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Unity Biotechnology, Inc. (UBX)

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  • Is Unity Biotechnology (UBX) A Good Stock To Buy Now?
    Insider Monkey

    Is Unity Biotechnology (UBX) A Good Stock To Buy Now?

    The financial regulations require hedge funds and wealthy investors that exceeded the $100 million equity holdings threshold to file a report that shows their positions at the end of every quarter. Even though it isn’t the intention, these filings to a certain extent level the playing field for ordinary investors. The latest round of 13F […]

  • UNITY Biotechnology, Inc. Reports Third Quarter 2020 Financial Results and Clinical Program Updates
    GlobeNewswire

    UNITY Biotechnology, Inc. Reports Third Quarter 2020 Financial Results and Clinical Program Updates

    SOUTH SAN FRANCISCO, Calif., Nov. 04, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today reported financial results for the third quarter ended September 30, 2020. “Over the past quarter we have focused our resources on cellular senescence programs in ophthalmology and neurology. Building on the strong foundation of our senolytics platform, we have made significant progress in advancing key programs in our pipeline,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “We have deep conviction around the role of senescent cells in diseases of aging, particularly in the eye and brain, and recently initiated a Phase 1 study of UBX1325 in diabetic macular edema (DME).”Clinical Program UpdatesOphthalmology – UBX1325In July 2020, UNITY announced that it had completed Investigational New Drug application (IND) -enabling studies with UBX1325, an investigational senolytic, small molecule inhibitor of the anti-apoptotic Bcl-2 family member, Bcl-xL. UNITY has initiated a Phase 1 safety study for UBX1325 and dosed the first patient in October 2020. Assuming clinical sites are able to recruit and retain investigators and study staff, and they can screen and enroll patients during the ongoing COVID-19 pandemic, UNITY expects to obtain initial results from the study in the first half of 2021. In addition, following assessment of the initial results, UNITY plans to initiate a proof of concept study in DME in the first half of 2021. The overall clinical program is directed at age-related diseases of the eye, such as diabetic retinopathy and age-related macular degeneration.Osteoarthritis – UBX0101In August 2020, UNITY announced the 12-week results from the Phase 2 study of UBX0101, a p53/MDM2 interaction inhibitor, in patients with moderate-to-severe painful osteoarthritis (OA) of the knee.  There was no statistically significant difference between any arm of UBX0101 and placebo at the 12-week endpoint for change from baseline in WOMAC-A, an established measurement of pain in OA. Given these results, UNITY does not anticipate progressing UBX0101 into pivotal studies. 24-week results from the Phase 1b and Phase 2 studies will be shared at a future scientific meeting.Financial OutlookUNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into mid-2022.Third Quarter Financial ResultsCash, cash equivalents and marketable securities totaled $132.2 million as of September 30, 2020 compared with $125.0 million as of December 31, 2019.Operating loss for the three months ended September 30, 2020 was $24.6 million compared to $22.4 million for the three months ended September 30, 2019. Cash used in operations during the nine months ended September 30, 2020 was $61.6 million compared to $56.7 million for the nine months ended September 30, 2019.Research and development expenses increased by $1.0 million, to $18.8 million for the three months ended September 30, 2020 from $17.8 million for the three months ended September 30, 2019. The increase was primarily due to a net increase of $1.3 million in personnel costs mainly due to accrued severance from corporate restructuring and an increase of $0.4 million in facilities-related costs, partially offset by a net decrease of $0.7 million in direct research and development expenses.General and administrative expenses increased by $0.8 million, to $6.5 million for the three months ended September 30, 2020 from $5.7 million for the three months ended September 30, 2019. The increase was primarily due to increases of $0.3 million in professional and consultant fees, $0.2 million in personnel costs mainly due to accrued severance from corporate restructuring, and $0.2 million in facilities-related costs.About UNITYUNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com or follow us on Twitter.Forward-Looking StatementsThis press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in diseases of aging, the potential for UNITY to develop therapeutics to slow, halt or reverse diseases of aging, including for ophthalmologic and neurologic diseases, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for diabetic macular edema and other ophthalmologic diseases, the expected timing of initial results of the Phase 1 study of UBX1325 in diabetic macular edema, and UNITY’s expectations regarding the sufficiency of its cash runway. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the Securities and Exchange Commission on November 4, 2020, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.Unity Biotechnology, Inc. Condensed Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited)  Three Months Ended  Nine Months Ended    September 30,  September 30,    2020  2019  2020  2019  Operating expenses:                 Research and development $18,830  $17,777  $54,218  $52,750  General and administrative  6,530   5,692   18,803   15,139  Change in fair value of contingent consideration  (718)  (1,115)  (33)  (1,327) Impairment of long-lived assets  —   —   2,159   —  Total operating expenses  24,642   22,354   75,147   66,562  Loss from operations  (24,642)  (22,354)  (75,147)  (66,562) Interest income  226   756   1,093   2,663  Interest expense  (499)  —   (499)  —  Other income (expense), net  (2,637)  (112)  296   (251) Net loss  (27,552)  (21,710)  (74,257)  (64,150) Other comprehensive loss                 Unrealized gain (loss) on marketable debt securities  (166)  (18)  (24)  190  Comprehensive loss $(27,718) $(21,728) $(74,281) $(63,960) Net loss per share, basic and diluted $(0.52) $(0.51) $(1.49) $(1.51) Weighted-average number of shares used in computing net loss per share, basic and diluted  52,482,200   42,965,945   49,926,396   42,584,835  Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands)  September 30,  December 31,    2020  2019    (Unaudited)      Assets         Current Assets:         Cash and cash equivalents $48,581  $37,473  Short-term marketable securities  83,633   84,508  Strategic investment  —   5,507  Prepaid expenses and other current assets  3,476   1,999  Total current assets  135,690   129,487  Property and equipment, net  13,503   16,636  Operating lease right of use asset  24,330   —  Long-term marketable securities  —   3,025  Restricted cash  1,446   1,446  Other long-term assets  2   627  Total assets $174,971  $151,221            Liabilities and Stockholders' Equity         Current liabilities:         Accounts payable $4,255  $5,185  Accrued compensation  5,730   5,905  Accrued and other current liabilities  6,940   4,995  Contingent consideration liability  —   1,131  Total current liabilities  16,925   17,216  Operating lease liability, net of current portion  35,632   —  Deferred rent, net of current portion  —   13,298  Long term debt, net  24,313   —  Total liabilities  76,870   30,514  Commitments and contingencies         Stockholders' equity:         Common stock  5   5  Additional paid-in capital  417,952   366,695  Related party promissory notes for purchase of common stock  (210)  (210) Employee promissory notes for purchase of common stock  —   (418) Accumulated other comprehensive income  66   90  Accumulated deficit  (319,712)  (245,455) Total stockholders' equity  98,101   120,707  Total liabilities and stockholders' equity $174,971  $151,221  Media Canale Communications Jason Spark jason.spark@canalecomm.com

