Unicycive Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
- FDA review of OLC progressing with PDUFA date set for June 28, 2025
- Patient survey data validates market demand for OLC's reduced pill burden solution
- Net income of $0.5M in Q1 2025, improved from $21.2M loss in Q1 2024
- R&D expenses decreased significantly from $6.8M to $2.2M YoY
- G&A expenses more than doubled to $5.8M from $2.4M YoY due to launch preparations
- Significant increase in prepaid expenses for manufacturing from $4.8M to $7.6M
- Commercial success depends on pending FDA approval
Insights
Unicycive's Q1 shows reduced R&D spend, increased commercial prep costs, with FDA decision on OLC approaching in June 2025.
Unicycive's financial performance reflects a company in transition from development to commercialization. The $2.2 million R&D expenses represent a significant 68% decrease from the $6.8 million in Q1 2024, indicating the company has largely completed clinical development for its lead candidate OLC. Simultaneously, G&A expenses have more than doubled to $5.8 million from $2.4 million year-over-year, primarily driven by commercial preparation activities for the anticipated OLC launch.
What's particularly noteworthy is the $7.6 million in prepaid expenses and other current assets (up from $4.8 million at year-end), reflecting significant investment in manufacturing commercial supplies ahead of the potential approval. This demonstrates management's confidence in receiving FDA approval by the PDUFA date of June 28, 2025.
The company reported net income of $0.5 million, but this warrants clarification - the profit stems from an $8.6 million accounting gain from decreased warrant liability valuation rather than operational profitability. Without this non-cash accounting adjustment, Unicycive would have posted an operational loss. With $19.8 million in cash, the company appears adequately funded for its immediate commercial launch preparations, but will likely need additional capital for a full-scale commercial rollout if OLC receives approval.
The company's financial strategy demonstrates a calculated shift of resources from R&D to commercialization, with manufacturing preparations already underway. This suggests management anticipates a successful FDA review, though investors should note that launch expenses will likely increase further post-approval.
OLC shows promise in addressing key hyperphosphatemia treatment barriers: pill burden and size, potentially improving patient adherence.
The patient survey data presented by Unicycive provides compelling evidence supporting the clinical need for their oxylanthanum carbonate (OLC) therapy. The survey of 200 dialysis patients conducted with the National Kidney Foundation identified three critical barriers to phosphate binder adherence: excessive pill numbers, large pill sizes, and forgetfulness. These findings align perfectly with OLC's value proposition as a high-potency phosphate binder requiring fewer and smaller pills.
Hyperphosphatemia management remains a significant challenge in dialysis patients, with poor medication adherence being a major contributing factor to suboptimal phosphate control. The current standard phosphate binders often require patients to take 9-12 pills daily, creating a substantial burden that impacts quality of life and treatment effectiveness. OLC's potential to significantly reduce this pill burden addresses a genuine unmet need in kidney care.
Particularly noteworthy are the patient-reported outcomes from the Phase 2 study showing patients preferred OLC over their previous phosphate binders. This patient preference data is crucial, as improved satisfaction correlates strongly with better medication adherence, which ultimately leads to better phosphate control and potentially improved clinical outcomes.
From a clinical perspective, OLC represents a meaningful advance in hyperphosphatemia management. The FDA's acceptance of the NDA and establishment of a PDUFA date suggests the agency recognizes the potential clinical value. If approved on June 28, OLC could significantly improve the treatment paradigm for hyperphosphatemia in dialysis patients by addressing the fundamental adherence challenges that have plagued existing therapies.
- Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in chronic kidney disease patients on dialysis under review by FDA with PDUFA target action date of June 28, 2025; ongoing commercial planning in preparation for anticipated commercial launch in late 2025
- New data from patient surveys and patient-reported outcomes studies highlight adherence challenges for patients with hyperphosphatemia on dialysis and emphasize the market potential of OLC
LOS ALTOS, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2025, and provided a business update.
“We are making incredible strides as we prepare for the potential FDA approval of oxylanthanum carbonate (OLC) so we can bring this treatment to people with chronic kidney disease (CKD) on dialysis as efficiently as possible,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The need for our differentiated treatment, which offers high potency and a significantly reduced pill burden for people struggling to control hyperphosphatemia, has been further validated by new patient survey findings and patient-reported outcomes data. We remain dedicated to bolstering our commercial infrastructure as we strive to deliver a much-needed solution to patients and healthcare providers.”
