Company Overview - UNITY Biotechnology, Inc. is focused on developing therapeutics aimed at slowing, halting, or reversing diseases associated with aging [4] - The company is currently concentrating on creating medicines that selectively eliminate or modulate senescent cells, targeting age-related ophthalmologic and neurologic diseases [4] Upcoming Event - UNITY will host a virtual investor event on March 24, 2025, featuring key opinion leader Robert Bhisitkul, MD, PhD, who will discuss the results from the Phase 2b ASPIRE study on UBX1325 [1][2] - The event will include a review of the 24- and 36-week results regarding the safety and efficacy of UBX1325 in patients with diabetic macular edema (DME) [2] Product Information - UBX1325 is an investigational compound being studied for retinal diseases, specifically DME, and is not yet approved for any use [3] - It is a potent small molecule inhibitor of BCL-xL, designed to inhibit the survival of senescent cells, with the aim of improving long-term visual outcomes [3] - The Phase 2 BEHOLD study showed that a single injection of UBX1325 led to a statistically significant improvement in mean best-corrected visual acuity (BCVA) through 48 weeks compared to sham treatment [3]

SAN FRANCISCO, March 10, 2025 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that Yehia Hashad, M.D., executive vice president of research and development and chief medical officer at Bausch + Lomb, has been appointed to the Company’s board of directors and as a member of its science committee. "Dr. Hashad is a highly respected leader in ophthalmology whose expertise will be i ...

