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].

Core Viewpoint - UNITY Biotechnology, Inc. (UBX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the changing earnings picture of a company [1][2]. - A strong correlation exists between changes in earnings estimates and near-term stock price movements, largely influenced by institutional investors who adjust their valuations based on these estimates [4]. Company Performance and Outlook - The upgrade for UNITY Biotechnology indicates an improvement in the company's underlying business, which is expected to positively impact its stock price [5]. - For the fiscal year ending December 2024, UNITY Biotechnology is projected to earn -$1.49 per share, representing a 45.6% change from the previous year, with a 24% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places UNITY Biotechnology in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - UNITY Biotechnology, Inc. reported its financial results for Q2 2024, highlighting progress in its clinical studies and a significant reduction in net loss compared to the previous year [1][5]. Financial Performance - Cash, cash equivalents, and marketable securities totaled $34.0 million as of June 30, 2024, down from $43.2 million as of December 31, 2023, indicating a decrease in liquidity [4]. - The net loss for Q2 2024 was $5.3 million, a significant reduction from $15.5 million in Q2 2023, reflecting improved operational efficiency [5]. - Cash used in operations during the first and second quarters of 2024 was $9.8 million, compared to $22.4 million in the same period of 2023, showing a decrease in operational cash burn [5]. Research and Development - Research and development expenses decreased by $3.0 million to $3.5 million in Q2 2024 from $6.4 million in Q2 2023, primarily due to reduced personnel costs and the completion of previous studies [6]. - General and administrative expenses also decreased by $1.9 million to $3.5 million in Q2 2024 from $5.4 million in Q2 2023, attributed to lower personnel-related expenses and professional fees [7]. Clinical Development - The ASPIRE study has been expanded to include 50 patients over 36 weeks to better assess the efficacy of UBX1325 compared to aflibercept, with enrollment goals exceeded [2][3]. - Topline data for the 24-week primary endpoint is expected in Q1 2025, with 36-week data anticipated in Q2 2025 [3]. 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 [8].

SOUTH SAN FRANCISCO, Calif., Aug. 06, 2024 (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, 2024. "Having expanded and extended our ASPIRE study to 50 patients and 36 weeks, respectively, to better assess the efficacy and durability of UBX1325 compared to aflibercept, we have been laser-focused on enrollment and execution this ...

Core Insights - UNITY Biotechnology, Inc. has appointed Alicia Tozier as chief strategy officer to develop and implement corporate and product strategies [1][6] - Ms. Tozier has 20 years of experience in the pharma and medical device industry, with a strong background in ophthalmology and a proven track record of successful product launches [2][6] - The company is focused on developing therapeutics to slow, halt, or reverse diseases of aging, particularly targeting age-related ophthalmologic and neurologic diseases [7] Company Overview - UNITY is a biotechnology company that aims to create medicines that selectively eliminate or modulate senescent cells [7] - The current lead program, UBX1325, is positioned to transform the treatment landscape for diabetic macular edema (DME) [6][7] - UNITY's strategic direction is expected to benefit from Ms. Tozier's expertise in commercial strategy and product planning [6] Leadership and Strategy - Alicia Tozier's previous roles include senior vice president at Outlook Therapeutics and head of ophthalmology at Genentech Pharmaceuticals, where she led significant market access and product launches [2][6] - The CEO of UNITY, Anirvan Ghosh, expressed confidence in Ms. Tozier's ability to drive the company's strategic vision and operational excellence [6] - Ms. Tozier is optimistic about UNITY's potential as it transitions into a late-stage clinical development organization [7]

UNITY Biotechnology, Inc. (UBX) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a changing ...

Unity Biotechnology, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________to _________ Commission File Number: 001-38470 (Exact Name of Registrant as Specified in its Charter) Delaware 26-4726035 (Sta ...

SOUTH SAN FRANCISCO, Calif., May 14, 2024 (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 first quarter ended March 31, 2024. Forward-Looking Statements "Our team remains focused on the enrollment and execution of our Phase 2b ASPIRE study in diabetic macular edema, comparing UBX1325 (foselutoclax) against aflibercept," said Anirvan Ghosh, Ph.D., chief exe ...

