Core Insights - The 2025 World Robot Conference (WRC) opened with over 200 companies showcasing more than 1,500 exhibits, emphasizing the rapid development of a complete industrial chain in embodied intelligence [5][7] - Major players like UBTECH and Yushutech presented innovative humanoid robots, highlighting advancements in automation and the growing demand for industrial humanoid robots [6][12] - The event marked a shift from showcasing technology to practical applications, indicating that robots are moving from mere demonstrations to real-world problem-solving capabilities [12][13] Company Highlights - UBTECH showcased five humanoid robots and introduced a group intelligence technology for multi-task industrial scenarios, predicting a delivery volume of around 500 industrial humanoid robots in 2025, a 50-fold increase from 2024 [6][12] - Yushutech launched its A2 quadruped robot and R1 humanoid robot, with the R1 priced at 39,900 yuan, demonstrating advanced movement capabilities [7][8] - JD.com made a significant presence at WRC, announcing an investment of over 10 billion yuan in the smart robot sector and setting ambitious sales targets for robot brands [8][10] Industry Trends - The conference highlighted a trend towards integrating embodied intelligence across various sectors, with companies like Hesai Technology and Suteng Technology showcasing laser radar products for humanoid robots [8][9] - The emergence of the Robot Mall, a 4S store for robots, signifies a new retail model that combines sales, service, and customer experience in the robotics industry [10][11] - The focus of the conference shifted from flashy demonstrations to practical applications, with robots now capable of performing complex tasks, indicating a maturation of the industry [12][13]

UBX1325 ASPIRE Study Results - UBX1325 showed a BCVA gain of 5.2 letters at week 24 and 5.5 letters at week 36[5] - Approximately 40% of UBX1325 patients did not require supplemental anti-VEGF treatment through week 36[5] - UBX1325 generally outperformed Aflibercept in subjects with less aggressive disease (baseline CST < 400 µm)[39] - Patients switching from Aflibercept to UBX1325 experienced consistent gains in BCVA and less variable CST[5, 39] - UBX1325 was non-inferior to Aflibercept at most time points through 36 weeks, but did not meet non-inferiority at the average of weeks 20 and 24 in the primary analysis[5] Market Opportunity and Unmet Needs in DME - The global Diabetic Macular Edema (DME) market is projected to reach $9.6 billion by 2031, with the US market reaching $5.5 billion[43] - Over 50% of patients discontinue anti-VEGF treatment by 6 months[43] - 58% of patients with DME exhibit suboptimal response to anti-VEGF therapies[43] - 28% of patients require frequent dosing (every 4 weeks) with current anti-VEGF treatments[43]

Core Insights - UBX1325 demonstrated vision gains comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat diabetic macular edema (DME) patient population [1][3] - The company plans to explore strategic alternatives to advance UBX1325 and reduce operational cash burn [1][4] Clinical Trial Results - The Phase 2b ASPIRE study showed that UBX1325 was non-inferior to aflibercept at week 36, with superior vision gains in patients with central subfield thickness (CST) <400 microns [1][6] - The ASPIRE study enrolled 52 subjects, randomized to receive either UBX1325 or aflibercept every eight weeks for six months [9] Corporate Strategy - The Board of Directors approved a revised operating plan focused on evaluating strategic alternatives, which may include asset sales, licensing, or partnerships [4] - The company will implement a reduction in force affecting its entire workforce to support the new operating plan [4] Product Overview - UBX1325 is an investigational compound targeting retinal diseases, specifically DME, and is a potent small molecule inhibitor of BCL-xL [10] - The compound has shown a favorable safety and tolerability profile, with no cases of intraocular inflammation or other serious adverse events reported across multiple studies [6][10] Future Plans - The company is exploring partnerships to further develop UBX1325, aiming to leverage the capabilities of companies with existing ophthalmic franchises [3] - Full results from the ASPIRE study will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting [3]

