress and upcoming catalysts driven by its first-in-class biased antagonist of PAR2 and best-in-class Treg-depleting anti-CCR8 antibody. Leveraging its robust pipeline of highly differentiated clinical and preclinical GPCR-targeting therapies, Domain continues to drive innovation in areas of high unmet medical need.

BIO-Europe Spring – March 17-19
Location: Milan, Italy

American Association for Cancer Research Annual Meeting (AACR) (Free AACR Whitepaper) – April 25-30
Location: Chicago, USA

Poster presentations: PAR2, CCR8, and EP4 candidates to be announced
4th GPCR Targeted Drug Discovery Summit – May 22-24
Location: Boston, USA

Fireside chat: Thursday, May 22, 09:30 EDT
Fireside chat topic: Uncovering Tools to Discover Synthetic Ligands for Orphan GPCRs to Advance the Development of Effective Therapies
Speaker: Laurent Sabbagh, Scientific Director Biology
Presentation: Thursday, May 22, 13:15 EDT
Presentation topic: Leveraging Effective Models for Anti-CCR8 Antibody to Inform First In-Human Clinical Trials
Presenter: Stephan Schann, Chief Scientific Officer
American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – May 30-June 3
Location: Chicago, USA

Jefferies Healthcare Conference – June 3-5
Location: New York, USA

BIO International – June 16-19
Location: Boston, USA

For more information or to arrange a meeting with Domain Therapeutics at these events, please contact [email protected].

On February 27, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Cullinan Oncology, FEB 27, 2025, View Source [SID1234650700]).

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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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"Building on our execution throughout 2024, we are positioned to again deliver meaningful catalysts in 2025, starting with key updates for CLN-978 and zipalertinib," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "We have established an important competitive advantage in the immunology space as CLN-978 remains the first and only development-stage CD19 T cell engager with U.S. Food and Drug Administration (FDA) IND clearance in autoimmune diseases. We are further strengthening our leadership position by rapidly expanding our site footprint and preparing to deliver initial clinical data in SLE in the fourth quarter of 2025. For zipalertinib, we recently announced that the pivotal Phase 2b portion of the REZILIENT1 study met the primary endpoint of overall response rate. This milestone marks a significant achievement for Cullinan, our partner, Taiho, and most importantly, patients with EGFR exon20 insertion mutation NSCLC who have received prior therapy. Together with Taiho, we look forward to discussing next steps with the U.S. FDA and expect to submit an NDA in the second half of 2025. We look forward to continuing to progress these programs along with the rest of our pipeline."

Portfolio Highlights

Immunology

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CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis
o
The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025.

o
The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025. The company-sponsored trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy.
Oncology

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CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies
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The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study. Cullinan remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025.
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Enrollment continues in the ongoing Phase 1 study of CLN-619 in patients with relapsed/refractory multiple myeloma.
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The full results will be submitted for presentation at an upcoming international medical conference and shared mid-year 2025. Pending discussions with the U.S. FDA, Taiho and Cullinan plan to submit for U.S. regulatory approval in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.
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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
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Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable residual disease (MRD) in AML.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $606.9 million as of December 31, 2024. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.

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R&D Expenses: Research and development expenses were $40.5 million for the fourth quarter of 2024, compared to $34.8 million for the same period in 2023, and $142.9 million for the full year 2024, compared to $148.2 million for the full year 2023.
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G&A Expenses: General and administrative expenses were $14.6 million for the fourth quarter of 2024, compared to $10.6 million for the same period in 2023, and $54.0 million for the full year 2024, compared to $42.5 million for the full year 2023.
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Net Loss: Net loss attributable to Cullinan was $47.6 million for the fourth quarter of 2024, compared to $23.8 million for the same period in 2023, and $167.4 million for the full year 2024, compared to $153.2 million for the full year 2023.

On February 27, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Crinetics Pharmaceuticals, FEB 27, 2025, View Source [SID1234650699]).

