Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics (UNCY) reported Q3 2024 financial results and business updates. Key highlights include FDA acceptance of the New Drug Application for oxylanthanum carbonate (OLC) with a PDUFA date of June 28, 2025, and successful completion of UNI-494 Phase 1 trial. Q3 financial results showed R&D expenses of $3.0M (down from $3.4M in Q3 2023), G&A expenses of $3.2M (up from $2.6M), and a net loss of $4.1M (improved from $4.4M). Cash position stands at $32.3M, sufficient to fund operations into 2026.
Unicycive Therapeutics (UNCY) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. I punti salienti includono l'accettazione da parte della FDA della Nuova Domanda di Farmaco per ossilantanico di carbonato (OLC) con una data PDUFA fissata per il 28 giugno 2025, e il completamento con successo della fase 1 della sperimentazione UNI-494. I risultati finanziari del terzo trimestre mostrano spese per R&S pari a $3.0 milioni (in calo rispetto ai $3.4 milioni del terzo trimestre 2023), spese generali e amministrative di $3.2 milioni (in aumento rispetto ai $2.6 milioni), e una perdita netta di $4.1 milioni (migliorata rispetto ai $4.4 milioni). La posizione di cassa è di $32.3 milioni, sufficiente a finanziare le operazioni fino al 2026.
Unicycive Therapeutics (UNCY) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones de negocios. Los aspectos más destacados incluyen la aceptación por parte de la FDA de la Solicitud de Nuevo Drug para carbonato de oxilantano (OLC) con una fecha PDUFA del 28 de junio de 2025, y la exitosa finalización del ensayo de fase 1 UNI-494. Los resultados financieros del tercer trimestre mostraron gastos de I+D de $3.0 millones (a la baja desde $3.4 millones en el tercer trimestre de 2023), gastos generales y administrativos de $3.2 millones (en aumento desde $2.6 millones), y una pérdida neta de $4.1 millones (mejorada desde $4.4 millones). La posición de caja se sitúa en $32.3 millones, suficiente para financiar operaciones hasta 2026.
유니사이브 테라퓨틱스 (UNCY)는 2024년 3분기 재무 성과 및 사업 업데이트를 보고했습니다. 주요 사항으로는 옥실란타늄 탄산염 (OLC)에 대한 새로운 약물 신청이 FDA에 수락되었고, PDUFA 날짜는 2025년 6월 28일로 설정되어 있으며 UNI-494 1상 시험의 성공적인 완료가 포함됩니다. 3분기 재무 결과는 R&D 비용이 $3.0M(2023년 3분기에서 $3.4M 감소), G&A 비용이 $3.2M(2023년 3분기에서 $2.6M 증가), 순손실이 $4.1M(2023년 3분기에서 $4.4M 개선)으로 나타났습니다. 현금 잔고는 $32.3M으로 2026년까지 운영 자금을 지원할 수 있습니다.
Unicycive Therapeutics (UNCY) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. Les points clés incluent l'acceptation par la FDA de la Demande de Nouveau Médicament pour carbonate d'oxylanthane (OLC) avec une date PDUFA fixée au 28 juin 2025, ainsi que l'achèvement réussi de l'essai de phase 1 UNI-494. Les résultats financiers du troisième trimestre ont montré des dépenses R&D de 3,0 millions de dollars (en baisse par rapport à 3,4 millions de dollars au troisième trimestre 2023), des dépenses générales et administratives de 3,2 millions de dollars (en hausse par rapport à 2,6 millions de dollars), et une perte nette de 4,1 millions de dollars (une amélioration par rapport à 4,4 millions de dollars). La position de trésorerie s'élève à 32,3 millions de dollars, suffisante pour financer les opérations jusqu'en 2026.
