UBX-0101

UBX1325 demonstrates favorable tolerability in Phase 1 safety study and improvement in visual acuity and central subfield thickness in majority of patients with diabetic macular edema (DME) and wet age-related macular degeneration (AMD) Results from Phase 1 study of UBX1325 in additional patients with wet AMD expected by end of year UBX1325 Phase 2a proof-of-concept study enrolling patients with DME; data expected first half of 2022 SOUTH SAN FRANCISCO, Calif., Aug. 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 second quarter ended June 30, 2021. “This quarter has been exciting and productive, marked by the compelling data from the Phase 1 study of UBX1325. In addition to the reassuring safety profile, we observed initial signs of efficacy in both vision and corresponding ocular structures in patients suffering from advanced DME and wet AMD for whom anti-VEGF therapy was no longer considered beneficial – and who in fact hadn’t received any anti-VEGF therapy for at least three months. This initial data has generated strong enthusiasm and support from the physician community, and we have both completed the enrollment of additional wet AMD patients in our Phase 1 study and are rapidly recruiting in our international Phase 2a study in DME,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “There’s a large unmet need for treatment options beyond anti-VEGF therapy, and UBX1325 may fill that void as a senolytic option working through an entirely novel and potentially disease-modifying mechanism. We look forward to sharing additional data from the Phase 1 study in the coming months, and the results of the Phase 2a study in the first half of 2022.” Key Business Highlights Ophthalmology – UBX1325 Phase 1 Results In July, UNITY announced positive data from its Phase 1 safety study of UBX1325 in patients with advanced disease from DME or wet AMD for whom anti-VEGF therapy was no longer considered effective. In addition to a favorable safety and tolerability profile, UBX1325, a small molecule inhibitor of Bcl-xL, showed rapid improvements in these advanced patients. Specifically, the majority of patients from this study showed a positive gain in key clinical measures of disease progression, including in best-corrected visual acuity (BCVA), central subfield thickness (CST), and sub- and intra-retinal fluid (SRF, IRF). The following improvements in vision and retinal structure were observed as summarized below: Treatment of patients with UBX1325 resulted in the following clinical changes as of June 30, 2021: Gain in ETDRS Letters from Baseline in Best-Corrected Visual Acuity (BCVA) Decrease in Central Subfield Thickness (CST) Reduction in Subretinal / Intraretinal Fluid Based on these data, the Company has, as of August 5, 2021, completed the enrollment of additional patients with advanced wet AMD in the Phase 1 study to inform a potential Phase 2a study in wet AMD to start this fall. A parallel Phase 2a proof-of-concept study in DME is actively recruiting patients, with information about that trial available here. Second Quarter Financial Results Cash, cash equivalents, and marketable securities totaled $97.5 million as of June 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 June 30, 2021 was $17.0 million compared to $23.3 million for the three months ended June 30, 2020. Cash used in operations during the first and second quarters of 2021 was $28.5 million compared to $44.4 million for the first and second quarters of 2020. Research and development expenses decreased by $5.1 million, to $11.0 million for the three months ended June 30, 2021 from $16.1 million for the three months ended June 30, 2020. The decrease was primarily due to decreases of $3.2 million in personnel costs due to reduction in force, $0.6 million in laboratory supplies, $0.8 million in facilities-related costs, $0.1 million in consultant expenses, and $0.4 million in net direct research and development expenses mainly due to termination of UBX0101 offset by increase of $2.0 million in license expense from Ascentage International reaching a milestone, which was a non-cash expense. General and administrative expenses decreased by $0.3 million, to $6.0 million for the three months ended June 30, 2021 from $6.3 million for the three months ended June 30, 2020. The decrease was primarily due to a decrease of $0.6 million in personnel costs due to reduction in force, offset by increases of $0.1 million in facilities-related costs, $0.1 million in professional fees and $0.1 million in insurance-related expense. 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  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. Unity Biotechnology, Inc. Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands)

SOUTH SAN FRANCISCO, Calif., May 07, 2020 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging, today reported financial results for the first quarter ended March 31, 2020. “During the first quarter, we sustained strong momentum on our UBX0101 development program,” said Anirvan Ghosh, chief executive officer of UNITY. “We completed enrollment of both our Phase 2 and Phase 1b studies in patients with osteoarthritis (OA) of the knee. This progress is particularly noteworthy given the impact of the COVID-19 pandemic on the clinical trial landscape.” Recent Highlights and Business Updates Osteoarthritis – UBX0101 In February 2020, UNITY announced completion of enrollment of a Phase 2 study of UBX0101 in patients with moderate-to-severe OA of the knee. The study is randomized, double-blind, and placebo-controlled and will evaluate three doses (0.5 mg, 2.0 mg and 4.0 mg) of UBX0101 administered via a single intra-articular injection. Consistent with prior guidance, both 12- and 24-week results are expected in the second half of 2020. In March 2020, UNITY announced completion of enrollment of a Phase 1b study of UBX010 in patients with moderate-to-severe OA of the knee. The study is randomized, double-blind, and placebo-controlled and will explore the safety, tolerability