Unity Biotechnology(UBX)

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UNITY Biotechnology, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
Newsfilter· 2024-04-15 11:00
SOUTH SAN FRANCISCO, Calif., April 15, 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 fourth quarter and full year ended December 31, 2023. "On the heels of positive BEHOLD data, our team is currently single-mindedly focused on the enrollment and execution of our Phase 2b ASPIRE study in diabetic macular edema, comparing UBX1325 (foselutoclax) agains ...
Unity Biotechnology(UBX) - 2023 Q4 - Earnings Call Transcript
2024-02-27 01:30
I think you said 23% of the subscription business to the majority of it over time. And then I have a follow-up. Thank you. Yeah, well, I will start and maybe I'll just give you a little bit of color on a couple of the use cases. And I'm going to try to take names out of it, because honestly, I'm not sure who we actually have commitments to be able to use their names. So and let me just do several real quick. So one is there are a number of luxury retailers who don't necessarily have all of their inventory i ...
Unity Biotechnology(UBX) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
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 September 30, 2023 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 Unity Biotechnology, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other juri ...
Unity Biotechnology(UBX) - 2023 Q3 - Earnings Call Transcript
2023-11-10 01:10
Finally, during today's meeting, we will discuss non-GAAP financial measures. Now, these non-GAAP financial measures are in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with GAAP. A full reconciliation of GAAP to non-GAAP is available in our shareholder letter and on the sec.gov website. You can find more information about these risks and uncertainties in the Risk Factors section of our filings at sec.gov. Actual results may differ, and we take ...
Unity Biotechnology(UBX) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
Financial Performance - The company reported net losses of $12.2 million and $13.1 million for the three months ended June 30, 2023 and 2022, respectively, and $23.1 million and $32.1 million for the six months ended June 30, 2023 and 2022, respectively [115]. - The net loss for the three months ended June 30, 2023, was $12.2 million, an improvement of $0.93 million compared to a net loss of $13.1 million for the same period in 2022 [130]. - The company incurred a net loss of $23.1 million for the six months ended June 30, 2023, compared to a net loss of $32.1 million for the same period in 2022, reflecting an improvement of $8.98 million [138]. - The company expects to continue incurring net operating losses for at least the next several years as it advances its drug candidates through clinical development [117]. - The company anticipates significant future funding requirements as it has not generated any product revenue and expects to incur increasing losses [149]. Accumulated Deficit and Cash Flow - As of June 30, 2023, the company had an accumulated deficit of $483.0 million and does not expect positive cash flows from operations in the foreseeable future [115]. - The company reported an accumulated deficit of $483.0 million as of June 30, 2023, with no products approved for sale and no revenue generated from product sales [138]. - The company expects its existing capital resources to fund planned operating expenses into the fourth quarter of 2024, primarily to advance the UBX1325 program [139]. - The company anticipates needing to raise additional capital to finance operations, as it has historically relied on equity and debt financing [142]. Research and Development - The company plans to initiate a head-to-head Phase 2b study (ASPIRE study) in the second half of 2023, comparing UBX1325 to aflibercept in patients with diabetic macular edema (DME) [107]. - In the BEHOLD study, a single injection of UBX1325 led to a statistically significant improvement in best-corrected visual acuity (BCVA) of +6.2 ETDRS letters from baseline at 24 weeks [105]. - Approximately 50% of UBX1325-treated patients did not require any additional injections through 48 weeks, compared to only 22% in the sham arm [107]. - The Phase 2b ASPIRE study is expected to enroll about 40 subjects, with 16-week data readout anticipated in the fourth quarter of 2024 [111]. Operating Expenses - Research and development expenses decreased by $1.1 million to $6.5 million for the three months ended June 30, 2023, compared to $7.6 million for the same period in 2022 [131]. - Total operating expenses for the three months ended June 30, 2023, were $11.96 million, a decrease of $0.53 million from $12.49 million in the same period of 2022 [130]. - General and administrative expenses increased by $0.5 million to $5.4 million for the three months ended June 30, 2023, compared to $4.9 million for the same period in 2022 [134]. Financing and Capital Resources - The company entered into a Loan Agreement with Hercules Capital, Inc., receiving $25.0 million, with an amortization date extended to April 1, 2023 [143]. - The outstanding principal amount of the term loan under the Hercules Loan Agreement was $16.8 million as of June 30, 2023 [169]. - The company closed an underwritten offering in August 2022, issuing 6,428,571 shares with net proceeds of approximately $41.7 million [146]. - The company has no committed external source of funds and plans to finance future cash needs through various means, including equity sales and debt [150]. - The company has entered into various license agreements obligating it to make milestone payments and tiered royalties based on sales of licensed products [160]. Cash Flow Activities - The company reported cash used in operating activities of $22.4 million for the six months ended June 30, 2023, compared to $29.8 million for the same period in 2022 [152][154]. - Cash provided by investing activities was $31.1 million for the six months ended June 30, 2023, primarily from maturities of marketable securities [155]. - Cash used in financing activities was $2.4 million for the six months ended June 30, 2023, mainly due to a $3.2 million principal repayment of long-term debt [157]. Restructuring and Operational Changes - The company has implemented restructuring actions, reducing headcount by approximately 29% to focus resources on ongoing clinical programs [114]. - The COVID-19 pandemic has impacted clinical trial operations, but the company has not experienced disruptions in the supply chain for drug manufacturers necessary for its studies [119]. Interest Rate and Investment Activities - The effective interest rate on the term loan was 20.03% as of June 30, 2023 [169]. - A hypothetical 1% change in interest rates would increase interest expense by approximately $0.1 million annually [169]. - The company aims to preserve capital while maximizing income from investments without assuming significant risk [168]. - The company believes its exposure to interest rate risk is not significant due to the short-term nature of its investments [168]. - Interest payments under the term loan may increase if market interest rates rise, impacting overall financial performance [169]. - The interest on the term loan accrues at a per annum rate of the greater of the Wall Street Journal prime rate plus 6.10% or 9.35% [169]. - The company’s investment activities primarily consist of bank deposits, money market funds, and marketable securities [168]. - A 1% movement in market interest rates would not have a significant impact on the total value of the company's investment portfolio [168].
