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Unicycive Announces Third Quarter 2024 Financial Results and Provides Business Update

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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.

Positive
  • 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
Negative
  • 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 $3.0M from $3.4M year-over-year, G&A costs increased to $3.2M from $2.6M. The net loss improved slightly to $4.1M from $4.4M, primarily due to warrant liability adjustments.

The company's $32.3M cash position, projected to fund operations into 2026, provides adequate runway for their upcoming OLC commercialization plans. The FDA acceptance of OLC's NDA with a PDUFA date of June 2025 represents a significant milestone, potentially transforming UNCY from a clinical-stage to commercial-stage company. The positive patient preference data (with 79% preferring OLC over current treatments) suggests strong market potential if approved.

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 90% serum phosphate control achievement in maintenance phase patients is clinically significant. The combination of high efficacy and reported superior patient satisfaction metrics (including 98% ease-of-use rating) could drive strong market adoption in the hyperphosphatemia space, where treatment adherence remains a critical challenge.

– 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 to 18% of patients who preferred their prior therapy; 98% of patients said that OLC was easy to take compared to 55% for their prior therapy; and 89% of patients said they were satisfied with OLC while only 49% 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 $3.0 million for the three months ended September 30, 2024, compared to $3.4 million for the three months ended September 30, 2023. The decrease in research and development expenses was primarily due to decreased drug development costs.

General and Administrative (G&A) expenses were $3.2 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023. The increase was primarily due to increased non-cash stock compensation expense.

Other Income was $2.2 million for the three months ended September 30, 2024 compared to $1.6 million in the three months ended September 30, 2023, due primarily to a decrease in the fair value of our warrant liability.

Net loss attributable to common stockholders for the three months ended September 30, 2024 was $4.1 million, compared to a net loss attributable to common stockholders of $4.4 million, for the three months ended September 30, 2023. The decreased net loss for the three-month period ended September 30, 2024 was attributable to a decrease in the fair value of our warrant liability.

As of September 30, 2024, cash and cash equivalents totaled $32.3 million. The Company believes that it has sufficient resources to fund planned operations into 2026.

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, $0.001 par value per share – 43,649 Series A-2 shares authorized at December 31, 2023 and 21,388.01 Series A-2 Prime shares authorized at September 30, 2024; 43,649 Series A-2 shares outstanding at December 31, 2023 and 11,111.24 Series A-2 Prime shares outstanding at September 30, 2024  -    -  
Series B-2 preferred stock, $0.001 par value per share – zero Series B-2 shares authorized at December 31, 2023 and 7,882 Series B-2 Prime shares authorized at September 30, 2024; zero Series B-2 shares outstanding at December 31, 2023 and 7,882 Series B-2 shares outstanding at September 30, 2024  -    -  
Preferred stock: $0.001 par value per share—10,000,000 shares authorized at December 31, 2023 and September 30, 2024; zero shares issued and outstanding at December 31, 2023 and September 30, 2024  -    -  
Common stock, $0.001 par value per share – 200,000,000 shares authorized at December 31, 2023 and 400,000,000 shares authorized at September 30, 2024; 34,756,049 and 97,858,406 shares issued and outstanding at December 31, 2023 and September 30, 2024, respectively  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 

FAQ

When is the PDUFA date for Unicycive's (UNCY) OLC drug?

The FDA set a PDUFA Target Action Date of June 28, 2025, for Unicycive's OLC drug application.

What were Unicycive's (UNCY) Q3 2024 financial results?

Unicycive reported R&D expenses of $3.0M, G&A expenses of $3.2M, and a net loss of $4.1M for Q3 2024.

How much cash does Unicycive (UNCY) have as of Q3 2024?

Unicycive reported $32.3M in cash and cash equivalents as of September 30, 2024.

What were the patient preference results for Unicycive's (UNCY) OLC drug?

79% of patients preferred OLC compared to 18% preferring prior therapy, with 98% finding OLC easy to take.

Unicycive Therapeutics, Inc.

NASDAQ:UNCY

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55.04M
94.36M
6.73%
38.13%
1.11%
Biotechnology
Pharmaceutical Preparations
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United States of America
LOS ALTOS