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"2024 was a year of significant progress and execution across all fronts," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The acceptance of our NDA for paltusotine in acromegaly was a key achievement, and under the leadership of our new chief commercial officer, Isabel Kalofonos, our commercial team is preparing for the expected launch, which will be a truly significant milestone for the company. Our ongoing clinical programs continue to yield promising results, paving the way to initiate four late-stage trials this year. We’re also advancing four new candidates toward IND filing, underscoring the power of our internal research and development engine. Our balance sheet empowers us to execute our strategic vision over the next several years, and we are excited to bring on board a new chief financial officer, Toby Schilke, to provide financial leadership during this next stage of growth. Building on the strong foundation we’ve established, 2025 is positioned to be a transformative year for Crinetics."

Full Year 2024 and Recent Highlights:

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Strengthened leadership team with key appointments across finance, commercial, medical and clinical development to strengthen organization ahead of launch. In February 2025, Crinetics appointed Tobin "Toby" Schilke as Chief Financial Officer. In December 2024, Crinetics appointed Isabel Kalofonos as Chief Commercial Officer. In April 2024, Crinetics appointed Lise Kjems, M.D., Ph.D. as Senior Vice President of Endocrinology Clinical Research, and in October 2024, appointed Bin Zhang, M.D., M.Sc. as Senior Vice President of Oncology Clinical Development. In May 2024, Crinetics appointed Robert M. Cuddihy, M.D., as Senior Vice President of Medical Affairs.
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New Drug Application (NDA) for paltusotine for the treatment of acromegaly filed and accepted for review by U.S. Food and Drug Administration (FDA). This submission was based on positive topline results from the PATHFNDR-1 trial reported in September 2023 and from the PATHFNDR-2 trial reported in March 2024.
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European Medicines Agency (EMA) granted paltusotine Orphan Drug Designation (ODD) for the treatment of acromegaly. Designation was given following a positive recommendation from the EMA Committee for Orphan Medicinal Products, highlighting the potential impact of paltusotine for acromegaly patients in the EU.
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Phase 2 open-label study of paltusotine in carcinoid syndrome reported positive results. In March 2024, Crinetics reported positive topline results; paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.

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Phase 2 TouCAHn open-label study of atumelnant in congenital adrenal hyperplasia (CAH) reported positive results. In January 2025, Crinetics reported positive topline results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in A4 levels, the key biomarker for disease control. Atumelnant was well-tolerated and treatment with atumelnant was associated with significant clinical improvements.
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Debut of novel Nonpeptide Drug Conjugate (NDC) platform. Presented data from CRN09682 at the North American Neuroendocrine Tumor Society (NANETS) Annual Meeting in November 2024.
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Development candidates nominated in multiple programs. Crinetics has identified an oral thyroid stimulating hormone (TSH) receptor antagonist development candidate for the potential treatment of Graves’ disease, including hyperthyroidism and thyroid eye disease (TED); an oral parathyroid hormone (PTH) antagonist development candidate for the treatment of hyperparathyroidism; and an SST3 agonist development candidate for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
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Strengthened balance sheet. Current cash position of $1.4B is expected to support our business activities into 2029.

Key Upcoming Milestones:

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FDA Prescription Drug User Fee Act (PDUFA) target action date of September 25, 2025 for paltusotine NDA for the treatment and maintenance therapy of acromegaly.
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Enrollment of the first patient in the pivotal Phase 3 trial of paltusotine in carcinoid syndrome is anticipated in the second quarter of 2025.
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Crinetics expects to begin enrollment of patients in two pivotal studies of atumelnant in CAH: Phase 3 in adults and Phase 2b/3 in pediatrics.
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Crinetics is also planning a study of atumelnant in Cushing’s disease. Enrollment of patients is expected to begin in late 2025 or early 2026.
•
Four novel IND filings expected in 2025 for the development candidates nominated in 2024.