Unity Biotechnology(UBX) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
PART I. FINANCIAL INFORMATION This section provides the company's unaudited financial statements and related disclosures [Item 1. Condensed Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents Unity Biotechnology's unaudited condensed financial statements and notes, detailing **Q1 2023** financial changes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section summarizes the company's financial position at **March 31, 2023**, and **December 31, 2022** Condensed Balance Sheets | Metric | March 31, 2023 (Unaudited, in thousands) | December 31, 2022 (Audited, in thousands) | Change (3M) | | :-------------------------------- | :--------------------------------------- | :-------------------------------------- | :---------- | | Cash and cash equivalents | **$22,972** | **$12,736** | **+$10,236** | | Short-term marketable securities | **$60,420** | **$82,059** | **-$21,639** | | Total current assets | **$86,381** | **$96,535** | **-$10,154** | | Total assets | **$114,255** | **$124,350** | **-$10,095** | | Total current liabilities | **$21,858** | **$19,620** | **+$2,238** | | Total liabilities | **$55,627** | **$57,502** | **-$1,875** | | Total stockholders' equity | **$58,628** | **$66,848** | **-$8,220** | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance and comprehensive loss for **Q1 2023** and **Q1 2022** Condensed Statements of Operations and Comprehensive Loss | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Change (YoY) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :----------- | | Research and development | **$5,835** | **$12,461** | **-$6,626** | | General and administrative | **$4,818** | **$5,806** | **-$988** | | Total operating expenses | **$10,653** | **$18,267** | **-$7,614** | | Loss from operations | **$(10,653)** | **$(18,267)** | **+$7,614** | | Interest income | **$855** | **$29** | **+$826** | | Interest expense | **$(1,002)** | **$(808)** | **-$194** | | Net loss | **$(10,865)** | **$(18,915)** | **+$8,050** | | Net loss per share, basic and diluted | **$(0.76)** | **$(2.80)** | **+$2.04** | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in stockholders' equity from **December 31, 2022**, to **March 31, 2023** Condensed Statements of Stockholders' Equity | Metric | December 31, 2022 (in thousands) | March 31, 2023 (in thousands) | Change (3M) | | :-------------------------- | :------------------------------- | :------------------------------ | :---------- | | Total Stockholders' Equity | **$66,848** | **$58,628** | **-$8,220** | | Additional paid-in capital | **$527,049** | **$529,593** | **+$2,544** | | Accumulated deficit | **$(459,951)** | **$(470,816)** | **-$10,865** | | Common Stock Shares (Dec 31, 2022) | **14,215,302** | **14,359,214** | **+143,912** | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the company's cash flow activities for **Q1 2023** and **Q1 2022** Condensed Statements of Cash Flows | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Change (YoY) | | :------------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :----------- | | Cash used in operating activities | **$(11,316)** | **$(14,972)** | **+$3,656** | | Cash provided by (used in) investing activities | **$21,278** | **$(5,817)** | **+$27,095** | | Cash provided by financing activities | **$274** | **$4,330** | **-$4,056** | | Net increase (decrease) in cash, cash equivalents and restricted cash | **$10,236** | **$(16,459)** | **+$26,695** | | Cash, cash equivalents and restricted cash at end of period | **$23,868** | **$17,892** | **+$5,976** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides an overview of Notes to Condensed Financial Statements [1. Organization](index=7&type=section&id=1.%20Organization) Unity Biotechnology, Inc. develops senolytic medicines for aging diseases, facing **going concern** doubt due to losses, partially alleviated by expenditure reductions - **Unity Biotechnology, Inc.** is a biotechnology company engaged in the research and development of therapeutics to slow, halt, or reverse diseases of aging, with a focus on **senolytic medicines**[25](index=25&type=chunk) Metric | Metric | March 31, 2023 (in millions) | December 31, 2022 (in millions) | | :--------------------- | :--------------------------- | :------------------------------ | | Accumulated Deficit | **$470.8** | **$460.0** | | Net Loss (Q1) | **$10.9** | **$18.9** | | Net Cash Used in Ops (Q1) | **$11.3** | **$15.0** | | Cash, Equivalents, Marketable Securities | **$83.4** | N/A | - The company's financial condition raised **substantial doubt** about its ability to continue as a **going concern**, which has been partially alleviated by a **29% reduction in force** and reduced clinical program spending. Future viability depends on raising additional capital[27](index=27&type=chunk) [2. Summary of Significant Accounting Policies](index=7&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Condensed financial statements follow **GAAP** and **SEC** rules, retroactively applying a **1-for-10 reverse stock split** and adopting new **ASUs** with no **material impact** - A **1-for-10 reverse stock split** was effected on **October 19, 2022**, and all share and per share amounts have been retroactively restated[31](index=31&type=chunk) - The company adopted **ASU 2016-13** (Financial Instruments—Credit Losses) and **ASU 2021-10** (Government Assistance) on **January 1, 2023**, with no **material impact** on its condensed consolidated financial statements[35](index=35&type=chunk)[36](index=36&type=chunk) [3. Fair Value Measurements](index=9&type=section&id=3.