Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update
- None.
- Net loss increased due to change in fair value of warrant liability.
- Licensing revenues decreased from 2022.
- Increase in R&D and G&A expenses.
- Cash position at $9.7 million as of December 31, 2023.
The recent update from Unicycive Therapeutics, Inc. regarding its clinical trials and financial results presents a multifaceted picture for stakeholders. The completion of enrollment for the OLC clinical trial marks a significant milestone in the drug's development pathway. If OLC shows positive results for treating hyperphosphatemia in CKD patients on dialysis, it could address a substantial unmet medical need. Given the proprietary nature of the nanoparticle technology, if approved, OLC could potentially capture a sizeable market share within the phosphate binder market, which is projected to grow in the coming years.
The designation of UNI-494 as an orphan drug for preventing DGF post-kidney transplantation is another positive development. Orphan drug status not only provides tax advantages and fee waivers but also market exclusivity, which could significantly enhance Unicycive's competitive positioning. However, it is important to note that the path from orphan drug designation to market approval is fraught with clinical and regulatory challenges and the market exclusivity is contingent upon eventual FDA approval.
From a financial perspective, the increase in R&D expenses reflects ongoing investment in their pipeline, which is expected for a clinical-stage biotech firm. The private placement leading to $50 million in gross proceeds boosts the company's cash runway, which is important for sustaining operations during the capital-intensive drug development phase. However, investors should monitor the burn rate and subsequent funding needs, as biotech firms often require substantial capital infusions before reaching profitability.
Unicycive's financial results indicate a net loss increase year-over-year, which is not uncommon in the biotech industry where upfront investments are substantial and returns may not be realized for several years. The reported increase in net loss is primarily due to the change in fair value of the company's warrant liability, which is a non-cash item and can be volatile. This accounting measure does not directly affect the company's cash flow, but it does impact the reported earnings and could influence investor perception.
The cash position, bolstered by a recent private placement, is a critical factor for Unicycive. The reported $9.7 million in cash and cash equivalents at the end of 2023, supplemented by an additional $50 million from the private placement, is a strong indicator that the company can sustain its current development plans without immediate financial distress. This extended cash runway into 2026 provides a cushion for the company to complete its ongoing trials and pursue FDA approval processes.
Investors should consider the potential dilutive effects of the private placement on existing shares. Additionally, licensing revenue fluctuations, though relatively minor in the context of the company's overall financials, should be tracked as they can provide insights into the company's ability to monetize its intellectual property through partnerships.
The pharmaceutical industry, particularly in the area of chronic diseases like CKD, is highly competitive and subject to rapid advancements. Unicycive's focus on kidney disease treatments places it in a niche yet growing market. The global burden of CKD and the associated complications like hyperphosphatemia are on the rise, indicating a growing market for effective treatments. OLC's potential as a next-generation treatment could position Unicycive favorably in the market if clinical outcomes are positive and the FDA approval is secured.
UNI-494's progress in clinical trials and its orphan drug status for DGF prevention is a strategic advantage. However, it is important to assess the size of the addressable market and the competitive landscape, as these factors will ultimately determine the commercial potential of the drug. Orphan drugs often command premium pricing due to their specialized nature, but the actual market impact will depend on the drug's efficacy, safety profile and the company's marketing strategy post-approval.
Investors should also be aware of the broader industry trends, such as regulatory changes or shifts in healthcare policy, which could affect the market dynamics for CKD treatments. As the company progresses towards potential commercialization, understanding payer dynamics and reimbursement scenarios will be essential for evaluating the long-term revenue potential of Unicycive's product candidates.
– Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 –
– UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury –
– UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete –
LOS ALTOS, Calif., March 28, 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 year ended December 31, 2023, and provided a business update.
“The last several months have been extremely productive for Unicycive as we advanced both of our clinical development programs and secured new funding from several leading healthcare institutional investors,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The completion of enrollment in our pivotal OLC clinical trial was a critical achievement as we believe the novel characteristics of oxylanthanum carbonate (OLC) will show its potential as a best-in-class product to treat hyperphosphatemia for patients with chronic kidney disease (CKD) on dialysis. Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), and we remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter.”