Financial Performance - The company reported a net loss of approximately $39.9 million for the year ended December 31, 2023, and $26.0 million for the year ended December 31, 2024, with an accumulated deficit of $510.3 million as of December 31, 2024[196]. - Existing capital resources are projected to fund planned operating expenses into the fourth quarter of 2025, raising substantial doubt about the company's ability to continue as a going concern[198]. - As of December 31, 2024, the company had capital resources of $23.2 million, which will be used for ongoing research and development activities[202]. - The company does not expect to generate revenue from drug candidates until they are approved for commercialization[213]. - The company has identified a material weakness in its internal control over financial reporting, which may lead to material errors in financial statements and affect compliance with reporting obligations[364]. - A material weakness was identified due to incorrect classification of warrants issued in August 2022, necessitating restatements of financial statements for multiple periods[365][366]. - The company does not currently intend to pay dividends on its common stock, focusing instead on reinvesting future earnings for growth[375]. - The public float remains below $75.0 million, increasing the risk that analysts may cease coverage, which could negatively impact stock price and trading volume[361]. - The company may experience ownership changes that could limit the use of net operating loss carryforwards, affecting future profitability[369]. Funding and Capital Needs - The company expects to continue incurring losses for the foreseeable future as it develops drug candidates and conducts clinical studies[197]. - The company has filed registration statements for offerings totaling up to $375 million, including common stock and debt securities, to raise additional capital[208]. - The company may need to seek additional funding through collaborations, public or private equity offerings, or debt financings, which could dilute existing stockholders[209]. - Substantial additional funding is required for the identification, development, and commercialization of drug candidates, which is inherently risky[258]. Clinical Development and Regulatory Challenges - The company is in Phase 2 clinical development for its drug candidate UBX1325 (foselutoclax) and aims to achieve key clinical data readouts[203]. - The company has one product candidate, UBX1325, in clinical development, with positive 24-week safety and efficacy data announced in November 2022 and April 2023[225]. - UBX1325 is currently in Phase 2 clinical development, with topline data from the ASPIRE study anticipated in the first quarter of 2025[225]. - The clinical development process is lengthy and expensive, with uncertain outcomes, and earlier positive results do not guarantee future success[231]. - The company may face significant delays or be unable to obtain regulatory approvals due to factors beyond its control, including unforeseen public health emergencies[228]. - The FDA has limited experience with senolytic medicines, which may complicate the regulatory approval process for the company's drug candidates[224]. - The company may face delays in obtaining regulatory approval for clinical studies due to various factors, including disagreements with regulatory authorities and difficulties in patient recruitment[234]. - The company’s drug candidates may cause undesirable side effects, which could lead to interruptions in clinical studies or regulatory approval delays[252]. - The company may incur unplanned costs and face delays in obtaining marketing approval for its drug candidates, which could harm its financial condition[241]. - Regulatory compliance is essential for drug candidates, with ongoing requirements for manufacturing, labeling, and post-marketing studies[329]. - The FDA's policies and regulations may change, impacting the approval process for drug candidates and potentially delaying commercialization[335]. Competition and Market Risks - The company faces significant competition from larger pharmaceutical and biotechnology companies, which may hinder its market penetration efforts[282]. - The commercial success of drug candidates will depend on broad adoption by physicians and patients, influenced by various factors including competition and reimbursement[266]. - The company is aware of competitors developing treatments for aging diseases, which may impact its market position if those products gain approval[283]. - The company may face significant competition in seeking appropriate collaborators for drug candidate commercialization, which could impact development efforts[298]. - Collaborators may not commit sufficient resources or may abandon drug candidates based on clinical study results, affecting the company's ability to commercialize products[299]. Intellectual Property and Legal Risks - The company owns, co-owns, or has exclusive licenses for over 170 patents and pending applications in the U.S. and foreign jurisdictions as of December 31, 2024[306]. - Intellectual property disputes can be costly and may adversely affect the company's business, operating results, and financial condition[302]. - The company may face allegations of infringing third-party intellectual property rights, which could lead to costly litigation[301]. - The outcome of any current or future litigation regarding intellectual property rights is uncertain and could materially impact the company's financial condition[304]. - The company uses a combination of patents, trademarks, and confidentiality procedures to protect its proprietary technology, but these protections may not be adequate[311]. - The company may not pursue patent protection in every country, which could limit its ability to protect its products and technology[308]. - Monitoring unauthorized use of intellectual property is challenging and may result in competitors offering similar products, reducing demand[322]. Operational and Management Challenges - The company has undergone restructuring efforts, reducing its headcount by approximately 29% to optimize resource allocation and focus on key clinical programs[203]. - The company has initiated restructuring efforts to focus on ongoing clinical programs and key development milestones, which are critical for financing and future revenue generation[226]. - Attracting and retaining key personnel is crucial for the successful development and commercialization of drug candidates, with competition in the biotechnology field being intense[276]. - The company has undergone restructuring to focus on key ophthalmology programs, particularly the UBX1325 program in DME[276]. - The company is vulnerable to natural disasters, such as earthquakes and wildfires, which could severely disrupt operations and adversely affect financial condition[377]. - Current disaster recovery and business continuity plans are limited, potentially leading to substantial expenses and material adverse effects on business operations[378]. - Significant disruptions in information technology systems or cybersecurity deficiencies could materially impact business results and financial condition[380]. - The company relies on third-party vendors for information technology infrastructure, increasing the risk of data breaches and unauthorized access to confidential information[381]. - Cybersecurity risks have increased due to the rise in attempted attacks, which could lead to loss of confidential information and damage to reputation[382]. - The company maintains cyber liability insurance, but it may not be sufficient to cover potential financial, legal, or reputational losses from security breaches[386]. Compliance and Regulatory Environment - The company must comply with various state and federal healthcare laws, which may impose additional operational constraints and reporting requirements[356]. - The company is exposed to significant penalties if found in violation of healthcare laws, which could include exclusion from government-funded healthcare programs[353]. - Future changes in U.S. tax legislation could adversely affect the company's financial condition and results of operations[354]. - Legislative changes, including the Affordable Care Act, have introduced significant costs and requirements for drug manufacturers, such as a 70% point-of-sale discount for Medicare beneficiaries during coverage gaps[345]. - The company is subject to a 23.1% minimum rebate requirement under the Medicaid Drug Rebate Program for branded drugs, which could impact financial performance[345]. - The Budget Control Act of 2011 has led to a 2% reduction in Medicare payments to providers, which will remain in effect through 2030, affecting the company's revenue[347]. - The company may face increased operational costs due to healthcare budgetary constraints and pricing restrictions in the European Union, impacting its ability to commercialize drug candidates[349].

