Cardiff Oncology Reports Third Quarter 2024 Results and Provides Business Update
Cardiff Oncology (CRDF) reported Q3 2024 results highlighting positive Phase 2 trial results of onvansertib combined with FOLFIRI and bev in second-line KRAS mutant mCRC. The trial showed a 7.7x greater clinical benefit in bev naïve patients. The company expects an initial data readout from first-line RAS-mutated mCRC randomized CRDF-004 trial by end of 2024. Financial highlights include $57.7 million in cash and equivalents, with quarterly cash burn of $10.5 million. Operating expenses increased to $12.8 million, up $1.8 million year-over-year. Current cash runway extends into Q1 2026.
Cardiff Oncology (CRDF) ha riportato i risultati del terzo trimestre 2024, evidenziando risultati positivi della fase 2 della sperimentazione clinica che combina onvansertib con FOLFIRI e bev in caso di mCRC mutante KRAS di seconda linea. La sperimentazione ha mostrato un beneficio clinico 7,7 volte maggiore nei pazienti naïve al bev. L'azienda prevede di ottenere un primo report di dati dal trial randomizzato CRDF-004 sui pazienti di prima linea con mCRC mutato RAS entro la fine del 2024. I risultati finanziari includono 57,7 milioni di dollari in contante e equivalenti, con una combustione di cassa trimestrale di 10,5 milioni di dollari. Le spese operative sono aumentate a 12,8 milioni di dollari, con un incremento di 1,8 milioni di dollari rispetto all'anno precedente. Il runway attuale di cassa si estende fino al primo trimestre del 2026.
Cardiff Oncology (CRDF) reportó los resultados del tercer trimestre de 2024, destacando los resultados positivos de la fase 2 de un ensayo clínico que combina onvansertib con FOLFIRI y bev en casos de mCRC mutante KRAS de segunda línea. El ensayo mostró un beneficio clínico 7.7 veces mayor en pacientes naive a bev. La compañía espera obtener un primer informe de datos del ensayo aleatorizado CRDF-004 en pacientes de primera línea con mCRC mutado RAS para finales de 2024. Los destacados financieros incluyen 57.7 millones de dólares en efectivo y equivalentes, con un consumo de efectivo trimestral de 10.5 millones de dólares. Los gastos operativos aumentaron a 12.8 millones de dólares, un incremento de 1.8 millones de dólares en comparación con el año anterior. La pista de efectivo actual se extiende hasta el primer trimestre de 2026.
카디프 온콜로지 (CRDF)는 2024년 3분기 결과를 보고하며, 2차 KRAS 변이 mCRC에서 FOLFIRI 및 bev와 함께하는 onvansertib의 긍정적인 2상 시험 결과를 강조했습니다. 이 시험에서는 bev에 경험이 없는 환자에서 임상적 이점이 7.7배 더 큰 것으로 나타났습니다. 회사는 2024년 말까지 RAS 변이 mCRC 1차 치료군을 대상으로 한 무작위 CRDF-004 시험의 첫 번째 데이터 결과를 발표할 것으로 예상하고 있습니다. 재무 요약에는 현금 및 현금성 자산이 5,770만 달러 포함되어 있으며, 분기별 현금 소모는 1,050만 달러입니다. 운영비용은 1,280만 달러로 증가했으며, 이는 전년 대비 180만 달러 증가한 수치입니다. 현재 현금 사용 가능 기간은 2026년 1분기까지입니다.
Cardiff Oncology (CRDF) a publié les résultats du troisième trimestre 2024, mettant en avant des résultats positifs d'un essai de phase 2 combinant onvansertib avec FOLFIRI et bev pour des cas de mCRC mutés KRAS en deuxième ligne. L'essai a montré un bénéfice clinique 7,7 fois supérieur chez les patients naïfs au bev. La société s'attend à une première lecture de données de l'essai randomisé CRDF-004 sur les patients en première ligne avec un mCRC muté RAS d'ici la fin de 2024. Les soulignement financiers comprennent 57,7 millions de dollars en liquidités et équivalents, avec une consommation de trésorerie trimestrielle de 10,5 millions de dollars. Les dépenses d'exploitation ont augmenté pour atteindre 12,8 millions de dollars, soit une hausse de 1,8 million de dollars par rapport à l'année précédente. La durée de trésorerie actuelle s'étend jusqu'au premier trimestre 2026.