Unicycive Therapeutics (UNCY) berichtete über die finanziellen Ergebnisse und Geschäftsinformationen für das dritte Quartal 2024. Zu den wichtigsten Punkten gehört die Genehmigung der FDA für die Neue Arzneimittelanmeldung für Oxylantanumcarbonat (OLC) mit einem PDUFA-Datum vom 28. Juni 2025 sowie der erfolgreiche Abschluss der Phase-1-Studie UNI-494. Die finanziellen Ergebnisse für das dritte Quartal zeigten F&E-Ausgaben von $3,0 Millionen (ein Rückgang von $3,4 Millionen im dritten Quartal 2023), allgemeine und administrative Ausgaben von $3,2 Millionen (ein Anstieg von $2,6 Millionen) und einen Nettoverlust von $4,1 Millionen (eine Verbesserung von $4,4 Millionen). Die Liquiditätsposition beläuft sich auf $32,3 Millionen, was ausreicht, um die Betriebe bis 2026 zu finanzieren.
- FDA acceptance of OLC New Drug Application with PDUFA date set for June 28, 2025
- Strong patient preference for OLC: 79% preferred it over prior therapy
- Successful completion of UNI-494 Phase 1 trial with positive safety profile
- Patent granted for UNI-494 valid until 2040
- Cash runway extended into 2026 with $32.3M cash position
- Reduced net loss to $4.1M from $4.4M year-over-year
- Increased G&A expenses by 23% to $3.2M compared to Q3 2023
Insights
The Q3 results showcase a mixed financial picture for Unicycive. While R&D expenses decreased to
The company's
The clinical development pipeline shows promising advancement. The successful completion of UNI-494's Phase 1 trial, demonstrating good tolerability up to 160mg single dose and 40mg twice-daily dosing, positions the company well for potential Phase 2 trials in acute kidney injury. The newly granted USPTO patent extending to 2040 strengthens their intellectual property position.
For OLC, the
– OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025–
– Commercial Planning in Progress for 2025 Launch –
– Late Breaker Poster Presentation on OLC at ASN Kidney Week –
– Successful Completion of UNI-494 Phase 1 Trial –
LOS ALTOS, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended September 30, 2024, and provided a business update.
“We are pleased with the tremendous progress we have made over the last several months highlighted by the acceptance of our New Drug Application for oxylanthanum carbonate (OLC) which may result in the potential approval of our first drug in 2025,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “If approved, we believe OLC’s high potency and low pill burden would provide a best-in-class option for patients with chronic kidney disease (CKD) on dialysis who have hyperphosphatemia and face adherence challenges with current treatment regimens. With the NDA acceptance now behind us, we are actively preparing to commercialize OLC with the goal of bringing this innovative new treatment to market in the second half of 2025.”
“We have also made progress on our second asset, UNI-494, as we announced the successful completion of our Phase 1 clinical trial providing the necessary data to potentially advance to Phase 2 clinical development. UNI-494 is targeting acute kidney injury (AKI), a challenging and often under-treated disease. We plan to request a meeting with the FDA by the end of this year to continue advancing our clinical development program for UNI-494,” concluded Dr. Gupta.
Key Highlights
- Announced the acceptance of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
- Announced initial results from the patient reported outcome survey conducted during the UNI-OLC-201 pivotal clinical trial. In the survey, OLC consistently outperformed the other phosphate binders in all categories:
79% of patients preferred OLC compared to18% of patients who preferred their prior therapy;98% of patients said that OLC was easy to take compared to55% for their prior therapy; and89% of patients said they were satisfied with OLC while only49% were satisfied with their prior therapy. - Announced the successful completion of the UNI-494 Phase 1 study in healthy volunteers. The Phase 1 study was a single center, double-blind, placebo-controlled, randomized single ascending dose (Part 1) and multiple ascending dose (Part 2) study in healthy volunteers conducted in the United Kingdom. UNI-494 was well-tolerated as a single dose up to 160 mg and in multiple doses at 40 mg twice-a-day. The absorption of UNI-494 was fast, and UNI-494 was rapidly metabolized to release nicorandil. Collectively, the results will help determine the dose and schedule of UNI-494 in a potential Phase 2 clinical trial in patients with acute kidney injury.
- Granted a patent on UNI-494 to treat AKI by the United States Patent and Trademark Office (USPTO). The patent, valid until 2040, secures protection of a method of treating a disease or a condition (“method of use”) related to AKI or contrast-induced-nephropathy by administering the UNI-494 compound.