Financial Performance - The net loss for the year ended December 31, 2024, was $26.0 million, a decrease from $39.9 million for the year ended December 31, 2023[5]. - The total net loss for the fourth quarter of 2024 was $8.4 million, compared to $4.3 million for the fourth quarter of 2023[5]. - The net loss per share for the year ended December 31, 2024, was $1.54, compared to $2.70 for the year ended December 31, 2023[12]. Cash and Cash Equivalents - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $23.2 million, down from $43.2 million as of December 31, 2023[4]. - The company anticipates that its current cash position is sufficient to fund operations into the fourth quarter of 2025[4]. Expenses - Research and development expenses decreased by $7.1 million to $13.0 million for the year ended December 31, 2024, compared to $20.1 million for the previous year[6]. - General and administrative expenses decreased by $3.5 million to $15.5 million for the year ended December 31, 2024, from $19.0 million for the year ended December 31, 2023[8]. - The total operating expenses for the fourth quarter of 2024 were $9.99 million, compared to $7.68 million for the fourth quarter of 2023[12]. Research and Development - The company expects to receive 24-week topline data from the Phase 2b ASPIRE study in diabetic macular edema (DME) in the first quarter of 2025[2]. - The Phase 2b ASPIRE study is designed to evaluate the safety and efficacy of UBX1325 in a head-to-head comparison to aflibercept[3].

Core Viewpoint - UNITY Biotechnology, Inc. is focused on developing therapeutics aimed at addressing diseases of aging, with a particular emphasis on diabetic macular edema (DME) through its candidate UBX1325, which is expected to provide a differentiated treatment option compared to existing therapies [2][4]. Financial Results - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $23.2 million, a decrease from $43.2 million as of December 31, 2023, but sufficient to fund operations into the fourth quarter of 2025 [4]. - The net loss for the year ended December 31, 2024, was $26.0 million, down from $39.9 million in 2023. For the fourth quarter of 2024, the net loss was $8.4 million compared to $4.3 million in the same quarter of 2023 [5]. - Cash used in operations for the year ended December 31, 2024, was $20.9 million, a reduction from $37.1 million in 2023. In the fourth quarter of 2024, cash used in operations was $5.9 million, down from $6.7 million in the fourth quarter of 2023 [5]. Research and Development - Research and development expenses decreased by $7.1 million to $13.0 million for the year ended December 31, 2024, primarily due to reduced personnel costs and the completion of previous studies. For the fourth quarter of 2024, R&D expenses were $3.1 million, slightly down from $3.3 million in the same quarter of 2023 [6]. - General and administrative expenses also saw a decrease of $3.5 million to $15.5 million for the year ended December 31, 2024, attributed to lower personnel costs and professional fees. In the fourth quarter, these expenses were $4.3 million, down from $4.4 million in the fourth quarter of 2023 [7]. Clinical Development - The company expects to receive 24-week topline data from its Phase 2b ASPIRE study in DME within the current quarter, with 36-week data anticipated in the second quarter of 2025. The study is designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept [2][3].

Core Viewpoint - UNITY Biotechnology, Inc. has granted a stock-based award to its new Chief Medical Officer, Federico Grossi, as part of its strategy to attract talent in the biotechnology sector focused on aging-related therapeutics [1][2]. Group 1: Stock-Based Award - The Compensation Committee of the Board granted options to purchase 150,000 shares of common stock to Federico Grossi [1]. - This award is part of the UNITY 2020 Employment Inducement Incentive Plan, which was approved by the Board in March 2020 [2]. Group 2: Company Focus - UNITY is developing therapeutics aimed at slowing, halting, or reversing diseases associated with aging, with a particular focus on age-related ophthalmologic and neurologic diseases [3].

