0001213900-24-027373.txt : 20240329 0001213900-24-027373.hdr.sgml : 20240329 20240328173128 ACCESSION NUMBER: 0001213900-24-027373 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240328 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240329 DATE AS OF CHANGE: 20240328 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Unicycive Therapeutics, Inc. CENTRAL INDEX KEY: 0001766140 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 813638692 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40582 FILM NUMBER: 24800679 BUSINESS ADDRESS: STREET 1: 4300 EL CAMINO REAL, SUITE 210 CITY: LOS ALTOS STATE: CA ZIP: 94022 BUSINESS PHONE: 650-384-0642 MAIL ADDRESS: STREET 1: 4300 EL CAMINO REAL, SUITE 210 CITY: LOS ALTOS STATE: CA ZIP: 94022 8-K 1 ea0202810-8k_unicycive.htm CURRENT REPORT
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 28, 2024

 

Unicycive Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40582   81-3638692
(State or other jurisdiction
of in corporation or organization)		   (Commission File Number)   IRS Employer
Identification No.)

 

4300 El Camino Real, Suite 210

Los Alto, CA 94022

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (650) 351-4495

 

(Former name or former address, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class:    Trading Symbol(s)    Name of each exchange on which registered: 
Common Stock   UNCY   Nasdaq Capital Market

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 2.02 Results of Operations and Financial Conditions.

 

On March 28, 2024, Unicycive Therapeutics, Inc. issued a press release announcing its financial results for the year ended December 31, 2023 and provided a business update. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.

 

The information disclosed under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1   Press Release of Unicycive Therapeutics, Inc. dated March 28, 2024.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

1

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: March 28, 2024

 

  UNICYCIVE THERAPEUTICS, INC.
   
  By: /s/ Shalabh Gupta
    Shalabh Gupta
    Chief Executive Officer

 

 

2

 

 EX-99.1 2 ea020281001ex99-1_unicycive.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED MARCH 28, 2024

Exhibit 99.1

 

 

Unicycive Announces Full Year 2023 Financial Results and Provides Business Update

 

– 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 – 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 $0.7 million compared to $1.0 million for the same period in 2022, due to an upfront payment for a licensing agreement entered into with Lotus International PTE Ltd in February 2023. We received an upfront payment of approximately $1.0 million associated with a licensing agreement entered into with Lee’s Pharmaceutical (HK) Limited in July 2022.

 

Research and Development (R&D) Expenses: R&D expenses for the full year were $12.9 million, compared to $12.4 million for the same period in 2022. The increase was primarily due to a $0.7 million increase in labor costs. Non-cash stock compensation increased $0.5 million. The increases were partially offset by a decrease in drug development costs of $0.7 million.

 

General and Administrative (G&A) Expenses: G&A expenses were $8.5 million, compared to $6.6 million for the same period in 2022. This increase was primarily due to an increase of $1.4 million in professional services costs. Labor costs increased $0.5 million, and other administrative costs increased $0.3 million. Non-cash stock compensation costs increased $0.3 million. The increases were partially offset by a decrease in insurance expense of $0.5 million.

 

Other Income (Expenses): Other income (expenses) increased $9.8 million due primarily to a $10.3 million change in fair value of our warrant liability. The Company earned interest income of $0.6 million on its cash balance during the year that was partially offset by a $0.1 million increase in interest expense.

 

Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2023 was $31.4 million, or $1.28 per share of common stock, compared to a net loss of $18.1 million, or $1.20 per share of common stock, for the same period in 2022. This increase was attributable primarily to the $10.3 million change in fair value of our warrant liability.

 

Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million. Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds. The Company believes that with the inclusion of the net proceeds from this offering, it will have sufficient resources to fund planned operations into 2026.

 

-2-

 

 

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--

 

-3-

 

 

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, $0.001 par value per share – zero and 43,649 shares authorized at December 31, 2022 and December 31, 2023, respectively; zero and 43,649 shares outstanding at December 31, 2022 and December 31, 2023, respectively   -    - 
Preferred stock, $0.001 par value per share – 10,000,000 and 9,926,161 shares authorized at December 31, 2022 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2022 and 2023   -    - 
Common stock, $0.001 par value per share – 200,000,000 shares authorized at December 31, 2022 and 2023; 15,231,655 shares issued and outstanding at December 31, 2022, and 34,756,049 shares issued and outstanding at December 31, 2023   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 

 

-4-

 

 

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 

 

 

-5-

 

 

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Cover
Mar. 28, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 28, 2024
Entity File Number 001-40582
Entity Registrant Name Unicycive Therapeutics, Inc.
Entity Central Index Key 0001766140
Entity Tax Identification Number 81-3638692
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 4300 El Camino Real
Entity Address, Address Line Two Suite 210
Entity Address, City or Town Los Alto
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94022
City Area Code 650
Local Phone Number 351-4495
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock
Trading Symbol UNCY
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
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