Financial Performance and Capital Resources - The company reported a net loss of $39.9 million for the year ended December 31, 2023, compared to $44.5 million in 2022[212] - As of December 31, 2023, the company had an accumulated deficit of $484.4 million[212] - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $43.2 million[217] - The company expects its existing capital resources to fund planned operating expenses into the third quarter of 2025, primarily for advancing UBX1325[213][219] - The company has shelf registration statements effective for up to $375.0 million in equity offerings, including $75.0 million through ATM offering programs[223][226] - The company's ability to raise capital is limited by SEC rules, allowing only one-third of its public float to be sold in any 12-month period if the public float is below $75.0 million[226] - The company's future capital requirements depend on factors such as clinical trial results, regulatory approval costs, and commercialization expenses[227][230] Restructuring and Operational Changes - The company reduced its headcount by 9 employees, approximately 29%, as part of restructuring efforts in May 2023[218] - The company has restructured to focus on its ophthalmology programs, optimize resource allocation, and extend its financial runway to achieve key clinical milestones for UBX1325[242] Clinical Development and Regulatory Risks - The company's core therapeutic approach focuses on cellular senescence, with its lead drug candidate UBX1325 targeting senescent cells in the eye, but this novel approach carries significant development and regulatory risks[237][238] - UBX1325 is currently in Phase 2 clinical trials for DME and nAMD, with positive 24-week and 48-week safety and efficacy data reported in 2022 and 2023[241] - The company's business is heavily dependent on the successful development of UBX1325, as it has no approved products and limited resources to develop other drug candidates[242] - Other than UBX1325, all of the company's programs are in preclinical or early research stages, facing substantial development and translational risks[245] - The company may face delays or failures in clinical trials due to factors such as regulatory disagreements, patient recruitment challenges, and supply chain disruptions[250] - Clinical development is a lengthy and expensive process with uncertain outcomes, and earlier study results may not predict future trial success[247] - The company may need to conduct additional clinical studies or testing beyond current plans, which could delay or prevent marketing approval and commercialization[251] - Clinical studies of drug candidates may produce negative or inconclusive results, potentially leading to modifications, additional studies, or abandonment of programs[252] - Delays in clinical studies due to patient enrollment challenges, higher dropout rates, or slower enrollment than anticipated[252] - Potential delays or termination of clinical studies due to regulatory noncompliance, safety issues, or unforeseen events like pandemics[253] - Risks associated with conducting clinical studies in foreign countries, including cultural differences, regulatory burdens, and political/economic risks[254] - Interim or preliminary clinical trial data may change as more patient data becomes available, leading to potential discrepancies in final results[262] - Disruptions at the FDA or other government agencies due to funding shortages or global health concerns could delay product approvals[267] - Undesirable side effects of drug candidates could delay or prevent regulatory approval, limit commercial profiles, or result in post-marketing issues[268] - The company's core therapeutic approach, based on eliminating senescent cells, has not yet been proven effective in treating diseases of aging[273] - Identifying and developing drug candidates for diseases of aging requires substantial funding and carries inherent risks of failure[274] - The company faces significant risks in obtaining regulatory approval for its drug candidates, including potential delays or denials due to safety and efficacy concerns[277][281] - The company has not previously submitted an NDA or BLA to the FDA, and regulatory filings require extensive preclinical and clinical data[278] Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for drug production, and any disruption in the supply chain could significantly impact its ability to develop and commercialize drug candidates[287][288] - The company's supply chain is complex and vulnerable to disruptions, including those caused by public health emergencies like COVID-19[288] - The company may face challenges in scaling up manufacturing capacity to meet anticipated market demand for its drug candidates[293] - The company relies on third-party suppliers for raw materials, and any supply interruption could harm its ability to manufacture drug candidates[297] Third-Party Dependencies and Collaboration Risks - The company depends on third parties for critical portions of its preclinical and clinical studies, and any failure by these third parties could delay regulatory approval[298] - The company relies on third parties for GLP-compliant preclinical studies and GCP-compliant clinical studies, with limited control over their performance[299] - Third-party failures in conducting studies could delay or terminate clinical trials, increasing costs and harming financial results[300] - Future collaborations for drug development and commercialization may not be successful or favorable to the company[321] - Collaborators may not devote the expected level of effort or resources, potentially delaying or terminating development programs[322] - Collaborators could independently develop competing products, impacting the company's market position[322] Competition and Market Risks - The company faces intense competition from larger pharmaceutical and biotechnology firms with greater resources and market penetration capabilities[302] - Competitors in the ophthalmology space include therapies like anti-VEGF antibodies, bispecific antibodies, and complement inhibitors[303] - Competitors may develop senolytic medicines using established molecules, potentially creating competitive drug candidates[304] - Pricing pressures from third-party payors and generic alternatives could limit the company's ability to charge competitive prices for its drug candidates[309] - The company currently lacks a sales organization and must build or partner to commercialize drug candidates, which is costly and time-consuming[317] Intellectual Property and Legal Risks - The company owns or has exclusive licenses to over 170 patents and pending applications globally, including 34 issued U.S. patents[330] - A key patent for UBX1325 extends exclusivity until 2039, not including potential adjustments or extensions[330] - Patent applications may be denied or narrowed, reducing protection for the company's products[331] - The company faces risks of third-party patent claims, which could result in substantial damages or redesign costs[325] - Competitors with greater resources may sustain litigation costs more effectively, potentially harming the company's financial position[329] - Changes in U.S. and international patent laws could increase uncertainties and costs for patent prosecution and enforcement[342] - International jurisdictions may offer weaker intellectual property protection, posing risks to the company's global business[343] - Intellectual property disputes may arise, leading to costly litigation and potential limitations on product commercialization[323] Product Liability and Insurance Risks - Product liability risks could result in substantial financial liabilities and limit commercialization efforts[318] - The company may face challenges in obtaining and maintaining sufficient product liability insurance coverage[320] Nasdaq Compliance and Stock Price Risks - The company regained compliance with Nasdaq's minimum bid price requirement after a 1-for-10 reverse stock split in October 2022[231] - The company may face delisting from Nasdaq if its stock price falls below $1.00 per share again, potentially leading to reduced liquidity and investor confidence[232] Operational and Financial Volatility - The company's operating results may fluctuate significantly due to factors such as R&D investment, clinical study enrollment, manufacturing costs, and regulatory approvals, making future performance difficult to predict[234] BIOSECURE Act and International Risks - Potential impact of the BIOSECURE Act on the company's ability to collaborate with Chinese biotech companies, affecting contracts and funding[255] Post-Approval Risks - The company's drug candidates may require costly additional clinical studies even after receiving regulatory approval, which could impact commercialization timelines[282] - The company's drug candidates may fail to achieve market acceptance due to factors such as competition, pricing, and physician preference[284][286] Personnel and Talent Risks - The company's success depends on its ability to attract and retain key personnel, and any loss of personnel could delay clinical trials and commercialization efforts[294]