Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics (UNCY) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. On track to submit OLC New Drug Application (NDA) by end of August 2024.
2. Positive topline data from OLC pivotal trial, with 90% of patients achieving phosphate control.
3. Completed enrollment in UNI-494 Phase 1 study, results expected in Q3 2024.
4. Granted new patent for UNI-494 to treat acute kidney injury (AKI).
5. Q2 2024 financial results: R&D expenses $4.9M, G&A expenses $2.5M, net income $3.0M (EPS $0.08 basic, -$0.15 diluted).
6. Cash position of $41.8M, sufficient to fund operations into 2026.
Unicycive Therapeutics (UNCY) ha riportato i risultati finanziari del secondo trimestre del 2024 e ha fornito un aggiornamento aziendale. I punti salienti includono:
1. Sulla buona strada per presentare la Domanda di Nuovo Farmaco OLC (NDA) entro la fine di agosto 2024.
2. Dati positivi dalla sperimentazione clinica decisiva di OLC, con il 90% dei pazienti che ha raggiunto il controllo del fosfato.
3. Completato il reclutamento nello studio di Fase 1 UNI-494, i risultati sono attesi nel terzo trimestre del 2024.
4. Concesso un nuovo brevetto per UNI-494 per il trattamento dell'insufficienza renale acuta (AKI).
5. Risultati finanziari del secondo trimestre del 2024: spese per R&S di 4,9 milioni di dollari, spese generali e amministrative di 2,5 milioni di dollari, reddito netto di 3,0 milioni di dollari (EPS 0,08 base, -0,15 diluito).
6. Posizione di cassa di 41,8 milioni di dollari, sufficiente per finanziare le operazioni fino al 2026.
Unicycive Therapeutics (UNCY) informó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los aspectos clave incluyen:
1. En camino de presentar la Solicitud de Nuevo Medicamento OLC (NDA) para finales de agosto de 2024.
2. Datos positivos del ensayo pivotal de OLC, con el 90% de los pacientes logrando control de fosfatos.
3. Se completó la inscripción en el estudio de Fase 1 UNI-494, se esperan resultados en el tercer trimestre de 2024.
4. Se otorgó una nueva patente para UNI-494 para el tratamiento de la lesión renal aguda (AKI).
5. Resultados financieros del segundo trimestre de 2024: gastos de I+D de 4,9 millones de dólares, gastos generales de 2,5 millones de dólares, ingresos netos de 3,0 millones de dólares (EPS 0,08 básico, -0,15 diluido).
6. Posición de efectivo de 41,8 millones de dólares, suficiente para financiar las operaciones hasta 2026.
유니사이브 테라퓨틱스 (UNCY)가 2024년 2분기 재무 실적을 보고하고 사업 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 2024년 8월 말까지 OLC 신규 약물 신청(NDA)을 제출할 예정입니다.
2. OLC의 중요한 시험에서 긍정적인 톱라인 데이터를 발표했으며, 90%의 환자가 인산 제어에 성공했습니다.
3. UNI-494 1상 연구에 대한 모집을 완료했으며, 결과는 2024년 3분기에 예상됩니다.
4. 급성 신손상(AKI) 치료를 위한 UNI-494의 새로운 특허가 부여되었습니다.
5. 2024년 2분기 재무 결과: R&D비용 490만 달러, 일반관리비용 250만 달러, 순이익 300만 달러(EPS 기본 0.08달러, 희석 0.15달러 적자).
6. 현금 보유액이 4180만 달러로, 2026년까지 운영 자금을 지원하기에 충분합니다.
Unicycive Therapeutics (UNCY) a reporté les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour commerciale. Les faits saillants incluent :
1. Sur la bonne voie pour soumettre la Demande de Nouveau Médicament OLC (NDA) d'ici la fin août 2024.
2. Données positives de l'essai pivot OLC, avec 90 % des patients atteignant un contrôle des phosphates.
3. Inscription terminée dans l'étude de phase 1 UNI-494, les résultats sont attendus au troisième trimestre 2024.
4. Nouveau brevet accordé pour UNI-494 pour traiter la lésion rénale aiguë (AKI).
5. Résultats financiers du deuxième trimestre 2024 : dépenses de R&D de 4,9 millions de dollars, dépenses générales de 2,5 millions de dollars, revenu net de 3,0 millions de dollars (BPA de 0,08 de base, -0,15 dilué).
6. Position de trésorerie de 41,8 millions de dollars, suffisante pour financer les opérations jusqu'en 2026.
Unicycive Therapeutics (UNCY) hat die Finanzergebnisse für das zweite Quartal 2024 gemeldet und ein Unternehmensupdate gegeben. Die wichtigsten Highlights sind:
1. Auf dem Weg, bis Ende August 2024 einen New Drug Application (NDA) für OLC einzureichen.
2. Positive Topline-Daten aus der entscheidenden OLC-Studie, mit 90 % der Patienten, die eine Kontrolle der Phosphatwerte erreicht haben.