Cardiff Oncology (CRDF) hat die Ergebnisse des 3. Quartals 2024 veröffentlicht und positive Ergebnisse der Phase-2-Studie zu onvansertib, kombiniert mit FOLFIRI und bev bei mCRC mit KRAS-Mutationen in der zweiten Linie hervorgehoben. Die Studie zeigte einen 7,7-fachen klinischen Vorteil bei bev-naiven Patienten. Das Unternehmen erwartet bis Ende 2024 einen ersten Datenbericht aus der randomisierten CRDF-004-Studie bei Patienten mit RAS-mutiertem mCRC in erster Linie. Die finanziellen Höhepunkte umfassen 57,7 Millionen Dollar in Bargeld und Äquivalenten, mit einem vierteljährlichen Cash-Burn von 10,5 Millionen Dollar. Die Betriebskosten sind auf 12,8 Millionen Dollar gestiegen, eine Erhöhung um 1,8 Millionen Dollar im Vergleich zum Vorjahr. Die aktuelle Cash-Reserve reicht bis ins erste Quartal 2026.
- Published positive Phase 2 trial results showing 77% ORR and 14.9 months mPFS in bev naïve patients
- Strong cash position of $57.7 million providing runway into Q1 2026
- Increased operating expenses by $1.8 million YoY to $12.8 million
- Higher cash burn rate at $10.5 million, up $2.5 million from prior year
Insights
The Phase 2 trial results published in JCO reveal compelling data for onvansertib in KRAS-mutant mCRC. The
The preclinical breast cancer data showing synergy between onvansertib and alpelisib in resistant tumors opens a promising new indication. The dual inhibition of PLK1 and PI3K pathways provides a novel mechanism to potentially overcome resistance in PIK3CA-mutated HR+ breast cancer.
With
- Published positive Phase 2 trial results of onvansertib in combination with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology -
- Initial data readout from first-line RAS-mutated mCRC randomized CRDF-004 trial expected by the end of 2024-
- Projected runway with current cash resources into Q1 2026 -
SAN DIEGO, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results and recent highlights for the third quarter ended September 30, 2024.
“This quarter has been exciting as our Phase 2 clinical trial in second-line KRAS-mutant mCRC was published in one of the most esteemed medical journals in the field of oncology, Journal of Clinical Oncology. Our findings demonstrated that onvansertib combined with FOLFIRI/bev was well-tolerated, and revealed a 7.7x greater clinical benefit in bev naïve patients compared to patients who were previously treated with bev,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “We believe the results of our JCO publication validate our ongoing CRDF-004 trial evaluating onvansertib + chemo for the treatment of mCRC in the first-line setting, where all patients are bev naïve. Furthermore, we are pleased with the progress we have made in the trial as we leverage Pfizer’s resources and capabilities, and are grateful for the commitment from the patients and investigators at our trial sites across the U.S. As of today, the trial continues to generate patient data that will allow us to provide an initial data release by the end of the year. Overall, we are optimistic about onvansertib’s potential to become a meaningful treatment option for the 50,000 new patients diagnosed with RAS-mutated mCRC in the U.S. every year who have not had access to any new treatment options in several decades.”
Upcoming expected milestones
- First-line RAS-mutated metastatic colorectal cancer (mCRC) randomized initial data readout from the CRDF-004 trial expected by end of 2024
Company highlights for the quarter ended September 30, 2024 and subsequent weeks include:
- 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)
- 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 of10% and mPFS of 6.6 months in those previously exposed to bev.
- Published promising preclinical data demonstrating the combination of onvansertib and alpelisib in PIK3CA-mutated HR-positive breast cancer resistant to palbociclib and endocrine therapy in the peer-reviewed journal, Cancers
- The combination of onvansertib and alpelisib synergistically inhibited cell viability, suppressed PI3K signaling, and induced G2/M arrest and apoptosis in PI3K-activated cell lines.
- The combination demonstrated superior anti-tumor activity compared to the single agents in three PDX models.
- Pharmacodynamic studies confirmed inhibition of both PLK1 and PI3K activity and pronounced apoptosis in the combination-treated tumors.
- The findings support that targeting PLK1 and PI3Kα with onvansertib and alpelisib, respectively, may be a promising strategy for patients with PIK3CA-mutant HR+ breast cancer failing ET + CDK4/6i therapies and warrant clinical evaluation.
Third Quarter 2024 Financial Results
Liquidity, cash burn, and cash runway
As of September 30, 2024, Cardiff Oncology had approximately
Net cash used in operating activities for the third quarter of 2024 was approximately
Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2026.
