UBX Unity Biotechnology Inc.

2.21
-0.11  -5%
Previous Close 2.32
Open 2.32
52 Week Low 2.2
52 Week High 9.78
Market Cap $127,570,436
Shares 57,724,179
Float 43,493,800
Enterprise Value $108,852,095
Volume 624,372
Av. Daily Volume 851,705
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Upcoming Catalysts

Drug Stage Catalyst Date
UBX1325
Diabetic macular edema / Age-related macular degeneration
Phase 2a
Phase 2a
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UBX1325
Diabetic macular edema (DME) / wet age-related macular degeneration (AMD)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
UBX0101
Osteoarthritis of the knee
Phase 2
Phase 2
Phase 2 top-line data failed to meet primary endpoint - August 17, 2020.

Latest News

  1. UBX1325 Phase 2 study in DME currently enrolling, with additional Phase 2 study in AMD planned for 1H22

    UNITY to present at invitation-only Eyecelerator innovation conference at AAO

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (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, 2021.

    "In our Phase 1 clinical study, UBX1325, a senolytic small molecule working through an entirely new mechanism of action, has shown a favorable safety profile and very promising evidence of biological activity through six months, demonstrating durability," said Anirvan…

    UBX1325 Phase 2 study in DME currently enrolling, with additional Phase 2 study in AMD planned for 1H22

    UNITY to present at invitation-only Eyecelerator innovation conference at AAO

    SOUTH SAN FRANCISCO, Calif., Nov. 10, 2021 (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, 2021.

    "In our Phase 1 clinical study, UBX1325, a senolytic small molecule working through an entirely new mechanism of action, has shown a favorable safety profile and very promising evidence of biological activity through six months, demonstrating durability," said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. "As announced yesterday, we share the excitement of the patient and physician community about the potential for UBX1325 as a possible disease-modifying treatment to fill the large and unmet need for options beyond anti-VEGF therapies. Our team continues to advance the UBX1325 program in a Phase 2 proof of concept study currently enrolling patients with diabetic macular edema (DME), and we are using the promising data from patients with age-related macular degeneration (AMD) in the Phase 1 study to inform design of a Phase 2 study in wet AMD to start in the first half of 2022."

    UNITY yesterday released 24-week data from its Phase 1 study of UBX1325 in DME, along with 24-week and 12-week (AMD-only cohort) data in patients with AMD, and will present information about the UBX1325 program at 2021 in New Orleans on November 11, 2021, an invitation-only event featuring ophthalmic innovation put on in partnership between the American Academy of Ophthalmology and ASCRS.

    Upcoming Milestones

    • UBX1325 Phase 2a proof of concept study in DME had a first patient dosed in June 2021 and is actively recruiting patients, with information about that trial available here. Twelve-week safety and efficacy data are expected in the first half of 2022.
    • UBX1325 Phase 2 proof of concept study in AMD is expected to initiate in the first half of 2022, with twelve-week safety and efficacy data expected in the second half of 2022.
    • UBX2050 (Tie2 mAb) and UBX2089 (alpha-Klotho) expected to enter IND-enabling studies in 2022.

    Third Quarter Financial Results

    Cash, cash equivalents, and marketable securities totaled $88.5 million as of September 30, 2021 compared with $115.6 million as of December 31, 2020. UNITY believes that current cash, cash equivalents, and marketable securities are sufficient to fund operations through the third quarter of 2022.

    Operating loss for the three months ended September 30, 2021 was $14.8 million compared to $24.6 million for the three months ended September 30, 2020. Cash used in operations during the nine months ended September 30, 2021 was $40.0 million compared to $61.6 million for the nine months ended September 30, 2020.

    Research and development expenses decreased by $9.7 million, to $9.1 million for the three months ended September 30, 2021 from $18.8 million for the three months ended September 30, 2020. The decrease was primarily due to decreases of $4.1 million in net direct research and development expenses mainly due to termination of OA studies, delayed manufacturing and reduction in pre-clinical safety studies, $3.4 million in personnel costs due to reduction in force, $1.2 million in facilities-related costs, $0.8 million in laboratory supplies and $0.2 million in consultant expenses.

    General and administrative expenses decreased by $0.8 million, to $5.7 million for the three months ended September 30, 2021 from $6.5 million for the three months ended September 30, 2020. The decrease was primarily due to a decrease of $0.4 million in personnel costs due to reduction in force, $0.3 million in facilities-related costs and $0.1 million in professional fees.