Fourth Quarter and Full Year 2024 Financial Results:

•
Research and development expenses were $66.6 million and $240.2 million for the three months and full year ended December 31, 2024, compared to $45.6 million and $168.5 million for the same periods in 2023. The increases were primarily attributable to an increase in personnel costs of $12.6 million for the quarter ended December 31, 2024 and $43.4 million for the year ended December 31, 2024, and increased clinical and preclinical development activities of $5.1 million and $10.2 million for the quarter and year ended December 31, 2024, respectively.
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General and administrative expenses were $28.2 million and $99.7 million for the three months and full year months ended December 31, 2024, compared to $17.1 million and $58.1 million for the same periods in 2023. The increases were primarily driven by an increase in personnel costs of $5.4 million for the quarter ended December 31, 2024 and $23.8 million for the year ended December 31, 2024.
•
Net loss for the three months ended December 31, 2024, was $80.6 million, compared to a net loss of $60.1 million for the same period in 2023. For the year ended December 31, 2024, the company’s net loss was $298.4 million compared to a net loss of $214.5 million for the year ended December 31, 2023.
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There were no revenues for the three months ended December 31, 2024 or 2023. Revenues were $1.0 million for the full year ended December 31, 2024, compared to $4.0 million for the same period in 2023. Revenues for 2024 were primarily derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. License revenues for 2023 were derived from licensing agreements with Sanwa Kagaku Kenkyusho Co., Ltd. and Cellular Longevity, Inc.
•
Cash, cash equivalents, and investments totaled $1.4 billion as of December 31, 2024, compared to $558.6 million as of December 31, 2023. This includes gross proceeds of $350 million from the February 2024 private placement equity financing and $575 million from the October 2024 public offering. Based on current projections, Crinetics expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2029. For 2025, we anticipate our cash used in operations to be between $340 and $380 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, February 27 at 4:30 p.m. ET. To participate, please dial 1-800-267-6316 (domestic) or 1-203-518-9783 (international) and refer to Conference ID CRNXQ4. To access the webcast, the direct link (HERE) or visit the Events section of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

On February 27, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the fourth quarter and year ended December 31, 2024 (Press release, Castle Biosciences, FEB 27, 2025, View Source [SID1234650689]).

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"Castle delivered an outstanding fourth quarter that rounded out an exceptional 2024, including 51% revenue growth and 36% test report volume growth compared to 2023," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "I am incredibly proud of our team’s hard work in achieving these results, including achieving our previously provided 2025 revenue guidance range one year ahead of expectations.

"We are extremely pleased with the progress we made across our initiatives in 2024 in the areas of our core growth drivers, including a 17% increase in our dermatologic test reports (DecisionDx-Melanoma and DecisionDx-SCC combined) and a 130% increase in our TissueCypher Barrett’s Esophagus test reports, over 2023. We believe this was driven largely by the clinical value of our tests, strong execution on our commercial strategy and expansion of our clinical evidence base.

"Building on our momentum and successes, we expect to continue to focus on delivering operational excellence. Further, sound capital allocation remains a priority, including pursuing strategic opportunities, aimed at driving stockholder value in 2025 and beyond."

Twelve Months Ended December 31, 2024, Financial and Operational Highlights
•Revenues were $332.1 million, a 51% increase compared to $219.8 million in 2023.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $333.8 million, a 49% increase compared to $224.3 million in 2023.
•Delivered 96,071 total test reports in 2024, an increase of 36% compared to 70,429 in 2023:
◦DecisionDx-Melanoma test reports delivered in 2024 were 36,008, compared to 33,330 in 2023.
◦DecisionDx-SCC test reports delivered in 2024 were 16,348, compared to 11,442 in 2023.
◦MyPath Melanoma test reports delivered in 2024 were 3,909, compared to 3,962 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in 2023.
◦TissueCypher Barrett’s Esophagus test reports delivered in 2024 were 20,956, compared to 9,100 in 2023.
◦IDgenetix test reports delivered in 2024 were 17,151, compared to 10,921 in 2023.
◦DecisionDx-UM test reports delivered in 2024 were 1,699, compared to 1,674 in 2023.
•Gross margin for 2024 was 79%, and Adjusted Gross Margin was 82%, compared to 75% and 80% respectively for the same periods in 2023.
•Net cash provided by operations was $64.9 million, compared to net cash used in operations of $5.6 million in 2023.