  • GlobeNewswire

    UNITY Biotechnology Announces First Patient Dosed in Phase 1 Study of UBX1325 in Diabetic Macular Edema

    SAN FRANCISCO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology (“UNITY”) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today announced that the first patient has been dosed in a Phase 1 study of UBX1325 in patients with diabetic macular edema (DME). “There is strong evidence of association between disease progression in DME and accumulation of senescent cells. There’s additional evidence that senescent cells secrete factors that can be damaging to the eye and lead to vascular leakage, a pathological hallmark of DME,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “Bcl-xL inhibition, a novel senolytic mechanism, has been shown in our preclinical tests to lead to an impact on senescent cells, reduction in vascular leakage, and improvement in retinal function. Our preclinical observations give us confidence in UBX1325 and we are excited to bring this therapeutic candidate into clinical development.”The Phase 1, first-in-human, open-label, single-ascending dose study is designed to evaluate the safety, tolerability and pharmacokinetics of UBX1325 in patients with advanced DME. The trial is designed to enroll approximately 15 patients, with safety and tolerability data expected in the first half of 2021. UNITY anticipates initiating a proof of concept study in the first half of 2021.About UBX1325 UBX1325 is a potent and selective small molecule inhibitor of Bcl-xL, an anti-apoptotic regulatory protein and a BCL-2 family member. Preclinically, UBX1325 has been shown to eliminate senescent cells and have a positive impact on inflammation, vascular leakage and visual function. UBX1325 is currently being evaluated in a first-in-human trial designed to treat patients with advanced diabetic macular edema. To learn more about the Phase 1 clinical trial of UBX1325, please visit the clinicaltrials.gov website here.About UNITY UNITY is developing a new class of therapeutics to slow, halt or reverse age-related diseases. UNITY's current focus is on creating medicines to selectively eliminate or modulate senescent cells and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. More information is available at www.unitybiotechnology.com and follow us on LinkedIn and Twitter.Forward-Looking StatementsThis press release contains forward-looking statements including statements related to UNITY’s understanding of cellular senescence and the role it plays in retinal diseases, the potential for UNITY to develop therapeutics to extend healthspan, including UBX1325 for retinal disease, the design of the UNITY’s Phase 1 study of UBX1325, the expected timing of initial study results of the Phase 1 study, and the expected timing of the commencement of a proof of concept study for UBX1325. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including the risk that the COVID-19 worldwide pandemic may continue to negatively impact the development of preclinical and clinical drug candidates, including delaying or disrupting the enrollment of patients in clinical trials. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements in this press release represent our views as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this release. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see UNITY’s most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the Securities and Exchange Commission on July 31, 2020, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.Investors Endurance Advisors Mike Zanoni mzanoni@enduranceadvisors.comMedia Canale Communications Jason Spark Jason.spark@canalecomm.com