UNCY Unicycive Therapeutics Inc.

2.59
-0.03  -1%
Previous Close 2.62
Open 2.65
52 Week Low 2.39
52 Week High 8.73
Market Cap $37,625,211
Shares 14,508,063
Float 8,576,997
Enterprise Value $41,262,641
Volume 74,192
Av. Daily Volume 189,991
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Drug Pipeline

Drug Stage Notes
Renazorb
Chronic kidney disease (CKD)
Phase 1
Phase 1
Phase 1 trial has been completed. Single open-label safety, tolerability, and efficacy dose-ranging trial planned and to be completed by 2H 2022. NDA filing to follow.

Latest News

  1. LOS ALTOS, Calif., Sept. 15, 2021 /PRNewswire/ -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced the Company is scheduled to be added as a member of the Russell Microcap® Index as part of the 2021 Russell indexes reconstitution after the market opens on September 20, 2021, based on a preliminary list of additions.  

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    "Joining the Russell Microcap® Index is an important event for Unicycive as we receive recognition from one of the most prominent index providers followed by investment managers across the country," said Shalabh Gupta, M.D., Chief Executive Officer. "As a newly public company, our addition to this index will expand the interest and visibility of Unicycive within the investment community.  We appreciate the recognition this achievement brings and will look to leverage our elevated platform to generate further interest and awareness in our clinical programs."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $17.9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell Microcap® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About FTSE Russell:

    FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.

    FTSE Russell is wholly owned by London Stock Exchange Group. 

    For more information, visit www.ftserussell.com.

    About Unicycive

    Unicycive is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit www.unicycive.com.

    Forward-looking statement

    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, including the outbreak of COVID-19 coronavirus, 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. Investors should read the risk factors set forth in our registration statement on Form S-1 and our periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Unicycive does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

    Contacts:

    Remy Bernarda

    ir@unicycive.com

    (650) 900-5470



    SOURCE: Unicycive Therapeutics, Inc.

     

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  2. LOS ALTOS, Calif., Sept. 7, 2021 /PRNewswire/ -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021. 

    A link to the webcast will be available on September 13, 2021 and may be accessed on the Unicycive website under the Investors section:Events and Presentations. An archive of the webcast will be available for three months.

    About Unicycive

    Unicycive is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit www.unicycive.com.

    Contacts:

    Remy Bernarda

    ir@unicycive.com

    (650) 900-5470

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/unicycive-therapeutics-to-present-at-the-hc-wainwright-23rd-annual-global-investment-conference-301369986.html

    SOURCE Unicycive Therapeutics Inc.

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  3. LOS ALTOS, Calif., Aug. 16, 2021 /PRNewswire/ -- Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today reported financial results for the second quarter ended June 30, 2021.

    "With our recent initial public offering, we believe we are now well positioned to advance our pipeline programs for the treatment of kidney diseases," said Shalabh Gupta, M.D., Chief Executive Officer. "Our lead program, Renazorb, is looking to address the challenging treatment burden faced by patients suffering from hyperphosphatemia as a result of their chronic kidney disease. Our preclinical studies are ongoing to support an expedited 505(b)(2) regulatory approval pathway with the U.S. Food and Drug Administration (FDA). We are also advancing UNI-494, our novel small-molecule mitochondrial protectant product candidate for the potential treatment of acute kidney injury and chronic kidney disease, through preclinical studies to support our planned investigational new drug application with the FDA next year.

    With the recent funding, we look forward to accomplishing numerous milestones for our key programs." 

    Key Highlights and Upcoming Milestones

    • Completed initial public offering in July 2021 with gross proceeds of $25 million
    • Planned meeting with the U.S. FDA in Q4 2021 regarding alignment on Renazorb program
    • Planned completion of pre-clinical studies with UNI-494 in the first half of 2022

    Second Quarter 2021 Financial Results

    Research and development expenses for the second quarter of 2021 were $0.5 million, compared to $0.2 million for the second quarter of 2020. This increase was primarily attributable to stock compensation expense recorded in the current period.

    General and administrative expenses for the second quarter of 2021 were $0.3 million, compared to $0.2 million for the second quarter of 2020. This increase was primarily attributable to increases in accounting and professional services costs in the current period.

    Net loss for the second quarter of 2021 was $1.1 million, or $0.13 per share of common stock, compared to a net loss of $0.3 million, or $0.04 per share of common stock, for the second quarter of 2020. This increase was primarily attributable to interest expense and stock compensation expense in the current period.

    About Unicycive

    Unicycive is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit www.unicycive.com.

    Forward-looking statement

    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 by the use of 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 a number of 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 pre-clinical studies 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, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; 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. There are no guarantees that any of our technology or product candidates will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in our Form 10-Q for the quarter ended June 30, 2021 and in our registration statement on Form S-1 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Unicycive does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. 

     

    Unicycive Therapeutics, Inc.

















    Balance Sheets

    (in thousands, except for share and per share amounts)





















    As of





    As of





    December 31,





    June 30,





    2020





    2021













    (unaudited)

    Assets















    Current assets:















    Cash



    $

    -





    $

    1

    Prepaid related party service fee





    -







    38

    Deferred offering costs





    200







    864

    Prepaid expenses and other current assets





    4







    10

    Total current assets





    204







    913

    Total assets



    $

    204





    $

    913

















    Liabilities and stockholders' deficit















    Current liabilities:















    Accounts payable



    $

    184





    $

    357

    Related party service fee payable





    9







    -

    Accrued liabilities





    168







    658

    Convertible notes





    1,528







    3,199

    Loan from stockholder





    967







    901

    Government loan





    19







    -

    Total current liabilities





    2,875







    5,115

    Total liabilities





    2,875







    5,115

    Commitments and contingencies (Note 7)















    Stockholders' deficit:















    Preferred stock: $0.001 par value per share—10,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); no shares issued and outstanding at December 31, 2020 and June 30, 2021 (unaudited)



    $

    -





    $

    -

    Common stock, $0.001 par value per share – 200,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); 8,514,070 shares issued and outstanding at December 31, 2020, and 8,771,290 shares issued and outstanding at June 30, 2021 (unaudited)





    9







    9

    Additional paid-in capital





    3,242







    3,775

    Accumulated deficit





    (5,922)







    (7,986)

















    Total stockholders' deficit





    (2,671)







    (4,202)

    Total liabilities and stockholders' deficit



    $

    204





    $

    913

















     

     

    Unicycive Therapeutics, Inc.

































    Statements of Operations

    (in thousands, except for share and per share amounts)

    (Unaudited)





































    Three Months Ended



    Six Months Ended

    June 30,



    June 30,





    2020



    2021



    2020



    2021

































    Operating expenses:































    Research and development



    $

    182





    $

    493





    $

    329





    $

    942

    General and administrative





    154







    286







    349







    568

    Total operating expenses





    336







    779







    678







    1,510

    Loss from operations





    (336)







    (779)







    (678)







    (1,510)

    Other expenses:































    Interest expense





    (2)







    (321)







    (4)







    (573)

    Gain on extinguishment of debt





    -







    -







    -







    19

    Total other expenses





    (2)







    (321)







    (4)







    (554)

    Net loss



    $

    (338)





    $

    (1,100)





    $

    (682)





    $

    (2,064)

    Net loss per share, basic and diluted



    $

    (0.04)





    $

    (0.13)





    $

    (0.08)





    $

    (0.24)

    Weighted-average shares outstanding used in computing net loss per share, basic and diluted





    8,483,382







    8,771,290







    8,472,866







    8,677,497

































    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/unicycive-therapeutics-announces-second-quarter-2021-financial-results-301355484.html

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