•Net income for 2024, which includes non-cash stock-based compensation expense of $50.3 million, was $18.2 million, compared to a net loss of $57.5 million in 2023.
•Adjusted EBITDA for 2024 was $75.0 million, compared to $(4.4) million in 2023.
Cash, Cash Equivalents and Marketable Investment Securities
As of December 31, 2024, the Company’s cash, cash equivalents and marketable investment securities totaled $293.1 million.
Fourth Quarter Ended December 31, 2024, Financial and Operational Highlights
•Revenues were $86.3 million, a 31% increase compared to $66.1 million during the same period in 2023.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $85.8 million, a 22% increase compared to $70.2 million for the same period in 2023.
•Delivered 24,071 total test reports, an increase of 19% compared to 20,284 in the same period of 2023:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,672, compared to 8,591 in the fourth quarter of 2023.
◦DecisionDx-SCC test reports delivered in the quarter were 4,299, compared to 3,530 in the fourth quarter of 2023.
◦MyPath Melanoma test reports delivered in the quarter were 879, compared to 1,018 in the fourth quarter of 2023.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 6,672, compared to 3,441 in the fourth quarter of 2023.
◦IDgenetix test reports delivered in the quarter were 3,125, compared to 3,299 in the fourth quarter of 2023. In late 2024, the Company made modifications to its promotional investments for IDgenetix, shifting resources to inside sales and non-personal promotion.
◦DecisionDx-UM test reports delivered in the quarter were 424, compared to 405 in the fourth quarter of 2023.
•Gross margin was 76%, and Adjusted Gross Margin was 81%, compared to 78% and 82% respectively for the same periods in 2023.
•Net cash provided by operations was $24.4 million, compared to $18.6 million for the same period in 2023.
•Net income, which includes non-cash stock-based compensation expense of $11.4 million, was $9.6 million, compared to a net loss of $2.6 million for the same period in 2023.
•Adjusted EBITDA was $21.3 million, compared to $9.4 million for the same period in 2023.
2025 Outlook
The Company anticipates generating between $280-295 million in total revenue in 2025.
Fourth Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: Findings from a prospective, multicenter study demonstrating the significant impact of the DecisionDx-Melanoma test on sentinel lymph node biopsy (SLNB) decision-making for patients with melanoma were recently published in the World Journal of Surgical Oncology; further; no patient with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to have an SLNB procedure had a positive node.
•DecisionDx-Melanoma: The Company announced the publication of a new independent meta-analysis in Cancers assessing the efficacy of its DecisionDx-Melanoma test in predicting melanoma patient outcomes. The article, titled "The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis," concluded that DecisionDx-Melanoma consistently provides improved risk stratification over staging alone to inform personalized management strategies for patients with cutaneous melanoma (CM). This recently published meta-analysis encompassed 13 peer-reviewed publications involving thousands of patients and affirmed the powerful risk stratification provided by DecisionDx-Melanoma and its potential to significantly improve care for patients with CM. See the Company’s news release from Dec. 12, 2024, for more information.

•DecisionDx-Melanoma: The Company announced the latest data from a prospective, multicenter study exploring the impact of integrating DecisionDx-Melanoma test results into SLNB decision-making for patients recently diagnosed with melanoma. The updated findings demonstrated the power of the test’s results to accurately identify patients with a low risk of metastasis who can safely forgo SLNB, thereby reducing unnecessary SLNB procedures and the associated costs and risks of complications that accompany them. The data was presented in a poster and oral presentation at The European Congress on Dermato-Oncology (Dermato-Onco2024) recently held in Vienna, Austria. See the Company’s news release from Nov. 6, 2024, for more information.
•DecisionDx-SCC: The Company announced that its poster on DecisionDx-SCC was selected as a "Late Breakers" top five finalist for the Akamai Award, recognizing the best posters at Maui Derm Hawaii 2025. Specifically, the poster shared new data from a study involving Castle’s largest cohort of patients with cutaneous squamous cell carcinoma (SCC) to date (n=1,408). This study demonstrated improved risk stratification of patients with SCC tumors located on the head or neck when the test’s results are combined with Brigham and Women’s Hospital (BWH) staging. See the Company’s news release from Jan. 17, 2025, for more information.
Gastroenterology
•The Company announced that it received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett’s Esophagus (BE) test. With this approval, all of the tests in Castle’s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh, are now approved by the state of New York. See the Company’s news release from Jan. 6, 2025, for more information.
Corporate
•The Company announced that it was named a Houston Top Workplace for 2024 by the Houston Chronicle. This was the fourth consecutive year the Company was ranked among the Houston metro area’s top workplaces. Castle also earned three Culture Excellence awards in the areas of Employee Appreciation, Employee Well-Being and Professional Development. See the Company’s news release from Nov. 19, 2024, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, Feb. 27, 2025, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2024 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 20, 2025.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 944585.