Key Highlights & Upcoming Milestones
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for OLC. Unicycive continues to prepare for the potential launch of OLC by building key functions, engaging directly with prescribers and other stakeholders, and supporting market access.
- Expanded awareness of OLC and its potential to address significant needs for CKD patients by publishing data and presentations at medical meetings.
- Recently, findings were presented at the National Kidney Foundation (NKF) Spring Clinical Meetings and the 2025 American Nephrology Nurses Association (ANNA) National Symposium from a patient survey conducted in partnership with the NKF. The survey included a total of 200 dialysis patients who identified excessive pill numbers, large pill sizes, and forgetfulness as the primary barriers to phosphate binder adherence. Patients also expressed a strong preference for medication regimens with fewer and smaller pills.
- New patient-reported outcomes data from the pivotal Phase 2 study of OLC were presented at the 2025 American Dialysis Conference (ADC) and the NKF Spring Clinical Meeting, which demonstrated that patients preferred OLC in comparison to their pre-trial phosphate binder medications and significantly enhanced patient satisfaction.
Financial Results for the Quarter Ended March 31, 2025
Research and Development (R&D) expenses were
General and Administrative (G&A) expenses were
In addition to the above launch expenses, we continue to focus on the manufacturing of commercial supplies, as reflected in prepaid expenses and other current assets on our balance sheet which increased from
Other income was
Net income attributable to common stockholders for the three months ended March 31, 2025, was
As of March 31, 2025, cash and cash equivalents totaled
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.
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; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. 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, 2024, 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 Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Media Contact:
Rachel Visi
Real Chemistry
redery@realchemistry.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, | March 31, | |||||||
| 2024 | 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 26,142 | $ | 19,769 | ||||
| Prepaid expenses and other current assets | 4,806 | 7,577 | ||||||
| Total current assets | 30,948 | 27,346 | ||||||
| Right of use asset, net | 645 | 518 | ||||||
| Property, plant and equipment, net | 75 | 83 | ||||||
| Total assets | $ | 31,668 | $ | 27,947 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,058 | $ | 1,397 | ||||
| Accrued liabilities | 3,562 | 4,143 | ||||||
| Warrant liability | 18,936 | 10,588 | ||||||
| Operating lease liability - current | 564 | 548 | ||||||
| Total current liabilities | 24,120 | 16,676 | ||||||
| Operating lease liability - long term | 117 | - | ||||||
| Total liabilities | 24,237 | 16,676 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Series A-2 Prime preferred stock, | - | - | ||||||
| Series B-2 preferred stock, | - | - | ||||||
| Preferred stock: | - | - | ||||||
| Common stock, | 114 | 120 | ||||||
| Additional paid-in capital | 108,587 | 111,851 | ||||||
| Accumulated deficit | (101,270 | ) | (100,700 | ) | ||||
| Total stockholders’ equity | 7,431 | 11,271 | ||||||
| Total liabilities and stockholders’ equity | $ | 31,668 | $ | 27,947 | ||||
| Unicycive Therapeutics, Inc. | ||||||||
| Statements of Operations | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2025 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 6,813 | $ | 2,171 | ||||
| General and administrative | 2,391 | 5,818 | ||||||
| Total operating expenses | 9,204 | 7,989 | ||||||
| Loss from operations | (9,204 | ) | (7,989 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 69 | 226 | ||||||
| Interest expense | (20 | ) | (15 | ) | ||||
| Change in fair value of warrant liability | (11,808 | ) | 8,348 | |||||
| Total other income (expenses) | (11,759 | ) | 8,559 | |||||
| Net (loss) income | (20,963 | ) | 570 | |||||
| Net (loss) income attributable to common stockholders, basic | (21,171 | ) | 510 | |||||
| Net loss attributable to common stockholders, diluted | (21,171 | ) | (6,214 | ) | ||||
| Net (loss) income per share: | ||||||||
| Basic | $ | (0.61 | ) | $ | - | |||
| Diluted | $ | (0.61 | ) | $ | (0.05 | ) | ||
| Weighted-average shares outstanding: | ||||||||
| Basic | 34,912,692 | 116,818,811 | ||||||
| Diluted | 34,912,692 | 123,834,773 | ||||||
FAQ
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