Dr. Gupta added, “We also made meaningful progress with our second clinical development program, UNI-494, targeting prevention of delayed graft function (DGF) and other conditions related to acute kidney injury. Earlier this month, UNI-494 was granted orphan drug designation by the FDA for the prevention of DGF after kidney transplantation, and we presented new data showing statistically significant results for UNI-494 in a preclinical model of DGF. We successfully completed the single ascending dose (SAD) portion of our Phase 1 clinical trial, and the multiple ascending dose (MAD) portion of the study is currently ongoing. We expect to complete the Phase 1 trial and report the full results in the second half of this year.”
“As we close out National Kidney Awareness Month, we remain inspired to continue our research and development efforts to provide improved therapies for individuals living with kidney disease,” concluded Dr. Gupta.
Key Highlights
- Completed enrollment in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC, a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with CKD on dialysis.
- Completed a private placement with new and existing healthcare institutional investors that generated
$50 million in gross proceeds to Unicycive. - Granted orphan drug designation (ODD) by the FDA to UNI-494 for the prevention of DGF in kidney transplant patients. ODD may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
- Presented new data demonstrating statistically significant results for UNI-494 in a preclinical model of DGF at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The data provides additional evidence that UNI-494 may be a valuable asset for prevention of DGF and other conditions related to acute kidney injury.
- Successfully completed the single ascending dose (SAD) portion of the Company’s ongoing Phase 1 clinical trial in UNI-494. UNI-494 was well-tolerated up to 160 mg administered as a single dose and was chosen as the go-forward dose based on promising safety, tolerability, and pharmacokinetic data. In the multiple ascending dose (MAD) portion of the study, 80 mg is now being administered twice-a-day to trial participants.
- Announced that two posters related to OLC will be presented at the National Kidney Foundation Spring Clinical Meeting taking place May 14-18, 2024, in Long Beach, California.
- Announced that multiple presentations will be delivered on OLC and UNI-494 at the 61st European Renal Association (ERA) Congress taking place May 23-26, 2024, in Stockholm, Sweden.
Financial Results for the Year Ended December 31, 2023
Licensing Revenues: Licensing revenues for the year ended December 31, 2023 were
Research and Development (R&D) Expenses: R&D expenses for the full year were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income (Expenses): Other income (expenses) increased
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2023 was
Cash Position: As of December 31, 2023, 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.
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, | December 31, | |||||||
| 2022 | 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 455 | $ | 9,701 | ||||
| Prepaid expenses and other current assets | 2,189 | 3,698 | ||||||
| Total current assets | 2,644 | 13,399 | ||||||
| Right of use asset, net | 152 | 766 | ||||||
| Property, plant and equipment, net | 22 | 26 | ||||||
| Total assets | $ | 2,818 | $ | 14,191 | ||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 892 | $ | 839 | ||||
| Accrued liabilities | 2,237 | 3,234 | ||||||
| Warrant liability | - | 13,134 | ||||||
| Operating lease liability - current | 155 | 327 | ||||||
| Total current liabilities | 3,284 | 17,534 | ||||||
| Operating lease liability - long term | - | 466 | ||||||
| Total liabilities | 3,284 | 18,000 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ deficit: | ||||||||
| Series A-2 preferred stock, | - | - | ||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 15 | 35 | ||||||
| Additional paid-in capital | 33,516 | 60,697 | ||||||
| Accumulated deficit | (33,997 | ) | (64,541 | ) | ||||
| Total stockholders’ deficit | (466 | ) | (3,809 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 2,818 | $ | 14,191 | ||||
| Unicycive Therapeutics, Inc. | ||||||||
| Statements of Operations | ||||||||
| (in thousands, except for share and per share amounts) | ||||||||
| Year Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2022 | 2023 | |||||||
| Licensing revenues: | $ | 951 | $ | 675 | ||||
| Operating expenses: | ||||||||
| Research and development | 12,436 | 12,902 | ||||||
| General and administrative | 6,567 | 8,547 | ||||||
| Total operating expenses | 19,003 | 21,449 | ||||||
| Loss from operations | (18,052 | ) | (20,774 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | - | 615 | ||||||
| Interest expense | (6 | ) | (82 | ) | ||||
| Change in fair value of warrant liability | - | (10,303 | ) | |||||
| Total other income (expenses) | (6 | ) | (9,770 | ) | ||||
| Net loss | (18,058 | ) | (30,544 | ) | ||||
| Deemed dividend to Series A-1 preferred stockholders | - | (867 | ) | |||||
| Net loss attributable to common stockholders | $ | (18,058 | ) | $ | (31,411 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.20 | ) | $ | (1.28 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 15,057,049 | 24,539,309 | ||||||
FAQ
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