%20Fair%20Value%20Measurements) The company measures financial assets and liabilities using a three-level **fair value hierarchy**, with **$80.226 million** in assets primarily in **Level 1** and **Level 2** securities - The company uses a **fair value hierarchy** (**Level 1**, **2**, **3**) for financial instruments, prioritizing observable inputs[37](index=37&type=chunk) Asset Category | Asset Category | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :----------------------------- | :---------------------------- | :----------------------------- | | Total assets subject to fair value measurements | **$80,226** | **$87,142** | | Money market funds (Level 1) | **$18,910** | **$5,083** | | Long-term certificates of deposits (Level 2) | **$896** | — | | U.S. treasuries (Level 2) | **$8,728** | **$30,758** | | U.S. government debt securities (Level 2) | **$51,692** | **$51,301** | [4. Marketable Securities](index=10&type=section&id=4.%20Marketable%20Securities) Marketable securities, primarily short-term, decreased to **$79.330 million**, with the company intending to hold unrealized losses until maturity or recovery Metric | Metric | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :----------------------------- | :---------------------------- | :----------------------------- | | Total Marketable Securities (Fair Value) | **$79,330** | **$87,142** | | Unrealized Gains | **$13** | **$7** | | Unrealized Losses | **$(163)** | **$(259)** | | Net Unrealized Loss | **$(150)** | **$(252)** | - All **available-for-sale securities** have remaining contractual maturities of less than **one year**. The company has the ability and intent to hold securities in a continuous **loss position** until maturity or recovery, and no significant credit losses were recorded[40](index=40&type=chunk) [5. License Revenue and Agreements](index=10&type=section&id=5.%20License%20Revenue%20and%20Agreements) The company holds various license agreements, including with **Jocasta Neuroscience, Inc.**, but recognized no license revenue in **Q1 2023** or **Q1 2022** - In **December 2021**, the company signed a License Agreement with **Jocasta Neuroscience, Inc.** for the **α-Klotho asset**, receiving a **$5.0 million** upfront cash payment. Additional payments are contingent on development milestones, approval milestones, and sales-based royalties[44](index=44&type=chunk) - No license revenue was recognized for the **three months** ended **March 31, 2023**, and **2022**, related to the **Jocasta Agreement**[47](index=47&type=chunk) - Commercial Agreements with **Ascentage Pharma** include potential cash payments up to **$70.3 million** and equity payments (up to **133,333 common shares**) based on preclinical, clinical development, and sales milestones, plus tiered low-single digit royalties. No shares were issued or royalties due in **Q1 2023**[52](index=52&type=chunk) [6. Government Assistance Program](index=12&type=section&id=6.%20Government%20Assistance%20Program) The company received a **$1.5 million** refundable **employee retention credit** under the **CARES Act**, recorded as contra-expense and a receivable - The company was approved for a **$1.5 million** refundable **employee retention credit** under the **CARES Act**[53](index=53&type=chunk) Expense Category | Expense Category | Q1 2023 Contra-Expense (in millions) | | :----------------------- | :--------------------------------- | | General and administrative | **$0.4** | | Research and development | **$1.1** | | Total | **$1.5** | - A **$1.5 million employee retention credit** receivable was included in other current assets as of **March 31, 2023**[54](index=54&type=chunk) [7. Commitments and Contingencies](index=12&type=section&id=7.%20Commitments%20and%20Contingencies) Operating lease costs decreased due to sublease income, with future minimum payments totaling **$35.876 million**; officers and directors are indemnified Lease Metric | Lease Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :----------------------- | :----------------------------------------------- | :----------------------------------------------- | | Operating lease cost | **$930** | **$1,078** | | Variable lease cost | **$203** | **$296** | | Sublease income | **$(963)** | **$(1,048)** | | Total lease cost | **$170** | **$326** | Maturity Period | Maturity Period | Amount (in thousands) | | :---------------------- | :-------------------- | | 2023 (remaining 9 months) | **$3,610** | | 2024 | **$4,964** | | 2025 | **$5,123** | | 2026 | **$5,287** | | 2027 | **$5,457** | | Thereafter | **$11,435** | | Total future minimum lease payments | **$35,876** | - The company indemnifies its officers and directors for certain events, with the maximum potential future indemnification being **unlimited**; however, the company holds director and officer liability insurance[62](index=62&type=chunk)[63](index=63&type=chunk) [8. Term Loan Facility](index=14&type=section&id=8.%20Term%20Loan%20Facility) The company has a **$20.0 million Term Loan Facility** with **Hercules Capital, Inc.**, with an extended amortization date and a **14.10% interest rate** - The company has a **Term Loan Facility** with **Hercules Capital, Inc.**, with an aggregate principal amount of up to **$80.0 million**. As of **March 31, 2023**, the carrying value of the **term loan** was **$20.0 million** principal outstanding less debt discount and issuance costs of approximately **$0.9 million**[64](index=64&type=chunk)[73](index=73&type=chunk) - The amortization date was extended from **March 1, 2023**, to **April 1, 2023**, with principal and interest repayments expected in equal monthly installments through **August 1, 2024**[68](index=68&type=chunk) Metric | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :------------------- | :----------------------------------------------- | :----------------------------------------------- | | Interest Expense | **$1,002** | **$808** | | Interest Rate (March 31, 2023) | **14.10% (effective 20.37%)** | N/A | - The company was in compliance with all covenants under the **Loan Agreement** as of **March 31, 2023**[72](index=72&type=chunk) [9. Equity Financing](index=16&type=section&id=9.