Full Press Release Details
Second Quarter 2024 Financial Results and Provides Business Update
On Track to Submit OLC New Drug Application (NDA) by End of August 2024 -
LOS ALTOS, Calif., August
14, 2024 - 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 90% of patients at the end of their titration. Our recent pharmacokinetic analysis of samples from the pivotal study
revealed that the systemic exposure of our drug is minimal and, as expected, the serum lanthanum levels are similar to that seen with
Fosrenol . With this data, we believe that we have completed all the necessary requirements from this pivotal clinical trial to fulfill
the FDA's requests. We remain on track to submit our NDA by the end of August 2024 and we maintain a high degree of confidence in
the potential for OLC to be a best-in-class commercial product, if approved."
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.
for the Quarter Ended June 30, 2024
Research and Development (R&D) expenses were
$4.9 million for the three months ended June 30, 2024, compared to $2.3 million for the three months ended June 30, 2023. The increase
in research and development expenses was primarily due to increased drug development costs.
General and Administrative (G&A) expenses
were $2.5 million for the three months ended June 30, 2024, compared to $2.1 million for the three months ended June 30, 2023. The increase
was primarily due to increased non-cash stock compensation costs.
Other Income (Expense) was $17.3 million for the
three months ended June 30, 2024 compared to $0.5 million in the three months ended June 30, 2023, due primarily to a decrease in the
fair value of our warrant liability.
Net income attributable to common stockholders
for the three months ended June 30, 2024 was $3.0 million, and basic earnings per share was $0.08. On a diluted basis, we reported a loss
per share for the same period of $0.15. The net income for the three-month period ended June 30, 2024 was attributable to a decrease in
the fair value of our warrant liability. For the three months ended June 30, 2023, we reported a net loss of $4.4 million, and basic loss
per share of $0.29. On a diluted basis, we reported a loss per share for the same period of $0.29.
As of June 30, 2024, cash and cash equivalents
totaled $41.8 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. UNI-494
is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. For
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.
SOURCE: Unicycive Therapeutics, Inc.
--Tables to Follow--
Unicycive Therapeutics, Inc.
(In thousands, except for share and per share
| 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, $0.001 par value per share - zero shares authorized at December 31, 2023, and 50,000 shares authorized at June 30, 2024; zero shares outstanding at December 31, 2023, and 50,000 shares outstanding at June 30, 2024 | - | 46,187 | ||||||
| Stockholders' deficit: | ||||||||
| Series A-2 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 June 30, 2024; 43,649 Series A-2 shares outstanding at December 31, 2023 and 17,073.07 Series A-2 Prime shares outstanding at June 30, 2024 | - | - | ||||||
| Preferred stock: $0.001 par value per share-9,926,161 and 9,904,773 shares authorized at December 31, 2023 and June 30, 2024, respectively; zero shares issued and outstanding at December 31, 2023 and June 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 June 30, 2024; 34,756,049 and 43,573,212 shares issued and outstanding at December 31, 2023 and June 30, 2024, respectively | 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
| 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 |