and initial efficacy of a single 8.0 mg dose or multiple doses (two 4.0 mg doses separated by one month) of UBX0101. Consistent with prior guidance, both 12- and 24-week results are expected in the second half of 2020. Ophthalmology UNITY is advancing its lead ophthalmology candidates, UBX1967 and UBX1325, through the final stages of Investigational New Drug (IND) -enabling studies. Both senolytic molecules are inhibitors of particular members of the Bcl-2 family of apoptosis regulatory proteins which have shown distinct pharmacokinetic profiles in preclinical studies. Consistent with prior guidance, UNITY continues to expect to file an IND for a Phase 1 safety study for this program in the second half of 2020 and, assuming clinical sites are able to recruit and retain investigators and study staff and screen and enroll patients, to initiate a Phase 1 study in the second half of 2020 and receive initial results from the study in 2021. However the impact of the COVID-19 pandemic is hard to assess due the rapidly evolving nature of the situation and it is possible that the study start could be delayed. The overall clinical program is directed at multiple age-related diseases of the eye, such as age-related macular degeneration, diabetic retinopathy and diabetic macular edema. Impact of COVID-19 Pandemic UNITY’s first priority during the COVID-19 pandemic has been to ensure the health and safety of employees and patients in its clinical programs as well as the integrity of the studies in which they participate. UNITY’s clinical and regulatory teams remain active and are working closely with its investigators in its ongoing clinical studies of UBX0101 to adapt to the current environment and ensure the studies remain on-track. UNITY is also following FDA guidance on clinical trial conduct during the COVID-19 pandemic, including with respect to the remote monitoring of clinical data. Further, UNITY has sufficient supply of UBX0101 for all ongoing clinical studies. In late February 2020, UNITY created a cross-functional COVID-19 Response Team to closely monitor the evolving situation and advise on UNITY’s response. In mid-March 2020, in alignment with public health guidance designed to slow the spread of COVID-19, UNITY implemented a reduced onsite staffing model and transitioned to a remote work plan for all employees other than those providing essential services, such as laboratory staff. For its onsite employees, UNITY implemented heightened safety measures designed to comply with applicable federal, state and local guidelines in response to the COVID-19 pandemic. All other employees continue to perform business activities from remote locations. Financial Outlook UNITY believes that current cash, cash equivalents and investments are sufficient to fund operations into the second half of 2021. First Quarter Financial Results Cash, cash equivalents and marketable securities totaled $109.2 million as of March 31, 2020 compared with $125.0 million as of December 31, 2019. Operating loss for the three months ended March 31, 2020 was $27.2 million compared to $19.7 million for the three months ended March 31, 2019. Cash used in operations during the first quarter of 2020 was $25.1 million compared to $20.6 million for the first quarter of 2019. Research and development expenses increased by $2.8 million, to $19.3 million for the three months ended March 31, 2020 from $16.5 million for the three months ended March 31, 2019. The increase was primarily due to increases of $1.5 million in clinical study costs driven by development costs associated with UBX0101, $1.4 million in facilities-related costs, and $0.6 million in personnel-related costs, of which $0.5 million was related to non-cash stock compensation expense, partially offset by a decrease of $0.6 million in laboratory supplies. General and administrative expenses increased by $1.5 million, to $6.0 million for the three months ended March 31, 2020 from $4.5 million for the three months ended March 31, 2019. The increase was primarily due to increases of $0.9 million in personnel-related costs, of which $0.8 million was related to non-cash stock compensation expense, $0.3 million in facilities-related costs and $0.2 million in professional fees. About UNITY UNITY is developing therapeutics to extend healthspan with an initial focus on cellular senescence. UNITY believes that the accumulation of senescent cells is a fundamental mechanism of aging and a driver of many common age-related diseases. Cellular senescence is a natural biological state in which a cell permanently halts division. As senescent cells accumulate with age, they begin secreting inflammatory factors, proteases, fibrotic factors, and growth factors, that disturb the tissue micro-environment. This collection of secreted proteins is referred to as the Senescence Associated Secretory Phenotype, or SASP. UNITY is developing senolytic medicines to eliminate senescent cells and thereby stop the production of the SASP, which UNITY believes addresses a root cause of age-related diseases. By stopping the production of the SASP at it source, UNITY believes senolytic medicines could slow, halt, or reverse diseases such as osteoarthritis and age-related eye diseases. More information is available at or follow us on Twitter . Forward-Looking Statements This press release contains forward-looking statements including statements related to the potential for UNITY to develop therapeutics to extend healthspan, statements related to the timing of certain regulatory filings and the release of clinical trial data and the extent to which COVID-19 may impact UNITY’s operations. 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 March 31, 2020, filed with the Securities and Exchange Commission on May 7, 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) Unity Biotechnology, Inc. Condensed Balance Sheets (In thousands) Investors Endurance Advisors Peter Rahmer prahmer@enduranceadvisors.com Media Canale Communications Jason Spark jason@canalecomm.com