%20Equity%20Financing) The company effected a **1-for-10 reverse stock split**, raised capital through offerings, and had **14,359,214 common shares** outstanding as of **March 31, 2023** - A **1-for-10 reverse stock split** of outstanding **common stock** was effected on **October 19, 2022**[77](index=77&type=chunk) Metric | Metric | March 31, 2023 | December 31, 2022 | | :-------------------------------- | :------------- | :---------------- | | Common Stock Shares Outstanding | **14,359,214** | **14,215,302** | | Convertible Preferred Stock | **0** | **0** | - The company closed a **Follow-On Offering** in **August 2022**, issuing **6,428,571 common shares** and warrants, generating approximately **$41.7 million** in net proceeds[80](index=80&type=chunk) - Under the **March 2022 ATM Offering Program**, **106,781 shares** were sold in **Q1 2023**, yielding approximately **$0.4 million** in net proceeds. **$15.2 million** of shares remained available for sale as of **March 31, 2023**[83](index=83&type=chunk) - No shares were sold under the **October 2022 ATM Offering Program** during the **three months** ended **March 31, 2023**[84](index=84&type=chunk) - The Equity Purchase Agreement with **Lincoln Park Capital Fund, LLC**, which allows for the sale of up to **$30.0 million** in **common stock**, requires a new prospectus supplement to continue using the facility[85](index=85&type=chunk)[89](index=89&type=chunk) [10. Stock-Based Compensation](index=18&type=section&id=10.%20Stock-Based%20Compensation) **Stock-based compensation expense** decreased to **$2.270 million** in **Q1 2023**, with **9,000 stock options** granted and **37,131 RSUs** vested Metric | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :----------------------------- | :----------------------------------------------- | :----------------------------------------------- | | Research and development | **$757** | **$1,004** | | General and administrative | **$1,513** | **$1,656** | | Total Stock-Based Compensation | **$2,270** | **$2,660** | - During the **three months** ended **March 31, 2023**, **9,000 stock options** were granted and **37,131 restricted stock units (RSUs)** vested[90](index=90&type=chunk) [11. Net Loss per Common Share](index=19&type=section&id=11.%20Net%20Loss%20per%20Common%20Share) **Net loss per share** improved to **$(0.76)** in **Q1 2023**, with dilutive securities excluded due to the company's **net loss** position Metric | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss | **$(10,865)** | **$(18,915)** | | Weighted-average shares outstanding | **14,312,887** | **6,752,855** | | Net loss per share—basic and diluted | **$(0.76)** | **$(2.80)** | - Potentially dilutive securities, including options, warrants, and **RSUs**, totaling **8,210,257** in **Q1 2023**, were excluded from **diluted EPS calculations** as their effects were anti-dilutive due to the **net loss** position[96](index=96&type=chunk)[98](index=98&type=chunk) [12. Defined Contribution Plan](index=20&type=section&id=12.%20Defined%20Contribution%20Plan) The company's **401(k) matching contributions** decreased to **$0.1 million** in **Q1 2023** Metric | Metric | Three Months Ended March 31, 2023 (in millions) | Three Months Ended March 31, 2022 (in millions) | | :-------------------------- | :---------------------------------------------- | :---------------------------------------------- | | 401(k) Matching Contributions | **$0.1** | **$0.2** | [13. Subsequent Events](index=20&type=section&id=13.%20Subsequent%20Events) The company implemented a **29% workforce reduction** and approved an **option repricing** to align strategy and incentivize key personnel - On **May 4, 2023**, the company implemented a **29% reduction in its workforce** (**9 employees**) to focus on resource optimization and key **data** readouts for **UBX1325**[100](index=100&type=chunk) - A one-time employee benefits and severance charge of approximately **$0.8 million** is expected in the **first half of 2023** due to the **workforce reduction**[100](index=100&type=chunk) - On **May 4, 2023**, the **Board of Directors** approved an **option repricing** for employees and service providers not affected by the reduction, reducing the exercise price of certain outstanding options to the closing price on **May 11, 2023**, to aid retention and motivation[101](index=101&type=chunk)[402](index=402&type=chunk)[404](index=404&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operations, and strategic focus on **senolytic medicines**, particularly **UBX1325** [Overview](index=21&type=section&id=Overview) **Unity Biotechnology** focuses on **senolytic medicines**, particularly **UBX1325** for **ophthalmologic diseases**, with recent restructuring extending **capital runway** despite ongoing **net losses** - **Unity Biotechnology** is a biotechnology company focused on researching and developing therapeutics to slow, halt, or reverse diseases of aging, with an initial focus on creating **senolytic medicines** for **ophthalmologic diseases**[103](index=103&type=chunk) - Positive **48-week data** from the **Phase 2 BEHOLD study** of **UBX1325** in **DME** showed a **statistically significant and clinically meaningful improvement** in vision (**+6.2 ETDRS letters** from baseline, **+5.6 ETDRS letters** compared to sham). Approximately **50%** of **UBX1325**-treated patients did not require additional injections through **48 weeks**[109](index=109&type=chunk) - In the **ENVISION study** for **nAMD**, **UBX1325 monotherapy** did not achieve **non-inferiority** through **24 weeks**, but maintained visual acuity. Part B **48-week data**, including combination efficacy with anti-VEGF therapy, is expected in **Q3 2023**[111](index=111&type=chunk)[112](index=112&type=chunk) - Restructuring actions in **February 2022** and **May 2023**, including a **29% headcount reduction**, aim to prioritize **ophthalmology programs** (**UBX1325**), optimize resource allocation, and extend the **capital runway** into the **fourth quarter of 2024**[113](index=113&type=chunk) - The company incurred **net losses** of **$10.9 million** and **$18.9 million** for the **three months** ended **March 31, 2023** and **2022**, respectively, with an **accumulated deficit** of **$470.8 million** as of **March 31, 2023**. No