    About UBX1325

    UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), and diabetic retinopathy (DR). UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis-regulatory proteins. UBX1325 is designed to inhibit the function of proteins senescent cells rely on for survival. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminates senescent cells from diseased tissue while sparing healthy cells. In its Phase 1 safety trial in patients with advanced DME or wet AMD who were no longer expected to benefit from anti-VEGF therapies, UBX1325 showed a favorable safety and tolerability profile as well as initial evidence of relevant biological efficacy. UNITY's goal with UBX1325 is to transformationally improve real-world outcomes for patients with DME, AMD, and DR.

    About UNITY

    UNITY 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 and LinkedIn.

    Forward-Looking Statements

    This 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, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, 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, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY's understanding of senescence biology. 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 UNITY in general, see UNITY's most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 10, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.

    Unity Biotechnology, Inc.

    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, 
      2021  2020  2021  2020 
    Operating expenses:                
    Research and development $9,081  $18,830  $28,815  $54,218 
    General and administrative  5,747   6,530   17,952   18,803 
    Change in fair value of contingent consideration     (718)     (33)
    Impairment of long-lived assets           2,159 
    Total operating expenses  14,828   24,642   46,767   75,147 
    Loss from operations  (14,828)  (24,642)  (46,767)  (75,147)
    Interest income  20   226   82   1,093 
    Interest expense  (792)  (499)  (2,351)  (499)
    Other income (expense), net  (850)  (2,637)  (996)  296 
    Net loss  (16,450)  (27,552)  (50,032)  (74,257)
    Other comprehensive gain (loss)                
    Unrealized loss on marketable debt securities     (166)     (24)
    Comprehensive loss $(16,450) $(27,718) $(50,032) $(74,281)
    Net loss per share, basic and diluted $(0.30) $(0.52) $(0.91) $(1.49)
    Weighted-average number of shares used in computing net loss per share, basic and diluted  55,436,444   52,482,200   54,826,481   49,926,396 
                     

    Unity Biotechnology, Inc.

    Condensed Balance Sheets

    (In thousands)

      September 30,  December 31, 
      2021  2020 
      (Unaudited)     
    Assets        
    Current Assets:        
    Cash and cash equivalents $21,994  $17,807 
    Short-term marketable securities  58,973   79,892 
    Prepaid expenses and other current assets  3,209   3,167 
    Restricted cash  550    
    Total current assets  84,726   100,866 
    Property and equipment, net  10,608   12,627 
    Operating lease right-of-use assets  21,856   23,509 
    Long-term marketable securities  7,500   17,871 
    Restricted cash  896   1,446 
    Other long-term assets  105    
    Total assets $125,691  $156,319 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable $1,773  $2,558 
    Accrued compensation  3,398   5,355 
    Accrued and other current liabilities  6,861   6,550 
    Current portion of long-term debt  945    
    Total current liabilities  12,977   14,463 
    Operating lease liability, net of current portion  30,812   34,468 
    Long-term debt, net  24,142   24,508 
    Other long-term liabilities  23    
    Total liabilities  67,954   73,439 
    Commitments and contingencies        
    Stockholders' equity:        
    Common stock  5   5 
    Additional paid-in capital  447,057   422,379 
    Related party promissory notes for purchase of common stock     (210)
    Accumulated other comprehensive gain  6   5 
    Accumulated deficit  (389,331)  (339,299)
    Total stockholders' equity  57,737   82,880 
    Total liabilities and stockholders' equity $125,691  $156,319 
             

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  2. Patients with diabetic macular edema in higher dose cohorts showed a mean BCVA gain of approximately 10 ETDRS letters sustained through 24 weeks after a single intravitreal injection

    Patients with wet age-related macular degeneration showed improvement in visual acuity through 12 weeks supporting initiation of Phase 2 study in AMD

    UNITY to host investor call with retinal experts Arshad Khanani, M.D., M.A., and Robert Bhisitkul, M.D., Ph.D., today, November 9, 2021 at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 24-week data from its Phase 1 single ascending…

    Patients with diabetic macular edema in higher dose cohorts showed a mean BCVA gain of approximately 10 ETDRS letters sustained through 24 weeks after a single intravitreal injection

    Patients with wet age-related macular degeneration showed improvement in visual acuity through 12 weeks supporting initiation of Phase 2 study in AMD

    UNITY to host investor call with retinal experts Arshad Khanani, M.D., M.A., and Robert Bhisitkul, M.D., Ph.D., today, November 9, 2021 at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Nov. 09, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 24-week data from its Phase 1 single ascending dose (SAD) safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) or wet age-related macular degeneration (AMD). A majority of patients with DME across all doses had rapid improvements in vision, and patients in the higher dose cohorts showed a mean gain of 9.5 ETDRS letters in best-corrected visual acuity (BCVA) at 24 weeks following a single injection of UBX1325. Similarly, a majority of wet AMD patients treated with UBX1325 showed rapid gains in visual acuity, which were maintained through 12 weeks. In most patients, central subfield thickness (CST) remained stable through the study period.

