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].

Financial Performance - As of June 30, 2024, Unity Biotechnology reported total assets of $53,522,000, a decrease of 18.5% from $65,690,000 on December 31, 2023[10]. - The company’s cash and cash equivalents decreased to $7,584,000 from $19,803,000, representing a decline of 61.7%[10]. - Total operating expenses for the six months ended June 30, 2024, were $14,578,000, an increase of 29.5% compared to $11,848,000 for the same period in 2023[12]. - The net loss for the six months ended June 30, 2024, was $11,069,000, a decrease of 28.5% from $15,456,000 in the same period of 2023[12]. - The company’s accumulated deficit increased to $495,422,000 as of June 30, 2024, compared to $484,353,000 on December 31, 2023[11]. - Total stockholders' equity decreased to $19,754,000 from $28,398,000, reflecting a decline of 30.5%[11]. - The company reported a comprehensive loss of $11,080,000 for the six months ended June 30, 2024, compared to $15,442,000 for the same period in 2023[12]. - The company reported a net loss of $11.1 million for the six months ended June 30, 2024, compared to a net loss of $20.7 million for the same period in 2023, representing a 46% improvement[17]. - Cash used in operating activities decreased to $9.8 million for the six months ended June 30, 2024, from $22.4 million in the same period of 2023, indicating a 56% reduction[19]. - The company incurred stock-based compensation expenses of $2.4 million for the six months ended June 30, 2024, down from $4.4 million in the same period of 2023[17]. - The company reported a net cash used in investing activities of $2.5 million for the six months ended June 30, 2024, compared to a net cash provided of $31.1 million in the same period of 2023[17]. - The company reported cash used in operating activities of $9.8 million for the six months ended June 30, 2024, primarily due to a net loss of $11.1 million[117]. - For the same period, cash used in operating activities was $22.4 million, with a net loss of $20.7 million[118]. Capital and Funding - The company plans to raise additional capital to finance its operations, as it has not generated any product revenue to date[19]. - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $34.0 million, which is projected to be insufficient to fund operations for the next 12 months[20]. - The company anticipates needing substantial additional funding to support ongoing operations and development programs[113]. - The company has primarily financed its operations through the sale of equity securities, with a shelf registration statement covering offerings of up to $375.0 million declared effective in 2022[142]. - The company plans to seek additional funding through collaborations, public or private equity offerings, or debt financings, which may result in dilution to stockholders[143]. - The company expects to incur operating losses and negative cash flows for at least the next several years as it continues research and development efforts[100]. - The company has not generated any product revenue to date and expects to incur significant losses as it develops drug candidates[112]. Research and Development - Research and development expenses for the six months ended June 30, 2024, were $7,184,000, compared to $12,195,000 for the same period in 2023, indicating a reduction of 41.2%[12]. - 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[71]. - In the ongoing Phase 2b ASPIRE study, the company has exceeded enrollment of approximately 50 participants with DME, aiming to evaluate UBX1325 against aflibercept[74]. - The ASPIRE study has been extended from 24 to 36 weeks to assess safety, efficacy, and durability, with topline results expected in Q1 and Q2 of 2025[75]. - The ENVISION study demonstrated that 40% of UBX1325-treated patients did not need anti-VEGF rescue through 48 weeks, with a median time to first rescue of 32 weeks[79]. - The company has narrowed its near-term focus mainly to ongoing ophthalmologic disease programs following the decision not to progress UBX0101 into pivotal studies[154]. - The company is currently dependent on the successful development of UBX1325, which is in early stages of clinical development[157]. - The company has initiated multiple clinical studies for UBX1325, including a Phase 2 proof-of-concept study in DME (BEHOLD) and nAMD (ENVISION)[157]. - The clinical and commercial success of UBX1325 will depend on factors such as the ability to raise additional capital and complete IND-enabling studies[159]. - The company has no products approved for sale, and all other drug candidates are in preclinical stages, facing significant development risk[161]. Operational Challenges - The company has not yet approved any drug product candidates for sale, which contributes to ongoing operating losses[19]. - The company has incurred significant losses since its inception in March 2009 and anticipates continuing losses for the foreseeable future as it develops drug candidates and conducts clinical studies[136]. - The company may face unforeseen risks in developing senolytic medicines due to the novel nature of the therapeutic approach and limited human clinical trial data[153]. - The company may face delays in clinical studies due to various factors, including regulatory requirements and patient enrollment challenges[164]. - Safety concerns related to senolytic medicines could negatively impact patient enrollment and increase costs, potentially delaying clinical studies[176]. - The company relies on third-party suppliers for the manufacturing of drug candidates, which poses risks if suppliers fail to meet regulatory requirements or quality standards[199]. - Logistical challenges in the supply chain are expected to grow as drug candidates progress through clinical trials, potentially impacting timelines[201]. - A specific manufacturer experienced a two-week shutdown due to a COVID-19 related incident, highlighting vulnerabilities in the supply chain[202]. - The company has not yet engaged manufacturers for commercial supply, which could adversely impact business if agreements are not reached[203]. - Disruptions to third-party manufacturers could significantly impact the ability to progress preclinical and clinical programs[204]. Stock and Market Considerations - The company received a notice from Nasdaq on June 3, 2022, indicating that the closing bid price of its common stock was below $1.00 per share, which is the minimum required for continued listing[147]. - A 1-for-10 reverse stock split was executed on October 19, 2022, to regain compliance with Nasdaq's listing standards, and compliance was achieved on November 3, 2022[147]. - The company may not be able to maintain compliance with Nasdaq's continued listing requirements, which could lead to delisting and adversely affect stock liquidity[146]. - Stock price volatility may affect the effectiveness of equity compensation strategies, impacting the ability to retain key employees[209]. Restructuring and Internal Controls - The company restructured in May 2023, reducing headcount by approximately 29% to optimize resource allocation and extend runway for ongoing clinical programs[79]. - The company plans to improve its review process for complex security transactions to address identified material weaknesses in its internal controls[127]. - The company has implemented restructuring actions to focus on key ophthalmology programs, which may lead to additional personnel loss despite retention efforts[208].

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 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].

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]

Exhibit 99.1 • In January, the Company published new research in Nature Medicine, "Therapeutics targeting of cellular senescence in diabetic macular edema: preclinical and phase 1 trial results" discussing the potential of UBX1325 to target senescence cells and thereby leading to long-lasting, disease-modifying intervention for DME • UBX1325 16-week safety and efficacy data from the Phase 2b ASPIRE DME study expected in the fourth quarter of 2024 • UBX1325 24-week safety and efficacy data from the Phase 2b ...