Core Insights - UNITY Biotechnology, Inc. has appointed Dr. Federico Grossi as chief medical officer, enhancing its executive leadership team [1][2] - Dr. Grossi's experience in clinical development and regulatory strategy is expected to support UNITY's strategic vision and accelerate the development of new therapeutics [3][4] Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases of aging, particularly in ophthalmologic and neurologic diseases [5] - The company is currently advancing UBX1325, a treatment for diabetic macular edema (DME), with key data readout from the Phase 2b ASPIRE study expected soon [3][4] Leadership Experience - Dr. Grossi has over 20 years of experience in the biotech industry, including significant roles in clinical strategy and development at Apellis Pharmaceuticals [3] - His leadership at Apellis included overseeing multiple concurrent clinical studies and leading to the approval of therapies such as EMPAVELI and SYFOVRE [3]

Financial Performance - The net loss for the three months ended September 30, 2024, was $6,481,000, compared to a net loss of $14,782,000 for the same period in 2023, representing a 56.1% improvement[14]. - The company reported a comprehensive loss of $6,407,000 for the three months ended September 30, 2024, compared to a comprehensive loss of $14,701,000 for the same period in 2023[14]. - The company reported a net loss of $17.6 million for the nine months ended September 30, 2024, compared to a net loss of $35.5 million for the same period in 2023, representing a 50.5% improvement[20]. - The net loss per share, basic and diluted, for the three months ended September 30, 2024, was $(0.38), compared to $(1.01) for the same period in 2023[14]. - The company reported a net loss of $6,481,000 for the three months ended September 30, 2024, compared to a net loss of $14,782,000 for the same period in 2023[76]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $6,602,000, a decrease of 54.7% compared to $14,581,000 for the same period in 2023[14]. - Research and development expenses for the nine months ended September 30, 2024, were $9,971,000, down 40.9% from $16,828,000 in the same period of 2023[14]. - Total operating expenses for the three months ended September 30, 2024, were $6,602,000, down from $14,581,000 in the same period last year, indicating a 55% reduction[14]. - Research and development expenses for the three months ended September 30, 2024, were $56,000, compared to $405,000 for the same period in 2023[73]. - General and administrative expenses for the three months ended September 30, 2024, were $741,000, down from $1,300,000 in the same period of 2023[73]. Cash Flow and Liquidity - Total cash flows used in operating activities for the nine months ended September 30, 2024, were not detailed but are critical for assessing liquidity[19]. - Cash used in operating activities decreased to $15.0 million for the nine months ended September 30, 2024, from $29.5 million in the same period of 2023, indicating a 49.1% reduction[23]. - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $29.0 million, which is projected to be insufficient to fund its current business plan for at least the next 12 months[24]. - The company reported a net decrease in cash and cash equivalents of $10.9 million for the nine months ended September 30, 2024[20]. - The company had cash, cash equivalents, and restricted cash of $9.8 million at the end of the period, compared to $8.8 million at the same time last year[20]. Stockholder Equity - The company had total stockholders' equity of $14,144,000 as of September 30, 2024, down from $28,398,000 at the end of 2023[15]. - The company had an accumulated deficit of $501.9 million as of September 30, 2024, up from $484.4 million at the end of 2023[23]. - The total stockholders' equity as of September 30, 2024, was $14,144,000, a decrease from $28,398,000 at the end of 2023[15]. - The company has 16,850,350 shares of common stock issued and outstanding as of September 30, 2024, compared to 16,784,969 shares at December 31, 2023[58]. Financing Activities - The company plans to raise additional capital to finance its operations, as it continues to incur operating losses and negative cash flows[24]. - The company has financed its operations primarily through private placements and public equity issuances, and will continue to depend on equity and/or debt financing[23]. - The company received gross proceeds of $4.4 million from the exercise of Existing Warrants by holders[68]. - The company recorded stock-based compensation expense of $797,000 for the three months ended September 30, 2024, down from $1.7 million in 2023, indicating a 53% decrease[73]. - The company reported stock-based compensation of $3.2 million for the nine months ended September 30, 2024, down from $6.1 million in the same period of 2023[20]. Lease and Sublease Agreements - The total operating lease liability was $24.4 million as of September 30, 2024, down from $27.0 million as of December 31, 2023[47]. - Sublease income from Initial Therapeutics for the three months ended September 30, 2024, was $0.9 million, compared to $0.4 million for the same period in 2023, representing a 125% increase[51]. - The Company has total future minimum lease payments of $28.6 million, with a present value of $24.4 million as of September 30, 2024[54]. - The Company entered into a sublease agreement with Initial Therapeutics for an additional 17,000 square feet at a monthly rent of $1.00 per square foot, increasing to $6.02 per square foot starting July 1, 2024, with a 3.5% increase in 2025[51]. - Total lease expense for 2024 was $118,000, down from $157,000 in 2023, while sublease income increased from $(976,000) in 2023 to $(1,067,000) in 2024[52].