product revenue has been generated to date, and additional capital will be needed[114](index=114&type=chunk)[115](index=115&type=chunk) [COVID-19 Update](index=23&type=section&id=COVID-19%20Update) The company adapted **UBX1325** clinical protocols for remote **data** collection, mitigating **COVID-19** impacts without supply chain disruptions - Clinical study protocols for **UBX1325** were amended to enable remote **data** collection and source verification to mitigate **COVID-19** impacts[119](index=119&type=chunk) - No disruptions in the supply chain of drug manufacturers for **UBX1325** have occurred, and sufficient drug inventories are available for current **Phase 1** and **Phase 2 studies**[120](index=120&type=chunk) [Reverse Stock Split](index=23&type=section&id=Reverse%20Stock%20Split) A **1-for-10 reverse stock split** was effected on **October 19, 2022**, to regain **Nasdaq** compliance, with all share **data** retroactively adjusted - A **1-for-10 reverse stock split** of **common stock** was effected on **October 19, 2022**, to regain compliance with **Nasdaq Global Select Market's** continued listing standards[121](index=121&type=chunk) - All share and per share information in this Quarterly Report on **Form 10-Q** has been adjusted to give effect to the **reverse stock split**[123](index=123&type=chunk) [Components of Our Results of Operations](index=24&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section outlines the primary components of the company's operating results, including **R&D**, **G&A**, **interest income/expense**, and other income/expense - **Research and development expenses** include personnel, laboratory, clinical trial, third-party contract, license, and facilities expenses, expected to increase with drug candidate advancement[124](index=124&type=chunk) - **General and administrative expenses** primarily consist of personnel costs, facilities, and professional services, expected to increase due to public company operations[125](index=125&type=chunk) - **Interest income** is mainly from marketable securities, while **interest expense** relates to the **Loan Agreement** with **Hercules Capital, Inc. Other income (expense)**, net, includes property taxes and gains/losses from debt extinguishment[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Total **operating expenses** decreased by **$7.614 million** in **Q1 2023**, driven by reduced **R&D** and **G&A**, leading to a lower **net loss** Metric | Metric | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | Change (YoY) | | :------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | :----------- | | Research and development | **$5,835** | **$12,461** | **-$6,626** | | General and administrative | **$4,818** | **$5,806** | **-$988** | | Total operating expenses | **$10,653** | **$18,267** | **-$7,614** | | Loss from operations | **$(10,653)** | **$(18,267)** | **+$7,614** | | Interest income | **$855** | **$29** | **+$826** | | Interest expense | **$(1,002)** | **$(808)** | **-$194** | | Net loss | **$(10,865)** | **$(18,915)** | **+$8,050** | - The decrease in **R&D expenses** was primarily due to a **$3.9 million** reduction in personnel costs and a **$1.7 million** decrease in direct **R&D expenses** as the **UBX1325 Phase 2 DME study** neared completion[130](index=130&type=chunk) - The increase in **interest income** was primarily attributable to higher market yields on cash equivalents and marketable securities[132](index=132&type=chunk) [Liquidity, Capital Resources and Capital Requirements](index=26&type=section&id=Liquidity,%20Capital%20Resources%20and%20Capital%20Requirements) The company faces **going concern** doubt due to historical losses, requiring substantial additional capital despite recent expenditure reductions extending **runway** into **Q4 2024** - The company had an **accumulated deficit** of **$470.8 million** as of **March 31, 2023**, and expects **operating losses** and **negative operating cash flows** to continue, raising **substantial doubt** about its ability to continue as a **going concern**[134](index=134&type=chunk) - Implementation of expenditure reductions, including a **29% reduction in force**, has alleviated **substantial doubt** regarding **going concern** within **one year** and is expected to fund planned **operating expenses** into the **fourth quarter of 2024**[134](index=134&type=chunk) - The company will need to raise substantial additional capital to finance operations and complete pivotal trials, with no assurance of obtaining such financing on acceptable terms, especially given current economic uncertainty and financial institution liquidity concerns[135](index=135&type=chunk)[136](index=136&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk) - Financing activities include proceeds from the **March 2022 ATM Offering Program** (**$0.4 million** net in **Q1 2023**) and the **August 2022 Follow-On Offering** (**$41.7 million** net). The company's ability to raise capital via shelf registration statements is limited by the "**baby shelf rule**" if its **public float** is less than **$75.0 million**[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk)[191](index=191&type=chunk) Cash Flow Activity | Cash Flow Activity | Three Months Ended March 31, 2023 (in thousands) | Three Months Ended March 31, 2022 (in thousands) | | :------------------------------------------ | :----------------------------------------------- | :----------------------------------------------- | | Cash used in operating activities | **$(11,316)** | **$(14,972)** | | Cash provided by (used in) investing activities | **$21,278** | **$(5,817)** | | Cash provided by financing activities | **$274** | **$4,330** | | Net increase (decrease) in cash, cash equivalents and restricted cash | **$10,236** | **$(16,459)** | - Contractual obligations relate primarily to the **Term Loan Agreement** and **operating leases**. The company has not entered into any off-balance sheet arrangements[154](index=154&type=chunk)[158](index=158&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces **interest rate risk** on its **$20.0 million variable-rate term loan**, though its **$83.4 million** in short-term investments has insignificant risk - As of **March 31, 2023**, the company had **$83.4 million** in **cash, cash equivalents, and marketable securities**. Due to the short-term duration of investments, exposure to **interest rate risk** is not significant[162](index=162&type=chunk) - The outstanding principal of the **term loan** under the **Hercules Loan Agreement** was **$20.0 million** as of **March 31, 2023**, with an **interest rate** of **14.10% (effective 20.37%)**. A hypothetical **1% change** in **interest rates** would increase annual expense by approximately **$0.2 million**, which is **not considered a material impact**[163](index=163&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded **disclosure controls and procedures** were effective, with no **material changes** in **internal control over financial reporting** during **Q1 2023** - Management concluded that the company's **disclosure controls and procedures** were effective at a **reasonable assurance level** as of **March 31, 2023**[164](index=164&type=chunk) - There were no **changes** in **internal control over financial reporting** during the quarter ended **March 31, 2023**, that materially affected, or are reasonably likely to materially affect, **internal control over financial reporting**[165](index=165&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other relevant disclosures [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any **material litigation** or other **material legal proceedings** - The company is not currently a party to any **material litigation** or other **material legal proceedings**[167](index=167&type=chunk) [Item 1A. Risk Factors](index=32&type=page&id=Item%201A.%20Risk%20Factors) This section details various forward-looking statements and associated risks that could materially affect the company's actual results [Risk Factor Summary](index=33&type=section&id=Risk%20Factor%20Summary) This summary outlines principal factors making an investment in the company's **common stock speculative or risky** - Key risks include limited operating history, significant losses, substantial need for additional financing, and **substantial doubt** about the ability to continue as a **going concern**[173](index=173&type=chunk) - The company's core therapeutic approach (**senolytic molecules**) is novel and exposes it to **unforeseen risks**, with business success dependent on **UBX1325** development[176](index=176&type=chunk) - Other risks include potential **Nasdaq** delisting, reliance on **third-party suppliers**, significant competition, **intellectual property** infringement, and ongoing regulatory scrutiny[176](index=176&type=chunk) [Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements](index=34&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Condition,%20and%20Capital%20Requirements) The company faces risks from its limited operating history, significant losses, **going concern** doubt, and substantial need for additional financing - The company has a limited operating history, no products approved for commercial sale, and has incurred significant losses since inception, with an **accumulated deficit** of **$470.8 million** as of **March 31, 2023**[174](index=174&type=chunk)[178](index=178&type=chunk) - The company's financial condition has raised **substantial doubt** about its ability to continue as a **going concern**, although recent expenditure reductions and a **29% workforce reduction** are expected to fund operations into **Q4 2024**[179](index=179&type=chunk)[180](index=180&type=chunk)[185](index=185&type=chunk) - Substantial additional financing is required to achieve goals, and failure to obtain it on acceptable terms could force delays, reductions, or termination of product development programs[181](index=181&type=chunk)[186](index=186&type=chunk)[192](index=192&type=chunk) - The ability to raise additional funds is dependent on financial, economic, and other factors, including current macroeconomic trends and the "**baby shelf rule**", which limits equity sales to **one-third** of the **public float** if it is less than **$75.0 million**[189](index=189&type=chunk)[191](index=191&type=chunk) [Risks Related to Our Business and Product Development](index=39&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Product%20Development) Risks include the novel therapeutic approach, dependence on **UBX1325**, clinical trial uncertainties, and reliance on **third-party suppliers** - The company's core therapeutic approach using **senolytic molecules** to treat diseases of aging is novel and has limited human **data**, exposing it to **unforeseen risks** and making drug development time and cost difficult to predict[201](index=201&type=chunk)[203](index=203&type=chunk) - The business is currently dependent on the successful development and **regulatory approval** of **UBX1325**; failure could lead to significant delays or abandonment of its development[204](index=204&type=chunk)[205](index=205&type=chunk) - Clinical development is a **lengthy, expensive, and uncertain process**, with results of earlier studies not necessarily predictive of future trial results. Delays or failures can occur at any stage due to various factors, including patient enrollment difficulties, regulatory disagreements, or unforeseen events like pandemics[210](index=210&type=chunk)[212](index=212&type=chunk)[225](index=225&type=chunk) - **Undesirable side effects** from drug candidates could delay or prevent **regulatory approval**, lead to **restrictive labeling**, or result in significant negative consequences post-approval, including **product recalls or lawsuits**[237](index=237&type=chunk)[238](index=238&type=chunk)[240](index=240&type=chunk) - The company relies heavily on **third-party suppliers** for raw materials and **contract manufacturers** for drug candidates, as well as **CROs** for preclinical and clinical