Core Insights - UNITY Biotechnology, Inc. is set to present 36-week data from the ASPIRE Phase 2B study at the ARVO 2025 Annual Meeting, focusing on therapeutics aimed at diseases of aging [1] - The presentation will cover the safety and efficacy of the senolytic candidate UBX1325 for Diabetic Macular Edema, highlighting findings from the BEHOLD Phase 2 and ASPIRE Phase 2B trials [2] Company Overview - UNITY is developing a new class of therapeutics designed to slow, halt, or reverse diseases associated with aging, with a current focus on age-related ophthalmologic and neurologic diseases [3]

Core Insights - UNITY Biotechnology, Inc. announced positive results from the Phase 2 BEHOLD study of UBX1325 for diabetic macular edema (DME), indicating potential for long-lasting vision improvements through selective clearance of senescent cells [1][2] - The BEHOLD study demonstrated that a single injection of UBX1325 led to statistically significant and clinically meaningful improvements in visual acuity for up to 48 weeks in patients with advanced DME [2][4] Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases of aging, particularly through the elimination or modulation of senescent cells [5] - UBX1325 is an investigational compound targeting retinal diseases, specifically designed to inhibit proteins that senescent cells rely on for survival [4] Study Details - The BEHOLD study was a multi-center, randomized, double-masked, sham-controlled trial involving 65 patients with persistent visual acuity deficits despite anti-VEGF treatment [3] - Patients in the study had an average visual acuity of 61.4 ETDRS letters and a central subfield thickness (CST) of approximately 439.6 microns at baseline [3] Future Developments - UNITY is conducting a Phase 2b ASPIRE study to evaluate multiple doses of UBX1325 in comparison to aflibercept, with topline data expected in the second quarter of 2025 [2][4]

Financial Performance - The company reported net losses of $7.3 million and $5.8 million for the three months ended March 31, 2025 and 2024, respectively, with an accumulated deficit of $517.6 million as of March 31, 2025[88]. - The company incurred a net loss of $7.3 million for the three months ended March 31, 2025, compared to a net loss of $5.8 million for the same period in 2024, representing an increase in loss of $1.5 million[100]. - Cash used in operating activities for Q1 2025 was $6.4 million, compared to $5.2 million in Q1 2024, reflecting a net loss of $7.3 million in 2025 and $5.8 million in 2024[123][124]. - The company expects to continue incurring net operating losses for several years as it advances drug candidates through clinical development and seeks regulatory approval[111]. - As of March 31, 2025, the company had an accumulated deficit of $517.6 million and does not expect positive cash flows from operations in the foreseeable future[107]. Research and Development - The Phase 2 BEHOLD study of UBX1325 showed a mean improvement in best corrected visual acuity (BCVA) of +6.2 ETDRS letters from baseline at 24 weeks, compared to +7.6 ETDRS letters compared to sham treatment (p=0.0084)[76]. - In the Phase 2b ASPIRE study, UBX1325 was non-inferior to aflibercept at week 24, with a +5.2 letter gain in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks[82]. - Approximately 50% of UBX1325-treated patients did not require any additional injections through 48 weeks, compared to only 22% in the sham arm[78]. - The company completed enrollment of 52 participants in the ASPIRE study, which is designed to evaluate UBX1325 against aflibercept in patients with active diabetic macular edema (DME)[79]. - The company anticipates receiving full 36-week topline data from the ASPIRE study in the second quarter of 2025[82]. - The company has maintained a favorable safety and tolerability profile for UBX1325 across multiple clinical studies, with no cases of intraocular inflammation reported[82]. Funding and Capital Resources - The company expects existing capital resources to fund planned operating expenses into the fourth quarter of 2025, raising concerns about its ability to continue as a going concern[89]. - The company received approximately $4.4 million from an inducement offer to exercise existing warrants at a reduced price, which will be used for working capital and clinical trial progression[87]. - The company anticipates needing substantial additional funding to support ongoing operations and development programs[117]. - The company has not sold any shares under its shelf registration statements during the three months ended March 31, 2025, indicating a lack of capital raising activity[115]. Expenses and Cash Flow - Research and development expenses decreased by $0.9 million to $2.8 million for the three months ended March 31, 2025, primarily due to a reduction in direct research expenses and personnel costs[101]. - General and administrative expenses increased by $0.2 million to $4.1 million for the three months ended March 31, 2025, mainly due to higher professional fees and reduced sublease income[102]. - Interest income decreased to $0.3 million for the three months ended March 31, 2025, down from $0.5 million in the same period in 2024, attributed to decreased cash on hand[104]. - The company reported an unrealized loss of $0.6 million on warrant liability for the three months ended March 31, 2025, compared to a gain of $1.4 million for the same period in 2024[105]. - The company incurred non-cash charges of $0.2 million in Q1 2025, primarily from stock-based compensation of $0.6 million and unrealized loss on warrant liability of $0.6 million[123]. - The net increase in cash, cash equivalents, and restricted cash for Q1 2025 was $419,000, contrasting with a decrease of $12.4 million in Q1 2024[121]. - Cash provided by investing activities in Q1 2025 was $6.8 million, primarily from maturities of marketable securities of $7.8 million, while Q1 2024 saw cash used in investing activities of $7.2 million due to purchases of marketable securities of $13.5 million[125]. Market Risks and Operational Strategy - The company is exposed to market risks primarily related to interest rate sensitivities, but believes that a 1% movement in market interest rates would not significantly impact the total value of its portfolio[136]. - The company aims to reduce operating expenses and is focused on the progress and costs of its drug candidates' research and development[122]. - The company has various license agreements that obligate it to make milestone payments related to clinical development and sales milestones, as well as tiered royalties in the low-single digits based on sales[128]. - There were no cash flows from financing activities in both Q1 2025 and Q1 2024[126]. - The company has not entered into any off-balance sheet arrangements[132].