- Delivered four presentations on OLC and UNI-494 at the American Society of Nephrology (ASN) Kidney Week 2024 including a late-breaker poster presentation highlighting favorable safety and tolerability data of OLC. The presentation highlighted the positive pivotal clinical trial data demonstrating that OLC was able to achieve serum phosphate control in more than
90% of patients with CKD on dialysis who entered the maintenance phase of the trial. A poster presentation also described the results from the UNI-494 Phase 1 study results, and two preclinical posters were presented. - Two preclinical studies for both OLC and UNI-494 were featured in two publications: “Systemic Absorption of Oxylanthanum Carbonate is Minimal in Preclinical Models” was published in the Pharmaceutical Chemistry Journal; “Evaluation of UNI-494 in Acute Kidney Injury Treatment Efficacy When Administered After Ischemia-Reperfusion in a Rat Model” was published in EC Pharmacology and Toxicology.
- UNCY was added to the Russell Microcap® Index effective July 1, 2024. Membership in the Russell Microcap® Index, which remains in place for one year is accompanied by automatic inclusion in the appropriate growth and value style indexes.
Financial Results for the Quarter Ended September 30, 2024
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
Other Income was
Net loss attributable to common stockholders for the three months ended September 30, 2024 was
As of September 30, 2024, cash and cash equivalents totaled
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
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 Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive'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 candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; 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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
SOURCE: Unicycive Therapeutics, Inc.
Unicycive Therapeutics, Inc. Balance Sheets (In thousands, except for share and per share amounts) | ||||||||||
As of | As of | |||||||||
December 31, | September 30, | |||||||||
2023 | 2024 | |||||||||
Assets | (Unaudited) | |||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 9,701 | $ | 32,347 | ||||||
Prepaid expenses and other current assets | 3,698 | 5,394 | ||||||||
Total current assets | 13,399 | 37,741 | ||||||||
Right of use asset, net | 766 | 772 | ||||||||
Property, plant and equipment, net | 26 | 61 | ||||||||
Total assets | $ | 14,191 | $ | 38,574 | ||||||
Liabilities and stockholders’ (deficit) equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 839 | $ | 548 | ||||||
Accrued liabilities | 3,234 | 2,992 | ||||||||
Warrant liability | 13,134 | 6,377 | ||||||||
Operating lease liability - current | 327 | 542 | ||||||||
Total current liabilities | 17,534 | 10,459 | ||||||||
Operating lease liability – long term | 466 | 265 | ||||||||
Total liabilities | 18,000 | 10,724 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ (deficit) equity: | ||||||||||
Series A-2 Prime preferred stock, | - | - | ||||||||
Series B-2 preferred stock, | - | - | ||||||||
Preferred stock: | - | - | ||||||||
Common stock, | 35 | 98 | ||||||||
Additional paid-in capital | 60,697 | 107,497 | ||||||||
Accumulated deficit | (64,541 | ) | (79,745 | ) | ||||||
Total stockholders’ (deficit) equity | (3,809 | ) | 27,850 | |||||||
Total liabilities and stockholders’ (deficit) equity | $ | 14,191 | $ | 38,574 | ||||||
Unicycive Therapeutics, Inc. Statements of Operations (In thousands, except for share and per share amounts) (Unaudited) | |||||||||
Three Months Ended September 30, | |||||||||
2023 | 2024 | ||||||||
Operating expenses: | |||||||||
Research and development | $ | 3,372 | $ | 3,045 | |||||
General and administrative | 2,566 | 3,206 | |||||||
Total operating expenses | 5,938 | 6,251 | |||||||
Loss from operations | (5,938 | ) | (6,251 | ) | |||||
Other income (expenses): | |||||||||
Interest income | 227 | 416 | |||||||
Interest expense | (18 | ) | (15 | ) | |||||
Change in fair value of warrant liability | 1,396 | 1,754 | |||||||
Total other income (expenses) | 1,605 | 2,155 | |||||||
Net loss | (4,333 | ) | (4,096 | ) | |||||
Deemed dividends to Series A-1 preferred stockholders | (72 | ) | - | ||||||
Net loss attributable to common stockholders | $ | (4,405 | ) | $ | (4,096 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.13 | ) | $ | (0.05 | ) | |||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 32,633,074 | 88,943,212 |
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