3. Rekrutierung in die UNI-494 Phase-1-Studie abgeschlossen, Ergebnisse werden im dritten Quartal 2024 erwartet.
4. Neuer Patentschutz für UNI-494 zur Behandlung von akuter Nierenverletzung (AKI) gewährt.
5. Finanzergebnisse für das zweite Quartal 2024: F&E-Ausgaben von 4,9 Millionen USD, allgemeine Verwaltungsausgaben von 2,5 Millionen USD, Nettoergebnis von 3,0 Millionen USD (EPS 0,08 Basis, -0,15 verwässert).
6. Liquidität von 41,8 Millionen USD, ausreichend zur Finanzierung der Betriebskosten bis 2026.
- Successful completion of OLC pivotal trial with positive safety and efficacy results
- On track for OLC NDA submission by end of August 2024
- 90% of patients achieved phosphate control in OLC trial
- Granted new patent for UNI-494 to treat acute kidney injury
- Inclusion in Russell Microcap® Index
- Strong cash position of $41.8M, funding operations into 2026
- Increased R&D expenses from $2.3M to $4.9M year-over-year
- Increased G&A expenses from $2.1M to $2.5M year-over-year
- Diluted loss per share of $0.15 in Q2 2024
Insights
Unicycive's Q2 2024 results show promising progress but financial caution is warranted. While R&D expenses increased to
The pivotal trial results for OLC are encouraging, particularly the
Unicycive's inclusion in the Russell Microcap® Index could enhance its visibility and liquidity. The company's focus on both chronic and acute kidney conditions positions it well in the growing renal disease market. Patient preference data for OLC suggests potential for market penetration if approved, addressing the unmet need for reduced pill burden in phosphate binders. However, the transition from clinical-stage to commercial organization will be challenging. Investors should watch for partnerships or licensing deals that could support commercialization efforts. The upcoming UNI-494 data will be important in assessing the company's diversification strategy beyond OLC.
– On Track to Submit OLC New Drug Application (NDA) by End of August 2024 –
LOS ALTOS, Calif., Aug. 14, 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 June 30, 2024, and provided a business update.
“Achieving successful results from our oxylanthanum carbonate (OLC) pivotal trial was a significant milestone for the company and brings us one step closer to becoming a commercial organization,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Importantly, the trial confirmed tolerability of OLC in patients with hyperphosphatemia on dialysis which is the final data component needed to support submission of a New Drug Application (NDA) to the FDA utilizing the 505(b)(2) regulatory pathway. In addition, we were able to achieve phosphate control in
“In July 2024 we were granted a new patent for UNI-494 by the USPTO which is an important component of our development strategy to target patients with acute kidney injury (AKI), a serious condition resulting from a sudden loss of kidney function. We have completed enrollment in the UNI-494 Phase 1 dose-ranging study and expect to report results in the third quarter of this year. With assets targeting both chronic and acute kidney conditions, we remain steadfastly focused on improving treatment options and overall quality of life for patients living with renal diseases,” concluded Dr. Gupta.
Key Highlights
- Reported positive topline data from the pivotal clinical trial of OLC with regard to both safety and tolerability endpoints. The study established promising tolerability of OLC at clinically effective doses in chronic kidney disease (CKD) patients on hemodialysis. In terms of tolerability, OLC had a low rate of discontinuation due to adverse events (AEs) with only 5/86 patients (
6% ) discontinuing from the Study. The primary endpoint was defined as the rate of discontinuations due to treatment-related AEs leading to discontinuation in the maintenance period. In the UNI-OLC-201 trial, the discontinuation rate was1.4% , as there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population (n=71). In the full Safety Population (n=86), a total of 3 patients discontinued due to treatment-related AEs, a rate of3.5% . There were no treatment-related serious adverse events (SAEs). - 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 while18% preferred their prior therapy,98% of patients said that OLC was easy to take compared to55% for their prior therapy,89% of patients said they were satisfied with OLC while49% were satisfied with their prior therapy. - Enrollment in the UNI-494 Phase 1 study is complete, and the Company expects to present the data in Q3 2024.
- 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 selected from AKI or contrast induced nephropathy by administering the UNI-494 compound.
- Included in the Russell Microcap® Index effective July 1, 2024. Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes.
- Delivered multiple presentations on OLC and UNI-494 at the 61st European Renal Association (ERA) Congress including two oral presentations and trial-in-progress posters on OLC and UNI-494. An oral presentation demonstrated a significant reduction in urinary phosphate excretion for OLC compared to vehicle treated animals. A second oral presentation evaluated the in vivo efficacy of UNI-494 and showed that a single oral dose of UNI-494 significantly reduced important kidney functional markers.