First Quarter 2025 Financial Results and Business Updates UNITY Biotechnology reported Q1 2025 financial results, including a net loss increase and decreased cash, alongside updates on the UBX1325 Phase 2b ASPIRE study [Business Highlights](index=1&type=section&id=Business_Highlights) UNITY's UBX1325 Phase 2b ASPIRE study showed comparable vision improvements, but missed the primary endpoint at weeks 20/24, though interim 36-week data showed non-inferiority [UBX1325 Phase 2b ASPIRE Study in DME](index=1&type=section&id=UBX1325_ASPIRE_Study) The UBX1325 Phase 2b ASPIRE study in DME showed vision improvements comparable to aflibercept, with non-inferiority at week 36 - UBX1325 showed vision improvements generally comparable to the aflibercept control in DME patients[2](index=2&type=chunk) - The Phase 2b ASPIRE study did not meet the primary endpoint of statistical non-inferiority to aflibercept based on BCVA average at weeks 20 and 24[2](index=2&type=chunk) - UBX1325 was **non-inferior to aflibercept at week 36**, based on interim data[2](index=2&type=chunk) - UNITY anticipates receiving the full 36-week data in the second quarter of 2025, which will be instrumental in shaping plans for subsequent studies[3](index=3&type=chunk) [Financial Performance Overview](index=1&type=section&id=Financial_Performance_Overview) UNITY reported a Q1 2025 net loss of **$7.3 million**, an increase from Q1 2024, with cash decreasing to **$16.9 million** and funds expected into Q4 2025 [Cash Position and Runway](index=1&type=section&id=Cash_Position_Runway) UNITY's cash, cash equivalents, and marketable securities decreased to **$16.9 million**, sufficient to fund operations into Q4 2025 | Metric | As of March 31, 2025 | As of December 31, 2024 | Change | | :-------------------------------- | :------------------- | :-------------------- | :----- | | Cash, cash equivalents and marketable securities | $16.9 million | $23.2 million | -$6.3 million | - UNITY believes that current cash, cash equivalents and marketable securities are sufficient to fund operations into the **fourth quarter of 2025**[4](index=4&type=chunk) [Operating Expenses](index=1&type=section&id=Operating_Expenses) Research and development expenses decreased by **$0.8 million**, while general and administrative expenses increased by **$0.1 million** in Q1 2025 | Expense Category | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) | | :----------------------- | :-------------------- | :-------------------- | :----------- | | Research and development | $2.9 | $3.7 | -$0.8 | | General and administrative | $4.0 | $3.9 | +$0.1 | - The decrease in research and development expenses was primarily due to the near completion of the Phase 2 ASPIRE study of UBX1325 in DME and reduced headcount[6](index=6&type=chunk) - The increase in general and administrative expenses was primarily due to higher professional fees, accounting service fees, and operating costs, partially offset by reduced personnel-related expenses and stock-based compensation[7](index=7&type=chunk) [Detailed Financial Statements](index=3&type=section&id=Detailed_Financial_Statements) This section provides unaudited Statements of Operations and Condensed Balance Sheets for Q1 2025, detailing financial performance and position [Statements of Operations and Comprehensive Loss](index=3&type=section&id=Statements_of_Operations) The unaudited Statement of Operations shows a net loss of **$7.3 million** for Q1 2025, an increase from **$5.8 million** in Q1 2024 | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $2,772 | $3,721 | | General and administrative | $4,119 | $3,878 | | Total operating expenses | $6,891 | $7,599 | | Loss from operations | $(6,891) | $(7,599) | | Interest income | $260 | $513 | | (Loss) gain on warrant liability | $(610) | $1,376 | | Net loss | $(7,302) | $(5,790) | | Net loss per share, basic and diluted | $(0.43) | $(0.34) | [Condensed Balance Sheets](index=4&type=section&id=Condensed_Balance_Sheets) The Condensed Balance Sheets show total assets decreased to **$30.3 million** and total stockholders' deficit increased to **$(0.2) million** as of March 31, 2025 | Metric (in thousands) | March 31, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------- | :---------------- | | Cash and cash equivalents | $7,999 | $7,580 | | Short-term marketable securities | $8,934 | $15,650 | | Total current assets | $17,647 | $24,267 | | Total assets | $30,347 | $37,662 | | Total current liabilities | $9,066 | $9,260 | | Total liabilities | $30,552 | $31,168 | | Total stockholders' (deficit) equity | $(205) | $6,494 | [About UNITY Biotechnology, Inc.](index=2&type=section&id=About%20UNITY%20Biotechnology%2C%20Inc.) UNITY Biotechnology develops therapeutics to address age-related ophthalmologic and neurologic diseases by targeting senescent cells - UNITY is developing a new class of therapeutics to slow, halt, or reverse diseases of aging[8](index=8&type=chunk) - The company's current focus is on creating medicines to selectively eliminate or modulate senescent cells for age-related ophthalmologic and neurologic diseases[8](index=8&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements regarding UNITY's therapeutics, clinical plans, and cash runway, with a disclaimer on inherent risks - The press release contains forward-looking statements related to UNITY's understanding of cellular senescence, potential therapeutics, clinical study plans for UBX1325, and cash runway[9](index=9&type=chunk) - These statements involve substantial known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially[9](index=9&type=chunk) - Readers should not place undue reliance on these statements and are advised to refer to UNITY's SEC filings for a further description of risks and uncertainties[9](index=9&type=chunk) [Contact Information](index=5&type=section&id=Contact%20Information) Contact details are provided for media inquiries via Inizio Evoke Comms and investor relations through LifeSci Advisors, LLC - Media contact: Katherine Smith at Inizio Evoke Comms[14](index=14&type=chunk) - Investor contact: Joyce Allaire at LifeSci Advisors, LLC[14](index=14&type=chunk)

