Overview

Unicycive is a clinical-stage biotechnology company focused on identifying, developing, and commercializing innovative therapies to address significant unmet medical needs, with an initial focus on kidney disease. The company was founded in 2016 with the goal of creating an efficient drug development platform to accelerate the advancement of promising therapies.

Unicycive’s current development programs are focused on two novel therapies:

1. Oxylanthanum Carbonate (OLC): A next-generation phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Hyperphosphatemia is a common and serious complication of chronic kidney disease, affecting an estimated 75% of dialysis patients in the U.S. OLC leverages proprietary nanoparticle technology to address the shortcomings of current phosphate binder therapies.

2. UNI-494: A novel drug candidate in development for the treatment of acute kidney injury (AKI). AKI is a sudden episode of kidney failure or damage that affects more than 2 million U.S. patients annually and has no FDA-approved treatments. If approved, UNI-494 has the potential to be a first-in-class drug for the treatment of AKI.

Unicycive’s business model is to in-license technologies and drugs, then pursue their development, regulatory approval, and commercialization in global markets. The company believes its management team’s expertise and track record give it an advantage in identifying and bringing these assets into the company.

Since its formation, Unicycive has devoted substantial resources to developing its product candidates. The company has incurred significant operating losses to date, with net losses of $30.5 million and $36.7 million for the years ended December 31, 2023 and 2024, respectively. As of December 31, 2024, Unicycive had an accumulated deficit of $101.3 million.

The company has funded its operations primarily through the sale and issuance of common stock, convertible promissory notes, and a loan from its Chief Executive Officer and principal stockholder. Unicycive expects to continue incurring losses in the future and will require additional capital to complete planned clinical trials, pursue product development, and prepare for potential commercialization of its products.

Recent Developments

In July 2024, Unicycive received notice from Nasdaq that the bid price of its common stock had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market. The company was granted an additional 180 calendar days, until July 7, 2025, to regain compliance.

On February 18, 2025, Unicycive issued 1,400,000 shares of common stock upon the conversion of 686.00 shares of the company’s Series A-2 Prime Preferred stock.

Components of Results of Operations

Revenues: Unicycive recognizes revenue from product sales or services rendered when control of the promised goods is transferred to a counterparty. The company may also earn licensing revenue in the future from business development arrangements with third parties.

Research and Development Expenses: Substantially all of Unicycive’s research and development expenses consist of costs incurred in connection with the development of its product candidates, including fees paid to third parties, consulting costs, laboratory supplies, product acquisition and license costs, payroll and personnel-related expenses, and allocated overhead. The company expects research and development expenses to increase substantially as it seeks to initiate additional clinical trials, complete its current programs, and pursue regulatory approval and potential commercialization of its product candidates.

General and Administrative Expenses: General and administrative expenses consist primarily of payroll and personnel expenses, professional fees, and other general operating expenses. Unicycive anticipates that its general and administrative expenses will increase as a result of increased personnel costs, expanded infrastructure, and higher consulting, legal, and accounting services costs associated with being a public company.

Other Expenses: Other expenses consist of the change in fair value of Unicycive’s warrant liability, interest income, and interest expense.

Results of Operations

Comparison of the Years Ended December 31, 2023 and 2024:

Key changes:

• Licensing revenues decreased by $675,000 (100%) due to the absence of a one-time upfront payment in 2023.
• Research and development expenses increased by $7.1 million (55%) primarily due to increased drug development costs and labor costs.
• General and administrative expenses increased by $3.5 million (42%) mainly due to higher consulting, professional services, and other operating costs.
• Other income (expenses) decreased by $5.2 million (53%) primarily due to changes in the fair value of the warrant liability.

Liquidity and Capital Resources

Unicycive has funded its operations primarily through the sale of common stock, convertible notes, and a loan from its CEO and principal stockholder. In July 2021, the company raised approximately $22.3 million in net proceeds from its initial public offering.

In March 2023, Unicycive entered into a $130 million private placement financing agreement, with an initial $30 million upfront. In March 2024, the company raised an additional $50 million through a private placement of Series B Convertible Preferred Stock. In November 2024, Unicycive entered into a $50 million at-the-market public offering sales agreement, of which it has utilized $0.7 million as of December 31, 2024.

Unicycive expects to continue incurring losses in the future and will require substantial additional capital to complete planned clinical trials, pursue product development, and potentially commercialize its products. The company believes it has sufficient resources to continue operations for at least one year after the date the financial statements were available to be issued.

Critical Accounting Policies, Significant Judgments and Use of Estimates

Unicycive’s critical accounting policies include revenue recognition, debt and equity classification, warrant liabilities, research and development, and stock-based compensation. The company also qualifies as an “emerging growth company” under the JOBS Act, allowing it to delay the adoption of certain accounting standards.

In summary, Unicycive is a clinical-stage biotechnology company focused on developing innovative therapies for kidney disease. The company has incurred significant losses to date but has secured financing through various equity and debt transactions to fund its ongoing research and development efforts. Unicycive expects to continue requiring substantial additional capital to advance its product candidates and potentially commercialize them in the future.