Financial Performance - Net loss for Q3 2024 was $6.5 million, a significant decrease from $14.8 million in Q3 2023, indicating a 56% improvement year-over-year[6] - The total operating expenses for Q3 2024 were $6.6 million, down from $14.6 million in Q3 2023, reflecting a 55% reduction[11] Cash and Assets - As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $29.0 million, down from $43.2 million as of December 31, 2023[5] - Total assets decreased to $47.1 million as of September 30, 2024, from $65.7 million as of December 31, 2023[12] - The company anticipates that current cash reserves will fund operations into Q3 2025[5] Expenses - Research and development expenses decreased by $1.8 million to $2.8 million in Q3 2024 from $4.6 million in Q3 2023, primarily due to reduced headcount and completion of studies[7] - General and administrative expenses decreased by $0.5 million to $3.8 million in Q3 2024 from $4.3 million in Q3 2023, attributed to lower personnel-related expenses[8] Future Expectations - The company expects topline 24-week primary endpoint data from the Phase 2b ASPIRE study in Q1 2025 and 36-week data in Q2 2025[4] - UNITY had a Type C interaction with the FDA regarding the development of UBX1325 for diabetic macular edema (DME), indicating a pivotal study will likely be a non-inferiority trial[2] Share Information - The weighted-average number of shares used in computing net loss per share for Q3 2024 was 16,849,283, compared to 14,598,218 in Q3 2023[11]

Core Insights - UNITY Biotechnology, Inc. reported its financial results for Q3 2024, highlighting a focus on developing therapeutics for aging-related diseases, particularly diabetic macular edema (DME) [1][5]. Company Developments - The CEO emphasized the significant unmet need in the DME market due to inadequate responses to current treatments and high treatment burdens [2]. - UNITY is advancing UBX1325 (foselutoclax), which utilizes a novel mechanism of action aimed at improving long-term visual outcomes for DME patients [2][3]. - A Type C interaction with the FDA indicated that a pivotal study for UBX1325 would likely need to be a non-inferiority trial against aflibercept, with best-corrected visual acuity as the primary endpoint [2][4]. Clinical Trials - The Phase 2b ASPIRE study is designed to evaluate the safety and efficacy of UBX1325 in comparison to aflibercept, with topline data expected in Q1 2025 and further data in Q2 2025 [4]. Financial Performance - As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $29.0 million, down from $43.2 million at the end of 2023, which is projected to fund operations into Q3 2025 [5]. - The net loss for Q3 2024 was $6.5 million, a decrease from $14.8 million in Q3 2023, with operational cash usage also reduced significantly [6]. - Research and development expenses decreased to $2.8 million from $4.6 million year-over-year, attributed to reduced personnel costs and the completion of certain studies [7]. - General and administrative expenses also saw a decline to $3.8 million from $4.3 million, primarily due to reduced headcount and lower bonus payments [8]. Balance Sheet Overview - Total assets as of September 30, 2024, were $47.1 million, down from $65.7 million at the end of 2023, with total liabilities at $33.0 million [12]. - The accumulated deficit increased to $501.9 million from $484.4 million, reflecting ongoing operational losses [12].