Core Viewpoint - UNITY Biotechnology, Inc. reported its financial results for Q1 2025, highlighting ongoing clinical trials and financial performance, including a net loss and cash position [1][4][5]. Financial Performance - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $16.9 million, down from $23.2 million as of December 31, 2024, with expectations to fund operations into Q4 2025 [4]. - The net loss for Q1 2025 was $7.3 million, compared to a net loss of $5.8 million in Q1 2024, with cash used in operations increasing to $6.4 million from $5.2 million year-over-year [5]. - Research and development expenses decreased by $0.9 million to $2.9 million, primarily due to reduced direct research costs and personnel expenses [6]. - General and administrative expenses increased by $0.2 million to $4.0 million, driven by higher professional fees and operating costs, partially offset by reduced personnel-related expenses [7]. Clinical Development - UNITY announced topline data from the Phase 2b ASPIRE study for diabetic macular edema (DME), showing vision improvements with UBX1325 comparable to aflibercept, although the primary endpoint was not met at weeks 20 and 24 [2][3]. - The full 36-week data is anticipated in Q2 2025, which will inform future study plans [3]. Company Overview - UNITY is focused on developing therapeutics aimed at slowing, halting, or reversing diseases of aging, particularly targeting age-related ophthalmologic and neurologic diseases [8].