Operating results
Total operating expenses were approximately
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to SoC alone. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of an epidemic or pandemic such as the COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Kiki Patel, PharmD
Gilmartin Group
332-895-3225
Kiki@gilmartinir.com
Media Contact:
Grace Spencer
Taft Communications
609-583-1151
grace@taftcommunications.com
| Cardiff Oncology, Inc. Condensed Statements of Operations (in thousands, except for per share amounts) (unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Royalty revenues | $ | 165 | $ | 141 | $ | 532 | $ | 332 | ||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development | 9,640 | 8,022 | 27,140 | 25,094 | ||||||||||||
| Selling, general and administrative | 3,126 | 2,939 | 9,471 | 10,318 | ||||||||||||
| Total operating expenses | 12,766 | 10,961 | 36,611 | 35,412 | ||||||||||||
| Loss from operations | (12,601 | ) | (10,820 | ) | (36,079 | ) | (35,080 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income, net | 741 | 1,068 | 2,472 | 3,061 | ||||||||||||
| Other income (expense), net | 5 | 21 | (37 | ) | (85 | ) | ||||||||||
| Total other income, net | 746 | 1,089 | 2,435 | 2,976 | ||||||||||||
| Net loss | (11,855 | ) | (9,731 | ) | (33,644 | ) | (32,104 | ) | ||||||||
| Preferred stock dividend | (6 | ) | (6 | ) | (18 | ) | (18 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (11,861 | ) | $ | (9,737 | ) | $ | (33,662 | ) | $ | (32,122 | ) | ||||
| Net loss per common share — basic and diluted | $ | (0.25 | ) | $ | (0.22 | ) | $ | (0.74 | ) | $ | (0.72 | ) | ||||
| Weighted-average shares outstanding — basic and diluted | 46,865 | 44,677 | 45,461 | 44,677 | ||||||||||||
| Cardiff Oncology, Inc. Condensed Balance Sheets (in thousands) (unaudited) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 13,038 | $ | 21,655 | ||||
| Short-term investments | 44,629 | 53,168 | ||||||
| Accounts receivable and unbilled receivable | 618 | 288 | ||||||
| Prepaid expenses and other current assets | 1,047 | 2,301 | ||||||
| Total current assets | 59,332 | 77,412 | ||||||
| Property and equipment, net | 993 | 1,238 | ||||||
| Operating lease right-of-use assets | 1,304 | 1,708 | ||||||
| Other assets | 1,267 | 1,279 | ||||||
| Total Assets | $ | 62,896 | $ | 81,637 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,643 | $ | 1,966 | ||||
| Accrued liabilities | 7,175 | 7,783 | ||||||
| Operating lease liabilities | 707 | 691 | ||||||
| Total current liabilities | 12,525 | 10,440 | ||||||
| Operating lease liabilities, net of current portion | 979 | 1,458 | ||||||
| Total Liabilities | 13,504 | 11,898 | ||||||
| Stockholders’ equity | 49,392 | 69,739 | ||||||
| Total liabilities and stockholders’ equity | $ | 62,896 | $ | 81,637 | ||||
| Cardiff Oncology, Inc. Condensed Statements of Cash Flows (in thousands) (unaudited) | ||||||||
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating activities | ||||||||
| Net loss | $ | (33,644 | ) | $ | (32,104 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 308 | 295 | ||||||
| Stock-based compensation expense | 3,556 | 3,600 | ||||||
| Accretion of discounts on short-term investments, net | (440 | ) | (716 | ) | ||||
| Changes in operating assets and liabilities | 2,794 | 5,177 | ||||||
| Net cash used in operating activities | (27,426 | ) | (23,748 | ) | ||||
| Investing activities | ||||||||
| Capital expenditures | (80 | ) | (574 | ) | ||||
| Net purchases, maturities and sales of short-term investments | 9,297 | 23,208 | ||||||
| Net cash provided by investing activities | 9,217 | 22,634 | ||||||
| Financing activities | ||||||||
| Proceeds from sales of common stock, net of expenses | 9,232 | — | ||||||
| Proceeds from exercise of options | 360 | — | ||||||
| Net cash provided by financing activities | 9,592 | — | ||||||
| Net change in cash and cash equivalents | (8,617 | ) | (1,114 | ) | ||||
| Cash and cash equivalents—Beginning of period | 21,655 | 16,347 | ||||||
| Cash and cash equivalents—End of period | $ | 13,038 | $ | 15,233 | ||||
FAQ
What were the key findings from Cardiff Oncology's (CRDF) Phase 2 trial in KRAS mutant mCRC?
What is Cardiff Oncology's (CRDF) cash position as of Q3 2024?
When will Cardiff Oncology (CRDF) release initial data from the CRDF-004 trial?