    UBX1325 Well-Tolerated at All Doses

    The study enrolled a total of 19 patients with advanced DME (n=8) and wet AMD (n=11) for whom anti-VEGF therapy was no longer considered beneficial. UBX1325 was well-tolerated at all doses tested (through 10 mcg) with no dose-limiting toxicities and no reported incidence of inflammation.

    Results from Patients with Diabetic Macular Edema Treated with UBX1325

    The Phase 1 data show rapid improvements in visual acuity as measured by BCVA in patients with DME, with the majority of patients demonstrating sustained responses through 24 weeks:

    • Across all DME patients enrolled (n=8), there was an improvement in visual acuity in 6 of 8 patients at 12 weeks, and in 5 of 8 patients at 24 weeks
    • In the higher dose cohorts (5, 10 mcg), patients had a mean improvement of 9.5 ETDRS letters from baseline at 24 weeks
    • Amongst all DME patients, 62.5% gained 5 or more letters at 24 weeks, and 50% gained 10 or more letters also at 24 weeks
    • In the majority of patients with DME, CST remained stable through 24 weeks

    "A 10 letter gain in DME patients, maintained through six months, is an impressive outcome, and is particularly noteworthy considering that it was achieved with a single injection," said Arshad Khanani, M.D., M.A., managing partner of Sierra Eye Associates. "Hard-to-treat patients require as many as 10 injections in the first year of treatment to see full benefits from currently available anti-VEGF therapies. A treatment that reduces the frequency of injections while showing meaningful and sustained improvements in BCVA would be of huge value for patients and physicians."

    Results from Patients with Wet Age-Related Macular Degeneration Treated with UBX1325

    The Phase 1 study included 11 wet AMD patients (4 in the SAD cohort, and an additional 7 in an expansion cohort). A majority of patients showed rapid improvements in visual acuity:

    • Across all evaluable patients with wet AMD enrolled (10 of 11), there was an improvement in visual acuity in 7 of 10 patients at 8 weeks, and in 5 of 10 patients at 12 weeks
    • 2 of 3 patients in the SAD cohort maintained their visual acuity gain through 24 weeks
    • Within the ten evaluable patients with wet AMD, CST remained stable through 12 weeks; this trend was also observed in the three evaluable patients with wet AMD at 24 weeks, and 2 of those 3 patients showed resolution of most subretinal fluid

    "Patients with wet AMD will lose vision without treatment and have a worse prognosis than patients with DME, which is why the letter gain seen in the AMD cohort is so meaningful," said Robert Bhisitkul, M.D., Ph.D., professor of ophthalmology and director of the Retina Fellowship at University of California, San Francisco. "The efficacy that we are seeing in AMD patients provides a convincing rationale for advancing this program into additional clinical studies."

    "We have now followed advanced DME and AMD patients for 24 weeks, and see clear evidence of rapid and sustained responses from a single injection of UBX1325," said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. "The improvements in vision and retinal structure suggest that this new mechanism of action – the selective elimination of senescent cells in diseased retinal tissue – has the potential for disease-modifying effect in a large proportion of patients struggling to manage their disease."

    UNITY's Phase 2 study of UBX1325 in DME is underway, with 12-week safety and efficacy data anticipated in the first half of 2022. A Phase 2 study in wet AMD is planned for the first half of 2022, with 12-week data expected in the second half of the year.

    Investor Conference Call at 8:00 a.m. ET Today

    UNITY will host a video conference call and webcast for investors and analysts on Tuesday, November 9 at 8:00 a.m. ET to discuss the most recent UBX1325 clinical data. Drs. Khanani and Bhisitkul, as well as members of the UNITY senior management team will lead the discussion on the 24-week DME and 12-week wet AMD results. The live webcast can be accessed in the "Investors and Media" section of our website, www.unitybiotechnology.com, under "Events & Presentations" or by clicking here. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, under "Events and Presentations."

    About UBX1325

    UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), and diabetic retinopathy (DR) that is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY's goal with UBX1325 is to transformationally improve real-world outcomes for patients with DME, AMD, and DR.

    About UNITY

    UNITY 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 and LinkedIn.