There will be a brief Question & Answer session following management commentary.

On February 27, 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 fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Cardiff Oncology, FEB 27, 2025, View Source [SID1234650690]).

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"2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We were excited to report that patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm. In the experimental arm, we observed a dose response relationship with the 30mg dose of onvansertib demonstrating increased ORR and deeper tumor regression compared to the 20mg dose of onvansertib with similar safety profiles for both doses. We believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as validation that onvansertib is a biologically active drug for the treatment of cancer, which we believe may translate to additional oncology indications in our pipeline. In addition to the robust efficacy signal in the CRDF-004 trial, these data suggest that onvansertib could safely be combined with both standard of care first-line chemotherapy options for mCRC in the U.S. With our balance sheet strengthened by a $40M investment from biotech specialist investors, we now look forward to sharing additional clinical updates from CRDF-004 in H1 2025."

Upcoming expected milestones

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Additional clinical data from CRDF-004 trial expected in 1H 2025

Company highlights for the quarter ended December 31, 2024, and subsequent weeks include:

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Announced positive initial data from ongoing first-line RAS-mutated mCRC clinical trial (CRDF-004)
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Phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to standard-of-care (SoC) consisting of FOLFIRI plus bevacizumab ("bev") or FOLFOX plus bev. Patients will be randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
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Patients on the 30mg onvansertib dose arm demonstrated 64% objective response rate (ORR) versus 33% ORR in the control arm.
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The 30mg dose of onvansertib demonstrated a higher ORR and deeper tumor regression compared to the 20mg dose of onvansertib (64% vs. 50%)
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Onvansertib was well tolerated at both doses.

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Raised $40 million in an oversubscribed underwritten registered direct offering
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The financing included participation from new and existing healthcare dedicated investors.
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Patent issuance from the United States Patent and Trademark Office (USPTO)
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U.S. patent No. 12,144,813 has an expected expiration date of no earlier than 2043. The patent claims cover the method of using onvansertib in combination with bev for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev ("bev naïve"). This patent is supported by the unexpected benefits of the treatment in such bev naïve patients.
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Presented two posters at the San Antonio Breast Cancer Symposium
▪
Onvansertib demonstrated synergy in combination with paclitaxel in hormone receptor positive (HR+) breast cancer cell lines and robust antitumor activity in patient-derived xenograft (PDX) models resistant to first-line therapies. These data support that onvansertib in combination with paclitaxel represents a promising therapeutic strategy for HR+ breast cancer patients after progression on endocrine therapy and CDK4/6 inhibitors. A phase 1b/2 clinical trial is ongoing to evaluate the safety and efficacy of onvansertib in combination with paclitaxel in advanced triple negative breast cancer (NCT05383196).
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Onvansertib in combination with trastuzumab deruxtecan (T-DXd) was well tolerated, overcame T-DXd resistance, and displayed enhanced anti-tumor activity compared to monotherapies in drug resistant HR+ breast cancer patient derived xenograft (PDX) models. The combination of T-DXd with onvansertib represents a promising therapeutic strategy for HR+ breast cancer patients resistant to first-line therapies.
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Published clinical data of the combination of onvansertib with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
▪
Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and exhibited clinical activity in the second-line setting.
▪
A post hoc analysis revealed a greater clinical benefit in bev naïve patients, who demonstrated an ORR of 77% and mPFS of 14.9 months compared to an ORR of 10% and mPFS of 6.6 months in those previously exposed to bev.

Full Year 2024 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2024 was approximately $37.7 million, an increase of approximately $6.8 million from $30.9 million for the same period in 2023.

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 $49.3 million for the full year ended December 31, 2024, an increase of $3.4 million from $45.9 million for the same period in 2023. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast today at 4:30 p.m. ET/1:30 p.m. PT. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website following the completion of the call.