- Presented two posters related to OLC at the National Kidney Foundation (NKF) Spring Clinical Meeting. Importantly, it was demonstrated that OLC is bioequivalent to lanthanum carbonate from the Phase 1, single-center, randomized 1:1, open-label, controlled, 2-way crossover study. In addition, a poster presentation on the findings of a survey of 100 renal dieticians concluded that strategies that reduce pill burden and increase ease of use for patients are needed. This poster was among the top-rated submissions to the Meeting.
Financial Results for the Quarter Ended June 30, 2024
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
Other Income (Expense) was
Net income attributable to common stockholders for the three months ended June 30, 2024 was
As of June 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. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. 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.
Fosrenol® is a registered trademark of Shire International Licensing BV.
Investor Contact:
ir@unicycive.com
(650) 900-5470
SOURCE: Unicycive Therapeutics, Inc.
--Tables to Follow--
| Unicycive Therapeutics, Inc. Balance Sheets (In thousands, except for share and per share amounts) | ||||||||||
| As of | As of | |||||||||
| December 31, | June 30, | |||||||||
| 2023 | 2024 | |||||||||
| Assets | (Unaudited) | |||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 9,701 | $ | 41,780 | ||||||
| Prepaid expenses and other current assets | 3,698 | 2,274 | ||||||||
| Total current assets | 13,399 | 44,054 | ||||||||
| Right of use asset, net | 766 | 604 | ||||||||
| Property, plant and equipment, net | 26 | 43 | ||||||||
| Total assets | $ | 14,191 | $ | 44,701 | ||||||
| Liabilities, mezzanine equity, and stockholders’ deficit | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable | $ | 839 | $ | 1,472 | ||||||
| Accrued liabilities | 3,234 | 3,122 | ||||||||
| Dividends payable | - | 1 | ||||||||
| Warrant liability | 13,134 | 8,131 | ||||||||
| Operating lease liability - current | 327 | 360 | ||||||||
| Total current liabilities | 17,534 | 13,086 | ||||||||
| Operating lease liability – long term | 466 | 274 | ||||||||
| Total liabilities | 18,000 | 13,360 | ||||||||
| Commitments and contingencies (Note 8) | ||||||||||
| Mezzanine equity: | ||||||||||
| Series B-1 preferred stock, | - | 46,187 | ||||||||
| Stockholders’ deficit: | ||||||||||
| Series A-2 preferred stock, | - | - | ||||||||
| Preferred stock: | - | - | ||||||||
| Common stock, | 35 | 43 | ||||||||
| Additional paid-in capital | 60,697 | 60,760 | ||||||||
| Accumulated deficit | (64,541 | ) | (75,649 | ) | ||||||
| Total stockholders’ deficit | (3,809 | ) | (14,846 | ) | ||||||
| Total liabilities and stockholders’ deficit | $ | 14,191 | $ | 44,701 | ||||||
| Unicycive Therapeutics, Inc. Statements of Operations (In thousands, except for share and per share amounts) (Unaudited) | ||||||||||
| Three Months Ended June 30, | ||||||||||
| 2023 | 2024 | |||||||||
| Operating expenses: | ||||||||||
| Research and development | $ | 2,267 | $ | 4,868 | ||||||
| General and administrative | 2,055 | 2,533 | ||||||||
| Total operating expenses | 4,322 | 7,401 | ||||||||
| Loss from operations | (4,322 | ) | (7,401 | ) | ||||||
| Other income (expenses): | ||||||||||
| Interest income | 234 | 462 | ||||||||
| Interest expense | (32 | ) | (16 | ) | ||||||
| Change in fair value of warrant liability | 282 | 16,810 | ||||||||
| Total other income (expenses) | 484 | 17,256 | ||||||||
| Net income (loss) | (3,838 | ) | 9,855 | |||||||
| Deemed dividend to Series A-1 preferred stockholders | (603 | ) | - | |||||||
| Dividend to Series B-1 preferred stockholders | - | (887 | ) | |||||||
| Net income attributable to participating securities | - | (5,925 | ) | |||||||
| Net income (loss) attributable to common stockholders | $ | (4,441 | ) | $ | 3,043 | |||||
| Net income (loss) per share attributable to common stockholders, basic | $ | (0.29 | ) | $ | 0.08 | |||||
| Net loss per share attributable to common stockholders, diluted | $ | (0.29 | ) | $ | (0.15 | ) | ||||
| Weighted-average shares outstanding used in computing net income (loss) per share, basic | 15,234,570 | 37,914,812 | ||||||||
| Weighted-average shares outstanding used in computing net loss per share, diluted | 15,234,570 | 94,052,853 | ||||||||
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