    Forward-Looking Statements

    This 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, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, 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, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY's understanding of senescence biology. 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 UNITY in general, see UNITY's most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 10, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.

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  3. SOUTH SAN FRANCISCO, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that from October 19, 2021, through November 2, 2021, the Compensation Committee of the Board of Directors (the "Board") granted two new employees stock-based awards covering an aggregate of 190,000 shares of UNITY common stock, including options to purchase an aggregate of 160,000 shares of UNITY common stock and one grant consisting of 30,000 restricted stock units which will vest on the one-year anniversary of the vesting commencement date. The stock-based awards were granted pursuant to the UNITY 2020 Employment Inducement…

    SOUTH SAN FRANCISCO, Calif., Nov. 03, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that from October 19, 2021, through November 2, 2021, the Compensation Committee of the Board of Directors (the "Board") granted two new employees stock-based awards covering an aggregate of 190,000 shares of UNITY common stock, including options to purchase an aggregate of 160,000 shares of UNITY common stock and one grant consisting of 30,000 restricted stock units which will vest on the one-year anniversary of the vesting commencement date. The stock-based awards were granted pursuant to the UNITY 2020 Employment Inducement Incentive Plan, as amended, which was approved by the Board in March 2020 to provide for grants to newly hired employees as a material inducement for them to commence employment with UNITY in accordance with Nasdaq Stock Market Rule 5635(c)(4).

    About UNITY

    UNITY 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 and LinkedIn.

    Media

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    Jason Spark



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  4. SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that from September 21, 2021, through October 5, 2021, the Compensation Committee of the Board of Directors (the "Board") granted 4 new employees stock-based awards covering an aggregate of 138,500 shares of UNITY common stock, including options to purchase an aggregate of 138,500 shares of UNITY common stock. The stock-based awards were granted pursuant to the UNITY 2020 Employment Inducement Incentive Plan, as amended, which was approved by the Board in March 2020 to provide for grants to newly hired employees as a material…

    SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that from September 21, 2021, through October 5, 2021, the Compensation Committee of the Board of Directors (the "Board") granted 4 new employees stock-based awards covering an aggregate of 138,500 shares of UNITY common stock, including options to purchase an aggregate of 138,500 shares of UNITY common stock. The stock-based awards were granted pursuant to the UNITY 2020 Employment Inducement Incentive Plan, as amended, which was approved by the Board in March 2020 to provide for grants to newly hired employees as a material inducement for them to commence employment with UNITY in accordance with Nasdaq Stock Market Rule 5635(c)(4).

    About UNITY

    UNITY 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 and LinkedIn.

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    Canale Communications

    Jason Spark



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  5. Evidence of improvement in vision and retinal structure in patients with DME and AMD sustained through 12 weeks

    Sustained responses following single treatment with UBX1325 support durability of senolytic therapeutic approach; data builds on previously reported results at 8 weeks

    Study remains on track with 24-week data expected before the end of the year

    UNITY to host investor call with retinal expert Robert Bhisitkul, M.D., Ph.D., on October 5, 2021 at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12-week data from its ongoing Phase 1 safety study…

    Evidence of improvement in vision and retinal structure in patients with DME and AMD sustained through 12 weeks

    Sustained responses following single treatment with UBX1325 support durability of senolytic therapeutic approach; data builds on previously reported results at 8 weeks

    Study remains on track with 24-week data expected before the end of the year

    UNITY to host investor call with retinal expert Robert Bhisitkul, M.D., Ph.D., on October 5, 2021 at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. ("UNITY") (NASDAQ:UBX), a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced 12-week data from its ongoing Phase 1 safety study of UBX1325 in patients with advanced disease from diabetic macular edema (DME) and wet age-related macular degeneration (AMD) for whom anti-VEGF therapy was no longer considered beneficial. The data show strong and sustained responses following a single injection of UBX1325 out to 12 weeks and add substantively to the previously reported 8-week dataset, which provided initial evidence of efficacy. The 24-week data from the study is expected before the end of the year.

    UBX1325, a small molecule inhibitor of Bcl-xL and the first senolytic drug candidate for ophthalmologic diseases targeting a distinctive biologic pathway from anti-VEGF therapies, continues to be well-tolerated with no treatment-related adverse events or dose-limiting toxicities up to 12 weeks. Additionally, UBX1325 showed sustained responses in key clinical measures of disease progression in most patients through 12 weeks, including substantial improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST).