Core Viewpoint - Shares of UNITY Biotechnology (UBX) fell by 28.8% following mixed results from a mid-stage study comparing its candidate UBX1325 to Regeneron's Eylea in diabetic macular edema (DME) patients [1] Group 1: Study Results - The phase IIb ASPIRE study aimed to demonstrate non-inferiority of UBX1325 to Eylea, measured by mean change in Best Corrected Visual Acuity from baseline to weeks 20 and 24 [2] - The study included 52 DME patients with poor vision despite prior anti-VEGF treatment, randomized to receive either 10 μg UBX1325 or 2 mg Eylea [2] - At weeks 24 and 36, patients treated with UBX1325 showed a +5.2 letter improvement in visual acuity at 24 weeks and a +5.5 letter gain at 36 weeks, indicating vision gains non-inferior to Eylea [3] Group 2: Statistical Analysis - UBX1325 demonstrated statistically significant non-inferiority to Eylea at all time points up to 36 weeks, except for the average of weeks 20 and 24, where it met non-inferiority at an 88% confidence interval, just below the 90% threshold [4] - Year to date, shares of UNITY Biotechnology have increased by 33.1%, compared to the industry's growth of 5.6% [4] Group 3: Safety and Efficacy - UBX1325 showed a favorable safety and tolerability profile across multiple clinical studies, with no reported cases of intraocular inflammation or other serious adverse events [7] - Patients with moderate disease severity (baseline CST less than 400 microns) showed better performance with UBX1325, comprising about 60% of the study population [6] Group 4: Competitive Landscape - Eylea, developed by Regeneron, is a leading drug for various eye diseases, already approved for multiple conditions including DME and wet age-related macular degeneration [8]

Core Insights - Unity Biotechnology's stock (UBX) experienced a significant decline of 34.8%, closing at $1.19, following the release of results from its Phase 2b ASPIRE clinical trial for UBX1325 [4] Group 1: Clinical Trial Results - The Phase 2b ASPIRE clinical trial involved patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment, with data collected through 24 weeks for all patients and most through 36 weeks [1] - UBX1325 treatment resulted in visual acuity gains of over 5 letters from baseline at both 24 and 36 weeks, demonstrating non-inferiority to Regeneron Pharmaceuticals' Eylea (aflibercept) at 9 out of 10 time points through 36 weeks [2][6] - At 24 weeks, UBX1325-treated patients had a mean change in Best Corrected Visual Acuity (BCVA) of +5.2 ETDRS letters, which was +0.4 letters better than the aflibercept arm; at 36 weeks, the mean change was +5.5 ETDRS letters, with a +0.2 letter difference compared to aflibercept [6] Group 2: Safety and Financials - UBX1325 continues to show a favorable safety and tolerability profile, with complete 36-week data results expected in the second quarter of 2025 [4] - As of December 31, 2024, Unity had cash, cash equivalents, and marketable securities totaling $23.2 million, which is projected to fund operations into the fourth quarter of 2025 [4] Group 3: Patient Outcomes - Patients treated with UBX1325 generally outperformed those on aflibercept, particularly those with moderate disease severity (baseline Central Subfield Thickness < 400 microns, representing approximately 60% of study patients) [6] - Patients who switched from aflibercept to UBX1325 before study enrollment exhibited the most consistent and durable vision gains [6]