studies. Loss or failure of these parties, or disruptions (e.g., **COVID-19**), could materially and adversely affect the business[253](index=253&type=chunk)[255](index=255&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk)[267](index=267&type=chunk) - The company faces **significant competition** from pharmaceutical and biotechnology companies with greater resources, and its drug candidates, if approved, will compete against existing therapies and other treatments for diseases of aging[268](index=268&type=chunk)[269](index=269&type=chunk) - Commercial success depends on obtaining **adequate coverage and reimbursement** from governmental and private health insurers, which is uncertain and subject to challenges over pricing and policies[273](index=273&type=chunk)[274](index=274&type=chunk) [Risks Related to Intellectual Property](index=57&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company faces risks from potential **intellectual property** infringement, challenges to **patent protection**, and reliance on confidentiality agreements - The company's commercial success depends on its ability to develop and market products without infringing third-party patent rights, and it faces the risk of **costly intellectual property litigation** and potential **substantial damages**[287](index=287&type=chunk)[289](index=289&type=chunk) - There is no certainty that pending patent applications will issue, or that issued patents will be broad enough, withstand challenges, or prevent others from designing around them. Patent terms may also be shortened or lengthened by various factors[296](index=296&type=chunk)[303](index=303&type=chunk)[308](index=308&type=chunk) - The company relies on **confidentiality agreements** to protect proprietary know-how, but these may be breached, or information independently discovered by competitors. Enforcing claims of **misappropriation** is difficult and expensive[309](index=309&type=chunk)[315](index=315&type=chunk) - Filing, prosecuting, and defending patents globally is expensive, and **intellectual property** rights in some foreign countries may be less extensive or difficult to enforce, potentially harming business prospects[306](index=306&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk) [Risks Related to Government Regulation](index=61&type=section&id=Risks%20Related%20to%20Government%20Regulation) Approved drug candidates face ongoing regulatory scrutiny, competition from generics, healthcare legislation impacts, and fraud and abuse law compliance - Approved drug candidates will be subject to **ongoing regulatory requirements** for manufacturing (**cGMP**), labeling, promotion, and post-marketing studies. Failure to comply can lead to **severe penalties**, including **withdrawal of regulatory approval**[316](index=316&type=chunk)[317](index=317&type=chunk)[319](index=319&type=chunk)[320](index=320&type=chunk) - Small molecule drug candidates, if approved, may face competition from generic versions under the **Hatch-Waxman Act**. Biologic drug candidates may face competition from biosimilar products, potentially sooner than anticipated[324](index=324&type=chunk)[328](index=328&type=chunk) - Enacted and future **healthcare legislation** (e.g., **Affordable Care Act**, state pricing controls) may increase costs, limit pricing, and hinder commercialization efforts, impacting the company's ability to generate revenue[331](index=331&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk) - The company's business operations are subject to various **healthcare regulatory laws**, including federal **Anti-Kickback Statute**, **False Claims Act**, **HIPAA**, and state equivalents, as well as international **data privacy laws** like **GDPR** and **CCPA**. Non-compliance could result in significant civil, criminal, and administrative penalties[338](index=338&type=chunk)[340](index=340&type=chunk)[341](index=341&type=chunk)[382](index=382&type=chunk)[385](index=385&type=chunk)[386](index=386&type=chunk) [Risks Related to Ownership of Our Common Stock](index=67&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Stock ownership risks include price volatility, delisting potential, dilution from future financings, and limitations on **NOL carryforwards** - The trading **price** of the **common stock** has been and may continue to be **highly volatile** due to factors such as clinical trial results, regulatory announcements, competition, and general economic conditions[344](index=344&type=chunk)[345](index=345&type=chunk) - A **1-for-10 reverse stock split** was effected on **October 19, 2022**, to regain **Nasdaq** compliance, but there is no assurance that compliance will be maintained, and **delisting risk** could adversely affect **stock price** and liquidity[347](index=347&type=chunk)[348](index=348&type=chunk) - Future equity financings, including through **ATM Offering Programs**, could result in **immediate dilution** to stockholders, and sales of substantial amounts of **common stock** by existing stockholders or large investors could lower the market **price**[350](index=350&type=chunk)[354](index=354&type=chunk) - The company's ability to use its **net operating loss carryforwards (NOLs)** and other tax attributes may be limited by **ownership changes** under **Sections 382 and 383** of the Internal Revenue Code[355](index=355&type=chunk) - **Anti-takeover provisions** in the company's charter documents and under Delaware law, such as a classified board and prohibition on stockholder action by written consent, could discourage takeovers[356](index=356&type=chunk)[357](index=357&type=chunk) - The company does not intend to pay **cash dividends** on its **common stock**, so investment return will depend on appreciation in the **stock price**[360](index=360&type=chunk) [General Risk Factors](index=71&type=section&id=General%20Risk%20Factors) General risks include unfavorable economic conditions, natural disasters, cybersecurity breaches, employee misconduct, and hazardous material handling - **Unfavorable global