    "It is promising to see improvements in vision sustained over three months after a single dose in these patients with advanced vascular eye disease, especially considering that these patients had gone at least six months without standard of care anti-VEGF therapy by this point," said Robert Bhisitkul, M.D., Ph.D., professor of ophthalmology and director of the Retina Fellowship at University of California, San Francisco. "There are limited treatment options for patients who do not benefit from standard of care, so a novel therapeutic approach like UBX1325 could provide significant benefit as an alternative or complement to anti-VEGF treatments."

    Treatment of patients with a single UBX1325 injection resulted in the following clinical changes at 12 weeks following treatment:

    Gain in ETDRS Letters from Baseline in Best-Corrected Visual Acuity (BCVA)

    • Overall (across all doses): 8 of 12 patients showed a gain in ETDRS letters from baseline in BCVA at 12 weeks
    • In high dose groups (5, 10 mcg): 5 of 6 patients showed a gain in ETDRS letters from baseline in BCVA at 12 weeks

    Decrease in Central Subfield Thickness (CST)

    • Overall (across all doses): 6 of 10 patients had a decrease (improvement) in CST at 12 weeks, excluding two patients who received anti-VEGF rescue therapy following progression of underlying disease
    • In high dose groups (5, 10 mcg): 3 of 5 patients showed decrease in CST at 12 weeks, excluding one patient who received anti-VEGF rescue following progression of underlying disease

    The Phase 1, open-label, single-ascending dose study includes 12 patients with advanced DME or wet AMD who were no longer expected to benefit from anti-VEGF therapies. Patients enrolled in the study could not have received an anti-VEGF therapy or corticosteroid for three months prior to receiving a single dose of UBX1325. At 12 weeks following treatment with study drug, UBX1325 demonstrated a favorable safety profile supporting further clinical development. There were no dose-limiting toxicities observed, with two nonserious, nondrug-related adverse events reported through 12 weeks.

    "We are excited by the trajectory of the data showing both a rapid response and sustained improvements in vision and retinal structure in most patients through 12 weeks following a single injection of UBX1325," said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. "The consistency of response at 8 and 12 weeks suggests that the functional gains seen to date may be sustained beyond 12 weeks. These data further support our Phase 2a Proof of Concept study in patients with DME, which is already underway, and we anticipate the 12-week safety and efficacy data from that study in the first half 2022."

    UNITY expects to share 8-week data from an additional cohort of patients with wet AMD, as well as complete 24-week data of the original cohort from the Phase 1 single ascending dose study, before the end of the year.

    Investor Conference Call at 8:00 a.m. ET Today

    UNITY will host a conference call and webcast for investors and analysts on Tuesday, October 5 at 8:00 a.m. ET to discuss the most recent UBX1325 clinical data. Dr. Bhisitkul and members of the UNITY senior management team will lead the discussion on the 12-week data results. The live webcast can be accessed in the "Investors and Media" section of our website, www.unitybiotechnology.com, under "Events & Presentations" or by clicking here. You may also listen to the call by dialing (877) 235-8637 within the U.S. or (704) 815-6400 outside the U.S. and providing conference ID 5226618. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, under "Events and Presentations."

      

    About UBX1325

    UBX1325 is an investigational compound being studied for age-related diseases of the eye, including diabetic macular edema (DME), age-related macular degeneration (AMD), and diabetic retinopathy that is not approved for any use in any country. UBX1325 is a potent small molecule inhibitor of Bcl-xL, a member of the Bcl-2 family of apoptosis regulating proteins. UBX1325 is designed to inhibit the function of proteins that senescent cells rely on for survival. In preclinical studies, UNITY has demonstrated that targeting Bcl-xL with UBX1325 preferentially eliminated senescent cells from diseased tissue while sparing cells in healthy tissue. UNITY's goal with UBX1325 is to transformationally improve real-world outcomes for patients with DR, DME, and AMD.

    About UNITY

    UNITY 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 and LinkedIn.

    Forward-Looking Statements

    This 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, our expectations regarding potential benefits, activity, effectiveness, and safety of UBX1325, the potential for UNITY to successfully commence and complete clinical studies of UBX1325 for DME, AMD, and other ophthalmologic diseases, the expected timing of results of our studies of UBX1325, the timing of the expected commencement, progression, and conclusion of our studies including those of UBX1325, 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, risks relating to the uncertainties inherent in the drug development process, and risks relating to UNITY's understanding of senescence biology. 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 UNITY in general, see UNITY's most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 10, 2021, as well as other documents that may be filed by UNITY from time to time with the Securities and Exchange Commission.

    Media

    Canale Communications

    Jason Spark

     



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