economic or political conditions**, including high **interest rates**, rising inflation, and liquidity concerns at financial institutions, could adversely affect demand for products and the ability to raise capital[361](index=361&type=chunk) - The company is vulnerable to **natural disasters** (e.g., earthquakes, wildfires) and **public health emergencies** (e.g., **COVID-19**), which could severely disrupt operations. Existing **disaster recovery** and business continuity plans are limited[362](index=362&type=chunk)[363](index=363&type=chunk) - Significant disruptions of **information technology systems** or **cybersecurity breaches** could materially adversely affect business, leading to **data loss**, operational interruptions, reputational damage, and potential litigation[365](index=365&type=chunk)[367](index=367&type=chunk)[371](index=371&type=chunk) - **Misconduct or improper activities by employees or third-party contractors**, including non-compliance with regulatory standards, could lead to significant penalties, reputational harm, and operational curtailment[372](index=372&type=chunk)[373](index=373&type=chunk) - The business involves the use of **hazardous materials**, requiring compliance with **environmental laws** and regulations, which can be expensive and pose risks of **contamination and liability**[374](index=374&type=chunk)[376](index=376&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no sales of unregistered equity securities or repurchases of company equity securities during the **three months** ended **March 31, 2023** [Sales of Unregistered Securities](index=77&type=section&id=Sales%20of%20Unregistered%20Securities) This section confirms no unregistered equity securities were sold during **Q1 2023** - There were no sales of unregistered securities during the **three months** ended **March 31, 2023**[395](index=395&type=chunk) [Repurchase of Shares or of Company Equity Securities](index=77&type=section&id=Repurchase%20of%20Shares%20or%20of%20Company%20Equity%20Securities) This section confirms no company equity securities were repurchased during **Q1 2023** - There were no repurchases of shares or of company equity securities during the **three months** ended **March 31, 2023**[396](index=396&type=chunk) [Item 3. Default Upon Senior Securities](index=77&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) This section confirms no default occurred on senior securities during **Q1 2023** - There was no default upon senior securities during the **three months** ended **March 31, 2023**[397](index=397&type=chunk) [Item 4. Mine Safety Disclosures](index=77&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **Mine Safety Disclosures** are not applicable to the company[398](index=398&type=chunk) [Item 5. Other Information](index=77&type=section&id=Item%205.%20Other%20Information) The **Board** approved a **29% workforce reduction** and an **option repricing** to align strategy and incentivize key personnel - On **May 4, 2023**, the **Board of Directors** approved a **reduction in workforce**, decreasing headcount by approximately **29%** (**nine employees**), to align operations with corporate strategy and focus on **UBX1325**[399](index=399&type=chunk) - A one-time employee benefits and severance charge of approximately **$0.8 million** is expected in the **first half of 2023** due to the **workforce reduction**[400](index=400&type=chunk) - An **option repricing** was approved on **May 4, 2023**, for non-affected employees and service providers, reducing the exercise price of certain outstanding options to the closing price on **May 11, 2023**, to help retain and incentivize them[402](index=402&type=chunk)[404](index=404&type=chunk) [Item 6. Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the **Form 10-Q**, including corporate documents, agreements, and certifications - The exhibits include corporate documents (e.g., Amended and Restated Certificate of Incorporation, Bylaws), various agreements (e.g., Separation Agreement, Consulting Agreement, Loan and Security Agreement Amendment, Sales Agreement Amendment), and certifications (e.g., **Principal Executive Officer** and **Principal Financial Officer** certifications)[407](index=407&type=chunk)[409](index=409&type=chunk) [SIGNATURES](index=81&type=section&id=SIGNATURES) The report was signed by the **Chief Executive Officer** and **Chief Financial Officer** on **May 9, 2023**, certifying its submission - The report was signed by **Anirvan Ghosh, Ph.D., Chief Executive Officer**, and **Lynne Sullivan, Chief Financial Officer**, on **May 9, 2023**[411](index=411&type=chunk)
Unity Biotechnology(UBX) - 2022 Q4 - Annual Report
2023-03-14 16:00
☐ 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR Unity Biotechnology, Inc. (Exact name of Registrant as specified in its Charter) ( State or other jurisdiction of incorporation ...
Unity Biotechnology(UBX) - 2022 Q3 - Quarterly Report
2022-11-07 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Mark One) WASHINGTON, DC 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 FORM 10-Q 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 Unity Biotechnology, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-4726035 ...
Unity Biotechnology(UBX) - 2022 Q2 - Earnings Call Presentation
2022-08-15 18:02
| --- | --- | --- | --- | --- | |-------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | Corporate Overview Corporate Deck | | | | | | NASDAQ: UBX | | | | | | August 2022 | | | | | 2 Special Note Regarding Forward-looking Statements This presentation and the accompanying oral commentary contain forward-looking statements including statements related to UNITY's understanding of cellular senescence and the role it plays in diseases of aging, the potential f ...
Unity Biotechnology(UBX) - 2022 Q2 - Quarterly Report
2022-08-11 16:00
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 June 30, 2022 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 Unity Biotechnology, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdict ...